text
stringlengths 947
62.2k
|
|---|
## Protocol Section
### Identification Module
**NCT ID:** NCT06432842
**Brief Title:** Knee Osteoarthritis and Rehabilitation
**Official Title:** Knee Osteoarthritis and Lazer Therapy
#### Organization Study ID Info
**ID:** Karabuk-80
#### Organization
**Class:** OTHER
**Full Name:** Karabuk University
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2023-12-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-25
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Karabuk University
#### Responsible Party
**Investigator Affiliation:** Karabuk University
**Investigator Full Name:** METEHAN YANA
**Investigator Title:** Director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Osteoarthritis (OA) is a chronic degenerative disease of articular cartilage that causes hypertrophic changes in bone. OA is a non-inflammatory progressive musculoskeletal disease and is one of the most common degenerative diseases in the general population. OA is characterized by progressive cartilage destruction in load-bearing joints, subchondral sclerosis, osteophyte formation, and some biochemical and morphological changes in the synovial membrane and joint capsule. Common symptoms of knee osteoarthritis are; Knee pain that increases with activity, limitation of normal joint movement of the knee, edema, and knee pain that begins with prolonged sitting.
The aim of this study is to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received PRP.
**Detailed Description:** OA is a non-inflammatory progressive musculoskeletal disease; damage begins in the cartilage and causes changes in the joint structure over time. Although intra-articular injection approaches have been frequently used in the treatment of OA recently, intra-articular injections known as Platelet Rich Plasma (PRP) have also started to be used frequently. Today, the areas of use of laser therapy have increased. When the laser beam is applied, it is absorbed by the tissue or scattered back. Laser has photochemical, thermal and ionizing effects on tissues. Laser has an analgesic effect by increasing endorphin synthesis and reducing C nerve fiber activation. Laser indirectly increases microcirculation by increasing temperature in the tissue. Although there are various studies on treatment options for OA in the literature, no studies have been found to investigate the effectiveness of laser treatment applied in addition to conventional treatment after PRP. In our study, we aimed to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received PRP.
### Conditions Module
**Conditions:**
- Knee Osteoarthritis
**Keywords:**
- Osteoarthritis
- Intra-articular injection
- PRP (Platelet-rich plasma)
- Physiotherapy
- Laser Treatment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Within the scope of conventional treatment, individuals were given Transcutaneous Electrical Nerve Stimulation (TENS), infrared, US and exercise therapy.
**Intervention Names:**
- Other: Laser Treatment
**Label:** Conventional treatment
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** In the study group, low-dose laser treatment was applied in addition to conventional treatment. Therapeutic Laser device was used for laser treatment. Laser treatment was applied to 8 sensitive points around the knee for 1 minute, for a total of 8 minutes.
**Intervention Names:**
- Other: Laser Treatment
**Label:** Laser treatment
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Conventional treatment
- Laser treatment
**Description:** In the study group, low-dose laser treatment was applied in addition to conventional treatment. Chattanoga Group Therapeutic Laser device was used for laser treatment. Laser treatment was applied to 8 sensitive points around the knee for 1 minute, for a total of 8 minutes. Laser treatment was applied continuously, with a wavelength of 830nm and a power of 6J.
**Name:** Laser Treatment
**Other Names:**
- conventional treatment
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Knee pain severity will measured using the Visual Analog Scale. Scale (VAS). The VAS is a 10 cm scale, where 0 represented no pain and 10 represented unbearable pain. Pain intensity was recorded by measuring the point marked between 0- 10.
**Measure:** Pain severity
**Time Frame:** Baseline and 2 weeks post-intervention
**Description:** WOMAC will be used to evaluate the degree of physical function. This scale has a total of 24 questions and 5 answers between 0-4 for each question. A high score indicates that the symptoms are severe.
**Measure:** Function
**Time Frame:** 2 weeks post-intervention
**Description:** Hip, knee flexor and extensor muscle strengths will be measured using a manual dynamometer.
**Measure:** MUSCLE STRENGTH
**Time Frame:** Baseline and 2 weeks post-intervention
**Description:** Dynamic balance of individuals through the Modified Star Balance Test will be evaluated.
**Measure:** BALANCE
**Time Frame:** Baseline and 2 weeks post-intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Volunteering to participate in the study
* Being diagnosed with knee OA by a specialist physician
* Having had PRP injection applied by a specialist physician
* Having unilateral knee OA
* Being stage I-stage III in the Kellgren-Lawrence OA classification
* Being between the ages of 18-65
Exclusion Criteria:
* Being stage IV in the Kellgren-Lawrence OA classification
* BMI being more than 40 kg/m2
* Patients who do not cooperate well
* Patients with neurological or neuromuscular disease
**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:** Sevde Nur AKTAŞ, MsC
**Phone:** 05438760764
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Metehan YANA, PhD
**Phone:** 05072665522
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Karabük
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Metehan YANA Phd
- **Phone:** 05072665522
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Karabük University
**Status:** RECRUITING
**Zip:** 78000
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Fitzgerald GK, Piva SR, Irrgang JJ. Reports of joint instability in knee osteoarthritis: its prevalence and relationship to physical function. Arthritis Rheum. 2004 Dec 15;51(6):941-6. doi: 10.1002/art.20825.
**PMID:** 15593258
**Citation:** Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
**PMID:** 26405113
**Citation:** Hedbom E, Hauselmann HJ. Molecular aspects of pathogenesis in osteoarthritis: the role of inflammation. Cell Mol Life Sci. 2002 Jan;59(1):45-53. doi: 10.1007/s00018-002-8404-z.
**PMID:** 11846032
**Citation:** Citaker S, Gunduz AG, Guclu MB, Nazliel B, Irkec C, Kaya D. Relationship between foot sensation and standing balance in patients with multiple sclerosis. Gait Posture. 2011 Jun;34(2):275-8. doi: 10.1016/j.gaitpost.2011.05.015. Epub 2011 Jun 16.
**PMID:** 21683600
**Citation:** Chapple CM, Nicholson H, Baxter GD, Abbott JH. Patient characteristics that predict progression of knee osteoarthritis: a systematic review of prognostic studies. Arthritis Care Res (Hoboken). 2011 Aug;63(8):1115-25. doi: 10.1002/acr.20492.
**PMID:** 21560257
**Citation:** MILLER JH, WHITE J, NORTON TH. The value of intra-articular injections in osteoarthritis of the knee. J Bone Joint Surg Br. 1958 Nov;40-B(4):636-43. doi: 10.1302/0301-620X.40B4.636. No abstract available.
**PMID:** 13610976
**Citation:** McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
**PMID:** 24462672
**Citation:** Hagiwara S, Iwasaka H, Okuda K, Noguchi T. GaAlAs (830 nm) low-level laser enhances peripheral endogenous opioid analgesia in rats. Lasers Surg Med. 2007 Dec;39(10):797-802. doi: 10.1002/lsm.20583.
**PMID:** 18081143
**Citation:** Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015.
**PMID:** 25624776
## Derived Section
### Condition Browse Module - Ancestors
- 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: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee Osteoarthritis
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- 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: D000010003
- Term: Osteoarthritis
- ID: D000020370
- Term: Osteoarthritis, Knee
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432829
**Brief Title:** Study on the Effectiveness and Differential Usability of the UP in Spanish University Students
**Official Title:** Study on the Efficacy and Differential Usability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Spanish University Students
#### Organization Study ID Info
**ID:** IPES/PU-E/2024
#### Organization
**Class:** OTHER
**Full Name:** Instituto de Investigación Sanitaria Aragón
### Status Module
#### Completion Date
**Date:** 2025-09-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Instituto de Investigación Sanitaria Aragón
#### Responsible Party
**Investigator Affiliation:** Instituto de Investigación Sanitaria Aragón
**Investigator Full Name:** Jorge Javier Osma López
**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 present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the Unified Protocol (UP) in its application in two cost-effective formats, the online group and the blended online group for the treatment of emotional disorders in university students in Spain.
**Detailed Description:** Introduction: Emotional Disorders (EDs) are the most common disorders among the young population. Despite their high prevalence in university students, data suggest that only 16.4% of students suffering from a mental health disorder receive treatment. Therefore, the present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the Unified Protocol (UP) in its application in two cost-effective formats, the online group and the Blended online group.
Method: The study population will be university students who meet diagnostic criteria for EDs. We estimate a sample of 70 students, 35 per condition. The intervention will consist of the application of the 8 modules of the UP in two formats: online group format of 8 weekly sessions of 2 hours duration and Blended format (4 online group sessions, of two hours duration in modules 1,4,6 and 7 of the UP + autonomous work through the UP-APP). The variables evaluated will be collected before the intervention, in the post-treatment and in the follow-ups at one month and 3 months.
This study responds to the need to implement services that improve the availability and access to the treatment of EDs in the university context in Spain, and in this particular case, through the formats offered by a transdiagnostic intervention such as the UP.
### Conditions Module
**Conditions:**
- Emotional Disorder
- Depression, Anxiety
- Emotion Regulation
**Keywords:**
- Emotional Disorders
- University Students
- Unified Protocol
- Blended format
- Online interventions
- Group formats
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants will be recruited through the Psychological Care Unit (UNAP) of the University of Cordoba (Spain). The UNAP will refer to the research team those persons whose reason for consultation refers to an emotional problem (anxious and/or depressive symptomatology). Potential participants will be contacted by the research team via email and will be sent an information sheet about the study and informed consent, which they will be able to read and sign online through a Google Forms link.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Participants are informed of the assigned intervention condition before the start of the intervention
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The participants assigned to this condition will receive the UP in group format through 8 sessions of 2 hours duration, once a week, in online format through the Google Meet platform. Participants will receive a brief manual with the important contents of each session, the exercises to be performed and the corresponding records.
**Intervention Names:**
- Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders
**Label:** UP in online group format
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants assigned to this condition will receive the PU in a blended group format (4 online group sessions, of two hours duration in modules 1,4,6 and 7 of the PU + autonomous work through the UP-APP). Thus, participants will receive a combined intervention format, working some contents in online group sessions and others through the PU-APP.
**Intervention Names:**
- Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders
**Label:** UP in blended format (UP online group + UP App)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- UP in blended format (UP online group + UP App)
- UP in online group format
**Description:** This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-group format. For ethical reasons, if any of the patients feel uncomfortable during the study with the online-group format, will may leave the group and receive individual attention. The study plans follow-ups at 1 and 3 months after the end of the treatment.
**Name:** Unified Protocol for the transdiagnostic treatment of emotional disorders
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Diagnostic interview to determine if the participant has a clinical diagnosis of emotional disorder (ET) and can be part of the study. The following diagnoses according to the DSM-V are included within the category of emotional disorder: major depressive disorder, dysthymic disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, post-traumatic stress disorder, social anxiety disorder, hypochondria, and adjustment disorders. Patients with anxiety disorders not otherwise specified and those with depressive disorders not otherwise specified will also be included in the study.
**Measure:** Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5; Brown & Barlow, 2014)
**Time Frame:** Only before of the treatment to check inclusion criteria
**Description:** Information will be collected on sex, age, marital status, employment status, type of study (bachelor's degree; postgraduate: master's degree, continuing education courses; doctorate), degree taken and course in which you are enrolled.
**Measure:** Questionnaire on Sociodemographic Data (ad hoc)
**Time Frame:** Pre-treatment data
**Description:** Evaluation through 5 items of the frequency, intensity, severity and interference of depressive symptomatology
**Measure:** General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)
**Time Frame:** Up to 3 months follow-up
**Description:** Evaluation through 5 items of the frequency, intensity, severity and interference of anxious symptomatology
**Measure:** General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)
**Time Frame:** Up to 3 months follow-up
**Description:** Evaluation through 49 items of the transdiagnostic profile of Emotional Disorders, which is composed of nine dimensions: neurotic temperament, positive temperament, depressed mood, somatic anxiety, arousal activation, social anxiety, intrusive cognitions, traumatic re-experiencing, and avoidance
**Measure:** Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023)
**Time Frame:** Up to 3 months follow-up
#### Secondary Outcomes
**Description:** Evaluation through 28 items of difficulties in emotional regulation by means of 5 subscales: lack of control, rejection, interference, inattention and emotional confusion.
**Measure:** Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)
**Time Frame:** Up to 3 months follow-up
**Description:** Evaluation of emotional regulation through 10 items, scored on a scale from 1 (strongly disagree) to 7 (strongly agree), with two subscales: cognitive restructuring and emotional suppression.
**Measure:** Emotional Regulation Questionnaire (ERQ; Gross & John, 2003. Validated in Spanish by Pineda et al., 2018)
**Time Frame:** Up to 3 months follow-up
**Description:** Evaluation of the five facets of mindfulness: observing, describing, acting consciously, not judging, internal experience and non-reactivity to internal experience, through 24 items.
**Measure:** Short Version of the Five Facets of Mindfulness Questionnaire (FFMQ-SF; Bohlmeijer et al., 2011. Validated in Spanish by Asensio-Martínez et al., 2019)
**Time Frame:** Up to 3 months follow-up
**Description:** Assessment of self-perceived health status.
**Measure:** EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)
**Time Frame:** Up to 3 months follow-up
**Description:** Evaluation of the therapeutic alliance through 12 items.
**Measure:** Short-format Therapeutic Alliance Inventory (WAI-S; Hatcher and Gillas, 2006. Validated in Spanish by Corbella et al., 2011)
**Time Frame:** Up to 3 months follow-up
**Description:** Evaluation through 6 items about the extent to which patients' psychological problems affect different areas of daily life: work or studies, social life, free time, couple relationship and family life.
**Measure:** Maladjustment Scale (EI; Echeburua; 2000; Validated in Spanish by Quiléz-Orden et al., in press)
**Time Frame:** Up to 3 months follow-up
**Description:** Our adaptation includes 6 of the 8 items of the CSQ-8 (perceived quality, adequacy to previous expectations, recommendation of the treatment to friends or family, usefulness of the techniques learned, general satisfaction with the intervention and probability that they will choose an intervention of this type again) and one more item related to the discomfort generated by the intervention. Likewise, a change has been made in the Likert response scale from 4 points in the original (0 = "Bad / Not at all" to 4 = "Excellent/Very Much") to 11 in the current one (0 = "Bad / Not at all to 10 = "Excellent/Very Much").
**Measure:** An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979
**Time Frame:** Up to 3 months follow-up
**Description:** Questionnaire prepared ad hoc composed of 7 questions; one of a general nature that evaluates the usefulness of the program to improve emotional regulation and six specific ones that separately evaluate the usefulness to better regulate emotions of each of the techniques that are worked on in the different modules of the PU. The response scale is Likert-type and ranges from 0 (not at all) to 10 (very much).
**Measure:** Evaluation questionnaire of the PU modules (Ad hoc)
**Time Frame:** Up to 3 months follow-up
**Description:** Scale used to evaluate the usability of the app included in PU condition in hybrid online group format
**Measure:** System Usability Scale (SUS; Brooke, 1996. Validated in Spanish by Sevilla-Gonzalez et al., 2020)
**Time Frame:** Up to 3 months follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Be enrolled at the University of Cordoba (Spain), in any of the degrees
* Have a diagnosis of anxiety or mood disorder from the Structured Interview for Anxiety and Related Disorders, according to the DSM-5 (ADIS-5)\*
* Be at least 18 years old
* Be fluent in the Spanish language
* Have a technological device (Computer, Tablet, cell phone) with internet connection
* Have a smartphone device with Android operating system
* In the case of taking pharmacological treatment for the treatment of their ED, maintenance of the same doses and medications for at least 3 months before starting their participation in the study and throughout the treatment
* Signature of the informed consent
Exclusion Criteria:
* Have a diagnosis of Obsessive Compulsive Disorder or Post Traumatic Stress Disorder
* Have a severe condition that requires priority for treatment will not be able to participate in the study. This includes a serious mental disorder (personality disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance abuse within the past three months.
**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:** Jorge Osma, Ph. D.
**Phone:** 978645390
**Phone Ext:** 34
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Teruel
**Country:** Spain
**Facility:** Instituto de investigación sanitaria de Aragón, universidad de Zaragoza
**Zip:** 44003
### IPD Sharing Statement Module
**Description:** Under request
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
### References Module
#### See Also Links
**Label:** IPES web (Investigation group)
**URL:** https://ipes-group.com/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood Disorders
- Relevance: HIGH
- As Found: Emotional Disorders
- 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: D000019964
- Term: Mood Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432816
**Brief Title:** Efficacy of Nano-Pso Therapy in Menopause
**Official Title:** Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause
#### Organization Study ID Info
**ID:** IMI-09-23
#### Organization
**Class:** INDUSTRY
**Full Name:** Distribuidora Biolife SA de CV
### Status Module
#### Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-28
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Distribuidora Biolife SA de CV
#### Responsible Party
**Investigator Affiliation:** Distribuidora Biolife SA de CV
**Investigator Full Name:** Dra Araceli Espinosa Guerrero
**Investigator Title:** DRA. Araceli Espinosa Guerrero
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Vasomotor syndrome is prevalent in 85% of postmenopausal women, hormone therapy in menopause is first-line therapy, but 38% of patients have some contraindication for its use. The medications indicated in this population presents adverse reactions, such as dryness of the mucous membranes, and insomnia in patients, and triggers to abandoned treatment due to poor response to the drug. Aligned with the safety of patients, we wish to test pomegranate seed oil with nanotechnology (NANOPSO), which has been reported to have positive results at a central level, due to its antioxidant effect, which could impact women in climacteric in a positive way. The study involves the participation of 90 patients divided into two groups, where placebo or Nano-PSO will be administered for 60 days, with a total follow-up of 120 days. It is established that patients must not have received previous treatments for menopausal symptoms. Therefore, it is expected that therapy with NANO-PSO compared to placebo will be more effective in controlling vasomotor symptoms in early menopause after 6 months of treatment evaluated by the MRS scale.
**Detailed Description:** The menopausal transition in women marks the end of female reproductive capacity and is associated with an estrogenic hormonal imbalance that begins to be noticeable around the fifth decade of life. This process, also known as climacteric, involves the transition from an active to an inactive reproductive stage, and can last for several years before menopause, which is defined as the last menstruation .
During the climacteric, the reduction of estrogen triggers clinical signs and symptoms that affect various systems of the body, such as the central nervous system, the cardio-metabolic system, the musculoskeletal system, and sexual function. Vasomotor symptoms, such as hot flashes, are common manifestations at this stage and affect approximately 75-80% of women in the transition to menopause, with an intensity ranging from moderate to severe in most cases. These symptoms can have a negative impact on quality of life, affecting sleep, functional capacity and work attendance .
Menopausal hormone therapy (MHT) with estrogens and progesterone is the first line of treatment for vasomotor symptoms in menopause. However, some women cannot or prefer not to use MHT due to its adverse effects, which has led to the development of second-line therapies, such as selective serotonin reuptake inhibitors, gabapentinoids, clonidine, and oxybutynin. These non-hormonal therapies may also have minor side effects that may lead to discontinuation of treatment.
In the search for therapeutic alternatives with fewer adverse effects, compounds such as punic acid (omega 5) and its metabolites, such as conjugated linoleic acid, have been investigated. Nanoemulsified pomegranate seed oil (omega 5) has been shown to be a compound with high antioxidant capacity and neuroprotective effects, making it a promising option for the management of symptoms associated with menopause, especially those related to alterations at the level of the menopause. central. Preliminary studies have shown encouraging results in animal models and initial clinical trials, suggesting the need for additional research in specific populations, such as menopausal women.
GENERAL OBJECTIVE
Compare 6-month NANO-PSO therapy versus placebo in the control of vasomotor symptoms in early menopause, assessed via the Menopause Rating Scale.
SPECIFIC OBJECTIVES
* Describe the sociodemographic and clinical characteristics of the Study population.
* Analyze vasomotor symptoms in menopausal patients at baseline with the MRS scale.
* Compare vasomotor symptoms with the use of NANO-PSO vs. Placebo
* Compare the percentage of treatment response regarding vasomotor symptoms with the use of nano pso vs placebo at 3 and 6 months.
Population study Patients who come first class. outpatient climacteric consultation that presents with early menopause and MRS scale \> 15 points without treatment.
With a sample convenience, the aim is to recruit 45 patients per group with a total of 90 patients. Intervention by compounds - Leading to treatment of NANO-PSO or Oil of pomegranate seed with nanotechnology, they are capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast
- Placebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO being the following information: Oil edible, oval shape, 640 mg.
### Conditions Module
**Conditions:**
- Menopause
- Vasomotor; Syndrome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This is a multicenter, prospective, analytical and longitudinal study. A sample calculation was made with a therapeutic efficiency of 30% in vasomotor syndrome, with a result of 210 participants, divided into 3 institutions.
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** The treatments were received, previously labeled and randomly drawn by the sponsor.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** NANO-PSO or Pomegranate seed oil with nanotechnology, capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast
**Intervention Names:**
- Dietary Supplement: NANO-PSO
**Label:** NANO-PSO
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** - Placebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO being the following information: Oil edible, oval shape, 640 mg.
**Intervention Names:**
- Other: PLACEBO
**Label:** PLACEBO
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- NANO-PSO
**Description:** NANO-PSO or Oil of pomegranate seed with nanotechnology, they are capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast
**Name:** NANO-PSO
**Other Names:**
- Oil of pomegranate seed with nanotechnology
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- PLACEBO
**Description:** Placebo physically identical to NANO-PSO capsules:
Soft gelatin capsules 640 mg edible oil 35for PLACEBO Oil edible, oval shape, 640 mg.
**Name:** PLACEBO
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** THE MRS IS A SCALE TO IDENTIFY THE FREQUENCY AND INTENSITY OF MENOPAUSE SYMPTOMS
**Measure:** MENOPAUSE RATING SCALE
**Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
**Description:** Follicle-stimulating hormone (FSH) is a pituitary hormone that regulates the reproductive cycle, helps control the menstrual cycle and the production of eggs in the ovaries.
**Measure:** FSH HORMONE
**Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
**Description:** The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire commonly used to evaluate sleep quality in adults. Created by the Department of Psychiatry at the University of Pittsburgh in 1988, the PSQI addresses both qualitative and quantitative aspects of sleep experienced during the month prior to its administration.
**Measure:** PITTSBURG SCALE
**Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
**Description:** The STRAW+10 system is a clinical and objective way to stage patients transitioning to menopause.
**Measure:** STRAW+10
**Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
#### Secondary Outcomes
**Description:** The PHQ-9 is a nine-item self-report measure that assesses the presence of depressive symptoms based on DSM-IV criteria.
**Measure:** PHQ-9
**Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
**Description:** Estradiol is a female sex hormone that regulates many processes in the body in the reproductive age, its evaluation will only be a control.
**Measure:** ESTRADIOL
**Time Frame:** EVALUATION WILL BE CARRIED OUT AFTER SIX MONTHS.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* In perimenopause with vasomotor syndrome and score greater than 15 points staged with the MRS scale
* They agree to participate and sign the consent informed.
* Without prior treatment to relieve the symptoms of menopause.
Exclusion Criteria:
* - With pharmacological and/or hormonal therapy prescribed for menopause symptoms.
* With psychiatric pathologies such as anxiety and depression.
* Hysterectomized patients or patients with induced menopause surgically early.
* Smoking
* Malnutrition or low weight determined by a BMI ≤ 18.5Kg/m2
Elimination criteria.
* Who do not attend follow-up to provide their treatment the 1, 2, 3 and 4 months for application of the MRS scale
* That they leave the study voluntarily.
* Who present any serious adverse effect to the drug.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 45 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ARACELI ESPINOSA GUERREO, DRA.
**Phone:** 527228228390
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Liliana D Esparragosa Salazar, MC
**Phone:** 527221486139
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Toluca
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** LILIANA D ESPARRAGOZA SALAZAR, PH
- **Phone:** 527221486139
- **Role:** CONTACT
***Contact 2:***
- **Name:** ARACELI ESPINOSA GUERRERO, PH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Mexico
**Facility:** Maternal and Child Institute of the State of Mexico
**State:** State OF Mexico
**Status:** RECRUITING
**Zip:** 50170
#### Overall Officials
**Official 1:**
**Affiliation:** Maternal and child institute of the State of Mexico
**Name:** ARACELI ESPINOSA GUERREO
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** El Khoudary SR, McClure CK, VoPham T, Karvonen-Gutierrez CA, Sternfeld B, Cauley JA, Khalil N, Sutton-Tyrrell K. Longitudinal assessment of the menopausal transition, endogenous sex hormones, and perception of physical functioning: the Study of Women's Health Across the Nation. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):1011-7. doi: 10.1093/gerona/glt285. Epub 2014 Jan 24.
**PMID:** 24465026
**Citation:** Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2.
**PMID:** 29393299
**Citation:** Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 Dec;45(4):629-640. doi: 10.1016/j.ogc.2018.07.005. Epub 2018 Oct 25.
**PMID:** 30401547
**Citation:** Kim MJ, Yim G, Park HY. Vasomotor and physical menopausal symptoms are associated with sleep quality. PLoS One. 2018 Feb 20;13(2):e0192934. doi: 10.1371/journal.pone.0192934. eCollection 2018.
**PMID:** 29462162
**Citation:** Petrou P, Ginzberg A, Binyamin O, Karussis D. Beneficial effects of a nano formulation of pomegranate seed oil, GranaGard, on the cognitive function of multiple sclerosis patients. Mult Scler Relat Disord. 2021 Sep;54:103103. doi: 10.1016/j.msard.2021.103103. Epub 2021 Jun 27.
**PMID:** 34243101
**Citation:** Auerbach L, Rakus J, Bauer C, Gerner C, Ullmann R, Wimmer H, Huber J. Pomegranate seed oil in women with menopausal symptoms: a prospective randomized, placebo-controlled, double-blinded trial. Menopause. 2012 Apr;19(4):426-32. doi: 10.1097/gme.0b013e3182345b2f.
**PMID:** 22240636
**Citation:** Mori-Okamoto J, Otawara-Hamamoto Y, Yamato H, Yoshimura H. Pomegranate extract improves a depressive state and bone properties in menopausal syndrome model ovariectomized mice. J Ethnopharmacol. 2004 May;92(1):93-101. doi: 10.1016/j.jep.2004.02.006.
**PMID:** 15099854
**Citation:** Valdes-Sustaita B, Estrada-Camarena E, Gonzalez-Trujano ME, Lopez-Rubalcava C. Estrogen receptors-beta and serotonin mediate the antidepressant-like effect of an aqueous extract of pomegranate in ovariectomized rats. Neurochem Int. 2021 Jan;142:104904. doi: 10.1016/j.neuint.2020.104904. Epub 2020 Nov 18.
**PMID:** 33220387
**Citation:** Adel-Mehraban MS, Tansaz M, Mohammadi M, Yavari M. Effects of pomegranate supplement on menopausal symptoms and quality of life in menopausal women: A double-blind randomized placebo-controlled trial. Complement Ther Clin Pract. 2022 Feb;46:101544. doi: 10.1016/j.ctcp.2022.101544. Epub 2022 Feb 2.
**PMID:** 35134697
**Citation:** Kim JH, Kim YJ, Park Y. Conjugated Linoleic Acid and Postmenopausal Women's Health. J Food Sci. 2015 Jun;80(6):R1137-43. doi: 10.1111/1750-3841.12905. Epub 2015 May 11.
**PMID:** 25962640
**Citation:** Posadzki P, Lee MS, Moon TW, Choi TY, Park TY, Ernst E. Prevalence of complementary and alternative medicine (CAM) use by menopausal women: a systematic review of surveys. Maturitas. 2013 May;75(1):34-43. doi: 10.1016/j.maturitas.2013.02.005. Epub 2013 Mar 14.
**PMID:** 23497959
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M19020
- Name: Primary Ovarian Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M11577
- Name: Menopause, Premature
- Relevance: LOW
- As Found: Unknown
- ID: T6036
- Name: Menopause
- Relevance: HIGH
- As Found: Menopause
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T257
- Name: Pomegranate
- Relevance: HIGH
- As Found: Polyphenols
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432803
**Acronym:** MIDAS
**Brief Title:** Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS
**Official Title:** Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS
#### Organization Study ID Info
**ID:** 69HCL24_0511
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Autoimmune encephalitis (AE) is a rare neurological disorder mediated by autoimmune antibody response against neuronal cell surface and intraneuronal proteins associated with specific brain areas, resulting in severe inflammation and damage in the associated brain regions, all most frequently manifesting diverse cognition and memory impairment symptoms at follow-up. However, these symptoms may co-exist or mimic other CNS autoimmune and neurodegenerative disorders. The most common guideline for diagnosing autoimmune encephalitis relies on cerebrospinal fluid (CSF) antibody testing which might take several weeks to obtain, making it not optimal for the early diagnosis of AE. As for magnetic resonance imaging (MRI), which is the most common imaging tool utilized for aiding in the diagnosis of AE, can possess several limitations as some patients, like anti-NMDAr AE patients, can present memory and behavioral deficits even in the presence of normal brain MRI. Positron emission tomography (PET) with 2-deoxy-2-\[fluorine-18\] fluoro-D-glucose (18F-FDG) have been addressed by several studies as an important examination for the early diagnosis of AE . One study demonstrated that the fraction of having an abnormal MRI in AE patients is lower than having an abnormal PET, by which certain PET patterns were associated with autoantibody types of AE. Moreover, one report demonstrated that even with autoantibody negative test and normal brain MRI, FDG-PET examination showed abnormal hypometabolism and hypermetabolism patterns. More specifically, these distinct patterns include medial temporal and striatal hypermetabolism with cortical diffuse hypometabolism. Leiris et al. revealed that the methadology used for the analysis of these PET images is highly variable, especially intensity normalization methods, where most possess some limitations (e.g., proportional scaling) as they can impede the accurate differential diagnosis of autoimmune encephalitis (AE) by potentially indicating false hypermetabolism in otherwise preserved brain regions. Absolute quantification is not possible since the disease presents both diffuse hypometabolism and hypermetabolism on PET images. So, they suggested that it's best to parametrize the brain's activity by dividing it by that of the striatum. Their voxel-based analysis, comparing individuals with AE to both healthy subjects and those with mild cognitive impairment (MCI), demonstrated that a decrease in the cortex/striatal metabolic ratio is a robust biomarker for the early diagnosis of AE.
### Conditions Module
**Conditions:**
- Paraneoplastic Neurological Syndrome
- Autoimmune Encephalitis
**Keywords:**
- Paraneoplastic neurological disorders
- autoimmune encephalitis
- auto-antibodies
- PET-SCAN
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 28
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Analysis of PET-scan
**Intervention Names:**
- Other: PET-Scan analysis
**Label:** Auto-immune encephalitis patients
#### Arm Group 2
**Description:** Analysis of PET-scan
**Intervention Names:**
- Other: PET-Scan analysis
**Label:** Paraneoplastic Neurological Syndromes patients
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Auto-immune encephalitis patients
- Paraneoplastic Neurological Syndromes patients
**Description:** Investigate and determine the clinical value of different cortex/striatal metabolic ratio patterns in each antibody-specific subtype of autoimmune encephalitis
**Name:** PET-Scan analysis
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Decrease in the metabolic ratio cortex/striatum in included patients, compared to a control reference cohort.
**Measure:** Ratio metabolic cortex-striatum
**Time Frame:** Up to 10 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patient with positivity of auto-antibody in CSF
* patient \>18 years old
* patient with auto-immune encephalitis or paraneoplastic neurological syndrome
Exclusion Criteria:
- patient without data
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients will be included from the from the database of the French Reference Centre for Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis (Lyon, France)
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pierre-Bénite
**Country:** France
**Facility:** CHU Lyon
**Zip:** 69495
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: D000090862
- Term: Neuroinflammatory Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
- ID: D000013967
- Term: Thyroiditis, Autoimmune
- ID: D000013966
- Term: Thyroiditis
- ID: D000013959
- Term: Thyroid Diseases
- ID: D000004700
- Term: Endocrine System 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: BC20
- Name: Immune System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M7825
- Name: Encephalitis
- Relevance: HIGH
- As Found: Encephalitis
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: HIGH
- As Found: Autoimmune Encephalitis
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26156
- Name: Hashimoto Disease
- Relevance: HIGH
- As Found: Autoimmune Encephalitis
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2803
- Name: Neuroinflammatory Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16725
- Name: Thyroiditis
- Relevance: LOW
- As Found: Unknown
- ID: M16726
- Name: Thyroiditis, Autoimmune
- Relevance: LOW
- As Found: Unknown
- ID: M16718
- Name: Thyroid Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T554
- Name: Autoimmune Encephalitis
- Relevance: HIGH
- As Found: Autoimmune Encephalitis
- ID: T2673
- Name: Hashimoto Encephalopathy
- Relevance: HIGH
- As Found: Autoimmune Encephalitis
- ID: T3542
- Name: Lymphomatous Thyroiditis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004660
- Term: Encephalitis
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000050031
- Term: Hashimoto Disease
### 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: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M4625
- Name: Autoantibodies
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432790
**Acronym:** CHAMPION
**Brief Title:** Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline
**Official Title:** Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)
#### Organization Study ID Info
**ID:** 2022A018209
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
#### Secondary ID Infos
**Domain:** Patient-Centered Outcomes Research Institute (PCORI)
**ID:** TE-2022C3-30362
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2028-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** American Academy of Pediatrics
#### Lead Sponsor
**Class:** OTHER
**Name:** Massachusetts General Hospital
#### Responsible Party
**Investigator Affiliation:** Massachusetts General Hospital
**Investigator Full Name:** Lauren G. Fiechtner, M.D.
**Investigator Title:** Assistant Professor of Pediatrics
**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 study is to evaluate the effectiveness of CHAMPION, a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. Intensive Health Behavior and Lifestyle Treatment (IHBLT), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma.
**Detailed Description:** This study will evaluate the comparative effectiveness of 1) telehealth delivery of CHAMPION vs. 2) in-person (standard of care) delivery of CHAMPION in a two-arm, individually randomized non-inferiority trial among 500 children. Obesity and asthma are two leading chronic diseases in children, and CHAMPION is an integration of the Healthy Weight Clinic (HWC) and pediatric Asthma Population Health Management Programming at Mass General Brigham. This study will address how to improve access to effective treatments consistent with United States Preventive Services Task Force and American Academy of Pediatrics guidelines that manage asthma and obesity concurrently in primary care among lower income diverse populations
### Conditions Module
**Conditions:**
- Overweight, Childhood
- Obesity, Childhood
- Asthma in Children
**Keywords:**
- telehealth
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * Intensive 0-6 months: 1 individual visit monthly (virtual), 1 group visit monthly (virtual)
* Maintenance 6-12 months: 1 individual visit monthly (virtual), 2 health coaching calls per month
**Intervention Names:**
- Behavioral: CHAMPION
**Label:** CHAMPION via Telehealth
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** * Intensive 0-6 months: 1 individual visit monthly (in-person), 1 group visit monthly (in-person)
* Maintenance 6-12 months: 1 individual visit monthly (in-person), 2 health coaching calls per month
**Intervention Names:**
- Behavioral: CHAMPION
**Label:** CHAMPION In-Person
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CHAMPION In-Person
- CHAMPION via Telehealth
**Description:** The CHAMPION program is an intensive health behavior and lifestyle treatment (IHBLT), formed through the integration of the Healthy Weight Clinic IHBLT and with MGB's pediatric Asthma Population Health Management Program. It consists of 30 hours of contact time with the CHAMPION team (physician, dietician, community health worker), consistent with the USPSTF and AAP recommendations, monthly individual clinic visits with the team (in person or virtual, per randomization), health coaching calls with a community health worker and/or registered dietician, monthly group sessions (in the first six months), and educational materials for families that reinforce healthy lifestyle behaviors and provide self-management education.
**Name:** CHAMPION
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Measured as BMI based on child height and weight
**Measure:** Change in Child BMI
**Time Frame:** 0-12 months
**Description:** Measured as BMI based on child height and weight, and derived from CDC growth curves accounting for child age and sex
**Measure:** Change in Child BMI z-score
**Time Frame:** 0-12 months
**Description:** Per Asthma Control Test
**Measure:** Change in Asthma Control Test
**Time Frame:** 0-12 months
**Description:** Per response to caregiver-proxy survey
**Measure:** Change in Asthma and Obesity Specific Quality of Life
**Time Frame:** 0-12 months
#### Secondary Outcomes
**Description:** Diet quality per Primescreen, via caregiver-proxy survey
**Measure:** Change in Child Diet Quality
**Time Frame:** 0-12 months
**Description:** Hours of sleep, via caregiver-proxy survey
**Measure:** Change in Child Average Hours of Sleep
**Time Frame:** 0-12 months
**Description:** Days physically active for at least 60 minutes per day, via caregiver-proxy survey
**Measure:** Change in Child Average Days of Physical Activity
**Time Frame:** 0-12 months
**Description:** Hours of sedentary screen time, via caregiver-proxy survey
**Measure:** Change in Child Average Hours of Screen Time
**Time Frame:** 0-12 months
**Description:** Per response to caregiver-proxy survey
**Measure:** Asthma-related healthcare utilization
**Time Frame:** 0-12 months
**Description:** Per response to caregiver-proxy survey
**Measure:** Change in perceived stress (caregiver)
**Time Frame:** 0-12 months
**Description:** Per response to caregiver-proxy survey
**Measure:** Family-centered care assessment
**Time Frame:** 12 months
**Description:** Per response to caregiver-proxy survey
**Measure:** Telehealth satisfaction
**Time Frame:** 12 months
**Description:** Per response to caregiver-proxy survey
**Measure:** Barriers to program attendance
**Time Frame:** 12 months
**Description:** Per response to caregiver-proxy survey
**Measure:** Change in disordered eating symptoms
**Time Frame:** 0-12 months
### Eligibility Module
**Eligibility Criteria:** Caregiver-proxies will be 18 years old or older, English or Spanish speaking, and a primary caregiver of a child meeting the following criteria:
Inclusion criteria
* Age 6-17.9 years at time of screening
* BMI ≥ 85th percentile
* Asthma diagnosis, per child's EHR documentation or caregiver report
Exclusion criteria
* Diagnosis of anorexia nervosa, per child's EHR or caregiver report
* Pregnant, per child's EHR
* Plan to change pediatricians in the next year, per caregiver report
* Opted out of research, per child's EHR
* Sibling currently enrolled in the research trial, per enrollment log or caregiver report
**Maximum Age:** 17 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lauren Fiechtner, MD
**Phone:** 617-726-8705
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sheila Kelly, MPH
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** The funder, PCORI, requires data to be deposited into the Patient Centered Outcomes Data Repository/University of Michigan ICPSR.
**Info Types:**
- STUDY_PROTOCOL
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Data will be deposited after study completion.
## 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
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
- ID: D000009765
- Term: Obesity
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M26186
- Name: Overweight
- Relevance: HIGH
- As Found: Overweight
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma
- ID: M30155
- Name: Pediatric Obesity
- Relevance: HIGH
- As Found: Overweight, Childhood
- 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: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
- ID: D000050177
- Term: Overweight
- ID: D000063766
- Term: Pediatric Obesity
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432777
**Acronym:** CABARET
**Brief Title:** Recurrent Campylobacter Bacteraemia in Immunocompromised Patients
**Official Title:** Recurrent Campylobacter Bacteraemia in Immunocompromised Patients: a Retrospective Nationwide Study in France, 2000-2025
#### Organization Study ID Info
**ID:** 69HCL24_0512
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2026-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Some rare cases of recurrent Campylobacter bacteraemia (RCB) exist with relapses months to years after an effective treatment and a negativation of all bacterial samples.
As of today, only around 20 cases have been described in the international literature for the last 30 years. The cases are likely highly underreported.
No study describes those recurrent Campylobacter bacteraemias at the scale of a country.
The aim of this multicentre, nationwide, retrospective study is to describe their precise epidemiology in France for the last 25 years, the immune profile of the patients, the specificities of the bacteria involved, the treatments received and the evolution of these infections.
The perspective is to propose a standardization of the medical care of those patients mainly by describing the effective treatments and the explorations of the immune system which should be considered.
### Conditions Module
**Conditions:**
- Campylobacter Infections
**Keywords:**
- primary immunodeficiency
- Campylobacter
- Relapsing bacteraemia
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients presenting at least two distinct episodes of Campylobacter bacteraemia separated by minimum 60 days and an immunodeficiency (innate or acquired)
and followed by a French hospital
**Intervention Names:**
- Other: Characteristics of patients and Campylobacter bacteraemia episodes
**Label:** Recurrent Campylobacter bacteraemia
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Recurrent Campylobacter bacteraemia
**Description:** Variables: characteristics of the patients (demographic characteristics; characteristics of immunodeficiency: diagnosis, immunoglobulin dosage, white cells count etc.; chronic inflammatory bowel disease \[IBD\]), the bacteria (species, antimicrobial susceptibility) and the infection (clinical presentation, evolution, treatment received)
**Name:** Characteristics of patients and Campylobacter bacteraemia episodes
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** -demographic characteristics
**Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
**Time Frame:** Baseline
**Description:** -characteristics of immunodeficiency: diagnosis, immunoglobulin dosage, white cells count, polyvalent Ig replacement therapy
**Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
**Time Frame:** Baseline
**Description:** -chronic inflammatory bowel disease \[IBD\]
**Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
**Time Frame:** Baseline
**Description:** -characteristics of bacteraemia: clinical presentation, bacteria (species, antimicrobial susceptibility), secondary localizations, evolution, treatment modalities (antibiotics and immunother
**Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 2 episodes or more of Campylobacter bacteraemia separated by at least 60 days
* AND immunodeficiency condition
* followed by a French hospital
Exclusion Criteria:
-Opposition of the patient
**Maximum Age:** 100 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** French hospitals
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anne CONRAD, Dr
**Phone:** +33 (0)4 72 07 11 07
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nicolas BENECH, Dr
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Lyon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anne CONRAD, MD-PhD
- **Phone:** +33472071107
- **Role:** CONTACT
**Country:** France
**Facility:** Infectious diseases department, Hospital de la Croix Rousse,
**Zip:** 69004
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: D000016905
- Term: Gram-Negative Bacterial Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- 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: M18877
- Name: Bacteremia
- Relevance: HIGH
- As Found: Bacteremia
- ID: M5429
- Name: Campylobacter Infections
- Relevance: HIGH
- As Found: Campylobacter Infections
- ID: M10199
- Name: Immunologic Deficiency Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M2285
- Name: Primary Immunodeficiency 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: M20818
- Name: Systemic Inflammatory Response Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M19249
- Name: Gram-Negative Bacterial Infections
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016470
- Term: Bacteremia
- ID: D000002169
- Term: Campylobacter Infections
### 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: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M19117
- Name: Immunoglobulins, Intravenous
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432764
**Brief Title:** Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease.
**Official Title:** A Phase Ib Open Label Positron Emission Tomography Study to Assess Changes in Intestinal [11C]AZ14132516 Uptake Following Administration of Multiple Doses of AZD7798 to Patients With Crohn's Disease.
#### Organization Study ID Info
**ID:** D9690C00007
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**Domain:** CTIS
**ID:** 2024-512992-11-00
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2026-02-13
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-02-13
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AstraZeneca
#### 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 measure the changes in intestinal uptake of radioligand \[11C\]AZ14132516 following multiple doses of AZD7798 in participants with Crohn's disease.
### Conditions Module
**Conditions:**
- Crohn Disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Masking Description:** Open label study
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Arm consists of up to 2 panels
**Intervention Names:**
- Drug: AZD7798
- Drug: [11C]AZ14132516
**Label:** AZD7798
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- AZD7798
**Description:** Each participating patient will receive the study drug as specified in the study protocol.
**Name:** AZD7798
**Other Names:**
- Study Drug
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- AZD7798
**Description:** A single microdose (≤ 10 μg) of radiopharmaceutical \[11C\]AZ14132516 will be extemporaneously prepared and administered to each participant prior to each PET examination
**Name:** [11C]AZ14132516
**Other Names:**
- Radioligand
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Safety will be assessed by Adverse Events, vital signs, haematology and clinical chemistry
**Measure:** Number of participants with safety findings, AEs
**Time Frame:** Until final follow-up, week 24 (may vary between participants)
#### Primary Outcomes
**Description:** Standardized uptake value (SUV) is the radioactivity concentration in given region of interest normalized for injected radioactivity and body weight.
Standardised uptake value ratio (SUVR) is the ratio of SUV in a given region of interest to a reference region without significant radioligand uptake
**Measure:** Change from baseline in intestinal SUV/SUVR
**Time Frame:** Weeks 13, 16, 20 and 24 (may vary between participants)
#### Secondary Outcomes
**Measure:** Serum AZD7798 concentration
**Time Frame:** Weeks 0, 4, 8, 12 (may vary between participants)
**Measure:** Incidence and titre of anti-drug antibodies
**Time Frame:** Week 0, 4, 8, 12 and 24 (may vary between participants)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant must be ≥ 20 to 80 years of age, inclusive, at the time of signing the informed consent.
* Participants with confirmed Crohn's disease with small bowel involvement (Montreal terminal ileum \[L1\] or ileocolon \[L3\]) per study gastroenterologist (diagnosed via combination of clinical findings and at least one of endoscopy and/or histology and/or imaging) with diagnosis made at least 6 months before screening.
* Participants with active Crohn's disease as determined by one of the following:
1. Evidence of active inflammation on cross-sectional imaging (CT, MRI or bowel ultrasound scan) or endoscopy within 6 months before screening OR EITHER
2. If no cross-sectional imaging or endoscopy performed within 6 months before screening, a bowel ultrasound scan may be performed to confirm active disease OR
3. If no cross-sectional imaging or endoscopy performed within 6 months before screening, elevated faecal calprotectin AND CRP
* Body habitus compatible with PET examination.
* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent
* Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.
Exclusion Criteria:
* Other form of IBD or concomitant, additional, active GI luminal inflammatory diseases.
* CMV colitis within 12 months before screening.
* Crohn's complications including short bowel syndrome, strictures that are symptomatic or with pre-stenotic dilatation or other conditions where surgery anticipated during study period.
* Planned bowel or perianal surgery within 6 months before screening.
* Bowel resection surgery within 6 months before screening.
* Undrained fistula or abscess (including active perianal disease).
* Positive Clostridium difficile toxin test during screening.
* Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, GI disease, or other major diseases other than active Crohn's disease and associated extra-intestinal manifestations.
* Ongoing psychiatric conditions that in the opinion of the Investigator, precludes study participation.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to biologic therapies.
* Participants with unstable hypertension (as judged by the Investigator) or symptomatic hypotension, history of pre-syncope or syncope due to orthostatic hypotension and/or induced by change of posture.
* Significant abnormalities on clinical examination, including neurological and physical examination, vital signs, and ECG, other than signs of Crohn's disease.
* Clinical chemistry, haematology, or urine analysis results that may interfere with the study or present a safety risk to the participant.
* Abnormal vital signs, after 10 minutes of supine rest as judged by the Investigator.
* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG that may interfere with the interpretation of QTc changes.
* Positive hepatitis B, hepatitis C, or HIV serology
* Treatment with an anti-TNF within 8 weeks of the first dose and throughout the study period, before the first dose and throughout study period, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable.
* Treatment with any biologic, other than an anti-TNF (including vedolizumab and ustekinumab) within 12 weeks prior to first dose and throughout the study period, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable.
* Treatment with rituximab within 12 months before first dose and throughout the study period.
* Treatment with Sphigosine-1-phosphate receptor modulators or Janus kinase inhibitors within 4 weeks before first dose and throughout the study period.
* Treatment with apheresis (eg, Adacolumn, Cellsorba) within 2 weeks prior to first dose and throughout the study period.
* Treatment with corticosteroids at a total daily dose of greater than 20 mg prednisone or equivalent (greater than 9 mg budesonide).
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or site staff).
* Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
* Suffers from claustrophobia that limits the ability to undergo the scanning procedure.
* Positive SARS-CoV-2 rapid antigen test at screening.
* Any other reason that, in the study Investigator opinion, prohibits the inclusion of the participants into the study.
* Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
* Live or attenuated vaccine within 4 weeks before screening and until 12 weeks after the end of the follow-up period (1 year for Bacillus Calmette-Guérin vaccination).
* An active infection, or history of serious infection within 28 days before screening.
* History of symptomatic herpes simplex (excluding cold sores) or herpes zoster infection within 3 months prior to screening.
* Positive or indeterminate TB QuantiFERON test performed within 1 year of screening (without known interval exposure to TB) or during screening period unless evidence of completion of full treatment course for latent TB with no clinical symptoms or signs indicative of re activation.
* Chest x-ray with signs of malignancy or latent or active TB infection performed within 1 year of screening (without known interval exposure to TB) or during screening period.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days/5 half-lives, whichever is longer, of the first administration of IMP in this study. The period of exclusion begins 30 days/5 half-lives after the final dose, whichever is longer, .
* Current malignancy or history of malignancy, except for:
1. Basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to screening.
2. Other non-GI malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years before screening.
* For females only: Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
**Maximum Age:** 80 Years
**Minimum Age:** 20 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:** Stockholm
**Country:** Sweden
**Facility:** Karolinska University Hospital Huddinge
**Zip:** 141 86
#### Overall Officials
**Official 1:**
**Affiliation:** Karolinska University Hospital
**Name:** Maria Creignou
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015212
- Term: Inflammatory Bowel Diseases
- 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: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6638
- Name: Crohn Disease
- Relevance: HIGH
- As Found: Crohn's Disease
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17917
- Name: Inflammatory Bowel Diseases
- Relevance: LOW
- As Found: Unknown
- 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
### Condition Browse Module - Meshes
- ID: D000003424
- Term: Crohn Disease
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21258
- Name: Radiopharmaceuticals
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432751
**Acronym:** SGLT2i-PO-AKI
**Brief Title:** Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery
**Official Title:** Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery
#### Organization Study ID Info
**ID:** 69HCL24_0517
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2024-05-10
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-10
**Type:** ACTUAL
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Cardiac surgery with cardiopulmonary bypass exposes patients to the risk of post-operative acute kidney injury. In the specific setting of cardiac surgery, acute kidney injury is often of multifactorial origindue to particular haemodynamic mechanisms, renal hypoxia, or damage linked in the inflammatory reaction or haemolysis.
In recent years, inhibitors of the sodium/glucose co-transporter type 2 have demonstrated their relevance in reducing the morbidity and mortality associated with chronic or acute heart failure and chronic kidney disease. These drugs were initially developed to optimise glycaemic control in diabetic patients. They are currently recommended as part of the management of diabetic patients at high cardiovascular risk, patients with systolic and/or diastolic heart failure, and patients with chronic kidney disease.
Some pharmacodynamic properties of SGLT2i suggest that they could have a beneficial effect in preventing the onset of acute kidney injury, but also that they could lead to potentially deleterious effects in renal haemodynamic in specific situations.
The aim of the study was to estimate the impact of pre-operative exposure to SGLT2i on the occurrence of post-operative acute kidney injury in high-risk renal patients undergoing cardiac surgery.
### Conditions Module
**Conditions:**
- Acute Kidney Injury
- Cardiac Surgery
- Sodium/Glucose Cotransporter Inhibitor 2
**Keywords:**
- Acute Kidney Injury
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 500
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Adults patients with pre-operative simplified predictive risk index for renal replacement therapy after cardiac surgery ≥2, with cardiac surgery performed in Louis Pradel Hospital between 08/2022 and 02/2024.
**Intervention Names:**
- Other: Post Operative Acute Kidney Injury
**Label:** Cohort
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort
**Description:** Serum creatinine increase by 0.3 mg/dl within 48 h OR Serum creatinine ≥ 1.5-1.9 times baseline within 7 days
Baseline creatinine is defined as the last pre-operative value available in the medical file
**Name:** Post Operative Acute Kidney Injury
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Serum creatinine increase by 0.3 mg/dl within 48 h
**Measure:** Post-operative acute kidney injury
**Time Frame:** Baseline creatinine is defined as the last pre-operative value available in the medical file Variation of the creatinine was explored in the first 7 postoperative days
**Description:** Serum creatinine ≥ 1.5-1.9 times baseline within 7 days
**Measure:** Post-operative acute kidney injury
**Time Frame:** Baseline creatinine is defined as the last pre-operative value available in the medical file Variation of the creatinine was explored in the first 7 postoperative days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years
* Cardiac surgery with cardiopulmonary bypass
* Presenting a simplified renal risk score ≥ 2 points defined as follows:
* Pre-operative glomerular filtration rate (≤ 60; ≤ 30 mL/min/1.73m2): 1-2 points
* Diabetes requiring treatment: 1 point
* LVEF ≤ 40%: 1 point
* Previous cardiac surgery: 1 point
* Pre-operative intra-aortic counter pulsation: 1 point
* Non elective surgery: 1 point
* Surgery other than closure of an atrial septal defect or coronary bypass surgery: 1 point
Exclusion Criteria:
* Haemodialysis prior to surgery
* Acute kidney injury prior to surgery as defined in the primary endpoint. If this criterion is not available, patients will only be included if glomerular filtration rate estimated by the CKD-EPI formula is ≥75 mL/min/1.73m2.
* Death in the operating theatre
* Opposition of the patient to the use of his/her health data
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** 1200 patients admitted in the Louis Pradel Hospital for cardiac surgery in the study period
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bron
**Country:** France
**Facility:** Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
**State:** Rhône
**Zip:** 69500
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007674
- Term: Kidney Diseases
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M28998
- Name: Acute Kidney Injury
- Relevance: HIGH
- As Found: Acute Kidney Injury
- ID: M26718
- Name: Renal Insufficiency
- Relevance: HIGH
- As Found: Renal Failure
- ID: M10698
- Name: Kidney Diseases
- 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: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000058186
- Term: Acute Kidney Injury
- ID: D000051437
- Term: Renal Insufficiency
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432738
**Brief Title:** ZL-82 Double-blind Clinical Trial
**Official Title:** A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Design to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and QTc Effect Research
#### Organization Study ID Info
**ID:** ZL82-H-Ib
#### Organization
**Class:** INDUSTRY
**Full Name:** Chengdu Zenitar Biomedical Technology Co., Ltd
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-24
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Chengdu Zenitar Biomedical Technology Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** ZL-82 tablets are highly selective covalent irreversible inhibitors of non-receptor tyrosine protein kinase 3 (Janus kinase 3, JAK3) developed by Chengdu Xiuling Biomedical Technology Co., Ltd. According to Document No. 44 of 2020 "Chemical Drug Registration Classification and Application Document Requirements", it belongs to Category 1 chemical drugs and is an innovative drug that has not been marketed at home or abroad.
ZL-82 tablets have completed non-clinical pharmacology, non-clinical PK, and toxicology experiments, and have obtained the first-in-human randomized double-blind, placebo-controlled, dose-increasing dose-increasing approval for single oral administration of ZL-82 tablets. Partial results of the phase I clinical study on safety tolerability, pharmacokinetics and preliminary pharmacodynamics. It is necessary to further explore the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of multiple administrations based on the results obtained from the first human trial.
Non-clinical in vitro hERG tests and in vivo animal safety pharmacology tests of ZL-82 tablets showed no relevant cardiac safety concerns. According to the ICH E14 guideline "Clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects of Non-Antiarrhythmic Drugs" Evaluation》2, it is recommended to conduct cardiac safety evaluation of experimental drugs with systemic bioavailability to evaluate the impact of experimental drugs on cardiac safety. This evaluation should include evaluation of the effect of the new drug on the QT/QTc interval and collection of adverse cardiovascular events. Establishing a relationship between ZL-82 drug concentration and QT/QTc interval changes will provide additional information for the analysis of cardiac repolarization trial planning and interpretation to facilitate analysis of the effects of drugs on QT/QTc interval changes. Concentration-response analysis, used to characterize the effect of the test drug on the QT/QTc interval, can be used as an alternative to time point analysis.
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of ZL-82 tablets in single/multiple oral doses in healthy subjects, and will also evaluate the effect of ZL-82 tablets on QTc.
### Conditions Module
**Conditions:**
- Healthy Person
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The subjects in the single-dose group were fasted and water-free for at least 10 hours the night before the administration. On the first day of the study (D1), the subjects were given ZL-82 tablets or placebo according to the requirements of the random table, and were followed as per the study. Schedule safety inspections and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; complete a series of safety inspections, PK, and PD sample collection on the 3rd day and leave the clinical trial facility on the 7th day Safety follow-up.
**Intervention Names:**
- Drug: ZL-82
**Label:** 600mg ZL-82
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The subjects in the single-dose group were fasted and water-free for at least 10 hours the night before the administration. On the first day of the study (D1), the subjects were given ZL-82 tablets or placebo according to the requirements of the random table, and were followed as per the study. Schedule safety inspections and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; complete a series of safety inspections, PK, and PD sample collection on the 3rd day and leave the clinical trial facility on the 7th day Safety follow-up.
**Intervention Names:**
- Drug: ZL-82 placebo
**Label:** 600mg ZL-82 placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility.
**Intervention Names:**
- Drug: ZL-82
**Label:** 50mg ZL-82
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility.
**Intervention Names:**
- Drug: ZL-82 placebo
**Label:** 50mg ZL-82 placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 5
**Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility.
**Intervention Names:**
- Drug: ZL-82
**Label:** 100mg ZL-82
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility.
**Intervention Names:**
- Drug: ZL-82 placebo
**Label:** 100mg ZL-82 placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 7
**Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility.
**Intervention Names:**
- Drug: ZL-82
**Label:** 200mg ZL-82
**Type:** EXPERIMENTAL
#### Arm Group 8
**Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility.
**Intervention Names:**
- Drug: ZL-82 placebo
**Label:** 200mg ZL-82 placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 100mg ZL-82
- 200mg ZL-82
- 50mg ZL-82
- 600mg ZL-82
**Description:** This group of subjects take ZL-82
**Name:** ZL-82
**Other Names:**
- 600mg ZL-82
- 50mg ZL-82
- 100mg ZL-82
- 200mg ZL-82
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 100mg ZL-82 placebo
- 200mg ZL-82 placebo
- 50mg ZL-82 placebo
- 600mg ZL-82 placebo
**Description:** This group of subjects take ZL-82 placebo
**Name:** ZL-82 placebo
**Other Names:**
- 600mg ZL-82 placebo
- 50mg ZL-82 placebo
- 100mg ZL-82 placebo
- 200mg ZL-82 placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** security indicators
**Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：Cmax
**Time Frame:** 72hours
**Description:** Estimation of time to reach Cmax
**Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：Tmax
**Time Frame:** 72hours
**Description:** Estimation of AUC from time zero to the last measured time point
**Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：AUC0-72h
**Time Frame:** 72hours
**Description:** Estimation of AUC from time zero extrapolated to infinity
**Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：AUC0-∞
**Time Frame:** 72hours
**Description:** Estimation of mean residence time
**Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：MRT
**Time Frame:** 72hours
**Description:** Estimation of apparent volume of distribution
**Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：Vd
**Time Frame:** 72hours
**Description:** Estimation of terminal elimination half-life
**Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：t1/2
**Time Frame:** 72hours
**Description:** Estimation of clearance when dosed orally
**Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：CLz/F
**Time Frame:** 72hours
#### Secondary Outcomes
**Description:** security indicators
**Measure:** Evaluation of the pharmacodynamic (PD) characteristics of single/multiple oral doses of ZL-82 tablets in healthy humans
**Time Frame:** Day 16
**Description:** security indicators
**Measure:** To evaluate the effect of ZL-82 tablets on QT/QTc interval in healthy subjects after single-dose administration.
**Time Frame:** Day 16
**Description:** security indicators
**Measure:** To evaluate the effect of ZL-82 tablets on ECG parameters (ΔQTcF/ΔΔQTcF and HR, PR, QRS intervals) in healthy subjects, as well as the effect on T wave morphology and U wave.
**Time Frame:** Day 16
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Those who can understand the informed consent form, voluntarily participate in the trial and sign the informed consent form.
2. Male or female; aged between 18 and 50 years old (including 18 and 50 years old).
3. Male subjects weigh ≥50kg, female subjects weigh ≥45kg, body mass index (BMI) between 19.0\~26.0kg/m2, BMI = weight (kg)/height 2 (m2), including boundary values.
4. The subject can communicate well with the researcher and complete the trial in compliance with the requirements of the protocol.
Exclusion Criteria:
-
Subjects who meet any of the following criteria will be excluded from the trial:
Current medical history, past medical history, and recent medication history:
1. Those who have a history of severe systemic diseases (including cardiovascular system, digestive system, urinary system, respiratory system, etc.), mental illness, and drug dependence;
2. Have a history of structural heart disease, heart failure, myocardial infarction, angina pectoris, torsade de pointes, ventricular tachycardia, QT prolongation syndrome or symptoms of QT prolongation syndrome (such as syncope) , convulsions) and family history (proven hereditary or close relatives died suddenly due to cardiac causes when young);
3. Physical examination, vital signs, laboratory examination items and test-related examinations and tests during the screening period or baseline period (for example: chest X-ray examination, abdominal color ultrasound, blood pregnancy test, ANA examination, gamma-interferon release Test, 12-lead electrocardiogram, etc.) with abnormal results and clinical significance;
4. Patients with a history of lipid metabolism defects, such as: familial hyperlipidemia, lipoid nephropathy, or patients with acute pancreatitis accompanied by hyperlipidemia;
5. Nervous/psychiatric, respiratory system, cardiovascular system, digestive tract system, blood and lymphatic system, endocrine system, musculoskeletal system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the test results during screening By;
6. Those with allergies, or those with a history of food or drug allergies or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) that are clinically significant as determined by the researcher; or those who are known to be allergic to JAK inhibitors or to the test Those who are allergic to the excipients contained in the medicine;
7. Those who have suffered from clinically significant diseases or undergone major surgeries within 3 months before screening;
8. Those who suffered from acute diseases within 2 weeks before screening; those who had clinically significant infections within 3 months before screening (such as upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.); those who had any evidence of infection within 7 days before screening (such as Fever, cough, sputum, headache, etc.); those with a history of herpes simplex infection or recurrent (\>1 time) herpes zoster or disseminated herpes zoster;
9. Those with a history of dysphagia or any gastrointestinal system disease (or gastrointestinal resection, etc.) that affects drug absorption;
10. Those who have donated blood within 3 months before screening, or those who plan to donate blood during this trial, or those who have had blood transfusion or blood loss ≥ 200mL within 4 weeks before the trial;
11. Those who have participated in 4 or more clinical trials as subjects in the past year; or those who have participated in any clinical trials as subjects within 3 months before participating in this trial;
12. Those who have a history of drug abuse within 5 years before screening or have used drugs within 3 months before screening;
13. Concomitant use of strong inducers of liver metabolic enzymes (such as: omeprazole, barbiturates, carbamazepine, aminoglutethimide, griseofulvin, promethazine) within 4 weeks (28 days) before screening esters, phenytoin, gramide, rifampicin, sulfinpyrazone, roxithromycin, etc.); those who have taken any drug known to cause QT/QTc interval prolongation within 4 weeks (28 days) before screening or have Medications that pose a risk of torsade de pointes (TdP);
14. Those who have been vaccinated within 8 weeks before screening, or plan to be vaccinated during the study or within 8 weeks after the last dose of study drug;
15. Those who have a history of fainting from blood and needles and cannot tolerate blood collection with intravenous indwelling needles;
Health status:
16. Those whose 12-lead electrocardiogram during the screening period or baseline period has the following results: QTcF interval corrected according to Fridericia's formula \>450ms; or those whose electrocardiogram is abnormal and the researcher believes that the abnormality is clinically significant (including but not limited to complete left bundle branch or right bundle branch block; second or third degree atrioventricular block (AVB); sustained atrial or ventricular arrhythmias; two consecutive ventricular premature contractions; ST-segment elevation pattern and myocardial ischemia Consistent; evidence of previous myocardial infarction (MI), left ventricular hypertrophy (LVH), or more than mild nonspecific ST-T wave changes; any features that make QT assessment unreliable, including flattened T waves);
17. Those with systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg during the screening period or baseline period;
18. Laboratory test results during the screening period or baseline period that the researcher considers to be abnormal and clinically significant, including but not limited to:
1. Abnormal renal function during the screening period or baseline period: serum creatinine \> upper limit of normal (ULN) or glomerular filtration rate (GFR, calculated by CKD-EPI formula) \<90mL/min/1.73m2;
2. Direct bilirubin and total bilirubin\>1.5xULN;
19. Those who are positive for hepatitis B virus surface antigen and/or positive for hepatitis B virus e antigen, positive for hepatitis C virus antibodies, positive for human immunodeficiency virus antibodies, or have abnormal Treponema pallidum antibodies during the screening period;
20. Those who have a positive alcohol breath test during the screening period or baseline period, or a positive urine drug abuse screen;
Lifestyle restrictions:
21. Have special requirements for diet and cannot comply with the diet and corresponding regulations provided by clinical research institutions;
22. Those who cannot control special diets (including dragon fruit, mango, grapefruit and/or xanthine diets, caffeinated foods or beverages, etc.) from 48 hours before the first dose to the end of the study;
23. Those who have taken special diets or exercised strenuously within 48 hours before the first dose, or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.;
24. Regular drinkers within 6 months before administration or during the trial, that is, drinking more than 21 units (men) or 14 units (women) of alcohol per week (1 unit = 360mL beer or 45mL liquor with an alcohol content of 40%) or 150mL wine);
25. Those who smoked more than 5 cigarettes per day in the 3 months before administration, or who will use any tobacco products during the trial; contraception:
26. Pregnant or lactating women or those with positive blood pregnancy test results;
27. Those who have used long-acting estrogen or progesterone injections or implants within 6 months before screening;
28. Women of childbearing age who had unprotected sex with their partners within 14 days before screening;
29. Male or female subjects of childbearing potential do not agree to use effective contraceptive methods from the time of signing the informed consent form to 6 months after the last dose.
Other standards:
30. Subjects who the researcher believes have poor compliance or have any factors that are not suitable for participating in this trial;
31. Relevant personnel of the research center and their family members;
32. Vulnerable subjects such as students and subordinates of researchers and employees of sponsors;
33. Subjects may not be able to complete this trial due to other reasons.
**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:** Hong Wang, Bachelor
**Phone:** 0533-7698395
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** jie hou, Doctor
**Phone:** 05337698395
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zibo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Suqin Fang, bachelor
- **Phone:** 18553376165
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hong Wang, bachelor
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Jie Hou, Doctor
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Peking University Medical Shandong Hospital of Traditional Chinese Medicine
**State:** Shandong
**Status:** RECRUITING
**Zip:** 255000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432725
**Brief Title:** Joining Under-connected Networks to Optimize "Salud" (Health) ("JUNTOS")
**Official Title:** Enhancing HIV Prevention and Treatment Referral and Engagement Among Latino Men Who Have Sex With Men (MSM): A Pilot Hybrid Effectiveness-Implementation Trial of the JUNTOS Referral Network
#### Organization Study ID Info
**ID:** 20230443
#### Organization
**Class:** OTHER
**Full Name:** University of Miami
#### Secondary ID Infos
**ID:** R34MH134670
**Link:** https://reporter.nih.gov/quickSearch/R34MH134670
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute of Mental Health (NIMH)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Miami
#### Responsible Party
**Investigator Affiliation:** University of Miami
**Investigator Full Name:** Audrey Harkness
**Investigator Title:** Assistant 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 objective of this study is to evaluate the JUNTOS Referral Network as an implementation strategy to enhance the reach of HIV-prevention and treatment services to Latino gay, bisexual, and other men who have sex with men (MSM).
### Conditions Module
**Conditions:**
- Hiv
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 245
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this group will get access to the JUNTOS Referral Network website/app through the 6-month follow up (HIV test counselors) and 3-month follow up (Latino MSM).
**Intervention Names:**
- Behavioral: JUNTOS
**Label:** JUNTOS
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in this group will get access to the referral sheet through the 6-month follow up (HIV test counselors) and 3-month follow up (Latino MSM).
**Intervention Names:**
- Behavioral: Referral Sheet
**Label:** Referral Sheet - HIV test counselors
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- JUNTOS
**Description:** HIV test counselor and Latino MSM participants will be given access to the JUNTOS website/app, which shows information about local HIV and ancillary services. HIV test counselor participants will also be given access to a training video explaining how to use the JUNTOS website/app. HIV test counselors are encouraged to use the website/app for approximately 10 minutes at least once a week when meeting with Latino MSM testing clients. Latino MSM are encouraged to use the website/app to locate HIV and ancillary services as needed.
**Name:** JUNTOS
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Referral Sheet - HIV test counselors
**Description:** HIV test counselor and Latino MSM participants will be given access to referral sheet, which is a list of local HIV and ancillary services. HIV test counselors are encouraged to use the referral sheet for approximately 10 minutes at least once a week when meeting with Latino MSM testing clients. Latino MSM are encouraged to use the referral sheet to locate HIV and ancillary services as needed.
**Name:** Referral Sheet
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The number of Latino MSM participants who indicated using a biomedical HIV prevention/treatment.
**Measure:** Use of Biomedical HIV Prevention/Treatment
**Time Frame:** 3-months
**Description:** The Referral Fidelity Questionnaire, developed for this study, has scores that range from 0% to 100%. Higher scores indicate more Latino MSM clients were referred to biomedical HIV Prevention/Treatment.
**Measure:** Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment
**Time Frame:** 3-months
#### Secondary Outcomes
**Description:** The Referral Fidelity Questionnaire, developed for this study, has scores that range from 0% to 100%. Higher scores indicate more Latino MSM clients referred to biomedical HIV Prevention/Treatment.
**Measure:** Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment
**Time Frame:** 6-months
**Description:** This will be measured by a self-report question of Latino MSM's HIV status.
**Measure:** HIV acquisition, measures by self-report
**Time Frame:** 3-months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
HIV Test counselors:
* 18 years of age or older
* Certified as an HIV test counselor in Miami-Dade County or Broward County (at the time of enrollment)
* Working or volunteering as an HIV test counselor in Miami-Dade County or Broward County and report testing 1 or more Latino MSM client per week (at the time of enrollment)
* Plans to continue working or volunteering as an HIV test counselor in Miami-Dade County or Broward County for the next 6 months
* Reports suboptimal fidelity to pre-exposure prophylaxis (PrEP) referral guidelines (\<80% fidelity)
* Willing and able to recruit 4-5 Latino MSM testing clients into the study
Latino MSM:
* 18 years of age or older
* Identifies as Latino/a/x or Hispanic
* Identifies as a sexual minority man or reports being a man who has sex with men
* Speaks English and/or Spanish
* Received an HIV test from an HIV test counselor participating in the study
* Lives in Miami-Dade County, Broward County, or Palm Beach County and anticipates living there for the next three months
Exclusion Criteria:
HIV test counselors:
* Unable to consent
* Study personnel unable to verify HIV test counselor role in Miami-Dade County or Broward County (e.g., confirmation of where they work/volunteer as HIV test counselor, location they state they provide services doesn't exist or does not provide HIV testing services)
* Works as an HIV test counselor in an incarceration/prison setting (i.e., clients are prisoners)
Latino MSM:
* Unable to consent
**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:** Audrey Harkness, PhD
**Phone:** 786-401-2846
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nicole Altenberg, BS
**Phone:** 786-401-2846
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Coral Gables
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nicole Altenberg, BS
- **Phone:** 786-401-2846
- **Role:** CONTACT
***Contact 2:***
- **Name:** Audrey Harkness, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Miami
**State:** Florida
**Zip:** 33146
#### Overall Officials
**Official 1:**
**Affiliation:** University of Miami
**Name:** Audrey Harkness, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432712
**Brief Title:** Comparison of Post Operative Endodontic Pain in Patients With Irreversible Pulpitis Treated With and Without Dexamethasone.
**Official Title:** Comparison of Post Operative Endodontic Pain in Patients With Irreversible Pulpitis Treated With and Without Dexamethasone.
#### Organization Study ID Info
**ID:** FUCDCLINIC-2404
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2025-06-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Foundation University Islamabad
#### Lead Sponsor
**Class:** OTHER
**Name:** Shoaib Rahim
#### Responsible Party
**Investigator Affiliation:** Foundation University Islamabad
**Investigator Full Name:** Shoaib Rahim
**Investigator Title:** Assistant professor
**Type:** SPONSOR_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:** Root canal procedure is a common procedure in dentistry. Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain.
Potential Solution: The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain.
Research Goal: Pain score of patients treated with dexamethasone infiltration will be less compared to patients treated with NSAIDS alone after canal instrumentation.
**Detailed Description:** Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain. The peak inflammatory response occurs after 24 - 48 hours of root canal instrumentation. As management of post-endodontic pain is still a challenge for clinicians several drugs which include NSAIDs, acetaminophen, opioids and steroids are used to reduce the inflammatory response. Corticosteroids possess anti-inflammatory efficacy, and they prevent the production and release of inflammatory mediators at the site of tissue injury thus reducing the signs \& symptoms of inflammation such as pain, swelling \& loss of function. Dexamethasone is a potent corticosteroid that has the ability to reduce the production of proinflammatory cytokines. Dexamethasone can be administered orally, or as an intraosseous, intra ligament periapical \& intracanal injection. Dexamethasone is effective in alleviating pain in first 24 hours post endodontic treatment. Previous research on the effect of dexamethasone injection on post-endodontic treatment pain in patients presenting with necrotic pulp treated with single visit endodontic treatment reported 25% post operative pain occurrence and 9% when treated with dexamethasone.
Study Goal : The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain as compared to the prescription of NSAIDs only. If dexamethasone infiltration is effective in pain relief after endodontic treatment, it can be a useful adjunct in managing patients presenting with acute pulpal pain.
### Conditions Module
**Conditions:**
- Pain
**Keywords:**
- Postoperative Pain
- Root canal therapy
- Dexamethasone
- Pulpitis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive dexamethasone infiltration or only analgesic therapy. They will remain in their assigned group throughout the study.
##### Masking Info
**Masking:** NONE
**Masking Description:** Interventional or control group will be selected randomly through sealed envelope by an independent researcher not involved in the study.
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 140
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this arm will receive routine root canal treatment with a prescription of NSAIDs post operatively.
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Participants in this arm will receive routine root canal treatment along with 2.5ml of dexamethasone 4mg/ml peri apical infiltration with a prescription of NSAIDs post operatively.
**Intervention Names:**
- Drug: Dexamethasone 4mg
**Label:** Experimental
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental
**Description:** 2.5ml of Dexamethasone 4mg/ml will be administered via periapical infiltration with a 23 gauge needle to the experimental group.
**Name:** Dexamethasone 4mg
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The patient's pain response before treatment will be recorded using visual analogue scale 0-10.Pain score of 3 and less than 3 will be categorized as no postoperative pain and score greater than 3 will be categorized as post operative pain.
**Measure:** post operative pain
**Time Frame:** 12 hours, 24 hours and 1 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients of age 18-50 years
* Maxillary molar and premolar teeth
* Pt diagnosed with irreversible pulpitis with or without apical periodontitis
Exclusion Criteria:
* Teeth with calcified canals.
* Teeth with incompletely formed apices.
* Teeth requiring retreatment.
* Taking analgesics, anti-inflammatory, or tri-cyclic anti-depressants for their medical conditions.
* Teeth with grade II or III mobility (more than 2 mm)
* Pregnant patients
* Pt who are immunocompromised (uncontrolled diabetes mellitus, renal impairment)
**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:** zainab butt, BDS
**Phone:** +93225667847
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Rozina Nazir, FCPS
**Phone:** +92 3215376612
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Suresh N, Nagendrababu V, Koteeswaran V, Haritha JS, Swetha SD, Varghese A, Natanasabapathy V. Effect of preoperative oral administration of steroids in comparison to an anti-inflammatory drug on postoperative pain following single-visit root canal treatment - a double-blind, randomized clinical trial. Int Endod J. 2021 Feb;54(2):198-209. doi: 10.1111/iej.13416. Epub 2020 Nov 12.
**PMID:** 32976660
**Citation:** Yeganegi S, Fazelian N, Layegh Nejad MK, Manzouri L. Comparison of the Efficacy of Dexamethasone and Methylprednisolone in Infiltration Injection for Postendodontic Pain in Patients with Necrotic Pulp: A Randomized Controlled Clinical Trial. Pain Res Manag. 2022 Feb 23;2022:4163120. doi: 10.1155/2022/4163120. eCollection 2022.
**PMID:** 35251416
**Citation:** Aksoy F, Ege B. The effect of pretreatment submucosal injections of tramadol and dexamethasone on post-endodontic pain in mandibular molar teeth with symptomatic irreversible pulpitis: a randomized controlled clinical trial. Int Endod J. 2020 Feb;53(2):176-185. doi: 10.1111/iej.13246. Epub 2019 Nov 28.
**PMID:** 31702056
**Citation:** Nogueira BML, Silva LG, Mesquita CRM, Menezes SAF, Menezes TOA, Faria AGM, Porpino MTM. Is the Use of Dexamethasone Effective in Controlling Pain Associated with Symptomatic Irreversible Pulpitis? A Systematic Review. J Endod. 2018 May;44(5):703-710. doi: 10.1016/j.joen.2018.02.006. Epub 2018 Mar 20.
**PMID:** 29571913
**Citation:** Yavari HR, Jafari F, Jamloo H, Hallaj-Nezhadi S, Jafari S. The Effect of Submucosal Injection of Corticosteroids on Pain Perception and Quality of Life after Root Canal Treatment of Teeth with Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2019 May;45(5):477-482. doi: 10.1016/j.joen.2019.01.005. Epub 2019 Mar 23.
**PMID:** 30910353
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003788
- Term: Dental Pulp Diseases
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: LOW
- As Found: Unknown
- ID: M14525
- Name: Pulpitis
- Relevance: HIGH
- As Found: Pulpitis
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M6984
- Name: Dental Pulp Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011671
- Term: Pulpitis
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000005765
- Term: Gastrointestinal 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: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M7102
- Name: Dexamethasone
- Relevance: HIGH
- As Found: Children
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4251
- Name: Antiemetics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal 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
### Intervention Browse Module - Meshes
- ID: D000003907
- Term: Dexamethasone
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432699
**Acronym:** MOPS
**Brief Title:** Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split Mouth Clinical Study
**Official Title:** Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split
#### Organization Study ID Info
**ID:** FF/FUMC/215-372Phy/23
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Foundation University Islamabad
#### Responsible Party
**Investigator Affiliation:** Foundation University Islamabad
**Investigator Full Name:** Shoaib Rahim
**Investigator Title:** ZAINAB BUTT
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** DEFINITION: A short description of clinical study , including a brief statement of clinical study's hypothesis, written in language intended for the lay public Limit: 5000 CHARACTERS
**Detailed Description:** Definition: Extended description of the protocol ,including more technical information(as compared to the brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
Limit:32,000 characters. For Patient Registries: Also describe the applicable registry procedures and other quality factors (for examples, third party certification, on site audit). In particular , summarize any procedures implemented as part of the patient registry, including , but not limited to the following:
* Quality assurance plan that addresses data validation and registry procedures, including and plans for site monitoring and auditing
* Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
* Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources( for example, medical records, paper or electronic case reports forms, or interactive voice response systems)
* Data Dictionary that contains detailed descriptions of each variable used by the registry, including, including the source of the variable, coding information if used (for example World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant.
* STANDARD OPERATING PROCEDURE TO ADDRESS REGISTRY REGISTRY OPERATIONS AND ANALYSISACTIVITIES, SUCH AS PATIENT RECRUITMENT DATA COLLECTION,DATA MANAGEMENT., DATA ANALYSIS, reporting for adverse events, and change management.
* Sample Size Assessment to specify the number of participants or participate years necessary to demonstrate an effect.
* Plan for missing data to address situations where variable are reported a missing , unavailable non-reported, interpretable, or considered missing because of data inconsistency or out-of-range results.
* Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives , as specified in the study protocol or plan
### Conditions Module
**Conditions:**
- Pain
- Rate of Canine Retraction
**Keywords:**
- MOP
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either MOPS or no Mops
##### Masking Info
**Masking:** NONE
**Masking Description:** Participants will be randomly assigned to receive Micro-osteoperforation and the other side will be control.
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this arm will receive no MOP treatment
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** participants in this arm will receive MOPS intervention
**Intervention Names:**
- Other: micro osteoperforation
**Label:** Experimental
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental
**Description:** one side used for mops while other side will be control in same patient
**Name:** micro osteoperforation
**Other Names:**
- Placebo/Controlled
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** patient after undergoing micro-osteoperforation will be aske to measure pain and check rate of canine retraction
**Measure:** pain will be measured after intervention of visual analogue scale
**Time Frame:** three months since the MOPS
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- 1. Age range around 15-40 years. 2. Patients which have class I malocclusion or class II Div I malocclusion and include first premolar extraction as part of treatment plan..
3. No orthodontic treatment previously 4. Radiographic evidence showing no bone loss 5. History showing no periodontal disease. 6. History showing no systemic disease. 7. Probing depth less than 4 mm across the entire dentition 8. No active carious lesion or any sign of gingivitus
Exclusion Criteria:
1. Presence of any craniofacial abnormality.
2. Any history of bleeding disorders.
3. Poor oral hygiene.
4. Use of bisphosphonates, analgesics, anti-inflammatory drugs, corticosteroids for more than three months prior to treatment or during treatment.
5. Active diseases such as metabolic bone disease.
6. Malocclusions requiring surgical intervention.
7. Smoker
-
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 14 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rozina Nazir, FCPS
**Phone:** +92 3215376612
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** zainab butt, BDS
**Phone:** +93225667847
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Islamabad
**Country:** Pakistan
**Facility:** Foundation University Islamabad
**State:** Punjab
**Zip:** 04403
### References Module
#### References
**Citation:** 1. Kundi, I., Alam, M. K., & Shaheed, S. (2020). Micro-osteo perforation effects as an intervention on canine retraction. The Saudi dental journal, 32(1), 15-20. https://doi.org/10.1016/j.sdentj.2019.05.009 2. Husain S, Sundari S. Comparison of the effectiveness of piezocision-aided canine retraction augmented with micro-osteoperforation: a randomized controlled trial. Angle Orthod. 2023 Oct 16. doi: 10.2319/052323-370.1. Epub ahead of print. PMID: 37839802. 12 3. Aboalnaga AA, Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split- mouth randomized controlled trial. Prog Orthod. 2019 Jun;20(1) 21. doi:10.1186/s40510-019-0274-0. PMID: 31155698; PMCID: PMC6545296. 4. Bolat Gümüş, E., Kınsız, E. Effects of miniscrew-facilitated micro- osteoperforations on the rate of orthodontic tooth movement. J Orofac Orthop 84 (Suppl 2), 104-110 (2023). 5. Martina K., Kumar P., Misra V., Attri S., Yadav A., Sam R., Kumar R.. To evaluate the rate of canine retraction and pain perception following micro- osteoperforation - a split-mouth clinical study. Australasian Orthodontic Journal. 2022;38(2): 388-395
## 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: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432686
**Brief Title:** Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS
**Official Title:** Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS - a Pilot Study
#### Organization Study ID Info
**ID:** MS-fMRI-TENS
#### Organization
**Class:** OTHER
**Full Name:** University Medical Center Groningen
### Status Module
#### Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Medical Center Groningen
#### 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:** Transcutaneous Electrical Nerve Stimulation (TENS) is a treatment that could potentially reduce walking problems and fatigue in persons with Multiple Sclerosis. However, extensive use of TENS in a clinical setting is hindered by a lack of neurophysiological understanding of the effects of TENS. The primary objective of this pilot study is therefore to investigate the effects of TENS on brain activity in pwMS measured with fMRI.
**Detailed Description:** This study is an exploratory study to see if we can detect changes in fMRI activity during TENS in persons with MS. This is a randomized, single-blind crossover design. Subjects will undergo an MRI scan while they receive sham stimulation of the tibialis anterior, active stimulation of the tibialis anterior, stimulation of the quadriceps, perform continuous movements of the foot (plantar \& dorsiflexion) and a combination of stimulation of the tibialis anterior and movement of the foot. This study will include 15 subjects with relapsing remitting or progressive MS and 15 healthy controls. Blood-oxygen-level-dependent (BOLD) activation changes and the interaction networks before, during and after active TENS and differences in activation due to stimulation on quadriceps vs. tibialis anterior, stimulation on tibialis anterior vs plantar/dorsiflexion and stimulation on tibialis anterior vs stimulation combined with plantar/dorsiflexion. This will be compared between pwMS and healthy controls. This study can add to the limited knowledge and possibly help to personalize and implement TENS in the clinic.
### Conditions Module
**Conditions:**
- Fatigue
- Walking, Difficulty
- Multiple Sclerosis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** * sham stimulation of the tibialis anterior,
* active stimulation of the tibialis anterior,
* active stimulation of the quadriceps,
* continuous movement of the foot (plantar \& dorsiflexion),
* a combination of sham stimulation of the tibialis anterior and movement of the foot,
* a combination of stimulation of the tibialis anterior and movement of the foot.
The order of these conditions is randomized.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** All participants receive both active and sham TENS. Subjects will be told they will get two types of stimulation but they are not being told that one is 'sham' and the other 'active', to minimalize a placebo effect. Researchers are not blinded, but also interacting minimally with the participant while they are lying in the scanner.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Transcutaneous Electrical Nerve Stimulation
**Label:** sham stimulation of the tibialis anterior
**Type:** SHAM_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Device: Transcutaneous Electrical Nerve Stimulation
**Label:** active stimulation of the tibialis anterior
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Device: Transcutaneous Electrical Nerve Stimulation
**Label:** active stimulation of the quadriceps
**Type:** EXPERIMENTAL
#### Arm Group 4
**Intervention Names:**
- Behavioral: Movement
**Label:** continuous movement of the foot (plantar & dorsiflexion)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 5
**Intervention Names:**
- Device: Transcutaneous Electrical Nerve Stimulation
- Behavioral: Movement
**Label:** a combination of sham stimulation of the tibialis anterior and movement of the foot
**Type:** SHAM_COMPARATOR
#### Arm Group 6
**Intervention Names:**
- Device: Transcutaneous Electrical Nerve Stimulation
- Behavioral: Movement
**Label:** a combination of active stimulation of the tibialis anterior and movement of the foot
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- a combination of active stimulation of the tibialis anterior and movement of the foot
- a combination of sham stimulation of the tibialis anterior and movement of the foot
- active stimulation of the quadriceps
- active stimulation of the tibialis anterior
- sham stimulation of the tibialis anterior
**Description:** Transcutaneous electrical nerve stimulation (TENS) is a safe, relatively cheap, and non-painful stimulation of the peripheral sensory and motor nerves. The stimulator is easy to operate and pwMS can apply the stimulation themselves at home. This makes TENS an interesting tool to augment sensory input. A high frequency and long pulse duration is used.
**Name:** Transcutaneous Electrical Nerve Stimulation
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- a combination of active stimulation of the tibialis anterior and movement of the foot
- a combination of sham stimulation of the tibialis anterior and movement of the foot
- continuous movement of the foot (plantar & dorsiflexion)
**Description:** Participants are instructed to perform plantar- and dorsi-flexion contraction in a relatively slow tempo. The movement of the ankle is measured by an MRI-compatible potentiometer and participants receive feedback of this movement on the screen inside the scanner.
**Name:** Movement
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Blood level detection activation (BOLD) changes and interaction networks before, during and after active TENS and differences in activation due to stimulation on quadriceps vs. tibialis anterior, stimulation on tibialis anterior vs plantar/dorsiflexion and stimulation on tibialis anterior vs stimulation combined with plantar/dorsiflexion. We focus on the thalamus (integration station of sensory input), sensory cortex (sensory awareness) and motor cortices (sensorimotor integration).
**Measure:** BOLD activation due to TENS
**Time Frame:** 1 hour fMRI scan
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age: 18-65 years
* EDSS score \< 7
Exclusion Criteria:
* metal or electrical implants
* BMI \> 40
* claustrophobia
* being pregnant
* having a psychiatric disorder
* having cognitive or communication problems which reduces the capacity to understand instructions
* having a neurological disorder other than MS
* having cardiac arrhythmia
**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:** Nikki Dreijer
**Phone:** 0625647172
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Inge Zijdewind
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System 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: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M15415
- Name: Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M26689
- Name: Mobility Limitation
- Relevance: HIGH
- As Found: Walking, Difficulty
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000051346
- Term: Mobility Limitation
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M251057
- Name: TEMPO
- Relevance: LOW
- As Found: Unknown
- ID: M186190
- Name: Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432673
**Acronym:** Attractive 2
**Brief Title:** The Attractive 2 Trial - Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers
**Official Title:** The Attractive 2 Trial - An Open-label, Randomised, 2-period Cross-over Trial to Assess the Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers
#### Organization Study ID Info
**ID:** ATR-258-trial-2
#### Organization
**Class:** INDUSTRY
**Full Name:** Atrogi AB
#### Secondary ID Infos
**ID:** 2023-508797-28-00
**Type:** CTIS
### Status Module
#### Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Atrogi AB
#### 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 single-centre, open-label, randomised, 2-period cross-over, Phase 1 comparative trial to assess the ATR-258 pharmacokinetic (PK) parameters of an oral capsule formulation in comparison with an oral solution formulation, both given as single doses to healthy volunteers. The order of treatment, i.e., the treatment sequence capsule - solution or solution - capsule, will be randomised.
### Conditions Module
**Conditions:**
- Type2diabetes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 21
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receive a single dose of ATR-28 in the order Oral capsule - Oral solution with a washout period in between.
**Intervention Names:**
- Drug: ATR-258 Oral solution
- Drug: ATR-258 Oral capsule
**Label:** Arm 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants receive a single dose of ATR-28 in the order Oral solution - Oral capsule with a washout period in between.
**Intervention Names:**
- Drug: ATR-258 Oral solution
- Drug: ATR-258 Oral capsule
**Label:** Arm 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm 1
- Arm 2
**Description:** Oral solution
**Name:** ATR-258 Oral solution
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Arm 1
- Arm 2
**Description:** Oral capsule
**Name:** ATR-258 Oral capsule
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Area under the plasma concentration versus time curve (AUC)
**Time Frame:** 48 hours
**Measure:** Peak Plasma Concentration (Cmax)
**Time Frame:** 48 hours
#### Secondary Outcomes
**Description:** Tmax
**Measure:** Time to maximum plasma concentration (Tmax)
**Time Frame:** 48 hours
**Measure:** Half life in plasma (T1/2)
**Time Frame:** 48 hours
**Measure:** Apparent total body clearance following extravascular administration (CL/F)
**Time Frame:** 48 hours
**Measure:** Volume of distribution following extravascular administration (Vz/F)
**Time Frame:** 48 hours
**Description:** Frequency, intensity and seriousness of reported adverse events
**Measure:** Adverse events
**Time Frame:** 7 days post last dose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Provision of informed consent
* Body mass index ≥ 18.5 and ≤ 30.0
* Medically healthy participant
* Willing to use of double barrier contraceptive method if of childbearing potential
Exclusion Criteria:
* History or clinical manifestation of any clinically significant disease
* History of dysphagia or any other swallowing disorder
* Current smokers or users of nicotine products
* History or manifestation of drug abuse, alcohol abuse and/or excessive intake of alcohol
**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:** Torbjörn Ström
**Phone:** +468590 745 80
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Uppsala
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Måns Jergil
- **Phone:** +46 18 30 33 00
- **Role:** CONTACT
**Country:** Sweden
**Facility:** Clinical Trial Consultants AB
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Atrogi AB
**Name:** Erik Waara
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### 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: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432660
**Acronym:** PROMPT
**Brief Title:** Eye Plaque Brachytherapy for Ocular Melanoma
**Official Title:** Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT)
#### Organization Study ID Info
**ID:** Pro00115893
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2029-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Duke 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 prospective registry study will evaluate doses utilized in eye plaque brachytherapy for the treatment of ocular melanoma and their associated outcomes. The goal of this study is to evaluate if lower doses of radiation can maintain high local control rates while minimizing the toxicities related to radiation therapy.
### Conditions Module
**Conditions:**
- Ocular Melanoma
**Keywords:**
- eye plaque brachytherapy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 5 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients 18 years of age or older with unilateral primary choroidal melanoma
**Intervention Names:**
- Other: Data collection
**Label:** Ocular Melanoma
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ocular Melanoma
**Description:** Information about radiation therapy via eye plaque brachytherapy and follow up
**Name:** Data collection
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Number of disease free participants expressed as a percentage of the total number of participants enrolled
**Measure:** Percentage of participants with no disease recurrence within the radiation therapy field.
**Time Frame:** 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients 18 years of age or older with unilateral primary choroidal melanoma
* Patients with diagnosis of small or medium ocular melanomas amenable to plaque brachytherapy (as determined by treating ocular oncologist). Typically this would include tumors with apical height ≤10mm and basal diameter ≤16mm (small and medium tumors per COMS (Collaborative Ocular Melanoma Study)
* Patients with no clinical evidence of metastatic disease as confirmed by negative staging imaging (CT, MRI, and/or ultrasound)
* Patients with best-corrected visual acuity in the fellow eye of 20/200 or better
* Patients must be treated with IsoAid Eye Physics eye plaques
Exclusion Criteria:
* Patients whose tumors are circumferential around the optic disc and cannot be adequately covered by the prescription dose are ineligible.
* Similarly, patients with extrascleral tumor extension detected during echography or clinical exam, diffuse, ring or multifocal tumors that cannot be encompassed in a single episcleral plaque or tumors judged to be predominantly ciliary body or iris melanoma will be considered ineligible
* Previous treatment for ocular melanoma in either eye or treatment of any condition secondary to the tumor are ineligible.
* Patients with a history of other primary or metastatic cancers are not eligible, except for non-melanotic skin cancers
* Patients with extraocular disease
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population will include adult patients seen at the Duke Eye Center and/or Duke Department of Radiation Oncology who meet the eligibility criteria.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Joan Cahill, BNS RN OCN
**Phone:** (919) 668-5211
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Duke University Health System (DUHS)
**Name:** Dianda Ayala-Peacock, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Meltsner SG, Rodrigues A, Materin MA, Kirsch DG, Craciunescu O. Transitioning from a COMS-based plaque brachytherapy program to using eye physics plaques and plaque simulator treatment planning system: A single institutional experience. J Appl Clin Med Phys. 2023 May;24(5):e13902. doi: 10.1002/acm2.13902. Epub 2023 Jan 13.
**PMID:** 36637797
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018358
- Term: Neuroendocrine Tumors
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
- ID: D000018326
- Term: Nevi and Melanomas
- ID: D000012878
- Term: Skin Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11528
- Name: Melanoma
- Relevance: HIGH
- As Found: Melanoma
- 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: 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: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M12448
- Name: Nevus, Pigmented
- Relevance: LOW
- As Found: Unknown
- ID: M12446
- Name: Nevus
- Relevance: LOW
- As Found: Unknown
- ID: M20470
- Name: Nevi and Melanomas
- Relevance: LOW
- As Found: Unknown
- ID: M15681
- Name: Skin Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4192
- Name: Ocular Melanoma
- Relevance: HIGH
- As Found: Ocular Melanoma
- ID: T4091
- Name: Neuroendocrine Tumor
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008545
- Term: Melanoma
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432647
**Brief Title:** A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105
**Official Title:** ATH-1105 A Phase 1, Double-Blind, Placebo-Controlled, Single-and-Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Male and Female Subjects
#### Organization Study ID Info
**ID:** ATH-1105-0101
#### Organization
**Class:** INDUSTRY
**Full Name:** Athira Pharma
### Status Module
#### Completion Date
**Date:** 2024-10-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Fortrea Holdings, Inc.
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Athira Pharma
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.
**Detailed Description:** The study is a Phase 1, First-In-Human study consisting of two parts (A and B). Part A will comprise a single-dose, double-blind, placebo-controlled, sequential-group design. Part B will comprise a multiple-dose, placebo-controlled, sequential-group design.
### Conditions Module
**Conditions:**
- Healthy Volunteers
**Keywords:**
- ATH-1105
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Part A: ATH-1105 administered once as an oral solution.
Part B: ATH-1105 administered once daily as an oral solution for 10 days.
**Intervention Names:**
- Drug: ATH-1105
**Label:** ATH-1105
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Part A: Placebo administered once as an oral solution
Part B: Placebo administered once daily as an oral solution
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ATH-1105
**Description:** ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B.
**Name:** ATH-1105
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Safety and tolerability of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG
**Measure:** Incidence of Treatment-Emergent Adverse Events
**Time Frame:** Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
**Description:** Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator.
**Measure:** Severity of Treatment-Emergent Adverse Events
**Time Frame:** Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
#### Secondary Outcomes
**Description:** AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
**Measure:** Area under the plasma concentration time curve (AUC)
**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
**Description:** Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
**Measure:** Maximum observed plasma concentration (Cmax)
**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
**Description:** Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
**Measure:** Time to maximum observed plasma concentration (Tmax)
**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
**Description:** t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
**Measure:** Half-life (t1/2)
**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
**Description:** Amount of IMP excreted unchanged in the urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose
**Measure:** Amount of IMP excreted unchanged in the urine (Ae)
**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
**Description:** Amount of IMP in the urine will be determined from all collected CSF samples from baseline through up to 48 hours post-dose
**Measure:** IMP Concentration in Cerebrospinal Fluid
**Time Frame:** Will occur at calculated maximum plasma concentration.
**Description:** Accumulation Ratio in urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose
**Measure:** Accumulation Ratio (AUC) of IMP in Urine
**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
**Description:** Accumulation Ratio in plasma will be determined from all collected plasma samples from baseline through up to 48 hours post-dose
**Measure:** Accumulation Ratio (AUC) of IMP in Plasma
**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Body mass index between 18.0 and 32.0 kg/m2 inclusive.
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check-in or predose on Day 1
* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion Criteria:
Medical Conditions:
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Any of the following:
1. QTcF \>450 ms in males or \>470 ms in females
2. QRS duration \>110 ms
3. PR interval \>220 ms
4. Findings which would make QTc measurements difficult or QTc data uninterpretable.
5. History of additional risk factors for torsades de pointes
* Confirmed systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, and pulse rate \>100 or \<40 beats per minute.
* Positive hepatitis panel and/or positive human immunodeficiency virus test
* Part B only: Current psychiatric disorder, suicidal ideation in the previous 2 years (as assessed by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or a lifetime suicide attempt.
Prior/concomitant therapy:
* Administration of any vaccine in the 30 days prior to dosing.
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes
* Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing
* Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in
* Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in
**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:** Javier San Martin, MD
**Phone:** 425-620-8501
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dallas
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jhande Gardiner
- **Phone:** 214-647-9399
- **Role:** CONTACT
***Contact 2:***
- **Name:** Adeyemi Gbohunmi, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Fortrea Clinical Research Unit Inc.
**State:** Texas
**Status:** RECRUITING
**Zip:** 75247
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432634
**Acronym:** CPRP
**Brief Title:** Effects of CPRP on Patients Undergoing Lung Resection
**Official Title:** Effects of Comprehensive Pulmonary Rehabilitation Programs (CPRP) on Patients Undergoing Lung Resection: a Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 202400512B0
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2027-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chang Gung Memorial Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this project is to investigate the effectiveness of implementing a Comprehensive Pulmonary Rehabilitation Program (CPRP) in patients undergoing lung resection surgery. The CPRP encompasses a training regimen combining aerobic exercise, resistance exercises, breathing exercises, and home activities, specifically tailored for patients with limited exercise capacity and impaired lung function. The study seeks to understand the physiological and biological effects of the CPRP in this patient population.
**Detailed Description:** Background: Elderly patients with compromised lung function or poor health conditions undergoing lung resection surgery face an increased risk of postoperative pulmonary complications. Pulmonary rehabilitation programs play a crucial role in enhancing recovery after surgery, having been shown to reduce postoperative pulmonary complications and enhance patients' pre- and post-operative exercise capacity, functional performance, and quality of life. However, due to the heterogeneity of interventions in pulmonary rehabilitation programs, the optimal timing, methods, or duration of exercise training for lung resection patients remain unclear. Additionally, there is a lack of comprehensive research on the changes and impacts of biomarkers in the blood of lung resection patients following intervention with pulmonary rehabilitation programs.
Objectives: This study aims to investigate the physiological and biological effects of a comprehensive pulmonary rehabilitation program in lung resection surgery patients with limited exercise capacity and impaired lung function.
Research Methods: This study adopts an open label, randomized, parallel design, intending to recruit 96 lung resection surgery participants divided into a control group receiving standard care and an experimental group receiving the comprehensive pulmonary rehabilitation programs. The intervention period spans 1-2 weeks pre-surgery, during hospitalization, and 3-6 weeks post-discharge. Participants will undergo four assessments at randomization (baseline, T0), one day pre-surgery (T1), the day of discharge post-surgery (T2), and at trial completion (T3). The primary endpoint is the six-minute walk test. Secondary endpoints include lung function, lung expansion volume, respiratory muscle strength, incidence of postoperative complications and pulmonary complications, chest tube duration, length of hospital stay, quality of life (EORTC QLQ-C30), and pain. Exploratory endpoints involve inflammation-related and immune-related biomarkers.
Expected Impact: This study will provide valuable insights into the physiological and biological effects of a comprehensive pulmonary rehabilitation programs for lung resection surgery patients. Results may contribute to improving patient outcomes and advancing academic understanding and clinical guidelines in this field.
### Conditions Module
**Conditions:**
- Rehabilitation
**Keywords:**
- lung resection surgery
- comprehensive pulmonary rehabilitation programs
- six-minute walk test
- quality of life
- biomarkers
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Masking Description:** The blinding of patients to their treatment group allocation is unattainable owing to the inherent nature of the exercise intervention.
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 96
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants randomize to the standard care group (SC) receive the standard care already established in Chiayi Chang Gung Memorial Hospital. Standard care comprises one therapeutic education session conducted by a respiratory therapist 1-2 weeks before surgery.
**Intervention Names:**
- Other: Standard care
**Label:** standard care group
**Type:** SHAM_COMPARATOR
#### Arm Group 2
**Description:** Participants randomize to the comprehensive pulmonary rehabilitation program group (CPRP) undergo an evidence-based and hospital-based comprehensive pulmonary rehabilitation program developed by the research group. This program is administered in addition to the standard care provided and spans across the preoperative, peri-operative, and postoperative periods, covering a total of 1-2 weeks preoperatively and 3-6 weeks postoperatively. CPRP involves warm-up and cool-down exercises, the aerobic training, and the resistance training. Additionally, participants are encouraged to continue exercising at home or in community sports facilities.
**Intervention Names:**
- Other: Standard care
- Other: Comprehensive pulmonary rehabilitation programs
**Label:** comprehensive pulmonary rehabilitation program group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- comprehensive pulmonary rehabilitation program group
- standard care group
**Description:** The pre-operative educational session has a duration of 40 minutes and covers pre-operative education, breathing exercises (diaphragmatic breathing, deep breathing techniques and sustained maximal inflation), and airway clearance techniques (directed cough, huffing, and chest physiotherapy). Patients are instructed to perform these techniques ten times per waking hour, every day. The in-patient peri-operative session incorporates intermittent positive pressure breathing inhalation (IPPB) administered for 15 minutes twice daily. Inhalation therapy involving mucolytics and bronchodilators is administered three times per day, and early mobilization is encouraged until discharge. Upon discharge, participants are encouraged to continue practicing breathing exercises, deep breathing techniques, and maintaining an active level of activity.
**Name:** Standard care
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- comprehensive pulmonary rehabilitation program group
**Description:** 1. Warm-up and cool-down exercises: stretching various muscle groups for a duration of 15 to 20 minutes and a slow 3-minute walk
2. Aerobic training: using a lower-limb cycle ergometer for a duration of 30 to 40 minutes. Initiated warm-up at 0 wattages for 5 minutes. Incrementally increased wattages within 5-10 minutes until reaching the 40-80% heart rate reserve or 4 to 6 of modified Borg scale for at least 20 minutes. Concludes with a 5-minute cool-down period at 10 wattages.
3. The resistance training involves both upper and lower limbs:
（1） Upper Limb Resistance Training: Shoulder lift, abduction, and horizontal abduction exercises are performed. Each exercise is repeated for three sessions comprising 10 repetitions each. A 0.5-2 kg dumbbell is utilized for resistance.
（2） Lower Limb Resistance Training: Sit-to-stand exercises are performed. Each session consists of three sets of 10 repetitions.
**Name:** Comprehensive pulmonary rehabilitation programs
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), C reactive protein (CRP), Surfactant Protein-D (SP-D), Granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-1 beta, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12 p70, IL-13, IL-18, tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma
**Measure:** inflammation-related and immune-related biomarkers
**Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
#### Primary Outcomes
**Description:** Six-minute walk test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance.
**Measure:** Six-minute walk distance (6MWD)
**Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
#### Secondary Outcomes
**Description:** Using spirometry to measure pulmonary function parameters.
**Measure:** Pulmonary function test
**Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
**Description:** Measurement of respiratory muscle strength includes maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), which assess the force exerted by muscles during maximal inspiratory and expiratory efforts, respectively. During the test, the subject sits and uses a mouthpiece connected to an electronic pressure gauge while wearing a nose clip to prevent air leakage. For MIP, the subject starts from residual volume and performs a maximal inspiratory effort. For MEP, the subject starts from total lung capacity and performs a maximal expiratory effort. The highest value from three measurements is recorded as the test result.
**Measure:** Respiratory muscle strength
**Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
**Description:** Length of hospital stay
**Measure:** Length of hospital stay (LoS)
**Time Frame:** an average of post-surgery 2 weeks
**Description:** Duration of chest-tube insertion
**Measure:** Duration of chest-tube insertion
**Time Frame:** an average of post-surgery 2 weeks
**Description:** The Numerical Rating Scale (NRS) is a commonly used clinical tool for assessing pain intensity, ranging from 0 to 10 to represent varying degrees of pain. It is scored from 0-10 (0 meaning no pain and 10 meaning the worst pain.
**Measure:** Numerical Rating Scale (NRS)
**Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
**Description:** The EORTC QLQ-C30 is designed to assess health-related quality of life in cancer patients, consisting of 30 items. It includes five functional scales: cognitive (2 items), emotional (4 items), physical (5 items), role (2 items), and social (2 items) functions. Symptom scales cover fatigue (3 items), nausea/vomiting (2 items), and pain (2 items). Single items assess appetite loss, constipation, diarrhea, dyspnea, sleep disturbances, and financial difficulties. Additionally, two items evaluate overall health status/quality of life. Each item is equally weighted, with scores linearly transformed to a 0-100 scale. For functional scales and overall health status/quality of life, higher scores indicate better function or quality of life, whereas higher scores on symptom scales denote more severe symptoms or problems.
**Measure:** European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30, version 3, Chinese Mandarin (Taiwan))
**Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
**Description:** Postoperative complications (POCs) and postoperative pulmonary complications (PPCs)
**Measure:** Postoperative complications (POCs) and postoperative pulmonary complications (PPCs)
**Time Frame:** an average of post-surgery 2 weeks
**Description:** measured by volume-oriented incentive spirometry
**Measure:** Lung expansion volume
**Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults (age ≥ 20 years old)
* Receiving lung resection surgery
* At least one of the following:
6MWD \< 500 meters, oxygen saturation by pulse oximetry (SpO2) drop ≥ 4% or SpO2\< 90% during 6MWT, pre-operative FEV1 or FVC ≤ 80% of predicted value or FEV1/FVC ratio ≤ 0.7
* Able to walk autonomously without mobility aids
* Written informed consent
Exclusion Criteria:
* Neoadjuvant therapy with chemo- or radiotherapy in the six months prior to surgery
* Received pulmonary rehabilitation programs six months prior to surgery
* Previous lung resection
* Inability to perform the exercise training
* Instability in cardiovascular disease, neurological disorders, or musculoskeletal conditions
* Have cognitive deficits with potential severe impact on compliance
* Do not provide written informed consent
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chun-Jung Chang
**Phone:** +886 5 362-1000
**Phone Ext:** 2597
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Chang Gung Memorial Hospital
**Name:** Chun-Jung Chang
**Role:** PRINCIPAL_INVESTIGATOR
### 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
### Intervention Browse Module - Browse Branches
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M8243
- Name: Expectorants
- Relevance: LOW
- As Found: Unknown
- ID: M5269
- Name: Bronchodilator Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432621
**Brief Title:** Role of Sugammadex and Neostigmine for Recovery From Rocuronium
**Official Title:** Sugammadex Versus Neostigmine for Recovery of Respiratory Muscle Strength Measured by Ultrasonography in the Postextubation Period in Laparoscopic Cholecystectomy
#### Organization Study ID Info
**ID:** MD201/2023
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-19
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** Ahmed wagih Ezzat deusouky
**Investigator Title:** lecturer of anasthesia,intensive care and pain management
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** evaluation the reversal of neuromuscular blocking by sugammadex versus neostigmine through assessing the residual neuromuscular blocking effect by ultrasound imaging of expiratory muscle strength and diaphragmatic excursion.
**Detailed Description:** All patients will be assessed preoperatively by careful history taking (history of allergy to rocuronium, neostigmine, or sugammadex), full medical history taking , ASA classification and surgical history Premedication with 2mg midazolam. Anesthesia will be induced with propofol 1-2 mg /kg and fentanyl 1-2 mic/kg. After calibration of TOF (train of four) rocuronium 0.6 mg/kg will be administered, and tracheal intubation will be performed in the absence of train-of four (TOF) count. Rocuronium 0.15mg/kg and Sevoflurane will be used for maintenance of anesthesia.
At the end of the surgery, patients in group A will receive sugammadex (2 mg/kg) and patients in group B will receive neostigmine (50 μg/kg, maximum 5 mg) combined with atropine (25 μg/kg, maximum 2.5 mg) after TOF counts at least exceeding 1 and extubation will be performed in the operating room when the patient is fully awake and fulfilled clinical criteria for extubation.
Diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography.
### Conditions Module
**Conditions:**
- Anesthesia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients who will receive sugammadex for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.
**Intervention Names:**
- Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation
**Label:** Group S
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** patients who will receive neostigmine for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.
**Intervention Names:**
- Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation
**Label:** Group N
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group N
- Group S
**Description:** patients will be randomly divided into two groups using a computer generated random number chart. Group S will receive sugammadex for reversal of rocuronium, whereas Group N will receive neostigmine for reversal of rocuronium using nerve stimulation and ultrasound to asses recovery of respiratory muscle
**Name:** using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** complete recovery of skeletal muscle assesed by train of four and diaghragmatic excursion by ultrasuond automatically recorded utilizing the TOF monitoring TFIO and diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography (Sonosite M-Turbo) at 3 predefined time points: before induction (baseline levels), TOFR ≥0.9 (postextubation), and after 30 minutes in the PACU.
**Measure:** effect of sugammadex and neostigmine on reversal of rocuronium
**Time Frame:** 4 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with American Society of Anesthesiology (ASA) physical status classification I and II
Exclusion Criteria:
* 1. American Society of Anesthesiology (ASA) physical status classification III-V 2. renal impairment 3. Significant liver disease (Child-Pugh B or C class) 4. History of chronic obstructive pulmonary disease 5. Known or suspected neuromuscular disease. 6. Cardiac arrhythmia or use of antiarrhythmic drugs.
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Faculty of Medicine, Ain Shams University
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000003473
- Term: Neuromuscular Nondepolarizing Agents
- ID: D000009466
- Term: Neuromuscular Blocking Agents
- ID: D000009465
- Term: Neuromuscular Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000002800
- Term: Cholinesterase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018678
- Term: Cholinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000010277
- Term: Parasympathomimetics
- ID: D000001337
- Term: Autonomic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12333
- Name: Neostigmine
- Relevance: HIGH
- As Found: Head and Neck Cancer
- ID: M1666
- Name: Rocuronium
- Relevance: HIGH
- As Found: Soft tissue
- ID: M6684
- Name: Neuromuscular Nondepolarizing Agents
- Relevance: LOW
- As Found: Unknown
- ID: M12409
- Name: Neuromuscular Blocking Agents
- Relevance: LOW
- As Found: Unknown
- ID: M6040
- Name: Cholinesterase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M20758
- Name: Cholinergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077123
- Term: Rocuronium
- ID: D000009388
- Term: Neostigmine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432608
**Acronym:** FC
**Brief Title:** Efficacy of Lacticaseibacillus Paracasei Strain Shirota on Clinical Manifestation of Functional Constipation in Mexican Adults
**Official Title:** Single Arm Study to Evaluate the Efficacy of Lacticaseibacillus Paracasei Strain Shirota (Formerly Lactobacillus Casei Strain Shirota) Fermented Milk (Yakult®) on the Maintenance of Clinical Manifestations of Functional Constipation in Mexican Adults
#### Organization Study ID Info
**ID:** UDG-FC-2024
#### Organization
**Class:** OTHER
**Full Name:** University of Guadalajara
### Status Module
#### Completion Date
**Date:** 2025-11-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Yakult Honsha Co., LTD
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Guadalajara
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Chronic functional constipation is a gastrointestinal disorder with an approximate prevalence of 14% of the Mexican population, which is characterized by difficult or incomplete defecation and/or infrequent bowel movements, with the absence of symptoms such as abdominal pain or inflammation, and in If they occur, they should not be the predominant symptoms. Its origin is multifactorial and includes variables such as diet, water consumption, alteration in motility, and intestinal microbiota, the latter as a source of different secondary metabolites such as short-chain fatty acids (SCFAs).
Lower SCFA values in constipation would alter the relationship between them, increasing the risk of clinical manifestations of functional chronic constipation. In addition to physical discomfort, subjects with this disease manifest alterations in their quality of life.
Recent studies have suggested using probiotic microorganisms to treat this functional disorder due to their beneficial effects on evacuation frequency, SCFAs, and quality of life. However, in Mexico, knowledge of the above is limited. Therefore, this research aims to determine the effect of consuming a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota on the clinical manifestations of functional constipation in Mexican adults and its relationship with SCFAs.
**Detailed Description:** 1. Background
Constipation is an intestinal disorder characterized by difficulty defecating, infrequent bowel movements, hard or lumpy stools, excessive straining, a feeling of incomplete evacuation, and, in some cases, the use of manual techniques to facilitate evacuation.
Due to its presentation time, constipation is classified as acute or chronic. The acute one lasts less than a week and is commonly determined by a change in diet and/or lifestyle (low fiber intake, decreased physical activity, stress, going to the bathroom in an unknown place, etc.). For its part, the symptoms of chronic illness have occurred over three to six months. Chronic constipation is among the most common gastrointestinal conditions, usually primary or secondary. The first is a consequence of multiple pathophysiological alterations, such as alteration of colonic regulation, lack of coordination of the neuromuscular apparatus, and dysfunction of the brain-gut axis. In turn, secondary chronic constipation can be caused by drugs, neurological disorders, anatomical processes, or metabolic diseases.
Chronic constipation is defined "from a clinical point of view, chronic constipation is considered secondary when it is a consequence of metabolic, neurological alterations, structural lesions or medications. When other causes have been excluded, it is considered primary, idiopathic, or functional constipation" (FD).
1.1. Clinical manifestations
Chronic constipation is a functional gastrointestinal disorder with a prevalence of 3 to 27%, mainly among women and older adults. Approximately 1 in 6 individuals experience chronic constipation. The Mexican Consensus on chronic constipation mentions a prevalence of 14.4% in Mexicans, while other studies carried out in the country have reported a prevalence between 2.4 and 22.3%.
This pathology is considered a syndrome with different symptoms that are expressed variably. For this reason, the ROMA (Rome Foundation for Functional Gastrointestinal Problems) criteria have been used to diagnose functional chronic constipation. In 2016, the ROMA criteria updated their guidelines, currently in version IV, and included eight categories: A) esophageal disorders; B) gastroduodenal disorders; C) intestinal disorders; D) gastrointestinal pain of centrally median disorders; E) disorders of the sphincter of Oddi and the gallbladder; F) anorectal disorders; G) functional gastrointestinal disorders of childhood and G) functional gastrointestinal disorders of adolescence. Functional intestinal disorders are defined by these criteria, which allow us to differentiate the symptoms of patients with chronic functional constipation from those with similar clinical conditions, such as irritable bowel syndrome.
In the ROME IV criteria, chronic functional constipation is a disorder characterized by persistent or incomplete difficult defecation and/or infrequent bowel movements without symptoms such as abdominal pain and/or inflammation or, if present, that are not the predominant symptoms. The Bristol scale supports the criteria in which grades 1 and 2 correspond to constipation and correlate with prolonged intestinal transit.
1.2. Constipation and short-chain fatty acids
Chronic constipation is a multifactorial process influenced by diet, stool volume, water content, and intestinal microbiota. In recent years, it has been considered that alterations in the balance of the intestinal microbiota may influence the clinical manifestations of chronic constipation. It has been reported that the intestinal microbiota of constipated patients differs from that of healthy adults and children, with a decrease in the genera Lactobacillus and Bifidobacterium. Studies with gnotobiotic animals and in vitro have suggested that the intestinal microbiota influences intestinal motility, the integrity of the intestinal barrier, the modulation of colonic pH, and the immune or nervous response through the production of short-chain fatty acids: butyrate, propionate, and acetate.
1.3. Constipation and probiotics
Patients with constipation usually have a prolonged intestinal transit time compared to healthy subjects, decreasing evacuation frequency and stool consistency. To achieve this, laxatives, dietary fiber supplements, and the prescription of some drugs are used as treatment. However, in recent years, the use of probiotics has been considered due to the impact of their consumption on the intestinal microbiota/metabolites and, in turn, on gastric motility.
It has been reported that consuming 10\^8 to 3 x 10\^10 CFU per day of specific probiotic strains improves intestinal transit, increases evacuation frequency, and improves symptoms related to constipation. Studies with Lacticaseibacillus paracasei strain Shirota (LcS) in the Chinese population showed improvement in the frequency and consistency of fecal matter and reduced intestinal discomfort. The intake of probiotics improves intestinal transit and increases the levels of organic acids that promote peristalsis. It also increases the Bifidobacterium and Lactobacillus genera, which are usually in lower abundance in constipation. Probiotics could not only directly improve intestinal discomfort but also through the formation of secondary metabolites of the intestinal microbiota, such as short-chain fatty acids.
Therefore, probiotics such as Lacticaseibacillus paracasei strain Shirota have begun to be studied in murine models and in the Asian population as a non-pharmacological alternative for functional chronic constipation. However, its effect on the Mexican population with constipation requires more evidence, as does the relationship between the intake of probiotics in functional constipation and short-chain fatty acids.
2. General objective:
To evaluate the efficiency of Lacticaseibacillus paracasei strain Shirota Shirota (formerly Lactobacillus casei strain Shirota) in fermented milk (Yakult®) on the maintenance of the clinical manifestations of functional constipation in Mexican adults.
3. Hypothesis:
The consumption of a product based on milk fermented with Lacticaseibacillus paracasei strain Shirota, has an effect on the maintenance of the clinical manifestations of functional constipation in Mexican adults.
4. Methodology:
An original longitudinal, analytical, and prospective quasi-experimental study in adults diagnosed with functional chronic constipation under the ROME IV criteria is planned. The study will provide a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota for four weeks. Before consuming the product, a baseline analysis of SCFAs will be carried out in fecal matter. As part of the techniques and procedures, height and weight will be measured using the ISAK methodology to obtain the body mass index (BMI). Meanwhile, the clinical manifestations of evacuation frequency and consistency of fecal matter will be evaluated, considering the ROME IV criteria, with visual support from the Bristol and symptom severity scales. The analysis of short-chain fatty acids will be done by gas chromatography, whose signal will be compared with an internal standard.
### Conditions Module
**Conditions:**
- Constipation
**Keywords:**
- functional constipation
- clinical manifestation
- mexican
- short fatty acids
- Lacticaseibacillus paracasei strain Shirota
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Original longitudinal, analytical, and prospective quasi-experimental study in adults diagnosed with functional chronic constipation under the ROME IV criteria. The study will provide a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota for 4 weeks.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The single arm contemplates providing the study subjects diagnosed with functional constipation with a product based on fermented milk (80mL) daily for 4 weeks.
**Intervention Names:**
- Dietary Supplement: fermented milk, Yakult
**Label:** Experimental group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group
**Description:** Study subjects will be provided with a product based on fermented milk, Yakult (80mL) daily for four weeks in order to know the effects of clinical manifestation of functional constipation and short-fatty acids in the Mexican population
**Name:** fermented milk, Yakult
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Clinical manifestation will be measure by Bristol scale (1-2 hard stools; 3-4 normal; 4-5 soft stools), Frequency of bowel movements will be obtained by the question of how many times per week have defecated, meanwhile severity of symptoms related to constipation will include indicators of difficulty passing stool, pain, and feeling of incomplete evacuation on a 4-point scale (1, none; 2, a little; 3, some; and 4, a lot)
**Measure:** Clinical manifestation of functional constipation
**Time Frame:** 2 months
#### Secondary Outcomes
**Description:** The short chain fatty acids acetate, butyrate and propionate will be analyzed from the fecal material sample. Fatty acids will be measured by gas chromatography equipped with a flame ionization detector and a MEGA-ACID (FFAD) chromatographic column of 30.0m length, with internal diameter: 0.25 ID, thickness: 0.40 µm and 3µL injector. Samples will be analyzed by chromatographic method through the MEGA-ACID column, with an injection of 3 µL and whose injection mode is Split 1:25. The column flow will be 3.0 mL/min, in 29 min at 250°C, with a gas flow of N2 30.0mL/min, H2 40mL/min, Air 400 mL/min. The signal ratio (peak area ratio) of the short chain fatty acid compared to internal standards: acetic acid (71251 Sigma-Aldrich), propionic acid (94425 Sigma-Aldrich), butyric acid (19215 Sigma-Aldrich); in a range of 3.13-400ppm. It will later be corrected by the relative correction factor. The above will be used to calculate the concentration of the short chain fatty acid.
**Measure:** Analysis of short-chain fatty acids
**Time Frame:** 2 months
**Description:** Height (mt) it will be recorded which technique extension requires the subject to stand with the feet apart at a 45° angle and the heels together, the posterior aspect of the buttocks and the upper back resting on the stadiometer.The head should be in the Frankfort plane. The subject is asked to take a deep breath and hold it, The scorer places the square triangular piece firmly over the vertex, squeezing the hair as tightly as possible. The measurement is taken at the end of a deep breath.
**Measure:** Height
**Time Frame:** 2 months
**Description:** Body weight (kg) will be checked that the scale is in the zero register. Then the subject stands in the center of it without support and with the weight distributed evenly between both feet. The head should be elevated and the eyes looking directly forward.
**Measure:** Body weight
**Time Frame:** 2 months
**Description:** The body mass index (BMI) will be calculated by dividing the weight, previously obtained from the person evaluated, by the squared height (mt). BMI will be reported in categories: \<18.5, 18.5 - 24.9, 25-29.9 and \>30
**Measure:** Body Mass Index (BMI)
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Men and women between 20 and 60 years old, diagnosed with functional chronic constipation (according to the Rome IV criteria).
* Men and women who have given informed consent.
Exclusion Criteria:
* Constipation due to neurological, pharmacological or organic causes.
* Pregnancy or pregnancy expected within the next month.
* Breastfeeding women.
* Diagnosed pathologies such as: diabetes mellitus, kidney or liver failure, infectious disease, inflammatory disease or any neoplastic disease.
* Use of laxatives within 14 days prior to the start of the intervention.
* Use of antibiotics within 14 days prior to the start of the intervention.
* Diagnosis of cancer in the last three years.
* History of drug and medication abuse.
* Active alcoholism with a daily intake greater than 50 g/day.
* Lactose intolerance.
* Known allergies to any substance in the study product (e.g., cow's milk proteins).
* Any subject who needs manual maneuvers to evacuate feces.
* Anticipated major changes in diet or exercise during the study period.
* Eating disorders.
* Participation in another study with any investigational product within 3 months prior to enrollment.
* Regular Yakult consumers
* Subject who does not have the capacity to consent.
**Maximum Age:** 60 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Angélica Villarruel, PhD
**Phone:** 52 (33) 1378 5900
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Guadalajara
**Name:** Ma.Refugio Torres Vitela, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** This is a project that involves data about patent
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Aziz I, Whitehead WE, Palsson OS, Tornblom H, Simren M. An approach to the diagnosis and management of Rome IV functional disorders of chronic constipation. Expert Rev Gastroenterol Hepatol. 2020 Jan;14(1):39-46. doi: 10.1080/17474124.2020.1708718. Epub 2020 Jan 2.
**PMID:** 31893959
**Citation:** Araujo MM, Botelho PB. Probiotics, prebiotics, and synbiotics in chronic constipation: Outstanding aspects to be considered for the current evidence. Front Nutr. 2022 Dec 8;9:935830. doi: 10.3389/fnut.2022.935830. eCollection 2022.
**PMID:** 36570175
**Citation:** Chen S, Ou Y, Zhao L, Li Y, Qiao Z, Hao Y, Ren F. Differential Effects of Lactobacillus casei Strain Shirota on Patients With Constipation Regarding Stool Consistency in China. J Neurogastroenterol Motil. 2019 Jan 31;25(1):148-158. doi: 10.5056/jnm17085.
**PMID:** 30646486
**Citation:** Cheng Y, Liu J, Ling Z. Short-chain fatty acids-producing probiotics: A novel source of psychobiotics. Crit Rev Food Sci Nutr. 2022;62(28):7929-7959. doi: 10.1080/10408398.2021.1920884. Epub 2021 May 6.
**PMID:** 33955288
**Citation:** Dimidi E, Christodoulides S, Fragkos KC, Scott SM, Whelan K. The effect of probiotics on functional constipation in adults: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2014 Oct;100(4):1075-84. doi: 10.3945/ajcn.114.089151. Epub 2014 Aug 6.
**PMID:** 25099542
**Citation:** Forootan M, Bagheri N, Darvishi M. Chronic constipation: A review of literature. Medicine (Baltimore). 2018 May;97(20):e10631. doi: 10.1097/MD.0000000000010631.
**PMID:** 29768326
**Citation:** Lange O, Proczko-Stepaniak M, Mika A. Short-Chain Fatty Acids-A Product of the Microbiome and Its Participation in Two-Way Communication on the Microbiome-Host Mammal Line. Curr Obes Rep. 2023 Jun;12(2):108-126. doi: 10.1007/s13679-023-00503-6. Epub 2023 May 19.
**PMID:** 37208544
**Citation:** Markowiak-Kopec P, Slizewska K. The Effect of Probiotics on the Production of Short-Chain Fatty Acids by Human Intestinal Microbiome. Nutrients. 2020 Apr 16;12(4):1107. doi: 10.3390/nu12041107.
**PMID:** 32316181
**Citation:** Morrison DJ, Preston T. Formation of short chain fatty acids by the gut microbiota and their impact on human metabolism. Gut Microbes. 2016 May 3;7(3):189-200. doi: 10.1080/19490976.2015.1134082. Epub 2016 Mar 10.
**PMID:** 26963409
**Citation:** Simren M, Palsson OS, Whitehead WE. Update on Rome IV Criteria for Colorectal Disorders: Implications for Clinical Practice. Curr Gastroenterol Rep. 2017 Apr;19(4):15. doi: 10.1007/s11894-017-0554-0.
**PMID:** 28374308
**Citation:** Schmulson Wasserman M, Francisconi C, Olden K, Aguilar Paiz L, Bustos-Fernandez L, Cohen H, Passos MC, Gonzalez-Martinez MA, Iade B, Iantorno G, Ledesma Ginatta C, Lopez-Colombo A, Perez CL, Madrid-Silva AM, Quilici F, Quintero Samudio I, Rodriguez Varon A, Suazo J, Valenzuela J, Zolezzi A. [The Latin-American Consensus on Chronic Constipation]. Gastroenterol Hepatol. 2008 Feb;31(2):59-74. doi: 10.1157/13116072. Spanish.
**PMID:** 18279643
**Citation:** Yuan F, Tan W, Ren H, Yan L, Wang Y, Luo H. The Effects of Short-Chain Fatty Acids on Rat Colonic Hypermotility Induced by Water Avoidance Stress. Drug Des Devel Ther. 2020 Nov 2;14:4671-4684. doi: 10.2147/DDDT.S246619. eCollection 2020.
**PMID:** 33173277
**Citation:** Zhuang M, Shang W, Ma Q, Strappe P, Zhou Z. Abundance of Probiotics and Butyrate-Production Microbiome Manages Constipation via Short-Chain Fatty Acids Production and Hormones Secretion. Mol Nutr Food Res. 2019 Dec;63(23):e1801187. doi: 10.1002/mnfr.201801187. Epub 2019 Oct 22.
**PMID:** 31556210
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M6472
- Name: Constipation
- Relevance: HIGH
- As Found: Constipation
- ID: M15974
- Name: Sprains and Strains
- Relevance: HIGH
- As Found: Strain
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003248
- Term: Constipation
- ID: D000013180
- Term: Sprains and Strains
### 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: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432595
**Brief Title:** Effect of Instability Resistance Training on Balance, Core Muscle Strength, and Athletic Performance
**Official Title:** Effect of Instability Resistance Training on Balance, Core Muscle Strength, and Athletic Performance Among Young Male Chinese Kayak Canoeists
#### Organization Study ID Info
**ID:** JKEUPM-2023-256
#### Organization
**Class:** OTHER
**Full Name:** Universiti Putra Malaysia
### Status Module
#### Completion Date
**Date:** 2023-09-22
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-09-22
**Type:** ACTUAL
#### Start Date
**Date:** 2023-06-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-07
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universiti Putra Malaysia
#### Responsible Party
**Investigator Affiliation:** Universiti Putra Malaysia
**Investigator Full Name:** Jianxin Gao
**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 experimental study is to examine the effect of instability resistance training (IRT) on balance ability, core muscle strength, and athletic performance of young Chinese male kayak canoeists. The main questions it aims to answer are:
Do the IRT and TRT methods have any effect on the subject's balance ability in terms of static balance and dynamic balance? Do the IRT and TRT methods have any effect on the subject's isometric strength of the core muscle group in terms of abdomen, back, left lateral, and right lateral? Do the IRT and TRT methods have any effect on the subject's isotonic strength of the core muscle group in terms of flexion, extension, left lateral flexion, and right lateral flexion? Do the IRT and TRT methods have any effect on the subject's athletic performance in terms of dynamometer performance and calm-water performance?
Researchers will compare the effect of instability resistance training (IRT) and traditional resistance training (TRT) on balance ability, core muscle strength, and athletic performance of young Chinese male kayak canoeists.
Participants will:
Take 12-week instability resistance training (IRT) and traditional resistance training (TRT) difficulty level (primary level 1-4 weeks, intermediate level 5-8 weeks, and advanced-level 9-12 weeks).
Take 3 training sessions per week and complete the training on Mondays, Wednesdays, and Fridays from 4 to 5 pm.
**Detailed Description:** This study aimed to investigate the effect of a 12-week IRT on balance, core strength, and athletic performance among young male Chinese kayak canoeists. A Cluster Randomized Controlled Trial (CRCT) study was conducted. Firstly, the 2 city-level representative teams were chosen from 4 city-level representative teams of Jiangxi province and randomly assigned as two groups (experimental group and control group) using the Lottery Method. Secondly, 64 eligible kayak canoeists between the ages of 16-22 years (19.10±1.38) were recruited from the selected 2 city-level representative teams and randomly assigned to the instability resistance training (IRT) for the experimental group and traditional resistance training (TRT) for the control group using the same Lottery Method. The intervention was divided into 3 levels (primary, intermediate, and advanced) for IRT and TRT. Both groups performed training for 60 minutes, three times a week. The Swiss ball, BOSU ball, and Wobble boards were only provided with unstable surfaces for the IRT group. The intensity was body weight for both training methods. Dependent variables involving balance, core muscle strength, and athletic performance were measured using Flamingo Balance Test (FBT), Star Excursion Balance Test (SEBT), Abdomen Bridge (AB), Back Bridge (BB), Left and Right Lateral Bridge (LLB and RLB), 1min Sit-Up (SU), 1min Back Hyperextension (BH), 1min Left and Right Lateral V-up (LLV and RLV), K-1 200m Dynamometer Performance (DP), and Men's K-1 200m Calm-Water Performance (CWP) tests respectively in pre-test, post-test 1 (week 6), post-test 2 (week 12).
### Conditions Module
**Conditions:**
- Athletic Performance
**Keywords:**
- Instability resistance training
- Balance ability
- Core muscle strength
- Athletic performance
- Kayak canoeists
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After pre-testing, participants were randomly assigned to two groups. The participants of the IRT group were conducted in a 12-week (July 3 to September 22, 2023) Instability resistance training program that was performed one hour and three times per week (Mondays, Wednesdays, and Fridays from 4 to 5 pm) in the Nanchang Yao Lake base.
**Intervention Names:**
- Other: Instability resistance training and Traditional resistance training
**Label:** Instability resistance training
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** After pre-testing, participants were randomly assigned to two groups. The participants of the TRT group were conducted in a 12-week (July 3 to September 22, 2023) traditional resistance training program that was performed one hour and three times per week (Mondays, Wednesdays, and Fridays from 4 to 5 pm) in the Ganzhou Shangyou base.
**Intervention Names:**
- Other: Instability resistance training and Traditional resistance training
**Label:** Traditional resistance training
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Instability resistance training
- Traditional resistance training
**Description:** The 20 intervention actions were divided into three levels (primary, intermediate, and advanced) for instability resistance training and traditional resistance training. Both groups performed training for 60 minutes three times a week. The Swiss ball, BOSU ball, and Wobble boards only provided an unstable surface environment for instability resistance training. The intensity/load was body weight for both training methods.
**Name:** Instability resistance training and Traditional resistance training
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Flamingo Balance Test
**Measure:** Static Balance
**Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention)
**Description:** Star Excursion Balance Test
**Measure:** Dynamic Balance
**Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention)
**Description:** Abdomen Bridge
**Measure:** Abdomen Core Strength
**Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention)
**Description:** Back Bridge
**Measure:** Back Core Strength
**Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention)
**Description:** Left Lateral Bridge
**Measure:** Left Lateral Core Strength
**Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention)
**Description:** Right Lateral Bridge
**Measure:** Right Lateral Core Strength
**Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention)
**Description:** Men's K-1 200m Dynamometer Performance
**Measure:** Dynamometer Performance
**Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention)
**Description:** Men's K-1 200m Calm-Water Performance
**Measure:** Calm-Water Performance
**Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Male, Aged 16-22, and Healthy
Exclusion Criteria:
Athletes who are systematically training their balance ability and core muscle strength
**Healthy Volunteers:** True
**Maximum Age:** 22 Years
**Minimum Age:** 16 Years
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Serdang
**Country:** Malaysia
**Facility:** Jianxin Gao
**State:** Selangor
**Zip:** 43400
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432582
**Brief Title:** hepatomiR cACLD Study
**Official Title:** Assessment of a hepatomiR Cut-off for Predicting Specific Hepatic Decompensation Events in Advanced Chronic Liver Disease
#### Organization Study ID Info
**ID:** UKStP_hepatomiR_cACLD
#### Organization
**Class:** OTHER
**Full Name:** Karl Landsteiner University of Health Sciences
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** University Hospital St. Pölten
#### Lead Sponsor
**Class:** OTHER
**Name:** Karl Landsteiner University of Health Sciences
#### 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 looks to gather data on hepatomiR, a CE-certified test already intended for gauging liver-related outcomes, in order to define a cut-off regarding specific decompensation events (ascites, variceal hemorrhage, hepatic encephalopathy) in chronic liver disease (CLD). Based on these data, it is aimed to advance the current understanding of factors driving decompensation, with potential repercussions for future risk management and therapy.
### Conditions Module
**Conditions:**
- Chronic Liver Disease and Cirrhosis
- Chronic Liver Disease
- Portal Hypertension
**Keywords:**
- hepatomiR
- micro-RNA
- hepatic decompensation
- ACLD
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 156
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with compensated advanced chronic liver disease (cACLD) regardless of etiology
**Intervention Names:**
- Diagnostic Test: hepatomiR
**Label:** cACLD
### Interventions
#### Intervention 1
**Arm Group Labels:**
- cACLD
**Description:** hepatomiR is a CE-certified test intended for gauging liver-related outcomes. It quantifies the levels of hsa-miR-122-5p, hsa-miR-192-5p, and hsa-miR-151a-5p in human plasma samples. A proprietary algorithm is then used to compute a liver function score (hepatomiR p-score).
**Name:** hepatomiR
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy)
**Measure:** Occurrence of any hepatic decompensation event (per patient)
**Time Frame:** 12 months
#### Secondary Outcomes
**Measure:** Number and type of individual decompensation events (per patient)
**Time Frame:** 12 months
**Measure:** Number of hospital admissions (per patient)
**Time Frame:** 12 months
**Description:** EF-CLIF (European Association for the Study of the Liver - Chronic Liver Failure) definition, CLIF-C (chronic liver failure score) ACLF (acute on chronic liver failure) grading
**Measure:** Number of acute on chronic liver failure events (per patient)
**Time Frame:** 12 months
**Measure:** Number of ICU (intensive care unit) admissions (per patient)
**Time Frame:** 12 months
**Measure:** Development of hepatocellular cancer or cholangiocarcinoma (per patient)
**Time Frame:** 12 months
**Measure:** Number of deaths
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years
* Chronic liver disease (more than 6 months)
* LSM ≥ 10 kPa
* Outpatient at the Clinical Department of Internal Medicine II, University Hospital St. Pölten
* Signed patient consent form
Exclusion Criteria:
* Age older than 18 years
* Pregnancy
* Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population is made up of patients with compensated advanced chronic liver disease (cACLD) regardless of etiology; cACLD will be defined as per the Baveno VII consensus (LSM values: ≥ 10 kPa ACLD, less than 10 kPa non-ACLD).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lukas Erhart, Mag. Dr.
**Phone:** 00432742900412311
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** St. Pölten
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lukas Erhart, Mag. Dr.
- **Role:** CONTACT
**Country:** Austria
**Facility:** University Hospital St. Pölten
**State:** Lower Austria
**Status:** RECRUITING
**Zip:** 3100
#### Overall Officials
**Official 1:**
**Affiliation:** Karl Landsteiner University of Health Sciences
**Name:** Andreas Maieron, PD Dr.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: HIGH
- As Found: Liver Disease
- ID: M11103
- Name: Liver Cirrhosis
- Relevance: LOW
- As Found: Unknown
- ID: M10026
- Name: Hypertension, Portal
- Relevance: HIGH
- As Found: Portal Hypertension
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
- ID: D000006975
- Term: Hypertension, Portal
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M9662
- Name: Altretamine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432569
**Acronym:** B/P3_1
**Brief Title:** Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1)
**Official Title:** Evaluation of Butyrate and Palmitoylethanolamide Effects on Intestinal Permeability and Microbiota Gut Composition in Patients With Irritable Bowel Syndrome - A Double-blind, Placebo-controlled Crossover Randomized Study
#### Organization Study ID Info
**ID:** 5475-AO-22
#### Organization
**Class:** OTHER
**Full Name:** University of Padova
### Status Module
#### Completion Date
**Date:** 2025-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-03-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-08
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-27
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Padova
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Evaluation of the effects of butyrate ( BitirBioma) and palmitoylethanolamide( PEA=PeaBioma) on intestinal permeability and gut microbiota composition in patients with irritable bowel syndrome.
Study B/P 3_1 is an interventional study involving the use of food supplements on the market (BitirBioma Plus and PeaBioma Plus), single-center, double-blind, placebo-controlled, crossover, randomized, in n=50 patients with bowel syndrome irritable, diarrheal and mixed variant (IBS-D and IBS-M), lasting for one year.
The study has two arms: Group 1: n=25 Treatment A e Group 2: n=25 Treatment B (with - Treatment A: 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 - Treatment B: Placebo (3+3/day capsules of starch).
Eligible subjects with IBS will be randomized in a 1:1 ratio to treatment A or treatment B for six weeks. After the first treatment period, there is a 14-day washout period.
Hence, individuals will be treated with B/A treatment for additional six weeks, according to the crossover design.
In the two treatment periods, subjects will be required to complete a visual analogue score VAS questionnaire to assess gastrointestinal symptoms and Stool Bristol Scales. During the visit, the subjects will have to record Questionnaire Rome IV to evaluate their quality of life. At the same time, it will be theirs required to provide:
* fecal sample for the evaluation of the composition of fecal microbiota (Biomaplan Kit)
* a urine sample for the evaluation of intestinal permeability (Gastropack) a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG )
* a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG )
**Detailed Description:** Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon, characterized by relapsing and remitting mucosal inflammation. It presents with symptoms like bloody diarrhea, rectal urgency, fatigue, and abdominal pain. While various therapies are available for managing UC, including medications like amino salicylates, corticosteroids, immunomodulators, and biologics, there's ongoing research into supportive treatments like probiotics.
Probiotics are beneficial microorganisms that can positively influence gut health by modifying the gut microbiota, improving intestinal barrier function, and balancing immune response. Several studies have investigated their efficacy in UC management. Notably, the probiotic mixture VSL#3, containing strains of Lactobacillus and Bifidobacteria, has shown promising results in inducing remission in UC patients.
Other probiotic products like E. coli Nissle 1917, L. rhamnosus GG, and L. casei DG have also demonstrated effectiveness in maintaining disease remission or prolonging relapse-free periods in UC patients. The product Prolife 10 FORTE, containing multiple strains of Lactobacillus, Bifidobacteria, and Bacillus coagulans, along with prebiotic components and vitamins, has shown potential in positively influencing gut microbiota composition and metabolic activity in healthy individuals.
Based on these promising findings, further investigation is warranted to evaluate the potential of Prolife 10 FORTE in improving the gut microbiota composition of UC patients during the remission phase.
### Conditions Module
**Conditions:**
- Irritable Bowel Syndrome With Diarrhea
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** The study has two arms: Group 1: n=25 Treatment A e Group 2: n=25 Treatment B (with - Treatment A: 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 - Treatment B: Placebo (3+3/day capsules of starch).
Eligible subjects with IBS will be randomized in a 1:1 ratio to the treatment A or treatment B for six weeks. After the first treatment period, there is a 14-day washout period.
Hence, individuals will be treated with B/A treatment for additional six weeks, according to the crossover design.
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Double-blind
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Treatment : 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1
**Intervention Names:**
- Dietary Supplement: ButirBioma + PeaBioma
**Label:** ButirBioma+PeaBioma
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Treatment Placebo :(3+3/day capsules of starch).
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ButirBioma+PeaBioma
**Description:** randomized in a 1:1 ratio to treatment Butir+Pea or treatment with Placebo for six weeks. After the first treatment period, there is a 14-day washout period.
**Name:** ButirBioma + PeaBioma
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo( 3+3 cps/die)
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Collection of faecal sample for the assessment of the faecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit which is used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq , in order to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.
**Measure:** Evaluation of the variation of gut microbiota composition (Microbiota test )
**Time Frame:** 9 months
#### Secondary Outcomes
**Description:** 1. Analysis of mannitol( normal range 15-25%), lactulose( n.r. 0,45%-0,75%), sucrose(normal \< 0,15%) and sucralose( normal\<1,5%); L/M (normal \<0.03%; borderline 0,03%-0,09%; \>0.09 severe):
2. a capillary blood sample for the detection of Zonulin (Healthy gut Kit) )/Immundiagnostik AG )( normal cut-off 6-10 ng/mL)
**Measure:** Evaluation of intestinal permeability(4 sugar test: Gastropack)
**Time Frame:** 12 months
**Description:** Every evening during the two treatment periods, subjects must record a VAS(Visual Analogue Scale : 1-10; 1= non pain; 10= worst pain possible) questionnaire to assess gastrointestinal symptoms and the Stool Bristol Scale.( 1-7; normal 3-4)
**Measure:** Evaluation of Gastrointestinal symptoms( questionary)
**Time Frame:** 4 months
**Description:** At the visit time points, subjects will have to record the IBS-SSS score( points 75-174 mild, 175-300 moderate; \>300 severe)
**Measure:** Evaluation of Quality of Life (IBS-SSS score) (questionary)
**Time Frame:** 4 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ● IBS patients (both males and females) with positive diagnosis based on Rome IV criteria (IBS-D and IBS-M)
* Age in the range 18-70 years
* Subjects capable of conforming to the study protocol
* Subjects who have given their free and informed consent
Exclusion Criteria:
-Any relevant organic, systemic or metabolic disease, including celiac disease, IDDM (Insulin- Dependant Diabetes Mellitus), Insulin-Independent Diabetes Mellitus, metabolic syndrome, pelvic organ prolapses, urinary incontinence, ulcerative colitis, Crohn's disease, microscopic colitis, infectious colitis, ischemic colitis, complicated diverticular disease.
* Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
* Prior major gastrointestinal surgeries
* Females of childbearing potential, in the absence of effective contraceptive methods
* Subjects who become unable to conform to protocol
* Subjects who are continuously taking contact laxatives
* Subjects who are treated continuously with glucocorticoids, anti-histaminergic and mast cell stabilizer drugs
* Subjects who are treated continuously with trimebutine
* Recent history or suspicion of alcohol abuse or drug addiction
* Subjects who are treated with antibiotics or probiotics
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Padua
**Country:** Italy
**Facility:** Edoardo Vinvenzo Savarino
**Zip:** 35128
#### Overall Officials
**Official 1:**
**Affiliation:** University of Padova
**Name:** Edoardo Savarino, Prof,MD
**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
- ID: D000012817
- Term: Signs and Symptoms, Digestive
### 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: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M7159
- Name: Diarrhea
- Relevance: HIGH
- As Found: Diarrhea
- 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
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000043183
- Term: Irritable Bowel Syndrome
- ID: D000013577
- Term: Syndrome
- ID: D000003967
- Term: Diarrhea
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M340341
- Name: Palmidrol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432556
**Acronym:** MastCellHet
**Brief Title:** Study of Cellular Heterogeneity in Patients With Mastocytosis
**Official Title:** Study of Cellular Heterogeneity in Patients With Mastocytosis (MastCellHet) Mastocytosis Cell Heterogeneity
#### Organization Study ID Info
**ID:** RC31/23/0362
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Toulouse
#### Secondary ID Infos
**Domain:** ID-RCB
**ID:** 2024-A00021-46
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Toulouse
#### 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 will aim to study the heterogeneity of skin-resident mast cells and of blood circulating hematopoietic progenitors in patients suffering from isolated Cutaneous Mastocytosis and from systemic Mastocytosis with skin lesions.
**Detailed Description:** Mastocytosis is a rare disease caused by abnormal mast cell accumulation/proliferation. Its clinical features are very heterogeneous. Among adult patients, 15% present an isolated cutaneous mastocytosis (CM), while 85% of them present a systemic mastocytosis (SM) with cutaneous lesions. In addition, regardless of the diagnosis (i.e., CM or SM), it is frequent to observe mast cell-dependent symptoms of variable severity, ranging from gastrointestinal discomfort to life-threatening reactions. To date, the origin of such heterogeneous manifestations in adult patients is still elusive. Researchers hypothesize that the heterogeneity in mastocytosis symptoms might originate, at least in part, from a broad diversity of mast cell populations in patients. This study will aim to uncover heterogeneity of skin-resident mast cells and of blood circulating hematopoietic progenitors in patients suffering from isolated CM or SM with skin lesions. Patients with isolated CM and patients with SM with cutaneous involvement will be recruited from the Mastocytosis Expert Center of Toulouse.
Cluster of Differentiation (CD) 45+ cells from skin biopsies and CD 34+ cells from blood will be isolated by magnetic cell sorting for scRNAseq. Bioinformatics analysis pipeline will be used in order to analyze the cellular heterogeneity of skin lesions and blood from CM and SM patients by comparing their transcriptomic signatures. Using trajectories analysis, the researchers will then deduce infer a differentiation pathway between blood progenitors and cutaneous mast cells at the patient level. Researchers will then confirm the expression of identified relevant biomarkers by highly multiplexed imaging in frozen skin biopsies from CM patients and from SM patients.
### Conditions Module
**Conditions:**
- Mastocytosis
**Keywords:**
- Mastocytosis
- Mast cells
- Cellular heterogeneity
- CD 45+
- CD 34+
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 26
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Genetic: scRNAseq
- Procedure: two Skin biopsies
**Label:** patients with isolated cutaneous mastocytosis with associated skin involvement - RNAseq
**Type:** OTHER
#### Arm Group 2
**Intervention Names:**
- Procedure: one Skin biopsies
**Label:** patients with mastocytosis indolent systemic with associated skin involvement
**Type:** OTHER
#### Arm Group 3
**Intervention Names:**
- Procedure: one Skin biopsies
**Label:** patients with isolated cutaneous mastocytosis with associated skin involvement
**Type:** OTHER
#### Arm Group 4
**Intervention Names:**
- Genetic: scRNAseq
- Procedure: two Skin biopsies
**Label:** patients with mastocytosis indolent systemic with associated skin involvement - RNAseq
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- patients with isolated cutaneous mastocytosis with associated skin involvement - RNAseq
- patients with mastocytosis indolent systemic with associated skin involvement - RNAseq
**Description:** A blood test tube (only for scRNAseq, 2 tubes of 10 ml per patient)
**Name:** scRNAseq
**Type:** GENETIC
#### Intervention 2
**Arm Group Labels:**
- patients with isolated cutaneous mastocytosis with associated skin involvement - RNAseq
- patients with mastocytosis indolent systemic with associated skin involvement - RNAseq
**Description:** 2 skin biopsies from a lesional area
**Name:** two Skin biopsies
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- patients with isolated cutaneous mastocytosis with associated skin involvement
- patients with mastocytosis indolent systemic with associated skin involvement
**Description:** 1 skin biopsies from a lesional area
**Name:** one Skin biopsies
**Type:** PROCEDURE
### Outcomes Module
#### Other Outcomes
**Description:** through advanced imaging techniques (multiplexed imaging), marker in patients with isolated cutaneous mastocytosis and systemic mastocytosis will be identified compared with control sample
**Measure:** marker
**Time Frame:** 24 month and one week
**Description:** through advanced imaging techniques (multiplexed imaging), marker in patients with isolated cutaneous mastocytosis will be identified compared with control sample
**Measure:** marker - isolated cutaneous mastocytosis
**Time Frame:** 24 month and one week
**Description:** through advanced imaging techniques (multiplexed imaging), marker in patients with systemic mastocytosis will be identified compared with control sample
**Measure:** marker - systemic mastocytosis
**Time Frame:** 24 month and one week
#### Primary Outcomes
**Description:** This study aims to examine the diversity of CD 45+ cells in the skin and CD 34+ cells in the circulating blood in patients. The approach used will be single cell sequencing (scRNAseq) to identify the transcriptomic profiles of the different cell populations in these two types of mastocytosis.
**Measure:** Study of the diversity of skin CD 45+ cells and circulating blood CD 34+ cells
**Time Frame:** 24 month and one week
#### Secondary Outcomes
**Description:** This part of the study will focus on analyzing common or differential genetic transcripts between patients with isolated cutaneous mastocytosis and those with systemic mastocytosis. The aim is to understand the underlying molecular differences between these two forms of the disease.
**Measure:** Study of common or differential transcripts
**Time Frame:** 24 month and one week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Criteria related to the study population:
* Subject affiliated with a social security or insurance scheme
* Subject who has given written consent to his participation in the study
* Criteria related to the studied pathology:
* Subject diagnosed with isolated cutaneous or indolent systemic mastocytosis with associated skin involvement defined according to World Health Organization criteria (and/or international criteria for cutaneous mastocytosis)
* Subjects whose KIT mutation status is known in the skin, bone marrow, and blood
Exclusion Criteria:
* Criteria related to the study population:
* Sun exposure of the biopsied areas expected within the 4 weeks preceding
* Subjects who have had exposure to sunlight or artificial UV radiation within the 2 weeks preceding inclusion at the biopsied areas
* Adult patients under legal protection, guardianship, or curatorship
* Pregnant or lactating women
* Criteria related to the studied pathology:
* Subjects with an advanced version of the pathology or advanced systemic mastocytosis (SAMA)
* Subjects with a known history of allergy or intolerance to local anesthetics
* Subjects who have previously shown abnormalities in skin healing or any other contraindication to skin biopsy
* Subjects with recognized addiction to alcoholism or drug abuse
* Subjects with a hereditary or acquired disorder of hemostasis
* Subjects with a severe or acute chronic condition judged by the investigator as incompatible with the trial
* Subjects presenting a clinically incompatible immune deficiency with the study
* Patients without a well-established diagnosis of mastocytosis
* Patients included in a therapeutic study for indolent systemic mastocytosis
* Treatment-related criteria:
* Any topical or systemic treatment for atopic dermatitis (including phototherapy) ongoing or stopped at least 14 days before the inclusion visit
* Systemic corticosteroids within the 4 weeks preceding the inclusion visit
* Ongoing systemic treatment likely to interfere with the healing process
* Subjects who have undergone physical treatment (radiotherapy, etc.) on the biopsy area in the past 6 months
* History of treatment or concomitant treatment that may interfere with the conduct of the study as determined by the investigator
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Cristina Bulai Livideanu, MD
**Phone:** 0567778138
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Toulouse
**Country:** France
**Facility:** University Hospital
**Zip:** 31059
#### Overall Officials
**Official 1:**
**Affiliation:** Toulouse univiversity hospital
**Name:** Cristina Bulai Livideanu, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009372
- Term: Neoplasms, Connective Tissue
- ID: D000018204
- Term: Neoplasms, Connective and Soft Tissue
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000090362
- Term: Mast Cell Activation Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11399
- Name: Mastocytosis
- Relevance: HIGH
- As Found: Mastocytosis
- ID: M12317
- Name: Neoplasms, Connective Tissue
- 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: M2776
- Name: Mast Cell Activation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3626
- Name: Mastocytosis
- Relevance: HIGH
- As Found: Mastocytosis
### Condition Browse Module - Meshes
- ID: D000008415
- Term: Mastocytosis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432543
**Brief Title:** Polyethylene Wear Particle Analysis of THA
**Official Title:** Polyethylene Wear Particle Analysis of Total Hip Arthroplasty -International Multicenter Study-
#### Organization Study ID Info
**ID:** OMU 2023-132
#### Organization
**Class:** OTHER
**Full Name:** Osaka Metropolitan University
### Status Module
#### Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Mayo Clinic
**Class:** OTHER
**Name:** Hospital for Special Surgery, New York
**Class:** OTHER
**Name:** Istituto Ortopedico Rizzoli
#### Lead Sponsor
**Class:** OTHER
**Name:** Osaka Metropolitan University
#### Responsible Party
**Investigator Affiliation:** Osaka Metropolitan University
**Investigator Full Name:** Yukihide Minoda
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Purpose of research The purpose of this study was to demonstrate that polyethylene (Vitamin E-containing polyethylene), a newly introduced biomaterial for tibial inserts in hip replacement surgery and widely used clinically, but whose mid- to long-term clinical results are still unknown, is superior to conventional polyethylene in vivo. The aim of this project is to conduct an international multi-center joint research study to determine whether polyethylene wear debris production can be reduced in the future, using an in vivo polyethylene wear debris analysis method that the investigators developed as a method that can provide early feedback.
**Detailed Description:** Research method In this study, the investigators conducted the following steps to determine the in vivo wear particles (number, size, and morphology) of conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose mid- to long-term results have not yet been clarified. Clarifying the difference.
Target of this research In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.
First total joint replacement
* 30 patients using polyethylene containing Vitamin E
* 30 patients using conventional polyethylene (no high cross-linking)
* 30 patients using conventional polyethylene (with high cross-linking)
Accumulation of periarticular tissue In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.
The test will be conducted after obtaining approval from the ethics committee at each facility and obtaining informed consent. The pericapsular tissue, which is removed during surgery and usually discarded, is obtained and fixed in formalin fixative. The tissue will be transported to the Department of Orthopedic Surgery, Osaka Public University Graduate School of Medicine for analysis. International transportation of tissues requires outsourcing to specialized companies with experience in transporting tissues from overseas.
Isolation of polyethylene wear debris The collected tissue around the joint capsule is immersed in 5Mol sodium hydroxide at 65°C for 1 hour to decompose the protein. Make a sucrose layer (5, 10, 20%) in a 14ml tube (14PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the dissolved solution, and place in an ultracentrifuge (CP100a, P28S1014 rotor, Hitachi Koki). Ultracentrifuge at 28,000 rpm \[103,7009g\] for 3 hours at 4°C. Prepare an isopropanol layer (0.90 and 0.96 g/mL) in a 40 ml tube (40PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the upper layer of sucrose layer, and centrifuge at 28,000 rpm (103,7009 g) and perform ultracentrifugation at 4°C for 1 hour. The isopropanol interlayer is collected to isolate polyethylene wear debris.
Analysis of polyethylene wear debris The isopropanol interlayer is filtered through a 0.1 μm polycarbonate filter (VCTP 013-00, Millipore Corporation, Bedford, MA). Dry the polycarbonate filter, fix it on an aluminum pedestal (M4, Nisshin EM Co, Ltd, Tokyo, Japan), and apply platinum coating (E-1030 ion sputter, Hitachi Science Systems Ltd, Tokyo, Japan). Observe the polyethylene wear particles on the polycarbonate filter using a scanning electron microscope (S4700SI, Hitachi Ltd, Tokyo, Japan), and analyze the following items using an image analyzer (Mac Scope, Mitani Co, Tokyo, Japan).
* Number of polyethylene wear particles (number per 1g of tissue)
* Size (Equivalent circle diameter \[μm\])
* Shape (aspect ratio, roundness)
Comparison of iv vivo polyethylene wear powder morphology depending on polyethylene material The number, size, and form of polyethylene wear debris will be compared between conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose medium- to long-term results have not yet been clarified. The investigators also investigated factors that affect polyethylene wear in vivo (age, height, weight, period from initial surgery to revision surgery, hip joint range of motion, hip prosthesis clinical score \[Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement \[HOOS Jr\], Harris Hip Score, University of California Los Angeles \[UCLA\] activity score\]).
### Conditions Module
**Conditions:**
- Wear of Articular Bearing Surface of Prosthetic Joint
- Hip Arthropathy
**Keywords:**
- Polyethylene wear particle
- Total hip arthroplasty
### Design Module
#### Bio Spec
**Description:** The pericapsular tissue, which is removed during surgery
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** polyethylene containing Vitamin E
**Intervention Names:**
- Device: polyethylene
**Label:** polyethylene containing Vitamin E
#### Arm Group 2
**Description:** conventional polyethylene (no highly cross-linking)
**Intervention Names:**
- Device: polyethylene
**Label:** conventional polyethylene (no highly cross-linking)
#### Arm Group 3
**Description:** conventional polyethylene (with highly cross-linking)
**Intervention Names:**
- Device: polyethylene
**Label:** conventional polyethylene (with highly cross-linking)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- conventional polyethylene (no highly cross-linking)
- conventional polyethylene (with highly cross-linking)
- polyethylene containing Vitamin E
**Description:** No intervention as this is an observational study
**Name:** polyethylene
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** counts / g (tissue sample)
**Measure:** Number of polyethylene wear particles
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** equivalent circle diameter \[㎛\]
**Measure:** Equivalent circle diameter of polyethylene wear particles
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** aspect ratio
**Measure:** Aspect ratio of polyethylene wear particles
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** roundness
**Measure:** Roundness of polyethylene wear particles
**Time Frame:** When tissue sample was collected during THA revision surgery
#### Secondary Outcomes
**Description:** kg/m2
**Measure:** Body mass index
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** Degrees
**Measure:** Hip joint flexion angle
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** Degrees
**Measure:** Hip joint exertion angle
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** Degrees
**Measure:** Hip joint adduction angle
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** Degrees
**Measure:** Hip joint abduction angle
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** 0(worse)-100(best)
**Measure:** Hip dysfunction and Osteoarthritis Outcome. Score for Joint Replacement
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** 0(worse)-100(best)
**Measure:** Harris Hip Score
**Time Frame:** When tissue sample was collected during THA revision surgery
**Description:** １(worse)-10(best)
**Measure:** University of California at Los Angeles activity score
**Time Frame:** When tissue sample was collected during THA revision surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients undergoing revision hip arthroplasty within the study period
2. Patients over 20 years old
3. Patients who have received a sufficient explanation, have sufficient understanding, and have given their free written consent.
4. Patients who have passed 2 years or more since their first total hip arthroplasty
Exclusion Criteria:
1. Patients who are judged to be unsuitable as research subjects by the research physician
**Minimum Age:** 20 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients undergoing revision hip arthroplasty within the study period
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yukihide Minoda, MD, PhD
**Phone:** 81-6-6645-3851
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Osaka Metropolitan University
**Name:** Yukihide Minoda, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Iwakiri K, Iwaki H, Kobayashi A, Minoda Y, Kagiyama H, Kadoya Y, Takaoka K. Characteristics of Hylamer polyethylene particles isolated from peri-prosthetic tissues of failed cemented total hip arthroplasties. J Biomed Mater Res B Appl Biomater. 2008 Apr;85(1):125-9. doi: 10.1002/jbm.b.30924.
**PMID:** 17806109
**Citation:** Hata K, Minoda Y, Ikebuchi M, Mizokawa S, Ohta Y, Miyazaki N, Miyake Y, Nakamura H. In vivo wear particles of remelted highly crosslinked polyethylene after total hip arthroplasty: report of four cases. J Mater Sci Mater Med. 2015 Mar;26(3):133. doi: 10.1007/s10856-015-5472-9. Epub 2015 Feb 25.
**PMID:** 25712074
**Citation:** Minoda Y, Kobayashi A, Sakawa A, Aihara M, Tada K, Sugama R, Iwakiri K, Ohashi H, Takaoka K. Wear particle analysis of highly crosslinked polyethylene isolated from a failed total hip arthroplasty. J Biomed Mater Res B Appl Biomater. 2008 Aug;86(2):501-5. doi: 10.1002/jbm.b.31048.
**PMID:** 18360879
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009140
- Term: Musculoskeletal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10621
- Name: Joint Diseases
- Relevance: HIGH
- As Found: Arthropathy
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007592
- Term: Joint Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M22972
- Name: Tocopherols
- Relevance: LOW
- As Found: Unknown
- ID: M17553
- Name: Vitamin E
- Relevance: LOW
- As Found: Unknown
- ID: M22975
- Name: Tocotrienols
- Relevance: LOW
- As Found: Unknown
- ID: M22969
- Name: alpha-Tocopherol
- Relevance: LOW
- As Found: Unknown
- ID: T466
- Name: Tocopherol
- Relevance: LOW
- As Found: Unknown
- ID: T467
- Name: Tocotrienol
- Relevance: LOW
- As Found: Unknown
- ID: T480
- Name: Vitamin E
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432530
**Brief Title:** Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis
**Official Title:** Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis
#### Organization Study ID Info
**ID:** University of Van Yüzüncü Yıl
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2024-03-08
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-09-15
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-09
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yuzuncu Yıl University
#### Responsible Party
**Investigator Affiliation:** Yuzuncu Yıl University
**Investigator Full Name:** Volkan Şah
**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:** Hematological inflammatory indices (Table 2) are currently very popular and have diagnostic, prognostic, and predictive, roles in various diseases. Considering their promising roles, we hypothesized that hematological inflammatory indices may have a distinctive value between brucella spondylodiscitis and type 1 Modic Changes (MCs). If the hypothesis is valid, early diagnosis-differential diagnosis-treatment processes may become easier and more successful. Given that hematological inflammatory indices are faster, practical, simpler, inexpensive, and easily accessible indicators, they may be more appropriate tools in differentiation between brucella spondylodiscitis and type 1 MCs.
**Detailed Description:** This is a retrospective comparative study focusing to distinguish between brucella spondylodiscitis and type 1 MCs considering hematological inflammatory indexes. Patients' data were obtained from Hospital Information Systems, between 2020 to 2024. A total of 35 patients with brucella spondylodiscitis and 37 type 1 MCs were enrolled in the study. Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR, MLR, PLR, NLPR, SII, SIRI, AISI) were derived from baseline CBC tests.
Based on the diagnostic tools and criteria1,2,14,21, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar MRI, Complete Blood Count (CBC) test, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) results, and aged 18-65 years were selected to yield a study population. On the other hand, cases with inadequate data, aged \<18 or \>64 years, other infectious spondylodiscitis types than brucella, other MCs types than type 1, and other non-infectious conditions such as rheumatic spondylodiscitis (ankylosing spondylitis or Andersson lesion) were excluded from the study. Also, previous or recurrent brucella spondylodiscitis, involved other spinal levels than the lumbar spine were exclusion causes.
The two groups were statistically assessed and compared for baseline features such as age, gender, symptom duration, CRP, ESR, CBC values, and indexes derived from the CBC.
### Conditions Module
**Conditions:**
- Brucella Spondylitis
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 72
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Based on the diagnostic tools and criteria, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and Erythrocyte Sedimentation Rate (ESR) results, and aged 18-65 years were selected to yield a study population
**Intervention Names:**
- Other: C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete Blood Count (CBC) values, and indexes derived from the CBC.
**Label:** 37 patients with type 1 Modic Changes (MCs)
#### Arm Group 2
**Description:** Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Based on the diagnostic tools and criteria, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and Erythrocyte Sedimentation Rate (ESR) results, and aged 18-65 years were selected to yield a study population
**Intervention Names:**
- Other: C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete Blood Count (CBC) values, and indexes derived from the CBC.
**Label:** 35 patients with brucella spondylodiscitis
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 35 patients with brucella spondylodiscitis
- 37 patients with type 1 Modic Changes (MCs)
**Description:** Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR: neutrophil/lymphocyte; MLR: monocyte/lymphocyte; PLR: platelet/lymphocyte; NLPR: neutrophil/(lymphocyte\*platelet); SII (neutrophil\*platelet/lymphocyte): systemic inflammatory index; SIRI (neutrophil\*monocyte/lymphocyte): systemic inflammatory response index; AISI (neutrophil\*platelet\*monocyte/lymphocyte): aggregate index of systemic inflammation. ) were derived from baseline CBC tests.
**Name:** C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete Blood Count (CBC) values, and indexes derived from the CBC.
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** As an inflammatory index.
**Measure:** C-Reactive Protein (CRP)
**Time Frame:** Baseline
**Description:** As an inflammatory index.
**Measure:** Erythrocyte Sedimentation Rate (ESR)
**Time Frame:** Baseline
**Description:** As a hematological inflammatory index
**Measure:** Neutrophil/Lymphocyte Rate (NLR)
**Time Frame:** Baseline
**Description:** As a hematological inflammatory index
**Measure:** Monocyte/Lymphocyte Rate (MLR)
**Time Frame:** Baseline
**Description:** As a hematological inflammatory index
**Measure:** Platelet/Lymphocyte Rate (PLR)
**Time Frame:** Baseline
**Description:** As a hematological inflammatory index
**Measure:** Neutrophil/(Lymphocyte*Platelet) Rate (NLPR)
**Time Frame:** Baseline
**Description:** As a hematological inflammatory index
**Measure:** (neutrophil*platelet/lymphocyte): Systemic Inflammatory Index (SII)
**Time Frame:** Baseline
**Description:** As a hematological inflammatory index
**Measure:** (neutrophil*monocyte/lymphocyte): Systemic Inflammatory Response Index (SIRI)
**Time Frame:** Baseline
**Description:** As a hematological inflammatory index
**Measure:** (neutrophil*platelet*monocyte/lymphocyte): Aggregate Index of Systemic Inflammation (AISI)
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Clinical diagnosis of lumbar brucella spondylodiscitis in the past 5 years
* Clinical diagnosis of or lumbar type 1 Modic Changes (MCs) in the past 5 years
* Having simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) results
* Being between the ages of 18-65
Exclusion Criteria:
* Cases with inadequate data
* Being under 18 years of age and over 65 years of age
* Having other infectious spondylodiscitis types than brucella
* Having other MCs types than type 1
* Having other non-infectious conditions such as rheumatic spondylodiscitis (ankylosing spondylitis or Andersson lesion)
* Having previous or recurrent brucella spondylodiscitis, involved other spinal levels than the lumbar spine
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** A total of 35 (17 female and 18 male) patients with brucella spondylodiscitis and 37 (26 female and 11 male) type 1 Modic Changes (MCs) were enrolled in the study. Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnotic tools. Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR: neutrophil/lymphocyte; MLR: monocyte/lymphocyte; PLR: platelet/lymphocyte; NLPR: neutrophil/(lymphocyte\*platelet); SII (neutrophil\*platelet/lymphocyte): systemic inflammatory index; SIRI (neutrophil\*monocyte/lymphocyte): systemic inflammatory response index; AISI (neutrophil\*platelet\*monocyte/lymphocyte): aggregate index of systemic inflammation. ) were derived from baseline CBC tests.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Van
**Country:** Turkey
**Facility:** Volkan Şah
**Zip:** 65040
#### Overall Officials
**Official 1:**
**Affiliation:** Yüzüncü Yıl Üniversitesi Tıp Fakültesi
**Name:** Ali İrfan Baran
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001850
- Term: Bone Diseases, Infectious
- ID: D000007239
- Term: Infections
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000013122
- Term: Spinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M15961
- Name: Spondylitis
- Relevance: HIGH
- As Found: Spondylitis
- ID: M17996
- Name: Discitis
- Relevance: HIGH
- As Found: Spondylodiscitis
- ID: M23035
- Name: Spondylarthritis
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- 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: M5129
- Name: Bone Diseases, Infectious
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15919
- Name: Spinal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013166
- Term: Spondylitis
- ID: D000015299
- Term: Discitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432517
**Brief Title:** Sources and Mechanisms of Energy Compensation
**Official Title:** Identification of the Sources and Mechanisms of Energy Compensation in Humans
#### Organization Study ID Info
**ID:** SIAT-IRB-230515-H0653
#### Organization
**Class:** OTHER
**Full Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-05-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-02
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
#### Responsible Party
**Investigator Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
**Investigator Full Name:** John R. Speakman
**Investigator Title:** Professor, Chief scientist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Excess energy, obesity and obesity-related diseases are important global health issues. Although it is known that obesity is an issue of energy balance, the components of energy expenditure seem to be inter-related in complex non-additive ways. The aim of this study is to explore the downstream impacts of exercise on short term changes in both expenditure and energy intake. The primary question the investigators are asking is whether moderate to high intensity exercise influences the basal energy expenditure and/or energy intake/macronutrient preference in young adult males? (A similar study will be performed on females in a different registration). The investigators will use a specially designed feeding table to measure energy intake and macronutrient intake, which is easy to quantify intake compensation. Basal metabolism will be measured by hood indirect calorimetry. The investigators will explore the factors that influence the level of compensation in expenditure and intake, in particular body composition. Participants will be asked to come to the lab after 10 hours fast for body composition tests including Dual Energy X-ray Absorptiometry(DXA), Magnetic Resonance Image(MRI) and Bioelectrical Impedance Analysis(BIA). They will then be asked (not) to do 30 minutes of moderate-to-vigorous exercise after an energy-limiting breakfast, during which metabolic rate levels and changes in dietary composition will be recorded by gas exchange and standardized buffet. In addition, participants' subjective hunger and preferences will also be recorded by questionnaires. Venous blood will be collected to measure metabolic and hormone factors, blood glucose will be measured by Continuous Blood Glucose Monitor (CGM).
**Detailed Description:** 81 participants will be recruited by posters and Wechat. The sample size is calculated using the paired t-test in power analysis, in which α value is 0.05, β value is 0.8, standard deviation is 372 (calculated from the energy intake data in the preliminary trial), and the difference is 108. The alternative hypothesis is greater than 108. The experiment lasted for 14 days, of which two and a half days will be carried out in the laboratory, and the other time only need to wear devices and live freely, which will not affect the normal life. The experiment is mainly divided into three parts:
1. Body composition: Items include weight, height, body fat mass (MRI), bone mass (DAX), body density (BODPOD), lean mass (MRI) and 3D parameters (3D scan). The participants will be required to fasting for at least 10 hours. After the test, they will be equipped with continuous glucose monitoring equipment (CGM), motion monitoring equipment (GT3X) and ambient temperature monitoring equipment (ibutton).
2. Controlled trial: The specific detection contents include resting energy expenditure (REE), active energy expenditure (AEE) and energy intake. The investigators will provide participants with three meals, as an energy restricted breakfast, a standard lunch and supper for dietary component testing. The subjective hunger and eating preference rate of participants will be measured by Visual Analogue Scale (VAS) and questionnaires. Non-physical activities such as working, reading and watching movies will be allowed during the experiment. Venous blood will be collected at several specific points (fasting 10 hours, after breakfast, before lunch and after lunch). In addition, sweat, urine and feces will also be collected.
3. Exercise trial: The schedule is the same as the control trial except for Blood drawing time and 30 minutes of power bike after breakfast, the intensity is 100 watt with 1 minute 25 watt break every 5 minute during the exercise. Venous blood will be collected at several specific points in time (just after exercise, before lunch and after lunch).
### Conditions Module
**Conditions:**
- Energy Expenditure
- Exercise
- Energy Intake
- Food Preferences
**Keywords:**
- Energy compensation
- Energy balance
- Food Preferences
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 81
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** BMI≥18.5, age between 18-40 years old, 81subjects.
**Intervention Names:**
- Other: Power Bike（Ergoselect 100P）
**Label:** Moderate to high intensity exercise
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Moderate to high intensity exercise
**Description:** Changes in the participants' energy balance will be measured through moderate to high intensity exercise. Observation of food intake, body composition, metabolic rate, food assimilation rate.
**Name:** Power Bike（Ergoselect 100P）
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Macronutrients preference will be recorded by the feeding table, macronutrient preference will be calculated in percentage(%).
**Measure:** Macronutrient preference
**Time Frame:** During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.
**Description:** Response on standard feeding table, the food consumption will be recorded continuously by balances underneath each food dish. The total energy intake will be calculated in kilojoule (KJ).
**Measure:** Energy intake
**Time Frame:** During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.
**Description:** Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Metabolic rate (oxygen consumption and carbon dioxide production) are monitored for 40 minutes. The last 10 minutes is used as the measurement. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements. Validation via an alcohol burn will be performed monthly.
**Measure:** Basal metabolic rate
**Time Frame:** The detection time spans over two days, the control day and the exercise day, from 8:00 am to 5:00 pm, with tests being conducted every hour and each test lasting for half an hour.
#### Secondary Outcomes
**Description:** Blood glucose will be recorded by the continuous glucose monitoring system(CGM) in mmol/L.
**Measure:** Blood glucose
**Time Frame:** Wear it for a total of 4 consecutive days, including the physical examination day, the control day, the exercise day, and the day following the exercise day.
**Description:** Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days.
**Measure:** Physical activity
**Time Frame:** Wear it for 14 days from the physical examination day
**Description:** The iButton (DS1921G) monitors will be provided for the assessment of both indoor and outdoor temperature of their living environment in centigrade(℃). The iButtons can be affixed to the hand bag (or clothes) to measure the subject exposure temperature, an indoor wall of home and workplace, and the building outside to measure the outdoor temperature using a strip of adhesive, water resistant, medical grade tape.
**Measure:** Ambient temperature
**Time Frame:** Wear it for 14 days from the physical examination day
**Description:** Levels of circulating hormones (including leptin, insulin, ghrelin etc) will be measured when fasted and after a standard intervention meal. Levels of circulating hormones in the serum will be measured by ELISA (Bio Tek, Synergy4) in mmol/L.
**Measure:** Circulating Biochemical indexes and hormones
**Time Frame:** The venous blood of volunteers will be collected 10 times on control and exercise days. (Control day: fasting, 1,2,3,4 hours after breakfast and 2 hours after lunch. Exercise day: 0,1,2 hours after exercise and 2 hours after lunch)
**Description:** Physical activity will be carried out by the Ergoselect 100P(Power bike) at 100 watts
**Measure:** Exercise
**Time Frame:** 30 minutes after breakfast(only on the exercise day), it last for 39 minutes, 30 minutes at 100 watts and 9 minutes at 25 watts.
**Description:** Basal metabolic rate will be recorded by the Quark PFT ergo, The energy expenditure will be calculated in kilojoule (kj).
**Measure:** Exercise metabolic rate
**Time Frame:** 30 minutes after breakfast(only on the exercise day), it last for 39 minutes, 30 minutes at 100 watts and 9 minutes at 25 watts.
**Description:** Volunteers will be asked to fast for 10 hours and measured fasting weight (kilogram, kg) with light clothes and no shoes.
**Measure:** Weight
**Time Frame:** On the first morning of the experiment, it last for 10 minutes.
**Description:** Height will be measured by seca 217 stable stadiometer in meter(m).
**Measure:** Height
**Time Frame:** On the first morning of the experiment, it last for 10 minutes.
**Description:** Waist circumferences will be measured using a whole body laser scanner in centimeter(cm).
**Measure:** Waist circumferences
**Time Frame:** On the first morning of the experiment, it last for 15 minutes.
**Description:** Hip circumferences will be measured using a whole body laser scanner in centimeter(cm).
**Measure:** Hip circumferences
**Time Frame:** On the first morning of the experiment, it last for 15 minutes.
**Description:** Bone mineral density will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).
**Measure:** Bone mineral density
**Time Frame:** On the first morning of the experiment, it last for 8 minutes.
**Description:** Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). and Bioimpedance Analysis (Tanita, MC-980).
**Measure:** Fat mass
**Time Frame:** On the first morning of the experiment, it last for 30 minutes.
**Description:** Fat free mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). and Bioimpedance Analysis (Tanita, MC-980).
**Measure:** Fat free mass
**Time Frame:** On the first morning of the experiment, it last for 30 minutes.
**Description:** Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.
**Measure:** Blood pressure
**Time Frame:** On both the control and exercise days, blood pressure will be measured prior to the basic energy expenditure(≈8:00 am), it last for 5 minutes.
**Description:** Body temperature will be measured during lunch using a thermal imager（Fluke RSE600）in centigrade(℃).
**Measure:** Body temperature
**Time Frame:** On both the control and exercise days, the change of body temperature will be measured during lunchtime and suppertime, each test lasting for 40 minutes.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy adults (men)
* 18-40 years old
* BMI (body mass index)≥18.5 kg/m2
Exclusion Criteria:
* Those who have undergone surgery in the past 6 months.
* People are requiring long-term medication.
* People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, et al.
* People have digestive diseases, like gastric ulcer, pancreatitis, Intestinal obstruction, et al.
* People have sports injury, like fracture, Joint injury, et al.
* Those who have recently lost weight for various medical reasons (e.g. cancer, etc.).
* People are losing weight by tablets.
* People are suffering from infectious diseases (e.g. HIV, etc.)
* People have blood phobia, pathological hypo or hyper tension.
* People with impaired glucose tolerance.
* Those who are afflicted with claustrophobia.
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** John R Speakman
**Phone:** +8615810868669
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Li Xue
**Phone:** 13538042185
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shenzhen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** John R Speakman, PhD
- **Phone:** +8615810868669
- **Role:** CONTACT
**Country:** China
**Facility:** Shenzhen Institute of Advanced Technology
**State:** Guangdong
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
**Name:** John Speakman
**Role:** STUDY_CHAIR
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432504
**Brief Title:** Variation in the Impact of Coffee on the Metabolic Rate
**Official Title:** Variation in the Impact of Coffee on the Metabolic Rate
#### Organization Study ID Info
**ID:** SIAT IRB 221115H0629
#### Organization
**Class:** OTHER
**Full Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-02
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
#### Responsible Party
**Investigator Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
**Investigator Full Name:** John R. Speakman
**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 purpose of this study is to explore variation in the impact of coffee on metabolic rate. The investigators plan to recruit healthy participants, half male and half female.
**Detailed Description:** The investigators will study the variation in the impact of coffee on metabolic rate and investigate the impacts of age, sex, body composition and regularity of habitual coffee consumption on this effect. The investigators will recruit healthy participants, half male and half female. Participants will be required to perform no strenuous exercise for 14 hours and no moderate of vigorous exercise for 2 hours before the measurements. When the participants arrive at the lab on the day of the experiment, they will sign an informed consent form, a health history questionnaire and a daily coffee consumption questionnaire. Participants will be randomly allocated into 3 groups and given 180mls of coffee to consume containing 100, 200 or 300 mg of caffeine. A fourth group will be dosed with 100 mg of caffeine containing 13C uniform labelled caffeine to trace the pattern of caffeine degradation via the appearance of 13CO2 in the breath and labelled compounds in the urine. The primary outcome is the change in resting metabolic rate from before and after coffee drinking. Secondary outcome measures are heart rate, electrocardiogram, blood pressure, body temperature which will be measured before and after the coffee consumption. Professional nurses will take 8ml of venous blood from all participants as genotyping blood samples. Genomic DNA will be extracted from whole blood samples and analysed for single nucleotide polymorphisms (SNPS).
### Conditions Module
**Conditions:**
- Healthy
**Keywords:**
- Coffee
- Caffeine
- Metabolic rate
- Caffeine clearance
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel Assignment
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The participants will drink 180 mls coffee
**Intervention Names:**
- Other: Caffeine content
**Label:** caffeine content 100mg
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The participants will drink 180 mls coffee.
**Intervention Names:**
- Other: Caffeine content
**Label:** caffeine content 200mg
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** The participants will drink 180 mls coffee
**Intervention Names:**
- Other: Caffeine content
**Label:** caffeine content 300mg
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** The participants will drink 180 mls coffee (caffeine content 100mg) containing 13C labelled caffeine to trace the pattern of caffeine degradation.
**Intervention Names:**
- Other: Caffeine content
**Label:** 13C3 caffeine content 100mg
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 13C3 caffeine content 100mg
- caffeine content 100mg
- caffeine content 200mg
- caffeine content 300mg
**Description:** Participants will drink the same volume of coffee with different amounts of caffeine.
**Name:** Caffeine content
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (COSMED). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Resting energy expenditure will be measured before and after coffee consumption.
The extra energy expenditure is equal to the resting energy expenditure after drinking coffee minus the resting energy expenditure before drinking coffee.
**Measure:** Resting energy expenditure
**Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours.
**Description:** The contents of metabolites will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).
**Measure:** Urine metabolites
**Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours.
**Description:** Gases will be collected before and after coffee consumption, Gases will be measured by CO2 isotope analyzer (CCIA2-912) to observe the change of labelled CO2.
**Measure:** Expired gases
**Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours.
#### Secondary Outcomes
**Description:** Body temperature of participants will be measured by body temperature patch (RIT-P02-MED) before and after coffee consumption.
**Measure:** Body temperature
**Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours.
**Description:** ECG of participants will be measured by Amu ECG belt before and after coffee consumption, the changes in P wave, PR interval, PR segment, QRS wave group, J point, ST segment, T wave, QT interval, and U wave will be observe.
**Measure:** Electrocardiogram (ECG)
**Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours.
**Description:** Venous blood collected by nurses, blood samples will be used for whole genome exon sequencing to analyze single nucleotide polymorphisms.
**Measure:** Blood samples
**Time Frame:** Baseline : empty stomach On the first moring of experiment.
**Description:** Systolic and diastolic blood pressure of participants will be measured by Omron digital sphygmomanometer before and after coffee consumption.
**Measure:** Blood pressure
**Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours.
**Description:** Height will be measured by seca 217 stable stadiometer.
**Measure:** Height
**Time Frame:** On the first moring of experiment, it lasts 5 minutes.
**Description:** Fasting body weight will be measured by Bioimpedance Analysis (TANITA, MC-980).
**Measure:** Body weight
**Time Frame:** On the first moring of experiment, it lasts 5 minutes.
**Description:** Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
**Measure:** Fat mass
**Time Frame:** On the second moring of experiment, it lasts 10 minutes.
**Description:** Fat free mass will be Bioimpedance Analysis (TANITA, MC-980).
**Measure:** Fat free mass
**Time Frame:** On the first moring of experiment, it lasts 5 minutes.
**Description:** Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).
**Measure:** Bone mass
**Time Frame:** On the first moring of experiment, it lasts 10 minutes.
**Description:** Heart rate will be measured by Omron sphygmomanometer.
**Measure:** Heart rate
**Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours.
**Description:** Body water, extracellular fluid and intracelluar fluid will be measured by Bioimpedance Analysis (TANITA, MC-980).
**Measure:** Body water, extracellular fluid and intracelluar fluid
**Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Healthy adults 18-40 years old
Exclusion Criteria:
Those who have undergone surgery in the past 6 months. People are requiring long-term medication. People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, etc.
People have digestive diseases, like gastric ulcer, pancreatitis, intestinal obstruction, etc.
Those who have recently lost weight for various medical reasons ( like cancer, etc.).
People are suffering from infectious diseases ( like HIV, etc.). People have blood phobia, pathological hypo or hyper tension. People with impaired glucose tolerance. Those who are afflicted with claustrophobia.
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** John R Speakman, PhD
**Phone:** 13466654659
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Huanan Zhang, Bachelor
**Phone:** 13371016641
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shenzhen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hannan Zhang, Bachelor
- **Phone:** 13371016641
- **Role:** CONTACT
**Country:** China
**Facility:** Shenzhen Institute of Advanced Technology
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 518055
#### Overall Officials
**Official 1:**
**Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
**Name:** John R Speakman, PhD
**Role:** STUDY_CHAIR
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000697
- Term: Central Nervous System Stimulants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000010726
- Term: Phosphodiesterase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000058915
- Term: Purinergic P1 Receptor Antagonists
- ID: D000058914
- Term: Purinergic Antagonists
- ID: D000058905
- Term: Purinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
### Intervention Browse Module - Browse Branches
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M5373
- Name: Caffeine
- Relevance: HIGH
- As Found: Continued
- ID: M4029
- Name: Central Nervous System Stimulants
- 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: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: T370
- Name: Caffeine
- Relevance: HIGH
- As Found: Continued
### Intervention Browse Module - Meshes
- ID: D000002110
- Term: Caffeine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432491
**Brief Title:** The Association Between Core Temperature and Health
**Official Title:** Study to Explore How Core Temperature Reduction Influence Health
#### Organization Study ID Info
**ID:** KYLLHS-20240201A
#### Organization
**Class:** OTHER
**Full Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
### Status Module
#### Completion Date
**Date:** 2026-05-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-01
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Shenzhen University General Hospital
**Class:** OTHER
**Name:** The Hong Kong Polytechnic University
#### Lead Sponsor
**Class:** OTHER
**Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
#### Responsible Party
**Investigator Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
**Investigator Full Name:** John R. Speakman
**Investigator Title:** Prof.
**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 cold water drinking could promote body composition and further extend healthy lifespan in Chinese older adults. The main questions it aims to answer are:
1. Does cold water drinking lower the body fat percentage?
2. Will cold water drinking positively extend lifespan in a long-term Researchers will compare cold water intervention group to a control group (drinking 37℃ water instead) to see if cold water drinking works to promote health and slow down ageing process.
Participants will:
1. Drink 4℃ or 37℃ water 4 times (9a.m., 12p.m., 15p.m., 18p.m.) every day for 6 months.
2. Visit the institute and health checkup department for tests and checkup at baseline, the end of the 3rd month, and the end of 6th month.
**Detailed Description:** According to pilot study, we found 4℃ water could significantly reduce core body temperature. Thus, we aim to explore whether 4℃ water drinking could promote body composition and further help to extend lifespan.
Participants will be randomly divided into intervention (drinking 4℃ water at 9a.m., 12p.m., 15p.m., 18p.m.) and control group (drinking 37℃ water at 9a.m., 12p.m., 15p.m., 18p.m.) for 6-month intervention. Tests will be conducted in Shenzhen Institute of Advanced Technology, while checkup will be tested at Health Checkup Department of Shenzhen University General Hospital. Body composition will be tested by Magnetic Resonance Imaging (MRI), Dual-Energy X-Ray Absorptiometry (DEXA), and TANITA (bioelectrical method). In addition, we will test participants' waist and hip circumferences using 3D scanning. Besides, we will test core body temperature and brown adipose tissue.
Apart from above main outcomes, we will also test their physical activity, food intake, metabolic rate, glucose, IL-6, TNF-alpha, HDL, LDL, insulin level. Meanwhile, ageing biomarkers, namely Phenotypic Age, eye fundus image, facial changes, bone density, gut microbiota, GlycanAge, will also be measured.
The whole intervention period will last for 6 months. All the tests and checkup will be tested at baseline, the end of the third month and the endpoint of the study.
### Conditions Module
**Conditions:**
- Body Temperature Changes
- Body Composition
- Aging
**Keywords:**
- Body temperature
- Body composition
- Aging
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants will be randomly divided into intervention group and control group. Intervention group will drink 4℃ water while control group will drink 37℃ water for 6 months.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** All the participants will only get access to their own group and will not get access to other group members.
The investigator who take charge of MRI test for participants' body composition will not have any idea about grouping.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Volunteers will drink 500ml 4℃ water within 10 minutes at 9a.m., 12p.m., 15p.m., 18p.m. everyday for 6 months.
**Intervention Names:**
- Behavioral: Drinking cold water
**Label:** 4℃ water drinking group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Volunteers will drink 500ml 37℃ water within 10 minutes at 9a.m., 12p.m., 15p.m., 18p.m. everyday for 6 months.
**Label:** 37℃ water drinking group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 4℃ water drinking group
**Description:** Volunteers in the intervention group will be asked to drink up 500 ml 4℃ water within 10 minutes four times per day throughout the study.
**Name:** Drinking cold water
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of albumin in g/L assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of creatinine in umol/L assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of C-reactive protein in mg/dL assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Percentage of lymphocyte assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Volume of mean (red) cell assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Coefficient of variation of red blood cell size (red cell distribution width) assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of alkaline phosphatase in U/L assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Number of white blood cell (white blood cell count) in 1000 cells/uL assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. Index of albumin, creatinine, glucose, c-creative protein, lymphocyte percentage, mean corpuscular volume, red cell distribution width, alkaline phosphatase, white blood cell count will be examined and calculated into Phenotypic Age.
**Measure:** Calculation of Phenotypic Age based on blood test
**Time Frame:** The calculation will cost 5 minutes. The calculation will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Bone mass will be measured by DEXA (Horizon Wi). Volunteers will be asked to lie on a special DEXA x-ray table. The technologist will help position your correctly and use positioning devices such as foam blocks to help hold the desired position. As the arm of the DEXA machine passes over the body, IT uses two different x-ray beams. The beams use very little radiation to keep the test safer, and help to distinguish bone from other tissues. The scanner translates the bone density measurement data into pictures and graphs. Bone is most easily seen in white, while the, fat and muscle tissue look like shadows in the background on the technologist's computer monitor.
**Measure:** Bone density in g/cm^2 assessed by Horizon Wi
**Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Volunteers will go to the Health Management Center of Shenzhen University General Hospital, where professional doctors will use a photocoherence tomography scanner (Spectralis OCT) for fundus examination, and fundus imaging will be collected without invasiveness and harm. Volunteers need to sit comfortably in a chair and move their face close to the camera device. Technologist will show where to place forehead and chin. Nothing touches volunteers' eye during retinal imaging.
**Measure:** Eye fundus imaging assessed by Spectralis OCT
**Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Facial features are captured using an infrared thermal imager (Fluke RSE600), which are then analyzed using artificial intelligence. When shooting, wait for the thermal imager to focus and press the shutter. During image acquisition, the frame should contain only one subject, whose face and head information are fully collected, and the area above the neck accounts for more than 35% of the thermal image captured. During the collection process, volunteers are reminded to look up at the camera, not to make expressions, not to wear glasses that cover their faces, masks, etc. In the event that the volunteer has bangs or long hair covering their face, the volunteer should be reminded to put on a headband and tie their hair back.
**Measure:** Picture of facial features assessed by Fluke RSE600
**Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Muscle strength will be measure by Jamar Plus+ Digital Hand Dynamometer. Volunteers will comfortably arrange the instrument in his/her hand. Have volunteers squeeze with their maximum strength. The peak-hold needle will automatically record the highest force exerted.
**Measure:** Muscle strength in kilogram assessed by Jamar Plus+ Digital Hand Dynamometer
**Time Frame:** Ten minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina. Volunteers will collect their feces by themselves using a specialized feces collection tubes. They need to submit the samples to the researcher within 30 minutes after collection or they need to first store in the freezer and then submit the sample when available.
**Measure:** Microbiome assessed by Illumina
**Time Frame:** Feces will be collected by volunteers themselves and send to the researchers. Feces will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** The researcher will take a drop of blood from the volunteers' finger stick, use the kit to store the fingerstick blood, and then send it to the company for testing. Biological age score based on glycan biomarkers that indicate inflammation will be available in 3-5 weeks.
**Measure:** Score of GlycanAge assessed by GlycanAge kit
**Time Frame:** Ten minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
#### Primary Outcomes
**Description:** Volunteers will swallow an electronic capsule called e-Celsius (BodyCap, France) which will be activated before use. Four hours after swallowing, the e-Celsius will enter intestine and data collection will start. A device call e-Viewer (KIT EPERF CE-SW, France) will be used to connect the capsules and collect data.
**Measure:** Value of core body temperature in centigrade assessed by e-Celsius
**Time Frame:** Twenty-four hours every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Volunteers will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes.
**Measure:** Value of weight in kilogram assessed by Seca body weight scale
**Time Frame:** Five minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Measured by Seca 217 Stable Stadiometer. Volunteers should not wear shoes and socks. Stand on the stadiometer platform with back against the wall and feet together. Stand up as straight as possible with heels, back, shoulders, and head all touching the wall. Tuck in chin and look straight ahead.
**Measure:** Value of height in meters assessed by Seca 217 stadiometer
**Time Frame:** Five minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** BMI will be calculated based on weight and height according to the formula: BMI=Weight/Height\^2
**Measure:** Value of body mass index (BMI) calculated by weight and height
**Time Frame:** The calculation will cost two minutes every three months for the 6 months of the experiments.The calculation will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). Volunteers should wear no metal jewelries or with metal implants. They should lie down on a movable table and be fasten by technologists. Volunteers should hold still during the test and perform a few small tasks, such as exhale, inhale, and hold breath following the broadcast.
**Measure:** Body composition- volume of fat mass in cm^3 assessed by uMR 790
**Time Frame:** Fifteen minutes every three months for the 6 months of the experiments.The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980). Demographic information of volunteers should be entered before test, including ID number, sex, age, height. When the signal showing the machine is ready, volunteers should stand on the scale without shoes, socks or any pieces which might influence weight. According to the instruction of display screen, volunteers need to hold the handle tightly.
**Measure:** Body composition-weight of fat free mass in gram assessed by Tanita MC-980
**Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Fat free mass will be measured by DEXA (Horizon Wi). Volunteers will be asked to lie on a special DEXA x-ray table. The technologist will help position your correctly and use positioning devices such as foam blocks to help hold the desired position. As the arm of the DEXA machine passes over the body, IT uses two different x-ray beams. The beams use very little radiation to keep the test safer, and help to distinguish bone from other tissues. The scanner translates the bone density measurement data into pictures and graphs. Bone is most easily seen in white, while the, fat and muscle tissue look like shadows in the background on the technologist's computer monitor.
**Measure:** Body composition-wegiht of fat mass in gram assessed by Horizon Wi
**Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Waist circumferences will be measured using a whole body laser scanner (TG2000-F). Volunteers should wear tight underwear during test and stand in front of the machine according to the stickers of instruction. Do some small movement according to instruction.
**Measure:** Waist circumferences in centimeter assessed by TG2000-F
**Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Hip circumferences will be measured using a whole body laser scanner (TG2000-F). Volunteers should wear tight underwear during test and stand in front of the machine according to the stickers of instruction. Do some small movement according to instruction.
**Measure:** Hip circumferences in centimeter assessed by by TG2000-F
**Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** The infrared thermal imager (Fluke RSE600) will be used to measure brown adipose tissue around clavicle. Each subject was in a relaxed "steady-state" within a familiar environment. They were seated in an upright posture, with arms adducted and with head, neck, and shoulders unclothed, in the center of the study room, away from all heat-emitting objects and 1.0 m away from a thermal imaging camera fixed on a tripod at a set distance, 1 m, from the floor. This positioning ensured comfort as well as the optimum position for visualization of the supraclavicular BAT depots. 5 images were taken at 1-minute intervals before each thermal challenge and represented the control period. Each subject then placed 1hand into cool tap water (20℃).The increase in temperature in the thermal area in the supraclavicular region was further collected.
**Measure:** Brown adipose tissue-areas of temperature increase in cm^2 assessed by Fluke RSE600
**Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
#### Secondary Outcomes
**Description:** Physical activity of the volunteers will be recorded using accelerometer (GT3X) worn near the hip for a consecutive period of 7 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days. The acceleration of three axises will be collected and then calculated into the intensity of physical activity.
**Measure:** Intensity of physical activity in three types (light, moderate, vigorous) assessed by GT3X
**Time Frame:** Seven days every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Food intake was monitored using the 24-hour Dietary Review questionnaire (a retrospective record of food intake (quantity and frequency) over the past 24 hours using a self-reported questionnaire).
**Measure:** Weight of food intake in gram assessed by 24-hour Dietary Review Questionnaire
**Time Frame:** One day every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The volunteer attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Metabolic rate (oxygen consumption and CO2 production) are monitored for 40 minutes. The last 10 minutes is used as the measurement. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements. Validation via an alcohol burn will be performed monthly.
**Measure:** Resting metabolic rate in kcal assessed by Cosmed
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for glucose test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of glucose in mmol/L assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for IL-6 test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of IL-6 in ng/L assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for TNF-Alpha test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of TNF-Alpha in ng/mL assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for HDL test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of High-Density Lipoprotein (HDL) in mmol/L assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for LDL test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of Low-Density Lipoprotein (LDL) in mmol/L assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for TG test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of triglyceride (TG) in mmol/L assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
**Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital.
**Measure:** Concentration of insulin in mU/L assessed by clinical blood test
**Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged between 50 and 65 years old (including 50 and 65)
* No surgery in the past 6 months
* Healthy (No metabolic diseases, cardiovascular diseases, lung diseases (COPD, asthma, et al.), endocrine diseases and gastrointestinal diseases)
* Based in Shenzhen during the whole study period
* No significant change on body weight in the past 3 months
Exclusion Criteria:
* Those who need to take medication for a long term (including diet pills)
* On a diet
* Disabled
* Females who are trying to get pregnant, pregnant, or breastfeeding
* Presence of a metal implant in the body (e.g. pacemaker)
* Those with claustrophobia
* Those with blood phobia, pathological hypotension or hypertension
* Those who are in other intervention studies
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** John R Speakman, PhD
**Phone:** 15810868669
**Phone Ext:** 0755-86528487
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yinuo Wang, Master
**Phone:** 15734075325
**Phone Ext:** 0755-86528487
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shenzhen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** John R Speakman, PhD
- **Phone:** 15810868669
- **Phone Ext:** 0755-86528487
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Yinuo Wang, Master
- **Phone:** 15734075325
- **Phone Ext:** 0755-86528487
- **Role:** CONTACT
**Country:** China
**Facility:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
**State:** Guangdong
**Zip:** 518055
#### Overall Officials
**Official 1:**
**Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
**Name:** John R Speakman, PhD
**Role:** STUDY_CHAIR
### 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: M5111
- Name: Body Temperature Changes
- Relevance: HIGH
- As Found: Body Temperature Changes
### Condition Browse Module - Meshes
- ID: D000001832
- Term: Body Temperature Changes
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432478
**Brief Title:** 3D Printed Custom Applicators for HDR BT (DISCO)
**Official Title:** Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
#### Organization Study ID Info
**ID:** DISCO
#### Organization
**Class:** OTHER
**Full Name:** Royal North Shore Hospital
### Status Module
#### Completion Date
**Date:** 2028-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2028-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-11
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Royal North Shore Hospital
#### Responsible Party
**Investigator Affiliation:** Royal North Shore Hospital
**Investigator Full Name:** Marita Morgia
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators.
**Detailed Description:** Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. Current workflows for designing and constructing custom applicators with wax moulds are complex, time consuming and can result in a device that fails to meet original design specifications dictated by the planning system. In contrast, 3D-printed custom applicators provide the ability to design and print patient-specific devices that match optimal design specifications. The workflow for 3D-printed applicators is also more efficient with lower turn-around time and labour/equipment costs, and ensures a more robust product for treatment. Despite these advantages there is currently no radiotherapy department offering 3D printed custom applicators at present. This study will investigate the feasibility of successfully treating gynaecological cancers with 3D-printed custom applicators.
### Conditions Module
**Conditions:**
- Gynecologic Cancer
- Endometrial Cancer
- Vaginal Cancer
- Vulva Cancer
**Keywords:**
- 3D-printed applicator
- Gynaecological Cancer
- Brachytherapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients
**Intervention Names:**
- Device: 3D-printed custom applicator
**Label:** Gynaecological HDR brachytherapy patients
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gynaecological HDR brachytherapy patients
**Description:** 3D-printed custom applicator
**Name:** 3D-printed custom applicator
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** To demonstrate the feasibility of successfully simulating, planning and treating a HDR BT gynaecological patient with a 3D-printed internal mould, such that there is a dosimetric and/or clinical benefit for the patient relative to the current standard of care (cylindrical vaginal applicator). Successful treatment indicated by achieving no adverse events or difference to standard of care, and dosimentic comparisons of the 3D printed applicator plan to the cylinder plan are equivalent or better. Feasibility also determined by achieving no logistical or design issues in using the 3D printed applicators clinically.
**Measure:** Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.
**Time Frame:** 5 years
#### Secondary Outcomes
**Description:** RT acute and late side effects will be assessed and quantified using CTCAE criteria via clinician assessment and PROs
**Measure:** To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria
**Time Frame:** 5 years
**Description:** The plan quality of treatment plans generated for 3D-printed moulds and cylindrical applicators will be compared using dosimetric indices including target coverage (D90, Dose Homogeneity index) and organs at risk doses (D2cc, D1cc and point max) as well as patient comfort. statistical analysis (p-value) and comparison with international guidelines will be used to assess the quality of the treatment plans.
**Measure:** To compare quality of treatment plans generated for 3D-printed moulds and cylindrical applicators assessed by dosimetric indices, statistical analysis (p-value) and comparison with international guidelines.
**Time Frame:** 5 years
**Description:** Feasibility of a pre-planned MR-only procedure will be determined using any of the patients that are accrued to the study who have both a CT and MRI performed at the time of simulation. The applicator and treatment plan will be generated based on the MRI and both compared to the CT-based plan and applicator. Feasibility will be indicated by generating equivalent plan quality and applicators from both methods.
**Measure:** Determine feasibility of a pre-planned MR-only procedure
**Time Frame:** 5 years
**Description:** The initial and final CT plan dosimetry will be compared to determine the feasibility of an initial CT-only process. Clinically insignificant differences between the plan dosimetry metrics and all within clinical tolerances will be used to quantify the difference. statistical analysis (p-value) will be used to assess the quality of the treatment plans.
**Measure:** To determine the feasibility of an initial CT-only process by comparing initial and final CT plan dosimetry assessed by dosimetric indices, clinical tolerances, and statistical analysis (p-value).
**Time Frame:** 5 years
**Description:** The feasibility of an optimised 3D-printed applicator design based on the cylinder fitting procedure will be assessed by comparison of the 3D-printed clinical applicators with applicators derived from CT/MR of the vault in a relaxed state with an expansion applied based on the size of the cylinder applied in the fitting procedure. Feasibility will be determined by looking for a correlation between the size of the 3D printed clinical applicators and the size of the cylinders tolerated by the patient in the fitting procedure.
**Measure:** Determine feasibility of optimising 3D-printed applicator design based on the cylinder fitting procedure
**Time Frame:** 5 years
**Description:** Procedure times will be recorded as per ARIA carepath tasks and time taken within the 3D-printed custom applicator workflow compared to the standard of care cylinder applicator workflow with equivalent or less time taken deemed acceptable
**Measure:** To measure resources such as procedure times and demonstrate acceptable timescales for the process
**Time Frame:** 5 years
**Description:** Costs associated with the 3D-printed design process will be defined and compared with the standard of care process via economic analysis of the resourcing and unit-price estimates in each arm of the respective workflows
**Measure:** To define the resource costs associated with the 3D-printed design process and perform a cost comparison with the standard of care process
**Time Frame:** 5 years
**Description:** Patient experience and acceptability of the 3D-printed simulation and treatment processes will be assessed with the EORTC QLQ-C30 questionnaires and success measured by comparison with the standard of care vaginal cylinder process. Questionnaires include questions with a scale of 1-4 where a higher number indicates a worse experience and a scale of 1-7 where a lower number indicates a worse experience.
**Measure:** To assess patient experience and acceptability of the process with questionnaires
**Time Frame:** 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Able to give informed consent
* Patients indicated for intracavitary brachytherapy
* FIGO stage I-IVA
* ECOG 0-2
* Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer
Exclusion Criteria:
* Pregnancy
* Patients contraindicated for brachytherapy
* Inflammatory bowel disease/history of adhesions/bowel obstruction
* Renal transplant/horseshoe kidney
* Patients with significant LVSI or pelvic sidewall invasion
* Patients requiring interstitial brachytherapy implants
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Marita Morgia, MD
**Phone:** 9463 1300
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jeremy Booth, PhD QMP
**Phone:** 94631300
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** St Leonards
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Carol Kwong
- **Phone:** 02 9463 1339
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Heidi Tsang
- **Phone:** 02 9463 1340
- **Role:** CONTACT
**Country:** Australia
**Facility:** Royal North Shore Hospital
**State:** New South Wales
**Status:** RECRUITING
**Zip:** 2067
#### Overall Officials
**Official 1:**
**Affiliation:** Royal North Shore Hospital
**Name:** Marita Morgia, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Royal North Shore Hospital
**Name:** Jeremy Booth, PhD QMP
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014594
- Term: Uterine Neoplasms
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000014591
- Term: Uterine Diseases
- 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
- ID: D000014623
- Term: Vaginal Diseases
- ID: D000014845
- Term: Vulvar Diseases
### 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M17589
- Name: Vulvar Neoplasms
- Relevance: HIGH
- As Found: Vulva Cancer
- ID: M17373
- Name: Vaginal Neoplasms
- Relevance: HIGH
- As Found: Vaginal Cancer
- ID: M19235
- Name: Endometrial Neoplasms
- Relevance: HIGH
- As Found: Endometrial Cancer
- ID: M17342
- Name: Uterine Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17339
- Name: Uterine Diseases
- Relevance: LOW
- As Found: Unknown
- 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
- ID: M17371
- Name: Vaginal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17588
- Name: Vulvar Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5877
- Name: Vulvar Cancer
- Relevance: LOW
- As Found: Unknown
- ID: T5829
- Name: Vaginal Cancer
- Relevance: HIGH
- As Found: Vaginal Cancer
### Condition Browse Module - Meshes
- ID: D000016889
- Term: Endometrial Neoplasms
- ID: D000014625
- Term: Vaginal Neoplasms
- ID: D000014846
- Term: Vulvar Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432465
**Brief Title:** tDCS to Decrease Opioid Relapse (UH3)
**Official Title:** tDCS to Decrease Opioid Relapse (UH3)
#### Organization Study ID Info
**ID:** 1317333
#### Organization
**Class:** OTHER
**Full Name:** Butler Hospital
#### Secondary ID Infos
**ID:** 4UH3DA047793
**Link:** https://reporter.nih.gov/quickSearch/4UH3DA047793
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
#### Lead Sponsor
**Class:** OTHER
**Name:** Butler Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. In Phase I, the EEG provided validation of expected changes in these networks following tDCS stimulation of the DLPFC. In this current phase (II), the investigators will perform a larger randomized clinical trial (RCT) (active vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes.
**Detailed Description:** Investigators will perform an RCT in 100 opioid dependent participants who recently initiated buprenorphine or methadone. Participants will be randomized to receive five sessions of tDCS+CCN priming stimulation vs. sham tDCS+CCN priming. Participants will be assessed three times using electroencephalographic (EEG), once prior to tDCS+CCN priming, right after the completion of 5 sessions of tDCS+CCN priming (one week later), and again 10 weeks later.
This phase will address long-term (3- and 6-month) neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes during a paradigm that challenges networks associated with craving (CR) and cognitive control (CCN). During the 24 weeks of buprenorphine or methadone maintenance treatment, the investigators will examine our primary clinical outcome, relapse (opioid use on \>4 days per month and having an opioid positive urine screen), as well as days of opioid use.
### Conditions Module
**Conditions:**
- Opioid Use Disorder
**Keywords:**
- opioid craving
- buprenorphine
- methadone
- EEG
- transcranial direct current stimulation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
**Intervention Names:**
- Device: tDCS
**Label:** tDCS
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
**Intervention Names:**
- Device: tDCS
**Label:** sham tDCS
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- sham tDCS
- tDCS
**Description:** The anode will be placed over the right DLPFC (F4 on the EEG 10-20 system) and the cathode over the left DLPFC65 (F3) using 25cm2 sponges at an intensity of 2mA. Stimulation will be delivered via two saline-soaked surface sponge electrodes and a battery-driven, constant current stimulator (NeuroConn DC Stimulator Plus). This device includes a study mode, in which subject-specific codes are entered to deliver active or sham stimulation, keeping the administrator blinded. Sham stimulation will use a method in which stimulation will be ramped up and back down over a 30-second period at the beginning and end of sham tDCS.
**Name:** tDCS
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Penn Alcohol Craving (Modified for Opioids) (scoring: 0 - 30, higher scores = more craving)
Penn Alcohol Craving (Modified for Opioids) (scoring: 0 - 30, higher scores = more craving)
Penn Alcohol Craving (Modified for Opioids) (scoring: 0-30, higher scores = more craving)
**Measure:** Changes in opioid craving
**Time Frame:** 2 weeks
**Description:** frontal theta activity during working memory
**Measure:** change in EEG oscillatory targets
**Time Frame:** 2 weeks
**Description:** Timeline followback interview and urine toxicology
**Measure:** lower rates of opioid relapse
**Time Frame:** 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
(a) current opioid dependence, (b) between 21-60 years of age, (c) recent initiation of buprenorphine or methadone (≤30days), and (d) enrolled in Butler Hospital's Alcohol and Drug Inpatient Unit, Alcohol and Drug Partial Hospital Treatment Program, Intensive Outpatient Services, or Outpatient Services at Butler Hospital OR receive opioid-treatment services in the community.
Exclusion Criteria:
(a) current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus), (b) bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder, (c) current suicidality, (d) evidence of significant neurocognitive dysfunction, (e) conditions associated with heightened tDCS risks, e.g., seizure disorder, nonremovable intracranial metal objects (other than dental fillings and dental implants), skin disease or active lesions on the scalp, migraine/other headache disorder with significant active symptoms, traumatic brain injury or skull fracture within the past year, any implanted medical devices or device components that can interact with electromagnetic fields or are controlled by physiological signals, (f) probation/parole requirements or an upcoming move that might interfere with protocol participation, (g) planning to terminate buprenorphine or methadone in less than 3 months, (h) current pregnancy or plan to become pregnant in the next month.
**Maximum Age:** 60 Years
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ana M Abrantes, Ph.D.
**Phone:** 4014556440
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Julie A Desaulniers, M.S.
**Phone:** 4014556219
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Providence
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ana M Abrantes, Ph.D.
- **Phone:** 401-455-6440
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ana M. Abrantes, Ph.D.
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Michael Stein, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Butler Hospital
**State:** Rhode Island
**Status:** RECRUITING
**Zip:** 02906
#### Overall Officials
**Official 1:**
**Affiliation:** Butler Hospital
**Name:** Abrantes Abrantes, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Boston University
**Name:** Michael Stein, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000079524
- Term: Narcotic-Related Disorders
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12244
- Name: Opioid-Related Disorders
- Relevance: HIGH
- As Found: Opioid Use Disorder
- ID: M2057
- Name: Narcotic-Related Disorders
- Relevance: LOW
- As Found: Unknown
- 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
### Condition Browse Module - Meshes
- ID: D000009293
- Term: Opioid-Related Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: NarcAntag
- Name: Narcotic Antagonists
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnTuAg
- Name: Antitussive Agents
- Abbrev: Resp
- Name: Respiratory System Agents
### Intervention Browse Module - Browse Leaves
- ID: M5317
- Name: Buprenorphine
- Relevance: LOW
- As Found: Unknown
- ID: M11671
- Name: Methadone
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432452
**Acronym:** EDIT-CAS
**Brief Title:** Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm
**Official Title:** Efficacy of Endothelin Receptor Antagonism in Treatment of Coronary Artery Spasm: a Randomized Controlled Clinical Trial
#### Organization Study ID Info
**ID:** 114746
#### Organization
**Class:** OTHER
**Full Name:** Radboud University Medical Center
### Status Module
#### Completion Date
**Date:** 2026-04-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** UMC Utrecht
**Class:** OTHER
**Name:** Catharina Ziekenhuis Eindhoven
**Class:** OTHER
**Name:** Maasstad Hospital
#### 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
**Is US Export:** False
### Description Module
**Brief Summary:** The goal of this randomized clinical trial is to assess if adjunctive bosentan therapy, in comparison to placebo, can reduce the rate of epicardial vasospasm at follow-up spasm provocation CFT (fuCFT) in patients with previously proven epicardial vasospasm on acetylcholine reactivity testing (at index CFT) and ongoing angina(-like) complaints.
Participants will
* Use either endothelin receptor antagonist or placebo for 10 weeks
* Undergo follow-up acetylcholine spasm provocation test after 10 weeks
* Answer online questionnaires on angina and quality of life
### Conditions Module
**Conditions:**
- Coronary Spasm
**Keywords:**
- epicardial spasm
- endothelin receptor antagonism
- angina
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Bosentan 62.5 mg twice daily Uptitrated to 125mg twice daily if tolerated after 4 weeks Total 10 weeks
**Intervention Names:**
- Drug: Endothelin Receptor Antagonist
**Label:** Bosentan
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo 62.5 mg twice daily Uptitrated to 125mg twice daily if tolerated after 4 weeks Total 10 weeks
**Intervention Names:**
- Other: Placebo control
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bosentan
**Description:** Oral capsules twice daily
**Name:** Endothelin Receptor Antagonist
**Other Names:**
- Bosentan
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Oral capsules twice daily
**Name:** Placebo control
**Other Names:**
- Placebo
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Measured with EuroQol 5 Dimensions (EQ5D) and separate SAQ domains. Scores can range from 0-100, with higher scores indicating better health status.
**Measure:** Improvement of quality of life
**Time Frame:** 10 weeks
**Description:** The rate of occurence of microvascular spasm according to COVADIS criteria at fuCFT
**Measure:** Microvascular spasm
**Time Frame:** 10 weeks
**Description:** Circulating endothelin-1 plasma levels in peripheral blood drawn at visit 1.
**Measure:** Endothelin levels at baseline
**Time Frame:** 10 weeks
**Description:** Any deterioration or improvement according to prespecified outcomes measured by repeated spasm provocation test. If a higher dose of acetylcholine is needed to induce epicardial spasm for example, this change will be documented. If microvascular spasm can, but epicardial can not be provoked, this will be documented. The incidence of these changes will be analyzed.
**Measure:** Change in spasm provocation reactivity
**Time Frame:** 10 weeks
**Description:** Assessed by means of repeat laboratory analysis
**Measure:** Incidence of liver panel disturbances
**Time Frame:** 10 weeks
**Description:** Assessed by means of repeat blood pressure measurements
**Measure:** Incidence of hypotension
**Time Frame:** 10 weeks
**Description:** Assessed by (S)AE reporting, during all follow-up contacts
**Measure:** Incidence of MACE
**Time Frame:** 10 weeks
**Description:** Assessed and captured at every follow-up contact moment.
**Measure:** Rate of study drug discontinuation / study withdrawal.
**Time Frame:** 10 weeks
#### Primary Outcomes
**Description:** On repeat invasive spasm provocation according to Coronary Vasomotor Disorders International Study Group (COVADIS) criteria. Successful treatment is defined as absence of epicardial vasospasm according to COVADIS criteria during repeat spasm provocation test at 10 weeks.
**Measure:** Successful treatment
**Time Frame:** 10 weeks
#### Secondary Outcomes
**Description:** As measured with Seattle Angina Questionnaire (SAQ) summary score and change from baseline to follow-up. Score can range from 0-100, with higher scores indicating better health status.
**Measure:** Improvement of anginal complaints
**Time Frame:** 10 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Definitive diagnosis of epicardial vasospasm on maximal acetylcholine dose of 100µg (at iCFT)
2. At least 18 years of age
3. On optimal regular care ( current or previous treatment with at least 2 daily anti-anginal medicines i.e. nitrate and calcium channel blocker
4. Continuing episodes of angina(-like) complaints at least once weekly despite 3.
5. Signed online informed consent for participation in NL-CFT registry (the Netherlands Registry of invasive coronary vasomotor function testing), or willing to co-sign for registry at time of inclusion in EDIT-CAS
6. Written informed consent for EDIT-CAS
Exclusion Criteria:
1. Systolic blood pressure (SBP) \<85 mmHg measured at Visit 1
2. Significant hepatic impairment at time of iCFT lab (ASAT/ALAT \>3x upper limit of normal (ULN)) or history of liver cirrhosis (Child-Pugh 7-15)
3. Severe anemia (Hb\<6.0mmol/L) without identified cause at time of inclusion
4. Patients with limited life expectancy (\<1 year)
5. Participation in another randomized clinical study with an use of an Investigational Medicinal Product (IMP) up to one month prior to enrolment.
6. Pregnancy, active desire to become pregnant or unwilling to take adequate\* contraceptive measures when of child bearing potential for the duration of 6 months (active medication period + 3 months safety).
7. Known heart failure with reduced ejection fraction\<35%
8. Known pulmonary hypertension of any type
9. Potentially dangerous interaction due to the use of another CYP3A4 or CYP2C9 substrate (e.g. ciclosporin A, glibenclamide, fluconazole, rifampicin, tacrolimus/sirolimus, lopinavir/ritonavir)
10. Repeat spasm provocation test deemed unsafe (e.g. allergic reaction at iCFT)
* Adequate in this case meaning if on hormonal contraceptives, additional measures to be taken (e.g. condom).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Peter Damman
**Phone:** 0243616785
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Caïa Crooijmans
**Phone:** 0243096546
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Eindhoven
**Contacts:**
***Contact 1:***
- **Name:** Annemiek de Vos, MD
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Catharina Ziekenhuis
**State:** Noord-Brabant
**Zip:** 5623EJ
**Location 2:**
**City:** Rotterdam
**Contacts:**
***Contact 1:***
- **Name:** Valeria Paradies, MD, PhD
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Maasstad Hospital
**State:** Zuid-Holland
**Zip:** 3079DZ
**Location 3:**
**City:** Nijmegen
**Contacts:**
***Contact 1:***
- **Name:** Peter Damman, MD, PhD
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** RadboudUMC
**Zip:** 6525GA
**Location 4:**
**City:** Utrecht
**Contacts:**
***Contact 1:***
- **Name:** Tim van de Hoef, MD, PhD
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** UMC Utrecht
**Zip:** 3584CX
#### Overall Officials
**Official 1:**
**Affiliation:** Radboud University Medical Center
**Name:** Peter Damman, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000003327
- Term: Coronary Disease
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular 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: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M15837
- Name: Spasm
- Relevance: HIGH
- As Found: Spasm
- ID: M4117
- Name: Angina Pectoris
- Relevance: LOW
- As Found: Unknown
- ID: M12077
- Name: Muscle Cramp
- Relevance: HIGH
- As Found: Spasm
- ID: M6551
- Name: Coronary Vasospasm
- Relevance: HIGH
- As Found: Coronary Artery Spasm
- ID: M22619
- Name: Neuromuscular Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M6549
- Name: Coronary Disease
- Relevance: LOW
- As Found: Unknown
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009120
- Term: Muscle Cramp
- ID: D000013035
- Term: Spasm
- ID: D000003329
- Term: Coronary Vasospasm
### Intervention Browse Module - Ancestors
- ID: D000000959
- Term: Antihypertensive Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: AnAg
- Name: Antihypertensive Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1753
- Name: Bosentan
- Relevance: HIGH
- As Found: FFR
- ID: M30466
- Name: Endothelin Receptor Antagonists
- Relevance: HIGH
- As Found: Acetylcholine Receptor
- ID: M4277
- Name: Antihypertensive Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077300
- Term: Bosentan
- ID: D000065128
- Term: Endothelin Receptor Antagonists
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432439
**Brief Title:** Impact of Microneedling on Coverage of RT1 Gingival Recession in Thin Phenotype.
**Official Title:** Microneedling And Its Effect On Outcome Of Root Coverage With Coronally Advanced Flap Involving Isolated RT1 Maxillary Gingival Recession In Thin Gingival Phenotype: A Randomized Controlled Clinical Trial
#### Organization Study ID Info
**ID:** Amisha perio
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Gingival Recession (GR) is a common finding in among adults, regardless of the oral hygiene levels. When it is associated with esthetic impairment, dentin hypersensitivity, root caries, surgical treatment is indicated. Mid-buccal Gingival Recessions are an extremely prevalent condition and have root coverage potential through periodontal plastic surgery procedures.
A flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in Coronally Advanced Flap (CAF)procedure.
The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by CAF procedures in thin gingival phenotype.
**Detailed Description:** Gingival recession is defined as the migration of the marginal tissue toward the apical of the cementoenamel junction. It is one of the most common mucogingival deformities requiring surgical correction. The rationale for treating buccal recessions are mainly aesthetic concerns, and clinical situations where unfavourable contour of the gingival margin might be an obstacle for proper plaque control. Cairo et al in 2018 categorised GRs into 3 types with reference to interdental clinical attachment loss as RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap is a simple and predictable treatment of gingival recession defects. It has been observed that a flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in CAF procedure. Microneedling (MN), creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors are released. MN as opposed to Connective Tissue Grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the Gingival Thickness of individuals with thin gingival phenotype.
### Conditions Module
**Conditions:**
- Gingival Recession, Localized
**Keywords:**
- microneedling
- phenotype
- gingival recession
- coronally advanced flap
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Isolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures
**Intervention Names:**
- Procedure: microneedling followed by CAF procedures
**Label:** TEST GROUP
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Isolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone.
**Intervention Names:**
- Procedure: CAF procedure
**Label:** CONTROL GROUP
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TEST GROUP
**Description:** microneedling will be done on gingiva of RT1 recession tooth in 4 sessions followed by CAF 2months later for root coverage
**Name:** microneedling followed by CAF procedures
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- CONTROL GROUP
**Description:** RT1 gingival recession coverage by CAF procedures alone.
**Name:** CAF procedure
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.
**Measure:** Recession Depth
**Time Frame:** 3 months
**Description:** recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.
**Measure:** RECESSION WIDTH (RW)
**Time Frame:** 3 months
**Description:** calculated according to the formula Root Coverage percentage = Recession depth (preop-postop)\*100 Recession depth preoperative
**Measure:** ROOT COVERAGE PERCENTAGE
**Time Frame:** 3 months
**Description:** GT is measured with the help of No:15 endodontic spreaders with silicon disc as stopper was inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue was felt. The depth of penetration was noted using digital calliper
**Measure:** Gingival thickness(GT)
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** Clinical attachment level will be measured as the distance between the cemento- enamel junction and the base of pocket. Measurements will be made at 6 sites of each tooth
**Measure:** CLINICAL ATTACHMENT LEVEL (CAL)
**Time Frame:** 3 months
**Description:** Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. The probing depth measurements will be assessed using the Periodontal probe
**Measure:** Probing Pocket Depth (PPD)
**Time Frame:** 3 months
**Description:** It will be measured by walking the periodontal probe at 6 sites of each tooth
**Measure:** Bleeding on Probing (BOP)
**Time Frame:** 3 months
**Description:** For the scoring, a mouth mirror, an explorer and a light source will be used on air dried teeth and gingiva
**Measure:** Plaque Index (PI)
**Time Frame:** 3 months
**Description:** Gingival index by Loe and Silness (1963)22 will be used to assess severity of gingival inflammation
**Measure:** Gingival Index (GI
**Time Frame:** 3 months
**Description:** Keratinized tissue width will be measured with the help of UNC 15 probe with silicon stopper from the mucogingival junction to the free gingival margin and measured on vernier caliper
**Measure:** Keratinized Tissue Width (KTW)
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** INCLUSION CRITERIA:
* Presence of isolated (RT1) by Cairo et al 2011 buccal maxillary gingival recessions in esthetic zone including maxillary central incisors, lateral incisors and canines associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
* Gingival Recession ≥2mm and clinically identifiable CEJ
* Age 20years-50 years
* Patient demonstrating compliance for maintaining good oral hygiene after Phase 1 thearpy Plaque index (PI) \<1, Gingival Index (GI) \<1
* Providing a written and verbal informed consent.
EXCLUSION CRITERIA
* Patient with systemic disease that can influence the outcome of therapy.
* Pregnant females or on oral contraceptive pills or hormone replacement therapy.
* Smokers and patients undergoing orthodontic therapy
* Physically and mentally impaired patients.
* Non vital, malpositioned tooth
* Presence of cervical abrasions or restorations in the area
* Previous history of periodontal surgery on the involved sites.
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nishi Tanwar, MDS
**Phone:** 8368126310
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Amisha Goyal, BDS
**Phone:** 9718413637
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS
**Name:** Amisha Goyal, BDS
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005882
- Term: Gingival Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000055093
- Term: Periodontal Atrophy
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9001
- Name: Gingival Recession
- Relevance: HIGH
- As Found: Gingival Recession
- ID: M8994
- Name: Gingival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- 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: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M28025
- Name: Periodontal Atrophy
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005889
- Term: Gingival Recession
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432426
**Brief Title:** Virtual Exercise on Elderly Breast Cancer Survivors
**Official Title:** The Effect of Virtual Exercise on Elderly Breast Cancer Survivors on Functionality, Muscular Strength, and Quality of Life Effecto-B):
#### Organization Study ID Info
**ID:** 38330628
#### Organization
**Class:** OTHER
**Full Name:** Pontificia Universidad Catolica de Chile
### Status Module
#### Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Pontificia Universidad Catolica de Chile
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Breast cancer (BC) is the most common neoplasia. Frequent for women and half of the new cases occur in people over 65 years of age. The treatment of BC generates adverse effects that deteriorate the physical functionality, muscle strength and quality of life of the survivors. This is more noticeable in elderly BC survivors. Physical exercise improves some adverse effects of BC, but few studies have focused on physical functionality, especially in older people. The elderly population reports the lowest adherence and lower level of physical activity. It is relevant to explore innovative and specific proposals for physical exercise for elderly survivors of BC. One solution may be virtual reality game-based exercise, which has been shown in healthy older people to significantly improve physical functionality and adherence compared to traditional physical exercise. The objective of our study is to estimate the feasibility and effect of a virtual reality-based exercise program on the functionality, muscle strength, and quality of life of older BC survivors, compared to a group undergoing traditional physical exercise.
**Detailed Description:** This is a randomized controlled study. It will be conducted at the Dr. Sotero del Río Assistance Complex, which receives Southeast Metropolitan Health Service patients. Participants: 60 women over 60yrs who completed their antineoplastic treatment at least two years ago will be recruited.
Functionality will be measured using the Short Physical Performance Battery (SPPB), which is specific for older individuals. Hydraulic Dynamometry (Jamar © hydraulic hand dynamometer) will evaluate isometric upper limb muscle strength. Quality of life shall be assessed using the EORTC QLQ C30 Quality of Life Questionnaire - with its EORTC QLQ-ELD14 module, validated in the Chilean population. Feasibility will be measured using recruitment rate (≥50%), retention rate (≥ 80%), adherence rate (75% of total sessions ≥14 sessions), and incidence of adverse events.
Candidates will be randomly assigned to either virtual reality or traditional exercise groups. Both training groups will involve supervised sessions twice a week for nine weeks. The traditional exercise group exercises will be for arms and legs, involving body weight and external weights. Meanwhile, the virtual reality group will follow a physical exercise protocol using the "Nintendo Wii Fit" console. After the 9th week, participants will be evaluated one month after completing the training program.
### Conditions Module
**Conditions:**
- Breast Cancer
**Keywords:**
- breast neoplasm
- elderly
- physical exercise
- virtual reality
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will undergo a postural balance rehabilitation program, utilizing a probed protocol for the elderly population with virtual reality via the Nintendo Wii Fit® and its peripheral Balance Board system. Supervised group sessions will be conducted twice a week for 9 weeks.
**Intervention Names:**
- Behavioral: Virtual reality training group
**Label:** Virtual Reality Training Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will undergo a standardized physical exercise program based on a validated protocol designed for elderly breast cancer survivors
**Intervention Names:**
- Behavioral: Standard physical exercise group
**Label:** Standard physical exercise Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Virtual Reality Training Group
**Description:** Participants will be given virtual reality games on Nintendo Wii Fit® and its peripheral Balance Board system. This equipment offers safe and engaging training protocols. Additionally, it ensures physical exercise in the three planes of movement (sagittal, frontal, and transverse) and with three difficulty levels, thus providing a linear progressive demand.
**Name:** Virtual reality training group
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Standard physical exercise Group
**Description:** Participants will be submitted to a standard physical exercise program based on the ACSM guidelines. Resistance training will involve exercises for arms and legs, using bodyweight self-loading and external weights. Balance exercises will include the three planes of movement.
**Name:** Standard physical exercise group
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Functionality will be measured by the Short Physical Performance Battery (SPPB). This battery is specific for older individuals and assess balance, walking speed, and lower extremity strength/endurance. It is a tool with moderate to excellent validity and excellent test-retest reliability (ICC=0.91).
**Measure:** Change in the functionality
**Time Frame:** Baseline, week 9 and week 13
#### Secondary Outcomes
**Description:** Upper body muscle strength will be assessed by manual grip strength measured with a hydraulic dynamometer (Jamar© hydraulic hand dynamometer) in kilograms. It is considered the gold standard for quantitative and objective evaluation of isometric hand and forearm muscle strength.
**Measure:** Change in upper limb muscle strength
**Time Frame:** Baseline, week 9 and week 13
**Description:** Lower body muscle strength will be measured using the 30-second Chair Stand Test. It has excellent validity and reliability in older adults. It is measured in the number of repetitions. The number of times the person can stand up from the chair in 30 seconds is recorded.
**Measure:** Change in lower limb muscle strength
**Time Frame:** Baseline, week 9 and week 13
**Description:** Quality if life will be assessed with the QLQ C-30 questionnaire and the specific module QLQ-ELD14. The questionnaire could be self-administered and is validated to assess health-related quality of life in breast cancer patients. It has been validated in Spanish and in the Chilean population. Better quality of life is defined by a higher score (0-100) for global health status or overall quality of life.
**Measure:** Change in the quality of life score
**Time Frame:** Baseline, week 9 and week 13
**Description:** It will be measured by the recruitment rate (\>50%), retention rate (\>80%), adherence rate (75% of total sessions \>14 sessions), and the incidence of adverse effects. The measurements will be reported together as feasibility
**Measure:** Feasibility assesment
**Time Frame:** Baseline, week 1-9 and week 13
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women between 60 and 80 years old.
* Diagnosis of primary breast carcinoma.
* Treated with at least two of the following treatments: surgery, radiotherapy, chemotherapy, hormone therapy, biological therapy.
* Minimum of 2 years and a maximum of 10 years after finishing treatments (surgery, chemotherapy, and radiotherapy).
* Being able to walk at least 4 meters independently or with a cane as assistive technology
Exclusion Criteria:
* Stage IV breast cancer.
* Previous cancer treatment for any type of cancer other than breast cancer (chemotherapy, radiotherapy, or endocrine therapy).
* Cognitive impairment measured by the abbreviated Mini-Mental State Examination with a score \< 13 points.
* Medical contraindication to perform physical exercise.
* Self-reported of physical activity equivalent to the recent American College of Sports Medicine Exercise Guidelines for Cancer Patients and Survivors (150 min/week of moderate aerobic exercise and strength exercise twice a week).
* Body mass index \< 18.5 kg/m2 or \> 40 kg/m2.
**Maximum Age:** 80 Years
**Minimum Age:** 60 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Karol Ramírez-Parada, PT
**Phone:** 22 3541168
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Santiago
**Contacts:**
***Contact 1:***
- **Name:** Karol Ramírez-Parada
- **Role:** CONTACT
***Contact 2:***
- **Name:** Scarlet Muñoz
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** Karol Ramírez-Parada
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Chile
**Facility:** Complejo Asistencial Dr. Sótero del Río
**State:** Puente Alto
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Pontificia Universidad Catolica de Chile
**Name:** Karol Ramírez-Parada, PT
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- 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: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432413
**Brief Title:** Emerging Role of NOTCH-related Long Non-coding RNA(s) as Biomarkers in Liquid Biopsy From Colorectal Cancer Patients
**Official Title:** Emerging Role of NOTCH-related Long Non-coding RNA(s) as Biomarkers in Liquid Biopsy From Colorectal Cancer Patients
#### Organization Study ID Info
**ID:** RHDIRB2020110301 REC #15
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2022-12-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-10-30
**Type:** ACTUAL
#### Start Date
**Date:** 2021-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This work aims to Investigate the role of circulating notch associated lncRNAs SNHG3 and LUNAR1 as possible non invasive prognostic biomarkers for colorectal cancer (CRC) monitoring via measuring the gene expression level of lncRNAs SNHG3 and LUNAR1 in serum of CRC patients compared with control subjects. Also, to investigate the correlation between SNHG3 and LUNAR1 expression levels and CRC clinicopathological features and their relevance for CRC patients' clinico-pathological features outcomes assessment
**Detailed Description:** 1. INTRODUCTION Background: Colorectal cancer (CRC) has been identified as a major public health concern given its high incidence and mortality rates (1). In 2020, CRC was the third-most prevalent malignancy after breast and lung cancer, accounting for 10% of new cases and ranking second in terms of mortality with 9.4% of deaths (2). Unfortunately, by year 2030, more than 2.2 million new cases and 1.1 million fatalities from CRC are globally anticipated (3).
Problem: Despite significant improvements in CRC surgical or radiological interventional treatment approaches with neo-adjuvant therapies, patients' prognosis remains bleak (4,5). Metastases and post-surgical tumor recurrence are prevalent, particularly, in more advanced cancer cases (6), which may account for the increased number of cases and fatalities prediction, being against the national efforts for achieving Egypt Vision 2030 implementing SDGs.
Problem statement: Conventionally used CRC prognostic markers for monitoring treatment outcome and pointing to cancer recurrence are carbohydrate antigen 19.9 (CA19.9) and/or carcinoembryonic antigen (CEA) that are not that sensitive (7) per patients subclassification or stratification related to CRC pathological characteristics for more efficient and earlier prognosis. Thence, a growing demand for sensitive and precise bio-molecular marker(s) better correlating with CRC prognostic markers and/or CRC clinical outcome (8), that is if successful would constitute the bases for "Better Health" SDG#3 and less cancer recurrence and, therefore, less mortality.
Liquid biopsies are used for cancer diagnosis or prognosis, like breast cancer, leukemia, liver cancer or CRC, via measurement of tumor-derived bio-molecular markers including circulating ncRNAs including long non-coding RNAs (lncRNAs), microRNA, exosomal ncRNAs, oncogenes or tumor suppressor genes, and their mutations, tumor-related-cytokines, and down-stream target proteins (9-22).
After extensive literature search and mining to mind-the-research-gap(s) for better "Cancer Epigenetics Study; a Step-toward ncRNA-Precision" we have chosen, in the current work, two notch-related lncRNAs to study in relation-to-CRC prognosis.
Notch-signaling pathway is an ubiquitous cascade within species to control a broad variety of biological events, including cell division, proliferation, and cell death (23,24). Recent investigations have revealed the fundamental role of Notch-cascade in CRC evolution (25). Intestinal epithelial cells' homeostatic self-renewal and tumor-promoting transformation can both be managed by Notch signaling (26). Stimulation of Notch-cascade can be epigenetically triggered by dysregulated non-protein coding RNAs' (ncRNAs) expressions (27); a hot area of research nowadays to figure out the impact of Notch-related ncRNAs on CRC risk and/or progression.
The significant utility of tumor-expressed Notch-associated lncRNAs as prognostic malignancy indicators proves how they are connected to carcinogenesis or metastasis and therefore, reflect the outcome(s) in different cancer types including CRC (28-31).
Small Nucleolar RNA Host Gene3 (SNHG3) is 4950bp lncRNA situated on chromosome 1p35.3 (32). In breast cancer, upregulated SNHG3 triggers Notch system activation as a result of its competitive binding to human homo sapiens (hsa) micro-RNA (miR) hsa-miR-154-3p exacerbating proliferation and metastasis of cancer cells (33). Moreover, SNHG3 positively regulates Notch1 expression in ovarian cancer through hsa-miR-139-5p suppression, accelerating tumor cells' proliferation and migration (34). SNHG3 exerted a carcinogenic role in prostate cancer, osteosarcoma, glioma, gastric cancer, laryngeal cancer, bladder cancer, and CRC (32). Huang et al. reported SNHG3 elevated expression in CRC cells and tissues, stimulating cancer progression through sponging hsa-miR-182-5p (35). Therefore, SNHG3 is considered as a malignancy enhancer that regulates Notch system in various cancer types.
Leukemia-associated nc-insulin-like growth factor1 receptor (IGF1R)-Activator RNA1 (LUNAR1) serves as a downstream target of Notch-signaling, in the same time LUNAR1 acts through Notch-signaling stimulation. LUNAR1 is a transcript of 491 nucleotides (nt) gene on chromosome 15q26.3 with four exons and poly (A) tail (36). LUNAR1 was identified to be elevated in CRC tissues, triggered by Notch1 stimulation, accelerating CRC progression via retaining IGF1R expression (37), being a positive regulator of cell division Aim of the study: Per, few research publications on both notch-related lncRNAs, SNHG3 and LUNAR1, in CRC prognosis or CRC risk assessment as well as patients' stratification based on clinico-pathological characteristics, therefore, assessment of the clinical utility of SNHG3 and LUNAR1 lncRNAs fold change expressions in CRC patients' peripheral blood liquid biopsy is alarming (as step toward implementing ncRNA precision) Study objective(s) to assess, first, the expression level and pattern of Notch-associated lncRNAs SNHG3 and LUNAR1 in peripheral blood liquid biopsy, polled from treatment-naïve Egyptian CRC patients' cohort, compared to age-matched and sex-matched apparently healthy volunteer subjects as controls. Second, to evaluate lncRNAs SNHG3 and LUNAR1 expression usefulness as sensitive, non-invasive prognostic bio-molecular marker(s) for CRC monitoring. Third, to investigate the correlation between SNHG3 and LUNAR1 expression with CRC clinic-pathological features. Finally, to explore the relevance of the investigated lncRNAs for CRC patients' clinical features outcomes assessment. All these objectives to be confirmed or ruled out by in silico analysis and bioinformatics databases search SUBJECTS 2.1. Sample Size and Power of the Study. In accordance with prior reference studies (36,38) the sample size was estimated utilizing sample size online calculator https://riskcalc.org/samplesize/# for comparison of the area under the curve (AUC) with a null hypothesis value (done January, 2021) through using two-sided significance level of 0.05 and the power (1-beta) of 0.95 as the two-sided confidence level of 95%. Groups will be 45 samples for CRC patients and 17 controls for SNHG3 and 48 CRC patients' vs 16 controls for LUNAR1.
2.2. Study Design. Case-controlled, retrospective observational study. The study was carried out from June, 2021 to October, 2022.
2.3. Institutional Review Board (IRB) Statement: This study was ethically approved by the review board Research Ethical Committee (REC) of Faculty of Pharmacy, Ain Shams University (REC ID 15, 2021) that was approved by the Faculty of Medicine, Ain Shams University Hospitals, Ain Shams University REC. This research investigation was conducted out in compliance with Declaration of Helsinki principles World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects, 2013. Every volunteering participant in the study, whether apparently healthy controls or CRC patients, were fully aware of the study's objective and signed a written comprehensive informed consent (I.C) form (ethically-approved) were considered in.
2.4. Study Participants 2.4.1. Patients group. 70 CRC Egyptian patients, admitted to the Oncology Center of the Faculty of Medicine, Ain Shams University Hospitals (ASUH) or the Oncological Surgery Department of Dar-El-Shafa Hospital, before surgical treatment or CRC neo-adjuvant treatment, if they were eligible and agreed to participate (signed the I.C) were recruited in the research. Male-to-female was 30:40 with an age-range; minimum-maximum 24 -79 years.
2.4.2. Apparently healthy control group. 26 randomly-chosen, age-matched, and sex-matched healthy subjects served as the control group. Male-to-female was 9:17 and age range; minimum-maximum 35 -78 years. Control group subjects were chosen from those who came to visit hospital workers in the hospital or from blood donors at the ASUH Blood Donation Unit. None of the control group did take any medications or have any diseases upon questioner and blood samples was taken for CBC.
2.4.3. Inclusion and Exclusion Criteria Patients, came to the Oncology Center of ASUH or the Oncological Surgery Department of Dar-El-Shafa Hospital, who experienced a range of colonic symptoms, such as constipation, abdominal discomfort, rectal bleeding, and abrupt weight loss were included in the study when diagnosis of CRC was clinically confirmed by abdominal radiography, colonoscopy, and histopathology.
Exclusion criteria patients who received chemotherapy, radiotherapy or undergone surgery. Patients with other types of cancer were also excluded. Individuals with missing data were not included.
2.4.4. Patients Pathological and Clinical Data For each CRC participant colonoscopy outcomes, abdominal radiographic imaging, pathological evaluations were used to define CRC staging. Tumor lymph-node metastasis (TNM) staging criteria was based on the American Joint Committee on Cancer (AJCC) (39) criterion.
CRC study participants' family history, hypertension (HTN) or diabetes mellitus (DM) were recorded as non-communicable diseases (NCD), to correlate them to notch-related lncRNAs studied.
Inflammatory conditions such as ulcerative colitis, tumor size, tumor location if rectal, colonic or rectosigmoid, being mucinous tumor or not, tumor invasion depth, lymph-node metastasis (LNM), presence of vascular invasion or not, tumor differentiation status; adenocarcinoma, moderately differentiated adenocarcinoma or poorly differentiated adenocarcinoma as well as the presence of the sub histologic features, signet ring cell, or not, were collected from eligible volunteering CRC patients' files.
3. Methods 3.1. In Silico Analysis 3.1.1. Notch-related lncRNA Bioinformatics from various databases via (accessed January, 2021 and revised July, 2023) Gene Set Enrichment Analysis (GSEA) (40) with ClusterProfiler utilizing the Kyoto Encyclopedia of Genes and Genomes (KEGG) (41,42) from Genome net https://www.genome.jp/ was used to analyze the functional enrichment of genes, diseases, networks, drugs, and pathways related to Notch-signaling. Ensemble database search (43) https://www.ensembl.org/index.html for the potential probable Notch-related lncRNAs SNHG3 and LUNAR1 genes National Center for Biotechnology Information (NCBI) https://www.ncbi.nlm.nih.gov/ search for characterization of the investigated hsa lncRNAs SNHG3 gene and transcripts (2) and hsa lncRNAs LUNAR1 gene and transcript (1). HUGO Gene Nomenclature Committee (HGNC) (44) https://www.genenames.org/ hsa lncRNAs genes SNHG3 and LUNAR1.
3.1.2. LncRNADisease v3.0 Expression LncRNA and Disease Database (version 3.0) (45) to explore the Notch-related lncRNAs expression CRC retrieved from validated experimental results in publications or predicted http://www.rnanut.net/lncrnadisease/index.php/home 3.1.3. Expression via ENCORI Project Pan-Cancer Analysis Platform (46) https://rnasysu.com/encori/panGeneDiffExp.php of lncRNA or genes across 32 types of Cancers. The expression box-plot values of genes from RNA-seq data were scaled with log2(FPKM + 0.01), while the ones from miRNA-seq data were scaled with log2(RPM + 0.01). Differential expression Analysis for SNHG3, LUNAR1 and its transcript IGF1R expression levels in CRC tumor samples vs control samples.
3.1.4. Functional Enrichment Analysis and Targeted Pathways KEGG Targeted Pathways and STRING Protein-Protein Interaction (PPI) Networks version 11.5 https://string-db.org/ (47,48) (Accessed on July, 2023).
LncRNAWiki 2.0 LncRNA - LncRNAWiki - CNCB-NGDChttps://ngdc.cncb.ac.cn/lncrnawiki/ (Accessed August 30th, 2023) 3.2. Blood Samples From CRC patients and healthy volunteers, five milliliters of peripheral venous blood fluid biopsy were collected and stored in clot-activating polymer gel vacutainers (Greiner Bio-One GmbH, Australia). The samples were centrifuged in vacutainers at a speed of 4000 rpm for ten minutes at room temperature (25°C). The obtained serum was aliquoted and stored at -80°C in RNAse-free Eppendorf tubes.
3.2.1. Total RNA Extraction Using the miRNeasy Mini kit (Cat. No. 217004; Qiagen, Hilden, Germany), total RNA was isolated from sera in accordance with the protocol's instructions. Aliquots of the extracted RNA were kept at -80°C after being dissolved in 30 μl of RNase-free water.
3.2.2. Quantitation of purified RNA Using a NanoDrop®-1000 spectrophotometer (Thermo Scientific, Wilmington, DE, USA), the isolated RNA's purity and concentration are evaluated. RNA's quantity was determined in the sample utilizing absorbance at 260 nm (A260 = 1 → 44 ng/μl). In addition, the purity of RNA was evaluated utilizing A260/280 nm ratios. The acceptable 260/280 ratio ranges from 1.8 to 2.1, whereas the 260/230 ratio is more than 1.7.
3.2.3. Reverse Transcription Complementary DNA (cDNA) synthesis was carried out using the High-Capacity cDNA Reverse Transcription Kit with RNase Inhibitor (Cat. No 4374966, Applied Biosystems, ThermoFisher Scientific, USA) according to the manufacturer's regulations. In a 20 µl reaction volume, reverse transcription was carried out at 25 °C for 10 minutes, 37 °C for 120 minutes, and then underwent heat inactivation for 5 minutes at 85 °C. The produced cDNA was maintained at -80°C till further investigations.
3.2.4. Expression Measurement of lncRNAs Using Quantitative Real-Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) QRT-PCR was carried out in a 20 µl reaction using the TaqMan® Gene Expression Master Mix (Cat. No 4370048, Applied Biosystems, ThermoFisher Scientific, USA). In order to determine the expression levels of lncRNAs SNHG3 and LUNAR1, TaqMan gene expression assays for human SNHG3 (Hs05055352_s1, Cat. No 4448892, ThermoFisher Scientific, USA) and human LUNAR1 (Hs03829521_s1, Cat. No 4426961, ThermoFisher Scientific, USA) were used and the TaqMan gene expression assay for human glyceraldehyde 3-phosphate dehydrogenase (GAPDH) (Cat. No 4326317E, ThermoFisher Scientific, USA) was used as an endogenous standard to normalize the values. The reaction was conducted using the StepOne™ qRT-PCR technique (Applied Biosystems, CA, USA). The thermal cycling strategy was as follows: a stage of initial uracil-N-glycosylase (UNG) incubation at 50°C for 2 minutes, followed by activation step lasting 10 minutes at 95 °C proceeded by 40 cycles of denaturation for 15 sec at 95 °C, annealing and extending for 1 minute at 60 °C.
Per the manufacturer, the assay "limit of detection" (LoD) can detect cDNA template from 1pg to 100 ng in nuclease free water.
The cycle threshold (Ct) technique as a fold change (2-ΔΔCt) was used to calculate and normalize the lncRNAs expression levels, utilizing GAPDH as the housekeeping gene. ΔCt was obtained by subtracting the Ct values of GAPDH from either SNHG3 or LUNAR1 Ct values (49), where; ΔΔCt = ΔCtCRC samples - ΔCthealthy control samples 3.2.5. CEA and CA19-9 determination by electrochemiluminescence immunoassay One portion of the obtained sera was utilized for the purpose of determining CEA and CA19-9 tumor markers. Electrochemiluminescence immunoassay utilizing Cobas® e 602 developed by Roche Diagnostics, GmbH, Germany was used to determine the serum concentrations of CEA (Cat. No 11731629 322) and CA19.9 (Cat. No 11776193500), according to the manufacturer's protocol.
3.2.6. Routine biochemical testing results record from patients' files Liver function tests; aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) as well as serum creatinine and serum urea levels, hemoglobin (Hgb), platelet count, lymphocytes count, and prothrombin time (PT) were all gathered from patients' files.
3.2.7. Ratios and Indices In meters, participants' heights and in kilograms their weights were recorded, to calculate Body mass index (BMI in kg/m2) where overweight subjects have BMI of 25-29.9 kg/m2, 30 kg/m2 or over are obese, while 18.5-24.9 kg/m2 is indicative of normal weight, https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm The immune response-related inflammation indicator biomarker able to predict the accompanying inflammatory disorder severity is the platelet-to-lymphocytes ratio (PLR) (10,50).
3.3. Statistical Analysis With the aid of GraphPad Prism® version 9.01 (GraphPad Software, San Diego, CA, USA, SPSS 23.0 (statistical package for social studies software) (IBM, Armonk, NY), MedCalc Statistic Software version 19.1 (MedCalc Software by Ostend, Belgium), and Microsoft Office Excel 2019, statistical analysis was carried out.
Chi-square test (χ2) was utilized to assess the associations between participants' characteristics and the groups. The Shapiro-Wilk normality test as well as Kolmogorov-Smirnov test were applied to determine the pattern of the normal distribution for the both groups and subgroups of data. Data was expressed as mean ±SD when it passed the normality test. Student's (t) test was utilized to determine any significant differences between two normally distributed groups. Additionally, one-way ANOVA (F) followed by post hoc Tukey's multiple comparison test was used, when required, to determine significant variations between multiple groups. While, the data that didn't pass the normality test was expressed as median (interquartile range) (IQR) (25th percentile-75th percentile). The Mann-Whitney (U) test was used to pinpoint the significant changes between two sets of participants. Moreover, the Kruskal-Wallis (H) test and consequently Dunn's multiple comparison test were used, when needed, to determine whether there were statistically significant differences between different groups.
The receiver operating characteristic (ROC) curve as well as AUC were implemented to evaluate the abilities of serum lncRNAs SNHG3 and LUNAR1 for discrimination between groups and with groups for subgrouping identification. The best cut-off, sensitivities (SNs), specificities (SPs) as well as negative and positive predictive values NPVs and PPVs, respectively, were all determined using the ROC curve, with AUC estimated range from 0 to 1.
Negative likelihood ratios (LRs) are employed in medical testing to evaluate the marker discriminative efficiency. The ratio, which denotes the likelihood that a person has the disease or condition, confirms the SNs and SPs identified by the ROC curve. SN and SP provide a different meaning for the LR, with negative LR equal to (100-SN)/SP.
Multiple regression models were used to assess the influence of the participants demographic and patients' clinicopathological data (as independent factors) on the expression levels of the lncRNAs SNHG3 and LUNAR1 that we considered as the dependent variables. Correlation between numerous variables was assessed using Spearman's correlation coefficient (r). Statistical analysis tests are set significant when the two-tailed p-value is \<0.05 (\*).
### Conditions Module
**Conditions:**
- Colorectal Cancer
**Keywords:**
- Notch; SNHG3; LUNAR1; lncRNAs; colorectal cancer; prognosis; epigenetics
### Design Module
#### Bio Spec
**Description:** five milliliters of peripheral venous blood fluid biopsy were collected and stored in clot-activating polymer gel vacutainers (Greiner Bio-One GmbH, Australia). The samples were centrifuged in vacutainers at a speed of 4000 rpm for ten minutes at room temperature (25°C). The obtained serum was aliquoted and stored at -80°C in RNAse-free Eppendorf tubes.
Using the miRNeasy Mini kit (Cat. No. 217004; Qiagen, Hilden, Germany), total RNA was isolated from sera in accordance with the protocol's instructions. Aliquots of the extracted RNA were kept at -80°C after being dissolved in 30 μl of RNase-free water.
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 96
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 70 CRC Egyptian patients, admitted to the Oncology Center of the Faculty of Medicine, Ain Shams University Hospitals or the Oncological Surgery Department of Dar-El-Shafa Hospital, before surgical treatment or CRC neo-adjuvant treatment, if they were eligible and agreed to participate (signed the Informed consent) were recruited in the research.
**Label:** Patients group
#### Arm Group 2
**Description:** 26 randomly-chosen, age-matched, and sex-matched healthy subjects served as the control group. Control group subjects were chosen from those who came to visit hospital workers in the hospital or from blood donors at the ASUH Blood Donation Unit. None of the control group did take any medications or have any diseases upon questioner and blood samples was taken for CBC.
**Label:** Apparently healthy control group
### Outcomes Module
#### Primary Outcomes
**Description:** the expression level and pattern of Notch-associated lncRNAs SNHG3 and LUNAR1 in peripheral blood liquid biopsy, polled from treatment-naïve Egyptian CRC patients' cohort, compared to age-matched and sex-matched apparently healthy volunteer subjects as controls.
**Measure:** measure the expression level and pattern of Notch-associated lncRNAs SNHG3 and LUNAR1 in peripheral blood liquid biopsy in relation to clinico-pathological tumor features.
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients, came to the Oncology Center of ASUH or the Oncological Surgery Department of Dar-El-Shafa Hospital, who experienced a range of colonic symptoms, such as constipation, ab-dominal discomfort, rectal bleeding, and abrupt weight loss were included in the study when di-agnosis of CRC was clinically confirmed by abdominal radiography, colonoscopy, and histo-pathology.
Exclusion Criteria:
* patients who received chemotherapy, radiotherapy or undergone surgery. Patients with other types of cancer were also excluded. Individuals with missing data were not included.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** for Patients group. CRC Egyptian patients, who admitted to the Oncology Center of the Faculty of Medicine, Ain Shams University Hospitals (ASUH) or the Oncological Surgery Department of Dar-El-Shafa Hospital, before surgical treatment or CRC neo-adjuvant treatment, if they were eligible and agreed to participate (signed the I.C) were recruited in the research.
Apparently healthy control group. randomly-chosen, age-matched, and sex-matched healthy subjects served as the control group. Control group subjects were chosen from those who came to visit hospital workers in the hospital or from blood donors at the ASUH Blood Donation Unit. None of the control group did take any medications or have any diseases upon questioner and blood samples was taken for CBC.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Faculty of Pharmacy, Ain Shams University, AdvancedBiochemistry Research Lab
**Zip:** 11566
#### Overall Officials
**Official 1:**
**Affiliation:** Faculty of pharmacy Ain Shams University
**Name:** Nadia Hamdy, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- 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
- ID: D000012002
- Term: Rectal 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: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- 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
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432400
**Acronym:** IRTIPAP
**Brief Title:** Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders
**Official Title:** Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders Followed up in the Medical and Psychological Centre: Multicentre Descriptive Study
#### Organization Study ID Info
**ID:** CHRD0824
#### Organization
**Class:** OTHER
**Full Name:** Hôpital NOVO
#### Secondary ID Infos
**Domain:** ANSM
**ID:** 2024-A00790-47
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**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:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hôpital NOVO
#### 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 aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery.
**Detailed Description:** Between 61% and 81% of men and 51% to 74% of women are exposed to a traumatic event in their lifetime. These events may be brief and discrete, prolonged and/or recurrent, and may be direct or indirect. Direct or indirect exposure to traumatic events can lead to serious negative psychological consequences, including post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD). People exposed to complex traumatic events are at risk not only of suffering from PTSD or Complex PTSD, but also from other mental health co-morbidities, such as substance use disorders (drugs, alcohol, benzodiazepine misuse) , often associated with the repetition of situations of interpersonal violence from which it is difficult, if not impossible, to escape.
Caring for people suffering from psychological trauma is a major public health issue. However, there are no good clinical practice guidelines for diagnosis, assessment and treatment, which would enable good practice to be standardised and disseminated. The prevention, detection, early support and appropriate guidance of people suffering from post-traumatic sequelae promote their recovery and improve their quality of life. The World Health Organization (WHO) refers to this as psychological distress, and points out that if it is not properly identified or accompanied, it can tip a person into illness or increase social difficulties. When it is temporary and follows a stressful event, it is considered a normal adaptive reaction. On the other hand, when it becomes intense and persistent, it may be an indicator of a psychological disorder. The public health challenge associated with PTSD is to better recognise, diagnose and treat it, as it can have serious consequences for the quality of life, social functioning and suicide risk of those affected.
The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery. It would also make it possible to provide individualised support for patients and improve their quality of life.
### Conditions Module
**Conditions:**
- Post Traumatic Stress Disorder
**Keywords:**
- Post Traumatic Stress Disorder
- Complex post traumatic stress disorder
- Medical and Psychological Centre
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group composed of patients suffering from disorders related to the use of alcohol, cannabis, opiates, inhalants, sedatives, hypnotics, anxiolytics, stimulants, hallucinogens (all of these disorders will have been diagnosed by a doctor before or during follow-up according to Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM 5) criteria)
**Intervention Names:**
- Other: Patient questionnaires
**Label:** Substance use disorders
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Substance use disorders
**Description:** Patients questionnaires, on paper and data collection on patients medical file
**Name:** Patient questionnaires
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of patients with PTSD among those with substance use disorders Patients with PTSD will be identified using the International Trauma Questionnaire (ITQ) : A diagnosis of PTSD requires the presence of at least one symptom in each of the following dimensions
* P1 or P2 ≥ 2
* P3 or P4 ≥ 2
* 5 or P6 ≥ 2 AND
* P7 or P8 or P9 ≥ 2
Score ITQ for PTSD : ≥ 8
**Measure:** Assessment of the proportion of Post-Traumatic Stress Disorder (PTSD) in patients with substance use disorders
**Time Frame:** At the end of the study, an average of 12 month
#### Secondary Outcomes
**Description:** Percentage of patients with CPTSD among those with substance use disorders Patients with CPTSD will be identified using the International Trauma Questionnaire (ITQ) : A diagnosis of CPTSD requires a PTSD : ≥ 8 and, at least, one symptom in each of the dimensions of disturbance of self-organisation
* C1 or C2 ≥ 2
* C3 or C4 ≥ 2
* C5 or C6 ≥ 2 AND
* C7 or C8 or C9 ≥ 2
Score ITQ for CPTSD : ≥ 16
**Measure:** Distinguishing between the prevalence of Post-Traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD)
**Time Frame:** At the end of the study, an average of 12 month
**Description:** Risk factors will be identified from the demographic data collected via the patient characteristics questionnaire between PTSD and CPTSD patients
**Measure:** Identification of risk factors by comparing demographic data of PTSD versus CPTSD patients
**Time Frame:** At the end of the study, an average of 12 month
**Description:** The pathologies most frequently associated with PTSD and CPTSD will be identified by collecting the pathologies present in the medical records of all patients.
**Measure:** Identification of the pathologies most associated with PTSD and CPTSD
**Time Frame:** At the end of the study, an average of 12 month
**Description:** Comparison for number of days between the start of treatment for substance use disorders and the identification of PTSD or CPTSD
**Measure:** Comparison of the time between management and identification of patients with PTSD versus CPTSD
**Time Frame:** At the end of the study, an average of 12 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria :
* Patient aged 18 or over
* Patient followed up at the adult Medical and Psychological Centre in the centres taking part in the study
* Patient suffering from disorders related to the use of alcohol, cannabis, opiates, inhalants, sedatives, hypnotics, anxiolytics, stimulants, hallucinogens (all of these disorders will have been diagnosed by a doctor before or during follow-up according to DSM 5 criteria).
* Patient aware of their substance use disorders
* Patient informed and did not object to participating in the study
Exclusion Criteria :
* Patient previously diagnosed with PTSD or CPTSD
* Patient agitated and/or aggressive
* Patient under guardianship/curators
* Patient who do not speak or understand French
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Maryline DELATTRE
**Phone:** +3333130754131
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Véronique DA COSTA
**Phone:** +3333130755069
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beaumont-sur-Oise
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Benjamin Schmidt
- **Phone:** +33 1 39 37 15 20
- **Role:** CONTACT
**Country:** France
**Facility:** Medical and Psychological Centre - Novo Hospital - Site Beaumont-sur-Oise
**Zip:** 95260
**Location 2:**
**City:** Clermont
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Deborah DELABY
- **Phone:** +33 6 09 62 50 12
- **Role:** CONTACT
**Country:** France
**Facility:** Medical and Psychological Centre - Isarien Hospital Centre
**Zip:** 60600
#### Overall Officials
**Official 1:**
**Affiliation:** Isarien Hospital Centre
**Name:** Déborah DELABY
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M16103
- Name: Stress Disorders, Post-Traumatic
- Relevance: HIGH
- As Found: Post Traumatic Stress Disorder
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: HIGH
- As Found: Traumatic Stress Disorder
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: HIGH
- As Found: Substance Use Disorders
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related 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: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000040921
- Term: Stress Disorders, Traumatic
- ID: D000013313
- Term: Stress Disorders, Post-Traumatic
### 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
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M4029
- Name: Central Nervous System Stimulants
- Relevance: LOW
- As Found: Unknown
- ID: M9305
- Name: Hallucinogens
- Relevance: LOW
- As Found: Unknown
- ID: M10043
- Name: Hypnotics and Sedatives
- Relevance: LOW
- As Found: Unknown
- ID: M16905
- Name: Anti-Anxiety Agents
- Relevance: LOW
- As Found: Unknown
- ID: M27371
- Name: Opiate Alkaloids
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432387
**Acronym:** CoFA-TAAA
**Brief Title:** Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair
**Official Title:** Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair (CoFA-TAAA); a Prospective Observational Study
#### Organization Study ID Info
**ID:** CoFA-TAAA
#### Organization
**Class:** OTHER
**Full Name:** University of Thessaly
### Status Module
#### Completion Date
**Date:** 2026-01-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Thessaly
#### Responsible Party
**Investigator Affiliation:** University of Thessaly
**Investigator Full Name:** Elena Arnaoutoglou
**Investigator Title:** Professor of Anaesthesiology
**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 will evaluate the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair.
**Detailed Description:** Endovascular aneurysm repair of abdominal aorta activates a significant inflammation reaction and has an impact on coagulation. Platelet activation seems to have a major role in this prothrombotic and hypercoagulable state. In complex thoraco-abdominal aortic aneurysm repair the implants are more complexed and the duration of operation longer. The main hypothesis is that all the above have a greater impact on platelet activation and coagulation alterations.
The aim of this study is the evaluation of the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair.
### Conditions Module
**Conditions:**
- Thoraco-abdominal Aortic Aneurysm Repair
- Coagulation Factors Alterations
- Platelet Activation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 58
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Perioperative laboratory examinations will follow institutional guidelines. These will include, but will not be limited to full blood count, conventional coagulation tests, liver function, and kidney function tests. Moreover, for the purpose of this study, the following parameters will also be obtained; vWF, factors VIII and XI, D-dimers, fibrinogen, platelets activation (multiplate), adams-13, anti-Xa and high sensitivity troponin. All samples will be obtained via puncture from a peripheral vein. Blood samples will obtained at three time points; preoperatively before induction to GA (01), postoperative day 1 (02) and postoperative day 3rd-4th (03). During hospitalization any myocardial injury after non cardiac surgery, acute kidney injure and post-implantation syndrome will be recorded.
Of note, at 30 days, 3, 6 and 12 months our patients will undergo an evaluation for any major cardiovascular event, implant failure or death of any cause.
**Intervention Names:**
- Other: Patients undergoing complex thoraco-abdominal aortic aneurysm repair
**Label:** Patients undergoing complex thoraco-abdominal aortic aneurysm repair
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients undergoing complex thoraco-abdominal aortic aneurysm repair
**Description:** Patients undergoing complex thoraco-abdominal aortic aneurysm repair
**Name:** Patients undergoing complex thoraco-abdominal aortic aneurysm repair
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Early preoperatively, early and late postoperatively
**Measure:** Coagulation status
**Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day
**Description:** Early preoperatively, early and late postoperatively
**Measure:** Myocardial injury after non cardiac surgery
**Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day
**Description:** Early preoperatively, early and late postoperatively
**Measure:** Acute kidney injury
**Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day
**Description:** Early preoperatively, early and late postoperatively
**Measure:** Post-implantation syndrome
**Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day
**Description:** Early preoperatively, early and late postoperatively
**Measure:** Major cardiovascular events
**Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day
**Description:** Early preoperatively, early and late postoperatively and 1 at one month
**Measure:** Major cardiovascular events, implant failure and death of any cause
**Time Frame:** 30 days, 3, 6, and 12 months postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Consecutive patients undergoing complex thoraco-abdominal aortic aneurysm repair in University Hospital of Larissa, after informed consent will be included.
Exclusion Criteria:
* Refuse to participate
* Prior surgery within 3 months
* ASA PS \> 3
* Known medical history of thrombophilia or functional platelet dysfunction
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All patients will be treated by the same medical team in UHL according to the European Society for Vascular Surgery (ESVS) guidelines. Preoperatively patients will be treated with aspirin 100 mg once daily for at least 5 days. Postoperatively in the absence of bleeding patients will receive aspirin 100 mg and in the absence of neurological dysfunction due to spine ischemia they will receive clopidogrel 150 mg and from the next day dual antiplatelet therapy (aspirin 100 mg and clopidogrel 75 mg). If the patient was treated with anticoagulant agents this will be discontinued preoperative according to ACCP guidelines and it will be restarted on the 1st or 2nd postoperative day based on hemostasis. In this case patients will be treated with aspirin 100 mg once daily five days preoperatively and aspirin will also be continued postoperatively.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eleni Arnaoutoglou, Prof
**Phone:** 6974301352
**Phone Ext:** +30
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Maria Ntalouka
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Larissa
**Country:** Greece
**Facility:** University of Thessaly
**Zip:** 41335
#### Overall Officials
**Official 1:**
**Affiliation:** University of Thessaly
**Name:** Eleni Arnaoutoglou, Prof
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001018
- Term: Aortic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4113
- Name: Aneurysm
- Relevance: HIGH
- As Found: Aneurysm
- ID: M4330
- Name: Aortic Aneurysm
- Relevance: HIGH
- As Found: Aortic Aneurysm
- ID: M19800
- Name: Aortic Aneurysm, Abdominal
- Relevance: HIGH
- As Found: Abdominal Aortic Aneurysm
- ID: M3070
- Name: Aortic Aneurysm, Thoracoabdominal
- Relevance: HIGH
- As Found: Thoraco-Abdominal Aortic Aneurysm
- ID: M19801
- Name: Aortic Aneurysm, Thoracic
- Relevance: HIGH
- As Found: Thoraco-Abdominal Aortic Aneurysm
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4334
- Name: Aortic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T66
- Name: Abdominal Aortic Aneurysm
- Relevance: HIGH
- As Found: Abdominal Aortic Aneurysm
### Condition Browse Module - Meshes
- ID: D000000783
- Term: Aneurysm
- ID: D000001014
- Term: Aortic Aneurysm
- ID: D000017544
- Term: Aortic Aneurysm, Abdominal
- ID: D000094624
- Term: Aortic Aneurysm, Thoracoabdominal
- ID: D000017545
- Term: Aortic Aneurysm, Thoracic
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: Coag
- Name: Coagulants
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M9581
- Name: Heparin, Low-Molecular-Weight
- Relevance: LOW
- As Found: Unknown
- ID: M20153
- Name: Dalteparin
- Relevance: LOW
- As Found: Unknown
- ID: M203832
- Name: Fibrin fragment D
- Relevance: LOW
- As Found: Unknown
- ID: M8312
- Name: Factor VIII
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432374
**Brief Title:** Written Exposure Therapy for Nurses
**Official Title:** Open Pilot of Written Exposure Therapy for Nurses Experiencing Work-Related Posttraumatic Stress
#### Organization Study ID Info
**ID:** HUM00203166
#### Organization
**Class:** OTHER
**Full Name:** University of Texas at Austin
### Status Module
#### Completion Date
**Date:** 2023-09-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Michigan
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Texas at Austin
#### Responsible Party
**Investigator Affiliation:** University of Texas at Austin
**Investigator Full Name:** Yang Li
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Nurses often experience elevated levels of stress, overwork, and trauma in the workplace, leading to posttraumatic stress disorder (PTSD), depression, burnout, and even nurse turnover. While effective therapies for PTSD exist, barriers to treatment arise from nursing culture, such as workplace stigma about mental health problems, fear that psychological status may impact performance evaluations, and demands of shiftwork. There is a pressing need for scalable evidence-based interventions tailored to nursing culture to effectively address PTSD and related mental health issues. The study aimed to assess the feasibility, safety, and acceptability of a tailored evidence-based treatment, Written Exposure Therapy (WET), for nurses experiencing work-related traumatic stress.
This single-arm open pilot study with pre- and post-intervention assessments, included participants from two nursing schools' alumni. Eligibility criteria included nurses screening positive for work-related trauma with a report of at least two PTSD symptoms. Participants engaged in a self-administered, asynchronous, five-week online writing session, facilitated by WET-trained nurses. Outcomes measures (PTSD, depression, anxiety, burnout, and intention to quit) were assessed at baseline, post-intervention, and 5-weeks follow-up.
### Conditions Module
**Conditions:**
- Posttraumatic Stress Disorder
- Depressive Symptoms
- Burn Out
- Anxiety
- Work Related Stress
**Keywords:**
- Nurses
- Written Exposure Therapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ACTUAL
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** WET is a trauma-focused therapy for PTSD. It includes five writing sessions.
**Intervention Names:**
- Behavioral: WET
**Label:** Written Exposure Therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Written Exposure Therapy
**Description:** The five weekly WET sessions were delivered online via Canvas. Five session modules were created, each containing writing instructions for the respective session and an assignment feature for participants to upload their narratives. All sessions included 30 minutes of writing. Following instructions, participants wrote about a specific work-related trauma event in detail and described the emotions and thoughts experienced during the event. While all sessions were self-paced, participants were advised to complete each subsequent session within one week. Participants had the option to self-administer sessions or participate in Zoom "office hours" for live writing sessions with a facilitator who had completed WET training providing the writing instructions.
**Name:** WET
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The PTSD Checklist for DSM-5 was used to assess symptoms of posttraumatic stress disorder in the past month. The total score ranges from 0-80, with higher scores indicating more severe PTSD symptoms.
**Measure:** Posttraumatic stress disorder
**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up
#### Secondary Outcomes
**Description:** The Patient Health Questionnaire-8 was used to assess the frequency of depressed mood in the past two weeks. The total score ranges from 0-24, with higher scores indicating more severe depression symptoms.
**Measure:** Depression
**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up
**Description:** The Generalized Anxiety Disorder-7 was used to assess the frequency of anxiety symptoms in the past two weeks. The total score ranges from 0-21, with higher scores indicating more severe anxiety symptoms.
**Measure:** Anxiety
**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up
**Description:** The Professional Quality of Life was used to assess compassion satisfaction, burnout, and secondary traumatic stress. Each subscale score ranges from 10-50, with higher scores indicating higher levels of compassion satisfaction, more burnout symptoms, and more secondary traumatic stress.
**Measure:** Professional Quality of Life
**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up
**Description:** Intention to quit the job or leave the nursing profession were asked using two questions - "How often have you thought about quitting your job in the past month?", "How often have you thought about leaving the nursing profession in the past month?". The five responses are "never," "rarely," "sometimes," "very often", and "always." The scores for both intention to quit the job and intention to leave the nursing profession range from 1-5, with higher scores indicating greater intention to quit the job or leave the nursing profession.
**Measure:** Intention to Quit
**Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Work-related trauma
* Posttraumatic stress disorder
Exclusion Criteria:
* Current substance abuse
* Current suicidality
* Current psychiatric treatment with psychotherapy or psychotropic medications other than selective serotonin (and norepinephrine) reuptake inhibitors (SSRI/SNRI).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ann Arbor
**Country:** United States
**Facility:** University of Michigan
**State:** Michigan
**Zip:** 48104
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000040921
- Term: Stress Disorders, Traumatic
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000009784
- Term: Occupational Diseases
- ID: D000013315
- Term: Stress, Psychological
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC24
- Name: Occupational Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M1167
- Name: Occupational Stress
- Relevance: HIGH
- As Found: Work Related Stress
- ID: M5326
- Name: Burns
- Relevance: LOW
- As Found: Unknown
- ID: M16103
- Name: Stress Disorders, Post-Traumatic
- Relevance: HIGH
- As Found: Posttraumatic Stress Disorder
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: LOW
- As Found: Unknown
- ID: M1658
- Name: Burnout, Psychological
- Relevance: LOW
- As Found: Unknown
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depressive Symptoms
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related 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: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M12719
- Name: Occupational Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16105
- Name: Stress, Psychological
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000073397
- Term: Occupational Stress
- ID: D000013313
- Term: Stress Disorders, Post-Traumatic
- ID: D000003863
- Term: Depression
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432361
**Brief Title:** Resource Allocation for Alcohol
**Official Title:** Resource Allocation for Alcohol
#### Organization Study ID Info
**ID:** STUDY00018018
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
#### Secondary ID Infos
**ID:** 1R34AA029478-01A1
**Link:** https://reporter.nih.gov/quickSearch/1R34AA029478-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**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:** Jennifer Cadigan
**Investigator Title:** Assistant Professor, Department of Psychiatry and Behavioral Sciences
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A total of 150 young adults (ages 21-29) will be randomized to receive a brief alcohol intervention (intended to reduce alcohol-related resource allocation (e.g., time and money spent on alcohol), alcohol consumption, and alcohol related consequences) or an assessment only control condition.
All participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Those in the intervention condition will receive weekly personalized information summarizing the previous week's resource allocation.
All participants will complete a 1 and 3 month follow up survey. Participants can earn up to $126 for completing all study components.
### Conditions Module
**Conditions:**
- Alcohol Drinking
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains during the time, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Each daily survey should take no longer than 5 minutes to complete.
Those in the intervention condition will receive weekly personalized information summarizing the previous week's resource allocation (e.g., personalized information on how they spent their time and money) in relation to their personal goals, interests, and alcohol use. They will also see a summary of how they spent their time and money in relation to their set goals for the week. The information in the intervention feedback will be obtained from participant's responses to the daily surveys on how they spent their time and money each day. Reviewing the intervention feedback should take no longer than 10 minutes.
**Intervention Names:**
- Behavioral: Resource Allocation
**Label:** Resource Allocation Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains during the time, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Each daily survey should take no longer than 5 minutes to complete.
**Intervention Names:**
- Other: assessment only control
**Label:** Assessment only control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Resource Allocation Intervention
**Description:** Those in the intervention condition will receive weekly personalized information summarizing the previous week's resource allocation (e.g., personalized information on how they spent their time and money) in relation to their personal goals, interests, and alcohol use. They will also see a summary of how they spent their time and money in relation to their set goals for the week The information in the intervention feedback will be obtained from participant's responses to the daily surveys on how they spent their time and money each day. Reviewing the intervention feedback should take no longer than 10 minutes.
**Name:** Resource Allocation
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Assessment only control
**Description:** participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains during the time, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Each daily survey should take no longer than 5 minutes to complete.
**Name:** assessment only control
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** We will assess the number of standard drinks, containing alcohol in a typical week collected on the Daily Drinking Questionnaire DDQ; Collins et al., 1985; Kivlahan et al., 1990)
**Measure:** Standard drinks containing alcohol-
**Time Frame:** past 1 month
**Description:** We will assess the number of alcohol-related consequences experienced using the Rutgers Alcohol Problem Index.
**Measure:** Alcohol-related problems
**Time Frame:** past 1 month
**Description:** Alcohol demand will be assessed with the Alcohol Purchase Task.
**Measure:** Alcohol Demand
**Time Frame:** past 1 month
**Description:** Time allocation will be assessed (Murphy et al.,2012) where participants will indicate, on average, how many hours they spend in a typical week in various domains including alcohol-related domains.
**Measure:** Time allocation
**Time Frame:** past 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1)21-29 years old, 2) reside within WA state, 3) report drinking 2+ days per week, on average, in the last six months, 4) report 4+ heavy drinking episodes (4+/5+ for women/men) in the past month,
Exclusion Criteria:
* 1) currently enrolled in a 4-year college, 2) currently in or seeking treatment for alcohol use
**Healthy Volunteers:** True
**Maximum Age:** 29 Years
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jennifer Cadigan, PhD
**Phone:** 206-543-5689
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Washington
**Name:** Jennifer Cadigan, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004327
- Term: Drinking Behavior
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M3774
- Name: Alcohol Drinking
- Relevance: HIGH
- As Found: Alcohol Drinking
- ID: M7502
- Name: Drinking Behavior
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432348
**Brief Title:** Pilates Exercises and Soccer: A Comparative Study of Mat vs. Reformer on FMS and ROM
**Official Title:** Pilates Exercises and Soccer: A Comparative Study of Mat vs. Reformer on FMS and ROM
#### Organization Study ID Info
**ID:** OsmaniyeKAU Osman Yılmaz
#### Organization
**Class:** OTHER
**Full Name:** Osmaniye Korkut Ata University
### Status Module
#### Completion Date
**Date:** 2022-04-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-04-30
**Type:** ACTUAL
#### Start Date
**Date:** 2021-11-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Osmaniye Korkut Ata University
#### Responsible Party
**Investigator Affiliation:** Osmaniye Korkut Ata University
**Investigator Full Name:** Osman Yılmaz
**Investigator Title:** PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Pilates exercises have been used to improve core strength, trunk and shoulder strength, lower body strength, agility, dynamic balance, coordination skills, flexibility, and posture in various sports. A previous study demonstrated the beneficial impact of mat Pilates exercises on the functional performance of soccer players. However, more research is needed to understand the effects of Pilates on the FMS and ROM. Consequently, this study aimed to investigate and compare the influence of mat Pilates and reformer Pilates exercises on FMS and ROM in soccer players, addressing this critical research gap.
### Conditions Module
**Conditions:**
- Sports, Mechanical
**Keywords:**
- Functional movement screening
- Mat pilates
- Reformer pilates
- Range of motion
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Before starting the exercises, a 5-minute warm-up session was performed. The reformer Pilates exercise program included movements such as the Footwork Series (Toes, Heels, Tendon Stretch, V Position), Supine Arm Series (Pull, Circle, Pull Head Up, Triceps Press), Short Box Series (Round, Flat Back, Twist), Short Box and Arm Series (Chest Fly, The Gift, Rhomboid, Biceps Curl, Rowing, Triceps), Long Box Series (Swan, Pulling Fly), Stomach Massage (Round, Twist), Knee Stretch (Round, Flat Back), Hip Work Series (Double Leg Press, Hamstring Pulls, Leg Circle, Frog), Elephant, and Side Stretch. Participants had two-minute rest intervals after the Supine Arm Series, Short Box, Arm Series, and Knee Stretch movements. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks.
**Intervention Names:**
- Other: Reformer pilates
**Label:** Reformer Pilates
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Before the exercises, a 5-minute warm-up session was performed. The mat Pilates exercise program included movements such as Rol Up, One Leg Circle, Double Leg Straight Lower, One Leg Stretch, Criss Cross, Toe Top, Shoulder Bridge, Seated Tracking, Spine Twist, Up-Down Side Kick, Front-Back Side Kick, Circle Side Kick, Flight, Swan, Rest Position, Swimming, Push Up, Long Stretch, Cat Cow, Mermaid Stretch. The participants had two-minute rest breaks after the toe-top, spine twist, and circle side-kick movements. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks.
**Intervention Names:**
- Other: Mat Pilates
**Label:** Mat Pilates
**Type:** EXPERIMENTAL
#### Arm Group 3
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Reformer Pilates
**Description:** Before starting the exercises, a 5-minute warm-up session was performed. The reformer Pilates exercise program included movements such as the Footwork Series (Toes, Heels, Tendon Stretch, V Position), Supine Arm Series (Pull, Circle, Pull Head Up, Triceps Press), Short Box Series (Round, Flat Back, Twist), Short Box and Arm Series (Chest Fly, The Gift, Rhomboid, Biceps Curl, Rowing, Triceps), Long Box Series (Swan, Pulling Fly), Stomach Massage (Round, Twist), Knee Stretch (Round, Flat Back), Hip Work Series (Double Leg Press, Hamstring Pulls, Leg Circle, Frog), Elephant, and Side Stretch. Participants had two-minute rest intervals after the Supine Arm Series, Short Box, Arm Series, and Knee Stretch movements. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks. The participants underwent six weekly training sessions over eight weeks, comprising three Reformer Pilates sessions and three team training days.
**Name:** Reformer pilates
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Mat Pilates
**Description:** Before the exercises, a 5-minute warm-up session was performed. The mat Pilates exercise program included movements such as Rol Up, One Leg Circle, Double Leg Straight Lower, One Leg Stretch, Criss Cross, Toe Top, Shoulder Bridge, Seated Tracking, Spine Twist, Up-Down Side Kick, Front-Back Side Kick, Circle Side Kick, Flight, Swan, Rest Position, Swimming, Push Up, Long Stretch, Cat Cow, Mermaid Stretch. The participants had two-minute rest breaks after the toe-top, spine twist, and circle side-kick movements. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks. The participants underwent six weekly training sessions over eight weeks, comprising three Mat Pilates sessions and three team training days.
**Name:** Mat Pilates
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Thirty voluntary participants were randomly assigned to either RP (n=10; mean age = 20.60 ± 1.65), MP (n=10; mean age = 19.40 ± 1.35), or CG (n=10; mean age = 20.10 ± 1.15). The Functional Movement Screening Test Kit was used in this study. It consists of seven movements: Deep Squat, Hurdle Step, In-Line Lunge, Shoulder Mobility, Active Straight Leg Raise, Trunk Stability Push-Up, and Rotary Stability. Each test was scored on a scale ranging from 0 to 3, with the highest possible score being 21 . Based on previous research, participants with a total FMS score lower than 14 were considered to have a higher risk of injury.
**Measure:** Functional Movement Screening and range of motion tests
**Time Frame:** One week
**Description:** Thirty voluntary participants were randomly assigned to either RP (n=10; mean age = 20.60 ± 1.65), MP (n=10; mean age = 19.40 ± 1.35), or CG (n=10; mean age = 20.10 ± 1.15). Joint range of motion measurements were made to evaluate the joint range of motion of the athletes. Tests were conducted: shoulder hyperextension, hip flexion, hip extension, hip abduction, hip internal rotation, hip external rotation, ankle dorsiflexion, and ankle plantar flexion. Joint range of motion measurement was performed with a goniometer.Measurements were recorded in centimeters (cm).
**Measure:** Range of motion tests
**Time Frame:** One week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age: Adults 19 to 20 years old
* Gender: Male
* Volunteering players
Exclusion Criteria:
- Diagnosis: Diagnosis of a specific medical condition
**Healthy Volunteers:** True
**Maximum Age:** 20 Years
**Minimum Age:** 19 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Osmaniye
**Country:** Turkey
**Facility:** Osmaniye Korkut Ata University
**Zip:** 80000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432335
**Brief Title:** E-Socket, Diagnostic Monitoring
**Official Title:** E-Socket, Diagnostic Monitoring
#### Organization Study ID Info
**ID:** STUDY00016676
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
### Status Module
#### Completion Date
**Date:** 2030-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Washington
#### Responsible Party
**Investigator Affiliation:** University of Washington
**Investigator Full Name:** Joan E Sanders
**Investigator Title:** Associate 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 long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3).
Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians.
Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.
### Conditions Module
**Conditions:**
- Trans-Tibial Amputation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: E-Socket Monitoring
**Label:** E-Socket Monitoring
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- E-Socket Monitoring
**Description:** Limb-socket motion data is collected during participant take-home use. Bimonthly telephone interviews are conducted to assess participant residual limb health status. Analysis is conducted to determine if limb motions and activity changes precede limb health changes.
**Name:** E-Socket Monitoring
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health. Interviews with the participants and questionnaires will be used to assess the outcome measure.
**Measure:** Anterior-Distal Limb Motion
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
-
Prosthesis Users:
Aims 1 and 2
* Over 18 years of age
* Unilateral or bilateral trans-tibial amputation at least 12 months prior
* Have a limb of length 9 cm or greater
* Are capable of at least 5 minutes of continuous walking
* Regularly use a definitive prosthesis
* Do not regularly use assistive devices (e.g., cane, walker) for ambulation
* Do not have open wounds on their residual limb at the time of enrollment
Aim 2
-Regularly visit their prosthetist at least twice a year,
Exclusion Criteria:
-
Prosthesis Users:
Aims 1 and 2
* Reduced skin sensation
* Presence of skin breakdown
* Regular use of an assistive device
* Persons with trans-femoral amputation
Aim 1 Only
-Vacuum suspension users
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nick McCarthy
**Phone:** 206-616-9148
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Washington
**Name:** Joan Sanders
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432322
**Acronym:** GluEsk
**Brief Title:** (GluEsk) Glutamate and Esketamine
**Official Title:** Effects of Esketamine Challenge on Brain Glutamate Release (fMRS), Resting State Connectivity (BOLD-rs-fMRI), and Neuroplasticity (Visual Task)
#### Organization Study ID Info
**ID:** R90468/RE001
#### Organization
**Class:** OTHER
**Full Name:** University of Oxford
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**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:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** NIHR Oxford Health Biomedical Research Centre
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Oxford
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Esketamine is the S-enantiomer of racemic ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist. Esketamine and other antidepressant NMDA receptor antagonists are hypothesised to act by producing a rapid increase in brain glutamate release, which then stimulates α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptors. This activity in turn is thought to restore synaptic functioning, neuroplasticity, and connectivity in brain regions involved in mood regulation, which would be ultimately responsible for the antidepressant effect of esketamine However, the effect of esketamine on glutamate release in humans has not previously been studied. In this study we therefore aim to ascertain the effect of esketamine on brain glutamate release, resting state connectivity, and neuroplasticity as measured via fMRS, BOLD-rs-fMRI, and a behavioural computerised visual task respectively.
**Detailed Description:** There is growing interest in the use of antagonists at the glutamate N-methyl-D-aspartate (NMDA) receptor in patients with treatment-resistant depression (TRD). Work in animal studies suggests that NMDA receptor antagonists act initially by increasing brain glutamate release, but whether such an action occurs in humans is not established.
Esketamine is the S-enantiomer of racemic ketamine: a non-selective, non-competitive, antagonist of the ionotropic glutamate NMDA receptor . It is the only NMDA receptor antagonist licensed in the UK for the treatment of patients with TRD. Esketamine is administered intranasally: it is rapidly absorbed by the nasal mucosa following nasal administration and can be measured in plasma within 7 minutes following a 28 mg dose. The time to reach maximum plasma concentration (tmax) is typically 20 to 40 minutes after the last nasal spray of a treatment session. It is hypothesised that through NMDA receptor antagonism, esketamine produces a transient increase in glutamate release leading to increases in α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor stimulation and subsequently to increases in neurotrophic signalling which may contribute to the restoration of synaptic function, neuroplasticity, and connectivity in brain regions involved with the regulation of mood.
Glutamate is the primary excitatory neurotransmitter in the brain and has been implicated in several neuropsychiatric disorders. "Gold-standard" methods to assess glutamate activity in the living human brain are expensive and involve radioactive injections and invasive blood sampling. More recently, work in our Clinical Psychopharmacology laboratory has shown that 7T fMRS (a more widely available, non-invasive, safe technique) that uses a visual stimulus ("flickering checkerboard") can reliably and sensitively measure changes in brain glutamate release. No prior study however has shown whether this effect is susceptible to pharmacological challenge. We therefore propose to assess whether through its NMDA/AMPA-mediated activity, esketamine can indeed produce an increase in brain glutamate release measured via this technique.
The aims of this study are to investigate the effect of esketamine on brain glutamate release and resting state connectivity, and on vision. Therefore, the primary objective of this study is to assess the effect of a single dose of esketamine 56mg intranasal vs placebo on brain glutamate release changes measured via 7T fMRS "flickering checkerboard" stimulus. Secondary objectives include the investigation of the effects of esketamine on brain resting state connectivity changes measured via 7T BOLD-rs-fMRI, and on neuroplasticity measured via a behavioural computerised visual task. Psychological questionnaires will also be measured to check for possible correlations with the outcomes measured.
### Conditions Module
**Conditions:**
- Depression
**Keywords:**
- Esketamine
- Brain glutamate release
- fMRS
- Resting state connectivity
- BOLD-rs-fMRI
- Neuroplasticity
- Visual task
- Healthy volunteers
- Magnetic Resonance Spectroscopy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Within-subject, cross-over design
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Self-administered by the participant wearing an eye mask, following instructions and under supervision of appropriately trained medical staff where resuscitation facilities are available, via a single-use device delivering 28 mg as two sprays (i.e., one spray per nostril).
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Nasal spray solution, 56mg (28mg per nostril), intranasal
**Intervention Names:**
- Drug: Esketamine nasal spray
**Label:** Esketamine
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Nasal spray solution, 0.9% NaCl, intranasal
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Esketamine
**Description:** Nasal spray solution, 56mg (28mg per nostril), intranasal
**Name:** Esketamine nasal spray
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Nasal spray solution, 0.9% NaCl, intranasal
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Brain glutamate release change measured via functional Magnetic Resonance Spectroscopy (fMRS) 7-Tesla (7T) "flickering checkerboard", comparing drug vs placebo occasions.
**Measure:** Brain glutamate release
**Time Frame:** Acute (40-60 minutes after nasal spray application)
#### Secondary Outcomes
**Description:** Brain resting state connectivity change measured via blood oxygenation level-dependent resting-state functional Magnetic Resonance Imaging (BOLD-rs-fMRI) 7T, comparing drug vs placebo occasions.
**Measure:** Brain resting state connectivity
**Time Frame:** Acute (40-60 minutes after nasal spray application)
**Description:** Behavioural visual response measured via a computerised visual task, comparing drug vs placebo occasions.
**Measure:** Visual response
**Time Frame:** Post-Acute (60-90 minutes after nasal spray application)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 18 to 50 years
* Body Mass Index in the range of 18-30
* Sufficiently fluent in English to understand the study instructions
* Willing and able to give informed consent for participation in the research
Exclusion Criteria:
* Currently on any regular prescribed medications (except the contraceptive pill), unless unlikely to compromise safety or affect data quality in the opinion of the Investigator
* Known hypersensitivity to the study drug (i.e., esketamine)
* History of, or current significant alcohol or substance misuse disorder
* Any use of recreational drugs over the last 3 months
* Any lifetime use of ketamine or phencyclidine (PCP)
* Currently smoking \>/=20 cigarettes/day
* History of, or current significant cardiovascular disorder (e.g., hypertension, myocardial infarction)
* History of, or current significant neurological disorder (e.g., epilepsy, migraine) or cerebrovascular disorder (e.g., haemorrhagic or ischemic stroke, aneurysmal vascular disease, raised intracranial pressure)
* History of, or current significant respiratory, hepatic, urinary tract, or thyroid disorders
* History of, or current acute porphyria
* History of, or current significant psychiatric disorder (e.g., psychosis, mania, depression)
* History of, or current eye disorder, not including refractive error that can be corrected with glasses or contact lenses)
* Pregnant, breast feeding, women of child-bearing potential not using appropriate contraceptive measures
* Any contraindication to 7T MRI (see Approved Procedure: IDREC_17 Title: Non-invasive Magnetic Resonance Investigations in Healthy Volunteers)
**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:** Wendy Howard
**Phone:** 01865 618238
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Oxford
**Country:** United Kingdom
**Facility:** Department of Psychiatry, University of Oxford
**State:** Oxfordshire
**Zip:** OX3 7JX
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Ip IB, Berrington A, Hess AT, Parker AJ, Emir UE, Bridge H. Combined fMRI-MRS acquires simultaneous glutamate and BOLD-fMRI signals in the human brain. Neuroimage. 2017 Jul 15;155:113-119. doi: 10.1016/j.neuroimage.2017.04.030. Epub 2017 Apr 19.
**PMID:** 28433623
**Citation:** Jewett BE, Thapa B. Physiology, NMDA Receptor. 2022 Dec 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519495/
**PMID:** 30137779
**Citation:** Li CT, Yang KC, Lin WC. Glutamatergic Dysfunction and Glutamatergic Compounds for Major Psychiatric Disorders: Evidence From Clinical Neuroimaging Studies. Front Psychiatry. 2019 Jan 24;9:767. doi: 10.3389/fpsyt.2018.00767. eCollection 2018.
**PMID:** 30733690
**Citation:** Rosenbaum SB, Gupta V, Patel P, Palacios JL. Ketamine. 2024 Jan 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470357/
**PMID:** 29262083
#### See Also Links
**Label:** Related Info
**URL:** https://www.psych.ox.ac.uk/getinvolved/gluesk-glutamate-and-esketamine-study
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
### Intervention Browse Module - Ancestors
- ID: D000000928
- Term: Antidepressive Agents
- ID: D000011619
- Term: Psychotropic Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M271980
- Name: Esketamine
- Relevance: HIGH
- As Found: Hrs
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: T5
- Name: Glutamic Acid
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000629870
- Term: Esketamine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432309
**Acronym:** OPAILEC
**Brief Title:** Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease
**Official Title:** Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel
#### Organization Study ID Info
**ID:** 480/2022/Oss/AOUFe
#### Organization
**Class:** OTHER
**Full Name:** University Hospital of Ferrara
### Status Module
#### Completion Date
**Date:** 2024-04-25
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-10-01
**Type:** ACTUAL
**Status Verified Date:** 2022-07
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital of Ferrara
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Levodopa-Carbidopa intestinal gel (LCIG) is an effective therapy for complicated Parkinson's disease (PD). Few studies have explored the efficacy and safety of the potential combination of LCIG with catechol-O-methyltransferase (COMT) inhibitors, particularly Opicapone (OPC).
**Detailed Description:** 22 PD patients were randomized into LCIG monotherapy (n-OPC 11 patients) and LCIG+OPC (add-OPC 11 patients), further divided according to OPC adding time (E-OPC within one month and L-OPC after one month from LCIG implant).
Data on PD clinical aspects, Montreal Cognitive Assessment (MoCA), Unified Parkinson's Disease Rating Scale (UPDRS), Unified Dyskinesia Rating Scale (UDysRS), electroneurography (ENG), and pharmacological therapy (Levodopa Equivalent Dose-LEDD) were collected before LCIG implanted (T0) and in the following 12 (T1) months.
### Conditions Module
**Conditions:**
- Parkinson Disease
- Effect of Drug
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Prospective randomised blinded End-point study
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 22
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.
**Intervention Names:**
- Drug: Duodopa
**Label:** nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy
**Type:** OTHER
#### Arm Group 2
**Description:** Levodopa carbidopa intestinal gel infusion (Diurnal infusion from 7 a.m to 11 p.m) plus Opicapone 50 mg 1 tablet at nighttime (11 p.m)
**Intervention Names:**
- Drug: Opicapone 50 mg
- Drug: Duodopa
**Label:** add-OPC: Duodopa plus OPC therapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- add-OPC: Duodopa plus OPC therapy
**Description:** Evaluate the addition of the COMT-I, Opicapone, to the Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.
**Name:** Opicapone 50 mg
**Other Names:**
- OPC
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- add-OPC: Duodopa plus OPC therapy
- nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy
**Description:** Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.
**Name:** Duodopa
**Other Names:**
- Levodopa/carbidopa intestinal gel (LCIG)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up.
**Measure:** Evaluation of motor fluctuations changes
**Time Frame:** 12 months
**Description:** Changes in UDysRS from the initial assessment to 12 months follow-up.
**Measure:** Evaluation of dyskinesia changes
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** Changes of MDS-UPDRS I score from the initial assessment to 12 months follow-up.
**Measure:** Changes in non-motor aspects of patients' daily living experiences
**Time Frame:** 12 months
**Description:** Changes of of MDS-UPDRS II score from the initial assessment to 12 months follow-up.
**Measure:** Changes in motor aspects of patients' daily living experiences
**Time Frame:** 12 months
**Description:** Changes of MOCA score from the initial assessment to 12 months follow-up.
**Measure:** Changes in non-motor symptoms in Parkinson's disease-cognition
**Time Frame:** 12 months
**Description:** Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up.
**Measure:** Neurophysiological outcome
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. LCIG implantation not longer than 30 months before the study enrollment,
2. Presence of nocturnal akinesia (assessed by medical history and through item 2.9 of MDS-UPDRS part II (\> 2), or/and
3. Persistence of morning or afternoon akinesia (assessed by item 4.3 in MDS UPDRS -IV( \>2 ).
Exclusion Criteria:
1. Hoehn \& Yahr (H\&Y) \>4,
2. Cognitive decline (MOCA\< 17),
3. more than 30 months after LCIG positioning,
4. not compliant with treatment and follow-up visits.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ferrara
**Country:** Italy
**Facility:** University Hospital of Ferrara - Arcispedale Sant'Anna
**State:** Emilia Romagna
**Zip:** 44122
#### Overall Officials
**Official 1:**
**Affiliation:** Azienda Ospedaliero -Universitaria S. Anna Ferrara
**Name:** Mariachiara Sensi, MD-Phd
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Nyholm D, Jost WH. Levodopa-entacapone-carbidopa intestinal gel infusion in advanced Parkinson's disease: real-world experience and practical guidance. Ther Adv Neurol Disord. 2022 Jun 26;15:17562864221108018. doi: 10.1177/17562864221108018. eCollection 2022.
**PMID:** 35785401
**Citation:** Fabbri M, Ferreira JJ, Lees A, Stocchi F, Poewe W, Tolosa E, Rascol O. Opicapone for the treatment of Parkinson's disease: A review of a new licensed medicine. Mov Disord. 2018 Oct;33(10):1528-1539. doi: 10.1002/mds.27475. Epub 2018 Sep 27.
**PMID:** 30264443
**Citation:** Ikenaka K, Kajiyama Y, Aguirre C, Choong CJ, Taniguchi S, Doi J, Wang N, Ajiki T, Ogawa K, Kakuda K, Kimura Y, Mochizuki H. Decreased hepatic enzymes reflect the decreased vitamin B6 levels in Parkinson's disease patients. Pharmacol Res Perspect. 2024 Feb;12(1):e1174. doi: 10.1002/prp2.1174.
**PMID:** 38287715
**Citation:** Leta V, van Wamelen DJ, Sauerbier A, Jones S, Parry M, Rizos A, Chaudhuri KR. Opicapone and Levodopa-Carbidopa Intestinal Gel Infusion: The Way Forward Towards Cost Savings for Healthcare Systems? J Parkinsons Dis. 2020;10(4):1535-1539. doi: 10.3233/JPD-202022.
**PMID:** 32597817
## 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: D000000978
- Term: Antiparkinson Agents
- ID: D000018726
- Term: Anti-Dyskinesia Agents
- ID: D000015259
- Term: Dopamine Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000065105
- Term: Aromatic Amino Acid Decarboxylase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000065098
- Term: Catechol O-Methyltransferase Inhibitors
- ID: D000000276
- Term: Adjuvants, Immunologic
- ID: D000007155
- Term: Immunologic Factors
- ID: D000018491
- Term: Dopamine Agonists
### Intervention Browse Module - Browse Branches
- Abbrev: AnDyAg
- Name: Anti-Dyskinesia Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CaAg
- Name: Cardiotonic Agents
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M10982
- Name: Levodopa
- Relevance: HIGH
- As Found: 30 seconds
- ID: M5489
- Name: Carbidopa
- Relevance: HIGH
- As Found: Experimental arm
- ID: M214057
- Name: Opicapone
- Relevance: HIGH
- As Found: Open reduction
- ID: M250674
- Name: Carbidopa, levodopa drug combination
- Relevance: HIGH
- As Found: Therapy dog
- ID: M4295
- Name: Antiparkinson Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7473
- Name: Dopamine
- 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: M30461
- Name: Aromatic Amino Acid Decarboxylase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M3628
- Name: Adjuvants, Immunologic
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M20595
- Name: Dopamine Agonists
- Relevance: LOW
- As Found: Unknown
- ID: T373
- Name: Catechol
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007980
- Term: Levodopa
- ID: D000002230
- Term: Carbidopa
- ID: C000549349
- Term: Opicapone
- ID: C000009265
- Term: Carbidopa, levodopa drug combination
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432296
**Brief Title:** Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody
**Official Title:** A Randomized, Controlled, Multi-Center Phase III Clinical Study to Evaluate the Efficacy and Safety of M701 for Intraperitoneal Injection in Patients With Malignant Ascites Caused by Advanced Epithelial Solid Tumors
#### Organization Study ID Info
**ID:** M70104
#### Organization
**Class:** INDUSTRY
**Full Name:** Wuhan YZY Biopharma Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-11-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-08-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Wuhan YZY Biopharma Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A Randomized, Controlled, Multi-Center Phase III Clinical Study to Compare the Efficacy and Safety of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody (M701) for Intraperitoneal Injection to Paracentesis alone in Patients with Malignant Ascites Caused by Advanced Epithelial Solid Tumors.
**Detailed Description:** The phase III study is a controlled, open-label trial designed to assess the effectiveness and safety of M701 intra-peritoneal infusion for controlling malignant ascites in patients with Malignant Ascites Caused by Advanced Epithelial Solid Tumors who are also receiving systemic therapy.
A total of 270 patients with malignant ascites caused by Malignant Ascites Caused by Advanced Epithelial Solid Tumors will be randomly assigned to two treatment arms in a 2:1 ratio. These patients must have experienced disease progression or intolerance after receiving at least two lines of systemic therapy.
Both treatment arms will receive the systemic therapy as per the investigator's instructions. The test arm will receive paracentesis and intra-peritoneal infusion of M701, while the control arm will receive paracentesis alone.
The primary endpoint of the study is the puncture-free survival, which evaluates the efficacy of M701 in controlling malignant ascites. Secondary endpoints include the overall survival (OS),Time to next puncture (TTNP), Patient-reported outcome (PRO) score, 6-month survival rate,1-month and 2-month puncture-free survival rate, safety profiles,and Anti-m701 antibody (ADA) and Neutralizing antibody (NAb).
### Conditions Module
**Conditions:**
- Malignant Ascites
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 270
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** M701 will be administered via intra-peritoneal infusion following sufficient drainage of malignant ascites.
The treatment regimen consists of a leading dose of 50μg on Day 1, followed by three infusions of the full dose of 400 μg M701 on Days 4, 11, and 18. If well tolerated, patients will continue to receive M701 infusions every 2 weeks as maintenance treatment.Additionally, these patients will receive systemic therapy as determined by the investigator.
**Intervention Names:**
- Drug: M701
**Label:** M701 group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients in the control group will undergo paracentesis on Day 1 and Day 18. If necessary, they may receive additional paracentesis during this period. Additionally, these patients will receive systemic therapy as determined by the investigator.
**Intervention Names:**
- Procedure: paracentesis
**Label:** Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- M701 group
**Description:** Intra-peritoneal infusion of M701 in experimental group (M701 group_
**Name:** M701
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control group
**Description:** Puncture and Draiange of ascites from the peritoneal cavity in both experimental group and control group
**Name:** paracentesis
**Type:** PROCEDURE
### Outcomes Module
#### Other Outcomes
**Description:** Time from the end of drainage of C1V4 ascites to the beginning of the next drainage (as the time of drainage)
**Measure:** TTNP
**Time Frame:** Time from the end of drainage of C1V4 ascites to the beginning of the next drainage (up to 6 months).
**Description:** The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 V3.0) was used to evaluate the quality of life of the subjects. This questionnaire is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. For the first 28 questions, the score is from 1-4, the lower score represents the better quality. For the last 2 quesionts, the score is from 1-7, the higher score represents the better health and quality of life.
**Measure:** The score of quality of life
**Time Frame:** Time from randomization to end of treatment. (up to 6 months).
**Description:** 1-month and 2-month PuFS rates
**Measure:** 1-month and 2-month PuFS rates
**Time Frame:** 1st and 2nd month from randomization
**Description:** 6-month survival rate
**Measure:** 6-month survival rate
**Time Frame:** 6th month from randomization
**Description:** Incidence of Treatment-Emergent Adverse Events, ≥grade 3 Treatment-Emergent Adverse Events, Serious Adverse Events and Treatment-Related Adverse Events.
**Measure:** Indidence of Adverse events
**Time Frame:** From the time of first dosing (Day 1) until one month after the end of treatment
**Description:** The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab) in the serum during the study
**Measure:** Positive rate of ADA and Nab in serum
**Time Frame:** Time from screening to end of treatment (up to 6 months).
**Description:** Measure the count of EpCAM postive cells in the ascites before and after M701 treatment
**Measure:** The EpCAM expression in ascites
**Time Frame:** From the time of first dosing (Day 1) until the end of treatment (up to 6 months).
#### Primary Outcomes
**Description:** Defined as the time from the end of C1V4 ascites drainage to the next drainage (based on the time of puncture) or the time of death is recorded as the PuFS.
**Measure:** PuFS
**Time Frame:** Time from the end of drainage of C1V4 ascites to the start of the next drainage or death (up to 6 months).
#### Secondary Outcomes
**Description:** Time from randomization to death from any cause
**Measure:** OS
**Time Frame:** Time from randomization to death from any cause (up to 6 months).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Able to understand and voluntarily sign the written informed consent form;
2. Age ≥18 years and ≤75 years;
3. Histologically or pathologically confirmed epithelial malignant solid tumors,including: advanced gastric cancer and colorectal cancer that have failed at least two lines of treatment (treatment failure is defined as progression after treatment or intolerance after treatment); or platinum-resistant (platinum-efractory) dvanced ovarian cancer;
4. Pathologically or clinically diagnosed with malignant ascites, and treatment for malignant ascites is required as judged by the investigator; B-mode ultrasound confirms that the volume of ascites is moderate or above (moderate or above ascites is defined as the maximum depth of ascites by B-mode ultrasound in supine position is ≥ 4.5 cm, or the actual amount of ascites drained is ≥ 1 L;
5. The time interval between the last anti-tumor treatment and Randomization should meet the following time intervals:
1. Intraperitoneal therapy: The time from the most recent intraperitoneal infusion therapy to randomization should be ≥ 2 weeks;
2. Systemic treatment: No washout required;
3. AEs should have recovered to Grade ≤ 1 from previous treatment (except for other adverse reactions (such as alopecia) that do not affect the safety evaluation of the investigational drug as judged by the investigator according to NCI-CTCAE V5.0);
6. ECOG PS score of 0 to 2;
7. An expected survival of ≥ 8 weeks;
8. Organ functions must meet the following criteria:
1. Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelets ≥90 ×10\^9/L, hemoglobin ≥ 85 g/L, and lymphocyte percentage ≥ 10%;
2. Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (AST and ALT ≤ 5 × ULN are allowed in case of liver metastasis);
3. Serum albumin ≥ 28 g/L;
4. Renal function: serum creatinine ≤ 1.5 × ULN.
9. Female subjects of childbearing potential should have a negative pregnancy test at screening; all female subjects of childbearing potential and male subjects should take adequate contraceptive measures throughout the treatment period and within 6 months after the end of the study.
Exclusion Criteria:
1. Patients with a known history of allergy to M701 or its components; patients with a known history of allergy to macromolecular ntibody drugs or a history of specific allergic reactions (asthma, rubella, and eczematous dermatitis);
2. Have previously used M701, or have used antibody drugs targeting EpCAM and/or CD3 within 4 months before the first dose;
3. Patients with central nervous system (CNS) metastases resulting in clinical symptoms or requiring therapeutic intervention; patients with previously treated brain metastases can be enrolled if they are asymptomatic and have stable disease as indicated by imaging examination ≥ 4 weeks before the first dose and do not require corticosteroids or anticonvulsant therapy;
4. Have undergone major surgery within 4 weeks prior to randomization or plan to undergo major surgery during the study(excluding exploratory surgery);
5. New or concurrent infection within 14 days prior to randomization that has not been controlled to clinical stability;
6. Patients with severe respiratory diseases at screening, leading to respiratory failure or those judged by the investigator to be unsuitable for enrollment;
7. Patients with active autoimmune diseases (e.g., inflammatory bowel disease,idiopathic thrombocytopenic purpura, lupus rythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, and rheumatoid arthritis), but patients with the following conditions are allowed to be screened: type I diabetes;hypothyroidism that can be controlled by replacement therapy only; skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, and alopecia);
8. Patients with severe cardiovascular and cerebrovascular diseases at screening,including cardiac insufficiency (NYHA Class III-IV); acute cardiovascular and cerebrovascular events (acute myocardial infarction, acute cerebral infarction,unstable angina, cerebral hemorrhage, etc.) orundergone vascular stenting within 6 months(Coronary artery stent implantation, intracranial artery stent implantation,etc.) or pulmonary embolism within the past 6 months; or venous thrombotic diseases such as venous thrombosis in lower limb within the past month;
9. Patients with complete intestinal obstruction within 30 days prior to Randomization,or those diagnosed with subileus but judged by the investigator as unsuitable for participating in the study based on their symptoms, signs, etc., or those have severe gastrointestinal disease such as gastric/intestinal perforation;
10. Unable to drain the ascites completely due to objective reasons (including ascites septation) or complicated with chylous ascites;
11. Portal vein embolism or portal hypertension confirmed by examinations;
12. Patients with active chronic hepatitis B \[such as positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis B core antibody (HBcAb), and HBV DNA ≥2000 IU/mL or HBV DNA ≥5000cps/mL\], active hepatitis C \[such as positive hepatitis C virus (HCV) antibody and HCV RNA ≥ lower limit of detection\], positive human immunodeficiency virus (HIV) antibody, or active syphilis infection (positive syphilis-specific antibody and positive syphilis non-specific antibody);
13. Patients with concurrent pleural effusion and clinical symptoms such as chest tightness and dyspnea, who have received clinical intervention or require clinical intervention as assessed by the investigator; or those with concurrent moderate to severe symptomatic pericardial effusion;
14. Pregnant or lactating women;
15. History of definitive neurological or mental disorders that, per the investigator's judgment, may affect the cognitive function or compliance of the patient, including unstable epilepsy, dementia, and schizophrenia;
16. Other conditions that the investigator considers unsuitable for participating in this clinical study.
**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:** Shaoyi Huang, PhD
**Phone:** 86-27-82668988
**Phone Ext:** 8440
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xiong Wang, MS
**Phone:** 86-27-82668988
**Phone Ext:** 8440
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jianming Xu, MD
- **Phone:** 010-68182255
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Rongrui Liu, MD
- **Phone:** 010-68182255
- **Role:** CONTACT
**Country:** China
**Facility:** The First Medical Center of Chinese PLA General Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100141
**Location 2:**
**City:** Harbin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yanqiao Zhang, PhD
- **Phone:** 0451-85718890
- **Role:** CONTACT
**Country:** China
**Facility:** Harbin Medical University Cancer Hospital
**State:** Heilongjiang
**Status:** RECRUITING
**Zip:** 150081
#### Overall Officials
**Official 1:**
**Affiliation:** The First Medical Center of Chinese PLA General Hospital
**Name:** Jianming Xu, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** The Second Affiliated Hospital of Harbin Medical University
**Name:** Yanqiao zhang, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- 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: M4509
- Name: Ascites
- Relevance: HIGH
- As Found: Ascites
### Condition Browse Module - Meshes
- ID: D000001201
- Term: Ascites
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M20194
- Name: Antibodies, Bispecific
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432283
**Brief Title:** A Machine Learning-based Estimated Survival Model
**Official Title:** Construction and Validation of a Machine Learning-based Estimated Survival Model for Elderly Patients With Advanced Malignancy
#### Organization Study ID Info
**ID:** 2024 Review (807)
#### Organization
**Class:** OTHER
**Full Name:** West China Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhao Siyao
#### Responsible Party
**Investigator Affiliation:** West China Hospital
**Investigator Full Name:** Zhao Siyao
**Investigator Title:** Sponser-Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Malignant tumors are the leading cause of death in elderly patients, and palliative care can improve the quality of life for elderly advanced cancer patients. One of the main reasons why these patients are not included in palliative care is the lack of accurate estimation of their survival period by patients, family members, and doctors. Both doctors and patients tend to be overly optimistic about the survival period of elderly advanced cancer patients, leading to overtreatment. Therefore, assessing the risk of death for these patients and further establishing a survival period estimation model can improve the accuracy of doctors' clinical predictions of patient survival, facilitate early referral to palliative care, and promote rationalization of medical decision-making.
**Detailed Description:** 1. By searching the literature, conducting systematic reviews, and meta-analyses, we aim to uncover the prognostic factors related to death in elderly advanced cancer patients.
2. Based on evidence-based data and considering the clinical conditions of elderly advanced cancer patients in China, we will establish relevant entries for a risk assessment scale for death in elderly advanced cancer patients. By using the Delphi expert consultation evaluation method, we will finalize the assessment scale framework, laying the theoretical foundation for the establishment and validation of a death risk prediction model for elderly advanced cancer patients in China.
3. Develop a survival estimation model for elderly advanced cancer patients; through metabolomics studies and other research methods, we will investigate metabolic biomarkers related to predicting the survival period of elderly advanced cancer patients.
### Conditions Module
**Conditions:**
- Advanced Solid Tumor
### 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:** advanced cancer (stage III and IV) patients aged 60 years and above who are receiving treatment at the mentioned institution. The research subjects voluntarily participate and sign informed consent forms.
**Label:** advanced cancer (stage III and IV) patients aged 60 years and above.
### Outcomes Module
#### Primary Outcomes
**Description:** Build a survival estimation model for elderly late-stage cancer patients.
**Measure:** A model
**Time Frame:** 2026-12-31
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:Inclusion criteria for late-stage malignant tumor patients: Must meet Condition 1) and also meet either Condition 2), 3), or 4):
1. Clinical diagnosis of advanced malignant tumor: TNM stage III or IV
2. "Surprise question": If this patient were to die within the next 6 months, it would not be surprising to you.
3. Karnofsky performance status (KPS) score ≤ 50
4. Palliative Performance Scale (PPS) ≤ 50%
Exclusion Criteria:
1. Patients who refuse to participate in the study;
2. Patients who, for various reasons, are unable to cooperate and complete the questionnaire survey;
3. Patients who, for various reasons, are unable to cooperate and complete the follow-up.
**Minimum Age:** 60 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Advanced cancer （stage III and IV） malignant tumor patients aged 60 years and above.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Chengdu
**Country:** China
**Facility:** Siyao Zhao
**State:** Sichuan
**Zip:** 610041
#### Overall Officials
**Official 1:**
**Affiliation:** West China Hospital
**Name:** Siyao Zhao, postgraduate
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432270
**Brief Title:** Effect of Diabetes Mellitus on Cardiac Autonomic Function in Surgical Patients Undergoing General Anesthesia
**Official Title:** A Prospective Cohort Study of the Effect of Diabetes Mellitus on Cardiac Autonomic Function in Surgical Patients Undergoing General Anesthesia
#### Organization Study ID Info
**ID:** 2022-KY-209-02
#### Organization
**Class:** OTHER
**Full Name:** Zhujiang Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhujiang 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:** Because autonomic neuropathy affects the constriction of thermoregulatory blood vessels, it is more difficult for diabetic patients to maintain their own body temperature in cold environments than normal people, and therefore it is more difficult for diabetic patients to maintain a relatively constant body temperature regardless of the temperature of the environment than normal people. So are diabetic patients under general anesthesia more susceptible to intraoperative hypothermia? How does heart rate variability change in diabetic patients under general anesthesia? If diabetic patients are more susceptible to intraoperative hypothermia under general anesthesia, is this related to their cardiac autonomic dysfunction?
**Detailed Description:** According to the latest version of data released by the International Diabetes Federation (IDF) in 2021, it can be seen that the number of people with diabetes globally or in China is high and the percentage is increasing.In 2021, there are 537 million people with diabetes globally, and there are about 141 million in China, which is an increase of about 21.55% compared with 2019 . Perioperative hypothermia is a clinical phenomenon in which a patient's core body temperature is below 36°C for non-medical purposes during the perioperative period, with an incidence of about 7-90%, which can lead to a variety of adverse outcomes.In hot environments, sweating and vasodilation are severely compromised in diabetic patients due to autonomic neuropathy, which prevents the body from transferring heat from the inside of the body to the skin through vasodilation, increased blood flow, and sweating. Similarly, because autonomic neuropathy affects the constriction of thermoregulatory blood vessels, it is more difficult for diabetic patients to maintain their own body temperature in cold environments than normal people, and therefore it is more difficult for diabetic patients to maintain a relatively constant body temperature regardless of the temperature of the environment than normal people. On the other hand, general anesthesia and external environmental factors in the operating room increase the incidence of intraoperative hypothermia, and theoretically, diabetic patients are more prone to dramatic fluctuations in their own body temperature during surgery, making it difficult for them to adapt to changes in the external environment. Due to the complex pathophysiological mechanism of diabetes, which affects multiple systems throughout the body, there are currently more than 100 complications of diabetes, of which autonomic neuropathy has the most serious impact on diabetic patients. Cardiac autonomic neuropathy is one of the most common and serious complications of diabetic autonomic neuropathy, with a prevalence of 63% . And heart rate variability is one of the most common tests for diabetic cardiac autonomic dysfunction. So are diabetic patients under general anesthesia more susceptible to intraoperative hypothermia? How does heart rate variability change in diabetic patients under general anesthesia? If diabetic patients are more susceptible to intraoperative hypothermia under general anesthesia, is this related to their cardiac autonomic dysfunction? However, there are still no studies and little attention has been paid to it.
### Conditions Module
**Conditions:**
- Diabetic Autonomic Neuropathy Type 2
- Perioperative Complication
- Temperature Change, Body
**Keywords:**
- diabetes
- general anesthesia
- Cardiac autonomic dysfunction
- perioperative temperature
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 388
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 3 Days
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with a diagnosis of diabetes mellitus who are about to undergo general anesthesia who are expected to undergo laparoscopic surgery
**Label:** diabetic group
#### Arm Group 2
**Description:** Nondiabetic patients anticipating laparoscopic surgery who are about to undergo general anesthesia
**Label:** Non-diabetic group
### Outcomes Module
#### Other Outcomes
**Description:** Age of the participants(years)
**Measure:** Age
**Time Frame:** the preoperative visit period
**Description:** Height of the participants(meters)
**Measure:** Height
**Time Frame:** the preoperative visit period
**Description:** BMI of the participants(kg/m2)
**Measure:** BMI
**Time Frame:** the preoperative visit period
#### Primary Outcomes
**Description:** The study was conducted by using a perioperative core body temperature monitoring system to continuously monitor and record core body temperature data for 12 hours preoperatively - intraoperatively - 12 hours postoperatively, and then calculating the mean core body temperature per minute at 12 hours preoperatively, intraoperatively, and 12 hours postoperatively, respectively, to compare whether diabetic patients had lower mean core body temperature per minute intraoperatively than non-diabetic patients, and whether diabetic patients had a decrease in intraoperative body temperature compared to 12 hours preoperatively and 12 hours postoperatively. Mean intraoperative core body temperature per minute (°C/min) = Mean intraoperative core body temperature/operating time.
**Measure:** Changes in perioperative core body temperature in diabetic patients
**Time Frame:** 12 hours before surgery,during operation,12 hours after surgery
#### Secondary Outcomes
**Description:** observing the time period during which diabetic and non-diabetic patients began to drop below the mean temperature at 12 hours preoperatively and comparing how early or late the temperature began to drop in both groups
**Measure:** time to onset of temperature drop
**Time Frame:** Baseline and 12 hours before surgery,0-30 minutes after induction ,30-60 minutes after induction,60-90 minutes after induction,90-120 minutes after induction,120-150 minutes after induction,150-180 minutes after induction,12 hours after surgery
**Description:** Observing the period of time during which diabetic and non-diabetic patients experienced a drop in temperature to nadir, and comparing how fast or slow the temperature dropped to the lowest point
**Measure:** time to temperature drop to nadir
**Time Frame:** Baseline and 12 hours before surgery,0-30 minutes after induction ,30-60 minutes after induction,60-90 minutes after induction,90-120 minutes after induction,120-150 minutes after induction,150-180 minutes after induction,12 hours after surgery
**Description:** Comparing whether the average core body temperature of diabetic patients was lower than that of non-diabetic patients at each time period after induction.
**Measure:** The magnitude of body temperature decline
**Time Frame:** Baseline and 12 hours before surgery,0-30 minutes after induction ,30-60 minutes after induction,60-90 minutes after induction,90-120 minutes after induction,120-150 minutes after induction,150-180 minutes after induction,12 hours after surgery
**Description:** using 24-hour Holter ECG to collect HRV data from 12 hours before surgery to induction (first administration of medication), and from the time the patients left the recovery room to 12 hours after surgery, and observing the changes in HRV data of the patients of the two groups in the two time periods
**Measure:** Changes in heart rate variability (HRV)
**Time Frame:** 12 hours before surgery,12 hours after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years old ≤ age ≤ 80 years old, gender is not limited;
* BMI index of 18-35 kg/m2 (including 18 kg/m2 and 35 kg/m2 );
* Diagnosed with diabetes mellitus;
* ASA Ⅰ - Ⅱ;
* Elective laparoscopic abdominal surgery under general anesthesia;
* Operating time \>2 hours and \<6 hours;
* Voluntary participation and signing of an informed consent form;
* Ability to be followed up in a timely manner.
Exclusion Criteria:
* Abnormally elevated preoperative inflammatory indicators;
* Core body temperature ≥37.5 degrees Celsius;
* Patients with previous clear central nervous system disease, history of psychiatric disorders, or epilepsy;
* Patients with verbal communication or hearing or visual impairment, who were unable to communicate well and had poor compliance;
* Intraoperative use of vasodilator (uradil, sodium nitroprusside, nitroglycerin);
* Any high-risk subjects with complete atrioventricular block or complete atrioventricular conduction tissue without implanted pacemakers, multiple premature ventricular beats, single premature ventricular beats (heart rate \<45 beats/min), heart failure in NYHA (New York Heart Association) class III or higher;
* Subjects with any other clinically significant 12-lead electrocardiogram (ECG) or echocardiogram abnormality at the time of screening, ejection fraction (EF) \<40%, or any other significant abnormality in the opinion of the investigator;
* Subjects deemed by the investigator to be unfit for this clinical trial for any other reason (anesthesia assessment unfit for surgery or preanesthetic hypertension).
Withdrawal Criteria:
* Serious adverse events, abnormal laboratory tests, or other conditions that indicate no further benefit or increased risk to the subject's safety from continued participation in the study;
* Incomplete recording of critical data (temperature or heart rate variability);
* Unstable condition requiring further admission to the intensive care unit;
* Intraoperative use of dexmedetomidine; 5. Perioperative nerve block.
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This study is expected to collect patients who are hospitalized in Zhujiang Hospital of Southern Medical University and are proposed to undergo surgery
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xinying Wang, Master
**Phone:** 86-13539410563
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Southern Medical University, China
**Name:** Zhujiang Hospital of Southern Medical University
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000048909
- Term: Diabetes Complications
### 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: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes Mellitus
- ID: M4643
- Name: Autonomic Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27979
- Name: Primary Dysautonomias
- Relevance: LOW
- As Found: Unknown
- ID: M7124
- Name: Diabetic Neuropathies
- Relevance: HIGH
- As Found: Diabetic Autonomic Neuropathy
- ID: M5111
- Name: Body Temperature Changes
- Relevance: HIGH
- As Found: Temperature Change, Body
- 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: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26004
- Name: Diabetes Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003929
- Term: Diabetic Neuropathies
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000001832
- Term: Body Temperature Changes
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432257
**Brief Title:** The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery
**Official Title:** The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery
#### Organization Study ID Info
**ID:** NO.SWYX2024-280
#### Organization
**Class:** OTHER_GOV
**Full Name:** Shandong Provincial Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2020-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Shandong University
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Shandong Provincial Hospital
#### Responsible Party
**Investigator Affiliation:** Shandong Provincial Hospital
**Investigator Full Name:** Guojun Wu
**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 collected data on open thyroidectomy patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery. This study investigated whether the application of head mounted magnifying glasses had an impact on preoperative and postoperative changes in PTH levels through inter group and self pre - and post control, in order to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery and provide reasonable suggestions for the selection of subsequent surgical treatment methods.
**Detailed Description:** In thyroid surgery, changes in postoperative parathyroid hormone (PTH) levels have a significant impact on the patient\'s recovery and long-term health status. Parathyroid hormone is responsible for regulating blood calcium levels, and its dysfunction can cause serious electrolyte imbalance and metabolic problems. In the process of thyroid surgery, especially in total thyroidectomy, protecting the function of the parathyroid gland is an important operation. The diameter of the parathyroid gland is small and similar to the morphology of lymph nodes, making it susceptible to damage during surgery. Although traditional magnification tools such as surgical microscopes have certain effects, their operation is complex and their adaptability to surgical scenes is limited.
In recent years, as an emerging magnifying tool, head mounted magnifying glasses have been increasingly used in thyroid surgery due to their portability, ease of operation, and providing a larger field of view. Wearing a head mounted magnifying glass can not only improve the clarity of vision during surgery, increase the recognition rate of parathyroid glands and nerves, but also reduce the risk of parathyroid injury by improving surgical accuracy, thereby more effectively maintaining the stability of postoperative PTH levels. In addition, the use of head mounted magnifying glasses can reduce surgical time, intraoperative uncertainty, and the risk of postoperative complications.
This study systematically evaluates the changes in PTH levels before and after surgery to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery, and further explores the effectiveness of parathyroid gland protection strategies, optimizing surgical techniques, and improving patient surgical safety and postoperative quality of life. In addition, the results of this study also have guiding significance for the innovation and improvement of surgical instruments, which may promote the development of related technologies and equipment, and thus promote their application in a wider range of surgical fields.
### Conditions Module
**Conditions:**
- Thyroid Cancer
**Keywords:**
- thyroid cancer
- PTH
- Head mounted magnifying glass
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 2000
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery.
**Intervention Names:**
- Device: head mounted magnifying glass assistance
**Label:** Using the head mounted magnifying glass
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Using the head mounted magnifying glass
**Description:** When performing thyroid surgery for patients in the experimental group, the surgeon uses a head mounted magnifying glass for assistance
**Name:** head mounted magnifying glass assistance
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** To verify the practical effectiveness of wearing a magnifying glass in thyroid surgery by examining changes in PTH levels before and after surgery.
**Measure:** PTH level
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All cases were the first to undergo open thyroidectomy surgery.
* All clinical data and research materials of the cases are complete.
* All cases underwent thyroid function examination before and after surgery.
* All cases in the experimental group were treated with a head mounted magnifying glass during surgery.
Exclusion Criteria:
* Except for cases of recurrence.
* Cases with incomplete clinical data and research materials are excluded.
* Cases that have not undergone thyroid function tests before and after surgery are excluded.
* Excluding cases of secondary surgery.
* Excluding cases in the experimental group who did not use a head mounted magnifying glass during surgery.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** This study collected patients who underwent open thyroidectomy surgery at the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023. All patients included in the study had complete clinical and research data, with approximately 2000 participants.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Jinan
**Country:** China
**Facility:** Shandong provincial hospital
**State:** Shandong
**Zip:** 250102
### IPD Sharing Statement Module
**Description:** The data are not publicly available due to privacy and ethical restrictions.
**IPD Sharing:** NO
## 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: BC04
- Name: Neoplasms
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16723
- Name: Thyroid Neoplasms
- Relevance: HIGH
- As Found: Thyroid Cancer
- ID: M16718
- Name: Thyroid Diseases
- Relevance: HIGH
- As Found: Thyroid
- 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432244
**Brief Title:** The Effect of the Number of Central Lymph Nodes on Changes in Parathyroid Function
**Official Title:** The Effect of the Number of Central Lymph Nodes on Changes in Parathyroid Function
#### Organization Study ID Info
**ID:** NO.SWYX2024-279
#### Organization
**Class:** OTHER_GOV
**Full Name:** Shandong Provincial Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2020-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Shandong University
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Shandong Provincial Hospital
#### Responsible Party
**Investigator Affiliation:** Shandong Provincial Hospital
**Investigator Full Name:** Guojun Wu
**Investigator Title:** 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:** This study collected data from patients who underwent thyroidectomy in the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. The main calculation indicator was the changes in PTH before and after surgery. This study grouped patients based on the number of central lymph nodes under postoperative paraffin pathology, and statistically analyzed the changes and differences in PTH before and after surgery in different groups to verify the relationship between the number of central lymph nodes in the thyroid gland and parathyroid function, and to provide reference for surgical selection in thyroid cancer patients with multiple cervical lymph node metastases.
**Detailed Description:** The central lymph nodes of the thyroid gland refer to the lymph nodes located around the thyroid and trachea. The central lymph nodes are the primary site of thyroid cancer metastasis, and therefore play an important role in thyroid surgery. In thyroid surgery, preventive central lymph node dissection is a routine procedure, but during this process, the parathyroid gland may be impaired due to surgical injury or insufficient blood supply.
Hypothyroidism, also known as parathyroidism, is a common complication of thyroid surgery. When the parathyroid gland is accidentally injured or its blood supply is disrupted, it can lead to insufficient production of parathyroid hormone. Parathyroid hormone is a key hormone that regulates blood calcium levels. Insufficient levels can lead to hypocalcemia, manifested as hand and foot spasms, muscle spasms, and even arrhythmia.
From a surgical perspective, the number of lymph nodes in the central region of the thyroid gland may affect the preservation and functional protection of the parathyroid gland. A large number of lymph nodes indicates that they may have a wider range of disease invasion, requiring more thorough lymph node dissection, thereby increasing the risk of damaging the parathyroid gland or its blood supply.
### Conditions Module
**Conditions:**
- Thyroid Cancer
**Keywords:**
- thyroid cancer
- central lymph nodes
- PTH
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 2000
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** By exploring the relationship between the number of lymph nodes in the central region of the thyroid gland and parathyroid function, evaluate the effectiveness of different surgical procedures and intraoperative protective measures on parathyroid function protection.
**Label:** Number of central lymph node dissection
### Outcomes Module
#### Primary Outcomes
**Description:** This study grouped the central lymph nodes based on postoperative paraffin pathology, and statistically analyzed the changes and differences in PTH before and after surgery in different groups to verify the relationship between the number of central lymph nodes in the thyroid gland and parathyroid function.
**Measure:** PTH level
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All cases were the first to undergo thyroidectomy surgery.
* All clinical data and research materials of the cases are complete.
* All cases underwent thyroid function examination before and after surgery.
* All cases underwent preoperative thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital.
Exclusion Criteria:
* Except for cases of recurrence.
* Cases with incomplete clinical data and research materials are excluded.
* Cases that have not undergone thyroid function tests before and after surgery are excluded.
* Excluding cases of secondary surgery.
* Cases that have not undergone thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital before surgery are excluded.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** This study collected data from patients who underwent thyroidectomy surgery at the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023. All patients included in the study had complete clinical data and research materials, with approximately 2000 participants.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Jinan
**Country:** China
**Facility:** Shandong provincial hospital
**State:** Shandong
**Zip:** 250102
### IPD Sharing Statement Module
**Description:** The IPD are not publicly available due to privacy and ethical restrictions.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013959
- Term: Thyroid Diseases
- 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: BC04
- Name: Neoplasms
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16723
- Name: Thyroid Neoplasms
- Relevance: HIGH
- As Found: Thyroid Cancer
- ID: M16718
- Name: Thyroid Diseases
- Relevance: LOW
- As Found: Unknown
- 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
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M13194
- Name: Parathyroid Hormone
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432231
**Brief Title:** Effects of Low Glycemic Index Diet in Children With Drug-resistant Epilepsy
**Official Title:** The Effects of Low Glycemic Index Diet on Epileptic Seizure Frequency, Oxidative Stress, Mental Health, and Health-related Quality of Life in Children With Drug-resistant Epilepsy
#### Organization Study ID Info
**ID:** 2022-GAP-SABF-0052
#### Organization
**Class:** OTHER
**Full Name:** Izmir Katip Celebi University
### Status Module
#### Completion Date
**Date:** 2024-02-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-02-20
**Type:** ACTUAL
#### Start Date
**Date:** 2022-08-28
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Izmir Katip Celebi University
#### Responsible Party
**Investigator Affiliation:** Izmir Katip Celebi University
**Investigator Full Name:** Gamze Yurtdaş Depboylu
**Investigator Title:** Associate 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 goal of this clinical trial was to evaluate the effectiveness of a low glycemic index diet (LGID) on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy. Based upon the aims, the following hypotheses were tested:
1. LGID reduces seizure frequency in children with drug-resistant epilepsy.
2. LGID improves oxidative parameters in children with drug-resistant epilepsy
3. LGID improves quality of life and mental health in children with drug-resistant epilepsy
Participants were prescribed the LGID for 3 months.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements were collected. Diet compliance was evaluated by food consumption records during monthly follow-up visits (at 1 , 2, and 3 months).
**Detailed Description:** The aim of this study was to evaluate the efficacy of a low glycemic index diet on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy.This study was a prospective, non-randomized, single centre intervention conducted in children with drug-resistant epilepsy. Low glycemic index diet was started on an out-patient basis. Children and their parents were educated about the diet and the effect of the diet on seizures. Children who were willing to follow the diet were included in the study. The research dietitian conducted interviews with patients and their parents at the beginning of the study to explain the principles of the diet.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements including oxidative stress parameters were collected. A 3-day dietary intake chart kept by the parents was reviewed at each monthly visit to check and reinforce compliance. Parents were asked to record the seizure frequency and severity in a seizure diary.
### Conditions Module
**Conditions:**
- Ketogenic Diet
- Drug Resistant Epilepsy
- Oxidative Stress
- Quality of Life
- Psychological Health
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 34
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Children with drug-resistant epilepsy were treated with a low glycemic index diet for 3 months.
**Intervention Names:**
- Other: Low glycemic index diet treatment
**Label:** Low glycemic index diet treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Low glycemic index diet treatment
**Description:** This study was a non-randomized, single centre, pre/post-intervention study. A low glycemic index diet was prescribed by a dietician for 3 months. LGID treatment consisted of 10% (40-60 g) low glycaemic index (glycaemic index \<50) carbohydrate, 20-30% protein and 60-70% lipid
**Name:** Low glycemic index diet treatment
**Other Names:**
- LGID
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Seizure diary was kept by parents to records seizure frequency and severity
**Measure:** Changes in seizure frequency
**Time Frame:** Baseline and Month 3
**Description:** Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS))
**Measure:** Concentration of antioxidant and oxidant status
**Time Frame:** Baseline and Month 3
**Description:** Measurement of Paraoxonase Enzyme Activity (PON-1)
**Measure:** Concentration of Paraoxonase Enzyme Activity
**Time Frame:** Baseline and Month 3
**Description:** Measurement of Malondialdehyde (MDA)
**Measure:** Concentration of Malondialdehyde (MDA)
**Time Frame:** Baseline and Month 3
**Description:** "Pediatric Inventory of Quality of Life" was applied to assess health-related quality of life. A higher score corresponds to a higher health-related quality of life. The score ranges from 0 to 100
**Measure:** Changes in quality of life
**Time Frame:** Baseline and Month 3
**Description:** Psychosocial problems were assessed by the "Strengths and Difficulties Questionnaire".The questionnaire includes 25 questions, some of which question positive and some of which question negative behavioral characteristics. These questions are grouped under 5 sub-headings. These are behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems and social behaviors. Each heading is evaluated in itself with scores that range from 0 to 10 and the sum of the first four headings gives the "total difficulty score". While high scores in social behavior reflect the individual's strengths in the social domain, high scores in the other four domains (behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems) reflect that the problem areas are severe.
**Measure:** Changes in psychosocial problems
**Time Frame:** Baseline and Month 3
**Description:** Depression status was assessed by the "Children's Depression Scale".Scores that can be obtained from the scale can vary between 0-54. The cut-off point of the depression scale for children is 19, and high scores indicate a high risk of depression.
**Measure:** Changes in depression level
**Time Frame:** Baseline and Month 3
#### Secondary Outcomes
**Description:** Measurement of glucose
**Measure:** Concentration of glucose
**Time Frame:** Baseline and Month 3
**Description:** Measurement of insulin
**Measure:** Concentration of insulin
**Time Frame:** Baseline and Month 3
**Description:** Measurement of Alanine transaminase (ALT) and Aspartate transaminase (AST)
**Measure:** Concentration of liver function tests
**Time Frame:** Baseline and Month 3
**Description:** Measurement of total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), serum triglyceride (mg/dl)
**Measure:** Changes in lipid profile
**Time Frame:** Baseline and Month 3
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being between the ages of 4-18,
* being diagnosed with drug-resistant epilepsy,
* having more than one seizure per week,
* not having followed a ketogenic diet before.
* willing to come for regular follow up
Exclusion Criteria:
* children with known or suspected congenital metabolic, chronic, and systemic diseases in which ketogenic diet is contraindicated.
* non-compliance with the diet recommended by the patient and/or parents
* enteral tube or parenteral feeding
**Maximum Age:** 18 Years
**Minimum Age:** 4 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Çi̇ğli̇
**Country:** Turkey
**Facility:** Gamze Yurtdaş Depboylu
**State:** İ̇zmi̇r
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M7983
- Name: Epilepsy
- Relevance: HIGH
- As Found: Epilepsy
- ID: M15452
- Name: Seizures
- Relevance: LOW
- As Found: Unknown
- ID: M369
- Name: Drug Resistant Epilepsy
- Relevance: HIGH
- As Found: Drug Resistant Epilepsy
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000004827
- Term: Epilepsy
- ID: D000069279
- Term: Drug Resistant Epilepsy
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432218
**Brief Title:** Patient Education in the Clinical Management of Pessary
**Official Title:** A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary
#### Organization Study ID Info
**ID:** K5558
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2026-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Peking University People's Hospital
**Class:** OTHER
**Name:** Shandong University
**Class:** OTHER
**Name:** Tongji Hospital
**Class:** OTHER
**Name:** Third Military Medical University
**Class:** OTHER
**Name:** Changsha Hospital for Maternal and Child Health Care
**Class:** UNKNOWN
**Name:** Hangzhou Women's Hospital
**Class:** OTHER
**Name:** Shenzhen People's Hospital
**Class:** UNKNOWN
**Name:** Foshan Women and Children Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking Union Medical College 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 is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared.
### Conditions Module
**Conditions:**
- Pelvic Organ Prolapse
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 280
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Watch video as well as receive conventional guidance.
**Intervention Names:**
- Other: video education
- Other: conventional education
**Label:** the conventional education plus video education group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Receive conventional guidance.
**Intervention Names:**
- Other: conventional education
**Label:** the conventional education group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- the conventional education plus video education group
**Description:** A re-watchable video provided before pessary fitting which mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy.
**Name:** video education
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- the conventional education group
- the conventional education plus video education group
**Description:** Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.
**Name:** conventional education
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Continued usage of the pessary and have very much or much improvement in the patient impression of improvement (PGI-I) questionnaire at 1 year.
**Measure:** Continued usage with satisfaction
**Time Frame:** 12 months after pessary fitting.
#### Secondary Outcomes
**Description:** Self-rated score from 0 to 10 points (higher scores mean a better outcome).
**Measure:** Knowledge of pessary
**Time Frame:** Baseline and at pessary fitting.
**Description:** Self-rated score from 0 to 10 points (higher scores mean a better outcome).
**Measure:** Willingness to treatment
**Time Frame:** Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.
**Description:** 7-item generalized anxiety disorder questionnaire (GAD-7) (the range of scores is 0-21, and higher scores mean a worse outcome), and self-rated score of sleep quality from 0 to 10 points (higher scores mean a better outcome).
**Measure:** Anxiety about pessary use
**Time Frame:** Baseline and at pessary fitting.
**Description:** Self-rated score from 0 to 10 points (higher scores mean a better outcome).
**Measure:** Ability to self-manage
**Time Frame:** 3 and 12 months after successful pessary fitting.
**Description:** Self report and physical examination.
**Measure:** Treatment-related symptoms and complications
**Time Frame:** 3 and 12 months after successful pessary fitting.
**Description:** Pelvic floor impact questionnaire-7 (PFIQ-7) (the range of scores is 0-300, and higher scores mean a worse outcome)
**Measure:** Improvement in symptoms
**Time Frame:** 3 and 12 months after successful pessary fitting.
**Description:** Pelvic floor distress inventory-20 (PFDI-20) (the range of scores is 0-300, and higher scores mean a worse outcome)
**Measure:** Improvement in quality of life
**Time Frame:** 3 and 12 months after successful pessary fitting.
**Description:** The pelvic organ prolapse/urinary incontinence sexual questionnaire short form (PISQ-12) (the range of scores is 0-48, and higher scores mean a worse outcome)
**Measure:** Improvement in sexual activity
**Time Frame:** 3 and 12 months after successful pessary fitting.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Symptomatic pelvic organ prolapse of stage II\~IV
* Ability to participate in clinical trial and follow-up
* The patient and family understand the study, are willing to participate in the 1-year study, and provide written informed consent
Exclusion Criteria:
* Acute phase of infection of the internal and/or external genital tracts
* Genital fistula
* Suspected or untreated lower genital tract tumors
* Abnormally elevated intra-abdominal pressure (e.g., ascites, tumors)
* Life expectancy less than 1 year
* Cognitive or language communication disorders
* Unable to watch video (e.g., blindness)
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ying Zhou, MD
**Phone:** +8613681253992
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ying Zhou, MD
- **Phone:** +8613681253992
- **Role:** CONTACT
***Contact 2:***
- **Name:** Lan Zhu, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Peking Union Medical College Hospital
**State:** Beijing
**Zip:** 100730
#### Overall Officials
**Official 1:**
**Affiliation:** Peking Union Medical College Hospital
**Name:** Lan Zhu, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14261
- Name: Prolapse
- Relevance: HIGH
- As Found: Prolapse
- ID: M28618
- Name: Pelvic Organ Prolapse
- Relevance: HIGH
- As Found: Pelvic Organ Prolapse
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011391
- Term: Prolapse
- ID: D000056887
- Term: Pelvic Organ Prolapse
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432205
**Brief Title:** The Effect of MDT Plus SDM on Survival Benefit of Advanced Gastric Cancer
**Official Title:** The Effect of Multi-Disciplinary Team Plus Shared-Decision Making on Survival Benefit of Advanced Gastric Cancer - a Single Center, Non-randomized, Prospective, Controlled Study
#### Organization Study ID Info
**ID:** 2023YJZ66
#### Organization
**Class:** OTHER
**Full Name:** Peking University
### Status Module
#### Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-09
**Type:** ACTUAL
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this observational study is to learn about the long-term effect of surgery in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation. The main question it aims to answer is:
Does surgery extend survival time in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation?
**Detailed Description:** Select metastatic gastric cancer patients that have the opportunity to undergo any forms of surgery through MDT. Then further evaluate these patients' risks and benefits. Let patients make their finally decision through shared-decision making (SDM). According to the actual decision, the patients are divided into surgery group and non-surgery group.
### Conditions Module
**Conditions:**
- Gastric Cancer
**Keywords:**
- multi-disciplinary Team
- shared-decision making
- surgery
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 121
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose to undergo surgery after MDT plus SDM.
**Intervention Names:**
- Procedure: surgery
**Label:** surgery group
#### Arm Group 2
**Description:** metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose not to undergo surgery after MDT plus SDM.
**Label:** non-surgery group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- surgery group
**Description:** any forms of surgery, such as all tumor resection, partial tumor resection and palliative tumor resection surgery
**Name:** surgery
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Measure:** overall survival
**Time Frame:** From diagnosis of metastatic gastric cancer to any cause of death，assessed up to 5 years
#### Secondary Outcomes
**Measure:** progression free survival
**Time Frame:** From diagnosis of metastatic gastric cancer to tumor progression or any cause of death, assessed up to 2 years
**Description:** any grade of adverse event
**Measure:** safety of surgery
**Time Frame:** after surgery, assessed up to 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥18 years old;
* Participate in the formal MDT discussion and evaluate feasible surgical treatment;
* Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histology;
* Immunotherapy must be received during the treatment;
* At least 1 distant metastatic organs, and the number of metastases is ≥1;
* The subject line blood routine (within 7 days) and biochemical indicators (within 14 days) meet the following standards:
hemoglobin≥90g/L； absolute count of neutral granulocytes (ANC) ≥1.5×10\^9/L； platelets≥100×10\^9/L； Alt, AST≤ 2.5 times the normal upper limit，≤5 times the normal upper limit value (with liver metastasis)； ALP ≤ 2.5 times the normal upper limit，≤5 times the normal upper limit (with liver or bone metastasis)； total bilirubin\<1.5 times the normal upper limit value of serum； serum creatinine\<1.5 times normal upper limit； albumin≥30g/L；
* ECOG 0 ～ 1 point;
* The expected life span is ≥3 months;
* Cardiopulmonary function is basically normal;
* Women and spouses of childbearing age are willing to adopt effective contraceptive methods.
Exclusion Criteria:
* Those who do not meet the above selected standards or have chemotherapy contraindications;
* Combined with other primary malignant tumors;
* Pregnancy, lactating women or women of childbearing age and spouses refuse to adopt effective contraceptive methods;
* History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation);
* History of long -term treatment of steroids (Note: Short -term users discontinue drugs\> 2 weeks can be selected);
* History of peripheral nervous system disorders or obvious mental disorders and central nervous system disorders;
* Accompanied by severe infection;
* Accompanied by swallowing difficulties, complete or incomplete digestive tract obstruction, gastrointestinal bleeding, perforation, etc.;
* Severe liver disease (such as liver cirrhosis, etc.), kidney disease, respiratory disease, or chronic system diseases such as diabetes, hypertension, high blood pressure;
* Coronary heart disease with obvious clinical symptoms, such as: congestive heart failure, obvious symptoms, cardiac disorders, hypertension, or myocardial infarction seizures, or inadequate heart function within 6 months;
* Persons without legal capacity, medical or ethical reasons affecting the continuation of research.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** patient in Beijing Cancer Hospital
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaotian Zhang, professor
**Phone:** 010-88196561
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Name:** Xiaotian Zhang, Professor
- **Role:** CONTACT
**Country:** China
**Facility:** Beijing Cancer Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100142
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Gastric Cancer
- 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: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5486
- Name: Stomach Cancer
- Relevance: HIGH
- As Found: Gastric Cancer
### Condition Browse Module - Meshes
- ID: D000013274
- Term: Stomach Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432192
**Acronym:** ApoDiag
**Brief Title:** A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
**Official Title:** ApoDiag: A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
#### Organization Study ID Info
**ID:** 2023-A02120-45
#### Organization
**Class:** INDUSTRY
**Full Name:** Firalis SA
### Status Module
#### Completion Date
**Date:** 2026-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Firalis SA
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro-diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests detect several gene mutations related to the above-mentioned pathologies. The development of IVD tools requires the evaluation of analytical parameters including biomarker stability.
The present specific study therefore aims to collect whole blood samples in PAXgene DNA tubes to complete the analytical validation of IVD tools and the evaluation of the stability of the DNA in PAXgene DNA tubes and the reagents in the IVD tools.
### Conditions Module
**Conditions:**
- Genetic Health Risks
**Keywords:**
- Polygenic risk, APOE, Apolipoprotein, Neurodegenerative disorders, dementia, Alzheimer disease, genetic risks
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 600
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The cohort will be genotyped to determine the phenotype of the APOE allele
**Intervention Names:**
- Diagnostic Test: APO-Easy
**Label:** APOE E
### Interventions
#### Intervention 1
**Arm Group Labels:**
- APOE E
**Description:** Testing for the APOE genotype using the APO-Easy Genotyping test
**Name:** APO-Easy
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Establish the feasibility of detecting several gene mutations associated with the risk of Alzheimer's disease/ Cardiovascular disorder and validation of analytical parameters
**Measure:** APOE Genotype
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** Establish the stability of PAXgene DNA samples at different timepoints after storage at -20° and -80°C.
**Measure:** Specimen stability
**Time Frame:** Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Donors who sign the informed consent forms for sample collection and for genotyping.
* Adults, both genders, aged 18-85 years.
* Not under any administrative or legal supervision
Exclusion Criteria:
* Anyone who did not sign the Informed Consent form.
* Subjects aged below 18 years and older than 85 years are excluded.
* Pregnant, parturient and nursing women are excluded
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Healthy donors
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rodwell Mkhwananzi, MD
**Phone:** 03 89 91 13 20
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Strasbourg
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Catherine HUMBRECHT, MD
- **Phone:** 03 88 21 25 25
- **Role:** CONTACT
**Country:** France
**Facility:** EFS GEST
**Status:** RECRUITING
**Zip:** 67000
#### Overall Officials
**Official 1:**
**Affiliation:** Firalis SA
**Name:** Huseyin Firat, MD PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### 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: LOW
- As Found: Unknown
- ID: M3885
- Name: Alzheimer Disease
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432179
**Acronym:** volunteer
**Brief Title:** Hospice Volunteer Community，Dying Patient Prepare Spirtal Care
**Official Title:** Pathways to Hospice Volunteering: a Grounded Theory Study
#### Organization Study ID Info
**ID:** 202303083RINC
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2023-06-15
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-29
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-01
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Taiwan 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:** Due to the aging population, the cases of elderly disability and death caused by chronic diseases and cancer are also increasing; thus increasing the demand and trend of community palliative care. Anning volunteers are members of the Anning team and play an integral role in the care of the "whole community". Partners who can provide psychosocial support in fear, grief, informal care, and "individualized care" can focus on patient and family needs and give their time and presence. And make up for the shortage of medical manpower. Assist nurses to take care of patients together, which is an important support for nursing care. In the community, An Ning volunteers are an important help to closely care for patients and support family members to take care of them at home and fulfill their wish of dying at home. In view of the community's peaceful home care, the trend and importance of hospice at home, it is necessary to cooperate with the "volunteers" of the tranquility team. Inquiry Only a few papers mentioned Anning volunteers' service history and research on the meaning of life, but there was a lack of in-depth and systematic discussions on Anning volunteers, including their motivation, training, process, care effectiveness, impact on training volunteer organization management, and volunteer retention. Therefore, the motivation of the research was aroused, and it was hoped to use grounded theory to explore the motivation and process of becoming an Anning volunteer, and to identify related concepts, and finally establish a theoretical framework to describe the relevant decision-making mentality. Also serves as a reference for volunteer organization management training and retention of palliative care volunteers.
**Detailed Description:** This study adopts the grounded theory method in qualitative research.The researchers recruited potential study participants at a community-based spiritual care training facility It is estimated that about 20-30 research participants are needed to achieve data saturation.
Inclusion criteria: (1) Adults aged 18 or above (2) Community peace volunteers who have served for more than one year (including one year), currently serving volunteers or stop serving volunteers (3) able to Communicate in Mandarin or Taiwanese. Those who could not understand or conduct the interview due to any physical or psychological or cognitive factors were excluded.used Semi-structured interview guide.
The data coding of grounded theory is divided into three layers: open coding, axial coding and selective coding; through these three layers of coding, the data are decomposed, compared, conceptualized and integrated, and finally form a theory we have 21 volunteers were interviewed. The average interview time was 44 minutes, with 20 women and 1 man.
It took a total of 6 weeks to complete the interviews 24 weeks analysis data
### Conditions Module
**Conditions:**
- Hospital Acquired Condition
**Keywords:**
- hospice Volunteer
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pathways to hospice volunteering: a grounded theory study
**Label:** hospice volunteer
### Outcomes Module
#### Primary Outcomes
**Description:** Using qualitative research to interview volunteers' motivations, journeys and training processes as volunteers
**Measure:** Pathways to hospice volunteering: a grounded theory study bason interview interview The 60-minute in week 24
**Time Frame:** base on week 24
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adults aged 18 or above (2) Community hospice volunteers, who have served for more than one year (including one year), are currently serving volunteers or have stopped serving volunteers (3) Can speak Mandarin or Taiwanese communicate.
Exclusion Criteria:
* Those who could not understand or conduct the interview due to any physical or psychological or cognitive factors were excluded.
* no Dmentia stroke
**Gender Based:** True
**Gender Description:** men and women
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Community hospice volunteers
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Taipei county
**Country:** Taiwan
**Facility:** Nation Taiwan university hospictal
**Zip:** 100
#### Overall Officials
**Official 1:**
**Affiliation:** professer
**Name:** Chia-Chun Tang, PHD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Possibility to give back to training institution results
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- 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: M10099
- Name: Iatrogenic Disease
- Relevance: HIGH
- As Found: Hospital Acquired Condition
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007049
- Term: Iatrogenic Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432166
**Acronym:** 2-HOBA
**Brief Title:** 2-Hydroxybenzylamine (2-HOBA) Study in Early Alzheimer's Patients
**Official Title:** 2-Hydroxybenzylamine (2-HOBA) Phase 1b/2a Proof-of Concept, Dose-Finding, Biomarker Study in Early Alzheimer's Patients
#### Organization Study ID Info
**ID:** MTI2024-CS01
#### Organization
**Class:** INDUSTRY
**Full Name:** MTI Biotech Inc
#### Secondary ID Infos
**Domain:** Alzheimer's Drug Discovery Foundation
**ID:** RC-201910-2019696
**Type:** OTHER_GRANT
**Domain:** VUMC IRB
**ID:** IRB 231544
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Vanderbilt University Medical Center
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** MTI Biotech 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:** Investigators propose a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250, 500, 750 mg 2-HOBA acetate TID or placebo for 16 weeks. Blood and cerebral spinal fluid (CSF) will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L.
**Detailed Description:** This is a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250, 500, 750 mg 2-HOBA acetate TID or placebo for 16 weeks. Blood and CSF will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L. Investigators anticipate screening 120 subjects to randomize up to 60 subjects with the goal of 48 patients completing the study (allowing for up to 25% dropout) for the 16-week study.
The primary aims of this project are to 1) Provide proof-of-concept that 2-HOBA protects proteins from covalent modification by inhibiting lysine-reacting dicarbonyls in the human brain. Investigators hypothesize that 16 weeks of 2-HOBA treatment will significantly reduce CSF levels of the dilysyl-MDA and IsoLG adduct of CSF proteins in a dose-responsive relationship. 2) Evaluate whether 2-HOBA is safe for extended use in patients with early AD. Investigators hypothesize that 2-HOBA will be safe and well tolerated through 16 weeks of use. Tolerability will be assessed by monitoring symptoms, adverse events, vital signs, ECG, and safety labs during the study.
The secondary aims are to evaluate the effect of 2-HOBA treatment on AD biomarkers, brain inflammation, disease severity, and cognitive performance.
### Conditions Module
**Conditions:**
- Alzheimer Disease
- Mild Cognitive Impairment
**Keywords:**
- Mild Cognitive Impairment
- Alzheimer Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study.
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Treatment will be supplied in capsules of the same size and color.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Placebo treatment TID for 16 weeks.
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** 250 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks.
**Intervention Names:**
- Drug: 2-hydroxybenzylamine acetate
**Label:** 250 mg 2-HOBA acetate
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** 500 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks.
**Intervention Names:**
- Drug: 2-hydroxybenzylamine acetate
**Label:** 500 mg 2-HOBA acetate
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** 750 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks.
**Intervention Names:**
- Drug: 2-hydroxybenzylamine acetate
**Label:** 750 mg 2-HOBA acetate
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 250 mg 2-HOBA acetate
- 500 mg 2-HOBA acetate
- 750 mg 2-HOBA acetate
**Description:** 2-hydroxybenzylamine acetate (2-HOBA) is taken three times per day for 16 weeks
**Name:** 2-hydroxybenzylamine acetate
**Other Names:**
- 2-HOBA
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo taken three times per day for 16 weeks.
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Change in the total score for the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
**Measure:** Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
**Time Frame:** Baseline to Week 16
**Description:** For Activities of Daily Living (ADLs), the Alzheimer's disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale to assess the competence of participants in basic and instrumental ADLs will be utilized. A lower score indicates greater functional impairment.
**Measure:** Activities of Daily Living (ADL)
**Time Frame:** Baseline to Week 16
**Description:** The change participants' electrical brain activity will be monitored using noninvasive scalp electrodes. Event-related potentials (ERP), or time-locked EEG, will be used to evaluate cognitive processes.
**Measure:** Quantitative Electroencephalography (EEG)
**Time Frame:** Baseline to Week 16
#### Primary Outcomes
**Description:** Rates of adverse events will be compared between active and placebo arms and presented as summary statistics.
**Measure:** Safety/Tolerability (adverse events)
**Time Frame:** Baseline to week 16
**Description:** Change in CSF levels of the dilysyl-malondialdehyde crosslink and the lysyl-levuglandin adduct of CSF proteins in a dose-responsive relationship
**Measure:** Change in dicarbonyl protein adducts
**Time Frame:** Baseline to week 16
#### Secondary Outcomes
**Description:** Treatment compliance will be assessed through pill counts at Week 8 and 16
**Measure:** Compliance
**Time Frame:** Baseline to week 16
**Description:** Change in phosphorylated-Tau-181 levels in CSF and plasma:
**Measure:** Measurement of biomarker, p-Tau181
**Time Frame:** Baseline to week 16
**Description:** Change in plasma concentration of human cartilage glycoprotein 39 (YKL-4)
**Measure:** Measurement biomarker, human cartilage glycoprotein 39 (YKL-4)
**Time Frame:** Baseline to week 16
**Description:** Change in the concentration of neurofilaments light chain protein (NF-L) in CSF and plasma
**Measure:** Measurment of biomarker, neurofilaments light chain protein (NF-L)
**Time Frame:** Baseline to week 16
**Description:** Change in concentration F2-Isoprostanes in plasma and urine:
**Measure:** Measurement of biomarker, F2-Isoprostanes
**Time Frame:** Baseline to week 16
**Description:** Change in concentration of 8-hydroxy-2'-deoxyguanosine in plasma
**Measure:** Measurement of biomarker, 8-hydroxy-2'-deoxyguanosine
**Time Frame:** Baseline to week 16
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
MCI due to AD:
1. Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
2. Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
3. Mini-Mental State Exam31 score between 24 and 30, inclusive
4. Clinical Dementia Rating (CDR)32 Global = 0.5. Memory Box score must be at least 0.5.
Mild AD:
1. Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
2. Mild dementia of the Alzheimer's type according to the NIA-AA 2018 criteria.
3. CDR global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home \& hobbies, community affairs) Or CDR global score of 1.0
4. MMSE ≥20
Additional Inclusion Criteria for Both Diagnoses:
1. Age 55-85 (inclusive)
2. Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised:
* Less than or equal to 11 for 16 or more years of education
* Less than or equal to 9 for 8 - 15 years of education
* Less than or equal to 6 for 0 - 7 years of education
3. Amyloid positivity established using the C2N Precivity2 Plasma test (Aβ42/40 plus p- tau217/np-tau217. (This test uses a statistical algorithm to integrate a patient's Aβ42/40 Ratio and p-Tau217 Ratio to calculate the Amyloid Probability Score 2 (APS2) and determines whether a patient is positive or negative for brain amyloid deposition based on a binary cutoff value).
4. Stable permitted medications for 4 weeks or longer as specified in Section 4.6.3, including:
a. Memantine and cholinesterase inhibitors are allowable if stable for 12 weeks prior to screen.
5. Geriatric Depression Scale33 score of less than or equal to 14.
6. Study Partner is available who has frequent contact with the participant (e.g., an average of 10 hours per week or more) and can accompany the participant to most visits to answer questions about the participant.
7. Adequate visual and auditory acuity to allow neuropsychological testing.
8. Good general health with no additional diseases/disorders expected to interfere with the study.
9. Participant is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile).
10. Completed six grades of education or has a good work history.
11. Must speak English fluently.
12. Provide written informed consent. Participants must have the capacity to consent.
Exclusion Criteria:
1. Any other significant neurologic disease including Parkinson's disease, multi- infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
2. Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation, or behavioral problems within 3 months, which could lead to difficulty complying with the protocol.
3. History of schizophrenia (DSM V criteria).
4. History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria).
5. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic (Class C defined by Child-Pugh criteria), endocrine, or other systemic disease in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study.
6. Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment.
7. Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary, unless the required follow-up labs (homocysteine (HC) and methylmalonic acid (MMA) indicate that it is not physiologically significant.
8. Clinically significant abnormalities in screening laboratories or ECG.
9. Residence in a skilled nursing facility.
10. Use of any excluded medication as described in Section 6.10, including:
* Use centrally acting anti-cholinergic drugs.
* Use of any investigational drugs within 4 weeks or 5 half-lives, whichever is longer, prior to screening.
11. A current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening.
12. Contraindications for MRI studies, including claustrophobia, the presence of metal(ferromagnetic) implants, or cardiac pacemaker.
13. Participants whom the Site PI deems to be otherwise ineligible.
**Maximum Age:** 85 Years
**Minimum Age:** 55 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** John A. Rathmacher, Ph.D.
**Phone:** 515-296-9916
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nashville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Amy R Boegel, Ph.D.
- **Phone:** 615-875-0955
- **Role:** CONTACT
***Contact 2:***
- **Name:** Paul Newhouse, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Jason K Russell, VetMB, Ph.D.
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Alexander C Conley, Ph.D.
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Center for Cognitive Medicine, Vanderbilt University Medical Center
**State:** Tennessee
**Zip:** 37212
#### Overall Officials
**Official 1:**
**Affiliation:** Vanderbilt University Medical Center
**Name:** Paul Newhouse, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** MTI Biotech Inc
**Name:** John A. Rathmacher, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003704
- Term: Dementia
- 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
- ID: D000003072
- Term: Cognition 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: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Mild Cognitive Impairment
- ID: M6904
- Name: Dementia
- 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: 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: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
- ID: D000060825
- Term: Cognitive Dysfunction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432153
**Brief Title:** Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation
**Official Title:** Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation
#### Organization Study ID Info
**ID:** N_112_0424
#### Organization
**Class:** OTHER
**Full Name:** Changhua Christian Hospital
### Status Module
#### Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-16
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Da-Yeh University
#### Lead Sponsor
**Class:** OTHER
**Name:** Changhua Christian 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:** Early assessment of kinesiophobia in cardiovascular disease patients is essential. However, measurement tools are scarce for assessing activity fear in cardiovascular disease patients domestically. Currently, the Tampa Scale of Kinesiophobia for the Heart, developed by Bäck et al. (2012), is the most commonly used scale for measuring kinesiophobia among cardiovascular disease patients. As there is no tool available domestically to measure kinesiophobia in cardiovascular disease patients, this research aims to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and subsequently verify its reliability and validity for clinical assessment of kinesiophobia among cardiovascular disease patients.
The methodology involves following the translation model by Jones et al. (2001) to translate the Tampa Scale of Kinesiophobia for Heart from the English version to the Taiwan version. Structured questionnaires, including demographic and disease-related information, the Tampa Scale of Kinesiophobia for Heart Taiwan Version, the International Physical Activity Questionnaire, the Six-Minute Walk Test, the Taiwan version of the World Health Organization Quality of Life Questionnaire-BREF, the Hospital Anxiety and Depression Scale, and the Pain Catastrophizing Scale will be used at the cardiological outpatient clinic and inpatient ward of a medical center in Central Taiwan. Patients meeting the study's inclusion criteria and consent to participate in this study will be interviewed. Tampa Scale of Kinesiophobia for Heart Taiwan Version will be examined for content validity, construct validity, internal consistency, and test-retest reliability.
**Detailed Description:** Cardiovascular disease patients may avoid physical activity or exercise due to concerns that engaging in physical activities might exacerbate their heart condition or lead to injury. Interpretation of potential injury as a threat can induce kinesiophobia (fear of movement), causing patients to avoid physical activities, which could negatively impact both their physiological and psychological well-being. Previous research indicates a high prevalence of kinesiophobia among cardiovascular disease patients, and this fear negatively affects their physical activity performance, unwillingness to engage in cardiac rehabilitation, and worse quality of life. Therefore, early assessment of kinesiophobia in cardiovascular disease patients is essential. However, measurement tools are scarce for assessing activity fear in cardiovascular disease patients domestically. Currently, the Tampa Scale of Kinesiophobia for the Heart, developed by Bäck et al. (2012), is the most commonly used scale for measuring kinesiophobia among cardiovascular disease patients. As there is no tool available domestically to measure kinesiophobia in cardiovascular disease patients, this research aims to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and subsequently verify its reliability and validity for clinical assessment of kinesiophobia among cardiovascular disease patients.
The objective of this study is to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and conduct reliability and validity verification.
The methodology involves following the translation model by Jones et al. (2001) to translate the Tampa Scale of Kinesiophobia for Heart from the English version to the Taiwan version. A longitudinal study design will verify the validity and reliability of the Taiwan version of the Tampa Scale of Kinesiophobia for Heart. Structured questionnaires, including demographic and disease-related information, the Tampa Scale of Kinesiophobia for Heart Taiwan Version, the International Physical Activity Questionnaire, the Six-Minute Walk Test, the Taiwan version of the World Health Organization Quality of Life Questionnaire-BREF, the Hospital Anxiety and Depression Scale, and the Pain Catastrophizing Scale will be used at the cardiological outpatient clinic and inpatient ward of a medical center in Central Taiwan. Patients meeting the study's inclusion criteria and consent to participate in this study will be interviewed. Tampa Scale of Kinesiophobia for Heart Taiwan Version will be examined for content validity, construct validity, internal consistency, and test-retest reliability. The collected data will be analyzed using SPSS/PC version 22.0, and statistical methods such as frequency, percentage, mean, standard deviation, reliability analysis, Pearson correlation, and exploratory factor analysis will be used.
This study aims to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and verify its reliability and validity for clinical assessment of Kinesiophobia among cardiovascular disease patients. It also aims to provide insight for future clinical research to analyze related factors further and develop intervention strategies, ultimately enhancing physical activity performance and quality of life and engaging in cardiac rehabilitation for cardiovascular disease patients.
### Conditions Module
**Conditions:**
- Cardiovascular Diseases
**Keywords:**
- Cardiovascular disease
- Kinesiophobia
- Scale reliability and validity
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The only group of participant. Participants are outpatient clinical patients diagnosed with cardiovascular disease.
**Intervention Names:**
- Other: observation
**Label:** participant
### Interventions
#### Intervention 1
**Arm Group Labels:**
- participant
**Description:** Participants who receive routine clinical care, without additional intervention from the study
**Name:** observation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This scale, developed by Bäck et al. (2012), assesses fear of movement in patients with coronary artery disease. It comprises four dimensions: exercise avoidance, fear of injury, dysfunctional self-perception, and perceived risk of heart problems, with 17 items. Each item is scored on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), and items 4, 8, 12, and 16 are reverse scored. The total score ranges from 17 to 68, with higher scores indicating greater fear of movement. A TSK Heart score below 37 indicates a low fear of movement, while a score of 37 or higher indicates a high fear of movement. The scale's intra-class correlation coefficient is 0.83, and its internal consistency (Cronbach's alpha) is 0.78 (Bäck et al., 2012).
**Measure:** Tampa Scale of Kinesiophobia for Heart
**Time Frame:** baseline and at the end of the third month
#### Secondary Outcomes
**Description:** This study uses the short form of the Taiwan version of the IPAQ, developed in collaboration with Liu Ying-Mei and the World Health Organization. It consists of 7 items assessing physical activity over the past week across work, household chores, transportation, and leisure activities, including time and frequency of walking, moderate and vigorous activities, and time spent sitting. The total physical activity is calculated by multiplying each activity category by its corresponding Metabolic Equivalent (MET), execution time, and activity days. An IPAQ score below 600 indicates low physical activity, 600-3000 indicates moderate physical activity, and above 3000 indicates high physical activity. The scale's content validity is 0.994, and its intra-class correlation coefficient is 0.704 (Liou et al., 2008).
**Measure:** International Physical Activity Questionnaire
**Time Frame:** baseline and at the end of the third month
**Description:** This test is commonly used in clinical settings to assess an individual's exercise capacity and endurance by measuring the distance walked in six minutes. During the test, participants are asked to walk as far as possible along a 30-meter corridor in six minutes. They can rest if they experience difficulty breathing (ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories, 2002).
**Measure:** 6-Minute Walk Test
**Time Frame:** baseline and at the end of the third month
**Description:** Professor Yao Kai-Ping developed this questionnaire after obtaining authorization; this questionnaire assesses the quality of life across four domains: physical health, psychological well-being, social relationships, and environment, with 28 items. Each item is scored on a 5-point scale. Scores for each domain are calculated by averaging the scores of the items within that domain and multiplying by 4. Items 3, 4, and 26 are reverse-scored by subtracting the original score from 6. Higher scores indicate a better quality of life. The internal consistency is 0.91, and the content validity of the domains ranges from 0.51 to 0.64 (Taiwan WHOQOL Group, 2000; Yao Kai-Ping, 2002).
**Measure:** Taiwan Brief Version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
**Time Frame:** baseline and at the end of the third month
**Description:** This study uses the Chinese version of the HADS, translated by Chen Mei-Ling, initially developed by Zigmond and Snaith (1983). The scale consists of 14 items scored on a 4-point Likert scale (0 to 3), with separate scores for anxiety and depression. Each subscale has a total score range of 0 to 21, with higher scores indicating greater levels of anxiety or depression.
**Measure:** Hospital Anxiety and Depression Scale (HADS)
**Time Frame:** baseline and at the end of the third month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* (1) diagnosed with cardiovascular diseases by a specialist, including coronary artery disease, arrhythmia, valvular heart disease, and heart failure, with stable conditions;
* (2) aged 18 or above;
* (3) clear consciousness and able to communicate in Mandarin or Taiwanese;
* (4) willing and consent to participate after being informed of the study purpose and procedures.
Exclusion Criteria:
* (1) cognitive impairment
* (2) psychiatric disorders
* (3) long-term bedridden patients who rely on others for daily activities.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** clinical patients diagnosed with cardiovascular diseases.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ai-Ling Chang, MSc
**Phone:** +886-048336558
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Wan-Ting Huang, PhD
**Phone:** +886-0953860172
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Changhua Christian Hospital
**Name:** Ai-Ling Chang, MSc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** No plans to share related information.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
**PMID:** 12091180
**Citation:** Back M, Jansson B, Cider A, Herlitz J, Lundberg M. Validation of a questionnaire to detect kinesiophobia (fear of movement) in patients with coronary artery disease. J Rehabil Med. 2012 Apr;44(4):363-9. doi: 10.2340/16501977-0942.
**PMID:** 22366980
**Citation:** Cakal B, Yildirim M, Emren SV. Kinesiophobia, physical performance, and health-related quality of life in patients with coronary artery disease. Postepy Kardiol Interwencyjnej. 2022 Sep;18(3):246-254. doi: 10.5114/aic.2022.122892. Epub 2022 Dec 17.
**PMID:** 36751297
**Citation:** Keessen P, Kan KJ, Ter Riet G, Visser B, Jorstad H, Latour C, van Duijvenbode I, Scholte Op Reimer W. Impact of kinesiophobia on initiation of cardiac rehabilitation: a prospective cohort path analysis. BMJ Open. 2022 Nov 25;12(11):e066435. doi: 10.1136/bmjopen-2022-066435.
**PMID:** 36428018
**Citation:** Jones PS, Lee JW, Phillips LR, Zhang XE, Jaceldo KB. An adaptation of Brislin's translation model for cross-cultural research. Nurs Res. 2001 Sep-Oct;50(5):300-4. doi: 10.1097/00006199-200109000-00008.
**PMID:** 11570715
**Citation:** Liou YM, Jwo CJ, Yao KG, Chiang LC, Huang LH. Selection of appropriate Chinese terms to represent intensity and types of physical activity terms for use in the Taiwan version of IPAQ. J Nurs Res. 2008 Dec;16(4):252-63. doi: 10.1097/01.jnr.0000387313.20386.0a.
**PMID:** 19061172
**Citation:** Lynn MR. Determination and quantification of content validity. Nurs Res. 1986 Nov-Dec;35(6):382-5. No abstract available.
**PMID:** 3640358
#### See Also Links
**Label:** WHOQOL BREF
**URL:** https://www.semanticscholar.org/paper/Development-and-verification-of-validity-and-of-the-Yao-Chung/260271b00a65ac23b1324e52ef1597c13559f95d
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010698
- Term: Phobic Disorders
- ID: D000001008
- Term: Anxiety Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M2922
- Name: Kinesiophobia
- Relevance: HIGH
- As Found: Kinesiophobia
- ID: M13603
- Name: Phobic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety 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: D000002318
- Term: Cardiovascular Diseases
- ID: D000092442
- Term: Kinesiophobia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432140
**Brief Title:** A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Severe AADC Deficiency
**Official Title:** An Open, Dose-escalating and Dose Confirmation Trial to Evaluate the Safety and Efficacy of VGN-R09b by Intra Putamen Injection in Patients With Severe Aromatic L-amino Acid Decarboxylase (AADC) Deficiency
#### Organization Study ID Info
**ID:** VGN-R09b-102
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Vitalgen BioPharma Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2030-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Vitalgen BioPharma Co., Ltd.
#### 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 trial includes dose-escalating part (phase 1) and dose confirming part, to prove the safety and efficacy of VGN-R09b to treat patients with severe AADC deficiency
**Detailed Description:** Aromatic L-amino acid decarboxylase (AADC) is an enzyme responsible for the final step in the synthesis of neurotransmitters dopamine and serotonin. AADC deficiency is a rare genetic disorder. VGN-R09b is a kind of Gene therapy with adeno-associated virus (AAV) serotype 9 (AAV9) driven human AADC (hAADC) being injected directly into putamen.
This is an open, dose-escalating and dose confirming study. The sponsor plans to explore two dose levels (6.0×1011vg and 1.28×1012vg) in dose-escalating phase (three subjects each cohort), then plans to have 10 subjects enrolled for dose confirmation phase.
This study is to give evidence for the safety and efficacy of VGN-R09b treatment for patients with severe Aromatic L-amino acid decarboxylase (AADC) deficiency.
### Conditions Module
**Conditions:**
- Aromatic L-amino Acid Decarboxylase Deficiency
**Keywords:**
- AADC
- AAV9
- Central Nervous System (CNS) gene therapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** VGN-R09b will be injected into bilateral putamen by stereotactic surgery
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 16
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Different levels of VGN-R09b will be injected into bilateral putamen by stereotactic surgery
**Intervention Names:**
- Genetic: VGN-R09b injection
**Label:** VGN-R09b injection
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- VGN-R09b injection
**Description:** Two levels of VGN-R09b will be injected into bilateral putamen in dose-escalating phase, and one dose level will be injected in dose confirming phase
**Name:** VGN-R09b injection
**Type:** GENETIC
### Outcomes Module
#### Primary Outcomes
**Description:** Vital signs, physical examination, laboratory test will be monitored after drug injection
**Measure:** Number of Adverse Events (AEs), Serious Adverse Events (SAEs)
**Time Frame:** up to Week 52
**Description:** Four milestones, including Head control, Sit independently, Stand/stepping with support, Walk with minimal assistant, would be assessed according to definition in Peabody Developmental Motor Scale 2nd edition (PDMS-2). Each milestone would be scored as 0, 1 or 2, and score 2 means achievement of the milestone.
**Measure:** Number of subjects who achieved motor development milestones
**Time Frame:** up to 24 months
#### Secondary Outcomes
**Description:** Increase in signal in the putamen and nigra on Fluorodopa-PET imaging as brain AADC activity measure
**Measure:** Change in brain AADC activity
**Time Frame:** up to 5 Years
**Description:** Neurotransmitter metabolite concentrations of Homovanillic Acid/Hydroxyindoleacetic Acid (HVA/5-HIAA) would be measured
**Measure:** Change in Cerebrospinal Fluid (CSF) neurotransmitter metabolite concentrations
**Time Frame:** up to 5 Years
**Description:** Motor function would be assessed by Peabody Developmental Motor Scale 2nd edition (PDMS-2). The score ranges from 0 to 482, and higher score means the better in motor function.
**Measure:** Change from baseline in motor function
**Time Frame:** up to 5 Years
**Description:** Number of disease related symptoms
**Measure:** Change in number of Clinical symptoms
**Time Frame:** up to 5 Years
**Description:** Concentrations of Viral genome in serum/urine would be measured
**Measure:** Viral shedding
**Time Frame:** up to 1 week
**Description:** Subject number with positive antibodies of AAV9/AADC/Glial Cell Line-Derived Neurotrophic Factor (GDNF) in blood would be reported
**Measure:** Immunogenicity after injection
**Time Frame:** up to 26 weeks
**Description:** Drug-related AEs and SAEs would be monitored as long as 5 years after injection
**Measure:** Number of Adverse Events (AEs), Serious Adverse Events (SAEs) in Long-term follow-up
**Time Frame:** up to 5 Years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. The child patient has to be ≥18 months old and \< 8 years old, and a head circumference big enough for surgery as judged by investigator.
2. Historical diagnosis of AADC deficiency with clinical symptoms consistency, AND with Molecular genetic confirmation of homozygous or compound heterozygous mutation point of IVS6+4A\>T in DDC gene.
3. With Plasma AADC activity less than or equal to 12 pmol/min/mL.
4. Motor development at baseline \<3 months (head fully uncontrollable at baseline）, and Failed to benefit from standard medical therapy (dopamine agonists, monoamine oxidase inhibitor or related form of Vitamin B6) at discretion of investigators.
5. Parent(s)/legal guardian(s) with custody of subject must give their consent for subject to enroll in the study.
6. Parent(s)/legal guardian(s) of the subject must agree to comply with the requirements of the study, including providing disease information and support disease assessment of symptoms.
Exclusion Criteria:
1. Intracranial neoplasm or any structural brain abnormality or lesion (e.g., severe brain atrophy, white matter degenerative changes), which, in the opinion of the study investigators, would confer excessive risk and/or inadequate potential for benefit.
2. Presence of other significant medical or neurological conditions that would create an unacceptable operative or anesthetic risk (including congenital heart disease, respiratory disease with home oxygen requirement, history of serious anesthesia complications during previous elective procedures, history of cardiorespiratory arrest), liver or renal failure, malignancy, or HIV positive.
3. Severe coagulopathy, or need for ongoing anticoagulant therapy.
4. clinically active infection or with severe infection within 12 weeks before screening (e.g. adenovirus or herpes virus, pneumonia, sepsis, central nervous system infection).
5. Previous stereotactic neurosurgery, or any gene/cell therapy.
6. Received live vaccination within 4 weeks.
7. Contraindication to sedation during surgery or imaging studies (PET or MRI).
**Maximum Age:** 8 Years
**Minimum Age:** 18 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiumin Wang, MD
**Phone:** +86-18017395221
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai Children's Medical Center, affiliated to Shanghai Jiao Tong University School of Medicine
**Name:** Xiumin Wang, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: Rare
- Name: Rare Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T481
- Name: Aromatic L-amino Acid Decarboxylase Deficiency
- Relevance: HIGH
- As Found: Aromatic L-amino Acid Decarboxylase Deficiency
### Intervention Browse Module - Browse Branches
- Abbrev: AnDyAg
- Name: Anti-Dyskinesia Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M7472
- Name: Dopa Decarboxylase
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432127
**Brief Title:** Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis
**Official Title:** Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis in Patients With Failed Oral Prophylaxis Medication : A Randomized Controlled Study in Thailand
#### Organization Study ID Info
**ID:** 256/2024
#### Organization
**Class:** OTHER
**Full Name:** Mahidol University
### Status Module
#### Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**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:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mahidol 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:** The goal of this randomized controlled study in Thailand. is to find if there is a role of local anesthetic greater occipital nerve block at Cervical spine level 2 under ultrasound guide in prophylaxis of episodic migraine and chronic migraine in patients with failed oral prophylaxis medication.
According to guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic and chronic migraine,the primary and secondary outcome were monitoring followed by these research guideline
After informed consent, volunteer will be stratified random into 2 groups of injection agent at unilateral greater occipital nerve block on headache site under US guide by pain physician
* Normal saline
* 0.5% bupivacaine the injection was done 2 times between Week 0 and week 4 as to wean off placebo effect the volunteer will be monitor by pain diary at 1 month before intervention at week 0,4,8,12 and follow up at week 24 for Migraine Disability Assessment Test (MIDAS) ,Thai Hospital-Anxiety-depression index(Thai-HADS)
**Detailed Description:** * Neurologist screening candidate volunteers for this study, following the inclusion and exclusion criteria
* Candidate volunteers attended pain clinic for he protocol detail about this research and informed consent
* After signing consent, Volunteers would be stratified randomization into 2 groups between Normal saline and bupivacaine
* Volunteers would be done base line headache diary for 1 month before performing the procedure (Week -4 to week0)
* At Week 0, Volunteers would be applied local anesthetic cream at skin injection site before done the procedure
* According to stratified randomization, Pain interventionist and also volunteers would be blinded to the group
* First Unilateral greater occipital nerve block at Cervical spine level 2 (C2) was done under ultrasound guide (Week0)
* Telemedicine Follow up at week 2
* Second Unilateral greater occipital nerve block at C2 level was done under ultrasound guide (Week4)
* Volunteers would be follow up via telemedicine and done headache diary until 3 months after 1st injection
* Volunteers would be follow up according to outcome monitoring protocol in Week 0,4,8,12,24
### Conditions Module
**Conditions:**
- Migraine Disorders
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 108
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Use Normal saline 3 ml as the injection agent
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Use 0.5% Bupivacaine 3ml as the injection agent
**Intervention Names:**
- Drug: Bupivacaine
**Label:** Bupivacaine
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Placebo
**Description:** Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL
**Name:** Placebo
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Bupivacaine
**Description:** Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL
**Name:** Bupivacaine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** by using headache diary
**Measure:** change of Frequency headache day /month
**Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
**Description:** by using headache diary
**Measure:** change of migraine attack day /month from headache diary
**Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
#### Secondary Outcomes
**Description:** decrease of moderate-severe pain day per month compare to baseline by using headache diary
**Measure:** change in severity of headache day per month (decrease of moderate-severe pain)
**Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
**Description:** Thai-Migraine Disability Assessment (MIDAS) ,Score 0 to 21+ ( 0-5 marks = little or no disability and more than 21+ =severe disability
**Measure:** Thai-Migraine Disability Assessment
**Time Frame:** at Week 12,24 compare to baseline
**Description:** Thai-Hospital Anxiety and Depression Scale (Thai HADS) , divided into anxiety and depression part ,if either of the score in each depression or anxiety more than 11 mean abnormal
**Measure:** Thai-Hospital Anxiety and Depression Scale
**Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
**Description:** by EuroQoL- (EQ-5D) measured health-related quality of life with 5 dimension (mobility, health care, usual activity, Pain, Anxiety/depression and in each of them had 5 grading 1-5 by 1 means no problem and 5 means extreme problem) after having score in each dimension, calculated utility score would be done
**Measure:** Healthcare outcomes/quality of life
**Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
**Description:** Patient's reported outcome measurement (PGI-C), score grading 1-7 by 1 very much worse to very much improved , 7 means very much worse
**Measure:** Patient's reported outcome measurement (PGI-C)
**Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age 18 -65 years old
2. Diagnosis as episodic migraine or chronic migraine and had indication to use migraine prophylaxis
3. Volunteer prefer to use research procedure as first choice of migraine prophylaxis
4. Volunteer already had migraine prophylaxis treatment but still has the one of these following problem 4.1 Frequency of migraine attack more than 4 times/month 4.2 Severe migraine headache \& disturb daily life in spite of using migraine prophylaxis 4.3 Having migraine medication side effect, either from prophylaxis or acute attack medication and cannot titration medication dosage 4.4 migraine attack not improved as using many migraine prophylaxis medications 4.5 Having contra-indication to use prophylaxis migraine medication or standard prophylaxis procedure such as botulinum toxin 4.6 Cannot take prophylaxis medication daily (low compliance) 4.7 Had financial problems in using standard prophylaxis migraine medication or procedure 4.8 Medication overuse headache
Exclusion Criteria:
1. Had these type of headache in combination with migraine
* cervicogenic headache
* occipital neuralgia
* secondary headache
2. Had contraindication on greater occipital nerve block injection at cervical spine level 2 under ultrasound-guided such as skin infection in needle site
3. Allergy to local anesthetic
4. Uncontrolled psychiatric disorder in 3 months before attending research
5. Cannot understand or reading, writing Thai language
**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:** RAVIWON ATISOOK, M.D.
**Phone:** +66819140784
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bangkok
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Raviwon Atisook, M.D
- **Phone:** +66819140784
- **Role:** CONTACT
**Country:** Thailand
**Facility:** Raviwon Atisook
**Zip:** 10700
#### Overall Officials
**Official 1:**
**Affiliation:** Siriraj Hospital
**Name:** RAVIWON ATISOOK, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** will be consider again after data collection
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000051270
- Term: Headache Disorders, Primary
- ID: D000020773
- Term: Headache Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System 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: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M11852
- Name: Migraine Disorders
- Relevance: HIGH
- As Found: Migraine
- ID: M9351
- Name: Headache
- Relevance: HIGH
- As Found: Headache
- ID: M22529
- Name: Headache Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M26657
- Name: Headache Disorders, Primary
- 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: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008881
- Term: Migraine Disorders
- ID: D000006261
- Term: Headache
### 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
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5315
- Name: Bupivacaine
- Relevance: HIGH
- As Found: Following
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000002045
- Term: Bupivacaine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432114
**Brief Title:** Sensory Awareness Program
**Official Title:** Coping Through Sensory Modulation. A Sensory Awareness Program (SAP) for Reducing Anxiety and Mobilizing Coping Strategies for People With Severe Mental Health Problems. A Randomized Controlled Trial.
#### Organization Study ID Info
**ID:** SAP
#### Organization
**Class:** OTHER
**Full Name:** Lund University
### Status Module
#### Completion Date
**Date:** 2025-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-17
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Lund University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Few alternatives to addictive medical treatment exists for persons with severe mental health problems (SMHP) and anxiety, often connected to high risk of suicide. Access to effective interventions that depart in individuals' needs to cope with anxiety in everyday life is crucial to provide and desperately warranted by service users. Service users are often unaware of sensory needs, connected to anxiety outburst. The Sensory Awareness Program (SAP) is a group-based self-management intervention of 10 weeks developed to meet complex needs of regulating anxiety and related self-destructive behaviors. SAP stems from theories on sensory modulation and is an approach to manage physiological arousal associated with anxiety through self-regulated sensory-based coping strategies. International research show that sensory modulation is effective both as a method to reduce anxiety and thus restraint in acute mental health services (MHS), and also to empower users. However, much research to date focus on using sensory strategies within wards. International research and pre-studies of testing the SAP in outpatient MHS indicate that it is a promising self-management intervention to support everyday life. Earlier studies further show that users' unawareness of sensory needs triggers anxiety, and that anxiety itself is the main contributing factor for disrupting everyday life. Also, staff acknowledge sensory modulation but lack knowledge on whether programs such as SAP is effective and possible to implement.
The overall aim is to investigate the effectiveness of SAP as compared to treatment as usual (TAU) among 200 outpatients. The investigators hypothesize that SAP will be more effective than TAU in terms of reduced anxiety (primary outcome) at three months follow-up. Secondary clinical and personal recovery outcomes post intervention and at three and six months follow up will also be targeted and assumed to be in favour of the SAP group. The implementation process of the SAP will also be explored.
### Conditions Module
**Conditions:**
- Anxiety
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Sensory Awareness Program (SAP)
- Other: Treatment as usual (TAU)
**Label:** Sensory Awareness Program
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Treatment as usual (TAU)
**Label:** Treatment as usual
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sensory Awareness Program
**Description:** SAP is a new rehabilitation program for people with severe mental health problems. SAP aims to help the target group manage anxiety outburst and live an active life through sensory modulation techniques.
**Name:** Sensory Awareness Program (SAP)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Sensory Awareness Program
- Treatment as usual
**Description:** Treatment as usual is standard psychiatric care for the target group.
**Name:** Treatment as usual (TAU)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Beck Anxiety Inventory (BAI) is a self-report questionnaire measuring the severity of anxiety symptoms with 21 questions, each describing a symptom of anxiety. The participant rates each item on a scale from 0 to 3, indicating how much he/she experiences each symptom. The scores range from 0 to 63, with higher scores indicating more severe levels of anxiety.
**Measure:** Becks anxiety inventory (BAI)
**Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months
#### Secondary Outcomes
**Description:** The Hopkins Symptoms Checklist (HSCL-25) is a widely used screening instrument with 25 items measuring symptoms of anxiety and depression. The scale for each question includes four response categories from 1 (not at all) to 4 (very much). The total score is the average of all 25 items.
**Measure:** Hopkins Symptom Checklist-25 (HSCL-25)
**Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months
**Description:** The Difficulties in Emotion Regulation Scale (DERS) is a self-report measure of emotion regulation difficulties. The total score ranges from 16-80 with higher scores indicating more difficulties with emotion regulation.
**Measure:** Difficulties in Emotion Regulation scale (DERS)
**Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months
**Description:** The Brief-COPE is an instrument reflecting individuals' coping strategies when exposed to a stressful situation. Brief-COPE is the short version and consists of 14 sub-scales, with 2 items in each scale, with a total of 28 items. The items are rated on a scale from 1 (seldom) to 4 (very often). In the current study, we will use the three-factor model of the instrument where the 14 subscales are divided into 3 factors; 'Problem-focused coping', 'Emotion-focused coping' and 'Avoidant coping'.
**Measure:** Coping Orientation of Problem Experience Inventory (COPE)
**Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months
**Description:** The Manchester Short Assessment of Quality of Life (MANSA) consists of 16 questions, covering different domains of life such as physical health, social relationships, employment, and overall life satisfaction. Each question is rated on a scale from 1 to 7, with higher scores indicating better quality of life.
**Measure:** Manchester Short Assessment of Quality of Life Scale (MANSA)
**Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months
**Description:** The Pearlin Mastery Scale is used to assess an individual's perceived sense of control over their life circumstances, containing seven questions to rate the level of agreement with statements about the ability to control and influence life. It covers areas such as personal growth, problem-solving, and self-mastery and is rated on a scale from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating greater levels of mastery.
**Measure:** Pearlin Mastery Scale
**Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months
**Description:** The Process of Recovery Questionnaire (QPR-7) is a short version of the instrument with 15 items (Argentzell et al., 2017). QPR-7 has seven questions concerning which aspects of recovery have been meaningful for the participants on a five-graded scale from 0 (disagree strongly) to 4 (agree strongly).
**Measure:** Process of Recovery Questionnaire (QPR-7)
**Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months
**Description:** POES is an instrument that helps to discern the level of occupational engagement. The POES has two parts, one being the 24-hour yesterday time use diary and a second part consisting of a self-rated questionnaire with 9 items representing different components of occupational engagement. Based on the time diary the participants reflect on the content and rate to what extent it corresponds to a lower or higher level of occupational engagement on a 4-point scale.
**Measure:** Profiles of Occupationa Engagement (POES)
**Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months
**Description:** The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a questionnaire used to assess an individual's perceived level of functioning and disability across six domains of life with 12 questions covering: activities and participation in society. Each question is rated on a scale from 0 to 4, with higher scores reflecting greater levels of disability.
**Measure:** The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
**Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Be assigned to a MHS
* Age over 18
* Having SMHP (including a diagnosis of mood disorder, anxiety disorder, eg PTSD, panic disorder etc, and/or psychotic disorder)
* Experience anxiety
Exclusion Criteria:
* Acutely mentally unwell
* Cognitively impaired
* Non-Swedish speaking
**Gender Based:** True
**Gender Description:** Male, female, non-binary
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Elisabeth Argentzell, PhD
**Phone:** +46702933552
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Helsingborg
**Contacts:**
***Contact 1:***
- **Name:** Jenny Ericsson
- **Role:** CONTACT
**Country:** Sweden
**Facility:** Region Skåne
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental 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
- 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432101
**Brief Title:** Acupuncture Combined With Hydroxychloroquine
**Official Title:** Clinical Efficacy of Acupuncture Combined With Hydroxychloroquine Sulfate Tablets in Improving Oral and Ocular Dryness in Primary Sjögren's Syndrome
#### Organization Study ID Info
**ID:** [email protected]
#### Organization
**Class:** OTHER
**Full Name:** Heilongjiang University of Chinese Medicine
### Status Module
#### Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Senyue Zhang
#### Responsible Party
**Investigator Affiliation:** Heilongjiang University of Chinese Medicine
**Investigator Full Name:** Senyue Zhang
**Investigator Title:** Principal Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To observe the clinical efficacy of acupuncture combined with hydroxychloroquine sulfate tablets on the symptoms of dry mouth and dry eyes in primary Sjögren's syndrome.
**Detailed Description:** Methods: Seventy-two patients with primary Sjögren's syndrome who met the inclusion criteria were randomly divided into the experimental group (36 patients, 3 patients who fell out) and the control group (36 patients, 4 patients who fell out). The control group was treated with oral hydroxychloroquine sulfate tablets alone, 0.2g each time, taken twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment, and the experimental group was treated with acupuncture treatment on the basis of the control group, acupuncture once a day, acupuncture for 5 days and 2 days of rest, 4 weeks for 1 course of treatment, a total of 2 courses of treatment. The changes in the outcome indicators of the two groups before and after treatment were observed, and the main outcome indicators included salivary flow rate (SFR) and Schirmer test. Secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient-Reported Index (ESSPRI), the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and laboratory measures (ESR, CRP, IgG).
### Conditions Module
**Conditions:**
- Primary Sjögren's Syndrome
### 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:** 65
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Acupuncture combined with oral hydroxychloroquine sulfate tablets
**Intervention Names:**
- Other: Acupuncture combined with oral hydroxychloroquine sulfate tablets
**Label:** acupuncture combined with hydroxychloroquine sulfate tablets
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Oral hydroxychloroquine sulfate tablets (Shanghai Shangyao Sino-Western Pharmaceutical Co., LTD., Fenle, Sinopyma approval number H19990263, 0.1g x 14 tablets) were treated with 0.2g each time, twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment.
**Label:** oral hydroxychloroquine sulfate tablets
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- acupuncture combined with hydroxychloroquine sulfate tablets
**Description:** Acupuncture combined with oral hydroxychloroquine sulfate tablets
**Name:** Acupuncture combined with oral hydroxychloroquine sulfate tablets
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Used to evaluate the salivary flow rate of pSS patients before and after treatment. Before the start of the experiment, the patient gargled with water to keep the mouth clean and free of irritation. Saliva collected at the bottom of the mouth and spit it into the measuring cup every 1min. After collecting it for 10min, the value was recorded. The less the saliva flow rate within 10 minutes, the worse the symptoms, and less than 1ml is abnormal.
**Measure:** Salivary flow rate (Sauf)
**Time Frame:** 8 weeks
**Description:** Used to evaluate the degree of tear secretion in pSS patients before and after treatment. The 5mm×35mm filter paper was folded at a right Angle at 5mm from one end, and the end was placed in the conjunctival sac at 1/3 of the outer eyelid of the patient. The eyes were closed and the clamp was held for 5min, and the wet length of the filter paper was measured, and the filter paper was positive if it was less than 5mm/5min. The less tears are secreted within five minutes, the more severe the symptoms.
**Measure:** Schirmer test
**Time Frame:** 8 weeks
#### Secondary Outcomes
**Description:** Used to assess the degree of dryness, pain, and fatigue in pSS patients, it is an evaluation of disease activity based on patients' subjective feelings. On a scale of 0 to 10 from mild to severe, the final ESSPRI score is the average score of dryness, pain and fatigue. Scores \<5 were classified as acceptable symptom status and \>5 as unsatisfactory symptom status.
**Measure:** Sjögren's syndrome patient-reported index (ESSPRI)
**Time Frame:** 8 weeks
**Description:** used to evaluate disease activity in patients with pSS, ESSDAI is an evaluation of disease activity based on objective facts. The score weight includes 12 dimensions, including systemic symptoms, lymph node disease, glandular disease, joint disease, skin disease, peripheral neuropathy, central neuropathy, lung disease, kidney disease, muscle disease, hematological diseases and serological changes. The total score of ESSDAI is equal to the sum of the score of the severity of each system × the product of the weight of the system. A scale of \<5 was classified as low disease activity, 5 to 13 as moderate disease activity, and \>14 as high disease activity.
**Measure:** EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score
**Time Frame:** 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Clinical diagnosis of primary Sjögren's syndrome
* Must be able to receive acupuncture treatment and swallow tablets
Exclusion Criteria:
* Patients with malignant tumors or severe organ function impairment
* Patients who are lactating or pregnant.
* Persons who are participating in clinical trials of other drugs.
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Harbin
**Country:** China
**Facility:** Senyue Zhang
**State:** Heilongjiang
**Zip:** 150040
#### Overall Officials
**Official 1:**
**Affiliation:** Heilongjiang University of Chinese Medicine
**Name:** Senyue Zhang
**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: D000001172
- Term: Arthritis, Rheumatoid
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000014987
- Term: Xerostomia
- ID: D000012466
- Term: Salivary Gland Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M15664
- Name: Sjogren's Syndrome
- Relevance: HIGH
- As Found: Sjogren's Syndrome
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M4480
- Name: Arthritis, Rheumatoid
- 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
- ID: M17724
- Name: Xerostomia
- Relevance: LOW
- As Found: Unknown
- ID: M15285
- Name: Salivary Gland Diseases
- 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: M18040
- Name: Dry Eye Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M10664
- Name: Keratoconjunctivitis Sicca
- Relevance: LOW
- As Found: Unknown
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- 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: D000012859
- Term: Sjogren's Syndrome
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Ancestors
- ID: D000000962
- Term: Antimalarials
- ID: D000000981
- Term: Antiprotozoal Agents
- ID: D000000977
- Term: Antiparasitic Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018501
- Term: Antirheumatic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9940
- Name: Hydroxychloroquine
- Relevance: HIGH
- As Found: L-arginine
- 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: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006886
- Term: Hydroxychloroquine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432088
**Brief Title:** Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
**Official Title:** Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
#### Organization Study ID Info
**ID:** LVT009
#### Organization
**Class:** INDUSTRY
**Full Name:** Levita Magnetics
#### Secondary ID Infos
**Domain:** Levita Magnetics
**ID:** CP009
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Levita Magnetics
#### 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:** The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
**Detailed Description:** The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures.
### Conditions Module
**Conditions:**
- Bariatric Surgery Candidate
- Hiatal Hernia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
**Intervention Names:**
- Device: Extended Magnetic Grasper Device
**Label:** Extended Magnetic Grasper Device
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Extended Magnetic Grasper Device
**Description:** The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
**Name:** Extended Magnetic Grasper Device
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
**Measure:** Adverse Events
**Time Frame:** 30 days
**Description:** Ability to adequately mobilize the liver to achieve an effective exposure of the target tissue. Adequate mobilization is not achieved if it is necessary to use another liver retractor during the procedure.
**Measure:** Mobilization
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* At least 18 years of age.
* Scheduled to undergo elective bariatric and/or hiatal hernia procedures.
* Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures.
Exclusion Criteria:
* Individuals with pacemakers, defibrillators, or other electromedical implants.
* Individuals with ferromagnetic implants.
* American Society of Anesthesiologists (ASA) score of III or IV.
* Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
* Clinical history of impaired coagulation confirmed by abnormal blood tests.
* Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.).
* Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use.
* Pregnant or wishes to become pregnant during the length of study participation.
* Individual is not likely to comply with the follow-up evaluation schedule.
* Participating in a clinical trial of another investigational drug or device.
* Prisoner or under incarceration.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Vivian Soto
**Phone:** +56958360507
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Santiago
**Contacts:**
***Contact 1:***
- **Name:** Julio Jimenez Lillo
- **Phone:** +56 2 2472 5690
- **Role:** CONTACT
**Country:** Chile
**Facility:** Hospital Santiago Oriente Dr. Luis Tisné Brousse
**State:** Metropolitana
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006547
- Term: Hernia
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000006548
- Term: Hernia, Diaphragmatic
- ID: D000082122
- Term: Internal Hernia
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9625
- Name: Hernia
- Relevance: LOW
- As Found: Unknown
- ID: M9629
- Name: Hernia, Hiatal
- Relevance: HIGH
- As Found: Hiatal Hernia
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M9626
- Name: Hernia, Diaphragmatic
- Relevance: LOW
- As Found: Unknown
- ID: M2344
- Name: Internal Hernia
- Relevance: LOW
- As Found: Unknown
- ID: M25675
- Name: Hernia, Abdominal
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006551
- Term: Hernia, Hiatal
### 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432075
**Brief Title:** Neoantigen Reactive T Cells c for Chinese Patients With Advanced Gastric Cancer
**Official Title:** Single Arm Clinical Prospective Study of Neoantigen Reactive T Cells (NRTs) in the Treatment of Chinese Patients With Advanced Gastric Cancer
#### Organization Study ID Info
**ID:** Neoantigen T Cells
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Wenzhou Medical University
### Status Module
#### Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** First Affiliated Hospital of Wenzhou Medical University
#### Responsible Party
**Investigator Affiliation:** First Affiliated Hospital of Wenzhou Medical University
**Investigator Full Name:** Shen Xian
**Investigator Title:** Chief Physician
**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 this study is to see the safety and efficient of neoantigen reactive T cells (NRTs) in the treatment of Chinese patients with advanced gastric cancer.
**Detailed Description:** The tumor-specific "none-self" immunogenic neoantigens encoded by either viral genes or somatic mutation genes, possess the potential to induce specific anti-cancer immunity, including cellular and humoral immune responses. Today, numerous clinical trials demonstrate that although these "none-self" antigens initiate the antigen-specific immunoglobulin G antibodies and cluster of differentiation 4（CD4）+/cluster of differentiation 8（CD8）+T-cells response, not all of them show a clinical benefit in the response rate, progression-free survival or overall survival.Personalized cell therapy maybe own a breakthrough in the treatment of those gastric cancer patients without standard options.The investigators' center has successfully established a new method for preparing personalized neoantigen reactive T cells(NRTS) for adoptive cell therapy(ACT). Today, the investigators will carry out a single arm clinical prospective study of NRTs for the treatment of Chinese patients with advanced gastric cancer. Participants are assigned to receive 4 circles of cell therapy, and IL-2 continuous intravenous infusion（CIV） will also be given for 5 consecutive days after each time's cell infusion. The safety and clinical response rate（RR） are evaluated. Biomarkers and immunological markers are also monitored.
### Conditions Module
**Conditions:**
- Advanced Gastric Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory;nab-paclitaxel 100-200mg/m2/D will be i.v. for 7 days before cell infusion; Cyclophosphamide 300mg/m2/D will be i.v. for 2 and 3 days before cell infusion; NRTs 0.5\~1 x 10\^10, will be i.v.Q3 weeks for total 4 doses;Interleukin-2 (IL-2) will be continuous intravenous infused since the first day of the cell infusion for 5 consecutive days, 1000,000 international unit per day.All Patients will receive a total of 4 cycles of treatment.
**Intervention Names:**
- Biological: Neoantigen Reactive T Cells(NRTs)
**Label:** Neoantigen Reactive T Cells
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Neoantigen Reactive T Cells
**Description:** Neoantigen Reactive T Cells in an expected volume of 100 milliliter（mL） will be given by intravenous injection over 2-10 minutes through either a peripheral or a central line.
**Name:** Neoantigen Reactive T Cells(NRTs)
**Type:** BIOLOGICAL
### Outcomes Module
#### Other Outcomes
**Description:** the duration is measured from the time of treatment to the time of death
**Measure:** Overall Survival (OS)
**Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
**Description:** T cells in the peripheral blood stimulated by tumor antigens for 24 hr，and then Interferon-gama secretion is measured
**Measure:** Interferon-gama change of PBMC cells in the peripheral blood stimulated by tumor antigens
**Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
#### Primary Outcomes
**Description:** using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
**Measure:** Number of participants with Adverse Events
**Time Frame:** up to 6 months
#### Secondary Outcomes
**Description:** Response Rate（RR）will be evaluated according Response Evaluation Criteria in Solid Tumors
**Measure:** Response Rate
**Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
**Description:** the duration of progression free survival is measured from the time of treatment to the first date that recurrent or progressive disease or for any reason of death is objectively documented.
**Measure:** Progression free survival (PFS)
**Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Voluntarily join the study and sign the informed consent;
2. Age: 18-75 years old, male or female;
3. Subjects with advanced gastric cancer who had received systematic standard treatment before enrollment and had no effective treatment at present. (Note: The effective treatment means refer to the latest version of the "Gastric Cancer Diagnosis and Treatment Guide" issued by China's "Chinese Clinical Oncology Society".) ;
4. Have at least one measurable lesion according to imRECIST evaluation criteria;
5. Expected survival ≥5 months (starting from the collection of tissue samples for sequencing);
6. The Eastern Cancer Consortium (ECOG) score was 0 or 1 or 2;
7. The following hematological indicators should be met: neutrophil count ≥ 1.5×109/L; Hemoglobin ≥ 10.0 g/dL; Platelet count ≥ 50×109/L;
8. The following biochemical indicators should be met: total bilirubin ≤2.0× upper limit of normal value (ULN); AST and ALT ≤2.0×ULN; Serum creatinine ≤1.5×ULN.
9. Before lymphocyte clearance preadministration: 1) any chemotherapy, small molecule targeted drugs and other antitumor therapy received have passed the 3-week washout period, and the toxic side effects have returned to grade 1 or lower (excluding hair loss, vitiligo and other events as determined by the investigator to be tolerated); 2) If surgical treatment is performed within 3 weeks, toxicity has returned to grade 1 or lower; 3) The immunotoxicity of major organs has returned to grade 1 or lower after receiving any antibody drug treatment, and the washout period of PD-1 antibodies has reached 6 weeks, and CTLA-4 antibodies and other antibodies have passed the washout period of 4 weeks.
Exclusion Criteria:
1. Subjects infected with HBV, HCV, HIV, syphilis and tuberculosis;
2. Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or what the investigator considers Other diseases not included in the group;
3. Patients with a history of bone marrow or organ transplantation; Patients with coagulation dysfunction;
4. Patients with immune deficiency diseases or autoimmune diseases who are treated with immunosuppressive drugs;
5. Central nervous system (CNS) metastatic and/or cancerous meningitis;
6. People who may be allergic to immunotherapy;
7. Drug abuse, clinical or psychological or social factors that affect informed consent or the conduct of the study;
8. Pregnant and lactating women;
9. Participating in other clinical trials;
10. An uncertainty that the investigator believes has an impact on the subject's safety or compliance.
**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:** Xian Shen
**Phone:** 13968888872
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Publications
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Gastric Cancer
- 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: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5486
- Name: Stomach Cancer
- Relevance: HIGH
- As Found: Gastric Cancer
### Condition Browse Module - Meshes
- ID: D000013274
- Term: Stomach Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M6727
- Name: Cyclophosphamide
- Relevance: LOW
- As Found: Unknown
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M10411
- Name: Interleukin-2
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432062
**Brief Title:** Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia
**Official Title:** Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia
#### Organization Study ID Info
**ID:** 2022-13596
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Saglik Bilimleri University
### Status Module
#### Completion Date
**Date:** 2024-05-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-04-15
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul Saglik Bilimleri University
#### Responsible Party
**Investigator Affiliation:** Istanbul Saglik Bilimleri University
**Investigator Full Name:** Hatice Karabulut
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The rectus abdominis, which enables the trunk to flex with its activation, and the erector spinae muscles, which provide trunk extension with its activation, are among the structures located in the core region and involved in the stabilization of the spine. While the muscles in the core area actively provide the stabilization of the medulla spinalis, this stabilization is also supported by passive subsystems. Passive subsystem fascia etc. creates structures. Thoracolumbar fascia is one of the important fascias due to its connections with the muscles in the core area. Fatigue etc. of the structures in the core area. As a result of physiological processes, their functionality may decrease, which may affect the stabilization of the core area. Fatigue occurs as a result of lactic acid accumulation in the structures in the body and this process is called the recovery period. The types of exercises performed also affect the recovery period. For this reason, different exercise types such as dynamic and static can be used when creating exercise programs. Due to the functions of the rectus abdominis and erector spinae muscles and thoracolumbar fascia in the body, their effects on the spine and their connections with each other; It is aimed to examine the effect of muscle fatigue in these muscles on the viscoelastic properties of the thoracolumbar fascia and their recovery rates.
### Conditions Module
**Conditions:**
- Muscle Weakness
**Keywords:**
- rectus abdominis
- erector spinae
- thoracolumbar fascia
### Design Module
#### Design Info
**Observational Model:** CASE_CROSSOVER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Viscoelastic properties of the thoracolumbal fascia (TFL) was performed with the MyotonPRO™ (Myoton AS, Estonia) device. Before and after imeddiately after application of the fatigue protocol. The measurement point determined for TFL of individuals rest were marked with a medical marker pen. During the measurement, the probe of the device was adjusted to pulse once into the skin with a force of 0.4 N and for 15 ms. During the test, the tip of the MyotonPro™ device was placed perpendicular to the marked area and gently pressed against the skin at a depth of 3 mm until the green light came on.
**Measure:** Thoracolumbal Fascia Viscoelastic Properties
**Time Frame:** 2 weeks
#### Secondary Outcomes
**Description:** Fatigue assessment will be made using the Modified Borg Scale. The Modified Borg Scale is a subjective evaluation method that evaluates fatigue and shortness of breath during activity or at rest between 0 and 10. 0 points "not at all" means the lowest, and 10 points "very severe" means the highest fatigue and shortness of breath.
**Measure:** Fatigue Assessment with Borg Scale
**Time Frame:** 2 weeks
**Description:** Moxy®, (Moxy®, Fortiori Design LLC, Minnesota, USA) Monitor will be used to detect the change in intramuscular oxygen saturation of the muscles and the time it takes to return to resting levels during and after fatigue protocols. The most swollen areas of the rectus abdominis and erector spinae muscles will be marked with a cosmetic pen and the device will be placed.
**Measure:** Investigations of Recovery Times
**Time Frame:** 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being a healthy individual between the ages of 18-35
* Not having any chronic disease
* Body mass index (BMI) is 24.9 kg/m2 or lower
* Volunteering to participate in the study
Exclusion Criteria:
* Having a chronic illness (Diabetes, blood pressure, etc.)
* Having a diagnosed spine problem
* Being diagnosed with scoliosis
* Pilates, yoga, etc. in the last 6 months. to have done sports
* Beighton score of 4 or above
* Being diagnosed with cardiopulmonary system disease
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- ADULT
**Study Population:** This study will be conducted with healthy male individuals between the ages of 18-35. Individuals without any orthopedic, neurological or chronic disease will be included in the study.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Istanbul Health Science University
**State:** Uskudar
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal 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: M20944
- Name: Muscle Weakness
- Relevance: HIGH
- As Found: Muscle Weakness
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M4554
- Name: Asthenia
- Relevance: LOW
- As Found: Unknown
- ID: M13204
- Name: Paresis
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- 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
### Condition Browse Module - Meshes
- ID: D000018908
- Term: Muscle Weakness
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432049
**Brief Title:** Endocrown Restoring First Permanent Molar in Children
**Official Title:** Clinical and Radiographic Outcome of Endocrown Restoring First Permanent Molar in Children: Clinical Randomized Study
#### Organization Study ID Info
**ID:** MKSU/22-11-4
#### Organization
**Class:** OTHER
**Full Name:** Kafrelsheikh University
### Status Module
#### Completion Date
**Date:** 2024-05-13
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-11-09
**Type:** ACTUAL
#### Start Date
**Date:** 2022-12-05
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kafrelsheikh University
#### Responsible Party
**Investigator Affiliation:** Kafrelsheikh University
**Investigator Full Name:** Ahmed Ismail Taha
**Investigator Title:** lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months
**Detailed Description:** This study comprised 30 children, with age range of (10-13) years old, with endodontically treated first permanent molars. Participants were classified into three groups according to type and material of the final restoration. All selected children were assigned to either PMC group (n=10) restored with performed metal crowns (Stainless-steel Molar Crowns) , EMX group (n=10) endocrown fabricated from CAD-CAM lithium disilicate glass ceramic , COP group (n=10) endocrown fabricated from CAD-CAM reinforced composite. After cementation, all children were evaluated over one year; at one week post-operative, 6 and 12 months for the following criteria: radiographic findings, plaque index, periodontal index, parent satisfaction.
### Conditions Module
**Conditions:**
- Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in Children
**Keywords:**
- Endocrown
- CAD-CAM
- Children
- Ceramic
- Molars
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** FACTORIAL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** endodontically treated molar restored with Stainless steel crown
**Intervention Names:**
- Other: restoration for endodontically treated molar
**Label:** PMC
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** endodontically treated molar restored with endocrown fabricated from CAD-CAM lithium disillicate
**Intervention Names:**
- Other: restoration for endodontically treated molar
**Label:** EMX
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** endodontically treated molar restored with endocrown fabricated from CAD-CAM composite
**Intervention Names:**
- Other: restoration for endodontically treated molar
**Label:** COP
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- COP
- EMX
- PMC
**Description:** prefabricated stainless steel crown or endocrown
**Name:** restoration for endodontically treated molar
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings
**Measure:** number of participants with pathological changes in radiographs
**Time Frame:** 6 months
**Description:** evaluation of the extent of parent satisfaction with different type of restorations using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.
**Measure:** degree of parent satisfaction with different restorations
**Time Frame:** 6 month
**Description:** plaque index evaluate the plaque accumulation around different type of restorations. this index involves:
* Plaque index 0: No plaque is in the area adjacent to the gingiva.
* Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.
* Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.
* Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.
**Measure:** rate of plaque accumulation on different type of restorations
**Time Frame:** 6 months
**Description:** gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.
**Measure:** effect of different restoration on surrounding gingiva
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings
**Measure:** number of participants with pathological changes in radiographs
**Time Frame:** 1 year
**Description:** using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.
**Measure:** degree of parent satisfaction with different restorations
**Time Frame:** 1 year
**Description:** plaque index evaluate the plaque accumulation around different type of restorations. this index involves:
* Plaque index 0: No plaque is in the area adjacent to the gingiva.
* Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.
* Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.
* Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.
**Measure:** rate of plaque accumulation on different type of restorations
**Time Frame:** 1 year
**Description:** gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.
**Measure:** effect of different restoration on surrounding gingiva
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient age ranging from 10-13 years old with closed apex.
* Normal occlusion without any para-functional habits.
* Decayed lower first molar.
* Supra-gingival margin was required after preparation.
* Absence of root fractures or cracks.
Exclusion Criteria:
* Difficulty to apply rubber dam for proper endocrown bonding.
* Lack of patient cooperation for post-operative recall and follow up.
* Bad oral hygiene
**Maximum Age:** 13 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kafr Ash Shaykh
**Country:** Egypt
**Facility:** Kafr El Shaikh University
**Zip:** 6860404
### IPD Sharing Statement Module
**Description:** all data will be shared after publishing.
**IPD Sharing:** UNDECIDED
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19022
- Name: Lithium Carbonate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432036
**Brief Title:** Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial
**Official Title:** RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open-Label, Prospective, Multi-Center, Phase 1/2 Safety Trial
#### Organization Study ID Info
**ID:** 23-001261
#### Organization
**Class:** OTHER
**Full Name:** Jonsson Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-03516
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2027-06
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-01-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Boston Scientific Corporation
#### Lead Sponsor
**Class:** OTHER
**Name:** Jonsson Comprehensive Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This phase I/II trial tests the safety, side effects and effectiveness of radioembolization with yttrium-90 (Y-90) in patients with early stage renal cell carcinoma. Y-90 is a radioactive chemical that is incorporated into millions of very tiny glass spheres. These spheres are injected into the artery that feeds the cancer. This process is called radioembolization. Y-90 radioembolization may be a safe and effective treatment for patients with early stage renal cell carcinoma.
**Detailed Description:** PRIMARY OBJECTIVE:
I. To assess safety and toxicity of Yttrium-90 radioembolization for renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
I. To assess tumor response and duration of response, based on Choi, Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST criteria.
II. To assess time to disease progression. III. To assess progression free survival and overall survival. IV. To assess stability of renal function via glomerular filtration rate (GFR) and cystatin-C.
V. To describe the difference in quality of life before and after treatment using Eastern Cooperative Oncology Group (ECOG) performance status and RCC-specific Quality of Life (QoL) questionnaire.
OUTLINE:
Patients undergo radioembolization with yttrium Y 90 glass microspheres (TheraSphere) given intra-arterially. Patients undergo angiogram during screening, single proton emission computed tomography (SPECT) scan on study and computed tomography (CT) scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 1 day, 1 week, and then monthly for 24 months.
### Conditions Module
**Conditions:**
- Stage I Renal Cell Cancer
- Stage II Renal Cell Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 25
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients undergo radioembolization with TheraSphere given intra-arterially. Patients undergo angiogram during screening, SPECT scan on study and CT scan and blood sample collection throughout the study.
**Intervention Names:**
- Procedure: Angiogram
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Radiation: Radioembolization
- Procedure: Single Photon Emission Computed Tomography
- Other: Survey Administration
- Radiation: Yttrium Y 90 Glass Microspheres
**Label:** Treatment (radioembolization, TheraSphere)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment (radioembolization, TheraSphere)
**Description:** Undergo angiogram
**Name:** Angiogram
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Treatment (radioembolization, TheraSphere)
**Description:** Undergo blood sample collection
**Name:** Biospecimen Collection
**Other Names:**
- Biological Sample Collection
- Biospecimen Collected
- Specimen Collection
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Treatment (radioembolization, TheraSphere)
**Description:** Undergo CT scan
**Name:** Computed Tomography
**Other Names:**
- CAT
- CAT Scan
- Computed Axial Tomography
- Computerized Axial Tomography
- Computerized axial tomography (procedure)
- Computerized Tomography
- Computerized Tomography (CT) scan
- CT
- CT Scan
- tomography
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Treatment (radioembolization, TheraSphere)
**Description:** Undergo radioembolization
**Name:** Radioembolization
**Other Names:**
- intra-arterial brachytherapy
**Type:** RADIATION
#### Intervention 5
**Arm Group Labels:**
- Treatment (radioembolization, TheraSphere)
**Description:** Undergo SPECT
**Name:** Single Photon Emission Computed Tomography
**Other Names:**
- Medical Imaging, Single Photon Emission Computed Tomography
- Single Photon Emission Tomography
- Single-Photon Emission Computed
- single-photon emission computed tomography
- SPECT
- SPECT imaging
- SPECT SCAN
- SPET
- ST
- tomography, emission computed, single photon
- Tomography, Emission-Computed, Single-Photon
**Type:** PROCEDURE
#### Intervention 6
**Arm Group Labels:**
- Treatment (radioembolization, TheraSphere)
**Description:** Ancillary study
**Name:** Survey Administration
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Treatment (radioembolization, TheraSphere)
**Description:** Given intra-arterially
**Name:** Yttrium Y 90 Glass Microspheres
**Other Names:**
- TheraSphere
- Y-90 Therasphere
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of treatment related adverse events
**Time Frame:** Up to 2 years
**Measure:** Number of serious adverse events
**Time Frame:** Up to 2 years
#### Secondary Outcomes
**Description:** According to Choi, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and modified RECIST. Will be summarized as count and percentage. The corresponding 95% confidence interval (CI) for the ORR will be computed using the methodology of Clopper-Pearson.
**Measure:** Overall response rate (ORR)
**Time Frame:** Up to 2 years
**Description:** According to Choi, RECIST 1.1, and modified RECIST. Will be analyzed by Kaplan Meier methodology.
**Measure:** Duration of response
**Time Frame:** From the first response and first observation of progressive disease, up to 2 years
**Description:** According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented.
**Measure:** Renal time to progression
**Time Frame:** Up to 2 years
**Description:** According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented.
**Measure:** Progression free-survival
**Time Frame:** Up to 2 years
**Description:** Kaplan Meier curves will be presented.
**Measure:** Overall survival
**Time Frame:** Up to 2 years
**Description:** Measured by glomerular filtration rate (GFR), creatinine, and cystatin-C.
**Measure:** Change in renal function
**Time Frame:** Up to 2 years
**Description:** Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson.
**Measure:** Proportion of patients receiving subsequent treatment for RCC after study treatment
**Time Frame:** Up to 2 years
**Description:** Will be summarized using descriptive summaries.
**Measure:** Type of subsequent RCC treatment received after study treatment
**Time Frame:** Up to 2 years
**Description:** Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson.
**Measure:** Proportion of patients to undergo curative therapy
**Time Frame:** Up to 2 years
**Description:** Will be summarized using descriptive summaries.
**Measure:** Time to subsequent RCC treatment (local or systemic therapy)
**Time Frame:** Up to 2 years
**Description:** Correlation between tumoral absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)
**Measure:** Correlation between tumoral absorbed dose, with efficacy and safety
**Time Frame:** Up to 2 years
**Description:** Correlation between normal tissue absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)
**Measure:** Correlation between normal tissue absorbed dose, with efficacy and safety
**Time Frame:** Up to 2 years
**Description:** The scale is Eastern Cooperative Oncology Group (ECOG). Scale is 1 to 5, with 5 being the worst outcome.
**Measure:** Change in Eastern Cooperative Oncology Group score
**Time Frame:** Up to 2 years
**Description:** Change in overall quality of life based on patient-reported outcomes
**Measure:** Change in quality of life as measured by the SF-36 (QualityMetrics) Quality of Life survey
**Time Frame:** Up to 2 years
**Measure:** Percentage of subjects with absorbed Y90 dose within range (+/- 20%) of planned dose
**Time Frame:** Up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants must be aged ≥ 18 years at the time of screening
* Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
* Life expectancy ≥ 12 months
* RCC, diagnosed by radiographic imaging and histology
* Clinical stage of RCC: T1 or T2a, Cancer stage (N0M0)
* 1-2 solid (\> 80% solid) target lesions
* Patient not an ideal candidate for partial nephrectomy or thermal ablation at the time of study entry, based on the decision of the institution's multidisciplinary tumor board. Contraindications for partial nephrectomy include inability to potentially partially resect the kidney, high risk of adverse events due to medical comorbidities, or potential high risk of adverse events due to general anesthesia. Contraindications to thermal ablation include potential inability to technically place ablation probes into the tumor, central tumors which risk thermal injury to the renal collecting system
* Patient not considered a candidate for long-term active surveillance due to oncologic risk due to tumor growth and/or tumor size
* Patient not considered ideal candidates for radical nephrectomy due to surgical comorbidity and/or development of adverse health outcomes
* Measurable tumor by RECIST 1.1 criteria
* Absence of bilateral renal tumors
* Negative serum pregnancy test in females of child-bearing potential; patients who are breast-feeding cannot participate in this trial
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Absolute lymphocyte count ≥ 1.0 x 10\^9/L
* Platelet count ≥ 75 x 10\^9/L
* Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m\^2
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
* Screening mapping angiogram demonstrates successful localization of tumor(s), where catheter placement location(s) would allow Y90 to distribute in the intended treatment area, without venous shunting
Exclusion Criteria:
* Any contraindication to angiography or selective renal artery catheterization
* Screening angiography with cone beam CT (CBCT) shows any arterial flow to the gastrointestinal tract uncorrectable by angiographic techniques
* Screening angiography with CBCT shows poor tumor targeting that would lead to a dose that does not meet the renal dosing criteria. This typically occurs when a feeding artery to the tumor cannot be identified
* Screening angiography demonstrates excessive non-tumoral renal parenchyma will be in the treatment field, that the new baseline glomerular filtration rate will be \< 45 mL/min/1.73 m\^2
* Screening angiography demonstrates renal venous shunting of iodinated contrast that is immediately visible upon arterial injection
* Extra-renal metastases, including patients with abdominal lymph nodes \>1.5 cm in shorter axis, or with lung nodules (single lesion, \>1 cm, or multiple smaller lesions with a total diameter \>2 cm)
* Brain metastases, leptomeningeal carcinomatosis or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry
* Evidence of any tumor invasion into the renal vein, renal artery, or renal collecting system
* Any prior radiation therapy to the abdomen, including localized radiation therapy to the index tumor
* Concurrent treatment for RCC or treatment in the last 6 months in another clinical study, unless it is an observational study (non-interventional) or during a non-interventional follow-up stage of an interventional study, or prior randomization to this study
* History of active primary/acquired immunodeficiency
* Presence of renal ureteral stent in the treatment kidney at any time
* History of malignancy, other than RCC, within three years, with the exception of adequately treatment carcinoma in situ of the cervix, early squamous cell carcinoma or basal cell carcinoma of the skin, localized prostate cancer, ductal carcinoma in situ, or low-grade endometrial carcinoma with no myometrial invasion (negligible risk of metastases or death 5-year overall survival \[OS\] rate \> 90%)
* Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment
* A history of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
* Active infection
* Female patients who are pregnant or breastfeeding or female patients of reproductive potential who are not willing to employ effective birth control from screening to 6 months after treatment
* Unstable chronic disease or evidence of any disease or condition that would place the patient at undue risk and preclude safe use of Y90 microspheres, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
* History of pulmonary insufficiency, measured by oxygen saturation of less than 90%
* Solitary kidney
* Patient not able to follow the study protocol requirements
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Arshia Mian
**Phone:** 310-906-6028
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Saima Chaabane
**Phone:** (310)794-8995
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Arshia A. Mian
- **Phone:** 310-906-6028
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Saima Chaabane
- **Phone:** (310)794-8995
- **Role:** CONTACT
***Contact 3:***
- **Name:** Siddharth A. Padia, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** UCLA / Jonsson Comprehensive Cancer Center
**State:** California
**Zip:** 90095
#### Overall Officials
**Official 1:**
**Affiliation:** UCLA / Jonsson Comprehensive Cancer Center
**Name:** Siddharth A Padia
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000007680
- Term: Kidney Neoplasms
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5548
- Name: Carcinoma, Renal Cell
- Relevance: HIGH
- As Found: Renal Cell Cancer
- 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: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M10703
- Name: Kidney Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- 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: M10698
- Name: Kidney 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: T4906
- Name: Renal Cell Carcinoma
- Relevance: HIGH
- As Found: Renal Cell Cancer
- ID: T1341
- Name: Clear Cell Renal Cell Carcinoma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002292
- Term: Carcinoma, Renal Cell
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432023
**Acronym:** I-CLEANED
**Brief Title:** Imaging - Clinical Evaluation of Altered Nervous System Drainage
**Official Title:** Multi-signal Analysis of the Composition and Movement of Fluid in Various Cerebral Compartments in Healthy Subjects and Subjects With White Matter Pathology
#### Organization Study ID Info
**ID:** 1022
#### Organization
**Class:** OTHER
**Full Name:** IRCCS Eugenio Medea
### Status Module
#### Completion Date
**Date:** 2026-01-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Ministry of Health, Italy
#### Lead Sponsor
**Class:** OTHER
**Name:** IRCCS Eugenio Medea
#### 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 current study aims to evaluate the aspects of perfusion, fluid diffusivity in the interstitium and the T1 and T2 signal of the PVS and WMH. The current study has the following objectives: a) evaluate the perfusion aspects using the gadolinium-based contrast medium of brain tissues in the short term; b) the direction of flow of fluids at very low speed in the white matter using the DTI sequences configured for this purpose; c) T1-mapping of the lesions of interest.
The expected results will help us understand two aspects of neurofluid dynamics: a) how the fluid moves within the central nervous system in the first minutes after the injection of the tracer (in our case the gadolinium-based contrast medium) and b) what is the composition of the fluid within the PVS and WMH and how can investigators characterize them more accurately.
**Detailed Description:** Among the various indirect markers of altered drainage of neuroglial waste metabolites, there is the widening of the perivascular spaces (PVS) and the presence of white matter signal alterations.
An increase in the number of PVS and their enlargement could represent an indirect marker of obstruction to the drainage of fluids and solutes along the arterial wall at the level of the white matter. This obstruction would also be the basis of tissue hypoxia resulting in the formation of areas of signal hyperintensity in the white matter (White Matter Hyperintensities, WMH) often observed in patients with neurodegenerative diseases and small vessel disease.
It is currently unclear what the main drainage route of brain waste metabolites is. Surely there are at least two.
The glymphatic theory proposes the entry of the cerebrospinal fluid (CSF) from the subarachnoid space towards the brain parenchyma in a centripetal direction and exit of the metabolic waste along the perivenous spaces. The drainage of metabolic waste could also be explained by the more recent "intramural periarterial drainage" (IPAD) theory which shows elimination along the arterial walls in a centrifugal direction.
In magnetic resonance imaging (MRI), the study of solute drainage requires a dynamic evaluation, which is able to evaluate the temporal movement of a tracer. There are several MRI techniques, already described in the literature, which can be used to obtain information relating to perfusion processes and the coupling of neuronal and vascular activity in different brain areas.
The circulation of CSF is well known, which is produced largely at the level of the choroid plexuses and is then partly reabsorbed by the arachnoid granulations at the level of the subarachnoid space. Recent studies demonstrate that the CSF re-enters the brain parenchyma in a centripetal manner, crossing the thickness of the gray matter and then the white matter. This movement is regulated by various factors, and in particular by the activity of the smooth muscle cells of the arterial walls, the aquaporin 4 receptors (water channels) and by the chemical-physical properties of the extracellular matrix in the extracellular space.
### Conditions Module
**Conditions:**
- Neuroinflammation
- Autism Spectrum Disorder
**Keywords:**
- magnetic resonance imaging
- autism spectrum disorder
- white matter disease
- glymphatic system
- brain waste clearance
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients with white matter hyperintensities, patients with enlarged perivascular spaces, Focus will be on patients with a clinical diagnosis of muscular dystrophy or autism spectrum disorder or traumatic brain injury.
**Intervention Names:**
- Diagnostic Test: Magnetic resonance imaging
**Label:** Patients
#### Arm Group 2
**Description:** Patients who need a diagnostic scan but do not carry a diagnosis of psychomotor or cognitive impairment or without a history of TBI and tumors. No white matter hyperintensities.
**Intervention Names:**
- Diagnostic Test: Magnetic resonance imaging
**Label:** Controls
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Controls
- Patients
**Description:** Diagnostic and research scanning using magnetic resonance imaging.
**Name:** Magnetic resonance imaging
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Number and distribution of enlarged perivascular spaces
**Measure:** Perivascular space count
**Time Frame:** once at recruitment
**Description:** correlation of parasagittal dura and perivascular count
**Measure:** Volume of parasagittal dura
**Time Frame:** once at recruitment
**Description:** effect of sedation on BOLD signal
**Measure:** fMRI signal during sedation
**Time Frame:** once at recruitment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients with white matter lesions and/or enlarged perivascular spaces
Exclusion Criteria:
* have contraindications to the use of contrast medium;
* are clinically unstable patients and prolonged sedation is inappropriate
* have tumors
* contraindications to perform MR.
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 2 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients with obvious white matter disease on T2 and FLAIR sequences will be included in this study. In particular patients with recent diagnosis of autism spectrum disorder, traumatic brain injury, Steinert's muscular dystrophy will be included.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bosisio Parini
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nivedita Agarwal, MD
- **Phone:** +39 031855
- **Phone Ext:** 398
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Noemi Miscioscia
- **Role:** CONTACT
**Country:** Italy
**Facility:** Scientific Institute IRCCS E. Medea
**State:** Lecco
**Status:** RECRUITING
**Zip:** 23842
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002659
- Term: Child Development Disorders, Pervasive
- ID: D000065886
- Term: Neurodevelopmental Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000007249
- Term: Inflammation
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4623
- Name: Autistic Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M206
- Name: Autism Spectrum Disorder
- Relevance: HIGH
- As Found: Autism Spectrum Disorder
- ID: M28591
- Name: Leukoencephalopathies
- Relevance: LOW
- As Found: Unknown
- ID: M2803
- Name: Neuroinflammatory Diseases
- Relevance: HIGH
- As Found: Neuroinflammation
- ID: M5903
- Name: Child Development Disorders, Pervasive
- Relevance: LOW
- As Found: Unknown
- ID: M5902
- Name: Developmental Disabilities
- Relevance: LOW
- As Found: Unknown
- ID: M30644
- Name: Neurodevelopmental 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: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000090862
- Term: Neuroinflammatory Diseases
- ID: D000067877
- Term: Autism Spectrum Disorder
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432010
**Acronym:** R-FORM'
**Brief Title:** Quality of Life and Behavioral Change of Retired Persons
**Official Title:** Effect of a Health Check-up Followed by a Collective Coaching on the Quality of Life and Behavioral Change of Retired Persons. A Prospective Study Conducted in Ambulatory.
#### Organization Study ID Info
**ID:** 2021-A00408-33
#### Organization
**Class:** OTHER
**Full Name:** Institut Pasteur de Lille
### Status Module
#### Completion Date
**Date:** 2023-12-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-21
**Type:** ACTUAL
#### Start Date
**Date:** 2021-06-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2021-10-11
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut Pasteur de Lille
#### Responsible Party
**Investigator Affiliation:** Institut Pasteur de Lille
**Investigator Full Name:** Jean-Michel Lecerf
**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:** Researchers have found that the first phase of aging, called "frailty", is insidious, silent and slowly progressive. It begins well before the first signs of aging and possibly before retirement age with physiological reserves that are gradually depleted. Frailty is multifactorial. It is situated between the "robust-vigorous" and "poly-pathological-dependent" stages of aging. This state remains dynamic and above all reversible through screening and awareness of the individual's health determinants as well as motivation to change.
The Longevity Pathway was designed to meet several concrete objectives ranging from improving prevention to advancing research on the topic of longevity and aging well.
This study aims to evaluate the effect of this personalized support on the quality of life of the consultants, but also on many health parameters, 12 months after the end of the proposed coaching.
**Detailed Description:** The study will be carried out on healthy volunteers, retired.
The main objective of the study is to evaluate the effect of a health check-up followed by a collective "coaching" type of support on the quality of life of retired people 12 months after the end of the coaching sessions.
### Conditions Module
**Conditions:**
- Healthy Volunteers
**Keywords:**
- Nutrition and Physical Activity coaching
- Cognition coaching
- Longevity
- Prevention
- Quality of life
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Exploratory prospective, monocentric, ambulatory study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Initial health check-up → 7 weeks nutrition and physical activity coaching → 2 telephone follow-ups at 3 and 6 months after → Final health check-up (12 months after)
**Intervention Names:**
- Other: Group nutrition and physical activity coaching
**Label:** Group nutrition and physical activity coaching
**Type:** OTHER
#### Arm Group 2
**Description:** Initial health check-up → 7 weeks cognition coaching → 2 telephone follow-ups at 3 and 6 months after → Final health check-up (12 months after)
**Intervention Names:**
- Other: Group cognition coaching
**Label:** Group cognition coaching
**Type:** OTHER
#### Arm Group 3
**Description:** The study is controlled by the presence of a control group (non-coaching group). 25 people will be included in the control group. They will only benefit from the initial and final health check-up.
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group nutrition and physical activity coaching
**Description:** Group nutrition and physical activity coaching consists of an initial health check-up, followed by nutrition and physical activity coaching sessions over 7 weeks, 2 telephone follow-ups at 3 and 6 months and finally a final health check-up, 12 months after the end of the group nutrition and physical activity coaching sessions.
**Name:** Group nutrition and physical activity coaching
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group cognition coaching
**Description:** Group cognition coaching consists of an initial health check-up, followed by cognition coaching sessions over 7 weeks, 2 telephone follow-ups at 3 and 6 months and finally a final health check-up, 12 months after the end of the cognition coaching sessions.
**Name:** Group cognition coaching
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Health quality will be evaluated thanks to a health quality questionnary validated by the World Health Organisation (WHO).
**Measure:** Change from baseline on quality of life of retired people 12 months after the end of the coaching sessions.
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Food behaviors will be measure with Balance and dietary diversity questionnaire proposed by the Institut Pasteur de Lille
**Measure:** Change from baseline on food behaviors at 1 year after the coaching
**Time Frame:** 1 year
**Description:** Food frequency will be measure with 24-hour reminder of ingestas
- Visual analogue scales on changes in eating behavior.
**Measure:** Change from baseline on food frequency at 1 year after the coaching
**Time Frame:** 1 year
**Description:** Food behaviors will be measure with Visual analogue scales on changes in eating behavior from 10 (yes really a lot) to 0 (not at all)
**Measure:** Change from baseline on food behavior at 1 year after the coaching
**Time Frame:** 1 year
**Description:** Visual Analog Scales for Behavioral Change Related to Physical Activity raging from 10 (yes really a lot) to 0 (not at all)
**Measure:** Change from baseline on physical activity behaviors at 1 year after the coaching
**Time Frame:** 1 year
**Description:** Marshall Questionnaire for Physical Activity frequency and two questions to evaluate the sedentarity livestyle level.
**Measure:** Change from baseline on physical activity frequency at 1 year after the coaching
**Time Frame:** 1 year
**Description:** The using test is :
• 6 minutes walk test (endurance) Measured in meters
**Measure:** Change from baseline on endurance at 1 year after the coaching
**Time Frame:** 1 year
**Description:** The using test is :
• Stand up chair test to calculate the number of raise on 30 seconds
**Measure:** Change from baseline on physical performances (lower limbs) at 1 year after the coaching
**Time Frame:** 1 year
**Description:** The using test is :
•Arm curl test to calculate the number of arm bend
**Measure:** Change from baseline on physical performances (upper limbs) at 1 year after the coaching
**Time Frame:** 1 year
**Description:** The using test is :
•Flexible trunk and posterior chain of lower limbs Measured by index ranging from 5 (the palms of the hands touch the ground) to 1 (the fingertips reach the lower shins)
**Measure:** Change from baseline on flexibility at 1 year after the coaching
**Time Frame:** 1 year
**Description:** The using test is :
Unipodal balance (static balance) Measured in seconds
**Measure:** Change from baseline on static balance at 1 year after the coaching
**Time Frame:** 1 year
**Description:** The using test is :
Get up and go test Measured by index ranging from 5 (the worst) to 1 (the best)
**Measure:** Change from baseline on mobility at 1 year after the coaching
**Time Frame:** 1 year
**Description:** The using test is :
4 meters walking speed
Measured in seconds
**Measure:** Change from baseline on speed at 1 year after the coaching
**Time Frame:** 1 year
**Description:** The using test is :
2 minutes on the spot knee climb This test explores the muscular strength of the lower limbs, dynamic balance and walking Measured in number of knee climb in 2 minutes
**Measure:** Change from baseline on dynamic balance at 1 year after the coaching
**Time Frame:** 1 year
**Description:** Cognitive performances will be measure with :
- Montreal cognitive assessment test (MOCA test) to evaluate mild cognitive dysfunction
**Measure:** Change from baseline on cognitive performances at 1 year after the coaching
**Time Frame:** 1 year
**Description:** It will be measure with :
- Working Memory Questionnaire
**Measure:** Change from baseline on memory at 1 year after the coaching
**Time Frame:** 1 year
**Description:** It will be measure with :
- Insomnia Severity Index (ISI) to assess sleep quality
**Measure:** Change from baseline on sleep quality at 1 year after the coaching
**Time Frame:** 1 year
**Description:** It will be measure with :
- Cohen's Questionnaire
**Measure:** Change from baseline on stress management at 1 year after the coaching
**Time Frame:** 1 year
**Description:** It will be measure with :
- Hospital Anxiety And Depression Queqtionnaire (HAD questionnaire to assess anxiety and depression)
**Measure:** Change from baseline on anxiety at 1 year after the coaching
**Time Frame:** 1 year
**Description:** Blood samples will be collected to analyse fasting blood glucose
**Measure:** Glucose metabolism
**Time Frame:** 1 year
**Description:** Blood samples will be collected to analyse: total cholesterol, HDL, LDL, TG
**Measure:** Lipids metabolism
**Time Frame:** 1 year
**Description:** Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2
**Measure:** Anthropometric parameters (Body Masse Index)
**Time Frame:** 1 year
**Description:** - Waist circumference in centimeters
**Measure:** Anthropometric parameters (waist circumference)
**Time Frame:** 1 year
**Description:** Measurement of body fat by DEXA (Dual X Ray Absorptiometry) for half of the total population :
* Body fat in grams
* Lean mass in grams
* Total mass in grams
* Visceral fat mass in grams
* subcutaneous fat mass in grams
* Bone mineral content in grams
**Measure:** Body composition
**Time Frame:** 1 year
**Description:** Measurement of lean mass by DEXA (Dual X Ray Absorptiometry) for half of the total population :
* Body fat in percentage
* Lean mass in percentage
* Visceral fat mass in percentage
* subcutaneous fat mass in percentage
**Measure:** Body composition
**Time Frame:** 1 year
**Description:** Measurement by DEXA (Dual X Ray Absorptiometry) for half of the total population :
- Bone mineral density in grams/cm²
**Measure:** Body composition (bone mineral density)
**Time Frame:** 1 year
**Description:** Systolic and diastolic blood pressure to calculate blood pressure
**Measure:** Systolic and diastolic blood pressure
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Man or Woman;
* Retired;
* Having the desire to change his/her lifestyle;
* Agreeing to follow the constraints generated by the study (presence during the coaching sessions and the final assessment).
* Having signed the informed consent form;
* Social insured;
Exclusion Criteria:
* Presenting a pathology requiring a complementary assessment and/or the implementation of a treatment that could prevent the realization of the coaching or that could modify its effect;
* Subject participating in another clinical study or in period of exclusion from another study;
* Subject deprived of liberty;
* Subject under judicial protection measure;
* Whose main investigator or a qualified co-investigator judges that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study;.
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lille
**Country:** France
**Facility:** NutrInvest - Institut Pasteur de Lille
**State:** Nord
**Zip:** 59019
#### Overall Officials
**Official 1:**
**Affiliation:** Institut Pasteur de Lille - NutrInvest
**Name:** Jean-Michel LECERF, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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: HIGH
- As Found: Quality of Life
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431997
**Brief Title:** A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM
**Official Title:** Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study
#### Organization Study ID Info
**ID:** FD153502
#### Organization
**Class:** OTHER
**Full Name:** Fudan University
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Shenzhen Maternity & Child Healthcare Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Fudan University
#### Responsible Party
**Investigator Affiliation:** Obstetrics & Gynecology Hospital of Fudan University
**Investigator Full Name:** Yu Xiong
**Investigator Title:** Clinical 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 is a randomized controlled trial, aiming to investigate whether a time-restricted eating (TRE) can reduce the incidence of gestational diabetes mellitus (GDM) in high-risk pregnant women. Investigators intend to conduct a 3-month randomized controlled study to compare the effects of 10-hour TRE and habitual eating time on GDM under the same energy intake.
**Detailed Description:** Investigators present a multicenter, open-label and parallel-group randomized study. Total 240 women in early pregnancy were randomly assigned to TRE group and SOC (standard of care) group according to the ratio of 1: 1. Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. All participants should follow moderate-intensity physical activity for about 30 minutes every day, and receive diet and exercise counseling during the study period. GDM was diagnosed by 75g oral glucose tolerance test (OGTT) test at 24-28 gestational weeks.
### Conditions Module
**Conditions:**
- Gestational Diabetes Mellitus
- Dietary Habits
- Lifestyle Intervention
- Randomized Controlled Study
**Keywords:**
- Gestational Diabetes Mellitus
- Metabolic Diseases
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks).
**Intervention Names:**
- Behavioral: Time-limited eating
**Label:** TRE(Time-restricted eating group)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months.
**Label:** SOC (standard of care group)
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TRE(Time-restricted eating group)
**Description:** All participants will be instructed to follow a diet of 1800-2200 kcal/d (45-50% of energy from carbohydrate, 15-20% from protein, 25-30% from fat) based primarily on Dietary Guidelines for Chinese Residents (2022), Dietary guidelines for pregnant women and Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022). Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months.
**Name:** Time-limited eating
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Adherence to the intervention measure by Chinese Dietary Guidelines Compliance Index for Pregnant Women (CDGCI-PW) and by counting the number of days in which participants consumed calories outside the time-window or exceeding the upper limit of the required energy intake.
Chinese Dietary Guidelines Compliance Index for Pregnant Women (CDGCI-PW): Scores range from 0-100, with higher score indicating better adherence.
**Measure:** Adherence to the intervention
**Time Frame:** From 14-26 gestational weeks
#### Primary Outcomes
**Description:** Diagnosed by the 75g oral glucose tolerance test (OGTT).
**Measure:** The incidence of GDM
**Time Frame:** 24-28 gestational weeks
#### Secondary Outcomes
**Description:** Number of newborns with birth weight ≥4000g.
**Measure:** Number of newborns with macrosomia
**Time Frame:** At delivery
**Description:** Number of newborns with birth weight \<2500g.
**Measure:** Number of newborns with low birth weight
**Time Frame:** At delivery
**Description:** Number of newborns with weight lies above the 90th percentile for the gestational age.
**Measure:** Number of newborns large for gestational age (LGA)
**Time Frame:** At delivery
**Description:** Number of newborns with weight lies below the 10th percentile for the gestational age.
**Measure:** Number of newborns small for gestational age (SGA)
**Time Frame:** At delivery
**Description:** The incidence of the condition in which normal traction on the fetal head does not lead to the delivery of the shoulders.
**Measure:** Incidence of shoulder dystocia
**Time Frame:** At delivery
**Description:** Number of newborns with an impairment of the neonate's body function or structure due to an adverse event that occurred at birth.
**Measure:** Number of newborns with birth injury
**Time Frame:** At delivery
**Description:** Number of neonatus with neonatal intensive care unit (NICU) admission.
**Measure:** Number of neonatus with neonatal intensive care unit (NICU) admission
**Time Frame:** Within the first 28 days after delivery
**Description:** Number of neonatus with clinical symptoms including tachypnea, nasal flaring, grunting, retractions (subcostal, intercostal, supracostal, jugular), cyanosis, apnea, bradypnea, irregular breathing, inspiratory stridor, wheeze and hypoxia, etc.
**Measure:** Number of neonatus with neonatal respiratory distress
**Time Frame:** Within the first 28 days after delivery
**Description:** Number of neonatus with venous glucose levels \<2.6mmol/L.
**Measure:** Number of neonatus with hypoglycemia
**Time Frame:** Within the first 48 hours after delivery
**Description:** Jaundice that arises from factors that alter the usual process involved in bilirubin metabolism in the liver that requires treatment.
**Measure:** Number of neonatus with pathologic jaundice
**Time Frame:** Within the first 28 days after delivery
**Description:** Intraventricular hemorrhage (IVH) of II grade or above diagnosed by ultrasound.
**Measure:** Number of neonatus with intraventricular hemorrhage (IVH) of II grade or above
**Time Frame:** Within the first 28 days after delivery
**Description:** Necrotizing enterocolitis (NEC) diagnosed by radiography or surgery.
**Measure:** Number of neonatus with necrotizing enterocolitis (NEC)
**Time Frame:** Within the first 28 days after delivery
**Description:** Number of neonatus managed with assisted ventilation \>24 hours via endotracheal tube.
**Measure:** Number of neonatus managed with assisted ventilation >24 hours via endotracheal tube.
**Time Frame:** Within 72 hours of birth
**Description:** Number of neonatus with septicemia ascertained by blood culture.
**Measure:** Number of neonatus with sepsis.
**Time Frame:** Within the first 28 days after delivery
**Description:** The incidence of deaths among live births during the first 28 completed days of life.
**Measure:** The incidence of neonatal death.
**Time Frame:** Within the first 28 days after delivery
**Description:** Maternal fasting plasma insulin level.
**Measure:** The level of maternal fasting plasma insulin
**Time Frame:** at 24-28 gestational weeks
**Description:** Maternal venous glycosylated hemoglobin A1c (HbA1c) level.
**Measure:** The level of maternal HbA1c
**Time Frame:** at 24-28 gestational weeks
**Description:** Insulin resistance calculated by homeostatic model assessment (HOMA-IR). HOMA-IR=fasting plasma glucose (FPG)× fasting plasma insulin (FINS)/22.5. The higher HOMA-IR value indicates higher severity of insulin resistance.
**Measure:** Insulin resistance calculated by homeostatic model assessment (HOMA-IR)
**Time Frame:** at 24-28 gestational weeks
**Description:** Level of maternal venous low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and total cholesterol.
**Measure:** Maternal lipid profile
**Time Frame:** at 24-28 gestational weeks
**Description:** Maternal change in depression, quality of sleep and quality of life measured by the Patient Health Questionnaire-9 (PHQ-9), Pittsburgh sleep quality index (PSQI) and 12-item Short-Form Health Survey Questionnaire (SF-12) according to pre-pregnancy status and 24-28 gestational weeks.
The Patient Health Questionnaire-9 (PHQ-9): Scores range from 0 to 27, with higher scores indicating severer depression. The standard cut-off score for screening to identify possible major depression is 10 or above.
Pittsburgh sleep quality index (PSQI): Scores range from 0 to 21, with higher scores indicating worse sleep quality.
12-item Short-Form Health Survey Questionnaire (SF-12): physical component score (PCS) range from 0 to 100, higher scores are better.
**Measure:** Maternal change in depression, quality of sleep and quality of life
**Time Frame:** From pre-pregnancy to 24-28 gestational weeks
**Description:** Measured according to pre-pregnancy weight and weight at 24-28 gestational weeks.
**Measure:** Gestational weight gain
**Time Frame:** From pre-pregnancy to 24-28 gestational weeks
**Description:** Measured according to pre-pregnancy waist circumference and waist circumference at 24-28 gestational weeks.
**Measure:** Change in waist circumference
**Time Frame:** From pre-pregnancy to 24-28 gestational weeks
**Description:** Incidence of hypertensive disorders of pregnancy, hydramnios, placental abruption, preterm/prelabor rupture of membranes (P/PROM), preterm birth, chorioamnionitis, postpartum hemorrhage and still birth.
**Measure:** Incidence of maternal morbidities
**Time Frame:** From 24-28 gestational weeks to delivery
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
1. Aged 18-50 years;
2. The risk for GDM includes overweight or obesity (BMI ≥ 24 kg/m2 before pregnancy), first-degree relative with diabetes, history of cardiovascular disease, hypertension (≥130/80 mmHg or on therapy for hypertension), HDL cholesterol level \< 1 mmol/L and/or a triglyceride level \> 2.8 mmol/L, history of GDM, history of macrosomia delivery, individuals with polycystic ovary syndrome, repeated positive fasting urine glucose in the first trimester, or age\>45 years according to Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022);
3. Less than 14 weeks of gestation;
4. Able to read and complete questionnaires in Chinese;
5. singleton pregnancy.
Exclusion criteria:
1. Pregestational diabetes (including diabetes diagnosed before conception; fasting blood glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester; typical symptoms of hyperglycemia or hyperglycemic crisis with optional blood glucose ≥ 11.1 mmol/L);
2. Impaired glucose tolerance (including fasting blood glucose ≥ 5.6 mmol/L or two fasting blood glucose ≥ 5.1 mmol/L in the first trimester);
3. Current or recent use of drugs that affect glucose metabolism such as metformin, glucocorticoids and Orlistat;
4. Severe comorbidities (including cardiac diseases, kidney diseases, hepatopathy, autoimmune diseases, uncontrolled thyroid disease, previous or current malignant tumors, etc.);
5. Fetal malformations or chromosomal abnormalities;
6. Cervical insufficiency (including ultrasonic cervical length \< 25 mm before 24 weeks of gestation, history of spontaneous preterm birth at 14-36 weeks of previous pregnancy, or cervical dilation in the past or current pregnancy);
7. Exercise contraindications (including continuous vaginal bleeding, threatened premature labor, placenta previa, premature rupture of membranes, severe anemia, etc.);
8. Drug abuse, which refers to the repetitive, heavy use of drugs with dependent characteristics such as narcotic, psychotropic substances, tobacco and alcohol;
9. Hyperemesis gravidarum, which refers to the severe and persistent nausea and vomiting, unable to eat or eat little that leads to dehydration, ketosis and even acidosis;
10. On a special or prescribed diet for other reasons;
11. Eating window\<10 h.
Exit criteria：
1. Failure to comply with or assume the corresponding responsibilities and obligations of the informed agreement;
2. Pregnant women who terminate their pregnancy before completing GDM diagnosis and screening at 24-28 weeks of pregnancy will automatically withdraw from the group, such as severe fetal malformation, eclampsia, abortion, etc.
3. Major diseases, such as particularly serious obstetric medical events, malignant tumors, serious cardiovascular and cerebrovascular diseases, brain injuries, paralysis and other major diseases, can not continue to accept this intervention plan and follow-up, and withdraw from the study;
4. Accidental disability or death caused by non-intervention factors occurred during the study period, and he withdrew from the study;
5. Subjects are subjectively unwilling to continue to accept the intervention program, and sign the withdrawal agreement to withdraw from the group on a voluntary basis, and decide whether to continue to follow up the pregnancy process and outcome according to the specific contents of the withdrawal statement.
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ying Zhao, PhD
**Phone:** 13061860396
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- 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: M19012
- Name: Diabetes, Gestational
- Relevance: HIGH
- As Found: Gestational Diabetes Mellitus
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: 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: M14127
- Name: Pregnancy Complications
- 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: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016640
- Term: Diabetes, Gestational
- ID: D000003920
- Term: Diabetes Mellitus
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431984
**Acronym:** PSK
**Brief Title:** Pharmacology Space Kit (PSK) - Dried Blood Spot for Caffeine Pharmacokinetics Under Microgravity Conditions
**Official Title:** Kit de Pharmacologie Spatial - Analyse de l'Utilisation Des Dried Blood Spot Pour le Dosage de la caféine Chez Des Volontaires Sains en microgravité au Cours Des Vols Paraboliques
#### Organization Study ID Info
**ID:** C22-80
#### Organization
**Class:** OTHER_GOV
**Full Name:** Institut National de la Santé Et de la Recherche Médicale, France
#### Secondary ID Infos
**Domain:** IDRCB
**ID:** 2022-A02794-39
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2024-04-03
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-03
**Type:** ACTUAL
#### Start Date
**Date:** 2023-03-27
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Institut National de la Santé Et de la Recherche Médicale, France
#### 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 PSK study is preliminary to the study of drug metabolism in space flight conditions. The investigators propose to use simplified blood sampling methods that can be applied in microgravity. This method is based on the use of capillary blood, obtained using an automatic lancet for diabetics, the blood droplet then being deposited on specific blotting paper, and then studied in the laboratory. In 2022, the investigators validated the transfer of artificial blood in parabolic flight conditions, as well as the validity of cardiovascular drug dosage.
The objective of the 2023 study is to validate the collection and transfer of capillary blood, on themselves, by healthy volunteers with little training, for the blood dosage of caffeine after intake of standard doses of alimentary caffeine.
The primary objective is a feasibility of 90% of sampling in microgravity, compared with 95% on ground. Secondary objectives are the pharmacokinetic of different forms of caffeine, according to genetic background and other modifiers of CYP1A2.
**Detailed Description:** The investigators propose to use simplified blood sampling methods that can be applied in microgravity. This method is based on the use of capillary blood, obtained using an automatic lancet for diabetics, the blood droplet then being deposited on specific blotting paper, and then studied in the laboratory.
The objective of the study is to validate the collection and transfer of capillary blood from finger prick test, performed on themselves, by healthy volunteers after a short training, for the blood dosage of caffeine. Dietary caffeine will be used, issued from standardized espresso, tea or dark chocolate.
Caffeine is a universally used food substance and is metabolised by a pathway common to many drugs (CYP 1A2). The aim is to show that it is possible to collect blood in this way, and to carry out assays of caffeine. Secondary objectives are to assess the kinetics of caffeine metabolism through the metabolic ratio (AUC paraxanthine/AUC caffeine), and to correlate these kinetics with genetic variations in CYP 1A2 activity.
Participants are healthy volunteers already selected to take part in the parabolic flight campaign.
A success rate of 95% for ground sampling, and 90% for in-flight sampling is assumed as satisfactory. If 5 volunteer participants during the 3 days of flying carry out 2 in-flight samplings, this results in 30 in-flight samplings. If the other 25 flying volunteers take only one in-flight sample, means 25 in-flight samples (total 55). On the ground, the 30 volunteers will take 90 samples, for a total of 145 minimum samples. An equivalence threshold for a maximum 20% difference between flight and ground conditions is considered. For a difference of 10, 15 and 20%, the power is 34, 79 and 97% respectively. It can therefore conclude that the difference between the two sampling conditions is not clinically significant.
### Conditions Module
**Conditions:**
- Drug Mechanism
- Metabolism Medication Toxicity
- Space Motion Sickness
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants are healthy volunteers selected by the investigating team. The size of the study is limited by the number of individuals authorised to board the aircraft.
The flying participants in the experiment will be the aircraft crew, i.e. volunteers from the research teams taking part in the parabolic flight.
Healthy volunteers over the age of majority will be included in the study.
**Intervention Names:**
- Diagnostic Test: prick test
**Label:** Healthy subjects
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy subjects
**Description:** self-sampling of capillary blood using the finger prick test method
**Name:** prick test
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** A blood transfer is considered as successful IF the 3 following criteria are fulfilled
1. Blood spot covering \> 8 mm2 (3 mm punch circle)
2. Obtaining a drop of blood within the allotted time of 22 sec of microgravity
3. The drop is neither smeared nor smashed on the blotting paper
**Measure:** Percentage of valid capillary blood deposit on dry support
**Time Frame:** through study completion, an average of 3 days
#### Secondary Outcomes
**Description:** Identification of self-sampling failure factors
* Deposition time in flight \> 22 seconds of weightlessness
* Blood stain covering 80% or more of the reference circle: diameter of the stain taken by photography
**Measure:** Identification of factors leading to self-sampling failure a. Time too short b. Insufficient drop c. Inadequate transfer
**Time Frame:** through study completion, an average of 1 year
**Description:** Area under the curve of caffeine and paraxanthine, metabolic ratio (para/caffeine)
**Measure:** Caffeine kinetic under different formulations and dosages
**Time Frame:** through study completion, an average of 3 days
**Description:** Area under the curve of caffeine and paraxanthine, metabolic ratio (para/caffeine)
**Measure:** Caffeine kinetic under different CYP1A2 genotypes
**Time Frame:** through study completion, an average of 3 days
**Description:** Area under the curve of caffeine and paraxanthine, metabolic ratio (para/caffeine)
**Measure:** Caffeine kinetic under different gravity conditions
**Time Frame:** through study completion, an average of 3 days
**Description:** A paper questionnaire will be handed out just after the parabolic flight at the time of the last sampling. It will be made up of closed questions based on 3 dimensions of satisfaction:
* The quality of the information given by the investigating team on the capillary blood sampling process in order to improve our paper-based operating procedure.
* Their physical and psychological well-being during the finger prick test demonstration phase before the flight, during the flight and at the end of the flight campaign to ensure that the participants felt comfortable and confident in the sampling situation.
* Assessment of their performance during the study in flight and on the ground, and whether they would be interested in self-sampling for a future space mission.
**Measure:** Acceptability
**Time Frame:** through study completion, an average of 1 year
**Description:** Area under the curve of caffeine and paraxanthin, metabolic ratio (para/caffeine) at 6 months interval
* Visual appearance (degradation, colour change, etc.)
* Comparison of relative areas obtained during the study with those obtained in a conventional laboratory situation
**Measure:** Stability of dry blood spots
**Time Frame:** through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Be affiliated to a social security scheme or benefit from such a scheme.
* Have obtained a medical certificate stating that they are fit for parabolic flights.
* Be aged between 18 and 70
* Be in good health: no chronic treatment that could interact with the metabolism of caffeine, no progressive disease
* Must not have any contraindications to taking caffeine (30 to 100 mg). Volunteers will also be asked not to consume caffeine (coffee, chocolate, energy drinks, tea, cola, etc.) in the 24 hours preceding the experiment.
Exclusion Criteria:
* Be the subject of a legal protection measure (safeguard of justice, curatorship or guardianship)
* suffer from haematophobia (irrational fear of blood)
* Have a current infectious disease, particularly viral
* Have an active chronic illness
* Have a high usual intake of caffeine (\>4 espressos, \>4 cups of tea, \>100g dark chocolate per day)
* Total intolerance to all forms of caffeine
* Smoke more than 20 cigarettes a day
* Have weaned themselves off smoking for less than a month
* Have a history of severe Raynaud's phenomenon
* Have a history of naupathy
* Suffering from naupathy during a flight
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Mérignac
**Country:** France
**Facility:** AIRBUS A 310 - Zero-G
**Zip:** 33700
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M12002
- Name: Motion Sickness
- Relevance: HIGH
- As Found: Motion Sickness
- ID: M20593
- Name: Space Motion Sickness
- Relevance: HIGH
- As Found: Space Motion Sickness
- ID: M8219
- Name: Exanthema
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009041
- Term: Motion Sickness
- ID: D000018489
- Term: Space Motion Sickness
### Intervention Browse Module - Browse Branches
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M5373
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
- ID: T370
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431971
**Brief Title:** Estimates of the Short-term Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease
**Official Title:** Estimates of the Short-term Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease: A Randomized, Placebo-controlled, Double-blinded, Parallel 2-arm, Multi-centre Pilot Trial
#### Organization Study ID Info
**ID:** LIBRA (TLN/PD/2)
#### Organization
**Class:** INDUSTRY
**Full Name:** InnoMedica Schweiz AG
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** InnoMedica Schweiz AG
#### 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 is double-blinded placebo controlled to estimate the short-term efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 18 times intravenously as an add-on therapy to the standard of care Parkinson medication.
Talineuren is a liposomal formulation containing GM1 (monosialotetrahexosylganglioside) as the pharmacological active substance.
The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.
**Detailed Description:** The ganglioside lipid GM1 (monosialotetrahexosylganglioside) has attracted attention in scientific literature as a promising neuroprotective agent. Research suggests that GM1 ganglioside holds promise not only in the treatment of neurodegenerative disorders like Parkinson disease (PD) and Alzheimer's disease but also in promoting nerve regeneration post-injury. Furthermore, investigations into its potential to improve cognitive function and memory underscore its versatility as a therapeutic agent. Numerous clinical studies have demonstrated its therapeutic potential in treating (PD) patients.
Talineuren (TLN) represents a novel approach to harnessing the therapeutic benefits of GM1. TLN is a liposomal formulation, comprising GM1 as its pharmacologically active ingredient, which is expected to cross the blood-brain barrier more efficiently as free GM1 and therefore is able to deliver more GM1 to the brain. This innovative composition is designed to optimize the neuroprotective effects of GM1.
Study Description:
This study is designed as a double-blinded, placebo-controlled trial to evaluate the short-term efficacy of TLN in PD management. The investigational Medicinal Product (IMP), TLN, is weekly intravenously administered 18 times as an add-on therapy alongside patients' current standard-of-care PD medication. Talineuren, encapsulating GM1 within liposomes, is anticipated to facilitate enhanced delivery and bioavailability of the neuroprotective agent, GM1.
Objectives:
The primary objective is to obtain statistical estimates of change from baseline and variance for TLN and placebo and to compare these between groups for MDS-UPDRS part III score in the "off" medication state (i.e. Levodopa challenge test (LCT); motor symptoms evaluated by physician).
Secondary objectives are to obtain the change from baseline and variance of TLN and placebo and compare these between the groups for :
* MDS-UPDRS total score (part I + part II + part III "off" + part IV)
* MDS-UPDRS part I (non-motor symptoms in daily life)
* MDS-UPDRS part II (motor symptoms in daily life)
* MDS-UPDRS part III "on medication"
* MDS-UPDRS total part IV (motor complications)
* Proportion of patients meeting or exceeding the minimum clinically important difference (MCID) in motor and non-motor symptoms (MDS-UPDRS) and quality of life (PDQ-39) over time
* Quality of life (PDQ-39)
* Mental condition (MoCA)
* Parkinson medication (LEDD)
Research objectives (biomarkers):
-Assessment of literature-described biomarkers (prognostic, predictive, monitoring and/or response biomarkers) pre- and post-TLN or placebo intervention.
Through evaluation and statistical analysis, this study seeks to elucidate the therapeutic potential of TLN in addressing the multifaceted challenges of Parkinson's disease. By providing insights into treatment efficacy, medication usage, symptom management, and quality of life improvements, our findings aim to inform future advancements in PD management and enhance patient care.
The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.
### Conditions Module
**Conditions:**
- Parkinson Disease
### 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:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receive standard of care PD treatment + 720 mg of Talineuren i.v. weekly for 18 infusions (18 weeks).
**Intervention Names:**
- Drug: Talineuren
**Label:** Talineuren
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants receive standard of care PD treatment + placebo (0.9% NaCl) i.v. weekly for 18 infusions (18 weeks).
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Talineuren
**Description:** Talineuren infusion weekly
**Name:** Talineuren
**Other Names:**
- TLN
- Liposomal GM1
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo infusion weekly
**Name:** Placebo
**Other Names:**
- 0.9% NaCl
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Incidence and severity of treatment-emergent AEs (TEAEs) from the start of the treatment until the safety visit (week 22) using CTCAE criteria (V5.0).
**Measure:** Number of IMP-related adverse events
**Time Frame:** From the date of the first administration until week 22
**Description:** Collecting of information for a subsequent larger phase II trial. The following information will be assessed:
* Acceptance proportion: the proportion of patients willing to participate in this trial
* Drop-out proportion \& reason: the proportion of enrolled subjects who pre-maturely discontinue the trial. The reason for the discontinuation shall be recorded, if possible, so to be able to identify any potential issues in the design and procedures of the trial that can be improved for the subsequent trial.
* Failure proportion of IMP-administration: Proportion of visits that need to be rescheduled because no vein for IMP-administration is found.
**Measure:** Proportion of feasibility parameters
**Time Frame:** Up to week 22
**Description:** -To detect and assess the presence of blood-derived biomarkers selected from literature at baseline and end of intervention, and to compare the obtained values in between treatment groups
**Measure:** Mean values of Biomarkers
**Time Frame:** Baseline, week 19
#### Primary Outcomes
**Description:** The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used by the patient and physician to evaluate various symptoms of Parkinson disease including non-motor and motor experiences of daily living and motor complications.
The MDS-UPDRS Scale consists of 4 parts:
* Part 1 (Nonmotor aspects of experiences of daily living) with 13 items.
* Part 2 (Motor aspects of experiences of daily living) with 13 items.
* Part 3 (Motor examination) with 18 items.
* Part 4 (Motor complications) with 6 items.
Each item is rated with 0=normal, 1=slight, 2=mild, 3=moderate, 4=severe. The lower the score, the fewer / less severe the symptoms.
**Measure:** Movement Disorder Society Unified Parkinson's Disease Rating Scale score
**Time Frame:** Baseline, week 7, 11, 15, 19 and 22
#### Secondary Outcomes
**Description:** Parkinson disease Quality of Life Questionnaire (PDQ-39) will be completed by the patient. The proportion of patients reaching or exceeding the minimal clinical important difference (MCID) will be assessed.
This questionnaire consists of 39 items in 8 dimensions with 0 = perfect health, 100 = worse health.
**Measure:** Parkinson disease Quality of Life Questionnaire score
**Time Frame:** Baseline, week 19
**Description:** Patient's mental condition is assessed using the Montreal Cognitive Assessment (MoCA) by the physician together with the patient where the patient can reach a score of 0-30. A final total score of 26 and above is considered normal.
**Measure:** Montreal Cognitive Assessment score
**Time Frame:** baseline, week 19
**Description:** Levodopa equivalent daily dose (LEDD) in \[mg\] will documented at each study visit.
**Measure:** Change in Levodopa equivalent daily dose
**Time Frame:** Through study completion, an average of 22 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Informed consent as documented by signature.
2. Male and female subjects, aged 30 to 85 years.
3. Confirmed PD according to British brain bank criteria.
4. Hoehn and Yahr Stage 0 - 2.5 on medication.
5. Stable dopaminergic PD treatment (including DBS) for a month at least.
6. Absence of dementia confirmed by cognitive testing (MoCA ≥24).
Exclusion Criteria:
1. Previous treatment with Talineuren (i.e. participants from NEON trial are not allowed)
2. Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational products.
3. Women who are pregnant or breast feeding, or planning to become pregnant during the course of the trial or in the 12 weeks following the trial.
4. Lack of safe contraception, defined as:
* Female participants of childbearing potential, not willing to use double method of contraception (hormonal and mechanical) for the entire study duration.
Note: Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
* Male participants, not using and not willing to use a medically reliable method of contraception for the entire study duration, such as condoms or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
5. Other clinically significant concomitant diseases states (e.g., renal failure, hepatic dysfunction, cardiovascular disease etc.) that is are not under stable control.
6. Known or suspected non-compliance, drug or alcohol abuse.
7. Inability to follow the procedures of the trial, e.g., due to language problems, psychological disorders etc. of the participant.
8. Participation in another trial with an investigational drug within the 30 days preceding and during the present trial.
9. Enrolment of the investigator, his/her family members, employees and other dependent persons.
10. Subject has an atypical parkinsonian syndrome or secondary parkinsonism.
11. Patients with comorbidity that may interfere with the course of the trial.
12. Patients who are not considered to be eligible to participate in clinical trial by the investigator.
13. Patients in adjustment of deep brain stimulation (DBS) parameters
14. Patients with known impaired granulopoiesis
**Maximum Age:** 85 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Konolfingen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michael Schüpbach, Dr. med.
- **Phone:** +41 31 790 01 30
- **Role:** CONTACT
***Contact 2:***
- **Name:** Michael Schüpbach, Dr. med
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Switzerland
**Facility:** Neurologisches Institut Konolfingen
**Zip:** 3510
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431958
**Acronym:** DDBIOS
**Brief Title:** Droplet Digital PCR and PCR-free BIOSensors for the Detection of Resistance-associated SNPs in Pneumocystis Jirovecii
**Official Title:** Droplet Digital PCR and PCR-free BIOSensors for the Detection of Resistance-associated SNPs in Pneumocystis Jirovecii
#### Organization Study ID Info
**ID:** 29BRC24.0085 - DDBIOS
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Brest
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Brest
#### 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 main objective of the proposed research is to identify Pneumocystis jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase (DHPS), dihydrofolate reductase (DHFR), cytochrome b (CYB), inosine-5'-monophosphate dehydrogenase (IMPDH) and therefore to assess the prevalence of potentially resistant strains in patients infected with P. jirovecii.
**Detailed Description:** Pneumocystis jirovecii (P. jirovecii) is an opportunistic pathogenic fungus responsible for pulmonary infection or Pneumocystis pneumonia (PCP) in immunocompromised patients. There is currently no system for its in vitro culture. The diagnostic methods used are mainly based on molecular biology techniques which also allow the detection and analysis of single nucleotide polymorphisms (SNPs), particularly at the level of genes coding for the targets of molecules widely used in the prevention and treatment of PCP. These SNPs may represent missense mutations potentially associated with treatment resistance. They may result from exposure of patients to these treatments before the development of P. jirovecii infection. However, data concerning the prevalence of these mutations remains scarce, particularly in France. Methods for detecting these mutations based on PCR followed by DNA sequencing have limitations in terms of sensitivity. The evaluation of new, more sensitive and rapid tools for the detection and characterization of pathogens in this context is necessary.
The main objective of the proposed research is to identify P. jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase (DHPS), dihydrofolate reductase (DHFR), cytochrome b (CYB), inosine-5'-monophosphate dehydrogenase (IMPDH) and therefore to assess the prevalence of potentially resistant strains in patients infected with P. jirovecii.
The secondary objectives are:
* to determine the factors associated (e.g. exposure to treatments) with mutant P. jirovecii strains
* to determine the impact of mutations on the effectiveness of anti-Pneumocystis treatment (e.g. favorable vs. unfavorable evolution of the infection)
* to evaluate two methods - digital droplet PCR and biosensors without PCR - for the detection and characterization of mutations associated with resistance in Pneumocystis jirovecii
### Conditions Module
**Conditions:**
- Pneumocystis Pneumonia
**Keywords:**
- Pneumocystis jirovecii
- mutant
- anti-microbial resistance
- DHPS
- DHFR
- Cytochrome b
- IMPDH
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Other Outcomes
**Measure:** to determine the impact of mutations on the effectiveness of anti-Pneumocystis treatment (e.g. favorable vs. unfavorable evolution of the infection)
**Time Frame:** 1 month and 3 month
**Measure:** to evaluate two methods - digital droplet PCR and biosensors without PCR - for the detection and characterization of mutations associated with resistance in Pneumocystis jirovecii
**Time Frame:** at inclusion
#### Primary Outcomes
**Description:** Four genes encoding therapeutic targets such as dihydropteroate synthase (DHPS), dihydrofolate reductase (DHFR), cytochrome b (CYB), inosine-5'-monophosphate dehydrogenase (IMPDH) will be amplified and sequenced to detect single nucleotide polymorphisms (Single Nucleotide Polymorphism, SNP), in particular those potentially linked to resistance to anti-Pneumocystis treatments.
**Measure:** Presence of specific strains of Pneumocystis jirovecii potentially resistant to treatments in patients infected with this fungus
**Time Frame:** at inclusion
#### Secondary Outcomes
**Measure:** to determine the factors associated (e.g. exposure to treatments) with P. jirovecii mutant strains
**Time Frame:** at inclusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients in whom P. jirovecii was detected in a pulmonary sample (bronchoalveolar lavage, sputum, bronchial aspiration, oropharyngeal rinse, nasopharyngeal sample)
* No opposition
* Patient affiliated to a social security system
Exclusion Criteria:
* Patients under legal protection (guardianship, curatorship)
* Refusal to participate
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients in whom P. jirovecii was detected in a pulmonary sample (bronchoalveolar lavage, sputum, bronchial aspiration, oropharyngeal rinse, nasopharyngeal sample) can be included in the study
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gilles NEVEZ
**Phone:** 0298345091
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Solène LE GAL
**Phone:** 0298345094
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Brest
**Country:** France
**Facility:** Chu Brest
**Zip:** 29609
### IPD Sharing Statement Module
**Access Criteria:** Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
**Description:** All collected data that underlie results in a publication
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** Data will be available beginning three years and ending fifteen years following the final study report completion
### References Module
#### References
**Citation:** Hoffmann CV, Nevez G, Moal MC, Quinio D, Le Nan N, Papon N, Bouchara JP, Le Meur Y, Le Gal S. Selection of Pneumocystis jirovecii Inosine 5'-Monophosphate Dehydrogenase Mutants in Solid Organ Transplant Recipients: Implication of Mycophenolic Acid. J Fungi (Basel). 2021 Oct 10;7(10):849. doi: 10.3390/jof7100849.
**PMID:** 34682270
**Citation:** Argy N, Le Gal S, Coppee R, Song Z, Vindrios W, Massias L, Kao WC, Hunte C, Yazdanpanah Y, Lucet JC, Houze S, Clain J, Nevez G. Pneumocystis Cytochrome b Mutants Associated With Atovaquone Prophylaxis Failure as the Cause of Pneumocystis Infection Outbreak Among Heart Transplant Recipients. Clin Infect Dis. 2018 Aug 31;67(6):913-919. doi: 10.1093/cid/ciy154. Erratum In: Clin Infect Dis. 2019 Jan 1;68(1):175.
**PMID:** 29514207
**Citation:** Bonnet PL, Hoffmann CV, Le Nan N, Bellamy L, Hoarau G, Flori P, Demar M, Argy N, Morio F, Le Gal S, Nevez G. Atovaquone exposure and Pneumocystis jirovecii cytochrome b mutations: French data and review of the literature. Med Mycol. 2023 Sep 4;61(9):myad095. doi: 10.1093/mmy/myad095.
**PMID:** 37656874
**Citation:** de la Horra C, Friaza V, Morilla R, Delgado J, Medrano FJ, Miller RF, de Armas Y, Calderon EJ. Update on Dihydropteroate Synthase (DHPS) Mutations in Pneumocystis jirovecii. J Fungi (Basel). 2021 Oct 13;7(10):856. doi: 10.3390/jof7100856.
**PMID:** 34682277
**Citation:** Nahimana A, Rabodonirina M, Bille J, Francioli P, Hauser PM. Mutations of Pneumocystis jirovecii dihydrofolate reductase associated with failure of prophylaxis. Antimicrob Agents Chemother. 2004 Nov;48(11):4301-5. doi: 10.1128/AAC.48.11.4301-4305.2004.
**PMID:** 15504856
**Citation:** Kojabad AA, Farzanehpour M, Galeh HEG, Dorostkar R, Jafarpour A, Bolandian M, Nodooshan MM. Droplet digital PCR of viral DNA/RNA, current progress, challenges, and future perspectives. J Med Virol. 2021 Jul;93(7):4182-4197. doi: 10.1002/jmv.26846. Epub 2021 Mar 11. Erratum In: J Med Virol. 2024 May;96(5):e29632.
**PMID:** 33538349
**Citation:** Pla L, Avino A, Eritja R, Ruiz-Gaitan A, Peman J, Friaza V, Calderon EJ, Aznar E, Martinez-Manez R, Santiago-Felipe S. Triplex Hybridization-Based Nanosystem for the Rapid Screening of Pneumocystis Pneumonia in Clinical Samples. J Fungi (Basel). 2020 Nov 17;6(4):292. doi: 10.3390/jof6040292.
**PMID:** 33213011
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008172
- Term: Lung Diseases, Fungal
- ID: D000009181
- Term: Mycoses
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000016720
- Term: Pneumocystis Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- 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: M13910
- Name: Pneumonia, Pneumocystis
- Relevance: HIGH
- As Found: Pneumocystis
- ID: M13904
- Name: Pneumonia
- 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: M14978
- Name: Respiratory Tract Infections
- 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: M11169
- Name: Lung Diseases, Fungal
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- 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: M19082
- Name: Pneumocystis Infections
- Relevance: LOW
- As Found: Unknown
- ID: T4598
- Name: Pneumocystis Jirovecii Pneumonia
- Relevance: HIGH
- As Found: Pneumocystis
- ID: T4599
- Name: Pneumocystosis
- Relevance: HIGH
- As Found: Pneumocystis
### Condition Browse Module - Meshes
- ID: D000011020
- Term: Pneumonia, Pneumocystis
### 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: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431945
**Acronym:** EDVIP
**Brief Title:** Early Detection of HCV in Injection Drug Users
**Official Title:** Early Detection of Hepatitis C in Injection Drug Users
#### Organization Study ID Info
**ID:** UZIS 2023/1
#### Organization
**Class:** OTHER_GOV
**Full Name:** Institute of Health Information and Statistics of the Czech Republic
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Institute for Clinical and Experimental Medicine
**Class:** OTHER
**Name:** Brno University Hospital
**Class:** OTHER
**Name:** České Budějovice Hospital
**Class:** OTHER
**Name:** University Hospital Hradec Kralove
**Class:** OTHER
**Name:** University Hospital Olomouc
**Class:** UNKNOWN
**Name:** Hepatogastroenterology Hradec Kralove
**Class:** UNKNOWN
**Name:** Regional Hospital Karlovy Vary
**Class:** UNKNOWN
**Name:** Clinic Podane ruce
**Class:** UNKNOWN
**Name:** Tomáš Baťa Regional Hospital in Zlín
**Class:** UNKNOWN
**Name:** Hospital Agel Prostějov
**Class:** UNKNOWN
**Name:** Hospital Jihlava
**Class:** UNKNOWN
**Name:** Hospital Havířov
**Class:** UNKNOWN
**Name:** Hospital Tábor
**Class:** UNKNOWN
**Name:** Remedis Prague
**Class:** UNKNOWN
**Name:** Hospital Opava
**Class:** OTHER
**Name:** Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
**Class:** OTHER
**Name:** Military University Hospital, Prague
**Class:** UNKNOWN
**Name:** Hospital Pardubice
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Institute of Health Information and Statistics of the Czech Republic
#### 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 project is a national, prospective, multicenter, non-interventional pilot project of screening HCV in PWID in the Czech Republic.
The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Hepatitis C and setting up and testing new methods and implementation into the system of social health care.
**Detailed Description:** The project is a national, prospective, multicenter, non-interventional pilot project of screening HCV in PWID in 18 clinical centers in the Czech Republic.
The main goal of the project is the elimination of further transmission of hepatitis C virus and to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Hepatitis C and setting up and testing new methods and implementation into the system of social health care.
The project will include testing the procedure on a sample of approx. 3,000 PWID which can help to identify weak points in the continuum of care. A methodology for the continuous care of the target group in the early diagnostic and therapeutic stages will be created. Proposal for a system change towards streamlining the screening process.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0000281.
### Conditions Module
**Conditions:**
- Hepatitis C Virus Infection
**Keywords:**
- HCV
- PWID
- Point of care testing
- Hepatitis
- Czech Republic
- HCV genotype
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 3000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Months
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Hepatitis C antibody (anti-HCV) test
- Diagnostic Test: Hepatitis C RNA test and genotype test
**Label:** People who inject drugs
### Interventions
#### Intervention 1
**Arm Group Labels:**
- People who inject drugs
**Description:** Testing for hepatitis C antibodies determines whether or not you have been exposed to HCV at some point in your life. This testing will be performed in all 3,000 persons who inject drugs enrolled in the project.
**Name:** Hepatitis C antibody (anti-HCV) test
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- People who inject drugs
**Description:** RNA is a type of genetic material from HCV that can be detected in the blood. This test will be used as a confirmation of the infection. This testing will be performed in all persons with positive antibody test who will come to clinical center.
**Name:** Hepatitis C RNA test and genotype test
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Measure:** Incidence of the hepatitis C virus in screened cohort of persons who inject drugs
**Time Frame:** Until 31. 12. 2025
#### Secondary Outcomes
**Measure:** Up to 3,000 persons who inject drugs (PWID) enrolled in the project
**Time Frame:** Until 31. 12. 2025
**Measure:** Optimal methodological settings for early detection of the Hepatitis C virus based on hepatitis C antibody and hepatitis C RNA testing
**Time Frame:** Until 31. 12. 2025
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age 18+
* an active injecting drug user or have used injecting drugs at any time in the past
Exclusion Criteria:
* not agreeing to participate in the project
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Any people who inject drugs with age 18+ tested by cetres participating in the project.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nikola Stourac
**Phone:** +42073901254
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Lucie Mandelova, PhD
**Phone:** +420 770190 828
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Brno
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Petr Husa, Prof.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Petr Husa, Prof.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Brno University Hospital
**Status:** RECRUITING
**Location 2:**
**City:** Brno
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Viktor Mravčík, Assoc. Prof.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Marek Bezděk, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Clinic Podane ruce
**Status:** RECRUITING
**Location 3:**
**City:** Havířov
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ivo Mifek, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ivo Mifek, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Hospital Havířov
**Status:** RECRUITING
**Location 4:**
**City:** Hradec Králové
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Miroslava Volfova, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Miroslava Volfova, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Hepatogastroenterology Hradec Kralove
**Status:** RECRUITING
**Location 5:**
**City:** Hradec Králové
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jaroslav Kapla, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jaroslav Kapla, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** University Hospital Hradec Kralove
**Status:** RECRUITING
**Location 6:**
**City:** Jihlava
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Josef Škárek, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Romana Kumštarová, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Hospital Jihlava
**Status:** RECRUITING
**Location 7:**
**City:** Karlovy Vary
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kateřina Záleská, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Kateřina Záleská, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Regional Hospital Karlovy Vary
**Status:** RECRUITING
**Location 8:**
**City:** Olomouc
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Květoslava Aiglová, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Květoslava Aiglová, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** University Hospital Olomouc
**Status:** RECRUITING
**Location 9:**
**City:** Opava
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Petr Kümpel, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Petr Kümpel, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Hospital Opava
**Status:** RECRUITING
**Location 10:**
**City:** Pardubice
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Šárka Kropáčková, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Šárka Kropáčková, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Hospital Pardubice
**Status:** RECRUITING
**Location 11:**
**City:** Prague
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Soňa Fraňková, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Soňa Fraňková, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Institute for Clinical and Experimental Medicine
**Status:** RECRUITING
**Location 12:**
**City:** Praha
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Petr Urbánek, Prof.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Petr Urbánek, Prof.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Military University Hospital, Prague
**Status:** RECRUITING
**Location 13:**
**City:** Praha
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Vratislav Řehák, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Vratislav Řehák, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Remedis Prague
**Status:** RECRUITING
**Location 14:**
**City:** Prostějov
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zdeněk Prokeš, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Zdeněk Prokeš, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Hospital Agel Prostějov
**Status:** RECRUITING
**Location 15:**
**City:** Tábor
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jana Sysová, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jana Sysová, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Hospital Tábor
**Status:** RECRUITING
**Location 16:**
**City:** Zlín
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ivan Macek, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ivan Macek, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Tomáš Baťa Regional Hospital in Zlín
**Status:** RECRUITING
**Location 17:**
**City:** Ústí Nad Labem
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pavel Dlouhý, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Pavel Dlouhý, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
**Status:** RECRUITING
**Location 18:**
**City:** České Budějovice
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Aleš Chrdle, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Aleš Chrdle, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** České Budějovice Hospital
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Charles University First Faculty of Medicine
**Name:** Viktor Mravcik, assoc. prof.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: D000004769
- Term: Enterovirus Infections
- ID: D000010850
- Term: Picornaviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000086982
- Term: Blood-Borne Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000018178
- Term: Flaviviridae Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M1557
- Name: Drug Misuse
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- 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: M9592
- Name: Hepatitis A
- Relevance: HIGH
- As Found: Hepatitis
- ID: M9611
- Name: Hepatitis C
- Relevance: HIGH
- As Found: Hepatitis C
- ID: M9591
- Name: Hepatitis
- Relevance: HIGH
- As Found: Hepatitis
- 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: M7930
- Name: Enterovirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M13745
- Name: Picornaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M2593
- Name: Blood-Borne Infections
- Relevance: LOW
- As Found: Unknown
- ID: M20324
- Name: Flaviviridae Infections
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006506
- Term: Hepatitis A
- ID: D000006526
- Term: Hepatitis C
- ID: D000006505
- Term: Hepatitis
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: HIGH
- As Found: Given
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M20971
- Name: Hepatitis C Antibodies
- Relevance: HIGH
- As Found: Paraaortic
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000906
- Term: Antibodies
- ID: D000018937
- Term: Hepatitis C Antibodies
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431932
**Brief Title:** Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity
**Official Title:** Pharmacokinetics, Safety, and Efficacy of Fisetin - A Phase I and Pilot Phase IIa Study
#### Organization Study ID Info
**ID:** Fisetin
#### Organization
**Class:** OTHER
**Full Name:** Hvidovre University Hospital
#### Secondary ID Infos
**ID:** 2023-506284-34-00
**Type:** CTIS
### Status Module
#### Completion Date
**Date:** 2034-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Southern Denmark
**Class:** OTHER
**Name:** Mayo Clinic
#### Lead Sponsor
**Class:** OTHER
**Name:** Ove Andersen
#### Responsible Party
**Investigator Affiliation:** Hvidovre University Hospital
**Investigator Full Name:** Ove Andersen
**Investigator Title:** Head of Research, Clinical Professor, Principal Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The accumulation of senescent cells with age is a central mechanism that contributes to the development of chronic diseases, primarily by driving systemic chronic inflammation. Senolytic compounds such as fisetin can selectively target senescent cells for elimination and reduce multiple age-related pathologies in animal models.
We will conduct a clinical trial in healthy volunteers and older patients with multiple chronic diseases. The participants will receive fisetin or placebo for two days, after which they will be examined at regular intervals for up to three months. We will investigate how fisetin is absorbed and metabolized by the body, and whether fisetin is safe. We will also identify methods to best measure the effect of fisetin on chronic inflammation, senescent cells, and general health.
**Detailed Description:** The goal of this pilot trial is to conduct a controlled clinical study to gather data on the pharmacokinetic profile of fisetin and its metabolites and on the safety and tolerability of fisetin in healthy volunteers as well as in older medical patients. Furthermore, we aim to identify potential outcome measures and perform sample size calculations for these outcomes, with the intent to conduct a larger scale effect study, at later date, given the result from this pilot study suggests that this would be feasible and safe.
The trial consists of:
* a single-arm open-label study, in which healthy volunteers (n=20) will receive fisetin corresponding to 20 mg/kg/day for two consecutive days.
* a 2-arm triple-blind randomized placebo-controlled study, in which older medical patients (n=40) will receive either:
* 20 mg/kg/day fisetin for two consecutive days, or
* placebo for two consecutive days.
Each of the studies (open-label study and randomized placebo-controlled study) consists of three sub-studies:
* Sub-study I aims to investigate the pharmacokinetic properties of fisetin and its main metabolites following oral administration at a dose of 20 mg/kg/day in healthy volunteers and in older medical patients.
* Sub-study II aims to assess the safety and tolerability of oral treatment with fisetin at a dose of 20 mg/kg/day fisetin for two consecutive days in healthy volunteers and in older medical patients.
* Sub-study III aims to gather representative measurements to assess the utility of inflammation, SASP, senescence, senolysis, and aging biomarkers, as well as measures of frailty, clinical parameters, physical and cognitive function, and quality of life as potential outcomes in future clinical trials; additionally, to perform sample size calculations for future trials based on these data.
### Conditions Module
**Conditions:**
- Multimorbidity
- Healthy
**Keywords:**
- Senolytic
- Pharmacokinetics
- Chronic inflammation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The trial consists of:
* a single-arm open-label study, in which healthy volunteers (n=20) will receive fisetin corresponding to 20 mg/kg/day for two consecutive days.
* a 2-arm triple-blind randomized placebo-controlled study, in which older patients with multimorbidity (n=40) will receive either:
* 20 mg/kg/day fisetin for two consecutive days, or
* placebo for two consecutive days.
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Healthy volunteers will receive fisetin.
**Intervention Names:**
- Drug: Fisetin
**Label:** Single-arm open-label study in healthy volunteers
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Older patients with multimorbidity will receive fisetin.
**Intervention Names:**
- Drug: Fisetin
**Label:** RCT - Treatment group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Older patients with multimorbidity will receive placebo.
**Intervention Names:**
- Drug: Placebo
**Label:** RCT - Placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- RCT - Treatment group
- Single-arm open-label study in healthy volunteers
**Description:** Subjects will receive fisetin corresponding to 20 mg/kg/day for two consecutive days.
**Name:** Fisetin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- RCT - Placebo group
**Description:** Subjects will receive a corresponding number of placebo capsules for two consecutive days.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To develop a population-based pharmacokinetic (popPK) model for fisetin and its main metabolites in healthy volunteers and older patients, covariates such as body weight, body composition, age, and CYP inducers/inhibitors will be tested for influence on interindividual variability.
**Measure:** Population-based pharmacokinetic model for fisetin and metabolites
**Time Frame:** 24 hours
**Description:** Number of participants to experience adverse events
**Measure:** Adverse events
**Time Frame:** Day 1 to 3
**Description:** The change in plasma levels of suPAR and a sample size calculation based on these data.
**Measure:** suPAR
**Time Frame:** Day 1 to 29
#### Secondary Outcomes
**Description:** Changes in any of the measured biomarkers and the relationship between the pharmacokinetics and pharmacodynamics of fisetin will be investigated using population PKPD modeling.
**Measure:** Population-based PKPD model for fisetin
**Time Frame:** 24 hours
**Description:** Urinary levels of fisetin and its main metabolites
**Measure:** Renal excretion of fisetin and its main metabolites
**Time Frame:** 24 hours
**Description:** Number of participants to experience symptoms and clinically significant changes in vital signs (i.e., blood pressure, pulse).
**Measure:** Symptoms and adverse events
**Time Frame:** Day 1 to 3
**Description:** The change in plasma levels of SASP factors and inflammation markers (e.g., cytokines, chemokines, proteases, growth factors).
**Measure:** SASP factors and inflammation markers
**Time Frame:** Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
**Description:** The change in expression levels of senescence markers (e.g., p16INK4a, p21CIP1/WAF1, SA-B-gal) in immune cells and tissue biopsies (skin and adipose tissue).
**Measure:** Senescence
**Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 8, 15, 29, 84.
**Description:** The change in expression levels of senolysis markers (e.g., leukotriene B4, dihomo-15d-PGJ2 (oxylipin or 1a,1b-dihomo-15-deoxy-D12,14-prostaglandin J2), and 15-Deoxy-delta 12, 14-prostaglandin J2).
**Measure:** Senolysis
**Time Frame:** Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 84.
**Description:** The change in plasma levels of aging markers (e.g., α-klotho, fibroblast growth factor 21).
**Measure:** Aging markers
**Time Frame:** Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
**Description:** The change in levels of routine biochemistry markers (e.g., alanine aminotransferase, albumin, alkaline phosphatase, bilirubin, blood urea nitrogen, coagulation factors II, VII and X and International Normalized Ratio, CRP, creatinine, hemoglobin, lactate dehydrogenase, mean corpuscular hemoglobin concentration, mean corpuscular volume, neutrophils, potassium, sodium, thrombocytes, white blood cell count, cholesterol (total, low-density lipoproteins, high-density lipoproteins), triglycerides, and hemoglobin A1c).
**Measure:** Clinical markers
**Time Frame:** Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
**Description:** The change in frailty status calculated as Frailty Index OutREF (FI-OutRef).
**Measure:** Frailty Index OutRef
**Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
**Description:** The change in frailty status calculated using a modified version of Fried frailty criteria.
**Measure:** Frailty Index
**Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
**Description:** The change in physical function (e.g., gait speed, hand grip strength, chair stand test, balance).
**Measure:** Physical function
**Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
**Description:** The change in cognitive function assessed using the MoCA score (0-30 with higher scores representing better cognitive function).
**Measure:** Cognitive function (Montreal Cogntive Assessment)
**Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
**Description:** The change in cognitive function assessed using the Digit Symbol Substitution Test (number of correct symbols).
**Measure:** Cognitive function (Digit Symbol Substitution Test)
**Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
**Description:** The change in quality of life assessed using the EuroQol-5D-5L (index value and VAS scale 0-100; with higher scores representing better quality of life).
**Measure:** Quality of life
**Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
**Description:** The change in self-rated health (score 1-5; 1:"excellent", 2:"very good", 3:"good", 4:"fair", or 5:"bad").
**Measure:** Self-rated health
**Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
### Eligibility Module
**Eligibility Criteria:** Healthy volunteers:
Inclusion Criteria:
* Aged 20-35 years
* suPAR levels \<3.5 ng/mL (± 15% corresponding to assay variation)
* Able to cooperate cognitively
* Able to read and understand Danish
* Women of childbearing potential must use effective contraception
Exclusion Criteria:
* Body weight \>100 kg
* Inability to swallow pills
* Pregnant and/or lactating
* Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
* Presence of any condition that the investigator believes would put the subject at risk or would preclude the participant from successfully completing all aspects of the trial
* Presence of known chronic diagnosis
* Active acute illness
* Prescribed medication, except contraceptives
* Previous cancer diagnosis or treatment
* Use of senolytic and other "anti-aging" supplements
Older patients with multimorbidity:
Inclusion Criteria:
At screening #1 during hospital admission:
* Acutely hospitalized medical patient
* Age ≥65 years
* suPAR \>5 ng/mL (± 15% corresponding to assay variation)
* Multimorbidity (≥2 chronic diagnoses)
* Able to cooperate cognitively
* Able to read and understand Danish
At screening #2 28 days after hospital discharge:
* suPAR \>5 ng/mL (± 15% corresponding to assay variation)
Exclusion Criteria:
At screening #1 during hospital admission:
* Body weight \>100 kg
* Inability to swallow pills
* Known human immunodeficiency virus infection, active hepatitis B or C infection, invasive fungal infection
* Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites
* New/active invasive cancer except non-melanoma skin cancers
* Active cancer treatment or disseminated cancer
* Known condition associated with major immunodeficiency
* Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
* Use of senolytic and other "anti-aging" supplements
At screening #2 28 days after hospital discharge:
* Body weight \>100 kg
* CRP \>30 mg/L (± 15% corresponding to assay variation)
* Inability to swallow pills
* Presence of any condition, or abnormal routine biochemistry test, that the investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial
* Unstable (as per clinical judgment) major disorders, e.g., cardiovascular, renal, endocrine, immunological, hepatic disorder, or cancer
* Estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 or as per clinical judgment (e.g., risk of acute kidney injury)
* Human immunodeficiency virus infection, known active hepatitis B or C infection, invasive fungal infection
* Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites
* New/active invasive cancer except non-melanoma skin cancers
* Active cancer treatment or disseminated cancer
* Known condition associated with major immunodeficiency
* Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
* Subjects taking strong inhibitors or inducers of CYP3A4 or as per clinical judgment
* Subjects taking specified substrates with a narrow therapeutic range for CYP3A4 or as per clinical judgment
* Subjects taking specified inhibitors, inducers, or substrates of CYP2D6, CYP2C9, or CYP2C8, or as per clinical judgment
* Subjects regularly using drug classes or specific medications or as per clinical judgment
* Use of senolytic and other "anti-aging" supplements
**Healthy Volunteers:** True
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Juliette Tavenier
**Phone:** +4538620640
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Line Jee Hartmann Rasmussen
**Phone:** +4538620640
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Copenhagen University Hospital, Amager and Hvidovre
**Name:** Juliette Tavenier
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Copenhagen University Hospital, Amager and Hvidovre
**Name:** Line Jee Hartmann Rasmussen
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Copenhagen University Hospital, Amager and Hvidovre
**Name:** Morten B Houlind
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** Copenhagen University Hospital, Amager and Hvidovre
**Name:** Ove Andersen
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Only aggregated data can be available for other researchers due to Danish Data Protection Law.
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Fl
- Name: Flavonoid
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T28
- Name: Fisetin
- Relevance: HIGH
- As Found: Stage III Non-Small Cell Lung Cancer
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431919
**Acronym:** CIRROSTAT
**Brief Title:** Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial
**Official Title:** Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial
#### Organization Study ID Info
**ID:** PGI/HEP/000214
#### Organization
**Class:** OTHER
**Full Name:** Post Graduate Institute of Medical Education and Research, Chandigarh
### Status Module
#### Completion Date
**Date:** 2027-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Indian Council of Medical Research
#### Lead Sponsor
**Class:** OTHER
**Name:** Post Graduate Institute of Medical Education and Research, Chandigarh
#### Responsible Party
**Investigator Affiliation:** Post Graduate Institute of Medical Education and Research, Chandigarh
**Investigator Full Name:** Madhumita Premkumar
**Investigator Title:** ASSOCIATE PROFESSOR
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.
Rationale:
Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 30-70% of patients, is characterized by structural and functional abnormalities in the heart, and is associated with progression of cirrhosis, impaired quality of life and poor survival. Statins play a crucial role in reducing proatherogenic LDL cholesterol levels, making them a cornerstone in managing diabetes and cardiovascular diseases (CVDs) with the aim of decreasing or reversing atherosclerosis. This trial aims to evaluate the impact and safety of simvastatin in cirrhotic cardiomyopathy.
Novelty: Simvastatin might be of special value in diastolic dysfunction through its hemodynamic and functional effects on LV remodeling and improve portal hemodynamics through the pleotropic effects of lipophilic statins.
Objectives:
The primary objective is to assess the combined effects of carvedilol and simvastatin in managing CCM vs carvedilol alone for a composite outcome to prevent decompensation and reduce all-cause mortality. We will comprehensively evaluate cardiac function, decompensation events and survival based on impact of simvastatin over the standard betablocker carvedilol.
Methods:
This is double-blinded randomized placebo-controlled trial involving patients diagnosed with CCM. Clinical data, including cardiac imaging, cardiac biomarkers, and survival outcomes, will be assessed for either group.
Expected Outcome:
We anticipate that the synergistic use of simvastatin and carvedilol will effectively reduce portal pressure, improve portal haemodynamic, and enhance cardiac remodelling. Successful reversal of LVDD can potentially prevent clinical events such as ascites, encephalopathy, and acute kidney injury (AKI).
**Detailed Description:** Cirrhotic cardiomyopathy (CCM) in chronic liver disease is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease(1, 6). Cirrhosis induces systemic inflammation, and oxidative stress leading to cardiac structural remodeling, including fibrosis, hypertrophy, and chamber dilation. CCM is associated with risk of LVDD which further lead to hepatorenal syndrome (HRS)(7), septic shock. (8) and peri transplant cardiac complications.(9) Autonomic dysfunction, and neurohormonal imbalances, cardiac arrhythmias, overt heart failure are common features of CCM in advanced liver disease. Efforts to ameliorate the abnormalities associated with CCM are crucial and necessitate a significant evidence-based therapeutic intervention. We have tested the use of carvedilol in this population and found that it causes an improvement in survival.
CCM can be managed by reducing preload (though nitrates), and by ameliorating neurohormonal activation. Lowering the heart rate to 55-65 beats per minute (bpm), as done with β-blockers, is likely to help by improving myocardial oxygen demand and coronary perfusion time with independent effects on portal hypertension, and heart failure(10, 11) β-blockers may reduce myocardial contractility and patients with cirrhosis have low tolerance to β-blocker dosages required to achieve a THR of 55-65 bpm. Ivabradine is useful in a subset with baseline tachycardia but does not offer survival benefit over carvedilol alone. Therefore, there is a great need to evaluate other agents that can achieve improvement in CCM related complications in cirrhosis.
* Furthermore, β-blockers might diminish myocardial contractility, and patients with cirrhosis may struggle to tolerate β-blocker doses necessary for attaining a target heart rate (THR) of 55-65 bpm. Hence, there's a critical necessity to assess alternative agents capable of ameliorating complications associated with cirrhotic cardiomyopathy (CCM).
* Early interventions to avert cardiovascular morbidity will prove to be cost effective in managing outcome, as they avert high cost of managing the public health burden of all-cause mortality in cirrhosis.
* Cardiovascular complications stand as the primary cause of mortality post-liver transplantation (LT), underscoring the need for thorough evaluation before LT.
* This study will systematically screen participants for coronary artery disease as an integral part of its screening process.
* Statins, particularly simvastatin, exert a favorable impact on vascular reactivity especially in cirrhosis. Simvastatin increases the production of nitric oxide(NO), leading to increased hepatic blood flow and reduced sinusoidal resistance, particularly upon short-term exposure. resistance (8).
* Kaplan et al showed extended exposure to simvastatin (1 month regimen, comprising 20 mg/day for the initial 15 days followed by 40 mg/day for the subsequent 15 days) resulted in a significant decrease in hepatic venous portal pressure as compared to control placebo. Additionally, this prolonged regimen exhibited improvements in hepatocyte metabolic function.(9).
* Simvastatin has an acceptable adverse event profile in decompensated Child B patients (10, 11). There is no high-quality evidence specifically evaluating the role of simvastatin in cirrhotic cardiomyopathy, although there are data to suggest its efficacy in portal hypertension. The proposed project covers an area of overlap between cardiovascular and liver disease outcomes, which reflect as decompensation events, worsening in liver severity scores and all-cause mortality.
### Conditions Module
**Conditions:**
- Decompensated Cirrhosis
- Cirrhotic Cardiomyopathy
- Cirrhosis, Liver
- Left Ventricular Diastolic Dysfunction
- Acute Kidney Injury
**Keywords:**
- Decompensated Cirrhosis
- Cirrhotic Cardiomyopathy
- Left ventricular diastolic dysfunction
- Acute kidney injury
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Double-blind randomized controlled trial
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 260
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * Simvastatin fixed dose of 20 mg per day
* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate
* Standard Medical Therapy
**Intervention Names:**
- Drug: Simvastatin 20mg
- Drug: Carvedilol 3.125 mg
**Label:** Experimental: Simvastatin + Carvedilol-arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** * Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate
* Standard Medical Therapy
**Intervention Names:**
- Drug: Carvedilol 3.125 mg
**Label:** Active Comparator: Carvedilol arm
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental: Simvastatin + Carvedilol-arm
**Description:** Simvastatin fixed dose of 20 mg per day
**Name:** Simvastatin 20mg
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Active Comparator: Carvedilol arm
- Experimental: Simvastatin + Carvedilol-arm
**Description:** Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate
**Name:** Carvedilol 3.125 mg
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome measure is defined as a composite end point of acute decompensation event (acute variceal bleeding, new ascites or recurrence of previously controlled ascites, episode of hepatic encephalopathy or acute kidney injury) OR all-cause death in patients with cirrhosis and cirrhotic cardiomyopathy
**Measure:** Time to acute decompensation event
**Time Frame:** 1 Year
#### Secondary Outcomes
**Measure:** All-cause Mortality
**Time Frame:** From enrollment until 1 year of follow up
**Measure:** New decompensation event
**Time Frame:** 1 Year
**Measure:** Improvement in CCM parameters (left ventricular diastolic function) in either arm based on Echocardiography and Cardiac Imaging
**Time Frame:** 1 Year
**Measure:** Episodes warranting hospitalization
**Time Frame:** 1 Year
**Description:** ELISA or autoanalyzer will be performed for qunatification
**Measure:** Serum level of BNP and other cardiac and inflammatory biomarkers
**Time Frame:** 1 Year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age range of 18-65 years
* Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,
* CCM (with EF\>50%) on 2D echocardiography with TDI
* Written informed consent.
Exclusion Criteria:
* Age \>65 years
* Serum Creatinine\>2 mg/dl
* Patient previously treated with statin (one month before the study)
* Contraindications to statins
* Advanced Cirrhosis (CTP score\>9)
* Coronary artery disease
* Sick sinus syndrome/ Pacemaker, valvular heart disease
* Cardiac rhythm disorder, Peripartum cardiomyopathy
* Portopulmonary hypertension/ hepatopulmonary syndrome
* Transjugular intrahepatic portosystemic shunt (TIPS) insertion
* Hepatocellular carcinoma
* Pregnancy or lactation
* Patients with HIV or retroviral therapy
* Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males
* Acute variceal bleeding in last 6 months.
* Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.)
**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:** Dr Madhumita Premkumar, DM
**Phone:** 7087003409
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** PGIMER
**Name:** Dr Madhumita Premkumar, DM
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000007674
- Term: Kidney Diseases
- 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: D000018754
- Term: Ventricular Dysfunction
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11107
- Name: Liver Diseases
- Relevance: HIGH
- As Found: Liver Disease
- ID: M28998
- Name: Acute Kidney Injury
- Relevance: HIGH
- As Found: Acute Kidney Injury
- ID: M12154
- Name: Cardiomyopathies
- Relevance: HIGH
- As Found: Cardiomyopathy
- ID: M11103
- Name: Liver Cirrhosis
- Relevance: HIGH
- As Found: Cirrhosis
- ID: M20591
- Name: Ventricular Dysfunction, Left
- Relevance: HIGH
- As Found: Left Ventricular Diastolic Dysfunction
- ID: M20824
- Name: Ventricular Dysfunction
- Relevance: LOW
- As Found: Unknown
- ID: M8485
- Name: Fibrosis
- Relevance: HIGH
- As Found: Cirrhosis
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M10698
- Name: Kidney Diseases
- 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: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
- ID: D000008103
- Term: Liver Cirrhosis
- ID: D000058186
- Term: Acute Kidney Injury
- ID: D000009202
- Term: Cardiomyopathies
- ID: D000018487
- Term: Ventricular Dysfunction, Left
- ID: D000005355
- Term: Fibrosis
### Intervention Browse Module - Ancestors
- ID: D000000924
- Term: Anticholesteremic Agents
- ID: D000000960
- Term: Hypolipidemic Agents
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000057847
- Term: Lipid Regulating Agents
- ID: D000019161
- Term: Hydroxymethylglutaryl-CoA Reductase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000000319
- Term: Adrenergic beta-Antagonists
- ID: D000018674
- Term: Adrenergic Antagonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000959
- Term: Antihypertensive Agents
- ID: D000000975
- Term: Antioxidants
- ID: D000020011
- Term: Protective Agents
- ID: D000002121
- Term: Calcium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000077264
- Term: Calcium-Regulating Hormones and Agents
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000058668
- Term: Adrenergic alpha-1 Receptor Antagonists
- ID: D000000317
- Term: Adrenergic alpha-Antagonists
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnAg
- Name: Antihypertensive Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Lipd
- Name: Lipid Regulating Agents
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M1718
- Name: Carvedilol
- Relevance: HIGH
- As Found: Package
- ID: M21713
- Name: Simvastatin
- Relevance: HIGH
- As Found: Analgesia
- ID: M4243
- Name: Anticholesteremic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4278
- Name: Hypolipidemic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M28883
- Name: Lipid Regulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21155
- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M3671
- Name: Adrenergic beta-Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- 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: M4277
- Name: Antihypertensive Agents
- 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: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5384
- Name: Calcium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M29194
- Name: Adrenergic alpha-1 Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M3669
- Name: Adrenergic alpha-Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077261
- Term: Carvedilol
- ID: D000019821
- Term: Simvastatin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431906
**Acronym:** FENTRA
**Brief Title:** Transdermal Fentanyl as a Form of Rebound Pain Reduction in Fast Track Programme in Primary Knee Arthroplasty.
**Official Title:** TRANSDERMAL FENTANYL AS A FORM OF REBOUND PAIN REDUCTION IN FAST TRACK PROGRAMME IN PRIMARY KNEE ARTHROPLASTY. Prospective Observational Non-inferiority Study Versus Morphine PCA.
#### Organization Study ID Info
**ID:** FEN
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitario La Fe
### Status Module
#### Completion Date
**Date:** 2026-03-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Oscar Diaz-Cambronero
#### Responsible Party
**Investigator Affiliation:** Hospital Universitario La Fe
**Investigator Full Name:** Oscar Diaz-Cambronero
**Investigator Title:** MÉDICO ADJUNTO ANESTESIOLOGÍA
**Type:** SPONSOR_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:** Total knee arthroplasty is a common surgery in routine clinical practice that, although it achieves an improvement in the functionality and quality of life of patients, it causes intense postoperative pain. In this regard, locoregional block techniques are commonly used for the immediate postoperative period. However, these techniques have the disadvantage of being of limited duration and the appearance of so-called "rebound pain" when their effect wears off. To counteract this problem and maintain adequate analgesic control over a longer period of time, the use of a transdermal fentanyl patch seems to be a good option, with advantages over the traditional approach of placing a morphine PCA.
Specifically, the aims of the study are: the evaluation of the decrease in the rate of rebound pain after locoregional techniques using a transdermal fentanyl patch after primary knee arthroplasty, as well as the evaluation of non-inferiority in terms of functional recovery, analgesic efficacy and adverse effects compared to morphine PCA.
Methods: This will be a prospective observational cohort study, with a total N of 106 patients undergoing total knee arthroplasty who meet the study inclusion criteria. The numerical pain rating scale score will be collected at 6,8,12,24 and 26h from which the "rebound pain score" will be calculated. The need for pharmacological rescue will be assessed as well as the appearance of adverse effects at 12, 24 and 36h and finally the QoR15 scale will be assessed at 36h.
**Detailed Description:** Total knee arthroplasty (TKA from now on) is a frequent surgery in routine clinical practice in constant evolution and improvement, with the objective being the earliest possible functional recovery of these patients, the role of the anaesthesiologist being fundamental in this sense throughout the perioperative period since, as we know, it is a surgery that improves the mobility and quality of life of the patient, but causes intense postoperative pain during the first 24 to 72 hours, it is a surgery that improves the patient's mobility and quality of life, but causes intense postoperative pain during the first 24 to 72 hours, a very important factor to take into account in these patients since it is known that adequate postoperative pain control promotes ambulation and the possibility of physiotherapy for the patient, This leads to an early recovery, a lower rate of complications (such as deep vein thrombosis or nosocomial infection) and a shorter hospital stay, allowing the strategy known as "fast-track" to be carried out, which would consist of achieving functional recovery and discharge as early as possible, this being the current trend in management by most trauma teams dedicated to this field, since it results in a decrease in morbidity and greater patient satisfaction. In relation to this approach, as has been mentioned, multiple studies have shown that one of the main causes of delayed hospital discharge is poor pain control and mobilisation problems.
Therefore, adequate postoperative pain control will be important in this surgery. This control could be achieved with a combination of locoregional techniques such as peripheral nerve blocks of the adductor canal (BCA) and the so-called "Infiltration between the Popliteal Artery and the Capsule of the Knee" (IPACK) together with conventional analgesia such as NSAIDs, paracetamol, metamizole and, if this is not sufficient, opioids.
The locoregional techniques mentioned (BCA + IPACK) have demonstrated their efficacy in controlling immediate postoperative pain in this type of surgery in multiple studies. The first of these, BCA, provides analgesia in the anteromedial area of the knee, avoiding the femoral nerve block with the consequent weakness of the quadriceps. The second of these, IPACK, is a relatively novel technique described to achieve analgesia in the posterior capsule of the knee that is achieved by blocking the popliteal plexus formed by the articular sensory branches of the tibial and obturator nerves arranged around the popliteal artery and vein without involving the motor branches of the tibial and peroneal nerves, avoiding the motor block resulting from performing a block of the sciatic nerve at the popliteal level.
From all of the above, we can deduce that both techniques are effective individually, but even more so, as is logical, in combination, allowing the entire joint territory to be covered with the least possible impairment of motor function, which will be of particular relevance in terms of starting the patient's mobilisation earlier, which is definitely an advantage over traditional femoral and sciatic nerve block techniques.
However, the duration of nerve blocks is less than 24h, which is a problem, since the period of maximum incidence of postoperative pain has not yet been completed and it is possible that just at this time (12-24h after the block, when the effect of the block ends) what is known as "rebound pain" may appear, considered a possible adverse effect of peripheral nerve blocks that is becoming increasingly important, as studies dedicated to its study emerge.
There are multiple definitions of rebound pain in the literature, but objectively, we can say that it is a quantifiable difference between scores on pain scales when the block works and when it stops working. Its incidence is not well established, although some studies report that it appears in up to 40% of cases receiving some type of peripheral nerve block, although its incidence in the type of patient on whom this study is to be performed has not been specifically defined in the literature available to date. As for its characteristics, we can say that it appears suddenly at 12-24h, lasting 3-6h, described by many patients as a burning sensation that worsens at night. Logically, this will have a negative impact on the patient's recovery, and will require the use of rescue drugs, mainly intravenous opioids.
To date, the pathophysiological mechanisms by which it occurs continue to be the subject of debate. It is definitely a sum of mechanical and chemical factors (neurotoxicity of local anaesthetics, hyperactivity of nerve fibres, hyperexcitability of nociceptors, direct mechanical damage, etc.) in patients with predisposing factors (young people, women, orthopaedic surgery, pre-existing pain, etc.).
Once its existence is known, the two most important aspects will be its proper diagnosis and definition, on the one hand, and its prevention and treatment, on the other.
In terms of its detection, rebound pain will be diagnosed when a difference in pain scale scores is observed at the end of the peripheral blockade effect, which is usually 12-24 hours after it has been performed. To quantify it, most studies use serial scores on the numerical pain scale (NRS), and even the "rebound pain score" has been described, which is obtained by subtracting the lowest pain score in the first 12 hours before the end of the block action from the highest pain score in the first 12 hours after the end of the block action.
In prevention and treatment, a multifactorial approach will be essential, employing pharmacological and non-pharmacological strategies (mainly patient education). Among the pharmacological strategies, there are multiple strategies that have been shown to reduce the rate of rebound pain but among which there is no clear consensus: the use of adjuvants such as dexamethasone or alpha2-agonists, which not only prolong the duration of the block but also seem to exert a neuromodulatory effect; use of continuous infusion catheters instead of a single puncture; combination of various types of peripheral blockade or intra-articular infiltration. Another option, this one highly recommended in general, is the initiation of analgesic treatment prior to the end of the blockade effect, since once it occurs, it will be very difficult to control, making it necessary to rescue with intravenous drugs, mainly major opioids such as morphine in the form of a PCA pump, an analgesic modality that has demonstrated its effectiveness but which has a number of negative aspects such as: the need for personnel capable of handling the device and a learning process on the part of the patient; the possibility of programming and medication administration errors; an increase in economic cost; in addition to the consequent limitation of mobility derived from the connection to the PCA device or the delay in discharge due to the patient being under intravenous treatment.
However, a new possibility has emerged in the form of the transdermal fentanyl patch (TFP); a skin patch that constantly releases fentanyl into the bloodstream according to the dose applied, traditionally used in the control of chronic pain but whose efficacy has already been demonstrated in multiple types of surgery such as abdominal, urological and orthopaedic procedures such as hip and knee surgery. Fentanyl is a major opioid with 75-100 times the potency of morphine. Because it is highly lipid soluble and has a low molecular weight (337da), it is ideal for administration in this transdermal format; it also produces fewer cardiovascular effects than other opioids and has a lower risk of histamine release than morphine. Once applied, the patch has a slow onset of action with a plasma peak in about 12-15h and stable plasma concentrations thereafter for approximately 72h of duration. It has many advantages over other forms of analgesia, such as ease of administration, reduced possibility of dosing error, no need for venous access, low risk of infection and easier to obtain than devices such as the PCA pump.
The main drawback to its use as a form of postoperative analgesia lies in its slow onset of action, since, as mentioned, its plasma peak would be reached at 15h, which makes it unsuitable for acute pain control. However, if applied at the time of surgery, it could superimpose its analgesia on the end of the analgesic effect of the peripheral nerve block, thus avoiding the appearance of rebound pain or at least reducing its rate of appearance.
Therefore, several positive aspects could be derived from this alternative: convenience in its dosage, reduction of resources necessary for the adequate control and functioning of a morphine PCA and improvement in postoperative pain control, resulting in an increase in the degree of patient satisfaction and autonomy and a shorter hospital stay.
With all of the above, we propose the hypothesis that the transdermal fentanyl patch is an effective postoperative analgesic strategy in primary knee arthroplasty after the disappearance of the analgesic effect of the peripheral nerve blocks Canal of the Adductors + IPACK, achieving a decrease in the rate of "rebound pain", our main objective being therefore the following:
Main objective:
- To evaluate the decrease in the rate of rebound pain after primary knee arthroplasty with the use of transdermal fentanyl patch versus morphine PCA.
To do all this we will use objective and validated tools. For the measurement of the first objective we will use the "Rebound Pain Score", described above.
As for the secondary objectives that we propose to evaluate in this work, on the one hand, we want to focus on assessing the functional recovery of patients, for which we will use the QoR 15 scale, developed from the QoR40 (27), which has proven to be a suitable tool for measuring postoperative recovery (28); and on the other hand, to compare the two pharmacological modalities under study in terms of analgesic quality and adverse effects. Therefore, the following would be our secondary objectives:
Secondary objectives:
* To assess the non-inferiority in terms of functional recovery after primary knee arthroplasty of the transdermal fentanyl patch versus morphine PCA.
* To assess the analgesic non-inferiority in terms of postoperative analgesia after primary knee arthroplasty of the 25mcg/h transdermal fentanyl patch versus morphine PCA.
* To assess the non-inferiority in terms of incidence of adverse effects in postoperative total knee arthroplasty of 25mcg/h transdermal fentanyl patch versus morphine PCA.
### Conditions Module
**Conditions:**
- Postoperative Pain
**Keywords:**
- fentanyl
- morphine PCA
- rebound pain
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 106
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects receiving a transdermal fentanyl patch for postoperative pain control will be included here.
**Label:** transdermal fentanyl
#### Arm Group 2
**Description:** Subjects receiving a morphine PCA for postoperative pain control will be included here.
**Label:** morphine PCA
### Outcomes Module
#### Primary Outcomes
**Description:** - Rebound pain score (RPS): Defined as the result of subtracting the minimum score on the pain scale the first 12 hours before the end of action of the peripheral blockade from the maximum score on the pain scale the first 12 hours after the disappearance of the action of the peripheral blockade. To calculate this variable, the numerical pain scale score will be collected 6, 8, 12, 24 and 36 hours after the peripheral nerve block.
**Measure:** - Responders to the decrease in the rate of "rebound pain" with the use of transdermal fentanyl patch relative to morphine PCA:
**Time Frame:** 6,8,12,24 and 36hours after the lock
#### Secondary Outcomes
**Description:** Quality of post-surgical recovery using the QoR 15 scale at 48 hours
**Measure:** non-inferiority of PFT vs PCA morphine in terms of early postoperative recovery:
**Time Frame:** 48 hours in the postoperative period
**Description:** * Need for prescribed pharmacological rescue at 12 hours: Yes or no
* Need for pharmacological rescue at 24 hours: Yes or no
* Need for pharmacological rescue at 48 hours: Yes or No
**Measure:** non-inferiority of PFT vs. morphine PCA in terms of post-surgical analgesia:
**Time Frame:** 48 hours in the postoperative period
**Description:** Presence or not of the following adverse effects at 48 hours: pruritus, urinary retention/bladder catheterisation, constipation or abdominal distention, limited mobility, tremor.
**Measure:** non-inferiority of PFT vs morphine PCA in terms of adverse effects:
**Time Frame:** 48 hours in the postoperative period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All patients undergoing primary knee arthroplasty ASA I-III between 18 and 80 years of age who have received a transdermal fentanyl patch or morphine PCA as part of their postoperative analgesic strategy
Exclusion Criteria:
* Prior opioid treatment.
* History of previous opioid adverse effects.
* History of PONV.
* History of medical history that conditions baseline alteration of the data to be collected.
* Contraindication to neuroaxial techniques.
* Difficulty in understanding the scales used.
* Patient's refusal.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All patients undergoing primary knee arthroplasty ASA I-III between 18 and 80 years of age who have received a transdermal fentanyl patch or morphine PCA as part of their postoperative analgesic strategy.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Beatriz García Rivas
**Phone:** 636054510
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Sathitkarnmanee T, Tribuddharat S, Noiphitak K, Theerapongpakdee S, Pongjanyakul S, Huntula Y, Thananun M. Transdermal fentanyl patch for postoperative analgesia in total knee arthroplasty: a randomized double-blind controlled trial. J Pain Res. 2014 Aug 1;7:449-54. doi: 10.2147/JPR.S66741. eCollection 2014.
**PMID:** 25120375
**Citation:** Matsumoto S, Matsumoto K, Iida H. Transdermal fentanyl patch improves post-operative pain relief and promotes early functional recovery in patients undergoing primary total knee arthroplasty: a prospective, randomised, controlled trial. Arch Orthop Trauma Surg. 2015 Sep;135(9):1291-7. doi: 10.1007/s00402-015-2265-z. Epub 2015 Jun 26.
**PMID:** 26112273
**Citation:** Hall MJ, Dixon SM, Bracey M, MacIntyre P, Powell RJ, Toms AD. A randomized controlled trial of postoperative analgesia following total knee replacement: transdermal Fentanyl patches versus patient controlled analgesia (PCA). Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1073-9. doi: 10.1007/s00590-015-1621-6. Epub 2015 Mar 11.
**PMID:** 25753087
**Citation:** Kehlet H, Thienpont E. Fast-track knee arthroplasty -- status and future challenges. Knee. 2013 Sep;20 Suppl 1:S29-33. doi: 10.1016/S0968-0160(13)70006-1.
**PMID:** 24034592
**Citation:** Lindberg-Larsen M, Petersen PB, Corap Y, Gromov K, Jorgensen CC, Kehlet H; Centre for Fast-track Hip and Knee Replacement Collaborating Group. Fast-track revision hip arthroplasty: a multicenter cohort study on 1,345 elective aseptic major component revision hip arthroplasties. Acta Orthop. 2022 Feb 23;93:341-347. doi: 10.2340/17453674.2022.2196.
**PMID:** 35195270
**Citation:** Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
**PMID:** 29721648
**Citation:** Abdullah MA, Abu Elyazed MM, Mostafa SF. The Interspace Between Popliteal Artery and Posterior Capsule of the Knee (IPACK) Block in Knee Arthroplasty: A Prospective Randomized Trial. Pain Physician. 2022 May;25(3):E427-E433.
**PMID:** 35652772
**Citation:** Tang X, Jiang X, Lei L, Zhu W, Fu Z, Wang D, Chen J, Ning N, Zhou Z. IPACK (Interspace between the Popliteal Artery and the Capsule of the Posterior Knee) Block Combined with SACB (Single Adductor Canal Block) Versus SACB for Analgesia after Total Knee Arthroplasty. Orthop Surg. 2022 Nov;14(11):2809-2821. doi: 10.1111/os.13263. Epub 2022 Sep 20.
**PMID:** 36125191
**Citation:** Ochroch J, Qi V, Badiola I, Grosh T, Cai L, Graff V, Nelson C, Israelite C, Elkassabany NM. Analgesic efficacy of adding the IPACK block to a multimodal analgesia protocol for primary total knee arthroplasty. Reg Anesth Pain Med. 2020 Oct;45(10):799-804. doi: 10.1136/rapm-2020-101558. Epub 2020 Aug 31.
**PMID:** 32868483
**Citation:** Kampitak W, Tanavalee A, Ngarmukos S, Tantavisut S. Motor-sparing effect of iPACK (interspace between the popliteal artery and capsule of the posterior knee) block versus tibial nerve block after total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2020 Apr;45(4):267-276. doi: 10.1136/rapm-2019-100895. Epub 2020 Feb 4.
**PMID:** 32024676
**Citation:** Guo J, Hou M, Shi G, Bai N, Huo M. iPACK block (local anesthetic infiltration of the interspace between the popliteal artery and the posterior knee capsule) added to the adductor canal blocks versus the adductor canal blocks in the pain management after total knee arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2022 Aug 12;17(1):387. doi: 10.1186/s13018-022-03272-5.
**PMID:** 35962410
**Citation:** Zheng FY, Liu YB, Huang H, Xu S, Ma XJ, Liu YZ, Chu HC. The impact of IPACK combined with adductor canal block under ultrasound guidance on early motor function after total knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):110-114. doi: 10.1016/j.bjane.2021.04.012. Epub 2021 Apr 26.
**PMID:** 33915199
**Citation:** Nobre LV, Cunha GP, Sousa PCCB, Takeda A, Cunha Ferraro LH. [Peripheral nerve block and rebound pain: literature review]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):587-593. doi: 10.1016/j.bjan.2019.05.001. Epub 2019 Nov 2.
**PMID:** 31690509
**Citation:** Admassie BM, Tegegne BA, Alemu WM, Getahun AB. Magnitude and severity of rebound pain after resolution of peripheral nerve block and associated factors among patients undergoes surgery at university of gondar comprehensive specialized hospital northwest, Ethiopia, 2022. Longitudinal cross-sectional study. Ann Med Surg (Lond). 2022 Nov 18;84:104915. doi: 10.1016/j.amsu.2022.104915. eCollection 2022 Dec.
**PMID:** 36536717
**Citation:** Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.
**PMID:** 30124544
**Citation:** Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011.
**PMID:** 17543812
**Citation:** Munoz-Leyva F, Cubillos J, Chin KJ. Managing rebound pain after regional anesthesia. Korean J Anesthesiol. 2020 Oct;73(5):372-383. doi: 10.4097/kja.20436. Epub 2020 Aug 10.
**PMID:** 32773724
**Citation:** Hade AD, Okano S, Pelecanos A, Chin A. Factors associated with low levels of patient satisfaction following peripheral nerve block. Anaesth Intensive Care. 2021 Mar;49(2):125-132. doi: 10.1177/0310057X20972404. Epub 2021 Mar 30.
**PMID:** 33784851
**Citation:** Dada O, Gonzalez Zacarias A, Ongaigui C, Echeverria-Villalobos M, Kushelev M, Bergese SD, Moran K. Does Rebound Pain after Peripheral Nerve Block for Orthopedic Surgery Impact Postoperative Analgesia and Opioid Consumption? A Narrative Review. Int J Environ Res Public Health. 2019 Sep 5;16(18):3257. doi: 10.3390/ijerph16183257.
**PMID:** 31491863
**Citation:** Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.
**PMID:** 33390261
**Citation:** Fang J, Shi Y, Du F, Xue Z, Cang J, Miao C, Zhang X. The effect of perineural dexamethasone on rebound pain after ropivacaine single-injection nerve block: a randomized controlled trial. BMC Anesthesiol. 2021 Feb 12;21(1):47. doi: 10.1186/s12871-021-01267-z.
**PMID:** 33579199
**Citation:** Abrisham SM, Ghahramani R, Heiranizadeh N, Kermani-Alghoraishi M, Ayatollahi V, Pahlavanhosseini H. Reduced morphine consumption and pain severity with transdermal fentanyl patches following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Jul;22(7):1580-4. doi: 10.1007/s00167-012-2287-9. Epub 2012 Dec 2.
**PMID:** 23212185
**Citation:** van Bastelaere M, Rolly G, Abdullah NM. Postoperative analgesia and plasma levels after transdermal fentanyl for orthopedic surgery: double-blind comparison with placebo. J Clin Anesth. 1995 Feb;7(1):26-30. doi: 10.1016/0952-8180(94)00000-t.
**PMID:** 7772354
**Citation:** Minville V, Lubrano V, Bounes V, Pianezza A, Rabinowitz A, Gris C, Samii K, Fourcade O. Postoperative analgesia after total hip arthroplasty: patient-controlled analgesia versus transdermal fentanyl patch. J Clin Anesth. 2008 Jun;20(4):280-3. doi: 10.1016/j.jclinane.2007.12.013.
**PMID:** 18617126
**Citation:** Nelson L, Schwaner R. Transdermal fentanyl: pharmacology and toxicology. J Med Toxicol. 2009 Dec;5(4):230-41. doi: 10.1007/BF03178274.
**PMID:** 19876859
**Citation:** Grond S, Radbruch L, Lehmann KA. Clinical pharmacokinetics of transdermal opioids: focus on transdermal fentanyl. Clin Pharmacokinet. 2000 Jan;38(1):59-89. doi: 10.2165/00003088-200038010-00004.
**PMID:** 10668859
**Citation:** Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
**PMID:** 23411725
**Citation:** Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.
**PMID:** 29397134
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- 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: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Postoperative Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AdjAn
- Name: Adjuvants, Anesthesia
### Intervention Browse Module - Browse Leaves
- ID: M11982
- Name: Morphine
- Relevance: LOW
- As Found: Unknown
- ID: M8418
- Name: Fentanyl
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431893
**Acronym:** ENSEMBLE
**Brief Title:** A Phase 3 Long-term Extension Study to Assess the Long-term Safety and Efficacy of Pegtibatinase Treatment in Participants ≥12 to ≤65 Years of Age With Classical Homocystinuria (HCU)
**Official Title:** An Open-Label, Phase 3 Long-Term Extension (LTE) Study To Assess The Safety, Tolerability, And Efficacy Of Treatment With Pegtibatinase In Participants With Classical Homocystinuria (HCU) Due To Cystathionine Beta Synthase Deficiency (ENSEMBLE)
#### Organization Study ID Info
**ID:** TVTX-TVT058-302
#### Organization
**Class:** INDUSTRY
**Full Name:** Travere Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Travere Therapeutics, 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:** The goal of this long-term extension (LTE) study is to evaluate the safety and efficacy of pegtibatinase in patients with classical homocystinuria (HCU). Patients who are active in the Phase 1/2 COMPOSE study or those who complete the 24 weeks of treatment in the Phase 3 HARMONY are eligible to participate.
Participants will be in this clinical study for up to about 13 months including:
* a treatment period of up to 52 weeks
* a 4-week safety follow-up period
**Detailed Description:** Overall Design:
This is a global, multicenter, single-arm, open-label study. Participants who meet all eligibility criteria may transition from other pegtibatinase studies and enroll into this LTE study for long-term safety, efficacy, and clinical assessments of pegtibatinase treatment.
All participants will follow a protocol of self-administration of pegtibatinase unless exempted. During the ENSEMBLE study, an optional protein tolerance modification (PTM) sub-study will also be conducted for eligible participants.
### Conditions Module
**Conditions:**
- Homocystinuria
**Keywords:**
- Classical homocystinuria
- HCU
- Cystathionine Beta Synthase Deficiency
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Pegtibatinase
**Label:** pegtibatinase
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- pegtibatinase
**Description:** Full Target Dose of pegtibatinase BIW
**Name:** Pegtibatinase
**Other Names:**
- OT-58
- TVT-058
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of treatment-emergent AEs
**Measure:** Treatment-emergent AEs
**Time Frame:** Week 1 - Week 56
**Description:** Incidence of hypermethioninemia
**Measure:** Hypermethioninemia
**Time Frame:** Week 1 - Week 56
**Description:** Incidence of hypomethioninemia
**Measure:** Hypomethioninemia
**Time Frame:** Week 1 - Week 56
**Description:** Incidence of dietary protein rescue
**Measure:** Dietary Protein Rescue
**Time Frame:** Week 1 - Week 56
#### Secondary Outcomes
**Description:** Relative and absolute changes from baseline in tHcy levels
**Measure:** Total Homocysteine (tHcy) Levels
**Time Frame:** Week 1 - Week 56
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants active in the Phase 1/2 COMPOSE study or who completed the 24-week blinded period in the Phase 3 HARMONY study
Exclusion Criteria:
* Participant permanently discontinued from study intervention treatment in a previous pegtibatinase study due to serious AE (SAE) or intolerance
**Maximum Age:** 65 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Culver City
**Country:** United States
**Facility:** Travere Investigational Site - Virtual Site
**State:** California
**Zip:** 90230
#### Overall Officials
**Official 1:**
**Affiliation:** Travere Therapeutics, Inc.
**Name:** Sagar A Vaidya, MD, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020739
- Term: Brain Diseases, Metabolic, Inborn
- ID: D000001928
- Term: Brain Diseases, Metabolic
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020138
- Term: Hyperhomocysteinemia
- ID: D000000592
- Term: Amino Acid Metabolism, Inborn Errors
- ID: D000008661
- Term: Metabolism, Inborn Errors
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9774
- Name: Homocystinuria
- Relevance: HIGH
- As Found: Homocystinuria
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5205
- Name: Brain Diseases, Metabolic
- Relevance: LOW
- As Found: Unknown
- ID: M22498
- Name: Brain Diseases, Metabolic, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21974
- Name: Hyperhomocysteinemia
- Relevance: LOW
- As Found: Unknown
- ID: M11641
- Name: Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M3932
- Name: Amino Acid Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2827
- Name: Homocystinuria
- Relevance: HIGH
- As Found: Homocystinuria
- ID: T2828
- Name: Homocystinuria Due to CBS Deficiency
- Relevance: LOW
- As Found: Unknown
- ID: T3036
- Name: Inborn Amino Acid Metabolism Disorder
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006712
- Term: Homocystinuria
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431880
**Brief Title:** External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain
**Official Title:** External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain: A Randomized Non-inferiority Trial
#### Organization Study ID Info
**ID:** 36246PR638/4/24
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tanta University
#### Responsible Party
**Investigator Affiliation:** Tanta University
**Investigator Full Name:** Mohammed Said ElSharkawy
**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 this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy.
**Detailed Description:** Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.
### Conditions Module
**Conditions:**
- External Oblique Intercostal Plane Block
- Thoracic Paravertebral Block
- Post Thoracotomy Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive external oblique intercostal plane block.
**Intervention Names:**
- Other: External oblique intercostal plane block
**Label:** External oblique intercostal plane block
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will receive thoracic paravertebral block.
**Intervention Names:**
- Other: Thoracic paravertebral block
**Label:** Thoracic paravertebral block
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- External oblique intercostal plane block
**Description:** Patients will receive external oblique intercostal plane block
**Name:** External oblique intercostal plane block
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Thoracic paravertebral block
**Description:** Patients will receive thoracic paravertebral block
**Name:** Thoracic paravertebral block
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the numeric rating scale \< 4. numeric rating scale will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
**Measure:** Total morphine consumption
**Time Frame:** 24 hours postoperatively
#### Secondary Outcomes
**Description:** Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
**Measure:** Intraoperative fentanyl consumption
**Time Frame:** Intraoperative
**Description:** Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
**Measure:** Mean arterial pressure
**Time Frame:** Till the end of surgery
**Description:** Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
**Measure:** Heart rate
**Time Frame:** Till the end of surgery
**Description:** All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale \> 3 to be repeated after 30 min if pain persists until the numeric rating scale \< 4. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively
**Measure:** Time to the 1st rescue analgesia
**Time Frame:** 24 hours postoperatively
**Description:** Degree of pain will be measured using numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable").NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
**Measure:** Degree of pain
**Time Frame:** 24 hours postoperatively
**Description:** Complications such as bradycardia, hypotension, nausea, vomiting, respiratory depression, local anesthetic systemic toxicity (LAST) or any other complication will be recorded.
**Measure:** Complications
**Time Frame:** 24 hour postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open thoracotomy
Exclusion Criteria:
* Patients with neurological or intellectual disability.
* Infection at the injection site.
* Opioid addiction.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Drug abuse.
* Pregnancy.
* Severe liver and/or renal failure.
* Uncontrolled hypertension.
* Severe cardiovascular problems.
* Diabetes mellitus.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mohammed S Elsharkawy, MD
**Phone:** 00201148207870
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tanta
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mohammed S Elsharkawy, MD
- **Phone:** 00201148207870
- **Role:** CONTACT
***Contact 2:***
- **Name:** Saad A Moharam, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Ahmed E Abo ElKheir, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Egypt
**Facility:** Tanta University Hospitals
**State:** El-Gharbia Governorate, Egypt
**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
### Condition Browse Module - Ancestors
- ID: D000094665
- Term: Dissection, Blood Vessel
- ID: D000000783
- Term: Aneurysm
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000094683
- Term: Acute Aortic Syndrome
- ID: D000001018
- Term: Aortic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M4114
- Name: Aortic Dissection
- Relevance: HIGH
- As Found: Thoracic
- ID: M3081
- Name: Dissection, Blood Vessel
- Relevance: LOW
- As Found: Unknown
- ID: M4113
- Name: Aneurysm
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M3085
- Name: Acute Aortic Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M4334
- Name: Aortic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000784
- Term: Aortic Dissection
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431867
**Brief Title:** Primary Care Management of Osteoporosis in Older Women
**Official Title:** A Qualitative Exploration of Older Women and Primary Healthcare Professional Experiences to Guide Improvements in Osteoporosis Care
#### Organization Study ID Info
**ID:** BTHFT2918
#### Organization
**Class:** OTHER
**Full Name:** Bradford Institute for Health Research
#### Secondary ID Infos
**Domain:** National Institute for Health and Care Research (NIHR)
**ID:** NIHR205378
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** National Institute for Health Research, United Kingdom
#### Lead Sponsor
**Class:** OTHER
**Name:** Bradford Institute for Health Research
#### Responsible Party
**Investigator Affiliation:** Bradford Institute for Health Research
**Investigator Full Name:** Anne Heaven
**Investigator Title:** Research Programme Manager
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The Investigators aim to improve primary-care for older women with osteoporosis.
Older women they spoke with previously felt unseen, unimportant, unheard and uninformed. These women felt that bone/joint health was an important issue for women aged 70+. Osteoporosis is a disease that makes bones more breakable and can lead to significant pain, disability and death, costing approximately £4.4 billion a year in the United Kingdom.
Women are four times more likely to have osteoporosis than men and suffer fractures earlier. Osteoporosis care is poor in primary care even though good guidelines are available.
The Investigators will work with older women and healthcare professionals to help guide the research. They have already looked at published research and will build on this. They will identify what is important for both older women and professionals to inform the first interview questions. The Investigators will ask older women and healthcare professionals about the diagnosis and treatment of osteoporosis. They will also ask them how they manage osteoporosis as a patient or care provider.
At regular intervals, the Investigators will look at the interview findings first and then share their thoughts with older women and professionals. Together they will explore what the interviews mean. These discussions may change the questions asked and who is interviewed next.
The Investigators will combine all the information from interviews to identify what works well and less well in osteoporosis care. They will check these findings against the guidelines. They will continue to work with older women and healthcare professionals to develop recommendations for improving care. The Investigators will also identify areas of further work.
They will share recommendations with healthcare commissioners and produce a summary for a variety of professional networks. They will also publish papers in journals aimed at healthcare professionals and produce a summary document and advice for older women to use.
**Detailed Description:** RESEARCH QUESTION How can older women and primary healthcare professionals be empowered to improve osteoporosis care?
BACKGROUND The Women's Health Strategy for England highlights the lack of focus on older women's needs and experiences. The Investigators talked to 32 older women across five public engagement workshops. These women felt unseen, unimportant, unheard and uninformed. They also felt bone/joint health and osteoporosis were important issues for older women (aged 70+). Osteoporosis leads to around 180,000 fractures per year causing significant pain, disability and death. The related cost, in the United Kingdom, is estimated at £4.4 billion a year. Women are four times more likely to suffer with osteoporosis than men and tend to suffer fractures earlier. Despite comprehensive guidelines being available, evidence suggests that osteoporosis care is lacking in primary care.
AIMS AND OBJECTIVES To develop strategies to improve osteoporosis care using insights from the experience of primary healthcare professionals and older women.
METHODS Ethnographic meta-analysis literature review, in-depth interviews and co-production workshops. An information specialist will update the preliminary literature review. The Investigators will synthesise evidence from older women and healthcare professionals to identify new theoretical constructs. Findings will be reviewed in co-production workshops and used to focus initial lines of enquiry. The Investigators will purposively sample 30 older women, from across England, aged 70+ to interview. They will also elicit the views of healthcare professionals in primary care. Interviews will explore the process of diagnosis, treatment and management of osteoporosis. Information from interviews will initially be reviewed by the Investigators.
Following a Constructivist Grounded Theory approach, the Investigators will take initial findings to co-production workshops on a regular basis throughout fieldwork. Workshops will facilitate iterative analysis and identify theoretical sampling gaps. This process may change the types of questions asked or who is interviewed. The Investigators will combine information from all interviews to identify barriers and facilitators for older women's osteoporosis care, and cross-reference this with existing guidelines. Professional 'expert witnesses' will join the workshops when required. Finally, recommendations for improving osteoporosis care will be co-produced . Areas of further work that would improve osteoporosis care in the future will also be identified.
PATIENT AND PUBLIC INVOLVEMENT Lay members will be involved in co-production workshops throughout the research. The Investigators will also work with an expert patient co-applicant in overall management of the project.
TIMELINES FOR DELIVERY Following 3 months of pre-award set-up, the Investigators will conduct the literature review and develop the interview schedule in months 1-3. Interviews and workshops will happen in months 4-11. A final analysis and report will be available in month 18.
IMPACT AND DISSEMINATION Findings will be sent to Integrated Care Boards responsible for local commissioning to facilitate 'better fit' services. The Investigators will also produce dissemination products for wide distribution through a variety of professional networks. Academic papers will be published in journals targeted at healthcare professionals. Summary information and advice, for older women, will be disseminated via national and community networks and presentations nationwide. These outputs will be aimed at supporting successful implementation of the All Party Parliamentary Group recommendations for better diagnosis, treatment and management.
### Conditions Module
**Conditions:**
- Osteoporosis
**Keywords:**
- women
- older
- primary-care
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Women aged 70 years and older with a diagnosis of osteoporosis
**Intervention Names:**
- Other: Guidelines for primary care management of osteoporosis
**Label:** Older women
#### Arm Group 2
**Description:** Any healthcare professional working in a primary care setting e.g. general practitioner, pharmacist, physiotherapist
**Intervention Names:**
- Other: Guidelines for primary care management of osteoporosis
**Label:** Primary healthcare professionals
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Older women
- Primary healthcare professionals
**Description:** All usual care of osteoporosis in primary care
**Name:** Guidelines for primary care management of osteoporosis
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Constructivist grounded theory about how osteoporosis in older women is treated and managed in primary care
**Measure:** Questionnaire
**Time Frame:** September 2025
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
Older women:
* Osteoporosis diagnosis - either self-reported following a clinical diagnosis or taken from the patient's medical record in the case of the Community Ageing Research 75+ (CARE75+) cohort and Fracture Liaison Service (FLS) patients.
* Aged 70 years or older to align with the recommendation from our preliminary engagement work.
* Community dwelling.
Healthcare professionals:
• Working in the National Health Service (NHS) in England to align with the participant sample.
Exclusion criteria
Older women:
* Aged under 70 years.
* Lacks capacity to consent to participate in research.
* Resident in a care home - care home residents are likely to need different types of interventions than community dwelling older women as there are organisational considerations.
* Member of the co-production workshop.
Healthcare professionals:
* Not performing any NHS work.
* \< 12 months in NHS practice.
**Minimum Age:** 70 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Thirty women with a diagnosis of osteoporosis aged 70 years and older. The Investigators will purposively sample for maximum variation to ensure inclusion of people from a range of living circumstances, from a mixture of urban and rural locations and spanning the least deprived and most deprived locations (identified from Index of Multiple Deprivation (IMD) deciles based on postcode areas). Interview findings will be reviewed on a regular basis during the co-production workshops and adjusted as necessary to follow emergent leads.
Thirty healthcare professionals using a purposive sample based on gender, number of years qualified and IMD score of practice catchment.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anne Heaven, MPhil
**Phone:** +44 1274382815
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nicol Kime, PhD
**Phone:** +44 1274383441
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Bradford Institute for Health Research
**Name:** Anne Heaven, MPhil
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** All external data requests will be reviewed by the Project Management Group. Permission to access anonymised data will be subject to a data sharing agreement. Participants will be asked to explicitly consent to secondary data analysis - this will be optional.
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Organisational website
**URL:** http://ageingstrokeresearch.org/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001851
- Term: Bone Diseases, Metabolic
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12947
- Name: Osteoporosis
- Relevance: HIGH
- As Found: Osteoporosis
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431854
**Brief Title:** Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program
**Official Title:** The Efficacy, Efficiency, and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders: MINERVA
#### Organization Study ID Info
**ID:** MINERVA
#### Organization
**Class:** OTHER
**Full Name:** Fundació Sant Joan de Déu
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-12
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University Ramon Llull
#### Lead Sponsor
**Class:** OTHER
**Name:** Fundació Sant Joan de Déu
#### 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 aim of this study is to investigate the efficacy, efficiency, and patient experience of a new intervention program on adolescents with high-complexity eating disorders (ED). A prospective group of adolescents with ED (N=60) will follow this treatment program including four different phases: 1) Inpatient treatment; 2) Family Treatment Apartment; 3) Home Treatment; 4) Recovery within the community. The investigators will use a retrospective, control group (N=60) that matched the prospective group in age, sex, ED diagnosis, and severe symptomatology. Primary variables regarding Body Mass Index (BMI), ED symptomatology, functionality, recovery (yes/no), type of outpatient services (low/mid/high intensity), number of readmissions, and patient experience will be assessed at discharge, and after 6 and 12 months. Secondary variables include anxiety, depression, readiness to recover, quality of life symptoms, caregiver skills, and functionality of the family
**Detailed Description:** The goal of this single-center, longitudinal study is to test the efficacy, efficiency, and patient experience of a new intensive treatment program in adolescents with high-complex eating disorders. The main questions it aims to answer are:
* What are the efficacy, efficiency, and patient experiences (families and patients) of the new treatment program in adolescents with high-complex eating disorders?
* What are the long-term effects of efficacy and efficiency (after 6 and after 12 months) of the new treatment program in adolescents with high-complex eating disorders?
Participants will receive this new treatment program in four different phases between 16 and 20 weeks approximately.
* 1st: inpatient treatment (4 weeks): Set-up: inpatient ED unit at the hospital (without the family). Objectives: maintenance of physical stabilization; ensuring adequate food intake while preventing compensatory behaviors; addressing ED-related problems; improving nutritional administration; enhancing awareness of the disorder and motivating the patient to change.
* 2nd: family treatment apartment (2-3 weeks): Set-up: apartments where patients and their families live together that is owned by the healthcare system provider. Family treatment apartments are within a hospital context to facilitate a good transition to home treatment.
Objectives: intensifying the treatment within a hospital setting that targets the difficulties the family encounter in managing ED symptoms; intervening from a systemic perspective; involving other family members in the treatment; collaborating with the family in developing skills to cope with the disorder; working on more autonomy and improved ED decision-making; facilitating the transition from hospitalization to home; facilitate access to the hospital staff and leads to a high frequency treatment.
* 3rd: home treatment (8-9 weeks): Set-up: Patients live in their own home. Objectives: facilitating a good transition from hospitalization and family treatment apartments to home; generalize psychological skills and learnings; assisting in the progress that began in the hospital environment; providing treatment in a more family and social context; empowering families in their natural setting; promoting integration of the patient into their family, social, and school environments.
* 4th: Recovery within the community (2-4 weeks): Set-up: transferring to the patients' specialized ED reference center. Objectives: gradually reducing the intervention from MINERVA; promoting autonomy and emotional management within their family and school environment; ensuring continued care with their ED reference unit; monitoring the implemented intervention.
The current model will provide different treatment models during these phases.
* family-based treatment
* cognitive behavioural therapy
* dialectical behavioural therapy
* systemic family therapy
### Conditions Module
**Conditions:**
- Eating Disorders in Adolescence
- Anorexia Nervosa
- Bulimia Nervosa
- Binge-Eating Disorder
- Other Specified Feeding or Eating Disorder
**Keywords:**
- Eating Disorders
- Adolescence
- Inpatient treatment
- Home treatment
- Cognitive Behaviorial Therapy
- Family-Based Treatment
- Dialectical Behavioral Therapy
- Systemic Family Treatment
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** This study will compare prospective data with retrospective data of patients that followed Treatment As Usual (TAU). Treatment As Usual (TAU) involves arranging visits for external consultations, partial hospitalization, and inpatient admissions as necessary, by following clinical guidelines. The retrospective control group consists of 60 patients, matched in age, sex, Body Mass Index (BMI), and diagnosis of eating disorder (ED) with the prospective group. Subjects are identified by reviewing medical records of patients treated at the ED unit of Hospital Sant Joan de Déu before the initiation of the MINERVA program. The temporal reference is the first day of admission to acute total hospitalization. Subjects present the same criteria of poor treatment response as the prospective group, ensuring severity comparability with the prospective group. Exclusion occurs if there is ≥20% missing data.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group comprises 60 patients aged 12 to 17 diagnosed with an eating disorder. They must have shown poor response to treatment, defined as having one of the two conditions: 1) undergoing over a year of treatment, including partial and total hospitalization, without symptom stabilization (needing high-intensive treatment units i.e. not being able to follow individual treatment in external consultations); 2) having more than three admissions without symptom stabilization in less than one year. They will be recruited from child/adolescent ED units in Catalonia. Exclusions will be acute ED pathology requiring urgent pediatric attention or admission to an acute psychiatric ward.
**Intervention Names:**
- Behavioral: ED-MINERVA Program
**Label:** Patient group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patient group
**Description:** ED-MINERVA Program aims to improve ED symptoms and related difficulties of the patient and provide tools to enhance the family's management (nutritionally, emotionally, and behaviorally) in their natural environment. The treatment consists of four phases with a gradually decreasing therapeutic intensity, ranging from total hospitalization, family treatment apartment, to home treatment and subsequent linkage with specialized local facilities. The ED-MINERVA program uses various aspects of family-based treatment, cognitive behavioral therapy, dialectical behavioral therapy, and systemic family therapy.
**Name:** ED-MINERVA Program
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate the change in BMI between the beginning and the end of the intervention of the patients included in the MINERVA program. Furthermore, BMI changes of the MINERVA group will be compared with retrospective data. Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs.
**Measure:** O1: Changes in BMI (efficacy)
**Time Frame:** Up to 20 weeks
**Description:** Evaluate the changes in clinical eating symptomatology between the beginning and the end of the intervention of patients included in the MINERVA program. The Eating Disorder Inventory 3 (EDI-3) will be used to assess clinical eating symptomatology. It comprises 91 items where responses are given on a Likert scale (0-4). The subscales regarding 'drive for thinness' and 'body dissatisfaction' will be used for the main objective, where improvements in both subscales need to be detected. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs.
**Measure:** O2: Changes in clinical eating symptomatology (efficacy)
**Time Frame:** Up to 20 weeks
**Description:** Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs.
**Measure:** O3: Changes in functionality of the patient (efficacy)
**Time Frame:** Up to 20 weeks
**Description:** Evaluate the percentage of patients who do no longer meet diagnostics criteria for a primary eating disorder. Furthermore, data will be compared with retrospective data. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs.
**Measure:** O4: Changes in recovery rates (efficacy)
**Time Frame:** 6 months after treatment completion
**Description:** Determine the percentage of patients in low-intensity care settings after 6 months of completing the program (including day hospital and specific outpatient consultations). The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units or community resources.
**Measure:** O5: Percentage of patients in low-intensity care settings (efficiency)
**Time Frame:** 6 months after treatment completion
**Description:** Determine the percentage of readmissions at 6 and 12 months after completing the program. Furthermore, this data will be compared with retrospective data. The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units. Furthermore, the program will be considered more efficient than TAU if significant lower readmission percentages in O6 and O7 will be detected.
**Measure:** Percentages of readmissions (efficiency)
**Time Frame:** 6 months after treatment completion
**Description:** Determine the percentage of readmissions at 6 and 12 months after completing the program. Furthermore, this data will be compared with retrospective data. The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units. Furthermore, the program will be considered more efficient than TAU if significant lower readmission percentages in O6 and O7 will be detected.
**Measure:** Percentages of readmissions (efficiency)
**Time Frame:** 12 months after treatment completion
**Description:** Evaluate the level of satisfaction with the received intervention, adherence, and the rate of patient and family dropout (less than 20%). Patient Experience will be assessed through individual interviews with the patient and their family, and Patient-Reported Experience Measures (PREMs) surveys. PREM is a systematic online survey that assesses and describes the experience regarding healthcare services. The survey consists of Likert-scale and open-ended questions to gather narrative information that enriches qualitative data with more details and context.
**Measure:** Patient experience
**Time Frame:** Up to 20 weeks
#### Secondary Outcomes
**Description:** Evaluate changes in symptoms of anxiety between the beginning and the end of the intervention of the patients included in the MINERVA program. The State-Trait Anxiety Inventory (STAI) will be used to assess anxiety. STAI is scored on a range from 20 to 80, whereby a higher score indicates a worse outcome.
**Measure:** Changes in symptoms of anxiety
**Time Frame:** Up to 20 weeks
**Description:** Evaluate changes in symptoms of depression between the beginning and the end of the intervention of the patients included in the MINERVA program. The Beck Depression Inventory (BDI) will be used to assess depression. It consists of 21 Likert-scale items, ranging from 0 to 3, with a cutoff point of 13 or higher that indicates the presence of depressive symptoms.
**Measure:** Changes in symptoms of depression
**Time Frame:** Up to 20 weeks
**Description:** Evaluate changes in readiness to recover between the beginning and the end of the intervention of the patients included in the MINERVA program. The Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) will be used to assess motivation of recovering. It consist of 20 Likert-scale items, ranging from 1 to 5, whereby a higher score indicates a better outcome.
**Measure:** Changes in readiness to recover
**Time Frame:** Up to 20 weeks
**Description:** Assess caregiver skill changes in the families of the included patients. The Caregiver Skills (CASK) will be used to assess caregiver skills. CASK is scored on a range from 0 to 100, whereby a higher outcome indicates a better outcome.
**Measure:** Changes in caregiver skills
**Time Frame:** Up to 20 weeks
**Description:** Examine changes in the quality of life of the patients and their families. The Kidscreen-27: Quality of Life Inventory will be used to assess the quality of life. It consists of 27 Likert-scale items, ranging from 1 to 5, whereby a higher score indicates a better outcome.
**Measure:** Changes in quality of life
**Time Frame:** Up to 20 weeks
**Description:** Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome.
**Measure:** Functionality of the patient
**Time Frame:** 6 months after treatment completion
**Description:** Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome.
**Measure:** Functionality of the patient
**Time Frame:** 12 months after treatment completion
**Description:** Mental illness in parents will be assessed at the beginning and the end of the intervention. The Kiddie Schedule For Affective Disorders and Schizophrenia-Present and Lifetime 5 (K-SADS-PL-5) will be used to assess mental illness in parents. The K-SADS-PL-5 is a semi-structured diagnostic interview designed to clinically diagnose ED and identify psychiatric comorbidities. It includes an introductory interview, a screening interview, and diagnostic supplements.
**Measure:** Mental illness in parents
**Time Frame:** Up to 20 weeks
**Description:** Skills in managing eating disorders of the parents will be assessed at the beginning and the end of the intervention. The Caregiver Skills (CASK) will be used to assess caregiver skills. CASK is scored on a range from 0 to 100, whereby a higher score indicates a better outcome.
**Measure:** Parental skills in managing eating disorders
**Time Frame:** Up to 20 weeks
**Description:** The functionality and dynamics of the family will be assessed at the beginning and the end of the intervention. The SCORE-15 will be used to assess changes in functionality and dynamics. SCORE-15 is a self-administered questionnaire that consists of 15 Likert-type items (1-5) and is divided into three scales: strengths and adaptability, concerns or distress, and communication difficulties. The total score can be on a range from 15 to 75, whereby a higher score indicates a worse outcome
**Measure:** Functionality and dynamics of the family
**Time Frame:** Up to 20 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria for the prospective experimental group:
* Patient diagnosed with an Eating Disorder (according to the DSM-5) through a semi-structured interview (K-SADS PL-5)
* Aged between 12 and 17 years old
* Both patients and parents are willing to participate in the study and sign the informed consent to accept participation
* Patient with a poor response to treatment, defined as having one of the following two conditions:
1. undergoing over a year of treatment, including partial and total hospitalization, without symptom stabilization, experiencing severe psychological distress, eating symptomatology, comorbidities, or family dysfunction during this period (clinical improvement of at least 50 on the CGAS functioning scale) OR
2. undergoing more than three admissions without symptom stabilization (clinical improvement of at least 50 on the CGAS functioning scale).
Exclusion criteria for the prospective group:
* Acute ED pathology and biological decompensation that require urgent pediatric attention or admission to an acute psychiatric ward.
Inclusion criteria for the retrospective control group:
* Aged between 12 and 17 years old
* Diagnosed with an Eating Disorder (according to the DSM-5)
* Received treatment in Sant Joan de Déu between 2012 and 2022
* Patient with a poor response to treatment, defined as having one of the following two conditions:
1. undergoing over a year of treatment, including partial or total hospitalization, without achieving stabilization of ED symptomatology (needing high-intensive treatment units i.e. not being able to follow individual treatment in external consultations) OR
2. undergoing more than three admissions without symptom stabilization once referred to partial hospitalization in less than one year, including a similar psychological state and characteristics as the first condition
Exclusion criteria for the retrospective control group:
* Missingness of 20% or more of the required data
**Maximum Age:** 17 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eduardo Serrano-Troncoso, Dr.
**Phone:** 0034673837093
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Eduardo Serrano-Troncoso, Dr.
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Sant Joan de Déu
**Status:** RECRUITING
**Zip:** 08950
#### Overall Officials
**Official 1:**
**Affiliation:** Hospital Sant Joan de Deu
**Name:** Eduardo Serrano-Troncoso, Dr.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Proposals should be directed to the Principal Investigator. To obtain access, data requestors will need to sign a data agreement with our institution, to comply with legal requirements and data protection rights. The study protocol and/or amendment to the protocol will be reviewed by the corresponding Ethics Committees.
**Description:** Data obtained through the current study may be provided to qualified researchers with academic interest in eating disorders. Data shared will be encoded, with no Protected Health Information (PHI) included.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Data requests can be submitted immediately following publication. There will be no end date.
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-08-31
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 321352
- Type Abbrev: Prot_SAP
- Upload Date: 2024-01-09T05:54
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
- ID: D000012817
- Term: Signs and Symptoms, Digestive
- ID: D000006963
- Term: Hyperphagia
### Condition Browse Module - Browse Branches
- 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: M4181
- Name: Anorexia
- Relevance: HIGH
- As Found: Anorexia
- ID: M4182
- Name: Anorexia Nervosa
- Relevance: HIGH
- As Found: Anorexia Nervosa
- ID: M5304
- Name: Bulimia
- Relevance: HIGH
- As Found: Bulimia
- ID: M26956
- Name: Bulimia Nervosa
- Relevance: HIGH
- As Found: Bulimia Nervosa
- ID: M28641
- Name: Binge-Eating Disorder
- Relevance: HIGH
- As Found: Binge Eating Disorder
- ID: M4380
- Name: Feeding and Eating Disorders
- Relevance: HIGH
- As Found: Eating Disorders
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
- ID: M10014
- Name: Hyperphagia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000855
- Term: Anorexia
- ID: D000002032
- Term: Bulimia
- ID: D000001068
- Term: Feeding and Eating Disorders
- ID: D000000856
- Term: Anorexia Nervosa
- ID: D000056912
- Term: Binge-Eating Disorder
- ID: D000052018
- Term: Bulimia Nervosa
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431841
**Acronym:** DIMS
**Brief Title:** Efficacy and Safety of Atropine and DIMS Lenses in Controlling Myopia in Children: A Randomized Clinical Trial.
**Official Title:** Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population.
#### Organization Study ID Info
**ID:** 21/522-EC_M
#### Organization
**Class:** OTHER
**Full Name:** Hospital San Carlos, Madrid
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-02-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-13
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital San Carlos, Madrid
#### Responsible Party
**Investigator Affiliation:** Hospital San Carlos, Madrid
**Investigator Full Name:** Noemi Guemes
**Investigator Title:** Principal Investigator and sponsor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial involving 50 subjects in each treatment arm (100 patients in total). The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.
### Conditions Module
**Conditions:**
- Myopia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Atropine 0,025% + DIMS Lenses
**Intervention Names:**
- Drug: Atropine 0,025% + DIMS/monofocal Lenses
**Label:** DIMS Lenses
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Atropine 0,025% + monofocal (single vision) Lenses
**Intervention Names:**
- Drug: Atropine 0,025% + DIMS/monofocal Lenses
**Label:** Monofocal Lenses
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- DIMS Lenses
- Monofocal Lenses
**Description:** Atropine 0,025% (1 drop per day) + DIMS/monofocal Lenses
**Name:** Atropine 0,025% + DIMS/monofocal Lenses
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Cycloplegic spherical equivalent refraction (SER) change
**Measure:** Cycloplegic spherical equivalent refraction (SER) change
**Time Frame:** 2 years (24 months)
**Description:** Axial length (AL) change
**Measure:** Axial length (AL) change
**Time Frame:** 2 years (24 months)
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria
* Age between 4-16 years.
* Signing of informed consent.
* Refractive error: myopia greater than -1.00 diopters (D).
* Myopia progression of at least -0.50 D in the last 12 months.
* Astigmatism of 2 D or less and anisometropia of 1.50 D or less.
* Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better.
Exclusion criteria
* Children under 4 years old and over 16 years old
* Strabismus and binocular vision anomalies.
* Alterations in eye fundus that the researcher consider necessary the patient exclution.
* Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision
* Amblyopia
* Previous eye surgery
* Systemic pathology (cardiopulmonary pathology, connective tissue alterations, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination to be carried out (such as mental or psychomotor retardation)
* Previous myopia control treatments including orthokeratology, rigid contact lenses, bifocal or myopia control soft contact lenses, bifocal and multifocal ophthalmic lenses within 3 months prior to the study.
**Maximum Age:** 16 Years
**Minimum Age:** 4 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Noemi Guemes, PHD
**Phone:** 913303000
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Name:** Noemi Guemes
- **Phone:** +34913303000
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** uicec
- **Phone:** +34913303000
- **Role:** CONTACT
***Contact 3:***
- **Name:** Noemi Guemes
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Noemi Guemes
**Status:** RECRUITING
**Zip:** 28040
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012030
- Term: Refractive Errors
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12168
- Name: Myopia
- Relevance: HIGH
- As Found: Myopia
- ID: M14872
- Name: Refractive Errors
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009216
- Term: Myopia
### Intervention Browse Module - Ancestors
- ID: D000000759
- Term: Adjuvants, Anesthesia
- ID: D000000889
- Term: Anti-Arrhythmia 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: D000009184
- Term: Mydriatics
- ID: D000010276
- Term: Parasympatholytics
- ID: D000018727
- Term: Muscarinic Antagonists
- ID: D000018680
- Term: Cholinergic Antagonists
- ID: D000018678
- Term: Cholinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: AdjAn
- Name: Adjuvants, Anesthesia
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M4590
- Name: Atropine
- Relevance: HIGH
- As Found: FDG
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4089
- Name: Adjuvants, Anesthesia
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M5269
- Name: Bronchodilator 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: M12139
- Name: Mydriatics
- Relevance: LOW
- As Found: Unknown
- ID: M13189
- Name: Parasympatholytics
- Relevance: LOW
- As Found: Unknown
- ID: M20801
- Name: Muscarinic Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20760
- Name: Cholinergic Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20758
- Name: Cholinergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001285
- Term: Atropine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431828
**Acronym:** BIOMONI-DIG
**Brief Title:** Remote Symptom Review in Patients With Implantable Diagnostic Holter
**Official Title:** Efficiency of a Clinical Process Based on Remote Review of Symptoms in Patients With an Implantable Diagnostic Holter.
#### Organization Study ID Info
**ID:** FF088
#### Organization
**Class:** OTHER
**Full Name:** Fundacin Biomedica Galicia Sur
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Fundacin Biomedica Galicia Sur
**Class:** OTHER
**Name:** Fundacion Investigacion Interhospitalaria Cardiovascular
#### Lead Sponsor
**Class:** OTHER
**Name:** Andres Iñiguez Romo
#### Responsible Party
**Investigator Affiliation:** Fundacin Biomedica Galicia Sur
**Investigator Full Name:** Andres Iñiguez Romo
**Investigator Title:** Head of Cardiology
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.
**Detailed Description:** Population of patients: Patients over 18 years old who require the implantation of an implantable diagnostic holter due to indications of syncope or atrial fibrillation, and who are willing to use an application installed on their phone to telematically send clinical symptoms that may occur during the active study period.
Design: Clinical, randomized, prospective, single-center study.
Investigational Device: BIOMONITOR III implantable cardiac holter and successive models with HOMEMONITORING remote monitoring system for constant monitoring of patient's cardiac signals. Installation of the Patient APP on the patient's phone for symptom transmission.
Overall Objective: To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.
### Conditions Module
**Conditions:**
- Atrial Fibrillation
- Syncope
- Bradycardia
- Arrythmia
**Keywords:**
- Implantable loop recorder
- Arrythmia
- Atrial Fibrillation
- Home Monitoring
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients receive the usual standard treatment with remote holter monitoring along with an app for the notification of adverse events.
**Intervention Names:**
- Other: APP
**Label:** Homemonitoring + APP
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The patients receive the usual standard treatment with remote holter monitoring
**Label:** Homemonitoring
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Homemonitoring + APP
**Description:** The patients will download an app through which they will be able to report adverse events related to their cardiovascular health.
**Name:** APP
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Time from the first alert by Home Monitoring of the implantable holter to the clinical diagnosis according to the patient's clinical indication.
**Measure:** TIME FRAME
**Time Frame:** one year
#### Secondary Outcomes
**Description:** Number of in-person visits in each group
**Measure:** Number of in-person visits in each group
**Time Frame:** one year
**Description:** Number of remote transmissions activated by patient indication
**Measure:** Incidence remote transmissions activated by patient indication
**Time Frame:** one year
**Description:** Number of false positives, according to physician's diagnosis.
**Measure:** Rate of false positives
**Time Frame:** one year
**Description:** Number of false positives (according to physician's diagnosis)
**Measure:** Rate of symptoms sent by the patient
**Time Frame:** one year
**Description:** Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient (e.g., the symptom corresponds to a detected arrhythmia)
**Measure:** Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient
**Time Frame:** one year
**Description:** Rate of symptoms not corresponding to detected arrhythmias(e.g., the symptom corresponds to a detected arrhythmia)
**Measure:** Rate of symptoms not corresponding to detected arrhythmias
**Time Frame:** one year
**Description:** Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.corresponds to a detected arrhythmia
**Measure:** Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.
**Time Frame:** one year
**Description:** Change in patient interaction with the physician - fewer calls/visits to the hospital.
**Measure:** Efficacy of implementing a clinical process based on remote monitoring of patient symptoms
**Time Frame:** one year
**Description:** Measured through a satisfaction survey on the use or non-use of the patient application to telematically send their symptoms
**Measure:** Qualitative Patient Objectives
**Time Frame:** one year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients indicated for implantation of a subcutaneous implantable holter due to syncope or cryptogenic stroke (atrial fibrillation detection)
* Patients over 18 years old.
* Patients who consent to the installation of a patient application for telematic submission of patient-related symptoms.
* Patients capable of using the patient application.
Exclusion Criteria:
* Patients over 80 years of age or, failing that, not able to use an application to send their symptoms.
* Life expectancy of less than 12 months for any reason.
**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:** Andrés Iñiguez Romo, MD, PhD
**Phone:** +34986825564
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Elvis Teijeira Fernández, MD, PhD
**Phone:** +34986825564
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vigo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pablo Juan Salvadores, MPH,PhD
- **Phone:** +34986825564
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Álvaro Cunqueiro
**Status:** RECRUITING
**Zip:** 36211
#### Overall Officials
**Official 1:**
**Affiliation:** Servicio Galego de Saude
**Name:** Andrés Iñiguez Romo, MD, phD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Gupta N, Yang J, Reynolds K, Lenane J, Garcia E, Sung SH, Harrison TN, Solomon MD, Go AS; KP-RHYTHM Study Group. Diagnostic Yield, Outcomes, and Resource Utilization With Different Ambulatory Electrocardiographic Monitoring Strategies. Am J Cardiol. 2022 Mar 1;166:38-44. doi: 10.1016/j.amjcard.2021.11.027. Epub 2021 Dec 23.
**PMID:** 34953575
**Citation:** Sharma AN, Baranchuk A. Ambulatory External Electrocardiography Monitoring: Holter, Extended Holter, Mobile Cardiac Telemetry Monitoring. Card Electrophysiol Clin. 2021 Sep;13(3):427-438. doi: 10.1016/j.ccep.2021.04.003. Epub 2021 Jul 8.
**PMID:** 34330370
**Citation:** Varma N, Epstein AE, Schweikert R, Michalski J, Love CJ; TRUST Investigators. Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) Trial. J Cardiovasc Electrophysiol. 2016 Mar;27(3):321-6. doi: 10.1111/jce.12895. Epub 2016 Jan 27.
**PMID:** 26661687
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014474
- Term: Unconsciousness
- ID: D000003244
- Term: Consciousness Disorders
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M4586
- Name: Atrial Fibrillation
- Relevance: HIGH
- As Found: Atrial Fibrillation
- ID: M16353
- Name: Syncope
- Relevance: HIGH
- As Found: Syncope
- ID: M4453
- Name: Arrhythmias, Cardiac
- Relevance: HIGH
- As Found: Arrhythmia
- ID: M5196
- Name: Bradycardia
- Relevance: HIGH
- As Found: Bradycardia
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17224
- Name: Unconsciousness
- Relevance: LOW
- As Found: Unknown
- ID: M6468
- Name: Consciousness 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: D000013575
- Term: Syncope
- ID: D000001281
- Term: Atrial Fibrillation
- ID: D000001145
- Term: Arrhythmias, Cardiac
- ID: D000001919
- Term: Bradycardia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431815
**Acronym:** ADVENT PAS
**Brief Title:** ADVENT Post-Approval Study
**Official Title:** Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
#### Organization Study ID Info
**ID:** PF304
#### Organization
**Class:** INDUSTRY
**Full Name:** Boston Scientific Corporation
### Status Module
#### Completion Date
**Date:** 2029-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Boston Scientific Corporation
#### 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:** The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
**Detailed Description:** The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).
### Conditions Module
**Conditions:**
- Paroxysmal Atrial Fibrillation
**Keywords:**
- Pulsed Field Ablation
- PFA
- Pulmonary Vein Isolation
- PVI
- Ablation
- Atrial Fibrillation
- AF
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 220
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** De-novo pulmonary vein isolation (PVI) will be performed with the FARAPULSE Pulsed Field Ablation (PFA) System.
**Name:** FARAPULSE™ Pulsed Field Ablation System
**Other Names:**
- FARAWAVE™ Pulsed Field Ablation Catheter
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The primary safety endpoint is defined as the primary safety event rate at 12 months post-Index Procedure. Primary safety events will consist of a composite of the following serious procedure-related and device-related adverse events:
* Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later.
* Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure:
* Atrial esophageal fistula
* Pulmonary vein stenosis (≥ 70% reduction of diameter)
**Measure:** Primary Safety Endpoint
**Time Frame:** 12 Months
**Description:** The primary effectiveness endpoint is treatment success in treated subjects, defined as:
* Acute Procedural Success AND
* Chronic Success, defined as freedom from the following:
After the Blanking Period up to the 12-Month Follow-up visit:
* Occurrence of any Detectable AF, AFL, AT
* ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care at the study center (excluding implantable loop recorders) or
* ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG
* Following interventions:
* Any cardioversion for AF, AFL or AT
* Prescribed a higher dose of any failed Class I or III AAD documented at baseline or any new Class I or III AAD
* Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter only)
**Measure:** Primary Effectiveness Endpoint
**Time Frame:** 12 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System\*;
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site;
* Subjects who are of legal age to give informed consent specific to the national law.
* Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.
For the LUX-Dx Sub-Study:
* Subjects with an existing LUX-Dx, inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.
Exclusion Criteria:
* Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU);
* Subjects with any prior LA ablation;
* Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL);
* Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion);
* Life expectancy of \< 1 year, per investigator's medical judgement.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a de-novo pulmonary vein isolation ablation with the FARAPULSE Pulsed Field Ablation (PFA) System.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Erin L Feddema, MPH
**Phone:** +1 651-582-5077
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html
**IPD Sharing:** UNDECIDED
## 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: Paroxysmal 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431802
**Brief Title:** Construction and Application of the Visualization Training Platform Based on a Multimodal Standardized Dataset for Pain Assessment in Critically Ill Children
**Official Title:** Construction and Application of the Visualization Training Platform Based on a Multimodal Standardized Dataset for Pain Assessment in Critically Ill Children
#### Organization Study ID Info
**ID:** FNF20231219
#### Organization
**Class:** OTHER
**Full Name:** Children's Hospital of Fudan University
### Status Module
#### Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Children's Hospital of Fudan University
#### Responsible Party
**Type:** SPONSOR
### 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 the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children is applicable for pain assessment training. The main questions it aims to answer are:
1. Does pain assessment training with a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children improve participants' knowledge level of pain assessment?
2. Does pain assessment training with a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children improve participants' skill level of pain assessment?
Researchers will compare a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children to on-site lesson to see how well the platform intervention can be applied to pain assessment training.
Participants will:
1. Use the visualisation platform or receive on-site lesson for pain assessment training every week for 1 month
2. Test before and 1 month after the start of the study
**Detailed Description:** In pediatric intensive care units, children are often faced with complex and critical conditions that require frequent pain-causing operations and experience varying degrees of pain. Pain has serious negative physiological, psychological, and social effects on critically ill children, and may even cause long-term distress, hindering individual growth and long-term health. Reliable pain assessment can help healthcare professionals to better understand the type and extent of pain in children, so that appropriate interventions can be taken to better manage the child's pain and thereby improve the child's health outcomes. However, pediatric nurses face challenges from the child, observational indicators, and the individual themselves during pain assessment in the clinic. Training in pain assessment can effectively improve nurses' knowledge, skills and attitudes towards pain assessment, enabling them to better cope with the difficulties associated with pain assessment, thereby improving the quality of pain management and providing optimal pain care for children. Traditional training has many drawbacks, and there are various difficulties in pain assessment training for critically ill children, which brings various challenges to pain assessment training for pediatric ICU nurses. Visualization training is intuitive, interactive and personalized, showing unique advantages different from traditional training. The union of deliberate practice with visualization training can further enhance the training effect, and help pediatric ICU nurses' pain assessment ability to be comprehensively improved through purposeful practice, timely feedback, and repeated training and challenges, so that they can more accurately identify and assess children's pain. Therefore, a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children will be constructed for pain assessment training to promote better improvement of pain assessment ability of pediatric ICU nurses, so that pain in critically ill children can be better managed.
### Conditions Module
**Conditions:**
- Pediatrics
- Critical Illness
- Pain Measurement
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** On-site course training in pain assessment
**Intervention Names:**
- Other: Conventional intervention
**Label:** Conventional intervention group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Pain assessment training using the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children
**Intervention Names:**
- Behavioral: Platform intervention
**Label:** Platform intervention group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Conventional intervention group
**Description:** A nursing specialist with extensive clinical and teaching experience will provide on-site course training. The training will cover topics related to pain and pain assessment, such as: pain definition, types, physiological mechanisms, performance, pain assessment tools, and frequency of pain assessment. Interventions will be provided once a week for 4 weeks.
**Name:** Conventional intervention
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Platform intervention group
**Description:** Using a pre-assigned account to log in to the platform, read the guidance instructions and enter the platform to start training. Basic knowledge of pain and pain assessment can be learnt through the Learning Resources module on the platform, and pain assessment training can be conducted through the Pain Assessment Exercise module. During pain assessment training the platform provides instant feedback based on the participant's exercises. Interventions will be completed in 4 weeks.
**Name:** Platform intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Use the Pediatric ICU Nurses' Pain Assessment Knowledge Test，which is measured on a scale from 0 to 100 points. The higher the total score, the higher the level of knowledge.
**Measure:** Knowledge level of pain assessment
**Time Frame:** before and 1 month after the start of the study
**Description:** The pediatric pain assessment cases developed by the research team will be utilized for evaluation. The correct percentage range is from 0% to 100%, with higher percentages indicating a higher skill level in pain assessment.
**Measure:** Skill level of pain assessment
**Time Frame:** before and 1 month after the start of the study
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Obtain a Nurse Practitioner's Certificate;
2. Nurses working in critical care;
3. Voluntarily participate in this study.
Exclusion Criteria:
1. Nurses in the neonatal unit (due to the specificity of pain assessment in neonates);
2. Not on duty during the survey period due to further training, rotations, sick leave, maternity leave, etc.;
3. Nurses who travel to our hospital for further training, rotations, or clinical placements during the survey period;
4. Those who fail to complete the full intervention or withdrew from the study midway.
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ying Gu, Doctor
**Phone:** +86 13816881726
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Children's Hospital of Fudan University
#### Overall Officials
**Official 1:**
**Affiliation:** Children's Hospital of Fudan University
**Name:** Ying Gu, Doctor
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- 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: M19010
- Name: Critical Illness
- Relevance: HIGH
- As Found: Critical Illness
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016638
- Term: Critical Illness
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431789
**Brief Title:** Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency
**Official Title:** Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency
#### Organization Study ID Info
**ID:** SLCO1B1
#### Organization
**Class:** OTHER
**Full Name:** Qianfoshan Hospital
### Status Module
#### Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Qianfoshan Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Yi Han
#### Responsible Party
**Investigator Affiliation:** Qianfoshan Hospital
**Investigator Full Name:** Yi Han
**Investigator Title:** Associate professor of pharmacy
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** 1. To provide reference for clinical rational use of edoxaban;
2. Optimize the individualized dosing regimen of edoxaban.
**Detailed Description:** In this study, patients with moderate and severe renal insufficiency receiving edoxaban were selected as research objects. The potential safety of edoxaban in patients with different genotypes was evaluated by detecting the anti-XA factor activity and SLCO1B1 genotyping, so as to optimize the individualized administration regimen of edoxaban.
### Conditions Module
**Conditions:**
- Gene Polymorphism
- Edoxaban
- Renal Insufficiency
**Keywords:**
- Anti-factor Xa activity
- Edoxaban
- Moderate to severe renal insufficiency
- Solute carrier organic anion transporter family member 1B1
### Design Module
#### Bio Spec
**Description:** blood
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 220
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Other Outcomes
**Description:** Thrombotic and bleeding events.
**Measure:** Safety index:Thrombotic and bleeding events.
**Time Frame:** six months
#### Primary Outcomes
**Description:** Anti-factor Xa activity
**Measure:** Anti-factor Xa activity
**Time Frame:** six months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Creatinine clearance of 15-50ml/min was calculated according to the Cockcroft-Gault formula
* Patients who received edoxaban 30mg once daily for more than 5 days for non-valvular atrial fibrillation (CHADS2VAS2 score ≥2) and deep vein thrombosis prevention or treatment
* Patients voluntarily participate and sign informed consent
Exclusion Criteria:
* Age \< 18 years old
* Moderate/severe mitral stenosis combined with valvular heart disease, mechanical valve replacement, or rheumatic heart disease
* The patient had used a combination of cyclosporine, erythromycin or ketoconazole or other P-glycoprotein inhibitors within 30 days prior to use or inclusion; Patients were using or had used amiodarone or dronedarone within 30 days prior to inclusion
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients treated with edoxaban at the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Hospital).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yi Han, doctorate
**Phone:** 15552565120
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Jinan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yi Han, doctorate
- **Phone:** 15552565120
- **Role:** CONTACT
**Country:** China
**Facility:** First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
**State:** Shandong
**Status:** RECRUITING
**Zip:** 250014
#### Overall Officials
**Official 1:**
**Affiliation:** Qianfoshan Hospital
**Name:** Yi Han, doctorate
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007674
- Term: Kidney Diseases
- 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
### 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: M26718
- Name: Renal Insufficiency
- Relevance: HIGH
- As Found: Renal Insufficiency
- ID: M10698
- Name: Kidney Diseases
- 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
### Condition Browse Module - Meshes
- ID: D000051437
- Term: Renal Insufficiency
### Intervention Browse Module - Browse Branches
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M261011
- Name: Edoxaban
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431776
**Brief Title:** Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
**Official Title:** An Open-label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
#### Organization Study ID Info
**ID:** SAV006-04
#### Organization
**Class:** INDUSTRY
**Full Name:** Savara Inc.
### Status Module
#### Completion Date
**Date:** 2027-08
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Savara 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:** The goal of this open-label study is to study molgramostim as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP) in pediatric patients between age 6 and 18. The main questions it aims to answer are:
The effect of molgramostim on breathing tests and activity in pediatric patients with aPAP and the safety of molgramostim in pediatric patients with aPAP.
This is an open-label study: all participants will receive treatment with molgramostim.
Patients will:
* Take molgramostim once daily via nebulizer every day for 12 months.
* Visit the clinic approximately every 12 weeks for checkups and tests.
* Keep a diary of any oxygen use.
**Detailed Description:** This is an interventional open-label, single arm, multi-center study in pediatric subjects, age 6 through 18 years, who are diagnosed with autoimmune pulmonary alveolar proteinosis (aPAP).
The diagnosis of aPAP should be confirmed by an anti-GM-CSF antibody test and a history compatible with PAP based on patient symptoms, high resolution computed tomography of the lung, lung biopsy or bronchoalveolar lavage cytology.
The study consists of a 4-week screening period followed by a 48-week open-label treatment period. After completing the 48-week treatment or early withdrawal, subjects will enter a 4-week safety follow up period. The maximum treatment duration is 48-weeks, and the maximum study period will be 56 weeks. During the trial, lung lavage will be allowed as a rescue treatment in case of worsening of aPAP.
### Conditions Module
**Conditions:**
- Autoimmune Pulmonary Alveolar Proteinosis
**Keywords:**
- alveolar proteinosis
- autoimmune
- lung lavage
- GM-CSF
- children
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Open-label study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 5
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Molgramostim 300 mcg administered once daily via nebulizer for 48 weeks.
**Intervention Names:**
- Drug: Molgramostim
**Label:** molgramostim
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- molgramostim
**Description:** Molgramostim nebulizer solution will be administered once daily using a proprietary nebulizer optimized for the delivery of high molecular weight biologic compounds.
**Name:** Molgramostim
**Other Names:**
- Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF).
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Adverse events (AEs), including clinically significant findings on pulmonary function tests and safety laboratory assessments and adverse events of special interest (AESIs; hypersensitivity and chest pain).
**Measure:** Adverse Events
**Time Frame:** 48 weeks
**Description:** Titers of anti-GM-CSF antibodies
**Measure:** Anti-GM-CSF Ab titer
**Time Frame:** 0, 4, 12,24,48 and 52 weeks
**Description:** Change from Baseline in forced expiratory volume in one second (FEV1) (% predicted)
**Measure:** FEV1
**Time Frame:** 24 and 48-weeks
**Description:** Change from Baseline in Forced vital capacity (FVC) (% predicted)
**Measure:** FVC
**Time Frame:** 24 and 48-weeks
#### Primary Outcomes
**Description:** Change in Hb-adjusted % predicted DLCO from Baseline.
**Measure:** DLCO
**Time Frame:** 24 weeks
#### Secondary Outcomes
**Description:** Change in Hb-adjusted % predicted DLCO from Baseline .
**Measure:** DLCO
**Time Frame:** 48-weeks
**Description:** Absolute change from Baseline in 6-minute walk distance (6MWD)
**Measure:** 6-minute walk distance
**Time Frame:** 24-weeks
**Description:** Absolute change from Baseline in 6-minute walk distance (6MWD).
**Measure:** 6-minute walk distance
**Time Frame:** 48-weeks
**Description:** Change from Baseline in Pediatric Quality of Life (PedsQLTM) Generic Core Scale score.
**Measure:** PedsQL
**Time Frame:** 24-weeks
**Description:** Change from Baseline in Pediatric Quality of Life (PedsQLTM) Generic Core Scale score.
**Measure:** PedsQL
**Time Frame:** 48-weeks
**Description:** Absolute change from Baseline in oxygen saturation (SpO2)
**Measure:** Oxygen Saturation (SpO2)
**Time Frame:** 24 weeks
**Description:** Absolute change from Baseline in oxygen saturation (SpO2)
**Measure:** Oxygen Saturation (SpO2)
**Time Frame:** 48 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Be ≥6 and \<18 years of age, at the time of signing the informed consent and informed assent (if applicable).
* Have a history of pulmonary alveolar proteinosis, based on examination of a lung biopsy, bronchoalveolar lavage cytology, or a high-resolution computed tomogram of the chest.
* Have a positive serum anti-GM-CSF autoantibody test result confirming aPAP.
* Have a hemoglobin (Hb)-adjusted diffusing capacity of the lung for carbon monoxide (DLCO) ≤70% predicted at Screening.
Exclusion Criteria:
* Have a diagnosis of hereditary (congenital) or secondary PAP, or a metabolic disorder of surfactant production.
* Have undergone treatment with Lung Lavage (WLL) within 1 month of Baseline
**Maximum Age:** 18 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yasmine Wasfi, MD, PhD,
**Phone:** 1 512 851 1364
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Raymond D Pratt, MD
**Phone:** 1 240 899 7058
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cincinnati
**Country:** United States
**Facility:** Cincinnati Children's Hospital Medical Center
**State:** Ohio
**Zip:** 45229-3039
#### Overall Officials
**Official 1:**
**Affiliation:** Savara Inc.
**Name:** Yasmine Wasfi, MD, Ph.D.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: LOW
- As Found: Unknown
- ID: M14503
- Name: Pulmonary Alveolar Proteinosis
- Relevance: HIGH
- As Found: Pulmonary Alveolar Proteinosis
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: HIGH
- As Found: Autoimmune Pulmonary Alveolar Proteinosis
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T568
- Name: Autoimmune Pulmonary Alveolar Proteinosis
- Relevance: HIGH
- As Found: Autoimmune Pulmonary Alveolar Proteinosis
### Condition Browse Module - Meshes
- ID: D000011649
- Term: Pulmonary Alveolar Proteinosis
- ID: D000001327
- Term: Autoimmune Diseases
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- 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: M257633
- Name: Molgramostim
- Relevance: HIGH
- As Found: Breaths/min
- ID: M219218
- Name: Sargramostim
- Relevance: HIGH
- As Found: MS-20
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000082430
- Term: Molgramostim
- ID: C000081222
- Term: Sargramostim
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431763
**Brief Title:** A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.
**Official Title:** A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of Inclisiran to Bempedoic Acid on LDL Cholesterol (LDL-C) Lowering in Participants With Atherosclerotic Cardiovascular Disease (VICTORION-CHALLENGE)
#### Organization Study ID Info
**ID:** CKJX839A1DE02
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2025-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Novartis Pharmaceuticals
#### 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 phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects (≥ 18 years) at very high and high risk for cardiovascular events as defined by the cardiovascular risk categories in the 2019 ESC/EAS guidelines for the management of dyslipidemias (Mach et al 2020) and elevated levels of LDL-C (≥ 70 mg/dL) despite being on a maximally tolerated high-intensity (HI) statin dose (+/- Ezetimibe). Currently, BPA is recommended ahead of injectables by German HTA body (GBA). A head-to-head trial is proposed to provide robust scientific data on the superiority of Inclisiran vs. BPA and to support the early use of Inclisiran.
**Detailed Description:** During the screening period study eligibility will be assessed and the participants' individual LDL-C target according to guideline (Mach et al., 2020) will be determined. Among other criteria, at screening, a participant must be on a stable maximally tolerated dose of a HI statin with either atorvastatin ≥40 mg once a day (QD) or rosuvastatin ≥20 mg QD (+/- Ezetimibe \[10mg\]) for ≥ 4 weeks with which, however, a target LDL-C of \< 70 mg/dL is not reached.
During the open-label treatment period, all participants, who fulfill the inclusion/exclusion criteria, will be randomized at V1 (Day 1) in a 1:1 open-label fashion to either Inclisiran sodium 300 mg s.c. (administered at Day 1 and Day 90) or to BPA tablets 180 mg p.o. (given once daily). Participants will be required to maintain their background lipid-lowering treatment (maximally tolerated statin dose +/- Ezetimibe) unchanged for the duration of the study. The end of treatment (EOT) is reached at day 150.
A Safety-Follow-up call will be conducted 30 days after EOT visit (Day 180).
The overall study duration is approximately 190 days but can vary depending on individual screening and the visit windows allowed for the treatment period and EOS visit.
### Conditions Module
**Conditions:**
- Hypercholesterolemia
**Keywords:**
- LDL-cholesterol
- atherosclerotic cardiovascular disease
- Inclisiran
- bempedoic acid
- BPA
- PCSK9 inhibitor
- head-to-head comparison
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Inclisiran treatment on top of background treatment (high intensity statin with/without ezetimibe)
**Intervention Names:**
- Drug: Inclisiran sodium
**Label:** Inclisiran
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** BPA treatment on top of background treatment (high intensity statin with/without ezetimibe)
**Intervention Names:**
- Drug: BPA
**Label:** Bempedoic acid (BPA)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Inclisiran
**Description:** 300 mg s.c. administered at day 1 and day 90
**Name:** Inclisiran sodium
**Other Names:**
- PCSK9 inhibitor, siRNA
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Bempedoic acid (BPA)
**Description:** 180 mg daily per oral
**Name:** BPA
**Other Names:**
- small molecule, ACL inhibitor
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To demonstrate superiority of Inclisiran compared to BPA, in combination with standard of care (maximally tolerated HI statin dose +/- Ezetimibe) in reducing relative LDL-C levels at Day 150.
**Measure:** Percent change from baseline in LDL-C levels
**Time Frame:** Baseline, Day 150
#### Secondary Outcomes
**Description:** To demonstrate superiority of Inclisiran compared to BPA, in patients on maximally tolerated HI statin dose without Ezetimibe in relative reduction of LDL-C levels at Day 150.
**Measure:** Percent change from baseline in LDL-C levels in patients without Ezetimibe
**Time Frame:** Baseline, Day 150
**Description:** To demonstrate superiority of Inclisiran compared to BPA, in patients on maximally tolerated HI statin dose with Ezetimibe in reducing relative LDL-C levels at Day 150.
**Measure:** Percent change from baseline in LDL-C levels in patients with Ezetimibe
**Time Frame:** Baseline, Day 150
**Description:** Number of patients who qualify for 'sufficient response' based on their individual risk class, defined through on treatment LDL-C levels.
For patients classified as 'very high risk', responsiveness is 'achieved' once the LDL-C drops below 55mg/dL, and for patients classified as 'high risk' responsiveness is 'achieved' once the LDL-C \< 70 mg/dL at Day 150.
**Measure:** Number of participants by individual responsiveness
**Time Frame:** Day 150
**Description:** Assess efficacy of Inclisiran compared to BPA in reducing LDL-C (absolute reduction).
**Measure:** Absolute change from Baseline in LDL-C
**Time Frame:** Day 150
**Description:** Assess efficacy of Inclisiran compared to BPA in reducing LDL-C \[time-adjusted percent change\] starting Day 30 and up to Day 150.
**Measure:** Percent change from Baseline in LDL-C levels
**Time Frame:** Baseline, from Day 30 up to Day 150
**Description:** Assess efficacy of Inclisiran compared to BPA in reducing LDL-C \[time-adjusted percent change\] between Day 90 and Day 150.
**Measure:** Percent change from Baseline in LDL-C levels
**Time Frame:** Between Day 90 and Day 150
**Description:** Assess adherence to lipid-lowering therapy over time in participants receiving Inclisiran compared to BPA on top of maximally tolerated HI statins (+/- Ezetimibe) using the Morisky 8-Item Medication Adherence Scale (MMAS-8).
The Morisky Medication Adherence Scale is an assessment tool used to measure non-adherence in patient populations. It consists of seven yes/no questions and one 5-point Likert scale with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence.
**Measure:** Mean change from baseline in MMAS-8 over time
**Time Frame:** From Baseline up to Day 150
**Description:** Assess effect of Inclisiran compared to BPA regarding treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM v. II).
The TSQM (version II) comprises 11 items across four domains focusing on effectiveness (two items), side effects (four items), convenience (three items), and global satisfaction (two item) of the medication over the previous weeks, or since the patient's last use. With the exception of item 3 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales had a nonneutral midpoint, such that there were more positive response options than negative response options, to allow for precise information to be obtained at the upper end of the score distribution. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Higher scores indicating higher patient satisfaction with medication.
**Measure:** Mean change from Baseline in TSQM over time
**Time Frame:** From Baseline up to Day 150
**Description:** Assess the effect of Inclisiran compared to BPA regarding pain-related quality of life using the Short Form Brief Pain Inventory (SF-BPI).
The SF-BPI is a self-administered standardized fifteen items questionnaire that assesses how pain interferes with or influences a participant's life. The SF-BPI includes two main scores: a pain severity score and a pain interference score. The pain severity score combines the information of the four items about pain intensity, which are rated from 0, no pain, to 10, pain as bad as you can imagine. To derive the pain severity score the average of the four items will be taken. The pain interference is calculated similarly using the seven items regarding pain interference, which are rated from 0, does not interfere, to 10, completely interferes. The pain interference score will be the average of these seven items. Both scores will be between 0 and 10. Higher scores correspond to a poorer condition of the participant.
**Measure:** Mean change from Baseline in SF-BPI over time
**Time Frame:** From Baseline up to Day 150
**Description:** Proportion of participants with clinically significant change from Baseline \[Minimal clinically important difference of 2 points\] in SF-BPI, to assess the effect of Inclisiran compared to BPA regarding pain-related quality of life using the Short Form Brief Pain Inventory (SF-BPI).
**Measure:** Proportion of participants with clinically significant change from Baseline in SF-BPI
**Time Frame:** At day 150
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Fasting LDL-C ≥ 70 mg/dL at screening
2. Participants must be on a stable (≥ 4 weeks) and well-tolerated lipid-lowering regimen (with or without Ezetimibe \[10mg\]) that must include a high-intensity statin therapy with either atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD in a maximally tolerated or maximally approved dose at screening
3. Participants categorized as very high or high CV risk, as defined below:
* Very high risk participants with at least one of the following:
* Documented ASCVD: ACS: Unstable angina or myocardial infarction, Stable angina, Coronary revascularization, Unequivocally documented ASCVD upon prior imaging Stroke and Transient Ischaemic Attack (TIA)
* Peripheral artery disease (PAD)
* Diabetes mellitus (DM) with target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), or at least ≥ 3 major risk factors, or early onset of Type 1 DM of long duration (\< 20 years)
* A calculated SCORE2 ≥ 7.5 % for age \< 50 years; SCORE2 ≥ 10 % for age 50-69 years; SCORE2-OP ≥ 15 % for age ≥ 70 years to estimate 10-year risk of fatal and non-fatal CVD
* Pre-existing diagnosis of heterozygous familial hyper-cholesterolemia (HeFH) with ASCVD or with another major risk factor OR
* High risk participants with at least one of the following:
* Markedly elevated single risk factors, in particular total cholesterol \> 310 mg/dL, LDL-C \> 190 mg/dL, or blood pressure ≥ 180/110 mmHg
* Pre-existing diagnosis of HeFH without other major risk factors
* DM without target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), with DM duration ≥ 10 years or other additional risk factor
* Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2)
* A calculated SCORE2 2.5 to \< 7.5 % for age \< 50 years; SCORE2 5 to \< 10 % for age 50-69 years; SCORE2-OP 7.5 to \< 15 % for age ≥ 70 years to estimate 10-year risk of fatal and non-fatal CVD as defined by the cardiovascular risk categories in the 2019 ESC/EAS guideline (Mach et al 2020), and updated SCORE2 and SCORE2-OP (Hageman et al 2021, de Vries et al 2021, Visseren et al 2021). Further details for documented ASCVD will be provided in the protocol.
4. Fasting triglyceride \< 400 mg/dL at screening
Exclusion Criteria:
1. Acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \< 4 weeks prior to screening visit.
2. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary re-vascularization within 6 months after screening visit.
3. Heart failure NYHA class IV at screening or baseline visit.
4. Participants on more than one other lipid-lowering drug on top of statin at screening visit.
5. Previous treatment with a mAb directed towards PCSK9 (e.g., evolocumab, alirocumab) or planned use after screening visit.
6. Previous treatment prior to screening with BPA within 90 days
7. Previous exposure to Inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug.
**Maximum Age:** 99 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Novartis Pharmaceuticals
**Phone:** +41613241111
**Role:** CONTACT
**Contact 2:**
**Name:** Novartis Pharmaceuticals
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Novartis Pharmaceuticals
**Name:** Novartis Pharmaceuticals
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006949
- Term: Hyperlipidemias
- ID: D000050171
- Term: Dyslipidemias
- ID: D000052439
- Term: Lipid Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M26188
- Name: Atherosclerosis
- Relevance: HIGH
- As Found: Atherosclerotic Cardiovascular Disease
- ID: M9988
- Name: Hypercholesterolemia
- Relevance: HIGH
- As Found: Hypercholesterolemia
- ID: M10002
- Name: Hyperlipoproteinemias
- Relevance: LOW
- As Found: Unknown
- ID: M10000
- Name: Hyperlipidemias
- 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
- 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
### Condition Browse Module - Meshes
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000050197
- Term: Atherosclerosis
- ID: D000006937
- Term: Hypercholesterolemia
### Intervention Browse Module - Ancestors
- ID: D000000924
- Term: Anticholesteremic Agents
- ID: D000000960
- Term: Hypolipidemic Agents
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000015842
- Term: Serine Proteinase Inhibitors
- ID: D000011480
- Term: Protease Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000057847
- Term: Lipid Regulating Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Lipd
- Name: Lipid Regulating Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M2849
- Name: PCSK9 Inhibitors
- Relevance: HIGH
- As Found: Node Positive
- ID: M409
- Name: Ezetimibe
- Relevance: LOW
- As Found: Unknown
- ID: M21155
- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4243
- Name: Anticholesteremic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4278
- Name: Hypolipidemic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M14343
- Name: Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M18391
- Name: Serine Proteinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M19609
- Name: HIV Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M28883
- Name: Lipid Regulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: T18
- Name: Serine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000091362
- Term: PCSK9 Inhibitors
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431750
**Acronym:** Toddler
**Brief Title:** Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis
**Official Title:** Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis (Toddler)
#### Organization Study ID Info
**ID:** CAIN457FRU02
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2028-08-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-08-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-04-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Novartis Pharmaceuticals
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis
**Detailed Description:** Rheumatologists and pediatricians actively managing pediatric Enthesitis-related Arthritis (ERA) and Juvenile Psoriatic Arthritis (jPsA) in different regions of Russia are planned to participate in the study. To be include in this study, physicians must consult more than 10 pediatric patients with ERA/jPsA in a typical month. Any pediatric patients with active ERA/jPsA who started secukinumab treatment (index date) within 4-8 weeks prior to inclusion can be enrolled. At the inclusion retrospective data collection is planned, then data will be collected 3 months of treatment), 6, 12, 18, and 24 months after index date. Therefore, maximum duration of prospective observation is expected to be 23 months. Data collection schedule fits routine (Juvenile Idiopathic Arthritis) JIA management guidelines for patients receiving biologics stating that treatment effectiveness should be evaluated at 3 and 6 months after biologic initiation and every 6 months thereafter. At each visit effectiveness and tolerability parameters, as well as the patients' Quality of life (QoL) will be documented. Retrospective data will be collected for medical history and JIA treatment, including secukinumab before inclusion, as well to describe all necessary parameters since the Index date. Expected look-back period is 12 months.
Initiation of secukinumab treatment will be considered the index date.
### Conditions Module
**Conditions:**
- Juvenile Idiopathic Arthritis
**Keywords:**
- Juvenile Idiopathic Arthritis
- JIA
- Secukinumab
- Cosentyx
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** pediatric patients with active ERA/jPsA for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 8 weeks prior to enrollment
**Intervention Names:**
- Other: Secukinumab
**Label:** Secukinumab
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Secukinumab
**Description:** This is an observational study, there is no treatment allocation.
**Name:** Secukinumab
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab
**Measure:** Drug survival rate
**Time Frame:** 24 months
**Description:** The ACR Pedi 30/50/70/90 is defined as a minimum of 30/50/70/90 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by \>30/50/70/90 percent.
The ACR Pedi consists of 6 core criteria:
1. physician global assessment (PGA) of disease activity (visual analog scale \[VAS\]) where 0 represents no disease activity and 100 represents the most disease activity
2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
3. functional ability (assessed using the Childhood Health Assessment Questionnaire \[CHAQ\]);
4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both)
5. number of joints with limited range of motion
6. laboratory marker of inflammation (C-reactive protein \[CRP\]).
**Measure:** American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90 achievement rates
**Time Frame:** Month 3, Month 6, Month 12, Month 18, and Month 24
**Description:** To state the absence of disease activity (inactive phase of the disease), the patient must meet all of the listed criteria.
* absence of joints with active arthritis,
* absence of fever, rash, serositis, splenomegaly or generalized lymphadenopathy typical of juvenile arthritis;
* absence of active uveitis,
* normal ESR and (or) CRP,
* absence of disease activity according to the doctor's general assessment (VAS),
* morning stiffness less than 15 minutes.
**Measure:** Clinical remission/inactive disease rates by Wallace criteria
**Time Frame:** Month 3, Month 6, Month 12, Month 18, and Month 24
#### Secondary Outcomes
**Description:** Describes the child's usual activities in eight domains over the past week. It include dressing, getting up, eating, walking, hygiene, reaching overhead objects, grip and activities. Each question is scored from 0 to 3 (0 = no difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable to do). The score for each of the eight functional areas will be averaged to calculate the disability index.
**Measure:** Childhood Health Assessment Questionnaire (CHAQ) score
**Time Frame:** Up to 24 months
**Description:** Physician global assessment of disease activity assessed on a VAS scale of 0 \[no activity\] to 10 \[extreme activity\]
**Measure:** Physician global assessment of disease activity
**Time Frame:** Up to 24 months
**Description:** Patient/legal representative global assessment of disease activity assessed on a VAS scale of 0 \[no activity\] to 10 \[extreme activity\]
**Measure:** Patient/legal representative global assessment of disease activity
**Time Frame:** Up to 24 months
**Description:** Time to treatment failure defined as time from index date to loss of ACR Pedi 30, 50, and 70 response.
**Measure:** Time to treatment failure
**Time Frame:** Up to 24 months
**Description:** The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by \>30 percent.
The ACR Pedi consists of 6 core criteria:
1. physician global assessment (PGA) of disease activity (visual analog scale \[VAS\]) where 0 represents no disease activity and 100 represents the most disease activity
2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
3. functional ability (assessed using the Childhood Health Assessment Questionnaire \[CHAQ\]);
4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both)
5. number of joints with limited range of motion
6. laboratory marker of inflammation (C-reactive protein \[CRP\]).
**Measure:** Proportion of patients not achieving ACR Pedi 30 response
**Time Frame:** Month 3
**Description:** Score to evaluate the number of joints inflamed. A joint is considered to be inflamed when at leats two of the following criteria are present:
* pain
* Swelling
* limited motion. The score range (total) is from 0-101, where higher scores indicate worse outcome.
**Measure:** Disease activity index in 71 joints Juvenile Arthritis Disease Activity Score (JADAS71)
**Time Frame:** Up to 24 months
**Description:** The JSpADA score is a comprehensive
clinical assessment tool designed to measure the impact of juvenile spondyloarthritis on the patient. The JSpADA scale includes 8 indicators that assess the signs and symptoms of spondyloarthritis. Patients receive an overall score based on scores on each of 8 indicators. There are two options for assessing morning stiffness, clinical sacroiliitis, uveitis and back mobility: presence or absence. Number of joints with active arthritis: 0 joints = 0; 1-2 joints = 0.5; \> 2 joints = 1; Number of active enthesites: 0 = 0; 1-2 = 0.5; \> 2 = 1; Patient-Reported Pain Score (VAS 0-10): 0 = 0; 1-4 = 0.5; 5-10 = 1; Assessment of ESR or CRP level: normal = 0; 1-2x = 0.5; \> 2x = 1.
As a result, we add up the scores for the obtained indicators and get an overall score, and the higher it is, the higher the disease activity.
**Measure:** Juvenile Spondyloarthritis (JSpA) Disease Activity - JSpADA
**Time Frame:** Up to 24 months
**Description:** Psoriasis Area and Severity Index (PASI) for patients with Juvenile Psoriatic Arthritis (jPsA) to be provided. Score can range from 0 (no disease) to 72 (maximal disease).
**Measure:** Psoriasis Area and Severity Index (PASI) for patients with Juvenile Psoriatic Arthritis (jPsA)
**Time Frame:** Up to 24 months
**Description:** Reasons for discontinuation:
* lack of efficacy,
* adverse events
* administrative reasons (no medication available in the hospital, etc.)
* lack of patient's adherence
* patient's or legal representative's wish
* other.
**Measure:** Number of participants by reasons of secukinumab discontinuation
**Time Frame:** Up to 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.
2. Age ≥6 to \<18 years old.
3. Recognized physician diagnosis of active ERA or jPsA:
* ERA per ILAR criteria:
* Peripheral arthritis and enthesitis, or
* Arthritis or enthesitis, plus ≥ 3 months of inflammatory back pain and sacroiliitis on imaging, or
* Arthritis or enthesitis plus 2 of the following: sacroiliac joint tenderness; inflammatory back pain; presence of HLA-B27 antigen; acute (symptomatic) anterior uveitis; and history of a spondyloarthritis in a first-degree relative.
* jPsA per ILAR criteria
* Arthritis and psoriasis, or
* arthritis and at least 2 of the following:
* Dactylitis
* Nail pitting or onycholysis
* Psoriasis in a first-degree relative.
4. Patient was prescribed with secukinumab within 4-8 weeks before inclusion.
5. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of this non-interventional study conduct.
6. The Purified Protein Derivative (PPD) Skin Test for Tuberculosis and/or Negative T-SPOT test and/or TB-feron test before secukinumab treatment and every 6 months.
Exclusion Criteria:
1. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
2. Chronic recurrent infections.
3. Clinically significant infection exacerbation, including active tuberculosis.
4. Age \<6 years or ≥18 years.
5. Pregnancy and breastfeeding.
6. Patients participating in parallel in an interventional clinical trial.
7. Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab.
8. Patients within the safety follow-up phase of interventional study.
9. Active inflammatory bowel disease at inclusion.
10. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
11. Any medical or psychological condition in the investigator's opinion which may prevent the study participation.
12. Concomitant conditions (Candida infections, other infections, inflammatory bowel disease \[IBD\], uveitis, skin and nail psoriasis for ERA patients, hepatitis B, hepatitis C, tuberculosis).
**Maximum Age:** 18 Years
**Minimum Age:** 6 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** Pediatric patients with active ERA/jPsA for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 8 weeks prior to enrollment
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Novartis Pharmaceuticals
**Phone:** +41613241111
**Role:** CONTACT
**Contact 2:**
**Name:** Novartis Pharmaceuticals
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Novartis Pharmaceuticals
**Name:** Novartis Pharmaceuticals
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000025242
- Term: Spondylarthropathies
- ID: D000025241
- Term: Spondylarthritis
- ID: D000013166
- Term: Spondylitis
- ID: D000013122
- Term: Spinal Diseases
- ID: D000001847
- Term: Bone Diseases
- ID: D000011565
- Term: Psoriasis
- ID: D000017444
- Term: Skin Diseases, Papulosquamous
- ID: D000012871
- Term: Skin Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC01
- Name: Infections
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4476
- Name: Arthritis
- Relevance: HIGH
- As Found: Arthritis
- ID: M18178
- Name: Arthritis, Psoriatic
- Relevance: HIGH
- As Found: Psoriatic Arthritis
- ID: M4479
- Name: Arthritis, Juvenile
- Relevance: HIGH
- As Found: Juvenile Idiopathic Arthritis
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23036
- Name: Spondylarthropathies
- Relevance: LOW
- As Found: Unknown
- ID: M15961
- Name: Spondylitis
- Relevance: LOW
- As Found: Unknown
- ID: M23035
- Name: Spondylarthritis
- Relevance: LOW
- As Found: Unknown
- ID: M15919
- Name: Spinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14422
- Name: Psoriasis
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19713
- Name: Skin Diseases, Papulosquamous
- 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
- 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
- ID: T5412
- Name: Spondylarthropathy
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001168
- Term: Arthritis
- ID: D000015535
- Term: Arthritis, Psoriatic
- ID: D000001171
- Term: Arthritis, Juvenile
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431737
**Brief Title:** Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication
**Official Title:** Comparison of Helicobacter Pylori Eradication Rates Between Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based Triple Therapy: A Propensity Score Matching Analysis
#### Organization Study ID Info
**ID:** SCH-HP-2024
#### Organization
**Class:** OTHER
**Full Name:** Soonchunhyang University Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Soonchunhyang University Hospital
#### Responsible Party
**Investigator Affiliation:** Soonchunhyang University Hospital
**Investigator Full Name:** Jun-Hyung Cho
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Gastric acid depressant play a major role in an H. pylori eradication therapy by (1) increasing the intragastric pH, which improves antibiotic stability and bioavailability; (2) increasing the intragastric pH to 6 or more, which prompts H. pylori to replicate and thus become more sensitive to antibiotics that are effective only against replicating bacteria, such as amoxicillin; (3) increasing the concentration of antibiotics in the stomach. Of antimicrobial agents against H. pylori, amoxicillin is a penicillin derivative that inhibits the synthesis of the bacterial cell wall. Therefore, amoxicillin's bactericidal effect requires the bacteria to be replicating. Amoxicillin is excreted by the kidneys, the plasma half-life is approximately 1 hour, and the bactericidal effect is time dependent. Theoretically, amoxicillin should be given 3 or 4 times daily to maximize the time above minimal inhibitory concentration (MIC) However, in most H. pylori eradication therapies, amoxicillin is given twice daily, where the estimated time above MIC attained by twice daily dosing is insufficient for amoxicillin. Because most strains of H. pylori are sensitive to amoxicillin, 3 or 4 times daily administration may be appropriate to increase the H. pylori eradication success. Nevertheless, data regarding the amoxicillin dosing interval for successful H. pylori eradication are lacking.
**Detailed Description:** The investigators aim to compare the H. pylori eradication rates between twice- and four-times-daily amoxicillin administration in 2-week tegoprazan-based triple therapy. Secondary outcomes are treatment compliance and drug-related adverse event rates.
### Conditions Module
**Conditions:**
- H.Pylori Infection
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days
**Intervention Names:**
- Drug: Amoxicillin
**Label:** BID group
#### Arm Group 2
**Description:** Tegoprazan 50 mg bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid for 14 days
**Intervention Names:**
- Drug: Amoxicillin
**Label:** QID group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BID group
- QID group
**Description:** Tegoprazan 50 mg bid, amoxicillin 1000 mg bid or 500 mg qid, clarithromycin 500 mg bid for 14 days
**Name:** Amoxicillin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Urea breath test after completing H. pylori eradication regimen
**Measure:** H. pylori eradication rates
**Time Frame:** 6 weeks
#### Secondary Outcomes
**Description:** Assessment of patients' numbers completing H. pylori eradication regimen
**Measure:** Treatment compliance
**Time Frame:** 6 weeks
**Description:** Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment
**Measure:** Drug-related adverse event rate
**Time Frame:** 6 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed
Exclusion Criteria:
* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* Drug allergy to antibiotics
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding
**Maximum Age:** 80 Years
**Minimum Age:** 20 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** H. pylori-infected patients
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jun-Hyung Cho, M.D.
**Phone:** +82-2-709-9202
**Phone Ext:** 9581
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jun-Hyung Cho, M.D.
- **Phone:** +82-2-709-9581
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jun-Hyung Cho, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Korea, Republic of
**Facility:** Soonchunhyang University Hospital
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Soonchunhyang University Hospital
**Name:** Jun-Hyung Cho, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### 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
### Intervention Browse Module - Ancestors
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3995
- Name: Amoxicillin
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M19585
- Name: Clarithromycin
- Relevance: LOW
- As Found: Unknown
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000658
- Term: Amoxicillin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431724
**Brief Title:** A Review of Cervical Cancer Screening Practices in Women Age >65
**Official Title:** A Prospective Analysis of Adherence to National Cervical Cancer Screening Recommendations in Women Age >65
#### Organization Study ID Info
**ID:** 23-ONC-34
#### Organization
**Class:** OTHER
**Full Name:** Sarasota Memorial Health Care System
### Status Module
#### Completion Date
**Date:** 2024-07-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-07-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-31
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sarasota Memorial Health Care System
#### Responsible Party
**Investigator Affiliation:** Sarasota Memorial Health Care System
**Investigator Full Name:** Tamela Fonseca
**Investigator Title:** Director of Research
**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 research study is to examine adherence to national guidelines for cervical cancer screening in women age \>65. Patient surveys will provide information about women age \>65 current cervical screening practices and allow researchers to compare that information to national recommended guidelines regarding cervical screenings. Provider surveys will provide information from surveyed providers about screening knowledge and current provider practices for women patients \> 65 for cervical cancer. The results may be used to make future recommendations for improving gynecological care and to help develop effective strategies for ensuring guideline adherence.
**Detailed Description:** This prospective study will be conducted to determine adherence to the national guidelines for cervical cancer screening in women \>65. A nonpaired patient and provider survey will be utilized to assess both provider and patient adherence to the national cervical cancer screening guidelines. Providers who meet study eligibility will be asked to complete a survey containing questions regarding their current practice for cervical cancer screening, the guidelines they follow, and their decision-making process when deciding who to screen. Patients who meet study eligibility will be asked to complete a survey detailing the frequency and types of cervical cancer screenings they have had and any relevant outcomes. The aims of the study are to assess cervical cancer screening practices among at risk women age \>65 years and describe adherence to nationally recommended cervical cancer screening guidelines for this same patient group and among primary care providers (PCPs) and gynecologists. To assess adherence, the Sarasota Memorial Research Institute (SMRI) will conduct a research study which includes patients age \>65 from the Sarasota Memorial Health Care System (SMHCS) and their First Physician's Group (FPG) affiliates and providers. Patients who agree to participle will be surveyed to determine their behaviors surrounding cervical cancer screenings. Primary care physicians and gynecologists who are either members of the American Academy of Family Physicians (AAFP), ACOG, or practice within SMHCS or FPG providers who agree to participate will also receive a separate one-time survey to assess adherence to the ACOG, ACS, and USPSTF guidelines for conducting cervical cancer screenings. The target survey sample size for this study will be 200 patients, women \>65 years who are considered at risk of developing cervical cancer (women with a history of a hysterectomy will be excluded) and receive gynecological services at SMHCS. In addition, 100 primary care physicians (PCPs) and gynecologists will be targeted.
### Conditions Module
**Conditions:**
- Cervical Cancer
**Keywords:**
- cervical cancer screening
- cervical cancer
- geriatric cancer
### Design Module
#### Design Info
**Observational Model:** ECOLOGIC_OR_COMMUNITY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 200 women \>65 years who are considered at risk of developing cervical cancer.
**Intervention Names:**
- Other: Patient Survey
**Label:** Women >65 years who are considered at risk of developing cervical cancer
#### Arm Group 2
**Description:** 100 Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians.
**Intervention Names:**
- Other: Provider Survey
**Label:** Primary care providers and gynecologic providers
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Women >65 years who are considered at risk of developing cervical cancer
**Description:** A simple data intake collection from the patients regarding their medical history that will allow the researchers to assess if recommended guidelines were followed.
**Name:** Patient Survey
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Primary care providers and gynecologic providers
**Description:** A survey will be used to evaluate providers' practices, knowledge and adherence to guidelines, and decision making related to current practice for cervical screening in women \>65.
**Name:** Provider Survey
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** To report adherence to national guidelines within each group, exact binomial 95% confidence intervals will be used. A multi-variant analysis will be conducted to determine the frequency, types, and outcomes of cervical cancer screening/s performed and patient and provider characteristics associated with guideline adherence.
**Measure:** Exact binomial 95% confidence intervals will be used.
**Time Frame:** Both patient and provider surveys are one-time only events. Their participation is limited to only the single time they take the survey which is estimated to take approximately 15 minutes.
### Eligibility Module
**Eligibility Criteria:** For participants:
Inclusion Criteria:
* Women age \>65 who have not had a hysterectomy.
* Women who received gynecological services within the SMHCS/FPG network FPG physician offices -Primary Care or Gynecologic Care))
Exclusion Criteria:
* Woman has a history of prior hysterectomy.
* Woman is age 65 years and under
* Woman does not receive gynecologic services within SMHCS/FPG network.
For providers:
Inclusion Criteria:
* Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians.
* Provider practices in the U.S.
* Provider performs gynecological screenings as part of their current practice.
Exclusion Criteria:
* Provider does not practice in the United States.
* Provider does not provide gynecological screenings.
* Provider does not have an active license as a Primary Care Provider or Gynecologic Provider (APRNs, PAs, or Physicians).
**Healthy Volunteers:** True
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The sample size for this study will consist of 200 patients and 100 providers who are comprised of PCPs and gynecologists affiliated with the American Academy of Family Physicians (AAFP) or the American College of Obstetricians and Gynecologists (ACOG) or who are practitioners within SMHCS/FPG locations.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Sarasota
**Country:** United States
**Facility:** Sarasota Memorial Health Care System
**State:** Florida
**Zip:** 34239
#### Overall Officials
**Official 1:**
**Affiliation:** Sarasota Memorial Health Care System Research Institute
**Name:** Tamela Fonseca, PhD, RN, CCRC
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Arbyn M, Weiderpass E, Bruni L, de Sanjose S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 2020 Feb;8(2):e191-e203. doi: 10.1016/S2214-109X(19)30482-6. Epub 2019 Dec 4. Erratum In: Lancet Glob Health. 2022 Jan;10(1):e41.
**PMID:** 31812369
**Citation:** Bujang MA, Omar ED, Baharum NA. A Review on Sample Size Determination for Cronbach's Alpha Test: A Simple Guide for Researchers. Malays J Med Sci. 2018 Nov;25(6):85-99. doi: 10.21315/mjms2018.25.6.9. Epub 2018 Dec 28.
**PMID:** 30914882
**Citation:** Dilley S, Huh W, Blechter B, Rositch AF. It's time to re-evaluate cervical Cancer screening after age 65. Gynecol Oncol. 2021 Jul;162(1):200-202. doi: 10.1016/j.ygyno.2021.04.027. Epub 2021 Apr 26.
**PMID:** 33926748
**Citation:** Feldman S, Cook E, Davis M, Gershman ST, Hanchate A, Haas JS, Perkins RB. Cervical Cancer Incidence Among Elderly Women in Massachusetts Compared With Younger Women. J Low Genit Tract Dis. 2018 Oct;22(4):314-317. doi: 10.1097/LGT.0000000000000435.
**PMID:** 30256336
**Citation:** Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
**PMID:** 18929686
**Citation:** Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
**PMID:** 31078660
**Citation:** Mills JM, Morgan JR, Dhaliwal A, Perkins RB. Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort. Gynecol Oncol. 2021 Aug;162(2):308-314. doi: 10.1016/j.ygyno.2021.05.035. Epub 2021 Jun 3.
**PMID:** 34090706
**Citation:** Qin J, Shahangian S, Saraiya M, Holt H, Gagnon M, Sawaya GF. Trends in the use of cervical cancer screening tests in a large medical claims database, United States, 2013-2019. Gynecol Oncol. 2021 Nov;163(2):378-384. doi: 10.1016/j.ygyno.2021.08.023. Epub 2021 Sep 8.
**PMID:** 34507826
**Citation:** Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J, Garcia FA, Moriarty AT, Waxman AG, Wilbur DC, Wentzensen N, Downs LS Jr, Spitzer M, Moscicki AB, Franco EL, Stoler MH, Schiffman M, Castle PE, Myers ER; American Cancer Society; American Society for Colposcopy and Cervical Pathology; American Society for Clinical Pathology. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol. 2012 Apr;137(4):516-42. doi: 10.1309/AJCPTGD94EVRSJCG.
**PMID:** 22431528
**Citation:** Surveillance, Epidemiology, and End Results (SEER) Cancer Stat Facts: Cervix uteri Cancer, n.d.
**Citation:** Tsang S, Royse CF, Terkawi AS. Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi J Anaesth. 2017 May;11(Suppl 1):S80-S89. doi: 10.4103/sja.SJA_203_17.
**PMID:** 28616007
**Citation:** Yost S, Hoekstra A. Cervical cancer in women over 65: An analysis of screening. Gynecol Oncol Rep. 2018 May 22;25:48-51. doi: 10.1016/j.gore.2018.05.010. eCollection 2018 Aug.
**PMID:** 30023421
#### See Also Links
**Label:** ACOG Updated Cervical Cancer Screening Guidelines
**URL:** https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical-cancer-screening-guidelines
**Label:** Centers for Disease Control and Prevention (CDC), 2019
**URL:** http://www.cdc.gov/cancer/uscs/about/data-briefs/no11-gynecologic-cancer-incidence-UnitedStates-2012-2016.htm
**Label:** U.S. Census Bureau (2022). QuickFacts
**URL:** http://www.census.gov/quickfacts/sarasotacountyflorida.
**Label:** United States Preventative Task Force (USPTF). Cervical Cancer Screening. August 21, 2018.
**URL:** http://www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014594
- Term: Uterine Neoplasms
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000002577
- Term: Uterine Cervical Diseases
- ID: D000014591
- Term: Uterine Diseases
- 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: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5830
- Name: Uterine Cervical Neoplasms
- Relevance: HIGH
- As Found: Cervical Cancer
- ID: M17342
- Name: Uterine Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5825
- Name: Uterine Cervical Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17339
- Name: Uterine Diseases
- Relevance: LOW
- As Found: Unknown
- 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: D000002583
- Term: Uterine Cervical Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431711
**Acronym:** FRESH-CSVD
**Brief Title:** Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
**Official Title:** Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
#### Organization Study ID Info
**ID:** KY2024050
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2034-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2029-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhejiang Provincial People's Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Cerebral small-vessel disease (CSVD) is a significant contributor to stroke and dementia, primarily impacting individuals over the age of 60. Its prevalence exceeds 70% in the elderly population, imposing a substantial burden on brain health and the economy. Optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which can perform multi-dimensional quantitative assessment of fundus retinopathy. Current studies have shown that fundus OCTA-derived parameters may have potential in characterizing imaging changes in CSVD. However, the correlation between retinal/choroidal parameters on OCTA and the CSVD imaging markers remains uncertain. FRESH-CSVD is a prospective, observational study that will use fundus OCTA-derived parameters to screen patients with CSVD, explore the relationship between relevant parameters based on OCTA measurements and CSVD, and evaluate the feasibility and clinical value of identification of CSVD through fundus OCTA.
### Conditions Module
**Conditions:**
- Cerebral Small Vessel Diseases
- Retinal Ischemia
- Choroid; Injury
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 2400
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This does not entail the application of interventions.
**Label:** Individuals with CSVD
### Outcomes Module
#### Primary Outcomes
**Description:** Investigators intend to use these indicators to assess the diagnostic accuracy of fundus OCTA for CSVD: area under the receiver operating characteristic curve (AUROC)
**Measure:** Diagnostic accuracy of fundus OCTA-derived parameters for CSVD
**Time Frame:** baseline ,6-month, and every 1 year, follow-up time up to 5 years
#### Secondary Outcomes
**Description:** Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points
**Measure:** The development of total CSVD burden in MRI
**Time Frame:** baseline ,6-month, and every 1 year, follow-up time up to 5 years
**Description:** Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA) and cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction.
Using the Chinese version of the MMSE scale, dementia is defined based on different levels of education (≤ 22, ≤ 23, ≤ 24, ≤ 26 points for illiteracy, primary school, junior high school, and university).
Death included any reason caused death.
**Measure:** Number of Patients with cerebrovascular events, cardiovascular events, dementia or death
**Time Frame:** baseline ,6-month, and every 1 year, follow-up time up to 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Older than 35 years old;
2. Patients who underwent Multimodal MRI with any CSVD imaging marker;
3. Subjects who have signed informed consent.
Exclusion Criteria:
1. Patient who was unable to cooperate with examinations;
2. There are known diseases that may cause or worsen CSVD (brain injury, Down syndrome, Alzheimer's disease, Parkinson's disease, etc.);
3. There are known eye diseases or severe underlying fundus lesions that may impact fundus assessment;
4. Suffering from serious systemic diseases, such as heart, liver, kidney diseases or major mental illnesses;
5. Contraindications for imaging examinations
Exit Criteria:
1. Not meet the inclusion criteria.
2. For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
3. Any adverse or serious adverse events during the study period judged by investigator
**Minimum Age:** 35 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The research population for this study consists of patients who have been diagnosed with non-acute ischemic symptoms of Cerebral Small Vessel Disease. Inclusion criteria: Patients with any of the CSVD-related MRI imaging markers; Patients aged old than 35 years; Sign informed consent. Exclusion criteria: Unable to cooperate with examinations; Known dementia; Serious systemic illness; Contraindications for imaging examination; Known retinal diseases. Exit criteria: not meet the inclusion criteria; For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator; Any adverse or serious adverse events during the study period judged by investigator.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sheng Zhang
**Phone:** +8618758188313
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sheng Zhang, M.D.
- **Phone:** +8618758188313
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sheng Zhang, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Weitao Yu, B.S.Med
- **Role:** SUB_INVESTIGATOR
**Country:** China
**Facility:** Zhejiang Provincial People's Hospital
**State:** Zhejiang
**Status:** RECRUITING
**Zip:** 310000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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
### 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
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M29437
- Name: Cerebral Small Vessel Diseases
- Relevance: HIGH
- As Found: Cerebral Small Vessel Disease
- 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: D000059345
- Term: Cerebral Small Vessel Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431698
**Acronym:** MOLDEAR
**Brief Title:** CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
**Official Title:** CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
#### Organization Study ID Info
**ID:** 21-0023
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Caen
### Status Module
#### Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-31
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Caen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group
### Conditions Module
**Conditions:**
- Ear Malformation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 134
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Correction of deformation using the adjustable Earwell device
**Intervention Names:**
- Device: adjustable Earwell device
**Label:** Control group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Correction of deformation using the custom-made silicone device
**Intervention Names:**
- Device: Custom-made silicone device
**Label:** Intervention group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** Correction of deformation using the custom-made silicone device
**Name:** Custom-made silicone device
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Control group
**Description:** Correction of deformation using the adjustable Earwell device
**Name:** adjustable Earwell device
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group.
**Measure:** Subjective ear deformation score
**Time Frame:** baseline and 1 year after
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Newborn, age between 8 days and 1 month
* newborn with ear malformation
Exclusion Criteria:
* Total chondrocutaneous agenesis of the ear
* polymalformative syndrome
* age greater than 4 weeks
* parental refusal
**Maximum Age:** 1 Month
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alexis VEYSSIERE
**Phone:** +33231063106
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** VEYSSIERE
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Caen
**Contacts:**
***Contact 1:***
- **Name:** Alexis VEYSSIERE, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Alexis VEYSSIERE
- **Phone:** +33231063106
- **Phone Ext:** +33
- **Role:** CONTACT
***Contact 3:***
- **Name:** Alexis VEYSSIERE, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Caen University Hospital
**State:** N
**Status:** RECRUITING
**Zip:** 14000
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12
- Name: Congenital Abnormalities
- Relevance: HIGH
- As Found: Deformity
### Condition Browse Module - Meshes
- ID: D000000013
- Term: Congenital Abnormalities
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431685
**Brief Title:** Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
**Official Title:** Phase I Study of Whole Brain Low Dose Radiotherapy Combined With ICI and Intrathecal Chemotherapy for Treatment of Refractory Meningeal Metastasis of Lung Cancer
#### Organization Study ID Info
**ID:** LM-001
#### Organization
**Class:** OTHER
**Full Name:** Sichuan University
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sichuan University
#### Responsible Party
**Investigator Affiliation:** Sichuan University
**Investigator Full Name:** You Lu
**Investigator Title:** Chair of Department of Thoracic Cancer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.
**Detailed Description:** This exploratory phase I study will be conducted in West China Hospital, Sichuan University. Three cohorts of whole brain low dose radiotherapy (3 patients per cohort) will be enrolled to determine the safety and efficacy of whole brain low dose radiotherapy combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.
Subjects who fulfil all the inclusion criteria and none of the exclusion criteria will be enrolled and receive treatment with WB-LDRT at same dose (4 Gy/2f) with diffent cycles (decried as below), PD-1 inhibitor, pemetrexed chemotherapy, and intrathecal pemetrexed every 3 weeks (Q3w) for 4 cycles.
Patients will receive WB-LDRT at 3 cohorts with increasing dose fractions: 4 Gy/2f of one cycle in group 1; 4 Gy/2f of two cycles in group 2; 4 Gy/2f of four cycles in group 3.
### Conditions Module
**Conditions:**
- NSCLC
- Low Dose Radiotherapy
- PD-1 Inhibitor
- Leptomeningeal Metastasis
### 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:** The treatment regimen consisted of intrathecal chemotherapy (via lumbar puncture, pemetrexed 30 mg, once per three weeks, 4 cycles in total), PD-1 inhibitor (Sintilimab, via intravenous infusion, once per three weeks, 4 cycles in total)), pemetrexed chemotherapy (via intravenous infusion, once per three weeks, 4 cycles in total) and radiotherapy. Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: 4 Gy/2f of 2 fraction (administered a daily dose of 2 Gy for two days) in group 1; 4 Gy/2f of 4 fractions (administered a daily dose of 2 Gy for two days, once per three weeks, 2 cycles in total) in group 2; 4 Gy/2f of 8 fractions (administered a daily dose of 2 Gy for two days, once per three weeks, 4 cycles in total) in group 3.
**Intervention Names:**
- Radiation: Whole Brain Low Dose Radiotherapy
- Drug: Pemetrexed
- Drug: Sintilimab
- Drug: Chemotherapy
**Label:** whole brain LDRT + ICI + intrathecal chemotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- whole brain LDRT + ICI + intrathecal chemotherapy
**Description:** Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: Group 1: 4 Gy/2f of one cycle; Group 2: 4 Gy/2f of two cycles (Q3w); Group 3: 4 Gy/2f of three cycles (Q3w). WB-LDRT will be administered in a 4 Gy of 2 fractions over two days, starting from Day 1 in the first cycle (a daily dose of 2 Gy, 4 Gy/2f for one cycle, once per three weeks, at minmum in one cycle and maximum in four cycles in total).
**Name:** Whole Brain Low Dose Radiotherapy
**Other Names:**
- WB-LDRT
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- whole brain LDRT + ICI + intrathecal chemotherapy
**Description:** Pemetrexed, 30 mg, intrathecal injection, once per three weeks, 4 cycles in total
**Name:** Pemetrexed
**Other Names:**
- Intrathecal Chemotherapy
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- whole brain LDRT + ICI + intrathecal chemotherapy
**Description:** PD-1 inhibitor (Sintilimab, dose as recommended in the instruction manual), intravenous infusion, once per three weeks, 4 cycles in total
**Name:** Sintilimab
**Other Names:**
- PD-1 Inhibitor
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- whole brain LDRT + ICI + intrathecal chemotherapy
**Description:** Pemetrexed at a dose of 500 mg/m\^2, intravenous infusion, once per three weeks, 4 cycles in total
**Name:** Chemotherapy
**Other Names:**
- One of the standard chemotherapy regimens
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The RANO proposal for response criteria of leptomeningeal metastasis was used to assess the clinical response in this study.
**Measure:** Clinical response rate
**Time Frame:** 48 months
**Description:** The incidence of treatment-related adverse events were measured for determing tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Events of grade 3-5 are defined as moderate and severe adverse events.
**Measure:** Incidence of treatment-related adverse events
**Time Frame:** 48 months
#### Secondary Outcomes
**Description:** NPFS was defined as time from the start of treatment until neurological progression or death. The neurological progression was determined based on the RANO proposal evaluation criteria which have been established and published on Neuro Oncol.
**Measure:** Neurological progression-free survival (NPFS)
**Time Frame:** 48 months
**Description:** Survival time was recorded since the date of patient enrollment. All patients were followed up until death or the end of the study.
**Measure:** Overall survival
**Time Frame:** 48 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. ≥ 18 years old and ≤ 75 years old;
2. Patients with a definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology, or patients with clinical diagnosis combined with tumor history, neuroimaging, clinical manifestations, cerebrospinal fluid examination, etc.;
3. Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment;
4. Efficacy of extracranial lesions SD;
5. Patients with no contraindications to craniocranial radiotherapy were judged by radiotherapy doctors. Subjects who agree to receive immunotherapy, Lumbar puncture, intrathecal chemotherapy, and radiotherapy;
6. Expected survival ≥3 months, PS score ≤3;
7. Agree to provide cerebrospinal fluid, blood and tissue samples for biomarker testing;
8. The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases;
9. One week before enrollment, bone marrow and liver and kidney function met the following criteria:
① Hemoglobin ≥80 g/L, neutrophils ≥1.5×10\^9/L and platelets ≥70×10\^9/L;
② Renal function: Cr≤ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr)≥55 ml/min; Liver function: total bilirubin ≤ULN × 1.5; ALT, AST≤ULN × 2.5; (In case of liver metastasis, total bilirubin should not be higher than 3 times the upper normal limit, and transaminase should not be higher than 5 times the upper normal limit);
10. The fertile women agreed to use contraception during the study period and for 6 months after the study ended; Patients who tested negative for a serum or urine pregnancy test within 7 days prior to joining the study and were not breastfed; Men who agreed to use contraception during the study period and for 6 months after the study ended
Exclusion Criteria:
1. Active autoimmune disease or history of autoimmune diseases;
2. Congenital or acquired immunodeficiency;
3. Uncontrolled cardiac clinical symptoms or diseases;
4. Severe infection or severe comorbidities, such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes;
5. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
6. Other systemic malignancies within the last 5 years;
7. Allergy to any test drug;
8. Uncontrolled epilepsy, neurological failure, or severe treatment-related neurological impairment, uncontrollable psychosis, and other conditions deemed unsuitable for inclusion by the investigator;
9. Pregnant and lactating women, subjects with reproductive capacity are unwilling to take effective contraceptive measures.
**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:** You Lu, MD
**Phone:** 18980601763
**Phone Ext:** +86
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Lisha Xiang, MD
**Phone:** 13320943069
**Phone Ext:** +86
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chengdu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lisha Xiang, MD
- **Phone:** 13320943069
- **Phone Ext:** +86
- **Role:** CONTACT
**Country:** China
**Facility:** West China Hospital, Sichuan University
**State:** Sichuan
**Status:** RECRUITING
**Zip:** 610041
#### Overall Officials
**Official 1:**
**Affiliation:** West China Hospital
**Name:** You Lu, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Cao M, Chen W. Epidemiology of lung cancer in China. Thorac Cancer. 2019 Jan;10(1):3-7. doi: 10.1111/1759-7714.12916. Epub 2018 Nov 28.
**PMID:** 30485694
**Citation:** Clarke JL, Perez HR, Jacks LM, Panageas KS, Deangelis LM. Leptomeningeal metastases in the MRI era. Neurology. 2010 May 4;74(18):1449-54. doi: 10.1212/WNL.0b013e3181dc1a69.
**PMID:** 20439847
**Citation:** Remon J, Le Rhun E, Besse B. Leptomeningeal carcinomatosis in non-small cell lung cancer patients: A continuing challenge in the personalized treatment era. Cancer Treat Rev. 2017 Feb;53:128-137. doi: 10.1016/j.ctrv.2016.12.006. Epub 2016 Dec 30.
**PMID:** 28110254
**Citation:** Gleissner B, Chamberlain MC. Neoplastic meningitis. Lancet Neurol. 2006 May;5(5):443-52. doi: 10.1016/S1474-4422(06)70443-4.
**PMID:** 16632315
**Citation:** Cheng H, Perez-Soler R. Leptomeningeal metastases in non-small-cell lung cancer. Lancet Oncol. 2018 Jan;19(1):e43-e55. doi: 10.1016/S1470-2045(17)30689-7.
**PMID:** 29304362
**Citation:** Le Rhun E, Weller M, van den Bent M, Brandsma D, Furtner J, Ruda R, Schadendorf D, Seoane J, Tonn JC, Wesseling P, Wick W, Minniti G, Peters S, Curigliano G, Preusser M; EANO Guidelines Committee and ESMO Guidelines Committee. Electronic address: [email protected]. Leptomeningeal metastasis from solid tumours: EANO-ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. ESMO Open. 2023 Oct;8(5):101624. doi: 10.1016/j.esmoop.2023.101624. Epub 2023 Sep 19.
**PMID:** 37863528
**Citation:** Chamberlain M, Junck L, Brandsma D, Soffietti R, Ruda R, Raizer J, Boogerd W, Taillibert S, Groves MD, Le Rhun E, Walker J, van den Bent M, Wen PY, Jaeckle KA. Leptomeningeal metastases: a RANO proposal for response criteria. Neuro Oncol. 2017 Apr 1;19(4):484-492. doi: 10.1093/neuonc/now183.
**PMID:** 28039364
**Citation:** Yin K, Li YS, Zheng MM, Jiang BY, Li WF, Yang JJ, Tu HY, Zhou Q, Zhong WZ, Yang XN, Chen HJ, Yan HH, Li LL, Wu YL, Zhang XC. A molecular graded prognostic assessment (molGPA) model specific for estimating survival in lung cancer patients with leptomeningeal metastases. Lung Cancer. 2019 May;131:134-138. doi: 10.1016/j.lungcan.2019.03.015. Epub 2019 Mar 18.
**PMID:** 31027690
**Citation:** Wang Y, Yang X, Li NJ, Xue JX. Leptomeningeal metastases in non-small cell lung cancer: Diagnosis and treatment. Lung Cancer. 2022 Dec;174:1-13. doi: 10.1016/j.lungcan.2022.09.013. Epub 2022 Oct 1.
**PMID:** 36206679
**Citation:** Thai K, Prat A. CNS therapeutics: Immune cells break the barriers. Sci Transl Med. 2023 Nov 8;15(721):eadh1150. doi: 10.1126/scitranslmed.adh1150. Epub 2023 Nov 8.
**PMID:** 37939159
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009385
- Term: Neoplastic Processes
- ID: D000009369
- Term: Neoplasms
- ID: D000010335
- Term: Pathologic Processes
### 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: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: HIGH
- As Found: Metastases
- ID: M12330
- Name: Neoplastic Processes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009362
- Term: Neoplasm Metastasis
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000005493
- Term: Folic Acid Antagonists
- ID: D000019384
- Term: Nucleic Acid Synthesis Inhibitors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M264
- Name: Pemetrexed
- Relevance: HIGH
- As Found: New
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: HIGH
- As Found: Nitrate
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M8619
- Name: Folic Acid Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: T447
- Name: Folinic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068437
- Term: Pemetrexed
- ID: D000082082
- Term: Immune Checkpoint Inhibitors
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431672
**Brief Title:** Perinatal Interpersonal Psychotherapy Group for Distressed Women
**Official Title:** The Feasibility and Effects of Perinatal Interpersonal Psychotherapy Group for Distressed Women
#### Organization Study ID Info
**ID:** MOST 106-2410-H-040-004 -SSS
#### Organization
**Class:** OTHER
**Full Name:** Chung Shan Medical University
#### Secondary ID Infos
**Domain:** Ministry of Science and Technology, Taiwan
**ID:** MOST 107-2410-H-040-005 -SSS
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2020-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2018-03-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chung Shan Medical University
#### Responsible Party
**Investigator Affiliation:** Chung Shan Medical University
**Investigator Full Name:** Peyling Shieh
**Investigator Title:** Associate 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 is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored.
**Detailed Description:** This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored. The third-trimester women were recruited as intervention and control group participants by a quasi-experimental design.
### Conditions Module
**Conditions:**
- Depression, Postpartum
- Social Adjustment
**Keywords:**
- feasibility
- group psychotherapy
- interpersonal psychotherapy
- maternal depression
- perinatal adjustment
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 258
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention was an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum. All participants replied to the measures at four waves from baseline to one year postpartum. The outcome variables were within-group and between-group changes in depression, social support, dyadic adjustment, interpersonal relationship satisfaction, and mother-infant bonding.
**Intervention Names:**
- Other: interpersonal group psychotherapy
**Label:** intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The participants of control group reply questionnaires for four times.
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- intervention group
**Description:** Interpersonal psychotherapy (IPT) was developed by Stuart and O'Hara (1995). It addresses four domains of conflict. The intervention is an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum.
**Name:** interpersonal group psychotherapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Edinburgh Postnatal Depression Scale (EPDS, Cox et al., 1987) was used to assess depressive symptoms. It consists of ten Likert-type items with 0 to 3 points, with higher scores indicating more depressive symptoms over the past week. Following the previous study (Su et al., 2007), we used higher than 12 to define participants with significant depressive tendencies.
**Measure:** Edinburgh Postnatal Depression Scale
**Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
**Description:** The Dyadic Adjustment Scale (DAS, Spanier, 1976) assessed women's perceived quality of either married or unmarried couple relationship. The scale consists of 32 items, primarily scored in a 6-point scale (27 items). It measures four factors: dyadic consensus, dyadic satisfaction, dyadic cohesion, and affectionate expression. Higher scores indicate better dyadic adjustment in respective aspects.
**Measure:** Dyadic Adjustment Scale
**Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
**Description:** The Social Network Interaction System Questionnaire (SNISQ, Lay \& Liu, 1996) was used to evaluate perceptions of social support from partners, original families, and in-laws. The SNISQ consists of nine Likert-type items with 1 to 4 points, with higher scores indicating better- perceived support from specific individuals.
**Measure:** Social Network Interaction System Questionnaire (SNISQ, Lay & Liu, 1996)
**Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
**Description:** Chan et al. (2002) used the Satisfaction with Interpersonal Relationships Scale (SWIRS,) to assess women's satisfaction with their relationships with partners and mothers-in-law over the past few weeks. We expanded the scale to include ratings of relationships with fathers, mothers, and fathers-in-law, resulting in five items. The SWIRS is a Likert-type item with 1 to 7 points, with higher scores indicating greater satisfaction with the relationship.
**Measure:** Satisfaction with Interpersonal Relationships Scale (Chan et al., 2002)
**Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
**Description:** The Mother-Infant Bonding Inventory (MIBI, Shieh et al., 2015) assessed mothers' thoughts, feelings, and commitment toward their infants. The MIBI consists of 25 items scored on 1 to 6 points. Its four factors are proximity, parental adjustment, commitment, and confidence of reciprocity. Higher scores indicate good mother-infant bonding in specific aspects.
**Measure:** Mother-Infant Bonding Inventory (Shieh et al., 2015)
**Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* women in the third trimester of pregnancy, at least 20 years old, able to read and write in Chinese, and "depressed, anxious, or wishing to improve family relationships."
Exclusion Criteria:
* women with schizophrenia, substance use, or suicide risk.
**Gender Based:** True
**Gender Description:** women in pregnancy and postpartum
**Healthy Volunteers:** True
**Minimum Age:** 20 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Taichung
**Country:** Taiwan
**Facility:** Chung Shan Medical University
**Zip:** 402
#### Overall Officials
**Official 1:**
**Affiliation:** Chung Shan Medical University, Taiwan
**Name:** Peyling Shieh, Ph. D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** For confidentiality, we plan to share IPD with other researchers by contact.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000003866
- Term: Depressive Disorder
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000011644
- Term: Puerperal Disorders
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M21076
- Name: Depression, Postpartum
- Relevance: HIGH
- As Found: Depression, Postpartum
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- 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: M14499
- Name: Puerperal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- 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: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019052
- Term: Depression, Postpartum
- ID: D000003863
- Term: Depression
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431659
**Brief Title:** Swedish Palliative Care Guide (S-PCG) at Residential Facilities
**Official Title:** Swedish Palliative Care Guide (S-PCG) at Residential Facilities
#### Organization Study ID Info
**ID:** 2023-02274-01-1
#### Organization
**Class:** OTHER
**Full Name:** Region Skane
### Status Module
#### Completion Date
**Date:** 2027-05-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2026-05-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Region Skane
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Palliative care aims to improve the quality of life for patients and families who are affected life-threatening, incurable disease. The care should be person-centred, but it is not entirely clear how this is best achieved. The Institute for Palliative Care, Lund, has developed the Swedish Palliative Care Guide (S-PCG) which support for a person-centred approach throughout the palliative care process. The aim of this study is to implement the Swedish Palliative Care Guide (S-PCG) part 2 at Residential Facilities and evaluate functionality, effect and patient benefit in clinical use.
**Detailed Description:** The concept of palliative care has changed over time and is not longer reserved for patients in the dying phase, on the contrary more and more studies show that early integration of palliative care and disease-specific care produce positive results. Specifically, palliative care is about prevent and alleviate suffering by early detection of symptoms and treatment of physical, psychological, social and existential problems. In order to provide the best care, a holistic approach is required that takes up what is important right now and not focus on individual diagnoses. The Swedish Palliative Care Guide (S-PCG) aims to support for a person-centred approach throughout the palliative care process. The purpose of S-PCG is to provide increased security and quality of life for patients and their relatives by identifying needs, make sure that these are addressed and followed up. S-PCG can be used cross-professionally and provides support for coordination and communication in care transitions, regardless of diagnosis or form of care.
The research questions for this study are:
1. Has people living at Residential Facilities to a greater extent treatment restrictions, a stated plan in case of deterioration and information to relatives documented in the medical record after S-PCG was implemented compared to people who were cared for, at the same Residential Facilities, before S-PCG was implemented?
2. Do patients cared for after S-PCG was implemented feel more involved in decisions about their care and do they feel more safe to discuss their thoughts about the end of life (if they so wish)?
### Conditions Module
**Conditions:**
- Age Problem
- Old Age; Debility
- Death
**Keywords:**
- Palliative care
- Elderly
- Residential Facilities
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Measured by likert scale, 1-5. Higher number indicate higher experience of security
**Measure:** Experience of security
**Time Frame:** baseline and 12 weeks after implementation of S-PCG
**Description:** Measured by likert scale, 1-5. Higher number indicate higher experience of participation
**Measure:** Experience of participation
**Time Frame:** baseline and 12 weeks after implementation of S-PCG
#### Secondary Outcomes
**Description:** Presence of documented break point conversations in medical records.
**Measure:** Breakpoint conversation
**Time Frame:** baseline and 12 weeks after implementation of S-PCG
**Description:** Presence of documented treatment limitations in medical records.
**Measure:** Treatment limitations
**Time Frame:** baseline and 12 weeks after implementation of S-PCG
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients living in residential facilities.
* Ability to answer a short survey in Swedish.
Exclusion Criteria:
- Patients with dementia or other Cognitive Dysfunction.
**Maximum Age:** 130 Years
**Minimum Age:** 65 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Patients living at included recidental facilities.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Stockholm
**Country:** Sweden
**Facility:** Valgossens äldreboende
**State:** Region Stockholm
**Zip:** 11219
#### Overall Officials
**Official 1:**
**Affiliation:** Region Skåne
**Name:** Maria Schelin, ass. prof.
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- 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: M6845
- Name: Death
- Relevance: LOW
- As Found: Unknown
- ID: M1175
- Name: Frailty
- Relevance: HIGH
- As Found: Debility
### Condition Browse Module - Meshes
- ID: D000073496
- Term: Frailty
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431646
**Brief Title:** Effectiveness of Web-Based Education on Symptoms and Quality of Life in University Students With Premenstrual Syndrome
**Official Title:** Evaluation of the Effectiveness of Web-Based Education on Premenstrual Syndrome (PMS) Symptoms and Quality of Life
#### Organization Study ID Info
**ID:** 60116787-020/31827
#### Organization
**Class:** OTHER
**Full Name:** Pamukkale University
#### Secondary ID Infos
**Domain:** PamukkaleU Scientific Research Projects Coordination Unit
**ID:** 2020SABE021
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2022-06-13
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-03-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Pamukkale University
#### Responsible Party
**Investigator Affiliation:** Pamukkale University
**Investigator Full Name:** Sevgi Özkan
**Investigator Title:** Dean of Health Sciences Faculty, Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Digital solutions are becoming increasingly prevalent, addressing health concerns through innovative means has become imperative. Among these concerns, Premenstrual Syndrome (PMS) stands out as a significant challenge that affecting the physical and emotional well-being of women of reproductive age. Despite previous studies demonstrating the effectiveness of health education for PMS, there remains a gap in providing accessible and cost-effective evidence-based interventions. The present study seeks to address this gap by using technology to provide targeted information and support to women. For this reason, the purpose of this randomized controlled study is to evaluate the effectiveness of a web-based health education in university students with PMS. The main questions it aims to answer are:
* Does web-based education lower the premenstrual symptoms in university students with PMS?
* Does web-based education improve the quality of life in university students with PMS?
Researchers compared web-based education to a control (no special intervention) to see if intervention works to management PMS. Intervention group participants received web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management strategies for 4 weeks.
**Detailed Description:** The study was planned as a parallel, single-blind, randomized, controlled experimental study with a pretest-posttest design. The sample group of the research was the nursing department of a Faculty of Health Sciences in Pamukkale University. Eligibility was determined by the Premenstrual Syndrome Scale and personal information form. The sample size was calculated in the PS Power and Sample Size Calculations 3.1.6 program by using data from a previous study with a large effect size (α =0.05, d=0.86). Accordingly, it was found that at least 32 participants should be taken for each group to sampling for 80% power. To avoid possible data loss, all participants (n=74) determined to be eligible were included in the study. A simple randomization method was used in this study. Outcomes were measured at baseline, 4 weeks, and 12 weeks after the intervention began. Data were collected using the Premenstrual Syndrome Scale, Premenstrual Symptoms Impact Scale, System Usability Scale, and personal information form.
### Conditions Module
**Conditions:**
- Premenstrual Syndrome
- Quality of Life
**Keywords:**
- Premenstrual Syndrome
- Web-Based
- Nurse-Led
- Health Education
- Quality of Life
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized controlled study with a pretest-posttest design
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Student
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 67
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention group received web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management (especially, non-pharmacologic strategies) for 4 weeks.
**Intervention Names:**
- Behavioral: A web-based education intervention developed for university students with PMS
**Label:** Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group received no special intervention.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Group
**Description:** The content of the web-based education program includes the definition, prevalence, importance, causes, symptoms, diagnosis, risk factors, management strategies and treatment options of PMS. The education emphasizes non-pharmacological strategies for managing PMS, including diet, exercise and body mass index (BMI), sleep hygiene, smoking cessation, stress management, as well as vitamin and mineral supplements, herbal therapy, acupuncture, acupressure and reflexology.
**Name:** A web-based education intervention developed for university students with PMS
**Other Names:**
- Premenstrual Syndrome Education Program
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** The form was designed by researchers to collect students' socio-demographic characteristics and factors related to PMS, including menstrual characteristics and associated risk factors.
**Measure:** Personal Information Form
**Time Frame:** Baseline
#### Primary Outcomes
**Description:** The scale consists of 44 questions about to experiences in the week before the menstrual period. The total score ranges from 44 to 220, and above the 132 points indicates the presence of PMS. The nine subscales are as follows: (1) depressive affect, (2) anxiety, (3) fatigue, (4) irritability, (5) depressive thoughts, (6) pain, (7) appetite changes, (8) sleep changes, and (9) swelling.
**Measure:** Premenstrual Syndrome Scale (PMSS)
**Time Frame:** Change from baseline score at 4 and 12 weeks
**Description:** The scale consists of six question to evaluate the impact of premenstrual symptoms on health-related quality-of-life. Each question measures the intensity of symptoms ranging from 1 (no influence) to 5 (severe influence), concerning the "last premenstrual period". The total score ranges from 6 to 30, with higher scores indicating worsening quality of life.
**Measure:** Premenstrual Symptoms Impact Scale (PMSIS)
**Time Frame:** Change from baseline score at 4 and 12 weeks
#### Secondary Outcomes
**Description:** The scale consists of 10 questions to evaluate user satisfaction with the usability of products and systems, including websites. Each question scored between 0 (strongly disagree) and 4 (strongly agree) and the total score obtained is multiplied by 2.5 to obtain a score between 0 and 100. A score of 68 or higher is considered above average and indicates the system is usable.
**Measure:** System Usability Scale (SUS)
**Time Frame:** At the end of the 4-week intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Presence of PMS, defined as a score of 132 and above on the PMSS
* Menstrual cycle within the normal range (21-35 days)
* Not using oral contraceptives
* Not having any psychiatric- related problems or treatment
* Actively using the Internet
* Be over 18 years old
* Volunteering to participate in research
Exclusion Criteria:
* Problems accessing the Internet
* Inability to log into the website
* Non-response to the survey questions
**Gender Based:** True
**Gender Description:** Female students with PMS
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Denizli
**Country:** Turkey
**Facility:** Pamukkale University
**Zip:** 20160
#### Overall Officials
**Official 1:**
**Affiliation:** Pamukkale University
**Name:** Ece Özkaradiğin, RN, MSc
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Pamukkale University
**Name:** Sevgi Özkan, RN, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Management of Premenstrual Syndrome: Green-top Guideline No. 48. BJOG. 2017 Feb;124(3):e73-e105. doi: 10.1111/1471-0528.14260. Epub 2016 Nov 30. No abstract available.
**PMID:** 27900828
**Citation:** Taghizadeh Z, Shirmohammadi M, Feizi A, Arbabi M. The effect of cognitive behavioural psycho-education on premenstrual syndrome and related symptoms. J Psychiatr Ment Health Nurs. 2013 Oct;20(8):705-13. doi: 10.1111/j.1365-2850.2012.01965.x. Epub 2012 Sep 10.
**PMID:** 22957993
**Citation:** Ayaz-Alkaya S, Yaman-Sozbir S, Terzi H. The effect of Health Belief Model-based health education programme on coping with premenstrual syndrome: a randomised controlled trial. Int J Nurs Pract. 2020 Apr;26(2):e12816. doi: 10.1111/ijn.12816. Epub 2020 Jan 27.
**PMID:** 31985138
**Citation:** Simsek Kucukkelepce D, Timur Tashan S. The effects of health belief model-based education and acupressure for coping with premenstrual syndrome on premenstrual symptoms and quality of life: A randomized-controlled trial. Perspect Psychiatr Care. 2021 Jan;57(1):189-197. doi: 10.1111/ppc.12546. Epub 2020 May 29.
**PMID:** 32468669
**Citation:** Borji-Navan S, Mohammad-Alizadeh-Charandabi S, Esmaeilpour K, Mirghafourvand M, Ahmadian-Khooinarood A. Internet-based cognitive-behavioral therapy for premenstrual syndrome: a randomized controlled trial. BMC Womens Health. 2022 Jan 8;22(1):5. doi: 10.1186/s12905-021-01589-7.
**PMID:** 34996424
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000008599
- Term: Menstruation Disturbances
### Condition Browse Module - Browse Branches
- 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: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M14167
- Name: Premenstrual Syndrome
- Relevance: HIGH
- As Found: Premenstrual Syndrome
- ID: M11582
- Name: Menstruation Disturbances
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000013577
- Term: Syndrome
- ID: D000011293
- Term: Premenstrual Syndrome
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431633
**Acronym:** ARIAN
**Brief Title:** Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.
**Official Title:** A Phase III Clinical Trial of Adjuvant Treatment With Sacituzumab and Zimberelimab for Stage IB-IIIA-IIIB(N2) Previously Resected (R0) Non-small Cell Lung Cancer Patients That Did Not Achieve Pathological Complete Response After Neoadjuvant treatment_ARIAN
#### Organization Study ID Info
**ID:** GECP 23/03_ARIAN
#### Organization
**Class:** OTHER
**Full Name:** Fundación GECP
### Status Module
#### Completion Date
**Date:** 2031-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2031-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-16
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Fundación GECP
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial.
129 resected patients (43 per arm) with stage from IB to IIIA and IIIB (N2) non-small cell lung cancer that do not achieve pathologic complete response (pCR) after neoadjuvant treatment.
This clinical trial has 3 arms of treatment. ARM 1: Observation 10 months, ARM 2: treatment with immunotherapy (Zimberelimab) for 13 cycles and ARM 3: treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles.
The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.
Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.
**Detailed Description:** This is an open-label, phase II, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial.
Patients stage IB to IIIA-IIIB (T3N2) after surgical resection if they did not achieve a pathological com-plete response (pCR) will be randomized 1:1:1 to:
* ARM 1: Observational Arm for 10 months
* ARM 2: Immunotherapy (Zimberelimab) treatment for 13 cycles, Q3W
* ARM 3: Sacituzumab Govitecan + Zimberelimab Q3W for 8 cycles + Zimberelimab Q3W for 5 cycles. Patients will receive 8 cycles of the combination and 5 cycles of Zimberelimab monotherapy.
The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.
Disease Free survival (DFS): The time from random assignment to cancer recurrence or death from any cause.
Secondary objectives:
* Overall survival (OS): at 12, 24 and 36 months after the start of adjuvant treatment
* Safety and tolerability of the combination of Sacituzumab Govitecan + Zimberelimab according to CTCAE v5.0.
Exploratory objectives
- To evaluate whether there is a significant association between change in levels of ctDNA between baseline and after adjuvant treatment and OS and DFS.
The total trial duration will be 7 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. One year of treatment and 3 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded
### Conditions Module
**Conditions:**
- Lung Diseases
- Carcinoma, Non-Small-Cell Lung
- Resectable Lung Non-Small Cell Carcinoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 129
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients randomized in this arm will be in observation for 10 months. It is allowed to administer adjuvant treatment according to investigator criteria. Immunotherapy is not allowed in this arm, only chemotherapy treatment is allowed.
**Intervention Names:**
- Drug: Cisplatin
- Drug: Carboplatin
**Label:** ARM 1: Observation-investigator decision
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Adjuvant treatment with Zimberelimab will start between the 3rd to the 10th week from surgery. 13 cycles will be administered in total. Cycles will be administered in 21-day intervals (Q3W).
Zimberelimab: day 1 360 mg IV Q3W (13 cycles)
**Intervention Names:**
- Drug: Zimberelimab
**Label:** ARM 2: Immunotherapy. Zimberelimab treatment for 13 cycles
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Sacituzumab Govitecan: day 1 and 8; 10mg/Kg IV Q3W Zimberelimab: day 1 360 mg IV Q3W
Treatment sequence:
Adjuvant treatment will start between the 3rd to the 10th week from surgery. 13 cycles will be administered in total. Cycles will be administered in 21-day intervals (Q3W).
Patients will receive 8 cycles of Sacituzumab Govitecan + Zimberelimab and 5 cycles of Zimberelimab monotherapy.
**Intervention Names:**
- Drug: Zimberelimab
- Drug: Sacituzumab govitecan
**Label:** ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cycles
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ARM 2: Immunotherapy. Zimberelimab treatment for 13 cycles
- ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cycles
**Description:** Zimberelimab is a fully human IgG4 monoclonal antibody targeting human PD-1. PD-1 is a type I transmembrane protein that is part of the immunoglobulin gene superfamily and the CD28 family of cell surface receptors. PD-1 is an inhibitory immune checkpoint protein that is expressed on activated B cells, T cells, and myeloid cells, and it plays a key role in limiting the activity of effector T cells.
Zimberelimab is formulated at 30 mg/mL in a buffer solution containing histidine/histidine-HCl buffer solution, sucrose, sodium chloride, and polysorbate 80, at pH 5.5. The investigational product is supplied as a vial contains 120 mg of active Zimberelimab at a concentration of 30mg/mL.
No premedication nor profilaxis is needed before Zimberelimab administration. Zimberelimab doses are administered by IV infusion over 60 minutes, followed by a 30- to 60-minute observation period, on D1 of each 21-day cycle.
**Name:** Zimberelimab
**Other Names:**
- anti-PD-1 monoclonal antibody AB122
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cycles
**Description:** Sacituzumab govitecan (SG) is an ADC composed of the following 3 components:
o The humanized monoclonal antibody hRS7 IgG1κ, which binds to Trop-2, a transmembrane calcium signal transducer that is overexpressed in many epithelial cancers.
o The camptothecin-derived agent SN-38, a topoisomerase I inhibitor. o A hydrolyzable linker, with the company designation as CL2A that links the humanized monoclonal antibody to SN-38.
Sacituzumab govitecan is approved globally for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and HR+ breast cancer.
**Name:** Sacituzumab govitecan
**Other Names:**
- Trodelvy
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- ARM 1: Observation-investigator decision
**Description:** Cisplatin-based adjuvant chemotherapy
Cisplatin - CAS 15663-27-1, is a platinum coordination complex with potent anti-neoplastic activity. Induces apoptosis in cancer cells, possibly via caspase-3 activation.
**Name:** Cisplatin
**Other Names:**
- Platinol
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- ARM 1: Observation-investigator decision
**Description:** Cisplatin-based adjuvant chemotherapy Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center. Other Name: ATC code: L01XA02
**Name:** Carboplatin
**Other Names:**
- Paraplatin
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Analyze plasma samples and quantifying the amount of circulating tumor DNA (ctDNA) by NGS.
**Measure:** Change in levels of ctDNA during treatment
**Time Frame:** To analyze at pretreatment, after 6 months of treatment, and at disease relapse, assessed up to 36 months
#### Primary Outcomes
**Description:** Defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.
**Measure:** Disease free survival
**Time Frame:** The time from random assignment to cancer recurrence or death from any cause, assessed up to 36 months
#### Secondary Outcomes
**Description:** defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
**Measure:** Overall survival
**Time Frame:** To evaluate at 12, 24 and 36 months after the start of adjuvant treatment
**Description:** Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
**Measure:** Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
**Time Frame:** From the subject's written consent to participate in the study through 180 days after the final administration of the drug
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed.
* 2. Patients should be classified postoperatively in stage IB, IIA, IIB, IIIA or IIIB (N2) according to pathological criteria (pTNM) and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
* 3. Complete surgical resection (R0) of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all accessible lymph node levels, as established in the European Society of Thoracic Surgeons guide. Consequently, at the end of the surgical intervention it is recommended to have obtained samples of a minimum of 3 specific mediastinal ganglionic lobe stations (N2), one of which should include station 7, and at least one N1 station
* 4. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon based on intraoperative findings. Patients who have had only segmentectomies or wedge resections are not considered eligible for participation in this study except if R0 resection can be confirmed.
* 5. Only patients that do not achieve pathological complete response (pCR) seen in the surgical piece after neoadjuvant therapy are eligible.
* 6. Preoperative (neoadjuvant) use of platinum-based chemotherapy + immunotherapy (anti PD-1) is mandatory.
* 7. Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible.
* 8. A minimum of 3 weeks must have elapsed between the surgical intervention performed for the NSCLC and the randomization. Adjuvant treatment must start between the 3rd and the 10th week from surgery.
* 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* 10. Patients aged ≥ 18 years.
* 11. PDL1 value analysed locally (hospital must be able to provide this value before randomization)
* 12. PET-CT and brain CT before randomization to confirm the absence of distant disease.
* 13. Adequate hematologic and organ function
* 14.All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.
* 15.For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception
* 16. For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception
* 17. Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs.
* 18.Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.
* 19.Patient capable of proper therapeutic compliance and accessible for correct follow-up
* 20. Patients with a life expectancy of at least more than 12 weeks
Exclusion Criteria:
* 1. Patients with a history of other malignant diseases, with the exception of the following:
* properly treated non-melanotic skin cancer
* cancer in situ treated with curative intent or other malignancies treated with curative intent and without signs of disease for a period of\> 3 years after the end of the treatment and which, in the opinion of the doctor in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease.
* 2.T4 patients with invasion of heart, great vessels, carina, trachea, oesophagus or spine
* 3. Patients with ALK translocation, STK11 o KEAP1 known mutations before inclusion in this trial.
* 4. Patients with adenocarcinoma NSCLC must be tested for the common EGFR mutations before inclusion. Patients with any known EGFR mutation cannot be enrolled in the study.
* 5. Patients with a combination of microcytic and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma
* 6. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of randomization.
* 7. Patients that received live attenuated vaccines within 30 days prior to randomization
* 8. History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments
* 9. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol.
* 10. Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction
* 11. Pregnant or breastfeeding women
* 12. Patients in whom R0 resection cannot be confirmed.
* 13. Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* 14.Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* 15. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
* 16. History of allergy or hypersensitivity to any of the study drug components
* 17. Pleural or pericardial effusion, both will be considered indicative of metastatic disease unless proven otherwise. Patients with pleural effusion not visible on chest-X-ray or too small to perform diagnostic puncture safely may be included.
* 18. Have known history of HIV-1 or 2 with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
* 19.Severe infections within 4 weeks prior to be included in the study, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
* 20.Patients with medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to understand the patient information sheet or comply with study procedures.
* 21. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder; any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement; or prior pneumonectomy.
* 22. Treatment with systemic immunosuppressive medications
* 23.Patients with uncontrolled comorbidities that may affect the clinical trial compliance.
* 24.Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eva Pereira
**Phone:** +34 934302006
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Elche
**Contacts:**
***Contact 1:***
- **Name:** Miguel Borregón Rivilla, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Miguel Borregón Rivilla, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital General de Elche
**State:** Alicante
**Zip:** 03203
**Location 2:**
**City:** Badalona
**Contacts:**
***Contact 1:***
- **Name:** Marta Domenech, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Marta Domenech, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** ICO Badalona, Hospital Germans Trias i Pujol
**State:** Barcelona
**Zip:** 08916
**Location 3:**
**City:** Hospitalet de Llobregat
**Contacts:**
***Contact 1:***
- **Name:** Ernest Nadal, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ernest Nadal, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** ICO Hospitalet
**State:** Barcelona
**Zip:** 08908
**Location 4:**
**City:** Jerez De La Frontera
**Contacts:**
***Contact 1:***
- **Name:** Mª Ángeles Moreno, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mª Ángeles Moreno, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario Jerez De La Frontera
**State:** Cádiz
**Zip:** 11407
**Location 5:**
**City:** A Coruña
**Contacts:**
***Contact 1:***
- **Name:** Rosario García Campelo, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Rosario García Campelo, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospitalario Universitario A Coruña
**State:** La Coruña
**Zip:** 15006
**Location 6:**
**City:** Las Palmas De Gran Canaria
**Contacts:**
***Contact 1:***
- **Name:** David Aguiar Bujanda, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** David Aguiar Bujanda
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitari de Gran Canària Doctor Negrín
**State:** Las Palmas
**Zip:** 35010
**Location 7:**
**City:** Majadahonda
**Contacts:**
***Contact 1:***
- **Name:** Mariano Provencio, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mariano Provencio, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario Puerta de Hierro
**State:** Madrid
**Zip:** 28222
**Location 8:**
**City:** Palma De Mallorca
**Contacts:**
***Contact 1:***
- **Name:** Aitor Azkárate Martínez, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Aitor Azkárate Martínez, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital de Son Espases
**State:** Mallorca
**Zip:** 07120
**Location 9:**
**City:** Vigo
**Contacts:**
***Contact 1:***
- **Name:** Gerardo Huidobro, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Gerardo Huidobro, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Complejo Hospitalario Universitario de Vigo
**State:** Pontevedra
**Zip:** 36036
**Location 10:**
**City:** Reus
**Contacts:**
***Contact 1:***
- **Name:** Clara Lucía Gozálvez, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Clara Lucía Gozálvez, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitari Sant Joan de Reus
**State:** Tarragona
**Zip:** 43204
**Location 11:**
**City:** Alicante
**Contacts:**
***Contact 1:***
- **Name:** Bartomeu Massuti, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Bartomeu Massuti, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital General Universitario de Alicante
**Zip:** 03010
**Location 12:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Name:** Alex Martínez, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alex Martínez, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitari Vall d' Hebron
**Zip:** 08035
**Location 13:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Name:** Noemí Reguart
- **Role:** CONTACT
***Contact 2:***
- **Name:** Noemí Reguart, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Clínic De Barcelona
**Zip:** 08036
**Location 14:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Name:** Andres Barba, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Andres Barba, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital de la Santa Creu i Sant Pau
**Zip:** 08041
**Location 15:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Name:** Laia Vilà, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Laia Vilà, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Parc Taulí
**Zip:** 08208
**Location 16:**
**City:** Bilbao
**Contacts:**
***Contact 1:***
- **Name:** Mª Ángeles Sala, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mª Ángeles Sala, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital De Basurto
**Zip:** 48013
**Location 17:**
**City:** León
**Contacts:**
***Contact 1:***
- **Name:** Blanca Távara, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Blanca Távara, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario de León
**Zip:** 24071
**Location 18:**
**City:** Lugo
**Contacts:**
***Contact 1:***
- **Name:** Begoña Campos, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Begoña Campos, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario Lucus Augusti
**Zip:** 27003
**Location 19:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Name:** Monica Antoñanzas, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Monica Antoñanzas, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Clínico San Carlos
**Zip:** 28040
**Location 20:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Name:** Manuel Dómine, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Manuel Dómine, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario Fundación Jiménez Díaz
**Zip:** 28040
**Location 21:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Name:** Javier De Castro, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Javier De Castro, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario la Paz
**Zip:** 28046
**Location 22:**
**City:** Ourense
**Contacts:**
***Contact 1:***
- **Name:** Karmele Areses, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Karmele Areses
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Santa María Nai
**Zip:** 32005
**Location 23:**
**City:** Palma De Mallorca
**Contacts:**
***Contact 1:***
- **Name:** Juan Coves Sarto, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Juan Coves Sarto, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitari Son Llatzer
**Zip:** 07198
**Location 24:**
**City:** Salamanca
**Contacts:**
***Contact 1:***
- **Name:** Alejandro Olivares Hernández, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alejandro Olivares Hernández, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario Salamanca
**Zip:** 37007
**Location 25:**
**City:** Santa Cruz De Tenerife
**Contacts:**
***Contact 1:***
- **Name:** Karla Mercedes Medina, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Karla Mercedes Medina, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario Nuestra Señora La Candelaria
**Zip:** 38009
**Location 26:**
**City:** Sevilla
**Contacts:**
***Contact 1:***
- **Name:** Reyes Bernabé, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Reyes Bernabé, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Virgen del Rocío
**Zip:** 41013
**Location 27:**
**City:** Terrassa
**Contacts:**
***Contact 1:***
- **Name:** Remei Blanco, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Remei Blanco, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Consorci Sanitari de Terrassa
**Zip:** 08227
**Location 28:**
**City:** Valencia
**Contacts:**
***Contact 1:***
- **Name:** Amelia Insa, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Amelia Insa, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Clínico de Valencia
**Zip:** 46010
**Location 29:**
**City:** Valencia
**Contacts:**
***Contact 1:***
- **Name:** Oscar Juan-Vidal, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Oscar Juan-Vidal, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario La Fe
**Zip:** 46026
**Location 30:**
**City:** Valladolid
**Contacts:**
***Contact 1:***
- **Name:** Rafael López, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Rafael López, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Clínico Universitario de Valladolid
**Zip:** 47003
#### Overall Officials
**Official 1:**
**Affiliation:** President of Fundacion GECP
**Name:** Mariano Provencio, MD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Web page of the sponsor where users can find more information about Fundación GECP studies
**URL:** http://www.gecp.org
## 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: D000012140
- Term: Respiratory Tract Diseases
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Carcinoma, Non-Small-Cell Lung
- ID: M11168
- Name: Lung Diseases
- Relevance: HIGH
- As Found: Lung Disease
- 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: 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
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
- ID: D000008171
- Term: Lung Diseases
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000018796
- Term: Immunoconjugates
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: AA
- Name: Amino Acids
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M6182
- Name: Cisplatin
- Relevance: LOW
- As Found: Unknown
- ID: M18650
- Name: Carboplatin
- Relevance: HIGH
- As Found: System
- ID: M1671
- Name: Irinotecan
- Relevance: LOW
- As Found: Unknown
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M287620
- Name: Sacituzumab govitecan
- Relevance: HIGH
- As Found: In blood
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5426
- Name: Camptothecin
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M19117
- Name: Immunoglobulins, Intravenous
- Relevance: LOW
- As Found: Unknown
- ID: M29349
- Name: Topoisomerase I Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M20855
- Name: Immunoconjugates
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: T8
- Name: Histidine
- Relevance: LOW
- As Found: Unknown
- ID: T395
- Name: Glucosamine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000016190
- Term: Carboplatin
- ID: C000608132
- Term: Sacituzumab govitecan
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431620
**Brief Title:** Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer
**Official Title:** Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer
#### Organization Study ID Info
**ID:** KY20240514-03
#### Organization
**Class:** OTHER
**Full Name:** Nanjing First Hospital, Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Nanjing First Hospital, Nanjing Medical University
#### Responsible Party
**Investigator Affiliation:** Nanjing First Hospital, Nanjing Medical University
**Investigator Full Name:** Feng Wang
**Investigator Title:** Director of nuclear medicine department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Exogenous injection of recombinant human thyroid stimulating hormone (rhTSH) can elevate TSH in the short term (2 days) to meet the requirements of diagnostic 131I SPECT/CT whole-body scans. Antiangiogenic tyrosine kinase inhibitors (TKI) couuld alter the uptake of radioactive 131I in locally advanced or metastatic differentiated thyroid cancer. rhTSH can help to perform the diagnostic 131I SPECT/CT whole-body scans before and after the TKI usage. rhTSH can reduce the risk of tumor progression caused by thyroid hormone withdrawal period and the side effects of hypothyroidism also caused by thyroid hormone withdrawal, and clarify the 131I uptake change after TKI treatment.
### Conditions Module
**Conditions:**
- Recombinant Human Thyroid Stimulating Hormone
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** rhTSH is used to raise blood TSH levels to meet the requirements of diagnostic 131I SPECT/CT whole-body scans before and after TKI medication.
**Intervention Names:**
- Drug: Recombinant Human Thyroid Stimulating Hormone
**Label:** rhTSH group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- rhTSH group
**Description:** recombinant human thyrotropin (rhTSH) injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days.
**Name:** Recombinant Human Thyroid Stimulating Hormone
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of patients with thyroid stimulating hormone\>30 mIU/L
**Measure:** TSH
**Time Frame:** 24 hours after the second TSH injection
#### Secondary Outcomes
**Description:** Positive diagnosis rate of lesions in diagnostic 131I SPECT/CT whole-body scans
**Measure:** Positive diagnosis rate of lesions
**Time Frame:** 72 hours after 131I treatment until progression or death, whichever came first
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age: 18\~75 years old (including 18 and 75 years old);
* ECOG: 0-2 points;
* Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker (tg), biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1.
* Hemoglobin ≥80g/L, neutrophil ≥1.5×109/L, platelet count ≥80×109/L, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml/min, Blood urea nitrogen ≤2.5× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g/L;
* Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men);
* Participants voluntarily joined the study and signed informed consent, with good compliance and follow-up;
* Patients diagnosed with iodine-refractory/potentially iodine-refractory DTC after multidisciplinary team discussion.
Exclusion Criteria:
* Accompanied by pleural effusion or ascites, causing respiratory distress;
* Symptoms of brain metastasis cannot be controlled and treated in less than 2 months; there is a risk of suffocation due to excessively large neck metastatic masses; patients with spinal bone metastases have a risk of spinal cord compression paralysis; cardiac metastasis, heart failure, and patients at risk of acute cardiovascular events;
* Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 2) Poorly controlled arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval (QTc) male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association (NYHA) classification); 3) Poorly controlled diabetes (fasting blood sugar \>10mmol/L); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU/mL; hepatitis C: positive hepatitis C virus (HCV) RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment.
* Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization;
* Unable to quit or with a history of psychiatric medication abuse;
* Allergic to the investigational drug (rhTSH or 131I) or its excipients;
* Had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening;
* Received lipophilic iodine contrast agents (such as iodized oil, iodized benzene, etc.) within the past 3 months or received water-soluble iodine contrast agents (such as iohexol, iodinated glycerol, etc.) within the past 1 month prior to screening;
* Pregnant or lactating women, or women who engaged in unprotected sexual intercourse within the two weeks prior to screening, or women with a positive blood pregnancy test at screening;
* Male subjects (or their partners) or female subjects who have plans for fertility or donation of sperm or ova during the entire study period and within 6 months after the end of the study, and who are unwilling to adopt contraceptive measures during the study period and within 6 months after the end of the study;
* Researchers believe that the presence of any condition may harm the subjects or prevent them from meeting or fulfilling the study requirements.
**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:** Feng Wang
**Phone:** 02552271455
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Liang Shi
**Phone:** 02552271491
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Feng Wang
- **Phone:** 02552271455
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Liang Shi
- **Phone:** 02552271491
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital of Nanjing Medical Univerity
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 210006
#### Overall Officials
**Official 1:**
**Affiliation:** Nanjing First Hospital, Nanjing Medical University
**Name:** Feng Wang
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: BC04
- Name: Neoplasms
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16723
- Name: Thyroid Neoplasms
- Relevance: HIGH
- As Found: Thyroid Cancer
- ID: M16718
- Name: Thyroid Diseases
- Relevance: HIGH
- As Found: Thyroid
- 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 - Ancestors
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9789
- Name: Hormones
- Relevance: HIGH
- As Found: Loss
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006728
- Term: Hormones
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431607
**Brief Title:** A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults
**Official Title:** A Phase 2a Randomized, Observer-blind, Dose-finding Study to Evaluate the Immunogenicity and Safety of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older
#### Organization Study ID Info
**ID:** 222853
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** GlaxoSmithKline
#### 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:** The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA).
### Conditions Module
**Conditions:**
- Influenza, Human
**Keywords:**
- Influenza
- Safety
- Reactogenicity
- Immunogenicity
- mRNA vaccine
- Healthy younger adults
- Healthy older adults
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** This is an observer blind study.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
**Intervention Names:**
- Biological: Flu Seasonal mRNA Formulation 1
**Label:** Flu mRNA_YA_Group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
**Intervention Names:**
- Biological: Flu Seasonal mRNA Formulation 2
**Label:** Flu mRNA_YA_Group 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
**Intervention Names:**
- Biological: Flu Seasonal mRNA Formulation 3
**Label:** Flu mRNA_YA_Group 3
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
**Intervention Names:**
- Biological: Flu Seasonal mRNA Formulation 4
**Label:** Flu mRNA_YA_Group 4
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Eligible participants receive 1 dose of an active comparator at Day 1 intramuscularly.
**Intervention Names:**
- Combination Product: Active Comparator 1
**Label:** YA_Active Comparator Group 1
**Type:** ACTIVE_COMPARATOR
#### Arm Group 6
**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
**Intervention Names:**
- Biological: Flu Seasonal mRNA Formulation 5
**Label:** Flu mRNA_OA_Group 1
**Type:** EXPERIMENTAL
#### Arm Group 7
**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
**Intervention Names:**
- Biological: Flu Seasonal mRNA Formulation 6
**Label:** Flu mRNA_OA_Group 2
**Type:** EXPERIMENTAL
#### Arm Group 8
**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
**Intervention Names:**
- Biological: Flu Seasonal mRNA Formulation 7
**Label:** Flu mRNA_OA_Group 3
**Type:** EXPERIMENTAL
#### Arm Group 9
**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
**Intervention Names:**
- Biological: Flu Seasonal mRNA Formulation 8
**Label:** Flu mRNA_OA_Group 4
**Type:** EXPERIMENTAL
#### Arm Group 10
**Description:** Eligible participants receive 1 dose of an active comparator at Day 1 intramuscularly.
**Intervention Names:**
- Combination Product: Active Comparator 2
**Label:** OA_Active Comparator Group 2
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Flu mRNA_YA_Group 1
**Description:** 1 dose of Flu mRNA Formulation 1 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
**Name:** Flu Seasonal mRNA Formulation 1
**Other Names:**
- GSK4382276A
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Flu mRNA_YA_Group 2
**Description:** 1 dose of Flu mRNA Formulation 2 is administered intramuscularly in the non-dominant upper deltoid to YA at Day 1.
**Name:** Flu Seasonal mRNA Formulation 2
**Other Names:**
- GSK4382276A
**Type:** BIOLOGICAL
#### Intervention 3
**Arm Group Labels:**
- Flu mRNA_YA_Group 3
**Description:** 1 dose of Flu mRNA Formulation 3 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
**Name:** Flu Seasonal mRNA Formulation 3
**Other Names:**
- GSK4382276A
**Type:** BIOLOGICAL
#### Intervention 4
**Arm Group Labels:**
- Flu mRNA_YA_Group 4
**Description:** 1 dose of Flu mRNA Formulation 4 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
**Name:** Flu Seasonal mRNA Formulation 4
**Other Names:**
- GSK4382276A
**Type:** BIOLOGICAL
#### Intervention 5
**Arm Group Labels:**
- Flu mRNA_OA_Group 1
**Description:** 1 dose of Flu mRNA Formulation 5 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
**Name:** Flu Seasonal mRNA Formulation 5
**Other Names:**
- GSK4382276A
**Type:** BIOLOGICAL
#### Intervention 6
**Arm Group Labels:**
- Flu mRNA_OA_Group 2
**Description:** 1 dose of Flu mRNA Formulation 6 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
**Name:** Flu Seasonal mRNA Formulation 6
**Other Names:**
- GSK4382276A
**Type:** BIOLOGICAL
#### Intervention 7
**Arm Group Labels:**
- Flu mRNA_OA_Group 3
**Description:** 1 dose of Flu mRNA Formulation 7 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
**Name:** Flu Seasonal mRNA Formulation 7
**Other Names:**
- GSK4382276A
**Type:** BIOLOGICAL
#### Intervention 8
**Arm Group Labels:**
- Flu mRNA_OA_Group 4
**Description:** 1 dose of Flu mRNA Formulation 8 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
**Name:** Flu Seasonal mRNA Formulation 8
**Other Names:**
- GSK4382276A
**Type:** BIOLOGICAL
#### Intervention 9
**Arm Group Labels:**
- YA_Active Comparator Group 1
**Description:** 1 dose of active comparator 1 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
**Name:** Active Comparator 1
**Type:** COMBINATION_PRODUCT
#### Intervention 10
**Arm Group Labels:**
- OA_Active Comparator Group 2
**Description:** 1 dose of active comparator 2 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
**Name:** Active Comparator 2
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Measure:** Geometric mean titer (GMT) of antigen 1 antibody
**Time Frame:** At Day 29
**Measure:** Geometric mean increase (GMI) of Antigen 1 antibody titer
**Time Frame:** From Day 1 to Day 29
**Measure:** Percentage of participants with antigen 1 seroconversion rate (SCR)
**Time Frame:** From Day 1 to Day 29
**Measure:** Percentage of participants with antigen 1 titer greater than or equal to (>=) the cut off value at Day 1
**Time Frame:** At Day 1
**Measure:** Percentage of participants with antigen 1 titer >= the cut off value at Day 29
**Time Frame:** At Day 29
#### Secondary Outcomes
**Measure:** GMT of antigen 2 antibody
**Time Frame:** At Day 29
**Measure:** GMI of antigen 2 antibody titer
**Time Frame:** From Day 1 to Day 29
**Measure:** Percentage of participants with Antigen 2 SCR
**Time Frame:** From Day 1 to Day 29
**Description:** The following administration site events are solicited: pain, redness, swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm).
**Measure:** Percentage of participants reporting each solicited administration site event
**Time Frame:** Day 1 to Day 7
**Description:** The following systemic events are solicited: fever, headache, myalgia, arthralgia, fatigue, chills. Fever is defined as temperature \>=38 °C/100.4°F regardless the location of measurement. The route for measuring temperature is oral.
**Measure:** Percentage of participants reporting each solicited systemic event
**Time Frame:** Day 1 to Day 7
**Description:** An unsolicited AE is defined as an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs.
**Measure:** Percentage of participants reporting unsolicited adverse events (AEs)
**Time Frame:** Day 1 to Day 28
**Description:** An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product.
**Measure:** Percentage of participants reporting serious adverse events (SAEs)
**Time Frame:** Day 1 to Day 183
**Description:** The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
**Measure:** Percentage of participants reporting adverse events of special interest (AESIs)
**Time Frame:** Day 1 to Day 183
**Description:** A MAAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physicians office visits, emergency room visits or hospitalization).
**Measure:** Percentage of participants reporting medically attended adverse events (MAAEs)
**Time Frame:** Day 1 to Day 183
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. A male or female between and including 18 and 85 years of age (YAs: 18-64; OAs: 65-85) at the time of the study intervention administration.
2. Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment.
3. Body mass index (BMI) \>=18 Kilograms per meter square (kg/m²) and less than or equal to (\<=) 35kg/m2.
4. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits), independently or with the assistance of a caregiver.
5. Written informed consent obtained from the participant prior to performance of any study-specific procedure.
6. Female participants of non-childbearing potential may be enrolled in the clinical study.
7. Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
* Has practiced adequate contraception for 1 month prior to the study intervention administration, and
* Has a negative pregnancy test within 24 hours prior to the study intervention administration, and
* Has agreed to continue adequate contraception for at least 1 month after study intervention administration.
Exclusion Criteria:
1. Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
2. Current or past malignancy, unless completely resolved without sequelae for greater than (\>) 5 years before the study intervention administration (excluding effectively treated basal cell skin cancer).
3. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is \>= 200/ cubic millimeter (mm³) and their viral load has been undetectable (i.e., HIV-RNA lesser than (\<) 50 copies/milliliter \[mL\]) (based on medical records, no laboratory testing required).
4. Participants with a history of, or current suspicion of myocarditis, pericarditis, or idiopathic cardiomyopathy (including a history of myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine), or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection will be excluded from the study.
5. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including polyethylene glycol, egg proteins and aminoglycoside antibiotics).
6. Hypersensitivity to latex.
7. Recurrent history or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
8. Any history of dementia or any medical condition that moderately or severely impairs cognition.
9. Any condition that in the judgment of the investigator would make intramuscular injection unsafe.
10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
11. Administration of an influenza vaccine within 180 days before enrollment or planned administration prior to Visit 2 (Day 29) after the study intervention administration.
12. Previous vaccination with a mRNA influenza vaccine.
13. Administration of a vaccine not foreseen by the study protocol in the period starting 30 days (Day -30) before the study intervention administration, or planned administration within 28 days (Visit 2 \[Day 29\]) after the study intervention administration\*.
* If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided it is used according to the local governmental recommendations and sponsor is notified.
14. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
15. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration or planned administration during the study period.
16. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
* Up to 3 months prior to the study intervention administration:
For corticosteroids, this will mean prednisone equivalent \>=20 mg/day. Inhaled, intraarticular and topical steroids are allowed.
* Up to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
17. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
18. Pregnant or lactating female participant.
19. Bedridden participants.
20. Female participant planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
21. History of chronic alcohol consumption and/or drug abuse in the past 5 years as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
22. Any study personnel or their immediate dependents, family, or household members.
23. Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.
**Healthy Volunteers:** True
**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:** 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:** Hialeah
**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:** Jose Cardona
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Florida
**Status:** RECRUITING
**Zip:** 33012
**Location 2:**
**City:** Miami
**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:** Kimberly S Cruz
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 33147
**Location 3:**
**City:** Miami
**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:** Rafael Ubeda
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Florida
**Status:** RECRUITING
**Zip:** 33186
**Location 4:**
**City:** Chicago
**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:** Rupal Trivedi
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Illinois
**Status:** NOT_YET_RECRUITING
**Zip:** 60640
**Location 5:**
**City:** Valparaiso
**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:** Robert J. Buynak
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Indiana
**Status:** NOT_YET_RECRUITING
**Zip:** 46383
**Location 6:**
**City:** El Dorado
**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:** Michael Rausch
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Kansas
**Status:** RECRUITING
**Zip:** 67042
**Location 7:**
**City:** Lenexa
**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:** Carlos A Fierro
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Kansas
**Status:** RECRUITING
**Zip:** 66219
**Location 8:**
**City:** Newton
**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:** Troy Holdeman
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Kansas
**Status:** RECRUITING
**Zip:** 67114
**Location 9:**
**City:** Wichita
**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:** Terry D Klein
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Kansas
**Status:** RECRUITING
**Zip:** 67207
**Location 10:**
**City:** Lexington
**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:** Mark S Adams
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Kentucky
**Status:** RECRUITING
**Zip:** 40509
**Location 11:**
**City:** Rochester
**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:** Patrick Connors
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** New York
**Status:** RECRUITING
**Zip:** 14609
**Location 12:**
**City:** Greensboro
**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:** Alexander Vance Murray
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** North Carolina
**Status:** RECRUITING
**Zip:** 27408
**Location 13:**
**City:** East Greenwich
**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:** David L Fried
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Rhode Island
**Status:** NOT_YET_RECRUITING
**Zip:** 02818
**Location 14:**
**City:** Knoxville
**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:** William Smith
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Tennessee
**Status:** RECRUITING
**Zip:** 37909
**Location 15:**
**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:** Laurence Chu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 78705
**Location 16:**
**City:** Fort Worth
**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:** William M Seger
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Texas
**Status:** RECRUITING
**Zip:** 76135
**Location 17:**
**City:** Tomball
**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:** Vicki Miller
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Texas
**Status:** RECRUITING
**Zip:** 77375
**Location 18:**
**City:** Newport News
**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:** George H Freeman
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Virginia
**Status:** RECRUITING
**Zip:** 23606
**Location 19:**
**City:** Norfolk
**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:** Mary Bailey
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Virginia
**Status:** NOT_YET_RECRUITING
**Zip:** 23502
### 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: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000009976
- Term: Orthomyxoviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- 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: M10295
- Name: Influenza, Human
- Relevance: HIGH
- As Found: Influenza
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12902
- Name: Orthomyxoviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007251
- Term: Influenza, Human
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431594
**Brief Title:** A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors
**Official Title:** A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects With Advanced Solid Tumors
#### Organization Study ID Info
**ID:** 222730
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
#### Secondary ID Infos
**Domain:** EU CT Number
**ID:** 2024-513860-25
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-01-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-10-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-29
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** GlaxoSmithKline
#### 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:** The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.
### Conditions Module
**Conditions:**
- Solid Tumors
**Keywords:**
- Solid Tumors
- GSK5733584
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: GSK5733584
**Label:** Part 1: Dose Escalation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: GSK5733584
**Label:** Part 2: Dose Expansion
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part 1: Dose Escalation
- Part 2: Dose Expansion
**Description:** GSK5733584 will be administered
**Name:** GSK5733584
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Part 1: Number of participants with dose limiting toxicity (DLT)
**Time Frame:** Up to 21 days
**Description:** ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
**Measure:** Part 2: Objective Response Rate (ORR)
**Time Frame:** Up to approximately 28 months
#### Secondary Outcomes
**Measure:** Part 1 and 2: Maximum observed concentration (Cmax) of GSK5733584
**Time Frame:** Up to approximately 31 months
**Measure:** Part 1 and 2: Time to reach Cmax (Tmax) of GSK5733584
**Time Frame:** Up to approximately 31 months
**Measure:** Part 1 and 2: Area under the concentration-time curve (AUC) of GSK5733584
**Time Frame:** Up to approximately 31 months
**Description:** ORR is defined as the proportion of participants with at least one confirmed CR or PR as defined by RECIST 1.1
**Measure:** Part 1: Objective Response Rate (ORR)
**Time Frame:** Up to approximately 31 months
**Description:** DCR is defined as the percentage of subjects whose best overall response is Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
**Measure:** Part 1 and 2: Disease control rate (DCR)
**Time Frame:** Up to approximately 31 months
**Description:** DoR is defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause
**Measure:** Part 1 and 2: Duration of response (DoR)
**Time Frame:** Up to approximately 31 months
**Description:** PFS is defined as the time interval between randomization (or from the first dose of the intervention) and the first documented disease progression or death due to any cause (whichever occurs first).
**Measure:** Part 1 and 2: Progression-free survival (PFS)
**Time Frame:** Up to approximately 31 months
**Measure:** Part 1 and 2:Number of participants with treatment-emergent Anti-drug antibodies (ADA)
**Time Frame:** Up to approximately 31 months
**Measure:** Part 1 and 2: Titers of ADA to GSK5733584
**Time Frame:** Up to approximately 31 months
**Measure:** Part 1 and 2: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** Up to approximately 31 months
**Measure:** Part 1 and 2: Number of participants with clinically significant changes in physical examination
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in body temperature (degree Celsius)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in respiratory rate (breaths per minute)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in pulse rate (beats per minute)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)]
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in weight [kilogram (kg)]
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in white blood cell count (cells per microliter)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from Baseline in Platelet count (cells per microliter)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from Baseline in Red Blood Cell Count (RBC) (million cells per microliter)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from Baseline in haematocrit (Proportion of red blood cells in blood)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from Baseline in Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Description:** Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
**Measure:** Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in Creatinine clearance (milliliter per minute)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) and Thrombin time (seconds)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in fibrinogen (milligrams per deciliter)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Description:** Leukocyte esterase measured as negative or positive
**Measure:** Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in routine urine tests: Occult blood (10^9 Cells Per Liter)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in routine urine tests: potential of hydrogen (pH) value
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in routine urine tests: Protein and bilirubin (Grams Per Liter)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio)
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in CA-125 tumor marker [units per milliliter (U/mL)]
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)]
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Measure:** Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage]
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Description:** ECOG PS is used for measuring how the disease impacts a patient's daily living abilities. The grades for the scale range from 0 (fully active) to 5 (dead), with increasing severity.
**Measure:** Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
**Time Frame:** Baseline (Day -1) and up to approximately 31 months
**Description:** OS is defined as the time interval between the date of randomization (or from the first dose of the investigational product) and the date of death due to any cause
**Measure:** Part 2: Overall Survival (OS)
**Time Frame:** Up to approximately 31 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Males or females aged 18 years or older (≥18 years).
* Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care).
* Participants have at least one target lesion as assessed per the RECIST 1.1
* Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.
* Have a life expectancy of at least 12 weeks.
Exclusion Criteria:
* Have received any of B7-H4-targeted therapies.
* Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.
* Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.
* Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion
* Major surgery within 4 weeks prior to the first dose of study treatment.
* Evidence of brain metastasis unless asymptomatic.
* Has inadequate bone marrow reserve or hepatic/renal functions.
* Mean Fridericia-corrected QT interval (QTcF) \> 470 millisecond (msec) on resting ECG.
* Evidence of current clinically significant arrhythmias or ECG abnormalities
* Risk factors of prolonged QTc or arrhythmia events,
* Left ventricular ejection fraction (LVEF) \< 50%.
* Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
* Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring high-dose systemic glucocorticoids.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_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:** Lake Mary
**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:** Alexander Philipovskiy
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Florida
**Zip:** 32746
**Location 2:**
**City:** Boston
**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:** Sara Bouberhan
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Massachusetts
**Zip:** 02114
**Location 3:**
**City:** Boston
**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:** Antonio Giordano
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Massachusetts
**Zip:** 02215
**Location 4:**
**City:** Detroit
**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:** Ira Winer
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Michigan
**Zip:** 48201
**Location 5:**
**City:** Dallas
**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:** Minal Barve
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Texas
**Zip:** 75230
**Location 6:**
**City:** West Valley City
**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:** William McKean
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** GSK Investigational Site
**State:** Utah
**Zip:** 84119
**Location 7:**
**City:** Sydney
**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:** Dhanusha Sabanathan
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Australia
**Facility:** GSK Investigational Site
**State:** New South Wales
**Zip:** 2109
**Location 8:**
**City:** Ottawa
**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:** Moira Katherine Rushton-Marovac
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** GSK Investigational Site
**State:** Ontario
**Zip:** K1H 8L6
**Location 9:**
**City:** Toronto
**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:** Philippe Bedard
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** GSK Investigational Site
**State:** Ontario
**Zip:** M5G 2M9
### 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 - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431581
**Brief Title:** Effect of a Mobile Health Intervention on Birth Outcome and Infant Health
**Official Title:** Effect of a Mobile Health Intervention on Birth Outcome and Infant Health in a Tertiary Healthcare Facility in Nepal
#### Organization Study ID Info
**ID:** NHRC 42-2042
#### Organization
**Class:** OTHER
**Full Name:** Kathmandu University School of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2027-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kathmandu University School of Medical Sciences
#### Responsible Party
**Investigator Affiliation:** Kathmandu University School of Medical Sciences
**Investigator Full Name:** Bhawana Shrestha
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight, preterm birth, and challenges in child growth and development. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviors for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery.
Accordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes and infant health in Nepal. In the initial phase, a qualitative study will be conducted to explore the enablers and barriers of perinatal care and preferences of pregnant women through focus group discussions. These insights will inform the development of user-centered educational videos and tailored m-Health interventions for pregnant women.
A two-arm parallel randomized controlled trial will then assess the m-Health intervention's effect on the birth outcomes and infant health of the pregnant women attending the antenatal care clinic of Dhulikhel Hospital. The investigaotors will randomize pregnant women at gestational age 14-22 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up).
Follow-up will be done from enrollment until the child reaches one year of age, with a focus on evaluating effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery) and infant health (growth and development of the infant). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analyzed using STATA 14, contributing valuable insights into the potential effect of m-Health intervention on birth outcomes and infant health.
**Detailed Description:** To evaluate the effect of mobile health intervention on birth outcome and infant health, the sequential exploratory research design will be used. In the initial phase, a qualitative study will be conducted. The researcher and the research assistant will employ purposive sampling to select pregnant women visiting Dhulikhel Hospital in the out patient department (OPD) of the Obstetric department. Written informed consent will be obtained from research participants by either the researcher or research assistant. A focus group discussion will be conducted with pregnant women regarding enablers, barriers, and preferences in perinatal care for improving birth outcomes and infant health. A topic guide will be used for data collection. Subsequently, another focus group discussion will be done with the same participants after developing the educational video to assess the satisfaction and acceptability of the video within the targeted group. The goal of these focus group discussions are to understand the user's needs in educational video. The investigators will ensure that the educational video is user-centered by involving end users (pregnant women) throughout the design and development process. Then after, the content of educational video will be subjected to content validity assessments by subject matter experts to ascertain its accuracy and suitability.
After development and finalization of tailored educational video, a randomized controlled trial will be conducted. Prior to data collection, the researcher will provide information regarding the study such as purpose of the study and assistance required to the health professionals of the antenatal OPD.
Phase 1: Recruitment, baseline data collection and randomization:
The head of the obstetrics and pediatric departments, as well as healthcare professionals at the antenatal care (ANC) clinic and immunization clinic, will be informed about the study. Their active cooperation will be sought throughout the study duration. Pregnant women who are of 14 to 22 weeks of gestation and meet the specified inclusion criteria, while attending the antenatal clinic at Dhulikhel Hospital, will be provided with comprehensive information about the study. This information will cover the study's rationale, procedures, follow-up schedules and voluntary nature of their participation. Eligibility assessments for pregnant women will be conducted by the researcher. Those who expresses a willingness to participate will be asked to provide written informed consent. To ensure impartial allocation of participants to either the intervention or control group, a random sequence number will be generated by a statistician using a computer. These numbers will be securely sealed in envelopes and provided to the enrolled pregnant women. Subsequently, pregnant women who have agreed to participate will be randomized into either the intervention or control group, with a 1:1 ratio, based on the group specified within the sealed envelopes provided to them. The researcher or research assistant will collect baseline information and gather data related to the knowledge of "perinatal care for a healthy birth and a healthy infant" from the participants in both the intervention and control groups.
Phase 2: Delivery of the intervention:
Development of intervention guide: To maintain consistent and standardized delivery of the intervention to all participants, an intervention guide, SMS guide and telephone guide will be developed.
Intervention group: Participants in the intervention group will have access to the educational videos and will be exposed to the following sequence of events:
* During the baseline data collection phase, the initial educational video addressing "perinatal care for a healthy birth and healthy infant" will be viewed by participants via a tablet in a separate designated setting.
* Subsequently, this video will be made available on their smartphones, and participants will be instructed to watch it multiple times during their pregnancy.
* Participants will receive reminder phone calls and SMS to encourage them to watch videos at least three more times after their initial viewing in the antenatal care clinic.
* To ensure continuous engagement, the researcher will maintain regular contact through phone call with intervention group participants, reminding them to view the videos every month from the time of enrollment until delivery and till the child reaches 1 year of age as per the reminder schedule.
* Additionally, pregnant mothers will be explicitly instructed to discuss the video content solely with their immediate family members and refrain from sharing it with others.
Control group: In contrast, participants in the control group will receive usual standard care and will be allowed to view a control video. Participants will be contacted through phone calls to remind their follow-up visit.
Phase 3: Follow up
Participant assessment and follow-up: The participants from both the intervention and control groups will undergo a series of assessments and follow -up visits.
• Post intervention knowledge assessment: Following the intervention phase, both groups will be subjected to a post-intervention knowledge assessment. The overall knowledge of perinatal care for birth outcome and infant health will be assessed approximately one month following the participants' initial viewing of the videos.
• Birth outcome assessment: Both the intervention and control group participants will be followed up within the first 24 hours of their delivery to evaluate and record the birth outcomes.
• Infant health assessment: In the subsequent phase of the study, which aims to evaluate the impact of the intervention on infant health, the growth and development of infant will be assessed. Both groups will be informed of the necessity of follow-up visits at the immunization clinic through phone calls. Following the notification, the growth and developmental assessments of the infants will be conducted at the immunization clinic on the day of their scheduled immunization visit (at 6 weeks, 14 weeks, 9 months, and 12 months of life). For those participants who are unable to visit immunization clinic of Dhulikhel Hospital, they will be followed up at their nearby health post or within their homes. This follow-up process will be conducted by the researcher, along with the assistance of a research assistant.
### Conditions Module
**Conditions:**
- Birth Outcomes
- Infant Health
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 494
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** An intervention group will receive standard care along with m-health intervention that includes tailored educational video, SMS and reminder phone call for follow up
**Intervention Names:**
- Behavioral: m-Health intervention (educational video, SMS and reminder phone call)
**Label:** Intervention group (educational video, SMS and reminder phone call)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A control group will receive standard care along with a control video and reminder phone call for follow-up
**Label:** Control Group (standard care, control video and reminder phone call for follow up)
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group (educational video, SMS and reminder phone call)
**Description:** Pregnant women meeting the inclusion criteria and assigned to the intervention group will receive m-health intervention that includes a tailored educational video regarding perinatal care targeting positive birth outcomes and infant health, SMS messages, and reminder phone calls for follow-up
**Name:** m-Health intervention (educational video, SMS and reminder phone call)
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The birth weight of the newborns delivered from the participants will be measured in grams. The mean birth weight of the newborns in both the intervention group and the control group will be compared.
**Measure:** Birth weight
**Time Frame:** 1-1.5 years
**Description:** The gestational age at delivery will be expressed in completed weeks of gestation. The mean gestational age at delivery will be compared between the intervention group and the control group.
**Measure:** Gestational age at delivery
**Time Frame:** 1-1.5 years
#### Secondary Outcomes
**Description:** Knowledge on perinatal care for healthy birth and healthy infant will be assessed through validated knowledge related questionnaire. The mean score will be be calculated for both the intervention and the control group and then will be compared.
**Measure:** Knowledge on perinatal care
**Time Frame:** 6 months
**Description:** The weight of the infant will be measured in grams and compared to the World Health Organization(WHO) standard for weight-for-age of the infant.
**Measure:** Weight of the infant
**Time Frame:** 2-2.5 years
**Description:** The height/length of the infant will be measured in centimeters and compared to the WHO standard for height-for-age of the infant.
**Measure:** Height/Length of the infant
**Time Frame:** 2-2.5 years
**Description:** The development of an infant will be evaluated using the Ages and Stages Questionnaire (ASQ) and average ASQ score will be determined
**Measure:** Development of an infant
**Time Frame:** 2-2.5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pregnant women of age 18 years and above;
* Pregnant with 14 to 22 weeks of gestation;
* Planned to deliver a child and come for infant's vaccination at Dhulikhel hospital;
* Pregnant women who use smart phone;
* Pregnant women who have plan to stay in Dhulikhel thorough out this study period;
* Can read and understand Nepali language
Exclusion Criteria:
* Vision impairment and diagnosed learning difficulties
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Bhawana Shrestha, M.Sc. Nursing
**Phone:** 977-9841748266
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kunta Devi Pun, PhD
**Phone:** 977-9841239826
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dhulikhel
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Bhawana Shrestha, M.Sc. Nursing
- **Phone:** 977-9841748266
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Kunta Devi Pun, PhD
- **Phone:** 977-9841239826
- **Role:** CONTACT
***Contact 3:***
- **Name:** Anjana Dongol, PhD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Archana Shrestha, PhD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Srijana Dongol, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Nepal
**Facility:** Bhawana Shrestha
**State:** Bagmati
**Zip:** 45210
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Lassi ZS, Middleton PF, Crowther C, Bhutta ZA. Interventions to Improve Neonatal Health and Later Survival: An Overview of Systematic Reviews. EBioMedicine. 2015 May 31;2(8):985-1000. doi: 10.1016/j.ebiom.2015.05.023. eCollection 2015 Aug.
**PMID:** 26425706
**Citation:** Khani Jeihooni A, Mohammadkhah F, Razmjouie F, Harsini PA, Sedghi Jahromi F. Effect of educational intervention based on health belief model on mothers monitoring growth of 6-12 months child with growth disorders. BMC Pediatr. 2022 Sep 23;22(1):561. doi: 10.1186/s12887-022-03593-8.
**PMID:** 36151526
**Citation:** Lassi ZS, Mansoor T, Salam RA, Das JK, Bhutta ZA. Essential pre-pregnancy and pregnancy interventions for improved maternal, newborn and child health. Reprod Health. 2014;11 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-11-S1-S2. Epub 2014 Aug 21.
**PMID:** 25178042
**Citation:** Taneja S, Chowdhury R, Dhabhai N, Mazumder S, Upadhyay RP, Sharma S, Dewan R, Mittal P, Chellani H, Bahl R, Bhan MK, Bhandari N; Women and Infants Integrated Growth Study (WINGS) Group. Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India. Trials. 2020 Jan 31;21(1):127. doi: 10.1186/s13063-020-4059-z.
**PMID:** 32005294
**Citation:** Toolan M, Barnard K, Lynch M, Maharjan N, Thapa M, Rai N, Lavender T, Larkin M, Caldwell DM, Burden C, Manandhar DS, Merriel A. A systematic review and narrative synthesis of antenatal interventions to improve maternal and neonatal health in Nepal. AJOG Glob Rep. 2022 Feb;2(1):100019. doi: 10.1016/j.xagr.2021.100019.
**PMID:** 35252905
**Citation:** Park JJH, Harari O, Siden E, Zoratti M, Dron L, Zannat NE, Lester RT, Thorlund K, Mills EJ. Interventions to improve birth outcomes of pregnant women living in low- and middle-income countries: a systematic review and network meta-analysis. Gates Open Res. 2020 Sep 24;3:1657. doi: 10.12688/gatesopenres.13081.2. eCollection 2019.
**PMID:** 33134854
#### See Also Links
**Label:** Effectiveness of Theory of Planned Behavior-Based Educational Intervention on Newborn Care in Pregnant Mothers: A Quasi-experimental Study. Jundishapur J Health Sci. 2021;13(4)
**URL:** https://brieflands.com/articles/jjhs-117452.html
**Label:** Early Childhood Development (ECD) \| UNICEF India
**URL:** https://www.unicef.org/india/what-we-do/early-childhood-development
**Label:** Effect of parenting intervention through "Care for Child Development Guideline" on early child development and behaviors: a randomized controlled trial. BMC Pediatr.2022;22(1):690
**URL:** https://doi.org/10.1186/s12887-022-03752-x
**Label:** Health Behaviors and Behavior Change during Pregnancy: Theory-Based Investigation of Predictors and Interrelations. Sexes. 2022 Sep;3(3):351-66.
**URL:** https://doi.org/10.3390/sexes3030027
**Label:** Pregnancy and Childbirth - Healthy People 2030 \| health.gov
**URL:** https://health.gov/healthypeople/objectives-and-data/browse-objectives/pregnancy-and-childbirth
**Label:** Lessons from digital technology-enabled health interventions implemented during the coronavirus pandemic to improve maternal and birth outcomes: a global scoping review. BMC Pregnancy Childbirth. 2023 Mar 20;23(1):195.
**URL:** https://doi.org/10.1186/s12884-023-05454-3
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431568
**Acronym:** Ondansetron
**Brief Title:** Ondansetron Prior Spinal Anaesthesia
**Official Title:** Effect of Prophylactic IV Ondansetron Prior Spinal Anaesthesia in Caesarean Section on Bradycardia and Hypotension (Observational Study)
#### Organization Study ID Info
**ID:** IRB0000871252
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
#### Secondary ID Infos
**Domain:** Maternity Hospital
**ID:** Kuwait MOH
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-02
**Type:** ACTUAL
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Kuwait Institute for Medical Specialization
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Abdelrady S Ibrahim, MD
**Investigator Title:** Professor of Anesthesia and ICU
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.
**Detailed Description:** Hypothesis:
Administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia.
Aim:
Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.
Objectives:
* Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not
* Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.
### Conditions Module
**Conditions:**
- Cesarean Section
**Keywords:**
- Spinal anesthesia, Cesarean section, Ondansetron
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 400
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
#### Arm Group 1
**Description:** Pregnant patients undergoing elective caesarean section with no co-morbidities will receive intravenous ondansetron
**Label:** Intravenous Ondansetron for patients undergoing Cesarean section under spinal Anesthesia
### Outcomes Module
#### Primary Outcomes
**Description:** incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron
**Measure:** Blood Pressure
**Time Frame:** one hour
#### Secondary Outcomes
**Description:** Incidence of bradycardia after ondansetron
**Measure:** Heart rate
**Time Frame:** One hour
**Description:** Incidence of use of ephedrine or phenylpherine
**Measure:** Vasopressor
**Time Frame:** One hour
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pregnant patients undergoing elective caesarean section
Exclusion Criteria:
* Preeclampsia
* Eclampsia
* Hypertension
* Diabetes
**Gender Based:** True
**Gender Description:** Pregnant patients undergoing elective cesarean section with no co-morbidities before or during pregnancy period
**Healthy Volunteers:** True
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Pregnant patients undergoing elective caesarean section with no co-morbidities before or during pregnancy period, e.g. HTN, DM, PET or Eclampsia, will be recruited. Attempt will be made to include all eligible participants
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Assiut
**Country:** Egypt
**Facility:** Assiut university faculty of medicine
#### Overall Officials
**Official 1:**
**Affiliation:** Assiut University Faculty Of Medicine
**Name:** Abdelrady S Ibrahim, .M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Hofhuizen C, Lemson J, Snoeck M, Scheffer GJ. Spinal anesthesia-induced hypotension is caused by a decrease in stroke volume in elderly patients. Local Reg Anesth. 2019 Mar 4;12:19-26. doi: 10.2147/LRA.S193925. eCollection 2019.
**PMID:** 30881108
## Derived Section
### 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: M10072
- Name: Hypotension
- Relevance: LOW
- As Found: Unknown
- ID: M5196
- Name: Bradycardia
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M19588
- Name: Ondansetron
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06431555
**Brief Title:** Magnetic Resonance Lung Function Imaging Study of Pulmonary Fibrosis Combined With Emphysema Syndrome
**Official Title:** Magnetic Resonance Lung Function Imaging Study of Pulmonary Fibrosis Combined With Emphysema Syndrome
#### Organization Study ID Info
**ID:** 2024-ke-107
#### Organization
**Class:** OTHER
**Full Name:** Beijing Chao Yang Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-10
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Beijing Chao Yang Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study intends to use magnetic resonance pulmonary function imaging technology to explore imaging markers for early diagnosis of patients with CPFE. Through baseline, 6-month and 12-month follow-up examinations, the changes in magnetic resonance pulmonary function in patients with CPFE and their correlation with disease progression were explored.
### Conditions Module
**Conditions:**
- Using Functional Lung MRI to Explore Pulmonary Perfusion Changes in Patients With Pulmonary Fibrosis and Emphysema Syndrome
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 55
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Non-contrast, free-breathing MRI scan
**Name:** MRI
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Calculate MRI lung perfusion defect as a percentage of the whole lung
**Measure:** perfusion defect percentage
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* (1) Chest HRCT shows emphysema mainly distributed in the upper lung field, manifesting as wallless or thin-walled (wall thickness \<1 mm) low-transmittance areas with clear boundaries with normal tissue, or multiple bullae (diameter \> 1 cm), and the emphysema area/total lung volume is ≥10%; (2) interstitial pulmonary fibrosis mainly distributed in the lower lung field and subpleura, manifesting as honeycomb shadow or grid shadow, and the lung structure is destroyed , may be accompanied by traction bronchiectasis, ground glass opacities and consolidation opacities.
Exclusion Criteria:
* (1) Refusal to sign the informed consent form; (2) MRI contraindications (implanted pacemaker/defibrillator, claustrophobia, or any clinical condition that prohibits longer MRI examinations).
**Healthy Volunteers:** True
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** (1) Chest HRCT shows emphysema mainly distributed in the upper lung field, manifesting as wallless or thin-walled (wall thickness \<1 mm) low-transmittance areas with clear boundaries with normal tissue, or multiple bullae (diameter \> 1 cm), and the emphysema area/total lung volume is ≥10%; (2) interstitial pulmonary fibrosis mainly distributed in the lower lung field and subpleura, manifesting as honeycomb shadow or grid shadow, and the lung structure is destroyed , may be accompanied by traction bronchiectasis, ground glass opacities and consolidation opacities.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tao Ouyang, PhD
**Phone:** +86 18720931226
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tao Ouyang, PhD
- **Phone:** +86 18720931226
- **Role:** CONTACT
**Country:** China
**Facility:** Beijing Chaoyang Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100020
#### Overall Officials
**Official 1:**
**Affiliation:** Beijing Chao Yang Hospital
**Name:** Shumin Wang, PhD
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000017563
- Term: Lung Diseases, Interstitial
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000029424
- Term: Pulmonary Disease, Chronic Obstructive
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
### 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M14512
- Name: Pulmonary Fibrosis
- Relevance: HIGH
- As Found: Pulmonary Fibrosis
- ID: M8485
- Name: Fibrosis
- Relevance: HIGH
- As Found: Fibrosis
- ID: M14510
- Name: Pulmonary Emphysema
- Relevance: HIGH
- As Found: Emphysema
- ID: M7812
- Name: Emphysema
- Relevance: HIGH
- As Found: Emphysema
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19813
- Name: Lung Diseases, Interstitial
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23449
- Name: Pulmonary Disease, Chronic Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- 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: D000011658
- Term: Pulmonary Fibrosis
- ID: D000011656
- Term: Pulmonary Emphysema
- ID: D000013577
- Term: Syndrome
- ID: D000005355
- Term: Fibrosis
- ID: D000004646
- Term: Emphysema
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
Subsets and Splits