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## Protocol Section ### Identification Module **NCT ID:** NCT06422832 **Acronym:** REMOTI-HF **Brief Title:** Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial **Official Title:** Remote Monitoring To Identify Worsening Heart Failure: The REMOTI-HF Randomized Clinical Trial #### Organization Study ID Info **ID:** RHF230808 #### Organization **Class:** OTHER **Full Name:** Centro Hospitalar e Universitário de Coimbra, E.P.E. ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centro Hospitalar e Universitário de Coimbra, E.P.E. #### Responsible Party **Investigator Affiliation:** Centro Hospitalar e Universitário de Coimbra, E.P.E. **Investigator Full Name:** Goncalo Terleira Batista **Investigator Title:** Cardiology Resident **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Heart failure, characterized by high mortality and morbidity rates, frequent hospital admissions, and prolonged stays in cardiology wards, significantly impacts patients' quality of life. The REMOTI-HF is a single-center randomized controlled trial designed to assess the impact of remote monitoring, utilizing the HeartLogic and TriageHF algorithms, in patients with heart failure with implantable cardioverter defibrillator or cardiac resynchronization therapy. The primary endpoints include mortality, hospital admissions related to heart failure, and visits for worsening heart failure. Moreover, we will explore the full capabilities of these algorithms, by analysing the association of physical activity, measured by the devices, with the same key outcomes. Additionally, the research will explore the relationship between the absolute values provided by the algorithms and NT-proBNP values. **Detailed Description:** Patients will be randomized into two arms: one with the activation of the algorithm and the other with no active algorithm. The algorithm is programmed to alert our team upon detecting a patient at risk of worsening heart failure. When an alarm is triggered, the patient will receive a telephone call from the investigation team. Subsequently, the patient may be scheduled for a hospital visit, or ambulatory medication adjustments can be made. For patients in whom the algorithm is deactivated, no such alarm mechanism will be in place. Patients in both arms will undergo comparison based on relevant heart failure events, defined as follows: * All-Cause Mortality * Hospital Admission for Heart Failure * Hospital Visit for Worsening Heart Failure * Ventricular Arrhythmias * Atrial Arrhythmias Additionally, the study will explore the association between physical activity measured by the devices and these specified events. In addition to evaluating patient outcomes, a correlation analysis will be conducted to examine the relationship between the absolute value provided by the algorithm and absolute NT-proBNP values. This analysis aims to assess the concordance and potential predictive value of the algorithm's output with established biomarkers, specifically NT-proBNP, in the context of heart failure progression and severity (if possible). ### Conditions Module **Conditions:** - Heart Failure - Arrythmia **Keywords:** - Heart Failure - Remote Monitoring - ICD - CRT ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Masking Description:** Patients will not know whether the algorithms was activated or not at the beginning of the study. However, if a contact with the patient is made due to the algorithm, the patient will then understand they are not on the control group. The person responsible for contacts will also know if an individual patient is on the control or intervention group. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 270 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this group the respective algorithm will be activated and alerts will be sent according to its design **Intervention Names:** - Other: HeartLogic or TriageHF Algorithms for implantable devices **Label:** Interventional group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The algorithm will not be activated and follow-up will continue as if the patient was not included in the study. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Interventional group **Description:** Activation of the HeartLogic and TriageHF algorithms for implantable devices and correctly act according to its design **Name:** HeartLogic or TriageHF Algorithms for implantable devices **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** All-cause mortality, Hospital Admission for Heart Failure, Ventricular Arrhythmias and Worsening Heart Failure as defined in the secondary outcome area. **Measure:** Primary Composite Outcome **Time Frame:** 2 years #### Secondary Outcomes **Description:** All-cause mortality **Measure:** All-cause mortality **Time Frame:** 2 years **Description:** Patient admission to the hospital with symptoms or signs of congestive heart failure, needing intravenous drugs for symptom relief, ultrafiltration therapy, or other parenteral therapy **Measure:** Hospital admission for Heart Failure **Time Frame:** 2 years **Description:** Unscheduled hospital visit (to the emergency department or unscheduled consultation) due to signs or symptoms of heart failure, where intravenous diuretics were administered or ambulatory diuretic dosage was increased. **Measure:** Worsening Heart failure **Time Frame:** 2 eras **Description:** Detection of any ventricular arrhythmia through hospital visit, appropriate device therapy or device detection **Measure:** Ventricular Arrhythmias **Time Frame:** 2 years **Description:** Occurrence of any atrial arrhythmia prompting medical evaluation. **Measure:** Atrial Arrhytmias **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Possession of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device that is compatible with the HeartLogic or TriageHF algorithms. * Left ventricular ejection fraction at the time of device implantation must be equal to or less than 35%. Exclusion Criteria: * Younger than 18 years old or older than 85 years old. * Unable to be contacted when out of the hospital. * Presence of severe cognitive impairment. * Currently on the heart transplant waiting list **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gonçalo Batista, MD **Phone:** 963596295 **Phone Ext:** 00351 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** ULS Coimbra **Name:** Gonçalo Batista, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422819 **Acronym:** HRV_BFB_FND **Brief Title:** Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo **Official Title:** Probing the Heart Rate Variability Biofeedback as an Innovative and Non-invasive Treatment for Functional Neurological Disorders Guided by a Multimodal Approach of Autonomic Nervous System. #### Organization Study ID Info **ID:** 2024-12156 #### Organization **Class:** OTHER **Full Name:** Centre hospitalier de l'Université de Montréal (CHUM) ### Status Module #### Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Laboratoire de Psychologie et NeuroCognition #### Lead Sponsor **Class:** OTHER **Name:** Centre hospitalier de l'Université de Montréal (CHUM) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo. **Detailed Description:** Although Functional Neurological Disorders (FND) represent one of the most common reasons for consultation in Neurology, the pathological mechanisms remain unexplained. Recent studies suggest disrupted emotional processes in patients with FND and disturbed autonomic nervous system profiles, highligting the hypothesis of autonomic endophenotypes among the FND population. The Heart Rate Variability Biofeedback (HRV-BFB) is an innovative and non-invasive approach, based on the self-regulation of autonomic physiological processes. It has shown promising results in clinical and non-clinical populations but has never been assessed in an adult FND population. Therefore, this approach appears particularly promising for understanding the mechanisms underlying FND and developing personalized therapy. The main objective is to investigate the clinical effects of HRV-BFB on FND patients compared to placebo in a single-blind crossover design. The investigators predict that depending on their autonomic profile, patients will respond to HRV-BFB to varying degrees. Firstly, patients with FND will prospectively undergo an comprehensive clinical evaluation considering symptoms, functional capacity, quality of life, and an assessment of the physical and psychological comorbidities. Then patients will complete an emotional task and undergo multimodal autonomic measures. Cluster analyses will be conducted to identify both dysfunctional and functional autonomic profiles associated with the clinical exploration, enabling confirmation of the endophenotypes hypothesis and allowing for specific characterization of the profils. The clinical evaluation of the beneficial effects of HRV BFB will rely on repeated mesures of symptoms, functional capacity, and quality of life at scheduled points in time before and after the both interventions (HRV-BFB and pseudo-BFB). The emotional task and autonomic measures will be repeated simultaneously. ### Conditions Module **Conditions:** - Functional Neurological Disorder **Keywords:** - Functional Neurological Disorder - Emotional dysregulation - Autonomic nervous system - Endophenotypes - Biofeedback of Heart Rate Variability - Transdiagnostic approach ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** This study consists of 5 visits (V1, V2, V3, V4, V5). At V1, participants will be randomized into two groups: HRV-BFB (experimental group) or Pseudo HRV-BFB (control group). Participants will remain single-blinded after randomization. Depending on the assigned group, participants will practice one specific intervention during the first 30-day period (V1-V2). At V2, participants will switch to the other arm and practice the second intervention during the second 30-day period (V2-V3). At V3, both interventions will end, and participants will be unblinded and encouraged to continue HRV-BFB at home. Clinical evaluation will be repeated 5 times at day 1 (V1), days 30 +/- 10 (V2), days 60 +/- 10 (V2), 6 months (V4) and 1 year (V5). The research team will exercise extreme caution to ensure consistent instructions and feedback, minimizing biases associated with lack of double-blinding. ##### Masking Info **Masking:** SINGLE **Masking Description:** The participants won't be informed of the condition to which they belong. A debriefing will be done at the end of the last intervention (V3) for each participant. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 31 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants assigned to the experimental group will undergo HRV Biofeedback training using the Inner Balance Coherence Plus® software. This software incorporates a Bluetooth plethysmograph ear sensor, which will transmit cardiac pulse data to the Inner Balance Coherence Plus smartphone app, where the EmWave Pro® Plus software will extract HRV in real-time. This software will display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). Fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the HRV-BFB intervention, participants will be instructed to maximize their HRV. **Intervention Names:** - Other: Heart rate variability Biofeedback [HRV-BFB] **Label:** Experimental group (HRV-BFB training) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants assigned to the placebo group will undergo a pseudo HRV Biofeedback training using the same Inner Balance Coherence Plus® software and ear sensor. The software will similarly display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). To manage placebo effects, the same fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the placebo pseudo BFB training, participants will be instructed to no have specific effect on HRV. **Intervention Names:** - Other: Pseudo HRV-BFB **Label:** Placebo Control group (Pseudo HRV-BFB training) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group (HRV-BFB training) **Description:** Biofeedback (BFB), sometimes referred to as "biological feedback technique," is a non-invasive and non-pharmacological approach based on physiological recordings that provide real-time feedback enabling people to learn how to control their physiological processes, which are typically unconscious and beyond their control. HRV-BFB specifically targets heart rate variability (HRV), which can help regulate the autonomic nervous system (including vagal tone and sympathetic-parasympathetic balance) as well as emotional states. HRV-BFB has been clinically and experimentally validated as a physiological intervention and has demonstrated its effectiveness. However, it has never been studied in an adult FND population. **Name:** Heart rate variability Biofeedback [HRV-BFB] **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Placebo Control group (Pseudo HRV-BFB training) **Description:** The pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV. **Name:** Pseudo HRV-BFB **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Day 1 (V1) **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Day 1 (V1) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Day 1 (V1) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Day 1 (V1) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Up to 360 days from V1 (V5) #### Secondary Outcomes **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Day 1 (V1) **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Day 1 (V1) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Day 1 (V1) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Day 1 (V1) **Description:** The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Up to 40 days from V1 (V2) **Description:** The quality of sleep measure will be measure using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Up to 80 days from V1 (V3) **Description:** The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Up to 180 days from V1 (V4) **Description:** The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Day 1 (V1) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Up to 360 days from V1 (V5) **Description:** Alexithymia score will be measured using the Toronto Alexithymia Scale (TAS-20; French version Loas, 1996). This scale includes 20 items. **Measure:** Alexithymia score **Time Frame:** Day 1 (V1) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Day 1 (V1) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Up to 40 days from V1 (V2) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Up to 80 days from V1 (V3) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Up to 180 days from V1 (V4) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Day 1 (V1) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Childhood Trauma profile will be measured using the Childhood Trauma Questionnaire-Short Form (CTQ; Frenc version Paquette et al., 2004). This scale includes 28 items. **Measure:** Childhood Trauma profile **Time Frame:** Day 1 (V1) **Description:** The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items. **Measure:** Positive Affect and Negative Affects **Time Frame:** Day 1 (V1) before the emotional induction task **Description:** The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items. **Measure:** Positive Affect and Negative Affects **Time Frame:** Day 1 (V1) after the emotional induction task **Description:** The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items. **Measure:** Positive Affect and Negative Affects **Time Frame:** Up to 40 days from V1 (V2) before the emotional re-exposure task **Description:** The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items. **Measure:** Positive Affect and Negative Affects **Time Frame:** Up to 40 days from V1 (V2) after the emotional re-exposure task **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Day 1 (V1) **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Up to 180 days from V1 (V4) **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Up to 360 days from V1 (V5) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Day 1 (V1) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Up to 40 days from V1 (V2) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Up to 80 days from V1 (V3) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Up to 180 days from V1 (V4) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Up to 360 days from V1 (V5) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Day 1 (V1) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Up to 40 days from V1 (V2) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Up to 80 days from V1 (V3) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Up to 180 days from V1 (V4) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Up to 360 days from V1 (V5) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Day 1 (V1) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Up to 40 days from V1 (V2) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Up to 80 days from V1 (V3) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Up to 180 days from V1 (V4) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Up to 360 days from V1 (V5) **Description:** Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Delta frequency (0-4Hz) **Time Frame:** Day 1 (V1) **Description:** Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Delta frequency (0-4Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Delta frequency (0-4Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Theta frequency (4-7Hz) **Time Frame:** Day 1 (V1) **Description:** Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Theta frequency (4-7Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Theta frequency (4-7Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Alpha frequency (8-12Hz) **Time Frame:** Day 1 (V1) **Description:** Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Alpha frequency (8-12Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Alpha frequency (8-12Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Beta frequency (13-30Hz) **Time Frame:** Day 1 (V1) **Description:** Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Beta frequency (13-30Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Beta frequency (13-30Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Gamma frequency (>30Hz) **Time Frame:** Day 1 (V1) **Description:** Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Gamma frequency (>30Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Gamma frequency (>30Hz) **Time Frame:** Up to 80 days from V1 (V3) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Functional Neurological Disorders (FND) diagnosis must be medically established * Participants must have a smartphone (android ou Iphone) * Participants must be of the age of majority * Participants must have signed an informed consent * Sufficiently fluent in French to understand study documents and instructions * Consistency in performing repeated questionnaires * Normal or corrected-to-normal visual acuity Exclusion Criteria: * Specially protected participants: juveniles, pregnant womens, nursing mothers, law's protection peoples * Participants suffering from a severe psychiatric disease needing specialised attention * History of severe neurosurgical pathology * Alcohol dependence or drug use * Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis) * Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole) * Participants placing under judicial or administrative supervisions **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jasmine Carlier, PhD student **Phone:** (+33)680891913 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Dang Khoa Nguyen, Pr **Phone:** 514-890-8000 **Phone Ext:** 28404 **Role:** CONTACT #### Locations **Location 1:** **City:** Montréal **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jasmine Carlier, MD - **Phone:** (+33)680891913 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Dang Khoa Nguyen, Md, PhD, Pr - **Phone:** H2X 0C1 - **Phone Ext:** 28404 - **Role:** CONTACT ***Contact 3:*** - **Name:** Dang Khoa Nguyen, Pr - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Pascal Hot, Pr - **Role:** SUB_INVESTIGATOR **Country:** Canada **Facility:** Université de Montréal's affiliated Hospital Research Centre (CRCHUM) **State:** Quebec **Zip:** H2X 0C1 #### Overall Officials **Official 1:** **Affiliation:** Université de Montréal's affiliated hospital research centre **Name:** Dang Khoa Nguyen **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available. **PMID:** 8598068 **Citation:** Lehrer P, Kaur K, Sharma A, Shah K, Huseby R, Bhavsar J, Sgobba P, Zhang Y. Heart Rate Variability Biofeedback Improves Emotional and Physical Health and Performance: A Systematic Review and Meta Analysis. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):109-129. doi: 10.1007/s10484-020-09466-z. Erratum In: Appl Psychophysiol Biofeedback. 2021 Dec;46(4):389. **PMID:** 32385728 **Citation:** Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017. **PMID:** 28265249 **Citation:** Pick S, Anderson DG, Asadi-Pooya AA, Aybek S, Baslet G, Bloem BR, Bradley-Westguard A, Brown RJ, Carson AJ, Chalder T, Damianova M, David AS, Edwards MJ, Epstein SA, Espay AJ, Garcin B, Goldstein LH, Hallett M, Jankovic J, Joyce EM, Kanaan RA, Keynejad RC, Kozlowska K, LaFaver K, LaFrance WC Jr, Lang AE, Lehn A, Lidstone S, Maurer CW, Mildon B, Morgante F, Myers L, Nicholson C, Nielsen G, Perez DL, Popkirov S, Reuber M, Rommelfanger KS, Schwingenshuh P, Serranova T, Shotbolt P, Stebbins GT, Stone J, Tijssen MA, Tinazzi M, Nicholson TR. Outcome measurement in functional neurological disorder: a systematic review and recommendations. J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):638-649. doi: 10.1136/jnnp-2019-322180. Epub 2020 Feb 28. **PMID:** 32111637 **Citation:** Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37. **PMID:** 20526405 **Citation:** Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008. **PMID:** 11914441 **Citation:** Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. **PMID:** 2748771 **Citation:** Steinberg M, Rounsaville B, Cicchetti D. Detection of dissociative disorders in psychiatric patients by a screening instrument and a structured diagnostic interview. Am J Psychiatry. 1991 Aug;148(8):1050-4. doi: 10.1176/ajp.148.8.1050. **PMID:** 1853955 **Citation:** Loas G, Otmani O, Verrier A, Fremaux D, Marchand MP. Factor analysis of the French version of the 20-Item Toronto Alexithymia Scale (TAS-20). Psychopathology. 1996;29(2):139-44. doi: 10.1159/000284983. **PMID:** 8861519 **Citation:** Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. **PMID:** 3397865 **Citation:** Boucsein W, Fowles DC, Grimnes S, Ben-Shakhar G, roth WT, Dawson ME, Filion DL; Society for Psychophysiological Research Ad Hoc Committee on Electrodermal Measures. Publication recommendations for electrodermal measurements. Psychophysiology. 2012 Aug;49(8):1017-34. doi: 10.1111/j.1469-8986.2012.01384.x. Epub 2012 Jun 8. **PMID:** 22680988 **Citation:** American Clinical Neurophysiology Society. Guideline 6: A proposal for standard montages to be used in clinical EEG. J Clin Neurophysiol. 2006 Apr;23(2):111-7. doi: 10.1097/00004691-200604000-00007. No abstract available. **PMID:** 16612227 #### See Also Links **Label:** Radloff LS. The CES-D scale: a self report depression scale for research in the general population. App Psycho Meas 1977;1:384-401. **URL:** http://conservancy.umn.edu/handle/11299/98561 **Label:** Paul Lehrer. Protocol for Heart Rate Variability Biofeedback Training. DOI:10.5298/1081-5937-41.3.08 **URL:** http://www.researchgate.net/publication/289937389_Protocol_for_Heart_Rate_Variability_Biofeedback_Training **Label:** Alain Leplège 2001. Le questionnaire MOS SF-36, manuel d'utilisation et guide d'interprétation des scores **URL:** http://www.researchgate.net/publication/281433197_Le_questionnaire_MOS_SF-36_manuel_d'utilisation_et_guide_d'interpretation_des_scores_French **Label:** Kathi Baron 2006 A User's Manual for the Occupational Self Assessment (OSA) : (Version 2.2) **URL:** http://search.worldcat.org/fr/title/A-User%27s-Manual-for-the-Occupational-Self-Assessment-(OSA)-:-(Version-2.2)/oclc/475547618 **Label:** C Demoulin 2017. Traduction en français du " Brief Illness Perceived Questionnaire " adapté aux patients lombalgiques et étude de ses qualités métrologiques. Doi : 10.1016/S1169-8330(16)30511-7 **URL:** http://www.em-consulte.com/article/1100188/traduction-en-francais-du-%C2%A0brief-illness-perceived **Label:** Daniel Paquette 2004. Validation de la version française du CTQ et prévalence de l'histoire de maltraitance. DOI: 10.7202/008831ar **URL:** http://www.erudit.org/fr/revues/smq/2004-v29-n1-smq755/008831ar/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013001 - Term: Somatoform Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000006677 - Term: Histrionic Personality Disorder - ID: D000010554 - Term: Personality Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6515 - Name: Conversion Disorder - Relevance: HIGH - As Found: Functional Neurological Disorder - ID: M10096 - Name: Hysteria - Relevance: HIGH - As Found: Functional Neurological Disorder - ID: M7394 - Name: Dissociative Disorders - Relevance: LOW - As Found: Unknown - ID: M15803 - Name: Somatoform Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M13462 - Name: Personality Disorders - Relevance: LOW - As Found: Unknown - ID: T1568 - Name: Conversion Disorder - Relevance: HIGH - As Found: Functional Neurological Disorder ### Condition Browse Module - Meshes - ID: D000009422 - Term: Nervous System Diseases - ID: D000003291 - Term: Conversion Disorder - ID: D000007046 - Term: Hysteria ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422806 **Brief Title:** Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas **Official Title:** A Randomized Phase II Trial of Doxorubicin + Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas #### Organization Study ID Info **ID:** NCI-2023-06412 #### Organization **Class:** NIH **Full Name:** National Cancer Institute (NCI) #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2023-06412 **Type:** REGISTRY **Domain:** ECOG-ACRIN Cancer Research Group **ID:** EA7222 **Type:** OTHER **Domain:** CTEP **ID:** EA7222 **Type:** OTHER **ID:** U10CA180820 **Link:** https://reporter.nih.gov/quickSearch/U10CA180820 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Cancer Institute (NCI) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This phase II trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable UPS or a related poorly differentiated sarcoma live longer without having disease progression. **Detailed Description:** PRIMARY OBJECTIVE: I. To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone. KEY SECONDARY OBJECTIVE: I. To assess whether the combination of doxorubicin and pembrolizumab versus (vs) the re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression (i.e., upfront pembrolizumab vs second line pembrolizumab) improves overall survival (OS). SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability in each treatment arm. II. To quantify overall response rate (ORR) and durability of response (DOR) in each treatment. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive doxorubicin intravenously (IV) over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity. Patients in both arms also undergo echocardiogram (ECHO) or multigated acquisition (MUGA) scan during screening, as well as standard imaging scans and blood sample collection throughout the study. After completion of study treatment, patients are followed up periodically for up to 5 years. ### Conditions Module **Conditions:** - Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 - Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 - Undifferentiated Pleomorphic Sarcoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan during screening, as well as standard imaging scans and blood sample collection throughout the study. **Intervention Names:** - Procedure: Biospecimen Collection - Procedure: Diagnostic Imaging - Drug: Doxorubicin - Procedure: Echocardiography - Procedure: Multigated Acquisition Scan - Biological: Pembrolizumab **Label:** Arm A (doxorubicin and pembrolizumab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan during screening, as well as standard imaging scans and blood sample collection throughout the study. **Intervention Names:** - Procedure: Biospecimen Collection - Procedure: Diagnostic Imaging - Drug: Doxorubicin - Procedure: Echocardiography - Procedure: Multigated Acquisition Scan **Label:** Arm B (doxorubicin) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Undergo blood sample collection **Name:** Biospecimen Collection **Other Names:** - Biological Sample Collection - Biospecimen Collected - Specimen Collection **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Undergo standard imaging scans **Name:** Diagnostic Imaging **Other Names:** - Medical Imaging **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Given IV **Name:** Doxorubicin **Other Names:** - Adriablastin - Hydroxydaunomycin - Hydroxyl Daunorubicin - Hydroxyldaunorubicin **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Undergo ECHO **Name:** Echocardiography **Other Names:** - EC **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Undergo MUGA scan **Name:** Multigated Acquisition Scan **Other Names:** - Blood Pool Scan - Equilibrium Radionuclide Angiography - Gated Blood Pool Imaging - Gated Heart Pool Scan - MUGA - MUGA Scan - Multi-Gated Acquisition Scan - Radionuclide Ventriculogram Scan - Radionuclide Ventriculography - RNVG - SYMA Scanning - Synchronized Multigated Acquisition Scanning **Type:** PROCEDURE #### Intervention 6 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab **Description:** Given IV **Name:** Pembrolizumab **Other Names:** - BCD-201 - Keytruda - Lambrolizumab - MK-3475 - Pembrolizumab Biosimilar BCD-201 - Pembrolizumab Biosimilar QL2107 - QL2107 - SCH 900475 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Will be compared between the treatment arms (doxorubicin + pembrolizumab versus \[vs\] doxorubicin alone). The comparison of PFS between treatment arms will be done using a stratified (on Eastern Cooperative Oncology group \[ECOG\] performance status \[0 vs 1\]) log-rank test with a 5% type I error (1-sided). **Measure:** Progression free survival (PFS) **Time Frame:** From randomization to documented progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1 or death from any cause without prior progression, up to 5 years #### Secondary Outcomes **Description:** Will be compared between doxorubicin + pembrolizumab vs doxorubicin alone to test the strategy of upfront pembrolizumab vs second line pembrolizumab. **Measure:** Overall survival **Time Frame:** From randomization to death, up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient must be \>= 18 years of age * Patient must have a confirmed histopathologic diagnosis of undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS can sometimes exist in a spectrum among related diagnoses, the following additional diagnostic will be allowed, but not limited to: * Pleomorphic sarcoma with inflammation or with limited areas of differentiation * Pleomorphic sarcoma with giant cells * Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes) * Myxofibrosarcoma, poorly differentiated sarcoma not otherwise specified (NOS) * Undifferentiated spindle cell sarcoma * Pleomorphic dermal sarcoma * Poorly differentiated spindle cell sarcoma NOS Any of these subtypes may have areas of focal myogenic differentiation * Patient must have metastatic or unresectable sarcoma * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has achieved menarche at some point * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 6 months after the last dose of doxorubicin for patients of child bearing potential and for 3 months after the last dose of doxorubicin for male patients with partners of child bearing potential. Contraception measures must also continue for 4 months after the last dose of pembrolizumab for patients of child bearing potential * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Patient must have a left ventricular ejection Fraction (LVEF) \> 50% by either MUGA scan or echocardiogram obtained within 28 days prior to randomization * Absolute neutrophil count (ANC) ≥ 1,500 cells/m\^3 (must be obtained ≤ 7 days prior to protocol randomization) * Platelets ≥ 75,000 cells/m\^3 (must be obtained ≤ 7 days prior to protocol randomization) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (must be obtained ≤ 7 days prior to protocol randomization) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (labs must be obtained ≤ 7 days prior to protocol randomization) * Creatinine ≤ 1.5 x institutional ULN or creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (labs must be obtained ≤ 7 days prior to protocol randomization) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Patient must have measurable disease. Baseline imaging, including a chest CT, of all measurable and non-measurable disease must be obtained within 28 days prior to randomization * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patient must not have had prior treatment with an anthracycline * Patient must not have a diagnosis of clinically significant immunodeficiency or an autoimmune disorder requiring the patient to use systemic steroid chronically, or systemic steroids within 7 days prior to randomization * Patient must not have a known history of active TB (Bacillus Tuberculosis) * Patient must not have a known hypersensitivity to doxorubicin or pembrolizumab or any of their excipients * Patients who have received prior chemotherapy, targeted small molecule therapy or radiation therapy must have recovered from the prior therapy at the time of randomization * Patient must have recovered adequately from any prior major surgery prior to randomization * Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent * Patient must not have an autoimmune or other disease that requires the use of daily corticosteroids of \> 10 mg of prednisone (or equivalent). Patients who are on an active steroid taper at the time of randomization must finish prior to beginning study treatment. Patients who require inhaled or topical steroids are eligible **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** ECOG-ACRIN Cancer Research Group **Name:** Seth M Pollack **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page. **IPD Sharing:** YES **URL:** https://grants.nih.gov/policy/sharing.htm ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000051642 - Term: Histiocytoma - ID: D000018218 - Term: Neoplasms, Fibrous Tissue - ID: D000009372 - Term: Neoplasms, Connective Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15327 - Name: Sarcoma - Relevance: HIGH - As Found: Sarcoma - ID: M26812 - Name: Histiocytoma, Malignant Fibrous - Relevance: HIGH - As Found: Undifferentiated Pleomorphic Sarcoma - ID: M3724 - Name: Aggression - Relevance: LOW - As Found: Unknown - ID: M26795 - Name: Histiocytoma - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20364 - Name: Neoplasms, Fibrous Tissue - Relevance: LOW - As Found: Unknown - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: HIGH - As Found: Sarcoma - ID: T5790 - Name: Undifferentiated Pleomorphic Sarcoma - Relevance: HIGH - As Found: Undifferentiated Pleomorphic Sarcoma ### Condition Browse Module - Meshes - ID: D000012509 - Term: Sarcoma - ID: D000051677 - Term: Histiocytoma, Malignant Fibrous ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M7492 - Name: Doxorubicin - Relevance: HIGH - As Found: Women - ID: M227339 - Name: Liposomal doxorubicin - Relevance: HIGH - As Found: Myocardial Ischemia - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Blind - ID: M6832 - Name: Daunorubicin - Relevance: HIGH - As Found: Size - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000582435 - Term: Pembrolizumab - ID: D000004317 - Term: Doxorubicin - ID: C000506643 - Term: Liposomal doxorubicin - ID: D000003630 - Term: Daunorubicin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422793 **Brief Title:** The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery **Official Title:** The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery #### Organization Study ID Info **ID:** 60940 #### Organization **Class:** OTHER **Full Name:** Nova Scotia Health Authority ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nova Scotia Health Authority #### Responsible Party **Investigator Affiliation:** Nova Scotia Health Authority **Investigator Full Name:** Katherine Curry **Investigator Title:** Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Postoperative nausea and vomiting (PONV) is a major concern for patients undergoing orthognathic surgery (corrective jaw surgery). These symptoms affect up to 60% of jaw surgery patients and can be quite distressing. The mechanisms underlying PONV are complex, but it is thought that surgical site bleeding and blood pooling in the stomach is the primary stimulus in this type of surgery. Nasogastric (NG) tubes have been used to suction out pooled blood in the stomach (gastric decompression), in hopes of minimizing symptoms. However, new research shows that NG tube gastric decompression may not demonstrate any benefit, and may even worsen PONV. Our study aims to directly compare PONV in participants undergoing gastric decompression or not. Participants will be randomized into two groups, either no NG tube gastric decompression or NG tube gastric decompression throughout the surgery and removed approximately one hour postoperatively. It is hypothesized that there will be less PONV in the group that does not undergo gastric decompression. We hope that the results from this study will better patient outcomes for this common postoperative problem and guide future practices for NG tube gastric decompression in orthognathic surgery. **Detailed Description:** Orthognathic surgery is a common surgical procedure performed to correct dentofacial deformities. Patients are held in maxillomandibular fixation with elastics for several weeks following surgery, limiting mouth opening during the postoperative period. Although fixation can be released, if necessary, PONV is distressing in this patient population and many patients voice concern around the idea of emesis. Patients who suffer from nausea and vomiting often have poor oral intake of fluids and analgesic medications, demonstrated by dehydration and suboptimal pain control. From a surgical perspective, vomiting puts tension on fragile oral wounds that can provoke wound dehiscence and surgical site bleeding, in turn worsening symptoms. Occasionally, PONV can necessitate increased length of stay in hospital thereby increasing costs to the healthcare system. The pathophysiology underlying nausea and vomiting is complex and multifactorial involving both centrally mediated and peripherally mediated pathways. Mechanisms that trigger emesis include, but are not limited to, activation of chemoreceptors and mechanoreceptors in the oropharynx and stomach by ingested blood and intraoperative manipulation, direct stimulation of the chemoreceptor trigger zone in the area postrema and stimulation of the glossopharyngeal and vagus nerves. In the gastrointestinal system, vagal afferents are activated by numerous emetogenic substances, of which blood is thought to be the strongest peripheral emetic stimulus. Activation of this pathway induces nausea and/or vomiting and is thought to be of particular importance in oral surgeries, specifically orthognathic surgery. Despite best hemostatic efforts with airway protection, thorough suctioning and primary wound closure, orthognathic surgery generates intraoral bleeding and ingestion of blood that is often seen in evacuated gastric contents. Gastric pooling of blood is thought to be one of the primary mechanisms by which orthognathic surgery stimulates PONV. Patient specific factors, anesthetic medications, and postoperative opioids are also thought to play key roles. In orthognathic surgery literature, prevalence of PONV is relatively high, documented at 40-60%. This is more than with general postoperative incidence of 50% for nausea and 30% for vomiting for all surgeries. Postoperative nausea and vomiting typically occur within the first 24 hours after surgery, although this is most prevalent in the first 2 hours following orthognathic surgery. This is generally considered to be early PONV, whereas delayed PONV occurs from 2 to 24 hours postoperatively. It has traditionally been believed that gastric evacuation of ingested blood using a NG tube should minimize PONV and increase patient comfort. Nasogastric tube insertion involves passing the NG tube through one nostril and maneuvering it down the oropharynx into the esophagus until adequately positioned in the stomach. It can then be hooked up to suction to remove gastric contents, a process commonly known as gastric decompression. Nasogastric tube insertion is a routine procedure that is minimally invasive, although major and minor complications have been documented in the literature. Nasogastric tube insertion has been associated with pain, tearing of the nasal mucosa, submucosal insertion, pulmonary insertion, and aspiration. Additionally, its presence can be anxiety-provoking for many patients. Several studies have previously evaluated the impact of NG tube gastric decompression on PONV for various surgical specialties. In anesthesia literature, one study looked at more than 1000 patients undergoing various surgeries and found strong evidence that the use of NG tubes does not decrease PONV. Based on this study, the routine use of NG tubes is no longer supported by the Consensus Guidelines for Management of PONV. In orthognathic surgery literature, there have been several studies with conflicting results. One retrospective study evaluated PONV in 772 orthognathic surgery patients with and without gastric suction and found that PONV was significantly worse in the group that did not have NG tube gastric decompression. Conversely, a randomized control trial evaluated PONV in 24 orthognathic surgery patients with and without gastric suction and could not associate gastric decompression with any meaningful decrease in PONV. Furthermore, another prospective study compared the incidence of PONV in 29 orthognathic surgery patients with and without NG tube gastric decompression and concluded that the presence of the NG tube instead increased the prevalence and severity of PONV. It is postulated that this may be related to stimulation of the glossopharyngeal nerve activating the gag reflex. At our institution, surgeons follow a variety of protocols for NG tube gastric decompression in orthognathic surgery. Historically, a NG tube was used in all cases, although practices have changed over the past several years. Whether a NG tube is used or not is dependent on the surgeon's expert judgement and experience. Common protocols include no NG tube and NG tube insertion at the start of surgery with intermittent suction and removal within the first hour postoperatively after transfer to the post anesthesia care unit (PACU). Our routine practices are in keeping with Canadian standards of practice. We recently conducted a survey of the Canadian Association of Oral and Maxillofacial Surgeons to better understand common practices and protocols relating to this topic. It was found 73% of respondents routinely use NG tube for gastric decompression and either remove the NG tube prior to extubation or in the PACU. The remaining 27% of respondents did not believe there is any benefit to gastric decompression and routinely do not use NG tubes for orthognathic surgery. To our knowledge, there has yet to be a randomized control trial directly comparing PONV in orthognathic surgery patients subject to these common NG tube regimens. An evidence-based protocol addressing the impact of NG tube gastric decompression in orthognathic surgery has yet to be determined. Oral and Maxillofacial Surgeons (OMFS) are using a variety of practices, including omitting NG tube gastric decompression altogether. Available literature is conflicting and some suggests that NG tube gastric decompression may worsen PONV. Further studies in this field have been recommended but not carried out to date. The aim of this study is to determine how NG tube gastric decompression impacts PONV. The results of this study will guide procedures and protocols that optimize care of this patient population at our institution, and possibly across other institutions in the future. As PONV can increase length of stay in hospital, this study may be helpful to decrease the occurrence of prolonged admission and its associated costs to the healthcare system. This research will benefit patients directly by determining a perioperative protocol to minimize PONV and may negate the need for NG tube insertion, possibly improving patient safety and outcomes. Research Question The aim of this study is to determine if nasogastric tube gastric decompression has any impact on PONV within the first 24 hours following orthognathic surgery. More specifically, this will be achieved by comparing the incidence of PONV in orthognathic surgery patients randomized into one of two study groups: A. No NG tube gastric decompression; B. NG tube insertion before surgery with intermittent suction and removal within the first hour post-operatively. Research Plan Study Arms This is a prospective study for all patients undergoing orthognathic surgery who meet inclusion criteria. Patients will be asked whether they would like to enroll in this study at their routine preadmission appointment, which typically occurs 1-2 weeks before their scheduled surgery date. Orthognathic surgery patients always require this appointment to take final measurements, models and photos that help the surgical team determine a precise final surgical plan. Another important part of this visit is reviewing the patient's past medical and surgical history, medications, allergies, smoking status, and other social history pertinent to surgery. This appointment allows ample time to thoroughly discuss our proposed study with all eligible patients and answer any questions they may have prior to consenting for enrollment. They will also be provided with a document explaining the nature of the study and will be informed they can withdraw from the study at any given time. If patients choose not to enroll, the decision around NG tube gastric decompression will be at the discretion of the surgical and anesthesia teams the day of surgery. If they do choose to enroll, their Apfel score will be calculated to determine pre-existing risk of PONV based on sex, smoking status, history of PONV or motion sickness, and use of postoperative opioid analgesics. They will be randomized into one of two study groups using a random treatment sequence determined on www.randomization.com. This randomization sequence is stratified with a 1:1(No NG: NG in at beginning of surgery and removed in PACU) allocation using random block sizes of 6 to ensure balance among groups of 14 blocks. Participants will be sequentially assigned to the next protocol group listed by the random generator at the time of enrollment. Participants will be blinded from their treatment group to minimize placebo effect, although they may later recall NG tube presence/removal if they belong in the group that gets the NG tube. Surgeons and anesthesiologists will not be blinded, as the nature of the study is not conducive to a double-blinded method. Pre-Operative and Intra-Operative Management All participants will be seen by the surgical team and the anesthesiologist the day of their surgery before being brought into the operating room. All participants receive Ibuprofen 600mg and Acetaminophen 975mg one hour pre-operatively. As all participants require nasal endotracheal intubation for orthognathic surgery, 0.1% Xylometazoline nasal spray (a topical vasoconstrictor) is administered in each nostril to minimize the likelihood of epistaxis from insertion of the nasal endotracheal tube and the NG tube, if applicable. All participants will receive a standard dose of pre-operative steroids (125-1000mg Methylprednisolone) and intravenous antibiotics (2g Cefazolin), with three doses of post-operative Cefazolin 2g IV every 8 hours. The anesthetic regimen will be determined by the attending anesthesiologist and may include total intravenous anesthetic or combined volatile and intravenous anesthesia. All participants are given a single dose of Ondansetron 4mg IV 15-30 minutes prior to completion of surgery as a prophylactic antiemetic as per anesthesia practice standards. Any given medications are documented on the Anesthesia Record accessible for later review. The surgery will be performed by one of 5 attending surgeons with a resident or fellow assist. The length of surgery often ranges from 1-3 hours depending on the procedure and its complexity. A mean arterial pressure of 60 is targeted throughout the procedure to minimize blood loss, particularly during the time of osteotomies. A throat pack is inserted and remains in place until surgery is complete to minimize the ingestion of blood from intraoral wounds. When surgery is complete, the throat pack is removed and thorough suctioning of the oropharynx using a Yankauer suction is carried out. Most patients will have an acrylic occlusal splint fixated to their maxillary orthodontic arch wire to guide their bite and are placed into maxillomandibular fixation (MMF) using a range from tight elastics to loose guiding elastics. The type of MMF depends on their pre-existing deformity, stability of the movement, surgeon preference and other patient specific factors. Participants will be assigned to their respective study arm at the time of surgery. The attending surgeon and resident /fellow will be aware of which group the participant is in and will inform the anesthesiologist before the patient is brought into the operating room. Group A: Participants in group A (No NG) will not have any intervention in the operating room. Group B: Participants in Group B will have a NG tube placed. In this group, participants will be anesthetized, intubated, and a NG tube will be inserted in the naris opposite the nasotracheal tube. A #14 French NG tube will be used, as the size allows for adequate suction while minimizing trauma on nasal passage. This measures 48 inches in length (122 cm) and is 4.7mm in diameter. Once inserted, it will be hooked up to low suction to confirm placement. If in the correct position, gastric contents will be seen in suction tubing. If no gastric contents are seen, the NG tube will be adjusted until appropriately positioned. The NG tube will be connected to suction until all stomach contents are effectively removed, as demonstrated by no new secretions in the suction tubing. The NG tube will be secured with tape throughout surgery and will be temporarily hooked back up to suction at the end of surgery to confirm its position and suction any stomach contents present. The NG tube will then be secured to the participant's nose using NG tape and will be left in place during extubation and transfer to PACU. The PACU nursing team will be asked to connect the NG tube to low intermittent suction and to complete the Study Form. The OMFS resident will complete the Study Form to document NG placement details and any complications. Post-Operative Management Orthognathic surgery patients are held in PACU for up to several hours following surgery, until they are suitable to be transferred to the inpatient unit. While in PACU, they are monitored by nursing for pain and PONV. Medications available in PACU are ordered by the attending anesthesiologist. Orders for multimodal analgesia often include acetaminophen, short-acting opioids, and long-acting opioids in keeping with routine anesthesia practice. Orders for antiemetics often include haloperidol, dimenhydrinate and ondansetron in keeping with routine anesthesia practice. While in PACU, nursing will be asked to fill out the Study Form to indicate whether the participant experienced nausea or emesis in the first 2 hours postoperatively. Episodes of nausea, vomiting, and antiemetics administered and associated time will be recorded on the Study Form. As per our routine practices, nursing will be instructed to remove the NG tube within the first hour post-operatively before transfer to the inpatient floor. Timing of removal is guided by signs and symptoms of PONV, participant comfort/ability to tolerate the tube, and quantity of gastric secretions. Once participants are transferred to the inpatient unit, their assigned nurse will be responsible for continuing completion of the Study Form. Patients are routinely ordered analgesics including Acetaminophen 650mg PO (orally) q6h (every 6 hours), Ibuprofen 600mg PO q6h, and Hydromorphone 2-4mg PO q6H as needed. Antiemetics are also available including Dimenhydrinate 25-50mg PO/IV q6h as needed and Ondansetron 4mg IV q8h as needed. All episodes of nausea, emesis and any antiemetics given with associated times will be documented on the Study Form. During morning rounds on postoperative day one, the surgical resident team will also ask the participant if they experienced nausea or emesis in the delayed postoperative period (2-24 hours postoperatively) to ensure no symptoms were missed and will document this information on the Study Form. Although most participants will not have completed a full 24-hour postoperative course at this time, this information should be representative of the delayed postoperative period. It unlikely to impact study results, as participants must not be reliant on antiemetics to manage PONV and must be tolerating adequate oral intake of fluids to meet discharge criteria from hospital. If any participant experiences delayed discharge secondary to PONV, this will be recorded on the Study Form. Patients are given post-operative instructions by an OMFS resident prior to discharge home, including instructions pertaining to management of PONV. Diet for the first several weeks is strictly liquid to allow for appropriate healing but is equally beneficial by preventing vomiting of solid foods in the postoperative period. Participants are sent home with suture scissors and are instructed that elastic MMF can be cut and released if there is ever airway concern. Under these circumstances, they are instructed to notify the OMFS resident on call and immediately proceed to the nearest emergency department. Participants are not routinely discharged with prescriptions for antiemetic medications since PONV should have largely resolved while in hospital for the patient to meet discharge criteria. If a participant has delayed discharge due to PONV, this will be considered an adverse event and will be recorded on the Study Form. Chart Review The Anesthesia Record and Progress Notes from each participant's surgery and subsequent hospital admission will be reviewed by the research team. Data collected from this review will include the type of anesthetic administered, the medication administration record, and nursing notes describing the patient's course in hospital. This information is necessary to better understand the course of PONV (if any) and to help minimize confounding variables by further evaluating study groups based on general anesthesia protocol and number of prophylactic antiemetics given. This information can only be accessed through the Nova Scotia Health Authority (NSHA) web-based application OneContent, which is password protected through NSHA Intranet. This data will be reviewed within two weeks of discharge home, once available in the OneContent system. Data Collection and Analysis Data will be obtained from pre-admission and inpatient records including the history and physical record, the anesthesia record, the intra-operative record, progress notes, study forms, and the medication administration record. Data collected will include the patient's age (years), weight (kg), sex, smoking status (smoker or non-smoker), history of PONV or motion sickness, length of time taken to insert NG tube successfully (seconds), complications arising from NG tube insertion, length of surgery (from first incision to closure), type of orthognathic surgery (LeFort, BSSO, or both), type of general anesthesia (total intravenous anesthetic vs combined volatile/ intravenous anesthetic), length of stay in hospital (hours), episodes of nausea or vomiting (yes or no) during two different time intervals (0-2 hours postoperatively and 2-24 hours postoperatively), and amount and frequency of antiemetics taken for the first 24 hours in hospital or until discharge home. This study will use descriptive statistics in the form of percentages and counts for categorical variables and means and standard deviations for continuous variables. Differences between groups will be analyzed with a chi square test. Final data analysis plan to be determined in conjunction with a biostatistician. Informed Consent Participants will be recruited and enrolled in this study during their routine preadmission appointment several days prior to their scheduled surgery. The consent discussion will be conducted by the resident completing the preoperative assessment. The resident having this discussion will have previously completed training regarding the study protocol and all aspects of the consent form. A SOP will be provided to all staff members outlining the procedures for obtaining informed consent, and all questions can be addressed at the training session or later by contacting the principal or supervising investigators. Contact information for the research team will be provided and available to all research team members. Documentation of training will be completed. Study enrollment and consent to participate will be completely voluntary and free of coercion or undue influence. Prior to consenting, all aspects of the study will be thoroughly discussed by the resident completing the assessment. The aim of this study, potential benefits and harms, group allocation and probability of assignment, expectations of participants, duration of participation, voluntariness of participation and ability to withdrawal any time will be addressed. Participants will be made aware that their surgical plan will be uninfluenced, and their care will be held to the same standard regardless of study enrollment. Potential participants will also be made aware that should they choose not to enroll in the study, the decision regarding nasogastric tube gastric decompression will be made by their surgical and anesthesia teams the day of surgery. Potential participants will be given a printed handout addressing all aspects of the study and a copy of the consent form to review. The study will be discussed in simple language, in keeping with the participant's health literacy. All questions will be answered as clearly as possible and potential participants will be given as much time as needed to decide whether to enroll. If a participant chooses to enroll, they will sign the consent form with a witness present. Participants will be made aware that they are able to withdraw from the study at any time. Participants will be given a phone number where they are able to contact the principal or supervising investigators, who will then assist them with withdrawal from the study as per their wishes. The quality of care they receive will not be affected by withdrawal from the study. Confidentiality Participants will be de-identified using a study number. No dates of birth will be recorded. Data described in the "Data Analysis" section will be obtained with only necessary information recorded. All electronic data will be stored on an encrypted, password protected NSHA computer located in a locked resident office in the Department of Oral and Maxillofacial Surgery at the Victoria General Hospital. Only research team members directly involved in patient care will have access to the office and computer. All hard copy data will be kept in a locked filing cabinet. Data will be kept for 15 years following completion of the study as per NSHA policy. When the data retention period is completed, the Director of Health Information Services will be contacted and all data will be destroyed in a way that is not recognizable, retrievable, or reconstructed. All electronic data will be wiped from the encrypted folder and computer, and all paper records will be shredded. Patient Benefits This study aims to establish an evidence-based protocol for nasogastric tube gastric decompression that can help to minimize PONV in patients undergoing orthognathic surgery. If one study arm is found to be superior to the others, future patients will benefit from their surgical team following this protocol. For study participants, potential benefits are dependent on study outcomes. The interventions proposed by this study are in keeping with routine practices at our institution. If one regimen is superior, participants in this group will benefit from decreased PONV, which is a major concern for many orthognathic surgery patients associated with suboptimal pain control, poor oral intake, increased length of stay in hospital, and poor overall experience. If the "No NG" group is found to be superior, patients in this group will benefit from not requiring insertion of the NG tube which is invasive, has potential complications, and is generally associated with patient anxiety. Patient Harms There are no hams to this study that differ from pre-existing risks for all orthognathic surgery patients. Interventions in both study arms are in keeping with current standards of practice at our institution. The decision around NG tube gastric decompression is currently decided by surgeon and anesthetist preference, which will instead be randomized for this study. As per our knowledge, to date, there has been no significant harm to patients who have not undergone NG tube gastric decompression. In case of patients experiencing PONV, the same antiemetic medications are available to both study groups. Patients are also provided with scissors and undergo teaching on how to cut MMF elastics in case of airway concern during vomiting. Patients are on a fully liquid diet, so there is little risk of aspirating any solids. For the study arm with NG tube insertion, there are potential complications associated with this procedure, including pain and epistaxis, and rarely, submucosal insertion or aspiration. Some patients may also voice anxiety around NG tube insertion. All NG tubes will be inserted when the patient is anesthetized, so they will not recall the insertion. Any complications that do arise will be recorded and managed appropriately by the surgical team. ### Conditions Module **Conditions:** - Postoperative Nausea - Postoperative Vomiting **Keywords:** - nasogastric tube - orthognathic surgery - gastric decompression ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a prospective study for all patients undergoing orthognathic surgery who meet inclusion criteria. If they choose to enroll, they will be randomized into one of two study groups using a random treatment sequence determined on www.randomization.com. This randomization sequence is stratified with a 1:1 (No NG: NG in at beginning of surgery and removed in PACU) allocation using random block sizes of 6 to ensure balance among groups in 14 blocks. Participants will be sequentially assigned to the next protocol group listed by the random generator at the time of enrollment. ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants will be blinded from their treatment group to minimize placebo effect, although they may later recall NG tube presence/removal if they belong in the NG group. Surgeons and anesthesiologists will not be blinded, as the nature of the study is not conducive to a double-blinded method. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** No NG tube gastric decompression for orthognathic surgery. This group will not have a NG tube inserted. The remainder of their surgical care will be identical to the other group. PONV will be evaluated by nursing and surgical team at two time points in the 24 hour postoperative period (early \[0-2 hours\] and delayed \[2-24 hours\]). **Intervention Names:** - Procedure: No NG tube gastric decompression **Label:** No NG Gastric Decompression **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will undergo NG tube gastric decompression according to our institution's typical gastric decompression regimen. Once patients are anesthetized and intubated, and a #14 French NG tube will be inserted in the naris opposite the nasotracheal tube and hooked up to low suction to confirm placement. If in the correct position, gastric contents will be seen in suction tubing. If no gastric contents are seen, the NG tube will be adjusted accordingly. The NG tube will be connected to suction until all stomach contents are effectively removed, as demonstrated by no new secretions in the suction tubing. It will then be disconnected from suction, secured with tape throughout surgery and temporarily hooked back up to suction at the end of surgery to reconfirm position and suction stomach contents present. The NG tube will then be secured to the participant's nose and left in place during extubation and transfer to PACU. **Label:** NG Gastric Decompression **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - No NG Gastric Decompression **Description:** Participants in this group will not undergo gastric decompression following orthognathic surgery at our institution. **Name:** No NG tube gastric decompression **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome for this study is PONV characterized by nausea and/or emesis in participants subject to one of two NG tube gastric decompression protocols during the 24-hour postoperative period. This will be characterized by indicating presence of nausea or vomiting with "yes" or "no" at two different time points (early vs delayed PONV). **Measure:** Postoperative Nausea and Vomiting **Time Frame:** Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). #### Secondary Outcomes **Description:** Evaluating factors related to NG tubes including the incidence of NG tube-related complications and the length of time taken to successfully insert a NG tube. Any complications will be documented. Length of time taken to insert the tube will be recorded in seconds. This data will be described using percent for incidence and descriptive statistics. **Measure:** NG Tube Related Complications/Factors **Time Frame:** Intraoperative documentation during NG tube insertion. **Description:** Evaluate whether participants tend to experience more early (0-2h) or delayed (2-24h) PONV, increasing our understanding of possible precipitants. This will be characterized by indicating presence of nausea or vomiting with "yes" or "no" at two different time points (early \[0-2 hours postoperatively\] vs delayed \[2-24 hours postoperatively\]). **Measure:** Incidence of Early vs Delayed PONV in our Study Population **Time Frame:** Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). **Description:** Gain better understanding how patient demographics, length of surgery, type of surgery, and type of general anesthesia impact PONV in our study population. Participant's age (years), sex (male or female), smoking status (smoker or non-smoker), history of PONV or motion sickness (positive or negative), length of surgery (from first incision to closure), type of orthognathic surgery (LeFort, BSSO, or both), type of general anesthesia (total intravenous anesthetic vs combined volatile/ intravenous anesthetic) will be evaluated for correlation to PONV in the 24 hour postoperative period. **Measure:** Other Factors Impacting PONV **Time Frame:** Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). **Description:** Evaluating whether Apfel scores correlate to PONV and can function as an accurate predictor of PONV in our study population.The Apfel score (0-4) will be documented for each patient. Apfel score means for groups experiencing nausea and/or vomiting will be compared to Apfel score means for participants who do not experience nausea and/or vomiting. **Measure:** Apfel Score as a Predictor of PONV in our Study Population **Time Frame:** Apfel score will be determined preoperatively. Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients over the age of 16 undergoing orthognathic surgery for the correction of dentofacial deformities at the Victoria General Hospital during the study period. Orthognathic surgery to include: 1. Patients who receive single-jaw surgery (i.e. BSSO \[Bilateral Sagittal Split Osteotomy\] only, or LeFort only). 2. Patients receiving double-jaw surgery (i.e. BSSO and LeFort). 3. Patients undergoing a functional genioplasty in addition to another osteotomy (i.e. BSSO and/or LeFort). Exclusion Criteria: * Patients will be excluded if they do not meet inclusion criteria or if they have risk factors known to directly impact PONV and/or cause delayed gastric emptying: 1. Patients under the age of 16 at the time of surgery. 2. Patients contraindicated to undergo elective surgery, including pregnant patients. 3. Patients undergoing a functional genioplasty procedure only. 4. Patients with a history of vertigo or migraines. 5. Patients taking Semaglutide (Ozempic). 6. Patients with known diabetic gastroparesis. **Healthy Volunteers:** True **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Katherine A Curry, DDS **Phone:** 9024732070 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** NSHA **Name:** Katherine A Curry, DDS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** This data will be anonymous. Participants will only be consenting to participate in this study. There is no future studies planned using this study data. **IPD Sharing:** NO ### References Module #### References **Citation:** Koivuranta M, Laara E, Snare L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia. 1997 May;52(5):443-9. doi: 10.1111/j.1365-2044.1997.117-az0113.x. **PMID:** 9165963 **Citation:** Becker DE. Nausea, vomiting, and hiccups: a review of mechanisms and treatment. Anesth Prog. 2010 Winter;57(4):150-6; quiz 157. doi: 10.2344/0003-3006-57.4.150. **PMID:** 21174569 **Citation:** Ghosh S, Rai KK, Shivakumar HR, Upasi AP, Naik VG, Bharat A. Incidence and risk factors for postoperative nausea and vomiting in orthognathic surgery: a 10-year retrospective study. J Korean Assoc Oral Maxillofac Surg. 2020 Apr 30;46(2):116-124. doi: 10.5125/jkaoms.2020.46.2.116. **PMID:** 32364351 **Citation:** Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088. **PMID:** 9717590 **Citation:** Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005. **PMID:** 10730546 **Citation:** Apipan B, Rummasak D, Wongsirichat N. Postoperative nausea and vomiting after general anesthesia for oral and maxillofacial surgery. J Dent Anesth Pain Med. 2016 Dec;16(4):273-281. doi: 10.17245/jdapm.2016.16.4.273. Epub 2016 Dec 31. **PMID:** 28879315 **Citation:** Zhong W, Shahbaz O, Teskey G, Beever A, Kachour N, Venketaraman V, Darmani NA. Mechanisms of Nausea and Vomiting: Current Knowledge and Recent Advances in Intracellular Emetic Signaling Systems. Int J Mol Sci. 2021 May 28;22(11):5797. doi: 10.3390/ijms22115797. **PMID:** 34071460 **Citation:** Dobbeleir M, De Coster J, Coucke W, Politis C. Postoperative nausea and vomiting after oral and maxillofacial surgery: a prospective study. Int J Oral Maxillofac Surg. 2018 Jun;47(6):721-725. doi: 10.1016/j.ijom.2017.11.018. Epub 2018 Jan 1. **PMID:** 29301675 **Citation:** Silva AC, O'Ryan F, Poor DB. Postoperative nausea and vomiting (PONV) after orthognathic surgery: a retrospective study and literature review. J Oral Maxillofac Surg. 2006 Sep;64(9):1385-97. doi: 10.1016/j.joms.2006.05.024. **PMID:** 16916674 **Citation:** Apfel CC, Roewer N. Risk assessment of postoperative nausea and vomiting. Int Anesthesiol Clin. 2003 Fall;41(4):13-32. doi: 10.1097/00004311-200341040-00004. No abstract available. **PMID:** 14574212 **Citation:** Laskin DM, Carrico CK, Wood J. Predicting postoperative nausea and vomiting in patients undergoing oral and maxillofacial surgery. Int J Oral Maxillofac Surg. 2020 Jan;49(1):22-27. doi: 10.1016/j.ijom.2019.06.016. Epub 2019 Jun 21. **PMID:** 31230771 **Citation:** Pourtaheri N, Peck CJ, Maniskas S, Park KE, Allam O, Chandler L, Smetona J, Yang J, Wilson A, Dinis J, Lopez J, Steinbacher DM. A Comprehensive Single-Center Analysis of Postoperative Nausea and Vomiting Following Orthognathic Surgery. J Craniofac Surg. 2022 Mar-Apr 01;33(2):584-587. doi: 10.1097/SCS.0000000000008052. **PMID:** 34510064 **Citation:** Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494. **PMID:** 24356162 **Citation:** Sanaie S, Mahmoodpoor A, Najafi M. Nasogastric tube insertion in anaesthetized patients: a comprehensive review. Anaesthesiol Intensive Ther. 2017;49(1):57-65. doi: 10.5603/AIT.a2017.0001. Epub 2017 Jan 13. **PMID:** 28084614 **Citation:** Kerger KH, Mascha E, Steinbrecher B, Frietsch T, Radke OC, Stoecklein K, Frenkel C, Fritz G, Danner K, Turan A, Apfel CC; IMPACT Investigators. Routine use of nasogastric tubes does not reduce postoperative nausea and vomiting. Anesth Analg. 2009 Sep;109(3):768-73. doi: 10.1213/ane.0b013e3181aed43b. **PMID:** 19690245 **Citation:** Wang J, Zhang Z. Gastric Negative Pressure Suction Method Reduces the Incidence of PONV after Orthognathic Surgery. Front Surg. 2022 May 20;9:882726. doi: 10.3389/fsurg.2022.882726. eCollection 2022. **PMID:** 35669253 **Citation:** Schmitt ARM, Ritto FG, de Azevedo JGRL, Medeiros PJD, de Mesquita MCM. Efficacy of Gastric Aspiration in Reducing Postoperative Nausea and Vomiting After Orthognathic Surgery: A Double-Blind Prospective Study. J Oral Maxillofac Surg. 2017 Apr;75(4):701-708. doi: 10.1016/j.joms.2016.10.002. Epub 2016 Oct 12. **PMID:** 27816732 **Citation:** Maza, C., López, A. M., Kulyapina, A., Leno, B., Tousidonis, M., Garcia, A. & Salmerón, J. I. (2013). Orthognathic surgery: nasogastric tube responsible of the nausea and vomiting?. International Journal of Oral and Maxillofacial Surgery, 42(10), 1333. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12273 - Name: Nausea - Relevance: HIGH - As Found: Nausea - ID: M17582 - Name: Vomiting - Relevance: HIGH - As Found: Vomiting - ID: M22074 - Name: Postoperative Nausea and Vomiting - Relevance: HIGH - As Found: Postoperative Nausea - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009325 - Term: Nausea - ID: D000014839 - Term: Vomiting - ID: D000020250 - Term: Postoperative Nausea and Vomiting ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422780 **Brief Title:** Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women **Official Title:** Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women: Randomised Controlled Trial With Postpartum Follow-up #### Organization Study ID Info **ID:** HÜ-ERG-AK-01 #### Organization **Class:** OTHER **Full Name:** Çankırı Karatekin University ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Çankırı Karatekin University #### Responsible Party **Investigator Affiliation:** Çankırı Karatekin University **Investigator Full Name:** Aysenur KARAKUS **Investigator Title:** Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study was to compare maternal role preparation and mindfulness-centred occupational therapy trainings in pregnant women: a randomised controlled trial with postpartum follow-up. **Detailed Description:** Pregnancy and postpartum are a major change and crisis process for women. Women undergo hormonal, vascular, anatomical, physiological, and psychological changes for 40 weeks to meet the biochemical needs of the developing fetus, maintain homeostasis, and prepare for childbirth and lactation. These changes occurring during pregnancy are necessary to protect the health of mother and baby, as well as to prepare women for childbirth and maternity. Psychological changes that vary from trimester to trimester, accompanied by physiological changes in pregnancy. Especially in the second and third trimester, changes in the biopsychosocial balance, affecting family and work roles, taking on new responsibilities, trying to adapt to new roles and meeting the baby increased perceived depression, anxiety and stress. These physiological and psychological symptoms during pregnancy have been to adversely affect the quality of life of pregnant women. In literature, participation in meaningful and purposeful activities, which is an important indicator of quality of life, is also believed to have an impact on occupational performance during pregnancy. During pregnancy, post-partum and postpartum, the mother is expected to adapt to the physiological and psychological changes she experiences, to be able to take care of herself and her baby, to play the role of mother and to accept her baby. Physical activity levels, sleep and quality of life during pregnancy are also likely to be affected by maternal role adaptation and participation in social life. In this context, it should be taken into account that the period of pregnancy is an important milestone for the end of childbirth and the postpartum period. Postpartum physical problems occur in 70% of women, while 17% of women are accompanied by emotional problems.Especially in the postpartum period, emotional changes have been to occur in between 24% and 89% of women with post-partum depression (PPD), between 40% and 50% of mothers and between 9% and 30% of female with anxiety. Emotional problems can also arise as a result of a mother's physical problems, such as providing baby care, creating a safe environment for the baby, communicating with the child, learning new roles, developing family sensitivity, and dealing with problems related to the baby. Therefore, the postpartum period can become a crisis life for the family, just like pregnancy.Physical and emotional symptoms may adversely affect family, work, and social life, thereby reducing quality of life. (14,15,24). Physical and emotional symptoms have also been to negatively affect the maternal bond between the mother and the baby, the mother's sense of self, occupational balance, and occupational performance. Occupational Theraphy is a health care profession that supports an individual's ability to sustain occupational performance through various interventions and person-centric practices, helping the individual to adapt to changes that are constantly encountered within and around him. In this context, one of the interventions used to enhance pregnancy coherence is maternal role preparation training. Maternal role preparation is an occupational training that focuses on improving motherhood competence and living a successful role-to-mother harmony when the mother becomes a mother for the first time. One of the other interventions used in occupational therapy is a person-centric occupation therapy. In today's occupational therapy interventions, person-centric practices have always been a key element. With a person-centric approach, consultants and therapists work together to identify the nature of their occupational performance problems, the focus and need of the intervention, and the consequences of the preferred treatment. In this context, the study was planned to study tangible behavioral changes resulting from interventions in healthy pregnant women and their impact on participation in daily life activities. Our study aims to study the effectiveness of maternal role preparation training and awareness-based occupational therapy and post-partum follow-up. This study is important for the continuation of valuable activities and roles within pregnant women's daily routines, for the development of new strategies to make them feel better during pregnancy, and for a clinically integrated approach. ### Conditions Module **Conditions:** - Pregnancy Related - Postpartum Complication **Keywords:** - pregnancy - postpartum period - occupational therapy - quality of life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Randomised controlled trial with follow-up ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pregnant women in the second trimester (14-27th week) will be included in the trainings. **Intervention Names:** - Other: Maternal Role Preparation Training **Label:** Maternal Role Preparation Training Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Pregnant women in the second trimester (14-27th week) will be included in the trainings. **Intervention Names:** - Other: Awareness Centred Occupational Therapy Group **Label:** Awareness Centred Occupational Therapy Group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Pregnant women in the second trimester (14-27th week) will be included in the trainings. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Maternal Role Preparation Training Group **Description:** Maternal Role Preparation Training: Maternal Role Preparation Training (MRHE) is an occupational training programme aimed at increasing the competence of first-time mothers regarding motherhood. In this four-session programme, pregnant women will be provided with written materials, face-to-face talks and practical training covering topics related to their babies (maternal attachment, training on the sensory and developmental abilities of babies) and themselves (training on adopting a new role as a mother).The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions. **Name:** Maternal Role Preparation Training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Awareness Centred Occupational Therapy Group **Description:** Awareness Centred Occupational Therapy (FME); In FME, areas that affect the occupational performance of pregnant women in their daily lives will be identified and appropriate occupational therapy interventions will be applied. Awareness training on the applications will be given before starting the sessions. The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions. Awareness training will be given before starting the sessions. **Name:** Awareness Centred Occupational Therapy Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Nottingham Health Profile will be used to assess the awareness of pregnant women about their own health status. The Nottingham Health Profile assesses self-perceived health status and includes subsections on pain, emotional reactions, sleep, social isolation, physical activity and energy. These sub-sections make up the more intensively used section 1, while work life, household chores, social life, home life, sexual life, interests and holidays make up section 2. Each section is scored on a scale of 0-100. In the sections consisting of questions answered yes and no, the highest score can be 0 and the lowest score can be 100 (40,41). Turkish adaptation was performed by Küçükdeveci et al. in 1997. **Measure:** Nothingham Health Profile(NHP) **Time Frame:** 3 weeks #### Secondary Outcomes **Description:** Physical, demographic and obstetric information of pregnant women will be recorded. In the physical information section, the height (m), body weight (kg) before pregnancy and at the time of assessment will be recorded. In the demographic information section, the age, marital status ("married" and "single"), educational status of the pregnant woman and the father, employment status ("working" and "not working") and occupation of the pregnant woman and the father will be questioned. Educational status will be recorded categorically as "only literate", "primary school", "secondary school", "high school", "associate degree", "bachelor's degree", "master's degree" and "doctorate" **Measure:** Demographic Data Form **Time Frame:** 1 weeks **Description:** The validity and reliability study of the Turkish version, developed by Wagman and Hakansson (2012), was carried out by Günal et al. (2019). The test-re-test reliability ratio for the Turkish version of the scale was 0.922, with the Cronbach alpha value being 0.785. The room is a self-reporting scale that evaluates a person's occupational balance in different dimensions. It is used to measure the satisfaction a person receives from the number and variety of daily activities and to determine the occupational balance based on the results obtained. The scale consists of 11 items rated at a 4-point range ranging from 0 (I totally disagree) to 3 (I absolutely agree). The scale's total score is the sum of the individual scores given to the questions and ranges from 0-33. High scores indicate a better occupational balance. **Measure:** Occupational Balance Questionnaire(OBQ11-T) **Time Frame:** 3 weeks **Description:** Time management of individuals will be evaluated by Time Management Questionnaire (TMQ) consisting of 27-items. Developed by Britton and Tesser (1991), Alay and Koçak (2002) conducted a Turkish reliability and validity study. The reliability coefficient calculated by Cronbach's alpha correlations was found to be 0.88 for Time Planning, 0.66 for Time Attitudes subscale and 0.87 for the whole scale. The ATI is an inventory with 3 subscales: 16-item Time Planning, 7-item Time Attitudes and 4-item Time Spenders. Each item is scored out of 5 and a five-point scale consisting of "always, often, sometimes, rarely and never" options is formed. In scoring, 5 is given to the answer at the end of the scale, while 1 is given to the answer on the other side of the scale. The maximum score that can be obtained from the RIQ is 135 and the minimum score is 27. **Measure:** Time Management Questionnaire(TMQ) **Time Frame:** 3 weeks **Description:** Hospital Anxiety and Depression Scale (HADS): HAD was developed by Zigmond and Snaith (47) in 1983. Turkish validity and reliability of the scale was performed by Aydemir in 1997. The scale consists of 14 items. Odd numbered items in the scale investigate anxiety and even numbered items investigate depression. Seven items measure anxiety and seven items measure depression. In the Turkish validity and reliability study of the scale, the cronbach alpha coefficient was found to be 0.85 for the anxiety subscale and 0.77 for the depression subscale. In this study, the cronbach alpha values of the scale sub-dimensions were found to be 0.88 for the anxiety sub-dimension and 0.79 for the depression sub-dimension. **Measure:** The Hospital Anxiety and Depression Scale(HADS) **Time Frame:** 3 weeks **Description:** It was developed by Garnefski, Kraaij, and Spinhoven (2001) and adapted into Turkish by Tuna and Bozo (2012) (50, 51). When the scale was analysed in terms of reliability, Cronbach's alpha coefficients of the subscales ranged between .68 and .86 in various populations. The five-point Likert-type scale (1= almost never, 2= rarely, 3= sometimes, 4= often, 5= almost always) consists of a total of 36 items. Each subscale consists of four items representing different emotion regulation strategies: self-blame, acceptance, rumination, perspective taking, positive refocusing, planning refocusing, positive reappraisal, catastrophising and blaming others. Subscale scores are obtained by summing the item scores corresponding to the relevant subscale and each subscale receives a score between 4 and 20. Higher scores on the subscales indicate a higher frequency of using the relevant emotion regulation strategy. **Measure:** The Cognitive Emotion Regulation Questionnaire **Time Frame:** 3 weeks **Description:** It is a 4-point Likert-type scale that evaluates individuals' coping styles with stress (44, 45). This scale was developed by Folkman and Lazarus (1988) and Turkish reliability and validity study was conducted by Şahin and Durak (1995). Cronbach alpha internal consistency coefficients were reported to be between 0.49-0.68 for optimistic approach, 0.62-0.80 for self-confident approach, 0.64-0.73 for helpless approach, 0.47-0.72 for submissive approach and 0.45-0.47 for social support seeking factor. SBSAS consists of 5 factors: self-confident approach, helpless approach, submissive approach, optimistic approach and seeking social support. The scale is a 5-point Likert-type self-report scale consisting of 31 items. The scale includes a metric measurement from "I Never Use" (0) to "I Always Use" (4). The scores obtained from the scale vary between 0-124. **Measure:** Coping Style Scales **Time Frame:** 3 weeks **Description:** The pain intensity of the pregnant women was questioned with a 10 cm visual analogue scale (VAS). In this scale, the beginning of the line indicates "no pain" (score 0) and the end of the line indicates "unbearable pain" (score 10). Pregnant women will be asked to mark the intensity of the pain they feel on the VAS. The marked point will be measured with a ruler and the results will be recorded in cm. **Measure:** Visual Pain Scale(VPS) **Time Frame:** 3 weeks **Description:** The degree of sleep problems of the pregnant women will be evaluated using a VAS consisting of a 10 cm line. On this 10 cm line, the pregnant women will be told that the point "0" means that there is no problem with sleep and the point "10" means a very severe sleep problem and they will be asked to mark their sleep problems on this line. The marking point will be measured with the help of a ruler and the value obtained will be recorded in cm. In addition, the total amount of sleep of the pregnant women and how much sleep they wake up at night will be questioned in hours. **Measure:** Visual Sleep Scale(VSS) **Time Frame:** 3 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion criteria for pregnant women: * 18 to 35 years of age * Having conceived naturally * Being between 14-27 weeks of gestation * To be literate * Being primiparous * Reading and understanding Turkish * Volunteering to participate in the study * To have attended 80% of the trainings given Inclusion criteria for women in the postpartum period: * Giving birth at term * Having a healthy newborn (newborn born at 38-42 weeks of gestation, without low birth weight, without any disease) * Providing active care to the newborn baby with or without assistance Exclusion criteria for pregnant women * Having a risky pregnancy (gestational diabetes, eclampsia, pre-eclampsia, threatened preterm birth, premature rupture of membranes, placental anomalies etc.) * Having a maternal physical anomaly * Communication difficulties and mental deficiency * Having a medical history of mental illness * Having a foetal abnormality during pregnancy * Having a disease/complication that developed during pregnancy Exclusion criteria for women in the postpartum period: * Experiencing a traumatic event within 6-8 weeks postpartum (loss/death of a close person, natural disasters, accident, assault) * Stillbirth or having a baby with anomalies * Having a baby that requires an intensive care environment in a hospital * Mothers diagnosed with psychiatric illness (schizophrenia, depression, anxiety, panic attacks) **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Aysenur KARAKUS, MSc **Phone:** +90 5073663434 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Gokcen+ AKYUREK, Assoc Prof **Role:** CONTACT #### Locations **Location 1:** **City:** Çankırı **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aysenur Karakus KARAKUŞ, MSc - **Phone:** +90 376 218 95 00 - **Role:** CONTACT ***Contact 2:*** - **Name:** Gokcen Akyurek, Assoc Prof - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Çankırı Karatekin University Occupational Therapy Department **Status:** RECRUITING **Zip:** 18100 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422767 **Brief Title:** Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers **Official Title:** A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers #### Organization Study ID Info **ID:** 205873 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline ### Status Module #### Completion Date **Date:** 2024-10-08 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** PPD **Class:** INDUSTRY **Name:** Laboratory Corporation of America #### Lead Sponsor **Class:** INDUSTRY **Name:** GlaxoSmithKline #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will evaluate the effect of a single dose of bepirovirsen on the QT interval corrected by Fridericia's formula (QTcF) as compared to placebo. The data generated will be used to model the relationship between bepirovirsen concentration and QTcF. ### Conditions Module **Conditions:** - Hepatitis B **Keywords:** - Bepirovirsen - Cardiac Conduction - Electrocardiogram - QT interval corrected by Fridericia's formula - Hepatitis B virus ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** This will be a double-blind study. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Bepirovirsen **Label:** Participants receiving Bepirovirsen **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Participants receiving Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants receiving Bepirovirsen **Description:** Bepirovirsen will be administered. **Name:** Bepirovirsen **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Participants receiving Placebo **Description:** Placebo will be administered. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change from Baseline in QT interval corrected by Fridericia's formula (QTcF) **Time Frame:** Baseline (Day 1) and up to Day 4 #### Secondary Outcomes **Measure:** Change from Baseline in heart rate (HR) using by-time point analysis **Time Frame:** Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose **Measure:** Change from Baseline in QT interval, corrected by Fridericia's formula (QTcF), using by-time point analysis **Time Frame:** Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose **Measure:** Change from Baseline in PR interval using by-time point analysis **Time Frame:** Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose **Measure:** Change from Baseline in QRS duration using by-time point analysis **Time Frame:** Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose **Measure:** Number of participants with outlier results for QT interval, corrected by Fridericia's formula (QTcF), HR, PR and QRS **Time Frame:** Up to Day 4 **Measure:** Number of participants with treatment emergent changes of T wave morphology and U-wave presence **Time Frame:** Up to Day 4 **Measure:** Plasma concentrations of Bepirovirsen **Time Frame:** Up to Day 4 **Measure:** Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of Bepirovirsen **Time Frame:** Up to Day 4 **Measure:** Area under the concentration-time curve from time zero (pre-dose) to 24 hours post-dose (AUC[0-24]) of Bepirovirsen **Time Frame:** Up to 24 hours **Measure:** Maximum concentration (Cmax) of Bepirovirsen in plasma **Time Frame:** Up to Day 4 **Measure:** Time to reach Cmax (Tmax) of Bepirovirsen **Time Frame:** Up to Day 4 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, Electrocardiogram (ECGs) and vital signs. * Body weight greater than equal to (\>=) 50 Kilograms (kg) and Body mass index (BMI) within the range 19-32 Kilograms per square meter (kg/m\^2) (inclusive). * Male Participants: There are no contraceptive requirements for male participants. * A female participant is eligible to participate: * if she is not pregnant or breastfeeding and 1 of the following conditions applies: 1. is a woman of non-childbearing potential (WONCBP). OR 2. is a WOCBP and using a contraceptive method. * Capable of giving signed informed consent. Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. * History of vasculitis or presence of symptoms and signs of potential vasculitis * A sustained supine systolic blood pressure greater than (\>)150 millimeters of mercury (mmHg) or less than (\<)90 mmHg or a supine diastolic blood pressure \>95 mmHg or \<50 mmHg at Screening or Check-in (Day -2). * Lymphoma, leukemia, or any malignancy except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Participants with any other medical conditions which, in the judgement of the investigator and/or Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant. * Platelets \<140 x 10\^9 cells/liter (L). * Serum calcium, magnesium or potassium levels outside the normal reference range at screening. * Past, current or intended use of over-the-counter or prescription medication, including herbal medications within 7 days or 5 half-lives (whichever is longer) before dosing. * Current or prior use of creatine-containing supplements, or intended use up to 50 days post-dosing. * Prior treatment with any oligonucleotide or small interfering Ribonucleic acid (RNA) (siRNA) within 12 months before dosing. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day * Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 5 half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or within the last 90 days (if half-life and duration of biological effect are unknown), before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research. * Current enrollment or past participation in this clinical study. * Positive pre-clinical drug/alcohol screen, including Tetrahydrocannabinol (tetrahydrocannabinol). * Positive Human Immunodeficiency Virus antibody test. * Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. * Regular alcohol consumption within 6 months prior to screening defined as an average weekly intake of \>14 units for males or females. * Regular use of known drugs of abuse, including tetrahydrocannabinol. * Sensitivity to heparin or history of heparin-induced thrombocytopenia. * History of sensitivity to bepirovirsen or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor contraindicates their participation. * Alanine aminotransaminase (ALT) \>1.5x Upper Limit of Normal (ULN). * Total bilirubin \>1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5x ULN as long as direct bilirubin is less than equal to (\<=) 1.5xULN. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention. * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. * Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. * Known history of heart disease, including ischemic heart disease, cardiomyopathy, clinically significant cardiac arrhythmias, clinically significant valvular disease, or hypertensive heart disease. 1. History of palpitations associated with presyncope or syncope, or history of unexplained syncope. 2. History of Brugada syndrome, ventricular pre-excitation syndromes, personal or family history of long QT syndrome, or family history of sudden cardiac death. * Exclusion criteria for Screening ECG: 1. A supine mean heart rate outside the range 50 to 100 beats per minute (bpm). A HR from 100 to 110 bpm can be rechecked by ECG or vital signs within 2 hours to verify eligibility. 2. QT interval corrected by Fridericia's formula (QTcF) \>450 milliseconds (msec). 3. QRS interval \>120 msec 4. PR interval \>210 msec 5. An uninterpretable ECG or any significant arrhythmia or conduction abnormality which, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, will interfere with the safety of the individual participant. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** US GSK Clinical Trials Call Center **Phone:** 877-379-3718 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** EU GSK Clinical Trials Call Center **Phone:** +44 (0) 20 89904466 **Role:** CONTACT #### Locations **Location 1:** **City:** Austin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Brian Spears - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Texas **Zip:** 78744 ### IPD Sharing Statement Module **Access Criteria:** Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months. **Description:** Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/ **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications. **URL:** https://www.gsk.com/en-gb/innovation/trials/data-transparency/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9592 - Name: Hepatitis A - Relevance: LOW - As Found: Unknown - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20487 - Name: Hepadnaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: T2787 - Name: Herpes Simiae (B Virus) - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006509 - Term: Hepatitis B - ID: D000006505 - Term: Hepatitis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422754 **Brief Title:** THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA: A RANDOMIZED CONTROLLED STUDY **Official Title:** THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA: A RANDOMIZED CONTROLLED STUDY #### Organization Study ID Info **ID:** GaziosmanpasaTREH-FTR-EK-01 #### Organization **Class:** OTHER_GOV **Full Name:** Gaziosmanpasa Research and Education Hospital ### Status Module #### Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-29 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Gaziosmanpasa Research and Education Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Objective: The aim of this study was to investigate the effects of virtual reality application on quality of life and functionality, especially sitting balance, in hemiplegic patients. **Detailed Description:** This study was planned as a single-blind randomized controlled prospective study. Patients over 18 years of age with a diagnosis of hemiplegia who applied to Gaziosmanpaşa Training and Research Hospital PTR outpatient clinic and were hospitalized in the rehabilitation service and started a rehabilitation program; will be evaluated with Modified Ashworth, Tardiue Scale, Brunstrom assessment, Stroke Specific Quality of Life Scale, Beck Anxiety Scale, Functional Independence Scale, Mini Mental State Test (MMDT), Mini Mental Test for the Uneducated, Postural Assessment Scale in Stroke Patients, Rivermead Motor Assessment Scale, Sitting Function Test, Berg Balance Scale, System Usability Scale before and after the program. Patients who apply to the rehabilitation program will be randomly selected by closed envelope method. The first group will receive conventional rehabilitation program and home program. Conventional exercises\* of the first group will be performed for 30 sessions of 1 hour every day, in addition to this, the patient will be given a home program. In the second group, conventional exercises will be performed for 30 sessions of 1 hour every day. In addition to conventional exercises, this group will be enrolled in a balance game group using the Becure Balance System application and the WI balance board for 45 minutes 5 sessions a week.The necessary software and equipment for the virtual reality program were donated by Becure GmbH. Both groups will be reassessed after 30 sessions. The physician performing the evaluation will be completed blindly by physiotherapists who apply the conventional exercises and the virtual reality program. The study is a single-center clinical study using prospective data. Between 01.05.2024-01.08.2024, 36 patients are planned to be enrolled in the study. \*:Conventional exercise therapy includes range of motion, stretching, strengthening and balance exercises in patients with hemiplegia. ### Conditions Module **Conditions:** - Hemiplegia **Keywords:** - virtual reality - hemiplegia - sitting balance ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The first group will receive 30 sessions of conventional exercises for 1 hour every day. In addition, the patient will be given a home program. **Intervention Names:** - Device: Becure GmbH **Label:** Conventional Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In the second group, conventional exercises will be applied for 1 hour and 30 sessions every day. In addition to conventional exercise, this group will be enrolled in the balance game group using the Becure Balance System application and Wİ balance board for 45 minutes 5 sessions a week. **Intervention Names:** - Device: Becure GmbH **Label:** Virtual Reality Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional Group - Virtual Reality Group **Description:** Becure Balance System **Name:** Becure GmbH **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone. **Measure:** modified ashworth scale **Time Frame:** 1 month **Description:** The Brunnstrom recovery stages (BRS) is a short and easily administered measure for assessing motor function. **Measure:** Brunnstrom Stages **Time Frame:** 1 month **Description:** The QOLS was originally a 15-item instrument that measured five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. **Measure:** stroke-specific quality of life **Time Frame:** 1 month **Description:** The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). **Measure:** beck anxiety inventory **Time Frame:** 1 month **Description:** The instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. **Measure:** The Functional Independence Measure **Time Frame:** 1 month **Description:** The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. **Measure:** mini mental state examination **Time Frame:** 1 month **Description:** It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting or standing posture. **Measure:** Postural Assessment Scale for Stroke **Time Frame:** 1 month **Description:** The Motor Assessment Scale (MAS) is a clinical assessment tool that evaluates eight areas of motor function in recovering stroke patients **Measure:** Rivermead Motor Assessment Scale **Time Frame:** 1 month **Description:** The FIST tests balance in seated position. The patient should perform items with their best posture and balance, and while moving in a seated position. The therapist will give them occasional light pushes to test for balance reactions. The therapist will make sure they won't lose their balance. **Measure:** function in sitting test **Time Frame:** 1 month **Description:** The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance. **Measure:** berg balance scale **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Stable medical condition 2. Over 18 years of age 3. A score of 23 or above on the mini mental state test (MMDT) or the mini mental state test for the untrained (MMDT-E) 4. Within the period of 1-18 months after stroke 5. A score of 3 or 4 on the 3rd item of the Berg Balance Scale (BBS), which evaluates the balance of sitting without support (3= can sit for 2 minutes under supervision, 4= can sit safely for 2 minutes). Exclusion Criteria: * 1. Previous history of stroke 2. Aphasic patients in whom information exchange is not possible 3. Patients with impaired vision, hearing and vestibular system 4. Musculoskeletal and nervous system disorders other than stroke that may cause physical disability 5. Patients with a history of epilepsy 6. Cerebrovascular attack involving more than one hemisphere 7. Presence of cerebellar lesions or impaired cerebellar tests **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ERVA KAHRAMAN, MD - **Phone:** +905392339083 - **Role:** CONTACT ***Contact 2:*** - **Name:** EBRU YILMAZ YALCINKAYA, PROF - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Erva Kahraman **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Fergusson D, Levac D, Finestone H. Does the addition of virtual reality training to a standard program of inpatient rehabilitation improve sitting balance ability and function after stroke? Protocol for a single-blind randomized controlled trial. BMC Neurol. 2016 Mar 31;16:42. doi: 10.1186/s12883-016-0563-x. **PMID:** 27036515 **Citation:** Karasu AU, Batur EB, Karatas GK. Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study. J Rehabil Med. 2018 May 8;50(5):406-412. doi: 10.2340/16501977-2331. **PMID:** 29620137 **Citation:** Marques-Sule E, Arnal-Gomez A, Buitrago-Jimenez G, Suso-Marti L, Cuenca-Martinez F, Espi-Lopez GV. Effectiveness of Nintendo Wii and Physical Therapy in Functionality, Balance, and Daily Activities in Chronic Stroke Patients. J Am Med Dir Assoc. 2021 May;22(5):1073-1080. doi: 10.1016/j.jamda.2021.01.076. Epub 2021 Feb 24. **PMID:** 33639116 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010243 - Term: Paralysis - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9515 - Name: Hemiplegia - Relevance: HIGH - As Found: Hemiplegia - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006429 - Term: Hemiplegia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422741 **Acronym:** CIRCAFENOL **Brief Title:** Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers **Official Title:** Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers With Moderate Hypercholesterolemia. Randomized, Crossover, Controlled and Triple Blind Study.(CIRCAFENOL) #### Organization Study ID Info **ID:** CIRCAFENOL #### Organization **Class:** OTHER **Full Name:** Fundació Eurecat ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University Rovira i Virgili #### Lead Sponsor **Class:** OTHER **Name:** Fundació Eurecat #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The physiological processes of the body present daily oscillations called circadian rhythm. The circadian rhythm is essential for maintaining the vital functions of organisms, intervening directly and indirectly in a multitude of key processes, such as hormone secretion, cycles of activity and rest throughout the day, body temperature, the metabolism or absorption, processing and detoxification of nutrients. There are factors such as certain work schedules, prolonged exposure to screens, certain eating patterns or social jetlag, which have a negative impact on the circadian rhythm, causing its disruption and favoring the appearance of health alterations. Thus, there is evidence that associates night shift work with a higher incidence of risk factors for developing metabolic syndrome and cardiovascular diseases, including obesity, elevated blood levels of glucose, triglycerides, and low-density lipoprotein cholesterol (LDL-C), as well as lower levels of high-density lipoprotein cholesterol (HDL-C). In addition, disorders in the sleep cycle are associated with the development of hypertension and type 2 diabetes. Several previous studies show that a grape seed proanthocyanidin extract (GSPE) has beneficial effects on different parameters by restoring the circadian rhythm. **Detailed Description:** The main objective of the study is to evaluate the effect of daily GSPE intake, in combined with dietary recommendations, on LDL-C levels in individuals with rotating night shift work. The secondary objectives are to evaluate the effects of GSPE on: anthropometric parameters,blood pressure, heart rate and endothelial function, markers of lipid and carbohydrate metabolism and insulin resistance, atherogenic indices, circulating levels of sex hormones and those related to hunger, satiety and stress; markers of systemic inflammation; circadian rhythm markers and sleep quality; level of physical activity, energy consumption, and changes in gene expression of key metabolic enzymes. A randomized, crossover, placebo-controlled, triple-blind nutritional intervention study will be conducted. The study will be carried out in a population of 22 volunteers. Men and women aged 18 years or older, who are working a rotating night shift for at least 1 year and with blood levels of LDL-C between 116 and 190 mg/dL may participate. Each volunteer will make 5 visits to the facilities of the EURECAT Nutrition and Health Technological Unit, in accordance with the study design: * A pre-selection visit (to check inclusion/exclusion criteria), and if the inclusion criteria are met. * Two study visits during consumption of the first product (GSPE or placebo), which will take place on the first day of study (visit 1) and after 6 weeks of treatment (visit 2). * Two study visits during consumption of the second product (GSPE or placebo), which will take place after a three-week washout period (visit 3), and after 6 weeks of treatment (visit 4). The main variable of the CIRCAFENOL study is circulating LDL-C levels. ### Conditions Module **Conditions:** - Cardiovascular Diseases - Circadian Rhythm Sleep Disorder, Shift Work Type - Cholesterol Level, High **Keywords:** - Proanthocyanidins - Circadian Rhythm - Metabolic Syndrome - Melatonin - Polyphenols ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 22 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive the grape seed proanthocyanidin extract (GSPE) for 6 weeks. **Intervention Names:** - Dietary Supplement: grape seed proanthocyanidin extract **Label:** grape seed proanthocyanidin extract **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive the placebo for 6 weeks. **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - grape seed proanthocyanidin extract **Description:** 250 mg of product presented in capsule form will be given. **Name:** grape seed proanthocyanidin extract **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** 165 mg of cellulose will be given presented in capsule form. **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Serum LDL cholesterol levels will be measured by commercial colorimetric kit. **Measure:** Change in LDL cholesterol levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). #### Secondary Outcomes **Description:** Body weight will be measured by standardized method. **Measure:** Change in body weight. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Height will be measured by standardized method. **Measure:** Height. **Time Frame:** At week 1. **Description:** Weight and height will be combined to report BMI in kg/m\^2. **Measure:** Change in BMI. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Waist circumference will be measured using a measuring tape. **Measure:** Change in waist circumference. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Weight, height and waist circumference will be combined to report Conicity index. **Measure:** Change in conicity index. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Waist circumference and height will be combined to report Waist circumference to Height ratio. **Measure:** Change in waist circumference to height ratio. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Body fat will be measured by TANITA SC330. **Measure:** Change in the amount of body fat. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Muscle mass will be measured by TANITA SC330. **Measure:** Change in the amount of muscle mass. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Bone mass will be measured by TANITA SC330. **Measure:** Change in the amount of bone mass. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Total body water will be measured by TANITA SC330. **Measure:** Change in the amount of total body water. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Systolic blood pressure will be measured using an automatic sphygmomanometer. **Measure:** Change in systolic blood pressure. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Diastolic blood pressure will be measured using an automatic sphygmomanometer. **Measure:** Change in diastolic blood pressure. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Resting heart rate will be measured using an automatic sphygmomanometer. **Measure:** Change in resting heart rate. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Endothelial function will be measured using the Laser-Doppler technique. **Measure:** Change in endothelial function. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum total cholesterol levels will be measured by standardized ultraviolet-visible spectrophotometry methods. **Measure:** Change in serum total cholesterol levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum HDL-c levels will be measured by standardized ultraviolet-visible spectrophotometry methods. **Measure:** Change in serum HDL-c levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum triglycerides levels will be measured by standardized ultraviolet-visible spectrophotometry methods. **Measure:** Change in serum Triglycerides levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Total cholesterol and HDL-c values will be combined to report Total cholesterol to HDL-c ratio. **Measure:** Change in total cholesterol to HDL-c ratio. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** LDL-c and HDL-c values will be combined to report LDL-c to HDL-c ratio. **Measure:** Change in LDL-c to HDL-c ratio. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Plasma atherogenic index will be calculated as the logarithm of the triglycerides levels to HDL-c levels ratio. **Measure:** Change in Plasma atherogenic index. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum glucose levels will be measured by standardized ultraviolet-visible spectrophotometry methods. **Measure:** Change in serum glucose levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum insulin levels will be measured by spectrophotometry methods. **Measure:** Change in serum insulin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum glycosylated hemoglobin levels will be measured by commercial kits. **Measure:** Change in serum glycosylated hemoglobin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** HOMA-IR will be calculated using serum glucose and insulin levels. **Measure:** Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR). **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum C-Reactive protein levels will be measured by plate test and by the agglutination of latex particles. **Measure:** Change in serum high sensitivity c-reactive protein levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum ghrelin levels will be measured by ELISA kits. **Measure:** Change in serum ghrelin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum leptin levels will be measured by ELISA kits. **Measure:** Change in serum leptin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum T3 levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating thyroid hormone T3 levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** SerumT4 levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating thyroid hormone T4 levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum testosterone levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating testosterone levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum estrone levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating estrone levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum 17-β-Estradiol levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating 17-β-Estradiol levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum estriol levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating estriol levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum melatonin levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in serum melatonin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** 6-Sulfatoxymelatonin levels will be measured in spontaneous urine samples from two times of the day: morning and night by ELISA kit. **Measure:** Change in urine 6-Sulfatoxymelatonin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Activity and rest cycles will be measured subjectively by dream diaries. The sleep diary will be self-completed by the participant and will determine the time at which the person attempted to sleep, the duration and interruptions of nighttime sleep, the person's sleep pattern, and how much of the day the person was active. **Measure:** Change in activity and rest cycles (subjective measurement). **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Activity and rest cycles will be measured objectively by actigraphs. The wrist actigraphs will be worn 24 hours a day and will measure heart rate, which will give an idea of the amount of time the person was asleep and active. **Measure:** Change in activity and rest cycles (objective measurement). **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** It is a validated scale that measures the usual sleep habits during the past month. It consist of 7 areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. It contains a total of 19 items, grouped into 10 questions where each of the areas evaluated is a scored between 0 and 3. The scores from the seven areas are finally added up to give an overall score. The component score are summed to produce a global score (range 0 to 21). Higher score indicate worse sleep quality. **Measure:** Pittsburgh Sleep Quality Index. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** The chronotype will be evaluated using the Horne-Ostberg Morningness-Eveningness Questionnaire. Which consists of 19 questions that will allow volunteers to be classified into morning, night or intermediate people. **Measure:** Chronotype. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** GSPE metabolites will be measured by LC-TQD-MS/MS. **Measure:** Change in circulating GSPE metabolites. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Food consumption will be evaluated through a 3-day food record. **Measure:** Change in food consumption habits. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Physical activity will be evaluated through the Physical Activity Questionnaire, Quick Physical Activity Classifier, adapted from the PEFS guide of the Generalitat de Catalunya. The questionnaire asks about three specific types of activity (walking, moderate-intensity activities and vigorous intensity activities) in the set domains leisure time, domestic and gardening (yard) activities, work-related and transport-related activities. Frequency and duration are collected separately for each specific type of activity. **Measure:** Change in Physical activity. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Body temperature will be measured using a infrared thermometer according to a standardized measurement protocol. **Measure:** Change in body temperature. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** The expression of key genes in lipid and carbohydrate metabolism and regulation of the circadian rhythm will be measured through transcriptomic analysis, performing RNA extraction, conversion to cDNA and subsequent analysis. **Measure:** Change in gene expression in peripheral blood mononuclear cells. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** serum metabolites will be determined by LC-TQD-MS/MS. **Measure:** Change in serum metabolite profile. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Possible adverse events derived from taking study's products will be recorded. **Measure:** Adverse events **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Dietary supplements consumed during the study will be recorded in the case report form. **Measure:** Consumption of dietary supplements. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Concomitant medication will be recorded in the case report form. **Measure:** Concomitant medication. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Age will be recorded in years. It will be recorded in the case report form. **Measure:** Age. **Time Frame:** At week 1. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men and women aged 18 years or older. * Follow a rotating night shift work schedule\* for at least one year before the start of the study. \* shift workers with at least 5 night shifts per month alternating with day and/or afternoon shifts, with a seniority equal to or greater than one year. * Have no intention of changing the work shift during the course of the study. * Circulating LDL-C levels between 116 -190 mg/dL\*, without pharmacological treatment with antihypertensives and/or lipid-lowering agents. \*Values of 116 to 190 mg/dl indicate moderate alteration in the lipid profile and a greater risk of suffering from cardiovascular diseases, according to the European Society of Cardiology, and the European Society of Atherosclerosis. * Have signed the informed consent before starting the study. * Know how to read, write and speak in Catalan or Spanish Exclusion Criteria: * BMI values \> 30 kg/m2 * Take supplements, multivitamin supplements (Vit.D, Vit. E and Vit.C), mineral supplements (Zinc, Selenium), essential fatty acids (omega-3), polyphenols, natural plant extracts, or phytotherapeutic products that interfere with the treatment under study. * Consumption of alcoholic beverages: * Men: consume 4 or more Standard Beverage Units daily or 28 Standard Beverage Units weekly. * Women: Consume 2 or more Standard Beverage Units daily or 17 Standard Beverage Units weekly. * Be an active smoker. * Having lost more than 3 kg of weight in the last 3 months. * Present food intolerances and/or allergies related to the study products, such as hypersensitivity to cellulose or proanthocyanidins. * Present any chronic or autoimmune disease in clinical manifestation that may affect the results of the study such as diabetes (type I or II), cardiovascular disease, chronic kidney disease, hyper or hypothyroidism, chronic gastrointestinal diseases or cancer. * Present familial hypercholesterolemia. * Present hypertension (Systolic ≥140 mmHg; Diastolic ≥90 mmHg) * Present any previous cardiovascular disease defined as myocardial infarction, angina pectoris, stroke or peripheral arterial disease. * Individuals with treatment in the last 3 months before the start of the study with lipid-lowering, antidiabetic and/or antihypertensive drugs, or other drugs that may interfere with the results of the study. * Taking supplements with polyphenol components or those aimed at lipid or blood pressure control in the last 3 months before the start of the study or during participation in the study. * Follow a diet to lose weight, or very restrictive types of eating, such as intermittent fasting, ketogenic diet, etc. * Being pregnant or intending to become pregnant. * Being breastfeeding. * Be participating or have participated in a clinical trial with medications or nutritional intervention study in the last 30 days before inclusion in the study. * Suffering from eating disorders or psychiatric disorders. * Being unable to follow study guidelines. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Antoni Caimari Palou, PhD **Phone:** 0034 977 300 805 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Anna Crescenti, PhD **Phone:** 0034 977 300 431 **Role:** CONTACT #### Locations **Location 1:** **City:** Reus **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Antoni Caimari Palou, PhD - **Phone:** 0034977300805 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Anna Crescenti, PhD - **Phone:** 0034977300431 - **Role:** CONTACT **Country:** Spain **Facility:** Eurecat **State:** Tarragona **Zip:** 43204 #### Overall Officials **Official 1:** **Affiliation:** UTNS (Eurecat, Reus) **Name:** Antoni Caimari Palou, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Description Technological Centre of Nutrition and Health. Eurecat_Reus **URL:** http://eurecat.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000001523 - Term: Mental Disorders - ID: D000021081 - Term: Chronobiology Disorders - ID: D000020920 - Term: Dyssomnias - ID: D000009784 - Term: Occupational Diseases - ID: D000006949 - Term: Hyperlipidemias - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC24 - Name: Occupational Diseases ### Condition Browse Module - Browse Leaves - ID: M23005 - Name: Metabolic Syndrome - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M9988 - Name: Hypercholesterolemia - Relevance: HIGH - As Found: Cholesterol Level, High - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22007 - Name: Sleep Disorders, Circadian Rhythm - Relevance: HIGH - As Found: Circadian Rhythm Sleep Disorder - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Disorders - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M22703 - Name: Chronobiology Disorders - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M12719 - Name: Occupational Diseases - Relevance: LOW - As Found: Unknown - ID: M10000 - Name: Hyperlipidemias - Relevance: LOW - As Found: Unknown - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: LOW - As Found: Unknown - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000020178 - Term: Sleep Disorders, Circadian Rhythm - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006937 - Term: Hypercholesterolemia ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: Fl - Name: Flavonoid - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M11533 - Name: Melatonin - Relevance: LOW - As Found: Unknown - ID: M170641 - Name: Proanthocyanidin - Relevance: HIGH - As Found: Classical music - ID: M266073 - Name: Procyanidin - Relevance: HIGH - As Found: Classical music - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: T410 - Name: Melatonin - Relevance: LOW - As Found: Unknown - ID: T39 - Name: Proanthocyanidin - Relevance: HIGH - As Found: Classical music - ID: T40 - Name: Procyanidin - Relevance: HIGH - As Found: Classical music - ID: T24 - Name: Anthocyanidin - Relevance: HIGH - As Found: Classical music - ID: T173 - Name: Grape - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000013221 - Term: Proanthocyanidin - ID: C000017674 - Term: Procyanidin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422728 **Brief Title:** The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders **Official Title:** The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders #### Organization Study ID Info **ID:** E-71395021-050.06.04-35012 #### Organization **Class:** OTHER **Full Name:** Ibn Haldun University ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ibn Haldun University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The transdiagnostic approach argues that the common features are needed to be taken into account \[e.g. distress intolerance (DI), intolerance of uncertainty (IU), worry)\] underlying emotional disorders rather than evaluating them separately due to the fact that the dissection of anxiety disorders has increased with each emerging version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), in which the classification of anxiety disorders resulted in an increased number of intervention protocols for each disorder. This also caused an increase of comorbidity among anxiety disorders. Transdiagnostic approach offers a unified protocol (UP) for strengthening the common features, and thereby both preventing the emergence of emotional disorders or intervening the symptom severity of emotional disorders, which can be applied to different types of emotional disorders. The main aim of this study is to develop a UP which is planned to be applied as a group therapy. The UP will include interventions developing the levels of common transdiagnostic features (DI, IU and worry). The study's second aim is to investigate the effect of the developed UP on DI, IU and worry. The third one is to search the effect of the developed UP on symptom severity levels of anxiety disorders. Fourthly, this study will search if the levels of transdiagnostic common features (DI, IU and worry) will predict the levels of symptom severity of anxiety disorders'. **Detailed Description:** The transdiagnostic approach argues that common features are needed to be taken into account \[e.g. distress intolerance (DI), intolerance of uncertainty (IU), worry\] underlying emotional disorders rather than evaluating them separately since the dissection of anxiety disorders has increased with each emerging version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), in which the classification of anxiety disorders resulted in an increased number of intervention protocols for each disorder. That is why an increase in comorbidity among anxiety disorders is observed. The transdiagnostic approach offers a unified protocol (UP) for strengthening the common features, thereby preventing the emergence and intervening in several emotional disorders. As part of dissertation, the main aim of this study is to develop UP in Turkish, and measure the effectiveness of the UP on anxiety disorders and the transdiagnostic features. The UP is planned in group therapy format and includes interventions strengthening the common transdiagnostic features (DI, IU, and worry). This protocol is based on cognitive behavioral therapy (CBT) model. The sessions in the protocol are planned as follows: Session 1 is assessment session and Session 2 is on psychoeducation, which mainly intend to introduce the CBT model. In session 3, emotions are discussed, revealing that emotions point out what is important for us in life. In session 4, 5 and 6, thoughts are worked on. The participants learn to deal with worry and to challenge unfunctional thoughts and generate alternative explanations. Session 7 focuses on behaviors, in which the role of behaviors and the things that can/cannot be controlled are discussed. Session 8 includes a review of what has been learnt during the group therapy and an evaluation on maintaining the accomplishments. In addition, a follow-up session is planned after one month. In this study, there will be an intervention (UP) group and a control group. The participants will be assigned to the groups randomly. The measurements are the Distress Intolerance Scale (DTS), Intolerance of Uncertainty Scale-12 (IUS-12), Penn State Worry Questionnaire (PSWQ), Metacognitions Questionnaire-30 (MCQ-30), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder Assessment (GAD-7). The uniqueness of this protocol is to be the first UP in Turkish with its own order. It is expected to promote transdiagnostic studies in Turkey. This research is also important in contributing to the literature on transdiagnostic studies, which offer an alternative to comorbidity and a decrease in the symptom severity of anxiety disorders. ### Conditions Module **Conditions:** - Anxiety Disorders - Social Anxiety Disorder - Generalized Anxiety Disorder - Panic Disorder - Anxiety Disorder NOS **Keywords:** - transdiagnostic approach - unified protocol, - anxiety disorders - CBT - cognitive behavioral therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study will search the effectiveness of the unified protocol on anxiety disorders. For this purpose, there will be an intervention group (unified protocol will be applied) and a control group. The participants will be assigned randomly to the groups. ##### Masking Info **Masking:** SINGLE **Masking Description:** In this study, single-blined procedure will be applied to reduce biases. For this purpose, participants will be informed only about the general procedure of group therapy (e.g. general focus of the group therapy, number of sessions, duration of sessions, number of participants) but will not be informed about which intervention they receive and which group they are assigned. **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention group will receive the transdiagnostic unified protocol (UP) for anxiety disorders that is developed in this study. The UP is based on CBT model and will last for 8 weeks and there will be a follow-up session after one month. Each session will last 1 and a half hours. The pre-, post- and follow-up tests will be given to them to test the effectiveness of the UP. **Intervention Names:** - Other: Unified Protocol for Anxiety Disorders **Label:** Transdiagnostic Unified Protocol **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The supportive therapy group will also last for 8 weeks and there will be a follow-up session after one month. Each session will last 1 and a half hours. The pre-, post- and follow-up tests will be given to them, too. **Intervention Names:** - Other: Client-centered Supportive Therapy **Label:** Client-Centered Supportive Therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Transdiagnostic Unified Protocol **Description:** The UP is planned in group therapy format and includes interventions on common transdiagnostic features. The sessions in the protocol are planned as follows: Session 1 - Assessment: introduction, talking on group rules and the process, setting goals Session 2 - Psychoeducation: the CBT model is introduced. Session 3 - Emotions: the role of emotions are discussed. Session 4, 5 \& 6 - Thoughts: the role of thoughts is mentioned. The participants learn to challenge unfunctional thoughts and generate alternative explanations. Also, exercises on excessive worry are applied. Session 7 - Behaviors: the role of behaviors and the things that can/cannot be controlled are discussed. Session 8 - Evaluation \& Maintaining Accomplishments: includes a review of what has been learnt during the group therapy and an evaluation on maintaining the accomplishments. Session 9 - Follow-up session: one month later. **Name:** Unified Protocol for Anxiety Disorders **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Client-Centered Supportive Therapy **Description:** Client-entered therapy provides a non-directive supportive environment for the participants, that includes reflective listening and nonjudgemental and empathic communication. In this group, no CBT intervention will be applied. Through the supportive and non-directive environment, only the effect of relationship will be investigated as a common factor in psychotherapy. **Name:** Client-centered Supportive Therapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Generalized Anxiety Disorder-7 (GAD-7) scale will be used to measure anxiety level. GAD-7 is a self-report scale consisting of 7 items. It is a 4-point Likert type scale. Items are scored between 0 (Not at all) and 3 (Nearly every day). Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety. In the total score, the cut-off score for GAD diagnosis is 10. **Measure:** Anxiety **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Distress Tolerance Scale (DTS) scale will be used to measure distress tolerance level. DTS consists of a total of 15 items. Each item is rated on a 5-point Likert scale range from 1 (Strongly disagree) to 5 (Strongly disagree). A low total score indicates low distress tolerance level. **Measure:** Distress Tolerance **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Intolerance of Uncertainty Scale (IUS) - Short Version will be used to measure the level of intolerance of uncertainty. IUS-12 is a self-report scale consisting of 12 items in total. It is a 5-point Likert scale. Each item is scored between 1 (not at all characteristic of me) to 5 (entirely characteristic of me). A high total score indicates a high level of intolerance to uncertainty. **Measure:** Intolerance of Uncertainty **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Penn State Worry Questionnaire will be used to measure the level of worry. PSWQ is a self-report scale with a 5-point Likert-type, consisting of a total of 16 items. Scale items are scored between 1 (Not at all typical) - 5 (Very typical of me). An increase in the PSWQ total score indicates a high level of worry. **Measure:** Worry **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Metacognition Questionnaire-30 Short Form will be used to measure metacognitive beliefs. MCQ-30, consisting of a total of 30 items, has a 4-point Likert-type scale. Each item is scored between 1 (Do not agree) and 4 (Agree very much). An increase in scale scores indicates an increase in pathological metacognitive activity. **Measure:** Metacognition **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Patient Health Questionnaire-9 (PHQ-9) will be used to measure the level of depression. PHQ-9 consists of 9 questions which is a 4-point Likert type scale. Each item is scored between 0 (Not at all) - 3 (Nearly every day). As the total score increases, the severity of depression increases. **Measure:** Depression **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being diagnosed with at least one of the following disorders in the pre-interview (SCID 5 interview for diagnosis): generalized anxiety disorder (GAD), panic disorder (PD), social anxiety disorder (SAD) or anxiety disorder not otherwise specified (NOS). Exclusion Criteria: * Active substance use or having a psychiatric history related to substance use * Having a co-diagnosis of psychotic disorders or bipolar disorders * Receiving active psychotherapy support * Being not graduated from primary school **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Iclal AYDIN, MA **Phone:** 00905353746285 **Role:** CONTACT #### Locations **Location 1:** **City:** Zeyti̇nburnu **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Iclal AYDIN, MA - **Phone:** 00905353746285 - **Role:** CONTACT **Country:** Turkey **Facility:** Iclal AYDIN **State:** İstanbul **Zip:** 34025 #### Overall Officials **Official 1:** **Affiliation:** İbn Haldun University **Name:** Iclal AYDIN, MA **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** There is no plan to share because of the ethical concerns of the participants' privacy. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000010698 - Term: Phobic Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety Disorder - ID: M18970 - Name: Panic Disorder - Relevance: HIGH - As Found: Panic Disorder - ID: M1117 - Name: Phobia, Social - Relevance: HIGH - As Found: Social Anxiety Disorder - ID: M13603 - Name: Phobic Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders - ID: D000016584 - Term: Panic Disorder - ID: D000072861 - Term: Phobia, Social ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422715 **Acronym:** FIL_PTLD **Brief Title:** PTLD: Multicentric Retrospective Study **Official Title:** Post-transplant Lymphoproliferative Disorders (PTLD): Multicentric Observational Retrospective Cohort Study #### Organization Study ID Info **ID:** FIL_PTLD #### Organization **Class:** OTHER **Full Name:** Fondazione Italiana Linfomi - ETS ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Pierre Fabre Pharma AG #### Lead Sponsor **Class:** OTHER **Name:** Fondazione Italiana Linfomi - ETS #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD. The aim of the study is to analyze the clinical features and survival of patients who received a PTLD diagnosis with the target to assess a survival outcome, to obtain an epidemiologic and clinical characterization of the subpopulations affected by PTLD, to recognize unfavorable properties, to report the current treatment strategies, to provide rationale for the design of a prospective registry in order to develop future novel treatments. **Detailed Description:** This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD. Retrospective data will be collected for all cases of PTLD diagnosed during a 10 years period since 1st January 2011 to 31th December 2021. The following clinical characteristics of the patient at the time of PTLD diagnosis and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted, and response obtained. ### Conditions Module **Conditions:** - PTLD **Keywords:** - PTLD - lymphoproliferative disorders - transplant ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients with histological diagnosis obtained from a biopsy sample in 10 years' time frame (from 01/01/2011 to 31/12/2021) of PTLD (from allogeneic transplantation (both SOT and HSCT)) **Label:** patients with histological diagnosis of PTLD ### Outcomes Module #### Primary Outcomes **Description:** survival after PTLD incidence rating **Measure:** Rate of Overall Survival **Time Frame:** from diagnosis of PTLD to patient's death / last FUP - up to 18 months. **Description:** analyze the clinical and epidemiological features (e.g. positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained) of PTLD patients **Measure:** clinical and epidemiological features **Time Frame:** from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. #### Secondary Outcomes **Description:** compare outcomes according to treatment approaches **Measure:** Rate of Progression Free Survival **Time Frame:** from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. **Description:** investigate potential treatment effect modifications on outcomes according to patient characteristics **Measure:** Overall Response Rate **Time Frame:** from treatment of PTLD to patient's death / last FUP - up to 18 months. **Description:** investigate potential treatment effect modifications on outcomes according to patient **Measure:** Complete Response Rate to first and subsequent treatments **Time Frame:** from treatment of PTLD to patient's death / last FUP - up to 18 months. **Description:** Overall Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant) **Measure:** Overall Survival stratified by prognostic factors **Time Frame:** from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. **Description:** Progression Free Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant) **Measure:** Progression Free Survival stratified by prognostic factors **Time Frame:** from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * histological diagnosis of PTLD obtained from a biopsy sample (availability of stocked biopsy sample is requested but not mandatory); * age over 18 years at time of diagnosis of PTLD; * previously subjected to allogeneic transplantation (both SOT and HSCT); * diagnosis of PTLD obtained in 10 years' time frame (from 01/01/2011 to 31/12/2021); * free and voluntary written informed consent (included unreachable subjects according to Art. 36 UE Regulation 2016/679 and to the current Italian Privacy Regulation). Exclusion Criteria: * Patients not meeting the above-mentioned inclusion criteria. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Population will be composed by patients with histological diagnosis of PTLD. The following clinical characteristics of the patient at the diagnosis of PTLD and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Uffici Studi FIL **Phone:** 0131033153 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Uffici Studi FIL **Phone:** 059 976 9910 **Role:** CONTACT #### Locations **Location 1:** **City:** Milano **Country:** Italy **Facility:** Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia **State:** MI **Zip:** 20122 **Location 2:** **City:** Ancona **Country:** Italy **Facility:** A.O. UNIVERSITARIA OSPEDALI RIUNITI - OSPEDALE UMBERTO I DI ANCONA - Clinica di Ematologia **Zip:** 60126 **Location 3:** **City:** Aviano **Country:** Italy **Facility:** Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati **Location 4:** **City:** Bergamo **Country:** Italy **Facility:** Azienda Ospedaliera Papa Giovanni XXIII - Ematologia **Zip:** 24127 **Location 5:** **City:** Bologna **Country:** Italy **Facility:** A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli" **Zip:** 40138 **Location 6:** **City:** Brescia **Country:** Italy **Facility:** A.O. Spedali Civili di Brescia - Ematologia **Location 7:** **City:** Cagliari **Country:** Italy **Facility:** Ospedale Businco - Divisione di Ematologia **Location 8:** **City:** Cuneo **Country:** Italy **Facility:** A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo **Location 9:** **City:** Firenze **Country:** Italy **Facility:** A.O. UNIVERSITARIA CAREGGI DI FIRENZE - Unità funzionale di Ematologia **Zip:** 50139 **Location 10:** **City:** Miano **Country:** Italy **Facility:** ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia **Location 11:** **City:** Milano **Country:** Italy **Facility:** Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia **Zip:** 20132 **Location 12:** **City:** Novara **Country:** Italy **Facility:** AOU Maggiore della Caritа di Novara - SCDU Ematologia **Location 13:** **City:** Padova **Country:** Italy **Facility:** IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1 **Zip:** 35128 **Location 14:** **City:** Pavia **Country:** Italy **Facility:** IRCCS Policlinico San Matteo - Divisione di Ematologia **Location 15:** **City:** Roma **Country:** Italy **Facility:** Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare **Zip:** 00128 **Location 16:** **City:** Roma **Country:** Italy **Facility:** Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia **Zip:** 00161 **Location 17:** **City:** Roma **Country:** Italy **Facility:** Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia **Location 18:** **City:** Siena **Country:** Italy **Facility:** AOU Senese - U.O.C. Ematologia **Zip:** 53100 **Location 19:** **City:** Torino **Country:** Italy **Facility:** A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia **Zip:** 10126 **Location 20:** **City:** Torino **Country:** Italy **Facility:** A.O. Città della Salute e della Scienza - Ematologia Universitaria **Location 21:** **City:** Udine **Country:** Italy **Facility:** Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica **Zip:** 33100 **Location 22:** **City:** Vicenza **Country:** Italy **Facility:** ULSS 8 Berica - Ospedale S. Bortolo - Ematologia **Zip:** 36100 #### Overall Officials **Official 1:** **Affiliation:** Ematologia Universitaria - A.O.U. Citta della Salute e della Scienza di Torino **Name:** Federica Cavallo, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: HIGH - As Found: Lymphoproliferative Disorders - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T4650 - Name: Post-transplant Lymphoproliferative Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008232 - Term: Lymphoproliferative Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422702 **Brief Title:** The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer **Official Title:** A Prospective, Randomized, Single-blind Study on the Effects of Psychosomatic Symptom Interventions on Patients With Differentiated Thyroid Cancer During the Initial Treatment Period #### Organization Study ID Info **ID:** HMUDQ20231116204 #### Organization **Class:** OTHER **Full Name:** Harbin Medical University #### Secondary ID Infos **Domain:** National Natural Science Foundation of China **ID:** 72004047 **Type:** OTHER_GRANT **Domain:** Fundamental Research Funds for the Provincial Universities，Heilongjiang,China **ID:** JFCX202303 **Type:** OTHER_GRANT **Domain:** Postgraduate Research & Practice Innovation Program of Harbin Medical University **ID:** YJSCX2023-295HYD **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2024-08-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-01-22 **Type:** ACTUAL #### Start Date **Date:** 2023-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Harbin Medical University #### Responsible Party **Investigator Affiliation:** Harbin Medical University **Investigator Full Name:** Shuhua Luo **Investigator Title:** researcher **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Dear Sir/Madam, You are cordially invited to participate in a clinical study. Before deciding whether to participate, it is important that you understand this study. Please read the following information carefully. If you have fully understood the study, have no further questions, and decide to participate, you will need to sign an informed consent form. 1. Study Background Thyroid cancer is the most common malignant tumor of the endocrine system, with differentiated thyroid cancer (DTC) accounting for over 95% of cases. The initial treatment phase typically refers to the first year after patients undergo surgery, TSH suppression therapy, or radioactive iodine treatment. Studies have found that DTC patients may experience a variety of health-related issues during this stage. For instance, many patients not only suffer from neck discomfort and pain post-surgery but may also face risks of postoperative bleeding, nerve damage, reduced bone density, and other physical complications. They are more susceptible to anxiety, depression, sleep disturbances, and fear of recurrence. These psychological and physical symptoms can affect patients' ability to achieve target TSH levels, which is crucial for their prognosis. Therefore, this study aims to design an intervention plan for the psychosomatic symptoms of DTC patients in the initial treatment phase to improve their physiological discomfort and negative psychological experiences, enhance their self-management efficacy, and promote TSH suppression therapy compliance and overall health. 2. Study Objectives * To explore the impact of the psychosomatic symptom intervention plan on TSH levels, anxiety, depression, and self-management efficacy in patients with differentiated thyroid cancer during the initial treatment phase. * To provide a basis for improving the physical and mental health of DTC patients in the initial treatment phase. 3. Study Design and Process This study targets patients with differentiated thyroid cancer in the initial treatment phase. Participants will be divided into an intervention group and a control group using a block randomization method. The effectiveness of the plan will be tested through a 3-month intervention in a randomized controlled trial. Data collection points are baseline, at the end of the intervention, and 3 months post-intervention. The primary outcome measure is TSH levels, with secondary outcomes including anxiety, depression, and self-management efficacy. This could provide a basis for formulating scientifically sound health service policies, rational allocation and utilization of health resources, reducing the burden of medical services, and establishing a fair and efficient healthcare system. 4. Potential Benefits and Risks We will provide necessary advice for your current concerns and offer information related to differentiated thyroid cancer. Should you experience any discomfort during the study, please provide feedback to the medical staff in the research team promptly. We will dynamically assess your physiological and psychological changes and address them promptly, so there is no need for concern. 5. Handling of Harm The study involves a psychosomatic intervention lasting 12 weeks, with two sessions per week, each approximately 30 minutes. If you have any concerns during the intervention, you may contact us at any time. Our researchers, after various assessments, believe that this study will not harm your physical health. Even if you have signed this informed consent, you still retain all your legal rights. 6. Principles of Privacy and Confidentiality Your personal health information will be stored at Harbin Medical University and may be accessed by researchers, regulatory authorities, and the ethics committee. Any public reports on the results of this study will not disclose your personal identity. We will make every effort to protect your personal privacy within the legally permitted scope. By signing this informed consent, you agree to the use of your personal and health information as described above. 7. Voluntary Principle Participation in this study is entirely voluntary. You may refuse to participate or opt out of the study at any time without any reason. This decision will not affect your future daily life. However, it is hoped that you will complete this study unless there are special reasons. If you decide to withdraw under any circumstances, please inform the researchers. 8. Participant's Responsibilities Once you agree to participate in this study, you should cooperate with the researchers to complete the intervention study and promptly feedback your health recovery status to the researchers during the intervention. 9. Consultation about the Study If you have any questions related to this study, please contact the project leader: Shuhua Luo, at 17382839336. ### Conditions Module **Conditions:** - Pathologically Confirmed Differentiated Thyroid Carcinoma - All Patients Are in the Initial Treatment Phase - Normal Cognitive and Communicative Abilities, Capable of Reading and Understanding Questionnaires in Chinese - Ability to Use a Smartphone - Voluntary Participation in the Study and Signed Informed Consent **Keywords:** - Differentiated thyroid cancer - Anxiety - Depression - Thyroid stimulating hormone - Randomized block design ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Implementation of a psychosomatic symptom intervention with a duration of three months. **Intervention Names:** - Other: Psychosomatic Symptoms Intervention **Label:** intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group implemented continuity of supportive care based on primary care **Intervention Names:** - Other: Extended supportive care **Label:** control group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - intervention group **Description:** Psychosomatic symptoms included intervention of negative psychological symptoms and intervention of physical discomfort symptoms. **Name:** Psychosomatic Symptoms Intervention **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - control group **Description:** The control group implemented continuity of supportive care based on primary care **Name:** Extended supportive care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This study is based on the recommended by 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. First, in patients with a structural incomplete response to therapy, the serum TSH should be maintained below 0.1 mU/L. Secondly, in patients with a biochemical incomplete response to therapy, the serum TSH should be maintained between 0.1 and 0.5 mU/L. In patients with an excellent (clinically and biochemically free of disease) or indeterminate response to therapy, the serum TSH may be kept within the low reference range (0.5-2 mU/L). Finally, in patients who have not undergone remnant ablation, the serum TSH can be allowed to rise to the low reference range (0.5-2 mU/L). **Measure:** TSH **Time Frame:** Before the start of the intervention (T0), at the end of the intervention (up to 12 weeks of intervention, i.e., three months postoperatively, T1), and six months after the end of the intervention (i.e., nine months postoperatively, T2). #### Secondary Outcomes **Description:** The Hospital Anxiety and Depression Scale (HADS) was used to assess the anxiety and depression levels of DTC patients. The scale was developed by Zigmond in 1983 and is primarily used to assess the anxiety and depression of the subjects over the past month. A total of 14 items were included, comprising an anxiety subscale and a depression subscale, each containing 7 items. According to the frequency of occurrence, the situation is divided into four levels, namely "1 to 4", scored from 0 to 3 points, and the two subscales range from 0 to 21 points. The lowest possible score is 0, while the highest is 42. Higher scores on the scale indicate more severe levels of anxiety and depression. **Measure:** anxiety and depression **Time Frame:** Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3). **Description:** The Chinese version of Strategies Used by People to Promote Health (C-SUPPH) was used to evaluate the self-management efficacy of DTC patients. The scale was developed in 1996, and the Chinese version was revised by Huijuan Qian et al. There were 28 items in total, including 3 dimensions of positive attitude (items 7, 15 to 28), self-decision-making (items 10 to 12) and self-decompression (items 1 to 6, 8, 14). Each item was scored using the Likert 5 scale, with a score of 1 indicating no confidence and a score of 5 indicating very confident. The total score ranged from 28 to 140, ranging from 0 to 55 (low level), from 55 to 112 (medium level), and from \>112 (high level), with higher scores indicating greater confidence in the individual to perform self-care. **Measure:** Self-management efficacy **Time Frame:** Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3). **Description:** The Constant-Murley Shoulder Function Scale (CMS) was used to assess the shoulder joint activity of the two groups. The scale includes two dimensions: subjective evaluation and objective evaluation. Subjective evaluation included pain levels and activities of daily living. Objective evaluation included assessing shoulder range of motion and muscle strength. The lowest score is 0, the highest score is 100, higher scores indicate better shoulder function. **Measure:** Shoulder function **Time Frame:** Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3). ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: 1. Clinical diagnosis of differentiated thyroid cancer 2. Participants had to be in the initial treatment phase 3. Cognitive and communication skills are normal 4. Can use a smartphone 5. Voluntary participation in the study Exclusion criteria: 1. History of neck or shoulder trauma 2. Coexisting serious heart, brain, or lung diseases 3. History of a major psychological disorder or mental illness 4. Patients taking hypnotics or psychotropic medications 5. have recently participated in a similar intervention or are receiving other psychotherapy **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Harbin **Country:** China **Facility:** Harbin Medical University **State:** Heilongjiang **Zip:** 150000 ## Document Section ### Large Document Module #### Large Docs - Date: 2023-05-01 - Filename: Prot_SAP_ICF_000.pdf - Has ICF: True - Has Protocol: True - Has SAP: True - Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Size: 191154 - Type Abbrev: Prot_SAP_ICF - Upload Date: 2024-05-15T22:50 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M16723 - Name: Thyroid Neoplasms - Relevance: HIGH - As Found: Thyroid Cancer - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000013959 - Term: Thyroid Diseases ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422689 **Acronym:** ANCHOR **Brief Title:** Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care **Official Title:** ANCHOR - Assessment of Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care #### Organization Study ID Info **ID:** D6930L00001 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2026-04-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-04-29 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Premier HealthCare Solutions Inc. #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** ANCHOR is a prospective, multi-center, phase IV, interventional, single-arm, open-label study of 2,000 adult participants with symptomatic asthma requiring the use of rescue therapy aimed to compare the asthma exacerbation rates before and after switching from albuterol or levalbuterol to albuterol plus budesonide inhalation aerosol as rescue therapy. **Detailed Description:** This study will primarily compare rates of asthma exacerbation during 12-month pre-switch period and 12-month post switch period among participants with asthma needing a rescue therapy. Other outcomes of interest for comparison between the pre- and post-switch periods include asthma-related oral corticosteroids (OCS) use, asthma exacerbation-related hospitalizations, emergency department (ED) visits, urgent care visits, outpatient visits, telehealth visits, and asthma-related and asthma exacerbation-related healthcare costs. The use of asthma control and rescue medications will be collected to understand treatment patterns in the real-world US context. ### Conditions Module **Conditions:** - Asthma **Keywords:** - Effectiveness - Asthma - Exacerbation - Healthcare resource utilization - Cost - Albuterol/budesonide - Short-acting beta-agonist (SABA) - Inhaled corticosteroids (ICS) - Rescue - Switch - Oral corticosteroid - Patients reported asthma symptoms - PT027 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive a fixed-dose combination of albuterol (90mcg) and budesonide (80mcg) administered as 2 inhalations (180mcg/160mcg) via pressurized metered dose inhaler (pMDI) as needed for asthma symptoms, for up to 12 inhalations (6 doses) in a 24-hour period. **Intervention Names:** - Drug: Albuterol and budesonide inhalation aerosol **Label:** Albuterol and budesonide inhalation aerosol **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Albuterol and budesonide inhalation aerosol **Description:** Participants will receive a fixed-dose combination of albuterol (90mcg) and budesonide (80mcg) administered as 2 inhalations (180mcg/160mcg) via pressurized metered dose inhaler (pMDI) as needed for asthma symptoms, for up to 12 inhalations (6 doses) in a 24-hour period. **Name:** Albuterol and budesonide inhalation aerosol **Other Names:** - PT027 **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Percentage of patients who reported improvement in asthma symptoms and satisfaction with albuterol and budesonide treatment as rescue therapy **Measure:** Improvement in patient reported asthma symptoms and treatment satisfaction using the ANCHOR PRO Questionnaire **Time Frame:** at 3-, 6-, 9-, and 12-month post-switch **Description:** Number of fills of asthma-related controllers and rescue medications **Measure:** Asthma-related controller and rescue medication use **Time Frame:** During 12-month pre-switch and 12-month post switch periods separately #### Primary Outcomes **Description:** Annualized Severe Asthma exacerbation rate **Measure:** Asthma exacerbation **Time Frame:** During 12-month pre-switch and 12-month post-switch periods #### Secondary Outcomes **Description:** Percentage of patients with Asthma exacerbation-related HCRU **Measure:** Asthma exacerbation-related HCRU **Time Frame:** During 12-month pre-switch and 12-mont post switch periods **Description:** Asthma exacerbation-related cost in US Dollars **Measure:** Asthma exacerbation-related cost **Time Frame:** During 12-month pre-switch and 12-month post-switch periods **Description:** Asthma-related cost in US Dollars **Measure:** Asthma-related cost **Time Frame:** During 12-month pre-switch and 12-month post-switch periods **Description:** Mean number of Asthma- related Oral Corticosteroid (OCS) prescriptions **Measure:** Asthma- related Oral Corticosteroid (OCS) use **Time Frame:** During 12-month pre-switch and 12-month post-switch periods **Description:** Percentage of patients with Asthma exacerbation-related HCRU at the health system level **Measure:** Change in asthma exacerbation-related HCRU at health system level **Time Frame:** During 12-month pre-switch and 12-month post-switch periods ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adults aged 18 years and above as of enrollment date. 2. At least 1 visit with primary or secondary diagnosis of asthma on or within 12 months prior to the enrollment date. 3. At least 1 prescription filled for Short-acting beta-agonist (SABA)-only inhaler (i.e., albuterol-only or levalbuterol only inhalers) within 12 months before enrollment date. 4. At least 1 asthma exacerbation within 12 months before enrollment date. 5. Had both medical and pharmacy insurance coverage (e.g., Medicare, Medicaid, and commercial insurance) for at least 12 months before enrollment date and without foreseeable plans to discontinue insurance coverage within 12 months after enrollment date. 6. Participants also need to meet each of the following inclusion criteria: 1. Willingness to use albuterol and budesonide as rescue as instructed by their physician, prescribing information, and United States instruction for use (USIFU). 2. Willingness to respond to quarterly safety inquiries. 3. Willingness to participate in quarterly electronic patient-reported outcome (PRO) surveys via email or text. 4. Physician decision that participant is eligible for treatment with albuterol and budesonide as rescue according to the approved United States prescribing information (USPI). Exclusion Criteria: 1. Conditions with major respiratory diagnoses including chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, bronchiectasis, respiratory tract cancer, bronchopulmonary dysplasia, sarcoidosis, lung cancer, interstitial lung disease, pulmonary hypertension, and tuberculosis in 12 months before the enrollment date. 2. Inpatient admission or emergency department or urgent care visit due to asthma in the 10 days before enrollment date, or self-reported use of systemic corticosteroid for the treatment of asthma in the 10 days before enrollment date. Participants who were screen-failed due to this criterion may be re-screened once the participant is more than 10 days post asthma-related inpatient admission, emergency department or urgent care visit, or systemic corticosteroid use. 3. Chronic use of oral corticosteroids (for any condition) within 3 months before enrollment date. Chronic use of oral corticosteroids is defined as: daily or every other day use for 14 days or longer. 4. History of albuterol and budesonide as rescue use within 12 months before enrollment date. 5. History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date. 6. For females only - currently pregnant or breastfeeding on enrollment date. Participants are excluded from the study if any of the following criteria apply. **Maximum Age:** 130 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Flint **Country:** United States **Facility:** Research Site **State:** Michigan **Status:** RECRUITING **Zip:** 48532 **Location 2:** **City:** Minneapolis **Country:** United States **Facility:** Research Site **State:** Minnesota **Status:** NOT_YET_RECRUITING **Zip:** 55425 #### Overall Officials **Official 1:** **Affiliation:** University of Michigan, Michigan, USA **Name:** Njira Lugogo, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Jefferson Health, Pennsylvania, USA **Name:** Neil Skolnik, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **URL:** https://vivli.org/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000001993 - Term: Bronchodilator Agents - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000058666 - Term: Adrenergic beta-2 Receptor Agonists - ID: D000000318 - Term: Adrenergic beta-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Leaves - ID: M3767 - Name: Albuterol - Relevance: HIGH - As Found: Adapted - ID: M21711 - Name: Budesonide - Relevance: HIGH - As Found: Metabolic - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M20963 - Name: Anti-Asthmatic Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M17869 - Name: Tocolytic Agents - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3670 - Name: Adrenergic beta-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019819 - Term: Budesonide - ID: D000000420 - Term: Albuterol ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422676 **Acronym:** MINERVA **Brief Title:** MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA **Official Title:** Open-label Single-arm, Non-interventional, Multi-centre, Cohort Study for Evaluation of Clinical and Patient Reported Outcomes in New Users of BREZTRI (Budesonide / Glycopyrronium / Formoterol) in Routine Care Settings #### Organization Study ID Info **ID:** D5980R00097 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-02-29 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a retrospective-prospective, non-interventional, multi-centre study that will be conducted in routine clinical settings in Russia. Eligible patients with moderate to severe COPD routinely treated with BREZTRI will be observed according to routine clinical practice for up to 24 weeks. **Detailed Description:** Chronic obstructive pulmonary disease (COPD) is a disease characterized by persistent airflow limitation that is usually progresses and is a consequence of a chronic inflammatory response of the respiratory pathways and lung tissue to the effects of inhaled harmful particles or gases. Exacerbations and comorbid conditions are an integral part of the disease and contribute significantly to the clinical picture and prognosis \[1\]. Patient-reported outcomes (both symptom-based and health-related quality of life-specific) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response in COPD patients \[12\]. There is a need to evaluate the patient-reported outcomes during a triple therapy with budesonide + glycopyrronium bromide + formoterol (Breztri) in a real-life clinical practice. The aim of the study is to evaluate clinical and patient-reported outcomes of treatment with BREZTRI through effectiveness measures assessed pre- and post-treatment initiation and safety monitoring. The study results will be interpreted in the context of an open label, single arm study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect. ### Conditions Module **Conditions:** - Chronic Obstructive Pulmonary Disease **Keywords:** - Chronic obstructive pulmonary disease - COPD - BREZTRI ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Change from baseline to 24 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome. **Measure:** Change in COPD Assessment Test (CAT) score **Time Frame:** 24 weeks #### Secondary Outcomes **Description:** Change from baseline to 12 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome. **Measure:** Change in COPD Assessment Test (CAT) score **Time Frame:** 12 weeks **Description:** Change from baseline to 24 weeks in FEV1 **Measure:** Change in FEV1 **Time Frame:** 24 weeks **Description:** Change from baseline to 24 weeks in the TSQM score. Minimum score - "1", maximum score - "7". Higher scores mean better outcome. **Measure:** Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) score **Time Frame:** 24 weeks **Description:** • Percent of responders using the CAT who achieved MCID (minimal clinically important difference) = 2 or more points after 24 weeks of treatment **Measure:** MCID >= 2 **Time Frame:** 24 weeks of treatment **Description:** Percent of patients who are high adherent to therapy (who received 20 or more points at MARS) during 24 weeks; **Measure:** >= 20 points at MARS **Time Frame:** 24 weeks **Description:** Percent of patients with response (any category better than "no change") at the PGI-C after 24 weeks of treatment **Measure:** PGI-C - any improvement **Time Frame:** 24 weeks of treatment **Description:** • Percent of patients with change from baseline (before Breztri treatment start) in the severity of general COPD symptoms at the PGI-S after 24 weeks of treatment **Measure:** PGI-S - change from baseline **Time Frame:** after 24 weeks of treatment **Description:** to monitor AE frequency **Measure:** To describe treatment safety by AE (adverse events) monitoring **Time Frame:** AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred **Description:** to collect information on treatment discontinuation due to AE **Measure:** Treatment safety by AE monitoring **Time Frame:** AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Physician-diagnosed COPD no less than 12 months before BREZTRI treatment start; 2. Patients who have not achieved adequate disease control when treated with a combination of ICS and LABA or a combination of LABA and LAMA 3. Initiated treatment with BREZTRI ≤12 weeks before inclusion as prescribed according to the label; 4. CAT score not more than 1 week before BREZTRI start is available; 5. Patients must be able and willing to read, comprehend and follow written instructions, and to comprehend and complete the questionnaires required by the protocol 6. Have signed a written Informed Consent Form (ICF). Exclusion Criteria: 1. Documented COPD due to α-1 antitrypsin deficiency; 2. Previous treatment with triple fixed-dose combination in 12 months prior to inclusion; 3. Pregnancy or lactation period; 4. Concomitant uncontrolled disease; 5. A diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis; 6. Participation in other non-interventional observational trials that might, in the investigator's opinion, influence the assessment for the current study, or participation in any observational or clinical trial in the last 30 days prior to inclusion. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients \>= 18 y.o. with moderate to severe COPD who are eligible for BREZTRI therapy ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Saint-Petersburg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Role:** CONTACT ***Contact 2:*** - **Name:** Veronika Popova - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Russian Federation **Facility:** Reavita Medical Centre **Status:** RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Pulmonary Disease - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: HIGH - As Found: Obstructive Pulmonary Disease - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: HIGH - As Found: Chronic Obstructive Pulmonary Disease - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21711 - Name: Budesonide - Relevance: LOW - As Found: Unknown - ID: M304 - Name: Formoterol Fumarate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422663 **Acronym:** PRESENT **Brief Title:** A Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China **Official Title:** A Prospective, Observational, Multicentre Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China #### Organization Study ID Info **ID:** D2287R00198 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-03-19 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a Prospective, Observational, Multicentre Study to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China. Sponsor by Astrazeneca Investment(China) Co., LTD. **Detailed Description:** This is a prospective, observational, multicentre study. Approximately 500 moderate-to-severe asthma patients from 30 sites across China. Patients will be treated following routine clinical practice. Study measures will be collected at week 0, week 12 and week 24. The primary objective of PRESENT study is to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China. ### Conditions Module **Conditions:** - Moderate-to-Severe Asthma ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** enroll 500 subjects **Label:** Moderate-to-Severe Asthma ### Outcomes Module #### Other Outcomes **Description:** To summarize the safety data, including frequency of adverse events **Measure:** Frequency of adverse events **Time Frame:** week 0, week 12 and week 24 **Description:** To summarize the safety data, including percentage of adverse events. **Measure:** Percentage of adverse events. **Time Frame:** week 0, week 12 and week 24 **Description:** To summarize the safety data, including frequency of serious adverse events. **Measure:** Frequency of serious adverse events. **Time Frame:** week 0, week 12 and week 24. **Description:** To summarize the safety data, including percentage of serious adverse events. **Measure:** Percentage of serious adverse events. **Time Frame:** week 0, week 12 and week 24 #### Primary Outcomes **Description:** To describe treatment modification of uncontrolled moderate-to-severe asthma patients in China. **Measure:** Proportion of uncontrolled patients with treatment modification, which is indicated by maintenance drug dosage change, switch, add-on, discontinue from week 0 to week 24 **Time Frame:** week 0, week 12 and week 24. #### Secondary Outcomes **Description:** To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) **Measure:** Ashma disease burden: Exacerbation rate **Time Frame:** week 0, week 12 and week 24 **Description:** To describe the proportion of severe asthma among all patients according to GINA 2023 \& CN 2020 guidelines **Measure:** Proportions of severe asthma (GINA 2023 & CN 2020 guideline) at baseline & each follow-up assessment **Time Frame:** week 0, week 12 and week 24 **Description:** To describe EOS levels and proportion of eosinophilic phenotype patients at week 0,12\&24 **Measure:** Levels of bEOS at each follow-up assessment. Proportions of eosinophilic phenotype **Time Frame:** week 0, week 12 and week 24 **Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe) **Measure:** Asthma-related emergency visit. **Time Frame:** week 0, week 12 and week 24 **Description:** To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) **Measure:** Ashma disease burden: Asthma Control Test **Time Frame:** week 0, week 12 and week 24 **Description:** To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) **Measure:** Ashma disease burden: Lung function (FEV1) **Time Frame:** week 0, week 12 and week 24 **Description:** To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) **Measure:** Asthma disease burden: Treatment patterns **Time Frame:** week 0, week 12 and week 24 **Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe) **Measure:** Asthma-related outpatient visit. **Time Frame:** week 0, week 12 and week 24 **Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe) **Measure:** Asthma-related hospitalization: Length of stay, Invasive and non-invasive ventilator use. **Time Frame:** week 0, week 12 and week 24 **Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe) **Measure:** Asthma-related diagnostic tests (X-ray, CT scan, et al.) **Time Frame:** week 0, week 12 and week 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests) 2. Written informed consent 3. Moderate-to-severe asthma (asthma patients with treatment of GINA Step 3-5) 4. Age 12 years old and above Exclusion Criteria: 1. Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma 2. Received an investigational therapy for asthma, allergy, atopic disease, or eosinophilic disease as part of a clinical trial during the 6 months prior to enrolment. (Once enrolled in the PRESENT Study, patients should not enrol in any investigational trials.) 3. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study 4. Disease or condition other than asthma that requires treatment with systemic or oral steroids 5. Patients with poor inhaler skills and adherence **Maximum Age:** 130 Years **Minimum Age:** 12 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Moderate-to-Severe Asthma Patients ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Shanghai Tongji Hospital **State:** Shanghai **Status:** RECRUITING **Zip:** 20000 ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. URL: https://vivli.org/ **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved. **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **URL:** https://vivli.org/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422650 **Brief Title:** Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia **Official Title:** Effect of Nigella Sativa on Blood Lipids as an add-on Therapy in Atorvastatin Treated Hyperlipidaemic Patients. A Randomized Controlled Trial #### Organization Study ID Info **ID:** BSMMU/2023/11004 #### Organization **Class:** OTHER **Full Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh #### Responsible Party **Investigator Affiliation:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh **Investigator Full Name:** Farzana Siddiqua **Investigator Title:** Resident, MD, Pharmacology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of Nigella Sativa in 84 Hyperlipidaemic patients. Participants will be assessed at baseline and after 8 weeks of intervention. Subjects will be randomized to receive either Nigella Sativa 500 mg capsule daily or placebo capsule identical to Nigella Sativa twice daily for 8 weeks. Evaluation of lipid profile, SGPT, S.Creatinine will be before and after 8 weeks of intervention. Nigella Sativa related adverse events will be identified. Study outcome will establish safety and efficacy of Nigella Sativa in atorvastatin treated hyperlipidaemic patients **Detailed Description:** Hyperlipidemia is one of the most important risk factors to cause atherosclerosis that ultimately triggers cardiovascular complications like myocardial infarction, ischemic stroke, peripheral vascular disease etc. These are considered as the leading cause of mortality and morbidity worldwide. Nigella sativa has both lipid lowering and anti-oxidant potentials. In this regard Nigella Sativa can be given with standard therapy to regulate blood lipids. Aim of this study: This proposed study is therefore an effort to find out the safety and efficacy of Nigella Sativa in patient with hyperlipidemia.This study will be a single center study, utilizing a randomized, double-blind, placebo controlled trial. It will be conducted in the department of pharmacology, BSMMU in collaboration with the department of cardiology, BSMMU from the day of approval by the Institutional Review Board to June, 2024. The study will involve a total of Eighty four (84) patients attended in the outpatient department of cardiology, BSMMU, diagnosed as hyperlipidemia, with 42 of them receiving standard treatment along with a twice daily dose of 500mg of Nigella Sativa capsule for 8 weeks. The remaining 42 patients will undergo standard treatment along with a placebo over the same duration. The data collected will be analyzed through descriptive statistical techniques, offering a comprehensive summary of the results. In this study we will assess various sociodemographic characteristics of all the participants, including like age, sex, body mass index (BMI).In addition to these factors we will also evaluate their lipid profile, serum glutamic pyruvic transaminase (SGPT), serum creatinine level at baseline and after 8 weeks of interventions. Addition of Nigella Sativa with the conventional treatment of Statin could potentially reduce blood lipids in patients with hyperlipidemia. ### Conditions Module **Conditions:** - Hyperlipidemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive Nigella Sativa (500mg) capsule twice daily for 8 weeks. **Intervention Names:** - Drug: Nigella Sativa capsule 500mg **Label:** Nigella Sativa **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will receive capsules of placebo twice daily for 8 weeks. **Intervention Names:** - Drug: Placebo **Label:** Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Nigella Sativa **Description:** Nigella Sativa capsule 500mg twice daily for 8 weeks **Name:** Nigella Sativa capsule 500mg **Other Names:** - Black seed oil **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control **Description:** Oral placebo identical to astaxanthin **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** 84 atorvastatin treated hyperlipidaemic patients will randomly receive 8 weeks oral twice daily course of either Nigella Sativa 500 mg capsule or placebo.Change in blood lipids will be measured by spectrophotometer. **Measure:** Change in blood lipids **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Newly diagnosed hyperlipidaemic patient. 2. Both male and female 3. Hyperlipidemic patients suffering from ischemic heart disease, diabetes mellitus, hypertension 4. Diagnostic criteria for dyslipidemic patients 1. Total cholesterol 200mg/dl 2. LDL-C 140mg/dl 3. Triglyceride 150mg/dl 4. HDL \<40mg/dl Exclusion Criteria: 1. Patients with renal impairment 2. Patients with active liver disease 3. Patients having history of hypersensitivity on any member of statins 4. Pregnant woman. 5. lactating mother **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Farzana Siddiqua, MBBS **Phone:** 01842378736 **Role:** CONTACT **Contact 2:** **Name:** Adhir K Das **Phone:** 01711961097 **Role:** CONTACT #### Locations **Location 1:** **City:** Dhaka **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Farzana Siddiqua, MBBS - **Phone:** 01842378736 - **Role:** CONTACT **Country:** Bangladesh **Facility:** BSMMU **Status:** RECRUITING **Zip:** 1000 #### Overall Officials **Official 1:** **Affiliation:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh **Name:** Farzana Siddiqua, MBBS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10000 - Name: Hyperlipidemias - Relevance: HIGH - As Found: Hyperlipidemia - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: HIGH - As Found: Hyperlipidemia - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006949 - Term: Hyperlipidemias - ID: D000006951 - Term: Hyperlipoproteinemias ### Intervention Browse Module - Browse Branches - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M351 - Name: Atorvastatin - Relevance: LOW - As Found: Unknown - ID: T238 - Name: Nigella - Relevance: HIGH - As Found: Radioembolization ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422637 **Brief Title:** A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy **Official Title:** INFORM: A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy #### Organization Study ID Info **ID:** ES-2024-025-02 #### Organization **Class:** OTHER **Full Name:** The First Affiliated Hospital of Guangzhou Medical University ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The First Affiliated Hospital of Guangzhou Medical University #### Responsible Party **Investigator Affiliation:** The First Affiliated Hospital of Guangzhou Medical University **Investigator Full Name:** Jianxing He **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This project aims to establish the MERCURY pilot screening program as part of the "Love Lung Project," employing a novel concept of lung cancer screening with the assistance of low-dose computer tomography (LDCT). By using clinical pathology as the gold standard, it will parallelly compare the performance (with a sensitivity of ≥90%) of the MERCURY early lung cancer screening model against the LDCT-only screening group within the "Love Lung Project." Ultimately, the objective is to reduce the proportion of overtreatment, achieve earlier staging, and extend patient survival, thus enhancing clinical value. **Detailed Description:** This study is the first international prospective interventional study for lung cancer screening. It designates the "Love Lung Program" using Low-Dose Computed Tomography (LDCT) screening as the control group and the MERCURY screening group as the intervention group. Participants from the general population were enrolled and randomly assigned to either group in a 1:1 ratio. The MERCURY group plans to collect baseline peripheral blood samples from 2,972 individuals for whole genome sequencing (WGS) based on plasma circulating free DNA (cfDNA). This will facilitate a comprehensive analysis of the fragmentomics characteristics of cfDNA. Through the MERCURY early lung cancer screening model, individuals potentially at early stages of lung cancer will be identified. Those showing positive signs will subsequently undergo sequential LDCT to further confirm lung cancer status, eventually confirmed via surgery or pathology. To minimize ethical risks, the negative cases will receive additional LDCT after three months to further confirm their lung status. The control group under the "Love Lung Program" will follow standard LDCT screening procedures with the same number of participants; those with positive LDCT results will undergo clinical diagnosis, while those with negative results will only be followed up for lung status. Relying on the "Love Lung Program," the objective is to establish a new concept of lung cancer screening that precedes with MERCURY screening assisted by LDCT diagnostics. ### Conditions Module **Conditions:** - Liquid Biopsy for Early Screening of Lung Cancer **Keywords:** - Lung Cancer - Liquid Biopsy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 5944 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** By collecting 2,972 peripheral blood samples from a natural population baseline, a comprehensive analysis of the fragmentomic characteristics of cfDNA was conducted based on whole-genome sequencing (WGS) of plasma cfDNA. **Intervention Names:** - Diagnostic Test: Liquid Biopsy Early Screening **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 2972 individuals were enrolled from the general population for routine LDCT screening. **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** An early screening model for lung cancer aids in identifying individuals with early-stage lung cancer. Those with positive indications of lung cancer will subsequently undergo confirmatory clinical assessments using Low-Dose Computed Tomography (LDCT) in sequence. Ultimately, a definitive diagnosis of lung cancer is established through surgical and pathological examination. **Name:** Liquid Biopsy Early Screening **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** When a test result indicates that a patient is positive, the probability that the true condition is positive. **Measure:** Positive Predictive Value **Time Frame:** 2 years #### Secondary Outcomes **Description:** the proportion of patients diagnosed with lung cancer through clinical pathology in both the intervention group and the control group. **Measure:** Detection rate of non-stage 0 lung cancer within 2 years **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age greater than 40 years old and less than 75 years old, regardless of gender. * Sign the informed consent form. Exclusion Criteria: * Pregnant women; * Individuals currently diagnosed with any tumors other than lung cancer, or who have a history of cancer; * Those who have undergone LDCT/CT screening within the past 1-3 years; * Individuals currently suffering from a febrile illness, or who have had an acute inflammatory disease episode requiring internal medicine treatment within the last 14 days prior to blood draw; * Individuals who have taken corticosteroids orally or through intravenous injection within the 14 days prior to blood draw; * Organ transplant recipients or those who have previously received a non-autologous (allogeneic) bone marrow or stem cell transplant; * Individuals in poor health or not suitable for blood drawing; * Any other clinically significant disease or condition considered by the researchers to potentially affect adherence to the protocol, impact the patient's ability to provide informed consent, or render the patient unsuitable for participation in the clinical trial. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jianxing He, MD **Phone:** 86-20-83337792 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College **State:** Guangdong **Zip:** 510120 #### Overall Officials **Official 1:** **Affiliation:** Department of Medical Oncology of Respiratory, Guangxi Medical University Cancer Hospital **Name:** Jianxing He, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** publish an article **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422624 **Brief Title:** A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human Subjects **Official Title:** An Open Label, Single Dose, Dose Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Semaglutide Extended-release Injectable Suspension in Normal Healthy, Adult, Human Study Participants Under Fasting Condition #### Organization Study ID Info **ID:** 15403/23-24 #### Organization **Class:** INDUSTRY **Full Name:** Bostal Drug Delivery Co., Ltd ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bostal Drug Delivery Co., Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The purpose of the trail is to evaluate the safety, tolerability and pharmacokinetics of a single escalated doses of semaglutide extended-release injectable suspension in healthy adult, human study participants under fasting condition. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 2 ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 14 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive a single of semaglutide ER injectable suspension at a lower dose 1 mg for safety, tolerability and pharmacokinetics assessements **Intervention Names:** - Drug: Semaglutide Extended-release for Injectable Suspension, 1 mg **Label:** Semaglutide ER Injectable Suspension, 1 mg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive a single of semaglutide ER injectable suspension at a medium dose 4 mg for safety, tolerability and pharmacokinetics assessements **Intervention Names:** - Drug: Semaglutide Extended-release for Injectable Suspension, 4 mg **Label:** Semaglutide ER Injectable Suspension, 4 mg **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants receive a single of semaglutide ER injectable suspension at a higher dose 8 mg for safety, tolerability and pharmacokinetics assessements **Intervention Names:** - Drug: Semaglutide Extended-release for Injectable Suspension, 8 mg **Label:** Semaglutide ER Injectable Suspension, 8 mg **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Semaglutide ER Injectable Suspension, 1 mg **Description:** Singel-dose; Subcutaneous **Name:** Semaglutide Extended-release for Injectable Suspension, 1 mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Semaglutide ER Injectable Suspension, 4 mg **Description:** Singel-dose; Subcutaneous **Name:** Semaglutide Extended-release for Injectable Suspension, 4 mg **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Semaglutide ER Injectable Suspension, 8 mg **Description:** Singel-dose; Subcutaneous **Name:** Semaglutide Extended-release for Injectable Suspension, 8 mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Maximum plasma concentration **Measure:** Cmax **Time Frame:** From time zero up to the last time point with measurable concentration **Description:** Area under the plasma concentration time curve from time zero to the last measurable concentration **Measure:** AUC0-t **Time Frame:** From time zero up to the last time point with measurable concentration **Description:** Area under the plasma concentration-time curve from time zero to infinity **Measure:** AUC0-inf **Time Frame:** From time zero up to the last time point with measurable concentration ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. He/She should provide written informed consent. 2. He/She must be a healthy adult human male or non-pregnant, non-lactating females,18 - 45 years of age (both years inclusive). 3. He/She should have a body mass index ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 with body weight at least 55 kg for men and at least 48 kg for women. 4. He/She should have a baseline systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly baseline diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg. 5. He/She should have pulse rate not less than 60 beats/min and not more than 100 beats/min and respiratory rate not less than 14 breaths/min and not more than 18 breaths/min. 6. He/She must be of normal health as determined by medical history (including medication history) and physical examination performed within 21 days prior to the dosing. 7. He/She should have normal ECG, chest X-ray and vital signs. 8. He/She should have normal or clinically non-significant thyroid function tests (T3, T4 and TSH). 9. Availability of a study volunteer for the entire study duration and willingness to adhere to protocol requirements as evidenced by written informed consent. 10. If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence for the duration of the study as judged by the investigator(s), or If she is postmenopausal with spontaneous amenorrhea for at least 01 year. or If she is surgically sterile (had a bilateral tubal ligation, bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 06 months). Exclusion Criteria: 1. He/She is incapable of understanding the informed consent. 2. He/She has a history of hypersensitivity (e.g. anaphylactic reactions, angioedema and serious skin reactions) or idiosyncratic reaction to active or inactive ingredient in the Semaglutide extended-release injectable suspension or any other related drugs. 3. He/She has a history of impairment of renal, hepatic, cardiac, pulmonary or gastrointestinal function. 4. He/She has a history of tuberculosis, epilepsy, asthma, diabetes, psychosis and eye disorders. 5. He/She has history of any pulmonary disorder (COPD, Asthma, Bronchitis, other respiratory disorders) and skin related disorders. 6. He/She has a personal or family history of Medullary Thyroid Carcinoma (MTC) or any other thyroid tumors or Multiple Endocrine Neoplasia 2 (MEN 2) or any other endocrine disorders. 7. He/She has a history of pancreatitis, diabetic retinopathy, gall bladder disease. 8. He/She has undergone surgery within the past 3 months prior to screening, or those planning to undergo surgery during the trial period. 9. He/She has any difficulty in swallowing. 10. He/She regularly smokes more than 10 cigarettes daily or has difficulty in abstaining from tobacco for the entire study duration. 11. He/She has taken over the counter or prescribed medications, including vitamins, herbal supplements, insulin or drugs which promote insulin secretion, Sulfonylureas, any oral medications or any systemic medication within the past 30 days prior to dosing. 12. He/She has a history of any psychiatric illness, which may impair the ability to provide written, informed consent. 13. He/She has a history of alcohol or substance abuse within the last 05 years. 14. He/she using prohibited medications (e.g., sedative hypnotics, CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating antiepileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants). 15. He/She has clinically significant abnormal values of laboratory parameters. 16. He/She has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 90 days. 17. He/She is unable to or unlikely to be compliant with protocol requirements or restrictions. 18. He/She, in whom study drug is contraindicated for medical reasons. 19. He/She is intolerant to venipuncture. 20. Positive results at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis C Virus (HCV) or syphilis. 21. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 06 months prior to study or used oral contraceptives within 14 days before dosing. 22. Female volunteer who demonstrates a positive pregnancy test. 23. Female study volunteer who is pregnant, breast-feeding or who is likely to become pregnant during the study. 24. Female using Hormonal IUD (Mirena), Norplant and other hormones, Depo-Provera, OCPs. (Females of child bearing age will be required to use 2 reliable forms of contraception such as condom and spermicidal or barrier method and spermicidal if sexually active. However, the use of Copper IUD or Tubal ligation are sufficient). **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Ancestors - ID: D000097789 - Term: Glucagon-Like Peptide-1 Receptor Agonists - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M353561 - Name: Semaglutide - Relevance: HIGH - As Found: Consent - ID: M9043 - Name: Glucagon - Relevance: LOW - As Found: Unknown - ID: M3401 - Name: Glucagon-Like Peptide-1 Receptor Agonists - Relevance: LOW - As Found: Unknown - ID: M26997 - Name: Glucagon-Like Peptide 1 - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000591245 - Term: Semaglutide ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422611 **Acronym:** Digital **Brief Title:** Comparing Dental Impression Methods for Children **Official Title:** Comparison of Traditional and Digital Impression Methods for Pediatric Patients in Terms of Satisfaction #### Organization Study ID Info **ID:** Ege U. Ethical Com. 23-4.1/5 #### Organization **Class:** OTHER **Full Name:** Ege University ### Status Module #### Completion Date **Date:** 2023-08-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-30 **Type:** ACTUAL #### Start Date **Date:** 2023-04-20 **Type:** ACTUAL **Status Verified Date:** 2023-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-02-16 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ege University #### Responsible Party **Investigator Affiliation:** Ege University **Investigator Full Name:** Dilsah Cogulu **Investigator Title:** Professsor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The precision of dental restorations and the production of dental models has improved due to the acceleration of technical advancement and the introduction of computer-aided manufacturing. The study's objective is to compare the conventional imprint approach with a digital one in order to compare patients' comfort levels, preferences, and treatment times among pediatric patients. **Detailed Description:** In this study, 60 volunteers without any prior exposure to traditional or digital impressions took part. Using a C-type impression medium, conventional impressions of the maxillary and mandibular dental arches were taken. Digital impressions are taken using an intra-oral scanner at the same appointment. Following the impressions, a standardized questionnaire was used to assess the individuals' attitudes, preferences, and perceptions of the impression procedures. The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. After taking the impression, the processing phases of the impression techniques (working time, etc.), and parental satisfaction were noted. ### Conditions Module **Conditions:** - Dental Impression, Pediatric Dentistry, Satisfaction ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Impression was taken with intraoral scanners **Intervention Names:** - Device: Impression methods **Label:** Digital #### Arm Group 2 **Description:** Impression was taken with silicone impression material **Intervention Names:** - Device: Impression methods **Label:** Conventional ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional - Digital **Description:** Both digital and conventional impressions were taken from same patients **Name:** Impression methods **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Parental satisfaction was measured with a structured questionnaire.The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. A survey was designed to test 3 areas of patient satisfaction regarding the impression experience: comfort, time, and novelty. The survey consisted of 7 statements with a 100-mm visual analog scale (VAS) below each statement anchored with "agree" and "disagree." The survey also included questions to determine whether the patient had previous experience with impressions. **Measure:** Assessing patient preference and treatment comfort **Time Frame:** March 2023-June 2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * not to have a history of digital or conventional impression taking * not to have temporomandibular joint and periodontal discomfort * not to be using psychiatric or neuropathic drugs Exclusion Criteria: * history of digital or conventional impression taking * TMJ disorder * Using any kind of drug that interferes pain perception **Healthy Volunteers:** True **Maximum Age:** 12 Years **Minimum Age:** 7 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Patients who needed routine diagnostic records were included in our study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Izmir **Country:** Turkey **Facility:** Ege University **Zip:** 35040 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422598 **Acronym:** BADAS **Brief Title:** Prevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh **Official Title:** Prevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh - An Exploratory Cross-Sectional Study #### Organization Study ID Info **ID:** BADAS-ERC/EC/24/23 #### Organization **Class:** OTHER **Full Name:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders #### Secondary ID Infos **Domain:** The Diabetic Association of Bangladesh (BADAS) **ID:** BADAS-ERC/EC/24/23 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Ibrahim Medical College #### Lead Sponsor **Class:** OTHER **Name:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders #### Responsible Party **Investigator Affiliation:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders **Investigator Full Name:** Wasim Md Mohosin Ul Haque **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Background: Diabetes is a growing public health concern in Bangladesh, with millions affected. Diabetic Kidney Disease (DKD) is a severe complication of diabetes, affecting approximately 21.3% of the diabetic population. To address this issue, a comprehensive assessment of DKD within the Bangladesh Diabetic Association\&#39;s (BADAS) affiliated healthcare centres is necessary. Objective: The study\&#39;s general objective is to determine the prevalence of DKD and evaluate its management at BADAS-affiliated healthcare centers. Specific objectives include assessing risk factors, screening practices, disease staging, management approaches, patient education, and providing evidence-based recommendations. Methodology: * Study Design: Cross-sectional * Study Population: All diabetic patients at BADAS-affiliated centers * Exclusion Criteria: Patients unwilling to participate or with kidney disease from other causes and with acute illness * Sample Size: \&#34;Forty patients will be selected from each center, resulting in a total sample size of 320 patients across eight centers, with one center randomly selected from each of the eight divisions in Bangladesh.\&#34; * Data Collection: Demographics, comorbidities, kidney function, blood pressure, HbA1c levels, medication records, treatment guideline adherence * Data Analysis: prevalence of diabetic kidney disease, factors affecting management, and potential barriers * Ethical Considerations: Ensure patient data privacy, obtain approvals, and informed consent Implications: The study aims to provide insights into the current state of magnitude (prevalence) of DKD, its management, highlighting areas for improvement in patient care, guideline adherence, and ultimately enhancing the well-being of diabetic patients in Bangladesh. **Detailed Description:** Background: Diabetes mellitus represents a significant public health challenge globally, and Bangladesh is no exception to this growing epidemic. According to the International Diabetes Federation (IDF), about 13.1 million people in Bangladesh have diabetes, and this number is expected to increase to 22.3 million by 2045(Sun et al., 2022). One of the most serious complications of diabetes is Diabetic Kidney Disease (DKD), which can lead to chronic kidney disease and end-stage renal disease (ESRD). DKD not only imposes a heavy burden on the healthcare system but also affects the economic and social well-being of the patients and their families. The prevalence of kidney disease among the diabetic population of Bangladesh is estimated to be around 21.3%. This number is based on a single center study conducted at the Bangladesh Institute of Health Sciences (BIHS) hospital in Dhaka, Bangladesh(Islam et al., 2021). This high prevalence highlights the need for a comprehensive evaluation of DKD within the centers affiliated with the Bangladesh diabetic association (BADAS), which is the largest non-governmental organization providing diabetes care and research in the country. The Bangladesh Diabetic Association (BADAS), with its extensive network of diabetes care centers and healthcare professionals, has long been at the forefront of addressing diabetes-related health concerns in the country. As a nation-wide institution dedicated to diabetes care, BADAS plays a pivotal role in delivering healthcare services and shaping the well-being of diabetic patients in Bangladesh. A comprehensive understanding of DKD prevalence and management status within BADAS centers is essential to enhance the quality of care for diabetic patients. Identifying areas for improvement is the first step towards effecting positive change. Our ultimate plan is to implement a nationwide DKD prevention program through affiliated diabetic centers. To achieve this, a comprehensive assessment of the current situation is an imperative foundation for program design, planning, and execution. The study will provide a rich dataset upon which evidence-based recommendations for preventing and managing DKD within BADAS-affiliated centers can be developed. These recommendations are essential for improving patient outcomes and ensuring the success of the future prevention program. In conclusion, the proposed study is a crucial undertaking aimed at addressing the pressing issue of DKD within the context of BADAS-affiliated healthcare centers. It serves as the first step towards the larger goal of implementing a nationwide DKD prevention program, with the potential to positively impact the health and well-being of diabetic patients across Bangladesh. Objective: General Objective: To determine the prevalence of diabetic kidney disease and assess the management status of diabetic kidney disease in patients attending affiliated healthcare centers of the Bangladesh Diabetic Associations. Specific Objectives: Determine the Prevalence of Diabetic Kidney Disease: Calculate the prevalence of DKD among diabetic patients visiting BADAS-affiliated healthcare centers using clinical and laboratory assessments. Assess Risk Factors for DKD: Identify and analyze demographic and clinical factors associated with the development of DKD in the study population. Evaluate Screening Practices: Evaluate the extent to which BADAS-affiliated healthcare centers conduct regular screening of registered diabetic patients for DKD and assess the effectiveness of current screening protocols. Characterize Disease Staging: Determine the stages of DKD among patients diagnosed with the condition and assess the proportion of patients with various stages of renal impairment. Analyze Management Approaches: Investigate the treatment modalities, including pharmacological interventions, lifestyle modifications, and patient education, used to manage DKD in the healthcare centers. Assess Healthcare Professional Awareness: Evaluate the awareness and knowledge of healthcare professionals working in BADAS-affiliated centres regarding DKD prevention, diagnosis, and management. Assess the infrastructural support of BADAS-affiliated centres regarding DKD prevention, diagnosis, and management. Examine Patient Education and Engagement: Assess the level of patient education and engagement in DKD management programs, including lifestyle modification guidance and adherence to treatment plans. Provide Recommendations: Based on the study findings, generate evidence-based recommendations for improving the prevention, early detection, and management of DKD in BADAS-affiliated healthcare centers to enhance the quality of care for diabetic patients. Material and Methodology: Study Design: Cross-sectional study design. Study Population: All registered diabetic patients receiving care at affiliated healthcare centres of Bangladesh Diabetic Associations. Exclusion criteria: Unwilling to participate in the study. Presence of AKI or acute illness Presence of Known kidney disease due to other cause. Sampling method: Multi-stage sampling. Sample size calculation: The formula to calculate the sample size: Where: n = required sample size Z = Z-score corresponding to the desired confidence level (e.g., 1.96 for a 95% confidence level) p = expected prevalence (in decimal form) E = margin of error (in decimal form) Expected prevalence of DKD to be 21.3% (0.213 in decimal form) Confidence level 95% Margin of error of 5% (0.05 in decimal form) Using these values, the sample size calculation would look like this: = 292 However, we will select forty patients from each centre, resulting in a total sample size of 320 patients across eight centres, with one centre will be randomly selected from each of the eight divisions in Bangladesh. Data Collection: Gather patient data, including demographics, comorbidities, kidney function (eGFR, UACR), blood pressure measurements, and HbA1c levels. Review medication records to determine the use of anti-proteinuric medications (e.g., ACE inhibitors, angiotensin receptor blockers, SGLT2i, nonsteroidal mineralocorticoids receptor antagonists and GLP analogues). Assess adherence to recommended treatment guidelines for diabetic kidney disease management. Collect data on healthcare professionals\&#39; awareness and knowledge of DKD prevention, diagnosis, and management. Gather data on the infrastructure available in BADAS-affiliated centres for DKD prevention, diagnosis, and management. Screening for the presence of DKD The diagnostic criteria for diabetic kidney disease (DKD)(McGrath and Edi, 2019, ElSayed et al., 2022): DKD is usually a clinical diagnosis in a patient with long-standing diabetes (\&gt;10 years) with albuminuria and/or reduced eGFR in the absence of signs or symptoms of other primary causes of kidney damage. Albuminuria: Increased urinary albumin excretion is defined as ≥30 mg/g. (2 out of 3 in 3 to 6 months). Reduced estimated Glomerular Filtration Rate (eGFR): \&lt;60ml/minute/1.73m2. for more than 3 months Duration of Diabetes: DKD is typically associated with a long duration of diabetes (\&gt;10 years' duration of type 1 diabetes; may be present at diagnosis in type 2 diabetes). Presence of Retinopathy: DKD is typically associated with retinopathy however the absence of retinopathy does not exclude DKD in type 2 diabetes. Data Analysis: Evaluate the proportion of patients achieving target blood pressure control (e.g., \&lt;130/80 mm Hg), glycaemic control (e.g., HbA1c \&lt;7%), and receiving appropriate anti-proteinuric medications. Examine factors associated with successful management, including age, gender, duration of diabetes, and comorbidities. Identify potential barriers to achieving optimal management. Ethical Considerations: Ensure patient data privacy and confidentiality. Obtain necessary approvals and informed consent for data access and analysis. Implications: Provide insights into the current magnitude and state of diabetic kidney disease management, specifically focusing on blood pressure and glycaemic control and the utilization of anti-proteinuric medications among diabetic patients. Highlight areas for improvement in patient care and guideline adherence to enhance diabetic kidney disease management. ### Conditions Module **Conditions:** - Diabetic Kidney Disease **Keywords:** - diabetes - Diabetic kidney disease - Prevalence - management ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 320 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Calculate the prevalence of DKD among diabetic patients visiting BADAS-affiliated healthcare centers using clinical and laboratory assessments. **Measure:** Prevalence of diabetic kidney disease **Time Frame:** Day 1 #### Secondary Outcomes **Description:** Identify and analyze demographic and clinical factors associated with the development of DKD in the study population. **Measure:** Risk Factors for DKD **Time Frame:** Day 1 **Description:** Evaluate the extent to which BADAS-affiliated healthcare centers conduct regular screening of registered diabetic patients for DKD and assess the effectiveness of current screening protocols. **Measure:** Screening Practices **Time Frame:** Day 1 **Description:** Investigate the treatment modalities, including pharmacological interventions, lifestyle modifications, and patient education, used to manage DKD in the healthcare centers. **Measure:** Management Approaches **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: • All registered diabetic patients receiving care at affiliated healthcare centres of Bangladesh Diabetic Associations. Exclusion Criteria: * Unwilling to participate in the study. * Presence of AKI or acute illness * Presence of Known kidney disease due to other cause. * Pregnancy **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** We will select forty patients from each centre, resulting in a total sample size of 320 patients across eight centres, with one centre will be randomly selected from each of the eight divisions in Bangladesh ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Wasim MM Haque, MBBS, FCPS **Phone:** +8801915472750 **Role:** CONTACT #### Locations **Location 1:** **City:** Chapainawabganj **Contacts:** ***Contact 1:*** - **Name:** Khokon - **Role:** CONTACT **Country:** Bangladesh **Facility:** Chapainawabganj Diabetes Center **Status:** RECRUITING **Location 2:** **City:** Cox's Bazar **Contacts:** ***Contact 1:*** - **Name:** Bivision - **Role:** CONTACT **Country:** Bangladesh **Facility:** Cox's Bazar Diabetic Hospital **Status:** RECRUITING **Location 3:** **City:** Meherpur **Contacts:** ***Contact 1:*** - **Name:** Jiptaho - **Role:** CONTACT **Country:** Bangladesh **Facility:** Meherpur diabetes hospital **Status:** NOT_YET_RECRUITING **Location 4:** **City:** Narayanganj **Contacts:** ***Contact 1:*** - **Name:** Rafiq - **Role:** CONTACT **Country:** Bangladesh **Facility:** Narayanganj Diabetic Hospital **Status:** RECRUITING **Location 5:** **City:** Panchagarh **Contacts:** ***Contact 1:*** - **Name:** Rowshan - **Role:** CONTACT **Country:** Bangladesh **Facility:** Diabetic Hospital Panchagarh **Status:** NOT_YET_RECRUITING **Location 6:** **City:** Pirojpur **Contacts:** ***Contact 1:*** - **Name:** Uzzal - **Role:** CONTACT **Country:** Bangladesh **Facility:** Pirojpur Diabetic Samiti **Status:** NOT_YET_RECRUITING **Location 7:** **City:** Rajbari **Contacts:** ***Contact 1:*** - **Name:** Shahid - **Role:** CONTACT **Country:** Bangladesh **Facility:** Rajbari Diabetes Center **Status:** RECRUITING **Location 8:** **City:** Sherpur **Contacts:** ***Contact 1:*** - **Name:** Ashish - **Role:** CONTACT **Country:** Bangladesh **Facility:** Sherpur Diabetic Hospital **Status:** NOT_YET_RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders **Name:** Wasim MM Haque, MBBS, FCPS **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Jeffrie Seley J, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S254-S266. doi: 10.2337/dc23-S015. **PMID:** 36507645 **Citation:** Islam SMS, Salehin M, Zaman SB, Tansi T, Gupta RD, Barua L, Banik PC, Uddin R. Factors Associated with Chronic Kidney Disease in Patients with Type 2 Diabetes in Bangladesh. Int J Environ Res Public Health. 2021 Nov 23;18(23):12277. doi: 10.3390/ijerph182312277. **PMID:** 34886001 **Citation:** McGrath K, Edi R. Diabetic Kidney Disease: Diagnosis, Treatment, and Prevention. Am Fam Physician. 2019 Jun 15;99(12):751-759. **PMID:** 31194487 **Citation:** Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6. Erratum In: Diabetes Res Clin Pract. 2023 Oct;204:110945. **PMID:** 34879977 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7123 - Name: Diabetic Nephropathies - Relevance: HIGH - As Found: Diabetic Kidney Disease - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000003928 - Term: Diabetic Nephropathies ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422585 **Brief Title:** Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery **Official Title:** Comparison of Three Different Analgesic Nerve Blocks in Total Knee Replacement Surgery #### Organization Study ID Info **ID:** PGBLOCK #### Organization **Class:** OTHER **Full Name:** Azienda Ospedaliero, Universitaria Pisana ### Status Module #### Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Azienda Ospedaliero, Universitaria Pisana #### Responsible Party **Investigator Affiliation:** Azienda Ospedaliero, Universitaria Pisana **Investigator Full Name:** Serena Ricalzone **Investigator Title:** principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to compare the equivalent analgesic efficacy of three regional anesthesia techniques in total knee replacement surgery. The main question it aims to answer is: • Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and the antalgic nerve block depending on the group they happen to be in. Researchers will compare the Femoral Nerve Group+IPACK block, the Saphenous Nerve block+IPACK and the Subsartorial Block groups to see if there is any difference in the pain control in the 24 hours after the surgery. **Detailed Description:** After adequate venous access is obtained, a light sedation with Midazolam 1-2 mg is administered. The patient will be monitored and a selective spinal anesthesia will be performed. After the neuraxial procedure the antalgic block of choice is performed with about 40 mL of long acting local anesthetic. Magnesium Solfate 1g and Dexametasone 4mg are administered after the block. If the patient wishes, a propofol continuos infusion may be administered for sedation during the surgery. Before the patient leaves the OR, Ketorolac 30mg will be administered. Pain control after surgery will be achieved with acetaminophen 1g t.i.d., Ketorolac 30mg on demand, and Morphine solfate if NRS \>5 after Ketorolac. Every 6 hours the patient will be monitored by the anesthesia team. After 24 hours the antalgic effect of the nerve block is reasonably thought to be over, so the follow up is interrupted. ### Conditions Module **Conditions:** - Knee Prosthesis - Pain, Procedural **Keywords:** - Knee - Post procedural pain - Regional anesthesia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 180 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which antalgic Femoral Nerve Block and IPACK Block will be performed. **Label:** Femoral Nerve Block + IPACK Block #### Arm Group 2 **Description:** After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Saphenous and IPACK Block will be performed. **Label:** Saphenous (Adductor Canal) Block + IPACK Block #### Arm Group 3 **Description:** After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Dual Subsartorial Block will be performed. **Label:** Dual Subsartorial Block ### Outcomes Module #### Primary Outcomes **Description:** To compare the analgesic effect at 24 hours, of a nerve block technique compared to others after selective spinal anesthetic is administerd to achieve surgical anesthesia.Evaluate pain for every group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three. Success of the block was defined as NRS≤3. **Measure:** NRS **Time Frame:** Baseline, every 6 hours for the first 24 hours after surgery #### Secondary Outcomes **Description:** Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours **Measure:** side effect **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 y/o * Total knee replacement elective surgery * Informed consent Exclusion Criteria: * Age \< 18 y/o * Surgery with general anesthesia * Patients with coagulopaties * Patients in chronic opioid therapy * Refuse to sign informed consent form * Unable to sign informed consent form * Know allergies to medication used for analgesia **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients meeting the inclusion criteria ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Serena Ricalzone, MD **Phone:** 050.997881 **Role:** CONTACT #### Locations **Location 1:** **City:** Pisa **Contacts:** ***Contact 1:*** - **Name:** Serena Ricalzone, MD - **Phone:** 050.997881 - **Role:** CONTACT **Country:** Italy **Facility:** Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello **State:** Toscana **Status:** RECRUITING **Zip:** 56124 #### Overall Officials **Official 1:** **Affiliation:** Azienda Ospedaliera Universitaria Pisana **Name:** Silvia Nardi, MD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Scuola Specializzazione - Università di Pisa **Name:** Alessandro Cardu, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M1219 - Name: Pain, Procedural - Relevance: HIGH - As Found: Pain, Procedural - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000073818 - Term: Pain, Procedural ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M1832 - Name: Levobupivacaine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422572 **Brief Title:** Tissue Kallikrein Protect Against Ischemic Stroke **Official Title:** The Role of Tissue Kallikrein - Bradykinin System Targeting the Protection of Neurovascular Units in Ischemic Areas of Stroke #### Organization Study ID Info **ID:** TJ-IRB202303109 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2023-12-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-30 **Type:** ACTUAL #### Start Date **Date:** 2023-05-01 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** National Natural Science Foundation of China #### Lead Sponsor **Class:** OTHER **Name:** Qin Zhang #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Qin Zhang **Investigator Title:** PROFESSOR **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The results of previous studies were used to assess the causal association between TK levels and stroke occurrence at 5 and 12 years of follow-up, respectively. **Detailed Description:** Analyze the data of a 5-year follow-up on 2115 control individuals from the case-control study of the previous research. We completed the 5-year follow-up on this group in 2016 (whether they had a stroke, whether they are alive, and the cause of death). Conduct a 12-year follow-up on 6487 community individuals from the previous study (whether they had a stroke within 12 years, whether they are alive, and the cause of death). We collaborated with the hospital platform's computer center to conduct follow-up through AI questionnaire surveys, followed by supplementing AI questionnaire data with telephone questionnaire surveys for those lost to follow-up. Utilize R language R Studio 4.11 for statistical analysis and plotting. Evaluate the distribution of TK levels in the control group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 5 years. Evaluate the distribution of TK levels in the community group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 12 years. ### Conditions Module **Conditions:** - Stroke, Ischemic **Keywords:** - Stroke ### Design Module #### Bio Spec **Description:** Part of the sample consisted of 1210 stroke controls and 905 coronary heart disease controls enrolled from December 2000 to November 2001 in the previous study. The other part comes from 6,487 cases of community population in Rizhao area from May to August 2010. **Retention:** NONE_RETAINED #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 8602 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1. Control population in a case-controlled study of prior stroke ; 2. Control population in a case-controlled study of preexisting coronary heart disease; 3. Population in previous community cross-sectional studies . **Intervention Names:** - Other: No Intervention **Label:** Population without stroke ### Interventions #### Intervention 1 **Arm Group Labels:** - Population without stroke **Description:** No Intervention **Name:** No Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome measure will be the occurrence of stroke during the 5-year follow-up period. Stroke events will be assessed and recorded based on predetermined diagnostic criteria, such as clinical symptoms, imaging findings, and/or medical records review. The data will be aggregated and reported as the total number of stroke cases observed in the study population. **Measure:** Incidence of Stroke **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1) Control population in the previous stroke case-control study; * 2) The CHD case-control population in the previous study; * 3) The population in the community cross-sectional study of the previous study. Exclusion Criteria: * Stroke patient **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 1. Control population in the previous stroke case-control study; 2. The CHD case-control population in the previous study; 3. The population in the community cross-sectional study of the previous study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Wuhan **Country:** China **Facility:** Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology **State:** Hubei **Zip:** 430030 #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital **Name:** QIN Zhang, phd **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M2400 - Name: Ischemic Stroke - Relevance: HIGH - As Found: Stroke, Ischemic - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemic - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke - ID: D000083242 - Term: Ischemic Stroke - ID: D000007511 - Term: Ischemia ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M10638 - Name: Kallikreins - Relevance: LOW - As Found: Unknown - ID: M5197 - Name: Bradykinin - Relevance: LOW - As Found: Unknown - ID: M10725 - Name: Kininogens - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422559 **Brief Title:** Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression **Official Title:** Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression #### Organization Study ID Info **ID:** MD.22.12.731 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** True ### Description Module **Brief Summary:** The goal of this interventional study is to learn if accelerated Intermittent Theta Burst Stimulation can improve symptoms of 30 participants with Unipolar depression in higher manner than symptoms of 30 participants with bipolar depression **Detailed Description:** We will apply stimulatory TMS protocol for participants with Unipolar depression and participants with bipolar depression using MagVenture MagPro R30 stimulator with the Cool-B65 coil ### Conditions Module **Conditions:** - Depressive Disorder ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks **Intervention Names:** - Device: Transmagnetic stimulation - Device: TMS **Label:** Participants with unipolar depression **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks **Intervention Names:** - Device: Transmagnetic stimulation - Device: TMS **Label:** Participants with bipolar depression **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants with bipolar depression - Participants with unipolar depression **Description:** Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil **Name:** Transmagnetic stimulation **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Participants with bipolar depression - Participants with unipolar depression **Description:** Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil **Name:** TMS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** We will use Young Mania Rating Scale._Young Mania Rating Scale:assess severity of manic symptoms, clinician rated,\<=12(remission)13_19(minimal symptoms)20_25(mild mania)26_37(moderate mania)38_60 severe mania **Measure:** Comparison of severity of manic symptoms before and after treatment **Time Frame:** One year for completion of the study **Description:** We will use Clinical Global Impression Severity Scale._Clinical Global Impression Severity Scale:rate the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis,1 normal not at all ill,2 borderline mentally ill,3 mildly ill,4 moderately ill,5 markedly ill,6 severely ill,7 extremely ill **Measure:** Comparison of the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis. **Time Frame:** One year for completion of the study **Description:** We will use Insomnia Severity Index scale._Insomnia Severity Index:assess the nature, severity and impact of insomnia,0_7(absence insomnia) 8_14(subthreshold insomnia)15_21(moderate insomnia)22_28(severe insomnia) **Measure:** Comparison of severity and impact of insomnia before and after treatment **Time Frame:** One year for completion of the study **Description:** We will use Hamilton Depression Rating Scale._Hamilton Depression Rating Scale:assess the severity of depressive symptoms, clinician rated,0_7(normal range)8_16(mild severity)17_23(moderate severity)\>23(severe depression) **Measure:** Comparison of depressive symptoms before and after treatment **Time Frame:** One year for completion of the study ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age:18_65 years * Sex:male and female * Patients with Unipolar depression and bipolar depression diagnosis confirmed by SCID according to DSM5 * No pharmacological change in the last 4 weeks before the beginning of the stimulantion cycle * Pharmacological resistance Exclusion Criteria: * Patients complaining of psychosis.Substance Use Disorder.current suicidal ideation.major medical and neurological disorder * Patients complaining of epilepsy * pregnancy and breastfeeding * peacemaker spinal or bladder stimulator * History of skull surgery and trauma * presence of metallic foreign body **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Shaimaa E. Mohamed **Phone:** Egypt 01014947026 **Role:** CONTACT **Contact 2:** **Name:** Warda F. Aboelez **Phone:** 01018186408 **Role:** CONTACT #### Locations **Location 1:** **City:** Mansoura **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Institutional R. Board - **Phone:** Egypt +2050-2202773:2202746 - **Role:** CONTACT ***Contact 2:*** - **Name:** Warda F. Aboelez - **Phone:** 01018186408 - **Role:** CONTACT ***Contact 3:*** - **Name:** Shaimaa E. Mohamed - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Mansoura University **Zip:** 35516 #### Overall Officials **Official 1:** **Affiliation:** Professor **Name:** Hala A. El-boraie **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Assistant professor **Name:** Ibrahim H. Rashed **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Lecturer **Name:** Hassan M. Sonbol **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Chang J, Chu Y, Ren Y, Li C, Wang Y, Chu XP. Maintenance treatment of transcranial magnetic stimulation (TMS) for treatment-resistant depression patients responding to acute TMS treatment. Int J Physiol Pathophysiol Pharmacol. 2020 Oct 15;12(5):128-133. eCollection 2020. **PMID:** 33224435 #### See Also Links **Label:** PMC 7675193 **URL:** https://pubmed.ncbi.nlm.nih.gov/33224435/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000068105 - Term: Bipolar and Related Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Depression - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M226 - Name: Bipolar and Related Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder - ID: D000001714 - Term: Bipolar Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422546 **Acronym:** pre-FLAME **Brief Title:** A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in EGFRm NSCLC **Official Title:** A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in Chinese Patients With Stage IV Metastatic or Recurrent Non-squamous EGFR-positive NSCLC #### Organization Study ID Info **ID:** pre-FLAME #### Organization **Class:** OTHER **Full Name:** Beijing Cancer Prevention & Treatment Society ### Status Module #### Completion Date **Date:** 2025-06-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-01-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences #### Lead Sponsor **Class:** OTHER **Name:** Beijing Cancer Prevention & Treatment Society #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC **Detailed Description:** Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment.To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment. ### Conditions Module **Conditions:** - Non Small Cell Lung Cancer ### Design Module #### Bio Spec **Description:** EGFR mutation in plasma **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 950 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Description:** To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment **Measure:** describe the characteristics of genetic variation associated with oxitinib treatment **Time Frame:** baseline and 3 weeks after oxitinib treatment #### Primary Outcomes **Description:** To characterize the changes in EGFR gene mutations at baseline and 3 weeks after oxitinib treatment **Measure:** changes in EGFR gene mutations **Time Frame:** baseline and 3 weeks after oxitinib treatment #### Secondary Outcomes **Description:** Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment **Measure:** Characteristics of EGFR gene mutation and efficacy of oxitinib treatment **Time Frame:** baseline and 3 weeks after oxitinib treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. ≥18 years old male or female 2. Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8); 3. Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy; 4. EGFR positive in blood or tissue tested in local laboratory; 5. Sufficient blood samples can be provided for molecular detection; 6. Signed informed consent forms are available. Exclusion Criteria: 1. Patients were unable to collect plasma samples at baseline; 2. The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory; 3. The patient refused subsequent treatment with oxitinib; 4）The investigator determines that may affect the conduct of the clinical study and the judgement of the study results. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** stage IV metastatic or recurrent non-squamous EGFR-positive NSCLC ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Qu Liudi - **Phone:** 18519773872 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Du Xueying - **Phone:** 18811792675 - **Role:** CONTACT **Country:** China **Facility:** Beijing Cancer Prevention society **State:** Beijing **Status:** RECRUITING **Zip:** 100021 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422533 **Brief Title:** Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients **Official Title:** Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia Due to Enterobacteriaceae and Pseudomonas Aeruginosa in Hemato-oncological Patients With Severe Neutropenia and Fever: Non-inferiority Study #### Organization Study ID Info **ID:** CI0565-2023 #### Organization **Class:** OTHER **Full Name:** Instituto Nacional de Cancerologia de Mexico ### Status Module #### Completion Date **Date:** 2025-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Instituto Nacional de Cancerologia de Mexico #### Responsible Party **Investigator Affiliation:** Instituto Nacional de Cancerologia de Mexico **Investigator Full Name:** Patricia Cornejo Juarez **Investigator Title:** Principal Investigato **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Patients with hematological malignancies receive highly myelotoxic chemotherapy regimens that cause periods of severe myelosuppression, which places them at high risk of developing bacteremia. At a global level, a very significant increase in multidrug-resistant (MDR) Gram-negative microorganisms, particularly Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL) and MDR P.aeruginosa, have been described during the last decade. Among the strategies to reduce bacterial resistance, ceftolozane/tazobactam (C/T) as a "carbapenem-sparing" antibiotic has been proposed. C/T has broad-spectrum activity since it has action against ESBL-producing Enterobacteriaceae and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens. At the National Cancer Institute (in Spanish, Instituto Nacional de Cancerologia), Gram-negative bacilli have been identified for more than 20 years as the pathogens most frequently associated with bacteremia. Escherichia coli occupies the first place in 25% (41% ESBL), followed by Klebsiella spp. in 5.6% (11.2% ESBL) and P. aeruginosa in 5.6% (11.2% MDR). The protocol for approaching and treating hematological malignancy patients with severe neutropenia and fever is to initiate an antimicrobial regimen with piperacillin/tazobactam (P/T). In patients who persist with fever after 48 to 72 hours of starting antibiotics, who present with clinical deterioration, or in whom P/T-resistant bacteria are identified, this is escalated to carbapenem. Therefore, it is proposed to compare the clinical and microbiological response in patients with hematological malignancies who present with severe neutropenia and fever and who present clinical data of bacteremia, with empirical treatment with C/T vs. P/T, trying to reduce the use of carbapenems in this group of patients. **Detailed Description:** At a global level, a very significant increase in multidrug-resistant (MDR) Gram-negative microorganisms has been described during the last decade, particularly Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL) and MDR Pseudomonas aeruginosa. This is directly related to the use of broad-spectrum antimicrobials, particularly carbapenems. Among the strategies to reduce bacterial resistance, using ceftolozane/tazobactam (C/T) as a "carbapenem-sparing" antibiotic is proposed. C/T has been administered in hemato-oncological patients with severe neutropenia, colonized by resistant strains in centers with a high prevalence of Enterobacteriaceae-ESBL and P. aeruginosa MDR. The study's purpose is to demonstrate non-inferiority between ceftolozane/tazobactam vs. piperacillin/tazobactam for patients with hematological malignancies who present severe neutropenia and fever, including those patients who have bacteremia due to Enterobacteriaceae and Pseudomonas aeruginosa. C/T is a combination antibiotic with a new cephalosporin, structurally similar to ceftazidime, plus tazobactam. The FDA approved This known beta-lactamase inhibitor in 2018 to treat intra-abdominal and complicated urinary infections. In 2019, its indication was expanded to nosocomial pneumonia and those associated with mechanical ventilation. In Mexico, it was approved for marketing in June 2019. C/T has broad-spectrum activity since it has action against ESBL-producing Enterobacteria and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens. At the National Cancer Institute, Gram-negative bacilli have been identified for more than 20 years as the pathogens most frequently associated with bacteremia, with Escherichia coli occupying first place at 25% (41% ESBL), followed by Klebsiella sp. in 5.6% (11.2% ESBL), and P. aeruginosa in 5.6% (11.2% MDR). The protocol for approaching and treating hemato-oncological patients with severe neutropenia and fever is to initiate an antimicrobial regimen with piperacillin/tazobactam (P/T) if they are hemodynamically stable. In patients who persist with fever after 48 to 72 hours of starting antibiotics, who present with clinical deterioration, or in whom P/T-resistant bacteria are identified, this is escalated to a carbapenem (usually meropenem). A randomized, open, non-inferiority clinical trial comparing 1:1 two antibiotics, P/T vs. C/T, for the treatment of severe neutropenia and fever and/or developing Enterobacteriaceae or P. aeruginosa bacteremia in patients with hematologic malignancies Methodological strategies All patients who come to the National Cancer Institute with signs of severe neutropenia (polymorphonuclear cells \<500 cells/mm3) and fever (\>38 oC) will be considered for inclusion. Blood cultures will be taken upon admission (catheter and peripheral in those with the same), or two peripherals with a difference of 15 minutes between each one. Blood cultures will be requested before signing the informed consent since they are part of the initial approach to these patients, regardless of whether they enter the study. They will be taken before the administration of antimicrobials. Medical staff from the infectious disease department will evaluate the inclusion and exclusion criteria and invite the candidate to the study. If the patient accepts, they will be provided informed consent to review it in detail, explaining any doubts. If they agree to participate, the corresponding signatures will be made. Randomization will be done based on a stratified method in two groups: Group 1, patients with leukemia, and Group 2, patients with other hemato-oncological pathologies. They will be randomized into ten blocks and divided into the two groups above. The administration of the P/T or C/T antimicrobial regimen will begin depending on the group to which they have been assigned, following the manufacturer's instructions and according to the administration standards at INCan. The clinical and microbiological response will be evaluated in the first 72-96 hours (taking randomization as day +1), defined as patient survival PLUS resolution of fever PLUS sterilization of blood cultures (taken within the first 72-96 hours). If patients have been fever-free for at least 48 hours and have no growth in blood cultures, they will receive at least five days of antibiotic treatment. The administration time will be at least seven days in patients with P. aeruginosa or Enterobacteriaceae growth in blood cultures. Patients whose blood cultures report growth of bacteria different from the previous ones, yeast, or polymicrobial growth will be excluded from the study. Treatment failure will be considered, and the following will be included in the intention-to-treat analysis: * If the growth in the blood culture is Enterobacteriaceae or P. aeruginosa, resistant to the antibiotic assigned. * There is growth of the same bacteria in control blood cultures taken 72-96 hours after starting antibiotics. * If, during treatment, the patient presents signs of hemodynamic instability, respiratory failure, clinical deterioration, or septic shock, changing the antimicrobial regimen will be considered. The following will be considered a relapse and will be included in the intention-to-treat analysis: * When the same microorganism is isolated at the beginning, it grows in blood cultures after having negative blood cultures. * Or in the first 30 days after completing the antibiotic regimen, considering the resolution of the primary infectious focus. During treatment, they will not be able to receive any other Gram-negative antibiotic, except prophylaxis against P. jirovecci (400/80 mg/dayTMP/SMX or 800/160 mg every 48 h). The number of days of antibiotics will be counted. It will be documented when an antibiotic is modified and the reason for the change (microbiological failure, clinical deterioration, drug-related adverse events, and others). The appearance of diarrhea will be monitored, and GDH and toxin for Clostridiodes difficile will be requested. Patients will be evaluated daily until fever resolution and until hospital discharge (if this occurs in the first 14 days), recording fever and adverse events, including diarrhea, leukocytes, and neutrophils. Follow-up will be carried out until day +30 from the patient's inclusion in the study. If the patient is discharged before this date, a telephone call will be made on day +30 to verify the clinical status. The evolution will be classified as alive without infection, alive with clinical or microbiological data of infection, also considering C. difficile infection, dead from infection without neutropenia, dead from infection with neutropenia, dead from terminal illness, or dead from another cause. ### Conditions Module **Conditions:** - Hematologic Neoplasms - Neutropenia **Keywords:** - ceftolozane/tazobactam - piperacillin/tazobacttam - neutropenia - hematologic neoplasms ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized, open, non-inferiority clinical trial comparing 1:1 two antibiotics, piperacillin/taobactam vs. ceftolozane/tazbobactam ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 226 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ceftozolane/Tazobactam (C/T) is a combination antibiotic with a new cephalosporin, structurally similar to ceftazidime, plus tazobactam. The FDA approved This known beta-lactamase inhibitor in 2018 to treat intra-abdominal infections and complicated urinary infections. In 2019, its indication was expanded to nosocomial pneumonia and those associated with mechanical ventilation. In Mexico, it was approved for marketing in June 2019. C/T has broad-spectrum activity since it has action against ESBL-producing Enterobacteria and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens. **Intervention Names:** - Drug: Ceftolozane/tazobactam **Label:** Ceftolozane/Tazobactam **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** At our hospital, Piperacillin/tazobactam is the primary drug used as an empirical treatment in patients with severe neutropenia and fever, according to Clinical Practice Guidelines for the use of antimicrobial agents in neutropenic patients with cancer. **Intervention Names:** - Drug: Piperacillin/tazobactam **Label:** Piperacillin/tazobactam **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ceftolozane/Tazobactam **Description:** Ceftolozane/tazobactam 1.5 g tid IV infusion for 1 hour during 5 to 7 days **Name:** Ceftolozane/tazobactam **Other Names:** - Zerbaxa **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Piperacillin/tazobactam **Description:** Piperacillin/tazobactam 4.5 g qid IV infusion for 30 minutes during 5 to 7 days **Name:** Piperacillin/tazobactam **Other Names:** - Tazocin - Pipertazo - Tazonam - Tazovak **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Number of patients who develop diarrhea or abdominal pain or disteded abdomen, with a test positive for C. difficile (toxin/GDH C. diffile test). **Measure:** Clostridioides difficile infection documented through toxin/GDH C. difficile test in those patients who develop diarrhea, abdominal pain and/or distended abdomen. **Time Frame:** Day 1 to day 30 #### Primary Outcomes **Description:** To assess the number of patients who will be alive or dead in the first 30 days. On day 30, a physical visit will be made to the patient's bedside if the patient is hospitalized. If the patient is not hospitalized, the clinical record will be evaluated, and one of the investigators will make a phone call to ensure the patient's status for that date. **Measure:** Mortality of all patients at day 30 **Time Frame:** Day 30 #### Secondary Outcomes **Description:** Number of patients that will have repeated blood cultures sterilized (no growth of the same bacteria isolated in the first set of blood cultures taken in day 1). **Measure:** Microbiological response through the sterilization of repeated blood cultures take **Time Frame:** Day 3 to day 4 **Description:** The presence of fever (\>38 Celsius degree) will be evaluated according to nursing records that are carried out three times a day (morning, afternoon, and night shifts). Clinical failure will be considered when the patient persists with fever (\>38 Celsius degrees) on day four after starting the antimicrobial regimen. Clinical success will be considered when the fever resolves between day 1 and day 3 of starting antibiotics. **Measure:** Clinical response measured through fever resolution **Time Frame:** Day 4 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: . Patients \>18 years old with a diagnosis of any hematological malignancy. * With severe neutropenia and fever. * With MAP ≥65 mmHg on admission, without signs of hemodynamic instability. * With rectal swab taken before the start of chemotherapy, without isolation of microorganisms resistant to P/T or C/T. * That the life expectancy is ≥ 5 days. * They must agree to participate in the study and sign the informed consent form. Exclusion Criteria: * Known hypersensitivity to cephalosporins or anaphylaxis with beta-lactams. * Concomitant use of another antibiotic with activity against Gram-negatives (except Trimethoprim/Sulfamethoxazole (TMP/SMX) as prophylaxis for P. jirovecci in the first five days of randomization * Patients with end-stage chronic renal failure (\<10 ml/min by creatinine clearance-ACCr) or on renal replacement therapy. * Patients with grade IV mucositis **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Diana Vilar Compte, M.D.,M.Sc. **Phone:** +52 5628 0400 **Phone Ext:** 12110 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Patricia Volkow, M.D. **Phone:** +52 5628 0400 **Phone Ext:** 12120 **Role:** CONTACT #### Locations **Location 1:** **City:** Mexico City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Diana Vilar Compte, M.D., M.Sc. - **Phone:** +52 56280400 - **Phone Ext:** 12110 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Patricia Volkow, M.D. - **Phone:** +52 56280400 - **Phone Ext:** 12120 - **Role:** CONTACT ***Contact 3:*** - **Name:** Beda D Islas-Muñoz, M.D., M.Sc - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Pamela Alatorre-Fernández, M.D. - **Role:** SUB_INVESTIGATOR **Country:** Mexico **Facility:** Instituto Nacional de Cancerologia **State:** Tlalpan **Status:** RECRUITING **Zip:** 14080 #### Overall Officials **Official 1:** **Affiliation:** Instituto Nacional de Cancerología, Mexico **Name:** Patricia Cornejo-Juarez, M.D.,M.Sc. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The data requisition must be carried out with a solid foundation for which the information will be used. The investigators and sub-investigators will review the criteria. **Description:** IPD could be shared with other researchers. **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** The data will become available at the end of the study. The plan is to finish the analysis and write the manuscript at the end of 2025. ### References Module #### References **Citation:** Karaiskos I, Giamarellou H. Carbapenem-Sparing Strategies for ESBL Producers: When and How. Antibiotics (Basel). 2020 Feb 5;9(2):61. doi: 10.3390/antibiotics9020061. **PMID:** 32033322 **Citation:** Xie O, Cisera K, Taylor L, Hughes C, Rogers B. Clinical syndromes and treatment location predict utility of carbapenem sparing therapies in ceftriaxone-non-susceptible Escherichia coli bloodstream infection. Ann Clin Microbiol Antimicrob. 2020 Nov 30;19(1):57. doi: 10.1186/s12941-020-00400-z. **PMID:** 33256752 **Citation:** Giacobbe DR, Bassetti M, De Rosa FG, Del Bono V, Grossi PA, Menichetti F, Pea F, Rossolini GM, Tumbarello M, Viale P, Viscoli C; ISGRI-SITA (Italian Study Group on Resistant Infections of the Societa Italiana Terapia Antinfettiva). Ceftolozane/tazobactam: place in therapy. Expert Rev Anti Infect Ther. 2018 Apr;16(4):307-320. doi: 10.1080/14787210.2018.1447381. Epub 2018 Mar 9. **PMID:** 29493397 **Citation:** Shortridge D, Pfaller MA, Castanheira M, Flamm RK. Antimicrobial Activity of Ceftolozane-Tazobactam Tested Against Enterobacteriaceae and Pseudomonas aeruginosa with Various Resistance Patterns Isolated in U.S. Hospitals (2013-2016) as Part of the Surveillance Program: Program to Assess Ceftolozane-Tazobactam Susceptibility. Microb Drug Resist. 2018 Jun;24(5):563-577. doi: 10.1089/mdr.2017.0266. Epub 2017 Oct 17. **PMID:** 29039729 **Citation:** Pfaller MA, Bassetti M, Duncan LR, Castanheira M. Ceftolozane/tazobactam activity against drug-resistant Enterobacteriaceae and Pseudomonas aeruginosa causing urinary tract and intraabdominal infections in Europe: report from an antimicrobial surveillance programme (2012-15). J Antimicrob Chemother. 2017 May 1;72(5):1386-1395. doi: 10.1093/jac/dkx009. **PMID:** 28165526 **Citation:** Livermore DM, Mushtaq S, Meunier D, Hopkins KL, Hill R, Adkin R, Chaudhry A, Pike R, Staves P, Woodford N; BSAC Resistance Surveillance Standing Committee. Activity of ceftolozane/tazobactam against surveillance and 'problem' Enterobacteriaceae, Pseudomonas aeruginosa and non-fermenters from the British Isles. J Antimicrob Chemother. 2017 Aug 1;72(8):2278-2289. doi: 10.1093/jac/dkx136. **PMID:** 28520867 **Citation:** Pfaller MA, Shortridge D, Sader HS, Flamm RK, Castanheira M. Ceftolozane-tazobactam activity against drug-resistant Enterobacteriaceae and Pseudomonas aeruginosa causing healthcare-associated infections in Australia and New Zealand: Report from an Antimicrobial Surveillance Program (2013-2015). J Glob Antimicrob Resist. 2017 Sep;10:186-194. doi: 10.1016/j.jgar.2017.05.025. Epub 2017 Jul 19. **PMID:** 28735046 **Citation:** Pfaller MA, Shortridge D, Sader HS, Gales A, Castanheira M, Flamm RK. Ceftolozane-tazobactam activity against drug-resistant Enterobacteriaceae and Pseudomonas aeruginosa causing healthcare-associated infections in Latin America: report from an antimicrobial surveillance program (2013-2015). Braz J Infect Dis. 2017 Nov-Dec;21(6):627-637. doi: 10.1016/j.bjid.2017.06.008. Epub 2017 Sep 21. **PMID:** 28941394 **Citation:** Seifert H, Korber-Irrgang B, Kresken M; German Ceftolozane/Tazobactam Study Group. In-vitro activity of ceftolozane/tazobactam against Pseudomonas aeruginosa and Enterobacteriaceae isolates recovered from hospitalized patients in Germany. Int J Antimicrob Agents. 2018 Feb;51(2):227-234. doi: 10.1016/j.ijantimicag.2017.06.024. Epub 2017 Jul 10. **PMID:** 28705666 **Citation:** Fernandez-Cruz A, Alba N, Semiglia-Chong MA, Padilla B, Rodriguez-Macias G, Kwon M, Cercenado E, Chamorro-de-Vega E, Machado M, Perez-Lago L, Garcia de Viedma D, Diez Martin JL, Munoz P. A Case-Control Study of Real-Life Experience with Ceftolozane-Tazobactam in Patients with Hematologic Malignancy and Pseudomonas aeruginosa Infection. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e02340-18. doi: 10.1128/AAC.02340-18. Print 2019 Feb. **PMID:** 30530598 **Citation:** Bergas A, Albasanz-Puig A, Fernandez-Cruz A, Machado M, Novo A, van Duin D, Garcia-Vidal C, Hakki M, Ruiz-Camps I, Del Pozo JL, Oltolini C, DeVoe C, Drgona L, Gasch O, Mikulska M, Martin-Davila P, Peghin M, Vazquez L, Laporte-Amargos J, Dura-Miralles X, Pallares N, Gonzalez-Barca E, Alvarez-Uria A, Puerta-Alcalde P, Aguilar-Company J, Carmona-Torre F, Clerici TD, Doernberg SB, Petrikova L, Capilla S, Magnasco L, Fortun J, Castaldo N, Carratala J, Gudiol C. Real-Life Use of Ceftolozane/Tazobactam for the Treatment of Bloodstream Infection Due to Pseudomonas aeruginosa in Neutropenic Hematologic Patients: a Matched Control Study (ZENITH Study). Microbiol Spectr. 2022 Jun 29;10(3):e0229221. doi: 10.1128/spectrum.02292-21. Epub 2022 Apr 27. **PMID:** 35475683 **Citation:** Criscuolo M, Trecarichi EM. Ceftazidime/Avibactam and Ceftolozane/Tazobactam for Multidrug-Resistant Gram Negatives in Patients with Hematological Malignancies: Current Experiences. Antibiotics (Basel). 2020 Feb 3;9(2):58. doi: 10.3390/antibiotics9020058. **PMID:** 32028615 **Citation:** Marchesi F, Toma L, Di Domenico EG, Cavallo I, Spadea A, Prignano G, Pimpinelli F, Papa E, Terrenato I, Ensoli F, Mengarelli A. Ceftolozane-Tazobactam for Febrile Neutropenia Treatment in Hematologic Malignancy Patients Colonized by Multi-Resistant Enterobacteriaceae: Preliminary Results from a Prospective Cohort Study. Mediterr J Hematol Infect Dis. 2020 Sep 1;12(1):e2020065. doi: 10.4084/MJHID.2020.065. eCollection 2020. No abstract available. **PMID:** 32952976 **Citation:** Clerici D, Oltolini C, Greco R, Ripa M, Giglio F, Mastaglio S, Lorentino F, Pavesi F, Farina F, Liberatore C, Castiglion B, Tassan Din C, Bernardi M, Corti C, Peccatori J, Scarpellini P, Ciceri F, Castagna A. The place of ceftazidime/avibactam and ceftolozane/tazobactam for therapy of haematological patients with febrile neutropenia. Int J Antimicrob Agents. 2021 Jun;57(6):106335. doi: 10.1016/j.ijantimicag.2021.106335. Epub 2021 Apr 7. **PMID:** 33838223 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000000380 - Term: Agranulocytosis - ID: D000007970 - Term: Leukopenia - ID: D000095542 - Term: Cytopenia - ID: D000006402 - Term: Hematologic Diseases - ID: D000007960 - Term: Leukocyte Disorders - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000018805 - Term: Sepsis - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M21314 - Name: Hematologic Neoplasms - Relevance: HIGH - As Found: Hematologic Neoplasms - ID: M18877 - Name: Bacteremia - Relevance: HIGH - As Found: Bacteremia - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M12443 - Name: Neutropenia - Relevance: HIGH - As Found: Neutropenia - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M14409 - Name: Pseudomonas Infections - Relevance: LOW - As Found: Unknown - ID: M3730 - Name: Agranulocytosis - Relevance: LOW - As Found: Unknown - ID: M10973 - Name: Leukopenia - Relevance: LOW - As Found: Unknown - ID: M3170 - Name: Cytopenia - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M10963 - Name: Leukocyte Disorders - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: T2606 - Name: Granulocytopenia - Relevance: HIGH - As Found: Neutropenia ### Condition Browse Module - Meshes - ID: D000016470 - Term: Bacteremia - ID: D000019337 - Term: Hematologic Neoplasms - ID: D000009503 - Term: Neutropenia ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000065093 - Term: beta-Lactamase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000892 - Term: Anti-Infective Agents, Urinary ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M1938 - Name: Tazobactam - Relevance: HIGH - As Found: Ancillary studies - ID: M13772 - Name: Piperacillin - Relevance: HIGH - As Found: Wide - ID: M261814 - Name: Ceftolozane - Relevance: HIGH - As Found: Recurrent adult immunoblastic large cell lymphoma - ID: M255449 - Name: Ceftolozane, tazobactam drug combination - Relevance: HIGH - As Found: Enhancer - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M5692 - Name: Ceftazidime - Relevance: LOW - As Found: Unknown - ID: M5760 - Name: Cephalosporins - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M30450 - Name: beta-Lactamase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1885 - Name: Piperacillin, Tazobactam Drug Combination - Relevance: HIGH - As Found: Amiodarone - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000078142 - Term: Tazobactam - ID: D000010878 - Term: Piperacillin - ID: D000077725 - Term: Piperacillin, Tazobactam Drug Combination - ID: C000519491 - Term: Ceftolozane - ID: C000594038 - Term: Ceftolozane, tazobactam drug combination ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422520 **Brief Title:** Phase 1 First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors **Official Title:** A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** BGB-C354-101 #### Organization **Class:** INDUSTRY **Full Name:** BeiGene #### Secondary ID Infos **ID:** 2024-513280-11-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-24 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** BeiGene #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. Study details include: * The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion). * The visit frequency will be approximately every 21 days during study treatment, and higher frequencies may be considered based on emerging data. The maximum treatment duration will be up to 2 years. * The study duration is estimated to be approximately 5 years. ### Conditions Module **Conditions:** - Advanced Solid Tumor **Keywords:** - BGB-C354 - Tislelizumab - First-in-human - Advanced solid tumor - Anti-PD-1 Monoclonal Antibody - B7H3 - antibody drug conjugate ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 62 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** BGB-C354 monotherapy doses at sequentially increasing levels. **Intervention Names:** - Drug: BGB-C354 **Label:** Phase 1a: Part A (Monotherapy Dose Escalation) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will enroll at safe dose levels recommended by the Safety Monitoring Committee (SMC) for further evaluation. **Intervention Names:** - Drug: BGB-C354 **Label:** Phase 1a: Part B (Safety Expansion) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The dose expansion phase begins after determining the recommended dose for expansion (RDFE) and schedule from Phase 1a, exploring at least 2 dose levels for optimization. **Intervention Names:** - Drug: BGB-C354 **Label:** Phase 1b: Part C (Monotherapy Expansion) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** BGB-C354 and tislelizumab will start at the RDFE-1 level set by the SMC using Phase 1a data, or at a dose level lower than the highest tolerable level established in Part A. **Intervention Names:** - Drug: BGB-C354 - Drug: Tislelizumab **Label:** Phase 1b: Part D (Combination Therapy Expansion) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Phase 1a: Part A (Monotherapy Dose Escalation) - Phase 1a: Part B (Safety Expansion) - Phase 1b: Part C (Monotherapy Expansion) - Phase 1b: Part D (Combination Therapy Expansion) **Description:** Administered by intravenous infusion **Name:** BGB-C354 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Phase 1b: Part D (Combination Therapy Expansion) **Description:** Administered by intravenous infusion **Name:** Tislelizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limitingtoxicity (DLT) criteria **Measure:** Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) **Time Frame:** Up to approximately 2 years **Description:** Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively **Measure:** Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-C354 **Time Frame:** Up to approximately 2 years **Description:** The potential RDFE(s) of BGB-C354 will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available **Measure:** Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354 **Time Frame:** Up to approximately 2 years **Description:** ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1). **Measure:** Phase 1b: Overall Response Rate (ORR) **Time Frame:** Up to approximately 2 years **Description:** The RP2D of BGB-C354 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available. **Measure:** Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-C354 alone and in combination with tislelizumab **Time Frame:** Up to approximately 2 years #### Secondary Outcomes **Description:** ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1. **Measure:** Phase 1a: ORR **Time Frame:** Up to approximately 2 years **Description:** DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator. **Measure:** Duration of Response (DOR) **Time Frame:** Up to approximately 2 years **Description:** DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1. **Measure:** Disease Control Rate (DCR) **Time Frame:** Up to approximately 2 years **Description:** PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.determined from tumor assessments by the investigator using RECIST v1.1. **Measure:** Phase 1b: Progression Free Survival (PFS) **Time Frame:** Up to approximately 2 years **Description:** Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limitingtoxicity (DLT) criteria **Measure:** Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events **Time Frame:** Up to approximately 2 years **Measure:** Maximum observed plasma concentration (Cmax) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Minimum observed plasma concentration (Cmin) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Time to maximum plasma concentration (Tmax) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Half-life (t1/2) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Area under the concentration-time curve (AUC) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Apparent clearance (CL/F) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Apparent volume of distribution (Vz/F) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Accumulation ratio for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Number of participants with anti-drug antibodies (ADAs) to BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Serum concentration of BGB-C354 **Time Frame:** Up to approximately 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent: 4. ≥ 1 measurable lesion per RECIST v1.1. 5. Able to provide an archived tumor tissue sample. 6. Adequate organ function. 7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s). 8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s). Exclusion Criteria: 1. Prior treatment with B7H3-targeted therapy. 2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts). 3. Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis 4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). 5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline 6. Uncontrolled diabetes, or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s). 7. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s). Note: Other protocol defined Inclusion/Exclusion criteria may apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Study Director **Phone:** 1.877.828.5568 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** BeiGene **Name:** Study Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Meet - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000707970 - Term: Tislelizumab ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422507 **Acronym:** PHOTONiC **Brief Title:** A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema **Official Title:** Multi-Center, Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of 8 mg Aflibercept in Chinese Participants With Diabetic Macular Edema #### Organization Study ID Info **ID:** 21583 #### Organization **Class:** INDUSTRY **Full Name:** Bayer ### Status Module #### Completion Date **Date:** 2026-05-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Regeneron Pharmaceuticals #### Lead Sponsor **Class:** INDUSTRY **Name:** Bayer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Researchers are looking for a better way to treat people who have diabetic macular edema. Diabetic macular edema (DME) is a diabetes-related eye disorder. In DME, the macula, which is the central part of the retina at the back of the eye, swells up resulting in vision problems. This happens due to leakage of fluid from damaged blood vessels. The study treatment, 8 milligram (mg) aflibercept is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. A lower dose of aflibercept (2 mg) is already approved for the treatment of DME. Based on the findings of another study, the higher dose of aflibercept (8 mg) is expected to reduce the frequency of injections required for treating DME while being equally safe and working as well as the lower dose. The higher dose could make it easier to treat DME and improve quality of life for people with DME. The main purpose of this study is to learn if high-dose (8 mg) aflibercept given every 16 weeks works as well as low-dose (2 mg) aflibercept given every 8 weeks in Chinese participants. For this, the researchers will compare the change in participants' 'best corrected visual acuity' (BCVA) after 48 weeks of starting the treatment. BCVA is the clearest vision a participant can have with the help of corrective lenses, such as glasses. It will be measured by the number of letters the participant can read on an eye chart. This is known as their Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. Participants will be randomly (by chance) assigned to one of two treatment groups to receive study treatment as an injection into the eye up to Week 56: * 2 mg aflibercept every 8 weeks after receiving 5 initial monthly doses * 8 mg aflibercept every 16 weeks after receiving 3 initial monthly doses Each participant will be in the study for around 63 weeks with up to 18 visits to the study site. This includes: * one visit up to 21 days before the treatment starts during which the doctors will confirm that the participant can take part in the study * 16 visits during which the treatment will be given. Most of these visits will have a gap of 4 weeks except for one visit that will happen a few days after the previous visit * one visit 4 weeks after the treatment ends During the study, the doctors and their study team will: * check the participants' vision and their overall eye health using different eye tests * check participants' health by performing tests such as blood and urine tests * ask the participants questions about the disease and study treatment and how these impact their quality of life * ask the participants what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment. Access to study treatment after the end of this study is not planned. Participants can switch to available approved treatments for DME. **Detailed Description:** EYLEA (aflibercept 40 mg/mL solution for injection) at a dosage level of 2 mg administered intravitreally (IVT) is approved in over 100 countries for the treatment of DME. Despite the proven efficacy and safety of EYLEA in patients with DME, there remains an unmet need for alternative therapies that can decrease the burden of DME treatment via a reduction in the required frequency of IVT injections, while improving visual and anatomic outcomes. The overall one and two year results of PHOTON, a global phase 2/3 trial evaluating high dose (HD or 8 mg) aflibercept in participants with center-involved diabetic macular edema (DME), demonstrate the benefit of HD aflibercept for reducing the frequency of injections required for the treatment of DME while providing visual and anatomic outcomes non-inferior to and a safety profile indistinguishable from EYLEA, 2 mg aflibercept, the established standard of care for the treatment of DME. The observed reduction in the number of HD aflibercept injections required for the treatment of DME over 2 years in PHOTON is expected to translate into the benefit of reducing the burden of treatment and, thereby improving the quality of life for DME patients, their caregivers and health care providers. This study aims to investigate the efficacy and safety of HD aflibercept in Chinese participants with DME over 60 weeks with the primary objective of achieving non-inferior best corrected visual acuity (BCVA) with an extended dosing interval (every 16 weeks after 3 initial monthly injections) vs. 2 mg aflibercept (every 8 weeks after 5 initial monthly injections) similar to the results obtained in PHOTON. This study is designed to support the registration of HD aflibercept for the treatment of DME in China. Primary Objective: The primary objective of the study is to determine if treatment with HD aflibercept at intervals of 16 weeks provides non-inferior best-corrected visual acuity (BCVA) compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants Secondary Objectives: * To determine the effect of HD aflibercept vs. 2 mg aflibercept on anatomic and other visual measures of response; * To evaluate the safety, immunogenicity and pharmacokinetics (PK) of HD aflibercept in Chinese participants. Primary endpoint: * Change from baseline in BCVA by ETDRS letter score at Week 48 Secondary endpoints: * Change from baseline in BCVA by ETDRS letter score at Week 60 * Participants gaining ≥15 letters at Week 48 and Week 60 * Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48 * Participants with no IRF and/or no SRF in the center subfield at Week 48 * Change from baseline in central subfield thickness (CST) at Week 48 * Change from baseline in leakage on fluorescein angiography (FA) at Week 48 * Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at Week 48 * Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 48 and 60 * Participants developing a treatment-emergent ADA response or Nabs to aflibercept through EOS at Week 60 * Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound, and total aflibercept from baseline through Week 48 This study is a phase 3, multi-center, randomized, double-masked, active-controlled study in Chinese participants with DME involving the center of the macula to investigate the efficacy and safety of HD aflibercept versus 2 mg aflibercept. The primary objective of the study is to determine if treatment with HD aflibercept at 16 week intervals provides non-inferior BCVA compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants. 322 eligible participants randomized in a 1:1 ratio to the following 2 treatment groups: 1. 2q8: 2 mg aflibercept every 8 weeks following 5 initial monthly doses (n=161) and 2. HDq16: HD aflibercept every 16 weeks following 3 initial monthly doses (n=161). The study consists of a screening period, a treatment period, and an end of study (EOS) visit at Week 60. The study duration for a participant is approximately 63 weeks. The EOS is defined as the last visit of the last participant. No study treatment will be administered at the EOS visit at Week 60. HD aflibercept is the sponsor's study intervention under investigation. The following intervention groups are included in the study: * 2 mg aflibercept every 8 weeks (2q8) * 8 mg aflibercept every 16 weeks (HDq16) ### Conditions Module **Conditions:** - Diabetic Macular Edema **Keywords:** - DME ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study duration for a participant is approx 63 weeks. EOS is defined as the last visit of the last participant. HD aflibercept is the sponsor's study intervention under investigation. 322 participants will be randomized into 2 treatment groups in a ratio of 1:1 to receive either 2 mg aflibercept every 8 weeks following 5 initial monthly doses (2q8) or HD aflibercept (8mg) every 16 weeks following 3 initial monthly doses (HDq16). Randomization will be stratified according to baseline Central subfield thickness (CST \<400µm, ≥400µm), baseline BCVA (\<60 vs ≥60 ETDRS letters) and prior treatment for DME. Only 1 eye per participant is identified as the study eye. If a participant's fellow (non-study) eye has DME or Neovascular age-related macular degeneration (nAMD) that requires anti-Vascular endothelial growth factor (VEGF) treatment during the participant's involvement in the study, this eye should be treated with EYLEA (2mg aflibercept) and won't be considered an additional study eye. ##### Masking Info **Masking:** DOUBLE **Masking Description:** The study will be conducted in double-masked fashion. Study participants and masked study site personnel will remain masked to all randomization assignments throughout the study. The Sponsor personnel who are in regular contact with the study site will remain masked to all participant randomization assignments. The operational conduct of the study after the primary analysis at Week 48 will be maintained by a masked team. No decisions on data will be taken by any of the unmasked study personnel. To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 322 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants that will be enrolled to this treatment arm will receive 2 mg aflibercept every 8 weeks following 5 initial monthly doses starting at Baseline (visit 2) (2q8) for the chosen "study eye". Randomization will be stratified according to baseline Central subfield thickness (CST) (\<400 µm, ≥400 µm), baseline Best corrected visual acuity (BCVA) (\<60 vs. ≥60 ETDRS letters) and prior treatment for DME. **Intervention Names:** - Drug: 2 mg aflibercept (EYLEA, BAY 86-5321) - Other: Sham **Label:** 2 mg aflibercept **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants that will be enrolled to this treatment arm will receive 8 mg (high dose - HD) aflibercept every 16 weeks following 3 initial monthly doses, starting at Baseline (Visit 2) (HDq16) for the chosen "study eye". Randomization will be stratified according to baseline Central subfield thickness (CST) (\<400 µm, ≥400 µm), baseline Best corrected visual acuity (BCVA) (\<60 vs. ≥60 ETDRS letters) and prior treatment for DME. **Intervention Names:** - Drug: 8 mg aflibercept (BAY 86-5321) (High Dose) - Other: Sham **Label:** 8 mg aflibercept (high dose) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 8 mg aflibercept (high dose) **Description:** High-dose (HD) aflibercept is the sponsor's study intervention under investigation. Dose formulation: solution in vial. Unit dose strength: 114.3 mg/mL, Dosage Level: 8 mg (70 µL), Route of Administration: Intravitreal (IVT) injection every 16 weeks following 3 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 3 mL glass vials. Each vial will be labeled as required per country requirement. **Name:** 8 mg aflibercept (BAY 86-5321) (High Dose) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 2 mg aflibercept **Description:** Aflibercept 2 mg is the sponsor's active comparator. Dose formulation: solution in vial. Unit dose strength: 40 mg/mL, Dosage Level: 2 mg (50 µL), Route of Administration: Intravitreal (IVT) injection every 8 weeks following 5 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 2 mL glass vials. Each vial will be labeled as required per country requirement. Aflibercept 2 mg for the non-study "fellow eye" treatment is considered an auxiliary medicinal product (AxMP) in this study. Fellow eye treatment will be allowed with 2 mg aflibercept, at the investigator's discretion for indications approved by governing authorities. The treated fellow eye will not be considered an additional study eye. **Name:** 2 mg aflibercept (EYLEA, BAY 86-5321) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - 2 mg aflibercept - 8 mg aflibercept (high dose) **Description:** To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56. Sham kits will be assigned for visits requiring sham injections. The sham kits are empty but should be handled in the same way as the active study intervention kits. Sham injections will be given on visits when an active injection is not planned. During the study treatment period all participants will receive either an active injection (8 mg or 2 mg aflibercept) or a sham injection (for masking purposes) following their assigned treatment group and eligibility for Dose regimen modification (DRM). **Name:** Sham **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint is the change from baseline in BCVA at Week 48. Efficacy analyses will be conducted using the Full analysis set (FAS). The primary efficacy analysis will be a comparison between 2 comparative arms: HDq16 vs. 2q8. The primary efficacy variable (Change from baseline in BCVA by ETDRS letter score at Week 48) will be analyzed using FAS with an Mixed Model for Repeated Measurements (MMRM) analysis model. The model includes baseline BCVA as a covariate, treatment group, baseline CST category, baseline BCVA category, prior DME treatment, and visit as fixed effects, and interaction terms for treatment by visit and baseline BCVA by visit. A Kenward-Roger approximation will be used for the denominator degrees of freedom. **Measure:** Change from baseline in Best corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 #### Secondary Outcomes **Measure:** Change from baseline in BCVA by ETDRS letter score at Week 60 **Time Frame:** Week 0 (Baseline) to Week 60 **Measure:** Participants gaining ≥15 letters at Week 48 and Week 60 **Time Frame:** Week 48 and Week 60 **Measure:** Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48 **Time Frame:** Week 48 **Measure:** Participants with no Intraretinal fluid (IRF) and/or no Subretinal fluid (SRF) in the center subfield at Week 48 **Time Frame:** Week 48 **Measure:** Change from baseline in central subfield thickness (CST) at Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 **Measure:** Change from baseline in leakage on fluorescein angiography (FA) at Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 **Measure:** Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 **Measure:** Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 48 and 60 **Time Frame:** Week 48 to Week 60 **Measure:** Participants developing a treatment-emergent Anti-drug antibody (ADA) response or Nabs to aflibercept through EOS at Week 60 **Time Frame:** Week 60 **Measure:** Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound, and total aflibercept from baseline through Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: * Men or women ≥18 years of age * Chinese participants with type 1 or type 2 diabetes mellitus and diabetic macular edema (DME) with central involvement defined as CST ≥300 µm (or ≥320 µm on Heidelberg Spectralis) in the study eye as determined by the reading center at the screening visit and confirmed by the site at baseline visit * BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye at the screening and baseline visits with decreased vision determined to be primarily the result of DME * Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Key Exclusion Criteria: * Evidence of macular edema due to any cause other than diabetes mellitus in either eye * Active proliferative diabetic retinopathy in the study eye * Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in the study eye within 12 weeks (84 days) of the screening visit * IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, conbercept, faricimab, brolucizumab, pegaptanib sodium) in the study eye within 12 weeks (84 days) of the screening visit * Previous use of topical steroids within 4 weeks (28 days) of the screening visit or of intraocular or periocular corticosteroids in the study eye within 16 weeks (112 days) of the screening visit, or ILUVIEN or OZURDEX IVT implants at any time * Prior ocular investigational agents (that have not been approved) in either eye (e.g., IVT, suprachoroidal injections, ocular implants, etc.) at any time. * Previous treatment with an investigational or approved intraocular gene therapy or cell therapy in either eye at any time. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bayer Clinical Trials Contact **Phone:** (+)1-888-84 22937 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008268 - Term: Macular Degeneration - ID: D000012162 - Term: Retinal Degeneration - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11261 - Name: Macular Edema - Relevance: HIGH - As Found: Macular Edema - ID: M7657 - Name: Edema - Relevance: HIGH - As Found: Edema - ID: M11260 - Name: Macular Degeneration - Relevance: LOW - As Found: Unknown - ID: M14997 - Name: Retinal Degeneration - Relevance: LOW - As Found: Unknown - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008269 - Term: Macular Edema - ID: D000004487 - Term: Edema ### Intervention Browse Module - Ancestors - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M257727 - Name: Aflibercept - Relevance: HIGH - As Found: Potential - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000533178 - Term: Aflibercept ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422494 **Acronym:** RAID-II **Brief Title:** The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II **Official Title:** The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II #### Organization Study ID Info **ID:** 115142 #### Organization **Class:** OTHER **Full Name:** Radboud University Medical Center ### Status Module #### Completion Date **Date:** 2025-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Radboud University Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this trial is to study the effect that adrenaline has on the immune reaction seen during a low blood sugar. People with type 1 diabetes do not produce their own insulin. The cells in the pancreas that produce insulin are destroyed. People with type 1 diabetes require daily insulin administration. As a consequence of this insulin therapy the blood sugar can dip too low, causing symptoms such as confusion, irritation and tiredness. This is called hypoglycaemia. Hypoglycaemia has been associated with an increased risk for cardiovascular disease such as heart attacks. During hypoglycaemia the immune system is activated. The immune system consists of white blood cells which produce cytokines, these are proteins used to kill pathogens such as bacteria. During hypoglycaemia there are no pathogens but the cytokines are still produced, leading to unwanted damage. A previous study performed by our research group showed that the immune system activation caused by hypoglycaemia is associated with the stress hormone adrenaline. Adrenaline is released by the body in moments of stress such as during running or bungee jumping. Adrenaline is also released by the body during hypoglycaemia to increase the sugar level. Our hypothesis is that adrenaline activates the immune system during hypoglycaemia. Adrenaline acts in the body through two receivers, these are called alpha and beta receptors. These are present on almost all cells in the body especially on the immune cells. With the study we want to study the situation where there is a hypoglycaemia without the adrenaline. We will achieve this by lowering the blood sugar in participants. During the low blood sugar we will administer two drugs, which will attach themselves to the adrenaline receivers, the alpha and beta receptor. With this method we hope to block the adrenaline effects and with that block the immune response caused by adrenaline. **Detailed Description:** Rationale: Hypoglycaemia has shown to cause a sustained pro-inflammatory response which could promote a pro-atherogenic state and explain the association between hypoglycaemia and cardiovascular events. This pro-inflammatory response has been linked to the adrenaline response to hypoglycaemia. Adrenergic blockade with α and β adrenergic receptor antagonists (ARA) has shown to blunt the leukocyte response after hypoglycaemia induction and adrenaline administration. Whether and to what degree a combined blockade blunts the hypoglycaemia induced pro-inflammatory response is unknown. Objective: to examine the effect of adrenergic inhibition on the hypoglycaemia induced inflammatory response (e.g. leukocyte phenotype, cytokines, inflammatory proteins) by performing a hyperinsulinaemic hypoglycaemic glucose clamp alongside infusion of α-ARA and β-ARA. Secondary objectives consist of the effect of adrenergic blockade during hypoglycaemia on atherogenic parameters and glucose metrics ( e.g. time in range). Study design: Intervention study with a cross-over design Study population: Potentially eligible adult ( 16 - 75 years) participants will be recruited through social media, the Radboudumc outpatient clinic and other advertisements. We will recruit a total of 24 individuals, i.e. 12 healthy participants and 12 participants with type 1 diabetes. Participants with type 1 diabetes will be twice ( as there are two investigational days) equipped with a blinded continuous glucose monitoring device (CGM) during the test, which will measure interstitial glucose levels for a total of 10 days. Intervention: All participants will undergo a hyperinsulinaemic hypoglycaemic glucose clamp ( nadir 2.8 mmol/L). During the clamp the participants will be randomized to receive an infusion of saline or an infusion of phentolamine and propranolol. This will be done using a cross-over design. The participants will undergo both the saline and adrenergic blockade. Main study parameters/endpoints: The main study parameter will be the monocyte count after 60 minutes hyperinsulinaemic hypoglycaemic clamp and adrenergic blockade during the clamp. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 1 - Inflammation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Potentially eligible adult ( 16 - 75 years) participants will be recruited through social media, the Radboudumc outpatient clinic and other advertisements. We will recruit a total of 24 individuals, i.e. 12 healthy participants and 12 participants with type 1 diabetes. Participants with type 1 diabetes will be twice ( as there are two investigational days) equipped with a blinded continuous glucose monitoring device (CGM) during the test, which will measure interstitial glucose levels for a total of 10 days. ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants will be blinded tot the co-infusion during hypoglycaemia. This will be achieved by similar labelling, with phentolamine having the label infusion A and the propranolol infusion having the label infusion B. When administering saline the 50 milliliter syringes will be filled with saline instead of the solution containing either phentolamine or propranolol. Both saline syringes will still have the labels infusion A and infusion B. The investigators will not be blinded as they will be preparing the adrenergic solutions and the saline solutions. The participants will receive the same amount of millilitres during both infusions, determined by the amount infused during adrenergic blockade. Participants will be block-randomized with blocks of 2 using a randomisation list allocated to receive either the adrenergic blockade or the saline first. The coordinating investigator will have access to this list. **Who Masked:** - PARTICIPANT **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants without type 1 diabetes **Intervention Names:** - Drug: hyperinsulinaemic hypoglycaemic clamp - Drug: Propranolol Hydrochloride 1 MG/ML - Drug: Phentolamine **Label:** Participants without type 1 diabetes **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants with type 1 diabetes **Intervention Names:** - Drug: hyperinsulinaemic hypoglycaemic clamp - Drug: Propranolol Hydrochloride 1 MG/ML - Drug: Phentolamine **Label:** Participants with type 1 diabetes **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants with type 1 diabetes - Participants without type 1 diabetes **Description:** Insulin will be infused at a continuous rate of 60 mU∙m-2 ∙min-1 and glucose 20% will be infused at a variable rate, aiming for stable plasma glucose levels of 5.0 mmol/L. The infusion rate of glucose will be adjusted by plasma glucose levels, measured at 5-minute intervals. After 30 minutes of stable euglycaemia, plasma glucose levels will be allowed to drop gradually to 2.8 mmol/L and will be maintained at this level for 60 minutes. Then, insulin infusion and adrenergic blockade infusions will be stopped. Glucose infusion will be increased and then tapered until stable euglycaemia plasma levels are reached. **Name:** hyperinsulinaemic hypoglycaemic clamp **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Participants with type 1 diabetes - Participants without type 1 diabetes **Description:** When euglycaemic level of 5.0mmol/L is achieved we will start the adrenergic blockade which will continue throughout euglycaemia and hypoglycaemia. The participants will be administered a bolus of phentolamine of 70µg/kg followed by a dose of 7.0µg/kg/min continuous infusion and a bolus of propranolol of 14µg/kg followed by a dose of 1.4µg/kg/min. **Name:** Propranolol Hydrochloride 1 MG/ML **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Participants with type 1 diabetes - Participants without type 1 diabetes **Description:** When euglycaemic level of 5.0mmol/L is achieved we will start the adrenergic blockade which will continue throughout euglycaemia and hypoglycaemia. The participants will be administered a bolus of phentolamine of 70µg/kg followed by a dose of 7.0µg/kg/min continuous infusion and a bolus of propranolol of 14µg/kg followed by a dose of 1.4µg/kg/min. **Name:** Phentolamine **Type:** DRUG ### Outcomes Module #### Other Outcomes **Measure:** HbA1c expressed in mmol/L **Time Frame:** At screening **Measure:** Serum creatinine for kidney function expressed in umol/L **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia **Description:** Measured by automatic sphygmomanometer **Measure:** Vitals ( blood pressure and heart rate) **Time Frame:** At both investigational days, every 15 minutes during each investigational day for a total of 8 hours. **Description:** Using length and weight expressed in kg/m\^2 **Measure:** Body mass index **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia **Measure:** Age **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia **Description:** Male or female **Measure:** Sex **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia **Measure:** Duration of diabetes ( years) **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia #### Primary Outcomes **Description:** The number of monocytes following 60 minutes hypoglycaemia and adrenergic blockade compared to baseline. Adrenergic blockade using Phentolamine and Propranolol intravenously. Expressed in 10\^3/µl measured using a sysmex machine. **Measure:** Monocyte count after 60 minutes of hypoglycaemia and adrenergic blockade **Time Frame:** After 60 minutes of hypoglycaemia and adrenergic blockade #### Secondary Outcomes **Description:** Leukocyte count at the time points 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia (e.g. Monocytes, granulocytes, lymphocytes). **Measure:** Leukocyte count at the time points **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia **Description:** Ex vivo production of pro- and anti-inflammatory cytokines and chemokines after ex vivo stimulation of isolated leukocytes, including Tumor necrosis factor-α, Interleukin-6, Interleukin-10 and Interleukin-1β, 1β **Measure:** Ex vivo production of pro- and anti-inflammatory cytokines and chemokines **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia **Description:** 92 circulating inflammatory proteins using Olink Proteomics inflammation panel **Measure:** 92 circulating inflammatory proteins **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Inflammatory plasma protein using ELISA,(e.g high sensitive-crp) **Measure:** Inflammatory plasma protein ( e.g. high-sensitive crp) **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Atherogenic parameters using ELISA including but not limited to, vascular endothelial cell adhesion molecule-1, vascular endothelial cell adhesion molecule-1, E-Selectin, P-selectin, Plasminogen activator inhibitor-1, Plasma Endothelin **Measure:** Atherogenic parameters **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Plasma levels of hormones ( Cortisol, insulin, glucagon, growth-hormone, adrenaline, noradrenaline) **Measure:** Plasma levels of hormones **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Amount of events **Measure:** Amount of hypoglycaemic events measured by the blinded continuous glucose monitor **Time Frame:** During the full study, 3 days before and 7 days after each investigational day **Description:** Variability of glucose expressed as a standard deviation of the mean glucose **Measure:** Variability measured by the blinded continuous glucose monitor **Time Frame:** During the full study, 3 days before and 7 days after each investigational day **Description:** Average glucose during the 10 days of measuring expressed as mmol/L **Measure:** Average glucose measured by the blinded continuous glucose monitor **Time Frame:** During the full study, 3 days before and 7 days after each investigational day **Description:** Amount of time that glucose is between 3.8 and 10 mmol/L expressed as a percentage **Measure:** Time in range measured by the blinded continuous glucose monitor **Time Frame:** During the full study, 3 days before and 7 days after each investigational day **Description:** Amount of plasma glycerol during and after hypoglycaemia **Measure:** Amount of plasma glycerol **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Amount of Non-esterified fatty acids (NEFAs) during and after hypoglycaemia **Measure:** Amount of Non-esterified fatty acids **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Measuring a panel of amino acids **Measure:** Untargeted metabolomics profiling **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Gene expression changes in leukocytes (e.g. using RNA sequencing, quantitative PCR) **Measure:** Gene expression changes in leukocytes **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Epigenetic changes in leukocytes (e.g. using Assay for Transposase- Accessible Chromatin using sequencing (ATACseq), DNA methylation analysis) **Measure:** Epigenetic changes in leukocytes **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Functional changes in monocytes (e.g. using adhesion assays, differentiation experiments) **Measure:** Functional changes in monocytes **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Measure:** Adrenergic symptoms assessed using the validated Edinburgh Hypoglycaemia Score **Time Frame:** 0, 30 minutes after euglycaemia, 30 minutes and 60 minutes during hypoglycaemia **Measure:** Hypoglycaemia awareness using the modified Clarke score **Time Frame:** At screening ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Overall inclusion criteria: * Ability to provide written informed consent * Body-Mass Index: 18,5-35 kg/m2 * Age ≥16 years, ≤ 75 years * Blood pressure: \<140/90 mmHg * Non-smoking * Electrocardiogram not showing any serious arrythmias (premature ventricular complexes and premature atrial complexes accepted) Diabetes group specific criteria: * Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump) * Duration of diabetes \> 1 year * HbA1c \< 100 mmol/mol, Exclusion Criteria: * Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, symptomatic peripheral arterial disease) * Pregnancy or breastfeeding or unwillingness to undertake measures for birth control * Active epilepsy ( with the need for treatment) * Allergy for sulphite * Active asthma with use of β2-bronchodilators or obstructive lung disease * Current treatment with Alpha- or beta-blockers (e.g. doxazosin, propranolol) * History of clinical significant Arrhythmias * Use of immune-modifying drugs or antibiotics * Use of antidepressants ( Including monoamine oxidase inhibitors, tricyclic antidepressants and serotonin-reuptake inhibitors) * Use of antipsychotics * Use of statins with the inability to stop statins \>2 weeks before the investigational day. * Proliferative retinopathy * Nephropathy with an estimated glomerular filtration rate (by Chronic Kidney Disease Epidemiology Collaboration equation, CKD-EPI) ˂60ml/min/1.73m2 **Gender Based:** True **Gender Description:** We aim to match our participants with each other to have comparable groups. So we aim to have the same amount of males and females. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ilyas Mustafajev, M.D. **Phone:** 0629669369 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rick Meijer, MD, PhD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Radboud University Medical Center (Radboudumc) **Name:** Cees Tack, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The coordinating researcher will review access requests. Seeing as the data are all anonymized access will be granted for additional research in the field of inflammation or diabetes. **Description:** We will share the study protocol using a data repository accessible through the research team on demand. Starting around 6 months after publication. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** 6 months after publication ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 1 - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M10053 - Name: Hypoglycemia - Relevance: HIGH - As Found: Hypoglycemia - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 - ID: D000007003 - Term: Hypoglycemia - ID: D000007249 - Term: Inflammation ### Intervention Browse Module - Ancestors - ID: D000000319 - Term: Adrenergic beta-Antagonists - ID: D000018674 - Term: Adrenergic Antagonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000000959 - Term: Antihypertensive Agents - ID: D000014665 - Term: Vasodilator Agents - ID: D000000317 - Term: Adrenergic alpha-Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: HIGH - As Found: Ketoconazole - ID: M14298 - Name: Propranolol - Relevance: HIGH - As Found: Sprain - ID: M13551 - Name: Phentolamine - Relevance: HIGH - As Found: Orthopedic Surgery - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3671 - Name: Adrenergic beta-Antagonists - Relevance: LOW - As Found: Unknown - ID: M20755 - Name: Adrenergic Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M3669 - Name: Adrenergic alpha-Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000011433 - Term: Propranolol - ID: D000010646 - Term: Phentolamine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422481 **Acronym:** MYOLOAD **Brief Title:** Echocardiographic Measurement of Myocardial Work **Official Title:** Non-invasive Measurement of Myocardial Work Using Transthoracic Echocardiography in Critically Ill Patients: the MYOLOAD Study #### Organization Study ID Info **ID:** 24-PP-04 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Nice ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Nice #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Echocardiography is recommended for the hemodynamic management of patients with shock. Recently, a new echocardiographic method has been proposed that provides a non-invasive measurement of myocardial work incorporating different components, namely total myocardial work (GWI), constructive myocardial work (GCW), lost myocardial work (GWW) and effective myocardial work (GWE). Echocardiographic measurement of myocardial work takes into account both myocardial deformation and left ventricular afterload (estimated by measuring systolic blood pressure) and, unlike the measurement of left ventricular ejection fraction and global longitudinal strain, could be less dependent on cardiac load conditions, particularly left ventricular afterload. To date, non-invasive measurement of myocardial work has never been validated in critically ill patients, and no study has assessed the effects of different therapies (fluids administration, administration of norepinephrine) on the different components of myocardial work in patients admitted to intensive care unit. ### Conditions Module **Conditions:** - Cardiovascular Physiological Phenomena - Intensive Care Unit Syndrome ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 110 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Fluid administration **Label:** Fluids **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Norepinephrine administration or increase in norepinephrine dosage **Label:** Norepinephrine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Fluids **Description:** Patients will receive fluid administration (500 mL of saline over 30 minutes). The indication of fluid administration will be left to the discretion of the attending physician. **Name:** Fluid administration **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Norepinephrine **Description:** Patients will receive norepinephrine or norepinephrine dosage will be increased if necessary to achieve the appropriate mean arterial pressure level. The indication of norepinephrine administration or increase in norepinephrine dosage will be left to the discretion of the attending physician. **Name:** Norepinephrine administration or increase in norepinephrine dosage **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome will be assess by evaluating the proportion of patients in whom non-invasive echocardiographic measurement of myocardial work is obtained. **Measure:** Determine the feasibility of echocardiographic measurement **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** The measurement of myocardial work will be performed non-invasively by cardiac ultrasound. The secondary outcomes will be assess the impact of fluid administration on the different components of myocardial work. as follows: (i) fluid-induced changes in the different components of myocardial work, (ii) concordance between changes in myocardial work and changes in cardiac output induced by fluid administration (iii), the ability of the different components of myocardial work to predict fluid responsiveness. **Measure:** measurement of myocardial by cardiac ultrasound during fluid administration **Time Frame:** through study completion, an average of 1 year **Description:** The measurement of myocardial work will be performed non-invasively by cardiac ultrasound. The secondary outcomes will be assess the impact of norepinephrine administration on the different components of myocardial work. as follows: (i) norepinephrine-induced changes in the different components of myocardial work, (ii) concordance between changes in myocardial work and changes in cardiac output induced by norepinephrine and (iii), the ability of the different components of myocardial work to predict fluid responsiveness. **Measure:** measurement of myocardial by cardiac ultrasound norepinephrine administration **Time Frame:** through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Indication to fluid administration left to the discretion of the attending physician * Indication to norepinephrine administration or increase in norepinephrine dosage left to the discretion of the attending physician. Exclusion Criteria: * Patients under protection. * Patients with do not ressuscitate order. * Patients with severe left-side or right-side valvulopathy. * Patients with atrial fibrillation. * Patients with ventricular aneuvrysm or severe regional wall motion abnormalities. * Patients with a pacemaker. * Patients' objections to the collection of their health data. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mathieu Jozwiak, MD **Phone:** +33492035510 **Role:** CONTACT #### Locations **Location 1:** **City:** Nice **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mathieu Jozwiak, MD - **Phone:** +33492035510 - **Role:** CONTACT ***Contact 2:*** - **Name:** THOMAS CITTI - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** CHU de NICE ARCHET **State:** CHU De Nice **Zip:** 06000 **Location 2:** **City:** Nice **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** DENIS DOYEN, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** DENIS DOYEN, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** CHU de NICE PASTEUR **State:** CHU De Nice **Zip:** 06000 **Location 3:** **City:** Marseille **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** CYRIL NAFATI, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** CYRIL NAFATI, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Aphm Hopital La Timone ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000316 - Term: Adrenergic alpha-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000013566 - Term: Sympathomimetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000014662 - Term: Vasoconstrictor Agents ### Intervention Browse Module - Browse Branches - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12575 - Name: Norepinephrine - Relevance: HIGH - As Found: Kinase - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3668 - Name: Adrenergic alpha-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M16345 - Name: Sympathomimetics - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009638 - Term: Norepinephrine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422468 **Acronym:** CARDS-pilot **Brief Title:** Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring **Official Title:** Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring: a Pilot Study #### Organization Study ID Info **ID:** Z-2023103 #### Organization **Class:** INDUSTRY **Full Name:** Qompium NV ### Status Module #### Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-02-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Qompium NV #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this interventional clinical trial is to investigate whether combining photoplethysmography (PPG) signals with accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (AF). ### Conditions Module **Conditions:** - Atrial Fibrillation **Keywords:** - Photoplethysmography - Single-lead Electrocardiography ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 125 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: FibriCheck recordings **Label:** FibriCheck recordings **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - FibriCheck recordings **Description:** PPG, ACC, GYR, ECG and sound measurements **Name:** FibriCheck recordings **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Detect or identify specific morphologic characteristics (changes or correlations) by the comparison of PPG signals, accelerometer signals, gyroscope signals, sound signals and ECG signals, derived via the smartphone data. **Measure:** Identification of morphologic characteristics of smartphone generated signals **Time Frame:** 1 day #### Secondary Outcomes **Description:** Evaluate the performance of our PPG FibriCheck Algorithm in cardiology patients and healthy volunteers, based on simultaneously recorded ECG data (RR intervals). **Measure:** Evaluate the performance of the FibriCheck Algorithm **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Inclusion criteria applicable for all groups: * At least 18 years old * Participants must have the ability to understand and provide written informed consent * Participants must have the ability to understand Dutch Group specific inclusion criteria: Group 1: Healthy volunteers * No cardiac conditions based on medical history. Group 2: Cardiology patients * Patients at the consultation or ambulatory unit of Cardiology (pre- cardioversion, pre-pulmonary vein isolation) with AF. * Patients without AF but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction). Exclusion Criteria: * Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device * Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement * Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow * Persons that have a disability to perform the measurements according to the instructions for use * Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lars Grieten, PhD **Phone:** +3211485953 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Annelies Geeraerts, PhD **Phone:** +3211485953 **Role:** CONTACT #### Locations **Location 1:** **City:** Genk **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Pieter Vandervoort, MD - **Phone:** 089/325050 - **Role:** CONTACT **Country:** Belgium **Facility:** Ziekenhuis Oost Limburg **State:** Limburg **Status:** RECRUITING **Zip:** 3600 #### Overall Officials **Official 1:** **Affiliation:** Ziekenhuis Oost-Limburg **Name:** Pieter Vandervoort, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001281 - Term: Atrial Fibrillation ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422455 **Brief Title:** Access to Genetic Testing in Underserved Patients With Cancer **Official Title:** Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent #### Organization Study ID Info **ID:** 19PS-22-3 #### Organization **Class:** OTHER **Full Name:** University of Southern California #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-02187 **Type:** REGISTRY **Domain:** USC / Norris Comprehensive Cancer Center **ID:** 19PS-22-3 **Type:** OTHER **ID:** P30CA014089 **Link:** https://reporter.nih.gov/quickSearch/P30CA014089 **Type:** NIH **ID:** R01CA263532 **Link:** https://reporter.nih.gov/quickSearch/R01CA263532 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** University of Southern California #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive information from a human genetics healthcare provider. Patients with cancer are increasingly recommended for genetic testing as standard of care. Multiple factors contribute to low usage of genetic testing but for many patients the lack of access to genetic counseling and testing is an important and flexible factor. Lack of access is especially relevant to racial/ethnic minority patients and those living in non-metropolitan rural settings who are frequently cared for at safety-net hospitals with limited genetics services. Alternative delivery models are necessary to improve rates of access to genetic testing in patients with cancer. Health information technology is under used by genetics providers. A patient-facing relational agent (PERLA) will provide pre-test genetics education in both English and Spanish across two clinical settings to facilitate more timely access to genetic testing. Using the PERLA intervention may help researchers learn different ways to provide education about genetic testing to patients with cancer compared to usual care. **Detailed Description:** PRIMARY OBJECTIVES: I. To obtain patient and provider input on the optimal content and format of a new relational agent (RA) intervention ("PERLA") for automated pre-test genetics education. II. To obtain patient feedback on the usability of the English- and Spanish-language PERLAs. III. To determine the acceptability of the newly designed English- and Spanish-language PERLAs among patients with cancer. IV. To evaluate the impact of the English- and Spanish-language PERLAs on the proportion of patients who meet cancer-based genetic testing guidelines who receive genetic test results within 3 months of initiating cancer care. V. To evaluate the potential barriers and facilitators to implementation of PERLA in the clinical setting. OUTLINE: DEVELOPMENT PHASE: Participants attend focus groups and provide feedback on the content, format, and usability of the PERLAs to enable to tailor the design of the intervention. USABILITY PHASE: Participants attend usability testing and provide feedback through cognitive interviews. PILOT TESTING PHASE: Participants evaluate the newly developed PERLAs and provide feedback through focused interviews and structured assessment. INTERVENTION PHASE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. ARM B: Patients receive access to usual care pre- and post-test provider-based genetic counseling. IMPLEMENTATION PHASE: Participants complete qualitative interviews to evaluate potential barriers and facilitators to implementation of PERLA in the clinic. After completion of study intervention, patients are followed up at 1, 3, and 6 months. ### Conditions Module **Conditions:** - Breast Carcinoma - Male Breast Carcinoma - Malignant Solid Neoplasm - Metastatic Prostate Carcinoma - Ovarian Carcinoma - Pancreatic Exocrine Neoplasm - Stage IVB Prostate Cancer American Joint Committee on Cancer v8 - Triple-Negative Breast Carcinoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 800 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. . **Intervention Names:** - Other: Educational Intervention - Other: Electronic Health Record Review - Other: Genetic Counseling - Other: Interview - Other: Survey Administration **Label:** Intervention Phase Arm A (PERLA) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients receive access to usual care pre- and post-test provider-based genetic counseling. **Intervention Names:** - Other: Best Practice - Other: Electronic Health Record Review - Other: Survey Administration **Label:** Intervention Phase Arm B (usual care) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Phase Arm B (usual care) **Description:** Receive provider-based genetic counseling **Name:** Best Practice **Other Names:** - standard of care - standard therapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) **Description:** Receive genetics education **Name:** Educational Intervention **Other Names:** - Education for Intervention - Intervention by Education - Intervention through Education - Intervention, Educational **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) - Intervention Phase Arm B (usual care) **Description:** Ancillary studies **Name:** Electronic Health Record Review **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) **Description:** Receive provider-based genetic counseling **Name:** Genetic Counseling **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) **Description:** Ancillary studies **Name:** Interview **Type:** OTHER #### Intervention 6 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) - Intervention Phase Arm B (usual care) **Description:** Ancillary studies **Name:** Survey Administration **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The proportion of participants who receive genetic testing will be reported. **Measure:** Proportion of participants who receive genetic testing **Time Frame:** Up 3 months #### Secondary Outcomes **Description:** Correlations with patient level factors, such as education, literacy, acculturation, and language will be examined. **Measure:** Patient-reported outcomes **Time Frame:** Up to 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 years old * Diagnosed with least one of the following: * Epithelial ovarian cancer * Exocrine pancreatic cancer * Metastatic or high or very high-risk prostate cancer * Breast cancer at or before age 50 * Bilateral breast cancer * Triple negative breast cancer * Male breast cancer OR * Healthcare provider who treats patients with any of the above types of cancer * Able to read and write in English or Spanish * Able to provide informed consent Exclusion Criteria: * Patients who cannot provide informed consent * Patients who cannot see, read, or write * Patients who have the cancer and clinical characteristics defined in the inclusion criteria, but who do not speak English or Spanish * Patients with none of the listed cancer diagnoses and clinical characteristics * Healthcare provider who do not treats cancer patients **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Charite Ricker, MS **Phone:** 323-409-7710 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Charite Ricker - **Phone:** 323-409-7710 - **Role:** CONTACT ***Contact 2:*** - **Name:** Charite Ricker - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** USC / Norris Comprehensive Cancer Center **State:** California **Zip:** 90033 **Location 2:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Meghan L. Underhill - **Role:** CONTACT ***Contact 2:*** - **Name:** Meghan L. Underhill - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Rochester **State:** New York **Zip:** 14642 #### Overall Officials **Official 1:** **Affiliation:** University of Southern California **Name:** Charite Ricker, MS **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009371 - Term: Neoplasms by Site - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Carcinoma - ID: M14335 - Name: Prostatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M12974 - Name: Ovarian Neoplasms - Relevance: LOW - As Found: Unknown - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: LOW - As Found: Unknown - ID: M20665 - Name: Breast Neoplasms, Male - Relevance: HIGH - As Found: Male Breast Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: LOW - As Found: Unknown - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: LOW - As Found: Unknown - ID: T861 - Name: Breast Cancer, Male - Relevance: HIGH - As Found: Male Breast Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000009369 - Term: Neoplasms - ID: D000001943 - Term: Breast Neoplasms - ID: D000018567 - Term: Breast Neoplasms, Male ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422442 **Brief Title:** Information Processing Biases in Adults Who Stutter **Official Title:** Information Processing Biases in Adults Who Stutter: Behavioral and Eye-tracking Indices of Threat-related Attention Allocation #### Organization Study ID Info **ID:** R21DC020557 **Link:** https://reporter.nih.gov/quickSearch/R21DC020557 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** University of Memphis ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Alabama, Tuscaloosa #### Lead Sponsor **Class:** OTHER **Name:** University of Memphis #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to examine whether stuttering is associated with a tendency to attend more quickly or for longer durations to threat-related information in the environment (threat-related attention bias). The main questions it aims to answer are: Do adults who stutter, relative to adults who do not stutter, attend to threat-related stimuli more than neutral information? Are attentional biases observed across different types of threat or are they specific to threats related to stuttering experiences? Do measures of attention bias explain individual differences in psychological reactions among adults who stutter? **Detailed Description:** The goal of the project is to examine threat-related attentional processes associated with stuttering. In Aim 1, investigators will establish differences in attention bias (AB) in adults who do and do not stutter and the processing stage at which differences emerge. In Aim 2, investigators will compare AB effects across different categories of threat stimuli to determine whether threat-related AB in adults who stutter is general or disorder-specific. In Aim 3, the investigators examine the role of AB as a causal factor mediating effects of individual risk-factors (related to temperament and attention control) on stuttering impact and anticipation. Participants will include 35 adults who stutter and 35 adults who stutter between the ages of 18-30 years, all meeting specified eligibility criteria. All participants will complete three experimental tasks for measuring AB: (1) a free-viewing task, (2) dot-probe task, and (3) emotional Stroop task. Study procedures will be administered over two sessions (2-2.5 hours each) scheduled within three weeks of each other. Key outcomes will include reaction time and eye-tracking measures, which will be used to extract multiple AB indices. Data will be analyzed via mixed-effects regression analysis with a random intercept for subject and maximal converging random-slopes structure. Age, gender, socioeconomic status and various measures used for inclusion purposes will be included as covariates. Mediation analyses will assess four relationships (Temperament -\> Stuttering impact, Temperament -\> Anticipation, Attention control -\> Stuttering impact, and Attention control -\> Anticipation), with AB as the mediator variable in each analysis. ### Conditions Module **Conditions:** - Stuttering, Adult ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Masking Description:** Individuals reviewing and coding data will not be aware of group status or diagnoses for participants. **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants complete three tasks in which they view threat-related and neutral stimuli (words or faces) **Intervention Names:** - Behavioral: Threat-related stimulus exposure **Label:** Eye tracking tasks **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Eye tracking tasks **Description:** Participants will view threat-related stimuli (words or faces) paired with nonthreat matches in three related experimental paradigms. **Name:** Threat-related stimulus exposure **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** A) A key outcome measure from the dot-probe task will consist of RTs for congruent trials (in which probe appears in the location of threat stimulus) vs. incongruent trials (probe replaces neutral stimulus). (B) Key outcome measure from the emotional Stroop will include RT for threat vs. neutral words. **Measure:** Reaction time (RT) measures **Time Frame:** Trial duration (maximum of 10 seconds) **Description:** This primary (and most reliable) index of AB will be extracted from eye movement data and represents the total duration of all fixations to areas of interest with threat stimuli for each trial of the free-viewing task. **Measure:** Total dwell time on threat **Time Frame:** Trial duration (8 seconds) #### Secondary Outcomes **Description:** Additional indices of AB will be extracted from eye movement data and examined in exploratory manner: (1) probability of first fixation to an area of of interest (AOI), (2) first fixation latency, (3) first fixation duration, 4) first-run dwell time (representing summed duration of all fixations to an AOI from the first fixation until the AOI is exited), and (5) second-run dwell time (summed duration of all fixations within an AOI from the second time the AOI is entered until it is exited). **Measure:** Eye tracking indices of AB **Time Frame:** Trial duration (8 seconds) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Speaks English as their primary language * Normal hearing (based on pure tone screening) * Normal or corrected vision (based on report) * Normal color vision (based on Ishihara Test, Concise Edition) * Nonverbal intelligence within at least average range based on Test of Nonverbal Intelligence, 4th Edition * Expressive language within at least average range score based on Expressive One-Word Picture Vocabulary Test Additional inclusion criteria for adults who stutter: * Self-identification as a person who stutters * Score of at least 11 (mild stuttering) on Stuttering Severity Index, 4th Edition Exclusion Criteria: * Reported significant medical history * Psychological or emotional disorder * History of frank neurological injury * Known speech, language, or learning disorder(s) other than stuttering * Reading difficulties * Score within clinically significant range for ADHD on Adults ADHD Self-Rating Scale * Score within clinically significant range for depression on Beck Depression Inventory * Score within clinically significant range for anxiety on State-Trait Anxiety Inventory **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Memphis **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Naomi Eichorn, PhD - **Phone:** 901-678-5825 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Edina Bene - **Phone:** (901) 678-2573 - **Role:** CONTACT **Country:** United States **Facility:** University of Memphis **State:** Tennessee **Status:** RECRUITING **Zip:** 38152 ### IPD Sharing Statement Module **Description:** Data will be made freely and publicly available on OSF (https://osf.io) together with our publications, with prior Institutional Review Board approval. Archived data will also be made available to other researchers upon request (by emailing the PI) and without cost. A signed data-sharing agreement will be required for researchers to access data; the agreement will stipulate that shared data must be used solely for the purpose of research, must not be transferred to or shared with others, must not be manipulated for the purpose of identifying subjects, and that the planned research must be reviewed and approved by an Institutional Review Board. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013064 - Term: Speech Disorders - ID: D000007806 - Term: Language Disorders - ID: D000003147 - Term: Communication Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M16132 - Name: Stuttering - Relevance: HIGH - As Found: Stuttering - ID: M15864 - Name: Speech Disorders - Relevance: LOW - As Found: Unknown - ID: M10823 - Name: Language Disorders - Relevance: LOW - As Found: Unknown - ID: M6374 - Name: Communication Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013342 - Term: Stuttering ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422429 **Brief Title:** Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health **Official Title:** Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health #### Organization Study ID Info **ID:** RCT_PI Youtiao #### Organization **Class:** OTHER **Full Name:** Zhejiang University ### Status Module #### Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-03-01 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-01-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yu Zhang #### Responsible Party **Investigator Affiliation:** Zhejiang University **Investigator Full Name:** Yu Zhang **Investigator Title:** professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to investigate the effects of personalized innovative fritters on the nutritional health of overweight and obese individuals aged 40 to 70 years. The main questions it aims to answer are: * How does consuming personalized innovative fritters affect the nutritional health of overweight and obese individuals? * What is the mechanism underlying the impact of personalized innovative oil bars on nutritional health? Participants will be randomly assigned to one of two groups: a trial group consuming personalized innovative fritters and a control group consuming traditional fritters with equal energy content. Over the course of 6 months, participants will undergo two phases of intervention separated by a two-month washout period. During the intervention, participants will be assessed comprehensively for sensory ratings and nutritional health status through biological indicators, physical examinations, and other relevant measures. Researchers will compare the trial group to the control group to determine if personalized innovative fritters lead to improvements in nutritional health compared to traditional fritters. **Detailed Description:** Participants entered the trial with a 1-week equilibration period during which baked and fried foods were prohibited. The test group will consume personalised innovative Youtiao and the control group will uniformly consume traditional Youtiao of equal energy, 45 g 4 times per week for 8 weeks, during which time we will periodically measure biological indicators and collect biological samples to gain insight into the effects of the personalised innovative Youtiao on the participants. After completion of the 8-week intervention, a washout phase is entered. During this phase, participants will no longer ingest the Youtiao to see how they trend after stopping the intervention. Participants then enter the second phase of the trial, where the intervention process described above is continued with appropriate consumption adjustments based on the initial results of the first phase of the intervention. ### Conditions Module **Conditions:** - Metabolism and Nutrition Disorder ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** traditional Youtiao **Intervention Names:** - Drug: Traditional deep-fried Youtiao **Label:** Control group **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Personalised and innovative Youtiao **Intervention Names:** - Drug: PI Youtiao **Label:** Intervention group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group **Description:** 45g 4 times a week for 4 months **Name:** Traditional deep-fried Youtiao **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Intervention group **Description:** 45g 4 times a week for 4 months **Name:** PI Youtiao **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The investigators will measure HbA1c in blood samples before and after treatment. **Measure:** Change in HbA1c **Time Frame:** 6 months **Description:** The investigators will measure fasting plasma glucose levels in blood samples before and after treatment. **Measure:** Change in blood glucose from baseline **Time Frame:** 6 months #### Secondary Outcomes **Description:** The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment. **Measure:** Change in blood lipids from baseline **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 40-70 years old (women need to be menopausal); * BMI\>24 kg/m2; * Consumption of fritters more than once a week. Exclusion Criteria: * history of diabetes mellitus, cardiovascular disease, dyslipidaemia, renal disease, - * liver disease or cancer; * surgical treatment within 3 months; * allergy/intolerance to the study food or any of its ingredients; * breastfeeding or pregnancy; * \>10% weight loss in the past 6 months; * smoking or alcohol abuse; * participation in another clinical study within the past 6 months **Maximum Age:** 70 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yu Zhang, PHD **Phone:** 86-0571-88982211 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12684 - Name: Nutrition Disorders - Relevance: HIGH - As Found: Nutrition Disorders ### Condition Browse Module - Meshes - ID: D000009748 - Term: Nutrition Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422416 **Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA] **Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info **ID:** 5047 #### Organization **Full Name:** [Redacted] ### Status Module **Delayed Posting:** True #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** WITHHELD #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Name:** [Redacted] #### Responsible Party **Old Name Title:** [Redacted] **Old Organization:** [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422403 **Acronym:** VALUE-CHECK **Brief Title:** A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers **Official Title:** A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK) #### Organization Study ID Info **ID:** 2024/00217 #### Organization **Class:** OTHER **Full Name:** National University Hospital, Singapore ### Status Module #### Completion Date **Date:** 2029-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-03-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National University Hospital, Singapore #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a prospective, open label, multi-centre phase 2 trial which assesses the efficacy and safety of standard dosing compared to extended dosing interval of nivolumab, atezolizumab or pembrolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma andnon-small cell lung cancer with PDL1 TPS≥50% with no prior treatment. The investigators hypothesize that nivolumab, pembrolizumab and atezolizumab can be used efficiently at extended dosing intervals, compared to their approved labels with comparable clinical outcome. **Detailed Description:** This study aims to assess the noninferiority of progression free survival of standard dosing compared to extended dosing interval of nivolumab, pembrolizumab and atezolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma, non-small cell lung cancer with PDL1 TPS≥50% and locally advanced/metastatic head and neck squamous cell carcinoma with PDL1 CPS ≥1% that have no prior treatment. Secondary Objective To investigate the safety, overall survival (OS) of ICI at extended dosing interval of the standard versus extended dosing interval groups. Exploratory endpoints We would detect minimal residual disease (MRD) using multiomics and compare the progress of the disease or the outcome of patients besides clinical assessments. ### Conditions Module **Conditions:** - Carcinoma, Hepatocellular - Gastric Adenocarcinoma - GastroEsophageal Cancer - Oesophageal Cancer - Non-small Cell Lung Cancer - Head and Neck Squamous Cell Carcinoma **Keywords:** - Nivolumab - Atezolizumab - Pembrolizumab - Extended dosing interval ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study is a prospective, open label, multi-centre phase 2 trial ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 310 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Nivolumab, XELOX/FOLFOX **Intervention Names:** - Drug: Standard of Care - A **Label:** Cohort A (SOC) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Nivolumab, XELOX/FOLFOX **Intervention Names:** - Drug: Extended Dosing Interval - A **Label:** Cohort A (EDI) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Bevacizumab, Atezolizumab **Intervention Names:** - Drug: Standard of Care - B **Label:** Cohort B (SOC) **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Bevacizumab, Atezolizumab **Intervention Names:** - Drug: Extended Dosing Interval - B **Label:** Cohort B (EDI) **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Pembrolizumab **Intervention Names:** - Drug: Standard of Care - C **Label:** Cohort C (SOC) **Type:** ACTIVE_COMPARATOR #### Arm Group 6 **Description:** Pembrolizumab **Intervention Names:** - Drug: Extended Dosing Interval - C **Label:** Cohort C (EDI) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort A (EDI) **Description:** Nivolumab 360mg 6 weekly (up to 2 years) + XELOX Nivolumab 240mg 4 weekly (up to 2 years) + FOLFOX **Name:** Extended Dosing Interval - A **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Cohort B (EDI) **Description:** Bevacizumab + Atezolizumab 1200mg 6 weekly (up to 2 years) **Name:** Extended Dosing Interval - B **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Cohort C (EDI) **Description:** Pembrolizumab 200mg 6 weekly (up to 2 years) **Name:** Extended Dosing Interval - C **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Cohort A (SOC) **Description:** Nivolumab 360mg 3 weekly (up to 2 years) + XELOX Nivolumab 240mg 2 weekly (up to 2 years) + FOLFOX **Name:** Standard of Care - A **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Cohort B (SOC) **Description:** Bevacizumab + Atezolizumab 1200mg 3 weekly (up to 2 years) **Name:** Standard of Care - B **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Cohort C (SOC) **Description:** Pembrolizumab 200mg 3 weekly (up to 2 years) **Name:** Standard of Care - C **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS is defined as the time from date of first dosing until the date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST 1.1) or death (by any cause in the absence of progression). **Measure:** Progression-free survival (PFS) **Time Frame:** Up to 2 years #### Secondary Outcomes **Description:** As defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 **Measure:** Number of participant with treatment related haematological and non-haematological toxicities **Time Frame:** Up to 2 years **Description:** Percentage of patients who have at least one confirmed response of 'complete response' or 'partial response' as defined by Response Evaluation Criteria in Solid Tumor (RECIST 1.1), that is confirmed at least 4 weeks later **Measure:** Objective response rate **Time Frame:** Up to 2 years **Description:** Duration of response will be defined as the time from the date of first documented response, that is subsequently confirmed until the date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. **Measure:** Duration of Response **Time Frame:** Up to 2 years **Description:** Disease control rate is defined as the proportion of patients with a best overall response of CR = complete response, PR = partial response, or SD = stable disease, as defined by Response Evaluation Criteria in Solid Tumor (RECIST 1.1) **Measure:** Disease control rate **Time Frame:** Up to 2 years **Description:** Overall survival will be assessed based on the date of first dose and survival status at the time of analysis. **Measure:** Overall survival **Time Frame:** Up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Provision of informed consent prior to any study-specific procedure 2. Patients with one of the following: * Cohort A: Previously untreated locally advanced/metastatic HER2 -ve gastric/gastroesophageal junction/esophageal (PDL1 CPS ≥5% adenocarcinomas not amenable to curative surgery or radiotherapy who are above to begin platinum double and nivolumab. * Cohort B: Previously untreated locally advanced/metastatic Child's A hepatocellular carcinoma not amenable to curative surgery or radiotherapy who are above to begin atezolizumab and bevacizumab. * Cohort C: Previously untreated locally advanced/metastatic lung adenocarcinoma (PDL1 TPS≥50%, EGFR/ALK wildtype) not amenable to curative surgery or radiotherapy who are above to begin pembrolizumab monotherapy 3. Measurable disease per RECIST 1.1 criteria 4. ECOG Performance status is 0-2 5. Normal organ and bone marrow function measured within 28 days before the study as defined below: * Haemoglobin ≥ 8.0 g/dL and no blood transfusions in the 28 days prior to entry * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L * No features suggestive of MDS/AML on peripheral blood smear * White blood cells (WBC) \> 3x10\^9/L * Platelet count ≥ 100 x 10\^9/L * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) * AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN * Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) 6. A life expectancy ≥ 12 weeks in all patients. 7. Females in childbearing age should be using adequate contraceptive measures, should not be breastfeeding and their pregnancy test prior to the start of treatment must be negative. Evidence of non-child-bearing potential is fulfilled by one of the following criteria at screening: 8. The post-menopausal period defined as age ≥50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments 9. Women \<50 years old they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range. 10. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not a tubal ligatio 11. Male patients should be willing to use barrier contraception 12. The patient is willing to comply with the protocol during the study including undergoing treatment and scheduled visits and examinations including follow up. 13. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is considered suitable for accurate repeated measurements Exclusion Criteria: 1. Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy. 2. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years 3. Unstable spinal cord compression/brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the start of study treatment. For patients with brain metastases, gamma knife or stereotactic brain surgery is allowed prior to study treatment. 4. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Minor surgery is allowed. 5. Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which based on investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or having active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required. 6. Autoimmune disorders 7. Males and females of reproductive potential who are not using an effective method of contraception and females who are pregnant or breastfeeding or have a positive serum pregnancy test prior to study entry 8. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements 9. Previous allogeneic bone marrow transplant. **Maximum Age:** 99 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Wei Peng Yong **Phone:** +65 6908 2222 **Role:** CONTACT #### Locations **Location 1:** **City:** Singapore **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Wei Peng Yong - **Phone:** +65 6908 2222 - **Role:** CONTACT **Country:** Singapore **Facility:** Department of Hematology-Oncology, National University Hospita #### Overall Officials **Official 1:** **Affiliation:** National University Hospital, Singapore **Name:** Wei Peng Yong **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000000230 - Term: Adenocarcinoma - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000008113 - Term: Liver Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: HIGH - As Found: Carcinoma, Hepatocellular - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M1689 - Name: Squamous Cell Carcinoma of Head and Neck - Relevance: HIGH - As Found: Head and Neck Squamous Cell Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11113 - Name: Liver Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Oesophageal Cancer ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000077195 - Term: Squamous Cell Carcinoma of Head and Neck - ID: D000006528 - Term: Carcinoma, Hepatocellular ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M246 - Name: Bevacizumab - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M349416 - Name: Pembrolizumab - Relevance: LOW - As Found: Unknown - ID: M1854 - Name: Nivolumab - Relevance: LOW - As Found: Unknown - ID: M349417 - Name: Atezolizumab - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422390 **Brief Title:** PRP for Rotator Cuff Tears **Official Title:** Platelet - Rich Plasma Injections for Rotator Cuff Tears #### Organization Study ID Info **ID:** 24-8331 #### Organization **Class:** OTHER **Full Name:** Scripps Clinic ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Scripps Clinic #### Responsible Party **Investigator Affiliation:** Scripps Clinic **Investigator Full Name:** Laika Nur **Investigator Title:** Clinical Assistant Professor of Orthopedic Surgery - Division of Sports Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Regenerative medicine, specifically orthobiologics is a hot topic in the community and in Sports Medicine. Riding the hype curve of a new treatment can be great when offering new procedures to patients. However, as the excitement regarding potential benefits of orthobiologics grows, it is valuable to grow the body of literature on their safety and efficacy in various musculoskeletal conditions. Furthering the body of data regarding which musculoskeletal conditions may benefit most from these treatments and which may not can help guide physicians on when to incorporate orthobiologics into clinical practice. More robust data can help physicians guide patients and patient expectations when discussing treatment options. Platelet rich plasma (PRP) in musculoskeletal medicine is most commonly used to treat tendinopathies and degenerative joint disease. The American Medical Society for Sports Medicine released a position statement in November of 2021 summarizing meta-analysis and systemic review data evaluating efficacy and major adverse events of PRP for tendinopathy and osteoarthritis1. At this time, the most robust data exists for lateral epicondylopathy as multiple randomized controlled trials demonstrate positive response to PRP. Gluteus medius tendinopathy and plantar fasciaopathy similarly have positive data. In Achilles tendinopathy, well designed RCTs have shown no difference between PRP and saline injections. These data should help guide physicians in responsible use and patient counseling. Data from Hurley et al. suggest PRP may augment rotator cuff repair with improved rates of healing and reduced overall pain. However, there are limited high quality studies on the efficacy of PRP alone in partial rotator cuff tear. Partial rotator cuff tear is a common musculoskeletal complaint that can be treated with conservative measures such as physical therapy and corticosteroid injection. It can also be treated with surgical intervention if those modalities provide incomplete or inadequate pain relief and functional restoration. This study aims to evaluate if PRP is an efficacious treatment modality for partial rotator cuff tear. ### Conditions Module **Conditions:** - Rotator Cuff Tears **Keywords:** - PRP ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 76 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI or ultrasound. **Intervention Names:** - Biological: Platelet - Rich Plasma **Label:** PRP Injection #### Arm Group 2 **Description:** Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI or ultrasound. **Label:** Placebo ### Interventions #### Intervention 1 **Arm Group Labels:** - PRP Injection **Description:** Platelet - Rich Plasma is a biologic injection created from the patient's own blood. 52cc of the patient's blood is drawn then mixed with 8cc of anticoagulant. The blood mixture will be spun down using a centrifuge that can separate the platelet-rich plasma from the other contents in the blood. Once the centrifuge process is complete the Platelet - Rich Plasma is ready to be used. **Name:** Platelet - Rich Plasma **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Primary outcome: Improvement in patients' subjective pain and function as measured by the American Shoulder and Elbow Surgeons (ASES) score at 6 weeks, 12 weeks, 6 months, and 1 year. **Measure:** Improvement of pain and function **Time Frame:** June 2024 to June 2025 #### Secondary Outcomes **Description:** Secondary Outcome: Improvement in visual analog scale (VAS) pain scores at 6 weeks, 12 weeks, 6 months, and 1 year. Additional secondary outcomes: Patients' perception of overall improvement with their shoulder, patient satisfaction with outcome, tendon healing assessed by ultrasound evaluation, progression to surgical management or other intervention such as corticosteroid injections (CSI), and association between volume of PRP and outcomes. **Measure:** Improvement in VAS scores and patient satisfaction **Time Frame:** June 2024 to June 2025 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI or ultrasound. Exclusion Criteria: * Patients who have had any an intervention within the past three months (CSI, PRP, prolotherapy), patient with previous surgical interventions on the same rotator cuff. Patients on aspirin who cannot discontinue medication for five weeks total. Patients who decline to discontinue anti-inflammatory medications or supplements for five weeks total. After identifying appropriate study participants and obtaining consent, participants will be randomized to either injection with sterile water without anesthetic or PRP injection without anesthetic. All injections will occur using US-guidance for placement of injection into tear. All participants will be asked to avoid NSAIDs, anti-inflammatory supplements for at least one week prior to injection and four weeks after injection. PRP patients will have 60cc of whole blood drawn and processed using Arthrex system using leukocyte poor protocol. This typically yields between 1-3cc of PRP. Volume of PRP will be noted by RN. Syringe will be occluded by RN performing draw and processing of PRP prior to procedure by MD. Injection will be performed using ultrasound guidance for proper placement into torn tendon. The placebo group will have 5-10cc of whole blood drawn and discarded to maintain double blind protocol prior to injection. 2cc sterile water will be drawn and syringe occluded by RN prior to procedure. Injection will be performed using ultrasound guidance for proper placement into torn tendon by MD. A power analysis showed that 33 patients will be needed in each group to detect a 20% improvement in ASES total scores by 6 months. We plan to enroll an additional 5 patients to each group in case any patients fail to return to all follow-up visits. Patients will complete the ASES and VAS at their procedure visit and all follow up visits (6 weeks, 12 weeks, 6 months, and 1 year). If participants miss in person follow up visits, these will be completed via phone or myscripps message with staff. Participates will also select their perceived percentage overall improvement at follow up visits. At 6 week follow up, patients will be encouraged to restart physical therapy or home exercise program in both groups. **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients who are 18 years or older but 90 years or younger with a diagnosis of a symptomatic partial rotator cuff tear of one rotator cuff tendon. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Emily Martin, MBt **Phone:** 858-554-7011 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Julie McCauley, MPh(c) **Phone:** 858-554-7122 **Role:** CONTACT #### Locations **Location 1:** **City:** La Jolla **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Program Director, Clinical Research - **Phone:** 858-554-7122 - **Role:** CONTACT ***Contact 2:*** - **Name:** Laika Nur, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Scripps Clinic - Torrey Pines **State:** California **Zip:** 92037 #### Overall Officials **Official 1:** **Affiliation:** Scripps Clinic Medical Group **Name:** Laika Nur, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Finnoff JT, Awan TM, Borg-Stein J, Harmon KG, Herman DC, Malanga GA, Master Z, Mautner KR, Shapiro SA. American Medical Society for Sports Medicine Position Statement: Principles for the Responsible Use of Regenerative Medicine in Sports Medicine. Clin J Sport Med. 2021 Nov 1;31(6):530-541. doi: 10.1097/JSM.0000000000000973. **PMID:** 34704973 **Citation:** Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968. **PMID:** 16551396 **Citation:** Giovannetti de Sanctis E, Franceschetti E, De Dona F, Palumbo A, Paciotti M, Franceschi F. The Efficacy of Injections for Partial Rotator Cuff Tears: A Systematic Review. J Clin Med. 2020 Dec 25;10(1):51. doi: 10.3390/jcm10010051. **PMID:** 33375716 **Citation:** Kwong CA, Woodmass JM, Gusnowski EM, Bois AJ, Leblanc J, More KD, Lo IKY. Platelet-Rich Plasma in Patients With Partial-Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared With Corticosteroid Injection: A Double-Blind Randomized Controlled Trial. Arthroscopy. 2021 Feb;37(2):510-517. doi: 10.1016/j.arthro.2020.10.037. Epub 2020 Oct 28. **PMID:** 33127554 **Citation:** Fitzpatrick J, Bulsara M, Zheng MH. The Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Clinical Trials. Am J Sports Med. 2017 Jan;45(1):226-233. doi: 10.1177/0363546516643716. Epub 2016 Jul 21. **PMID:** 27268111 **Citation:** Prodromos CC, Finkle S, Prodromos A, Chen JL, Schwartz A, Wathen L. Treatment of Rotator Cuff Tears with platelet rich plasma: a prospective study with 2 year follow-up. BMC Musculoskelet Disord. 2021 May 29;22(1):499. doi: 10.1186/s12891-021-04288-4. **PMID:** 34051761 **Citation:** DeLong JM, Russell RP, Mazzocca AD. Platelet-rich plasma: the PAW classification system. Arthroscopy. 2012 Jul;28(7):998-1009. doi: 10.1016/j.arthro.2012.04.148. **PMID:** 22738751 **Citation:** Kesikburun S, Tan AK, Yilmaz B, Yasar E, Yazicioglu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26. **PMID:** 23893418 **Citation:** Sung CM, Hah YS, Kim JS, Nam JB, Kim RJ, Lee SJ, Park HB. Cytotoxic effects of ropivacaine, bupivacaine, and lidocaine on rotator cuff tenofibroblasts. Am J Sports Med. 2014 Dec;42(12):2888-96. doi: 10.1177/0363546514550991. Epub 2014 Oct 8. **PMID:** 25296645 **Citation:** Honda H, Gotoh M, Kanazawa T, Nakamura H, Ohta K, Nakamura K, Shiba N. Effects of lidocaine on torn rotator cuff tendons. J Orthop Res. 2016 Sep;34(9):1620-7. doi: 10.1002/jor.23153. Epub 2016 Feb 11. **PMID:** 26742649 **Citation:** Chen X, Jones IA, Park C, Vangsness CT Jr. The Efficacy of Platelet-Rich Plasma on Tendon and Ligament Healing: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2018 Jul;46(8):2020-2032. doi: 10.1177/0363546517743746. Epub 2017 Dec 21. **PMID:** 29268037 **Citation:** Rossi LA, Piuzzi N, Giunta D, Tanoira I, Brandariz R, Pasqualini I, Ranalletta M. Subacromial Platelet-Rich Plasma Injections Decrease Pain and Improve Functional Outcomes in Patients With Refractory Rotator Cuff Tendinopathy. Arthroscopy. 2021 Sep;37(9):2745-2753. doi: 10.1016/j.arthro.2021.03.079. Epub 2021 Apr 20. **PMID:** 33892072 **Citation:** Thepsoparn M, Thanphraisan P, Tanpowpong T, Itthipanichpong T. Comparison of a Platelet-Rich Plasma Injection and a Conventional Steroid Injection for Pain Relief and Functional Improvement of Partial Supraspinatus Tears. Orthop J Sports Med. 2021 Sep 1;9(9):23259671211024937. doi: 10.1177/23259671211024937. eCollection 2021 Sep. **PMID:** 34485587 **Citation:** Snow M, Hussain F, Pagkalos J, Kowalski T, Green M, Massoud S, James S. The Effect of Delayed Injection of Leukocyte-Rich Platelet-Rich Plasma Following Rotator Cuff Repair on Patient Function: A Randomized Double-Blind Controlled Trial. Arthroscopy. 2020 Mar;36(3):648-657. doi: 10.1016/j.arthro.2019.09.026. Epub 2019 Nov 27. **PMID:** 31784365 **Citation:** Chen X, Jones IA, Togashi R, Park C, Vangsness CT Jr. Use of Platelet-Rich Plasma for the Improvement of Pain and Function in Rotator Cuff Tears: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2020 Jul;48(8):2028-2041. doi: 10.1177/0363546519881423. Epub 2019 Nov 19. **PMID:** 31743037 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012421 - Term: Rupture - ID: D000014947 - Term: Wounds and Injuries - ID: D000070599 - Term: Shoulder Injuries - ID: D000013708 - Term: Tendon Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15241 - Name: Rupture - Relevance: LOW - As Found: Unknown - ID: M22785 - Name: Lacerations - Relevance: LOW - As Found: Unknown - ID: M624 - Name: Rotator Cuff Injuries - Relevance: HIGH - As Found: Rotator Cuff Tears - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000070636 - Term: Rotator Cuff Injuries ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422377 **Brief Title:** A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine **Official Title:** An Open-label, Nonrandomized, Phase 3 Study to Evaluate the Efficacy and Safety of Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine #### Organization Study ID Info **ID:** TAK-935-3004 #### Organization **Class:** INDUSTRY **Full Name:** Takeda #### Secondary ID Infos **Domain:** EU CTIS **ID:** 2023-504104-29 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Takeda #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False ### Description Module **Brief Summary:** The purpose of this study is to check how soticlestat impacts symptoms of Dravet syndrome \[DS\] and Lennox-Gastaut syndrome \[LGS\] in participants who have been exposed to fenfluramine. **Detailed Description:** The drug being tested in this study is called soticlestat. Soticlestat is being tested to treat people who have DS or LGS and have been exposed to fenfluramine. This study will assess the efficacy and safety of soticlestat in addition to standard care in the treatment of DS or LGS. The study will enroll approximately 45 patients. This study comprises a screening period of up to 6 weeks, a 4-week titration period, a 48-week maintenance period, a taper period of up to 1 week and a follow-up safety visit. Participants will be enrolled to receive soticlestat along with the standard of care: • Soticlestat 100-300 mg Participants will receive oral administration of soticlestat Dose 1 (days 1 to 7), Dose 2 (days 8 to 14), and Dose 3 (Days 15 to 28) with a minimum dose of 100 mg to a maximum dose of 300 mg depending on participant's body weight in the titration period followed by maintenance period up to end of treatment (up to approximately 52 weeks). Percent change from baseline in convulsive in participants with DS and major motor drop (MMD) in participants with LGS seizure frequency per 28 days during the initial 12 weeks of the maintenance period will be assessed. This multi-center trial will be conducted in the United Kingdom and Europe. The overall time to participate in this study is approximately 60 weeks. Participants will make multiple visits to the clinic and will be followed up for safety by visiting the clinic or by telephone approximately 2 weeks after the last dose of the study drug. ### Conditions Module **Conditions:** - Dravet Syndrome (DS) - Lennox-Gastaut Syndrome (LGS) **Keywords:** - Drug Therapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants with DS or LGS will receive soticlestat, mini-tablets, at the starting dose of 100 mg to 300 mg, administered orally with or without food (oral or enteral feeds), twice daily (BID) based on body weight up to 4 weeks in Titration Period. Participants will continue to receive the dose that they are on at the end of the titration period, for first 12 weeks in the Maintenance Period. The dose can be adjusted in the maintenance period as per the body weight after the initial 12 weeks. Dose will be tapered down if participants decide to discontinue the treatment. Total duration of the treatment will be up to approximately 52 weeks. **Intervention Names:** - Drug: Soticlestat **Label:** Soticlestat **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Soticlestat **Description:** Soticlestat tablets or mini-tablets **Name:** Soticlestat **Other Names:** - TAK-935 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Percent Change from Baseline in Convulsive Seizure Frequency per 28 days During First 12 Weeks of Maintenance Period for DS Participants **Time Frame:** Baseline to Week 12 of Maintenance Period **Measure:** Percent Change from Baseline in Major Motor Drop (MMD) Seizure Frequency per 28 days During First 12 Weeks of Maintenance Period for LGS Participants **Time Frame:** Baseline to Week 12 of Maintenance Period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The participant has been exposed to fenfluramine (currently on or used previously). 2. The participant has a clinical diagnosis of LGS and a history of, on average, ≥12 MMD seizures in the last 90 days immediately before screening based on historical information, and the participant has ≥4 MMD seizures during a minimum of 4 weeks of seizure data collection during the prospective baseline period. 3. The participant is currently taking 0 to 5 antiseizure treatments (eg. antiseizure medications \[ASMs\], vagus nerve stimulation \[VNS\], ketogenic diet) at stable doses. Exclusion Criteria: 1. The participant is currently enrolled in a clinical study involving an investigational product or treatment device (ie, not approved in that country, other than soticlestat), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Note: Compatibility will be determined on the basis of consultation with the sponsor/designee. 2. The participant has a known hypersensitivity to any component of the soticlestat formulation. 3. Participants aged ≥6 years who have positive answers on item numbers 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) before dosing are excluded. This scale will only be administered to participants aged ≥6 years at the time of enrollment or participants who turn 6 after enrollment. **Maximum Age:** 65 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Takeda Contact **Phone:** +1-877-825-3327 **Role:** CONTACT #### Locations **Location 1:** **City:** Dianalund **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Site Contact - **Phone:** +4558264200 - **Role:** CONTACT ***Contact 2:*** - **Name:** Cathrine Elisabeth Gjerulfsen - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Epilepsihospitalet Filadelfia **State:** Zealand **Status:** RECRUITING **Zip:** 4293 **Location 2:** **City:** Cardiff **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Site Contact - **Phone:** +442920715434 - **Role:** CONTACT ***Contact 2:*** - **Name:** Khalid Hamandi - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** University Hospital of Wales **State:** Wales **Status:** RECRUITING **Zip:** CF14 4XW #### Overall Officials **Official 1:** **Affiliation:** Takeda **Name:** Study Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. **Description:** Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000004829 - Term: Epilepsy, Generalized - ID: D000004827 - Term: Epilepsy - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000073376 - Term: Epileptic Syndromes - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M30593 - Name: Lennox Gastaut Syndrome - Relevance: HIGH - As Found: Lennox-Gastaut Syndrome - ID: M7983 - Name: Epilepsy - Relevance: LOW - As Found: Unknown - ID: M7987 - Name: Epilepsies, Myoclonic - Relevance: HIGH - As Found: Dravet Syndrome - ID: M7985 - Name: Epilepsy, Generalized - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M1165 - Name: Epileptic Syndromes - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T1938 - Name: Dravet Syndrome - Relevance: HIGH - As Found: Dravet Syndrome - ID: T1024 - Name: CDKL5 Deficiency Disorder - Relevance: HIGH - As Found: Dravet Syndrome - ID: T3371 - Name: Lennox-Gastaut Syndrome - Relevance: HIGH - As Found: Lennox-Gastaut Syndrome ### Condition Browse Module - Meshes - ID: D000004831 - Term: Epilepsies, Myoclonic - ID: D000065768 - Term: Lennox Gastaut Syndrome - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M8414 - Name: Fenfluramine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422364 **Brief Title:** Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep **Official Title:** Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep #### Organization Study ID Info **ID:** 21638 #### Organization **Class:** OTHER **Full Name:** Indiana University ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Dreamland Baby Co. #### Lead Sponsor **Class:** OTHER **Name:** Indiana University #### Responsible Party **Investigator Affiliation:** Indiana University **Investigator Full Name:** Harish Rao **Investigator Title:** Assistant Professor of Clinical Pediatrics **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to assess the risk of an infant overheating and/or experiencing lowered respiration via measurement of vital signs in a controlled clinical environment while wearing a weighted wearable blanket in male/female infant healthy volunteers, 0-12 months of age. The main questions it aims to answer are: Primary Objective: To pilot an investigation on the impact of weighted wearable blankets on vital signs and infant movement in healthy infants during nap polysomnogram. Secondar Objective: To investigate the efficacy of weighted wearable blankets on sleep patterns in healthy infants during overnight sleep. **Detailed Description:** To date, there is no evaluation of the safety or efficacy of weighted wearable blankets on healthy infants during overnight use in the peer-reviewed scientific literature. These are the conditions in which these products are used by consumers, with infants sleeping unobserved throughout the night. Given the rising popularity in the use of weighted wearable blankets in infants and the risk speculated, a study of the potential impact of weighted wearable blankets on infant vital signs is warranted. Study Design: Direct observational pilot study of the safety of weighted wearable blankets on a minimum (10) healthy infants aged 0-12 months with nap polysomnogram. Participants will be placed in a weighted wearable blanket, in accordance with their age/weight/height, by their parent or caregiver under the supervision of a member of the study team. After being put to sleep on their back, the participant will remain in the weighted wearable blanket until completion of the nap polysomnogram. There are stopping parameters (outlined elsewhere) that will be used for this study. If any of the stopping parameters are met, the weighted blanket will be opened to assess if the weighted blanket is responsible for the change. If determined yes, the weighted blanket will be removed and the nap polysomnogram will be terminated. ### Conditions Module **Conditions:** - Sleep **Keywords:** - Sleep - Healthy - Infant ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Weighted wearable blanket, provided by Dreamland Baby Co. **Intervention Names:** - Device: Weighted Wearable Blanket provided by Dreamland Baby Co. **Label:** Pilot **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Pilot **Description:** All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete a nap polysomnogram. **Name:** Weighted Wearable Blanket provided by Dreamland Baby Co. **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Measured by EKG **Measure:** Heart Rate **Time Frame:** Day 1, during polysomnogram, up to 8 hours **Description:** Measured by Respiratory effort belts **Measure:** Respiratory Rate **Time Frame:** Day 1, during polysomnogram, up to 8 hours **Description:** Manually measured by ear thermometer **Measure:** Body Temperature **Time Frame:** Day 1, during polysomnogram, up to 8 hours **Description:** Measured by pulse oximetry **Measure:** Oxygen Saturation **Time Frame:** Day 1, during polysomnogram, up to 8 hours **Description:** The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question. **Measure:** Number of Infants with Observed Head Movement **Time Frame:** Day 1, during polysomnogram, up to 8 hours **Description:** The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question. **Measure:** Number of Infants with Observed Arm Movement **Time Frame:** Day 1, during polysomnogram, up to 8 hours **Description:** The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question. **Measure:** Number of Infants with Observed Body Movement **Time Frame:** Day 1, during polysomnogram, up to 8 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ability of parent, caregiver or legal guardian/representative to understand a written informed consent document and choose to participate in the study * 0-12 months of age * Weight greater than or equal to 8 pounds * Gestational age 37 weeks or greater * Health status: healthy infant without underlying cardiac, neurological, or pulmonary disorders * Infant is naive to a weighted wearable blanket Exclusion Criteria: * Health status: medical diagnosis associated with underlying cardiac, neurological, or pulmonary disorder * Weight \< 8 pounds * Gestational age \< 37 weeks * Gestational use of marijuana, alcohol, or illicit drugs * Home environment: use of cigarettes, vaping, e-cigarettes, or marijuana * Infant is not naive to a weighted wearable blanket **Healthy Volunteers:** True **Maximum Age:** 12 Months **Minimum Age:** 1 Day **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lori Trotter, RN **Phone:** 317-278-7121 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lisa Bendy, BA **Phone:** 317-278-7152 **Role:** CONTACT #### Locations **Location 1:** **City:** Indianapolis **Contacts:** ***Contact 1:*** - **Name:** Harish Rao, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Riley Hospital for Children at Indiana University Health **State:** Indiana **Status:** RECRUITING **Zip:** 46202 #### Overall Officials **Official 1:** **Affiliation:** Riley Hospital for Children at Indiana University Health **Name:** Harish Rao, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Weighted ### Condition Browse Module - Meshes - ID: D000001835 - Term: Body Weight ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422351 **Brief Title:** Clinical Trial to Evaluate the Efficacy of Gene Therapy for Pyruvate Kinase Deficiency **Official Title:** A Phase 2 Clinical Trial to Evaluate the Efficacy of the Infusion of Autologous CD34+ Cells Transduced With a Lentiviral Vector Carrying the Codon Optimized Red Cell Pyruvate Kinase (coRPK) Gene in Subjects With Pyruvate Kinase Deficiency #### Organization Study ID Info **ID:** RP-L301-0124 #### Organization **Class:** INDUSTRY **Full Name:** Rocket Pharmaceuticals Inc. ### Status Module #### Completion Date **Date:** 2029-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Rocket Pharmaceuticals Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is an open-label Phase II trial to evaluate the efficacy of a hematopoietic cell-based gene therapy for patients with Pyruvate Kinase Deficiency (PKD). **Detailed Description:** Autologous hematopoietic stem cells from mobilized peripheral blood will be transduced ex vivo (outside the body) with a lentiviral vector carrying a correct copy of the deficient PKLR (Pyruvate Kinase L/R) gene. The corrected stem cells will be infused intravenously back into the patient to correct the hematological manifestations of the disease. ### Conditions Module **Conditions:** - Pyruvate Kinase Deficiency ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** RP-L301 is a gene therapy product containing autologous genetically modified CD34+ hematopoietic stem cells containing the corrected PKLR (Pyruvate Kinase L/R) gene **Intervention Names:** - Biological: RP-L301 **Label:** Participant Group/Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Participant Group/Arm **Description:** Autologous genetically modified CD34+ hematopoietic stem cells containing the corrected PKLR (Pyruvate Kinase L/R) gene **Name:** RP-L301 **Other Names:** - Intervention/Treatment **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Hemoglobin (Hb) level increase of ≥1.5g/dL at 12 months post-infusion, compared to baseline. **Measure:** Improvement in Anemia **Time Frame:** 12 months post-infusion #### Secondary Outcomes **Description:** Time to Hemoglobin level increase of ≥1.5g/dL post-infusion, compared to baseline. **Measure:** Durability Improvement anemia sustained **Time Frame:** 24 months post-infusion **Description:** Hemoglobin level within normal range (≥ lower limit of normal) at 12 months post-infusion. **Measure:** Resolution of anemia **Time Frame:** 12 months post-infusion **Description:** * a: ≥50% reduction in Pyruvate Kinase Deficiency (PKD)-related Red Blood Cells (RBC) transfusion requirements in the 12 months post-infusion, relative to the annualized event rate for 24 months prior to enrollment; or, * b: Absence of PKD-related RBC transfusion requirements in the 12 months post-infusion. **Measure:** Reduction of transfusion requirements **Time Frame:** 12 months post-infusion **Description:** Improvements in bilirubin, each evaluated at 12 months post-infusion, compared to baseline. **Measure:** Improvements of hemolysis parameters (bilirubin) **Time Frame:** 12 months post-infusion **Description:** Improvements in Lactate Dehydrogenase (LDH), each evaluated at 12 months post-infusion, compared to baseline. **Measure:** Improvements of hemolysis parameters (Lactate Dehydrogenase (LDH)) **Time Frame:** 12 months post-infusion **Description:** Improvements in erythropoietin, each evaluated at 12 months post-infusion, compared to baseline. **Measure:** Improvements of hemolysis parameters (erythropoietin) **Time Frame:** 12 months post-infusion **Description:** Improvements in reticulocyte, each evaluated at 12 months post-infusion, compared to baseline. **Measure:** Improvements of hemolysis parameters (reticulocyte) **Time Frame:** 12 months post-infusion **Description:** Genetic correction demonstrated by vector copy number (VCN) of 0.1 in Peripheral Blood mononuclear cells, evaluated at 12 months post-infusion. **Measure:** Peripheral blood genetic correction **Time Frame:** 12 months post-infusion **Description:** Improvement in fatigue as compared with baseline, as assessed by: * Age ≥18: FACIT Fatigue; or, * Age \<18: PROMIS Fatigue Short Form 10a **Measure:** Improvement in fatigue **Time Frame:** 12 months post-infusion **Description:** Improvement in Pyruvate Kinase Deficiency symptoms, compared with baseline, as assessed by: * PROMIS Dyspnea Severity SF10; or, * Dyspnea severity **Measure:** Improvement in dyspnea **Time Frame:** 12 months post-infusion **Description:** Improvement in Pyruvate Kinase Deficiency symptoms, compared with baseline, as assessed by: * jaundice severity evaluated at 12 months post-infusion; or, * and jaundice severity **Measure:** Improvement in jaundice **Time Frame:** 12 months post-infusion **Description:** Incidence, type, severity, frequency, time to onset, and duration of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), clinical laboratory abnormalities, and adverse events of special interest (AESIs). **Measure:** Safety and tolerability of RP-L301 **Time Frame:** 24 months post-infusion **Description:** Hemoglobin (Hb) level within normal range (≥ lower limit of normal). **Measure:** Evaluate durable resolution of anemia **Time Frame:** 24 months post-infusion **Description:** 1. ≥50% reduction in Pyruvate Kinase Deficiency (PKD)-related Red Blood Cell (RBC) transfusion requirements in the 24 months post-infusion, relative to the annualized event rate for 24 months prior to enrollment; or, 2. Absence of PKD-related RBC transfusion requirements in the 24 months post-infusion. **Measure:** Evaluate durable resolution of transfusion requirements (where relevant). **Time Frame:** 24 months post-infusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria 1. Pyruvate Kinase Deficiency (PKD) diagnosis with a confirmed PK-LR mutation 2. Significant anemia defined as: * Hemoglobin (Hb) levels \<9.5 g/dL documented during 2 or more assessments in the 12 months prior to screening and either: 1. at least 6 Red Blood Cell (RBC) transfusion episodes over the 12- month period prior to screening or 2. at least 3 Red Blood Cell (RBC) transfusion episodes each year for 2 years prior to screening; or * Hemoglobin (Hb) levels \<8.5 g/dL irrespective of transfusions (documented during 2 or more assessments during the prior 2 years); or * Hemoglobin (Hb) levels \<10.0 g/dL irrespective of transfusions (documented during 2 or more assessments during the prior 2 years) and the presence of either: * Fatigue or energy-related symptoms limiting activities of daily living (The National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0 (NCI CTCAE v5.0 grade 3)); or * Fatigue or energy-related symptoms limiting activities of daily living (The National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0 (NCI CTCAE v5.0 grade 2)) not responsive to available medical therapy; or * Icterus limiting social interactions, education or work activities and not responsive to available medical therapy; 3. Subject age: age ≥8 years and ≤55 years 4. Prior splenectomy 5. Adequate cardiac, pulmonary, renal and hepatic function, as detailed in relevant exclusion criteria 6. Availability of detailed medical records, including accurate transfusion history and blood count assessments, for the prior 2 years 7. Willing and able to read and correctly understand the patient information sheet and provide consent (or informed assent for minors) regarding study participation, willing and able to comply with all study-related procedures including follow-up visits. 8. Negative serum pregnancy test for female subjects of childbearing potential. Exclusion Criteria 1. Presence of other known causes of hemolysis (in addition to Pyruvate Kinase Deficiency (PKD)). Patients with concurrent G6PD deficiency diagnosed during pre-study evaluation may be considered for eligibility if in the opinion of the Investigator, the hemolytic anemia is the result of PKD and the Glucose-6-phosphate dehydrogenase (G6PD) deficiency is considered an incidental finding. 2. A venous thromboembolic event (VTE; i.e., pulmonary embolism or deep vein thrombosis) or arteriothromboembolic event (ATE; including unstable angina, myocardial infarction, stroke or transient ischemic attack) during the prior 12 months. 3. Evidence of bridging fibrosis, cirrhosis or active hepatitis on liver biopsy. 1. Liver biopsy is required when liver iron concentration (LIC) is ≥15 mg/g on T2\* magnetic resonance imaging (MRI) of liver. 2. If a liver biopsy has been performed less than 6 months prior to enrollment, it does not need to be repeated. 4. Cardiac T2\* \<10 ms by magnetic resonance imaging (MRI) or left ventricular ejection fraction (LVEF) \<45% by echocardiogram or multiple gated acquisition scan (MUGA). 5. Any evidence of severe iron overload beyond parameters stipulated in exclusion criteria 3 and 4 that, per Investigator discretion, warrants exclusion. 6. Significant medical conditions including documented HIV (human immunodeficiency virus) infection, active viral hepatitis, poorly controlled hypertension, pulmonary hypertension, cardiac arrhythmia or congestive heart failure; or arteriothromboembolic events (ATEs) (including stroke or myocardial infarction) within the 12 prior months. 7. Active hematologic or solid organ malignancy, not including non-melanoma skin cancer or another carcinoma in situ. Patients with previously resected solid organ malignancies or definitively treated hematologic malignancies may be eligible if there has been no evidence of active malignancy during the prior 3 years. 8. Uncontrolled seizure disorder. 9. Hepatic dysfunction as defined by Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5× the upper limit normal (ULN). 10. Renal dysfunction defined as serum creatinine \>upper limit normal (ULN). Patients with creatinine above ULN may be eligible pending documentation of a glomerular filtration rate ≥60 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease equation (Stevens 2006), or 24-hour urine collection. 11. Pulmonary dysfunction as defined by either: 1. Need for supplemental oxygen during the prior 2 weeks (in absence of acute infection) OR 2. Clinically significant pulmonary disease that may impair ability to tolerate study procedures and treatments. 12. Any medical or other contraindication for leukapheresis as determined by the treating Investigator. 13. Any medical or psychiatric condition that in the opinion of the Investigator renders the patient unfit for trial participation or at higher than acceptable risk for participation. 14. Poor functional status evidenced by Karnofsky Index \<70 in subjects ≥16 years old and Lansky Play-Performance Scale \<70 in subjects \<16 years old. 15. Participation in another clinical trial with an investigational drug within 14 days before the informed consent signature. Participation in observational studies is allowed. Patients who are receiving mitapivat in non-investigational settings are eligible provided they discontinue mitapivat at least 90 days prior to the start of mobilization. 16. Pregnant women or women with a positive serum pregnancy test at screening or breast feeding or planning to become pregnant within the next 24 months. Female participants or female partners of male participants not willing to use highly effective contraceptive methods during the complete study period. 17. Previous allogeneic or other hematopoietic stem cell transplant. **Maximum Age:** 55 Years **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rocket Clinical Trials **Phone:** 646-627-0033 **Role:** CONTACT #### Locations **Location 1:** **City:** Palo Alto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ami Shah, MD - **Phone:** 650-497-8953 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ami J. Shah, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Stanford University **State:** California **Zip:** 94305 **Location 2:** **City:** Madrid **Country:** Spain **Facility:** Hospital Infantil Universitario Niño Jesús **Zip:** 28009 **Location 3:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario Fundación Jiménez Díaz #### Overall Officials **Official 1:** **Affiliation:** Stanford University **Name:** Ami Shah, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Hospital Infantil Universitario Niño Jesús **Name:** Julian Sevilla Navarro, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Hospital Universitario Fundación Jiménez Díaz **Name:** José Luis López Lorenzo, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Rocket Pharmaceuticals Inc. **Name:** Elieen Nicoletti, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000745 - Term: Anemia, Hemolytic, Congenital - ID: D000000743 - Term: Anemia, Hemolytic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000002239 - Term: Carbohydrate Metabolism, Inborn Errors - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M4076 - Name: Anemia, Hemolytic, Congenital Nonspherocytic - Relevance: HIGH - As Found: Pyruvate Kinase Deficiency - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M4073 - Name: Anemia, Hemolytic - Relevance: LOW - As Found: Unknown - ID: M4075 - Name: Anemia, Hemolytic, Congenital - Relevance: LOW - As Found: Unknown - ID: M18016 - Name: Pyruvate Metabolism, Inborn Errors - Relevance: HIGH - As Found: Pyruvate Kinase Deficiency - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M5498 - Name: Carbohydrate Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T4852 - Name: Pyruvate Kinase Deficiency - Relevance: HIGH - As Found: Pyruvate Kinase Deficiency ### Condition Browse Module - Meshes - ID: D000000746 - Term: Anemia, Hemolytic, Congenital Nonspherocytic - ID: D000015323 - Term: Pyruvate Metabolism, Inborn Errors ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T424 - Name: Pyruvate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422338 **Brief Title:** A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients) **Official Title:** A Multi-country, Two-arm, Open-label, Superiority, Randomised Controlled Trial to Study the Performance of a Rapid Triage Test Compared to Standard of Care (IMCI-based) to Guide Admission/Discharge Decisions During the First Clinical Assessment of Children With Fever #### Organization Study ID Info **ID:** EChiLiBRiST CT1 #### Organization **Class:** OTHER **Full Name:** Barcelona Institute for Global Health ### Status Module #### Completion Date **Date:** 2027-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-12-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Barcelona Institute for Global Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The overall aim of the study is to provide evidence that introducing soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) evaluation at triaging (first clinical assessment), in combination with IMCI-based guidelines (SoC), is a viable strategy to enhance rapid and accurate identification of febrile children at increased risk of life-threatening infections compared to IMCI-based strategies alone (SoC), and to demonstrate whether this results in enhanced decisions of admission/referral vs discharge, and enhanced overall health outcome of children with acute fever in sub-Saharan Africa. **Detailed Description:** This is a multi-country, open label, two-arm, parallel-group, superiority, individually randomised clinical trial involving 2,606 febrile children per country (two countries, total n=5212). The trial will compare the performance of a point-of-care rapid triage test (POC-RTT) based on sTREM-1 levels (i.e. B-Triage) (in combination with IMCI-based strategies, which are the SoC) to appropriately support admission/referral vs discharge decisions during the first clinical assessment of febrile children aged 2-\<60 months compared to the standard of care based on IMCI guidelines. Febrile children meeting the study eligibility criteria will be randomly allocated (1:1) to one of the two triaging approaches (arms): 1) IMCI-based standard of care (SoC); or 2) IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC). Blood will be collected from all participants and only those randomised to the intervention arm (arm 2) will have sTREM-1 levels determined at the POC using B-Triage device. At baseline, all children will undergo two clinical assessments. Primary composite endpoint of "appropriateness of discharge" will be based on the first clinical assessment, which is more representative of real-world clinical practice. However, the ultimate decision on admission/referral vs discharge will be based on the second clinical assessment, which will ensure the safest possible clinical practice in the context of a clinical trial. 1. At baseline, during the first clinical assessment, all participants will be evaluated following the SoC based on IMCI guidelines, which will guide management decisions, including clinical diagnosis and treatment. This IMCI-guideline based evaluation during this first clinical assessment will be conducted by a health worker as per routine clinical practice in the outpatient departments of each study site. 1. In the participants randomised to the control arm, decision of admission/referral vs discharge home will be informed by IMCI-based evaluation alone (SoC). 2. In the participants randomised to the intervention arm, decision of admission/referral vs discharge home will be informed by IMCI-based evaluation enhanced by sTREM-1 levels (SoC + sTREM-1 POC). Clinicians will be instructed to admit for further observation any child with sTREM-1 levels equal or superior to 200 pg/mL, as these patients are at moderate or high risk of adverse outcomes and death. On the other hand, children with sTREM-1 levels below 200 pg/mL will be eligible for discharge home at the criteria of the clinician, considering the signs and symptoms found, and based on IMCI guidelines. Hence, should clinicians in charge deem that any of these children still require admission, they will be instructed to continue with the admission regardless of sTREM-1 levels. The study intervention will be implemented during the first clinical assessment, and consequently, primary composite endpoint of "appropriateness of discharge" will be based on the decision of admission/referral vs discharge home during this first clinical assessment, which is more representative of routine clinical practice in each study site. 2. All randomised participants will be also evaluated by an independent study physician in a second clinical assessment, for the implementation of a systematised clinical evaluation (IMCI-based) to uncover any danger signs or severity criteria potentially missed or misinterpreted during the first assessment. This second assessment will also include clinical variables of the clinical scores Paediatric Early Warning Score (ED-PEWS), Lactate enhanced-quick Sequential Organ Failure Assessment (LqSOFA) and Logistic Organ Dysfunction Score (LODS), as well as temperature and oxygen saturation measures. Hence, study clinicians during this second clinical assessment might be able to uncover more symptoms and signs that are admission criteria due to the tools available in the context of this clinical trial. Initially discharged patients from both arms showing a danger sign or other severity criteria during this second assessment will be admitted, as well as those from the intervention arm with sTREM-1 high-risk (red light) and moderate-risk (yellow light) levels, in case that the first clinician might not have adhered to the protocol during the first assessment. On the other hand, this second assessment will not overturn the decision of the first clinician if admission has been decided in case of sTREM-1 levels below 200 pg/mL (green light, low-risk). This second clinical assessment will guide the ultimate decision on admission/referral vs discharge in order to ensure the safest possible clinical practice in the context of a clinical trial. Moreover, those participants with respiratory symptoms will be eligible for the respiratory tract infection (RTI) sub-study, where digital lung auscultations, a mid-turbinate nasal swab and a saliva sample will be collected. Throughout the study, all participants will receive treatment as per the routine clinical practice and SoC for each diagnosis at each study site, administered by clinical staff routinely working in the participating facilities. All participants will have follow-up evaluations by study clinicians on days 3 and 7 post-enrolment, or at any time in-between in case of clinical deterioration according to caregivers' evaluation. All participants will be also followed-up on day 28 for an interview to follow-up on serious adverse events (SAEs), as well as to collect information on secondary consultations and hospitalisation, or death. A follow-up extra visit at day 91 (month 3) can be conducted for an interview to ask for hospitalisation or death. ### Conditions Module **Conditions:** - Infectious Disease - Febrile Illness - Child, Only ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 5212 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** IMCI-guidelines (standard of care) + Point-Of-Care Rapid Triage Test (POC-RTT) based on sTREM-1 quantification **Intervention Names:** - Other: IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC) **Label:** IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** IMCI-guidelines (standard of care) **Label:** IMCI alone **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC) **Description:** IMCI-guidelines (standard of care) + Point-Of-Care Rapid Triage Test (POC-RTT) based on sTREM-1 quantification **Name:** IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC) **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Proportion of secondary consultations or admissions on day 91 (month 3) among the two study arms **Measure:** Secondary consultations or admission **Time Frame:** Up to day 91 **Description:** Proportion of mortality on day 91 (month 3) among the two study arms. **Measure:** Mortality **Time Frame:** Up to day 91 #### Primary Outcomes **Description:** The primary outcome is the proportion of "appropriateness of discharge" according to the first clinical assessment of febrile children aged 2-\<60 months compared among the 2 study arms. Inappropriate discharge is defined as a composite of (fulfilling at least one of the following): 1. Presence at baseline of World Health Organization (WHO)-proposed danger signs in discharged children; OR 2. Presence of WHO-proposed danger signs on day 3 post-discharge; OR 3. Requirement for additional visit at the health facility or admission at day 7; OR 4. Death on day 7 post-discharge. The absence of any of these endpoints will be considered an appropriate discharge. **Measure:** Appropriateness of discharge **Time Frame:** Up to day 7 #### Secondary Outcomes **Description:** Proportion of secondary consultations or admissions on day 7 and day 28 among the two study arms. **Measure:** Secondary consultations or admissions **Time Frame:** Up to day 28 **Description:** Proportion of mortality on day 7 and day 28 among the two study arms. **Measure:** Mortality **Time Frame:** Up to day 28 **Description:** Proportion of referrals of mild infections to higher level facilities at day 7 and day 28 among the two study arms. **Measure:** Referrals to higher level facilities **Time Frame:** Up to day 28 **Description:** Proportion of participants diagnosed with severe disease as described in IMCI (i.e. very severe diseases, severe pneumonia, severe dehydration, severe persistent diarrhoea, very severe febrile diseases, severe complicated measles, complicated severe acute malnutrition, mastoiditis, and severe anaemia), at day 3 and day 7 among the two study arms. **Measure:** Severe disease **Time Frame:** Up to day 7 **Description:** Median time to symptoms resolution among the two study arms until day 28. **Measure:** Symptoms duration **Time Frame:** Up to day 28 **Description:** Median length of hospital stay among the two study arms until day 28 **Measure:** Hospital stay length **Time Frame:** Up to day 28 **Description:** Proportion of serious adverse events (SAEs) at day 3, day 7, and day 28, among the two study arms. **Measure:** Serious adverse events **Time Frame:** Up to day 28 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥2 months and \<60 months * Written informed consent from the child's parent or caregiver * History of fever for ≤7 days OR hypothermia (i.e., axillary temperature \<35.5ºC) OR suspected severe infection (e.g., in children with moderate or severe acute malnutrition). * Lives within the catchment area of the study facility and must intend to continue to reside there for the duration of the study * For the RTI sub-study only: presence of respiratory symptoms compatible with RTI. Exclusion Criteria: * Weight less than 2.5kg * Main reason for consultation is an injury, trauma or acute poisoning * Enrolled in another clinical trial testing a new drug * Enrolled in a vaccine trial in the last 3 months. * Any other condition determined by the investigators that makes it unlikely that the participant would complete the study **Maximum Age:** 60 Months **Minimum Age:** 2 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Quique Bassat, Prof **Phone:** 93 227 92 12 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Barbara Baro, PhD **Phone:** 93 227 92 12 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Barcelona Institute for Global Health **Name:** Quique Bassat, Prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** On request to any interested professional **Description:** This clinical trial, as part of the wider EChiLiBRiST project, is committed to European Union-funded Horizon 2021 aims to improve and maximize access to and reuse of research data generated by the Project. Biological samples and data will be shared using material and data transfer agreements with the collaborating institutions. The full protocol will be available on request to any interested professional and may be published in peer-reviewed journals or deposited in an online repository. A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the the analysis is completed and no later than five years after the publication of the trial. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the data analysis is completed and no later than five years after the publication of the trial. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001832 - Term: Body Temperature Changes - ID: D000018882 - Term: Heat Stress Disorders - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infectious Disease - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infectious Disease - ID: M2454 - Name: Hyperthermia - Relevance: HIGH - As Found: Febrile - ID: M8464 - Name: Fever - Relevance: HIGH - As Found: Febrile - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M5111 - Name: Body Temperature Changes - Relevance: LOW - As Found: Unknown - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: LOW - As Found: Unknown - ID: M20924 - Name: Heat Stress Disorders - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000084462 - Term: Hyperthermia - ID: D000005334 - Term: Fever ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422325 **Brief Title:** Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide **Official Title:** A Crossover Study to Evaluate Insulin/Pramlintide Versus Insulin Alone Delivery Strategy #### Organization Study ID Info **ID:** 25279 #### Organization **Class:** OTHER **Full Name:** Oregon Health and Science University ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Oregon Health and Science University #### Responsible Party **Investigator Affiliation:** Oregon Health and Science University **Investigator Full Name:** Leah Wilson **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 CGM and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery. **Detailed Description:** Participants will undergo two 12.5 hour clinic visits. Participants will complete a training on how to start the Dexcom G6 sensor at home. Participants will start the G6 sensor the day before each study visit. For one visit, the system will use insulin only for managing blood sugar. For the other study, the system will use both insulin and pramlintide. The order of the visits will be randomly chosen. For 3 days before the insulin and pramlintide visit, participants will dose with pramlintide before each meal. During the visits, participants will wear one or two Omnipods to delivery insulin and insulin/pramlintide and a Dexcom G6 CGM. The CGM system will provide sensor glucose data every 5 minutes. Sensor glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G6 to the smartphone master controller every 5 minutes. The smartphone will communicate via BTLE to an Omnipod for insulin delivery. The closed loop system will receive activity data through a Polar M600 watch worn by the participant. Participants will eat breakfast and lunch in clinic. ### Conditions Module **Conditions:** - Type 1 Diabetes **Keywords:** - automated insulin delivery systems - glucose sensor - pramlintide ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 35 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. **Intervention Names:** - Device: MPC closed-loop system in insulin only mode **Label:** Insulin Only Arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. **Intervention Names:** - Device: MPC closed-loop system in insulin/pramlintide mode **Label:** Insulin and Pramlintide Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Insulin Only Arm **Description:** The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer insulin continuously for managing blood sugar. **Name:** MPC closed-loop system in insulin only mode **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Insulin and Pramlintide Arm **Description:** The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer both insulin and pramlintide continuously for managing blood sugar. The system will deliver pramlintide in a fixed ratio to insulin at 6 mcg of pramlintide delivered for every 1 unit of insulin. **Name:** MPC closed-loop system in insulin/pramlintide mode **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Incremental area under the curve (iAUC) of postprandial glucose as measured by the Dexcom G6 CGM in the 6 hours following the start of first meal. iAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values in the 6 hour period following the meal above the starting glucose. **Measure:** Incremental area under the curve of postprandial glucose following the first meal **Time Frame:** 6 hours following first meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. **Measure:** Percent of time with sensed glucose between 70 - 180 mg/dl following first meal **Time Frame:** 6 hours following first meal #### Secondary Outcomes **Description:** Incremental area under the curve (iAUC) of postprandial glucose as measured by the Dexcom G6 CGM in the 6 hours following the start of second meal. iAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values in the 6 hour period following the meal above the starting glucose. **Measure:** Incremental area under the curve of postprandial glucose following the second meal **Time Frame:** 6 hours following second meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal. **Measure:** Percent of time with sensed glucose between 70 - 180 mg/dl following second meal **Time Frame:** 6 hours following second meal **Description:** Net area under the curve (netAUC) of postprandial glucose as measured by CGM in the 6 hours following the start of first meal. netAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values in the 6 hour period following the meal above the starting glucose and subtracts CGM values below the starting glucose. **Measure:** Net area under the curve of postprandial glucose following the first meal **Time Frame:** 6 hours following first meal **Description:** Net area under the curve (netAUC) of postprandial glucose as measured by CGM in the 6 hours following the start of second meal. netAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values in the 6 hour period following the meal above the starting glucose and subtracts CGM values below the starting glucose. **Measure:** Net area under the curve of postprandial glucose following the second meal **Time Frame:** 6 hours following second meal **Description:** Net area under the curve (netAUC) of postprandial glucose as measured by CGM over the 12 hour study visit. netAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values above the starting glucose and subtracts CGM values below the starting glucose. **Measure:** Net area under the curve of postprandial glucose **Time Frame:** 12 hour clinic visit **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. **Measure:** Percent of time with sensed glucose <70 mg/dL following first meal **Time Frame:** 6 hours following first meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal. **Measure:** Percent of time with sensed glucose <70 mg/dL following second meal **Time Frame:** 6 hours following second meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor. **Measure:** Percent of time with sensed glucose <70 mg/dL **Time Frame:** 12 hour clinic visit **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-140 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. **Measure:** Percent of time with sensed glucose between 70-140 mg/dL following first meal **Time Frame:** 6 hours following first meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-140 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal. **Measure:** Percent of time with sensed glucose between 70-140 mg/dL following second meal **Time Frame:** 6 hours following second meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-140 mg/dl using Dexcom sensor. **Measure:** Percent of time with sensed glucose between 70-140 mg/dL **Time Frame:** 12 hour clinic visit **Description:** Assess mean sensed glucose from the Dexcom G6 sensor in the 6 hours following the start of the first meal. **Measure:** Mean sensed glucose following first meal **Time Frame:** 6 hours following first meal **Description:** Assess mean sensed glucose from the Dexcom G6 sensor in the 6 hours following the start of the second meal. **Measure:** Mean sensed glucose following second meal **Time Frame:** 6 hours following second meal **Description:** Assess mean sensed glucose from the Dexcom G6 sensor. **Measure:** Mean sensed glucose **Time Frame:** 12 hour clinic visit **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. **Measure:** Percent of time with sensed glucose <54 mg/dL following first meal **Time Frame:** 6 hours following first meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal. **Measure:** Percent of time with sensed glucose <54 mg/dL following second meal **Time Frame:** 6 hours following second meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor. **Measure:** Percent of time with sensed glucose <54 mg/dL **Time Frame:** 12 hour clinic visit **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. **Measure:** Percent of time with sensed glucose >180 mg/dL following first meal **Time Frame:** 6 hours following first meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal. **Measure:** Percent of time with sensed glucose >180 mg/dL following second meal **Time Frame:** 6 hours following second meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor. **Measure:** Percent of time with sensed glucose >180 mg/dL **Time Frame:** 12 hour clinic visit **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. **Measure:** Percent of time with sensed glucose >250 mg/dL following first meal **Time Frame:** 6 hours following first meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal. **Measure:** Percent of time with sensed glucose >250 mg/dL following second meal **Time Frame:** 6 hours following second meal **Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor. **Measure:** Percent of time with sensed glucose >250 mg/dL **Time Frame:** 12 hour clinic visit **Description:** Assess the mean amount of insulin delivered (in units and units/kg) in the 6 hours following the first meal. **Measure:** Mean amount of insulin delivered following first meal **Time Frame:** 6 hours following the first meal **Description:** Assess the mean amount of insulin delivered (in units and units/kg) in the 6 hours following the second meal. **Measure:** Mean amount of insulin delivered following second meal **Time Frame:** 6 hours following the second meal **Description:** Assess the mean amount of insulin delivered (in units and units/kg). **Measure:** Mean amount of insulin delivered **Time Frame:** 12 hour clinic visit **Description:** Assess the mean amount of pramlintide delivered (in mcg and mcg/kg) in the 6 hours following the first meal. **Measure:** Mean amount of pramlintide delivered following first meal **Time Frame:** 6 hours following the first meal **Description:** Assess the mean amount of pramlintide delivered (in mcg and mcg/kg) in the 6 hours following the second meal. **Measure:** Mean amount of pramlintide delivered following second meal **Time Frame:** 6 hours following the second meal **Description:** Assess the mean amount of pramlintide delivered (in mcg and mcg/kg). **Measure:** Mean amount of pramlintide delivered **Time Frame:** 12 hour clinic visit **Description:** Assess the coefficient of variation based on the Dexcom sensor values across both study arms in the 6 hours following the first meal. **Measure:** Coefficient of variation following first meal **Time Frame:** 6 hours following the first meal **Description:** Assess the coefficient of variation based on the Dexcom sensor values across both study arms in the 6 hours following the second meal. **Measure:** Coefficient of variation following second meal **Time Frame:** 6 hours following the second meal **Description:** Assess the coefficient of variation based on the Dexcom sensor values across both study arms. **Measure:** Coefficient of variation **Time Frame:** 12 hour clinic visit **Description:** Assess low blood glucose index based on the Dexcom sensor values for the 6 hours following the first meal. **Measure:** Low Blood Glucose Index (LBGI) following the first meal **Time Frame:** 6 hours following the first meal **Description:** Assess low blood glucose index based on the Dexcom sensor values for the 6 hours following the second meal. **Measure:** Low Blood Glucose Index (LBGI) following the second meal **Time Frame:** 6 hours following the second meal **Description:** Assess low blood glucose index based on the Dexcom sensor values. **Measure:** Low Blood Glucose Index (LBGI) **Time Frame:** 12 hour clinic visit **Description:** Assess high blood glucose index based on the Dexcom sensor values for the 6 hours following the first meal. **Measure:** High Blood Glucose Index (HBGI) following the first meal **Time Frame:** 6 hours following the first meal **Description:** Assess high blood glucose index based on the Dexcom sensor values for the 6 hours following the second meal. **Measure:** High Blood Glucose Index (HBGI) following the second meal **Time Frame:** 6 hours following the second meal **Description:** Assess high blood glucose index based on the Dexcom sensor values. **Measure:** High Blood Glucose Index (HBGI) **Time Frame:** 12 hour clinic visit **Description:** Assess the number of adverse events probably or possibly associated with pramlintide administration. **Measure:** Adverse events related to pramlintide **Time Frame:** 4 days of pramlintide use **Description:** Assess discomfort level due to gastrointestinal issues by participant rating from 0-10 with 1 being no discomfort and 10 being worst possible discomfort 6 hours after the first meal. **Measure:** Baxter Retching Faces (BARF)/VAS scale for gastrointestinal issues after the first meal **Time Frame:** 6 hours following first meal **Description:** Assess gastrointestinal issues by participant rating from 0-10 with 1 being no discomfort and 10 being worst possible discomfort 6 hours after the second meal as reported using the BARF/VAS scale. **Measure:** Baxter Retching Faces (BARF)/VAS scale for gastrointestinal issues after the second meal **Time Frame:** 6 hours following second meal **Description:** Assess the average duration of gastrointestinal issues reported by the participant at 6 hours after the first meal as reported by participant. **Measure:** Mean duration of gastrointestinal issues after the first meal **Time Frame:** 6 hours following first meal **Description:** Assess the average duration of gastrointestinal issues reported by the participant at 6 hours after the second meal as reported by participant. **Measure:** Mean duration of gastrointestinal issues after the second meal **Time Frame:** 6 hours following second meal **Description:** Assess the number of rescue carbohydrate treatments (defined as 15 grams of carbohydrate intake) needed to treat hypoglycemia. **Measure:** Episodes of carbohydrate intake to treat hypoglycemia **Time Frame:** 12 hour clinic visit **Description:** Assess the number of episodes of hypoglycemia defines as CGM \< 70 mg/dl for 10 minutes or more. **Measure:** Episodes of hypoglycemia **Time Frame:** 12 hour clinic visit **Description:** Assess the number of provider-administered insulin injections due to hyperglycemia. **Measure:** Number of provider-administered insulin injections **Time Frame:** 12 hour clinic visit ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus for at least 1 year. * Participants 18 to 70 years of age. * Current use of an insulin pump for at least 3 months with stable insulin pump settings for \>2 weeks OR current use of multiple day injection insulin therapy with stable doses for \>2 weeks. * Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin. * HbA1c ≤ 10.5% at screening. * Total daily insulin requirement is less than 139 units/day. * Willingness to follow all study procedures, including attending all clinic visits. * Willingness to sign informed consent and HIPAA documents. Exclusion Criteria: * Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence. * Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary. * Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as reported by the OHSU laboratory). * Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator. * History of severe hypoglycemia during the past 3 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses. * History of diabetes ketoacidosis during the prior 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator. * Adrenal insufficiency. * Any active infection requiring treatment (example soft tissue infection requiring antibiotics). * Known or suspected abuse of alcohol, narcotics, or illicit drugs. * Seizure disorder. * Active foot ulceration. * Major surgical operation within 30 days prior to screening. * Use of an investigational drug within 30 days prior to screening. * Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus). * Bleeding disorder, treatment with warfarin, or platelet count below 50,000. * Allergy to aspart insulin. * Allergy to pramlintide. * Current administration of oral or parenteral corticosteroids. * Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer). * Current use of any medication intended to lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin). * Gastroparesis * Diets consisting of less than 50 grams of carbohydrates per day. * Dietary restrictions or allergies to the study meals * Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Leah Wilson, MD **Phone:** 503-494-3273 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Deborah Branigan **Phone:** 503-418-9070 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Oregon Health and Science University **Name:** Leah Wilson, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: HIGH - As Found: Day 1 - ID: M250016 - Name: Pramlintide - Relevance: HIGH - As Found: Basal Cell Carcinoma - ID: M17768 - Name: Zinc - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin - ID: C000557859 - Term: Insulin, Globin Zinc - ID: C000105254 - Term: Pramlintide ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422312 **Brief Title:** A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients. **Official Title:** Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy. #### Organization Study ID Info **ID:** USA001 #### Organization **Class:** INDUSTRY **Full Name:** Guangzhou Red Pine Medical Instrument Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Texas Southwestern Medical Center **Class:** OTHER **Name:** University of Washington **Class:** OTHER **Name:** Penn State University #### Lead Sponsor **Class:** INDUSTRY **Name:** Guangzhou Red Pine Medical Instrument Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal. **Detailed Description:** This randomized study will compare the cumulative procedure time between cystoscopy performed with the Redpine® Rflex endo(trademark) High-Definition Cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. The study will evaluate the user experience and product performance during cystoscopic procedures. Participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. The hypothesis is that the RedPine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time. ### Conditions Module **Conditions:** - Bladder Cancer - Bladder Stone - Bladder Outlet Obstruction - Renal Stone - Renal Disease **Keywords:** - cystoscopy - urinary stint removal - bladder biopsy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice. **Intervention Names:** - Device: Cystoscopy with RedPine flexible disposable cystoscope **Label:** Control **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope. **Intervention Names:** - Device: Cystoscopy with RedPine flexible disposable cystoscope **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control - Intervention **Description:** Use of a flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents. **Name:** Cystoscopy with RedPine flexible disposable cystoscope **Other Names:** - Cystoscopy with standard of care flexible reusable scope **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure. 1. All urologic adverse events, both device and procedure related, during the cystoscopy procedure through 7 (+/- 3) days post-procedure. 2. All reported device and/or procedural related adverse events through 7 (+/- 3) days post- procedure 3. All Serious Adverse Events (SAEs) through 7 (+/- 3) days post-procedure **Measure:** Safety Endpoints **Time Frame:** 4 to 10 days #### Primary Outcomes **Description:** To compare the Cumulative Procedure Time between cystoscopy performed with the Redpine® Rflex endo(trademark) High Definition (endoTMHD) Cysto scope and the site's Standard of Care reusable flexible cystoscope as measured by: * Scope preparation for procedure * Actual procedure time (insertion of cystoscope to complete bladder examination) and * Time to dispose of or prepare for reprocessing of cystoscopy equipment. **Measure:** Cumulative Procedure Time **Time Frame:** 30 minutes #### Secondary Outcomes **Description:** Physician satisfaction, rated on a five-point scale. i) Ease of insertion ii) Ability to visualize anatomical landmarks and/or urothelium changes iii) Perception of image quality iv) Maneuverability in the bladder v) Scope articulation with tools in the working channel vi) Visualization while tools are in the working channel **Measure:** User experience and product performance during cystoscopic procedures **Time Frame:** within 24 hours **Description:** Participants will be interviewed using a questionnaire. **Measure:** Participant comfort during the procedure **Time Frame:** 30 minutes **Description:** Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope. **Measure:** RedPine Cystoscope Conversion Rate **Time Frame:** 30 minutes **Description:** Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope. **Measure:** Device Failure Rate **Time Frame:** 30 minutes **Description:** Device malfunction including any device-related issue or observation whether it leads to an SAE, termination of the procedure or conversion to a reusable cystoscope. **Measure:** Device Malfunction Rate **Time Frame:** 30 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female, aged at least 18 years old 2. Patient undergoing routine flexible cystoscopy 3. No active urinary tract infection 4. Subject is willing and able to sign informed consent and HIPAA authorization. Exclusion Criteria: 1. Known unpassable urethral stricture 2. Febrile patient with active urinary tract infection (UTI) 3. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis) 4. Subject with severe coagulopathy 5. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control. **Maximum Age:** 120 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Greg Lips **Phone:** 800-570-4962 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Daniel S Laferriere, MS **Phone:** 5037586788 **Role:** CONTACT #### Locations **Location 1:** **City:** Hershey **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Suzanne L Boltz, B.S. - **Phone:** 717-531-0003 - **Phone Ext:** 287502 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Amogh Pande, M.S. - **Phone:** 717-531-5930 - **Role:** CONTACT **Country:** United States **Facility:** Pennsylvania State University **State:** Pennsylvania **Zip:** 17033 **Location 2:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Brett Johnson, MD - **Phone:** 214-645-8765 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Sonobia Garrett, BS - **Phone:** 214-645-8482 - **Role:** CONTACT ***Contact 3:*** - **Name:** Brett Johnson, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** UT Southwestern Medical Center **State:** Texas **Zip:** 75390 #### Overall Officials **Official 1:** **Affiliation:** UT Southwestern Medical Center **Name:** Yair Lotan, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Samplaski MK, Jones JS. Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8. **PMID:** 19076146 **Citation:** O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5. **PMID:** 8081563 **Citation:** Poulton LJ, Joyce AD. Flexible cystoscopy: Training and Assessment Guideline. Br Assoc Urol Nurses. 2012;(November). **Citation:** Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. doi: 10.12968/hmed.2009.70.10.44626. **PMID:** 19966704 **Citation:** Kadi N, Menezes P. ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19. **PMID:** 21887113 **Citation:** Steinberg. Cystoscopy in Bladder Carcinoma [Internet]. Medscape. 2015 [cited 2018 Jan 18]. Available from: https://emedicine.medscape.com/article/1950345-overview **Citation:** Doizi S, Kamphuis G, Giusti G, Palmero JL, Patterson JM, Proietti S, Straub M, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris): a European prospective multicenter study. World J Urol. 2017 Aug;35(8):1269-1275. doi: 10.1007/s00345-016-1986-0. Epub 2016 Dec 17. **PMID:** 27988848 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000002137 - Term: Calculi - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000052878 - Term: Urolithiasis - ID: D000014545 - Term: Urinary Calculi - ID: D000014524 - Term: Urethral Obstruction - ID: D000014522 - Term: Urethral Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M10693 - Name: Kidney Calculi - Relevance: LOW - As Found: Unknown - ID: M27126 - Name: Nephrolithiasis - Relevance: LOW - As Found: Unknown - ID: M5399 - Name: Calculi - Relevance: LOW - As Found: Unknown - ID: M5030 - Name: Urinary Bladder Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5029 - Name: Urinary Bladder Neck Obstruction - Relevance: HIGH - As Found: Bladder Outlet Obstruction - ID: M5025 - Name: Urinary Bladder Calculi - Relevance: HIGH - As Found: Bladder Stone - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M27103 - Name: Urolithiasis - Relevance: LOW - As Found: Unknown - ID: M17295 - Name: Urinary Calculi - Relevance: LOW - As Found: Unknown - ID: M17274 - Name: Urethral Obstruction - Relevance: LOW - As Found: Unknown - ID: M17272 - Name: Urethral Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001748 - Term: Urinary Bladder Neck Obstruction - ID: D000001744 - Term: Urinary Bladder Calculi ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422299 **Brief Title:** Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples **Official Title:** Developing and Testing an Online Intervention for Decreasing Alcohol and Cannabis Misuse and Increasing Healthy Relationship Skills Among Young Adult Couples: A Comprehensive Mixed-methods Approach #### Organization Study ID Info **ID:** STUDY00017992 #### Organization **Class:** OTHER **Full Name:** University of Washington #### Secondary ID Infos **ID:** K23AA031034-01 **Link:** https://reporter.nih.gov/quickSearch/K23AA031034-01 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2026-07-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-02-08 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institutes of Health (NIH) **Class:** NIH **Name:** National Institute on Alcohol Abuse and Alcoholism (NIAAA) #### Lead Sponsor **Class:** OTHER **Name:** University of Washington #### Responsible Party **Investigator Affiliation:** University of Washington **Investigator Full Name:** Katherine Walukevich-Dienst **Investigator Title:** Acting Assistant Professor, School of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to develop and test a brief online intervention to reduce alcohol and cannabis misuse and improve healthy relationship skills among young adult couples. The main questions it aims to answer are: * Will the intervention be feasible and acceptable to young adult couples? * Will the intervention demonstrate initial efficacy in reducing risky substance use and increasing relationship functioning? Eligible couples will complete a virtual baseline session and be randomized to intervention condition (online intervention with 3-5 weeks of self-paced modules) or control condition (no intervention). Couples will complete two follow-up surveys (post-assessment - approximately 5 weeks after baseline, 3-month). Couples in the control condition will be offered the intervention after 3-month follow-up. Researchers will compare intervention and control groups to see if there there is a difference between the groups on substance misuse and relationship functioning at post-assessment and 3-month follow-up. ### Conditions Module **Conditions:** - Alcohol Drinking - Cannabis Use - Couples **Keywords:** - alcohol use, cannabis use, couples, healthy relationships, young adults ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A novel, brief online intervention for young adults community couples who engage in alcohol and cannabis co-use. **Intervention Names:** - Behavioral: Online, couples-based intervention **Label:** Online, couples-based intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Couples in the control condition will not receive an intervention. **Label:** Assessment-only control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Online, couples-based intervention **Description:** During Phase 1 of the present study, the intervention will be iteratively developed using a rigorous, user-centered design approach through integration of knowledge gained from Phase 1 dyadic analyses and qualitative interviews, and existing gold-standard treatments for substance use among couples, including Integrative Behavioral Couples Therapy (IBCT; Christensen \& Doss, 2016) and Behavioral Couples Therapy for Alcohol (ABCT; McCrady et al, 1995) and substance use brief interventions for young adults (Halladay, et al., 2019; Tanner-Smith et al., 2015). **Name:** Online, couples-based intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Alcohol use - number of days in the past month participant engaged in heavy episodic drinking (4+/5+ drinks in one occasion for women/men) and high intensity drinking (8+/10+ drinks in one occasion for women/men) **Measure:** Heavy episodic and high intensity drinking **Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup **Description:** Alcohol use - Average total drinks per week will be calculated as the sum of the total number of drinks reported. **Measure:** Daily Drinking Questionnaire (DDQ) **Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup **Description:** Cannabis use - Average total hours high from cannabis per week will be calculated as the sum of the total hours high reported **Measure:** Daily Marijuana Questionnaire (DMQ) **Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup **Description:** Cannabis use intensity - Average number of times used cannabis per day will be calculated as the mean number of times participant reports using cannabis per each day of a typical week in the past month **Measure:** Intensity of Marijuana Use **Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup **Description:** Healthy relationship self-efficacy - 3 items assessing perceived intervention impacts on healthy relationship self-efficacy scored 0=strongly disagree to 5=strongly agree. Scores will be summed, total scores will range from 0 to 15, with higher scores indicating greater healthy relationship self-efficacy **Measure:** Perceived Program Effects on Healthy Relationship Self-Efficacy items **Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup **Description:** Relationship satisfaction - sum of 4 items ranges from 0 to 21, higher scores indicate greater relationship satisfaction **Measure:** Couples Satisfaction Index **Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Both partners in the couple are 18-29 years old * In a committed romantic relationship (e.g., dating seriously, cohabiting, married) with each other for at least 3 months * Face-to-face contact their partner at least 5 days per week * Live in Washington State * Have a valid email address and access to a cell phone * Report alcohol and cannabis co-use at least three times in the past month * Willingness to: complete online surveys during the allotted time frames, receive text messages and emails from the project, complete a baseline session, and participate during the same time period as their partner Exclusion Criteria: * Couples who endorse any perpetration or receipt of severe interpersonal aggression during screening will be excluded and provided with resources **Healthy Volunteers:** True **Maximum Age:** 29 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Katherine Walukevich-Dienst, PhD **Phone:** 508-282-0413 **Role:** CONTACT **Contact 2:** **Name:** Hana Basu, BA **Phone:** 425-372-6459 **Role:** CONTACT ### References Module #### References **Citation:** Patrick ME. A Call for Research on High-Intensity Alcohol Use. Alcohol Clin Exp Res. 2016 Feb;40(2):256-9. doi: 10.1111/acer.12945. No abstract available. **PMID:** 26842244 **Citation:** Collins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available. **PMID:** 3998247 **Citation:** Lee CM, Kilmer JR, Neighbors C, Atkins DC, Zheng C, Walker DD, Larimer ME. Indicated prevention for college student marijuana use: a randomized controlled trial. J Consult Clin Psychol. 2013 Aug;81(4):702-9. doi: 10.1037/a0033285. Epub 2013 Jun 10. **PMID:** 23750464 **Citation:** Patrick ME, Veliz PT, Terry-McElrath YM. High-intensity and simultaneous alcohol and marijuana use among high school seniors in the United States. Subst Abus. 2017 Oct-Dec;38(4):498-503. doi: 10.1080/08897077.2017.1356421. Epub 2017 Jul 20. **PMID:** 28726580 **Citation:** Scott ME, Moore KA, Fish H, Benedetti A, Erikson S. OPRE Report #2015-65a. Prepared by Child Trends. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services. 2015. https://www.acf.hhs.gov/sites/default/files/documents/b_hmre_recommended_outcome_measures_for_adolescents_508_0.pdf **Citation:** Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572. **PMID:** 18179329 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000004327 - Term: Drinking Behavior ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC25 - Name: Substance Related Disorders ### Condition Browse Module - Browse Leaves - ID: M3774 - Name: Alcohol Drinking - Relevance: HIGH - As Found: Alcohol Drinking - ID: M5449 - Name: Marijuana Abuse - Relevance: HIGH - As Found: Cannabis - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M7502 - Name: Drinking Behavior - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002189 - Term: Marijuana Abuse - ID: D000000428 - Term: Alcohol Drinking ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422286 **Brief Title:** Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children **Official Title:** Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children During Taking Dental Impression #### Organization Study ID Info **ID:** 0800_11/2023 #### Organization **Class:** OTHER **Full Name:** Alexandria University ### Status Module #### Completion Date **Date:** 2024-12-16 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-16 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Alexandria University #### Responsible Party **Investigator Affiliation:** Alexandria University **Investigator Full Name:** Marwa Baraka **Investigator Title:** Lecturer, Pediatric dentistry department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** the aim of the current study is to evaluate the effectiveness of the laser acupuncture in comparison to the electroacupuncure for controlling gag reflex in children **Detailed Description:** the study will select children who are suffering from gag reflex that can affect their dental appointments negatively. they will be diagnosed then randomly distributed to one of the 3 groups of the study gag reflex and anxiety will be measured before and after the intervention then the results will be compared. ### Conditions Module **Conditions:** - Gagging **Keywords:** - gag reflex - dental anxiety - low-level laser ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 63 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The laser device with wavelength 940 nm, energy 4J, and 3-4 mm away from the tissue is applied on PC6 acupoint without causing pain to the patient for 1 minute. Immediately after the laser acupuncture, an alginate impression is going to be taken. **Intervention Names:** - Device: low-level laser **Label:** children allocated to low-level laser **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A meridian acupuncture pen with AA battery will be applied on PC6 for one minute. Immediately after using the meridian pen, an alginate impression is going to be taken. **Intervention Names:** - Biological: microcurrent stimulation **Label:** children allocated to microcurrent electrical stimulation **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** A meridian acupuncture pen will be deactivated by the operator. Then an alginate impression is going to be taken. **Intervention Names:** - Device: placebo **Label:** placebo control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - children allocated to low-level laser **Description:** children will be allocated to the device then the gag reflex will be re-evaluated **Name:** low-level laser **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - children allocated to microcurrent electrical stimulation **Description:** children will be allocated to the device then the gag reflex will be re-evaluated **Name:** microcurrent stimulation **Other Names:** - meridian pen **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - placebo control group **Description:** children will be allocated to a deactivated meridian pen **Name:** placebo **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** the difference in gagging preventive index before and after the intervention **Measure:** gagging prevetive index **Time Frame:** immediately after the intervention #### Secondary Outcomes **Description:** dental anxiety will be measured before and after the intervention using pulse oximeter **Measure:** anxiety **Time Frame:** immediately after the intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * children free of any systemic disease or special health care needs * children with score 2 or 3 according to the frankle behavioral rating scale * a full arch maxillary alginate impression is needed * moderate to severe gagging according to the gagging severity index * written informed consent of the legal guardian Exclusion Criteria: * children taking anti-emetic drugs * children sensitive to alginate **Maximum Age:** 9 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** sara salim, master **Phone:** 01026643894 **Role:** CONTACT **Contact 2:** **Name:** marwa baraka, PHD **Phone:** 01000804757 **Role:** CONTACT #### Locations **Location 1:** **City:** Alexandria **Country:** Egypt **Facility:** Alexandria University **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Alexandria University **Name:** sawsan hafez, PHD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M8802 - Name: Gagging - Relevance: HIGH - As Found: Gag Reflex - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005683 - Term: Gagging ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422273 **Brief Title:** Protest Trial: TXA vs Saline **Official Title:** Prophylactic Use of Tranexamic Acid Versus Saline to Prevent Bleeding During Transbronchial Biopsy in Lung Transplant Recipients- A Randomized Double-Blind Trial (Protest Trial) #### Organization Study ID Info **ID:** 2024-0552 #### Organization **Class:** OTHER **Full Name:** Spectrum Health Hospitals ### Status Module #### Completion Date **Date:** 2026-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Spectrum Health Hospitals #### Responsible Party **Investigator Affiliation:** Spectrum Health Hospitals **Investigator Full Name:** Sheila Krishnan **Investigator Title:** Principle Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** To determine if endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk. **Detailed Description:** Tranexamic acid (TXA) is an antifibrinolytic agent. It forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis. It also inhibits proteolytic activity of plasmin. TXA is frequently used in clinical practice and can be administered via multiple delivery methods, including intravenous, nebulized, and topical. It has been shown to reduce blood loss in a variety of clinical settings without significant adverse effects. It has also been evaluated for prophylactic use with mixed results in reducing bleeding. In our current general pulmonary practice, topical TXA is used variably by pulmonologists during bronchoscopy for post-biopsy bleeding or pulmonary hemorrhage. The purpose of this research study is to determine if prophylactic topical TXA can reduce bleeding risk in lung transplant patients who undergo transbronchial biopsies. A finding of reduced bleeding would be significant as it could improve clinical outcomes, allow for improved diagnostic yield of biopsy samples, and improve patient experience. It therefore has the potential to change clinical practice and standardize bronchoscopy procedures. ### Conditions Module **Conditions:** - Lung Transplant; Complications ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study design will be a single-center, randomized, double-blinded, placebo-controlled study. The control group will receive topical saline (placebo) and the experimental treatment group will receive topical Tranexamic acid (TXA active drug). ##### Masking Info **Masking:** TRIPLE **Masking Description:** The investigational pharmacist will be responsible for randomizing on the day of bronchoscopy to placebo or Tranexamic acid in a 1:1 fashion using REDCap software. The pharmacist will be the only individual aware of the randomization assignment. All other study personnel will be blinded to the randomization assignment. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 94 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients. **Intervention Names:** - Drug: Tranexamic Acid **Label:** TXA **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Topical Saline (placebo) administered as endobronchial topical application. **Intervention Names:** - Other: Saline (placebo) **Label:** Saline **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - TXA **Description:** Endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients **Name:** Tranexamic Acid **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Saline **Description:** Topical Saline (placebo) administered as endobronchial topical application prior to performing transbronchial biopsies in lung transplant recipients. **Name:** Saline (placebo) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive **Measure:** Bleeding Risk **Time Frame:** up to 1 hour #### Secondary Outcomes **Description:** Procedure times will be recorded for both the tranexamic acid and the control saline group. **Measure:** Procedure time Reduction **Time Frame:** up to 1 hour **Description:** This will be measured by the number of pieces of tissue from the pathology report **Measure:** Greater yield in tissue samples **Time Frame:** up to 1 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Single or double lung transplant recipients 2. Patients \>18 years old 3. Willingness and ability to sign an informed consent for study participation Exclusion Criteria: 1. Platelet count (\<50k/uL) 2. INR (\>1.6) 3. Active bleeding 4. Decompensated liver disease 5. History of uremic bleeding or BUN \>50 6. Severe pulmonary hypertension (mean PA pressure \>40 mmHg on RHC or estimated PA systolic pressure \>62 mmHg on TTE within one year of procedure) 7. Known bleeding disorder 8. Allergy to TXA 9. Prior history of severe TBBx-related airway bleeding requiring admission or advanced maneuvers for hemostasis (examples including intubation, bronchial artery embolization, surgical intervention) 10. Contraindications to topical TXA 11. Pregnancy 12. Vulnerable populations 13. Adults of limited English proficiency/non-English speakers **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Grand Rapids **Country:** United States **Facility:** Spectrum Health Hospitals **State:** Michigan **Zip:** 49503 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Document Section ### Large Document Module #### Large Docs - Date: 2024-02-20 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 375346 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-16T12:12 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000933 - Term: Antifibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16902 - Name: Tranexamic Acid - Relevance: HIGH - As Found: Stage IV - ID: M4252 - Name: Antifibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014148 - Term: Tranexamic Acid ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422260 **Brief Title:** Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials **Official Title:** Clinical and Radiographic Outcomes of Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials #### Organization Study ID Info **ID:** ADMNF-0030324 #### Organization **Class:** OTHER **Full Name:** Menoufia University ### Status Module #### Completion Date **Date:** 2025-01-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-22 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Menoufia University #### Responsible Party **Investigator Affiliation:** Menoufia University **Investigator Full Name:** Mohammed El-Sawy **Investigator Title:** lecturer, Department of prosthodontics, principle investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability. **Detailed Description:** One objective of implant dentistry is to provide excellent esthetics and soft-tissue profiles in the esthetic zone. Esthetic requirements have focused primarily on the position, inclination, shape, and color of the restoration. However, the peri-implant soft tissue also plays a major role in the esthetics of an implant-supported restoration especially in the anterior region. ### Conditions Module **Conditions:** - Prosthesis Survival - Bone Loss ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 4 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PFM **Intervention Names:** - Other: Prosthesis superstructure **Label:** Porcelin fused to metal (PFM) group #### Arm Group 2 **Description:** Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from ceramics **Intervention Names:** - Other: Prosthesis superstructure **Label:** Zirconia group #### Arm Group 3 **Description:** Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PEEK **Intervention Names:** - Other: Prosthesis superstructure **Label:** Polyetheretherketone (PEEK) group ### Interventions #### Intervention 1 **Arm Group Labels:** - Polyetheretherketone (PEEK) group - Porcelin fused to metal (PFM) group - Zirconia group **Description:** Prosthesis superstructure for 2 implant supported short span fixed bride constructed from different materials **Name:** Prosthesis superstructure **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measurement of alveolar bone loss around implants. **Measure:** Bone loss **Time Frame:** 4 years #### Secondary Outcomes **Description:** Such as fracture of the prosthesis. **Measure:** Clinical performance of the prosthesis superstructure **Time Frame:** 4 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * No systemic diseases that might alter the tissue response to implantation. * Mobility grade 3 at the site of the 4 lateral incisors. * sufficient available inter-arch space * normal maxillomandibular relation. * no temporomandibular joint Exclusion Criteria: * Grade 1 or 2 mobility at the incisor's region. * Patients with systematic diseases that contraindicate implant placement. **Maximum Age:** 50 Years **Minimum Age:** 30 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** 60 participants who needed an implant-supported fixed partial denture (FPD) in the esthetic zone. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mohammed A. El-Sawy, PhD **Phone:** 01061314522 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mohammed T. Khater, PhD **Phone:** 01003854552 **Role:** CONTACT #### Locations **Location 1:** **City:** Mansoura **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mohammed A. El-Sawy - **Phone:** 161314522 - **Role:** CONTACT **Country:** Egypt **Facility:** Mohammed A. El-Sawy **Status:** RECRUITING **Zip:** 12345 #### Overall Officials **Official 1:** **Affiliation:** Menoufia University **Name:** Mohammed A. El-Sawy, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The result can be shared upon request from the corresponding author **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14338 - Name: Prosthesis Failure - Relevance: HIGH - As Found: Prosthesis Survival - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011475 - Term: Prosthesis Failure ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422247 **Brief Title:** Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy **Official Title:** Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy #### Organization Study ID Info **ID:** CA073-1019 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The purpose of this study is to describe the therapeutic practices and the prognosis of patients with relapsed or refractory peripheral T-cell lymphoma in Japan ### Conditions Module **Conditions:** - Peripheral T-cell Lymphoma ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Systemic therapy **Label:** Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy ### Interventions #### Intervention 1 **Arm Group Labels:** - Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy **Description:** Approved peripheral T-cell lymphoma systemic treatments prescribed by the treating physician **Name:** Systemic therapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Overall survival (OS) **Time Frame:** From baseline until date of death from any cause or last known alive date, assessed up to 6 years #### Secondary Outcomes **Measure:** Participant baseline demographics **Time Frame:** Baseline **Measure:** Participant baseline clinical characteristics **Time Frame:** Baseline **Measure:** Participant treatment sequence from initial diagnosis **Time Frame:** From date of initial diagnosis until death from any cause or last known alive date, assessed up to 6 years **Measure:** Frequency of treatment regimen by treatment line **Time Frame:** End date of each treatment-line of therapy, assessed up to 6 years **Measure:** Time to next treatment line or death (TTNT) **Time Frame:** From date of first-line therapy initiation until death from any cause or last known alive date, assessed up to 6 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female participants with a confirmed diagnosis of the specific subtypes of peripheral T-cell lymphoma (PTCL) according to The World Health Organization (WHO) classification of lymphoid neoplasm, 4th edition defined by WHO and International Agency for Research on Cancer (IARC). * Participates aged ≥18 years of age at diagnosis of PTCL. * Participates who have been treated with a systemic therapy for PTCL and have initiated a systemic therapy as a second-line therapy for relapsed or refractory PTCL between April 1, 2018 and March 31, 2023. Exclusion Criteria: * Participates who have medical history of peripheral T-cell lymphoma (PTCL) treatment by unapproved drug in Japan as of 31 March 2024 or off-label drug for PTCL in Japan as of 31 March 2024. * Participates who have medical history of participation to a separately defined registration study for regulatory approval in PTCL. * Participates who have medical history of PTCL treatment in a separately defined clinical study with intervention by on-label regimen for PTCL. * Participates judged to be inappropriate for enrollment in this study by the site investigator. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult participants with peripheral T-cell lymphoma in Japan initiating second-line systemic therapy ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com **Phone:** 855-907-3286 **Role:** CONTACT **Contact 2:** **Name:** First line of the email MUST contain NCT # and Site #. **Role:** CONTACT #### Locations **Location 1:** **City:** Minato-ku **Country:** Japan **Facility:** Mebix, Inc **State:** Tokyo **Status:** RECRUITING **Zip:** 105-0001 #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** BMS Clinical Trial Information **URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html **Label:** FDA Safety Alerts and Recalls **URL:** https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000008228 - Term: Lymphoma, Non-Hodgkin ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M18829 - Name: Lymphoma, T-Cell - Relevance: HIGH - As Found: T-cell Lymphoma - ID: M18833 - Name: Lymphoma, T-Cell, Peripheral - Relevance: HIGH - As Found: Peripheral T-cell Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T4496 - Name: Peripheral T-cell Lymphoma - Relevance: HIGH - As Found: Peripheral T-cell Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000016399 - Term: Lymphoma, T-Cell - ID: D000016411 - Term: Lymphoma, T-Cell, Peripheral ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422234 **Brief Title:** Effect of Exergame-Based Exercise on Hamstring and Quadriceps Isokinetic Muscle Parameters **Official Title:** Effect of Exergame-Based Exercise on Hamstring and Quadriceps Isokinetic Muscle Parameters, Balance and Explosive Power #### Organization Study ID Info **ID:** ACetinkaya001 #### Organization **Class:** OTHER **Full Name:** Halic University ### Status Module #### Completion Date **Date:** 2024-06-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-27 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Medipol University #### Lead Sponsor **Class:** OTHER **Name:** Halic University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to investigate the effects of two different exercise methods (video-based game exercise group and real (non-game) exercise group) to increase knee strength in healthy individuals on muscle strength, balance and lower extremity functional parameters. In our study, it will be revealed which technique will have what effect in the strengthening, which will be done by taking certain criteria into consideration. Participants will be randomized into three different groups. Two groups, except the control group, will exercise three times a week for 6 weeks. All participants will be assessment twice in total, at the beginning of the study and 6 weeks later. It is thought that the results obtained here will contribute to the literature. **Detailed Description:** The study was planned to include individuals studying at Halic University, who met the inclusion criteria and volunteered to participate in the study. Evaluated participants will be randomly assigned to three different groups (control group, video-based game exercise group, real game-free exercise group). The sealed envelope method will be used in randomization. All evaluations by the same physiotherapist will be performed twice, before exercise and after 6 weeks of exercise. Both exercise groups will practice under the supervision of a physiotherapist. The control group will not exercise and will only be evaluated twice. At the end of the study, those in the control group will be able to participate in any exercise group they want for 6 weeks. ### Conditions Module **Conditions:** - Exergaming - Sedentary Behavior - Muscle Strength **Keywords:** - Exergaming - Muscle Strength Dynamometer - Physical Inactivity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will exercise 3 days a week for 6 weeks with the Ring Fit Adventure game on Nintendo Switch. The exergames to be played are selected by the physiotherapist and become more difficult as the weeks progress. **Intervention Names:** - Other: Exergame **Label:** Exergame Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The games selected for the exergame group will be held in a real environment, without games, 3 days a week for 6 weeks. **Intervention Names:** - Other: Game-free Exercise **Label:** Game-free Exercise Group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Participants in this group will continue their normal life routines and the evaluations will be repeated 6 weeks after the first evaluation. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Exergame Group **Description:** Video-based game exercises will be performed 3 days a week for 6 weeks. Participants will be taught how to play the games before starting the game called Ring Fit Adventure, one of the Nintendo Switch games. Among the games within Ring Fit, games that aim to increase lower extremity muscle strength, core stabilization and balance have been selected, and game types and number of repetitions are changed every week. **Name:** Exergame **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Game-free Exercise Group **Description:** All activities in the exergame group were done without games and screens. The progression of the exercises proceeds in the same way as the other group. **Name:** Game-free Exercise **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Biodex System 4 device will be used to evaluate quadriceps and hamstring isokinetic muscle strength. All tests were planned to be performed on the dominant and non-dominant sides of the participants. Isokinetic muscle strength test will be performed in concentric/concentric mode at speeds of 60°/sec, 90°/sec, 240°/sec in concentric strength test. Isokinetic test will be performed at 0° extension and 90° flexion joint range of motion. Before the isokinetic test, the participant will have 2 repetitions at 60°/sec for adaptation, and then 5 repetitions for the test. After the participant rests for 120 seconds, the participant will first have 4 repetitions for adaptation and then 15 repetitions for the test at 240°/sec. During the tests, the participant will be verbally motivated by the same person. .As a result of the tests, quadriceps and hamstring peak torque (PT) values will be recorded. **Measure:** Isokinetic Evaluation-Peak Torque **Time Frame:** at baseline and at week 6 **Description:** Biodex System 4 device will be used to evaluate quadriceps and hamstring isokinetic muscle strength. All tests were planned to be performed on the dominant and non-dominant sides of the participants. Isokinetic muscle strength test will be performed in concentric/concentric mode at speeds of 60°/sec, 90°/sec, 240°/sec in concentric strength test. Isokinetic test will be performed at 0° extension and 90° flexion joint range of motion. Before the isokinetic test, the participant will have 2 repetitions at 60°/sec for adaptation, and then 5 repetitions for the test. After the participant rests for 120 seconds, the participant will first have 4 repetitions for adaptation and then 15 repetitions for the test at 240°/sec. During the tests, the participant will be verbally motivated by the same person. As a result of the tests, peak torque/body weight (PT/VA) values will be recorded. **Measure:** Isokinetic Evaluation-Peak Torque / Body Weight **Time Frame:** at baseline and at week 6 **Description:** Biodex System 4 device will be used to evaluate quadriceps and hamstring isokinetic muscle strength. All tests were planned to be performed on the dominant and non-dominant sides of the participants. Isokinetic muscle strength test will be performed in concentric/concentric mode at speeds of 60°/sec, 90°/sec, 240°/sec in concentric strength test. Isokinetic test will be performed at 0° extension and 90° flexion joint range of motion. Before the isokinetic test, the participant will have 2 repetitions at 60°/sec for adaptation, and then 5 repetitions for the test. After the participant rests for 120 seconds, the participant will first have 4 repetitions for adaptation and then 15 repetitions for the test at 240°/sec. During the tests, the participant will be verbally motivated by the same person. As a result of the tests, Hamstring/Quadriceps (H/Q) values will be recorded. **Measure:** Isokinetic Evaluation-Peak Torque / Hamstring/Quadriceps (H/Q) **Time Frame:** at baseline and at week 6 **Description:** Biodex System 4 device will be used to evaluate quadriceps and hamstring isokinetic muscle strength. All tests were planned to be performed on the dominant and non-dominant sides of the participants. Isokinetic muscle strength test will be performed in concentric/concentric mode at speeds of 60°/sec, 90°/sec, 240°/sec in concentric strength test. Isokinetic test will be performed at 0° extension and 90° flexion joint range of motion. Before the isokinetic test, the participant will have 2 repetitions at 60°/sec for adaptation, and then 5 repetitions for the test. After the participant rests for 120 seconds, the participant will first have 4 repetitions for adaptation and then 15 repetitions for the test at 240°/sec. During the tests, the participant will be verbally motivated by the same person. As a result of the tests, total work values will be recorded. **Measure:** Isokinetic Evaluation-Peak Torque / Total Work **Time Frame:** at baseline and at week 6 #### Secondary Outcomes **Description:** Individuals' joint position sense of the knee joint will be evaluated at 30°, 45° and 75° knee flexion angles using the Biodex System 4 device. While the individual's eyes are closed, the knee joint will be brought to the targeted angle by the researcher, and the subject will be asked to stay in this position for 5 seconds and perceive this angular position. Afterwards, the individuals' knee angle will be flexed to 90° and they will be asked to bring the knee joint to the targeted angle. The test will be repeated three times and the average of the deviation degrees from the targeted angle in the three tests will be recorded regardless of the direction of movement. The less deviation from the target angle, the better the sense of proprioception. **Measure:** Proprioception Assessment **Time Frame:** at baseline and at week 6 **Description:** It is asked to jump to maximum height from the double-leg squat position. Between jumps, 15 to 30 seconds of listening time is given for recovery. Athletes are asked to perform 3 repetitions and the average of the values is recorded. The jump height is recorded in centimeters. The EZEJUMP (vertical jump testing system) System will be used for this test.The higher the jump height, the better the performance. **Measure:** Vertical Jump Test **Time Frame:** at baseline and at week 6 **Description:** It is asked to open his legs shoulder-width apart, and without taking a step, he jumps forward, gaining momentum with his arms. The distance between the starting line and the heel closest to this line is recorded as the score. The jump distance is recorded in centimeters Three attempts are made and the best score is noted. The higher the jump distance, the better the performance. **Measure:** Standing long jump **Time Frame:** at baseline and at week 6 **Description:** While the individual tries to balance on a 15 cm long, 4 cm wide wooden plate prepared in the dimensions specified in the literature, the number of times he falls in 1 minute will be recorded. He stands on the bench with his dominant foot lengthwise, bends his free foot backwards and holds it with his hand on the same side. The other arm is released to maintain balance. During this period, the stopwatch will be stopped during each fall and the individual will be waited to get into position again. As the number of falls decreases during one minute, static balance performance increases. **Measure:** Flamingo Balance Test **Time Frame:** at baseline and at week 6 **Description:** The maximum distance that a person can travel while balancing on one leg in three directions is recorded in centimeters. At the furthest point they lie down, the person is asked to lightly touch the ground and balance standing again. The test is completed by moving clockwise or counterclockwise. While stretching, your hands are asked to be on the iliac crests. A trial tour is conducted before the test. The average of the subject's three attempts in each direction is taken, the result is divided by the leg length and multiplied by 100. Increasing the distance a person can reach with the other leg while remaining in balance indicates that dynamic balance performance increases. **Measure:** Modified Star Balance Test **Time Frame:** at baseline and at week 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being a woman between the ages of 18-25 * Being a 1st or 2nd year physiotherapy and rehabilitation student or a student in any department other than sports sciences * Being sedentary or underweight according to fit score * Being at normal values according to body mass index * Full knee flexion-extension joint range of motion * Volunteering to participate in the study Exclusion Criteria: * Knee pain, history of injury in the last 6 months, * Doing regular physical activity in the last 6 months, * Neurological, cardiorespiratory, musculoskeletal, endocrine, renal, metabolic and other related disease(s) that will prevent the performance of exercises * History of lower extremity orthopedic surgery * Chronic use of medications or anti-inflammatory drugs **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ayşenur Çetinkaya, MSc **Phone:** +905077218827 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Devrim Tarakcı, Asst. Prof. **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Name:** Ayşenur Çetinkaya, MSc - **Role:** CONTACT ***Contact 2:*** - **Name:** Ayşenur Çetinkaya, MSc - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Devrim Tarakcı, Asst. Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Halic University **State:** Eyüpsultan **Status:** RECRUITING **Zip:** 34060 #### Overall Officials **Official 1:** **Affiliation:** Halic University **Name:** Ayşenur Çetinkaya, MSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422221 **Brief Title:** An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures **Official Title:** An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures #### Organization Study ID Info **ID:** Doxycycline Regimen #### Organization **Class:** OTHER **Full Name:** University of Santiago de Compostela ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hospital Clinico Universitario de Santiago #### Lead Sponsor **Class:** OTHER **Name:** University of Santiago de Compostela #### Responsible Party **Investigator Affiliation:** University of Santiago de Compostela **Investigator Full Name:** Pedro DIz DIos **Investigator Title:** Full Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Although controversy exists regarding the efficacy of antibiotic prophylaxis for patients at risk of infective endocarditis, expert committees continue to publish recommendations for antibiotic prophylactic regimens. The last American Heart Association (AHA) and European Society of Cardiology (ESC) guidelines include several important changes, highlighting that clindamycin (CLI) is no longer recommended as an alternative to amoxicillin in those allergic to penicillin. This new project aims to evaluate the effectiveness of oral doxycycline in preventing post-dental extraction bloodstream infection. **Detailed Description:** PURPOSE: Despite the controversy about the risk of developing bacterial endocarditis of oral origin, numerous Expert Committees in different countries continue to publish prophylactic regimens. To date, the literature is unclear about the role of antimicrobial prophylaxis in the prevention of bacteremia following dental procedures. The aim of this study is to evaluate the efficacy of prophylactic dosage with oral doxycycline (DXC) in the prevention of bacteremia following dental extractions. SELECTION OF THE STUDY GROUP AND STUDY DESIGN: The study group will comprise patients who, for behavioral reasons (autism, learning disabilities, phobias, etc.), will undergo dental extractions under general anesthesia in the Santiago de Compostela University Hospital (Santiago de Compostela, Spain). 150 patients will be selected and will be randomly distributed into 3 study groups: control group (receiving no prophylaxis), CLI group (receiving 600 mg oral CLI) and DXC group (receiving 100 mg oral DXC). COLLECTION OF SAMPLES FOR BLOOD CULTURE: To determine the prevalence of bacteremia, a peripheral venous blood sample (10 ml) will be drawn from each patient. Samples will be inoculated in BACTEC plus (Becton Dickinson and Company, Sparks, MD) aerobic and anaerobic blood culture bottles, and will be processed in the Bactec 9240 (Becton Dickinson). MICROBIOLOGICAL ANALYSIS OF BLOOD CULTURES: A Gram stain will be performed on each positive blood culture. The positive blood cultures in the aerobic media will be subcultured on blood agar and chocolate agar in an atmosphere of 5 to 10% carbon monoxide and on MacConkey agar under aerobic conditions. The same protocol will be used for the positive blood cultures in the anaerobic media, with subculture on Schaedler agar and incubation in an anaerobic atmosphere. The bacteria isolated will be identified by using the battery of biochemical tests provided with the Vitek system for Gram-positive bacteria, Neisseria spp., Haemophilus spp., and obligate anaerobic bacteria. The viridans group streptococci will be classified into five groups, the Streptococcus mitis, S. anginosus, S. salivarius, S. mutans, and S. bovis groups, by applying the Ruoff criteria. Facklam's criteria will be used to identify unusual Streptococcus spp. and other Gram-positive cocci in chains. The subculture and further identification of the isolated bacteria will be performed by conventional microbiological techniques. The collection, handling, and transport of the blood samples for blood culture will be performed according to the recommendations of the Spanish Society of Infectious Diseases and Clinical Microbiology. ### Conditions Module **Conditions:** - Bacteremia - Endocarditis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Single **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Receiving no prophylaxis **Label:** No Intervention **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Receiving 600 mg oral Clindamycin 1 hour before general anesthesia and before any dental manipulation **Intervention Names:** - Drug: Clindamycin **Label:** Clindamycin **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Receiving 100 mg oral Doxycycline 1 hour before general anesthesia and before any dental manipulation **Intervention Names:** - Drug: Doxycycline **Label:** Doxycycline **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Clindamycin **Description:** Receiving 600 mg oral Clindamycin 1 hour before general anesthesia and before any dental manipulation **Name:** Clindamycin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Doxycycline **Description:** Receiving 100 mg oral Doxycycline 1 hour before general anesthesia and before any dental manipulation **Name:** Doxycycline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Positive cultures **Measure:** Bacteremia in participants receiving a prophylactic dosage with oral doxycyclin **Time Frame:** Changes from baseline in prevalence of bacteremia at 30 seconds and 15 minutes after the final dental extraction #### Secondary Outcomes **Description:** Positive cultures **Measure:** Bacteremia in participants receiving a prophylactic dosage with oral clindamycin **Time Frame:** Changes from baseline in prevalence of bacteremia at 30 seconds and 15 minutes after the final dental extraction **Description:** Positive cultures **Measure:** Bacteremia in participants receiving no prophylaxis **Time Frame:** Changes from baseline in prevalence of bacteremia at 30 seconds and 15 minutes after the final dental extraction ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects must have at least 10 teeth. * Subjects must have the need for a dental extraction under general anesthesia (for behavioral reasons). * Subjects will be recruited regardless of the extent and severity of their dental and/or periodontal disease. Exclusion Criteria: * Age under 18 years * Body weight under 40 kg * Receipt of antibiotics in the previous 3 months * Routine use of oral antiseptics * A history of allergy or intolerance to doxycycline * A history of allergy or intolerance to cindamycin * Any type of congenital or acquired immunodeficiency * Any known risk factor for bacterial endocarditis * Any known risk factor for prolonged bleeding **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** JAVIER Feijoo **Phone:** +34636962202 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Pedro Diz Dios **Phone:** +34617864293 **Role:** CONTACT #### Locations **Location 1:** **City:** Santiago De Compostela **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Javier Fernandez Feijoo - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Pedro Diz Dios - **Role:** CONTACT **Country:** Spain **Facility:** Santiago de Compostela University Hospital **State:** A Coruña **Zip:** 15782 #### Overall Officials **Official 1:** **Affiliation:** Santiago de Compostela University **Name:** Pedro Diz Dios **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** On request **Description:** IPD will be available on request **Info Types:** - CSR **IPD Sharing:** YES **Time Frame:** By the end of the study (for 1 year) ### References Module #### References **Citation:** Diz Dios P. Infective endocarditis prophylaxis. Oral Dis. 2014 May;20(4):325-8. doi: 10.1111/odi.12221. Epub 2014 Jan 13. **PMID:** 24373017 **Citation:** Valdes C, Tomas I, Alvarez M, Limeres J, Medina J, Diz P. The incidence of bacteraemia associated with tracheal intubation. Anaesthesia. 2008 Jun;63(6):588-92. doi: 10.1111/j.1365-2044.2008.05449.x. **PMID:** 18477269 **Citation:** Pineiro A, Tomas I, Blanco J, Alvarez M, Seoane J, Diz P. Bacteraemia following dental implants' placement. Clin Oral Implants Res. 2010 Sep;21(9):913-8. doi: 10.1111/j.1600-0501.2010.01928.x. **PMID:** 20701619 **Citation:** Diz Dios P, Tomas Carmona I, Limeres Posse J, Medina Henriquez J, Fernandez Feijoo J, Alvarez Fernandez M. Comparative efficacies of amoxicillin, clindamycin, and moxifloxacin in prevention of bacteremia following dental extractions. Antimicrob Agents Chemother. 2006 Sep;50(9):2996-3002. doi: 10.1128/AAC.01550-05. **PMID:** 16940094 **Citation:** Limeres Posse J, Alvarez Fernandez M, Fernandez Feijoo J, Medina Henriquez J, Lockhart PB, Chu VH, Diz Dios P. Intravenous amoxicillin/clavulanate for the prevention of bacteraemia following dental procedures: a randomized clinical trial. J Antimicrob Chemother. 2016 Jul;71(7):2022-30. doi: 10.1093/jac/dkw081. Epub 2016 Mar 29. **PMID:** 27029851 **Citation:** Relvas M, Diz P, Seoane J, Tomas I. Oral Health Scales: design of an oral health scale of infectious potential. Med Oral Patol Oral Cir Bucal. 2013 Jul 1;18(4):e664-70. doi: 10.4317/medoral.18427. **PMID:** 23524418 **Citation:** Martins CC, Lockhart PB, Firmino RT, Kilmartin C, Cahill TJ, Dayer M, Occhi-Alexandre IGP, Lai H, Ge L, Thornhill MH. Bacteremia following different oral procedures: Systematic review and meta-analysis. Oral Dis. 2024 Apr;30(3):846-854. doi: 10.1111/odi.14531. Epub 2023 Mar 29. **PMID:** 36750413 **Citation:** Thornhill MH, Gibson TB, Yoon F, Dayer MJ, Prendergast BD, Lockhart PB, O'Gara PT, Baddour LM. Endocarditis, invasive dental procedures, and antibiotic prophylaxis efficacy in US Medicaid patients. Oral Dis. 2024 Apr;30(3):1591-1605. doi: 10.1111/odi.14585. Epub 2023 Apr 27. **PMID:** 37103475 **Citation:** Diniz Freitas M, Alvarez Fernandez M, Vasallo Vidal FJ, Limeres Posse J, Diz Dios P, Fernandez Feijoo J. Oral amoxicillin/clavulanate for the prevention of bacteremia following dental extractions. Oral Dis. 2023 Jul;29(5):2272-2276. doi: 10.1111/odi.14221. Epub 2022 May 13. **PMID:** 35467064 **Citation:** Dayer MJ, Jones S, Prendergast B, Baddour LM, Lockhart PB, Thornhill MH. Incidence of infective endocarditis in England, 2000-13: a secular trend, interrupted time-series analysis. Lancet. 2015 Mar 28;385(9974):1219-28. doi: 10.1016/S0140-6736(14)62007-9. Epub 2014 Nov 18. **PMID:** 25467569 **Citation:** Lean SSH, Jou E, Ho JSY, Jou EGL. Prophylactic antibiotic use for infective endocarditis: a systematic review and meta-analysis. BMJ Open. 2023 Aug 22;13(8):e077026. doi: 10.1136/bmjopen-2023-077026. **PMID:** 37607797 **Citation:** Dayer MJ, Thornhill M, Baddour LM. Antibiotic prophylaxis for patients at risk of infective endocarditis: an increasing evidence base? Br J Cardiol. 2023 Feb 21;30(1):6. doi: 10.5837/bjc.2023.006. eCollection 2023. **PMID:** 37705833 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000018805 - Term: Sepsis - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7858 - Name: Endocarditis - Relevance: HIGH - As Found: Endocarditis - ID: M18877 - Name: Bacteremia - Relevance: HIGH - As Found: Bacteremia - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016470 - Term: Bacteremia - ID: D000004696 - Term: Endocarditis ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000962 - Term: Antimalarials - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000011500 - Term: Protein Synthesis Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M7493 - Name: Doxycycline - Relevance: HIGH - As Found: Open-Label Study - ID: M6214 - Name: Clindamycin - Relevance: HIGH - As Found: Currently - ID: M220697 - Name: Clindamycin palmitate - Relevance: HIGH - As Found: Currently - ID: M231711 - Name: Clindamycin phosphate - Relevance: HIGH - As Found: Currently - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4280 - Name: Antimalarials - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004318 - Term: Doxycycline - ID: D000002981 - Term: Clindamycin - ID: C000000489 - Term: Clindamycin palmitate - ID: C000007084 - Term: Clindamycin phosphate ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422208 **Brief Title:** Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinson's Disease **Official Title:** A Phase 1 Clinical Trial of Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinson's Disease #### Organization Study ID Info **ID:** 2023P003609 #### Organization **Class:** OTHER **Full Name:** Mclean Hospital #### Secondary ID Infos **ID:** U01NS109463 **Link:** https://reporter.nih.gov/quickSearch/U01NS109463 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Neurological Disorders and Stroke (NINDS) #### Lead Sponsor **Class:** OTHER **Name:** Penelope J. Hallett, Ph.D. #### Responsible Party **Investigator Affiliation:** Mclean Hospital **Investigator Full Name:** Penelope J. Hallett, Ph.D. **Investigator Title:** Associate Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This research study is evaluating an investigational cell product called autologous induced pluripotent stem cell (iPSC)-derived dopamine neurons. This research study is a single-center Phase 1 clinical trial, which will test the safety of injecting the investigational cell product into the brain of subjects with Parkinson's disease. **Detailed Description:** The goal of this research study is to test a new treatment for Parkinson's disease. Parkinson's disease is a progressive disease that causes people to lose specific brain cells called midbrain dopamine neurons. When these dopamine neurons are lost, it leads to a lack of dopamine in the brain. When there is not enough dopamine, people with Parkinson's disease experience problems with their movement. This trial will test whether new dopamine neurons made from blood cells from subjects with Parkinson's disease are safe when surgically injected into the area of the brain affected (called the putamen) of the same subjects (called autologous transplantation). The trial will assess the safety of the injected cells and will also measure the effects of the transplanted autologous dopamine neurons on Parkinson's disease symptoms. ### Conditions Module **Conditions:** - Parkinson Disease ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 6 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: Autologous midbrain dopamine neurons **Label:** Autologous midbrain dopamine neurons **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Autologous midbrain dopamine neurons **Description:** The autologous midbrain dopamine neurons are a experimental cryopreserved cell product derived from human autologous induced pluripotent stem cells. The autologous midbrain dopamine neurons will be surgically administered into the putamen, unilaterally, in a single surgical session. **Name:** Autologous midbrain dopamine neurons **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** To assess the safety of autologous transplantation of cryopreserved midbrain dopamine neurons into the putamen of subjects with Parkinson's disease by measuring (1) the incidence of serious adverse events at 12 months and 18 months post-transplantation and (2) the incidence and severity of all intervention emergent adverse events. **Measure:** Safety: number and severity of adverse events and serious adverse events **Time Frame:** Baseline to 12 months post-transplant and baseline to 18 months post-transplant #### Secondary Outcomes **Description:** Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (UPDRS) motor (Part III) compared to the baseline. UPDRS Part III assesses motor function and is measured in both "Off" and "On" states. UPDRS Part III score range: 0-132. A lower score is associated with milder Parkinson's disease motor symptoms. **Measure:** Change in UPDRS Part III **Time Frame:** 18 months following transplantation **Description:** Change in ON time without troublesome dyskinesia is measured using a Parkinson's disease patient diary card. **Measure:** Change in ON time without troublesome dyskinesia **Time Frame:** 18 months following transplantation **Description:** Change in OFF time is measured using a Parkinson's disease patient diary card. **Measure:** Change in OFF time **Time Frame:** 18 months following transplantation **Description:** Change in Levodopa Equivalent Daily Dose (LEDD) which measures Parkinson's medications. **Measure:** Change in baseline Levodopa Equivalent Daily Dose **Time Frame:** 18 months following transplantation **Description:** The Unified Dyskinesia Rating Scale evaluates dyskinesia in patients with Parkinson's disease (range 0-104). A lower score indicates less dyskinesia. **Measure:** Change in Unified Dyskinesia Rating Scale **Time Frame:** 18 months following transplantation **Description:** Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (UPDRS) Part II, which assesses the motor aspects of experiences of daily living in the week prior to the visit. Score range: 0-52. A lower score is associated with less disability. **Measure:** Change in UPDRS Part II **Time Frame:** 18 months following transplantation **Description:** Change in Montreal Cognitive Assessment (MoCA), which measures various aspects of cognitive function. Score range 0-30. A higher score is associated with better cognitive function. **Measure:** Change in MoCA **Time Frame:** 18 months following transplantation **Description:** DaTscan (SPECT neuroimaging for dopamine transporter, DAT) imaging is performed to assess changes in dopamine neuron function in the putamen (the transplanted area of the brain). **Measure:** Change in DaTscan **Time Frame:** Baseline to 18 months following transplantation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males and females between ages 55 to eighty. * Diagnosis of Parkinson's disease with motor symptoms by neurologist according to Movement Disorder Society (MDS) 2015 Clinical Diagnostic Criteria for Parkinson's disease. * Diagnosis of Parkinson's disease for at least 5 years. * Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale. * No gross abnormalities on MRI, including hydrocephalus or extensive white matter disease. * No significant cognitive impairment (Montreal Cognitive Assessment). * No significant untreated depression (Beck Depression Inventory 2). * Up to date cancer screening per primary MD. * Able to understand trial requirements and intervention procedures and provide written informed consent. Exclusion Criteria: * History of intracranial surgeries. * Any previous thalamotomy, pallidotomy or deep brain stimulation. * Atypical Parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, hereditary parkinsonism) * History of psychiatric disorders including schizophrenia or psychosis likely to compromise with ability to comply with trial protocol requirements. * Prior history of intracerebral, subdural, or epidural hemorrhage. * History of malignancy within 5 years. * Inability to have an MRI. * Life expectancy \< 6 months due to concomitant illnesses. * Ingestion of investigational drug or recipient of investigational procedure within 6 months prior to trial. * Subjects with active cardiovascular and cerebrovascular disease within 6 months prior to signing the informed consent form: 1. History of severe heart failure (congestive heart failure of New York Heart Association Class II or above or left ventricular ejection fraction \< 35% by any examination method), unstable angina pectoris and myocardial infarction 2. Severe arrhythmia 3. History of cardiovascular surgery (cardiac, vascular stent surgery, angioplasty); 4. History of stroke or transient ischemic attack 5. History of subarachnoid hemorrhage 6. Subjects with major vascular diseases (aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis) * Hypertensive subjects with poorly controlled blood pressure (defined as blood pressure above 160/100 mmHg despite treatment with antihypertensive drugs) and subjects with severe postural hypotension. * Abnormal pre-operative coagulation labs. * Any necessary chronic anticoagulation medication in use (not including antiplatelet therapy and chronic NSAID). * Diabetic subjects with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 11.1 mmol/L). * Active infectious disease. Subjects known to have tested positive for HIV, Human T-lymphotropic Virus, Hepatitis B Virus, Hepatitis C Virus, Cytomegalovirus (IgM \> IgG) and/or syphilis will be evaluated by an expert as to subject eligibility based on the subject's infectious status. * Any illness which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromise subject safety, or interfere with the interpretation of the trial results. * Active clinical infection being treated by antibiotics within one week of enrollment. * Known drug or alcohol dependence or any other clinical factors or conditions (for example, history of seizures) which will interfere with the trial conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * Unwilling and/or not able to give written informed consent. **Maximum Age:** 80 Years **Minimum Age:** 55 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Penelope Hallett, Ph.D. **Phone:** 617-732-6564 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Brigham & Women's Hospital **State:** Massachusetts **Zip:** 02215 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Osborn TM, Hallett PJ, Schumacher JM, Isacson O. Advantages and Recent Developments of Autologous Cell Therapy for Parkinson's Disease Patients. Front Cell Neurosci. 2020 Apr 3;14:58. doi: 10.3389/fncel.2020.00058. eCollection 2020. **PMID:** 32317934 **Citation:** Hallett PJ, Deleidi M, Astradsson A, Smith GA, Cooper O, Osborn TM, Sundberg M, Moore MA, Perez-Torres E, Brownell AL, Schumacher JM, Spealman RD, Isacson O. Successful function of autologous iPSC-derived dopamine neurons following transplantation in a non-human primate model of Parkinson's disease. Cell Stem Cell. 2015 Mar 5;16(3):269-74. doi: 10.1016/j.stem.2015.01.018. Epub 2015 Feb 26. **PMID:** 25732245 **Citation:** Hallett PJ, Cooper O, Sadi D, Robertson H, Mendez I, Isacson O. Long-term health of dopaminergic neuron transplants in Parkinson's disease patients. Cell Rep. 2014 Jun 26;7(6):1755-61. doi: 10.1016/j.celrep.2014.05.027. Epub 2014 Jun 6. **PMID:** 24910427 **Citation:** Cooper O, Hallett P, Isacson O. Using stem cells and iPS cells to discover new treatments for Parkinson's disease. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1(0 1):S14-6. doi: 10.1016/S1353-8020(11)70007-4. **PMID:** 22166414 **Citation:** Hargus G, Cooper O, Deleidi M, Levy A, Lee K, Marlow E, Yow A, Soldner F, Hockemeyer D, Hallett PJ, Osborn T, Jaenisch R, Isacson O. Differentiated Parkinson patient-derived induced pluripotent stem cells grow in the adult rodent brain and reduce motor asymmetry in Parkinsonian rats. Proc Natl Acad Sci U S A. 2010 Sep 7;107(36):15921-6. doi: 10.1073/pnas.1010209107. Epub 2010 Aug 23. **PMID:** 20798034 **Citation:** Cooper O, Astradsson A, Hallett P, Robertson H, Mendez I, Isacson O. Lack of functional relevance of isolated cell damage in transplants of Parkinson's disease patients. J Neurol. 2009 Aug;256 Suppl 3:310-6. doi: 10.1007/s00415-009-5242-z. **PMID:** 19711122 **Citation:** Mendez I, Vinuela A, Astradsson A, Mukhida K, Hallett P, Robertson H, Tierney T, Holness R, Dagher A, Trojanowski JQ, Isacson O. Dopamine neurons implanted into people with Parkinson's disease survive without pathology for 14 years. Nat Med. 2008 May;14(5):507-9. doi: 10.1038/nm1752. Epub 2008 Apr 6. **PMID:** 18391961 **Citation:** Fink JS, Schumacher JM, Ellias SL, Palmer EP, Saint-Hilaire M, Shannon K, Penn R, Starr P, VanHorne C, Kott HS, Dempsey PK, Fischman AJ, Raineri R, Manhart C, Dinsmore J, Isacson O. Porcine xenografts in Parkinson's disease and Huntington's disease patients: preliminary results. Cell Transplant. 2000 Mar-Apr;9(2):273-8. doi: 10.1177/096368970000900212. **PMID:** 10811399 **Citation:** Schumacher JM, Ellias SA, Palmer EP, Kott HS, Dinsmore J, Dempsey PK, Fischman AJ, Thomas C, Feldman RG, Kassissieh S, Raineri R, Manhart C, Penney D, Fink JS, Isacson O. Transplantation of embryonic porcine mesencephalic tissue in patients with PD. Neurology. 2000 Mar 14;54(5):1042-50. doi: 10.1212/wnl.54.5.1042. **PMID:** 10720272 **Citation:** Mendez I, Sanchez-Pernaute R, Cooper O, Vinuela A, Ferrari D, Bjorklund L, Dagher A, Isacson O. Cell type analysis of functional fetal dopamine cell suspension transplants in the striatum and substantia nigra of patients with Parkinson's disease. Brain. 2005 Jul;128(Pt 7):1498-510. doi: 10.1093/brain/awh510. Epub 2005 May 4. **PMID:** 15872020 **Citation:** Wernig M, Zhao JP, Pruszak J, Hedlund E, Fu D, Soldner F, Broccoli V, Constantine-Paton M, Isacson O, Jaenisch R. Neurons derived from reprogrammed fibroblasts functionally integrate into the fetal brain and improve symptoms of rats with Parkinson's disease. Proc Natl Acad Sci U S A. 2008 Apr 15;105(15):5856-61. doi: 10.1073/pnas.0801677105. Epub 2008 Apr 7. **PMID:** 18391196 **Citation:** Cooper O, Hargus G, Deleidi M, Blak A, Osborn T, Marlow E, Lee K, Levy A, Perez-Torres E, Yow A, Isacson O. Differentiation of human ES and Parkinson's disease iPS cells into ventral midbrain dopaminergic neurons requires a high activity form of SHH, FGF8a and specific regionalization by retinoic acid. Mol Cell Neurosci. 2010 Nov;45(3):258-66. doi: 10.1016/j.mcn.2010.06.017. Epub 2010 Jul 24. **PMID:** 20603216 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Intervention Browse Module - Ancestors - ID: D000002316 - Term: Cardiotonic Agents - ID: D000013566 - Term: Sympathomimetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000015259 - Term: Dopamine Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents ### Intervention Browse Module - Browse Branches - Abbrev: CaAg - Name: Cardiotonic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7473 - Name: Dopamine - Relevance: HIGH - As Found: Insight - ID: M5572 - Name: Cardiotonic Agents - Relevance: LOW - As Found: Unknown - ID: M16345 - Name: Sympathomimetics - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004298 - Term: Dopamine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422195 **Brief Title:** Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach **Official Title:** Does the Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach (DNTP - SA) Provides a Faster Ultrasound-guided Arterial Cannulation Than Long Axis (LA) Approach: A Prospective Randomized Controlled Study #### Organization Study ID Info **ID:** 36197/12/22 #### Organization **Class:** OTHER **Full Name:** Tanta University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tanta University #### Responsible Party **Investigator Affiliation:** Tanta University **Investigator Full Name:** Maram Ibrahim Elmazny **Investigator Title:** Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of the present study is to compare between Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach (DNTP - SA) and Long Axis (LA) Approach for Ultrasound-guided Arterial Cannulation as regard time to successful arterial cannula insertion as well as the success rate in the first trial of insertion, number of attempts till successful arterial line placemen, complications, and operators' satisfaction. **Detailed Description:** Intraoperative Arterial cannulation is recently frequently required especially in high-risk patients or patients with expected major fluid shift. The most common site for arterial cannulation is the radial artery because of ease of accessibility, dual blood supply to the hand via the ulnar artery, and a low rate of complications. Complications from arterial cannulation include thrombosis, hematoma formation, edema and vasospasm. Two approaches are basically identified for ultrasound-guided radial artery cannulation, i.e., short-axis out-of-plane (SA-OOP) and long-axis in-plane (LA-IP) techniques. The dynamic needle tip positioning (DNTP) technique uses the short-axis view of the radial artery with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery ### Conditions Module **Conditions:** - Dynamic Needle Tip Positioning - Short Axis - Arterial Cannulation - Long Axis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 164 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ultrasound guided radial artery cannulation by Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. The ultrasound transducer is oriented transversely to the radial artery at the wrist, and the vessel appears as a circular anechoic structure in the ultrasound screen with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery. **Intervention Names:** - Other: Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) **Label:** Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Ultrasound guided radial artery cannulation in Long Axis Approach (LA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. In the LA-IP approach, an ultrasound probe is placed parallel to the radial artery and the artery appears as a tubular anechoic structure in ultrasound. **Intervention Names:** - Other: Long Axis Approach (LA) **Label:** Long Axis Approach (LA) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) **Description:** Ultrasound guided radial artery cannulation by Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. The ultrasound transducer is oriented transversely to the radial artery at the wrist, and the vessel appears as a circular anechoic structure in the ultrasound screen with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery. **Name:** Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Long Axis Approach (LA) **Description:** Ultrasound guided radial artery cannulation in Long Axis Approach (LA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. In the LA-IP approach, an ultrasound probe is placed parallel to the radial artery and the artery appears as a tubular anechoic structure in ultrasound. **Name:** Long Axis Approach (LA) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Time to achieve successful cannulation will be measured from initial skin puncture until the catheter is placed into the radial artery. **Measure:** Time to achieve successful cannulation **Time Frame:** Immediately after catheterization #### Secondary Outcomes **Description:** The success rate in the first trial of insertion between the two different approaches will be assessed. **Measure:** The success rate **Time Frame:** Immediately after catheterization **Description:** Number of attempts till successful arterial cannula insertion will be recorded. **Measure:** Number of attempts till successful arterial cannula insertion **Time Frame:** Immediately after catheterization **Description:** Complications including edema, hematoma, vasospasm, ischemia, thrombosis and nerve injury will be recorded. **Measure:** Incidence of complications **Time Frame:** 24 hours postoperatively **Description:** Operators' satisfaction (Level of operators' satisfaction will be assessed with a Scale from 1-5) **Measure:** Operators' satisfaction **Time Frame:** Immediately after catheterization ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 18 and 70 years. * Both sexes. * American Society of Anesthesiologists physical status II-IV. * Patients scheduled for elective surgery procedure that requires the use of invasive arterial pressure monitoring, as determined by the attending anesthesiologist. Exclusion Criteria: * Emergency patients or with Hemodynamic instability. * Patients who have cellulitis or infection at the site of insertion. * Patients with a positive modified Allen test. * Raynaud disease or any Peripheral vascular disease. * Patients with Multiple previous radial artery interventional therapies in the previous 30 days. * Patients scheduled for Surgery at site of insertion like forearm flap. * Refusal to participate by the patient. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Maram I Elmazny, MD **Phone:** 00201014137093 **Role:** CONTACT #### Locations **Location 1:** **City:** Tanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Maram I Elmazny, MD - **Phone:** 00201014137093 - **Role:** CONTACT ***Contact 2:*** - **Name:** Sarah A Afifi, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Tanta University **State:** El-Gharbia **Status:** RECRUITING **Zip:** 31527 ### IPD Sharing Statement Module **Access Criteria:** The data will be available upon a reasonable request from the corresponding author. **Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** After the end of study for one year. ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422182 **Brief Title:** Erector Spinae Plane Block in Radical Cystectomy **Official Title:** Ultrasound-Guided Erector Spinae Plane Block in Radical Cystectomy: A Randomized Controlled Study #### Organization Study ID Info **ID:** 2112-301-058 #### Organization **Class:** OTHER **Full Name:** Kafrelsheikh University ### Status Module #### Completion Date **Date:** 2024-01-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-15 **Type:** ACTUAL #### Start Date **Date:** 2021-07-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kafrelsheikh University #### Responsible Party **Investigator Affiliation:** Kafrelsheikh University **Investigator Full Name:** Tarek Ezzat Abd El Galil **Investigator Title:** Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy. **Detailed Description:** Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life. Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses. One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries. ### Conditions Module **Conditions:** - Erector Spinae Plane Block - Radical Cystectomy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery. **Intervention Names:** - Drug: Bupivacain 25% (Erector Spinae Plane Block) **Label:** Erector Spinae Plane Block group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine **Intervention Names:** - Drug: Morphine (Intravenous patient-controlled analgesia) **Label:** Intravenous patient-controlled analgesia group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Erector Spinae Plane Block group **Description:** Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery. **Name:** Bupivacain 25% (Erector Spinae Plane Block) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Intravenous patient-controlled analgesia group **Description:** Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine **Name:** Morphine (Intravenous patient-controlled analgesia) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4. **Measure:** Total morphine consumption **Time Frame:** 48 hours postoperatively #### Secondary Outcomes **Description:** Time from end of surgery to first dose of morphine administrated. **Measure:** The time of first rescue analgesia **Time Frame:** 48 hours postoperatively **Description:** Pain assessment will be done at rest and during coughing or movement by numeric rating scale (NRS) from 0 to 10 where 0 means no pain and 10 being worst pain) at PACU, 2, 4, 8, 12, 16 24, 36 and 48 postoperative. **Measure:** Degree of pain **Time Frame:** 48 hours postoperatively **Description:** Side effects such as hypotension, bradycardia, respiratory depression (respiratory rate \<10/minute), urinary retention and postoperative nausea and vomiting (PONV) will be recorded and managed. **Measure:** Incidence of side effects **Time Frame:** 48 hours postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age of the patient between 21 to 65 years. * Both sexes. * Body mass index (BMI): 20 - 40 kg/m2. * American Society of Anesthesiologists (ASA) physical status II-III. * Elective radical cystectomy. Exclusion Criteria: * Patient refusal. * Psychiatric and cognitive disorders. * Local infection at the site of injection. * Allergy to study medications. * Anatomic abnormalities. * Inability to comprehend or participate in pain scoring system. **Maximum Age:** 65 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kafr Ash Shaykh **Country:** Egypt **Facility:** Kafrelsheikh University **State:** Kafrelsheikh **Zip:** 33516 ### IPD Sharing Statement Module **Access Criteria:** The data will be available upon a reasonable request from the corresponding author. **Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** After the end of study for one year. ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000000700 - Term: Analgesics ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: HIGH - As Found: Following - ID: M11982 - Name: Morphine - Relevance: HIGH - As Found: Site - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009020 - Term: Morphine - ID: D000002045 - Term: Bupivacaine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422169 **Brief Title:** Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain **Official Title:** Interventistic Monocentric Pre-market Clinical Investigation on the Use of Medical Device "ArToFILL" in Subjects With Mild-moderate Osteoarticular Pain #### Organization Study ID Info **ID:** ARTO/09/2023 #### Organization **Class:** INDUSTRY **Full Name:** PromoPharma spa ### Status Module #### Completion Date **Date:** 2025-05-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** PromoPharma spa #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain **Detailed Description:** Monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of ArToFILL for the treatment of mild-moderate osteoarticular pain. ### Conditions Module **Conditions:** - Osteoarthritis, Knee ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 35 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** One vial for intra-articular infiltration every 7 days, for three consecutive weeks. After the injection it is necessary to keep the infiltrated joint at rest for at least 24 hours. In addition, as with all invasive joint treatments, the patient is advised to avoid any physical activity 2-3 days after the injection. Do not repeat the treatment before 7 days from the previous one. **Intervention Names:** - Device: ArToFILL **Label:** Artofill **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Artofill **Description:** ArToFILL is an injectable medical device (class III) intended for use as a temporary filler in joints. It is a sterile, non-pyrogenic, colorless and transparent hyaluronic acid gel of non-animal origin. ArToFILL is a hydrogel consisting of a mixture of two different molecular weights of hyaluronic acid, for a total HA concentration of 2.7 %. **Name:** ArToFILL **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Investigator Global Assessment of Safety (IGAS): using the 4- point scale:1= very good safety, 2 =good safety, 3 = moderate safety and 4 = poor safety. Counting the number of files used for the patient confirmed by the number of traceability labels detached and kept by the Investigator **Measure:** Evaluation of the safety and tolerability of treatment of medical device. **Time Frame:** 180 days **Description:** Evaluation of reported adverse effects/incidents, monitoring of concomitant treatments, and the possible intake of rescue medication, assessment of patient compliance with the medical device in the study, **Measure:** Evaluation of the safety and tolerability of treatment of medical device. **Time Frame:** Up to 180 days #### Primary Outcomes **Description:** Assessment of pain reduction using the visual analogue scale (VAS) ranging from 0 to 100 mm (where 0 = absent and 100 = strongest pain) **Measure:** Reduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline **Time Frame:** Up to 180 days #### Secondary Outcomes **Description:** Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The total score is the result of the sum of 3 groups of questions with 5 possible answers (between 0 and 4, where 0=none and 4=extreme) for the self-assessment of: * pain:five questions (score from 0 to 20); * joint stiffness: two questions (score from 0 to 8); * functional limitations: 17 questions (score from 0 to 68). **Measure:** Clinical improvement assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) **Time Frame:** Up to 180 days **Description:** The variation of the ROM joint excursion used for the analysis of the joint excursion (flexion-extension), will be calculated as the difference between maximum width and minimum width of the angular profile on the basis of the following formula: ROMα = max (α) - min (α) (flexion-extension) **Measure:** Improved range of motion (ROM) of the knee joint **Time Frame:** Up to 180 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient (males and females) aged between 18 and 84 years (limits included); * Patient able to understand the nature and purpose of the study, including possible risks and side effects; * Patient able to provide written Informed Consent, in accordance with good clinical practice and current legislation; * Pain ≥ 40 mm on the VAS score in the target knee for at least 2 months; * Patient with knee osteoarthritis assessed radiographically, grade 1 to 3 according to the Kellgren-Lawrence scale (K-L); * Body Mass Index (BMI) ≤ 35; * Patient who will benefit from this treatment; * Patient available for the entire study period; * Patient able to cooperate and meet the requirements of the clinical investigation plan. Exclusion Criteria: * Patient with knee osteoarthritis, assessed radiographically, grade 4 by the K-L scale; * Patient presenting ongoing inflammation/infection at the level of the joint being investigated; * Patient with abundant intra-articular effusion; * Patient with symptoms of viral or bacterial infections or similar; * Patient with insertion point of the joint infected or in the presence of a skin disease; * Simultaneous treatment with disinfectants containing quaternary ammonium salts or chlorhexidine; * Patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device; * Concomitant treatments with thrombolytic or anticoagulant therapies, for less than 2 weeks prior to the screening visit; * Intra-articular treatments carried out in the last 3 months (9 months if with products containing hyaluronic acid) of the target joint; * Topical treatments of the target joint in progress or performed within 1 week of the screening visit; * Taking NSAIDs and/or paracetamol as rescue treatment for more than two consecutive days; * Surgical interventions of prosthetic replacement in the target joint; * Physiotherapy and instrumental physical therapy treatments for the target joint performed in the last 2 weeks prior to the screening visit, and during the study period; * Participation in another clinical trial within 60 days prior to the screening visit; * Evidence of severe or uncontrolled systemic disease or any other significant disorder (e.g. haemophilia, bleeding disorders etc.); which do not allow participation in the study or could compromise the results. * Patients who are pregnant or breastfeeding; * Subject unable to follow clinical investigation procedures and follow-up visits; * Any other medical condition which could influence participation in the clinical investigation or compromise its results. **Maximum Age:** 84 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Michele Vecchio **Phone:** +39 0953782702 **Role:** CONTACT #### Locations **Location 1:** **City:** Catania **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Michele Vecchio - **Phone:** +39 0953782702 - **Role:** CONTACT ***Contact 2:*** - **Name:** Michele Vecchio - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** U.O. Recupero e riabilitazione funzionale P.O. "G.Rodolico", Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco", P.O. "G. Rodolico" **Name:** Michele Vecchio **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010003 - Term: Osteoarthritis - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: LOW - As Found: Unknown - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Osteoarthritis, Knee - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020370 - Term: Osteoarthritis, Knee ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422156 **Acronym:** Nim-PC-28 **Brief Title:** SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer **Official Title:** A Prospective, Multicenter, Single Arm Study of SBRT Combined With Nimotuzumab and Mono-chemotherapy in the Treatment of Locally Advanced Pancreatic Cancer #### Organization Study ID Info **ID:** M2023639 #### Organization **Class:** OTHER **Full Name:** Peking University Third Hospital ### Status Module #### Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-03-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Biotech Pharmaceutical Co., Ltd. #### Lead Sponsor **Class:** OTHER **Name:** Peking University Third Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a prospective, multicenter, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of SBRT combined with Nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC). **Detailed Description:** This clinical study is designed as a prospective, multicenter, single arm study to evaluate the clinical efficacy and safety of SBRT combined with nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC). All eligible patients will receive SBRT with doses ranging from 35-40 Gy in five fractions, intravenous nimotuzumab 400mg weekly or 600mg on day 1 and 8 of a 21-day cycle, and mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease progression, death, unacceptable toxicity, or consent withdrawal. The main endpoint is progression-free survival (PFS). ### Conditions Module **Conditions:** - Advanced Pancreatic Cancer **Keywords:** - advanced pancreatic cancer - stereotactic body radiation therapy (SBRT) - Nimotuzumab ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 73 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All eligible patients will receive SBRT combined with nimotuzumab and mono-chemotherapy. **Intervention Names:** - Radiation: Stereotactic body radiation - Drug: Nimotuzumab - Drug: mono-chemotherapy **Label:** SBRT+Nimotuzumab+ mono-chemotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SBRT+Nimotuzumab+ mono-chemotherapy **Description:** Patients will receive SBRT with doses ranging from 35-40 Gy in five fractions. **Name:** Stereotactic body radiation **Other Names:** - SBRT **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - SBRT+Nimotuzumab+ mono-chemotherapy **Description:** Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg on day 1 and 8 of a 21-day cycle until disease progression. **Name:** Nimotuzumab **Other Names:** - h-R3 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - SBRT+Nimotuzumab+ mono-chemotherapy **Description:** Patients will receive mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease progression. **Name:** mono-chemotherapy **Other Names:** - chemotherapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. **Measure:** progression-free survival (PFS) **Time Frame:** Up to 12 months #### Secondary Outcomes **Description:** The time from the beginning of treatment to death due to any cause. **Measure:** overall survival (OS) **Time Frame:** Up to 12 months **Description:** Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions. **Measure:** Objective response rate (ORR) **Time Frame:** Up to 12 months **Description:** Disease control rate (DCR), including complete response (CR) and partial response (PR) and stable disease(SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of the longest diameter of target lesions. SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (PD, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions). **Measure:** Disease control rate (DCR) **Time Frame:** Up to 12 months **Description:** The proportion of patients with pain relief after treatment to the total number enrolled. **Measure:** Pain relief rate **Time Frame:** Up to 12 months **Description:** Frequency and severity of adverse events. **Measure:** adverse events **Time Frame:** Up to 30 days after last administration ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Age 18-75 years old, gender unlimited; * 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC); * 3. Locally advanced pancreatic cancer (according to the NCCN criteria), unresectable or surgically declined; * 4. The maximum diameter of the primary tumor was \< 5.0cm; * 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * 6. No prior radiotherapy (upper abdomen) or tumor systemic therapy; * 7. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN; * 8. Left ventricular ejection fraction ≥50%; * 9. Fertile subjects are willing to take contraceptive measures during the study period; * 10. Woman who are breastfeeding during the study period or within 150 days after the last treatment; * 11. Survival was expected to be ≥3 months; * 12.Good compliance and signed informed consent voluntarily. Exclusion Criteria: * 1. Tumor invasion of gastrointestinal tract; * 2. Woman who are pregnant or breastfeeding; * 3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years; * 4. History of uncontrolled epilepsy, central nervous system disease, or mental disorder, which may influence the signing of informed consent or affect the patient's adherence; * 5.Serious heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more, severe congestive heart failure or severe arrhythmia requiring medical intervention, or a history of myocardial infarction within the past 12 months; * 6. Patients requiring immunosuppressive; * 7.Accompanied by active infections, or a major hematological, renal, metabolic, gastrointestinal, endocrine, or metabolic disorder determined by the investigator, or other serious uncontrolled concomitant disease; * 8. Known allergy to prescription or any component of the prescription used in this study; * 9. Immunodeficiency, including HIV infection or other acquired immunodeficiency, or a history of organ transplantation, or other immune-related disorders requiring medical intervention; * 10. Patients with acute and chronic tuberculosis infection; * 11. Received Chinese herbal medicines or immune-modulators for anti-tumor within 2 weeks prior to initial administration; * 12.History of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration; * 13. Received any other form of immunosuppressive therapy within 7 days prior to the initial of study administration; * 14. Participated in other clinical trials within 4 weeks, or received another investigational drugs or investigational device within 4 weeks prior to the initial administration; * 15.Other reasons that are not suitable to participate in this study according to the researcher's judgment. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bin Qiu, MD **Phone:** +86 010-82265968 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Peking University Third Hospital **Name:** Junjie Wang, Dr **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Pancreatic Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T4387 - Name: Pancreatic Cancer - Relevance: HIGH - As Found: Pancreatic Cancer ### Condition Browse Module - Meshes - ID: D000010190 - Term: Pancreatic Neoplasms ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2985 - Name: Gemcitabine - Relevance: LOW - As Found: Unknown - ID: M377 - Name: Capecitabine - Relevance: LOW - As Found: Unknown - ID: M288889 - Name: Nimotuzumab - Relevance: HIGH - As Found: Details - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000501466 - Term: Nimotuzumab ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422143 **Brief Title:** Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] **Official Title:** Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer #### Organization Study ID Info **ID:** 2870-023 #### Organization **Class:** INDUSTRY **Full Name:** Merck Sharp & Dohme LLC #### Secondary ID Infos **Domain:** EU CT **ID:** 2023-510128-66 **Type:** OTHER **Domain:** UTN **ID:** U1111-1301-2790 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2031-02-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-01-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-02 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS). **Detailed Description:** All participants undergo an initial induction phase of four cycles, each cycle consisting of a 3-week cycle of pembrolizumab q3w + carboplatin q3w + paclitaxel q3w or nabpaclitaxel weekly. Participants are then randomly assigned to pembrolizumab maintenance vs. pembrolizumab + sac-TMT maintenance. ### Conditions Module **Conditions:** - Non-small Cell Lung Cancer - NSCLC ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants are allocated to a single induction arm, then assigned randomly to one of 2 maintenance arms. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 851 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) after receipt of an antihistamine, H2 receptor antagonist, acetaminophen (or equivalent), and dexamethasone (or equivalent) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks. **Intervention Names:** - Biological: Pembrolizumab - Biological: sac-TMT **Label:** Maintenance Arm 1: Pembrolizumab + sac-TMT **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** During the induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks. **Intervention Names:** - Biological: Pembrolizumab **Label:** Maintenance Arm 2: Pembrolizumab Monotherapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Maintenance Arm 1: Pembrolizumab + sac-TMT - Maintenance Arm 2: Pembrolizumab Monotherapy **Description:** Intravenous (IV) infusion **Name:** Pembrolizumab **Other Names:** - KEYTRUDA® - MK-3475 - SCH 900475 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Maintenance Arm 1: Pembrolizumab + sac-TMT **Description:** IV infusion **Name:** sac-TMT **Other Names:** - MK-2870 - Sacituzumab tirumotecan **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** OS is the time from randomization to death due to any cause. **Measure:** Overall survival (OS) **Time Frame:** Up to ~79 months #### Secondary Outcomes **Description:** PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). **Measure:** Progression-Free Survival (PFS) **Time Frame:** Up to ~79 months **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. **Measure:** Number of participants with ≥1 adverse event (AE) **Time Frame:** Up to ~79 months **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. **Measure:** Number of participants discontinuing from study therapy due to AE(s) **Time Frame:** Up to ~79 months **Description:** European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a 30-item scale to assess the overall quality of life in cancer patients. The global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status. **Measure:** Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30) **Time Frame:** Baseline and up to ~79 months **Description:** EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms. **Measure:** Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8) **Time Frame:** Baseline and up to ~79 months **Description:** EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough. **Measure:** Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31) **Time Frame:** Baseline and up to ~79 months **Description:** EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The chest pain score is based on participant responses to item 40 e (1 = "Not at All" to 4 = "Very Much"). **Measure:** Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40) **Time Frame:** Baseline and up to ~79 months **Description:** EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. TTD in global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status. **Measure:** Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30) **Time Frame:** Up to ~79 months **Description:** EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. TTD in dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms. **Measure:** TTD in Dyspnea Score (EORTC QLQ-C30 Item 8) **Time Frame:** Up to ~79 months **Description:** EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough. **Measure:** TTD in Cough (EORTC QLQ-LC13 Item 31) **Time Frame:** Up to ~79 months **Description:** EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in chest pain score is based on participant responses to item 40 ("Have you had pain in your chest?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse chest pain. **Measure:** TTD in Chest Pain (EORTC QLQ-LC13 Item 40) **Time Frame:** Up to ~79 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\] * Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology * Has life expectancy ≥3 months * Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation * Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible) * Has adequate organ function * For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 * For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit * For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered * For Maintenance only (prior to randomization): has adequate organ function Exclusion Criteria: * Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Grade ≥2 peripheral neuropathy * History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing * Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention * HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Received prior systemic anticancer therapy for their metastatic NSCLC * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic Tlymphocyte-associated protein 4, OX-40, CD137) \[Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\] * Received prior treatment with a TROP2-targeted antidrug conjugate (ADC) * Received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation * Received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Participants who have not adequately recovered from major surgery or have ongoing surgical complications * Received prior treatment with a topoisomerase I inhibitor-containing ADC * Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks) * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has known CNS metastases/carcinomatous meningitis (participants with previously treated brain metastases may participate provided they are clinically stable for t least 2 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Subjects with known untreated, asymptomatic brain metastases \[ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion \>1.5 cm\] may participate but will require regular imaging of the brain as a site of disease) * Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy * Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \[eg, thyroxine, insulin, or physiologic corticosteroid\] is allowed) * History of (noninfectious)pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Active infection requiring systemic therapy * History of allogeneic tissue/solid organ transplant **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf **IPD Sharing:** YES **URL:** http://engagezone.msd.com/ds_documentation.php ### References Module #### See Also Links **Label:** Merck Clinical Trials Information **URL:** https://www.merckclinicaltrials.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: Antipy - Name: Antipyretics - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M7102 - Name: Dexamethasone - Relevance: LOW - As Found: Unknown - ID: M2340 - Name: Acetaminophen - Relevance: LOW - As Found: Unknown - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Blind - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M9709 - Name: Histamine Antagonists - Relevance: LOW - As Found: Unknown - ID: M9710 - Name: Histamine H1 Antagonists - Relevance: LOW - As Found: Unknown - ID: M147959 - Name: Taxane - Relevance: LOW - As Found: Unknown - ID: M9711 - Name: Histamine H2 Antagonists - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000582435 - Term: Pembrolizumab ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422130 **Acronym:** MATCHLESS **Brief Title:** Ningbo Maternity-Child Linked Database Study **Official Title:** Ningbo Maternity-Child Linked Database Study(MATCHLESS): Using Electronic Health Records to Improve Maternal and Child Health Care and Outcomes in China #### Organization Study ID Info **ID:** NBU-2023-240 #### Organization **Class:** OTHER **Full Name:** Ningbo University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2021-12-31 **Type:** ACTUAL #### Start Date **Date:** 2016-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Ningbo Health Information Center #### Lead Sponsor **Class:** OTHER **Name:** Ningbo University #### Responsible Party **Investigator Affiliation:** Ningbo University **Investigator Full Name:** Liya Liu **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** With the implementation of China's two-child policy and a marked increase in adverse pregnancy outcomes, leveraging electronic health records (EHR) to enhance maternal and child healthcare and outcomes in China has emerged as a novel strategy to tackle this pivotal demographic and health challenge. Given the mature construction of the information platform and the well-established maternal and child health service system in Ningbo, this study utilized the Ningbo Maternal and Child Health Electronic Monitoring Information Management System and the Ningbo Regional Health Information Platform to conduct the Ningbo maternity-child linked database study (MATCHLESS), which involved over 300,000 mother-child pairs in China. MATCHLESS not only allows for longitudinal follow-up of pregnant women and their offspring but also expands its scope from prenatal exposure to long-term outcomes through data linkage. The longitudinal scope of MATCHLESS facilitates the elucidation of the relationship and etiological significance of early-life exposures and adverse pregnancy outcomes. It also permits the exploration of the health trajectory of women and children over their life-course. During the past 5 years (October 2016 to December 2021), a substantial amount of maternal and child health data has been recorded in MATCHLESS, including socio-demographics, health care services and medications, as well as clinical outcome events. Additionally, it contains longitudinal measurements on risk factors for adverse pregnancy outcomes, which provides a robust foundation for future real-world studies of dynamic predictive models. This study was approved by the Ethics Review Committee of the Ningbo University Health Science Center. Considering the safety, privacy, and confidentiality concerns surrounding the storage and processing of personal EHR data, the responsibility for data storage and management is undertaken by the Health Commission of Ningbo. Researchers are required to submit applications to the local health department, and all studies undergo ethical review and research registration procedures to access EHR data for health research purposes. ### Conditions Module **Conditions:** - Pregnant Women - Children **Keywords:** - Population-based healthcare database - Longitudinal study - Ambispective Cohort - Pregnant women and offspring ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 325596 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 10 Years ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Pregnant women and their offspring without intervention **Label:** Pregnant women and their offspring ### Interventions #### Intervention 1 **Arm Group Labels:** - Pregnant women and their offspring **Description:** Pregnant women and their offspring with those exposures of interest determined in specific research based on the database **Name:** Pregnant women and their offspring without intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Regular contractions accompanied by cervical change at less than 37 weeks' gestation. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O60. **Measure:** Incidence of preterm birth **Time Frame:** Up to 42 weeks **Description:** New onset hypertension (\>140 mm Hg systolic or \>90 mm Hg diastolic) after 20 weeks of pregnancy and the coexistence of one or both of the following new-onset conditions: proteinuria (urine protein:creatinine ratio ≥30 mg/mmol, or albumin: creatinine ratio ≥8 mg/mmol, or ≥1 g/L \[2+\] on dipstick testing), other maternal organ dysfunction, including features such as renal or liver involvement, neurological or haematological complications, or uteroplacental dysfunction (such as fetal growth restriction, abnormal umbilical artery Doppler waveform analysis, or stillbirth). Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O14. **Measure:** Incidence of pre-eclampsia **Time Frame:** Up to 42 weeks **Description:** The occurrence of new-onset, generalized, tonic-clonic seizures or coma in a patient with preeclampsia or gestational hypertension. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O15. **Measure:** Incidence of eclampsia **Time Frame:** Up to 42 weeks **Description:** Impaired Glucose Tolerance (IGT) with onset or first recognition during pregnancy. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O24.4. **Measure:** Incidence of gestational diabetes mellitus **Time Frame:** Up to 42 weeks **Description:** Weight at birth of \< 2500 g. Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : P07.0, P07.1. **Measure:** Incidence of low birth weight **Time Frame:** Up to 42 weeks **Description:** Less than the tenth birth weight centile using INTERGROWTH-21st. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : P05. **Measure:** Incidence of small for gestational age **Time Frame:** Up to 42 weeks **Description:** The following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : F84. **Measure:** Incidence of autism **Time Frame:** Up to 10 years **Description:** Birth defects such as congenital malformations of the nervous system, congenital malformations of eye, ear, face and neck, congenital malformations of the circulatory system, congenital malformations of the respiratory system, or other birth defects. Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : Q00-Q99. **Measure:** Incidence of birth defects **Time Frame:** Up to 10 years **Description:** Blood loss exceeding 500 mL following vaginal birth and 1000 mL following cesarean. Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O72. **Measure:** Incidence of postpartum hemorrhage **Time Frame:** Within 24 hours after delivery **Description:** Death of a fetus that has reached a birth weight of 500 g, or if birth weight is unavailable, gestational age of 22 weeks or crown-to-heel length of 25 cm. Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : Z37.1, Z37.3, Z37.4, Z37.7. **Measure:** Incidence of stillbirth **Time Frame:** Up to 42 weeks **Description:** Uterine rupture is confirmed by laparotomy. Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O71.0, O71.1, O34.5, O62.4. **Measure:** Incidence of ruptured uterus **Time Frame:** Up to 42 weeks **Description:** Death of women while pregnant or within 42 days of termination of pregnancy irrespective of the site and size of pregnancy but related to or aggravated by the pregnancy or its management but not from accidental or incidental causes. **Measure:** Incidence of maternal death **Time Frame:** Up to 52 weeks **Description:** Deaths among live births during the first 28 completed days of life. **Measure:** Incidence of neonatal death **Time Frame:** Within 28 days after delivery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant women and their offspring who registered at the Ningbo maternal and child health electronic monitoring information management system. Exclusion Criteria: * None. **Gender Based:** True **Gender Description:** All pregnant women and their offspring registered at the Ningbo maternal and child health electronic monitoring information management system were enrolled. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Pregnant women and their offspring who registered at the Ningbo maternal and child health electronic monitoring information management system. ### Contacts Locations Module #### Locations **Location 1:** **City:** Ningbo **Country:** China **Facility:** Ningbo University **State:** Zhejiang **Zip:** 315000 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422117 **Brief Title:** Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate and Severe Central Neuropathic Pain in China **Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate to Severe Central Neuropathic Pain in China #### Organization Study ID Info **ID:** HSK16149-305 #### Organization **Class:** INDUSTRY **Full Name:** Haisco Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2027-08-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-16 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Haisco Pharmaceutical Group Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo. ### Conditions Module **Conditions:** - Central Neuropathic Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 408 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Oral administration of 20mg twice daily for 12 weeks can be adjusted to 40mg twice daily based on the efficacy and tolerability of the subject **Intervention Names:** - Drug: HSK16149 20mg-40mg BID **Label:** HSK16149 20mg-40mg bid **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Placebo,Oral,2 capsules, twice daily for 12 weeks **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - HSK16149 20mg-40mg bid **Description:** Oral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy; **Name:** HSK16149 20mg-40mg BID **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo, oral, 2 capsules twice daily **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Changes in mean pain intensity (ADPS) at week 12 between HSK16149 and placebo were compared from baseline;The pain NRS score divides a straight line into 10 segments, with 0 to 10 indicating pain (a total of 11 points), 0 indicating no pain, and 10 indicating the most intense pain. The pain NRS scores of the past 7 days were collected and the average value was used as the ADPS score. **Measure:** The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline **Time Frame:** week12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Voluntarily sign an informed consent form; 2. Able to read and complete survey questionnaires; 3. Male or female patients aged ≥ 18 years old; 4. The subject has a medical history and symptoms related to central neuropathic pain, including spinal cord related neuropathic pain (subject enrollment ≥ 50%), post-stroke central neuropathic pain, Parkinson's disease pain, and multiple sclerosis pain, and must meet the following criteria: a) pain duration ≥ 3 months; b) Characteristics that conform to neuropathic pain: DN4 scale score ≥ 4 points; 5. During screening visits, patients were assessed to have an average pain visual analogue scale (VAS) score of ≥ 40 mm over the past 24 hours. Exclusion Criteria: 1. The presence of other painful diseases that may affect the evaluation of neuropathic pain; 2. Patients with spinal cord injury or stroke whose condition is unstable and is expected to require surgical treatment; 3. There is a chronic systemic disease that the investigator has assessed may affect the participant's participation in the study； 4. Meet any of the following laboratory test results: a) Hematology: WBC\<3×109/L, N\< 1.5 ×109/L, PLT\< 75 ×109/L, or HB\< 90 g/L; b) Liver function: ALT or AST\> 2.5 × ULN; Or TBIL\> 1.5 × ULN; c) eGFR\< 60 mL/min/1.73 m2; d) Creatine kinase \> 2.0 × ULN; 5. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period; 6. Mechanical operators engaged in high-altitude work, motor vehicle driving and other dangerous activities during the study period; 7. Participated in any other clinical study within 30 days prior to screening; 8. The investigator determined that there were other conditions that were not suitable for study participation. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuropathic Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009437 - Term: Neuralgia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422104 **Brief Title:** Neuromodulation Therapy for Task-Specific Dystonia **Official Title:** Development of Mechanistically Informed Therapy for Task-Specific Dystonia Using Noninvasive Neuromodulation #### Organization Study ID Info **ID:** Pro00094131 #### Organization **Class:** OTHER **Full Name:** Duke University ### Status Module #### Completion Date **Date:** 2023-01-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-01-13 **Type:** ACTUAL #### Start Date **Date:** 2018-08-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Doris Duke Charitable Foundation **Class:** OTHER **Name:** Dystonia Coalition **Class:** OTHER **Name:** Dystonia Study Group **Class:** NIH **Name:** National Center for Advancing Translational Sciences (NCATS) #### Lead Sponsor **Class:** OTHER **Name:** Duke University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after active rTMS compared to sham rTMS. A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS. The study will evaluate rTMS response using measures if writing on a sensor tablet, examiner and patient dystonia rating scales and brain imaging scan (functional MRI) to understand brain changes after rTMS. Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures. **Detailed Description:** The primary objective of this study is to develop rTMS for FHD. The focus is to assess whether stimulating the PMC or PSC will show greater improvement in writing behavior. This research builds upon prior studies that have demonstrated improvement in behavior after rTMS to PMC and PSC. The study includes five sequential visits: * Visit 1 behavior writing measures and dystonia rating scales. * Visit 2 includes task-based functional MRI brain scans to develop cortical target for rTMS sessions. * Visits 3, 4, and 5: FHD participants receive 10 Hz rTMS to PMC, PSC and sham rTMS to PMC in a cross over design with at minimum one week of washout between sessions. Participants complete behavior writing measures and rating scales on same day before and after each TMS session and an fMRI after each TMS session. Up to 5 Healthy Volunteers were recruited to help develop the TMS visits. The information in this record reflects Visits 2-5 ### Conditions Module **Conditions:** - Isolated Focal Hand Dystonia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Double-blind cross-over design with participants receiving TMS at two cortical locations. ##### Masking Info **Masking:** DOUBLE **Masking Description:** The TMS intensity and cortical location delivered at each TMS visit will be masked **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 12 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 10 Hz rTMS to premotor cortex **Intervention Names:** - Device: Repetitive transcranial magnetic stimulation **Label:** 10 Hz rTMS to premotor cortex **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 10 Hz rTMS to primary somatosensory cortex **Intervention Names:** - Device: Repetitive transcranial magnetic stimulation **Label:** 10 Hz rTMS to primary somatosensory cortex **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** 0.7 Hz rTMS to premotor cortex **Intervention Names:** - Device: Repetitive transcranial magnetic stimulation **Label:** 0.7 Hz rTMS to premotor cortex **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 0.7 Hz rTMS to premotor cortex - 10 Hz rTMS to premotor cortex - 10 Hz rTMS to primary somatosensory cortex **Description:** 10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session **Name:** Repetitive transcranial magnetic stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Feasibility of accurately delivering TMS during the task of writing as measured by number of participants who completed the TMS sessions **Time Frame:** Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3) #### Secondary Outcomes **Measure:** Safety, as measured by TMS acute side effects **Time Frame:** Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3) **Description:** Using change in peak accelerations to assess writing behavior and further develop this writing behavior assessment tool throughout the study. **Measure:** Feasibility, as measured by change in behavioral writing measure **Time Frame:** Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3) **Description:** using functional magnetic resonance imaging of the brain **Measure:** Change in brain connectivity in the motor network **Time Frame:** Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy Control Participants: 1. 18yrs and older 2. Left or Right hand dominance 3. Age-matched to Focal Hand dystonia patients 4. Must be able to sign informed consent 5. Must be literate * Focal Hand dystonia Patients: 1. 18yrs and older 2. Left or Right hand dominance 3. Diagnosed with Writer's Cramp dystonia in left or right hand 4. Must be able to sign informed consent 5. Must be literate Exclusion Criteria: Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5): 1. Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor 2. Botulinum toxin injections within 3 months of research study 3. Medications with effects on the central nervous system including anticholinergic, benzodiazepines, and muscle relaxants among others within 1 week of the study 4. No physical or occupational therapy of the upper extremities 5. Any contraindications to MRI (ie: metal in body or implanted medical devices, etc) 6. Any contraindication on TMS adult safety screening (TASS form) including seizure history, pregnancy, brain injury, cranial metal implants, known structural brain lesion **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Durham **Country:** United States **Facility:** Duke University Health System **State:** North Carolina **Zip:** 27705 #### Overall Officials **Official 1:** **Affiliation:** Duke Health **Name:** Noreen Bukhari-Parlakturk, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Mulcahey PJ, Peterchev AV, Calakos N, Bukhari-Parlakturk N. Transcranial magnetic stimulation: the road to clinical therapy for dystonia. Dystonia. 2023 August; 2. **Citation:** Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Organization of Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation. **Citation:** Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Dystonia Symposium. Dublin, Ireland. June 1-3, 2023. poster presentation. **Citation:** Bukhari-Parlakturk N, Lutz MW, Al-Khalidi HR, Unnithan S, Wang JE, Scott B, Termsarasab P, Appelbaum LG, Calakos N. Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp. Mov Disord. 2023 Jan;38(1):123-132. doi: 10.1002/mds.29237. Epub 2022 Oct 13. **PMID:** 36226903 **Citation:** Dannhauer M, Huang Z, Beynel L, Wood E, Bukhari-Parlakturk N, Peterchev AV. TAP: targeting and analysis pipeline for optimization and verification of coil placement in transcranial magnetic stimulation. J Neural Eng. 2022 Apr 21;19(2):10.1088/1741-2552/ac63a4. doi: 10.1088/1741-2552/ac63a4. **PMID:** 35377345 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7595 - Name: Dystonia - Relevance: HIGH - As Found: Dystonia - ID: M22575 - Name: Dystonic Disorders - Relevance: HIGH - As Found: Dystonia - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T2358 - Name: Focal Task-specific Dystonia - Relevance: HIGH - As Found: Task-Specific Dystonia ### Condition Browse Module - Meshes - ID: D000004421 - Term: Dystonia - ID: D000020821 - Term: Dystonic Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422091 **Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA] **Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info **ID:** ET2-ASF #### Organization **Full Name:** [Redacted] ### Status Module **Delayed Posting:** True #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** WITHHELD #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Name:** [Redacted] #### Responsible Party **Old Name Title:** [Redacted] **Old Organization:** [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422078 **Acronym:** AIR POWER **Brief Title:** A Non-interventional, Prospective Study With Benralizumab **Official Title:** A Non-interventional, Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life #### Organization Study ID Info **ID:** D3250R00124 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a prospective, non-interventional, single-arm, multicenter study to investigate asthma control, and health-related quality of life (HRQL), lung function and asthma medication intake in severe eosinophilic asthma patients treated with benralizumab in a real-life setting in Germany. **Detailed Description:** This is a prospective observational study to investigate the asthma control and health realted quality of life (HRQL) of benralizumab treated patients in routine clinical practice, their asthma medication intake, and their changes in asthma medication during the study, up to 52 weeks. The asthma control will be analyzed by using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at different timepoints during the study period either collected by the investigator or self-reported by the patient. In addition, health realted quality of life will be assessed at baseline and routine follow-up visits using the mini Asthma Quality of Life Questionnaire (miniAQLQ) which is collected by the investigator. To investigate the medication intake and assess the changes in asthma medication, the patients will record their weekly medication intake in a paper-based or an electronic medication diary throughout the study. ### Conditions Module **Conditions:** - Asthma, Bronchial **Keywords:** - benralizumab - severe eosinophilic asthma - quality of life - asthma control ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** To assess asthma control in patients initiating treatment with benralizumab over time. The ACT includes 5 questions. The score can range from 5 (worst control) to 25 (best control). Scores between 20 and 25 indicate well-controlled asthma, and scores lower than 20 indicate patients with not-well controlled asthma. **Measure:** Change in Asthma Control Test (ACT) total score in patients from baseline to week 12, 24 and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To assess asthma control in patients initiating treatment with benralizumab. Responders are defined as patients with well-controlled asthma (ACT score ≥20). **Measure:** Proportion of responders at baseline, week 12, 24 and 52 after first benralizumab dose, using ACT **Time Frame:** At baseline, week 12, 24 and 52 **Description:** To assess prescribed daily ICS dose of benralizumab treated patients over time. Doses of medication will be converted to equivalents to be able to make comparisons. **Measure:** Change in daily doses of prescribed inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To assess patient-reported daily ICS dose of benralizumab treated patients over time. Doses of medication will be converted to equivalents to be able to make comparisons. **Measure:** Change in daily doses of patient-reported inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To assess prescribed daily ICS dose of benralizumab treated patients with ICS dose reduction. **Measure:** Reduction (in percentage) in prescribed daily ICS dose intake from baseline to week 52 after first benralizumab dose **Time Frame:** From baseline to week 52 **Description:** To assess patient-reported daily ICS dose of benralizumab treated patients with ICS dose reduction. **Measure:** Reduction (in percentage) in patient-reported daily ICS dose intake from baseline to week 52 after first benralizumab dose **Time Frame:** From baseline to week 52 #### Secondary Outcomes **Description:** To describe the proportion of patients who meet any individual criteria for remission. Criteria for remission are defined as no exacerbation, no prescribed use of oral corticosteroids (OCS) for asthma, ACT score ≥20, and stable lung function). **Measure:** Proportion of patients meeting any individual criteria for remission at baseline, week 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 24 and 52 **Description:** To describe the proportion of patients who meet all criteria for remission after initiation of benralizumab treatment. **Measure:** Proportion of patients fulfilling all the criteria for remission at baseline, week 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 24 and 52 **Description:** To assess diaries reported asthma control in patients initiating treatment with benralizumab using the AIRQ® score. The AIRQ® includes 10 questions (7 assessing symptom impairment and 3 assessing risk) concerning patient medication use, asthma symptoms, medical visits, and tests. The AIRQ® can predict the risk for exacerbations and assess the quality of life of asthma patients. AIRQ® score: well-controlled (0-1 points), not well-controlled (2-4 points) and very poorly controlled (≥5 points) asthma **Measure:** Total Asthma Impairment and Risk Questionnaire® (AIRQ®) score reduction from baseline to every 4 weeks after first benralizumab dose **Time Frame:** From baseline to week 52 **Description:** To assess diaries reported asthma control in patients initiating treatment with benralizumab using the ACT score. **Measure:** Total ACT score reduction from baseline to every 4 weeks after first benralizumab dose **Time Frame:** From baseline to week 52 **Description:** To describe patient-reported health-related quality of life (HRQL) in patients initiating treatment with benralizumab using the miniAQLQ. The miniAQLQ is composed of 15 questions covering 4 different domains, namely symptoms, activities, emotions, and environment experienced during the previous 2 weeks. The score in each item can vary from 1 to 7, with a higher score indicating better quality of life (QoL). The mean score is calculated as the total score divided by the number of items, and the domain scores are calculated as the total score divided by the number of items for respective domain. A change in score of ≥0.5 can be considered clinically important **Measure:** Change in total Mini Asthma Quality of Life Questionnaire (miniAQLQ) score from baseline to week 12, 24, and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To describe the proportion of patients regarding prescribed standard-of-care (SOC) asthma medication dose change in patients initiating treatment with benralizumab. **Measure:** Change in daily doses of prescribed relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To describe the proportion of patients regarding prescribed increased SOC asthma medication dose in patients initiating treatment with benralizumab. **Measure:** Proportion of patients with increased daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To describe the proportion of patients regarding prescribed decreased SOC asthma medication dose in patients initiating treatment with benralizumab. **Measure:** Proportion of patients with decreased daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To describe the proportion of patients regarding prescribed equal SOC asthma medication dose in patients initiating treatment with benralizumab. **Measure:** Proportion of patients with equal daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To assess the annualized asthma exacerbation rate in patients initiating treatment with benralizumab. **Measure:** Annualized exacerbation rate assessed at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To describe the proportion of patients without asthma exacerbations in patients initiating treatment with benralizumab. **Measure:** Proportion of patients without exacerbations at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** From baseline to week 12, 24 and 52 **Description:** To describe the FEV1 and FVC levels in patients initiating treatment with benralizumab. From FEV1 and FVC the Tiffenau-Index will be calculated as follows: FEV1/FVC **Measure:** Level of lung function parameters - forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 12, 24 and 52 **Description:** To describe the level of RV in patients initiating treatment with benralizumab. **Measure:** Level of lung function parameters - residual volume (RV) at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 12, 24 and 52 **Description:** To describe the level of TLC in patients initiating treatment with benralizumab. **Measure:** Level of lung function parameters - total lung capacity (TLC) at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 12, 24 and 52 **Description:** To describe the level of sRtot in patients initiating treatment with benralizumab. **Measure:** Level of lung function parameters - total specific airway resistance (sRtot) at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 12, 24 and 52 **Description:** To describe the level of DLCO in patients initiating treatment with benralizumab. **Measure:** Level of diffusing capacity of the lungs for carbon monoxide (DLCO) at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 12, 24 and 52 **Description:** To describe the level of eosinophils in patients initiating treatment with benralizumab. Measured in cells per microliter. **Measure:** Level of biomarkers - eosinophils at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 12, 24 and 52 **Description:** To describe the level of total IgE in patients initiating treatment with benralizumab. Total IgE, measured in international units per milliliter (IU/ml). **Measure:** Level of biomarkers - total immunglobulin E (IgE) at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 12, 24 and 52 **Description:** To describe the level of FeNO in patients initiating treatment with benralizumab. Measured in parts per billion (ppb). **Measure:** Level of biomarkers - fractional exhaled nitric oxide (FeNO) at baseline, week 12, 24 and 52 after first benralizumab dose **Time Frame:** At baseline, week 12, 24 and 52 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female patients aged 18 years or older * Confirmed diagnosis of severe eosinophilic asthma (defined according to the European Respiratory Society and American Thoracic Society and local German guidelines) treated with high-dose inhaled corticosteroids (ICS) plus long-acting beta agonists (LABA) * Prescribed treatment with benralizumab according to label and local market reimbursement criteria * Benralizumab treatment was not part of the study decision and treatment decision was met prior and independently of the study * Patients must be able and willing to read and comprehend written instructions * After full explanation, patients must have signed an informed consent form (ICF) indicating that they understand the purpose of, and the procedures required for the study and are willing to participate in the study * Patients must be willing to report asthma patient-reported outcomes (PROs) every 4 weeks and medication intake weekly Exclusion Criteria: * Patients who participate in an observational trial that might, in the investigators' opinion, influence the assessment for current study; or participated in a randomized clinical trial in the last 3 months * History of anaphylaxis to any biologic therapy * Prior treatment with any asthma biologic therapy within the last 6 months * Concurrent biologic therapy * Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent was obtained that had not been treated with, or had failed to respond to standard of care (SOC) therapy * Any other pulmonary disease than asthma that, in the investigator's point of view, would have an impact on the interpretation of results * An acute or chronic condition that, in the investigator's point of view, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results * Current or history of malignancy within 5 years before the enrolment date with the following exceptions: * In-situ carcinoma of the cervix where curative therapy has been completed and patients are in remission for at least 12 months prior to enrolment date * Basal cell or superficial squamous skin cancer * Pregnancy or lactation period (status to be proactively asked by the investigator) * Any condition, that, in the opinion of the investigator, could jeopardize the safety of the patient **Maximum Age:** 120 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population will consist of adult patients, who were diagnosed with severe eosinophilic asthma treated by pulmonary specialists, for whom the indication to start benralizumab therapy was received independently of study participation. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved, AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure **URL:** https://vivli.org/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma, Bronchial - ID: M14511 - Name: Pulmonary Eosinophilia - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Browse Branches - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M287399 - Name: Benralizumab - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422065 **Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA] **Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info **ID:** SRF-21625 #### Organization **Full Name:** [Redacted] ### Status Module **Delayed Posting:** True #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** WITHHELD #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Name:** [Redacted] #### Responsible Party **Old Name Title:** [Redacted] **Old Organization:** [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422052 **Brief Title:** Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms **Official Title:** Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms #### Organization Study ID Info **ID:** rjhy20240504 #### Organization **Class:** OTHER **Full Name:** Shanghai Jiao Tong University School of Medicine ### Status Module #### Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai Jiao Tong University School of Medicine #### Responsible Party **Investigator Affiliation:** Shanghai Jiao Tong University School of Medicine **Investigator Full Name:** Hong Lu, MD **Investigator Title:** Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objectives of this multicenter, prospective, observational study were to investigate the incidence of dyspeptic symptoms in patients with Helicobacter pylori (H. pylori) infection and to continuously follow up the remission of dyspeptic symptoms after H. pylori eradication, so as to provide reference for the clinical diagnosis and treatment strategies of patients with H. pylori infection and dyspeptic symptoms. ### Conditions Module **Conditions:** - Helicobacter Pylori Infection - Dyspepsia **Keywords:** - Helicobacter Pylori Infection - Dyspepsia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2242 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD） **Label:** Dyspepsia with Helicobacter pylori infection ### Interventions #### Intervention 1 **Arm Group Labels:** - Dyspepsia with Helicobacter pylori infection **Description:** H. pylori infection was confirmed by 13C/ 14C-breath test and/or rapid urease test under endoscopy and histopathological examination. Epidemiological questionnaire and Functional Dyspepsia Symptom Diary (FDSD) were used to investigate basic information and assess dyspeptic symptoms. Patients with dyspepsia who successfully eradicated Helicobacter pylori infection will be followed up for dyspeptic symptoms after 2 months and 6 months to evaluate the relief of dyspeptic symptoms. **Name:** Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD） **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms **Measure:** the incidence of dyspepsia in patients with Helicobacter pylori infection **Time Frame:** Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary **Description:** The Functional Dyspepsia Symptom Diary (FDSD) will be used to evaluate the dyspepsia symptoms of the patients **Measure:** Relief of Helicobacter pylori related dyspepsia **Time Frame:** Patients with dyspepsia who have successfully eradicated Helicobacter pylori infection will be followed up for dyspepsia symptoms after 2 months and after 6 months to assess the remission of dyspepsia symptoms ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female patients aged 15-80 years * H. pylori infection diagnosed by 13C/ 14C-UBT (\> 2 times the cutoff value) and/or gastroscopy (rapid urease strong positive and histological positive) * Treatment-naive patients with Helicobacter pylori * Ability and willingness to participate in the study and to sign and give informed consent Exclusion Criteria: * Under 18 or over 80 years old * Organic digestive diseases, such as active peptic ulcer, gastroesophageal reflux, gastrointestinal bleeding, acute/chronic pancreatitis, acute/chronic cholecystitis, gallstones, intestinal obstruction, inflammatory bowel disease, etc. * Combined with melena, hematemesis, anemia, emaciation and other alarm symptoms * Pregnant and lactating women * History of cancer * History of subtotal gastrectomy * Severe organ dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases, such as grade IV heart failure, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population targets male and female patients aged 15-80 who have not previously been treated for Helicobacter pylori and have been diagnosed via 13C/14C urea breath test or gastroscopy. Participants must be willing and able to give informed consent. Exclusions include individuals under 18 or over 80, those with organic digestive diseases, pregnant or nursing women, those with a history of cancer or partial gastrectomy, and individuals with severe organ dysfunction or congenital diseases. Also excluded are those with symptoms like melena, hematemesis, anemia, or cachexia. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hong Lu, MD **Phone:** +8613611958022 **Role:** CONTACT #### Locations **Location 1:** **City:** Chongqing **Contacts:** ***Contact 1:*** - **Name:** Qiang Wu - **Phone:** +8618223960853 - **Role:** CONTACT **Country:** China **Facility:** The People's Hospital of Kaizhou District, CQ **State:** Chongqing **Status:** RECRUITING **Location 2:** **City:** Xiamen **Contacts:** ***Contact 1:*** - **Name:** Jinyan Zhang - **Phone:** +8615160042319 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Xiamen University **State:** Fujian **Status:** RECRUITING **Location 3:** **City:** Wuwei **Contacts:** ***Contact 1:*** - **Name:** Xiaoyun Ma - **Phone:** +8613639359150 - **Role:** CONTACT **Country:** China **Facility:** The People's Hospital of Wuwei **State:** Gansu **Status:** RECRUITING **Location 4:** **City:** Qinzhou **Contacts:** ***Contact 1:*** - **Name:** Meimei Zeng - **Phone:** +8615107774335 - **Role:** CONTACT **Country:** China **Facility:** The First People's Hospital of Qinzhou **State:** Guangxi **Status:** RECRUITING **Location 5:** **City:** Baotou **Contacts:** ***Contact 1:*** - **Name:** Qiang Liu - **Phone:** +86 15174918099 - **Role:** CONTACT **Country:** China **Facility:** Baotou Central Hospital **State:** Inner Mongolia **Status:** RECRUITING **Location 6:** **City:** Dalian **Contacts:** ***Contact 1:*** - **Name:** Lina Liang - **Phone:** +8618098875591 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Dalian Medical University **State:** Liaoning **Status:** RECRUITING **Location 7:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hong Lu, MD - **Phone:** +8613611958022 - **Role:** CONTACT **Country:** China **Facility:** Renji Hospital, School of Medicine, Shanghai Jiao Tong University **State:** Shanghai **Status:** RECRUITING **Zip:** 200127 **Location 8:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Qi Liao - **Phone:** +8613512128067 - **Role:** CONTACT **Country:** China **Facility:** Shanghai Construction Group Hospital **State:** Shanghai **Status:** RECRUITING **Location 9:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Name:** Yan Ou - **Phone:** +8615008228212 - **Role:** CONTACT **Country:** China **Facility:** West China Fourth Hospital, Sichuan University **State:** Sichuan **Status:** RECRUITING **Location 10:** **City:** Kashgar **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jilin Wang - **Phone:** +8613761853016 - **Role:** CONTACT **Country:** China **Facility:** The Second People's Hospital of Kashgar, Xinjiang **State:** Xinjiang **Status:** RECRUITING **Location 11:** **City:** Kunming **Contacts:** ***Contact 1:*** - **Name:** Zhouhua Li - **Phone:** +8613769108442 - **Role:** CONTACT **Country:** China **Facility:** Second People's Hospital of Jinning District, Kunming City **State:** Yunnan **Status:** RECRUITING **Location 12:** **City:** Ningbo **Contacts:** ***Contact 1:*** - **Name:** Shuliang Zhao - **Phone:** +057458993397 - **Role:** CONTACT **Country:** China **Facility:** Ningbo Hangzhou Bay Hospital **State:** Zhejiang **Status:** RECRUITING **Location 13:** **City:** Ningbo **Contacts:** ***Contact 1:*** - **Name:** Shan Yu - **Phone:** +8613456521442 - **Role:** CONTACT **Country:** China **Facility:** The People's Hospital of Shengzhou **State:** Zhejiang **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M7589 - Name: Dyspepsia - Relevance: HIGH - As Found: Dyspepsia - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004415 - Term: Dyspepsia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422039 **Brief Title:** Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects **Official Title:** A Clinical Study to Evaluate the Relative Bioavailability of HRS-7535 Tablets of Different Formulating Processes and the Effects of Food on New Formulates (Single Center, Random, Open, Cross) #### Organization Study ID Info **ID:** HRS-7535-103 #### Organization **Class:** INDUSTRY **Full Name:** Shandong Suncadia Medicine Co., Ltd. ### Status Module #### Completion Date **Date:** 2024-06-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Shandong Suncadia Medicine Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study was designed as a a single-center, randomized, open, interleaved (3-cycle, 3-sequence) trial. It is planned to enroll 18 healthy subjects. ### Conditions Module **Conditions:** - Type 2 Diabetes Mellitus ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** This study was an open, fixed-sequence clinical trial in healthy adult subjects ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 18 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: HRS-7535（D）Tablets - Drug: HRS-7535（C）Tablets **Label:** Treatment group A **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: HRS-7535（D）Tablets - Drug: HRS-7535（C）Tablets **Label:** Treatment group B **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: HRS-7535（D）Tablets - Drug: HRS-7535（C）Tablets **Label:** Treatment group C **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment group A - Treatment group B - Treatment group C **Description:** One HRS-7535（D）Tablet is administered to healthy subjects. **Name:** HRS-7535（D）Tablets **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment group A - Treatment group B - Treatment group C **Description:** Two HRS-7535（C）Tablets is administered to healthy subjects. **Name:** HRS-7535（C）Tablets **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** PK parameters：Cmax **Time Frame:** 0 hour to 72 hours after the last dosing **Measure:** PK parameters：AUC0-t **Time Frame:** 0 hour to 72 hours after the last dosing **Measure:** PK parameters：AUC0-∞ **Time Frame:** 0 hour to 72 hours after the last dosing **Measure:** Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal **Time Frame:** 0 hour to 72 hours after the last dosing **Measure:** Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status **Time Frame:** 0 hour to 72 hours after the last dosing #### Secondary Outcomes **Measure:** PK parameters：Tmax **Time Frame:** 0 hour to 72 hours after the last dosing **Measure:** PK parameters： t1/2 **Time Frame:** 0 hour to 72 hours after the last dosing **Measure:** PK parameters： CL/F **Time Frame:** 0 hour to 72 hours after the last dosing **Measure:** PK parameters： V/F **Time Frame:** 0 hour to 72 hours after the last dosing **Measure:** Incidence and severity of adverse events (AEs) **Time Frame:** from screening to 72 hours after the last dosing ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Able and willing to provide a written informed consent; 2. Male or female aged 18-45 at screening (both inclusive); 3. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) : 18-30 kg/m2 (including both ends of the value); 4. Subjects (including male subjects) are willing to have no birth plan and voluntarily adopt effective contraceptive measures and no sperm donation plan from Signed informed consent to the last two weeks after the administration of no fertility plan and no sperm donation, egg donation plan, and agree to take effective contraceptive measures. Exclusion Criteria: 1. Those who had a smoking history in the 3 months before screening (average daily smoking \> 5 cigarettes), or could not stop using any tobacco products during the test; 2. Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL beer, 250 mL wine, or 50 mL liquor) in the three months prior to screening, or who could not abstain during the trial period; 3. Consumed any beverage or food containing grapefruit in the 7 days prior to screening; Or consumed any beverage or food containing methylxanthine within 2 days prior to screening, such as coffee, tea, cola, chocolate, etc. 4. Allergy, or suspected allergy to any ingredient in HRS-7535 preparation; 5. A history of drug abuse in the past five years or use of drugs in the three months prior to the test; Or a positive urine drug test; 6. A history of any clinically serious disease or disease or condition that the investigator believes may affect the test results, including but not limited to circulatory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, or metabolic disorders; 7. Abnormalities with QTcF \> 450 ms detected by 12-lead electrocardiogram at screening or baseline and judged by investigators to be clinically significant; 8. Vital signs, physical examination, laboratory examination, abdominal ultrasound or chest imaging examination at the time of screening or at baseline suggest abnormalities that the investigators have determined to be clinically significant; 9. Positive hepatitis B surface antigen (HBsAg), positive antibodies against hepatitis C virus (HCV), positive antibodies against human immunodeficiency virus (HIV), or positive antibodies against syphilis within 4 weeks prior to screening; 10. Use of any prescription, over-the-counter, herbal or dietary supplements (excluding regular vitamins) in the 2 weeks prior to screening; 11. Participants in clinical trials of any other drug or medical device within the 3 months prior to screening or within the 5 half-life of the drug (based on whether the drug was administered or used, excluding placebo); 12. Received BCG vaccine within 12 months prior to screening; Vaccination or exposure to other live or attenuated vaccines (other than COVID-19 vaccines) within 3 months prior to screening; Or who plan to be vaccinated during the trial; 13. Patients who have had any surgery in the 3 months prior to screening, have not recovered from surgery, or are likely to have surgery or hospitalization plans during the trial period; 14. Blood donation (or blood loss) and blood donation (or blood loss) ≥400 mL within 3 months before screening, or receiving blood transfusion; 15. Positive results of serum pregnancy test (serum beta-HCG test) during screening period or baseline examination in women; 16. The woman had any form of pregnancy (including spontaneous abortion, delivery, ectopic pregnancy, etc.) in the 3 months prior to the screening, or was breastfeeding at the time of the screening visit; 17. Women use the following contraceptive methods during screening visits: medicated extended-release Iuds, extended-release contraceptives (subcutaneous implants, vaginal rings, microspheres and microcapsules); Use of long-acting contraceptive injections before screening (medroxyprogesterone acetate should be prohibited 3 months before screening, other injections should be prohibited 1 month before screening), use of oral contraceptives 2 months before screening, and use of contraceptive patches 1 month before screening; Special cases are judged by the researcher; 18. Subjects have conditions that, as determined by the investigator, affect drug absorption, distribution, metabolism, and excretion, or reduce adherence, or other factors that make participation in the study inappropriate. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sheng Feng **Phone:** +86-0518-82342973 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Chang Shu **Phone:** +86-0518-82342973 **Role:** CONTACT #### Locations **Location 1:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Name:** Wei Hu, Doctor - **Role:** CONTACT **Country:** China **Facility:** The Second Hospital of Anhui Medical Uniersity **State:** Anhui **Zip:** 230601 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes Mellitus - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422026 **Brief Title:** Evaluated the Efficacy and Safety of APCP on Hair Health **Official Title:** A 24 Week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of APCP on Hair Health #### Organization Study ID Info **ID:** AP-PV-2022-02 #### Organization **Class:** INDUSTRY **Full Name:** Amorepacific Corporation ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-30 **Type:** ACTUAL #### Start Date **Date:** 2023-03-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Amorepacific Corporation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is designed to evaluate the efficacy and safety of APCP in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control. ### Conditions Module **Conditions:** - Hair Damage ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 150 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Dietary Supplement: APCP I **Label:** APCP I **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Dietary Supplement: APCP II **Label:** APCP II **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - APCP I **Description:** Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 3 g. **Name:** APCP I **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - APCP II **Description:** Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 4 g. **Name:** APCP II **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - Placebo **Description:** Each subject takes one active bottle per day for 24 weeks. **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Hair tensile strength measured by UTM(Universal Testing Machine) etc. **Measure:** Change from baseline in hair tensile strength **Time Frame:** Baseline, 24 week #### Secondary Outcomes **Description:** Hair gloss measured by Glossymeter etc. **Measure:** Change from baseline in hair gloss **Time Frame:** Baseline, 24 week **Description:** Hair density measured by Folliscope **Measure:** Change from baseline in hair density **Time Frame:** Baseline, 24 week **Description:** Hair volume measured by I Max-plus **Measure:** Change from baseline in hair volume **Time Frame:** Baseline, 24 week **Description:** Satisfaction surveys are evaluated on a 10-point scale. Survey items are evaluated on a scale from '0 - Not at all' to '10 - Very much so' (although scoring may be reversed depending on the question). **Measure:** Change from baseline in satisfaction survey **Time Frame:** Baseline, 24 week **Description:** scalp moisture measured by DermaLab Hydration Pin Probe **Measure:** Change from baseline in scalp moisture **Time Frame:** Baseline, 24 week **Description:** scalp percutaneous moisture loss measured by Tewameter TM Nano **Measure:** Change from baseline in scalp percutaneous moisture loss **Time Frame:** Baseline, 24 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors * A person capable of maintaining the same hair shape and color during this human body application test * A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form Exclusion Criteria: * A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc * As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection * A person who plans to manage and operate hair supplies, hair products during this human body application test * A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1 * A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1 * Those who have been administered systemic steroids, cell death agents, vasodilators, antihypertensive agents, antiepileptic agents, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, and Ketoconazole for the last 1 month or more (30 days) * A person who has applied topical steroids to the scalp for the last 1 month (30 days) or more as of Visit 1 * A person who has participated in other interventional clinical trials (including human application tests) within one month (30 days) of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test * A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test * A person who is sensitive to or allergic to food ingredients for this human body application test * A person who is deemed inappropriate by the tester for other reasons **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Yonsei University Health System, Severance Hospital ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422013 **Brief Title:** Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of GTB1 **Official Title:** A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of Lactiplantibacillus Plantarum APsulloc 331261(GTB1) #### Organization Study ID Info **ID:** AP-PV-2022-01 #### Organization **Class:** INDUSTRY **Full Name:** Amorepacific Corporation ### Status Module #### Completion Date **Date:** 2023-12-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-08 **Type:** ACTUAL #### Start Date **Date:** 2022-10-28 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Amorepacific Corporation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study was conducted to investigate the effects of daily supplementation of GTB1 on decrease of body fat. **Detailed Description:** This study was a 12 week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into GTB1 group and placebo group. It is to evaluate the changes in the displayed evaluation items when taking GTB1 once a day, in comparison with taking a placebo. ### Conditions Module **Conditions:** - Body Fat ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Once-daily, once a packet, for 12 week **Intervention Names:** - Dietary Supplement: GTB1 **Label:** GTB1 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Once-daily, once a packet, for 12 week **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - GTB1 **Description:** oral administration of GTB1 powder packet once daily **Name:** GTB1 **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** oral administration of placebo powder packet once daily **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Measurement is made using dual-energy X-ray absorptiometry(DEXA) **Measure:** Changes of percent body fat(trunk, total ect.) **Time Frame:** Baseline, Week 12 #### Secondary Outcomes **Description:** Measurement of the target area is made using dual-energy X-ray absorptiometry (DEXA) **Measure:** Changes of fat free mass(trunk, total ect.) **Time Frame:** Baseline, Week 12 **Description:** Measurement of the target area is made using computed tomography (CT) **Measure:** Changes of total abdominal fat area, visceral fat area and subcutaneous fat area **Time Frame:** Baseline, Week 12 **Description:** Measurement of waist and hip circumference is performed following the WHO guideline **Measure:** Changes of waist, hip circumference and waist/hip circumference ratio **Time Frame:** Baseline, Week 12 **Description:** Indicator of lipid metabolism(i.e., Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol) **Measure:** Changes of indicator of lipid metabolism **Time Frame:** Baseline, Week 12 **Description:** Obesity-related hormone indexes(Adiponectin, Leptin etc.). As blood adiponectin levels increase, blood leptin concentrations decrease, indicating a positive change. **Measure:** Changes of obesity-related hormone index **Time Frame:** Baseline, Week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males and females aged between 19\~65 years at the screening * Participants who were BMI 25.0\~34.9 kg/m\^2 (Excluding those who need to take or be prescribed medication that affects fat reduction, if the BMI is between 30.0\~34.9 kg/m\^2) * Participants who have a waist circumference of 90 cm for men and 85 cm or more for women * Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions Exclusion Criteria: * Participants who decrease 10% more of weight within 3 months period to the screening * Participants who have undergone surgical procedures (such as gastrectomy) for weight loss * Participants who have a history of malignant tumors within 5 years prior to participating in the clinical study * Participants who have a systolic blood pressure of 160 mmHg or higher, or a diastolic blood pressure of 100 mmHg or higher (those who are stably controlling their blood pressure with medication can participate) * Participants who are taking beta-blockers or diuretics as part of their hypertension treatment * Patients who have been diagnosed with Type 1 or Type 2 diabetes and are taking oral hypoglycemic agents and insulin * Participants who have taken antibiotics within 4 weeks prior to the screening examination * Participants who have taken health functional foods, herbal medicine, or general foods for the purpose of weight loss within 4 weeks prior to the screening visit * Participants with clinically significant acute or chronic diseases of the cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic, gastrointestinal diseases, and other diseases requiring treatment * Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial * Participants who have participated in other clinical study within 3 months prior to the screening examination * Women who are pregnant or breastfeeding * Women who may become pregnant and have not used appropriate contraceptives * Participants who show the following relevant results in a Laboratory test * Aspartate Transaminase (AST), Alanine Transaminase (ALT) \> Reference range 3 times upper limit * Serum Creatinine \> 2.0 mg/dl * Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jeonju **Country:** Korea, Republic of **Facility:** Jeonbuk National University Hospital **State:** Jeollabuk-do ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06422000 **Brief Title:** Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis **Official Title:** Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis #### Organization Study ID Info **ID:** pentoxifylline probiotic NEC #### Organization **Class:** OTHER **Full Name:** Tanta University ### Status Module #### Completion Date **Date:** 2023-12-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-01 **Type:** ACTUAL #### Start Date **Date:** 2022-06-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2022-11-11 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tanta University #### Responsible Party **Investigator Affiliation:** Tanta University **Investigator Full Name:** Alaa Mohamed Ahmed Rowisha **Investigator Title:** clinical pharmacist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis. **Detailed Description:** This randomized clinical trial includes 75 preterm infants who met the inclusion criteria for stage I and stage II NEC. Patients are allocated randomly into three groups (each included 25 neonates); group I (traditional therapy group) received antibiotics according to culture and sensitivity results, group II (pentoxifylline group) received antibiotics and IV pentoxifylline at a dose of 30 mg/ Kg given over 6 hours daily until discharge from the unit, and group III (probiotics group) received antibiotics and probiotics sachets supplementation in a dose of 100 mg mixed with 10 ml sterile water and given by Ryle tube once daily until discharge. The serum level of high-mobility group box protein 1 (HMGB-1), intestinal fatty acid binding proteins (I-FABP), and total antioxidant capacity (TAC) were measured on admission and at discharge. ### Conditions Module **Conditions:** - Necrotizing Enterocolitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 75 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** will include 25 preterm neonates with NEC who will receive traditional therapy of NEC including antibiotics and normal incubator care measures **Label:** control group (group I) **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with IV pentoxifylline at a dose of 30 mg/kg given over 6 hours daily (Schüller et al., 2020) until discharge from the unit after clinical and laboratory improvement . **Intervention Names:** - Drug: Pentoxifylline **Label:** pentoxifylline group (group II) **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF\* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement . **Intervention Names:** - Drug: Probiotic Formula **Label:** probiotic group (group III) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - pentoxifylline group (group II) **Description:** Pentoxifylline 30 mg/kg given over 6 hours daily **Name:** Pentoxifylline **Other Names:** - group 2 (Pentoxifylline group) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - probiotic group (group III) **Description:** probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF\* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement . **Name:** Probiotic Formula **Other Names:** - group 3 (Probiotic group) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** record mortality rate in each group during treatment **Measure:** Mortality rate **Time Frame:** 2 months **Description:** record any complications or side effects of the treating drugs **Measure:** complications and side effects **Time Frame:** 2 months **Description:** Change in serum C-reactive protein at baseline and after 2 months **Measure:** Inflammatory parameter **Time Frame:** 2 months #### Secondary Outcomes **Description:** blood sample will be collected at baseline and after 2 months **Measure:** change in serum high-mobility group box protein 1 (HMGB1) **Time Frame:** 2 months **Description:** blood sample will be collected at baseline and after 2 months **Measure:** change in serum Intestinal fatty acid binding protein (I-FABP). **Time Frame:** 2 months **Description:** Blood sample will be collected at baseline and after 2 months **Measure:** change in serum total antioxidant capacity (TAC) **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male and female preterm neonates less than 37 weeks gestational age * Suffering from necrotizing enterocolitis (NEC), according to Modified Bell's system which was first proposed by Bell et al., 1978 as stage I (suspected), II (proven) . * Diagnosis of NEC depends on; history, physical examination, laboratory and radiographic findings . * Signs and symptoms of NEC (at least three or more ), including; unstable temperature, apnea, increased residual milk in stomach, mid abdominal distension, vomiting coffee-like substances, bloody stool * Laboratory findings including; thrombocytopenia, hypernatremia, metabolic acidosis, neutropenia and leukocytosis. * Anterior posterior abdominal radiograph is used for diagnosis in which pneomatosis intestinalis in stage II NEC Exclusion Criteria: * Term and post term neonates * Neonates with congenital infections * Neonates with major congenital anomalies * Neonates with stage III NEC **Maximum Age:** 37 Weeks **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Tanta **Country:** Egypt **Facility:** Tanta University **State:** El Gharbia #### Overall Officials **Official 1:** **Affiliation:** professor and head of clinical pharmacy department, faculty of Pharmact, Tanta University, Egypt **Name:** Sahar Hegazy, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M7922 - Name: Enterocolitis - Relevance: HIGH - As Found: Enterocolitis - ID: M22151 - Name: Enterocolitis, Necrotizing - Relevance: HIGH - As Found: Necrotizing Enterocolitis - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: T4055 - Name: Necrotizing Enterocolitis - Relevance: HIGH - As Found: Necrotizing Enterocolitis ### Condition Browse Module - Meshes - ID: D000004760 - Term: Enterocolitis - ID: D000020345 - Term: Enterocolitis, Necrotizing ### Intervention Browse Module - Ancestors - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000010975 - Term: Platelet Aggregation Inhibitors - ID: D000011837 - Term: Radiation-Protective Agents - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014665 - Term: Vasodilator Agents - ID: D000016166 - Term: Free Radical Scavengers - ID: D000000975 - Term: Antioxidants ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M13342 - Name: Pentoxifylline - Relevance: HIGH - As Found: Manufacturer - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M13629 - Name: Phosphodiesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M13865 - Name: Platelet Aggregation Inhibitors - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M14684 - Name: Radiation-Protective Agents - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: T355 - Name: Acidophilus - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000010431 - Term: Pentoxifylline ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421987 **Brief Title:** Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors **Official Title:** Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors #### Organization Study ID Info **ID:** HODNIRS #### Organization **Class:** OTHER **Full Name:** St. Jude Children's Research Hospital ### Status Module #### Completion Date **Date:** 2027-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-01 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** St. Jude Children's Research Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** SURVIVORS Study participants are being asked to take part in this research study called HODNIRS because the participant is a survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital. The study is being done to help investigators understand the link between long term effects of chest radiation and bleomycin for HL and brain function in survivors. Primary Objective To evaluate dynamic changes in CBF and oxygenation during exercise with Near Infrared Spectroscopy (NIRS) in HL survivors and non-cancer controls matched for age, sex, race, and ethnicity. . Secondary Objectives To examine the degree of CO2 clearance (DLCO/ETCO2) during rest and exercise in Hodgkin Lymphoma (HL) survivors compared to non-cancer controls matched for age, sex, race, and ethnicity. CONTROLS Volunteers are being asked to take part in this research study because they are non-first degree relative or friend of someone who received treatment for a childhood cancer or similar illness at St. Jude Children's Research Hospital or are an employee/affiliate of St. Jude Children's Research Hospital and have agreed to be a St. Jude Life Cohort Study (SJLIFE) community control. **Detailed Description:** NIRS is a portable, non-invasive, brain imaging device that uses low levels of non-ionizing light to record variations in blood flow in the brain. The NIRS is wearable and can read blood flow to the brain during physical activity. ### Conditions Module **Conditions:** - Hodgkin Lymphoma, Adult ### Design Module #### Design Info **Observational Model:** CASE_CROSSOVER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital. and Control: Voluntarily taking part in this study because you are a relative, friend or employee of St. Jude Children's Research Hospital. **Intervention Names:** - Device: Near Infrared Spectroscopy (NIRS) **Label:** SURVIVOR ### Interventions #### Intervention 1 **Arm Group Labels:** - SURVIVOR **Description:** NIRS is a portable, non-invasive, brain imaging device. **Name:** Near Infrared Spectroscopy (NIRS) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** a non-invasive imaging technology that is used to measure regional or global cerebral tissue oxygenation and cerebral blood flow (CBF) during exercise. NIRS takes advantage of the fact that oxygenated blood and de-oxygenated blood absorb light differently. By measuring the reflected light from blood, the concentration of both oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (HbdO2) using the modified Beer-Lambert Law can be calculated. **Measure:** Near-Infrared Spectroscopy (NIRS) **Time Frame:** Baseline #### Secondary Outcomes **Description:** Cardiopulmonary Exercise Testing (CPX) will be performed with the goal of maximal exertion. Participants are monitored with 12-lead electrocardiogram (ECG) and serial blood pressure measurements during and after exercise, and during recovery. Study participants whose physical performance does not permit walking safely on the treadmill, will perform CPX on a bicycle or upper extremity ergometer using a comparable testing protocol. Oxygen consumption during CPX- Oxygen will be measured at baseline and continuously during CPX. Total minute ventilation (respiratory rate X tidal volume; l/min), and ventilatory reserve (l/min) will be used to assess the ability of the pulmonary system to respond to exercise. **Measure:** Cardiopulmonary Exercise Testing (CPX) **Time Frame:** Baseline **Description:** As part of the St. Jude Life (SJLIFE) study visit, participants will complete PFT's performed in a single laboratory according to the American Thoracic Society Task Force Guidelines. Pulmonary Function Tests (PFTs) will include: 1. Forced vital capacity (FVC) - measured in liters 2. Forced expiratory volume in 1 second (FEV1) - measured in liters/per second 3. FEV1/FVC ratio - measurement will be a percent. 4. DLCO capacity of lung to transfer carbon monoxide - measured in mL/min/mm Hg. These measurements will be compared with those predicted for the participant's age, race, sex, and height. **Measure:** Pulmonary Function Testing **Time Frame:** Baseline **Description:** - As part of the SJLIFE study visit, participants will complete neurocognitive testing (Wechsler Abbreviated Scale of Intelligence; Connors Continuous Performance; California Verbal Learning; Coding Digital Symbol; Grooved Pegboard; Trail Making; Verbal Fluence; Visual Selective; Digital Span; and Rey Complex). All tests are converted to z-scores (1.0 z-score is 1 standard deviation lower than the mean). **Measure:** Neurocognitive Outcomes **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: HL Survivors * Completed bleomycin and/or thoracic radiation therapy for HL at SJCRH. * \<21-years old at diagnosis; currently ≥18-years of age and ≥2-years post therapy. * SJLIFE or ACT/SJLIFE participants * English language proficiency. Community Controls * SJLIFE control. * ≥18-years of age at the time of enrollment with age sampling to broadly match the HL survivors. Exclusion Criteria: HL Survivors * History of cranial or total-body irradiation therapy. * History of intrathecal or high dose intravenous antimetabolite therapy. * History of head injury or diagnosis of a genetic disorder associated with cognitive impairment. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All participants who meet eligibility criteria and consent to enrollment on the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nicholas Phillips, PhD **Phone:** 866-278-5833 **Role:** CONTACT #### Locations **Location 1:** **City:** Memphis **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nicholas Phillips, PhD - **Phone:** 866-278-5833 - **Role:** CONTACT ***Contact 2:*** - **Name:** Nicholas Phillips, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** St. Jude Children's Research Hospital **State:** Tennessee **Zip:** 38105 #### Overall Officials **Official 1:** **Affiliation:** St. Jude **Name:** Nicholas Phillips, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** St. Jude Children's Research Hospital **URL:** http://www.stjude.org **Label:** Clinical Trials Open at St. Jude **URL:** http://www.stjude.org/protocols ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M9751 - Name: Hodgkin Disease - Relevance: HIGH - As Found: Hodgkin Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T2817 - Name: Hodgkin Lymphoma - Relevance: HIGH - As Found: Hodgkin Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000006689 - Term: Hodgkin Disease ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5042 - Name: Bleomycin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421974 **Brief Title:** Effectiveness of Robotic Surgery for Right Colon Cancer **Official Title:** A Prospective, Multicenter, Randomized Controlled Trial of the Effectiveness of Robotic Versus Laparoscopic Surgery for Right Colon Cancer #### Organization Study ID Info **ID:** SRRS-ERSRCC #### Organization **Class:** OTHER **Full Name:** Sir Run Run Shaw Hospital ### Status Module #### Completion Date **Date:** 2027-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Zhejiang University **Class:** OTHER **Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University **Class:** OTHER **Name:** Zhejiang Cancer Hospital **Class:** OTHER **Name:** Zhejiang Provincial People's Hospital **Class:** OTHER **Name:** First Affiliated Hospital of Wenzhou Medical University **Class:** OTHER **Name:** Ningbo No. 1 Hospital #### Lead Sponsor **Class:** OTHER **Name:** Sir Run Run Shaw Hospital #### Responsible Party **Investigator Affiliation:** Sir Run Run Shaw Hospital **Investigator Full Name:** Zhangfa Song **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study aims to explore through a multi-center, randomized controlled clinical study whether robot-assisted radical resection of right colon cancer is superior to laparoscopic surgery in terms of surgical quality and oncological prognosis. **Detailed Description:** The incidence rate of colorectal cancer has risen to the second place in my country, highlighting its significant impact on public health. It is a high-incidence malignant tumor that seriously threatens the health of our people. Surgery is the core treatment method for curing colorectal cancer. With the promotion of multidisciplinary comprehensive treatment models, in-depth understanding of abdominal and pelvic anatomy, and innovations in surgical instruments and techniques, colorectal cancer surgery is gradually developing in the direction of minimally invasive and organ function preservation. This advancement not only improves the safety and effectiveness of surgery, but also improves patients' postoperative quality of life. Laparoscopic surgery has obvious minimally invasive advantages in the treatment of right colon cancer. Compared with traditional laparotomy, laparoscopic surgery has the advantages of less trauma, less postoperative pain, faster recovery, and shorter hospital stay. Since Hohenberger proposed the concept of complete mesocolic excision (CME), the principle of CME has become a key technique in colon cancer surgery, which emphasizes thorough lymph node dissection and precise tumor resection. In radical resection of right colon cancer, CME technology ensures complete resection of surrounding tissue by performing surgery along the natural anatomical plane of blood vessels and nerve plexuses, thereby reducing the local recurrence rate of the tumor. A retrospective cohort study of 1395 cases included in the Danish Colorectal Cancer Study Group showed that the 4-year disease-free survival rate of patients of all stages after CME surgery was 85.8% (95% CI 81.4-90.1), and that after non-CME surgery, the 4-year disease-free survival rate was 85.8% (95% CI 81.4-90.1). The 4-year disease-free survival rate was 75.9% (95% CI 72.2-79.7) (log-rank p=0.0010), which preliminarily proved that the CME principle can significantly improve the disease recurrence-free survival (DFS) rate. This method aims to achieve better tumor cure results through more extensive and complete resection. However, with the continuous innovation of surgical instruments and technologies, laparoscopic surgery is also facing some challenges. Laparoscopic surgery often provides a two-dimensional field of view, which may limit the surgeon's depth perception and accuracy when performing complex procedures. In addition, the operating rods of traditional laparoscopic tools are relatively long and the operating space is limited, which may lead to difficulties in gesture amplification and fine motor control during surgery, resulting in certain defects in surgical operation accuracy and visual field stability. The robot-assisted surgical system provides a new technical platform for improving the quality of surgical operations with its enhanced visual capabilities, stable field of view and flexibility of surgical instruments. The stability of the three-dimensional stereo vision system and camera platform can significantly improve the surgical field of view, while the high flexibility of the robotic arm optimizes surgical operations. Existing clinical studies show that compared with traditional laparoscopic surgery, robot-assisted surgical systems have potential advantages in reducing the proportion of conversions to laparotomy, reducing the occurrence of postoperative complications, and shortening postoperative recovery time. When considering the economic burden of robotic-assisted surgical systems relative to conventional laparoscopic surgery, more rigorous and quantitative evidence is necessary to assess their economic benefits in daily clinical practice. Although robot-assisted surgical systems offer operational advantages, their high equipment investment and maintenance costs remain a major obstacle to their adoption. Therefore, a comprehensive cost-effectiveness analysis, combined with an assessment of surgical outcomes, patient recovery, and long-term health-related quality, is critical to determine its suitability in the healthcare system. The REAL randomized controlled study led by Professor Xu Jianmin compared the surgical quality and long-term tumor prognosis of robot-assisted surgery and conventional laparoscopic surgery in patients with middle and low rectal cancer. The primary endpoint of the study was the 3-year local recurrence rate, while the secondary endpoints focused on the positive circumferential margin rate and the 30-day postoperative complication rate. The short-term secondary endpoint data that have been published so far are encouraging. However, there is still a lack of multicenter randomized controlled clinical studies on the long-term oncological outcomes of robotic surgery for right colon cancer. This study aims to compare the 3-year disease recurrence-free survival (DFS) between robot-assisted radical right hemicolectomy (RA-LSRHC) and conventional laparoscopic radical right hemicolectomy (LSRHC) through a multicenter, randomized controlled study. The non-inferiority in terms of surgery provides high-quality evidence-based medical evidence for robot-assisted right colon cancer surgery, further optimizes treatment strategies, and improves patients' quality of life. ### Conditions Module **Conditions:** - Colon Cancer - Robotic Surgery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 610 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Robot-assisted right colon cancer radical resection group, referred to as robotic surgery group **Intervention Names:** - Procedure: DaVinci si or xi system **Label:** Robotic surgery for right colon cancer **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Laparoscopic right colon cancer radical resection group, referred to as laparoscopic surgery group **Intervention Names:** - Procedure: laparoscopic radical resection **Label:** laparoscopic surgery for right colon cancer **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Robotic surgery for right colon cancer **Description:** In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group). **Name:** DaVinci si or xi system **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - laparoscopic surgery for right colon cancer **Description:** In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group). **Name:** laparoscopic radical resection **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The time from randomization to first tumor recurrence/metastasis or death from any cause was defined as the time of last follow-up for patients lost to follow-up(Patients still alive at the end of the study, the end of follow-up). **Measure:** 3-year disease-free survival rate **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months #### Secondary Outcomes **Description:** Perioperative complications were classified according to the Clavien-Dindo system, including intraoperative, short-term and long-term postoperative complications. **Measure:** 30-day perioperative complications **Time Frame:** up to 1 month. **Description:** 5-year overall survival rate **Measure:** Overall survival **Time Frame:** 5-year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-75 years old. 2. ASA classification ≤ Level III. 3. Colon adenocarcinoma was confirmed by colonoscopy and biopsy pathology. 4. Transabdominal enhanced CT showed that the distal and proximal ends of the primary tumor were located in the right colon (cecum to the proximal 1/3 of the transverse colon). 5. Preoperative clinical stage: TanyNanyM0. 6. The patient's condition meets the indications for robotic surgery and is willing to accept the robotic surgery treatment plan. 7. Voluntarily participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity or other reasons, his or her guardian must be responsible for the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form. Exclusion Criteria: 1. Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring intestinal segmental resection. 2. The results of preoperative imaging examination or intraoperative exploration suggest: 1) The tumor involves surrounding organs and requires combined organ resection; 2) There is distant metastasis; 3) R0 resection cannot be performed. 3. Additional radical surgery after emr and esd surgery. 4. Have a history of any other malignant tumor or familial adenomatous polyposis in the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma or cutaneous squamous cell carcinoma. 5. Combined intestinal obstruction, intestinal perforation, intestinal bleeding, etc. require emergency surgery. 6. Patients who are not suitable for or cannot tolerate robotic or laparoscopic surgery. 7. Pregnant or lactating women. 8. Patients with a history of mental illness. 9. Patients who have received neoadjuvant treatment before surgery. 10. MDT discusses patients who are not suitable for entering the study. 11. Patients who refuse to undergo either robotic or laparoscopic surgery. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hanzhou **Country:** China **Facility:** Sir Run Run Shao hospital **State:** Zhejiang **Zip:** 310012 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6338 - Name: Colonic Neoplasms - Relevance: HIGH - As Found: Colon Cancer - ID: M17890 - Name: Colorectal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003110 - Term: Colonic Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421961 **Brief Title:** Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers **Official Title:** Digital Techniques for Measuring Chronic Leg Ulcers in Peripheral Arterial Disease: Aspects of Measurement Precision and Evaluation of Wound Treatment #### Organization Study ID Info **ID:** AW-trail20240409 #### Organization **Class:** OTHER **Full Name:** Sahlgrenska University Hospital, Sweden ### Status Module #### Completion Date **Date:** 2026-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sahlgrenska University Hospital, Sweden #### Responsible Party **Investigator Affiliation:** Sahlgrenska University Hospital, Sweden **Investigator Full Name:** Louise Koch-Nielsen **Investigator Title:** Specialist nurse, PhD student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with arterial ulcers on the lower leg. The expectation is that the digital measurement tool can provide healthcare providers with better opportunities to objectively monitor and detect changes in the wound healing process in patients with peripheral arterial disease. ### Conditions Module **Conditions:** - Chronic Limb-Threatening Ischemia **Keywords:** - Wound Healing - Artificial Intelligence - Digital Technology ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** OTHER #### Enrollment Info **Count:** 223 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** The size of the wound will be determined using three different measurement techniques, with images captured during a single session. 1. Traditional Method for Area Measurement: This method utilizes a Canon EOS 700D camera and a 10 cm ruler for reference. The area is calculated using Picsara software, yielding results in square centimeters (cm²). 2. SeeWound Method Version 1.6.4 for Area Measurement with reference card: This technique employs a specialized app to calculate the wound area in square centimeters (cm²) with the reference card. 2. SeeWound Method Version 1.6.4 for Research: This app utilizes lidar technology to measure the area in square centimeters (cm²). **Measure:** Assessing the agreement between two methods of measuring the size of arterial wounds. **Time Frame:** Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks. **Description:** The Depth of the wound will be determined using two different measurement techniques, with measurement taken during a single session. 1. Manual Depth Measurement with a Cotton Swab: A cotton swab is inserted into the wound to measure its depth. The measurement is taken at the deepest point and recorded in millimeters (mm). 2. SeeWound Method Version 1.6.4 for Research: This app utilizes lidar technology to measure the depth of the wound in millimeters (mm). **Measure:** Assessing the agreement between two methods of measuring the depth of arterial wounds. **Time Frame:** Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults with peripheral arterial disease. * Arterial or arteriovenous ulcers on lower leg * Age \<18 Exclusion Criteria: * Adults with non-ischemic ulcers, * Purely venous ulcers, * Purely traumatic wounds, * Wounds resulting from non-atherosclerotic chronic vascular conditions of the lower extremity (e.g.,vasculitis, Buerger disease, radiation arteritis), **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patienten seeking care and being diagnos with peripheral arterial disease and having hard to heal wounds on lower leg or foot. ### Contacts Locations Module #### Locations **Location 1:** **City:** Gothenburg **Country:** Sweden **Facility:** Sahlgrenska University Hospital #### Overall Officials **Official 1:** **Affiliation:** Sahlgrenska Academy **Name:** Monica Ms Pettersson, PhD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Sahlgrenska University Hospital, Sweden **Name:** Joakim Mr Nordanstig, PhD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Karolinska Institutet **Name:** Sara Ms Haile, PhD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases - ID: D000058729 - Term: Peripheral Arterial Disease - ID: D000050197 - Term: Atherosclerosis - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000016491 - Term: Peripheral Vascular Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: LOW - As Found: Unknown - ID: M18894 - Name: Peripheral Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M2714 - Name: Chronic Limb-Threatening Ischemia - Relevance: HIGH - As Found: Chronic Limb-Threatening Ischemia - ID: M10883 - Name: Leg Ulcer - Relevance: HIGH - As Found: Leg Ulcers - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M26188 - Name: Atherosclerosis - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000089802 - Term: Chronic Limb-Threatening Ischemia - ID: D000007871 - Term: Leg Ulcer ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421948 **Brief Title:** Linperlisib Combined With Chidamide in Patients With PTCL **Official Title:** PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib/II Study #### Organization Study ID Info **ID:** HNSZLYYML08 #### Organization **Class:** OTHER_GOV **Full Name:** Henan Cancer Hospital ### Status Module #### Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Yanyan Liu #### Responsible Party **Investigator Affiliation:** Henan Cancer Hospital **Investigator Full Name:** Yanyan Liu **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to determine the maximum tolerated dose (MTD) of PI3Kδ inhibitor linperlisib when combined with fixed dose of HDAC inhibitor chidamide in participants with peripheral T-cell lymphoma (PTCL), and to compare the combination of linperlisib and chidamide to standard CHOP (cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone) regimen chemotherapy in the frontline treatment of PTCL to see which therapy is better. **Detailed Description:** In the phase Ib trial, participants with newly diagnosed or relapsed/refractory PTCL will receive fixed dose of chidamide (20 mg, twice a week) and escalating dose of linperlisib (40 mg, 60 mg, or 80 mg, once a day), to find out the optimal dose of linperlisib. In the phase II trial, participants with newly diagnosed PTCL will be randomized into experimental arm (arm A) to receive linperlisib in combination with chidamide, or control arm (arm B) to receive standard CHOP regimen chemotherapy. Interim efficacy assessment will be performed after three cycles of treatment. Responded participants will receive another three cycles of treatment. After a total of 6 cycles of treatment, participants can choose autologous hematopoietic stem cell transplantation, maintenance treatment with linperlisib and/or chidamide, or watch and wait. ### Conditions Module **Conditions:** - Peripheral T-cell Lymphoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive a combination of linperlisib in combination with chidamide orally. **Intervention Names:** - Drug: Linperlisib and chidamide **Label:** Orally administered, targeted therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive standard CHOP regimen chemotherapy including cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone. **Intervention Names:** - Drug: cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone **Label:** Intravenously chemotherapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Orally administered, targeted therapy **Description:** A combination of linperlisib and chidamide will be administered for 6 cycles in patients responded to treatment. **Name:** Linperlisib and chidamide **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Intravenously chemotherapy **Description:** A combination of cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone (CHOP) will be administered for 6 cycles in patients responded to treatment. **Name:** cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Complete response rate **Measure:** CRR **Time Frame:** Through study completion, an average of 3 years #### Secondary Outcomes **Description:** Progression-free survival **Measure:** PFS **Time Frame:** 12 months **Description:** Overall survival **Measure:** OS **Time Frame:** 12 months **Description:** Adverse event **Measure:** AE **Time Frame:** Through study completion, an average of 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib study) * Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma and NK/T-cell lymphoma are not included. * ECOG PS 0-2 at protocol entry * Estimated life expectancy of 6 months or longer * Measurable disease * Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50% * Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs; Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential * Written informed consent Exclusion Criteria: * Patients previously treated with PI3K inhibitor * Patients previously treated with chidamide (phase Ib study is not limited by this item) * Suspected or documented central nervous system involvement by lymphoma * Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection * Patients with active, uncontrolled infections * Unwillingness or inability to comply with the protocol * Deemed 'unfit' by the treating physician * Pregnant and/or breastfeeding women * Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related * Patients with contraindications to chemotherapy * Known hypersensitivity to one or more of the study drugs **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yanyan Liu **Phone:** 86 037165587791 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Zheng Yan **Phone:** 86 13598097015 **Role:** CONTACT #### Locations **Location 1:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yanyan Liu - **Phone:** 86-037165587791 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Zheng Yan - **Phone:** 86+13598097015 - **Role:** CONTACT **Country:** China **Facility:** Affiliated Cancer Hospital of Zhengzhou University **State:** Henan **Status:** RECRUITING **Zip:** 450008 #### Overall Officials **Official 1:** **Affiliation:** A **Name:** Yanyan Liu **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000008228 - Term: Lymphoma, Non-Hodgkin ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M18829 - Name: Lymphoma, T-Cell - Relevance: HIGH - As Found: T-cell Lymphoma - ID: M18833 - Name: Lymphoma, T-Cell, Peripheral - Relevance: HIGH - As Found: Peripheral T-cell Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown - ID: T4496 - Name: Peripheral T-cell Lymphoma - Relevance: HIGH - As Found: Peripheral T-cell Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000016399 - Term: Lymphoma, T-Cell - ID: D000016411 - Term: Lymphoma, T-Cell, Peripheral ### Intervention Browse Module - Ancestors - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019653 - Term: Myeloablative Agonists - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M7492 - Name: Doxorubicin - Relevance: HIGH - As Found: Women - ID: M227339 - Name: Liposomal doxorubicin - Relevance: LOW - As Found: Unknown - ID: M14121 - Name: Prednisone - Relevance: HIGH - As Found: Min - ID: M17495 - Name: Vincristine - Relevance: HIGH - As Found: Volume - ID: M17954 - Name: Epirubicin - Relevance: HIGH - As Found: Mass - ID: M28511 - Name: Histone Deacetylase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011241 - Term: Prednisone - ID: D000003520 - Term: Cyclophosphamide - ID: D000004317 - Term: Doxorubicin - ID: D000014750 - Term: Vincristine - ID: D000015251 - Term: Epirubicin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421935 **Brief Title:** M9466 as Single Agent or in Combination With Tuvusertib in Advanced Solid Tumors (DDRiver 501) **Official Title:** An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 as a Single Agent and in Combination With the ATR Inhibitor Tuvusertib in Participants With Advanced Solid Tumors (DDRiver 501) #### Organization Study ID Info **ID:** MS202659_0001 #### Organization **Class:** INDUSTRY **Full Name:** EMD Serono #### Secondary ID Infos **Domain:** EU CTR **ID:** 2024-513492-41-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-03-26 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Merck KGaA, Darmstadt, Germany #### Lead Sponsor **Class:** INDUSTRY **Name:** EMD Serono Research & Development Institute, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 as monotherapy or in combination with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period. ### Conditions Module **Conditions:** - Advanced Solid Tumor **Keywords:** - PARP inhibitor - castration-resistant prostate cancer - ovarian cancer ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: M9466 - Drug: Tuvusertib **Label:** M9466 plus Tuvusertib **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: M9466 **Label:** M9466 Monotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - M9466 Monotherapy - M9466 plus Tuvusertib **Description:** Participants will be administered M9466 orally. **Name:** M9466 **Other Names:** - HRS-1167; **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - M9466 plus Tuvusertib **Description:** Participants will be administered Tuvusertib orally. **Name:** Tuvusertib **Other Names:** - Substance code MSC2584415A; also known as M1774, VXc-400, or VR 1363004 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Module 1 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs **Time Frame:** Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months) **Measure:** Module 1 Part A1: Number of Participants with Dose Limiting Toxicity (DLT)-like events **Time Frame:** Day 1 up to Day 21 of Cycle 1 (each cycle is of 21 days) **Measure:** Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 **Time Frame:** Day 1, Day 8 and Day 15 #### Secondary Outcomes **Measure:** Module 1 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 and Tuvusertib **Time Frame:** Day 1, Day 8 and Day 15 **Measure:** Module 1 Part A1: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as Assessed by Investigator **Time Frame:** Time from first treatment to planned assessment at 12 months **Measure:** Module 1 Part A1: Effect of M9466 in combination with tuvusertib on QTc interval as determined by Digital ECGs **Time Frame:** Time from first treatment to planned assessment at 12 months **Measure:** Module 2 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-Related AEs **Time Frame:** Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months) **Measure:** Module 2 Part A1: Number of Participants with Abnormalities in Digital Electrocardiogram (ECG) Measures **Time Frame:** Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months) **Measure:** Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 and Tuvusertib **Time Frame:** Day 1, Day 8 and Day 15 **Measure:** Module 2 Part A1: Relative Changes in Pharmacodynamic Markers In Paired Tumor Biopsies **Time Frame:** Day 1, Day 8 and Day 15 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Module 1 Part A1 and Module 2 Part A1: Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator * Eastern Cooperative Oncology Group Performance Status less than or equal to (\<=) 1 * Life expectancy of more than 6 months * Have adequate hematologic function * Participants who received chemotherapy, extensive radiotherapy, biological therapy (e.g. antibodies) or investigational agents will have a washout period of 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior to starting study intervention with M9466 (± tuvusertib) * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Persistence of Adverse Events related to any prior treatments that have not recovered to Grade less than 1 by NCI Common Terminology Criteria for Adverse Events- v5.0 unless AEs are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator (e.g. neuropathy or alopecia) * Participant has a history of malignancy within 5 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years) * Participants with known brain metastases, except if clinically controlled, which is defined as individuals with Central Nervous System (CNS) tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for more than 28 days * Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy), and/or other situations that may preclude adequate absorption of oral medications * Cerebrovascular accident or stroke * Other protocol defined exclusion criteria could apply **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** US Medical Information **Phone:** 888-275-7376 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Communication Center **Phone:** +49 6151 72 5200 **Role:** CONTACT #### Locations **Location 1:** **City:** Rockland **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Please Contact U.S. Medical Information - **Phone:** 888-275-7376 - **Role:** CONTACT **Country:** United States **Facility:** Please Contact U.S. Medical Information **State:** Massachusetts **Zip:** 02370 **Location 2:** **City:** Darmstadt **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Please Contact the Communication Center - **Phone:** +49 6151 72 5200 - **Role:** CONTACT **Country:** Germany **Facility:** Please Contact the Communication Center **Zip:** 64293 #### Overall Officials **Official 1:** **Affiliation:** EMD Serono Research & Development Institute, Inc. **Name:** Medical Responsible **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21 **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Trial Awareness and Transparency website **URL:** https://clinicaltrials.emdgroup.com/en ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12974 - Name: Ovarian Neoplasms - Relevance: LOW - As Found: Unknown - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: LOW - As Found: Unknown - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421922 **Brief Title:** Effect of Different Dietary Therapies on Intestinal Barrier Integrity in Patients With Irritable Bowel Syndrome **Official Title:** The Effects of Supplementation of Diet With Fiber or Probiotic Yogurt on the Intestinal Barrier Integrity in Individuals With Constipation-predominant Irritable Bowel Syndrome #### Organization Study ID Info **ID:** 50687469-799 #### Organization **Class:** OTHER_GOV **Full Name:** Gulhane Training and Research Hospital #### Secondary ID Infos **Domain:** TUEK **ID:** 50687469-799 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2020-06-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-10-15 **Type:** ACTUAL #### Start Date **Date:** 2019-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Gulhane Training and Research Hospital #### Responsible Party **Investigator Affiliation:** Gulhane Training and Research Hospital **Investigator Full Name:** Emine Nuket Unsal **Investigator Title:** PhD, Dietitian, Head of Clinical Nutrition Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to evaluate the effects of different dietary treatments on intestinal integrity in female subjects aged 19-50 years previously diagnosed with constipation-predominant irritable bowel syndrome (IBS). At the Gülhane Training and Research Hospital's gastroenterology clinic in Ankara, Turkey, a randomized controlled experiment was carried out. 60 individuals with IBS were randomly divided into three groups. Group 1 was assigned to a regular constipation diet, group 2 to a constipation diet rich in soluble fibers, and group 3 to a constipation diet with probiotic yogurt supplementation. Every individual was monitored for eight weeks. Plasma zonulin level was used to measure intestinal integrity both before and after treatment. **Detailed Description:** This was a non-pharmacological randomized controlled trial conducted at Ankara Gülhane Training and Research Hospital Gastroenterology Polyclinic between June 2019 and March 2020. Participants of this study were women aged 19 to 50 years with a diagnosis of IBS according to the Rome IV criteria (2017). The sample size was calculated with G\*Power software. With an estimated power of 90%, a Type I error of 0.05, and an effect size of f=0.25, the total sample size required was 54, consisting of 18 participants in each group. The sample size was calculated using G\*Power software. The total sample size, with an estimated strength of 90%, Type I error of 0.05, and effect size f = 0.25, was 54, consisting of 18 participants in each group. 60 participants were targeted due to compensation for potential drop-out from protocol. Using random assignment software, participants were divided into three groups at random for parallel group randomized trials. Group 1 received a standard constipation diet; Group 2 received a soluble fiber-rich constipation diet; and Group 3 received a probiotic yogurt-supplemented constipation diet. The three groups-regular constipation diet, constipation diet high in soluble fiber, and constipation diet fortified with probiotic yogurt-were coded R 1-2, F 1-2, and P 1-2 to protect patient confidentiality. Twice a week, two liters of water, two servings of vegetables, and three servings of fruits, and legumes were the staples of the constipation diet. For the first four weeks, Group 2's constipation diet included 1 sachet of soluble fiber (resistant starch) (5 g/day), and in the second week, 2 sachets of soluble fiber (10 g/day) were added. It happens after four weeks. In Group 3, the yogurt ingested before lunch was supplemented with the IBS-specific strain "Bifidobacterium Infantis 35624 (B. Infantis 35624)". For eight weeks, there was a follow-up. All data were collected by face-to-face survey method. At the first visit, sociodemographic characteristics and three-day food consumption were recorded. Food consumption was recorded for 3 days, 2 days on weekdays, and 1 day on weekends. Serum Zonulin level and biochemical tests were evaluated at the beginning of the diet and the 8th week. Serum Zonulin level was measured using the "BT Lab Human Zonulin ELISA Kit" (China, E1117). Daily energy and nutrient amounts taken from the diet were analyzed using the Nutrition Information System 8 (BeBis 8) computer package program. IBM SPSS Statistics 22.00 program was used to analyze the data obtained. The normal distribution of the data was evaluated with the Shapiro-Wilk test. To increase clarity and ensure consistency with other studies, continuous variables are presented as mean ± standard deviation. Spearman rank correlation coefficients are a way to represent correlations between continuous variables. Analysis of variance or the Kruskal Wallis test was used to compare groups. Wilcoxon signed-rank test was used to compare groups within the same group from baseline to week eight. The significance threshold of p\<0.05 was determined. ### Conditions Module **Conditions:** - Irritable Bowel Syndrome-IBS ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group 1 received a regular constipation diet (n=21) **Intervention Names:** - Dietary Supplement: Group 1 received a regular constipation diet **Label:** Group 1-regular constipation diet **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** group 2 received a constipation diet rich in soluble fiber (n=17) **Intervention Names:** - Dietary Supplement: Group 2 received a constipation diet rich in soluble fiber **Label:** Group 2-soluble fiber **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** group 3 received a constipation diet with added probiotic yogurt (n=22). **Intervention Names:** - Dietary Supplement: Group 3 received a constipation diet supplemented with probiotic yogurt. **Label:** Group 3-probiotic yogurt **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1-regular constipation diet **Description:** Group 1 received only regular constipation diet, the constipation diet included 2 litres of water, 2 portions of vegetables, 3 portions of fruits and legumes 2 times a week. Followed 8 weeks. **Name:** Group 1 received a regular constipation diet **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Group 2-soluble fiber **Description:** Soluble fiber (resistant starch) (5 g/day) was added to the constipation diet in group 2 as 1 sachet/day (5 g/day) during the initial 4 weeks and 2 sachets/day (10 g/day) in the following 4 weeks. **Name:** Group 2 received a constipation diet rich in soluble fiber **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - Group 3-probiotic yogurt **Description:** "Bifidobacterium İnfantis 35624 (B. İnfantis 35624)\&#34; strain, which is specific to IBS, was added to yogurt in group 3, consumed before the lunch. The follow-up period was 8 weeks. **Name:** Group 3 received a constipation diet supplemented with probiotic yogurt. **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome was the change in blood Zonulin level after adding probiotic yogurt to a regular constipation diet instead of soluble fiber. Serum zonulin levels were analysed to evaluate the effect of dietary compliance on intestinal barrier integrity. Lower serum zonulin levels indicate a better intestinal barrier integrity. **Measure:** Serum Zonulin level **Time Frame:** 0-8 weeks #### Secondary Outcomes **Description:** The secondary outcomes were changes in fasting blood glucose, cholesterol, blood triglyceride, LDL cholesterol and CRP levels after adding probiotic yogurt to a regular constipation diet instead of soluble fiber. **Measure:** Other biomarkers (fasting blood glucose, cholesterol, blood triglyceride, LDL cholesterol and CRP) **Time Frame:** 0-8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women aged 19-50 years who were diagnosed with IBS according to Rome IV criteria * Any metabolic disease (diabetes, heart disease, etc.), cancer and autoimmune no history of chronic diseases such as illness * Not being pregnant or lactating * Body mass index (BMI) of 18.5-29.9 kg/m2 Exclusion Criteria: * Chronic disease history such as cancer and autoimmune diseases * Probiotics use or nutritional supplement use (vitamins, minerals) in the last 6 months. * Pregnancy. **Gender Based:** True **Maximum Age:** 50 Years **Minimum Age:** 19 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** GulhaneTRH **State:** Keçiören **Zip:** 06010 #### Overall Officials **Official 1:** **Affiliation:** Gulhane Training and Research Hospital **Name:** Emine Nuket Unsal, Phd **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000003109 - Term: Colonic Diseases, Functional - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M6472 - Name: Constipation - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M25118 - Name: Irritable Bowel Syndrome - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M6337 - Name: Colonic Diseases, Functional - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000043183 - Term: Irritable Bowel Syndrome - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T367 - Name: Bifidobacterium - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421909 **Acronym:** mindmenopaus **Brief Title:** Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman **Official Title:** Effect of Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman. #### Organization Study ID Info **ID:** 99-b #### Organization **Class:** OTHER **Full Name:** Alexandria University ### Status Module #### Completion Date **Date:** 2024-08-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Alexandria University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life. **Detailed Description:** Menopause is a significant transitional phase in a woman's life, often accompanied by various physical, emotional, and psychological challenges. Common issues during menopause include anxiety, depression, stress, and a decreased quality of life. Addressing these concerns holistically is crucial for improving overall well-being. Mindfulness-based educational interventions have gained recognition for their effectiveness in enhancing mental health and quality of life by promoting awareness and acceptance of present experiences. This study investigates the impact of a mindfulness-based educational intervention on anxiety, depression, stress, and quality of life in menopausal women. ### Conditions Module **Conditions:** - Menopause ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: mindfulness-based educational intervention **Label:** mindfulness-based educational intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** non-intervention group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - mindfulness-based educational intervention group **Description:** Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life. **Name:** mindfulness-based educational intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** menopausal women who participate in the mindfulness-based educational intervention will experience significant reductions in anxiety inventory score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered **Time Frame:** three months #### Secondary Outcomes **Measure:** menopausal women who participate in the mindfulness-based educational intervention will experience reductions in stress scale score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered **Time Frame:** three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * in age of menopause Exclusion Criteria: * age of menarche * older than 70 years old **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 50 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Alexandria **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** mohamed H atta - **Phone:** 2026609088 - **Role:** CONTACT **Country:** Egypt **Facility:** Alexandria university **State:** Al Iskandariyah **Status:** RECRUITING **Zip:** 21913 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life - ID: T6036 - Name: Menopause - Relevance: HIGH - As Found: Menopause ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421896 **Acronym:** METgeriatri **Brief Title:** Motivational Enhancement Therapy's Impact on d COPD Outcomes in Geriatric Patient **Official Title:** Exploring the Motivational Enhancement Therapy's Impact on Motivation, Resilience, Anxiety Reduction, and COPD Outcomes in Geriatric Patient #### Organization Study ID Info **ID:** 85-a #### Organization **Class:** OTHER **Full Name:** Alexandria University ### Status Module #### Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Alexandria University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Motivational Enhancement Therapy (MET) is a systematic intervention that focuses on eliciting and strengthening a person's intrinsic motivation to change. MET is rooted in motivational interviewing principles, emphasizing empathy, autonomy, and the evocation of the patient's own motivations for change. The therapy typically involves several sessions where therapists help patients identify personal goals, explore ambivalence towards change, and develop actionable plans to achieve their desired outcomes. **Detailed Description:** Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide, particularly among the elderly. Managing COPD effectively in geriatric patients requires addressing not only the physiological aspects of the disease but also the psychological and motivational factors that can influence treatment adherence and overall well-being. Motivational Enhancement Therapy (MET) is a counseling approach designed to help individuals enhance their motivation to change and engage in healthier behaviors. This study explores the impact of MET on motivation, resilience, anxiety reduction, and COPD outcomes in geriatric patients. ### Conditions Module **Conditions:** - COPD ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** COPD geriatric patients who receive motivational Enhancement Therapy **Intervention Names:** - Behavioral: motivational Enhancement Therapy **Label:** experimental group: geriatric who receive motivational Enhancement Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** COPD geriatric patients who don't receive motivational Enhancement Therapy **Label:** non- experimental group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - experimental group: geriatric who receive motivational Enhancement Therapy **Description:** Motivational Enhancement Therapy (MET) is a systematic intervention that focuses on eliciting and strengthening a person's intrinsic motivation to change. MET is rooted in motivational interviewing principles, emphasizing empathy, autonomy, and the evocation of the patient's own motivations for change. The therapy typically involves several sessions where therapists help patients identify personal goals, explore ambivalence towards change, and develop actionable plans to achieve their desired outcomes. **Name:** motivational Enhancement Therapy **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** primary objective **Measure:** COPD geriatric patients who entered motivational Enhancement Therapy will demonstrate a higher score in resilience scale ( ( total score range from 15 to 75, a higher score of more than 50)than those who not entered **Time Frame:** three months #### Secondary Outcomes **Description:** secondary **Measure:** OPD geriatric patients who entered motivational Therapy will demonstrate a lower score in anxiety inventory ( total score range from 10 to 50, a lower score of more than 20)than those who not entered **Time Frame:** three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * more than 60 years Exclusion Criteria: * more than 80 years **Maximum Age:** 80 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Alexandria **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** mohamed H atta - **Phone:** 2026609088 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Phone Ext:** atta - **Role:** CONTACT ***Contact 3:*** - **Name:** mohamed H atta - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Alexandria university **State:** Al Iskandariyah **Status:** RECRUITING **Zip:** 21913 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421883 **Acronym:** probiotic **Brief Title:** Study the Effect of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in Hemodialysis Patients **Official Title:** The Potential Impact of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in End Stage Renal Disease Patients Undergoing Hemodialysis #### Organization Study ID Info **ID:** Interventional clinical trial #### Organization **Class:** OTHER **Full Name:** Al-Azhar University ### Status Module #### Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Al-Azhar University #### Responsible Party **Investigator Affiliation:** Al-Azhar University **Investigator Full Name:** Nehal Kamal Bazid **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if probiotic has an effect on Trimethylamine-N-Oxide Plasma Level in plasma, which represent strong risk factor for Atherosclerosis in end stage renal disease patients who undergoing hemodialysis the main questions to answer are : Does probiotic lower Trimethylamine-N-Oxide concentration? does probiotic participating in decreasing risk of atherosclerosis in end stage renal disease patients undergoing hemodialysis ? research will compare between patients who are taking probiotic and control group (taking no drug) participants will take probiotic for 3 months visit the clinic once every 2 weeks for checkups and tests All Patients will be subjected to the following: 1. Informed consent. 2. Demographics and history taking: Using Patient Data sheet. 3. Laboratory evaluation including: Kidney function tests: blood urea,serum creatinine, albumin ,uric acid. Complete blood count (CBC). C-reactive protein (CRP). **Detailed Description:** Chronic Kidney Disease (CKD) is considered as a major public health problem as it can lead to end-stage kidney failure, which requires replacement therapy. A prompt and accurate diagnosis, along with the appropriate treatment, can delay CKD's progression End-stage renal disease (ESRD) is associated with significant alterations in cardiovascular function; homeostasis of body fluid, electrolytes, and acid-base equilibrium; bone metabolism, erythropoiesis; and blood coagulation. The prevalence of ESRD is increasing rapidly worldwide, as is the number of patients requiring surgery under general anesthesia. Patients with ESRD have significantly higher risks of perioperative morbidity and mortality due to multiple comorbidities Trimethylamine N-oxide (TMAO) is a gut microbiota metabolite derived from trimethylamine containing nutrient precursors such as choline, L-carnitine, and betaine. An increasing number of clinical studies have demonstrated a strong relationship between elevated plasma TMAO levels and adverse cardiovascular events. It is commonly agreed that TMAO acts as both an independent risk factor and a prognostic index for patients with cardiovascular disease , TMAO is considered as a potential biomarker and/or therapeutic target for diagnosis and treatment of patients with cardiovascular disease Probiotic work as antagonist for those strains which are responsible for the synthesis of TMAO precursor molecules in the gut and modulate miRNAs associated with the genes which are responsible for TMA lyases and ultimately play a role in conversion of diet precursor into TMA Control group: 40 patients will receive their standard therapy only. Intervention group (probiotic group): 40 patients will receive probiotic 5 billion unit per day with their standard therapy for 3 months ### Conditions Module **Conditions:** - End Stage Renal Disease **Keywords:** - hemodialysis - probiotic - Trimethylamine-N-Oxide - TMAO ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients will be randomized into two groups each group includes 40 patients: Control group: 40 patients will receive their standard therapy only. Intervention group (probiotic group): 40 patients will receive probiotic 5 billion unit per day with their standard therapy for 3 months. ##### Masking Info **Masking:** NONE **Masking Description:** (Open Label) **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Experimental probiotic group patients will receive probiotic 5 billion unit per day with their standard therapy collect blood sample and measure TMAO at baseline and after 3 months **Intervention Names:** - Dietary Supplement: Lactobacillus containing probiotic **Label:** Experimental probiotic group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No Intervention: control group patients will receive their standard therapy only collect blood sample and measure TMAO at baseline and after 3 months **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental probiotic group **Description:** Patients will be randomized into two groups each group includes 40 patients: Control group: 40 patients will receive their standard therapy only. Intervention group (probiotic group): 40 patients will receive probiotic 5 billion unit per day with their standard therapy for 3 months. **Name:** Lactobacillus containing probiotic **Other Names:** - probiotic **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** probiotic is expected to lower Trimethylamine-N-Oxide Plasma Level in dialysis patients **Measure:** change in Trimethylamine-N-Oxide Plasma Level **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who diagnosed as End Stage Renal Disease with hemodialysis * Aged 18 years or older. * Both sexes. * No known contraindications to therapy with probiotic * Patients who accept to participate in the study. Exclusion Criteria: * Pregnant and breast-feeding women * History of severe allergic reactions to the study medication. * Current medication regimen including probiotic * chronic liver disease * Patients receiving chronic anti-inflammatory therapy * Non-compliant patients: those who did not adhere to the medications during the study. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Al Azhar University ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Renal Disease - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: End Stage Renal Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000007676 - Term: Kidney Failure, Chronic ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T355 - Name: Acidophilus - Relevance: HIGH - As Found: Students ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421870 **Brief Title:** Renoprotective Effects of Dapagliflozin Versus Pentoxiphylline in Chronic Kidney Disease Patients **Official Title:** Renoprotective Effects of Dapagliflozin Versus Pentoxiphylline in Chronic Kidney Disease Patients #### Organization Study ID Info **ID:** MD277/2023 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** nahla mohamed elsayed teama **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Kidneys have a vital role in glucose homeostasis by various mechanisms, one of the major mechanisms is through SGLT2. This role was commonly overlooked till development of the new SGLT2 inhibitors. (Ni, L., et al 2020) The SGLT2 inhibitor class of glucose-lowering agents has recently shown beneficial effects to reduce the onset and progression of renal complications in people with and without diabetes, through slow the decline in glomerular filtration rate (GFR), delaying the onset of microalbuminuria and slow or reverse the progression of proteinuria. (Nespoux, J., \& Vallon, V. 2020) The drug pentoxifylline is a methyl-xanthine derivative and a nonselective phosphodiesterase inhibitor with anti-inflammatory, antiproliferative and antifibrotic actions currently indicated for peripheral artery disease. (Panchapakesan U et al.,2018) Chronic kidney disease is a progressive disorder in which patients are treated according to complications presented such as hypocalcemia, hyperkalemia, anemia and metabolic acidosis. **Detailed Description:** It is only in recent years that the attention was drawn on the key role of the kidney in glucose homeostasis. Nevertheless, along with the liver, the kidney has a key role in ensuring the energy needs during fasting periods. This organ has a vital role in absorbing the entire quantity of the filtered glucose. Having a glomerular filtration rate of 180 litres per day, it filters approximately 180 grams of glucose per day, bringing its contribution in maintaining normal fasting plasma glucose (FPG) levels. (Cersosimo, E.et al 2014) The reabsorption of glucose is ensured by the sodium-glucose cotransporter (SGLT) 2, responsible for the reabsorption of 90% of glucose, and SGLT1, that reabsorbs the remaining glucose. (Mota, M., et al 2015) Glomerular hyperfiltration is a common pathway of kidney injury both in diabetic and non-diabetic settings and is associated with progression of kidney function decline. (Hoogeveen, E. K. 2022) Sodium-glucose co-transporter-2 (SGLT2) inhibitors are glucose-lowering agents that eliminate excess glucose through a glucosuric effect by reducing glucose reabsorption from the renal filtrate (Thomson, S. C., et al. 2019) It is indicated that the expression of high mobility group box 1 (HMGB1) increased in patients with kidney disease, and may result in renal injury through the activation of nuclear factor- κB (NF- κB) and an increase in receptor for advanced glycation end products (RAGE) expression. It is suggested that Dapagliflozin achieves its reno-protective status through its antioxidative stress and anti-inflammatory action via inhibition of the HMGB1 - RAGE - NF- κB signalling pathway. (Yao, D et al., 2018) SGLT2 is found almost exclusively in the luminal membranes of epithelial cells lining the first and second segments of the proximal tubules, where it mediates reabsorption of most (typically ≥ 90%) of filtered glucose. (Mudaliar S, et al. 2015) By inhibiting SGLT2 beneficial kidney effects are thought to be mediated by various mechanisms, including restoration of tubule-glomerular feedback leading to a reduction in intraglomerular pressure and hyperfiltration. Both conditions are considered core components of the pathophysiology contributing to progression of diabetic as well as nondiabetic CKD. Reductions in intraglomerular pressure, as shown by agents blocking the renin-angiotensin system, are frequently accompanied by a hemodynamic acute decrease in GFR, which is reversible after treatment cessation. (Wanner et al., 2018). Common drug side effects of dapagliflozin include urinary tract infections, cystitis, hypotension, dehydration and female genital mycotic infections. Hypoglycemic episodes were reported in 6% to 10% of patients who administer dapagliflozin concurrently with insulin and insulin secretagogues. (Anderson SL et al., 2014) Pentoxifylline (PTF) is a synthetic dimethylxanthine derivative that modulates the rheological properties of blood and has both anti-oxidant and anti-inflammatory properties. PTF has been investigated for its possible use in diverse conditions, including osteoradionecrosis, diabetic kidney disease, and generally any condition associated with fibrosis. (Wen WX et al., 2017) PTF reduces levels of inflammatory markers: high-sensitivity C-reactive protein (hs-CRP), serum fibrinogen and TNF-α, this could reduce albuminuria and slow renal disease progression. (de Morales AM et al, 2019) Thus, we need to evaluate the effect of Dapagliflozin versus Pentoxifylline on GFR among CKD non-diabetic patients. ### Conditions Module **Conditions:** - Chronic Kidney Diseases **Keywords:** - Dapagliflozin - Chronic kidney disease - Pentoxiphylline ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 210 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 70 patients will take dapagliflozin 10 mg per day for 1 year in addition to standard management for chronic kidney disease **Intervention Names:** - Drug: Dapagliflozin 10mg Tab **Label:** Dapagliflozin arm **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 70 patients will take pentoxifylline 400 mg twice daily for 1 year in addition to standard management for chronic kidney disease **Intervention Names:** - Drug: Pentoxifylline 400 MG **Label:** Pentoxiphylline arm **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** 70 patients won't take either dapagliflozin or pentoxiphylline but they will continue their standard management for chronic kidney disease **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Dapagliflozin arm **Description:** Patients will be given dapagliflozin 10 mg once daily **Name:** Dapagliflozin 10mg Tab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Pentoxiphylline arm **Description:** Patients will be given pentoxyifylline 400 mg twice daily **Name:** Pentoxifylline 400 MG **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** eGFR will be based on serum creatinine and will be calculated by CKD-EPI 2021 **Measure:** Change in estimated glomerular filtration rate **Time Frame:** 1 year **Description:** Proteinuria quantification done by urine protein to creatinine ratio **Measure:** Change in proteinuria **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * CKD stage 2 and 3 Exclusion Criteria: * Diabetes mellitus * History of recurrent or recent genitourinary infections * Immunosuppressive medications * Malignancy **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mohamed A Mohamed, MSc **Phone:** 1119090018 **Phone Ext:** +20 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mohamed A Mohamed, MSc - **Phone:** 1119090018 - **Phone Ext:** +20 - **Role:** CONTACT **Country:** Egypt **Facility:** Ain Shams University **Status:** RECRUITING **Zip:** 1181 #### Overall Officials **Official 1:** **Affiliation:** Ain Shams University **Name:** Saeed A Saeed, Professor **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Ni L, Yuan C, Chen G, Zhang C, Wu X. SGLT2i: beyond the glucose-lowering effect. Cardiovasc Diabetol. 2020 Jun 26;19(1):98. doi: 10.1186/s12933-020-01071-y. **PMID:** 32590982 **Citation:** Nespoux J, Vallon V. Renal effects of SGLT2 inhibitors: an update. Curr Opin Nephrol Hypertens. 2020 Mar;29(2):190-198. doi: 10.1097/MNH.0000000000000584. **PMID:** 31815757 **Citation:** Panchapakesan U, Pollock C. Drug repurposing in kidney disease. Kidney Int. 2018 Jul;94(1):40-48. doi: 10.1016/j.kint.2017.12.026. Epub 2018 Apr 6. **PMID:** 29628139 **Citation:** Cersosimo E, Solis-Herrera C, Triplitt C. Inhibition of renal glucose reabsorption as a novel treatment for diabetes patients. J Bras Nefrol. 2014 Jan-Mar;36(1):80-92. doi: 10.5935/0101-2800.20140014. **PMID:** 24676619 **Citation:** DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab. 2012 Jan;14(1):5-14. doi: 10.1111/j.1463-1326.2011.01511.x. **PMID:** 21955459 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000010975 - Term: Platelet Aggregation Inhibitors - ID: D000011837 - Term: Radiation-Protective Agents - ID: D000020011 - Term: Protective Agents - ID: D000014665 - Term: Vasodilator Agents - ID: D000016166 - Term: Free Radical Scavengers - ID: D000000975 - Term: Antioxidants ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors ### Intervention Browse Module - Browse Leaves - ID: M348449 - Name: Dapagliflozin - Relevance: HIGH - As Found: COPD - ID: M13342 - Name: Pentoxifylline - Relevance: HIGH - As Found: Manufacturer - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M13629 - Name: Phosphodiesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M13865 - Name: Platelet Aggregation Inhibitors - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M14684 - Name: Radiation-Protective Agents - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000529054 - Term: Dapagliflozin - ID: D000010431 - Term: Pentoxifylline ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421857 **Brief Title:** Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma **Official Title:** Bipolar Coagulation Versus Suturing During Laparoscopic Endometriotic Cystectomy #### Organization Study ID Info **ID:** ASU Hemostasis #### Organization **Class:** OTHER **Full Name:** Ain Shams Maternity Hospital ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams Maternity Hospital #### Responsible Party **Investigator Affiliation:** Ain Shams Maternity Hospital **Investigator Full Name:** Nagat Hesham Abdelhai Mohammed **Investigator Title:** postgraduate student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected ### Conditions Module **Conditions:** - Endometrioma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 48 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** after ovarian cystectomy for endometrioma, separate sutures were applied if there was significant bleeding **Intervention Names:** - Procedure: suturing **Label:** suturing **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** after ovarian cystectomy for endometrioma, the inner wall was coagulated using bipolar electrocoagulation if there was significant bleeding **Intervention Names:** - Procedure: bipolar electrocoagulation **Label:** bipolar electrocoagulation **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - suturing **Description:** laparoscopic cystectomy for endometrioma and hemostasis was done using suturing **Name:** suturing **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - bipolar electrocoagulation **Description:** laparoscopic cystectomy for endometrioma and hemostasis was done bipolar electrocoagulation **Name:** bipolar electrocoagulation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** measuring AMH level **Measure:** ovarian reserve **Time Frame:** 6 weeks after procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 to 35 years * unilateral endometriotic cyst Exclusion Criteria: anovulatory women women with decreased ovarian reserve women receiving hormonal treatment three months prior to surgery women with any contraindication to laparoscopy women with previous ovarian surgery possible ovarian malignancy. **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Ain Shams university **Zip:** 11566 #### Overall Officials **Official 1:** **Affiliation:** Ain Shams University **Name:** Osama Kamel, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometrioma - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004715 - Term: Endometriosis ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421844 **Brief Title:** A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images **Official Title:** A Prospective Study: A Computer Vision Model on a Smartphone Platform for Real-time Evaluation of Serum Bilirubin Through Sclera Images #### Organization Study ID Info **ID:** KY20242031-F-1 #### Organization **Class:** OTHER **Full Name:** Air Force Military Medical University, China ### Status Module #### Completion Date **Date:** 2024-07-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Air Force Military Medical University, China #### Responsible Party **Investigator Affiliation:** Air Force Military Medical University, China **Investigator Full Name:** Yanglin Pan **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary efficacy endpoints are the standard deviation and coefficient of determination (R2) between predicted and actual values for the bilirubin regression model, and the grading accuracy for the jaundice severity classification model. The secondary efficacy endpoint is the mean percentage error between predicted and actual bilirubin values. There are no relevant safety risks. Statistical differences for categorical variables (e.g., jaundice grading evaluation indicators) will be analyzed using the chi-square test or Fisher's exact probability test. For continuous variables (e.g., bilirubin prediction evaluation indicators), t-tests (normal distribution) or non-parametric tests (non-normal distribution) will be used. The 95% confidence interval for jaundice grading accuracy will be calculated using the Wilson method. The study duration is estimated to be 3 months. ### Conditions Module **Conditions:** - Jaundice - Deep Learning - Hyperbilirubinemia - Sclera **Keywords:** - Smart phone - Hyperbilirubinemia - Real-time - Deep learning - Sclera ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 270 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Weeks ### Arms Interventions Module #### Arm Group 1 **Description:** The cohort consists of at least 270 subjects consecutively enrolled from the Department of Gastroenterology at Xijing Hospital. The subjects will be followed prospectively over a period of time to collect data on their age, medical information, scleral images, and liver function test results. The cohort includes patients with various liver diseases and varying degrees of jaundice severity. **Label:** Real-Time Scleral Jaundice Evaluation in Gastroenterology Cohort ### Outcomes Module #### Primary Outcomes **Description:** Standard deviation and mean average percentage error between predicted and actual bilirubin levels for the bilirubin regression model. **Measure:** Loss of predicted bilirubin levels **Time Frame:** Immediately after test completion **Description:** Classification accuracy for the jaundice severity grading model **Measure:** Classification accuracy **Time Frame:** Immediately after test completion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Age 14 years or older. Subjects who are visiting the Gastroenterology Department of Xijing Hospital and will undergo liver function tests on the same day. The disease spectrum of the subjects mainly includes pancreatitis, pancreatic tumors, hepatobiliary stones, biliary tumors, and colonic polyps. Exclusion Criteria: Subjects with diseases that may cause abnormal changes in scleral color, such as glaucoma, Wilson's disease, pterygium, or scleritis. Subjects who have recently consumed a large amount of carotenoid-rich foods (such as oranges or carrots). Subjects who are unable to provide informed consent. Elimination Criteria: Subjects with incomplete scleral exposure due to limited eye movement or excessive tension during external eye examination. Subjects who are unable to understand the instructions for eye rotation during scleral examination or are unable to cooperate due to reasons such as poor hearing. **Healthy Volunteers:** True **Minimum Age:** 14 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Study Population Description: The study will include a total of 270 patients, both male and female, aged 14 years and above. The participants should not have any pre-existing conditions that may affect the color of their sclera. They should be able to follow instructions and complete the scleral imaging procedure. The patient population will primarily consist of individuals undergoing treatment for colorectal polyps, pancreatitis, pancreatic tumors, hepatobiliary stones, or biliary tract tumors. Screening Procedure: Potential participants will be screened using oral queries to assess their eligibility based on the inclusion and exclusion criteria. A brief ocular examination will be performed to rule out any apparent ocular surface disorders. Eligible participants will be provided with a detailed explanation of the study objectives, procedures, and potential risks and benefits. Written informed consent will be obtained from all participants prior to enrollment in the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yanglin Pan, MD **Phone:** 86-13991811225 **Role:** CONTACT #### Locations **Location 1:** **City:** Xi'an **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yanglin Pan - **Phone:** 13991811225 - **Role:** CONTACT ***Contact 2:*** - **Name:** Xintain Yang - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** First Affiliated Hospital of Air Force Military Medical University **State:** Shaanxi **Status:** RECRUITING **Zip:** 710032 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Bang JY, Navaneethan U, Hasan M, Hawes R, Varadarajulu S. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos). Gastrointest Endosc. 2018 Jul;88(1):9-17. doi: 10.1016/j.gie.2018.03.012. Epub 2018 Mar 21. **PMID:** 29574126 **Citation:** Inamori G, Kamoto U, Nakamura F, Isoda Y, Uozumi A, Matsuda R, Shimamura M, Okubo Y, Ito S, Ota H. Neonatal wearable device for colorimetry-based real-time detection of jaundice with simultaneous sensing of vitals. Sci Adv. 2021 Mar 3;7(10):eabe3793. doi: 10.1126/sciadv.abe3793. Print 2021 Mar. **PMID:** 33658197 **Citation:** Bian Y, Zheng Z, Fang X, Jiang H, Zhu M, Yu J, Zhao H, Zhang L, Yao J, Lu L, Lu J, Shao C. Artificial Intelligence to Predict Lymph Node Metastasis at CT in Pancreatic Ductal Adenocarcinoma. Radiology. 2023 Jan;306(1):160-169. doi: 10.1148/radiol.220329. Epub 2022 Sep 6. **PMID:** 36066369 **Citation:** Wu HL, Yao LW, Shi HY, Wu LL, Li X, Zhang CX, Chen BR, Zhang J, Tan W, Cui N, Zhou W, Zhang JX, Xiao B, Gong RR, Ding Z, Yu HG. Validation of a real-time biliopancreatic endoscopic ultrasonography analytical device in China: a prospective, single-centre, randomised, controlled trial. Lancet Digit Health. 2023 Nov;5(11):e812-e820. doi: 10.1016/S2589-7500(23)00160-7. Epub 2023 Sep 27. **PMID:** 37775472 **Citation:** Park JH, Yang MJ, Kim JS, Park B, Kim JH, Sunwoo MH. Deep-Learning-Based Smartphone Application for Self-Diagnosis of Scleral Jaundice in Patients with Hepatobiliary and Pancreatic Diseases. J Pers Med. 2021 Sep 18;11(9):928. doi: 10.3390/jpm11090928. **PMID:** 34575705 **Citation:** Xiao W, Huang X, Wang JH, Lin DR, Zhu Y, Chen C, Yang YH, Xiao J, Zhao LQ, Li JO, Cheung CY, Mise Y, Guo ZY, Du YF, Chen BB, Hu JX, Zhang K, Lin XS, Wen W, Liu YZ, Chen WR, Zhong YS, Lin HT. Screening and identifying hepatobiliary diseases through deep learning using ocular images: a prospective, multicentre study. Lancet Digit Health. 2021 Feb;3(2):e88-e97. doi: 10.1016/S2589-7500(20)30288-0. **PMID:** 33509389 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000012877 - Term: Skin Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10595 - Name: Jaundice - Relevance: HIGH - As Found: Jaundice - ID: M9983 - Name: Hyperbilirubinemia - Relevance: HIGH - As Found: Hyperbilirubinemia - ID: M15680 - Name: Skin Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007565 - Term: Jaundice - ID: D000006932 - Term: Hyperbilirubinemia ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M4949 - Name: Bilirubin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421831 **Brief Title:** Evaluation of Safety and Efficacy of Gene Therapy Drug in the Treatment of Spinal Muscular Atrophy (SMA) Type 3 Patients **Official Title:** A Multi-center, Open Label, Single-arm, Dose Ascending Clinical Trial for Evaluation of Safety and Efficacy of Gene Therapy Drug GC101 in the Treatment of Spinal Muscular Atrophy (SMA) Type 3 Patients #### Organization Study ID Info **ID:** JLJY-GC101-SMA-010 #### Organization **Class:** INDUSTRY **Full Name:** GeneCradle Inc ### Status Module #### Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** GeneCradle Inc #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study will evaluate safety and efficacy of intrathecal delivery of GC101 gene therapy drug as a treatment of spinal muscular atrophy Type 3 (SMA 3) patients. **Detailed Description:** The purpose of this trial is to evaluate safety and efficacy of gene therapy drug GC101 in SMA 3 patients. Open-label, dose-escalation clinical trials of GC101 will be conducted in multiple centers in China. GC101 will be administrated intrathecally. Short-term safety will be evaluated in 52 weeks and enter long-term follow-up study of 5 years at will. Patients will be tested at baseline and followed up at various time points. The primary analysis for efficacy will be assessed at 12 months after treatment with GC101 on the changes from baseline HFMSE (Hammersmith Functional Motor Scale Expanded) and RULM（Revised Upper Limb Module) scores for patients of age ≥ 6 years old. ### Conditions Module **Conditions:** - Spinal Muscular Atrophy Type 3 **Keywords:** - SMA type 3 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 21 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1.2x10\^14 vg/person of GC101 delivered one-time intrathecally **Intervention Names:** - Genetic: GC101 **Label:** single dose cohort **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - single dose cohort **Description:** Self-complementary AAV9 carrying a codon-optimized SMN coding sequence(coSMN1) driven by CMV enhancer and chicken β-actin promoter **Name:** GC101 **Type:** GENETIC ### Outcomes Module #### Other Outcomes **Measure:** The proportion of patients whose Clinical Global Impression (CGI) is improved at Month 12 **Time Frame:** 52 weeks **Measure:** The proportion of patients whose Motor Function Measure (MFM) is improved or maintained at Month 12 **Time Frame:** 52 weeks **Measure:** Change from baseline of Forced Vital Capacity (FVC) at Month 12 ( for patients > 6 years) **Time Frame:** 52 weeks **Measure:** Change from baseline of Forced Expiratory Volume in 1 Second (FEV1) at Month 12 ( for patients > 6 years) **Time Frame:** 52 weeks **Measure:** Change from baseline of Maximal Inspiratory Pressure (MIP) at Month 12 ( for patients > 6 years) **Time Frame:** 52 weeks **Measure:** Change from baseline of Maximal Expiratory Pressure (MEP) at Month 12 ( for patients > 6 years) **Time Frame:** 52 weeks **Description:** The 6MWT is used for ambulatory participants with SMA and measures the total distance walked in 6 minutes. **Measure:** Change from baseline of 6 minutes walk test (6MWT) at Month 12 (for ambulatory patients) **Time Frame:** 52 weeks **Description:** The SMA Independence Scale (SMAIS) is a self-reported questionnaire to assess the amount of assistance patients require to perform daily activities. Higher SMAIS scores indicate greater independence. (range: 0-44). **Measure:** Change from baseline of SMA Independence Scale (SMAIS) at Month 12 **Time Frame:** 52 weeks #### Primary Outcomes **Description:** Frequency of treatment-related adverse events (AEs), serious adverse events (SAEs), and changes from baseline in relevant clinical laboratory tests **Measure:** Incidence of Treatment-Emergent Adverse Events **Time Frame:** 52 weeks **Description:** HFMSE consists of 33 activities that can be scored one of three ways: 0 for unable to perform, 1 for performs with modification/adaptation, and 2 for performs without modification. **Measure:** Change from baseline on Hammersmith Functional Motor Scale - Expanded (HFMSE) scores at Month 12 **Time Frame:** 52 weeks #### Secondary Outcomes **Description:** HFMSE ≥3 points：minimal clinically important differences (MCID) were considered for the outcomes: **Measure:** The proportion of patients whose HFMSE improvement ≥ 3 points at Month 12 **Time Frame:** 52 weeks **Description:** RULM is a 20-item evaluation of upper limb function primarily used for those with SMA who are non-ambulatory (young children through adults). **Measure:** Change from baseline on Revised Upper Limb Module (RULM) scores at Month 12 **Time Frame:** 52 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥2 years of age on the day of signing the informed consent form; * Genetic and clinical diagnosis of type 3 SMA with bi-allelic deletion of SMN1 of 5qSMA; * Hammersmith Functional Motor Scale - Expanded (HFMSE) score is between 10 and 54 at screening; * Female patients of childbearing age who are pregnant or lactating, as well as all enrolled patients （both male and female), should take effective contraceptive measures within 6 months after the treatment; * Patients or patient's legal guardian(s) must be able to understand the purpose and risks of the study and voluntarily provide signed and dated informed consent prior to any study-related procedures being performed. Exclusion Criteria: * Patient who has participated in any previous gene therapy research trials; * Patient who has AAV9 neutralizing antibody titer ≥1:200; * Patient who has received Nusinersen within 120 days and Risdiplam within 15 days before treatment; * Patient who requires invasive or non-invasive ventilatory support averaging≥16 hours/day at screening; * SMN2 copy numbers \>4； * Patient who needs nasal or gastric tube feeding for eating; * Patient who is positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis C antibody, or treponema pallidum antibody; * Known allergy or hypersensitivity to prednisolone or other glucocorticosteroids or their excipients * Severe contractures at screening that interfere with either the ability to attain/demonstrate functional measures or with the ability to receive intrathecal (IT) dosing; * Patient who has other serious diseases, such as severe cardiovascular and cerebrovascular diseases, digestive system diseases, urinary system diseases, endocrine system diseases, hematological diseases, immune system diseases, nervous system diseases (including but not limited to epilepsy, meningitis, history of convulsions or seizures, cerebrospinal fluid circulation disorders), and mental illnesses, etc.; * Patient with previous injuries (such as upper or lower limb fractures) or surgical operations that have not fully recovered or reached a stable state; * Vaccination no longer than 2 weeks before treatment; * Patient who has any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study. **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** GeneCradle, Inc China **Phone:** +8613501380583 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** Kang Zhang - **Role:** CONTACT ***Contact 2:*** - **Name:** Zaiqiang Zhang - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Yajie Wang - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Beijing Tiantan Hospital, Capital Medical University **State:** Beijing **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000016472 - Term: Motor Neuron Disease - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000009468 - Term: Neuromuscular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4589 - Name: Atrophy - Relevance: HIGH - As Found: Atrophy - ID: M12090 - Name: Muscular Atrophy - Relevance: HIGH - As Found: Muscular Atrophy - ID: M12091 - Name: Muscular Atrophy, Spinal - Relevance: HIGH - As Found: Spinal Muscular Atrophy - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M18879 - Name: Motor Neuron Disease - Relevance: LOW - As Found: Unknown - ID: M4024 - Name: Amyotrophic Lateral Sclerosis - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: T5342 - Name: Spinal Muscular Atrophy - Relevance: HIGH - As Found: Spinal Muscular Atrophy - ID: T5347 - Name: Spinal Muscular Atrophy Type 3 - Relevance: HIGH - As Found: Spinal Muscular Atrophy Type 3 - ID: T349 - Name: Amyotrophic Lateral Sclerosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009133 - Term: Muscular Atrophy - ID: D000009134 - Term: Muscular Atrophy, Spinal - ID: D000001284 - Term: Atrophy ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421818 **Brief Title:** Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis **Official Title:** Formula-to-Syndrome Effect and Pharmacomicrobiomics Mechanism of Colon Delivery of Baitouweng Decoction for Treating Large Intestine Damp-heat Syndrome of Ulcerative Colitis #### Organization Study ID Info **ID:** BTW-RCT #### Organization **Class:** OTHER **Full Name:** The Second Hospital of Nanjing Medical University ### Status Module #### Completion Date **Date:** 2026-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Heilongjiang University of Chinese Medicine #### Lead Sponsor **Class:** OTHER **Name:** The Second Hospital of Nanjing Medical University #### Responsible Party **Investigator Affiliation:** The Second Hospital of Nanjing Medical University **Investigator Full Name:** Faming Zhang **Investigator Title:** chief physician, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Baitouweng Decoction is traditionally used to treat large intestine damp-heat syndrome of ulcerative colitis (UC) by oral administration and rectal enema.The project applicant's invention of transendoscopic entral tubing (TET) has been used in Baitouweng Decoction for the treatment of UC across the whole colon, however, the efficacy have not been reported and the underlying mechanism is still unclear. Compared with oral and rectal enema, Baitouweng Decoction by colon TET can improve the therapeutic effect by increasing the concentration of drugs in the whole colon, which need to be verified. This project will reveal the prescription effect and drug-microbiome interaction mechanism of whole colon repeated administration of Baitouweng Decoction in the treatment of UC through clinical randomized controlled studies, deep intestinal dynamic sampling, integrated analysis of multi-omics and TCM prescription metabolomics studies, and provide key scientific basis for the establishment of a new approach of whole colon repeated administration of TCM and a new strategy for the treatment of UC. **Detailed Description:** A multi-center randomized controlled study will be conducted to compare the efficacy differences and multi-omics changes of colon TET, rectal enema and oral Baitouweng Decoction in the control of intestine damp-heat syndrome of UC. Moreover，a group of patients was designed to receive blank carrier solution through colon TET tube. After the study, the patients in this group were given compensation treatment of fecal microbiota transplantation as an ethical protection measure.The colonic TET will be implanted into the intestine and the whole colon will be covered with Baitouweng Decoction. The treatment period is 10 days. The primary outcome measure is the changes of fecal calprotectin before and after oral, colonic TET and rectal enema administration. And the secondary outcomes measure are the changes of disease condition, Mayo score and safety. Deep intestine fluid, stool, blood and urine samples were collected before and after treatment to study the changes of microbiomes, metabolomics and immunoomics. Identify the difference of the key material basis of Baitouweng Decoction and analyze its mechanism comprehensively. The key beneficial and harmful bacteria were identified by comprehensive analysis. A total of not less than 144 subjects are expected to be included and divided into colonic TET treatment group, colonic TET placebo group, rectal enema group, and oral group according to a ratio of 1:1:1:1. ### Conditions Module **Conditions:** - Ulcerative Colitis **Keywords:** - Baitouweng Decoction - Formula-to-Syndrome Effect - Ulcerative colitis - Pharmacomicrobiomics - Colon delivery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** For groups receiving Baitouweng Decoction by oral administration and rectal edema，the interventions are single-blind to investigators and outcomes assessor. For groups receiving Baitouweng Decoction or placebo by colonic TET, the interventions are double-blind to participants, care provider, investigators and outcomes assessor. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 144 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Baitouweng Decoction is administered through the colonic TET. **Intervention Names:** - Drug: Baitouweng Tang **Label:** Colonic TET treatment group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The same volume of placebo as the colonic TET treatment group was administered through the colonic TET. **Intervention Names:** - Other: Placebo **Label:** Colonic TET placebo group **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Baitouweng Decoction is administered through rectal enema. **Intervention Names:** - Drug: Baitouweng Tang **Label:** Rectal enema group **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Baitouweng Decoction is administered through oral. **Intervention Names:** - Drug: Baitouweng Tang **Label:** Oral group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Colonic TET treatment group - Oral group - Rectal enema group **Description:** Baitouweng Decoction is composed of four herbs: Baitouweng, Rhizoma coptidis, Phellodendri huangbai and Qin Pi. **Name:** Baitouweng Tang **Other Names:** - Baitouweng Decoction **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Colonic TET placebo group **Description:** The same volume and color as Baitouweng Decoction. **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** To compare the concentration of fecal calprotecin before and after oral, colonic TET and rectal enema administration. **Measure:** The concentration of fecal calprotecin. **Time Frame:** Baseline; Day 15; Day 53 #### Secondary Outcomes **Description:** To compare the change of Mayo score before and after oral, colonic TET and rectal enema administration. The Mayo score included the number of bowel movements, blood in the stool, endoscopic findings and overall physician evaluation. The total score was 12 points. The higher the score, the higher the degree of disease activity. **Measure:** The change of Mayo score. **Time Frame:** Baseline; Day 15; Day 22; Day 53; Day 99. **Description:** The number of adverse reactions that are associated with Baitouweng Decoction reported by subjects from the start of treatment to the end of follow-up. **Measure:** Incidence of Treatment-Emergent Adverse Events **Time Frame:** Day 15; Day 22; Day 53; Day 99. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients diagnosed with ulcerative colitis; 2. The patients are in mild to moderate active stage with Mayo score of 3-8. 3. Patients with damp-heat syndrome of large intestine according to TCM syndrome differentiation: according to the expert consensus on integrated traditional Chinese and Western medicine diagnosis and treatment of UC, the main symptoms are diarrhea, mucopurulent and bloody stool, abdominal pain, and tenesmus. Secondary symptoms: anal burning, body heat is not Yang, dry mouth and bitter mouth, short red urine. Tongue pulse: tongue red fur yellow greasy, pulse slippery number. The determination of the above 8 syndromes can be made if there are 2 main symptoms and 1-2 secondary symptoms. The tongue pulse is for reference only. 4. The patients who can tolerate Baitouweng Decoction; 5. The patients who tolerance to colonoscopy and TET; 6. The patients who know and agree to participate in the clinical trial. Exclusion Criteria: 1. The patients are complicated with other diseases that may cause diarrhea, such as infectious colitis, radiation enteritis, Crohn's disease, etc. 2. Patients with heart, brain, lung, liver, kidney and other serious diseases; 3. Patients do not cooperate to complete the clinical trial process; 4. Other cases considered unsuitable for inclusion. **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Faming Zhang, PhD **Phone:** 02558509670 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Bota Cui **Phone:** 02558509883 **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Faming Zhang, PhD - **Phone:** 086-025-58509883 - **Role:** CONTACT **Country:** China **Facility:** Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University **State:** Jiangsu **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** The Second Hospital of Nanjing Medical University **Name:** Faming Zhang, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Wang W, Lu G, Wu X, Wen Q, Zhang F. Colonic Transendoscopic Enteral Tubing Is a New Pathway to Microbial Therapy, Colonic Drainage, and Host-Microbiota Interaction Research. J Clin Med. 2023 Jan 18;12(3):780. doi: 10.3390/jcm12030780. **PMID:** 36769429 **Citation:** Zhang X, Zhang L, Chan JCP, Wang X, Zhao C, Xu Y, Xiong W, Chung WC, Liang F, Wang X, Miao J, Bian Z. Chinese herbal medicines in the treatment of ulcerative colitis: a review. Chin Med. 2022 Apr 4;17(1):43. doi: 10.1186/s13020-022-00591-x. **PMID:** 35379276 **Citation:** Gou H, Su H, Liu D, Wong CC, Shang H, Fang Y, Zeng X, Chen H, Li Y, Huang Z, Fan M, Wei C, Wang X, Zhang X, Li X, Yu J. Traditional Medicine Pien Tze Huang Suppresses Colorectal Tumorigenesis Through Restoring Gut Microbiota and Metabolites. Gastroenterology. 2023 Dec;165(6):1404-1419. doi: 10.1053/j.gastro.2023.08.052. Epub 2023 Sep 12. **PMID:** 37704113 **Citation:** Wei P, He Q, Liu T, Zhang J, Shi K, Zhang J, Liu S. Baitouweng decoction alleviates dextran sulfate sodium-induced ulcerative colitis by suppressing leucine-related mTORC1 signaling and reducing oxidative stress. J Ethnopharmacol. 2023 Mar 25;304:116095. doi: 10.1016/j.jep.2022.116095. Epub 2022 Dec 26. **PMID:** 36581160 **Citation:** Gu X, Miao Z, Wang Y, Yang Y, Yang T, Xu Y. New Baitouweng decoction combined with fecal microbiota transplantation alleviates DSS-induced colitis in rats by regulating gut microbiota metabolic homeostasis and the STAT3/NF-kappaB signaling pathway. BMC Complement Med Ther. 2022 Nov 24;22(1):307. doi: 10.1186/s12906-022-03766-z. **PMID:** 36424592 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000015212 - Term: Inflammatory Bowel Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M17206 - Name: Ulcer - Relevance: HIGH - As Found: Ulcerative - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M6320 - Name: Colitis - Relevance: HIGH - As Found: Colitis - ID: M6321 - Name: Colitis, Ulcerative - Relevance: HIGH - As Found: Ulcerative Colitis - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003092 - Term: Colitis - ID: D000003093 - Term: Colitis, Ulcerative - ID: D000013577 - Term: Syndrome - ID: D000014456 - Term: Ulcer ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421805 **Acronym:** MTDPUMCH **Brief Title:** Establishing Prospective Mediastinal Tumor Database of PUMCH **Official Title:** A Single-center, Prospective, and Observational Study on Population Characteristics, Pathological Features, and Prognostic Factors of Patients With Mediastinal Tumor: Establishing Mediastinal Tumor Database of PUMCH. #### Organization Study ID Info **ID:** MTDPUMCH #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2045-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2044-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2012-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-20 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Investigator Affiliation:** Peking Union Medical College Hospital **Investigator Full Name:** Xuehan Gao **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to prospectively document the population characteristics, imaging findings, pathological features, prognostic factors, etc., of patients with mediastinal tumors. Clinical information will be structured and processed, and it is recommended to establish a mediastinal tumors database at Peking Union Medical College Hospital. The goal is to provide support for the quality of diagnosis and treatment, clinical protocols, and medical decision-making related to mediastinal tumors. **Detailed Description:** Mediastinal tumors encompass a variety of tumors originating in the mediastinum, comprising both benign and malignant tumors, those invading mediastinal structures during disease progression, or metastases from malignant tumors originating elsewhere in the body. Based on their relationship with the pericardium, mediastinal tumors can be categorized into anterior mediastinal tumors, commonly including thymomas, retrosternal goiters, teratomas, and germ cell tumors; middle mediastinal tumors, which often include bronchogenic cysts, lymphomas, malignant lymphomas, pericardial cysts, lipomas, and esophageal cysts; and posterior mediastinal tumors, where neurogenic tumors and neurofibromas are prevalent. Mediastinal tumors are relatively rare compared to other solid tumors and exhibit complex pathological types. Consequently, conducting prospective randomized controlled clinical trials is challenging, and the significant treatment disparities among different types of mediastinal tumors affect patient survival outcomes. Clinicians often have limited understanding of some complex mediastinal tumors due to the lack of quality and reliable diagnostic and treatment standards or survival data. Therefore, establishing a specialized database for mediastinal tumor research holds great practical significance for the effective development of clinical practice. Tumor registration databases in North America and Europe have been established earlier, with wide coverage and relatively mature development. For example, the National Cancer Database (NCDB) in the United States is the largest tumor registration database globally, with over 1500 hospitals reporting tumor data to it, covering approximately 70% of newly diagnosed cancer cases. The Surveillance, Epidemiology, and End Results (SEER) database is a public health database based on tumor populations in some states and counties in the United States (17 regional registration centers). It has been registering data since 1973, covering tumor monitoring, epidemiology, and prognosis information. Both databases have high coverage and reasonable registration and verification systems, providing a wealth of high-level evidence for the formulation of tumor prevention and control strategies. In China, the development in this field started relatively late. To integrate resources, deeply explore data information, and further improve the diagnosis and treatment level and patient management level of mediastinal tumors in China, it is necessary to establish a scientifically standardized specialized mediastinal tumor database. ### Conditions Module **Conditions:** - Thymic Epithelial Tumor - Teratoma - Thymic Cyst - Retrosternal Goitre - Germ Cell Tumor - Lymphoma - Schwannoma **Keywords:** - mediastinal tumors - database - thymic epithelial tumor ### Design Module #### Bio Spec **Description:** After obtaining informed consent from the patients, tumor tissue specimens will be stored in the sample repository of PUMCH at -80 degrees Celsius. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 20 Years ### Arms Interventions Module #### Arm Group 1 **Description:** mediastinal tumors_thymoma **Label:** thymoma #### Arm Group 2 **Description:** mediastinal tumors_teratomas **Label:** teratoma #### Arm Group 3 **Description:** mediastinal tumors_germ cell tumors **Label:** germ cell tumor #### Arm Group 4 **Description:** mediastinal tumor_lymphoma **Label:** lymphoma #### Arm Group 5 **Description:** mediastinal tumor_NETs, including neuroendocrine tumours and neuroendocrine carcinomas. **Label:** mediastinal neuroendocrine tumors (NETs) #### Arm Group 6 **Description:** mediastinal tumor_neurinoma **Label:** neurinoma #### Arm Group 7 **Description:** mediastinal tumor_thymic carcinoma **Label:** thymic carcinoma #### Arm Group 8 **Description:** mediastinal tumors_other tumors **Label:** others ### Outcomes Module #### Primary Outcomes **Description:** Overall survival of patients with mediastinal tumors **Measure:** Overall survival (OS) **Time Frame:** From date of enrollment until the date of death from any cause, assessed up to 20 years #### Secondary Outcomes **Description:** Progression free survival of patients with mediastinal tumors **Measure:** Progression free survival (PFS) **Time Frame:** From date of enrollment until the date of first documented progression, assessed up to 20 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Clinical or pathological diagnosis of mediastinal tumors; 2. Written consent is able to obtained. Exclusion Criteria: 1. Incomplete clinicopathological information. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients diagnosed with mediastinal tumors clinically or pathologically. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xuehan Gao, MD **Phone:** +86 18801341299 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yeye Chen, MD **Phone:** 13671338819 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xuehan Gao, MD - **Phone:** 18801341299 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Yeye Chen, MD - **Phone:** 13671338819 - **Role:** CONTACT ***Contact 3:*** - **Name:** Xuehan Chen, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Peking Union Medical College Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100730 #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital **Name:** Shanqing Li, Prof. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** The research results have not been published. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009463 - Term: Neuroma - ID: D000018317 - Term: Nerve Sheath Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000008477 - Term: Mediastinal Diseases - ID: D000013896 - Term: Thoracic Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000003560 - Term: Cysts ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M16494 - Name: Teratoma - Relevance: HIGH - As Found: Teratoma - ID: M12386 - Name: Neurilemmoma - Relevance: HIGH - As Found: Schwannoma - ID: M11462 - Name: Mediastinal Neoplasms - Relevance: HIGH - As Found: Mediastinal Tumor - ID: M9147 - Name: Goiter - Relevance: LOW - As Found: Unknown - ID: M6765 - Name: Cysts - Relevance: LOW - As Found: Unknown - ID: M11459 - Name: Mediastinal Cyst - Relevance: HIGH - As Found: Thymic Cyst - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12406 - Name: Neuroma - Relevance: LOW - As Found: Unknown - ID: M20461 - Name: Nerve Sheath Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11460 - Name: Mediastinal Diseases - Relevance: LOW - As Found: Unknown - ID: M16655 - Name: Thoracic Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown - ID: T2475 - Name: Germ Cells Tumors - Relevance: HIGH - As Found: Germ cell tumor - ID: T5139 - Name: Schwannoma - Relevance: HIGH - As Found: Schwannoma - ID: T5647 - Name: Thymic Epithelial Tumor - Relevance: HIGH - As Found: Thymic Epithelial Tumor - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000013724 - Term: Teratoma - ID: D000009442 - Term: Neurilemmoma - ID: D000008479 - Term: Mediastinal Neoplasms - ID: D000008476 - Term: Mediastinal Cyst ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421792 **Acronym:** POISON **Brief Title:** PrOtamIne doSing clOt imagiNg (POISON) Study **Official Title:** Scanning Electron Microscopy (SEM) and Confocal Imaging of Clot in Two Different Protamine Environments (PrOtamIne doSing clOt imagiNg (POISON) Study) #### Organization Study ID Info **ID:** T03024 #### Organization **Class:** OTHER_GOV **Full Name:** Papworth Hospital NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-21 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Oxford **Class:** OTHER **Name:** University of Liverpool **Class:** OTHER_GOV **Name:** Medical Research Council #### Lead Sponsor **Class:** OTHER_GOV **Name:** Papworth Hospital NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 1:1 protamine / heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm. Patients will be treated according to the routine clinical practice of their individual care team. **Detailed Description:** Sample collection at RPH Patients will have a total of 14ml of blood taken during the procedure. The first 7ml will be taken after induction of anaesthesia along with routine blood gas and coagulation sampling through the routinely indwelling arterial catheter. The initial sample must be taken before any heparin has been administered. This will be used to fill 2 x 3.5ml citrated (green top) blood tubes. These will be clearly labelled as "pre-heparin" with a Tissue Bank ID number. The second 7ml will be taken 5 minutes after heparin has been reversed with protamine after cessation of cardiopulmonary bypass. It will again be taken at the same time as routine sampling for blood gas and coagulation studies. Analog to the first sample, it will again be divided and used to fill 2 x 3.5ml citrated (green top) blood tubes. These will be clearly labelled as "post-protamine" with the same ID number and whether "1:1" or a "PRODOSE algorithm determined" protamine: heparin ratio was used. In keeping with clinical routine, ROTEM coagulation testing and full blood counts will be requested as seen necessary by the clinical team. The samples will be sent to Royal Papworth Hospital (RPH) Tissue Bank for initial processing. Samples need to be processed within 4 hours of blood draw. After initial processing, samples will be sent for confocal imaging to the MRC Laboratory of Molecular Biology (LMB) and for SEM imaging to the University of Oxford respectively. Clinical data to be collected (to be completed by anaesthetic team). 1. Demographic information: Age / Gender / Weight / Height / Medication history; 2. Type of surgery; 3. Cardiac drug history and antiplatelets / anticoagulants and timing; 4. Coagulation tests (ACT / ROTEM) at the following points: a) Pre-heparin, b) Post-heparin, pre-CPB, c) Throughout CPB, c) Post-protamine; 5. Full blood count at the following points: a) Pre-surgery and date of sample, b) Post-protamine; 6) CPB and x-clamp times, nadir temperature ### Conditions Module **Conditions:** - Cardiac Surgery ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** OTHER #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 10 patients receiving standard reversal with 1:1 protamine / heparin ratio **Label:** Standard #### Arm Group 2 **Description:** 10 patients who had heparin reversed using the PRODOSE algorithm anticipated (average protamine / heparin ratio 0.6:1). **Label:** PRODOSE Algorithm ### Outcomes Module #### Primary Outcomes **Description:** The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 1:1 protamine / heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm. This is an observational study in which differences between images of clot obtained from samples from the two patient groups and before and after cardiopulmonary bypass will be described. **Measure:** High-resolution microscopic images (Scanning Electron Microscopy and Confocal Imaging) **Time Frame:** Pre Heparin and Post Protamine [5 minutes after heparin has been reversed] ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * undergoing elective, uncomplicated single procedure cardiac surgery with anticipated CPB duration \< 120 min * with all anticoagulant drugs stopped at least 5 days before surgery, apart from aspirin * with normal full blood count and clotting screen pre-OP. Exclusion Criteria: * emergency surgery * inability to stop anticoagulants except aspirin for 5 days pre-OP * complex surgery with anticipated CPB duration \> 120min * operations planned to be done at temperature on CPB \< 34 degrees * operations requiring deep hypothermic circulatory arrest, solid organ transplantation * know blood dyscrasia * intra-operative blood or blood product transfusion or post-operative coagulopathy **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients undergoing elective, uncomplicated single procedure cardiac surgery with anticipated CPB duration \< 120 min ### Contacts Locations Module #### Locations **Location 1:** **City:** Cambridge **Country:** United Kingdom **Facility:** Royal Papworth Hospital NHS Foundation Trust **State:** Cambridgeshire **Zip:** CB23 3RE ### IPD Sharing Statement Module **Description:** Small observational study so IPD not relevant **IPD Sharing:** NO ### References Module #### References **Citation:** Miles LF, Burt C, Arrowsmith J, McKie MA, Villar SS, Govender P, Shaylor R, Tan Z, De Silva R, Falter F. Optimal protamine dosing after cardiopulmonary bypass: The PRODOSE adaptive randomised controlled trial. PLoS Med. 2021 Jun 7;18(6):e1003658. doi: 10.1371/journal.pmed.1003658. eCollection 2021 Jun. **PMID:** 34097705 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Coag - Name: Coagulants ### Intervention Browse Module - Browse Leaves - ID: M9579 - Name: Heparin - Relevance: LOW - As Found: Unknown - ID: M46053 - Name: Calcium heparin - Relevance: LOW - As Found: Unknown - ID: M14342 - Name: Protamines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421779 **Brief Title:** The Effect of Virtual Reality (VR) on Skin Prick Test Related Pain and Fear in Children **Official Title:** A Game-Like Skin Testing Experience: The Effect of Virtual Reality (VR) on Skin Prick Test Related Pain and Fear in Children (Randomized Controlled Trial) #### Organization Study ID Info **ID:** ADUPIA-CSAHIN-1 #### Organization **Class:** OTHER **Full Name:** Aydin Adnan Menderes University ### Status Module #### Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Aydin Adnan Menderes University #### Responsible Party **Investigator Affiliation:** Aydin Adnan Menderes University **Investigator Full Name:** Cihangir Sahin **Investigator Title:** Research Assistant Medical Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to show the effect of VR on skin prick test-related pain and fear in children. The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR. **Detailed Description:** Pain and fear during interventional procedures in pediatric patients are some of the most difficult problems in hospitals. While bad experiences in childhood can lead to increased sensitivity to pain, sleep problems, social learning difficulties, phobias, pre-treatment anxiety disorders, and treatment resistance; increases the risk of anxiety and depression in adulthood. Skin prick test is the gold standard diagnostic method most frequently used in Pediatric Allergy clinics for the detection of allergens with high sensitivity, specificity, and reliability. The numerous pricking procedures performed during the skin test may turn into a painful and frightening experience for children. Virtual reality (VR) is often accomplished using a special headset or glasses and can create for children a virtual world separate from their current physical environment, effectively distracting them from the possible pain and fear experience. There is no study in the literature investigating the effect of VR on skin prick test-related pain and fear in children. This study aims to show the effect of VR on skin prick test-related pain and fear in children. The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR. The hypotheses of this study were to: H1: The virtual reality (VR) group will experience less pain due to the skin prick test than the control group. H2: The virtual reality (VR) group will experience less fear due to the skin prick test than the control group. Study Design: This study is a parallel group randomized controlled trial planned to be conducted in the skin testing unit of a tertiary reference center of a pediatric allergy outpatient clinic between March and June 2024. The CONSORT guideline will be followed in the study. Fifty children between the ages of 4 and 10 years, who decided to undergo skin prick testing, will be randomized into two groups: using VR (VR group, n = 25) and not using VR (Control group; n = 25) by block randomization method. The reason for choosing this age group is that this age group is the common validation age range of the Wong-Baker FACES Pain Rating Scale (WB-FACES) and Child Fear Scale (CFS), which the investigators will use in the evaluation of pain and fear, in the Turkish children. At the same time, children in this age group are curious about technology and open to collaboration. Sample Size and Randomization: The number of patients was determined by taking the data obtained from the reference study titled "The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy® (Randomized Controlled Trial)". Power analysis was performed based on self-report data of the WB-FACES Pain Rating scale in the study. According to the calculation by G\*Power 3.1.9.7, the effect size was determined as 0.92, the alpha margin of error was 0.05, the statistical power was 80%, and it was determined that at least 19 participants in each group were required to conduct the study. The analysis showed that a total sample size of 38 participants would be sufficient to detect significant differences. In light of the potential losses of 10% that may occur during the study, the investigators planned to include at least 21 participants in both groups to obtain a total of 42 participants. In the literature, the studies show that gender and age affect pain and fear associated with invasive procedures in children. Therefore, gender (girls and boys) and age group (4-6 years (preschool) and 7-10 years (school age)) variables were used for block randomization. Blocks were repeated 5 times in each group. 25 participants were assigned to each of the VR and Control groups. A blocked randomization list was developed using an online randomization tool. The investigators were not blinded to group allocation because they performed the randomization themselves. Ethics: The study was approved by the local research ethics committee of our institution (2024/66). All participants will take part voluntarily, and personal written informed consent will be obtained from the parents of all participants, and verbal consent will be obtained from the participants before participation. Data Collection Tools: Data will be collected with a case report form created using WB-FACES and CFS. Both scales are suitable for personal, parent, and researcher evaluation. In our study, children's personal, parent, and researcher reporting data will be evaluated for both scales. Investigator reporting data will be evaluated by a specialist nurse trained on the scales. Wong-Baker FACES Pain Rating Scale (WB-FACES): The Wong-Baker FACES Pain Rating Scale (WB-FACES) was developed in 1981 and revised in 1983. WB-FACES is a reliable scale that has been validated for the Turkish population. The scale is used to diagnose pain in children ages 3-18 years. It consists of six facial expressions, each representing increasing degree of pain scored from 0 to 5 from left to right (0 = very happy face/no pain, 5 = a crying face/worst pain imaginable). High scores indicate low pain tolerance. The child is asked to rate his/her pain by asking "Can you show me the face that shows how you feel right now?". Children's Fear Scale (CFS): The Child Fear Scale (CFS) was developed in 2011. It was adapted into Turkish in 2018, by studying it with children aged 4-10 years. It consists of five facial expressions representing a range from neutral=0 to extreme fear=4. Virtual Reality (VR): Virtual reality (VR) allows the user to visit a three-dimensional world, isolating them from real life. VR is an advanced technology that offers a 360-degree visual and audio simulation that surrounds the user and allows them to look in all directions. In this study, VR intervention will be performed using a smartphone (Samsung Galaxy S23 Ultra, Qualcomm Snapdragon 8 Gen 2 processor, 12 GB RAM, Android 14 version, One UI 6.0 version, Dynamic AMOLED 1440x3088 QHD+ Pixel Screen, Stereo Dual Speakers), VR glasses (Schulzz VRG Pro) and a VR underwater experience video (2160p resolution video suitable for VR format) that will attract the attention of age groups. Procedure: Each child will be admitted to the skin testing unit with his/her parents. The skin testing unit has the same environmental conditions (seat, temperature, light, noise, etc.). Participants will be randomly selected into groups. The researcher will inform the participants and parents about the skin prick test and scales (WB-FACES and CFS). Before the procedure, all participants will be asked verbally about their baseline fear status due to the skin prick test. Participants in the VR group will put on VR glasses for approximately two minutes before the skin prick test and watch a VR underwater experience video throughout the procedure. Participants in the control group will undergo a routine skin prick test procedure. The VR intervention and skin prick testing will terminate at the same time. The researcher will use a case report form to collect data for participants and their parents. Immediately after the procedure, participants will describe their pain levels with WB-FACES and their fear levels with CFS. Meanwhile, a volunteer parent and a specialist nurse will observe the children's behavior and perform the WB-FACES and CFS evaluations separately. The data collection process will be planned to be completed in approximately ten minutes. Skin prick test: Skin prick tests will be performed over the same period by a volunteer nurse with at least 5 years of experience. All participants will undergo the same aeroallergen skin test panel. Skin prick tests will be performed using a prick test applicator (MedBlue One, Türkiye) on the flexural aspect of the forearm by standard guidelines using standardized glycerinated extracts (1% weight/volume) from LOFARMA (Milan, Italy). Statistical analysis: SPSS version 23.0 statistical software (IBM SPSS Inc., Chicago, IL, USA) will be used for statistical analysis. Categorical variables will be presented as numbers (%), and continuous variables will be presented as mean±SD and median values (interquartile range-IQR). Univariate analyses including categorical data will be performed using the χ2 test. If data exhibit normality according to the Shapiro-Wilk normality test, parametric values will be analyzed using the Student's t-test, and non-parametric variables will be analyzed using the Mann-Whitney U test. P\<0.05 value was considered statistically significant. ### Conditions Module **Conditions:** - Pain - Fear - Fear of Pain - Child, Only - Allergy **Keywords:** - Skin Prick Test - Virtual Reality - Pain - Fear - Child - Allergy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A Prospective parallel group randomized controlled trial. ##### Masking Info **Masking:** SINGLE **Masking Description:** Children aged 4 to 10 years for whom a skin prick test has been decided. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Children in the VR group put on VR glasses for approximately two minutes before the skin prick test and watched a VR underwater experience video throughout the procedure. **Intervention Names:** - Behavioral: Virtual reality (VR) **Label:** Experimental: VR **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Children in the control group underwent a routine skin prick test procedure. Control group children did not receive any distraction techniques. **Label:** No Intervention: Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental: VR **Description:** Children watch underwater experience video by wearing the virtual reality glass during the skin prick test. **Name:** Virtual reality (VR) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Wong-Baker FACES (WB-FACES) Pain Rating Scale used. The Wong-Baker FACES Pain Rating Scale (WB-FACES) was developed in 1981 and revised in 1983. WB-FACES is a reliable scale that has been validated for the Turkish population. The scale is used to diagnose pain in children ages 3-18 years. It consists of six facial expressions, each representing increasing degree of pain scored from 0 to 5 from left to right (0 = very happy face/no pain, 5 = a crying face/worst pain imaginable). High scores indicate low pain tolerance. The child is asked to rate his/her pain by asking "Can you show me the face that shows how you feel right now?". **Measure:** Skin prick test-related pain **Time Frame:** Through painful procedure completion, an average of 10 minutes. **Description:** The Child Fear Scale (CFS) used. The Child Fear Scale (CFS) was developed in 2011. It was adapted into Turkish in 2018, by studying it with children aged 4-10 years. It consists of five facial expressions representing a range from neutral=0 to extreme fear=4. **Measure:** Skin prick test-related fear **Time Frame:** Through fearful procedure completion, an average of 10 minutes. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * being between the ages of 4-10 years * requirement of skin prick test due to allergic diseases Exclusion Criteria: * having chronic diseases (except allergic diseases) * vision, hearing, and speech disorders * psychiatric and neurological diseases * mental status disorder, learning and perception disorder * a history of pre-procedure sedative, analgesic or narcotic drug use within 24 hours * a history of active infection * those who are scheduled to undergo a skin test other than an aeroallergen panel * contra-indicated conditions for skin prick testing such as dermographism, severe eczema, being under drugs (immunosuppressive drugs, antihistamine, steroid, etc) **Healthy Volunteers:** True **Maximum Age:** 10 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cihangir Sahin **Phone:** +905544113216 **Role:** CONTACT #### Locations **Location 1:** **City:** Aydin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Cihangir Sahin - **Phone:** +905544113216 - **Role:** CONTACT **Country:** Turkey **Facility:** Aydin Adnan Menderes University, School of Medicine, Department of Pediatric Immunology and Allergy **Status:** RECRUITING **Zip:** 09100 #### Overall Officials **Official 1:** **Affiliation:** Aydin Adnan Menderes University, Department of Pediatric Immunology and Allergy, Aydin, Türkiye **Name:** Cihangir Sahin **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Allergy - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006967 - Term: Hypersensitivity ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421766 **Brief Title:** Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures **Official Title:** Retrospective Study of Outcomes With 3 mm Implant for Percutaneous Bone-anchored Hearing System (BAHS) Procedures #### Organization Study ID Info **ID:** BC122 #### Organization **Class:** INDUSTRY **Full Name:** Oticon Medical ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Oticon Medical #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This retrospective study is conducted to gain more knowledge on use and complications of 3mm long implants used in percutaneous (through the skin) bone-anchored hearing system (BAHS) surgeries in adults. Patients included have already been treated and recieved an implant with the wide diameter (Ø: 4.5 mm) design, either of 3- or 4mm length. The main purpose of the study is to investigate implant survival three months after implantation. **Detailed Description:** BAHS systems are intended for patients with conductive or mixed hearing loss, and for patients with single-sided deafness. In BAHS surgery, an implant - coupled to a skin-penetrating abutment - is implanted in the bone behind the ear and is later loaded with a sound processor. The sound processor transforms sound waves to sound vibrations that are transferred through the skull bone to the inner ear(s)/cochlea. Thus, sound can be transmitted directly to the cochlea and bypass any problems in the ear canal or middle ear. Today, more than 400,000 implantations have been made around the world and the long-term success rate of BAHS surgery is high, with a low rate of major complications. Over the years, both implant design and surgical techniques have developed, with improved patient outcomes as a result. Wider diameter implants, 4.5mm in diameter, increased the implant stability and have become standard. The implants exist in two different lengths, 3- and 4mm, to accomodate for different bone thickness. The shorter implant has primarily been used for (young) children and for adults with thinner bone. The aim of this restrospective study is to investigate the outcomes after implantation of a 3mm implant in an adult population. ### Conditions Module **Conditions:** - Hearing Loss ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients recieving a 3mm long implant **Intervention Names:** - Device: BAHS **Label:** 3mm implant #### Arm Group 2 **Description:** Patients recieving a 4mm long implant **Intervention Names:** - Device: BAHS **Label:** 4mm implant ### Interventions #### Intervention 1 **Arm Group Labels:** - 3mm implant - 4mm implant **Description:** Implantation of a percutaneous bone-anchored hearing system **Name:** BAHS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Implant in place in skull bone at 3 months (Yes/No). **Measure:** Implant survival **Time Frame:** 3 months after implant surgery #### Secondary Outcomes **Description:** Implant in place in skull bone at end of observation (Yes/No). **Measure:** Implant survival **Time Frame:** Through study completion, with minimum 3 months **Description:** Assessment of intraoperative events during surgery by the investigator. Will be presented in a frequency table. **Measure:** Number and type of intraoperative events **Time Frame:** During surgery **Description:** Assessment of postoperative events during the initial postoperative period (0-3 months) by the investigator. Will be presented in a frequency table. **Measure:** Number and type of postoperative events **Time Frame:** Up to 3 months **Description:** Time from surgery to sound processor loading **Measure:** Time to sound processor loading **Time Frame:** Up to 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patient (≥19 years) receiving percutaneous BAHS treatment using an implant with the wide diameter (Ø: 4.5 mm) design. Exclusion Criteria: * Patient undergoing re-implantation due to previous failure of osseointegration or other spontaneous implant loss. * Patient undergoing conversions from passive transcutaneous devices (i.e. BAHA Attract) to active percutaneous devices (using an abutment), using the same implant for attachment. **Minimum Age:** 19 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients that have already obtained surgical intervention with a percutaneous bone anchored hearing system. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sara Svensson, PhD **Phone:** +46735042041 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nicole Amichetti, PhD **Phone:** +1 609-366-0424 **Role:** CONTACT #### Locations **Location 1:** **City:** Birmingham **Contacts:** ***Contact 1:*** - **Name:** Dennis G Pappas, MD - **Role:** CONTACT **Country:** United States **Facility:** Alabama Ear Specialists **State:** Alabama **Status:** RECRUITING **Zip:** 25233 #### Overall Officials **Official 1:** **Affiliation:** Alabama Ear Specialists **Name:** Dennis G Pappas, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006311 - Term: Hearing Disorders - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M24420 - Name: Hearing Loss - Relevance: HIGH - As Found: Hearing Loss - ID: M6840 - Name: Deafness - Relevance: LOW - As Found: Unknown - ID: M9400 - Name: Hearing Disorders - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000034381 - Term: Hearing Loss ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421753 **Acronym:** SDSS_UMS **Brief Title:** Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients **Official Title:** Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients #### Organization Study ID Info **ID:** 2024-01-VR #### Organization **Class:** OTHER **Full Name:** UGECAM Rhône-Alpes ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** UGECAM Rhône-Alpes #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To determine whether Spatially Distributed Sequential Functional Electrical Stimulation is more effective than Standard Electrical Stimulation During Functional Electrical Stimulation in Upper Motor Neuron Patients **Detailed Description:** Design: SCED (single case experimental design) prospective, monocentric, comparative interventional study (SDSS versus SES) Population: patients with motor deficit due to upper motor neuron syndrome Setting: Neurologic Rehabilitation Unit Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling. Participants will be evaluated before and during the training. ### Conditions Module **Conditions:** - Upper Motor Neuron Disease **Keywords:** - functional electrical stimulation - muscle fatigue - rehabilitation - spinal cord injury - stroke - multiple sclerosis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** SCED : Single Case Experimental Design Each patient is his own control Patient will be randomised to receive FES-cycling with SDSS or standard electrical stimulation ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling. **Intervention Names:** - Device: SDSS **Label:** Spatially Distributed Sequential Functional Electrical Stimulation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out. During the second session, the order of the stimulation phases is reversed. **Intervention Names:** - Device: Standard Electrical Stimulation During Functional Electrical Stimulation **Label:** Standard Electrical Stimulation During Functional Electrical Stimulation **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Spatially Distributed Sequential Functional Electrical Stimulation **Description:** Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out During the second session, the order of the stimulation phases is reversed. **Name:** SDSS **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Standard Electrical Stimulation During Functional Electrical Stimulation **Description:** Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out During the second session, the order of the stimulation phases is reversed. **Name:** Standard Electrical Stimulation During Functional Electrical Stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The subjects are installed on a Hepha Bike electrostimulation bike, equipped with force-torque measuring pedals (ICS_RM, Sensix, France), synchronized with a MotiMove-8 stimulator. The average quadriceps power (watts) during the first and last 30 seconds of each stimulation phase, as well as the total average power (Pm) are calculated. **Measure:** Average quadriceps power output (watts) measured during 3 minutes of FES cycling **Time Frame:** during sessions of FES cycling #### Secondary Outcomes **Description:** Dry electrode then hydrogel electrode are placed on the quadriceps' motor point The amplitude of stimulation is increased in steps of 3 mA followed by 5 seconds of rest for subsequent trains until the subject feels a burning sensation. the stimulation threshold (mA) is compared between dry and hydrogel electrode **Measure:** Evaluate the comfort of dry and hydrogel based functional electrical stimulation electrodes **Time Frame:** before the first session of FES cycling ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients with Upper Motor Neuron syndrome: * adult (\> 18 years) * motor deficit due to an acquired traumatic or neurodegenerative motor deficiency of the central nervous system (MRC\<4/5) * stable clinical condition, particularly on the cardiovascular level (recent assessment by a cardiologist with stress test) * non denervated muscles * tolerant to muscle electrical stimulation * having given written consent * able to cycle 30 minutes with FES-cycling Exclusion Criteria: * major cognitive comprehension disorders that could compromise understanding of the protocol and the smooth running of the study * cardiac pacemaker and other contraindications relating to the use of electrostimulation (in particularly "deep vein thrombosis") * spasticity of the lower limbs making flexion/extension movement difficult * participation in another study * pregnancy * people with the following legal and administrative states or situations: * people placed under judicial protection; * persons deprived of their liberty, persons subject to psychiatric care and persons admitted to a health or social establishment for purposes other than that of clinical investigation; * unemancipated minors; * people who are not affiliated to a social security scheme or beneficiaries of such a scheme **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** julie di marco, MD **Phone:** 01133472532161 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** sarah finel **Role:** CONTACT #### Locations **Location 1:** **City:** Saint didier au mont d'or **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** julie di marco, MD - **Phone:** 01133472532161 - **Role:** CONTACT ***Contact 2:*** - **Name:** julie di marco, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** SMR Val Rosay **Status:** RECRUITING **Zip:** 69370 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000057177 - Term: TDP-43 Proteinopathies - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M22306 - Name: Stroke - Relevance: LOW - As Found: Unknown - ID: M15916 - Name: Spinal Cord Injuries - Relevance: LOW - As Found: Unknown - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M15415 - Name: Sclerosis - Relevance: LOW - As Found: Unknown - ID: M12060 - Name: Multiple Sclerosis - Relevance: LOW - As Found: Unknown - ID: M18879 - Name: Motor Neuron Disease - Relevance: HIGH - As Found: Motor Neuron Disease - ID: M4024 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Motor Neuron Disease - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M28759 - Name: TDP-43 Proteinopathies - Relevance: LOW - As Found: Unknown - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T349 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Motor Neuron Disease - ID: T4699 - Name: Primary Lateral Sclerosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016472 - Term: Motor Neuron Disease - ID: D000000690 - Term: Amyotrophic Lateral Sclerosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421740 **Acronym:** REACH-AD **Brief Title:** An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China **Official Title:** REal-world Utilization and Treatment Target ACHievement With Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis in China #### Organization Study ID Info **ID:** P24-965 #### Organization **Class:** INDUSTRY **Full Name:** AbbVie ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AbbVie #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Upadacitinib is an approved drug for treating AD. Approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in China. Participants will receive oral upadacitinib tablets as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 12 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. ### Conditions Module **Conditions:** - Atopic Dermatitis **Keywords:** - Upadacitinib - Rinvoq ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive upadacitinib as prescribed by their physician according to local label. **Label:** Upadacitinib ### Outcomes Module #### Primary Outcomes **Description:** Dose change includes: Changed dose, dose escalation or dose tapering. **Measure:** Number of participants with a dose change **Time Frame:** 12 Months **Description:** Interruption: Upadacitinib is temporarily interrupted due to atopic dermatitis disease condition, economic, tolerance, AE, or personal reasons, and the investigator considers there is still possibility of Upadacitinib re-initiating within the patient's study follow-up period. Discontinuation: Upadacitinib is permanently discontinued for safety or any other reasons, and the investigator considers Upadacitinib will not be used again, at least within the participant's study follow-up period. **Measure:** Number of participants with interruption or permanent discontinuation **Time Frame:** 12 Months **Description:** The participants missed medication, regardless of reason, or incompliance with the prescription as per medical advice are to be recorded in the eDiary, choosing the reason: "Forgot, Self-reduction of medication, interruption because of AE, interruption not due to safety/tolerability, for other reasons". If no eDiary entries are found within 30 days before the visit, the participant will need to complete the following question in ePRO: timely Upadacitinib intake per medical advice in past 30 days (yes/no); if "no", days-off-drug, intentionally or accidentally, and if "intentionally", reason for incompliance with medical prescription. **Measure:** Number of participants with Upadacitinib drug compliance **Time Frame:** 12 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adolescents (body weight \>= 40 kg at the Baseline Visit for patients between \>= 12 and \< 18 years of age) and adults at the time of enrollment. * Clinical diagnosis of moderate to severe atopic dermatitis at the time of enrollment. * UPA treatment is indicated for AD and prescribed as per Chinese label / SmPC. * The decision to prescribe UPA is made prior to and independent of study participation. * The participant should not be treated with UPA prior to this study. * Participants who are willing and able to participate in the collection of patient-reported data, including ePROs and eDiary via apps. * The participant (legal representative for adolescents) voluntarily signed an informed consent before any study-related activities are conducted. Exclusion Criteria: * The participant is currently participating in interventional research (not including noninterventional study, observational study, or registry participation). * Any circumstances that the investigator believes may limit the patient's participation and compliance with study procedures. **Minimum Age:** 12 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Adolescent and adult Chinese participants with atopic dermatitis (AD) who are prescribed Upadacitinib by their physician according to their local label. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Judy Yu **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** AbbVie **Name:** ABBVIE INC. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### See Also Links **Label:** Related Info **URL:** https://www.abbvieclinicaltrials.com/study/?id=P24-965 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases - ID: D000012873 - Term: Skin Diseases, Genetic - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000017443 - Term: Skin Diseases, Eczematous - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M7071 - Name: Dermatitis, Atopic - Relevance: HIGH - As Found: Atopic Dermatitis - ID: M7655 - Name: Eczema - Relevance: HIGH - As Found: Atopic Dermatitis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15676 - Name: Skin Diseases, Genetic - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M19712 - Name: Skin Diseases, Eczematous - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003876 - Term: Dermatitis, Atopic - ID: D000003872 - Term: Dermatitis - ID: D000004485 - Term: Eczema ### Intervention Browse Module - Browse Branches - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M275493 - Name: Upadacitinib - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421727 **Brief Title:** Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness. **Official Title:** Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness: A Longitudinal Study #### Organization Study ID Info **ID:** Soh-Med-24-01-06MD #### Organization **Class:** OTHER **Full Name:** Sohag University ### Status Module #### Completion Date **Date:** 2026-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-20 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sohag University #### Responsible Party **Investigator Affiliation:** Sohag University **Investigator Full Name:** Nada Mostafa Abdelhamid **Investigator Title:** Assistant lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness: A longitudinal Study **Detailed Description:** this study will be conducted to show the long term effect of combined vestibular rehabilitation incorporating optokinetic stimulation and virtual reality exercises on persistent postural perceptual dizziness patients. Aim:1.Evaluate the balance control function in patients with persistent postural perceptual dizziness using computerized dynamic posturography. 2.To study effect of rehabilitation using optokinetic stimulation and virtual reality on persistent postural perceptual dizziness patients. 3.To follow up patients after the vestibular rehabilitation therapy to study the persistence of improvement" if any" in patients with persistent postural perceptual dizziness . Type of the study : prospective cohort and longitudinal study. Sources of data : Audio-vestibular medicine unit , Sohag University Hospital. Study group : consists of 36 patients age ranged from 18-65 years suffering from symptoms of persistent postural perceptual vertigo. All subjects will be submitted to: A- Detailed medical history, full history of dizziness. B-Acoustic impedance test. C-Basic audiological evaluation. D- Vestibular assessment. ### Conditions Module **Conditions:** - Persistent Postural Perceptual Dizziness ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** combined vestibular rehabilitation incorporating optokinetic stimulation and virtual reality exercises on persistent postural perceptual dizziness patients. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** combined vestibular rehabilitation incorporating optokinetic stimulation and virtual reality exercises (by device Virtual reality system(Meta Quest 2_Advanced All-In-One Virtual Reality Headset_ 128 GB)) on persistent postural perceptual dizziness patients. **Intervention Names:** - Other: Rehabilitation by optokinetic stimulation and virtual reality exercises . **Label:** Rehabilitation by optokinetic stimulation and virtual reality exercises . **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Rehabilitation by optokinetic stimulation and virtual reality exercises . **Description:** Rehabilitation by optokinetic stimulation and virtual reality exercises(by deviceVirtual reality system(Meta Quest 2_Advanced All-In-One Virtual Reality Headset_ 128 GB)). **Name:** Rehabilitation by optokinetic stimulation and virtual reality exercises . **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Improvement of dizziness measured by Computerized dynamic posturography:6 conditions, the maximum handicap score 0/6 and the minimum 6/6. **Measure:** Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness : A longitudinal Study **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age: from 18 years to 65 years old. * Gender: males and females. * Can withstand and willing to undergo repeated vestibular rehabilitation therapy .\*No history of any disease required to give treatment that could affect results. Exclusion Criteria: * Neurological disorders, paresis, paralysis, motor disorder, ataxia, brain mass, multiple sclerosis and stroke with grade 4 muscle power or below. * Otological disorders e.g. middle ear pathology (chronic suppurative otitis media, Tumor). * Psychiatric disorders e.g. Schizophrenia and endogenous depression. * Severely ill patients who would not tolerate vestibular rehabilitation therapy . **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** nada elhakeem **Phone:** 01000401121 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** mostafa yossif **Phone:** 01001313395 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** sohag university hospital **Name:** Maha Ahmed **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000015837 - Term: Vestibular Diseases - ID: D000007759 - Term: Labyrinth Diseases - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17462 - Name: Vertigo - Relevance: HIGH - As Found: Dizziness - ID: M7420 - Name: Dizziness - Relevance: HIGH - As Found: Dizziness - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M18387 - Name: Vestibular Diseases - Relevance: LOW - As Found: Unknown - ID: M10779 - Name: Labyrinth Diseases - Relevance: LOW - As Found: Unknown - ID: M10782 - Name: Labyrinthitis - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014717 - Term: Vertigo - ID: D000004244 - Term: Dizziness ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421714 **Brief Title:** A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants **Official Title:** A Phase I, Single-Center, Open-Label, Two-Period, Single Sequence, Two Treatment Drug-Drug Interaction Study of GZ/SAR402671 (Venglustat) and Itraconazole in Healthy Male Subjects #### Organization Study ID Info **ID:** INT14339 #### Organization **Class:** INDUSTRY **Full Name:** Sanofi #### Secondary ID Infos **ID:** 2014-002550-39 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2018-10-14 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-10-14 **Type:** ACTUAL #### Start Date **Date:** 2018-08-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Genzyme, a Sanofi Company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to assess in healthy adult male participants the effects of itraconazole on the pharmacokinetics of venglustat and to assess the safety and tolerability of venglustat with and without coadministration of itraconazole. The maximum duration for participants from screening is between 32 to 62 days. **Detailed Description:** Total study duration for participants is up to 62 days including screening up to 28 days, 1 day of treatment in period 1, washout of 7 days, 13 days of treatment in period 2, and follow up period 10-14 days after last dose. ### Conditions Module **Conditions:** - Healthy Volunteers ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 8 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The first period will include a single dose administration of venglustat followed by a second period including a multiple dose administration of itraconazole for 12 days and a second single dose administration of venglustat on the 6th day of itraconazole administration **Intervention Names:** - Drug: Venglustat - Drug: Itraconazole **Label:** Venglustat and Itraconazole **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Venglustat and Itraconazole **Description:** Pharmaceutical form:Capsule-Route of administration:Oral **Name:** Venglustat **Other Names:** - GZ/SAR402671 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Venglustat and Itraconazole **Description:** Pharmaceutical form:Capsule-Route of administration:Oral **Name:** Itraconazole **Other Names:** - ITZ - Sporanox **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Area under the plasma concentration versus time curve (AUC) of venglustat **Time Frame:** Multiple time points up to 21 days **Measure:** Area under the plasma concentration versus time curve calculated from time zero to the real time (tlast) (AUClast) of venglustat **Time Frame:** Multiple time points up to 21 days #### Secondary Outcomes **Measure:** Maximum plasma concentration observed (Cmax) of venglustat **Time Frame:** Multiple time points up to 21 days **Measure:** Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of venglustat **Time Frame:** Multiple time points up to 21 days **Measure:** Time to reach Cmax (tmax) of venglustat **Time Frame:** Multiple time points up to 21 days **Measure:** Terminal half-life (t1/2) of venglustat **Time Frame:** Multiple time points up to 21 days **Measure:** Maximum plasma concentration observed (Cmax) of itraconazole **Time Frame:** Multiple time points up to 21 days **Measure:** Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of itraconazole **Time Frame:** Multiple time points up to 21 days **Measure:** Time to reach Cmax (tmax) of itraconazole **Time Frame:** Multiple time points up to 21 days **Measure:** Area under the plasma concentration versus time curve calculated over the dosing interval (12 h) (AUC0-12) of itraconazole **Time Frame:** Multiple time points up to 21 days **Measure:** Maximum plasma concentration observed (Cmax) of hydroxyitraconazole **Time Frame:** Multiple time points up to 21 days **Measure:** Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of hydroxyitraconazole **Time Frame:** Multiple time points up to 21 days **Measure:** Time to reach Cmax (tmax) of hydroxyitraconazole **Time Frame:** Multiple time points up to 21 days **Measure:** Area under the plasma concentration versus time curve over the dosing interval (12 h) (AUC0-12) of hydroxyitraconazole **Time Frame:** Multiple time points up to 21 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: -Male participants, between 18 and 55 years of age, inclusive. * Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 30.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). * Normal vital signs, electrocardiogram, and laboratory parameters. * Having given written informed consent prior to undertaking any study-related procedure. * Not under any administrative or legal supervision. * Male participant, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing. * Male participant, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing. * Male participant has agreed not to donate sperm from the inclusion up to 4 months after the last dosing. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. * Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). * Blood donation, any volume, within 2 months before inclusion. * Symptomatic postural hypotension excluding vasovagal episode associated with a blood draw. * Presence or history of clinically significant drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). * Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day). * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency Virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab). * Positive result on urine drug screen or urine alcohol test. * Any contraindications to itraconazole, according to the applicable labeling. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Austin **Country:** United States **Facility:** PPD **State:** Texas **Zip:** 78744 ### IPD Sharing Statement Module **Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org **IPD Sharing:** YES ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000935 - Term: Antifungal Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000058888 - Term: 14-alpha Demethylase Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000065692 - Term: Cytochrome P-450 CYP3A Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M20133 - Name: Itraconazole - Relevance: HIGH - As Found: Part A - ID: M349697 - Name: Venglustat - Relevance: HIGH - As Found: Intelligibility - ID: M256158 - Name: Hydroxyitraconazole - Relevance: LOW - As Found: Unknown - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M30564 - Name: Cytochrome P-450 CYP3A Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017964 - Term: Itraconazole - ID: C000608118 - Term: Venglustat ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421701 **Brief Title:** Anti-CD19 CAR-NK Cells in Refractory/Relapsed Systemic Lupus Erythematosus **Official Title:** A Clinical Study of Anti-CD19 CAR-NK Cells in the Treatment of Refractory/Relapsed Systemic Lupus Erythematosus #### Organization Study ID Info **ID:** 2024-0530 #### Organization **Class:** OTHER **Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University ### Status Module #### Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus. ### Conditions Module **Conditions:** - Systemic Lupus Erythematosus ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** To evaluate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19 CAR-NK cells infusion on Day 0, 7, and 14. **Intervention Names:** - Drug: anti-CD19 CAR-NK cells **Label:** anti-CD19 CAR-NK cells **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - anti-CD19 CAR-NK cells **Description:** Patients will receive Fludarabine (25 mg/m2 per day) and Cyclophosphamide (500mg/m2 per day) on day -5, -4, and -3. Doses of 2×10\^6/kg, 3×10\^6/kg, 4×10\^6/kg anti-CD19 CAR-NK cells will be infused in each group on Day 0, 7, and 14 using the "3 + 3" dose-escalation strategy. **Name:** anti-CD19 CAR-NK cells **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** DLT definition is dose-limiting toxicity. **Measure:** The proportion of subjects with DLT **Time Frame:** Within 28 days after anti-CD19 CAR-NK cells infusion **Description:** Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs as assessed by CTCAE v5.0. **Measure:** The proportion of subjects with adverse events **Time Frame:** 12 months #### Secondary Outcomes **Description:** Proportion of patients with SRI-4 response: including SELENA-SLEDAI ≥4-Point improvement, BILAG 2004 with no new A domain score AND no more than 1 new B domain scores, PGA with No worsening (\<0.3-point increase). **Measure:** Proportion of subjects with Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response **Time Frame:** 4, 8, 12, 16, 20, 24, 36 and 52 weeks after infusion **Description:** The Definition of Remission in SLE (DORIS) is a standardized criterion to clearly define what constitutes remission in patients with systemic lupus erythematosus. **Measure:** Proportion of participants achieving definition of remission in SLE (DORIS) remission **Time Frame:** 4, 8, 12, 16, 20, 24, 36 and 52 weeks after infusion **Description:** The Lupus Low Disease Activity State (LLDAS) is a clinical treatment target designed for patients with systemic lupus erythematosus. It represents a state where the disease activity is kept at a low level, aiming to minimize symptoms and prevent long-term damage caused by the disease. **Measure:** Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) **Time Frame:** 4, 8, 12, 16, 20, 24, 36 and 52 weeks after infusion **Description:** Assessment of SLEDAI-2000 from baseline administration at various timepoints up to month 12 follow up visit. **Measure:** Changes in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score from baseline **Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion **Description:** Assessment of SELENA-SLEDAI from baseline administration at various timepoints up to month 12 follow up visit. **Measure:** Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline **Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion **Description:** Assessment of BILAG-2004 from baseline administration at various timepoints up to month 12 follow up visit. **Measure:** Changes in the British Isles Lupus Assessment Group 2004 index (BILAG-2004) from baseline **Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion **Description:** Assessment of PGA from baseline administration at various timepoints up to month 12 follow up visit. **Measure:** Changes in the Physician Global Assessment (PGA) from baseline **Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion **Description:** Assessment of 24h proteinuria or urine protein creatinine ratio (UPCR) from baseline administration at various timepoints up to month 12 follow up visit. **Measure:** Change in proteinuria measured by 24h proteinuria or urine protein creatinine ratio (UPCR) from baseline **Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion **Description:** Assessment of ANA from baseline administration at various timepoints up to month 12 follow up visit. **Measure:** Changes in level of anti-nuclear antibody (ANA) in peripheral blood from baseline **Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion **Description:** Assessment of C3 and C4 from baseline administration at various timepoints up to month 12 follow up visit. **Measure:** Changes in levels of complement C3 and C4 in peripheral blood from baseline **Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion **Description:** CMAX is defined as the highest concentration of anti-CD19 CAR-NK cell expansion in the peripheral blood. **Measure:** CMAX of anti-CD19 CAR-NK cells **Time Frame:** 3 months **Description:** TMAX is defined as the time to reach the highest concentration of anti-CD19 CAR-NK cell expansion in the peripheral blood. **Measure:** TMAX of anti-CD19 CAR-NK cells **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up; * Age range from 18 to 65 years old, regardless of gender; * Fulfilling the 2019 ACR/EULAR classification criteria of SLE; * Presence of anti-dsDNA or anti-Sm antibodies and decreased C3 or C4 levels; * SELENA-SLEDAI≥8； * Subject has ≥ 1 organ system with BILAG-2004 Class A mobility score or ≥ 2 organ systems with BILAG-2004 Class B mobility score prior to screening; * Routine treatment is ineffective or the disease relapses after remission. Definition of routine treatment: use more than two drugs, including glucocorticoid (more than 1mg/kg/d), and any two or more of the following immunomodulatory drugs for more than 6 months: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, tacrolimus, ciclosporin, and biological agents, including rituximab, belizumab, or telitacicept； * Hemoglobin ≥ 85g/L; white blood cell count ≥ 3 × 10\^9/L；neutrophil count ≥ 1.5 × 10\^9/L; platelets ≥ 50 × 10\^9/L; * The functions of important organs are basically normal: ALT ≤ 2 × ULN; AST ≤ 2 × ULN; eGFR ≥ 60ml/min/1.73m2; total bilirubin ≤2.0 mg/dL; cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; non-oxygenated blood oxygen saturation \>94%; prothrombin time (PT) ≤ 1.5 × ULN；international standardized ratio (INR) ≤ 1.5 × ULN； * Females of childbearing potential must use effective contraception during the study. In addition, subjects must not donate eggs during the study and for at least 90 days after the last dose of study treatment； Exclusion Criteria: * History of severe allergy or known hypersensitivity to any of the active ingredients of the cell product； * Pregnant (or lactating) women; * Severe lupus nephritis (defined as serum creatinine \> 2.5 mg/dL or 221 μmol/L), treatment with hemodialysis within 8 weeks prior to screening； * Other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis within 8 weeks prior to screening； * Combined with other autoimmune diseases requiring systemic therapy; * Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; * Abnormal test results for hepatitis B or C indicate the presence of an active or chronic infection, including positive HBsAg or positive HBcAb with HBV DNA levels exceeding the normal upper limit，positive hepatitis C antibody and detectable HCV RNA；positive serology for human immunodeficiency virus (HIV) or a known history of HIV infection； * Cytomegalovirus DNA levels and EB (Epstein-Barr) virus DNA levels in the peripheral blood exceeding the normal upper limits； * Active or latent tuberculosis； * Presence of uncontrollable bacterial, fungal, viral or other infections, requiring antibiotic therapy; * Acquired and congenital immunodeficiency diseases； * IgA deficiency; * Other uncontrolled diseases: acute or chronic diseases that are clinically unstable or have not been effectively controlled and are not related to SLE； * History of malignant diseases such as malignant tumors, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, superficial bladder cancer, breast cancer; * Any active skin disease that may interfere with the study assessment of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE cutaneous lupus manifestations (eg, cutaneous vascular disease, periungual telangiectasia, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers) or drug-induced lupus； * Prior treatment with cell therapy or any prior gene therapy product； * Contraindication to cyclophosphamide in combination with fludarabine; * Prior CD19-targeted therapy; * Received live vaccine treatment within 4 weeks prior to screening; * Subjects who have undergone major surgery within 8 weeks prior to screening, or who are scheduled to have surgery during the trial； * Have received B-cell targeted therapy within 4 weeks prior to screening; * Have received immunosuppressants within 1 week prior to screening; * Have received plasmapheresis or intravenous immunoglobulin within 3 months prior to screening; * Have participated in other clinical studies within 3 months prior to screening; * History of vital organ transplantation (eg, heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation； * Situations in which investigators consider it inappropriate to participate in the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Huaxiang Wu, PhD **Phone:** 86-13757118395 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Name:** Huaxiang Wu, PhD - **Phone:** 86-13757118395 - **Role:** CONTACT **Country:** China **Facility:** The Second Affiliated Hospital of Zhejiang University School of Medicine **Zip:** 310016 #### Overall Officials **Official 1:** **Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University **Name:** Huaxiang Wu **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: HIGH - As Found: Systemic Lupus Erythematosus - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008180 - Term: Lupus Erythematosus, Systemic ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6727 - Name: Cyclophosphamide - Relevance: LOW - As Found: Unknown - ID: M283230 - Name: Fludarabine - Relevance: LOW - As Found: Unknown - ID: M225513 - Name: Fludarabine phosphate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421688 **Brief Title:** Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery **Official Title:** Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial: a Randomized, Double-blind, Placebo-controlled Study #### Organization Study ID Info **ID:** YXLL-KY-2024(039) #### Organization **Class:** OTHER **Full Name:** Qianfoshan Hospital ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-05 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Qianfoshan Hospital #### Responsible Party **Investigator Affiliation:** Qianfoshan Hospital **Investigator Full Name:** Dong Wang **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to investigate the effect of perioperative administration of vitamin C on postoperative pulmonary complications, with the aim of providing a safe and effective medication regimen for the prevention and treatment of postoperative pulmonary complications in patients undergoing surgery for craniocerebral tumors. The main questions it aims to answer are: 1. To determine whether vitamin C can reduce pulmonary complications after surgery for intracranial tumors. 2. Does intraoperative vitamin C improve the prognosis of surgical patients Researchers will compare vitamin C to a placebo (saline) to see if vitamin C is effective for postoperative lung complications in patients undergoing surgery for cranial tumors. 1. Participants will be intravenously pumped with vitamin C for two hours after induction of anesthesia. 2. Participants will have intraoperative plasma sampling and recording of ventilator parameters, monitor parameters and perioperative data. 3. Participants will be followed up until discharge from the hospital to record symptoms and adverse events, and will be called at six months to check on their prognosis. **Detailed Description:** Neurosurgery has a high incidence of postoperative pulmonary complications, increasing patient costs and affecting patient prognosis. Neurosurgery often requires hyperventilation to reduce intracranial pressure, so methods to reduce postoperative pulmonary complications such as small tidal volumes cannot be used routinely, and larger tidal volumes often result in injury to pulmonary endothelial cells, which leads to increased permeability of the pulmonary microvasculature, resulting in mechanically ventilated lung injury. Of course surgical injuries and mechanical ventilation can also cause oxidative stress injury to the lungs. Vitamin C is a common antioxidant drug and cofactor in the synthesis of many substances in the body, and many studies have shown that vitamin C prevents the increase in endothelial barrier permeability due to many causes. During the COVID-19 epidemic, vitamin C is seen as an important adjunct in preventing and ameliorating symptoms of COVID-19 patients. not only that, but vitamin C also assisted in postoperative analgesia and promote incision healing, so investigators would like to observe that by giving vitamin C during the surgery is able to prevent the occurrence of postoperative pulmonary complications or improve the prognosis of participants. ### Conditions Module **Conditions:** - Ascorbic Acid - Neurosurgical Procedures - Humans - Ventilator-Induced Lung Injury - Postoperative Complications ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 86 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients received 50 mg/kg of Ascorbic acid after induction of anesthesia **Intervention Names:** - Drug: Ascorbic acid **Label:** Ascorbic acid group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients receive 50ml saline after induction of anesthesia **Intervention Names:** - Drug: Saline **Label:** Control comparator group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ascorbic acid group **Description:** After participants underwent induction of anesthesia, Ascorbic acid (Vitamin C Injection) was administered at a dosage of 50 mg/kg, diluted to 50 ml using saline, with a total amount not exceeding 4 g; pumping was performed using a micro pump at a rate of 25 ml/h. **Name:** Ascorbic acid **Other Names:** - vitamin C **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control comparator group **Description:** After participants underwent induction of anesthesia, 50 ml of saline was used and pumped using a micro pump at a rate of 25 ml/h. **Name:** Saline **Other Names:** - saline (medicine) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** This will be assessed using the Postoperative Pulmonary Complications Score, which ranges from 0 to 5, with a score of ≥3 being considered positive for postoperative pulmonary complications. It was assessed every day before discharge and the highest score that occurred was recorded. **Measure:** incidence of postoperative pulmonary complications **Time Frame:** About 10 days #### Secondary Outcomes **Description:** Plasma levels of neuron-specific enolase, unit is ng/ml **Measure:** Neuron-specific enolase levels **Time Frame:** Post operative day 1 **Description:** Length of time between participant's completion of surgery and discharge **Measure:** Length of hospitalization **Time Frame:** About 10 days **Description:** PaO2/FiO2, in millimeters of mercury **Measure:** Oxygenation index **Time Frame:** One hour postoperative **Description:** Patient's postoperative pain level; Using a "Pain Visual Analogue Scale", a 10-centimeter-long ruler was used, with 0 indicating no pain and 10 representing the most intense pain that was intolerable. During the test, the participant points to the scale that best represents the level of pain, and the researcher assigns the participant a score based on the location of the point. **Measure:** Pain scores **Time Frame:** 1 day, 3 days, 7 days postoperative **Description:** lung compliance in Milliliter/ centimeter water column **Measure:** pulmonary compliance **Time Frame:** Last hour of surgery. **Description:** The level of Interleukin-6 in the blood, in nanograms per liter **Measure:** Interleukin-6 **Time Frame:** 1 day, 3 days, 7 days postoperative **Description:** Blood levels of superoxide dismutase, in units per milliliter **Measure:** superoxide dismutase (SOD) **Time Frame:** 1 day, 3 days, 7 days postoperative **Description:** Postoperative body temperature in degrees Celsius **Measure:** body temperature **Time Frame:** 1 day, 3 days, 7 days postoperative **Description:** Systolic and diastolic blood pressure，In millimeters of mercury **Measure:** blood pressure **Time Frame:** About 10 days **Description:** Plasma levels of brain-specific cardiolipin **Measure:** Brain-specific cardiolipin **Time Frame:** About 3 days **Description:** Levels of neutrophils in the blood, measured in units per liter. **Measure:** neutrophil **Time Frame:** About 10 days **Description:** Level of C-reactive protein in the blood in milligrams per liter **Measure:** C-reactive protein **Time Frame:** 1 day, 3 days, 7 days postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients who need craniotomy treatment due to intracranial tumors; 2. age 18-75 years old; 3. American Society of Anesthesiologists classification: 1\~3; 4. Patients and their families agree to participate in the study and sign the informed consent form. Exclusion Criteria: 1. Patients with severe pulmonary infection or respiratory failure prior to surgery; 2. Patients with previous history of neurological or psychiatric diseases; 3. Patients with cardiac, hepatic and renal insufficiency; 4. patients who are receiving parenteral nutrition; 5. pregnant patients; 6. Patients ruled out by medication instructions; 7. Patients who require emergency surgery; 8. patients with combination of other malignant tumors; 9. patients who have participated in other clinical studies of drugs within 3 months. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Dong Wang, M.D **Phone:** 18353173516 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Linquan Shao **Phone:** 15864548531 **Role:** CONTACT #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dong Wang, Doctor of Medicine(M.D.) - **Phone:** +86-18353173516 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Shandong First Medical University **State:** Shandong **Zip:** 250000 #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital of Shandong First Medical University **Name:** Dong Wang, M.D **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Individual Participant Data(IPD) will be available when this trial is finished and the article have been published **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Sogame LC, Vidotto MC, Jardim JR, Faresin SM. Incidence and risk factors for postoperative pulmonary complications in elective intracranial surgery. J Neurosurg. 2008 Aug;109(2):222-7. doi: 10.3171/JNS/2008/109/8/0222. **PMID:** 18671633 **Citation:** May JM, Harrison FE. Role of vitamin C in the function of the vascular endothelium. Antioxid Redox Signal. 2013 Dec 10;19(17):2068-83. doi: 10.1089/ars.2013.5205. Epub 2013 May 29. **PMID:** 23581713 **Citation:** Holford P, Carr AC, Jovic TH, Ali SR, Whitaker IS, Marik PE, Smith AD. Vitamin C-An Adjunctive Therapy for Respiratory Infection, Sepsis and COVID-19. Nutrients. 2020 Dec 7;12(12):3760. doi: 10.3390/nu12123760. **PMID:** 33297491 **Citation:** Wang D, Wang M, Zhang H, Zhu H, Zhang N, Liu J. Effect of Intravenous Injection of Vitamin C on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery: A Double-Blind, Randomized Trial. Drug Des Devel Ther. 2020 Aug 11;14:3263-3270. doi: 10.2147/DDDT.S254150. eCollection 2020. **PMID:** 32848365 **Citation:** Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297. **PMID:** 28322416 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000013898 - Term: Thoracic Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M14065 - Name: Postoperative Complications - Relevance: HIGH - As Found: Postoperative Complications - ID: M28143 - Name: Lung Injury - Relevance: HIGH - As Found: Lung Injury - ID: M28152 - Name: Ventilator-Induced Lung Injury - Relevance: HIGH - As Found: Ventilator-Induced Lung Injury - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M16657 - Name: Thoracic Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055370 - Term: Lung Injury - ID: D000055397 - Term: Ventilator-Induced Lung Injury - ID: D000011183 - Term: Postoperative Complications ### Intervention Browse Module - Ancestors - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M4513 - Name: Ascorbic Acid - Relevance: HIGH - As Found: Heparin - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T477 - Name: Vitamin C - Relevance: HIGH - As Found: SARS-CoV-2 - ID: T437 - Name: Ascorbic Acid - Relevance: HIGH - As Found: Heparin ### Intervention Browse Module - Meshes - ID: D000001205 - Term: Ascorbic Acid ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421675 **Acronym:** EMBRACE **Brief Title:** Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma **Official Title:** A Study of Elranatamab Management With Outpatient and Intermittent Dosing in Relapsed/Refractory Multiple Myeloma #### Organization Study ID Info **ID:** OCOG-2023-EMBRACE #### Organization **Class:** OTHER **Full Name:** Ontario Clinical Oncology Group (OCOG) ### Status Module #### Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-03-11 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Pfizer #### Lead Sponsor **Class:** OTHER **Name:** Ontario Clinical Oncology Group (OCOG) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** A phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed and/or refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy. **Detailed Description:** This is a multi-centre, single arm, phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. Potential study participants must have documented evidence of refractory or progressive disease during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry. Study participants will receive SC administration of elranatamab until disease progression, unacceptable toxicity or death. The primary short term outcome is hospitalization rate within the first 2 weeks of Cycle 1 of treatment; the primary long term outcome is rate of grade 3+ infections within the first 24 months of treatment. Study participants will be followed for survival for 36 months from the date of enrollment. A total of 40 study participants will be enrolled across approximately 5 Canadian clinical trial sites. ### Conditions Module **Conditions:** - Refractory Multiple Myeloma **Keywords:** - relapsed - refractory - multiple myeloma - elranatamab - cytokine release syndrome - immune effector-cell associated neurotoxicity ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Multi-center, single-arm, phase II study of single-agent elranatamab in patients with relapsed and/or refractory multiple myeloma. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The administration of two step-up elranatamab doses (12 mg and 32 mg) and full dose 76 mg. The dosing interval for the first 6 cycles (each cycle q28 days) is every week, cycles 7-12 are bi-weekly. The dosing interval will increase to q4 weeks (cycle 13+) according to IMWG dose-response criteria of \>= VGPR. Further dosing interval increase to q8weeks (cycles 19+) will be done among participants based on response criteria IMWG of \>= CR. **Intervention Names:** - Drug: Elranatamab injection **Label:** Elranatamab injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Elranatamab injection **Description:** Elranatamab (Elrexfio) is a humanized bispecific antibody that targets both BCMA-expressing multiple myeloma (MM) cells and CD3-expressing T cells. **Name:** Elranatamab injection **Other Names:** - Elrexio **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** BCMA levels in blood and their relationship to clinical response and progression. **Measure:** Exploratory outcome BCMA expression (biologic tumor characteristics) **Time Frame:** 36 months **Description:** Feasibility, adherence and satisfaction of remote patient monitoring during the first 9 days of treatment using an outpatient remote monitoring device **Measure:** Feasibility, adherence and satisfaction of remote patient monitoring **Time Frame:** First 9 days of treatment. **Description:** Patient satisfaction with the use of the remote monitoring device will be captured using a single, 5-point likert scale question, asked when the device is returned. **Measure:** Patient satisfaction with the use of the remote monitoring device **Time Frame:** First 9 days of treatment. #### Primary Outcomes **Description:** Hospitalization rate, defined as the number of patients who are hospitalized within the first 2 weeks of Cycle 1 of treatment, due to any cause, divided by the number of patients who are treated with elranatamab. **Measure:** Hospitalization rate **Time Frame:** 2 weeks **Description:** Rate of grade 3+ infections as grade by NCI CTCAE v5 within the first 24 months of treatment, defined as the number of patients who experience a grade 3+ infection within 24 months of treatment, divided by the number of patients who are treated with elranatamab. **Measure:** Rate of grade 3+ infections **Time Frame:** 24 months #### Secondary Outcomes **Description:** Overall response rate, defined by the IMWG criteria. **Measure:** Overall response rate. **Time Frame:** 36 months **Description:** PFS, defined as the time from the date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurs first. **Measure:** Progression free survival. **Time Frame:** 36 months **Description:** DOR is defined, for participants with an overall response per IMWG criteria, as the time from the first documentation of overall response that is subsequently confirmed, until confirmed PD per IMWG criteria, or death due to any cause, whichever occurs first. **Measure:** Duration of response. **Time Frame:** 36 months **Description:** TTR is defined, for participants with an overall response per IMWG criteria, as the time from the date of first dose to the first documentation of overall response that is subsequently confirmed. **Measure:** Time to response. **Time Frame:** 36 months **Description:** AEs will be graded according to NCI CTCAE Version 5. CRS and ICANS will be assessed. AEs will be characterized by type, frequency, severity, timing, seriousness, and relationship to elranatamab. AEs will be presented with and without regard to causality based on the investigator's judgment. The frequency of overall toxicity, categorized by toxicity Grades 1 through 5, will be described. Additional summaries will be provided for AEs that are observed with higher frequency and for AESIs (including CRS and ICANS). **Measure:** Adverse Events **Time Frame:** 36 months **Description:** Clinical laboratory data will be classified by grade according to NCI CTCAE version 5.0 and will be analyzed using summary statistics. The worst on-treatment grades during the treatment period will be summarized. **Measure:** Clinical laboratory data **Time Frame:** 36 months. **Description:** OS, defined from the date of study registration to the date or death due to any cause. **Measure:** Overall survival **Time Frame:** 36 months **Description:** Frailty will be measured using the IMWG frailty score and the time for the 4-meter walk test will be recorded. **Measure:** Patient Frailty **Time Frame:** To the time of disease progression. **Description:** Frequency and timing hospitalization will be recorded during the first two weeks of the study treatment. **Measure:** Frequency and Timing of Hospitalization **Time Frame:** 2 weeks. **Description:** QoL during treatment measured using the EORTC QOL Questionnaire-C30 instrument EORTC QLQ-C30 **Measure:** Patient Quality of Life **Time Frame:** To the time of disease progression. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Relapsed and/or refractory MM defined as: 1. Documented evidence of progressive disease (PD) after achieving at least minimal response (MR) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM). 2. Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM). 2. Measurable disease based on IMWG criteria, defined as at least one of the following, documented within 28 days before enrollment: 1. Serum M-protein ≥ 0.5 g/dl. 2. Urine M-protein excretion ≥ 200 mg/24 h. 3. Serum-free light chains (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) AND an abnormal serum-free light chain ratio (\< 0.26 or \> 1.65) only for patients without measurable serum or urine M protein. 3. Receipt of at least three prior classes of drugs either in separate regimens or as combinations. The three classes are defined as: An immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor (bortezomib, ixazomib, carfilzomib), and an anti-CD38 drug (daratumumab or isatuximab). 4. At least 18 years of age. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2. Exclusion Criteria: Medical conditions 1. Active plasma cell leukemia (either 20% of peripheral white blood cells or \> 2.0 × 109/L circulating plasma cells by standard differential). 2. Amyloidosis. 3. POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma cell disorder, Skin Changes). 4. Monoclonal gammopathy of unknown significance or smoldering multiple myeloma. 5. Solitary plasmacytoma. 6. Stem cell transplant within 12 weeks prior to enrollment or active graft versus host disease. 7. History of prior treatment with a BCMA targeting agent. Laboratory Parameters 8. Laboratory results within 28 days as per below prior to enrollment: * Absolute neutrophil count (ANC) ≤ 1.0 x 109 /L) (use of growth factor is permitted if completed at least 7 days prior to enrollment). * Platelet count ≤ 25 x 109 /L (transfusion support permitted if completed at least 7 days prior to enrollment). * Hemoglobin ≤ 8.0 g/dL (transfusion support permitted if completed at least 7 days prior to enrollment, concurrent erythropoietin stimulating agents allowed). * Serum AST and ALT \> 2.5 x upper limit of normal (ULN). * Creatinine clearance \< 30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method). * Total bilirubin \> 2.0 x ULN (≥ 3.0 unless known to have Gilbert's disease). Support Requirement 9. As this protocol requires outpatient administration, the patient will be excluded if they cannot agree to the following for the first 9 days post-first dose of drug administration: 1. Staying within 60 minutes of travel distance to their trial-based hospital. 2. Must have a caregiver/support person who will stay with the patient. 3. Patient and/or their caregiver/support person agree to monitor and record oral temperature q8 hours. 4. Patients must agree that if they have an oral temperature of (≥38°C), they must report to the study team within 1 hour and can come to the hospital for admission within 2 hours. Other co-morbidities 10. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months before enrollment: * Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion). * Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia). * Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \[unless associated with a central venous access complication\], or pulmonary embolism). * Prolonged QT syndrome (or triplicate average QTcF \>470 msec at screening). 11. Ongoing Grade ≥2 peripheral sensory or motor neuropathy. 12. History of Guillain-Barre Syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy. 13. Unresolved acute effects of any prior therapy for MM in the last three months to either baseline severity or NCI CTCAE ≤Grade 1. 14. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection. 15. Any other active malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. 16. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities), or surgical (major surgery within 14 days prior to enrollment) that could interfere with the patient's safety, obtaining informed consent or compliance to the study procedures. 17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to elranatamab or any of the components of the study treatment. Concomitant Medications 18. Treatment with a chemotherapeutic or anti-MM drug within the last 28 days or 5 half-lives (whichever is shorter) prior to enrollment or are currently enrolled in another interventional clinical study. 19. Receipt of any other therapy to treat cancer (including radiation, biologics, cellular therapies, and/or steroids at doses \> 20 mg dexamethasone or equivalent) within 14 days prior to the enrollment. 20. Receipt of any live vaccine within 30 days prior to enrollment or expected need of live vaccination during study participation. (Administration of locally approved non-live vaccine can be done as per local guidelines during the screening and/or treatment period including the COVID-19 mRNA vaccine. Elranatamab should be administered ± 7 days from the SARS-CoV-2 vaccine administration). Pregnancy and Contraception 21. Pregnancy or lactating female or inability of female patients of childbearing potential (FCBP) to meet contraception requirements (see Section 5.1.3.). Informed Consent 22. Inability to provide signed, informed consent. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Emilio Aguirre, CRA,HIT,CHIM **Phone:** 905-527-2299 **Phone Ext:** 42650 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sharon Nason **Phone:** 905-527-2299 **Phone Ext:** 42622 **Role:** CONTACT #### Locations **Location 1:** **City:** Calgary **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nazir Jacques Bahlis, MD - **Phone:** 403-944-1880 - **Role:** CONTACT **Country:** Canada **Facility:** Arnie Charbonneau Cancer Institute **State:** Alberta **Zip:** T2N 4Z6 **Location 2:** **City:** Edmonton **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Irwindeep Sandhu, MD - **Phone:** 780-432-8757 - **Role:** CONTACT **Country:** Canada **Facility:** Cross Cancer Institute **State:** Alberta **Zip:** T6G 1Z2 **Location 3:** **City:** Vancouver **Contacts:** ***Contact 1:*** - **Name:** Christopher Venner, MD - **Phone:** 604-877-6000 - **Role:** CONTACT **Country:** Canada **Facility:** Vancouver Cancer Center **State:** British Columbia **Zip:** V5Z 1L3 **Location 4:** **City:** Hamilton **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hira Mian, MD - **Phone:** 905-387-9495 - **Role:** CONTACT **Country:** Canada **Facility:** Juravinski Cancer Center **State:** Ontario **Zip:** L8V 1C3 **Location 5:** **City:** Ottawa **Contacts:** ***Contact 1:*** - **Name:** Arleigh Robertson McCurdy, MD - **Phone:** 613-737-8899 - **Phone Ext:** 71281 - **Role:** CONTACT **Country:** Canada **Facility:** Ottawa Hospital **State:** Ontario **Zip:** K1H 8L6 #### Overall Officials **Official 1:** **Affiliation:** McMaster University **Name:** Hira Mian, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** OCOG - McMaster University **Name:** Jim Wright, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010265 - Term: Paraproteinemias - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12058 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: HIGH - As Found: Multiple Myeloma - ID: M2157 - Name: Cytokine Release Syndrome - Relevance: LOW - As Found: Unknown - ID: M22080 - Name: Neurotoxicity Syndromes - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma - ID: T4120 - Name: Neurotoxicity Syndromes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009101 - Term: Multiple Myeloma - ID: D000054219 - Term: Neoplasms, Plasma Cell ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M20194 - Name: Antibodies, Bispecific - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421662 **Brief Title:** The Role of Attachment Training in Mother-infant Attachment **Official Title:** The Effect of Attachment Training Given to Pregnant Women on Mother Infant Attachment #### Organization Study ID Info **ID:** mother-infant attachment #### Organization **Class:** OTHER **Full Name:** Saglik Bilimleri Universitesi ### Status Module #### Completion Date **Date:** 2024-03-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-01 **Type:** ACTUAL #### Start Date **Date:** 2023-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Saglik Bilimleri Universitesi #### Responsible Party **Investigator Affiliation:** Saglik Bilimleri Universitesi **Investigator Full Name:** GÜVEN BEKTEMUR **Investigator Title:** Assoc.Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aimed to investigate the effect of attachment training given to pregnant women on mother-infant attachment.Primiparous pregnant women between 28.-38. weeks were randomized into two groups. Pregnant women in the study group were given attachment training for 15 days and the effect of the training on mother-infant attachment was investigated by using the mother-infant attachment scale at postpartum week 8 in comparison with the control group. **Detailed Description:** Pregnant women between 28th and 38th weeks of gestational age who applied to an outpatient clinic of a training and research hospital were randomized into two groups. The study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was applied as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory" developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak. Maternal Attachment Inventory, Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104 ### Conditions Module **Conditions:** - Mother-Infant Interaction - Infant Development - Maternal Behavior **Keywords:** - infant - maternal attachment - attachment training ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Thirty pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the study group. During the training, 7 participants were excluded due to premature birth. **Intervention Names:** - Behavioral: Attachment Training **Label:** Study Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Thirty-one pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the control group. The control group was administered only the "Maternal Attachment Inventory " developed by Mary Muller in 1994 and the Turkish validity and reliability study was conducted by Şirin and Kavlak at the 8th week after birth. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Study Group **Description:** The study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was used as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory " developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak. **Name:** Attachment Training **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Maternal Attachment Inventory (MAI) Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104. **Measure:** Maternal Attachment **Time Frame:** 10 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-40 years old with a primiparous pregnancy, * 28 to 38 weeks of gestation, * At least primary school graduate, * Who can use the internet actively and can receive planned training online, * Can speak and understand Turkish like a native speaker, * Expectant mothers who voluntarily accepted the study. Exclusion Criteria: * Transferring the pregnant woman to another hospital for follow-up and treatment * Those who cannot use active internet and will not be able to receive online education * Not completing the post-test after the training * Not completing the postpartum maternal attachment scale * Expectant mothers receiving psychiatric treatment * Those with risky pregnancies * Any congenital anomaly in the baby * Unwanted baby status * Withdrawal of the candidate from the study **Gender Based:** True **Gender Description:** Primiparous pregnant women **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** University of Health Sciences ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421649 **Acronym:** PRONTO **Brief Title:** Investigating the Role of Adjuvant Proton Beam Therapy in Patients With Parotid Carcinoma **Official Title:** An Evaluative Commissioning Study to Investigate the Role of Adjuvant Proton Beam Radiotherapy in Patients With Localised Parotid Carcinoma #### Organization Study ID Info **ID:** CFTSp218 (01) #### Organization **Class:** OTHER **Full Name:** The Christie NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2029-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Royal Marsden NHS Foundation Trust **Class:** OTHER **Name:** University College London Hospitals #### Lead Sponsor **Class:** OTHER **Name:** The Christie NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the UK, one in Manchester and one in London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT treatment. Evaluative Commissioning in Protons (ECIP) is a programme of studies that explore the role of PBT for patients with different types of cancer. They are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered proton therapy. Any patient in the United Kingdom (UK) can be referred, and for patients that need to travel far to their nearest centre, accommodation will be available. The main benefit of PBT, compared with photon radiotherapy, is the predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects. PRONTO is a study within the ECIP programme exploring whether PBT can reduce treatment side effects for patients with salivary gland cancers who need radiotherapy following surgery. Whilst radiotherapy is associated with good cancer control, it commonly causes problematic side-effects such as loss of taste and dry mouth. These can be permanent and can negatively affect someone's quality of life. PRONTO's main aim is to see if PBT can reduce the loss of taste following radiotherapy. Participants in PRONTO will be closely monitored by the medical team and with questionnaires. The patient experience will be compared to what we would expect with standard photon radiotherapy. **Detailed Description:** Malignant parotid tumours are uncommon. Whilst 85% of salivary gland tumours originate in the parotid gland, only 20-25% of these are malignant, representing only 3-6% of head and neck cancers. This is about 650 patients/year in the UK. Standard treatment for local disease is with surgical resection followed by adjuvant radiotherapy for patients with high-risk features. Local control and 5-year survival rates are good, at \>70% and \>80% respectively, but radiotherapy is associated with considerable toxicity. More than 70% of patients receiving photon therapy experience significant dysgeusia (taste loss/alteration). This can be permanent, is associated with weight loss, diminished appetite, dry mouth, and negatively impact on Quality of Life (QoL). The putative benefit of proton beam radiotherapy (PBT) relates to its characteristic deposition in the body, which limits the radiation dose received by surrounding healthy tissues. We hypothesise that irradiating the post-operative parotid bed with PBT rather than Intensity Modulated Radiation Therapy (IMRT), will reduce the dose delivered to the Organs at Risk (OAR), in particular the oral cavity (OC), leading to a reduction in acute and long term taste loss/alteration. The advantageous physical properties of PBT may also improve other side effects including fatigue, mucositis, nausea \& vomiting and potentially hearing problems, as well as overall QoL. Radiotherapy planning studies: Radiation planning studies have repeatedly shown statistically significant reductions in the dose delivered to healthy tissues including: the oral cavity, brainstem, spinal cord, contralateral parotid, ipsilateral and contralateral submandibular glands and ipsilateral temporal lobe. In particular, radiotherapy doses to the oral cavity are significantly reduced, typically to below 10 Gray (Gy). No routinely contoured OAR or region of interest was consistently found to have higher doses planning with protons, although skin dose may be higher. Clinical Trials: Whilst there are no randomised control trials comparing protons and photons for this cohort. However, there is some clinical evidence that the use of PBT leads to clinically meaningful improvements in the side effects experienced by patients. One study compared acute toxicities between matched groups receiving either protons or photons, demonstrating statistically significant reductions in dysgeusia, fatigue, mucositis and nausea and vomiting in patients undergoing proton treatment. In other studies, PBT is associated with very low toxicity level, such as less than 30% of patients experiencing any dysgeusia. This compares favourably to photon experience, such as in the phase 3 randomised controlled trial 'A Multicentre Randomised Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients with Parotid Tumours' (COSTAR) where approximately 60% of patients reported dysgeusia in the Head \& Neck 35 (HN35) questionnaire at 1 year. The PRONTO study is powered to identify a clinically meaningful reduction in taste dysfunction of at least 20%. Whilst late toxicities are also likely under-reported in the retrospective international data, the published literature to date is very reassuring. The mean dose to the ipsilateral temporal lobe is reportedly reduced, and reflected in low levels of subsequent headache, fatigue and/or memory change. Similarly, whilst poorly captured, low levels of hearing dysfunction or otalgia have also been reported following PBT. There is no rationale at all that cancer outcomes, either local control or overall survival, will be worse with PBT than photon treatment. In studies to date, local control (approximately 95%) and overall survival (89%-96%) has been excellent, and comparative to known photon experience. ### Conditions Module **Conditions:** - Parotid Cancer **Keywords:** - proton beam therapy - protons - evaluative commissioning ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Evaluative commissioning study. This is a single arm, non-randomised study. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 97 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients will be offered radical adjuvant proton beam therapy to a dose of 60-66 Gray (Gy) in 30-33 fractions delivered Monday to Friday over 6-6.5 weeks. **Intervention Names:** - Radiation: Proton Beam Therapy **Label:** Proton Beam Therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Proton Beam Therapy **Description:** All patients will be offered radical adjuvant proton beam therapy to a dose of 60-66 Gray (Gy) in 30-33 fractions delivered Monday to Friday over 6-6.5 weeks. **Name:** Proton Beam Therapy **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Taste dysfunction as recorded on the European Organisation for the Research \& Treatment of Cancer (EORTC) Head \& Neck 43 (HN43) patient reported questionnaire. 43 questions with a Likert scale of 1 - 4 Higher score may mean a worse outcome **Measure:** Taste dysfunction **Time Frame:** 12 months #### Secondary Outcomes **Description:** Using the CTCAE toxicity grade Grades 1 - 5 Higher score may mean a worse outcome **Measure:** Clinician reported acute and late toxicity using Common Terminology Criteria for Adverse Events (CTCAE) grades **Time Frame:** up to 24 months **Description:** Using the LENT-SOMA scale A multiple item scoring system composed of four domains; subjective, objective, management and analytic. Grades 0-4 Higher score may mean a worse outcome **Measure:** Clinician reported acute and late toxicity using Late Effects Normal Tissue - Subjective Objective Management Analytic (LENT-SOMA) scale **Time Frame:** up to 24 months **Description:** Using pure tone audiometry to measure hearing changes Loss of hearing may mean a worse outcome **Measure:** Clinician reported acute and late toxicity - measurement of hearing changes **Time Frame:** up to 24 months **Description:** Using the EORTC QLQ-C30 30 questions using a Likert scale of 1-4 Higher score may mean a worse outcome **Measure:** Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 module questionnaire **Time Frame:** up to 24 months **Description:** Using the EORTC HN43 patient reported questionnaire 43 questions using a Likert scale of 1-4 Higher score may mean a worse outcome **Measure:** Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Head & Neck 43 (HN43) patient reported questionnaire. **Time Frame:** up to 24 months **Description:** Using the UW-QoL questionnaire Most questions are scored on a Likert scale, 0=worst, 100=best Lower score may mean worse outcomes **Measure:** Patient reported acute and late toxicity using University of Washington Quality of Life (UW-QoL) questionnaire **Time Frame:** up to 24 months **Description:** Using the GHABP questionnaire Possible values for response options (0=not applicable, 5=cannot manage at all) Higher score may mean worse outcomes **Measure:** Patient reported acute and late toxicity using Glasgow hearing Aid Benefit Profile (GHABP) questionnaire **Time Frame:** up to 24 months **Description:** This will be measured as time to recurrence (measured in months from completion of treatment) and location of recurrence (within the primary nodal regional or distant spread) **Measure:** Loco-regional tumour control **Time Frame:** up to 24 months **Description:** This will be measured in months from completion of treatment to death **Measure:** Overall survival **Time Frame:** up to 24 months **Description:** Number of patients referred to and participating in the study annually **Measure:** Patient participation in the study each year **Time Frame:** up to 24 months **Description:** Review the number of patients completing radiotherapy and the number of patients completing follow up on the study as per protocol. **Measure:** Study completion rates **Time Frame:** up to 24 months **Description:** Patients will be re-planned with photon radiotherapy, the dose distribution differences between the treatment proton plans and photon plans will be recorded in particular the dose to the oral cavity **Measure:** Oral cavity radiation dose **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. ≥ 18 years old. 2. Histologically confirmed primary malignant tumours of parotid gland. 3. Requiring post-operative radiotherapy to the parotid bed, with a dose equivalent of at least 60 Gray (Gy) in 2 Gy / fraction. 4. Treatment delivered with radical intent. 5. All patients must be suitable to attend regular follow-up, audiograms, toxicity monitoring, and be available for long term follow-up. 6. Willingness to comply with the protocol, including travel to the proton centre for Intensity Modulated Proton Therapy (IMPT) treatment. 7. Written informed consent. Exclusion Criteria: 1. Previous radiotherapy to the head and neck region; 2. Parotid tumours requiring primary radiation or those with gross residual disease; 3. Metastases from squamous cell carcinoma of the head and neck to the parotid gland; 4. Benign tumours requiring post operative radiotherapy; 5. Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up; 6. Patients requiring or receiving neoadjuvant, concomitant or planned adjuvant chemotherapy. 7. Patients who are eligible for PBT under routine commissioning **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Romelie Rieu **Phone:** 0044 1619187172 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sally Falk **Phone:** 0044 1619187172 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Royal Marsden NHS Foundation Trust **Name:** Chris Nutting **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Romesser PB, Cahlon O, Scher E, Zhou Y, Berry SL, Rybkin A, Sine KM, Tang S, Sherman EJ, Wong R, Lee NY. Proton beam radiation therapy results in significantly reduced toxicity compared with intensity-modulated radiation therapy for head and neck tumors that require ipsilateral radiation. Radiother Oncol. 2016 Feb;118(2):286-92. doi: 10.1016/j.radonc.2015.12.008. Epub 2016 Feb 8. **PMID:** 26867969 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000012468 - Term: Salivary Gland Neoplasms - ID: D000009062 - Term: Mouth Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000010305 - Term: Parotid Diseases - ID: D000012466 - Term: Salivary Gland Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M13220 - Name: Parotid Neoplasms - Relevance: HIGH - As Found: Parotid Cancer - ID: M15287 - Name: Salivary Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12022 - Name: Mouth Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M13218 - Name: Parotid Diseases - Relevance: LOW - As Found: Unknown - ID: M15285 - Name: Salivary Gland Diseases - Relevance: LOW - As Found: Unknown - ID: T4265 - Name: Oral Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010307 - Term: Parotid Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421636 **Acronym:** FERVENT-1 **Brief Title:** A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body **Official Title:** A PHASE 2, TWO-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SUBCUTANEOUSLY ADMINISTERED REGN7999 (AN INHIBITOR OF TMPRSS6) IN PARTICIPANTS WITH IRON OVERLOAD DUE TO NON-TRANSFUSION DEPENDENT β-THALASSEMIA #### Organization Study ID Info **ID:** R7999-BThal-2350 #### Organization **Class:** INDUSTRY **Full Name:** Regeneron Pharmaceuticals #### Secondary ID Infos **Domain:** EU CT Number **ID:** 2023-508604-37-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-01-24 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-01-24 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Regeneron Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is researching an experimental drug called REGN7999 (called "study drug"). The study is focused on patients with non-transfusion dependent beta-thalassemia. The aim of the study is to see how safe and effective the study drug is. The study is looking at several other research questions, including: * Whether the study drug lowers extra iron levels in the body * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) ### Conditions Module **Conditions:** - Non-transfusion Dependent Beta-thalassemia (NTDT) **Keywords:** - Beta-thalassemia - Resultant Iron overload (IOL) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 95 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Randomized 2:2:1 **Intervention Names:** - Drug: REGN7999 **Label:** Part A High Dose **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Randomized 2:2:1 **Intervention Names:** - Drug: REGN7999 **Label:** Part A Low Dose **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Randomized 2:2:1 **Intervention Names:** - Drug: Placebo **Label:** Part A Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 4 **Description:** Randomized 2:2:1 **Intervention Names:** - Drug: REGN7999 **Label:** Part B High Dose **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Randomized 2:2:1 **Intervention Names:** - Drug: REGN7999 **Label:** Part B Low Dose **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Randomized 2:2:1 **Intervention Names:** - Drug: Placebo **Label:** Part B Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Part A High Dose - Part A Low Dose - Part B High Dose - Part B Low Dose **Description:** Administered subcutaneous (SC) **Name:** REGN7999 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part A Placebo - Part B Placebo **Description:** Administered SC **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change in Liver iron concentration (LIC) by R2* magnetic resonance imaging (MRI) **Time Frame:** Baseline to week 24 **Measure:** Incidence of Treatment-emergent adverse events (TEAEs) **Time Frame:** Up to week 72 **Measure:** Severity of Treatment-emergent adverse events (TEAEs) **Time Frame:** Up to week 72 #### Secondary Outcomes **Measure:** Achievement of ≥20% reduction in LIC by R2* MRI **Time Frame:** Baseline to week 52 **Measure:** Change in hemoglobin **Time Frame:** Baseline to week 24 **Measure:** Change in LIC by R2* MRI **Time Frame:** Baseline to week 52 **Measure:** Percent change in LIC by R2* MRI **Time Frame:** Baseline to week 24 and week 52 **Measure:** Achievement of ≥20% reduction in LIC by R2* MRI **Time Frame:** Baseline to week 24 **Measure:** Change in hemoglobin over time **Time Frame:** Up to week 56 **Measure:** Achievement of ≥1.5 g/dL increase in hemoglobin for two consecutive assessments in the absence of red blood cell (RBC) transfusions **Time Frame:** Baseline to week 56 **Measure:** Number of RBC transfusions required **Time Frame:** Baseline to week 72 **Measure:** Achievement of transfusion independence **Time Frame:** Baseline to week 72 **Measure:** Change in RBC counts over time **Time Frame:** Baseline to week 56 **Measure:** Concentrations of REGN7999 in serum over time **Time Frame:** Up to week 56 **Measure:** Incidence of anti-drug antibody (ADA) to REGN7999 over time **Time Frame:** Up to week 56 **Measure:** Titer of ADA to REGN7999 over time **Time Frame:** Up to week 56 ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: 1. Clinical diagnosis of NTDT as described in the protocol 2. IOL, defined as LIC ≥ 5 mg Fe/g DW as measured by R2\* MRI at screening 3. Serum ferritin ≥ 300 ng/mL as described in the protocol Key Exclusion Criteria: 1. Hemoglobin ≤ 8 g/dL 2. Any RBC transfusion within approximately 8 weeks prior to screening as described in the protocol 3. For Part A only: Any ICT use in approximately 12 weeks prior to screening as described in the protocol 4. For Part B only: If on ICT, any change in Iron chelation therapy (ICT) dose in approximately 12 weeks prior to screening as described in the protocol 5. Any use of luspatercept or mitapivat in 6 months prior to screening as described in the protocol 6. Absolute contraindication to MRI Note: Other protocol-defined Inclusion/ Exclusion Criteria apply **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Clinical Trials Administrator **Phone:** 844-734-6643 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Regeneron Pharmaceuticals **Name:** Clinical Trial Management **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf **Description:** All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy. **URL:** https://vivli.org/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000745 - Term: Anemia, Hemolytic, Congenital - ID: D000000743 - Term: Anemia, Hemolytic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000006453 - Term: Hemoglobinopathies - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16557 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - ID: M19408 - Name: beta-Thalassemia - Relevance: HIGH - As Found: Beta Thalassemia - ID: M21178 - Name: Iron Overload - Relevance: HIGH - As Found: Iron Overload - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M4073 - Name: Anemia, Hemolytic - Relevance: LOW - As Found: Unknown - ID: M4075 - Name: Anemia, Hemolytic, Congenital - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9539 - Name: Hemoglobinopathies - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M21177 - Name: Iron Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: T5622 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - ID: T737 - Name: Beta-thalassemia - Relevance: HIGH - As Found: Beta Thalassemia ### Condition Browse Module - Meshes - ID: D000013789 - Term: Thalassemia - ID: D000017086 - Term: beta-Thalassemia - ID: D000019190 - Term: Iron Overload ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421623 **Acronym:** MINIPAS **Brief Title:** Preserving Autonomy Through Foot Health: a Study on the Acceptability of a Program Including Various Workshops for the Elderly **Official Title:** Préserver Son Autonomie Par la santé du Pied : Etude d'acceptabilité d'un Programme Incluant différents Ateliers Chez Les Personnes âgées #### Organization Study ID Info **ID:** RIPH2-FUNDENBERGER-MINIPAS #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Emile Roux #### Secondary ID Infos **Domain:** ID-RCB **ID:** 2024-A00086-41 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-03-12 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Emile Roux #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Every year in France, 2 million falls by people over 65 are responsible for 10,000 deaths, the leading cause of accidental death, and more than 130,000 hospitalizations. The investigators will combine minimalist footwear, plantar massage, and workshops to re-learn walking and posture. The main objective of this study is to verify the acceptability and feasibility of this program among the elderly. **Detailed Description:** Study participants will benefit from a plantar massage session (5-10 min massage performed by a podiatrist) and one posture and walking workshop per week, also supervised by the podiatrist. Minimalist shoes have been purchased by the centers and used during the workshops. They will also be available to participants outside the workshops for the duration of the study. ### Conditions Module **Conditions:** - Falling ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 59 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study participants will benefit from a plantar massage session (5-10 min foot massage) and one posture and walking workshop per week, supervised by a trained health professional. Minimalist shoes have been purchased by the centers and used during the workshops. They will also be available to participants outside the workshops for the duration of the study. **Intervention Names:** - Other: Program Including Various Workshops aiming to preserve elderly's autonomy through foot health **Label:** Workshops aiming to preserve elderly's autonomy through foot health **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Workshops aiming to preserve elderly's autonomy through foot health **Description:** Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture **Name:** Program Including Various Workshops aiming to preserve elderly's autonomy through foot health **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Participant acceptability will be assessed by workshop attendance rates. **Measure:** The acceptability of foot health workshops conducted by a podiatrist with elderly people **Time Frame:** At the end of the 12 weeks program #### Secondary Outcomes **Description:** In centimeters (cm) **Measure:** Foot Length measurement **Time Frame:** Before and immediately after the intervention **Description:** Thanks to the stabilometry platform **Measure:** The distance of the center of gravity from the center **Time Frame:** Before and immediately after the intervention **Description:** Thanks to the stabilometry platform **Measure:** Measurement of bearing surface and force distribution in static position **Time Frame:** Before and immediately after the intervention **Description:** Measured by the Weight-Bearing Lunge Test **Measure:** Joint capacity for ankle flexion and extension **Time Frame:** Before and immediately after the intervention **Description:** Numerical scale from 0 to 10 (0 meaning no fear and 10 the worst fear imaginable) **Measure:** Fear of falling scale **Time Frame:** Before and immediately after the intervention **Description:** Timed up and go test **Measure:** The risk of falling **Time Frame:** Before and immediately after the intervention **Description:** Numerical scale from 0 to 10 (0 meaning no pain and 10 the worst pain imaginable) **Measure:** Foot pain scale **Time Frame:** Before and immediately after the intervention **Measure:** Number and type of foot disorders **Time Frame:** Before and immediately after the intervention **Description:** To evaluate participants' perception of the minimalist footwear and the various workshops (foot massage and walking) **Measure:** A specifically made satisfaction questionnaire **Time Frame:** Immediately after the intervention **Measure:** Number of hours shoes used **Time Frame:** Immediately after the intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * People over 65 years of age * Able to walk independently with or without a walking aid (cane, walker, etc.) * Persons affiliated with a social security system or assimilated * Persons (participants, guardians, or curators where applicable) who have been informed and have given their written consent to participate in the study. Exclusion Criteria: * People with a contraindication to wearing minimalist shoes * Persons unable to participate in the various workshops * Refusal to participate in research * Persons under court protection * Persons unable to walk * Persons with any other contraindication at the investigator's discretion **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beaulieu **Country:** France **Facility:** EHPAD "Foyer Notre-Dame" **Zip:** 43800 **Location 2:** **City:** Brives-Charensac **Country:** France **Facility:** EHPAD "Vert-Bocage" **Zip:** 43700 **Location 3:** **City:** Le Puy En Velay **Country:** France **Facility:** Ssiad " Amadom43 " **Zip:** 43000 **Location 4:** **City:** Le Puy-en-Velay **Country:** France **Facility:** Ehpad Nazareth **Zip:** 43000 **Location 5:** **City:** Vals Pres Le Puy **Country:** France **Facility:** EHPAD Foyer " Saint-Dominique " **Zip:** 43750 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421610 **Brief Title:** OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion. **Official Title:** Implementation and Evaluation of Pressurized Intrathoracic Aerosol Chemotherapy (PITAC) for the Treatment of Patients With Malignant Pleural Effusion. A Danish Phase I Study (OPC5 Study) #### Organization Study ID Info **ID:** PITAC-OPC5 #### Organization **Class:** OTHER **Full Name:** Odense University Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2023-04-26 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Odense University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will monitor and evaluate patient and personnel safety and toxicity during the implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) directed treatment. Furthermore, this study will focus on Quality of Life questionnaires, LENT score, and evaluate pain and breathlessness using af visual analogue scales (VAS). **Detailed Description:** This is a safety and feasibility study of repeated (minimum two procedures) PITAC directed treatments, and the primary outcome is the number of patients with medical adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) and/or surgical complications according to the Clavien-Dindo classification. This study will include consecutive MPE patients until 20 patients have completed at least two PITAC´s. The PITAC directed treatment will be performed in 4 week intervals. Bedside ultrasound, VAS-pain and VAS-breathlessness, and Quality of Life questionnaires will be performed at baseline, one month follow-up and three months follow-up. Patients with MPE who are eligible for surgery are identified during the multidisciplinary tumor (MDT) conference at the Department of Surgery, Odense University Hospital (OUH), and included based on predefined in- and exclusion criteria. Patients with MPE from non-colorectal or -appendix cancer will be treated with a combination of cisplatin and doxorubicin. Patients with MPE from colorectal or appendix cancer will be treated with oxaliplatin. In brief, The PITAC procedure is the application of aerosolized chemotherapy into the pleural cavity using thoracoscopy. PITAC is performed in the prone or lateral position. A double lumen endotracheal tube is used to allow exclusion of the ipsilateral lung, but this is not (always) necessary with the patient in the prone position. The first trocar is placed guided by ultrasound, and after safe positioning a second trocar can be inserted guided by video thoracoscopy. The chemotherapy is applied to the pleural cavity through a nebulizer inserted through one of the trocars and linked to a high-pressure injector. After five minutes the chemotherapy has been delivered to the pleural cavity, and after an additional 30 minutes of simple diffusion, the intrathoracic air saturated with chemotherapy is evacuated through a series of filters. The patients are monitored for a minimum of one day and will after each PITAC directed treatment be screened for adverse events. ### Conditions Module **Conditions:** - Malignant Pleural Effusion - Pleural Neoplasms - Quality of Life - Chemotherapy Effect - Chemotherapeutic Toxicity - Pleural Carcinomatosis - Pleural Cavity Effusion ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Cohort study ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Malignant Pleural Effusion (MPE) from colorectal or appendix cancer will be treated with Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) using oxaliplatin 92 mg/m2 in 150 ml dextrose. MPE from non-colorectal or -appendix cancer will be treated with PITAC using cisplatin 10.5 mg/m2 in 150 ml saline and 2.1 mg/m2 in 50 ml saline. PITAC is performed with a intrapleural pressure of 12 mmHg and the aerosolised chemotherapy will be nebulized at a maximum pressure of 300 PSI and a flow-rate of 0.5-1.8 ml/min. The PITAC directed treatment will be planned with 4 week intervals and patients may receive bi-directional systemic chemotherapy simultaneously. **Intervention Names:** - Drug: PITAC **Label:** PITAC **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - PITAC **Description:** Cisplatin, oxaliplatin and doxorubicin are standard, commercially available intravenous cytostatic drugs in oncologic treatment with alkylating and topoisomerase inhibitor effect, respectively. Based on the available data and experience from 11 PITAC procedures at OPC, PITAC with cisplatin, oxaliplatin and doxorubicin for intrapleural administration is expected to be well tolerated with a minimal of nausea, subcutaneous emphysema and transient chest pains. **Name:** PITAC **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of patients with medical adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 defined as CTCAE ≥ 4 within 30 days after the procedure. **Measure:** Medical adverse events **Time Frame:** 30 days from PITAC directed treatment **Description:** Number of patients with surgical complications according to the Clavien-Dindo classification defined as Clavien-Dindo ≥ 3b within 30 days after the procedure. **Measure:** Surgical complications **Time Frame:** 30 days from PITAC directed treatment #### Secondary Outcomes **Description:** To evaluate the number of patients completing three PITAC treatments **Measure:** Number of patients completing three PITAC treatments **Time Frame:** 12 months **Description:** To macroscopically evaluate the extent of visible pleural metastasis (PLM) during PITAC directed therapy via the new PLM-score based on size of lesions (LS). LS 0 No tumor seen LS1 Tumor up to 0.5 cm LS2 Tumor up to 5.0 cm LS3 Tumor \> 5.0 cm or confluence **Measure:** Extent of visible pleural metastasis **Time Frame:** 12 months **Description:** To evaluate Pleural Regression Grade Score (Ple-RGS) in biopsies from visible pleural metastasis Ple-RGS is a modification of the Peritoneal Regression Grading score (PRGS). Ple-RGS 1: Complete histological response Ple-RGS 2: Regressive changes are predominant over cancer cells (major response) Ple-RGS 3: Cancer cells are predominant over regressive changes (minor response) Ple-RGS 4: No response **Measure:** Pathology on pleural metastasis biopsies **Time Frame:** 12 months **Description:** To evaluate cytology on MPE during PITAC directed therapy. The cells will be graded according to a five-tiered score: malignant cells, suspicious cells, atypical cells, no malignant cells and other **Measure:** Cytology on malignant pleural effusion fluid **Time Frame:** 12 months **Description:** To evaluate the LENT score after each PITAC directed therapy. Low risk: 0-1 Moderate risk: 2-4 High risk: 5-7 **Measure:** LENT score **Time Frame:** 12 months **Description:** Quantify the length of stay (LOS) (surgery = day 0) **Measure:** Length of Stay (LOS) **Time Frame:** 12 months **Description:** Assess personnel safety by measuring of platinum traces in the operating room. **Measure:** Personnel safety (environmental) **Time Frame:** 12 months **Description:** Assess personnel safety by measuring of platinum traces in blood samples from surgeons and/or OR nurses. **Measure:** Personnel safety (biological) **Time Frame:** 12 months **Description:** To evaluate lung function by saturation (SAT) before PITAC directed treatment (day 0) and at discharge (day 1), day 30 and 3 months after the last PITAC directed treatment **Measure:** Lung function evaluation by SAT **Time Frame:** 12 months **Description:** To evaluate breathlessness using visual analogue scales (VAS-breath) before PITAC directed treatment (day 0) and at discharge (day 1), day 30, and 3 months after the last PITAC directed treatment **Measure:** Breathlessness **Time Frame:** 12 months **Description:** To evaluate pain using visual analogue scales (VAS-pain) before PITAC directed treatment (day 0) and at discharge (day 1), day 30, and 3 months after the last PITAC directed treatment **Measure:** Pain assessment **Time Frame:** 12 months **Description:** To evaluate the quality of life with EORTC-QLQ-C30 at baseline, day 30 and 3 months after the last PITAC directed treatment **Measure:** Quality of Life questionnaires **Time Frame:** 12 months **Description:** To calculate the change in volume of drained MPE from 2 months before the first PITAC treatment to three months after the last PITAC treatment **Measure:** Change in MPE volume **Time Frame:** 12 months **Description:** To assess long-term complications 3 months after the third PITAC directed treatment **Measure:** Long term complications **Time Frame:** 12 months **Description:** Median overall survival **Measure:** Survival **Time Frame:** 12 months **Description:** To evaluate lung function by Forced Expired Volume in the first second (FEV1) before PITAC directed treatment (day 0) and at discharge (day 1), day 30 and 3 months after the last PITAC directed treatment **Measure:** Lung function evaluation by FEV1 **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Symptomatic MPE visible with bedside ultrasound * Histologically or cytologically verified malignancy * Status CT-scan not older than four weeks * MPE requiring at least one drainage procedure * Drained ≥ 14 days before the first PITAC directed treatment * Bidirectional systemic chemotherapy or immunotherapy ≥ 14 days before the first PITAC directed treatment or no simultaneous systemic chemotherapy or immunotherapy * ECOG Performance status 0-2 * Life expectancy ≥ 3 months * Age ≥ 18 years * Danish-speaking and reading patients * Written informed consent according to the local Ethics Committee requirements Exclusion Criteria: * A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin * Renal impairment, defined as GFR \< 40 ml/min (Cockcroft-Gault Equation) * Myocardial insufficiency, defined as NYHA class \> 2 * Impaired liver function defined as bilirubin ≥1.5 * Fertility, pregnancy and lactation: Female subjects will be considered of non-reproductive potential if they are either a, b or c: 1. postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 2. have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening. 3. have a congenital or acquired condition that prevents childbearing. Previous intrathoracic chemotherapy, intrathoracic antibody treatment or chemical pleurodesis * Any other condition or therapy, which in the investigator´s opinion may pose a risk to the patient or interfere with the study objects **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Pernille Schjødt Hansen, Student **Phone:** +45 65411857 **Role:** CONTACT #### Locations **Location 1:** **City:** Odense **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Martin Graversen, MD - **Phone:** +45 30549497 - **Role:** CONTACT ***Contact 2:*** - **Name:** Martin Graversen, MD, Ph.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Odense PIPAC Center, Department of Surgery, Odense University Hospital **Status:** RECRUITING **Zip:** 5000 ### IPD Sharing Statement Module **Description:** Publications and presentations will be based on patient data, but the database is not open to other researchers. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010995 - Term: Pleural Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M18563 - Name: Pleural Effusion, Malignant - Relevance: HIGH - As Found: Malignant Pleural Effusion - ID: M13886 - Name: Pleural Effusion - Relevance: HIGH - As Found: Pleural Effusion - ID: M13887 - Name: Pleural Neoplasms - Relevance: HIGH - As Found: Pleural Neoplasms - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinomatosis - ID: M13885 - Name: Pleural Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000016066 - Term: Pleural Effusion, Malignant - ID: D000010997 - Term: Pleural Neoplasms - ID: D000010996 - Term: Pleural Effusion ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7492 - Name: Doxorubicin - Relevance: LOW - As Found: Unknown - ID: M227339 - Name: Liposomal doxorubicin - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M1674 - Name: Oxaliplatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421597 **Acronym:** RIGID **Brief Title:** Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease **Official Title:** Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease #### Organization Study ID Info **ID:** 2023-506949-27-00 #### Organization **Class:** OTHER **Full Name:** Odense University Hospital ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hospital of South West Jutland **Class:** OTHER **Name:** University of Ulm **Class:** OTHER **Name:** University of Birmingham #### Lead Sponsor **Class:** OTHER **Name:** Odense University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients' bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and a mixed meal test is performed. ### Conditions Module **Conditions:** - Osteoporosis Secondary ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Prednisolone **Label:** Prednisolone group **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Placebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Prednisolone group **Description:** prednisoline 25 mg/day for seven days **Name:** Prednisolone **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo group **Description:** Placebo treatment for seven days **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Untargeted proteomics will be used to try to identify a biomarker for individuals at risk of glucocorticoid induced bone loss **Measure:** Biomarker **Time Frame:** Baseline #### Primary Outcomes **Description:** Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8 **Measure:** Procollagen type 1 N-terminal propeptide (P1NP) **Time Frame:** Baseline to day 8 #### Secondary Outcomes **Description:** Changes in the level of the bone turnover marker CTX in peripheral blood from baseline to day 8 and 15 **Measure:** Collagen 1 cross link C-terminal telopeptide (CTX) **Time Frame:** Baseline to day 8 and 15 **Description:** Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 15 **Measure:** P1NP (baseline to day 15) **Time Frame:** Baseline to day 15 **Description:** Changes in the levels of glucocorticoid metabolites in blood from baseline to day 8 **Measure:** Concentration of Glucocorticoid metabolites **Time Frame:** Baseline to day 8 **Description:** Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 8 **Measure:** Adipose tissue **Time Frame:** Baseline to day 8 **Description:** Changes in gene expression in bone tissue from baseline to day 8 **Measure:** Bone tissue **Time Frame:** Baseline to day 8 **Description:** Changes in glucose levels during a mixed meal test from baseline to day 8 **Measure:** Glucose **Time Frame:** Baseline to day 8 **Description:** Changes in c-peptid levels during a mixed meal test from baseline to day 8 **Measure:** C-peptid **Time Frame:** Baseline to day 8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men and women aged 18-50 years. Exclusion Criteria: * Uncontrolled thyrotoxicosis * Chronic kidney disease (eGFR \<30) * Known Cushing's syndrome * Previous gastric bypass and/or known ongoing malabsorption * Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment) * Use of oral or inhaled glucocorticoids within the past year * Menopause (defined as 1 year without menstrual bleeding) * Pregnancy (defined as elevated HCG) * Ongoing infection * Allergy to prednisolone or one of the excipients * Systematic fungal infections * Vaccination with living or weaken viral or bacterial vaccines in patient who or immunocompromised. In these cases, prednisolone treatment should not be administered two weeks before and after vaccination * Not able to provide informed consent (e.g., dementia, not able to understand Danish). **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Catharina Vind Nielsen, MD **Phone:** +45 21351124 **Role:** CONTACT #### Locations **Location 1:** **City:** Esbjerg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Catharina Vind Nielsen, MD - **Phone:** +45 21351124 - **Role:** CONTACT **Country:** Denmark **Facility:** Hospital of South West Jutland **Zip:** 6700 **Location 2:** **City:** Odense C **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Catharina Vind Nielsen, MD - **Phone:** +45 21351124 - **Role:** CONTACT **Country:** Denmark **Facility:** Odense University Hospital **Zip:** 5000 #### Overall Officials **Official 1:** **Affiliation:** Odense University Hospital **Name:** Morten Frost, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Hospital of South West Jutland **Name:** Claus Bogh Juhl, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Individual participant data will not be shared with other researchers other than collaborators. Since the data contains personal information from the study participants **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001851 - Term: Bone Diseases, Metabolic - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M12947 - Name: Osteoporosis - Relevance: HIGH - As Found: Osteoporosis - ID: M5126 - Name: Bone Diseases - Relevance: HIGH - As Found: Bone Disease - ID: M5130 - Name: Bone Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010024 - Term: Osteoporosis - ID: D000001847 - Term: Bone Diseases ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnEm - Name: Antiemetics - Abbrev: NeuroAg - Name: Neuroprotective Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M14120 - Name: Prednisolone - Relevance: HIGH - As Found: High Risk - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M11749 - Name: Methylprednisolone - Relevance: LOW - As Found: Unknown - ID: M1833 - Name: Methylprednisolone Acetate - Relevance: LOW - As Found: Unknown - ID: M11750 - Name: Methylprednisolone Hemisuccinate - Relevance: LOW - As Found: Unknown - ID: M229449 - Name: Prednisolone acetate - Relevance: LOW - As Found: Unknown - ID: M211887 - Name: Prednisolone hemisuccinate - Relevance: LOW - As Found: Unknown - ID: M248881 - Name: Prednisolone phosphate - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011239 - Term: Prednisolone ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421584 **Acronym:** SURGTEACH **Brief Title:** Evaluating the Role of SURGical TElementoring in Acquisition of Surgical Skills of Laparoscopic Cholecystectomy. SURGTEACH Trial **Official Title:** Laparoscopic Cholecystectomy - A Randomized Controlled Trial Evaluating The Role Of Surgical Telementoring In Acquisition of Surgical Skills #### Organization Study ID Info **ID:** Nordlandssykehuset #### Organization **Class:** OTHER **Full Name:** Nordlandssykehuset HF ### Status Module #### Completion Date **Date:** 2025-11-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-11 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Olympus #### Lead Sponsor **Class:** OTHER **Name:** Nordlandssykehuset HF #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Surgical telementoring (ST) has the potential to become an integrated part of everyday surgical teaching practice. Its educational benefits require investigation. This is a randomized controlled trial evaluating ST in a clinical setting. Laparoscopic cholecystectomy will be performed by eligible surgical residents randomized to the intervention group or the control group. The control group being guided by traditional onsite mentoring and the intervention group being telementored by a distantly located telementor during ongoing procedure. The primary outcome will be the video recorded GOALS-score (Global Operative Assessment of Laparoscopic Skills) and NOTSS-score (Non Technical Surgical Skills) assessment of each procedure while secondary outcomes will be satisfaction scores of the involved residents and mentors. **Detailed Description:** Background: Developing surgical skills among residents takes time and resources. Surgical practice is increasingly driven by efficacy and hospital economics. Operating room surgical education might conflict with these goals. The identified factors need optimizing surgical resident training. Surgical telementoring (ST) seems natural in surgery. Some ST-systems are cost-effective and safe. Despite recent technical breakthroughs and growing experience with telemedicine in the health sector, data on educational outcomes is still being determined. Objective: ST will be evaluated for efficiency and safety as a skill development tool for laparoscopic cholecystectomy. In this randomized controlled trial, surgical residents will be randomly assigned in a 1:1 ratio to the intervention group (real-time telementoring and postoperative coaching) or the control group (traditional intraoperative hands-on teaching). The research follows CONSORT, SPIRIT 2013 statements and the intention to treat principle (ITT). The study is approved by the Norwegian ethical committee (REK HELSE NORD 32592) and the data protection officer (PVO) at Nordland Hospital trust Bodø (NLSH Bodø). Two groups of residents will be allocated. The control group will follow the traditional hands-on surgical training method. In the intervention group, an expert surgeon will telementor the surgical residents. General surgery trainees in years 1-6 who have completed more than five laparoscopic abdominal surgeries are eligible. Stratification according to previous experience of the mentee will be made. All residents must agree with the mentor on surgical communication. This model uses LapcoNor principles for intraoperative communication and the GROW-model as an educational model. The GOALS score is the primary trial outcome. It consists of a five-item global rating scale for laparoscopic surgical skills. Each item may be scored from 1 to 5, where 1 is the lowest and five is the highest. The max score is 25. We hypothesize that the intervention group will enhance clinical skills by 3-5 points on the GOALS score compared to the control group. To attain 0.8 statistical power, a p-value of less than 0.05, and a 20% dropout rate, 12 residents per group are needed. In addition to the GOALS-score assessment of video records, the NOTSS-score evaluating non-surgical technical skills will be assessed. The NOTSS score is based on 4 categories where each category consists of 3 elements. Each element may be graded from 1 to 4 , where 1 is the lowest and 4 is the highest. The highest achievable score is 48. The higher the score, the better the outcome for both scoring systems. Results: Lapco TT courses were given to all telementors and onsite consulting surgeons before the trial start. In December 2023, the Medprescence (c) telementoring system was installed in three local hospitals. Residents, consultant surgeons, and telementors learned Medprescence setup and use. Surgical residents will be recruited once this research protocol is evaluated and accepted for publication to accommodate any necessary changes before the study begins. Starting recruitment in spring 2024 is feasible. This would allow data analysis by end of 2024 and publication in an international peer-reviewed journal by spring 2025. Conclusions: The SURGTEACH trial is the first randomized trial of telementoring for surgical education. The surgical education system and surgeon supply are limited globally and locally. Due to geographical and educational barriers, the Norwegian healthcare system requires support in educating enough surgeons. Therefore, surgical education must evolve, and surgical telementoring may help solve these challenges. This research may give high quality evidence to improve surgical education, especially in rural hospitals. ### Conditions Module **Conditions:** - Surgical Education - Surgical Telementoring **Keywords:** - Competency based surgical education - Surgical telementoring - Laparoscopic cholecystectomy - Randomized controlled clinical trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This randomized controlled trial (RCT) was designed as a superiority trial to demonstrate the superiority of telementored resident skill learning in the operating room (OR) compared to standard training methods. ##### Masking Info **Masking:** DOUBLE **Masking Description:** Mentors and telementors performing the GOALS-assessment of the video records are blinded to the temporal order of the performed procedures by the residents in both groups. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The residents randomized to the control arm will receive traditional intra operative guidance by the mentor holding the laparoscopic camera during the procedure. **Label:** Control group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** The residents randomized to the intervention arm will receive telementored guidance. This guidance is provided by telecommunication setup allowing the remotely located mentor to see the live footage of the laparoscopic procedure and to verbally communicate with the resident performing the surgical procedure. **Intervention Names:** - Device: Surgical telementoring **Label:** Interventional arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Interventional arm **Description:** The intervention group receives intraoperative guidance by telementoring. The telementor is remotely located but able to see the real-time footage of the ongoing procedure and simultaneously verbally communicate with the operating resident wearing a headset during surgery. Additionally, feedback by telestration may be given to the operating resident if required. This involves graphic annotations on a still picture of the ongoing surgery which the telementor may design if required. **Name:** Surgical telementoring **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** GOALS-score is a validated scoring system for laparoscopic surgical skills. Each performed procedure in the control group and the intervention group will be divided into 5 key-steps and each step will be scored by the 5 involved mentors and telementors. The video records of the procedures will be edited by the main author into 5 key-steps. Each recorded procedure will not exceed 1hours duration. All five procedures by each resident will be edited and presented to 5 mentors/telementors for GOALS-score assessment. Total GOALS-score will be calculated by adding the scores of each key-step. Every resident in each of the 2 groups will perform 5 consecutive procedures within 3-5 consecutive days. The GOALS-assessment will be required with 1 week after presenting the procedures to the 5 mentors/telementors **Measure:** GOALS-score (Global Operative Assessment of Laparoscopic Skills) **Time Frame:** Each resident in both the intervention group and the control group will be scheduled to perform 5 consecutive laparoscopic cholecystectomies within 3-5 days. **Description:** Assessing non-surgical technical skills by assessment of 4 categories (Situation awareness, Decision making, Communication and teamwork and Leadership. Each category consists of 3 elements. Each category is rated from 1-4 and each of the 3 elements within each category is rated from 1-4. Each recorded and edited video record of the 5 consecutive laparoscopic procedures by the residents in both groups will be presented to mentors/telementors (5 members) for NOTSS-score assessment. The NOTSS-assessment will be required with 1 week after presenting the procedures to the 5 mentors/telementors. **Measure:** NOTSS-score (Non-technical surgical skills) **Time Frame:** Each resident in both the intervention group and the control group will be scheduled to perform 5 consecutive laparoscopic cholecystectomies within 3-5 days. #### Secondary Outcomes **Description:** Each resident (both groups) will be given a predetermined form for self-reported satisfaction score. Resident satisfaction survey was based on a 5-point Likert scale. 7 statements are to be assessed with answers ranging from 1= strong disagreement with the statement and 5=strong agreement with the statement. 5 is the best outcome for each statement and 35 is the best overall result for the survey. **Measure:** Satisfaction score of residents in the control group and the intervention group. **Time Frame:** 5 subsequent procedures will be performed by each resident within a periode of 3-5 days. Satisfaction score form will be asked for within 1 hour after each procedure. **Description:** Each mentor and telementor (both groups)will be given a predetermined form for self-reported satisfaction score. The mentor/telementor satisfaction survey was based on a 5-point Likert scale. 7 statements are to be assessed with answers ranging from 1= strong disagreement with the statement and 5=strong agreement with the statement. 5 is the best outcome for each statement and 35 is the best overall result for the survey. **Measure:** Satisfaction score of mentors (control group) and telementors (intervention group) **Time Frame:** Each mentor and telementor will be given a satisfaction score form to fill out within 1 hour after each procedure. ### Eligibility Module **Eligibility Criteria:** Inclusion criteria for residents in control- and intervention group: * General surgery residents in years 1 to 6 of their specialty education having performed more than five laparoscopic procedures. * Stratification according to experience will be made for the subject in the control arm and in the intervention arm. * Having passed the prerequisite mandatory national course of general laparoscopic principles. * All residents had to undergo agreement with the mentor about communication model during surgery. This model is derived from LapcoNor principals (11). Residents in the intervention group underwent an additional introduction to the principals of communication through telementoring at the OR. They were introduced to the telementoring equipment. Inclusion criteria for on-site mentors (control group) and telementors (intervention group): • - Consultant surgeon with more than 3 years of experience with independently performing laparoscopic cholecystectomies. * Having acquaintance with assessment of videos for GOALS-score (12) * Both telementors and on-site mentors had to show certificate of having done the national LapCo-Nor "train the trainer" course and followed standardized norms of communication with the mentee during surgical mentoring thus diminishing bias of communicative difference. Inclusion criteria for included patients: * Gallstone disease without clinical history of cholecystitis * BMI \< 38 * No previous history of upper abdominal laparotomy * No previous history of percutaneous gallbladder drainage * Patient provided informed consent. **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Khayam Butt, Medical doctor **Phone:** 004799560985 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Knut-Magne Augestad, Professor **Phone:** 004797499442 **Role:** CONTACT #### Locations **Location 1:** **City:** Bodø **Country:** Norway **Facility:** NordlandssykehusetHF **State:** Nordland **Zip:** 8004 #### Overall Officials **Official 1:** **Affiliation:** Head of research department **Name:** Petter Øien, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** All raw data will be shared on request. **Description:** Video records of the procedures will be stripped for patient-ID and stored anonymously on a secured website. Each video will be given an URL-address. The study secretary will have the key enabling recognition of each video to the specific patient and performing surgeon. The anonymous video records will be made available for each of the 5 mentors/telementors after being edited and labelled with key-steps of the procedure. Blinded GOALS- and NOTSS-assessment by the mentors/telementors will be performed. The assessment results will be collected by the study secretary on a questback scheme handed out in advance to the evaluators. The study secretary possesses the key enabling recognition of the video records according to patient-ID and performing residents. An Excel file with the results will be constructed by the study secretary and the data analysis will be commenced. The video records and the Excel file, constituting the raw data, will be available as IPD for sharing. **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** Data will be available as it is collected. Videorecords of the procedures by the residents are planned to be finished by end of November 2024. The video records will be stored continuously and the website will be availabe at the starting point. The GOALS-scores and NOTSS-scores will be collected continuously as the video records are edited and presented to the mentors (control arm) and the telementors (intervention arm) ### References Module #### References **Citation:** Holmer H, Lantz A, Kunjumen T, Finlayson S, Hoyler M, Siyam A, Montenegro H, Kelley ET, Campbell J, Cherian MN, Hagander L. Global distribution of surgeons, anaesthesiologists, and obstetricians. Lancet Glob Health. 2015 Apr 27;3 Suppl 2:S9-11. doi: 10.1016/S2214-109X(14)70349-3. No abstract available. **PMID:** 25926323 **Citation:** Vickers AJ, Bianco FJ, Gonen M, Cronin AM, Eastham JA, Schrag D, Klein EA, Reuther AM, Kattan MW, Pontes JE, Scardino PT. Effects of pathologic stage on the learning curve for radical prostatectomy: evidence that recurrence in organ-confined cancer is largely related to inadequate surgical technique. Eur Urol. 2008 May;53(5):960-6. doi: 10.1016/j.eururo.2008.01.005. Epub 2008 Jan 14. **PMID:** 18207316 **Citation:** Zorn KC, Gautam G, Shalhav AL, Clayman RV, Ahlering TE, Albala DM, Lee DI, Sundaram CP, Matin SF, Castle EP, Winfield HN, Gettman MT, Lee BR, Thomas R, Patel VR, Leveillee RJ, Wong C, Badlani GH, Rha KH, Eggener SE, Wiklund P, Mottrie A, Atug F, Kural AR, Joseph JV; Members of the Society of Urologic Robotic Surgeons. Training, credentialing, proctoring and medicolegal risks of robotic urological surgery: recommendations of the society of urologic robotic surgeons. J Urol. 2009 Sep;182(3):1126-32. doi: 10.1016/j.juro.2009.05.042. Epub 2009 Jul 21. **PMID:** 19625032 **Citation:** Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available. **PMID:** 8000648 **Citation:** Yun Kyung Jung et al: What is the safe training to educate the laparoscopic cholecystectomy for surgical residents in early learning curve ? J. Minim Invasive Surg 2016; 19(2): 70-74 **Citation:** Doarn CR. Telemedicine in tomorrow's operating room: a natural fit. Semin Laparosc Surg. 2003 Sep;10(3):121-6. doi: 10.1177/107155170301000305. **PMID:** 14551654 **Citation:** Ohinmaa A, Vuolio S, Haukipuro K, Winblad I. A cost-minimization analysis of orthopaedic consultations using videoconferencing in comparison with conventional consulting. J Telemed Telecare. 2002;8(5):283-9. doi: 10.1177/1357633X0200800507. **PMID:** 12396857 **Citation:** Schulam PG, Docimo SG, Saleh W, Breitenbach C, Moore RG, Kavoussi L. Telesurgical mentoring. Initial clinical experience. Surg Endosc. 1997 Oct;11(10):1001-5. doi: 10.1007/s004649900511. **PMID:** 9381336 **Citation:** Augestad KM, Bellika JG, Budrionis A, Chomutare T, Lindsetmo RO, Patel H, Delaney C; Mobile Medical Mentor (M3) Project. Surgical telementoring in knowledge translation--clinical outcomes and educational benefits: a comprehensive review. Surg Innov. 2013 Jun;20(3):273-81. doi: 10.1177/1553350612465793. Epub 2012 Oct 30. **PMID:** 23117447 **Citation:** Wood D. No surgeon should operate alone: how telementoring could change operations. Telemed J E Health. 2011 Apr;17(3):150-2. doi: 10.1089/tmj.2011.9986. No abstract available. **PMID:** 21500973 **Citation:** Hanna GB, Mackenzie H, Miskovic D, Ni M, Wyles S, Aylin P, Parvaiz A, Cecil T, Gudgeon A, Griffith J, Robinson JM, Selvasekar C, Rockall T, Acheson A, Maxwell-Armstrong C, Jenkins JT, Horgan A, Cunningham C, Lindsey I, Arulampalam T, Motson RW, Francis NK, Kennedy RH, Coleman MG; on behalfofLapco program. Laparoscopic Colorectal Surgery Outcomes Improved After National Training Program (LAPCO) for Specialists in England. Ann Surg. 2022 Jun 1;275(6):1149-1155. doi: 10.1097/SLA.0000000000004584. Epub 2020 Oct 19. **PMID:** 33086313 **Citation:** Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondre K, Stanbridge D, Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg. 2005 Jul;190(1):107-13. doi: 10.1016/j.amjsurg.2005.04.004. **PMID:** 15972181 **Citation:** Mackenzie H, Cuming T, Miskovic D, Wyles SM, Langsford L, Anderson J, Thomas-Gibson S, Valori R, Hanna GB, Coleman MG, Francis N. Design, delivery, and validation of a trainer curriculum for the national laparoscopic colorectal training program in England. Ann Surg. 2015 Jan;261(1):149-56. doi: 10.1097/SLA.0000000000000437. **PMID:** 24374538 **Citation:** Manatakis DK, Antonopoulou MI, Tasis N, Agalianos C, Tsouknidas I, Korkolis DP, Dervenis C. Critical View of Safety in Laparoscopic Cholecystectomy: A Systematic Review of Current Evidence and Future Perspectives. World J Surg. 2023 Mar;47(3):640-648. doi: 10.1007/s00268-022-06842-0. Epub 2022 Dec 6. **PMID:** 36474120 **Citation:** Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. **PMID:** 15273542 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421571 **Acronym:** GR-CTCL_CL **Brief Title:** The Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients **Official Title:** A Greek, Prospective Non-interventional Study Investigating the Effectiveness and the Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients #### Organization Study ID Info **ID:** 441/05-08-2020 #### Organization **Class:** OTHER **Full Name:** National and Kapodistrian University of Athens ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2023-02-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-03-26 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Recordati Rare Diseases #### Lead Sponsor **Class:** OTHER **Name:** National and Kapodistrian University of Athens #### Responsible Party **Investigator Affiliation:** National and Kapodistrian University of Athens **Investigator Full Name:** Evangelia Papadavid **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Chlormethine is a topical alkylating agent whose role in MF-CTCL has been extensively studied over the last 40 years. While its efficacy is well established, many safety concerns have been raised due to high rates of delayed cutaneous hypersensitivity to aqueous solutions that limit the prolonged use of chlormethine in clinical practice. It has been shown that complete response to topical chlormethine is associated with lower risk of disease progression. Accordingly, clinical data from the investigators' clinic confirm that chlormethine gel is a safe and effective treatment, which be used in early and advanced stages of cutaneous lymphomas. Based investigators' clinical and biological results , the investigators like to further investigate the change in the percentage as well as the profile of malignant and inflammatory cells by CyTOF analysis and further investigate the pathways (eg OX40, PDL1) involved in this process. **Detailed Description:** 1. RATIONALE Chlormethine is a topical alkylating agent whose role in MF-CTCL has been extensively studied over the last 40 years. While its efficacy is well established, many safety concerns have been raised due to high rates of delayed cutaneous hypersensitivity to aqueous solutions that limit the prolonged use of chlormethine in clinical practice. It has been shown that complete response to topical chlormethine is associated with lower risk of disease progression. Accordingly, the clinical data confirm that chlormethine gel is a safe and effective treatment, which be used in early and advanced stages of cutaneous lymphomas. In a study of 23 patients with stage IA-IIB mycosis fungoides from investigators' center an overall response of 65.22% at 9 months of treatment with topical chlormethine was recorded. Moreover in a recent multicenter greek study that included 58 patients with stage IA-IIB mycosis fungoides an overall response rate of 80.8% at 9 months of treatment was achieved. In the same study better response in patients with patches in comparison to plaques or tumors was also depicted. Unfortunately, the occurrence of skin drug reactions was the leading cause of treatment discontinuation in studies evaluating chlormethine irrespective of drug formulation, negatively affecting the achievement of a therapeutic response. In investigators' study, severe dermatitis was one of the main causes of treatment discontinuation, occuring in 15.5% of patients. Taper of application frequency (as per SmPC) and topical steroid use represent strategies allowing the management of dermatitis in order to maintain patients on CL gel treatment and prevent treatment discontinuation. The presence or severity of dermatitis in the study population was not associated with ORR, indicating that the development of dermatitis did not affect the likelihood of response. It has previously been suggested that dermatitis may be a prognostic indicator for clinical response. These data highlight the unmet need to explain the significance of dermatitis after topical chlomethine application and the immunological changes behind and how these affect the clinical response. Additionally by standardizing a CyTOF technique in CTCL samples from skin biopsies of CTCL patients, investigators established the methodology for identification and enumeration of different cells populations in situ and their interactions with tumor microenvironment. Investigators' preliminary data demonstrated that the evaluation of MF-CTCL patients' immune profile revealed differences in cell proportion pinpointing the heterogeneity that characterizes different stages of MF. Based on investigators' clinical and biological results investigators would like to further examine the change in the percentage as well as the profile of malignant and inflammatory cells by CyTOF analysis and further investigate the pathways (eg OX40, PDL1) involved in this process. 2. STUDY DESIGN 2.1 Study Description The proposed study is a non-interventional, prospective (data collection), open-label, single-arm study. Data collection will be done prospectively. The management of patients will be done in the classic framework of the management of adult patients with MF-CTCL in principal investigator's university hospital. 3. RESEARCH OBJECTIVES (CLINICAL, BIOLOGICAL AND PATIENT-REPORTED OUTCOMES - QUALITY OF LIFE) 3.1 Clinical objectives 3.1.1 Effectiveness of CL gel treatment in routine medical practice in MF patients by: • Evaluation of clinical response by mSWAT * Duration of response (defined as the interval from the time measurement criteria for CR and PR are first met until the first date that progressive disease is documented), time to next treatment (TNTT: defined as the time from the time the next treatment is recorded) * Correlation between dermatitis occurrence and clinical response * quality of life of the patients * Chlormethine gel tube consumption * safety and tolerability of the treatment with CL gel: frequency of skin side effects 3.2 Biological objectives For this part of the study the percentage change of malignant and inflammatory cells, profile of inflammatory (new and existing) and malignant cells in all MF patients treated with chlormethine gel (with or without dermatitis), cytokines and signaling pathways at a single cell level will be also measured. 3.2.1 Assessments Dermatitis occurrence (before any topical steroids application) Clinical response (at least score \>50% improvement from baseline) At months 6 and 12 * Evaluation of the impact of chlormethine gel treatment on malignant and inflammatory cells * Evaluation of the impact of chlormethine gel treatment exhibits on the profile of Th1/Th2 cytokines (ELISA) * Evaluation of the impact that CL gel treatment exerts on the JAK/STAT, NF-κB AKT, MAP signaling pathways (Western Blotting) 3.3 Patient-Reported Outcomes - quality of life (SKINDEX-29) Quality of Life (QoL) change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the SKINDEX-29 at every visit. 3.4 Study Population MF patients treated with CL gel as monotherapy. Study design is presented in figure below. This study will include 40 patients treated with CL gel as monotherapy. Patients will discontinue study treatment permanently if the following condition is met: • Patients are still unable to tolerate CL gel treatment at reduced frequency with co-administration of corticosteroids. All patients will be assessed every month for the first three months, and every 3 months thereafter (at months 6, 9, 12), as per current clinical practice. In case of dermatitis, the patient is encouraged to continue treatment with reduced frequency at every other day or every third day. Steroids will be used only if the reduced schedule is not sufficient. A temporary treatment interruption might occur for a period of 2 weeks and then treatment can be restarted. 3.5 Research objectives (detailed) Clinical, biological and patient quality of life 3.5.1 Clinical objective • Effectiveness of CL gel treatment in routine medical practice in MF patients: Overall Response Rate (ORR), defined as the proportion of patients who achieved a CR or PR (at least score \>50% improvement from baseline), in all patients determined by mSWAT, within 12 months of the start of CL gel treatment. * Duration of response (RD), time to next treatment (TNTT) in the framework of the trial * safety and tolerability of the drug: Frequency of skin side effects with a focus on dermatitis, the time to occurrence and duration of dermatitis as well as the percentage of patients with dermatitis remaining on treatment at the end of the study * Correlation between dermatitis occurrence and clinical response (ORR in patients experiencing or not dermatitis during treatment by chlormethine gel) * quality of life of the patients (using Skindex-29 tool) receiving CL gel for at baseline and at the end of treatment * Chlormethine gel tube consumption estimated from medical prescription and patients' statement 3.6 Biological objectives For this part of the study the percentage change of malignant and inflammatory cells, profile of inflammatory (new and existing) and malignant cells in all MF patients treated with chlormethine gel (with or without dermatitis), cytokines and signaling pathways at a single cell level will be also measured at: * Baseline o Dermatitis occurrence (before any topical steroids application) * Clinical response (at least score \>50% improvement from baseline) * At months 6 and 12 * Evaluation of the impact of chlormethine gel treatment on malignant and inflammatory cells using mass cytometry (CyTOF) * Evaluation of the impact of chlormethine gel treatment exhibits on the profile of Th1/ Th2 cytokines (ELISA) * Evaluation of the impact that CL gel treatment exerts on the JAK/STAT, NF-κB, AKT, MAP signalling pathways (western blot analysis) Skin histology description, immunohistochemistry and PCR are used in clinical routine practice to assess malignant T cells and clonality. The exploratory study will use both blood samples and skin biopsies taken as per routine management of the patients tests for the study of • CL gel mechanism of action (1) • the pathophysiology of dermatitis after CL gel application (2) We will correlate the above with the clinical effectiveness of CL gel treatment (3) as well as dermatitis occurrence and clinical response in MF patients (4). More specifically • the profile of malignant cells and inflammatory, by characterizing the immune cells deriving from single cell suspensions from biopsies and/or PBMCs by mass cytometry The signaling pathways involved, such as JAK/STAT, NF-κB, AKT, MAP kinases by identifying the phosphorylation status of implicated proteins by Western blot analyses 3.7 Patient-Reported Outcomes - quality of life (SKINDEX-29) Definition: Quality of Life (QoL) change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the SKINDEX-29 at every visit. The Skindex-29 is a skin disease-specific questionnaire that comprehensively assesses the effects of skin diseases on patient's quality of life. It was specifically developed to detect changes throughout time, as well as differences among patients with different skin diseases. The questionnaire covers areas considered crucial in an instrument designed to evaluate quality of life, such as: degree of symptoms, psychosocial functioning, and emotional status. The 29-item version is a refinement of a previous 61-item version. It was originally written in English and has already been translated and validated in other languages. The Skindex-29 inquiries about how often (Never, Rarely, Sometimes, Often, All the time) during the previous four weeks the patient experienced the effect described in each item. Seven items address the Symptoms domain, ten items the Emotional domain, and twelve items the Functioning domain. All responses are transformed to a linear scale of 100 varying from 0 (no effect) to 100 (effect experienced all the time). Skindex scores are reported as three scale scores, corresponding to the three domains; a scale score is the average of a patient's responses to items in a given domain. Five distinct categories for the Symptoms scale, and four for the Emotions and Functioning scales have been categorized as summarized in the table below: Emotional Symptoms Functioning Very little \<6 \<4 \<4 Mild 6-24.9 4-10.9 4-10.9 Moderate 25-49.9 11-25.9 11-32.9 Severe ≥50 26-49.9 ≥33 Extreme ≥50 ### Conditions Module **Conditions:** - Mycosis Fungoides ### Design Module #### Bio Spec **Description:** Skin biopsies and blood from MF-CTCL patients **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Number of participants with treatment-related adverse events as assessed by CTCAEv4.0. **Measure:** Clinical objectives: Number of participants with treatment-related adverse events as assessed by CTCAEv4.0. **Time Frame:** 12 months **Description:** Clinical response mSWAT (at least score ≥50% improvement from baseline) every month for the first three months, and every 3 months thereafter (at months 6, 9, 12), as per current clinical practice **Measure:** Clinical objectives: Clinical response mSWAT **Time Frame:** 12 months **Description:** Dermatitis occurrence (before any topical steroids application) **Measure:** Clinical objectives: Dermatitis occurrence **Time Frame:** 12 months **Description:** Determine and compare immune cells vs malignant cells at single cell level **Measure:** Biological objectives: Evaluation of the impact of chlormethine gel treatment on malignant and inflammatory cells **Time Frame:** 12 months **Description:** Evaluation of the impact of chlormethine gel treatment exhibits on the profile of Th1/Th2 cytokines (ELISA) **Measure:** Biological objectives:Evaluation of the impact of chlormethine gel treatment exhibits on the profile of cytokines **Time Frame:** 12 months **Description:** Evaluation of the impact that CL gel treatment exerts on the JAK/STAT, NF-κB AKT, MAP signaling pathways (Western Blotting) **Measure:** Biological objectives:Evaluation of the impact that CL gel treatment exerts on the major signaling pathways **Time Frame:** 12 months **Description:** Questionnaires of Quality of Life **Measure:** Patient-Reported Outcomes **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * MF-CTCL early-stage diagnosed patients, or late-stage patients that relapse without current active tumoral disease who still have patches and/or plaques. * Age ≥ 18 years * Patients naïve from CL gel treatment * Early-stage patients who will be using CL as monotherapy: at enrolment without any concomitant MF treatment * Early-stage patients if treated with other topical or systemic (late or early-stage patients) at enrolment, then a 2 week for topical steroids (and/or other topical treatment) and 4 weeks for systemic treatments wash out period will be required * Women of child bearing potential must have a negative serum pregnancy test within 3 days prior enrolment. * Women of child bearing potential should use adequate birth control measures, during the study treatment period until 30 days after treatment * Women who are breast feeding should discontinue nursing prior to the first application of study treatment and until 30 days after the last study treatment * Before patient enrolment, written informed consent must be given according to ICH/GCP Exclusion Criteria: * - Patients diagnosed with stage III and IV, unless they meet the inclusion criteria for late stage disease (see above) * Patients with multiple active tumors - progressive disease * Patients with concomitant and chronic use of topical or systemic corticosteroids for the treatment of any other disease * Patients treated with concomitant topical (except chlormethine gel) and/or systemic MF treatments who have missed the wash-out period (2 weeks for topical treatment and 4 weeks for systemic treatment) * Acute flare or atopic dermatitis or other dermatosis in the last 3 weeks * Pregnant and breast-feeding women * Patients unable to comply with study procedures (e.g. provide written consent, fill in the questionnaires, geographical condition potentially hampering compliance with the study protocol and follow-up schedule). * Known hypersensitivity to any component of the CL gel formulation * Concurrent or planned local or systemic anti-CTCL therapies **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** MF-CTCL patients, from outpatient PCL clinic from Attikon University Hospital, who will be candidates for topical treatment with chlormethine gel will be informed and invited to participate in this prospective data collection. All clinical and biological investigations (including blood samplings and biopsies) will be prescribed and arranged as part of standard routine clinical practice at PCL center. ### Contacts Locations Module #### Locations **Location 1:** **City:** Athens **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Evangelia Papadavid - **Phone:** +302105832458 - **Role:** CONTACT ***Contact 2:*** - **Name:** Evangelia Papadavid - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Greece **Facility:** 1 Rimini Street, ATTIKON University Hospital **Status:** RECRUITING **Zip:** 12462 ### References Module #### References **Citation:** Inturi S, Tewari-Singh N, Agarwal C, White CW, Agarwal R. Activation of DNA damage repair pathways in response to nitrogen mustard-induced DNA damage and toxicity in skin keratinocytes. Mutat Res. 2014 May-Jun;763-764:53-63. doi: 10.1016/j.mrfmmm.2014.04.002. Epub 2014 Apr 13. **PMID:** 24732344 **Citation:** Lessin SR, Duvic M, Guitart J, Pandya AG, Strober BE, Olsen EA, Hull CM, Knobler EH, Rook AH, Kim EJ, Naylor MF, Adelson DM, Kimball AB, Wood GS, Sundram U, Wu H, Kim YH. Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013 Jan;149(1):25-32. doi: 10.1001/2013.jamadermatol.541. **PMID:** 23069814 **Citation:** Kim EJ, Guitart J, Querfeld C, Girardi M, Musiek A, Akilov OE, Angello JT, Bailey WL, Geskin LJ. The PROVe Study: US Real-World Experience with Chlormethine/Mechlorethamine Gel in Combination with Other Therapies for Patients with Mycosis Fungoides Cutaneous T-Cell Lymphoma. Am J Clin Dermatol. 2021 May;22(3):407-414. doi: 10.1007/s40257-021-00591-x. Epub 2021 Mar 3. Erratum In: Am J Clin Dermatol. 2022 May;23(3):425. **PMID:** 33656660 **Citation:** Kim YH, Liu HL, Mraz-Gernhard S, Varghese A, Hoppe RT. Long-term outcome of 525 patients with mycosis fungoides and Sezary syndrome: clinical prognostic factors and risk for disease progression. Arch Dermatol. 2003 Jul;139(7):857-66. doi: 10.1001/archderm.139.7.857. **PMID:** 12873880 **Citation:** Kim YH, Martinez G, Varghese A, Hoppe RT. Topical nitrogen mustard in the management of mycosis fungoides: update of the Stanford experience. Arch Dermatol. 2003 Feb;139(2):165-73. doi: 10.1001/archderm.139.2.165. **PMID:** 12588222 **Citation:** Koumourtzis M, Lampadaki K, Dalamaga M, Papadavid E. Chlormethine Gel is Efficient and Safe in Mycosis Fungoides Skin Lesions. Acta Derm Venereol. 2022 Jun 9;102:adv00730. doi: 10.2340/actadv.v102.1095. **PMID:** 35199177 **Citation:** Lampadaki K, Koumourtzis M, Karagianni F, Marinos L, Papadavid E. Chlormethine Gel in Combination with Other Therapies in the Treatment of Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: Three Case Reports. Adv Ther. 2021 Jun;38(6):3455-3464. doi: 10.1007/s12325-021-01721-x. Epub 2021 Apr 30. **PMID:** 33928511 **Citation:** Papadavid E, Koumourtzis M, Nikolaou V, Lampadaki K, Marinos L, Patsatsi A, Georgiou E, Dalamaga M, Stratigos A. Chlormethine gel is effective for the treatment of skin lesions in patients with early- and late-stage mycosis fungoides in clinical practice. J Eur Acad Dermatol Venereol. 2022 Oct;36(10):1751-1757. doi: 10.1111/jdv.18183. Epub 2022 May 12. **PMID:** 35470483 **Citation:** Ramsay DL, Parnes RE, Dubin N. Response of mycosis fungoides to topical chemotherapy with mechlorethamine. Arch Dermatol. 1984 Dec;120(12):1585-90. **PMID:** 6508330 **Citation:** Querfeld C, Scarisbrick JJ, Assaf C, Guenova E, Bagot M, Ortiz-Romero PL, Quaglino P, Bonizzoni E, Hodak E. Post hoc Analysis of a Randomized, Controlled, Phase 2 Study to Assess Response Rates with Chlormethine/Mechlorethamine Gel in Patients with Stage IA-IIA Mycosis Fungoides. Dermatology. 2022;238(2):347-357. doi: 10.1159/000516138. Epub 2021 Jun 4. **PMID:** 34091453 **Citation:** Pavlidis A, Karagianni F, Vetsika EK, Koumourtzis M, Lampadaki K, Piperi C, Pappa V, Papadavid E. Bio-P-10 - Evaluation of the role of different cell populations in mycosis fungoides microenvironment as a tool for biomarker identification for disease progression and individualized therapy. EJC 2021:156(S1);S40-S41 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000016410 - Term: Lymphoma, T-Cell, Cutaneous - ID: D000016399 - Term: Lymphoma, T-Cell - ID: D000008228 - Term: Lymphoma, Non-Hodgkin - ID: D000008223 - Term: Lymphoma - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12136 - Name: Mycoses - Relevance: HIGH - As Found: Mycosis - ID: M12137 - Name: Mycosis Fungoides - Relevance: HIGH - As Found: Mycosis Fungoides - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M18829 - Name: Lymphoma, T-Cell - Relevance: LOW - As Found: Unknown - ID: M18832 - Name: Lymphoma, T-Cell, Cutaneous - Relevance: LOW - As Found: Unknown - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3986 - Name: Mycosis Fungoides - Relevance: HIGH - As Found: Mycosis Fungoides - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009181 - Term: Mycoses - ID: D000009182 - Term: Mycosis Fungoides ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11449 - Name: Mechlorethamine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421558 **Brief Title:** Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy **Official Title:** Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Lumbosacral Radiculopathy #### Organization Study ID Info **ID:** Pro00077736 #### Organization **Class:** INDUSTRY **Full Name:** NeuFit - Neurological Fitness and Education ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** NeuFit - Neurological Fitness and Education #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating lumbosacral radiculopathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is much less common and there is less known about its impact on physical therapy outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct current device, compared to traditional TENS unit in clinical physical therapy treatment of radiculopathy. Outcomes measured will include: pain intensity, functional status, neurological status, electrophysiological changes and patient satisfaction. **Detailed Description:** To determine the efficacy of direct current electrical stimulation (the Neubie device) on long-term symptoms and severity of lumbosacral and thoracic radiculopathy, participants will enroll in a 6-week treatment regimen at one of 9 Hands-On Physical Therapy associated clinic sites listed included in application. The first session will consist of an intake evaluation session that will include: Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root irritation or compression, and Electrophysiological evaluation to determine the nerve function. These tests will serve as baseline (and a within subject control) for the intervention. Participants will then undergo a specialized radiculopathy protocol that includes traditional PT therapy as well as treatment with the Neubie (or traditional electrical stimulation) both during PT exercises and as additional treatment after sessions. Subjects receive an evaluation session that includes Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root irritation or compression, and Electrophysiological evaluation to determine the nerve function. The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include 30 min of various physical therapy exercises with the Neubie. The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min of various physical therapy exercises with TENS application. At the end of the 12 sessions of treatment, subjects receive a final evaluation session that includes Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root irritation or compression, Electrophysiological evaluation to determine the nerve function, and a patient satisfaction questionnaire to assess patient satisfaction with the treatment. Participants will receive 12 treatments over 6 weeks. Measurement of these variables will provide both quantitative and qualitative data on the severity of radiculopathy symptoms (see "Tools for data collection" below). ### Conditions Module **Conditions:** - Radiculopathy Lumbar - Radiculopathy Sacral - Radiculopathy Multiple Sites **Keywords:** - electrical stimulation - direct current - e-stim - neubie - emg ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Study will be divided into two randomly assigned groups - control and experimental. Control group will receive traditional e-stim treatment with TENS plus physical therapy. Experimental group will receive direct current e-stim treatment with the Neubie device plus physical therapy. ##### Masking Info **Masking:** SINGLE **Masking Description:** Outcomes will be assessed by clinicians at Hands on Diagnostics locations. Assessors will be blinded to which intervention participant has received. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include 30 min of various physical therapy exercises with the Neubie. **Intervention Names:** - Device: Neubie Direct Current Electrical Stimulation Device **Label:** Neubie Direct Current Electrical Stimulation Device **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min of various physical therapy exercises with TENS application. **Intervention Names:** - Device: Transcutaneous Electrical Stimulation **Label:** Transcutaneous Electrical Stimulation **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Neubie Direct Current Electrical Stimulation Device **Description:** Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers. **Name:** Neubie Direct Current Electrical Stimulation Device **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Transcutaneous Electrical Stimulation **Description:** Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin. **Name:** Transcutaneous Electrical Stimulation **Other Names:** - TENS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex. **Measure:** H-Reflex **Time Frame:** Pre-intervention **Description:** Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex. **Measure:** H-Reflex **Time Frame:** 6 weeks **Description:** EMG detection of presence of degree of spontaneous electrical activity such as fibrillation potentials and positive sharp waves of muscles innervated by L4, L5, and S1 nerve roots **Measure:** EMG detection of spontaneous electrical activity **Time Frame:** Pre-intervention **Description:** EMG detection of presence of degree of spontaneous electrical activity such as fibrillation potentials and positive sharp waves of muscles innervated by L4, L5, and S1 nerve roots **Measure:** EMG detection of spontaneous electrical activity **Time Frame:** 6 weeks **Description:** Straight Leg Raise Test degrees of movement **Measure:** Straight Leg Raise Test **Time Frame:** Pre-intervention **Description:** Straight Leg Raise Test degrees of movement **Measure:** Straight Leg Raise Test **Time Frame:** 6 weeks **Description:** Oswestry Disability Index Questionnaire Score **Measure:** Oswestry Disability Index **Time Frame:** Pre-intervention **Description:** Oswestry Disability Index Questionnaire Score **Measure:** Oswestry Disability Index **Time Frame:** 6 weeks **Description:** Visual Analog Score for pain **Measure:** Visual Analog Score **Time Frame:** Pre-intervention **Description:** Visual Analog Score for pain **Measure:** Visual Analog Score **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Must show evidence of lumbo-sacral radiculopathy as determined by EMG and straight leg raise test. * Must be able to attend weekly sessions for the 6-week period of the study (no extended travel) * Must be at least 18 years old. Exclusion Criteria: * Currently pregnant * Cardiac pacemaker * Active or recent cancer * Active or recent blood clots * History of epilepsy * Open wounds * Spinal fusion surgery **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Dimitrios Kostopoulos, MD, PhD, DPT **Phone:** 9175382242 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ramona von Leden, PhD **Phone:** 5303832292 **Role:** CONTACT #### Locations **Location 1:** **City:** Escondido **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** NCEPT Physical Therapy **State:** California **Status:** RECRUITING **Zip:** 92025 **Location 2:** **City:** Cape Coral **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** APEX Physical Therapy **State:** Florida **Status:** RECRUITING **Zip:** 33991 **Location 3:** **City:** Clearwater **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** Catalyst Physical Therapy **State:** Florida **Status:** RECRUITING **Zip:** 33756 **Location 4:** **City:** Fort Myers **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** APEX Physical Therapy **State:** Florida **Status:** RECRUITING **Zip:** 33908 **Location 5:** **City:** Gainesville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** Kinetix Haile Plantation **State:** Florida **Status:** RECRUITING **Zip:** 32608 **Location 6:** **City:** Gainesville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** Kinetix Arbor Greens - Jonesville **State:** Florida **Status:** RECRUITING **Zip:** 32669 **Location 7:** **City:** Portland **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** Adams Physical Therapy Services **State:** Indiana **Status:** RECRUITING **Zip:** 47371 **Location 8:** **City:** Bardstown **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** KORT Bardstown **State:** Kentucky **Status:** RECRUITING **Zip:** 40004 **Location 9:** **City:** Shepherdsville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** KORT Sheperdsville **State:** Kentucky **Status:** RECRUITING **Zip:** 40165 **Location 10:** **City:** Astoria **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopoulos, MD, PhD, DPT - **Phone:** 917-538-2242 - **Role:** CONTACT **Country:** United States **Facility:** Hands On Physical Therpay **State:** New York **Status:** RECRUITING **Zip:** 11106 **Location 11:** **City:** Deer Park **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** WellHealth Physical Therapy **State:** New York **Status:** RECRUITING **Zip:** 11729 **Location 12:** **City:** Hicksville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** WellHealth Physical Therapy **State:** New York **Status:** RECRUITING **Zip:** 11801 **Location 13:** **City:** Queens Village **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous, MD, PhD, DPT - **Phone:** 917-538-2242 - **Role:** CONTACT **Country:** United States **Facility:** Hands On Physical Therapy of Queens Village **State:** New York **Status:** RECRUITING **Zip:** 11428 **Location 14:** **City:** Edmond **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** Courcier Clinic **State:** Oklahoma **Status:** RECRUITING **Zip:** 73013 **Location 15:** **City:** El Paso **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimi Kostopolous - **Role:** CONTACT **Country:** United States **Facility:** Spine & Rehab Specialists **State:** Texas **Status:** RECRUITING **Zip:** 79925 **Location 16:** **City:** El Paso **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dimitrios Kostopoulos - **Role:** CONTACT **Country:** United States **Facility:** Spine & Rehab Specialists **State:** Texas **Status:** RECRUITING **Zip:** 79936 #### Overall Officials **Official 1:** **Affiliation:** NeuFit - Neurological Fitness and Education **Name:** Ramona von Leden, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934. **PMID:** 31788391 **Citation:** Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008. **PMID:** 17445735 **Citation:** Sharma H, Lee SW, Cole AA. The management of weakness caused by lumbar and lumbosacral nerve root compression. J Bone Joint Surg Br. 2012 Nov;94(11):1442-7. doi: 10.1302/0301-620X.94B11.29148. **PMID:** 23109619 **Citation:** Lewis R, Williams N, Matar HE, Din N, Fitzsimmons D, Phillips C, Jones M, Sutton A, Burton K, Nafees S, Hendry M, Rickard I, Chakraverty R, Wilkinson C. The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model. Health Technol Assess. 2011 Nov;15(39):1-578. doi: 10.3310/hta15390. No abstract available. **PMID:** 22078311 **Citation:** Aono H, Iwasaki M, Ohwada T, Okuda S, Hosono N, Fuji T, Yoshikawa H. Surgical outcome of drop foot caused by degenerative lumbar diseases. Spine (Phila Pa 1976). 2007 Apr 15;32(8):E262-6. doi: 10.1097/01.brs.0000259922.82413.72. **PMID:** 17426622 **Citation:** Girardi FP, Cammisa FP Jr, Huang RC, Parvataneni HK, Tsairis P. Improvement of preoperative foot drop after lumbar surgery. J Spinal Disord Tech. 2002 Dec;15(6):490-4. doi: 10.1097/00024720-200212000-00010. **PMID:** 12468976 **Citation:** Bauer P, Krewer C, Golaszewski S, Koenig E, Muller F. Functional electrical stimulation-assisted active cycling--therapeutic effects in patients with hemiparesis from 7 days to 6 months after stroke: a randomized controlled pilot study. Arch Phys Med Rehabil. 2015 Feb;96(2):188-96. doi: 10.1016/j.apmr.2014.09.033. Epub 2014 Oct 18. **PMID:** 25449195 **Citation:** Glaser JA, Baltz MA, Nietert PJ, Bensen CV. Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial. J Pain. 2001 Oct;2(5):295-300. doi: 10.1054/jpai.2001.25523. **PMID:** 14622808 **Citation:** Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434. **PMID:** 14622708 **Citation:** Peters EJ, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA. The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus. J Foot Ankle Surg. 1998 Sep-Oct;37(5):396-400; discussion 447-8. doi: 10.1016/s1067-2516(98)80048-3. **PMID:** 9798171 **Citation:** Gilcreast DM, Stotts NA, Froelicher ES, Baker LL, Moss KM. Effect of electrical stimulation on foot skin perfusion in persons with or at risk for diabetic foot ulcers. Wound Repair Regen. 1998 Sep-Oct;6(5):434-41. doi: 10.1046/j.1524-475x.1998.60505.x. **PMID:** 9844163 **Citation:** da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10. **PMID:** 25665520 **Citation:** Ordog GJ. Transcutaneous electrical nerve stimulation versus oral analgesic: a randomized double-blind controlled study in acute traumatic pain. Am J Emerg Med. 1987 Jan;5(1):6-10. doi: 10.1016/0735-6757(87)90281-6. **PMID:** 3545246 **Citation:** Zhao M, Bai H, Wang E, Forrester JV, McCaig CD. Electrical stimulation directly induces pre-angiogenic responses in vascular endothelial cells by signaling through VEGF receptors. J Cell Sci. 2004 Jan 26;117(Pt 3):397-405. doi: 10.1242/jcs.00868. Epub 2003 Dec 16. **PMID:** 14679307 **Citation:** Kanno S, Oda N, Abe M, Saito S, Hori K, Handa Y, Tabayashi K, Sato Y. Establishment of a simple and practical procedure applicable to therapeutic angiogenesis. Circulation. 1999 May 25;99(20):2682-7. doi: 10.1161/01.cir.99.20.2682. **PMID:** 10338463 **Citation:** Thakral G, Kim PJ, LaFontaine J, Menzies R, Najafi B, Lavery LA. Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy. J Diabetes Sci Technol. 2013 Sep 1;7(5):1202-9. doi: 10.1177/193229681300700510. **PMID:** 24124947 **Citation:** Wang TJ, Sung K, Wilburn M, Allbright J. Russian Stimulation/Functional Electrical Stimulation in the Treatment of Foot Drop Resulting from Lumbar Radiculopathy: A Case Series. Innov Clin Neurosci. 2019 May 1;16(5-6):46-49. **PMID:** 31440402 **Citation:** Martimbianco ALC, Porfirio GJ, Pacheco RL, Torloni MR, Riera R. Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain. Cochrane Database Syst Rev. 2019 Dec 12;12(12):CD011927. doi: 10.1002/14651858.CD011927.pub2. **PMID:** 31830313 **Citation:** Reichstein L, Labrenz S, Ziegler D, Martin S. Effective treatment of symptomatic diabetic polyneuropathy by high-frequency external muscle stimulation. Diabetologia. 2005 May;48(5):824-8. doi: 10.1007/s00125-005-1728-0. Epub 2005 Apr 14. **PMID:** 15830180 **Citation:** DeSantana JM, Walsh DM, Vance C, Rakel BA, Sluka KA. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep. 2008 Dec;10(6):492-9. doi: 10.1007/s11926-008-0080-z. **PMID:** 19007541 **Citation:** Doucet BM, Griffin L. High-versus low-frequency stimulation effects on fine motor control in chronic hemiplegia: a pilot study. Top Stroke Rehabil. 2013 Jul-Aug;20(4):299-307. doi: 10.1310/tsr2004-299. **PMID:** 23893829 **Citation:** Najafi B, Talal TK, Grewal GS, Menzies R, Armstrong DG, Lavery LA. Using Plantar Electrical Stimulation to Improve Postural Balance and Plantar Sensation Among Patients With Diabetic Peripheral Neuropathy: A Randomized Double Blinded Study. J Diabetes Sci Technol. 2017 Jul;11(4):693-701. doi: 10.1177/1932296817695338. Epub 2017 Feb 1. **PMID:** 28627217 **Citation:** Chandrasekaran S, Davis J, Bersch I, Goldberg G, Gorgey AS. Electrical stimulation and denervated muscles after spinal cord injury. Neural Regen Res. 2020 Aug;15(8):1397-1407. doi: 10.4103/1673-5374.274326. **PMID:** 31997798 **Citation:** Zehr EP, Collins DF, Chua R. Human interlimb reflexes evoked by electrical stimulation of cutaneous nerves innervating the hand and foot. Exp Brain Res. 2001 Oct;140(4):495-504. doi: 10.1007/s002210100857. **PMID:** 11685403 ## Document Section ### Large Document Module #### Large Docs - Date: 2024-03-29 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 186037 - Type Abbrev: Prot_SAP - Upload Date: 2024-04-08T16:34 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14689 - Name: Radiculopathy - Relevance: HIGH - As Found: Radiculopathy - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011843 - Term: Radiculopathy ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06421545 **Acronym:** RT-D ADRD **Brief Title:** Resilient Together for Dementia **Official Title:** Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis #### Organization Study ID Info **ID:** GCO 23-0519 #### Organization **Class:** OTHER **Full Name:** Icahn School of Medicine at Mount Sinai #### Secondary ID Infos **ID:** 1K23AG075188-01A1 **Link:** https://reporter.nih.gov/quickSearch/1K23AG075188-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Aging (NIA) #### Lead Sponsor **Class:** OTHER **Name:** Icahn School of Medicine at Mount Sinai #### Responsible Party **Investigator Affiliation:** Icahn School of Medicine at Mount Sinai **Investigator Full Name:** Sarah Bannon **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD). **Detailed Description:** Both persons living with dementia (PWDs) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population during the window of opportunity when PWDs can participate has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones. In the Intervention Phase (Aims 2 and 3), an open pilot (N=5 dyads) of the newly developed RT-D followed by exit interviews will be conducted to explore the initial feasibility and acceptability of the adapted protocol and to further refine the intervention content, materials, and procedures (Aim 2; NIA Stage 1A). Next, a pilot feasibility randomized control trial (RCT; Aim 3; NIA Stage 1B; N=50 dyads) will be conducted of the refined RT-D versus a minimally enhanced educational control (MEUC). Primary outcomes will be feasibility, credibility, and acceptability markers to inform a hybrid efficacy effectiveness R01 (year 4) of RT-D vs. MEUC (NIA Stage III). In this subsequent R01, the researcher will examine RT-D's impact on emotional distress and quality of life outcomes and test mechanisms of change (individual and interpersonal resiliency skills) through mediation and moderation. The researcher will revise the approach if feasibility benchmarks are not met. ### Conditions Module **Conditions:** - Alzheimer's Disease and Related Dementias ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Persons living with dementia (PWDs) and their spousal care-partners **Intervention Names:** - Behavioral: Resilient Together for Dementia **Label:** Open Pilot RT-D Dyads **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Open Pilot RT-D Dyads **Description:** A novel live video dyadic resiliency intervention **Name:** Resilient Together for Dementia **Other Names:** - RT-D **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Feasibility of recruitment - Recruitment will be monitored by screening clinic visits for potentially eligible individuals and review recruitment progress in weekly meetings to promote completion within the study time frame. Recruitment will be monitored but will not set official benchmarks and modify procedures after each dyad. **Measure:** Proportion of potential eligible participants **Time Frame:** After each dyad completion, throughout study of 1.5-2 months #### Secondary Outcomes **Description:** Feasibility of screening - the portion of individuals who undergo screening that screen eligible and ineligible, and the reasons for ineligibility with detailed descriptions will be monitored and will review progress in weekly team meetings. Screening will be monitored but will not set official benchmarks and modify procedures after each dyad. **Measure:** Proportion of participants screened **Time Frame:** After each dyad completion, throughout study of 1.5-2 months **Description:** Feasibility of consent by keeping a record of all individuals who complete screening that consent, refuse to consent, and the reasons for refusal will be monitored and will review progress in weekly team meetings. Feasibility of consent will be monitored but will not set official benchmarks and modify procedures after each dyad. **Measure:** Proportion of participants who consent or not consent to participate **Time Frame:** After each dyad completion, throughout study of 1.5-2 months **Description:** Feasibility of treatment -The number of sessions that enrolled dyads attend as well as missed sessions, treatment dropouts, and reasons for non attendance will be monitored and will review progress in weekly meetings. Feasibility of treatment will be monitored but will not set official benchmarks and modify procedures after each dyad. **Measure:** Proportion of sessions participants attend **Time Frame:** After each dyad completion, throughout study of 1.5-2 months **Description:** Change in emotional distress assessed with the Hospital Anxiety and Depression Anxiety Scale which is a 14-items scale with responses scored from 0-3, scores for each subscale (anxiety and depression) from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress. **Measure:** Change in Hospital Anxiety and Depression Scale (HADS) **Time Frame:** Baseline and 6 weeks (post-intervention) ### Eligibility Module **Eligibility Criteria:** PWD inclusion criteria are: * Recent (\~1 month) chart documented ADRD diagnosis, * ADRD symptom onset after age 65 , * cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0 * cognitive awareness of his/her problems (as determined by the treating neurologist), and * ability to understand study and research protocol, as determined by a standardized teach-back method assessment84. Additional inclusion criteria for dyads are: * English speaking adults (18 years or older), * dyad lives together, * at least one partner endorses clinically significant emotional distress during screening (\>7 on Hospital Anxiety and Depression scale subscales) Exclusion Criteria: * patient is deemed inappropriate by the neurology team, * either partner has a co-occurring terminal illness, * patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team. **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sarah M Bannon, PhD **Phone:** 212-241-0787 **Role:** CONTACT **Contact 2:** **Name:** Sydney M McCage, MA **Phone:** 212-241-6866 **Role:** CONTACT #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sarah Bannon, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Sarah Bannon - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Brain Injury Research Center at Mount Sinai **State:** New York **Status:** RECRUITING **Zip:** 10029 #### Overall Officials **Official 1:** **Affiliation:** Icahn School of Medicine at Mount Sinai **Name:** Sarah Bannon **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link tbd). **Description:** All of the individual participant data collected during the trial, after deidentification. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Immediately following publication. No end date. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000024801 - Term: Tauopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6904 - Name: Dementia - Relevance: HIGH - As Found: Dementia - ID: M3885 - Name: Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M23002 - Name: Tauopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000544 - Term: Alzheimer Disease - ID: D000003704 - Term: Dementia ### Misc Info Module - Version Holder: 2024-05-31