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## Protocol Section ### Identification Module **NCT ID:** NCT06426732 **Brief Title:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females **Official Title:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females #### Organization Study ID Info **ID:** 2022-919 #### Organization **Class:** OTHER **Full Name:** The Second Hospital of Shandong University ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Second Hospital of Shandong University #### Responsible Party **Investigator Affiliation:** The Second Hospital of Shandong University **Investigator Full Name:** Linlin Cui **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The incidence of gestational hypertension and preeclampsia in the assisted reproductive technology population during pregnancy was significantly higher than that in the general normal pregnancy population. The use of assisted reproductive technology in this population due to infertility is often accompanied by many hypertension-related factors. We established a prospective cohort study based on assisted reproductive technology pregnancy population and natural pregnancy population. Through continuous monitoring of blood pressure changes and other risk factors during pregnancy in the two groups, we explored the trajectory trend and inflection point of assisted reproductive technology pregnancy population blood pressure during pregnancy. Through factor analysis, the risk factors of elevated blood pressure during pregnancy can be clearly identified, so as to carry out early intervention and strengthen the control of risk factors of elevated blood pressure in assisted reproductive technology population, in order to expect benign maternal and infant outcomes. ### Conditions Module **Conditions:** - Blood Pressure ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** Natural pregnancy group #### Arm Group 2 **Label:** Assisted Reproductive Technology Group ### Outcomes Module #### Primary Outcomes **Description:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females **Measure:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females **Time Frame:** from pregnancy to delivery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: -Exposure group: Mother: Seen in the obstetrics department of our hospital and meet the following conditions at the same time: 1. Complete at least one cycle of IVF or ICSI, PGD or IVM treatment (including natural cycles); 2. Clinical pregnancy was obtained after treatment. Offspring: Offspring born after in vitro fertilization-embryo transfer technique. * Non-exposed group: Mother: A mother who conceived naturally. Offspring: 1) Offspring born by natural pregnancy. 2) Offspring born from natural pregnancy of exposed mothers. Exclusion Criteria: * Unwilling to participate in this research; * Unable to participate in this study due to special reasons, such as death, immigration, loss to follow-up; * Hereditary diseases, mental diseases, malignant tumors, pre-pregnancy hypertension, uterine malformations and other reproductive organ malformations; * Pregnant women who voluntarily terminate pregnancy due to non-preeclampsia factors; **Maximum Age:** 45 Years **Minimum Age:** 20 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** collect sixty patients in each group ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Wenting Wang, M.D. Ph.D. **Phone:** +86 17660082326 **Role:** CONTACT #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** cui lin lin, doctor - **Phone:** 17660082326 - **Role:** CONTACT ***Contact 2:*** - **Name:** wang wen ting, doctor - **Phone:** 13188936075 - **Role:** CONTACT **Country:** China **Facility:** Cui linlin **Status:** RECRUITING ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426719 **Brief Title:** Efficiency of Using Osseodensification Protocol **Official Title:** Efficiency of Using Osseodensification Protocol for Alveolar Ridge Expansion in Edentulous Alveolar Ridges #### Organization Study ID Info **ID:** 28908210103756 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2024-02-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-20 **Type:** ACTUAL #### Start Date **Date:** 2022-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Cairo University #### Lead Sponsor **Class:** OTHER **Name:** Mohamed Magdy Mostafa Shehata #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Mohamed Magdy Mostafa Shehata **Investigator Title:** doctor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** the goal of this clinical trial is to learn if the new osseo-densification technique works to provide enough bone width and quality prior to implant placement in the upper jaw the main question it aims to answer is: Is the use of osseo-densification protocol better than the standard alveolar ridge widening techniques; regarding efficiency and comfort in obtaining sufficient alveolar ridge width in horizontally atrophic alveolar ridges? **Detailed Description:** a new osseo-densification protocol using specially designed Densah burs was compared to conventional hand Osteotome technique to test its efficiency in providing sufficient bone quantity and quality in cases of horizontally deficient maxillary edentulous alveolar ridge sites that require expansion prior to dental implant placement ### Conditions Module **Conditions:** - Alveolar Bone Resorption **Keywords:** - Densah burs - Osseodensification - OsseoHand Osteotomes - alveolar ridge wideninig ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** a new technique used to provide sufficient alveolar ridge width and enhance bone quality at horizontally deficient maxillary alveolar ridges prior to implant placement. the new technique uses specially designed burs called Densah burs that act by causeing bone compaction rather than bone removing from the osteotomy site ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 18 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the group in which alveloalr ridge widening is done using densah burs, it is the study group **Intervention Names:** - Procedure: Alveolar ridge wideninig via applying osseodensification protocol using densah burs **Label:** intervention group osseodensification **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** the group in which alveolar ridge expansion is done using hand driven osteotomes . it is the conventional froup **Intervention Names:** - Procedure: Alveolar ridge widening via hand osteotomes **Label:** conventional osteotome group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - intervention group osseodensification **Description:** alveolar ridge expansion using densah burs in horizontally deficient maxillary alveolar ridges prior to dental implants insertion **Name:** Alveolar ridge wideninig via applying osseodensification protocol using densah burs **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - conventional osteotome group **Description:** Alveolar ridge expansion using hand driven osteotomes in horizontally deficient maxillary alveolar ridges prior to dental Implant insertion **Name:** Alveolar ridge widening via hand osteotomes **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** the amount of ridge width gain is measured both clinically via a caliber and radiographically on CBCT **Measure:** efficiency of ridge widening technique **Time Frame:** intraoperative and within 3 days post operative #### Secondary Outcomes **Description:** the primary stability of the inserted dental implant is measured via osstell device **Measure:** primary stability of implant **Time Frame:** intra-operative after dental implant placement **Description:** the time required for completion of the surgical procedure is measured in minutes using stop watch **Measure:** length of surgical procedure **Time Frame:** During surgery **Description:** the degree of pain or discomfort examined by the patient during the ridge widening procedure is recorded using a visual scale where 0 represents no pain while 1 minimum pain and 10 is maximum pain **Measure:** Value of pain **Time Frame:** Immediate post operative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years old. * In cases of an initial ridge width ≤ 5mm that contains ≤ 2mm of trabecular bone core. * Alveolar ridges with narrow crest and wider base. Exclusion Criteria: * Uncontrolled diabetic patients * Heavy Smokers * Patients suffering from osteoporosis * Patients receiving chemo or radio therapy * Patients suffering from bleeding disorders * Patients suffering from intraosseous lesions at the proposed site of implant * Patients with insufficient alveolar bone hight less than 10 mm. * Resorbed ridge with a narrow base. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Mohamed Magdy Mostafa shehata **Zip:** 11799 #### Overall Officials **Official 1:** **Affiliation:** Cairo University **Name:** Mohamed M Shehata **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** IDP will be shared with researchers and clinical investigators who require them for further systematic review or retrograde studies via contacting the principal investigator through email **Description:** all IPD that underlie results in a publication **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** within 6 months from publication ### References Module #### References **Citation:** Tian JH, Neiva R, Coelho PG, Witek L, Tovar NM, Lo IC, Gil LF, Torroni A. Alveolar Ridge Expansion: Comparison of Osseodensification and Conventional Osteotome Techniques. J Craniofac Surg. 2019 Mar/Apr;30(2):607-610. doi: 10.1097/SCS.0000000000004956. **PMID:** 30507887 **Citation:** Bassetti MA, Bassetti RG, Bosshardt DD. The alveolar ridge splitting/expansion technique: a systematic review. Clin Oral Implants Res. 2016 Mar;27(3):310-24. doi: 10.1111/clr.12537. Epub 2015 Jan 14. **PMID:** 25586966 **Citation:** Jha N, Choi EH, Kaushik NK, Ryu JJ. Types of devices used in ridge split procedure for alveolar bone expansion: A systematic review. PLoS One. 2017 Jul 21;12(7):e0180342. doi: 10.1371/journal.pone.0180342. eCollection 2017. **PMID:** 28732054 **Citation:** Inchingolo AD, Inchingolo AM, Bordea IR, Xhajanka E, Romeo DM, Romeo M, Zappone CMF, Malcangi G, Scarano A, Lorusso F, Isacco CG, Marinelli G, Contaldo M, Ballini A, Inchingolo F, Dipalma G. The Effectiveness of Osseodensification Drilling Protocol for Implant Site Osteotomy: A Systematic Review of the Literature and Meta-Analysis. Materials (Basel). 2021 Feb 28;14(5):1147. doi: 10.3390/ma14051147. **PMID:** 33671038 **Citation:** Padhye NM, Padhye AM, Bhatavadekar NB. Osseodensification -- A systematic review and qualitative analysis of published literature. J Oral Biol Craniofac Res. 2020 Jan-Mar;10(1):375-380. doi: 10.1016/j.jobcr.2019.10.002. Epub 2019 Nov 2. **PMID:** 31737477 **Citation:** Witek L, Alifarag AM, Tovar N, Lopez CD, Gil LF, Gorbonosov M, Hannan K, Neiva R, Coelho PG. Osteogenic parameters surrounding trabecular tantalum metal implants in osteotomies prepared via osseodensification drilling. Med Oral Patol Oral Cir Bucal. 2019 Nov 1;24(6):e764-e769. doi: 10.4317/medoral.23108. **PMID:** 31655837 **Citation:** Starch-Jensen T, Becktor JP. Maxillary Alveolar Ridge Expansion with Split-Crest Technique Compared with Lateral Ridge Augmentation with Autogenous Bone Block Graft: a Systematic Review. J Oral Maxillofac Res. 2019 Dec 30;10(4):e2. doi: 10.5037/jomr.2019.10402. eCollection 2019 Oct-Dec. **PMID:** 32158526 **Citation:** Demetriades N, Park JI, Laskarides C. Alternative bone expansion technique for implant placement in atrophic edentulous maxilla and mandible. J Oral Implantol. 2011 Aug;37(4):463-71. doi: 10.1563/AAID-JOI-D-10-00028. Epub 2010 Jul 21. **PMID:** 20662673 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M5141 - Name: Bone Resorption - Relevance: HIGH - As Found: Bone Resorption - ID: M12026 - Name: Mouth, Edentulous - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001862 - Term: Bone Resorption ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426706 **Brief Title:** TPVB or SPSIPB in Pain Management After VATS **Official Title:** Paravertebral Block or Serratus Posterior Superior Intercostal Plane Block in Pain Management After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** 2024.174.IRB1.019 #### Organization **Class:** OTHER **Full Name:** Koç University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Koç University #### Responsible Party **Investigator Affiliation:** Koç University **Investigator Full Name:** Kamil Darcin **Investigator Title:** MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to compare the analgesic efficacy of thoracal paravertebral block (TPVB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing video-assisted thoracoscopic surgery (VATS). The main questions it aims to answer are: How will the total perioperative opioid consumption of the patients receiving two different blocks change? How will TPVB and SPSIPB effect the patients' numeric rating scores for pain in the postoperative 24-hour period? How will TPVB and SPSIPB effect the incidence of opioid related side effects? Participants will be divided in two groups: TPVB group will receive a TPVB before the surgery. SPSIPB group will receive a SPSIPB nerve block before the surgery. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and opioid associated side effects. The hypothesis of this study is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively. **Detailed Description:** Video-assisted thoracoscopic surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing VATS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. The gold standard peripheric nerve block is considered to be thoracal paravertebral block (TPVB). Recently, a new nerve block called serratus posterior superior intercostal plane block (SPSIPB) has been described. The anatomic and radiologic studies of SPSIPB suggest that the local anaesthetic distributes from C7 to T10 vertebrates, covering the surgical site of VATS. This study aims to compare the analgesic efficacy of TPVB and SPSIPB for VATS. The hypothesis is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores and opioid related side effects of the participants will be recorded. Participants will be divided in two groups. The group P will receive a TPVB preoperatively in the operating room. The group S will receive a SPSIPB preoperatively in the operating room. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated. ### Conditions Module **Conditions:** - Video-assisted Thoracoscopic Surgery - Paravertebral Block - Serratus Posterior Superior Intercostal Plane Block - Regional Anesthesia Morbidity **Keywords:** - video-assisted thoracoscopic surgery - paravertebral block - serratus posterior superior intercostal plane block ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 44 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who will be receiving a serratus posterior superior intercostal plane block **Intervention Names:** - Procedure: Serratus Posterior Superior Intercostal Plane Block **Label:** Group S **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants who will be receiving a thoracal paravertebral block **Intervention Names:** - Procedure: Paravertebral Block **Label:** Group P **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group S **Description:** Before the induction of general anesthesia, under aseptic conditions, serratus posterior superior intercostal plane block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist. **Name:** Serratus Posterior Superior Intercostal Plane Block **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group P **Description:** Before the induction of general anesthesia, under aseptic conditions, paravertebral block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist. **Name:** Paravertebral Block **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage **Measure:** Total opioid consumption **Time Frame:** 24 hours post-surgery #### Secondary Outcomes **Description:** the scale between 0: no pain and 10:highes pain answered by the participants **Measure:** Numeric rating scale scores for pain **Time Frame:** 24 hours post-surgery **Description:** Nausea, vomiting, pruritis, respiratory depression assessed by yes/no questions **Measure:** Opioid related side effects **Time Frame:** 24 hours post-surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients between the age of 18-80 undergoing video-assisted thoracoscopic surgery Exclusion Criteria: * Allergy to local anaesthetics Chronic opioid use history Patients with psychiatric disorders Patients who are not open to communication Patients with chronic organ failure Patients that do not give consent Patients that need emergency surgery within the first 24 hours of the initial surgery **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:** Kamil Darçın, MD **Phone:** +90 505 589 50 99 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yasemin Sincer, MD **Phone:** +90 531 204 08 34 **Role:** CONTACT #### Locations **Location 1:** **City:** İstanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kamil Darçın - **Phone:** +905055895099 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Yasemin Sincer - **Phone:** +90512040834 - **Role:** CONTACT ***Contact 3:*** - **Name:** Kamil Darçın - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Koc University **Status:** RECRUITING **Zip:** 34010 #### Overall Officials **Official 1:** **Affiliation:** Koç University **Name:** Kamil Darçın, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** no access criteria **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Starting from 6 months after publication for 5 years ## 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 ### 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: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426693 **Brief Title:** Craving Network Neurofeedback **Official Title:** Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity #### Organization Study ID Info **ID:** 2000037084 #### Organization **Class:** OTHER **Full Name:** Yale University #### Secondary ID Infos **ID:** 1R01DK136623-01A1 **Link:** https://reporter.nih.gov/quickSearch/1R01DK136623-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** Yale 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:** This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior. **Detailed Description:** Aim 1 of this study is to test whether neurofeedback from the craving network is associated with reduced craving network strength. Aim 2 of this study is to test whether neurofeedback from the craving network is associated with reduced food craving and changes in eating behavior. Aim 3 of this study is to test whether neurofeedback from the craving network is associated with changes in resting state functional connectivity. ### Conditions Module **Conditions:** - Overweight or Obesity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Three imaging (fMRI) sessions of experimental feedback. **Intervention Names:** - Device: Experimental feedback **Label:** Neurofeedback **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Three imaging (fMRI) sessions of sham feedback. **Intervention Names:** - Device: Control feedback **Label:** Control neurofeedback **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Neurofeedback **Description:** Participants provided with feedback of target brain activation patterns (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer). **Name:** Experimental feedback **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control neurofeedback **Description:** Participants provided with control (sham, yoked to another participant) feedback (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer). **Name:** Control feedback **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Craving network strength will be measured during transfer (i.e., no feedback) runs and compared across scan sessions. **Measure:** Change in craving network strength during transfer runs **Time Frame:** Week 1 and 3 **Description:** Food Craving Inventory has 28 items rated 1-5 and overall mean is calculated, range 1-5 with higher score indicating higher craving. FCI will be compared between baseline and 1 month follow-up. **Measure:** Change in Food Craving Inventory Mean Score **Time Frame:** Week 1, Week 7 **Description:** ASA-24 HEI is scored 0-100 with 100 indicating healthier diet and composite scores examined to interpret the overall score. HEI will be compared between baseline and 1 month follow-up. **Measure:** Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI). **Time Frame:** Week 1, Week 7 **Description:** Craving network strength will be measured during resting state runs and compared across scan sessions. **Measure:** Change in craving network strength during resting state runs **Time Frame:** Week 1 and 3 **Description:** Food Rating Task outcomes include healthiness, tastiness, and choice. Healthiness and tastiness mean score is taken, range 1-5, with 5 indicating higher healthiness or tastiness. Choice is counted from 0-48 items choosing the food item over the neutral reference food item, with higher values indicating more frequent choice. Food Ratings will be compared between baseline and 1 month follow-up. **Measure:** Change in Food Rating Task healthiness, tastiness, and choice scores **Time Frame:** Week 1, Week 7 **Description:** Food Snack Task will be used to measure caloric intake (out of a maximum value to calories offered) and compared across scan sessions. **Measure:** Change in Food Snack Task caloric intake **Time Frame:** Week 1 and 3 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ages 18 to 60 years * Body mass index \>25 kg/m2 * \>2.37 Food Craving Inventory score Exclusion Criteria: * Use of anti-obesity medications * Weight-reduced state defined as \>10% weight reduction in the past 6 months. * Nicotine use * Current diagnosis of neurological or psychiatric disorder * Obesity-related diseases such as type-2 diabetes * Contraindications to MRI * Baseline scanning with motion \>0.15mm frame to frame displacement. **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kathleen A Garrison, PhD **Phone:** 2037376232 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - 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: D000050177 - Term: Overweight ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426680 **Brief Title:** A Study of the ILB-3101 in Patients With Advanced Solid Tumors **Official Title:** Phase I/II Study of the ILB-3101 in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** CILB3101A101 #### Organization **Class:** INDUSTRY **Full Name:** Innolake Biopharm ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Innolake Biopharm #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients. **Detailed Description:** This is an open-label, multi-center, dose-escalation and expansion, first-in-human phase 1 study in Chinese adult participants with locally advanced or metastatic solid tumors. This study will consist of two parts: A Part Ia dose escalation stage and a Part Ib dose expansion stage. The objectives of this study are to evaluate the safety, tolerability, PK and preliminary anti-tumor activity, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of HS-20093. Part I: Participants with advanced cancer are eligible for dose escalation study if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. The dose escalation will include an initial accelerated titration design followed by 3+3 design. Part II: Enrollment into dose expansion will begin after identification of the MTD or MAD in Phase I. The dose expansion study will be conducted in populations with the following indications: ovarian cancer, small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma (including uterine sarcoma), triple negative breast cancer, esophageal squamous cell carcinoma, prostate cancer, etc.. All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists. ### Conditions Module **Conditions:** - Advanced Solid Tumor ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** There are eight escalating dose cohorts. Intravenous (IV) administration of ILB-3101 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. **Intervention Names:** - Biological: ILB-3101 **Label:** ILB-3101 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ILB-3101 **Description:** There are eight escalating dose cohorts. **Name:** ILB-3101 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Dose-limiting toxicity for ILB-3101 **Measure:** DLT **Time Frame:** Up to day 21 from the first dose **Description:** Maximum tolerated dose (MTD) for ILB-3101 **Measure:** MTD **Time Frame:** Up to day 21 from the first dose #### Secondary Outcomes **Description:** Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1. **Measure:** ORR **Time Frame:** From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months **Description:** AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc. **Measure:** Incidence and severity of adverse events (AEs) **Time Frame:** From the first dose through 90 days post end of treatment **Description:** Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points. **Measure:** Percentage of participants with antibodies to ILB-3101 in serum **Time Frame:** From pre-dose to 90 days post end of treatmen **Description:** Cmax will be obtained following administration of the first dose of ILB-3101 during the first cycle. **Measure:** Observed maximum plasma concentration (Cmax) of ILB-3101 in participants with advanced solid tumor **Time Frame:** From pre-dose to 21 days after the first dose on Cycle 1 **Description:** Tmax will be obtained following administration of the first dose of ILB-3101 during the first cycle. **Measure:** Time to reach maximum plasma concentration (Tmax) of ILB-3101 following the first dose in participants with advanced solid tumor **Time Frame:** From pre-dose to 21 days after the first dose on Cycle 1 **Description:** Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. **Measure:** Terminal half-life (T1/2) of ILB-3101 following IV dose in participants with advanced solid tumor **Time Frame:** From pre-dose to 21 days after the first dose on Cycle 1 **Description:** Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule. **Measure:** Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of ILB-3101 **Time Frame:** From pre-dose to 21 days after the first dose on Cycle 1 **Description:** DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]. **Measure:** Duration of response (DOR) determined by investigators according to RECIST 1.1 **Time Frame:** From the first dose up to PD or death, whichever came first, assessed up to 24 months **Description:** Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\]. **Measure:** Disease control rate (DCR) determined by investigators according to RECIST 1.1 **Time Frame:** From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months **Description:** Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause. **Measure:** Progression-free survival (PFS) determined by investigators according to RECIST 1.1 **Time Frame:** From the randomization/first dose up to PD or death, whichever came first, assessed up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Have signed informed consent forms voluntarily. 2. 18-80 years old. 3. Having an ECOG performance status score of 0 or 1. 4. With an expected survival of more than 12 weeks. 5. Diagnosed histologically or cytologically with local advanced or metastatic solid cancer, and under one of following situations: standard treatment-refractory (disease progression or no response), treatment-resistant, unable to receive treatment, or the standard treatment is unavailable. 6. Need to provide archived tumor tissue samples (Formalin fixed or paraffin embedded tissue blocks or at least 5 unstained sections); During the dose escalation stage, for subjects who are unable to provide tumor samples or have insufficient samples, the decision to enroll may be made based on specific circumstances after discussion with the sponsor. 7. At least one assessable tumor lesion is present during the dose escalation phase, and according to RECIST version 1.1, at least one measurable tumor lesion is present during the dose escalation phase (CRPC can be determined based on PCWG3). 8. Having sufficient bone marrow, liver, and kidney functions (based on the normal value of the clinical trial site): 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L. 2. Platelets ≥ 75×109/L. 3. Hemoglobin ≥ 90g/L. 4. Total serum bilirubin ≤ 1.5×upper limit of normal (ULN). 5. Without liver metastases, ALT, AST ≤ 2.5×ULN; with liver metastases, ALT, AST ≤ 5×ULN. 6. Serum creatinine ≤1.5 × ULN. 7. Creatinine clearance rate (CrCl) (creatinine only ˃ Calculation required for 1.5 × ULN ≥50 mL/min (Calculate according to Cockcroft Fault formula), 8. International Normalized Ratio (INR) ≤ 1.5×ULN, APTT ≤ 1.5×ULN. 9. Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%. 10. QT interval corrected by Fridericia method (QTcF) Male\<450ms; Female\<470ms. 9. The serum pregnancy test results of female subjects of childbearing age are negative. 10. Male or female patients of childbearing potential must agree to use effective methods of contraception (such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives and intrauterine devices) during the study period and within 90 days after the last dosing. Exclusion Criteria: 1. Within 3 weeks prior to the first administration, systemic anti-tumor therapy has been received, including chemotherapy, curative radiotherapy (palliative radiotherapy for a single lesion within 3 weeks prior to enrollment is allowed, and radiotherapy is not allowed for measurable lesions before enrollment unless it is confirmed that the lesion has progressed after radiotherapy), biological therapy, immunotherapy, etc., except for the following: 1. Received urea nitrite or mitomycin C within 6 weeks prior to the first use of the study drug. 2. Oral administration of fluorouracil or small molecule targeted drugs within 2 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is longer). 3. Individuals who have received endocrine therapy within 2 weeks prior to the first use of the investigational drug. 4. Traditional Chinese patent medicines and simple preparations or traditional Chinese medicine with anti-tumor indication within 1 week before the first use of the study drug. 2. Patients who received other clinical trial drug within 4 weeks before the first dosing. 3. Within 3 years prior to the first trial drug treatment, the patient had other active malignant tumors, except for the tumors participating in this study and other locally cured tumors (such as basal skin cancer, papillary thyroid cancer, or any type of in situ cancer that has been completely removed, such as cervical in situ cancer, ductal carcinoma in situ, etc.). 4. The presence of clinically uncontrollable pleural/abdominal effusion, pericardial effusion, determined by the investigators as unsuitable for inclusion. 5. Suffering from central nervous system metastasis and/or cancerous meningitis. Except for asymptomatic or asymptomatic central nervous system metastases that have been clinically controlled but are judged stable by investigators, the following conditions must also be met: 1. Stable clinical symptoms for at least 4 weeks before receiving trial drug treatment. 2. No evidence of central nervous system disease progression was found in imaging examinations within 4 weeks prior to the first trial drug treatment. 3. Antiepileptic drugs have been discontinued at least 2 weeks prior to the first trial drug treatment, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of steroids. 4. For patients with intracranial lesions, if they have received treatment (such as radiotherapy) before the first trial drug treatment, elution should be ≥ 2 weeks. Cancer induced encephalitis should be excluded regardless of its stable clinical condition. 6. Receiving drug therapy known to prolong the QT interval or potentially lead to torsade de pointe ventricular tachycardia; Or continue to receive these medications during the research period. 7. Acute coronary syndrome occurring within the past 6 months, including myocardial infarction, unstable angina, symptomatic congestive heart failure (New York Heart Association classification II-IV), aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events; Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III-degree atrioventricular block, etc. 8. Suffering from clinically uncontrollable diseases, including but not limited to severe diabetes (diabetes ketoacidosis or hyperglycemia hyperosmolality occurred within 6 months before the first administration, and the detection value of glycosylated hemoglobin in the screening period was ≥ 7.5%); Refractory hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg after optimal medical treatment within the first month of screening) or a history of hypertensive crisis or hypertensive encephalopathy. 9. Individuals with previous or current interstitial lung disease (excluding radiation pneumonia that does not require hormone therapy). 10. Evidence of persistent uncontrolled systemic bacterial, fungal, or viral infections (including HIV infection, HIV antibody positive; syphilis infected individuals) and current need for intravenous anti infection treatment. 11. Provisions on hepatitis B and hepatitis C: if hepatitis B surface antigen (HBsAg) is positive, and HBV-DNA\>2000 IU/ml or 104 copies/ml, hepatitis B virus infected persons should receive antiviral treatment according to local guidelines and standards and are willing to receive antiviral treatment throughout the study period; Hepatitis C antibody positive, and HCV RNA higher than the upper limit of normal values in the study site; 12. Within 14 days prior to the first administration, systemic corticosteroids (prednisone\>10mg/day or equivalent doses of similar drugs) or other immunosuppressive treatments have been received, except for the following: 1. Use local, ocular, intra-articular, intranasal, and inhaled corticosteroids for treatment. 2. short term use of glucocorticoids for preventive treatment (such as preventing contrast agent allergies). 13. Within 4 weeks before the first administration or planned to receive attenuated live vaccines during the study period. 14. Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first administration or requiring elective surgery during the trial period. 15. Individuals who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past. 16. Known to have alcohol or drug dependence. 17. Individuals with mental disorders or poor compliance. 18. The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE5.0 ≤ Grade 1 (excluding toxicity judged by the investigators to have no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.); 19. Known to cause clinically significant allergic reactions to the active ingredients and excipients, antibodies, and other monoclonal antibodies. 20. Pregnant (positive pregnancy test prior to dosing) or breast-feeding women. 21. The investigators believe that the subjects are not suitable to participate in this clinical study due to other reasons. **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:** Yan Li, MD **Phone:** 18610580233 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Xue Wang **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Fudan University **Name:** Jian Zhang, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Fudan University **Name:** Hongxia Wang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426667 **Brief Title:** Effect of Radiofrequency Treatment in Plantar Fasciitis Patients **Official Title:** Effect of Radiofrequency Treatments on Foot Functionality Index, Patient Satisfaction and Pain Scores in Plantar Fasciitis Patients #### Organization Study ID Info **ID:** 2024/202 #### Organization **Class:** OTHER **Full Name:** Ankara University ### Status Module #### Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara University #### Responsible Party **Investigator Affiliation:** Ankara University **Investigator Full Name:** Hanzade Aybuke Unal **Investigator Title:** Medical Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In adults, chronic plantar fasciitis stands as the predominant cause of persistent heel discomfort.Usually, individuals depict a pulsating pain concentrated around the point of origin of the plantar fascia on the calcaneus. Numerous randomized and non-randomized studies have demonstrated the effectiveness of radiofrequency as a treatment modality for chronic plantar heel pain.In this study, our objective is to assess the impact of radiofrequency modalities applied to the posterior tibial nerve and/or the calcaneal spur area, guided by ultrasound, on patient satisfaction, pain scores, and functional improvement in individuals with chronic plantar fasciitis **Detailed Description:** Chronic plantar fasciitis is the most common cause of chronic heel pain in adults. Typically, patients describe a throbbing pain localized around the origin of the plantar fascia on the calcaneus. This pain is often most severe when taking the first steps in the morning or rising after sitting. It typically improves with activity but worsens with prolonged activity. The primary aim of heel spur treatment is to alleviate pain and restore function. Surgical interventions are recommended for chronic plantar heel pain resistant to conservative options. However, surgery may be associated with prolonged recovery, and in one study, superiority over conservative treatment was not demonstrated. Radiofrequency has been shown to be an effective treatment method for chronic plantar heel pain in many randomized and non-randomized studies. In many studies, most of these procedures are applied blindly based on anatomical landmarks, with attention drawn in many studies to applications targeting the terminal branches of the posterior tibial nerve or the spur region. Only a few studies have been performed using fluoroscopy and ultrasound guidance. Ultrasound guidance offers several advantages over fluoroscopy and blind landmark techniques, especially in interventional procedures targeting neural and soft tissues. These advantages include the ability to visualize vascular and neural structures, very low risk of vascular-neural injury, absence of radiation exposure, and superiority in cases of anatomical variation. However, a common point in many studies related to plantar fasciitis is that applications are either directed to the spur area or to neural structures leading to the heel region. In this study, we aim to compare the effects of radiofrequency modalities applied to the posterior tibial nerve and/or calcaneal spur area under ultrasound guidance on patient satisfaction, pain scores, and patient functionality in cases of chronic plantar fasciitis (heel spur). ### Conditions Module **Conditions:** - Fasciitis, Plantar **Keywords:** - Fasciitis, Plantar - Radiofrequency Therapy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 108 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** posterior tibial nerve pulsed radiofrequency treatment **Intervention Names:** - Procedure: posterior tibial nerve radiofrequency **Label:** posterior tibial nerve radiofrequency #### Arm Group 2 **Description:** calcaneal spur thermocoagulation radiofrequency treatment **Intervention Names:** - Procedure: plantar fasciitis radiofrequency **Label:** plantar fasciitis radiofrequency #### Arm Group 3 **Description:** posterior tibial nerve pulsed radiofrequency and calcaneal spur thermocoagulation radiofrequency treatment **Intervention Names:** - Procedure: posterior tibial nerve radiofrequency - Procedure: plantar fasciitis radiofrequency **Label:** posterior tibial nerve and plantar fasciitis radiofrequency ### Interventions #### Intervention 1 **Arm Group Labels:** - posterior tibial nerve and plantar fasciitis radiofrequency - posterior tibial nerve radiofrequency **Description:** pulse radiofrequency at 45 V for 300 seconds at 42 degrees Celsius is applied to the posterior tibial nerve area. During the procedure, the temperature at the electrode tip is kept below 42°C. Following negative aspiration (in the absence of blood), 2 cc of 1% lidocaine + 4 mg dexamethasone is applied to the same area. **Name:** posterior tibial nerve radiofrequency **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - plantar fasciitis radiofrequency - posterior tibial nerve and plantar fasciitis radiofrequency **Description:** the spur area on the calcaneal bone is identified, and sensory and motor stimulations are applied using the RF cannula. If no sensory or motor response is elicited in the area, conventional radiofrequency at 45 V for 60 seconds at 80 degrees Celsius is applied to the spur area after confirming the placement of the RF cannula. **Name:** plantar fasciitis radiofrequency **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** pain severity change by using Numeric Rating Scala will be observed before and at 1, 3 months after the procedure. pain severity change by using Numeric Ratin Scala was observed 3 months after the procedure.The 11-point numerical scale ranges from '0', representing "no pain", to '10', representing extreme pain (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). **Measure:** pain severity **Time Frame:** 1 and 3 months **Description:** Patients will evaluate their satisfaction after the procedure as "satisfied", "uncertain" or "not satisfied". **Measure:** Patient satisfaction after the procedure **Time Frame:** 1 and 3 months **Description:** Functionality of foot will be observed at before the procedure and 1, 3 months after the procedure. Foot functionalliy index will be used. Foot function index consists of 23 items with 3 subgroups: pain, disability and activity limitation. To calculate the subscales and total score, the scores of each item are summed, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability, and activity limitation. The survey score varies between 0-100, and as the score increases, the disability increases. **Measure:** functionallity **Time Frame:** 1 and 3 months **Description:** number of medication use (nonsteroidal anttinflamatort drugs, opioids, muscle relaxants) wiil be evaluated **Measure:** medication use **Time Frame:** 1 and 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-65 years old, * Heel pain for at least 6 months and a diagnosis of plantar fasciitis confirmed by direct radiography and physical examination, * Visual analog scale is 4 or more * No response to conservative treatment (medical and physical medicine modalities) Exclusion Criteria: * History of trauma or calcaneus fracture, * Osteoarthritis, Diabetes mellitus, chronic heart disease * Presence of pregnancy, * Pain due to peripheral neuropathy or ischemia * Inability to tolerate injections in the heel area, * Allergy to local anesthetics or steroids, * Presence of an open wound on the side of the foot that the injection will be performed * Local or systemic infection at the time of the procedure * Previous steroid injection, radiofrequency application or ESWT (electroshock wave) treatment into the heel * History of surgical intervention to the heel * Presence of any functional limitation in the affected foot * Presence of neurological, hepatic and/or metabolic diseases; dermatological infections, seronegative spondyloarthropathy, bleeding diathesis * Failure to discontinue anticoagulant or antiaggregant within the specified periods * Absence of follow-up throughout the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients between the ages of 18 and 65 who are scheduled to receive radiofrequency tretament due to plantar fasciitis will be included in the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hanzade A Unal, MD **Phone:** +905057179039 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Gungor E Özgencil, Prof **Phone:** +903125852404 **Role:** CONTACT #### Locations **Location 1:** **City:** Ankara **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hanzade A Ünal, MD - **Phone:** +905057179039 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Güngör E Özgencil, Prof - **Phone:** +903125082404 - **Role:** CONTACT **Country:** Turkey **Facility:** Ankara University **Status:** RECRUITING **Zip:** 06230 #### Overall Officials **Official 1:** **Affiliation:** Ankara University **Name:** Hanzade A Unal, MD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan. **PMID:** 35097359 **Citation:** Li X, Zhang L, Gu S, Sun J, Qin Z, Yue J, Zhong Y, Ding N, Gao R. Comparative effectiveness of extracorporeal shock wave, ultrasound, low-level laser therapy, noninvasive interactive neurostimulation, and pulsed radiofrequency treatment for treating plantar fasciitis: A systematic review and network meta-analysis. Medicine (Baltimore). 2018 Oct;97(43):e12819. doi: 10.1097/MD.0000000000012819. **PMID:** 30412072 **Citation:** Wu YT, Chang CY, Chou YC, Yeh CC, Li TY, Chu HY, Chen LC. Ultrasound-Guided Pulsed Radiofrequency Stimulation of Posterior Tibial Nerve: A Potential Novel Intervention for Recalcitrant Plantar Fasciitis. Arch Phys Med Rehabil. 2017 May;98(5):964-970. doi: 10.1016/j.apmr.2017.01.016. Epub 2017 Feb 14. **PMID:** 28209507 **Citation:** Orhurhu V, Urits I, Orman S, Viswanath O, Abd-Elsayed A. A Systematic Review of Radiofrequency Treatment of the Ankle for the Management of Chronic Foot and Ankle Pain. Curr Pain Headache Rep. 2019 Jan 19;23(1):4. doi: 10.1007/s11916-019-0745-5. **PMID:** 30661127 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000005534 - Term: Foot Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8351 - Name: Fasciitis - Relevance: HIGH - As Found: Fasciitis - ID: M24656 - Name: Fasciitis, Plantar - Relevance: HIGH - As Found: Fasciitis, Plantar - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M8658 - Name: Foot Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005208 - Term: Fasciitis - ID: D000036981 - Term: Fasciitis, Plantar ### 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 - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: LOW - As Found: Unknown - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426654 **Brief Title:** Sintilimab Combined With LDRT for Neoadjuvant Treatment of Locally Advanced dMMR/MSI-H Gastric Cancer **Official Title:** Sintilimab Combined With Low-dose Radiation Therapy for Neoadjuvant Treatment of Locally Advanced Deficient Mismatch Repair/Microsatellite Instability-high Gastric Cancer: a Prospective, Multi-center, Single-arm, Phase Ib/II Clinical Trial #### Organization Study ID Info **ID:** WCH242145 #### Organization **Class:** OTHER **Full Name:** West China Hospital ### Status Module #### Completion Date **Date:** 2027-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** West China Hospital #### Responsible Party **Investigator Affiliation:** West China Hospital **Investigator Full Name:** Ming Liu **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:** Recently, growing evidences have suggested that immunotherapy represents a promising treatment option for the neoadjuvant treatment of locally advanced mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) gastric cancer. In this study, we will explore the efficacy and safety of sintilimab and LDRT in the neoadjuvant treatment for locally advanced dMMR/MSI-H G/GEJ cancer. **Detailed Description:** This is a prospective, multicenter, single-arm, phase Ib/II trial. In the phase Ib, 4 cases will be enrolled in each treatment group. In the phase II study, a total of 33 patients will be enrolled. Eligible patients will be registered and receive four cycles of sintilimab. Simultaneously, LDRT will be planned and administered. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The primary endpoint of phase Ib is to determine the optimal radiation dose for phase II study. The primary endpoint of phase II is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), objective response rate (ORR), 3-year event-free survival (EFS) rate, 3-year overall survival (OS) rate and safety profile of the neoadjuvant regimen. ### Conditions Module **Conditions:** - Gastric Cancer **Keywords:** - gastric cancer - neoadjuvant therapy - sintilimab - LDRT ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Laparoscopic exploration is required in all patients to detect occult peritoneal metastases. All patients will start with one cycle of neoadjuvant therapy of sintilimab: 200 mg, iv drip, d1, q3w. Then, LDRT will be performed in the target area (including the primary gastric lesion and positive/suspected positive lymph nodes). After radiotherapy, patients will receive another three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles. **Intervention Names:** - Drug: sintiliman plus LDRT **Label:** sintilimab+LDRT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - sintilimab+LDRT **Description:** All patients will start with one cycle of neoadjuvant therapy of sintilimab: sintilimab 200 mg, iv drip, d1, q3w. LDRT will be performed in the target area. After radiotherapy, patients will receive another three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles. **Name:** sintiliman plus LDRT **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy **Measure:** pCR rate **Time Frame:** 5 months after the last subject participating in #### Secondary Outcomes **Description:** defined as the rate of the complete surgical removal of any residual cancer cells in the tumor bed **Measure:** R0 resection rate **Time Frame:** 5 months after the last subject participating in **Description:** defined as tumor residual cells ≤10% in the surgical specimen **Measure:** MPR rate **Time Frame:** 5 months after the last subject participating in **Description:** defined as the proportion of patients without event 23 years after enrolment **Measure:** 3-year event-free survival (DFS) **Time Frame:** every 3 month postoperation up to 36 months **Description:** defined as the proportion of patients survived 3 years after enrolment **Measure:** 2-year OS rate **Time Frame:** every 3 month postoperation up to 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-80 years. 2. Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT2N+M0 or cT3-4aNanyM0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI. 3. Resectable G/GEJ cancer, as judged by experienced surgeons. 4. dMMR and/or MSI-H. 4. Eastern Cooperative Oncology Group performance score (ECOG PS) ≤1. 5. Agree to provide blood, feces, and tissue specimens. 6. The expected survival is longer than 6 months. 7. There was no previous antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and other treatments with antitumor effects). 8. Adequate organ and hematological function. 9. Strict contraception. 10. Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. Exclusion Criteria: 1. Unable to comply with the research program or procedures. 2. Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment. 3. Active autoimmune disease or history of refractory autoimmune disease. 4. Receiving corticosteroids (\> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting. 5. Active or clinically significant cardiac disease: 1. Congestive heart failure \> New York Heart Association (NYHA) class 2; 2. Active coronary artery disease; 3. Arrhythmias requiring treatment other than β-blockers or digoxin; 4. Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment 6. Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment. 7. Patients with a history of HIV infection or active hepatitis B/C. 8. Ongoing \> level 2 infection. 9. Symptomatic brain metastasis or meningioma. 10. Unhealed wounds, ulcers or fractures. 11. Renal failure patients requiring blood or peritoneal dialysis. 12. Epileptic that needs medication. 13. Active, symptomatic interstitial pneumonia, pleural or ascites that causes dyspnea (dyspnea ≥ 2 grade). 14. History of organ transplantation (including corneal transplantation). 15. Allergic to research drugs or similar drugs, or suspected allergies. 16. Pregnant or lactating women. 17. The investigator believes that patients who are not suitable for the study. 18. Medical, psychological or social conditions can affect the recruitment of patients and evaluation of study results. 19. Other antitumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs. Palliative external irradiation for non-target lesions is allowed. 20. Previously used similar immune checkpoint inhibitors. 21. Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery (excluding biliary stents, or percutaneous biliary drainage). 22. Treatment with antitumor Chinese herbal medicine. **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:** Pengfei Zhang, M.D **Phone:** +86-17828163584 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ming Liu, M.D. **Phone:** +86-18980606324 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** West China Hospital **Name:** Kun Yang, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **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: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M27510 - Name: Microsatellite Instability - 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: 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: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426641 **Brief Title:** Polyethylene Wear Particle Analysis of TKA **Official Title:** Polyethylene Wear Particle Analysis of Total Knee Arthroplasty -International Multicenter Study- #### Organization Study ID Info **ID:** OMU 2023-108 #### 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:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **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:** Istituto Ortopedico Rizzoli **Class:** OTHER **Name:** Hospital for Special Surgery, New York #### 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:** The purpose of this study was to investigate whether polyethylene (Vitamin E-containing polyethylene), which has been newly introduced and widely used clinically as a biomaterial for tibial inserts in total knee arthroplasty, but whose mid- to long-term clinical results are still unknown, is more effective than conventional polyethylene. Our goal is to clarify through an international multi-center joint study using in vivo polyethylene wear particle analysis, which the investigators developed as a method to provide early feedback, as to whether polyethylene wear debris production in vivo can be reduced. **Detailed Description:** Anticipated medical contribution and significance In this study, the investigators investigate whether a newly introduced polyethylene (highly cross-linked polyethylene, vitamin E-containing polyethylene in vivo) can suppress wear debris production more than conventional polyethylene. If the newly introduced polyethylene can reduce wear debris production, it is expected to reduce failure of artificial joints in the future. However, if newly introduced polyethylene is actually increasing wear debris production, it could be an early alarm bell for surgeons around the world. In other words, the international and social impact of this research is extremely large. Two unique requirements are necessary to carry out this research. Firstly, in vivo analysis of polyethylene wear particles is possible, and secondly, the number of surgical cases of revision knee arthroplasty targeted for investigation is large. The first requirement is that the applicants have published many English-language papers on in vivo polyethylene wear debris analysis, and that their facilities are the most suitable and fully capable of carrying out the analysis worldwide. be. The second requirement is that the investigators need to collaborate not only with our hospital but also with facilities that perform a large number of revision knee arthroplasty surgeries. Not only our hospital, but also our affiliated hospital, which is one of the facilities in Japan that performs the most knee joint surgeries (Naniwa Ikuno Hospital), and the hospital that performs the most knee joint surgeries worldwide (Mayo Clinic \[USA\]). , Hospital for Special Surgery \[USA\], Istituto Ortopedico Rizzoli \[Italy\]). 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 \[Figure 3\]. Target of this research In this study, the investigators will focus on patients undergoing revision knee arthroplasty as a routine medical treatment. First total joint replacement * 30 patients using polyethylene containing Vitamin E * 30 patients using conventional polyethylene (no highly cross-linking) * 30 patients using conventional polyethylene (with highly cross-linking) Accumulation of periarticular tissue In this study, the investigators will focus on patients undergoing revision knee 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 5M NaOH 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, knee joint range of motion, knee prosthesis clinical score \[Knee Society Score, University of California at Los Angeles activity score\]). Evaluation items (outcome) Main evaluation items: Polyethylene wear particle morphology (number of wear particles, equivalent circle diameter \[㎛\], aspect ratio, roundness) \[Reason for setting primary endpoints\] Because it is a standard evaluation item for evaluating polyethylene wear debris. Secondary endpoints: * Body mass index * Knee joint range of motion * Clinical score (2011Knee Society Score, Knee injury and Osteoarthritis Outcome Score for Joint Replacement, University of California at Los Angeles activity score) \[Reason for setting secondary endpoints\] Because it may affect the production of polyethylene wear debris. Planned number of research subjects and basis for setting it (including cases where the number of research subjects is set without relying on statistical grounds) Total 90 cases * 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) Rationale for setting: The target number of cases was determined from the number of cases at related institutions within the study period. ### Conditions Module **Conditions:** - Wear of Articular Bearing Surface of Prosthetic Joint - Total Knee Arthroplasty **Keywords:** - Polyethylene wear particle ### Design Module #### Bio Spec **Description:** 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:** There is no intervention **Name:** Polyethylene **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** counts / g (tissue sample) **Measure:** Number of polyethylene wear particles **Time Frame:** Time of revision surgery **Description:** Equivalent circle diameter (㎛) **Measure:** Equivalent circle diameter of polyethylene wear particles **Time Frame:** Time of revision surgery **Description:** Aspect ratio **Measure:** Aspect ratio of polyethylene wear particles **Time Frame:** Time of revision surgery **Description:** Roundness **Measure:** Roundness of polyethylene wear particles **Time Frame:** Time of revision surgery #### Secondary Outcomes **Description:** kg/m2 **Measure:** Body mass index **Time Frame:** Time of revision surgery **Description:** degrees **Measure:** Knee joint extension angle **Time Frame:** Time of revision surgery **Description:** degrees **Measure:** Knee joint flexion angle **Time Frame:** Time of revision surgery **Description:** 0(worse)-100(best) **Measure:** 2011 Knee Society Score: An "Objective" Knee Score **Time Frame:** Time of revision surgery **Description:** 0(worse)-40(best) **Measure:** 2011 Knee Society Score: A Patient Satisfaction Score **Time Frame:** Time of revision surgery **Description:** 0(worse)-15(best) **Measure:** 2011 Knee Society Score: A Patient Expectation Score **Time Frame:** Time of revision surgery **Description:** 0(worse)-100(best) **Measure:** 2011 Knee Society Score: A Functional Activity Score **Time Frame:** Time of revision surgery **Description:** 0(worse)-100(best) **Measure:** Knee injury and Osteoarthritis Outcome Score for Joint Replacement **Time Frame:** Time of revision surgery **Description:** 1(worse)-10(best) **Measure:** University of California at Los Angeles activity score **Time Frame:** Time of revision surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients undergoing revision knee 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 knee 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 surgery ### Contacts Locations Module #### Locations **Location 1:** **City:** Osaka **Country:** Japan **Facility:** Osaka Metroplitan Univerity **Zip:** 545-8585 #### 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:** Minoda Y, Kobayashi A, Iwaki H, Iwakiri K, Inori F, Sugama R, Ikebuchi M, Kadoya Y, Takaoka K. In vivo analysis of polyethylene wear particles after total knee arthroplasty: the influence of improved materials and designs. J Bone Joint Surg Am. 2009 Nov;91 Suppl 6:67-73. doi: 10.2106/JBJS.I.00447. No abstract available. **PMID:** 19884413 **Citation:** Minoda Y, Kobayashi A, Iwaki H, Miyaguchi M, Kadoya Y, Ohashi H, Yamano Y, Takaoka K. Polyethylene wear particles in synovial fluid after total knee arthroplasty. Clin Orthop Relat Res. 2003 May;(410):165-72. doi: 10.1097/01.blo.0000063122.39522.c2. **PMID:** 12771827 ## Derived Section ### 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: 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: M17558 - Name: Vitamins - 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: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426628 **Acronym:** NIGHTINGALE **Brief Title:** Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier **Official Title:** Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier #### Organization Study ID Info **ID:** DHF009-050P #### Organization **Class:** INDUSTRY **Full Name:** Veracyte, Inc. ### Status Module #### Completion Date **Date:** 2026-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-07-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Veracyte, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to learn how a physician uses the results of the Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule. The main questions it aims to answer are: * Does the use of the Percepta Nasal swab test reduce the number of invasive procedures in people with a low-risk result and whose nodule is benign? * Does the use of the Percepta Nasal swab test decrease the time to treatment in people with a high-risk result and whose nodule is cancer? Participants will be randomly assigned to either a group where the test result is provided to the physician (test arm) or to a group where the test result is not provided (control arm). Researchers will compare management of participants in the two groups. **Detailed Description:** This is a prospective, multicenter, randomized study to evaluate the clinical utility of the Percepta® Nasal Swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. Patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. The study will observe and evaluate how the addition of the Percepta Nasal Swab classifier result impacts current management of newly identified lung nodules. The study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the US. Enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer. ### Conditions Module **Conditions:** - Pulmonary Nodule, Solitary - Lung Cancer ### Design Module #### Bio Spec **Description:** Nasal swab **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2400 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Percepta Nasal Swab test result will be returned to the physician investigator. **Label:** Test Arm #### Arm Group 2 **Description:** Percepta Nasal Swab test result will not be returned to the physician investigator. **Label:** Control Arm ### Outcomes Module #### Primary Outcomes **Description:** Invasive diagnostic procedures performed in the diagnostic workup of newly identified nodules that are benign. **Measure:** Number of invasive diagnostic procedures **Time Frame:** From date of randomization until the date the nodule is diagnosed as benign or demonstrates up to 24 months radiographic stability or resolution, assessed up to a total of 30 months. #### Secondary Outcomes **Description:** Time to treatment in the diagnostic workup of newly identified nodules that are primary lung cancer **Measure:** Time to treatment **Time Frame:** From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to tolerate nasal epithelial specimen collection * Signed written Informed Consent obtained * Subject clinical history available for review by sponsor and regulatory agencies * New nodule identified on imaging \< 90 days prior to nasal sample collection * CT report available for index nodule * 29 - 85 years of age * Current or former smoker (\>100 cigarettes in a lifetime) * Pulmonary nodule ≤30 mm detected by CT Exclusion Criteria: * Active cancer (other than non-melanoma skin cancer) * Prior primary lung cancer (prior non-lung cancer acceptable) * Prior participation in this study (i.e., subjects may not be enrolled more than once) * Current active treatment with an investigational device or drug * Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule * Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators **Maximum Age:** 85 Years **Minimum Age:** 29 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Current or former smokers (\>100 cigarettes in a lifetime) who are 29 - 85 years of age with a newly identified pulmonary nodule ≤30 mm detected by CT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lori Lofaro, MSHS **Phone:** 6502436389 **Role:** CONTACT #### Locations **Location 1:** **City:** Stamford **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Majed Albache, MD, MPH - **Phone:** 203-276-4362 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Adrienne S Scott, MS, CCRC - **Phone:** 203-276-4362 - **Role:** CONTACT **Country:** United States **Facility:** The Stamford Health/The Stamford Hospital **State:** Connecticut **Status:** RECRUITING **Zip:** 06904 **Location 2:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Phillip Cooper - **Phone:** 312-503-0406 - **Role:** CONTACT **Country:** United States **Facility:** Northwestern University **State:** Illinois **Status:** NOT_YET_RECRUITING **Zip:** 60611 **Location 3:** **City:** Greensboro **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bradley L Icard, DO - **Phone:** 336-522-8870 - **Role:** CONTACT **Country:** United States **Facility:** PulmonIx, LLC **State:** North Carolina **Status:** RECRUITING **Zip:** 27401 #### Overall Officials **Official 1:** **Affiliation:** Veracyte, Inc. **Name:** Phillip G Febbo, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M28260 - Name: Multiple Pulmonary Nodules - Relevance: HIGH - As Found: Pulmonary Nodules - ID: M6303 - Name: Solitary Pulmonary Nodule - Relevance: HIGH - As Found: Pulmonary Nodule, Solitary - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055613 - Term: Multiple Pulmonary Nodules - ID: D000003074 - Term: Solitary Pulmonary Nodule ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426615 **Acronym:** CONSCIUS **Brief Title:** Connectivity and Neural Signatures of Consciousness in Unresponsive States **Official Title:** Connectivity and Neural Signatures of Consciousness In Unresponsive States (CONSCIUS) - a Study of Brain Activity in Disorders of Consciousness #### Organization Study ID Info **ID:** s67062 #### Organization **Class:** OTHER **Full Name:** Universitaire Ziekenhuizen KU Leuven ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-03-29 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Research Foundation Flanders #### Lead Sponsor **Class:** OTHER **Name:** Universitaire Ziekenhuizen KU Leuven #### 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 CONSCIUS study is a prospective, interventional study including patients with acute brain injury and impaired consciousness implanted with intracranial electrodes. The aim of the study is to investigate seizures and thalamocortical neural dynamics underlying behavioral unresponsiveness. **Detailed Description:** Individuals with severe brain injury often require extensive treatment in intensive care units (ICU) and hospitalization wards while uncertainty prevails about the recovery of consciousness and cognitive abilities. Especially in the acute phase after injury, treatment decisions have a tremendous impact on outcome, but rely on assessments of behavioral responsiveness which are known to be unreliable and subject to many confounders. Objective, quantifiable diagnostic and prognostic measures that can be deployed at the bedside during the ICU stay are lacking. Development of new metrics are hampered by our lack of a fundamental understanding of (i) thalamocortical network mechanisms underlying consciousness and (ii) brain-injury induced neural dynamics impacting both consciousness and outcome. Continuous EEG monitoring has been used to aid in this respect to (i) predict recovery of consciousness and outcome, and (ii) diagnose nonconvulsive seizures in unresponsive patients. Although promising, it lacks sensitivity, spatial resolution, and causal power. There is an urgent need for techniques allowing high-precision detection of pathological dynamics, patient stratification and prediction of a capacity for consciousness recovery in acute unresponsive patients with brain injury. Intracranial electrodes as part of multimodal monitoring in subjects with impaired consciousness and severe brain injury allow continuous bedside recordings of high spatiotemporal resolution in different network nodes and allows inducing brain perturbations, transcending correlational evidence of network analysis. This technique could increase the detection and treatment of nonconvulsive seizures contributing to brain injury and unresponsiveness and simultaneously allows to study networks supporting consciousness. This can lead to new diagnostic and prognostic biomarkers for recovery based on thalamocortical profiles of activity, reactivity (complexity) and connectivity, ultimately paving to way for the development of biomarker-driven treatments to support early recovery such as deep brain stimulation. Eventually this can contribute to clinical decision making: abstaining from aggressive treatment in patients with no potential for recovery, and more importantly, continuing treatment in subjects with a responsive brain but without clear behavioural correlate. ### Conditions Module **Conditions:** - Acute Brain Injury - Traumatic Brain Injury - Consciousness Disorders - Seizures **Keywords:** - Consciousness - Seizures - Neural dynamics - Intracranial recordings and stimulation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Prospective inclusion of patients implanted with intracranial electrodes. ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with acute brain injury with reduced consciousness that undergo multimodal intracranial monitoring, or with suspected seizures **Intervention Names:** - Device: Intracranial electrodes **Label:** Acute brain injury **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Acute brain injury **Description:** Placement of intracranial electrodes in the cortico-subcortical system **Name:** Intracranial electrodes **Other Names:** - Depth electrodes **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The primary aim is to compare the incidence of ictal and ictal-interictal continuum epileptiform activity on intracranial versus scalp EEG. **Measure:** Incidence of electrographic epileptiform activity (ictal and ictal-interictal continuum activity) on intracranial versus scalp electroencephalography (EEG). **Time Frame:** A maximum of 4 weeks after electrode implantation. #### Secondary Outcomes **Description:** Correlation of profiles of neural activity and reactivity with the behavioral state using the Coma Recovery Scale-Revised (CRS-R). **Measure:** Correlating neural activity patterns (local field potentials and complexity) with behavioral responsiveness (measured using the Coma Recovery Scale-Revised). **Time Frame:** A maximum of 4 weeks after electrode implantation. **Description:** Effects of electrical stimulation on behavioral responsiveness will be measured using the Coma Recovery Scale Revised (CRS-R). **Measure:** Acute effects of electrical stimulation on behavioral responsiveness (measured using the Coma Recovery Scale-Revised). **Time Frame:** During electrical stimulation trials, performed in the first 4 weeks after electrode implantation. **Description:** Profiles of activity and reactivity identified during the acute stage of the disease will be correlated with long-term outcome measures mainly at 6m and 1y, using Coma Recovery Scale-Revised and Glasgow Outcome Scale-Extended. **Measure:** Correlation of neural activity profiles with long-term outcome (Coma Recovery Scale-Revised and Glasgow Outcome Scale-Extended) **Time Frame:** At 6 months and 1 year follow-up. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years old or older * Brain injury of any kind, with impaired consciousness or suspected seizures Exclusion Criteria: * \< 18 years old * Known pregnancy * Any condition that, in the judgement of the investigator, makes participation in the study unsafe or unfeasible (e.g., irreversible coagulopathy, large intracranial tumors, surgical technical problems...) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Steven Smeijers, MD **Phone:** +32 16 34 48 00 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Tom Theys, MD PhD **Phone:** +32 16 34 48 00 **Role:** CONTACT #### Locations **Location 1:** **City:** Leuven **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Steven Smeijers, MD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Tom Theys, MD PhD - **Role:** CONTACT **Country:** Belgium **Facility:** UZLeuven **State:** Vlaams-Brabant **Status:** RECRUITING **Zip:** 3000 #### Overall Officials **Official 1:** **Affiliation:** Universitaire Ziekenhuizen KU Leuven **Name:** Tom Theys, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ## 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: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System - ID: D000009461 - Term: Neurologic Manifestations - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5207 - Name: Brain Injuries - Relevance: HIGH - As Found: Brain Injury - ID: M628 - Name: Brain Injuries, Traumatic - Relevance: HIGH - As Found: Traumatic Brain Injury - ID: M15452 - Name: Seizures - Relevance: HIGH - As Found: Seizures - ID: M6468 - Name: Consciousness Disorders - Relevance: HIGH - As Found: Consciousness Disorders - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - 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: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001930 - Term: Brain Injuries - ID: D000070642 - Term: Brain Injuries, Traumatic - ID: D000012640 - Term: Seizures - ID: D000003244 - Term: Consciousness Disorders - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426602 **Brief Title:** mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness **Official Title:** Unlocking Functional Communication for Patients With Disorders of Consciousness With Innovative Brain Computer Interface Technology #### Organization Study ID Info **ID:** STUDY23080022 #### Organization **Class:** OTHER **Full Name:** University of Pittsburgh #### Secondary ID Infos **Domain:** UPMC Beckwith Institute **ID:** BECKW/12863 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-01-16 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** The Beckwith Institute #### Lead Sponsor **Class:** OTHER **Name:** Amy Wagner #### Responsible Party **Investigator Affiliation:** University of Pittsburgh **Investigator Full Name:** Amy Wagner **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to test how effective the mindBEAGLE device is in allowing people who are unconscious (due to a brain injury or other condition) to communicate using brain waves to answer Yes/No questions. Participants will wear a cap that will be connected to a computer that measures brain waves, wrist bands that vibrate at different strengths, and ear phones that create different levels of loud tones and will be asked to associate Yes/No answers with the vibrations or tones. They will also be asked to "think about" moving different parts of their body to answer Yes or No. The mindBEAGLE device has already been proven effective for this kind of communication in a previous study, and the study team would like to trial it on a population of unconscious people who enter the UPMC Rehabilitation Institute to see if patients are able to be trained to use the device as part of their everyday inpatient rehabilitation until they are discharged, or until they are able to regain consciousness. **Detailed Description:** The team's research reflects an integrated clinical and research team who will characterize and implement an aggressive and innovative approach using brain-computer interface (BCI) technology for Disorders of Consciousness (DoC) evaluation, prognostication, and rehabilitation care. The work proposed strives for equity in accessing healthcare systems and technology effectively, even among vulnerable individuals with profound levels of disability due to their DoC state. The "gold-standard" for assessing cognitive capacity among patients with DoC relies on behavioral response observations and neuroimaging modalities. However, these approaches underestimate patients' capabilities. The current problem is that without other clinical data, rehabilitation teams rely solely on observable behavioral changes in patients' awareness of their environment in order to treat and improve communication. The project's challenge rests with implementing BCI focused assistive technology that identifies a unique and specific electrophysiological biomarker of cognitive and communication capacities that cannot be tapped using current clinical tools. If successful, this approach will allow clinical teams to initiate treatment and communication, avoiding therapeutic delays arising from traditional methods that require behavioral indicators needed to participate in functional communication. The P300 wave is a positive deflection in the human event-related potential. It is most commonly elicited in an "oddball" paradigm when a subject detects an occasional "target" stimulus in a regular train of standard stimuli. This project will compare standard awareness training methods used at the UPMC RI Brain Injury program with novel BCI research by using mindBEAGLE, a suite of P300 paradigms (vibrations, sound tones, and mental visualization) used for cognitive and communication assessment and treatment. European studies using the mindBEAGLE system with DoC patients reveal patients' cognitive and communication capabilities that impact current functional assessment and influence prognostication and recovery. The mindBEAGLE gives additional diagnostic data to enhance clinical neuroscience practice by showing reactions to stimuli that benefit from electroencephalogram (EEG) P300 use. However, clinical neuroscience implementation studies have not been conducted. Armed with more detailed and accurate assessments from this study, the investigators are confident that the clinical teams will be able to offer exciting rehabilitation treatments designed by UPMC RI treatment teams, patients, and families that leverage the mindBEAGLE interface for functional communication. Specifically, the EEG-based mindBEAGLE BCI suite will provide a practical platform for cognitive assessment of command following and a communication system for patients with DoC that will allow the research teams to offer more intensive, multidimensional rehabilitation treatments that meet the UPMC ideal of Life Changing Medicine. ### Conditions Module **Conditions:** - Disorders of Consciousness **Keywords:** - Coma - Locked-in syndrome - Vegetative state - Unresponsive wakefulness syndrome - Minimally conscious state ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single arm Phase 2 experimental device efficacy clinical trial ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients identified as "disorders of consciousness" admitted to UPMC Rehabilitation Institute will be considered for the trial. As patients will not be able to communicate, health care proxy will provide consent. Participants will undergo 3 trials within a 7 day period (2-3 hours each ) to assess if they are responding to the device. **Intervention Names:** - Device: mindBEAGLE daily device use **Label:** mindBEAGLE trial participants **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - mindBEAGLE trial participants **Description:** If participants are considered responsive, they will continue to use the device daily for the remainder of their stay at inpatient rehab, or until they regain consciousness. **Name:** mindBEAGLE daily device use **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The ability to answer Yes/No questions at over above 60% accuracy using 1 of the following paradigms: 1. vibro-tactile (VT) stimulation with 3 tractors; 2. VT stimulation with 7 tractors; 3. motor imagery **Measure:** Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment **Time Frame:** 18 months **Description:** Among DOC patients who pass initial classification assessment: ability to communicate yes/no questions at or above 60% accuracy with one of the two P300 paradigms. mindBEAGLE P300 paradigm #1 1. Baseline - No response to yes/no questions 2. Change in baseline - Response to yes/no questions using mindBEAGLE mindBEAGLE P300 paradigm #2 1. Baseline - 0% accuracy on yes/no questions 2. Change in baseline - 60% or higher in response to yes/no questions. **Measure:** DOC mindBEAGLE Communication Assessment **Time Frame:** 18 months **Description:** Clinicians agree that mindBEAGLE is feasible to implement with DOC patients in the inpatient setting. **Measure:** Acceptability of mindBEAGLE treatment by clinical staff. **Time Frame:** Within 2 weeks Post-intervention **Description:** Family/Caregivers of DOC patient agree that the mindBEAGLE was beneficial. **Measure:** Acceptability of mindBEAGLE treatment by families of DOC patients. **Time Frame:** Within 2 weeks Post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18-50 * Medically able to tolerate Disorders of Consciousness (DoC) rehabilitation program as determined by UPMC Physicians * Clinically assessed capacity for functional improvement in the rehabilitation environment * Measuring improvements with pharmacological stimulation (using JFK Coma Recovery Scale) * Electrophysiological prognostic testing confirming brain activity. Exclusion Criteria: * Coma * Bilateral non-response with standard electrophysiological studies * Medical instability * Open scalp wound **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Amy K. Wagner, M.D. **Phone:** 412-648-6666 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Katherine Hill, Ph.D. **Phone:** (412) 647-1310 **Role:** CONTACT #### Locations **Location 1:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vince Schiappa, MS, ATP - **Phone:** 412-647-1310 - **Role:** CONTACT **Country:** United States **Facility:** UPMC Center for Assistive Technology **State:** Pennsylvania **Zip:** 15213 **Location 2:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Amy Wagner, M.D. - **Phone:** 412-648-6666 - **Role:** CONTACT **Country:** United States **Facility:** UPMC Rehabilitation Institute **State:** Pennsylvania **Zip:** 15219 #### Overall Officials **Official 1:** **Affiliation:** University of Pittsburgh **Name:** Amy Wagner, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Pittsburgh **Name:** Katherine Hill, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** It is possible that the investigators may use the information obtained from this study in other future research studies. All information disseminated to outside collaborators or entities will be done in a de-identified manner so as to mitigate a breach of confidentiality and protect PHI/PII. Data will be coded using unique identifying numbers that do not contain PII. Any links to PII will be kept locally but will not be disseminated to outside collaborators. Any data shared with outside institutions or collaborators will be conducted under the guidelines of an approved data use agreement between the University of Pittsburgh and the collaborating entity. This includes any plans to publish published peer-reviewed manuscripts. **IPD Sharing:** YES ### References Module #### References **Citation:** Kondziella D, Amiri M, Othman MH, Beghi E, Bodien YG, Citerio G, Giacino JT, Mayer SA, Lawson TN, Menon DK, Rass V, Sharshar T, Stevens RD, Tinti L, Vespa P, McNett M, Venkatasubba Rao CP, Helbok R; Curing Coma Campaign Collaborators. Incidence and prevalence of coma in the UK and the USA. Brain Commun. 2022 Sep 1;4(5):fcac188. doi: 10.1093/braincomms/fcac188. eCollection 2022. **PMID:** 36132425 **Citation:** Godbolt AK, Deboussard CN, Stenberg M, Lindgren M, Ulfarsson T, Borg J. Disorders of consciousness after severe traumatic brain injury: a Swedish-Icelandic study of incidence, outcomes and implications for optimizing care pathways. J Rehabil Med. 2013 Sep;45(8):741-8. doi: 10.2340/16501977-1167. **PMID:** 24002309 **Citation:** Mainali S, Aiyagari V, Alexander S, Bodien Y, Boerwinkle V, Boly M, Brown E, Brown J, Claassen J, Edlow BL, Fink EL, Fins JJ, Foreman B, Frontera J, Geocadin RG, Giacino J, Gilmore EJ, Gosseries O, Hammond F, Helbok R, Claude Hemphill J, Hirsch K, Kim K, Laureys S, Lewis A, Ling G, Livesay SL, McCredie V, McNett M, Menon D, Molteni E, Olson D, O'Phelan K, Park S, Polizzotto L, Javier Provencio J, Puybasset L, Venkatasubba Rao CP, Robertson C, Rohaut B, Rubin M, Sharshar T, Shutter L, Sampaio Silva G, Smith W, Stevens RD, Thibaut A, Vespa P, Wagner AK, Ziai WC, Zink E, I Suarez J; Curing Coma Campaign collaborators. Proceedings of the Second Curing Coma Campaign NIH Symposium: Challenging the Future of Research for Coma and Disorders of Consciousness. Neurocrit Care. 2022 Aug;37(1):326-350. doi: 10.1007/s12028-022-01505-3. Epub 2022 May 10. Erratum In: Neurocrit Care. 2022 Jun 17;: **PMID:** 35534661 **Citation:** Torres-Saavedra PA, Winter KA. An Overview of Phase 2 Clinical Trial Designs. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):22-29. doi: 10.1016/j.ijrobp.2021.07.1700. Epub 2021 Aug 4. **PMID:** 34363901 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M6468 - Name: Consciousness Disorders - Relevance: HIGH - As Found: Disorders of Consciousness - ID: M6356 - Name: Coma - Relevance: LOW - As Found: Unknown - ID: M2155 - Name: Locked-In Syndrome - 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 - 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: T3491 - Name: Locked-in Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003244 - Term: Consciousness Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426589 **Brief Title:** Exercise and Nutrition in the Mental Health of the Older Adult Population **Official Title:** Resistance Training and Mediterranean Diet in the Mental Health of the Older Adult Population: a Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** UJA.2024 #### Organization **Class:** OTHER **Full Name:** University of Jaén ### Status Module #### Completion Date **Date:** 2024-01-26 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-19 **Type:** ACTUAL #### Start Date **Date:** 2023-10-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Jaén #### Responsible Party **Investigator Affiliation:** University of Jaén **Investigator Full Name:** Agustín Aibar Almazán **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:** Resistance exercise and the Mediterranean diet are complementary, evidence-based approaches to improving physical and mental health throughout all stages of life. For older adults, maintain flexibility, muscle strength, balance and posture, reducing the risk of falls and injuries; They relieve chronic pain, improve sleep quality, and reduce stress and anxiety. For young people, they improve concentration, attention and memory, reduce stress and anxiety, promote a positive body image and increase self-esteem. Overall benefits include promoting the mind-body connection, facilitating healthy aging, and being accessible and adaptable to various individual and socioeconomic needs. The main components of the Mediterranean diet are: high in fruits, vegetables, legumes, nuts, whole grains, fish and olive oil; moderate in dairy and red wine; and low in red meat and processed products. Benefits for older adults include reducing the risk of cardiovascular disease, decreasing chronic diseases and pro-inflammatory factors, and preventing obesity and cognitive decline. The overall impact improves bone and cardiovascular health, and strengthens the immune system. The combination of resistance exercise and a Mediterranean diet offers a comprehensive approach to improving health and well-being throughout life, promoting physical and mental health, facilitating active and healthy aging, and being accessible and beneficial for people of all socioeconomic backgrounds ### Conditions Module **Conditions:** - Older Adults ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 108 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The control group (CG) will not undergo treatment, which will be evaluated in the pre- and post-phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity, and they will be given the guide of recommendations for the promotion of physical activity. **Label:** Control Group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** The experimental group (EG), after an initial evaluation, will be subjected to a physical training program based on the resistance training, for 12 weeks with 2 weekly sessions (Tuesday and Thursday), with a duration of 45 minutes per session. Once the intervention is finished, you will undergo a final evaluation again to see if there is a difference or not with the results obtained at the beginning. In addition to the resistance training intervention, the experimental group received a Mediterranean diet protocol. **Intervention Names:** - Other: Resistence training and mediterranean diet **Label:** Experimental Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental Group **Description:** Resistance training. Subjects assigned to the experimental group participated in resistance program twice a week (on Tuesdays and Thursdays) for a period of 12 weeks, totaling 24 sessions of 60 minutes each. Each session during this time was divided into three clearly differentiated parts: i) 5-minute warm-up comprised of a series of gentle, low-intensity exercises designed to gradually prepare the muscles and joints of older adults for the main exercise. Mediterranean Diet. In addition to the resistance intervention, the experimental group received a Mediterranean diet protocol based on the study by Ismail et al. \[34\] with the following meal plan: i) carbohydrates constituted 50% of daily intake; ii) fats repre-sented 35%; and iii) proteins accounted for 15%. **Name:** Resistence training and mediterranean diet **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This was measured using the 14-item Mediterranean Diet Adherence Questionnaire (MEDAS) questionnaire, developed by the Prevention with Mediterranean Diet (PREDIMED) researchers. The questionnaire consists of 12 queries regarding how often various foods are eaten and two additional questions concerning typical eating habits in Spain \[35\]. Each question could be answered with a score of either zero or one. The total possible score ranged from 0 to 14, with a total of 9 or higher signifying sufficient compliance with the Mediterranean diet. **Measure:** Adherence to the Mediterranean Diet **Time Frame:** Up to twelve weeks **Description:** To evaluate anxiety and depression levels, the Hospital Anxiety and Depression Scale (HADS) was used \[36,37\]. This instrument is frequently used in populations of older adults who are not institutionalized \[38\] and includes 14 questions, divided equally between anxiety (even questions) and depression (even questions). Items are scored on a scale of 0 to 3, resulting in a total score range of 0 to 21 for both anxiety and depression, with a higher number indicating a greater presence of symptoms. Sleep quality **Measure:** Anxiety and depression **Time Frame:** Up to twelve weeks **Description:** The Pittsburgh Sleep Quality Index (PSQI) \[39,40\], a widely recognized tool for the assessment of sleep quality, was the questionnaire selected for this task. The PSQI includes 19 self-report items and 5 additional items that must be completed by the participant's bed partner or roommate (the latter are used only to obtain clinical data). From these items, a global score is calculated and seven dimensions or areas are evaluated: sleep quality; time to fall asleep; sleep duration; sleep efficiency; problems during sleep; consumption of sleep medication; and daytime functioning problems. The total score on the PSQI ranges from 0 to 21, with higher scores indicating poor sleep quality. **Measure:** Sleep quality **Time Frame:** Up to twelve weeks **Description:** The measurement of perceived stress was carried out using the Perceived Stress Scale (PSS) \[41\] in its version for the Spanish language \[42\], an instrument composed of 14 questions that determines the degree of stress felt in the last month. This questionnaire uses a response system based on a five-point scale (0 = never, 1 = almost never, 2 = occasionally, 3 = frequently, 4 = very frequently). To calculate the total score on the PSS, the response values for items 4, 5, 6, 7, 9, 10, and 13 are reversed (so that 0 becomes 4, 1 becomes 3, etc.) and Then all the items are added. The score ranges from 0-56, with a higher score on the scale indicating a higher level of perceived stress. **Measure:** Perceived stress **Time Frame:** Up to twelve weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Were 65 years or older were eligible for the study * Had not been part of any resistance program in the last 12 months * They could understand and follow the instructions, activities and protocols of the exercise program. Exclusion Criteria: * They suffered from any systemic condition (e.g., neurodegenerative, musculoskeletal, or visual diseases) that prevented them from performing the exercises. * Had any vestibular disease or disorder * Consumed medications that influenced the central nervous system, balance or coordination (for example, antidepressants, vestibular sedatives or anxiolytics). **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jaén **Country:** Spain **Facility:** Agustín Aibar Almazán ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426576 **Brief Title:** Load Limits After Orthopaedic Surgery: Biofeedback vs. Conventional Method (AppPWB) **Official Title:** Application of Load Limits After Orthopaedic Surgery With Biofeedback-based Instructions Compared to a Conventional Method #### Organization Study ID Info **ID:** 2024-00106; mu24Mauch #### Organization **Class:** OTHER **Full Name:** University Hospital, Basel, Switzerland ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Basel, Switzerland #### 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 single-centre prospective randomized-controlled clinical trial is to assess whether patients adhere to prescribed weight bearing limits after surgical orthopaedic or traumatological interventions more accurately after instruction using a biofeedback method than using the standard method. **Detailed Description:** Partial weight bearing, commonly prescribed post-surgery in orthopaedics and traumatology, aims to stimulate healing while preventing overloading. Partial weight bearing refers to that the patient is only allowed to put 10 to 50% of their body weight on the affected limb. The most commonly used method for instructing partial weight bearing with the patient is using a personal scale. This means that the patient can only exercise in a static position and the perceived load must be transferred to dynamic activities of daily living without further feedback. Previous reports indicate that patients often struggle to adhere to prescribed partial weight-bearing limits, frequently exceeding the specified load by 100% or more. However, when additional feedback was incorporated into training, approximately 90% of subjects successfully adhered to the partial load. Portable or wearable measuring systems, such as pressure-sensitive insoles, offer feedback during dynamic tasks, facilitating a smoother transition to daily activities. Unlike the standard one-time instruction using a scale, these systems provide repeated feedback at each step, promoting a higher frequency of exercises. This aids patients in developing a better sense of the correct load. This single-centre prospective randomized-controlled clinical trial aims to investigate the effectiveness of pressure insoles connected to a smartphone via Bluetooth and operated using an app in improving partial weight bearing adherence. The insoles provide direct feedback through acoustic and visual signals if the affected leg is overloaded, possibly leading to a lower proportion of steps over the load limit compared to those without feedback. Participants are randomized into either the intervention group (dynamic condition - plantar pressure insoles) or the control group (static condition - standard one-off instruction using a scale). The primary objective is to determine whether the proportion of steps exceeding the weight bearing limit is lower in the intervention group compared to the control group 2 weeks after surgery. Secondary objectives include assessing subjective ratings of the permitted load, perceived pain, and mobility. Additionally, the trial hypothesizes that patients using the insoles can estimate applied load more accurately. The intervention group will also provide feedback on the usability of the app and insoles. The results of this trial will contribute to enhancing postoperative treatment of patients undergoing orthopaedic surgery, thereby improving treatment outcomes and optimizing therapy regimens. ### Conditions Module **Conditions:** - Surgery **Keywords:** - Orthopaedic surgery - Partial weight bearing - Portable measurement systems - Plantar pressure insoles - Biofeedback function ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The control group receives instructions on partial weight bearing using the standard method. **Intervention Names:** - Other: Standard one-off instruction using a scale **Label:** Control group **Type:** OTHER #### Arm Group 2 **Description:** The intervention group receives instructions on partial weight bearing using a plantar pressure sole inserted into the shoe that measures the force/weight applied to the foot and indicates the applied weight to the patient both visually and acoustically via a smartphone app. **Intervention Names:** - Device: Plantar pressure insoles **Label:** Intervention group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group **Description:** The permitted weight is demonstrated to the patient once using a scale in the static position. The patient repeatedly places the foot with the permitted weight on a scale in order to develop a feeling for the load. After this exercise in the static position, the patient applies the perceived load to dynamic activities of daily living without receiving any feedback. The instruction is given by a trained physiotherapist. Simultaneously with the instruction, the effective weight applied on the leg will be measured using instrumented insoles without any feedback. **Name:** Standard one-off instruction using a scale **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Intervention group **Description:** The insoles are used in both static and dynamic conditions such as walking straight along the hallway or walking stairs if applicable. Initial instruction is given by a trained physiotherapist and will be continuously applied at home using the smartphone app for 5 out of 7 days per week during the first 2 weeks after surgery. **Name:** Plantar pressure insoles **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** After 2 weeks of continuous use of the feedback-providing insoles by the intervention group, the adherence to load limits is evaluated at the follow-up visit. This assessment aims to determine if the intervention group adheres better to the prescribed weight-bearing limits compared to the control group, which did not receive feedback during this period. Both groups have the proportion of steps (%) exceeding the prescribed weight-bearing limit on the injured leg while walking assessed using instrumented insoles. **Measure:** Proportion of steps (%) over of the prescribed weight bearing limit on the injured leg while walking, assessed with the instrumented insoles. **Time Frame:** At 2 weeks post-surgery #### Secondary Outcomes **Description:** To assess the pain level, the numeric analog scale is used. Patients are asked to rate their pain on a scale from 0 to 10, where 0 indicates no pain while 10 indicates the worst possible pain. **Measure:** Assessment of perceived pain **Time Frame:** Baseline and at 2 weeks post-surgery **Description:** To assess the physical activity, the UCLA Activity Scale(UCLA) is used The UCLA Activity Scale consists of questions related to different activities, and patients rate their ability to perform each activity on a scale from 1 to 10, with higher scores indicating greater activity levels. **Measure:** Assessment of physical activity **Time Frame:** Baseline and at 2 weeks post-surgery **Description:** To assess the mobility, the Life Space Questionnaire and Parker Mobility Score are used. The former asks respondents to report on their frequency of movement and the distance traveled within various zones, such as within their home, neighborhood, and beyond. The latter evaluates an individual's ability to perform three basic mobility tasks. A score is given to each activity on a 4 point scale (0 - not at all, 1 - assistance of one person, 2 - with an aid, 3 - no difficulty and no aid) and then combined to provide a final score between 0 and 9, where 9 is independent with no aid in all three activities, and 0 is not able to carry out any of the activities. **Measure:** Assessment of mobility **Time Frame:** Baseline and at 2 weeks post-surgery **Description:** The health-related quality of life is assessed using the EuroQol-5 Dimensions (EQ-5D). It is a standardized questionnaire used to assess an individual's health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels of severity (no problems, some problems, extreme problems), allowing for the classification of 243 unique health states. **Measure:** Assessment of the quality of life **Time Frame:** Baseline and at 2 weeks post-surgery **Description:** Patients are asked to estimate the applied load. **Measure:** Assessment of perceived load applied **Time Frame:** At 2 weeks post-surgery **Description:** The intervention group is asked to provide feedback on the usability of the app and insoles using a questionnaire. **Measure:** Assessment of the usability of the planar pressure insoles (intervention group only) **Time Frame:** At 2 weeks post-surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with prescribed partial weight bearing (joint-independent) for at least 2 weeks * Unilateral injury of the lower extremity * Having their own smartphone * Age 18 years and older Exclusion Criteria: * Patients with prescribed full weight bearing * Patients with prescribed complete unloading * Patients with prescribed self-selected loading "according to pain" * Bilateral injuries of lower extremities * Upper extremity injuries precluding the use of crutches * Use of walking aids prior to injury * Neurological conditions affecting gait * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc., * Previous enrolment in a clinical trial * Body mass \> 135 kg * Age under 18 years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marlene Mauch, Dr. **Phone:** +41 61 26 59444 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mandy Mathys **Phone:** +41 61 55 65 279 **Role:** CONTACT #### Locations **Location 1:** **City:** Basel **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marlene Mauch, Dr. - **Phone:** +41 61 26 59444 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mandy Mathys - **Phone:** +41 61 55 65 279 - **Role:** CONTACT ***Contact 3:*** - **Name:** Marlene Mauch, Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Svenja Schneider - **Role:** SUB_INVESTIGATOR **Country:** Switzerland **Facility:** Department of Orthopaedics and Traumatology, University Hospital Basel, Bethesda Spital Basel **State:** Basel-Stadt **Zip:** 4052 #### Overall Officials **Official 1:** **Affiliation:** Department of Orthopaedics and Traumatology, University Hospital Basel **Name:** Marlene Mauch, Dr. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426563 **Brief Title:** MWA vs RFA for the Treatment of Moderate-sized Benign Thyroid Nodules **Official Title:** Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Moderate-sized Benign Thyroid Nodules, a Randomized Controlled Trial #### Organization Study ID Info **ID:** UW 24-141 #### Organization **Class:** OTHER **Full Name:** The University of Hong Kong ### Status Module #### Completion Date **Date:** 2028-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Hong Kong #### Responsible Party **Investigator Affiliation:** The University of Hong Kong **Investigator Full Name:** Man Him Matrix Fung **Investigator Title:** Clinical 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:** Thyroid nodule is a common condition that affects up to 60% of the population. There is an estimated 10% lifetime probability of developing a thyroid nodule. Although most thyroid nodules are benign, up to 10-15% can enlarge to cause compressive symptoms including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. The conventional treatment for these benign but problematic nodules has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation. Since the early 2000s, ultrasound-guided percutaneous thermal ablation has emerged as a potential alternative treatment to surgery for benign thyroid nodules. Of the myriad ablation methods, the most commonly used techniques are radiofrequency ablation (RFA) and microwave ablation (MWA). \[1-3\] A growing body of evidence shows that RFA is an effective treatment for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-80% at 1 year, with durable resolution of compressive and hyperthyroid symptoms. However, RFA is not without its limitations. Radiofrequency waves can be limited by the heat sink effect and tissue char leading to longer procedure times and potentially less optimal outcomes in larger, hypervascular, and/or more cystic nodules. Microwave ablation (MWA) is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis. It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect, and therefore can facilitate more efficient ablation procedures. Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective, non-randomized \[4-9\], under-powered, or with an unequal baseline. The results from these studies were also conflicting, suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies. To date, there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules. Given the higher ablation temperatures, freedom from heat sink effect, and no influence from impedance changes during ablation, MWA may achieve different treatment efficacy. ### Conditions Module **Conditions:** - Thyroid Nodule \(Benign\) - Ablation Therapy **Keywords:** - Ablation therapy - Thyroid nodule - benign - RFA - MWA ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** One group is for radiofrequency ablation treatment (RFA), another group is for microwave ablation treatment (MWA) ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who are undergo thyroid nodule treatment by RFA **Intervention Names:** - Procedure: Ablation treatment of thyroid nodule **Label:** Radiofrequency ablation treatment (RFA) to thyroid nodule **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants who are undergo thyroid nodule treatment by MWA **Intervention Names:** - Procedure: Ablation treatment of thyroid nodule **Label:** Microwave ablation treatment (MWA) to thyroid nodule **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Microwave ablation treatment (MWA) to thyroid nodule - Radiofrequency ablation treatment (RFA) to thyroid nodule **Description:** Use Radiofrequency or Microwave ablation device to treat thyroid nodule **Name:** Ablation treatment of thyroid nodule **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** To measure the volume reduction ratio (VRR) of the first ablated nodule at each procedure at 12-months post-procedure **Time Frame:** 12 months #### Secondary Outcomes **Measure:** To measures nodule recurrence rate **Time Frame:** 12-24 months **Measure:** To measures thyroid nodule regrowth rate **Time Frame:** 12-24 months **Description:** To measure cosmetic score from 1 to 4 (1 is No palpable goitre, 2 is Palpable goitre but invisible, 3 is Goitre only visible to experienced clinician, 4 is Easily visible goitre) **Measure:** To measure cosmetic score by investigator (1-4) **Time Frame:** 12-24 months **Description:** compressive symptom score from 0 (no compression feeling) to 100 (the most compressive) **Measure:** To measure the compressive symptom scores (from 0 - 100) **Time Frame:** 12-24 months **Description:** Swallowing Impairment Index (SIS-6) is an assessment tool about swallowing dysfunction and symptom. It comprises six question items ranging from 0 (no impairment) to 24 (maximum impairment) **Measure:** To measure swallowing impairment scores by questionnaire (SIS-6) **Time Frame:** 12-24 months **Description:** 0 is no pain, 10 is the most painful **Measure:** To measure pain score (0-10) after ablation treatment **Time Frame:** 12-24 months **Description:** SF-12(v2) is an assessment tool about quality of life. It comprises 12 question items ranging from 11 (worst quality of life) to 56 (best quality of life). **Measure:** Change of quality of life by SF12 ver 2 **Time Frame:** 12-24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adult patients \&gt;/=18 years of age 2. Nodule maximal diameter ≥2cm and nodule volume \&lt;20ml 3. Nodule being predominantly solid (≥80% solid) 4. Confirmed benign nature of nodules, either by : two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound 5. Both functional and non-functional nodules are eligible. Exclusion Criteria: 1. Cytologically indeterminate nodules 2. Nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound 3. current pregnancy or cardiac arrhythmias; presence of pacemaker or any medical condition that renders patient unfit for thermal ablation **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Man Him, Matrix Fung, MBBS **Phone:** +852-22554232 **Role:** CONTACT #### Locations **Location 1:** **City:** Hong Kong **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Man Him, Matrix Fung, MBBS - **Phone:** +852-22554232 - **Role:** CONTACT ***Contact 2:*** - **Name:** Man Him, Matrix Fung, MBBS - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Hong Kong **Facility:** Queen Mary Hospital **Status:** RECRUITING **Zip:** 00000 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Lang BHH, Fung MMH. Safety and Efficacy of Single-Session Radiofrequency Ablation Treatment for Benign Non-toxic Multinodular Goiter. World J Surg. 2022 Jul;46(7):1704-1710. doi: 10.1007/s00268-022-06527-8. Epub 2022 Mar 21. **PMID:** 35313358 **Citation:** Cheng Z, Che Y, Yu S, Wang S, Teng D, Xu H, Li J, Sun D, Han Z, Liang P. US-Guided Percutaneous Radiofrequency versus Microwave Ablation for Benign Thyroid Nodules: A Prospective Multicenter Study. Sci Rep. 2017 Aug 25;7(1):9554. doi: 10.1038/s41598-017-09930-7. **PMID:** 28842651 **Citation:** Wu W, Gong X, Zhou Q, Chen X, Chen X. Ultrasound-Guided Percutaneous Microwave Ablation for Solid Benign Thyroid Nodules: Comparison of MWA versus Control Group. Int J Endocrinol. 2017;2017:9724090. doi: 10.1155/2017/9724090. Epub 2017 Nov 23. **PMID:** 29333159 **Citation:** He L, Zhao W, Xia Z, Su A, Li Z, Zhu J. Comparative efficacy of different ultrasound-guided ablation for the treatment of benign thyroid nodules: Systematic review and network meta-analysis of randomized controlled trials. PLoS One. 2021 Jan 20;16(1):e0243864. doi: 10.1371/journal.pone.0243864. eCollection 2021. **PMID:** 33471820 **Citation:** Hu K, Wu J, Dong Y, Yan Z, Lu Z, Liu L. Comparison between ultrasound-guided percutaneous radiofrequency and microwave ablation in benign thyroid nodules. J Cancer Res Ther. 2019;15(7):1535-1540. doi: 10.4103/jcrt.JCRT_322_19. **PMID:** 31939434 **Citation:** Guo DM, Chen Z, Zhai YX, Su HH. Comparison of radiofrequency ablation and microwave ablation for benign thyroid nodules: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2021 Jul;95(1):187-196. doi: 10.1111/cen.14438. Epub 2021 Mar 2. **PMID:** 33556187 **Citation:** Jin H, Fan J, Lu L, Cui M. A Propensity Score Matching Study Between Microwave Ablation and Radiofrequency Ablation in Terms of Safety and Efficacy for Benign Thyroid Nodules Treatment. Front Endocrinol (Lausanne). 2021 Mar 9;12:584972. doi: 10.3389/fendo.2021.584972. eCollection 2021. **PMID:** 33767666 **Citation:** Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14. **PMID:** 29962870 **Citation:** Huh JY, Baek JH, Choi H, Kim JK, Lee JH. Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology. 2012 Jun;263(3):909-16. doi: 10.1148/radiol.12111300. Epub 2012 Mar 21. **PMID:** 22438360 **Citation:** Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol. 2013 Apr;23(4):1044-9. doi: 10.1007/s00330-012-2671-3. Epub 2012 Oct 25. **PMID:** 23096937 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000013964 - Term: Thyroid Neoplasms - 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: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M18986 - Name: Thyroid Nodule - Relevance: HIGH - As Found: Thyroid Nodules - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M16723 - Name: Thyroid Neoplasms - 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: D000016606 - Term: Thyroid Nodule - ID: D000013959 - Term: Thyroid Diseases ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426550 **Brief Title:** Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV **Official Title:** Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV #### Organization Study ID Info **ID:** 78007624.4.0000.5626 #### Organization **Class:** OTHER **Full Name:** Universidade Federal Fluminense ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidade Federal Fluminense #### Responsible Party **Investigator Affiliation:** Universidade Federal Fluminense **Investigator Full Name:** Gabriela Alessandra da Cruz Galhardo Camargo **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this clinical trial is to evaluate photodynamic therapy and photobiomodulation in the periodontitis treatment. To evaluate the clinical and microbiological response of conventional periodontal treatment associated with photodynamic therapy and photobiomodulation with red or infrared laser. Participants will receive periodontal treatment carried out with the use 0.005% methylene blue and laser therapy (photodynamic therapy), associated with conventional periodontal treatment, as well as the use of photobiomodulation with red or infrared laser associated with conventional periodontal treatment in participants with periodontitis. So, twenty periodontitis patients will be selected and separated in two groups compared with placebo. Clinical and microbiological parameters will be evaluated at baseline and 3 months after periodontal treatment: plaque Index, bleeding on probe, probing depth, gingival recession and clinical attachment level. **Detailed Description:** Periodontitis is a chronic, inflammatory and multifactorial disease, caused by an interaction between debiotic biofilm and its products and an exacerbated host response, leading to the progressive destruction of the supporting periodontium (bone, cement and periodontal ligament), causing loss of clinical attachment. and radiographic, bleeding on probing and periodontal pocket formation. Periodontal disease has a high prevalence and is one of the main causes of edentulism, with a great negative impact on chewing function, aesthetics and quality of life related to oral health. It is, therefore, considered a serious public health problem. Conventional periodontal therapy consists of scaling and root planing (SRP) and control of supragingival plaque, but in some cases it has been shown to be ineffective in treating periodontitis, especially in difficult to access areas such as furcations and deep pockets. These cases benefit from adjuvant therapies, such as laser therapy, to help heal periodontal tissues, reduce microorganisms and improve clinical parameters. Photobiomodulation and photodynamic therapy have been widely applied in the treatment of periodontal disease, due to their clinical, cellular and bactericidal effects. When associated with conventional periodontal therapy, its benefits increase, promoting a significant reduction in probing depth, number of deep pockets and bleeding. Furthermore, significant reduction of periodontopathogens and Candida albicans can be observed in the literature after photobiomodulation and photodynamic therapy. Despite the benefits found when different laser therapy protocols are used in periodontal treatment, due to the lack of studies with high methodological quality and weak evidence in the existing literature, more studies are needed to prove their effects, establish appropriate protocols and evaluate the antimicrobial potential in periodontopathogens, which remains debatable, as recent systematic reviews point out. The direct benefits of this study are the treatment of periodontal disease for the participants and for the scientific community to indicate new forms of periodontal therapy using different protocols of laser therapy associated with periodontal instrumentation. All tooth pocket sites in all groups will receive treatment. ### Conditions Module **Conditions:** - Periodontitis - Periodontitis, Adult **Keywords:** - Periodontal Diseases - Periodontal Pocket - Laser Therapy - Methylene Blue ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Clinical, laboratory, longitudinal split-mouth study carried out in humans. ##### Masking Info **Masking:** TRIPLE **Masking Description:** Randomization will be carried out by a blind clinician for the initial assessment of participants, using a computer program (Spyder 5.5.4), in which each patient will be randomly selected to define the site to receive one of the treatments. Next, gels will be encoded in a syringe and applied by a researcher blind to the sites and reagents, each of the 4 sites will receive one of the following treatments: 1 - photosensitization with 0.005% AM gel (Fórmula e Ação Farmácia, São Paulo, SP, Brazil) for 5 minutes, and apply photodynamic therapy with a red laser; 2 - photobiomodulation with red laser; 3 - photobiomodulation with infrared laser; and 4 - control, application of saline gel and, after 5 minutes, simulate the application of the laser, with the device in inactive mode, in order to maintain blinding of the patients (control). In groups 2 and 3, as no gel will be applied, the application of the gel with an empty syringe will be simulated, to keep patients blind **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After conventional periodontal treatment, photosensitization will be performed with 0.005% methylene blue gel (Fórmula e Ação Farmácia, São Paulo, SP, Brazil) for 5 minutes, and photodynamic therapy will be applied with a red laser (660 nm) using a DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. **Intervention Names:** - Procedure: Periodontal treatment **Label:** Photodynamic therapy and 0.005% methylene blue (PDT) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** After conventional periodontal treatment, photobiomodulation will be performed with a red laser (660 nm) using a DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. As no gel will be applied, the application of the gel with an empty syringe will be simulated, and waited 5 minutes, to keep patients blind to the intervention received. **Intervention Names:** - Procedure: Periodontal treatment **Label:** Photobiomodulation with a red laser (PBMV) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** After conventional periodontal treatment, photobiomodulation will be performed with an infrared laser (808 nm) using a DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. As no gel will be applied, the application of the gel with an empty syringe will be simulated, and waited 5 minutes, to keep patients blind to the intervention received. **Intervention Names:** - Procedure: Periodontal treatment **Label:** Photobiomodulation with an infrared laser (PBMIV) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** After conventional periodontal treatment, saline gel will be applied in the periodontal pocket and, after 5 minutes, the laser application will be simulated, with the device in inactive mode, in order to maintain blinding of the patients. **Intervention Names:** - Procedure: Periodontal treatment **Label:** Saline solution - Control (C) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Photobiomodulation with a red laser (PBMV) - Photobiomodulation with an infrared laser (PBMIV) - Photodynamic therapy and 0.005% methylene blue (PDT) - Saline solution - Control (C) **Description:** An experienced periodontist will access clinical periodontal parameters, including plaque index, bleeding on probing, pocket probing depth, gingival recession, clinical attachment level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars. Conventional periodontal treatment, scaling and root planning, will be performed with ultrasound (Dabi Atlante, Rio de Janeiro, RJ, Brazil) complemented with Gracey curettes (Golgran, São Caetano do Sul, SP, Brazil) on each patient under local anesthesia. The maintenance therapy will include professional plaque control and scaling and root planning in recurrent periodontal pockets, every 30 days, until 3 months, when the periodontal parameters will be reassessed. **Name:** Periodontal treatment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Plaque index will be expressed in percentage per individual to evaluate the supragingival plaque control. **Measure:** Plaque index (PI) **Time Frame:** Baseline and 3 months **Description:** Bleeding on probing (BOP) will be expressed in percentage per individual to evaluate presence of BOP \<20% good results. **Measure:** Bleeding on probing (BOP) **Time Frame:** Baseline and 3 months **Description:** Pocket probing depth (PPD) will be evaluated in millimeters. The measure will be performed at six sites per tooth using a periodontal probe. The PPD corresponds to the distance from the gingival margin to the apical portion of the gingival sulcus or periodontal pocket. **Measure:** Pocket probing depth (PPD) **Time Frame:** Baseline and 3 months **Description:** Gingival recession (GR) will be measured clinically in millimeters with a periodontal probe as the distance from the cemento-enamel junction to the depth of the free gingival margin. **Measure:** Gingival recession (GR) **Time Frame:** Baseline and 3 months **Description:** Clinical attachment level (CAL) will be measured clinically in millimeters with a periodontal probe and corresponds as the distance from the cemento-enamel junction to the base of the periodontal pocket. CAL represents the extension of periodontal support that has been lost around a tooth. **Measure:** Clinical attachment level (CAL) **Time Frame:** Baseline and 3 months #### Secondary Outcomes **Description:** Pooled biofilms from gingival fluid of four sites with PPD with 6 mm or more will be collected to evaluate the presence of periodontal pathogens. The samples will be collected from the selected sites and stored in eppendorfs with PBS 1X in -20oC until the microbiological analyses, that will consist in DNA extraction, electroforesis and qualitative polymerase chain reaction (PCR). **Measure:** Microbiogical analysis **Time Frame:** Baseline and 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult participants with periodontal disease; * Four or more periodontal sites with PPD≥6 mm and CAL≥5 mm, non-adjacent; * Generalized periodontitis, with more than 30% of the sites involved (Caton et al., 2018); * Stages III and IV of periodontal disease (Caton et al., 2018); Exclusion Criteria: * Participants with hypersensitivity to the components of the 0.005% methylene blue gel; * Received periodontal treatment in the last six months; * Drugs (alcoholics, use of anti-inflammatories and antibiotics in the last 3 months); Any evidence of systemic modifying factors which may directly interfere with the completion of the work (bias), such as: * Pregnant and breastfeeding women; * Hormone replacement therapy; * Smoking; * Hyperglycemia; * Osteoporosis; * Diagnosed with HIV+ or AIDS. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gabriela AC Camargo, PhD **Phone:** 12981815874 **Phone Ext:** 55 **Role:** CONTACT #### Locations **Location 1:** **City:** Nova Friburgo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gabriela AC Camargo, PhD - **Phone:** 12981815874 - **Phone Ext:** 55 - **Role:** CONTACT **Country:** Brazil **Facility:** Fluminense Federal University **State:** Rio De Janeiro **Status:** RECRUITING **Zip:** 28625650 #### Overall Officials **Official 1:** **Affiliation:** Fluminense Federal University **Name:** Gabriela AC Camargo, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The result will be communicated verbally to each participant. **IPD Sharing:** NO ### References Module #### References **Citation:** Akram Z, Al-Shareef SA, Daood U, Asiri FY, Shah AH, AlQahtani MA, Vohra F, Javed F. Bactericidal Efficacy of Photodynamic Therapy Against Periodontal Pathogens in Periodontal Disease: A Systematic Review. Photomed Laser Surg. 2016 Apr;34(4):137-49. doi: 10.1089/pho.2015.4076. Epub 2016 Mar 16. **PMID:** 26982216 **Citation:** Akram Z. How effective is adjunctive antimicrobial photodynamic therapy in treating deep periodontal pockets in periodontal disease? A systematic review. J Investig Clin Dent. 2018 Nov;9(4):e12345. doi: 10.1111/jicd.12345. Epub 2018 Jun 4. **PMID:** 29863310 **Citation:** Ren C, McGrath C, Jin L, Zhang C, Yang Y. The effectiveness of low-level laser therapy as an adjunct to non-surgical periodontal treatment: a meta-analysis. J Periodontal Res. 2017 Feb;52(1):8-20. doi: 10.1111/jre.12361. Epub 2016 Mar 2. **PMID:** 26932392 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13423 - Name: Periodontal Pocket - Relevance: LOW - As Found: Unknown - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M13419 - Name: Periodontal Diseases - Relevance: HIGH - As Found: Periodontal Diseases - ID: M28044 - Name: Chronic Periodontitis - Relevance: HIGH - As Found: Periodontitis, Adult - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010518 - Term: Periodontitis - ID: D000010510 - Term: Periodontal Diseases - ID: D000055113 - Term: Chronic Periodontitis ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M11726 - Name: Methylene Blue - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426537 **Brief Title:** Colchicine's Efficacy in MI Patients: Comparing PCI and Non-Reperfusion Approaches **Official Title:** A Comparative Study of Colchicine's Role in Reducing Cardiac Fibrosis in Acute Myocardial Infarction Patients: Evaluating Outcomes With Percutaneous Coronary Intervention Versus Without Reperfusion #### Organization Study ID Info **ID:** 400/235/K.3/302/2020 #### Organization **Class:** OTHER **Full Name:** University of Brawijaya ### Status Module #### Completion Date **Date:** 2023-11-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-03-25 **Type:** ACTUAL #### Start Date **Date:** 2022-10-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Brawijaya #### Responsible Party **Investigator Affiliation:** University of Brawijaya **Investigator Full Name:** Tri Astiawati **Investigator Title:** Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study investigates the effect of Colchicine in preventing heart structure changes following ST-segment elevation myocardial infarction. Through a clinical trial involving patients requiring coronary intervention, we explore how Colchicine can reduce inflammation and fibrosis, two crucial factors influencing heart failure post-heart attack. The outcomes are expected to offer new insights into post-heart attack treatments to prevent heart failure. **Detailed Description:** This clinical trial, a prospective, focuses on patients with ST-Elevation Myocardial Infarction (STEMI) requiring Percutaneous Coronary Intervention (PCI) within 12 hours of onset. The study aims to control bias effectively through randomization, evenly distributing confounding factors across two groups. Patients, unknown to both researchers and themselves whether receiving Colchicine or a placebo, will undergo reperfusion therapy and optimal medicinal treatment according to the latest guidelines. The study population includes all STEMI patients in three cities in East Java (Jember, Malang, Tulungagung), selected through purposive sampling. The independent variable is Colchicine administration, while dependent variables include ventricular remodeling assessed by Left Ventricular End-Diastolic Volume (LVEDV) via echocardiography, serum levels of caspase-1, TGF-β, NT pro BNP and Galectin-3. All patients receive standard medical treatment pre-PCI, including aspirin and antiplatelet drugs, with post-PCI Optical Medical Treatment (OMT) following the latest guidelines. The trial is randomized, double-blinded, and placebo-controlled, with participants divided into four groups: early PCI with Colchicine or placebo, and STEMI without reperfusion, receiving either Colchicine or placebo. This setup allows for a comprehensive comparison across different patient management strategies, exploring Colchicine's potential benefits in post-AMI care and its effects on key inflammatory and fibrotic markers. ### Conditions Module **Conditions:** - ST-Elevation Myocardial Infarction ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study investigates the impact of Colchicine on patients with ST-Elevation Myocardial Infarction (STEMI) undergoing different treatment strategies, including percutaneous coronary intervention (PCI) and no revascularization. ##### Masking Info **Masking:** SINGLE **Masking Description:** The subjects of this study are patients with ST-Elevation Myocardial Infarction (STEMI) who have undergone Percutaneous Coronary Intervention (PCI) and those without reperfusion. Subject selection was conducted using purposive sampling. Patients who received early PCI without reperfusion were divided into four groups: 1). Early PCI with Colchicine, 2). Early PCI with placebo, 3). STEMI without reperfusion with Colchicine and STEMI without reperfusion with placebo. This approach aims to rigorously evaluate the effects of Colchicine in managing inflammation and cardiac remodeling in STEMI patients, comparing its efficacy against standard placebo treatment. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 63 **Type:** ACTUAL **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive colchicine according to protocol: Loading dose of 1 mg 1-2 hours before PCI, 0.5 mg colchicine 1 hour after loading, Maintenance dose of 1 x 0.5 mg colchicine for 1 month and OMT **Intervention Names:** - Drug: Colchicine 0.5 MG Oral Tablet **Label:** Colchicine Intervention in STEMI Patients Onset < 12 Hours Undergoing PCI **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients receive placebo according to protocol: Placebo administration and OMT **Intervention Names:** - Drug: Colchicine 0.5 MG Oral Tablet **Label:** Placebo in STEMI Patients Onset < 12 Hours Undergoing PCI **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Patients receive colchicine according to protocol: Loading dose of 1 mg, 0.5 mg colchicine 1 hour after loading, Maintenance dose of 1 x 0.5 mg colchicine for 1 month and OMT **Intervention Names:** - Drug: Colchicine 0.5 MG Oral Tablet **Label:** Colchicine Intervention in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Patients receive placebo according to protocol: Placebo administration and OMT **Intervention Names:** - Drug: Colchicine 0.5 MG Oral Tablet **Label:** Placebo in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Colchicine Intervention in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion - Colchicine Intervention in STEMI Patients Onset < 12 Hours Undergoing PCI - Placebo in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion - Placebo in STEMI Patients Onset < 12 Hours Undergoing PCI **Description:** Oral administration of Colchicine in STEMI patients **Name:** Colchicine 0.5 MG Oral Tablet **Other Names:** - Colchicine Tablets - Generic Colchicine - Colchicine Oral Administration **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** This study assesses the impact of colchicine on ventricular remodeling by measuring changes in the expression of NLRP3 inflammasome, TGF-β, and galectin-3. These biomarkers are indicative of inflammation and fibrotic activity affecting ventricular structure and function in acute STEMI patients post-PCI or without reperfusion therapy **Measure:** mpact of Colchicine on Ventricular Remodeling in Acute ST-Elevation Myocardial Infarction (STEMI) Patients Post-PCI **Time Frame:** Baseline and 1 month post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Men and women aged 18 years or older. Able and willing to provide informed consent. Presenting with clinical symptoms and supporting examinations indicative of a first-time diagnosis of IMA-EST. Eligible for treatment according to the IMA-STEMI guidelines, which may include: Antiplatelet therapy Renin-angiotensin-aldosterone system inhibitors Beta-blockers Specifically, includes patients who have: Undergone early PCI. Not received reperfusion therapy. Female patients must commit to avoiding pregnancy during the study. Willing to participate in follow-up via face-to-face or telephone contact. Exclusion Criteria: Presence of concurrent diseases such as infections, inflammation, or malignancy. Diagnosed with gastrointestinal disorders including Crohn's disease, ulcerative colitis, or exhibiting chronic diarrhea. Recent abnormal laboratory results (within the last 30 days) including: Hemoglobin below 11.5 g/L Leukocytes below 3.0 x 10\^9/L Platelets below 110 x 10\^9/L ALT more than three times the upper limit of normal Total bilirubin more than twice the upper limit of normal Creatinine more than twice the upper limit of normal History of liver cirrhosis, acute hepatitis exacerbation, or severe liver disease. Currently pregnant, breastfeeding, or planning to become pregnant during the study. History of alcohol abuse. Receiving long-term steroid therapy or using colchicine for other indications. History of hypersensitivity to colchicine. Severe renal failure (eGFR below 30). History of cardiac arrest, ventricular fibrillation, cardiogenic shock, or hemodynamic instability. Unwilling or unable to provide informed consent. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tulung Agung **Country:** Indonesia **Facility:** Tri Astiawati **State:** East Java **Zip:** 66223 #### Overall Officials **Official 1:** **Affiliation:** Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia **Name:** Tri Astiawati, MD. SpJp **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** we will distribute the informed consent form and the study protocol **IPD Sharing:** NO ### References Module #### Available IPDs **Type:** Study Protocol **URL:** http://drive.google.com/drive/u/3/folders/15qW39gHRtgwIuP8rGm8ukhXtYnLRCFNO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis - 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: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12155 - Name: Myocardial Infarction - Relevance: HIGH - As Found: Myocardial Infarction - ID: M1072 - Name: ST Elevation Myocardial Infarction - Relevance: HIGH - As Found: ST Elevation Myocardial Infarction - ID: M10282 - Name: Infarction - Relevance: HIGH - As Found: Infarction - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - 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 - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009203 - Term: Myocardial Infarction - ID: D000072657 - Term: ST Elevation Myocardial Infarction - ID: D000007238 - Term: Infarction ### Intervention Browse Module - Ancestors - ID: D000006074 - Term: Gout Suppressants - ID: D000018501 - Term: Antirheumatic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6307 - Name: Colchicine - Relevance: HIGH - As Found: Acquired - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003078 - Term: Colchicine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426524 **Brief Title:** Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study **Official Title:** Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study #### Organization Study ID Info **ID:** SVSInstituteDS1 #### Organization **Class:** OTHER **Full Name:** SVS Institute of Dental Sciences ### Status Module #### Completion Date **Date:** 2024-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dr R Viswa Chandra #### Responsible Party **Investigator Affiliation:** SVS Institute of Dental Sciences **Investigator Full Name:** Dr R Viswa Chandra **Investigator Title:** PROFFESSOR AND HEAD OF THE DEPARTMENT **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects. **Detailed Description:** In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed. In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed. ### Conditions Module **Conditions:** - Intrabony Periodontal Defect ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed. **Intervention Names:** - Procedure: IGF-1 Gel **Label:** Test group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed. **Intervention Names:** - Procedure: Hydroxyapatite **Label:** Control group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Test group **Description:** After degranulation of the defect, IGF-1 gel mixed with Hydroxyapatite graft will be placed in the defect. **Name:** IGF-1 Gel **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Control group **Description:** After degranulation of the defect, Hydroxyapatite graft will be placed in the defect. **Name:** Hydroxyapatite **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months. **Measure:** Bone Regeneration **Time Frame:** 3 months and 6 months **Description:** Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months. **Measure:** clinical attachment level **Time Frame:** 3 months and 6 months **Description:** Assessment of probing depth using UNC-15 probe at baseline and postoperatively at 3 and 6 months. **Measure:** Probig depth **Time Frame:** 3 months and 6 months #### Secondary Outcomes **Description:** Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970. **Measure:** Plaque Index **Time Frame:** 3 months and 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Systemically healthy male and female patients of age \>18 years Intrabony defects - two wall or three wall defects Probing pocket depths (PPD) of \>5mm. Exclusion Criteria: Medically compromised patients Pregnant women Heavy smokers Patients who underwent radiotherapy or chemotherapy are excluded **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:** Dr R Viswa Chandra, MDS;DNB;PhD **Phone:** 8179367147 **Role:** CONTACT #### Locations **Location 1:** **City:** Hyderabad **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rampalli Viswa Chandra, MDS; DNB - **Phone:** 9908183071 - **Role:** CONTACT **Country:** India **Facility:** SVS Institute of Dental Sciences, Mahabubnagar **State:** Telangana **Status:** RECRUITING **Zip:** 509002 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M11900 - Name: Mitogens - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426511 **Acronym:** CONTINUE **Brief Title:** ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC **Official Title:** Consolidation Toripalimab Therapy Guided by Circulating Tumor DNA (ctDNA)-Minimal Residual Disease (MRD) for Completely Resected Stage IB-IIIA Non-small-cell Lung Cancer (Without EGFR or ALK Alterations for Nonsquamous Lung Cancer) #### Organization Study ID Info **ID:** GASTO10112 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2029-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Si-Yu Wang **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study aims to incorporate circulating tumor DNA (ctDNA)-minimal residual disease (MRD) to personalize the administration of consolidation toripalimab therapy in resected stage IB-IIIA non-small-cell lung cancer (NSCLC) after adjuvant therapy. Toripalimab is a humanized monoclonal antibody for human programmed cell death protein 1. Toripalimab was approved as a consolidation treatment after perioperative therapy in combination with chemotherapy for resectable stage III NSCLC. **Detailed Description:** Most patients with stage IB-IIIA non-small cell lung cancer (NSCLC) are managed with surgery, follow by standard-of-care adjuvant platinum-based chemotherapy. However, postoperative recurrence rates remain high. Recent years, the role of checkpoint inhibitors has been proven to be effective in patients with advanced NSCLC, and even in patients with resectable NSCLC. Emerging data supports the use of consolidation checkpoint inhibitors therapy in localized NSCLC. Based on the results from Neotorch trial, consolidation toripalimab therapy led to a significant improvement in event-free survival for patients with resectable NSCLC. However, not all patients may benefit from consolidation therapy. Circulating tumor DNA (ctDNA) has emerged as a promising biomarker for early detection of minimal residual disease (MRD) in cancer surveillance. There is a critical need to identify MRD after curative therapies to determine which patients may benefit from consolidation toripalimab therapy. The aim of this study is to explore whether observation follow-up for patients with negative ctDNA after adjuvant therapy has a non-inferior prognosis for patients with positive ctDNA and received consolidation toripalimab therapy. This study aims to incorporate ctDNA-MRD to personalize the administration of consolidation toripalimab therapy for completely resected stage IB-IIIA NSCLC (without EGFR or ALK alterations for nonsquamous NSCLC). ### Conditions Module **Conditions:** - Lung Cancer, Nonsmall Cell ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Incorporate ctDNA-MRD to personalize the administration of consolidation toripalimab therapy for completely resected stage IB-IIIA NSCLC ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Observation follow-up for patients with undetectable ctDNA after 4 cycles of adjuvant chemotherapy plus toripalimab. **Intervention Names:** - Drug: Toripalimab+Chemotherapy **Label:** Observation for undetectable ctDNA after adjuvant therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Consolidation toripalimab therapy for up to 13 cycles for patients with detectable ctDNA after 4 cycles of adjuvant chemotherapy plus toripalimab. **Intervention Names:** - Drug: Toripalimab+Chemotherapy followed by consolidation toripalimab **Label:** Consolidation toripalimab for detectable ctDNA after adjuvant therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Observation for undetectable ctDNA after adjuvant therapy **Description:** After surgical resection, patients received 4 cycle of toripalimab (240 mg) in combination with platinum-based adjuvant treatment. Administration of standard postoperative adjuvant chemotherapy for stage IB disease was not mandatory; decisions about whether patients with IB disease would receive adjuvant chemotherapy were made by the physicians. **Name:** Toripalimab+Chemotherapy **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Consolidation toripalimab for detectable ctDNA after adjuvant therapy **Description:** After surgical resection, patients received 4 cycle of toripalimab (240 mg) in combination with platinum-based adjuvant treatment, and then maintenance treatment with single-agent toripalimab (240 mg) once every 3 weeks for up to 13 cycles. Administration of standard postoperative adjuvant chemotherapy for stage IB disease was not mandatory; decisions about whether patients with IB disease would receive adjuvant chemotherapy were made by the physicians. **Name:** Toripalimab+Chemotherapy followed by consolidation toripalimab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Determine if ctDNA-MRD guided consolidation toripalimab has a non-inferior 2-year DFS to direct 13 cycles of consolidation toripalimab therapy. 2-year DFS was defined as the proportion of patients who were disease free at 2 years. **Measure:** The 2-year DFS rate of ctDNA-MRD guided consolidation toripalimab **Time Frame:** Baseline to 24 months #### Secondary Outcomes **Description:** Determine if ctDNA-MRD guided consolidation toripalimab has a non-inferior 2-year OS to direct 13 cycles of consolidation toripalimab therapy. 2-year OS was defined as the proportion of patients who were alive at 2 years. **Measure:** The 2-year OS rate of ctDNA-MRD guided consolidation toripalimab **Time Frame:** Baseline to 24 months **Description:** Estimate the 2-year DFS in patients with persistently detectable ctDNA after receiving ≥6 months of consolidation toripalimab. **Measure:** The 2-year DFS in patients with persistently detectable ctDNA **Time Frame:** Baseline to 24 months **Description:** Percentage of patients with undetectable ctDNA after consolidation toripalimab of 13 cycles. **Measure:** Percentage of patients with undetectable ctDNA after consolidation toripalimab. **Time Frame:** Baseline to 15 months **Description:** Percentage of patients with detectable ctDNA after 4 cycles of adjuvant chemotherapy plus toripalimab. **Measure:** Percentage of patients with detectable ctDNA after adjuvant chemotherapy plus toripalimab. **Time Frame:** Baseline to 3 months **Description:** Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. **Measure:** Adverse Events **Time Frame:** Baseline to 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects must have undergone complete surgical resection (R0) of their stage IB , II and select IIIA NSCLC according to the AJCC 8th edition staging; * Squamous or non-squamous NSCLC histology; * Subjects should be without EGFR or ALK alterations for nonsquamous NSCLC; * Male and female, aged 18-75 years; * Surgery for lung cancer must be completed ≤ 60 days prior to study treatment; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; * Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level); * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN; * Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min; * Female subjects should not be pregnant or breast-feeding; * Written informed consent provided. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study. Exclusion Criteria: * Not R0 resection, or metastatic disease. * Subjects with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous NSCLC; * Previous treatment with systemic antitumor therapy for NSCLC; * Severe allergic reaction to other monoclonal antibodies; * Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes; * Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); active hepatitis C (defined as positive hepatitis C surface antibody in screening period and positive HCV-RNA); * Vaccination of live vaccine within 30 days prior to the first dose; * Evidence of clinically active interstitial lung disease; * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); * Inability to comply with protocol or study procedures; * Any unstable systemic disease (including active infection, active tuberculosis uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease); * A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study and may confuse the study results; * History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted. * Women who are pregnant or nursing. * Ingredients mixed with small cell lung cancer patients. **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:** Si-Yu Wang, MD **Phone:** +86 20 87343439 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Sun Yat-sen University **Name:** Si-Yu Wang, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Lung Cancer, Nonsmall Cell - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M20497 - Name: Neoplasm, Residual - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426498 **Brief Title:** tFUS Induced Transient Scotoma for Individual Dosing **Official Title:** Developing a Method of Adjusting the Strength of Transcranial Focused Ultrasound (tFUS) to Personalize Treatment. #### Organization Study ID Info **ID:** Pro00132894 #### Organization **Class:** OTHER **Full Name:** Medical University of South Carolina ### Status Module #### Completion Date **Date:** 2025-08-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medical University of South Carolina #### Responsible Party **Investigator Affiliation:** Medical University of South Carolina **Investigator Full Name:** Mark S. George **Investigator Title:** Professor-Faculty **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purposes of this research study is to: 1. Develop a technique of transcranial Focused Ultrasound Stimulation (tFUS) where meaningful effects on the brain can be easily measured. 2. Use this technique to measure threshold for effective tFUS in individuals. 3. Determine whether disruption of conscious visual detection, versus non-conscious visually-guided behavior have different thresholds for disruption with tFUS. **Detailed Description:** Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. Investigators do not yet have an easily observable way to know whether they are in the right brain location with the correct dose for that person. Investigators wonder if they can produce a transient change in someone's visual field, called a scotoma, and whether they can use that to determine the minimum tFUS dose for that person. ### Conditions Module **Conditions:** - Healthy **Keywords:** - ulltrasound - tFUS - scotoma - visual field ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Masking Description:** The device will be on either right or left V1, and the ultrasound will be cycling on or off during the session. Subjects and investigators will be masked to on/off timing and puck location. **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All subjects will get tFUS, open label **Intervention Names:** - Device: Brainsonix Bx Pulsar machine tFUS **Label:** tFUS over V1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - tFUS over V1 **Description:** This is a tFUS device, delivering ultrasound at a dose within the FDA safety guidelines. **Name:** Brainsonix Bx Pulsar machine tFUS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Production of a temporary Scotoma as assessed by visual field testing of briefly presented objects in different quadrants while staring at a central cross on a computer screen. **Measure:** Temporary Scotoma **Time Frame:** During and immediately after (10 minutes) the tFUS ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female * Age 18-70 * Normal or corrected-to normal vision and hearing * No neurological or psychological illness Exclusion Criteria: * Diagnosis of any depressive or anxiety disorder * Diagnosis of schizophrenia or bipolar disorder * Current use of any non-prescribed psychoactive medications or drugs * Contraindication to enter the MRI environment. * Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). * Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study include: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant. * Inability to adhere to treatment schedule. * Initiation of new antidepressant treatment at the time of study randomization. NOTE: There will be no exclusion based upon gender or minority status. We anticipate that at least 50% of the participants will be women. The percentage of minority participants is expected to be at least 5%. We will make vigorous attempts to increase this number by posting advertisement flyers in minority communities. Children, prisoners, and institutionalized individuals will not be recruited, because they are beyond the scope of the objectives. Moreover, we will emphasize that participation in this study is completely voluntary. Recruitment of women and minorities has been addressed above. Non-English speaking subjects will not be recruited because they may not be able to understand instructions, which could undermine the validity of the results. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bridgette Holland **Phone:** 843 638 7517 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mark S George, MD **Phone:** 843 876 5142 **Role:** CONTACT #### Locations **Location 1:** **City:** Charleston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mark S George, MD - **Phone:** 843-876-5142 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Baron E Short, MD - **Phone:** 843 876 5142 - **Role:** CONTACT **Country:** United States **Facility:** Medical University of South Carolina Brain Stimulation Division **State:** South Carolina **Status:** RECRUITING **Zip:** 29425 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014786 - Term: Vision Disorders - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15424 - Name: Scotoma - Relevance: HIGH - As Found: Scotoma - ID: M17530 - Name: Vision Disorders - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012607 - Term: Scotoma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426485 **Brief Title:** To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets **Official Title:** A Multicenter, Randomized Withdrawal, Double-blind, Parallel, Placebo-controlled Design Clinical Trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets #### Organization Study ID Info **ID:** LY03005/CT-CHN-408 #### Organization **Class:** INDUSTRY **Full Name:** Luye Pharma Group Ltd. ### Status Module #### Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Luye Pharma Group 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 is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression. ### Conditions Module **Conditions:** - Major Depressive Disorder ### 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:** 736 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** orally once a day **Intervention Names:** - Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablets **Label:** Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg or 160 mg group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** orally once a day **Intervention Names:** - Drug: placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg or 160 mg group **Description:** orally once a day **Name:** Toludesvenlafaxine Hydrochloride Sustained-release Tablets **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** orally once a day **Name:** placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Time to relapse. **Time Frame:** from Baseline to week 24 #### Secondary Outcomes **Measure:** Change From Double-Blind Treatment Period Baseline in Montgomery - Eisberg Depression Rating Scale (MADRS) Total Score; **Time Frame:** from Baseline to week 24 **Measure:** Change from Double-Blind Treatment Period Baseline in Clinical Global Impression Scale - Severity of Illness (CGI-S) score and Clinical Global Impression Scale - Global Improvement (CGI-I) score **Time Frame:** from Baseline to week 24 **Measure:** Change From Double-Blind Treatment Period Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score. **Time Frame:** from Baseline to week 24 **Measure:** Change From Double-Blind Treatment Period Baseline in the Anhedonia Rating Scale (DARS) Score **Time Frame:** from Baseline to week 24 **Measure:** Change From Double-Blind Treatment Period Baseline in SHEEHAN Disability Scale (SDS) Score **Time Frame:** from Baseline to week 24 **Measure:** Change from Double-Blind Treatment Period Baseline in Digit Symbol Substitution Test (DSST) Score **Time Frame:** from Baseline to week 24] ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The subject voluntarily signs the informed consent form and is able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures; 2. Aged 18 years and above, male or female; 3. Outpatients with the main diagnosis of depression meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for recurrent episodes (without psychotic features) (F33.1/F33.2); 4. MADRS total score ≥ 26 at baseline of screening and open treatment phase. Exclusion Criteria: 1. Patients who meet the criteria of treatment-resistant depression, that is, patients who have failed to respond to at least two antidepressants with different mechanisms of action in the case of adequate treatment (at least 8 weeks of treatment at the maximum recommended therapeutic dose); 2. Known to have a history of allergy to any component of the investigational product or similar drugs, or allergic constitution (allergic to two or more drugs or food) and the investigator considers it inappropriate to participate in the trial; 3. Significant suicide attempt (defined as a score of ≥ 4 on item 10 of the MADRS scale) or suicidal behavior in the past 6 months on the Columbia-Suicide Severity Rating Scale (C-SSRS) ("actual attempt","interrupted attempt", and"abandoned attempt"with any outcome of"yes"); 4. Other diseases meeting DSM-5 diagnostic criteria, including organic mental disorders, substance-related and addictive disorders (except nicotine or caffeine), schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, substance/drug-induced depressive disorders, depressive disorders due to other physical/mental diseases, obsessive-compulsive and related disorders, traumatic and stress-related disorders, dissociative disorders, anorexia nervosa or bulimia, personality disorders; 5. Previous history of increased intraocular pressure or closed glaucoma; 6. Patients with poorly controlled hypertension \[screening or baseline sitting systolic blood pressure (SBP) ≥ 160 mmHg or sitting diastolic blood pressure (DBP) ≥ 100 mmHg\]; 7. Total bilirubin (TBIL) value 1.5 times higher than the upper limit of normal, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times higher than the upper limit of normal, or creatinine 1.5 times higher than the upper limit of normal at screening; 8. Female patients who are pregnant or have a positive pregnancy test result, or male and female subjects of childbearing potential do not agree to use effective contraception throughout the study and for at least 1 month after discontinuation; 9. Patients who received electroconvulsive therapy (ECT) within 3 months before screening or currently require ECT according to the investigator's judgment; 10. Patients who have received or are receiving systemic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before screening or currently need systemic psychotherapy according to the investigator's judgment; 11. Patients who received physical therapy such as transcranial magnetic stimulation (TMS), deep brain stimulation, vagus nerve stimulation and transcranial electrical stimulation within 3 months before screening; 12. Patients who received phototherapy within 2 weeks before screening; 13. Patients who have stopped antidepressant drugs for less than 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors (MAOIs) and 1 month for fluoxetine) before enrollment; 14. Those who have participated in other clinical trials within 1 month before screening (excluding those who are not eligible after screening and not enrolled); 15. Currently suffering from acute or severe unstable physical illness, or other conditions that the investigator judges the subject is not suitable for the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hongyan Zhang **Phone:** 13601237138 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood 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: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depressive Disorder - 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 ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder - ID: D000003865 - Term: Depressive Disorder, Major ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426472 **Brief Title:** An Intervention on Psychosocial Health in Women With Unsuccessful IVF Experience **Official Title:** The Effect of Web-Based Support Program on Psychosocial Health Status in Women With Unsuccessful IVF Experience #### Organization Study ID Info **ID:** EBIstanbulUC #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) #### Secondary ID Infos **Domain:** TUBITAK **ID:** 1649B032306898 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Elif Balkan **Investigator Title:** PhD Student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this interventional study is to learn if web-based support program can improve the psychosocial health status in women with unsuccessful IVF experience. The main questions it aims to answer are: Does web-based support decrease the depressive symptoms, anxiety and infertility-related stress? Does web-based support decrease the hopelessness? Does web-based support increase the coping skills with infertility-related stress? Researchers will compare this intervention to a control group to see if web-based support program improves psychosocial health. Participants will: Use the web-based support intervention for 5 weeks or have no intervention. Complete the surveys on the website before and after the intervention. ### Conditions Module **Conditions:** - Infertility - Failed in Vitro Fertilisation **Keywords:** - infertility - web-based - support - psychosocial health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Interventional group which will be given the web-based fertility support **Intervention Names:** - Other: Web-based support program **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group will not be given any intervention **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Web-based support program for infertile women with failed IVF experience **Name:** Web-based support program **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Beck Depression Inventory (BDI) will be used to evaluate the participants' anxiety outcome. This inventory, whose validity and reliability in Turkish was studied by Hisli (1989), consists of a total of 21 items and four interpreted sub-dimensions. The scoring of the scale is a four-point Likert type (0 = positive statements about depression; 3 = negative statements about depression). The total score that can be obtained from the scale varies between 0-63; 0-9 points indicate minimal depression, 10-16 points indicate mild depression, 17-29 points indicate moderate depression, and 30-63 points indicate severe depression. **Measure:** Depression (Beck Depression Inventory) **Time Frame:** 24 months **Description:** The Infertility Stress Scale will be used to assess participants' infertility-related stress. Schmidt (2006) developed this scale in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 14 items consisting of three sub-dimensions and answers are given in a Lykert type. Calculations per subdimensions requires a special formula for each subdimension. An increase in score is interpreted as an increase in stress. **Measure:** Infertility-related stress (The Infertility Stress Scale) **Time Frame:** 24 months **Description:** Coping with Infertility Stress Scale: Developed by Schmidt (2006) in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 19 items consisting of four sub-dimensions. e Active-Struggle Coping, Passive-Struggle Coping, Passive-Ignoring Coping and Meaning-Based Coping Method. Each subscale score can be calculated seperately. **Measure:** Coping Skills with Infertility Stress (Coping with Infertility Stress Scale) **Time Frame:** 24 months #### Secondary Outcomes **Description:** Beck Hopelessness Scale: Beck et al. (1974) to measure the individual's negative expectations for the future. Although the Turkish adaptation of this scale was made by Seber (1993), Durak (1994) examined the validity, reliability and factor structure of the scale in more detail. The scale consists of a total of 20 questions and the answers are given as true/false. The scale consists of three subscales: feelings about the future, loss of motivation, and expectations about the future. 1 point for incorrect answers to items 1-3-5-6-8-10-13-15 and 19, and 1 point for correct answers to items 2-4-7-9-11-14-16-17-18 and 20. and a total score between 0 and 20 can be obtained from the scale. The "arithmetic sum" found by calculation is accepted as the "despair score". The scale does not have a cut-off score; as the scores obtained from the scale increase, it is interpreted that the individual's level of hopelessness also increases. **Measure:** Hopelessness **Time Frame:** 24 months **Description:** Web-Based Psychosocial Support Evaluation Form: It is an 8-question form created by researchers to evaluate opinions about the psychosocial support initiative applied to the web-based support program. System Usability Scale: The Turkish validity and reliability of the scale developed by Brooke (1996) was tested by Demirkol and Şeneler (2018). "The scale consisting of ten items is a five-point Likert type (1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, 5=Strongly Agree)." Items numbered 1, 3, 5, 7, 9 in the scale are scored positively, and items numbered 2, 4, 6, 8, 10 are reverse scored because they contain negative expressions. The answer "I strongly disagree" is calculated as "0" and the answer "I strongly agree" is calculated as 4 points. To obtain the total score, the score from each item is multiplied by 2.5 to obtain a score ranging from 0 to 100. A score between 65-70 is sufficient to show that the website is usable. **Measure:** Effect of the Web-based study program **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Having at least three repeated unsuccessful IVF experiences, 2. Maximum one month has passed since the negative IVF experience, 3. Participating in the study voluntarily, 4. Being able to read, understand and communicate in Turkish. Exclusion criteria 1. Not having access to the internet/not knowing how to use it, 2. Having any psychiatric disease/being in the 'severe depression' grade as a result of the Beck Depression Inventory, 3. Having at least one living child. Exclusion criteria from the study in the stages after including the study: 1. Spontaneous pregnancy occurring, 2. Starting a new treatment cycle, 3. Not continuing to monitor the modules on the website. **Gender Based:** True **Healthy Volunteers:** True **Minimum Age:** 21 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Elif Balkan, PhD Student **Phone:** +90 5423513125 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: 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: M10290 - Name: Infertility - Relevance: HIGH - As Found: Infertility - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007246 - Term: Infertility ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426459 **Brief Title:** Social Media Usage in Adolescent Girls **Official Title:** Positive and Negative Effects of Social Media Usage in Adolescent Girls #### Organization Study ID Info **ID:** IRTG_P09 #### Organization **Class:** OTHER **Full Name:** International Research Training Group 2804 ### Status Module #### Completion Date **Date:** 2026-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** German Research Foundation **Class:** OTHER **Name:** University Hospital Tuebingen **Class:** OTHER **Name:** Uppsala University #### Lead Sponsor **Class:** OTHER **Name:** International Research Training Group 2804 #### 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 study aims to explore the effects of hormonal fluctuations throughout the menstrual cycle on social media use, brain architecture, neural reward processing and reward behavior, and affective status in adolescent girls. Additionally, it strives to compare the effects of exogenous and endogenous hormones on the above-mentioned aspects. For this purpose, the investigators will compare two main groups in the study: 1. Naturally cycling adolescent girls, 2. Adolescent girls using combined oral contraceptives. This study will combine self-report data via questionnaires, ecological data via Ecological Momentary Assessment (EMA), endocrine data via blood collection, and neural data via fMRI assessment to enhance the understanding of the neurobiological mechanisms underlying social media use in adolescent girls. Furthermore, it seeks to elucidate whether there are vulnerable periods throughout the menstrual cycle when adolescent girls are especially prone to dysfunctional social media use and help to design more specific interventions as well as therapy. **Detailed Description:** For each participant, there is a screening session, a month-long EMA assessment and two experimental fMRI sessions are planned. After making sure the participants fill the inclusion and exclusion criteria, the investigators will invite them to the laboratory for a screening session (T0). In this session, the participants will provide written informed consent and assent in case of those under 18 years old and written, informed consent for those who are 18 year old. Furthermore, the participants will participate in a standardized clinical interview to screen for mental disorders (Kinder-DIPS). Subsequently, they will be informed about the study details. Finally, they will fill out questionnaires about personality, depressive symptoms, anxiety symptoms, gender identity and norms, mood, loneliness, social media disorder, internet use, social support, and fear of missing out. Naturally cycling adolescent girls will join the two fMRI measurements (T1 \& T2) during the follicular and luteal phase of the menstrual cycle. Adolescent girls using combined oral contraceptives will join the first fMRI measurement during the pill intake period, and the second measurement during the break period. The fMRI sessions will comprise of filling out questionnaires, fMRI measurements, and blood collection for hormonal assessment. Questionnaires on depressive symptoms, state anxiety, mood, gender identity, self-esteem, loneliness, fear of missing out (FOMO), social media disorder, internet use, social support and social media use will be administered through RedCap platform. This will ensure the assessment of subjective, self-report data and its changes throughout the measurement time of one month. The sequence of fMRI measurements incudes four main parts, namely anatomical scan, resting-state scan, Effort Allocation Task (EAT), and diffusion tensor imaging (DTI). This protocol ensures the acquisition of the structural and functional data of the brain in the participants. The detailed protocol components are as follows: 1. Anatomical scan: This first sequence of the protocol ensures assessment and insight into the anatomy of the brain, thus providing structural data of the participants' brain. This will last approximately 8 minutes. 2. Resting-state scan: The next sequence involves participants watching a movie that was designed to improve imaging at rest for approximately 10 minutes. This sequence ensures insight into brain activity when no task is being performed and when the participant is at rest. 3. Effort Allocation Task (EAT): This next sequence aims to assess reward processing and reward behavior in the participants. During this task, participants have to exert physical effort on a grip force device when faced with monetary points at stake. There are two types of reward a participant can face; low and high reward. Additionally, there are two difficulty levels during the task, one being easier and the other more difficult. The payoff for the invested effort will be proportional to its duration. The task will last approximately 17 minutes. 4. Diffusion Tensor Imaging (DTI): During the final sequence, participants will undergo DTI assessment to ensure insight into white matter microstructure and connectivity. This will last approximately 7-8 minutes. To thoroughly investigate the participants' experiences in their natural environments, Ecological Momentary Assessment (EMA) will be conducted. This will be done through an app called m-Path where participants will fill out daily questionnaires about social media use, self-esteem, premenstrual symptoms, and mood throughout one month. A daily questionnaire lasts approximately 10 minutes. This assessment will ensure data about subjective experiences with high ecological validity. ### Conditions Module **Conditions:** - Menstrual Cycle - Oral Contraceptive **Keywords:** - Social media use - Adolescent girls - Menstrual cycle - Oral contraceptive - Neuroimaging - Women's mental health ### Design Module #### Bio Spec **Description:** Blood collection for hormonal assessment **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** OTHER #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adolescent girls who have a natural menstrual cycle and have not used any kind of hormonal contraception for at least 6 months. **Label:** Natural menstrual cycle #### Arm Group 2 **Description:** Adolescent girls who use combined oral contraceptives for at least 4 months. **Label:** Oral contraceptive ### Outcomes Module #### Primary Outcomes **Description:** Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain structure **Measure:** Brain disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives **Time Frame:** Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time **Description:** Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain function (functional activation based on BOLD effect) **Measure:** Brain disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives **Time Frame:** Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time] **Description:** Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives on reward processing **Measure:** Reward-processing disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives **Time Frame:** Measured twice appr. 2-3 weeks apart; approx. 17 minutes each time **Description:** Possible differences in social media use between the two groups **Measure:** Social media use disparities: Contrasting naturally cycling adolescent girls and those using combined oral contraceptives **Time Frame:** Measured through ecological momentary assessment every day throughout one month #### Secondary Outcomes **Description:** Possible differences between the two phases of the menstrual cycle in social media use **Measure:** Social media use disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls **Time Frame:** Measured through ecological momentary assessment every day throughout one month **Description:** Possible differences in brain function and structure in naturally cycling girls in follicular vs. luteal phase **Measure:** Brain Disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls **Time Frame:** Measured twice appr. 2-3 weeks apart; circa 45 minutes each time **Description:** Possible differences in reward processing and reward behavior between the two menstrual cycle phases **Measure:** Reward-processing disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls **Time Frame:** Measured twice appr. 2-3 weeks apart; circa 45 minutes each time **Description:** Possible effects of personality type on brain structure and brain function for both groups. Personality measured by the NEO-Five-Factor-Inventory. **Measure:** Associations between personality and brain function & structure **Time Frame:** Measured twice appr. 2-3 weeks apart; circa 45 minutes each time **Description:** Possible effects of personality type on reward processing for both groups. Personality measured by the NEO-Five-Factor-Inventory. **Measure:** Associations between personality and reward processing & behavior **Time Frame:** Measured twice appr. 2-3 weeks apart; circa 17 minutes each time **Description:** Possible differences in self-esteem between the two phases of the menstrual cycle **Measure:** Self-esteem differences: Contrasting follicular and luteal phase in naturally cycling adolescent girls **Time Frame:** Measured through ecological momentary assessment every day throughout one month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Between 15 and 18 years old adolescent girls * Body mass index(18-25kg/m2) * Natural menstrual cycle (between 25 to 31 days) OR use of combined oral contraceptives for at least 4 months * Social media use (e.g., Instagram, TikTok, Snapchat, Facebook, X, BeReal) * Non-smoking * German language fluency * Attending age-appropriate school Exclusion Criteria: * Any neurological or psychiatric disease based on the standardized diagnostic interview (Kinder-DIPS) * Medical problems such as hormonal, metabolic, developmental or chronic diseases (e.g., congenital disorders, diabetes, dysfunctions of the thyroid, or congestive heart failure) * Pregnancy * Females who gave birth or were breastfeeding within the last year * Use of any other kind of steroid hormonal treatment (except combined oral contraceptives) or psychotropic treatment in the last three months * Females with premenstrual dysphoric disorder(PMDD) * Not willing to be informed about incidental fMRI findings Additional exclusion criteria for fMRI: * Individuals with non-removable metal objects on or in the body such as cardiac pacemaker, artificial heart valve, metal prostheses, metal implants, metal splinters, etc. * Tattoos (if fMRI-incompatible according to expert guidelines) * Claustrophobia * Surgery less than three months ago * Pathological hearing or increased sensitivity to loud noises * Neurological disease or injury * Moderate or severe head injury * Restricted (corrected) vision **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 15 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT **Study Population:** The study participants will be primarily recruited from residents of Tübingen and surrounding areas. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Edita Karavidaj, MSc **Phone:** +491746443856 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Isabel Brandhorst, Dr. Dipl.-Psych. **Role:** CONTACT #### Locations **Location 1:** **City:** Tuebingen **Country:** Germany **Facility:** University Clinic Tuebingen, Department of Psychiatry & Psychotherapy **State:** Baden-Wuerttemberg **Zip:** 72076 #### Overall Officials **Official 1:** **Affiliation:** Child Psychiatry, University Clinic Tübingen **Name:** Tobias Renner, Prof. Dr. med. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Department of Psychology, Uppsala University, Sweden **Name:** Tomas Furmark, Dr. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown - ID: M6500 - Name: Contraceptives, Oral - Relevance: LOW - As Found: Unknown - ID: M6501 - Name: Contraceptives, Oral, Combined - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426446 **Acronym:** TELE-SEMA **Brief Title:** Monitoring Patients With Severe Obesity Treated With Wegovy® Using Connected Device: Real-world Data **Official Title:** Monitoring Patients With Severe Obesity Treated With Wegovy® Using Connected Device: Real-world Data #### Organization Study ID Info **ID:** APHP230587 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** BPIfrance **Class:** INDUSTRY **Name:** Withings #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### 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 involves collecting real-world data on body weight, body composition, cardiovascular parameters, and neurovegetative parameters using a connected scale in patients with severe obesity treated with Wegovy®. **Detailed Description:** Obesity is a chronic disease associated with numerous co-morbidities. New treatments for obesity, notably GLP-1 (Glucagon-like peptide 1) analogs, have led to promising advances. Semaglutide 2.4 mg weekly subcutaneous injection, marketed under the brand name Wegovy®, was recently approved in France for weight loss in patients with severe obesity and at least one comorbidity. Several real-world studies have confirmed the effectiveness of semaglutide in reducing body weight and HbA1c. However, few studies have evaluated the kinetics and interindividual variability of changes in body weight and composition as well as cardiovascular health. There appears to be a need for a comprehensive real-world assessment of patients living with severe obesity receiving Wegovy®. The TELE-SEMA project involves collecting real-world data on body weight, body composition, cardiovascular and neurovegetative parameters via connected scales in patients with severe obesity treated with Wegovy®. The main objectives will be to assess inter-individual weight variability and explore the determinants that may influence weight loss, body composition and possible eating disorders. ### Conditions Module **Conditions:** - Obesity **Keywords:** - Obesity - Wegovy - Semaglutide 2.4 mg/week ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receiving connected scale **Intervention Names:** - Device: Withings Body Comp Pro **Label:** Connected scale **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Connected scale **Description:** Withings Body Comp Pro from which the following features will be used: body weight, body composition (fat, muscle and bone mass, cardiovascular health (pulse wave velocity, arterial stiffness, vascular age, standing heart rate), nervous health (electrochemical skin conductance) **Name:** Withings Body Comp Pro **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Body weight measured at month 0 and 6 **Measure:** The relative difference in weight loss achieved at 6 months of treatment at the maximum tolerated dose ((weight after 6 months of treatment at the maximum tolerated dose - baseline weight) / baseline weight) **Time Frame:** 6 months #### Secondary Outcomes **Description:** Body weight measured weekly **Measure:** The variation of body weight measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Body composition measured weekly **Measure:** The variation of body composition (fat mass, muscle mass, and bone mass) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Pulse wave velocity **Measure:** The variation of pulse wave velocity measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Arterial stiffness **Measure:** The variation of arterial stiffness measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Vascular age **Measure:** The variation of vascular age measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Heart rate **Measure:** The variation of heart rate measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Nervous system health measured weekly **Measure:** The variation of nervous system health (electrochemical skin conductance) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Pulse wave velocity at month 0 and 6 **Measure:** Difference in mean pulse wave velocity before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Arterial stiffness at month 0 and 6 **Measure:** Difference in mean arterial stiffness before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Vascular age at month 0 and 6 **Measure:** Difference in mean vascular age before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Heart rate at month 0 and 6 **Measure:** Difference in mean heart rate before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Eating behavior at month 0 and 6 **Measure:** Difference in eating behavior assessed by the BES questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Level of physical activity at month 0 and 6 **Measure:** Difference in the level of physical activity assessed by the IPAQ short version questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** missed doses compared to the total number of prescribed doses at month 6 **Measure:** Percentage of missed doses compared to the total number of prescribed doses after 6 months of treatment at the maximum tolerated dose **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Man or woman aged over 18 years * Patients who have reached the maximum dose of their treatment with Wegovy® * Written consent Exclusion Criteria: * Patient on AME (state medical aid) * Pregnant or breastfeeding woman * Patient who does not speak French * Adults under legal protection **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Josephine BRAUN **Phone:** 01 44 84 17 38 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Liliane HAMMANI-BERKANI **Phone:** 01 56 09 37 62 **Role:** CONTACT #### Locations **Location 1:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sébastien Czernichow, MD, PhD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Nathalie Alrassy, PhD - **Role:** CONTACT **Country:** France **Facility:** Hôpital européen Georges Pompidou - APHP **Zip:** 75015 #### Overall Officials **Official 1:** **Affiliation:** Assistance Publique - Hôpitaux de Paris **Name:** Sébastien Czernichow, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR) **Description:** Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** Two years after the last publication ### References Module #### References **Citation:** World Obesity Federation. World obesity atlas 2022. Ludgate House, London; 2022. **Citation:** ANAES. Rapport sur la chirurgie de l'obésité morbide de l'adulte. 2001. **Citation:** Czernichow S, Renuy A, Rives-Lange C, Carette C, Airagnes G, Wiernik E, Ozguler A, Kab S, Goldberg M, Zins M, Matta J. Evolution of the prevalence of obesity in the adult population in France, 2013-2016: the Constances study. Sci Rep. 2021 Jul 8;11(1):14152. doi: 10.1038/s41598-021-93432-0. **PMID:** 34238998 **Citation:** Pan A, Sun Q, Czernichow S, Kivimaki M, Okereke OI, Lucas M, Manson JE, Ascherio A, Hu FB. Bidirectional association between depression and obesity in middle-aged and older women. Int J Obes (Lond). 2012 Apr;36(4):595-602. doi: 10.1038/ijo.2011.111. Epub 2011 Jun 7. **PMID:** 21654630 **Citation:** Schneider P, Popkin B, Shekar M, Eberwein JD, Block C, Okamura KS. Health and Economic Impacts of Overweight/Obesity. In: Obesity: Health and Economic Consequences of an Impending Global Challenge [Internet]. The World Bank; 2020 [cited 2021 Nov 5]. p. 69-94. (Human Development Perspectives). Available from: https://elibrary.worldbank.org/doi/10.1596/978-1-4648-1491-4_ch3 **Citation:** Thereaux J, Lesuffleur T, Czernichow S, Basdevant A, Msika S, Nocca D, Millat B, Fagot-Campagna A. Long-term adverse events after sleeve gastrectomy or gastric bypass: a 7-year nationwide, observational, population-based, cohort study. Lancet Diabetes Endocrinol. 2019 Oct;7(10):786-795. doi: 10.1016/S2213-8587(19)30191-3. Epub 2019 Aug 2. **PMID:** 31383618 **Citation:** Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10. **PMID:** 33567185 **Citation:** Wilding JPH, Batterham RL, Calanna S, Van Gaal LF, McGowan BM, Rosenstock J, et al. Impact of Semaglutide on Body Composition in Adults With Overweight or Obesity: Exploratory Analysis of the STEP 1 Study. J Endocr Soc. 2021 May 3;5(Suppl 1):A16-7. **Citation:** Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28. **PMID:** 36200477 **Citation:** Gabery S, Salinas CG, Paulsen SJ, Ahnfelt-Ronne J, Alanentalo T, Baquero AF, Buckley ST, Farkas E, Fekete C, Frederiksen KS, Helms HCC, Jeppesen JF, John LM, Pyke C, Nohr J, Lu TT, Polex-Wolf J, Prevot V, Raun K, Simonsen L, Sun G, Szilvasy-Szabo A, Willenbrock H, Secher A, Knudsen LB, Hogendorf WFJ. Semaglutide lowers body weight in rodents via distributed neural pathways. JCI Insight. 2020 Mar 26;5(6):e133429. doi: 10.1172/jci.insight.133429. **PMID:** 32213703 **Citation:** Wharton S, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Garvey WT. Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Obesity (Silver Spring). 2023 Mar;31(3):703-715. doi: 10.1002/oby.23673. Epub 2023 Jan 18. **PMID:** 36655300 **Citation:** BROWN RE, LIU AR, MAHBUBANI R, ARONSON R. 995-P: Semaglutide in Patients with Type 2 Diabetes: Real-World Analysis in the Canadian LMC Diabetes Registry: The SPARE Study. Diabetes. 2019 Jun 1;68(Supplement_1):995-P. **Citation:** VISARIA J, DANG-TAN T, PETRARO PV, NEPAL BK, WILLEY V. 1006-P: Real-World Effectiveness of Semaglutide in Early Users from a U.S. Commercially Insured (CI) and Medicare Advantage (MA) Population. Diabetes. 2019 Jun 1;68(Supplement_1):1006-P. **Citation:** Di Loreto C, Minarelli V, Nasini G, Norgiolini R, Del Sindaco P. Effectiveness in Real World of Once Weekly Semaglutide in People with Type 2 Diabetes: Glucagon-Like Peptide Receptor Agonist Naive or Switchers from Other Glucagon-Like Peptide Receptor Agonists: Results from a Retrospective Observational Study in Umbria. Diabetes Ther. 2022 Mar;13(3):551-567. doi: 10.1007/s13300-022-01218-y. Epub 2022 Mar 1. Erratum In: Diabetes Ther. 2022 Jun;13(6):1251. **PMID:** 35230650 **Citation:** Rajamand Ekberg N, Bodholdt U, Catarig AM, Catrina SB, Grau K, Holmberg CN, Klanger B, Knudsen ST. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Denmark/Sweden multicentre, prospective, observational study. Prim Care Diabetes. 2021 Oct;15(5):871-878. doi: 10.1016/j.pcd.2021.06.008. Epub 2021 Jun 25. **PMID:** 34183269 **Citation:** Garcia de Lucas MD, Miramontes-Gonzalez JP, Aviles-Bueno B, Jimenez-Millan AI, Rivas-Ruiz F, Perez-Belmonte LM. Real-world use of once-weekly semaglutide in patients with type 2 diabetes at an outpatient clinic in Spain. Front Endocrinol (Lausanne). 2022 Sep 16;13:995646. doi: 10.3389/fendo.2022.995646. eCollection 2022. **PMID:** 36187123 **Citation:** Yale JF, Bodholdt U, Catarig AM, Catrina S, Clark A, Ekberg NR, Erhan U, Holmes P, Knudsen ST, Liutkus J, Sathyapalan T, Schultes B, Rudofsky G. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: pooled analysis of data from four SURE studies by baseline characteristic subgroups. BMJ Open Diabetes Res Care. 2022 Apr;10(2):e002619. doi: 10.1136/bmjdrc-2021-002619. **PMID:** 35383100 **Citation:** Stewart T, Han H, Allen RH, Bathalon G, Ryan DH, Newton RL Jr, Williamson DA. H.E.A.L.T.H.: efficacy of an internet/population-based behavioral weight management program for the U.S. Army. J Diabetes Sci Technol. 2011 Jan 1;5(1):178-87. doi: 10.1177/193229681100500125. **PMID:** 21303642 **Citation:** Beleigoli AM, Andrade AQ, Cancado AG, Paulo MN, Diniz MFH, Ribeiro AL. Web-Based Digital Health Interventions for Weight Loss and Lifestyle Habit Changes in Overweight and Obese Adults: Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Jan 8;21(1):e298. doi: 10.2196/jmir.9609. **PMID:** 30622090 **Citation:** Garcia-Ulloa AC, Almeda-Valdes P, Aguilar-Salinas CA, Hernandez-Jimenez S; Group of Study CAIPaDi. Development and Validation of a Software Linked to an Internet Portal That Facilitates the Medical Treatment and Empowerment of Patients with Type 2 Diabetes, Interaction with Medical Personnel, and the Generation of a Real-Time Registry. J Diabetes Sci Technol. 2021 Mar;15(2):525-527. doi: 10.1177/1932296820949941. Epub 2020 Aug 19. No abstract available. **PMID:** 32814459 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M12702 - Name: Obesity, Morbid - Relevance: HIGH - As Found: Severe Obesity - ID: M26186 - Name: Overweight - 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: D000009765 - Term: Obesity - ID: D000009767 - Term: Obesity, Morbid ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M353561 - Name: Semaglutide - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426433 **Brief Title:** Investigation of The Effects of Proprioceptive Exercise Training on Motor Performance Parameters in Healthy Adults **Official Title:** Investigation of The Effects of Proprioceptive Exercise Training on Motor Performance Parameters in Healthy Adults #### Organization Study ID Info **ID:** E-94603339-604.01.02-268134 #### Organization **Class:** OTHER **Full Name:** Hacettepe University ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2023-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hacettepe University #### Responsible Party **Investigator Affiliation:** Hacettepe University **Investigator Full Name:** Cigdem Ayhan **Investigator Title:** Professor Doctor of Physical Therapy and Rehabilitation Faculty **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study was conducted to investigate the effect of two different exercise protocols applied to healthy individuals on motor performance parameters. Forty-one healthy participants were included in the study. Participants were divided into 2 groups (wrist proprioceptive exercise group, general exercise group) and attended exercise training targeting the hand and wrist for a total of 6 weeks. Before and after the exercises, sociodemographic evaluation, Quick Disability of Arm Shoulder and Hand questionnaire, pain assessment, grip strength measurement, weight transfer tolerance test, wrist joint position sense, Nelson hand reaction test, upper extremity Y balance test, lateral grip and tripod grip measurements, manual muscle testing, and surface electromyography analysis were evaluated in both groups. **Detailed Description:** Healthy volunteers who met the inclusion criteria were included in the study upon agreement to participate. The participants were divided into two groups. One group received 6 weeks of general upper extremity exercises along with proprioceptive exercise training. The proprioceptive exercise training consisted of a 10-minute warm-up period including active and passive upper extremity exercises followed by 30 minutes of proprioceptive exercises. The exercise program progressed weekly, and exercises were performed in standardized positions. To ensure adherence to the exercises, they were recorded on video and sent to participants' phones. The second group performed general upper extremity exercises for 6 weeks. The reason for creating the second group was to eliminate the time-dependent effect of changes in electromyographic activation levels of muscles. Additionally, the bilateral effects of unilateral upper extremity exercise training are observed. Comparing the electromyographic activities of untrained healthy individuals at the end of the treatment may enhance the quality of data interpretation. However, other factors that increase the risk of error in evaluating distal motor performance of the upper extremity were also considered in our study. It is expected that the motor performance of the dominant side will be greater than that of the non-dominant side. However, the non-dominant side is more frequently used in daily activities, resulting in a higher frequency and intensity of daily life activities being loaded onto the dominant side. To reduce the potential error resulting from daily life activities, exercise training was given to the non-dominant side of the healthy individuals participating in our study. Detailed evaluations were performed on the individuals participating in the study, as described below. Evaluations were conducted twice, before starting the exercise program and after the 6-week exercise program. ### Conditions Module **Conditions:** - Exercise - Proprioception - Wrist Injuries **Keywords:** - Wrist - Proprioception ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Wrist Proprioceptive Exercises are neuromuscular exercises for wrist stabilization and control. **Intervention Names:** - Other: Proprioceptive Exercises - Other: Upper Extremity Exercises **Label:** Wrist Proprioceptive Exercises and General Upper Extremity Exercises **Type:** OTHER #### Arm Group 2 **Description:** These exercises are traditional rehabilitation exercises. **Intervention Names:** - Other: Upper Extremity Exercises **Label:** General Upper Extremity Exercises **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Wrist Proprioceptive Exercises and General Upper Extremity Exercises **Description:** In our study, participants were divided into two different exercise groups, starting with the same warm-up exercise program, and a 6-week exercise training program was implemented. To reduce the potential error resulting from daily life activities, exercise training was given to the non-dominant side of the participants. Proprioceptive exercises aim to restore muscle balances, unconscious joint control with reactive muscle activations and feedforward joint control. **Name:** Proprioceptive Exercises **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - General Upper Extremity Exercises - Wrist Proprioceptive Exercises and General Upper Extremity Exercises **Description:** In our study, participants were divided into two different exercise groups, starting with the same warm-up exercise program, and a 6-week exercise training program was implemented. To reduce the potential error resulting from daily life activities, exercise training was given to the non-dominant side of the participants. Upper extremity exercises are traditional rehabilitation exercises for strength, endurance and range of motion. **Name:** Upper Extremity Exercises **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measurement of wrist muscles activation levels **Measure:** Surface Electromyography **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise #### Secondary Outcomes **Description:** Measurement of hand grip force **Measure:** Grip Force **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of weight bearing capacity of healthy wrist **Measure:** Weight Bearing Tolerance Test **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of position senses for 4 wrist range of motion directions **Measure:** Joint Position Sense **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of Nelson hand reaction time **Measure:** Reaction time **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of upper extremity balance and mobility **Measure:** Upper extremity y balance test **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of tripod hand grip force **Measure:** Tripod grip **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of lateral hand grip force **Measure:** Lateral grip **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of manual muscle dynamometer **Measure:** Manual muscle test **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * To be between the ages of 18 and 30 * To be willing to participate in the study * To have cognitive abilities to understand the tasks required in the study. Exclusion Criteria: * Experiencing acute/chronic bilateral or unilateral upper extremity pain * Having neurological and/or rheumatological diseases * Chronic medication usage * Regular smoking/alcohol consumption currently or in the past * Taking cortisone orally or via injection * Suffering from upper extremity musculoskeletal injuries in the past year * Undergoing upper extremity surgery * Having a body mass index greater than 24.9 kg/m2 * Scoring above 6 on the Beighton hypermobility score * Engaging in regular exercises involving the upper extremities * History of autoimmune and/or rheumatic diseases * Regular use of anti-inflammatory medications, etc. * Having cardiovascular disease and diabetes **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation **Zip:** 06100 #### Overall Officials **Official 1:** **Affiliation:** Hacettepe University **Name:** Semiha Tomiris Erzincanlı, MSc Student **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001134 - Term: Arm Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17692 - Name: Wrist Injuries - Relevance: HIGH - As Found: Wrist Injuries - ID: M4444 - Name: Arm Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014954 - Term: Wrist Injuries ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426420 **Brief Title:** Endometriosis and ATR-FTIR Spectroscopy **Official Title:** Detection of Endometriosis Using ATR-FTIR Spectroscopy #### Organization Study ID Info **ID:** FTIR-ENDOMETRIOSIS #### Organization **Class:** OTHER **Full Name:** Federal University of Espirito Santo ### Status Module #### Completion Date **Date:** 2026-04-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-04-29 **Type:** ESTIMATED #### Start Date **Date:** 2022-09-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Conselho Nacional de Desenvolvimento Científico e Tecnológico #### Lead Sponsor **Class:** OTHER **Name:** Federal University of Espirito Santo #### Responsible Party **Investigator Affiliation:** Federal University of Espirito Santo **Investigator Full Name:** VALERIO GARRONE BARAUNA **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 goal of this study is to explore the use of mid-infrared spectroscopy (ATR-FTIR) as a detection tool for endometriosis in urine. **Detailed Description:** Endometriosis is a chronic gynecological disease that is considered debilitating and multifactorial. Its diagnosis is invasive and can be prolonged due to non-specific symptoms and erroneous or late investigations, which can lead to delays and impair the provision of adequate treatment. ATR-FTIR Spectroscopy is a non-invasive technique with the capability to identify the chemical composition and molecular changes of samples through its interaction with mid-infrared radiation. The aim of this work is to develop a rapid test for the detection of endometriosis in urine samples using spectroscopy and machine learning algorithms. ### Conditions Module **Conditions:** - Endometriosis - Endometriomas **Keywords:** - Endometriosis - Diagnosis - Spectroscopy - FTIR - Urine - Detection - Infrared ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients referred to the gynecology outpatient clinic, with complain of pelvic pain. Positives and negatives for endometriosis will be outlined by an expert gynecologist according to the following criteria: * Pelvic MRI (Magnetic Resonance Imaging) report; * Gynecologic exam; * Clinical symptoms and history; The intervention is the use of the ATR-FTIR Spectrometer in patient's urine samples to develop and validate a tool for detecting endometriosis. **Intervention Names:** - Diagnostic Test: FTIR spectroscopy analysis **Label:** Pelvic Pain **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Pelvic Pain **Description:** ATR-FTIR Spectroscopy analysis combined with machine learning algorithms. **Name:** FTIR spectroscopy analysis **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome is the evaluation of specificity, sensitivity and accuracy of the diagnostic. Acceptable diagnostic metrics must be comparable to MRI, which will demonstrate if spectroscopy can discriminate between negative and positive endometriosis patients. **Measure:** Spectroscopy Reliability (diagnostic metrics) **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female * Pelvic pain complain Exclusion Criteria: * Age under 18 or above 55 * Lack of informed consent **Gender Based:** True **Gender Description:** Biological woman self-identified as woman **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Valerio G Barauna, PhD **Phone:** +5527996892407 **Role:** CONTACT #### Locations **Location 1:** **City:** Vitória **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Neide A Boldrini, phD - **Phone:** +552733357100 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mara RB Barcelos, phD - **Phone:** +5527999829511 - **Role:** CONTACT ***Contact 3:*** - **Name:** Neide A Boldrini, phD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Mara RB Barcelos, phD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Brazil **Facility:** University Hospital Cassiano Antonio Moraes at Federal Univeristy Of Espírito Santo **State:** Espírito Santo **Status:** RECRUITING **Zip:** 29041-295 #### Overall Officials **Official 1:** **Affiliation:** Universidade Federal do Espírito Santo **Name:** Valerio G Barauna, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometriosis - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004715 - Term: Endometriosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426407 **Brief Title:** Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator **Official Title:** Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator #### Organization Study ID Info **ID:** 21-047 #### Organization **Class:** OTHER **Full Name:** The Cleveland Clinic ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **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:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-02-16 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Cleveland Clinic #### Responsible Party **Investigator Affiliation:** The Cleveland Clinic **Investigator Full Name:** Seth Bauer **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to learn about blood pressure response to the vasopressor drug vasopressin in people with septic shock. The main questions it aims to answer are: * Are the levels of molecules showing communication between cells different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication? * Are measurements found on echocardiography (heart ultrasound) different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication? Participants will be asked to contribute one or two blood samples. Participants who are ordered the drug vasopressin will contribute two blood samples. Both samples will be about two tablespoons for a total of about four tablespoons. One sample will be drawn before starting vasopressin infusion and the second sample will be drawn between one and six hours after starting the vasopressor drug infusion. At the same time points, advanced echocardiography pictures will be taken. Participants who are not ordered the drug vasopressin and only ordered the drug norepinephrine will contribute only one sample. At the time the sample is collected, advanced echocardiography pictures will be taken. This research also involves analyzing data obtained during the participant's hospital stay. **Detailed Description:** Septic shock mortality remains high at 33% in North America; current clinical predictors of poor outcomes in septic shock are suboptimal. In addition to antibiotics and intravenous fluids, vasoactive agents are initiated to restore effective tissue perfusion. Norepinephrine (NE) is the recommended first-line vasopressor, but adjunctive arginine vasopressin is used in over one-third of patients to improve blood pressure or decrease NE dosage. However, less than half of vasopressin recipients have a clinically-apparent hemodynamic response (defined as a decrease in NE dosage at 6 hours after vasopressin initiation). Vasopressors, particularly norepinephrine, are known to be immune modulators. Further, each vasopressor has its own unique effect on a patient's hemodynamic profile as assessed by echocardiography. In the current study, the investigators seek to clarify the link between vasopressin, immune response, and hemodynamic profile. The central goal of this proposal is to identify "vasopressin response" as an easily-identifiable bedside indicator of a distinct septic shock subphenotype. ### Conditions Module **Conditions:** - Shock, Septic ### Design Module #### Bio Spec **Description:** Blood collected into EDTA test tubes **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with septic shock ordered vasopressin as an adjunct to norepinephrine **Intervention Names:** - Drug: Vasopressin **Label:** Vasopressin plus norepinephrine #### Arm Group 2 **Description:** Active control cohort of patients with septic shock who are only receiving norepinephrine **Label:** Norepinephrine ### Interventions #### Intervention 1 **Arm Group Labels:** - Vasopressin plus norepinephrine **Description:** Fixed dosage vasopressin ordered as an adjunctive vasopressor to norepinephrine **Name:** Vasopressin **Other Names:** - antidiuretic hormone (ADH) - arginine vasopressin (AVP) **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Compare plasma interleukin-1β (IL-1β) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma interleukin-1β (IL-1β) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma interleukin-6 (IL-6) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma interleukin-6 (IL-6) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma interferon-gamma (IFN-γ) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma interferon-gamma (IFN-γ) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma C-X-C motif chemokine ligand 10 (CXCL10, also known as interferon gamma-induced protein 10 \[IP-10\]) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma C-X-C motif chemokine ligand 10 (CXCL10, also known as interferon gamma-induced protein 10 [IP-10]) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma granulocyte-colony stimulating factor (G-CSF) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma granulocyte-colony stimulating factor (G-CSF) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma E-selectin concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma E-selectin concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Evaluate the association of plasma vasopressin concentration with ratio of plasma interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) over time. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma vasopressin concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma copeptin concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma copeptin concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare left ventricular ejection fraction (LVEF) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Left ventricular ejection fraction (LVEF) change **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare stroke volume (SV) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Stroke volume (SV) by echocardiography **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare tricuspid annular plane systolic excursion (TAPSE) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Tricuspid annular plane systolic excursion (TAPSE) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare tricuspid annular systolic plane velocity (TAPSV, also known as RV S') over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Tricuspid annular systolic plane velocity (TAPSV, also known as RV S') **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare venous-arterial carbon dioxide tension gradient (Pva-CO2) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Venous-arterial carbon dioxide tension gradient (Pva-CO2) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare central venous oxygen saturation (ScvO2) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Central venous oxygen saturation (ScvO2) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare dynamic arterial elastance (Eadyn) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Dynamic arterial elastance (Eadyn, the ratio of pulse pressure variation to stroke volume variation) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare the ordinal outcome clinical trajectory (comprised of rapid recovery, chronic critical illness, and early recovery) between vasopressin responders vs. non-responders. **Measure:** Clinical trajectory **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through the sooner of intensive care unit discharge or 14 days. **Description:** Compare the incidence of hospital mortality in vasopressin responders vs. non-responders. **Measure:** Incidence of in-hospital mortality **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through hospital discharge. **Description:** Compare intensive care unit length of stay in vasopressin responders vs. non-responders. **Measure:** Intensive care unit length of stay **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through intensive care unit discharge. #### Primary Outcomes **Description:** Compare baseline ratio of plasma concentrations of interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Ratio of plasma interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement). #### Secondary Outcomes **Description:** Compare baseline left ventricular ejection fraction (LVEF) in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Left ventricular ejection fraction (LVEF) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement). **Description:** Compare left ventricular-arterial coupling (ratio of arterial elastance \[Ea\] to left ventricular end-systolic elastance \[Ees\]) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Ratio of ratio of arterial elastance (Ea) to left ventricular end-systolic elastance (Ees) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare lipopolysaccharide-stimulated monocyte TNF-α secretion over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Lipopolysaccharide-stimulated monocyte TNF-α secretion **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare monocyte adhesion over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Monocyte adhesion **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma renin concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma renin concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma angiopoietin-2 concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma angiopoietin-2 concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (≥18 years old) * Septic shock (as defined by Sepsis-3) * Receiving norepinephrine * Admitted to a medical, surgical, NeuroSciences, or mixed intensive care unit * Central venous catheter in place * Ordered fixed-dose vasopressin as an adjunct to norepinephrine by the primary care team (unless in active control cohort) Exclusion Criteria: * Vasopressin ordered for an indication other than septic shock * Vasopressin initiated at another institution * Receiving a primary vasopressor other than norepinephrine (eg, phenylephrine) * Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within the preceding 28 days * Blood hemoglobin concentration \<7 g/dL * Primary treatment team determines that vasopressin initiation is emergent * Patient or their legal authorized representative opts to not participate in the study **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients with septic shock are eligible for this study. Patients ordered vasopressin as an adjunct to norepinephrine as part of routine care comprise the primary cohort of interest. An active control cohort of patients who are only receiving norepinephrine will also be enrolled. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Seth Bauer, PharmD **Phone:** 2169522553 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The Cleveland Clinic **Name:** Seth Bauer, PharmD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Individual participant data may be available through reasonable request to the study principal investigator and completion of a data use agreement. **Description:** Individual participant data may be available through reasonable request to the study principal investigator and completion of a data use agreement. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Study data will become available at the time of initial manuscript publication and remain available for 5 years after initial manuscript publication. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000018805 - Term: Sepsis - ID: D000007239 - Term: Infections - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: HIGH - As Found: Shock - ID: M15580 - Name: Shock, Septic - Relevance: HIGH - As Found: Shock, Septic - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - 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: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012772 - Term: Shock, Septic - ID: D000012769 - Term: Shock ### Intervention Browse Module - Ancestors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants - ID: D000014662 - Term: Vasoconstrictor Agents - ID: D000050034 - Term: Antidiuretic Agents - ID: D000045283 - Term: Natriuretic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Coag - Name: Coagulants - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M17414 - Name: Vasopressins - Relevance: HIGH - As Found: Contained - ID: M4437 - Name: Arginine Vasopressin - Relevance: HIGH - As Found: Contained - ID: M12575 - Name: Norepinephrine - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown - ID: T1 - Name: Arginine - Relevance: HIGH - As Found: 6 hours ### Intervention Browse Module - Meshes - ID: D000014667 - Term: Vasopressins - ID: D000001127 - Term: Arginine Vasopressin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426394 **Brief Title:** Effect of Positive End-expiratory Pressure on Gastic Residual Volume **Official Title:** The Effect of End-expiratory Positive Pressure on Gastric Residual Volume in Elective Pediatric Outpatient Surgery Where Laryngeal Mask is Applied #### Organization Study ID Info **ID:** 2023-541 #### Organization **Class:** OTHER_GOV **Full Name:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital ### Status Module #### Completion Date **Date:** 2025-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Başakşehir Çam & Sakura City Hospital #### Lead Sponsor **Class:** OTHER_GOV **Name:** Duygu Akyol #### Responsible Party **Investigator Affiliation:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital **Investigator Full Name:** Duygu Akyol **Investigator Title:** M.D, co-investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study was designed as a prospective observational study. **Detailed Description:** In this study, it was planned to evaluate the effect of positive end-expiratory pressure on gastric residual volume in patients who will undergo outpatient pediatric surgery with laryngeal mask application on the specified dates. Patients aged 1-11 years, ASA I-II and undergoing outpatient lower abdominal and genitourinary surgery were included in the study. Since the use of positive end-expiratory pressure varies in our clinic depending on the anesthesiologist preference, the effect of this application on gastric volume will also be evaluated primarily by recording images with gastric ultrasonography at certain perioperative time periods. Secondarily, the effect of this positive end-expiratory pressure on mechanical ventilator parameters and airway pressures will be evaluated. ### Conditions Module **Conditions:** - Pediatrics - Fasting Period **Keywords:** - Gastric ultrasonography - gastric residual volume - pediatric outpatient surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Outcomes Module #### Primary Outcomes **Description:** The primary purpose of this study is to measure gastric residual volume with peroperative gastric ultrasonography measurements. Gastric residual volume will be calculated according to gastric ultrasonography measurements. **Measure:** Gastric residual volume **Time Frame:** preoperatively, intraoperatively after laryngeal mask placement, before laryngeal mask removal at the end of surgery #### Secondary Outcomes **Description:** The secondary aim of this study was to evaluate the effect of positive end-expiratory pressures on airway pressures **Measure:** Airway pressures **Time Frame:** intraoperative process ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pediatric patients who will undergo elective outpatient minor surgery (lower abdominal and urogenital) * 1-11 years old * American Society of Anesthesiology (ASA) classification 1-2 patient groups * Patients who are fully hungry and whose fasting period is appropriate for their age and diet. Exclusion Criteria: * Patients whose fasting period is not appropriate * Acute abdominal and emergency surgeries * ASA 3-4 patient group * Patients with diseases or medication use that will affect gastric emptying time * Previous nasogastric tube placement and re-operation • Patients with known difficult airway or failure to fit the laryngeal mask **Healthy Volunteers:** True **Maximum Age:** 11 Years **Minimum Age:** 1 Year **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** A total of 90 patients were planned for this study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Duygu Akyol, M.d **Phone:** +905447616034 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Musa Akdağ, M.d **Phone:** +905317347672 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Gunasekaran A, Govindaraj K, Gupta SL, Vinayagam S, Mishra SK. Comparison of Gastric Insufflation Volume Between Ambu AuraGain and ProSeal Laryngeal Mask Airway Using Ultrasonography in Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Cureus. 2022 Aug 11;14(8):e27888. doi: 10.7759/cureus.27888. eCollection 2022 Aug. **PMID:** 36110490 **Citation:** Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18. **PMID:** 30443057 **Citation:** Beck CE, Rudolp D, Becke-Jakob K, Schindler E, Etspuler A, Trapp A, Fink G, Muller-Lobeck L, Roher K, Genahr A, Eich C, Sumpelmann R. Real fasting times and incidence of pulmonary aspiration in children: Results of a German prospective multicenter observational study. Paediatr Anaesth. 2019 Oct;29(10):1040-1045. doi: 10.1111/pan.13725. Epub 2019 Sep 4. **PMID:** 31435997 **Citation:** Fiedler MO, Schatzle E, Contzen M, Gernoth C, Weiss C, Walter T, Viergutz T, Kalenka A. Evaluation of Different Positive End-Expiratory Pressures Using Supreme Airway Laryngeal Mask during Minor Surgical Procedures in Children. Medicina (Kaunas). 2020 Oct 21;56(10):551. doi: 10.3390/medicina56100551. **PMID:** 33096743 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426381 **Brief Title:** The Effect of Therapeutic Touch Applied During Knee Replacement Surgery on Anxiety, Vital Signs and Comfort Level **Official Title:** The Effect of Therapeutic Touch Applied During Knee Replacement Surgery on Anxiety, Vital Signs and Comfort Level / Experimental Randomized Controlled Trial #### Organization Study ID Info **ID:** ayse25 #### Organization **Class:** OTHER **Full Name:** Ataturk University ### Status Module #### Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dilek GÜRÇAYIR #### Responsible Party **Investigator Affiliation:** Ataturk University **Investigator Full Name:** Dilek GÜRÇAYIR **Investigator Title:** Academician **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to investigate the effect of therapeutic touch on patients' anxiety, vital signs and comfort levels during knee replacement surgery performed under local anesthesia. The study will be completed with a total of 128 participants, including 64 experimental and 64 control participants. As a randomization method, the simple randomization method will be used to ensure an equal number of samples in two groups, and patients will be assigned to the experimental and control groups. In the research, patients will be given verbal information about the research, and written informed consent will be obtained from the patients who accept it. In the study, therapeutic touch was applied for 15-20 minutes during knee replacement surgery and the effect of this application on vital signs, anxiety level and comfort was evaluated. **Detailed Description:** Knee replacement surgeries are a common treatment method for patients with problems such as pain and limitation of movement resulting from knee joint disorders. This type of surgery is usually performed under general anesthesia, allowing patients to lose consciousness during surgery. However, general anesthesia may have some risks and complications. For this reason, local anesthesia has become increasingly popular. Local anesthesia is a method of anesthesia used to numb the surgical area. In this method, anesthesia is injected directly into the surgical area and the patient is awake and conscious throughout the surgery. Local anesthesia may have fewer side effects and complications compared to general anesthesia. However, the effects of emotional factors such as stress, anxiety and discomfort experienced by patients during surgeries performed under local anesthesia are still poorly understood . The human body is surrounded by an aura and open energy fields. It is reported that when these energy fields are balanced, the individual is healthy, and when they are irregular, the individual experiences health problems. Asymmetric energy fields can be balanced using the therapeutic touch method and treatment becomes easier. In this way, the person regains his health or can be helped to regain his health. Nursing theorist Martha Rogers supports this statement. Rogers defined human beings as an open system with a complex and interactive energy field covering the entire universe. It is assumed that the energy surrounding humans is in wave form and that changes in the human body are controlled by these energy fluctuations. If the person has health problems, this manifests itself in the form of energy blockages or rhythm disorders. By correcting these energy rhythm disorders discovered by the nurse with the therapeutic touch method, the person's health problem can be treated. In recent years, there has been increasing evidence that alternative approaches, such as therapeutic touch, have positive effects on surgical outcomes. Therapeutic touch is a method that aims to provide relaxation, calming and healing through physical contact. This method can reduce patients' stress levels, relieve pain, and increase their overall comfort level. However, there are limited studies on the effect of therapeutic touch on vital signs during knee replacement surgery performed under local anesthesia. Surgeries are widely used as a method of treating various health problems that require medical treatment. Knee prosthesis surgeries are one of the frequently used surgical interventions in the treatment of painful and limiting diseases of the knee joint. Although such surgeries have the potential to significantly improve individuals' mobility and quality of life, the stress, anxiety and physical discomfort that may occur during and after the surgery can be a significant source of concern for patients. Anxiety is a common psychological reaction before and after surgical interventions and is an important factor affecting the surgical process. Patients may experience increased levels of anxiety when faced with uncertainty about the results of surgery, possible complications, and the recovery process. The importance of this situation is of great importance in terms of the success of the surgery and the patients' ability to better manage the postoperative period. Anxiety negatively affects the patient's comfort level after surgery and can prolong the recovery process. Lack of comfort can lead to increased physical and emotional stress caused by surgery. It is important to note that because therapeutic touch has the potential to increase patients' relaxation, stress reduction, and overall comfort level, research has also been conducted in this area. However, there is no definitive information about the effect of therapeutic touch on the comfort level during knee replacement surgery performed under local anesthesia. The aim of this study is to investigate the effect of therapeutic touch on patients' vital signs, anxiety and comfort level during knee replacement surgery performed under local anesthesia. This study aims to offer an alternative approach to improve patients' quality of life by continuing to improve the results of surgeries performed under local anesthesia. This study aims to fill the gap in this field by investigating the effect of therapeutic touch on vital signs, anxiety and comfort level during knee replacement surgery performed under local anesthesia. The findings may guide clinical practice in providing an alternative approach to improve surgical outcomes and reduce discomfort experienced by patients. It may also provide basic information to evaluate the feasibility of therapeutic touch in other surgical procedures under local anesthesia. This study was conducted as an experimental randomized controlled study. This method was preferred because it allows the situations and attitudes of the individuals in the group selected as a sample, regarding a phenomenon or event, and to describe the phenomena and events in their own conditions and as they are. In addition, in randomized controlled studies, the factors that cause events and situations and the degree of influence of these factors can be determined. In the study, therapeutic touch was applied for 15-20 minutes during knee replacement surgery and the effect of this application on vital signs, anxiety level and comfort was evaluated. The hypotheses created in the research are listed below; The research was conducted in the orthopedics and traumatology room in the operating room department of Atatürk University Training and Research Hospital between September 2023 and June 2024. The population of the research consists of patients who had knee replacement surgery between September 2023 and February 2024. The sample of the research consists of patients who meet the inclusion criteria between the specified dates. Cohen's standard effect sizes were used as reference in the power analysis. In this case, in this study, for the t test in independent groups where the effect of therapeutic touch during knee prosthesis surgery will be compared on vital signs, anxiety and comfort levels, if the study is conducted with a total of 128 participants in two groups with 64 participants in each group, 80% confidence interval is 95% at a significance level of 0.05. It has been determined that power can be achieved. As a randomization method, the "simple randomization method" was used to ensure an equal number of samples in two groups, and the patients were assigned to the experimental and control groups. In the study, patients were given verbal information about the research, and written informed consent was obtained from the patients who agreed. Four different forms were used to collect data in the study. The Anxiety and Comfort Scale, which was determined as the data collection tool in the study, was chosen by the researcher as it was deemed suitable for the purpose. Analyzes were carried out with the data obtained to test the validity and reliability of the selected scale. In order to ensure that the data collection tools do not pose an ethical problem, people with expertise on the subject were consulted and it was ensured that they would not cause any problems. However, the scale questions were reviewed in detail by the researcher and the consultant, and since an application was actually made in the form of a Likert scale, leaving the selection decision entirely to the participants refutes the idea that it is a manipulation. The forms used to collect data are listed below; 1. Patient Introduction Form 2. Vital Signs Record Form 3. Spielberg State-Trait Anxiety Scale 4. Perianesthesia Comfort Scale (PCS) In order to conduct the research, firstly, approval was obtained from the Atatürk University Faculty of Medicine Ethics Committee and institutional permission was obtained from the hospital where the research was conducted. Verbal consent was obtained from the patients before data collection, and data collection forms were collected by the researcher in the orthopedics and traumatology room in the operating room department by face-to-face interview. Patients who accepted the study and met the criteria were included in the experimental/control group by randomization. In patients included in the experimental group; On the day of surgery, patients who met the research criteria were met, the purpose of the study was explained, and their written consent was obtained. The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were administered in the patient room using face-to-face interview technique. When the patient was taken to the operating table, the Vital Signs Record Form was filled out. Then, therapeutic touch was applied for 15-20 minutes during the surgery. After the procedure was completed, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) were administered. In patients included in the control group; On the day of surgery, patients who met the research criteria were met, the purpose of the study was explained, and their written consent was obtained. The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were administered in the patient room using face-to-face interview technique. When the patient was taken to the operating table, the Vital Signs Record Form was filled out. After the procedure is completed, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) will be administered. No procedure was applied to the control group. ### Conditions Module **Conditions:** - Intraoperative Complications **Keywords:** - therapeutic touch - anxiety - comfort ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 130 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be administered an Introduction Form and Spielberg State-Trait Anxiety Scale before surgery. The Vital Signs Record Form will be filled out on the patient's operating table. Then, therapeutic touch will be applied for 15-20 minutes during the surgery. After the procedure, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) will be administered. **Intervention Names:** - Behavioral: Therapeutic Touch **Label:** There is therapeutic touch **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** An Introduction Form and the Spielberg State-Trait Anxiety Scale will be administered to the patients. When you are taken to the operating table, a Vital Signs Record Form will be filled out. After the procedure is completed, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) will be administered. **Label:** No therapeutic touch **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - There is therapeutic touch **Description:** Asymmetric energy fields can be balanced using the therapeutic touch method and treatment becomes easier. In this way, the person regains his health or can be helped to regain his health. **Name:** Therapeutic Touch **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The survey form, created by the researcher by scanning the literature on the subject, consists of a total of 13 questions including questions about gender, age, place of residence, education, status, profession, marital status, and total knee replacement surgery. **Measure:** Patient Introduction Form **Time Frame:** up to 24 weeks **Description:** An observation form was used to observe the patients in the experimental and control groups to whom therapeutic touch was applied during surgery. This form was used to record the duration of therapeutic touch, respiration, oxygen saturation, pulse, systolic blood pressure, and diastolic blood pressure. **Measure:** Vital Signs Record Form **Time Frame:** up to 24 weeks **Description:** There are 4 different options in the section that the individuals to whom the scale is applied will mark. These options consist of "not at all", "somewhat", "a lot" and "completely" in order to determine the intensity of the expressed behaviors and emotions. The total score obtained from both scales varies between 20-80. High scores indicate high anxiety levels, low scores indicate low anxiety levels. There are two types of statements in the State-Trait Anxiety Scale. Direct expressions express negative emotions, while inverted expressions express positive emotions. The reversed expressions in the State Anxiety Scale are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The reversed expressions in the Trait Anxiety Scale constitute items 26, 27, 30, 33, 36 and 39. After finding the total weights of direct and reverse expressions separately, the total weight score of reverse expressions is subtracted from the total weight score obtained for direct expressions. **Measure:** Spielberg State-Trait Anxiety Scale **Time Frame:** Before and after surgery **Description:** The scale consists of 24 items that reflect the individual's general thought process before and after the surgical intervention and question his/her self-conception and feelings. Each statement in the scale has a Likert-type scoring ranging from 1 to 6, from "strongly disagree" to "strongly agree". The response patterns of the scale, which consists of positive and negative items, are given in mixed order. 12 of the statements are positive (1.5, 6, 11, 14, 16, 18, 19, 20, 21, 23, 24), 12 are negative (2, 3, 4, 7, 8, 9, 10, 12, 13, 15, 17, 22); Negative statements are reversed in scoring. Accordingly, in positive statements, a high score (6) indicates high comfort, a low score (1) indicates low comfort, and in negative items, a low score (1) indicates high comfort and a high score (6) indicates low comfort. **Measure:** Perianesthesia Comfort Scale (PCS) **Time Frame:** up to 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Being between the ages of 18-85 2. No communication problems (speaks Turkish) 3. No vision or hearing problems 4. No cognitive problems 5. The patient agrees to participate in the study 6. Having knee replacement surgery with local anesthesia Exclusion Criteria: 1. Being under the age of 18 and over the age of 85 2. Having a communication problem (does not speak Turkish) 3. The patient wants to leave the study 4. Not agreeing to participate in the research 5. Not being at a cognitive level to answer the questions asked. 6. Patients with vision and hearing problems 7. Having knee replacement surgery with general anesthesia **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:** Ayşe ÇELİK **Phone:** 05417967629 **Role:** CONTACT #### Locations **Location 1:** **City:** Palandöken **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ayşe ÇELİK - **Phone:** 05417967629 - **Role:** CONTACT **Country:** Turkey **Facility:** Ayşe ÇELİK **State:** Erzurum **Status:** RECRUITING **Zip:** 25000 #### Overall Officials **Official 1:** **Affiliation:** Ataturk University **Name:** Dilek GÜRÇAYIR, Dr. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M10465 - Name: Intraoperative Complications - Relevance: HIGH - As Found: Intraoperative Complications ### Condition Browse Module - Meshes - ID: D000007431 - Term: Intraoperative Complications ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426368 **Brief Title:** Soluble ST2 in Patients With Heart Failure" **Official Title:** " Prognostic Value of Soluble ST2 Beyond B-Type Natriuretic Peptide in Management of Patients With Heart Failure" #### Organization Study ID Info **ID:** ST2 in H.F patients #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Dalia Mohamed Hesham Ahmed Mohamed **Investigator Title:** doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** 1. The aim of this study was to explore the relationship between peripheral circulating serum soluble suppression of tumorigenicity-2 (sST2) levels and inflammatory biomarkers in patients with heart failure 2. Additive role of sST2 to NPs in of heart failure patients **Detailed Description:** Heart failure (HF), a complex and heterogeneous medical syndrome characterized by structural and functional cardiac abnormalities and hemodynamic disruptions, represents the end-stage manifestation of numerous cardiovascular disorders . HF is categorized into three groups based on the measurement of the left ventricular (LV) ejection fraction (LVEF) according to the European Society of Cardiology (ESC) Guidelines issued in 2021: HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%), HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%), and HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%) . Quantifying concentrations of circulating biomarkers plays a major role in most cardiovascular (CV) diseases, including (HF) . An ideal biomarker in HF should be measured non-invasively and at low cost, highly sensitive to allow for the early detection of the disease . N-terminal pro-B-type natriuretic peptide (NT-proBNP) released by cardiac muscle tissue in response to abnormal volume load is an established indicator for the diagnosis and prognosis of HF . However, there are important limitations to natriuretic peptide (NP) testing in HF . Soluble suppression of tumorigenicity-2 (sST2) is the circulating form of the interleukin-33 membrane receptor released in response to inflammation, fibrosis in various organs, and myocardium stress . Soluble (s)ST2 has been proposed as a useful biomarker for heart failure (HF) patient management. Myocardial damage or mechanical stress stimulate sST2 release. ST2 competes with a membrane bound receptor (ST2 ligand, or ST2L) for interleukin-33 (IL-33) binding, inhibiting the effects induced by the ST2L/IL-33 interaction so that excessive sST2 may contribute to myocardial fibrosis and ventricular remodelling. So biomarkers such as NT-proBNP and sST2 could potentially be used as surrogates for clinical outcomes in patients with HF and may be useful in monitoring disease progression and assessing the response to therapy . ### Conditions Module **Conditions:** - Heart Failure Patients ### 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:** HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%) **Intervention Names:** - Diagnostic Test: ST2 **Label:** Group I #### Arm Group 2 **Description:** HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%) **Intervention Names:** - Diagnostic Test: ST2 **Label:** Group II #### Arm Group 3 **Description:** HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%) **Intervention Names:** - Diagnostic Test: ST2 **Label:** Group III ### Interventions #### Intervention 1 **Arm Group Labels:** - Group I - Group II - Group III **Description:** ELISA used to detect levels of ST2 and BNP as inflammatory biomarkers in patients with heart failure **Name:** ST2 **Other Names:** - BNP **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Study ST2 level in heart failure patients and correlate results with clinical data and other inflammatory biomarker **Measure:** To evaluate if Soluble ST2 is strongly associated with measures of HF severity and poor outcome **Time Frame:** Baseline **Description:** Study value of BNP in prognosis and compare it with ST2 **Measure:** Evaluation of BNP and ST2 could have a potential role in prognosis. **Time Frame:** Baseline #### Secondary Outcomes **Description:** Evaluate ST2 as a novel biomarker which provide risk stratification of patients with acute and chronic HF beyond BNPs **Measure:** • Clinical Impact and Treatment Decision Support **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients 18-80 years. * Both sexes will be included. * including signs and symptoms of HF (e.g., elevated jugular venous pressure and altered apical beat position), altered LVEF (\< 40%; 40%-49%; ≥ 50%) Exclusion Criteria: * Patients \<18 years * Patients with documented evidence of cardiogenic shock . * Patients with Acute coronary syndrome within 30 days. * chronic kidney disease patients with glomerular filtration rate \< 30 * Patients with interstitial pulmonary fibrosis . **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study will be conducted at Chemistry unit of Clinical Pathology Department and Cardiovascular Department, Assiut University Hospitals, Assiut University, Egypt Heart failure patients will be classified according to NYHA classification ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Dalia Hesham **Phone:** 01149936172 **Role:** CONTACT **Contact 2:** **Name:** randa ahmed **Phone:** 01003390690 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Assiut University **Name:** Randa Ahmed **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Assiut University **Name:** Hanan Omer **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Assiut University **Name:** Yousra Mamdouh **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Purdy GE, Payne SM. The SHI-3 iron transport island of Shigella boydii 0-1392 carries the genes for aerobactin synthesis and transport. J Bacteriol. 2001 Jul;183(14):4176-82. doi: 10.1128/JB.183.14.4176-4182.2001. **PMID:** 11418557 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Intervention Browse Module - Browse Branches - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21935 - Name: Natriuretic Peptide, Brain - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426355 **Brief Title:** The Effeciency of NMN in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With DOR **Official Title:** The Effeciency of Nicotinamide Mononucleotide (NMN) in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With Decreased Ovarian Reserve（DOR): a Randomized Double-blind Placebo Control Clinical Trail #### Organization Study ID Info **ID:** M2023557 #### Organization **Class:** OTHER **Full Name:** Peking University Third Hospital ### Status Module #### Completion Date **Date:** 2027-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-03-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking University Third Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve and the outcomes of IVF/ICSI-ET. ### Conditions Module **Conditions:** - Diminished Ovarian Reserve ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dietary Supplement: NMN intervention NMN capsules (total of 600mg/day) for 2-5 months **Intervention Names:** - Dietary Supplement: NMN **Label:** NMN intervention **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Placebo NMN-free placebo capsules for 2-5 months **Intervention Names:** - Other: Placebo **Label:** Placebo intervention **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - NMN intervention **Description:** NMN capsules (total of 600mg/day) for 2-5 months **Name:** NMN **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo intervention **Description:** NMN-free placebo capsules for 2-5 months **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The pregnancy rate of IVF/ICSI-ET **Measure:** The clinical pregnancy rate **Time Frame:** through study completion, an average of 2 year #### Secondary Outcomes **Description:** Changes in endocrine hormones including AMH levels in serum after the intervention. **Measure:** Endocrine hormones including AMH **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant. **Measure:** Follicle number **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** Number of oocytes obtained, number of MII oocytes, fertilization rate, number of available embryos, number of high-quality embryos, cycle cancellation rate **Measure:** In vitro fertilization - outcome indicators of embryo culture **Time Frame:** Day of oocyte retrieval and 1 week after oocyte retrieval。Within three months after the end of treatment with NMN or placebo **Description:** Biochemical pregnancy rate **Measure:** Biochemical pregnancy rate **Time Frame:** after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo **Description:** live birth rate **Measure:** live birth rate **Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo **Description:** abortion rate **Measure:** abortion rate **Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo **Description:** pregnancy complications, the condition of newborn births **Measure:** pregnancy complications **Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo **Description:** the condition of newborn births **Measure:** the condition of newborn births **Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo **Description:** Intestinal flora and metabolite changes **Measure:** Metabolism-related index **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** HOMA index **Measure:** Metabolism-related index **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** waist-hip ratio **Measure:** Metabolism-related index **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** BMI **Measure:** Metabolism-related index **Time Frame:** Within three months after the end of treatment with NMN or placebo ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Individuals who are 20 to 40 years old. 2. At least two of the following three conditions should be met: 1. The concentrations of anti-Mullerian hormone \< 1.1 ng/ml, 2. the values of antral follicle count was less than 7 3. serum concentrations of day-3 follicle-stimulating hormone (FSH)： 10 IU/L ≤ FSH\<20 IU/L 3. Individuals who can insist on continuous monitoring in the outpatient clinic. 4. Individuals who are not participating in other research projects currently or 3 months before the intervention. Exclusion Criteria: 1. Individuals who are during pregnant, lactation or menopause. 2. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology. Individuals who had pelvic surgery. 3. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years. 4. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. 5. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. 6. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months. 7. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months. 8. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months. 9. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. 10. A medical history of severe cardiovascular and cerebrovascular diseases. 11. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. 12. Individuals who drink more than 15g of alcohol per day or have a smoking habit. 13. Individuals who need drug treatment for any mental illness such as epilepsy and depression. 14. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc. 15. Unable or unwilling to follow the study protocol. Individuals who are during pregnant, lactation or menopause. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology. Individuals who had pelvic surgery. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. A medical history of severe cardiovascular and cerebrovascular diseases. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. Individuals who drink more than 15g of alcohol per day or have a smoking habit. Individuals who need drug treatment for any mental illness such as epilepsy and depression. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc. Unable or unwilling to follow the study protocol. - **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mengyu Liu, PhD **Phone:** 15611555481 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jie Qiao - **Phone:** 010-82265080 - **Role:** CONTACT **Country:** China **Facility:** Peking University Third Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100000 ### IPD Sharing Statement Module **Description:** Patients' information is requested to be confidential. **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M12476 - Name: Niacinamide - Relevance: LOW - As Found: Unknown - ID: M12465 - Name: Niacin - Relevance: LOW - As Found: Unknown - ID: M12479 - Name: Nicotinic Acids - Relevance: LOW - As Found: Unknown - ID: T455 - Name: Nicotinamide - Relevance: LOW - As Found: Unknown - ID: T453 - Name: Niacin - Relevance: LOW - As Found: Unknown - ID: T454 - Name: Niacinamide - Relevance: LOW - As Found: Unknown - ID: T456 - Name: Nicotinic Acid - Relevance: LOW - As Found: Unknown - ID: T471 - Name: Vitamin B3 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426342 **Brief Title:** Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression **Official Title:** Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression: Applying Intervention Mapping #### Organization Study ID Info **ID:** Mindguide_Employee #### Organization **Class:** OTHER **Full Name:** Ewha Womans University ### Status Module #### Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ewha Womans University #### Responsible Party **Investigator Affiliation:** Ewha Womans University **Investigator Full Name:** Suk-Sun Kim, PhD. MSN. RN **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this feasibility study is to develop a new metaverse-based blended online intervention using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. In addition, this study primarily explores reach and acceptability and secondarily evaluates the preliminary effectiveness of this preventive intervention on Korea's Gen MZ Employees. ### Conditions Module **Conditions:** - Depression and Suicide ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: metaverse-based blended online intervention **Label:** Mindguide_employee **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mindguide_employee **Description:** A new metaverse-based blended online intervention was developed using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. **Name:** metaverse-based blended online intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Recruitment will be assessed by the number of potentially eligible participants enrolled. **Measure:** Recruitment **Time Frame:** Initial (before intervention) **Description:** The retention rate will be calculated as the percentage of completion rates for the entire intervention and questionnaires until the completion of a 5 weeks after intervention. **Measure:** The retention rate **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** Acceptability refers to how participants perceive and feel about the intervention and its components (Ayala \& Elder, 2011; Sekhon et al., 2017). A 13- item questionnaire was developed based on the Client Satisfaction Questionnaire (CSQ) (Larsen et al., 1979; Sveen et al., 2021) to measure acceptability with three subcategories: helpfulness (three items), suitability (seven items), and satisfaction (three items). Participants responded on a 5- point Likert scale ranging from 1 (not at all) to 5 (very). **Measure:** Acceptability **Time Frame:** at 5 weeks after intervention. #### Secondary Outcomes **Description:** The Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977; Chon et al., 2001) with 20- item will be used to measure depressive symptoms using a 4- point Likert scale. The total score ranges from 0 to 60, with higher scores indicating higher levels of depressive symptoms. **Measure:** Depression scale **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** Positive and Negative Affect Schedule (PANAS; Watson et al., 1988; Park \& Lee, 2016) will used to measure positive and negative affect using a 5- point Likert scale. The total score ranges from 10 to 50, with higher scores indicating a greater perception of positive affect or negative affect. **Measure:** Positive and Negative Affect Schedule **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** the Satisfaction with Life Scale (SWLS; Diener et al., 1985; Lim et al., 2010) with 5- items will be used to assess life satisfaction using a 7- point Likert scale. The total score ranges from 5 to 35, with higher scores indicating greater life satisfaction. **Measure:** Satisfaction with Life Scale **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** Burnout assessment tool (BAT; Schaufeli et al., 2020; Cho, 2020) with 23 items will be used to measure burnout including four core burnout symptoms: Exhaustion, Mental Distance, Emotional Impairment, and Cognitive Impairment. Exhaustion is the loss of physical and mental energy. Mental distance refers to psychological distancing from work or people at work. Emotional impairment is emotional reactions, such as frustration and irritability, brought on by burnout; and Cognitive impairmentthe is memory problems, attention and concentration deficits and poor cognitive performance. **Measure:** Burnout assessment tool **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989; Sohn, 2012) with 19 items will be used to evaluate overall sleep quality. 19 self-reported items includes seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep effi ciency, sleep disturbances, use of sleeping medication, and daytime dysfunction **Measure:** Sleep Quality scale **Time Frame:** Initial(before intervention), at 5 weeks after intervention. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Generation MZ Employees of South Korea who are aged between 20 and 42; Millennials were born between 1981 to 1996, and Generation Zs were born between 1997 to 2004 Exclusion Criteria: * 1) being unemployed or having less than 1 year job experience, * 2) having mental disorders such as schizophrenia or substance abuse (as this is a preventive intervention) and currently attending other mental health therapy to avoid mixing effects. **Healthy Volunteers:** True **Maximum Age:** 42 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Suk-Sun Kim, PhD **Phone:** +82-2-3277-2885 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000016728 - Term: Self-Injurious Behavior ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M16191 - Name: Suicide - Relevance: HIGH - As Found: Suicide - 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: M19089 - Name: Self-Injurious Behavior - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000013405 - Term: Suicide ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426329 **Brief Title:** The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety **Official Title:** The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety #### Organization Study ID Info **ID:** TR SİVAS 04 #### Organization **Class:** OTHER **Full Name:** Cumhuriyet University ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-03-27 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cumhuriyet University #### Responsible Party **Investigator Affiliation:** Cumhuriyet University **Investigator Full Name:** Sukran Ertekin Pinar **Investigator Title:** Doç. Profesör Doktor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Aim: This study was planned to determine the effect of therapeutic touch applied at birth on pain, birth duration, traumatic birth perception and anxiety. **Detailed Description:** Methods: The sample of this randomized controlled experimental research consisted of 66 (intervention group: 33; control group: 33) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Traumatic Childbirth Perception Scale. ### Conditions Module **Conditions:** - Pregnancy - Vaginal Delivery **Keywords:** - Therapeutic Touch - Labor Pain - Birth Duration - Anxiety - Traumatic Birth Perception ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Therapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the latent phase of the first stage of labour, and the second was done in the active phase of labour. **Intervention Names:** - Behavioral: Therapeutic Touch **Label:** Therapeutic touch Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group did not receive any treatment. **Label:** Standard of care Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Therapeutic touch Group **Description:** Therapeutic touch, as meaningful touch, is included in complementary medicine in the literature. It provides physical, emotional and spiritual relief, improves physiological health, makes the person feel valuable, gives confidence, peace, calmness and increases self-confidence. **Name:** Therapeutic Touch **Other Names:** - Control Group **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain. **Measure:** Visual Analogue Scale **Time Frame:** Baseline **Description:** It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety". **Measure:** State Anxiety Inventory **Time Frame:** Baseline **Description:** It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth **Measure:** Traumatic Birth Perception Scale **Time Frame:** Baseline #### Secondary Outcomes **Description:** It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain. **Measure:** Visual Analogue Scale **Time Frame:** Postpartum in 2 hour **Description:** It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety". **Measure:** State Anxiety Inventory **Time Frame:** Postpartum in 2 hour **Description:** It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth **Measure:** Traumatic Birth Perception Scale **Time Frame:** Postpartum in 2 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Not having a high-risk pregnancy Having no health problems with the baby or herself Having a single foetus Being about to have a vaginal delivery Not having a chronic physical or psychiatric diagnosis Agreeing to participate in the research Not having communication and perception problems Miad (37W\<) pregnancy Having with induction application Exclusion Criteria: having vacuum, forceps etc. intervention such as **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sukran Ertekin Pinar, Ph.D. **Phone:** 05342831124 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Busra Akkaya **Phone:** 05347880166 **Role:** CONTACT #### Locations **Location 1:** **City:** Sivas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sukran Ertekin Pinar - **Phone:** +905342831124 - **Role:** CONTACT ***Contact 2:*** - **Name:** Busra Akkaya, MSc. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Sukran Ertekin Pinar **Status:** RECRUITING **Zip:** 58140 #### Overall Officials **Official 1:** **Affiliation:** Cumhuriyet University **Name:** Sukran Ertekin Pinar, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** There is not a plan to make IPD available. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M26008 - Name: Labor Pain - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M5002 - Name: Birth Injuries - Relevance: HIGH - As Found: Traumatic Birth - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001720 - Term: Birth Injuries ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426316 **Acronym:** SIIM **Brief Title:** The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology. **Official Title:** Immune System, Inflammation, Migraine - The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology #### Organization Study ID Info **ID:** RBHP 2023 STUCHFIELD #### Organization **Class:** OTHER **Full Name:** University Hospital, Clermont-Ferrand #### Secondary ID Infos **Domain:** ANSM **ID:** 2023-A01503-42 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Clermont-Ferrand #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Migraine is a frequent and debilitating neurologic disorder. It is more frequent in women, and more prevalent in patients with autoimmune and/or inflammatory diseases such as multiple sclerosis (MS), rheumatoid arthritis (RA), Crohn's disease (CD), systemic lupus erythematosus (SLE) and endometriosis, whereas patients with long standing type 1 diabetes mellitus (T1DM) - an autoimmune but non inflammatory disease - seem to be less affected compared to the general population. Despite new migraine prevention treatments, a large number of patients remain unresponsive to currently available anti-migraine therapy and migraine pathophysiology remains unclear. Several peptides (calcitonin gene-related peptide (CGRP), pituitary adenylate cyclase activating peptide-38 (PACAP-38), vasoactive intestinal polypeptide (VIP)) and hormones (estrogens, prolactin) and the immune system play an important role in migraine pathophysiology. Among T lymphocytes, regulatory T (Treg) cells suppress inflammation. Studies have evidenced higher levels of inflammatory molecules (cytokines) in migraine patients and have suggested decreased proportions of Treg cells in migraine, as well as in MS, RA, CD and SLE, whereas inflammation declines and Treg levels seem increased in long-standing T1DM. Inflammation, which participates in migraine pain, seems to be a common factor for migraine and these diseases. However, these studies display conflicting results and further investigation is required to better understand the mechanisms behind migraine. In this study, the investigators will compare Treg levels, as well as identify Treg subpopulations and measure cytokine levels in migraine and migraine-free participants with and without an autoimmune/inflammatory disorder (MS, RA, CD, SLE, T1DM and endometriosis). **Detailed Description:** Migraine is the 6th most frequent disease (14% of the population) and the second leading cause of disability worldwide. From puberty and onward, migraine is 2 to 3 times more frequent in women, which also suffer from more severe attacks. Migraine is also up to twice as prevalent in patients suffering from autoimmune or inflammatory diseases such as multiple sclerosis (MS), rheumatoid arthritis (RA), Crohn disease (CD), systemic lupus erythematosus (SLE) and endometriosis, whereas patients with long standing type 1 diabetes mellitus (T1DM) - an autoimmune but non inflammatory disease - seem to be less affected compared to the general population. Despite the identification of the role of peptides such as CGRP in migraine pathophysiology and the development of targetted anti-CGRP treatments, many patients remain unresponsive and the mechanisms behind migraine are still unclear. The trigemino-vascular system is involved in the perception of migraine pain. Migraine occurs with trigemino-cervical neuron sensitization, leading to peptide secretion (such as CGRP, PACAP-38 and VIP), which induce neurogenic inflammation that is responsible for vasodilation, capillary leakage, oedema and further sensitization of the trigemino-vascular system, leading to amplified perception of migraine pain. CGRP, PACAP-38 and VIP infusions all induce migraine attacks in migraine patients, and only mild or no headache in healthy volunteers. Sex hormones, prolactin and insulin are also involved in migraine pathophysiology, and the immune system, through cytokine production and immune cell dysregulations seems to also play a role in the pathogenesis of migraine. Both are closely related as sex hormone levels may have an influence on the levels of certain immune cell subtypes. Several pro-inflammatory cytokines (tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma and interleukin (IL)-6) were shown to be elevated in migraine patients but also inflammatory diseases such as MS and endometriosis compared to controls and are associated with migraine pathophysiology. Inflammation seems to be a common factor for migraine and these diseases. However, these studies provide conflicting results and further investigation is needed to better understand the role of inflammation in migraine pathophysiology. Among T lymphocytes, regulatory T (Treg) cells regulate inflammation by suppressing effector T cells through several suppressive mechanisms such as IL-10 secretion or the hydrolysis of pro-inflammatory and nociceptive adenosine triphosphate (ATP) into anti-inflammatory and anti-nociceptive adenosine by cluster of differentiation (CD) 39 and 73 enzymes on the Treg cell surface. Recent studies have suggested decreased Treg proportions in migraine patients, particularly CD 39 and CD 73-positive Treg cells, whereas Treg cells were shown to be increased in T1DM patients. This suggests the role of Treg cells in migraine, but further studies are needed. In this study, the investigators aim to compare Treg levels, as well as identify Treg subpopulations and measure cytokine levels in migraine and migraine-free participants with and without an autoimmune/inflammatory disorder (MS, RA, CD, SLE, T1DM and endometriosis). This will provide better understanding of migraine pathophysiology and lead to the development of targeted and personalized treatment strategies, according to the immune pain profile and associated inflammatory diseases of migraine patients. ### Conditions Module **Conditions:** - Migraine Disorders - Pain - Autoimmune Diseases - Multiple Sclerosis - Endometriosis - Rheumatoid Arthritis - Crohn Disease - Lupus Erythematosus **Keywords:** - Migraine Disorders - Pain - Cytokines - Regulatory T cell ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 396 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Migraine - no autoimmune/inflammatory disease group **Intervention Names:** - Biological: Blood test **Label:** Migraine - no autoimmune/inflammatory disease **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No migraine - no autoimmune/inflammatory disease group **Intervention Names:** - Biological: Blood test **Label:** No migraine - no autoimmune/inflammatory disease **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) group **Intervention Names:** - Biological: Blood test **Label:** No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) group **Intervention Names:** - Biological: Blood test **Label:** Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) - Migraine - no autoimmune/inflammatory disease - No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) - No migraine - no autoimmune/inflammatory disease **Description:** 1 blood test of maximum 40 millilitres per patient **Name:** Blood test **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** To measure Treg cell levels in migraine and migraine-free participants, with and without autoimmune/inflammatory diseases (MS, RA, CD, SLE, endometriosis, T1DM) using flow cytometry **Measure:** Treg cell levels in cell/microliter (cell/µL) **Time Frame:** Once, at inclusion **Description:** To measure Treg cell levels in migraine and migraine-free participants, with and without autoimmune/inflammatory diseases (MS, RA, CD, SLE, endometriosis, T1DM) using flow cytometry **Measure:** Treg cell levels in percentage (%) of white blood cells **Time Frame:** Once, at inclusion **Description:** Age at inclusion **Measure:** Age in years **Time Frame:** Once, at inclusion **Description:** Weight on scales during inclusion visit **Measure:** Weight in kilograms (kg) **Time Frame:** Once, at inclusion **Description:** Score to be answered at inclusion to determine anxiety and depression levels : ranges from 0 to 21 for each (anxiety and depression). A score of 11 and above ascertains anxiety or depression. Licence n° 2403391 with Mapi Research Trust. **Measure:** Score on the Hospital Anxiety and Depression Scale **Time Frame:** Once, at inclusion **Description:** Score to be answered at inclusion to determine the impact of headache on patients' daily life, ranging from 36 to 78. The higher the score, the higher the impact of headache on daily life. Licence to be signed shortly with QualityMetrics **Measure:** Score on the Headache Impact Test **Time Frame:** Once, at inclusion **Description:** To be completed at inclusion to confirm migraine diagnosis. No licence needed **Measure:** Migraine diagnostic criteria from the International Classification of Headache Disorders 3rd edition (ICHD-3) **Time Frame:** Once, at inclusion **Description:** Number of days with a headache to determine whether migraine is episodic or chronic (average during last 3 months) **Measure:** Number of headache days per month in days/month **Time Frame:** Once, at inclusion **Description:** To measure the absolute white blood cell count to determine the percentage of Treg cells **Measure:** White blood cell count in giga/liter (G/L) **Time Frame:** Once, at inclusion **Description:** For sex repartition **Measure:** Sex (female, male) **Time Frame:** Once, at inclusion **Description:** Date of last menstrual period start day to measure the impact of the menstrual cycle on Treg levels **Measure:** Date of last menstrual period as a date in the form: day/month/year **Time Frame:** Once, at inclusion **Description:** To insure exclusion of pregnant women **Measure:** Human chorionic gonadotropin subunit beta level in milli-international units per milliliter (mIU/mL) **Time Frame:** Once, at inclusion **Description:** Measured at inclusion **Measure:** Height in meters (m) **Time Frame:** Once, at inclusion **Description:** Weight in kilograms and height in meters will be combined to determine the body mass index in kilogram per square meter **Measure:** Body mass index (BMI) in kilogram per square meter (kg/m2) **Time Frame:** Once, at inclusion #### Secondary Outcomes **Description:** To measure cytokine levels (interleukin 1b, interleukin 2, interleukin 6, interleukin 10, interleukin 12, interleukin 17, interleukin 18, interleukin 21, interleukin 23, interleukin 35, tumor necrosis factor a, interferon g and transforming growth factor b) using a LUMINEX method **Measure:** Cytokine levels in picogram per milliliter (pg/mL) **Time Frame:** Once, at inclusion **Description:** To determine correlation with Treg cell levels **Measure:** Progesterone in nanogram per milliliter (ng/mL) **Time Frame:** Once, at inclusion **Description:** To determine correlation with Treg cell levels **Measure:** Estrogen in picogram per milliliter (pg/mL) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between the menstrual cycle period and Treg cell levels **Measure:** Follicle stimulating hormone (FSH) in milli-international units per milliliter (mIU/mL) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between the menstrual cycle period and Treg cell levels **Measure:** Luteinizing hormone in international units per liter (IU/L) **Time Frame:** Once, at inclusion **Description:** To measure the general level of inflammation **Measure:** Levels of C-reactive protein (CRP) in milligram per liter (mg/L) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between sugar levels and Treg cell levels **Measure:** Fasting blood glucose concentration in gram per liter (g/L) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between insulin levels and Treg cell levels **Measure:** Insulin levels in milligram per deciliter (mg/dL) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between the presence of migraine and prolactin levels **Measure:** Prolactin levels in nanogram per milliliter (ng/mL) **Time Frame:** Once, at inclusion **Description:** To study association between CGRP levels and migraine **Measure:** Calcitonin gene-related peptide (CGRP) in picogram per milliliter (pg/mL) **Time Frame:** Once, at inclusion **Description:** To study association between VIP levels and migraine **Measure:** Vasoactive intestinal polypeptide (VIP) in picogram per milliliter (pg/mL) **Time Frame:** Once, at inclusion **Description:** To study association between PACAP levels and migraine **Measure:** Pituitary adenylate cyclase-activating polypeptide (PACAP) levels in nanogram per milliliter (ng/mL) **Time Frame:** Once, at inclusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * female * 18 - 50 years of age * at least 50 kg Exclusion Criteria: * menopause * type 2 diabetes * pregnancy (or delivery \< 3 months) * breast feeding * hysterectomy or adnexectomy * characterized immune deficiency * active cancer (or remission \< 1 year) * bone marrow or solid organ transplant * hormone therapy (other than birth control) * migraine attack within 12 hours before or after blood test * person under guardianship **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lise LACLAUTRE **Phone:** 334.73.754.963 **Role:** CONTACT #### Locations **Location 1:** **City:** Clermont-Ferrand **Country:** France **Facility:** CHU de Clermont-Ferrand - Service de Neurologie **State:** Aura **Zip:** 63000 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Clermont-Ferrand **Name:** Xavier MOISSET **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Al-Hassany L, Haas J, Piccininni M, Kurth T, Maassen Van Den Brink A, Rohmann JL. Giving Researchers a Headache - Sex and Gender Differences in Migraine. Front Neurol. 2020 Oct 22;11:549038. doi: 10.3389/fneur.2020.549038. eCollection 2020. **PMID:** 33192977 **Citation:** Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34. doi: 10.1186/s10194-022-01402-2. **PMID:** 35410119 **Citation:** Ashina M. Migraine. N Engl J Med. 2020 Nov 5;383(19):1866-1876. doi: 10.1056/NEJMra1915327. No abstract available. **PMID:** 33211930 **Citation:** Pellesi L, Al-Karagholi MA, De Icco R, Coskun H, Elbahi FA, Lopez-Lopez C, Snellman J, Hannibal J, Amin FM, Ashina M. Effect of Vasoactive Intestinal Polypeptide on Development of Migraine Headaches: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2118543. doi: 10.1001/jamanetworkopen.2021.18543. **PMID:** 34357396 **Citation:** Al-Karagholi MA, Kalatharan V, Ghanizada H, Gram C, Dussor G, Ashina M. Prolactin in headache and migraine: A systematic review of clinical studies. Cephalalgia. 2023 Feb;43(2):3331024221136286. doi: 10.1177/03331024221136286. **PMID:** 36718026 **Citation:** Bhoi SK, Kalita J, Misra UK. Metabolic syndrome and insulin resistance in migraine. J Headache Pain. 2012 Jun;13(4):321-6. doi: 10.1007/s10194-012-0416-y. Epub 2012 Jan 26. **PMID:** 22278639 **Citation:** Schetters STT, Gomez-Nicola D, Garcia-Vallejo JJ, Van Kooyk Y. Neuroinflammation: Microglia and T Cells Get Ready to Tango. Front Immunol. 2018 Jan 25;8:1905. doi: 10.3389/fimmu.2017.01905. eCollection 2017. **PMID:** 29422891 **Citation:** Watkins LR, Maier SF. Glia: a novel drug discovery target for clinical pain. Nat Rev Drug Discov. 2003 Dec;2(12):973-85. doi: 10.1038/nrd1251. No abstract available. **PMID:** 14654796 **Citation:** Perini F, D'Andrea G, Galloni E, Pignatelli F, Billo G, Alba S, Bussone G, Toso V. Plasma cytokine levels in migraineurs and controls. Headache. 2005 Jul-Aug;45(7):926-31. doi: 10.1111/j.1526-4610.2005.05135.x. **PMID:** 15985111 **Citation:** Vignali DA, Collison LW, Workman CJ. How regulatory T cells work. Nat Rev Immunol. 2008 Jul;8(7):523-32. doi: 10.1038/nri2343. **PMID:** 18566595 **Citation:** Arumugam M, Parthasarathy V. Reduction of CD4(+)CD25(+) regulatory T-cells in migraine: Is migraine an autoimmune disorder? J Neuroimmunol. 2016 Jan 15;290:54-9. doi: 10.1016/j.jneuroim.2015.11.015. Epub 2015 Nov 28. **PMID:** 26711570 **Citation:** Faraji F, Shojapour M, Farahani I, Ganji A, Mosayebi G. Reduced regulatory T lymphocytes in migraine patients. Neurol Res. 2021 Aug;43(8):677-682. doi: 10.1080/01616412.2021.1915077. Epub 2021 Apr 14. **PMID:** 33853506 **Citation:** Okimura H, Tanaka Y, Fujii M, Shimura K, Maeda E, Ito F, Khan KN, Nakamura Y, Mori T, Kitawaki J. Changes in the proportion of regulatory T cell subpopulations during menstrual cycle and early pregnancy. Am J Reprod Immunol. 2022 Dec;88(6):e13636. doi: 10.1111/aji.13636. Epub 2022 Oct 21. **PMID:** 36217280 **Citation:** Moisset X, Bommelaer G, Boube M, Ouchchane L, Goutte M, Dapoigny M, Dallel R, Guttmann A, Clavelou P, Buisson A. Migraine prevalence in inflammatory bowel disease patients: A tertiary-care centre cross-sectional study. Eur J Pain. 2017 Oct;21(9):1550-1560. doi: 10.1002/ejp.1056. Epub 2017 May 16. **PMID:** 28508514 **Citation:** Moisset X, Giraud P, Dallel R. Migraine in multiple sclerosis and other chronic inflammatory diseases. Rev Neurol (Paris). 2021 Sep;177(7):816-820. doi: 10.1016/j.neurol.2021.07.005. Epub 2021 Jul 27. **PMID:** 34325914 **Citation:** Yang MH, Wang PH, Wang SJ, Sun WZ, Oyang YJ, Fuh JL. Women with endometriosis are more likely to suffer from migraines: a population-based study. PLoS One. 2012;7(3):e33941. doi: 10.1371/journal.pone.0033941. Epub 2012 Mar 19. **PMID:** 22442736 **Citation:** Hagen K, Asvold BO, Midthjell K, Stovner LJ, Zwart JA, Linde M. Inverse relationship between type 1 diabetes mellitus and migraine. Data from the Nord-Trondelag Health Surveys 1995-1997 and 2006-2008. Cephalalgia. 2018 Mar;38(3):417-426. doi: 10.1177/0333102417690488. Epub 2017 Jan 23. **PMID:** 28114807 **Citation:** Malutan AM, Drugan T, Costin N, Ciortea R, Bucuri C, Rada MP, Mihu D. Pro-inflammatory cytokines for evaluation of inflammatory status in endometriosis. Cent Eur J Immunol. 2015;40(1):96-102. doi: 10.5114/ceji.2015.50840. Epub 2015 Apr 22. **PMID:** 26155190 **Citation:** Gobel K, Ruck T, Meuth SG. Cytokine signaling in multiple sclerosis: Lost in translation. Mult Scler. 2018 Apr;24(4):432-439. doi: 10.1177/1352458518763094. Epub 2018 Mar 7. **PMID:** 29512406 **Citation:** Shi JL, Zheng ZM, Chen M, Shen HH, Li MQ, Shao J. IL-17: an important pathogenic factor in endometriosis. Int J Med Sci. 2022 Apr 11;19(4):769-778. doi: 10.7150/ijms.71972. eCollection 2022. **PMID:** 35582411 **Citation:** Viisanen T, Gazali AM, Ihantola EL, Ekman I, Nanto-Salonen K, Veijola R, Toppari J, Knip M, Ilonen J, Kinnunen T. FOXP3+ Regulatory T Cell Compartment Is Altered in Children With Newly Diagnosed Type 1 Diabetes but Not in Autoantibody-Positive at-Risk Children. Front Immunol. 2019 Jan 22;10:19. doi: 10.3389/fimmu.2019.00019. eCollection 2019. **PMID:** 30723474 ## 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: D000007154 - Term: Immune System Diseases - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - 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 - 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: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M15415 - Name: Sclerosis - Relevance: LOW - As Found: Unknown - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M4629 - Name: Autoimmune Diseases - Relevance: HIGH - As Found: Autoimmune Diseases - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: LOW - As Found: Unknown - ID: M6638 - Name: Crohn Disease - Relevance: HIGH - As Found: Crohn's Disease - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine Disorders - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometriosis - 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 - ID: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - 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: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal 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 - 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: D000003424 - Term: Crohn Disease - ID: D000009103 - Term: Multiple Sclerosis - ID: D000008881 - Term: Migraine Disorders - ID: D000004715 - Term: Endometriosis - ID: D000001327 - Term: Autoimmune Diseases ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426303 **Acronym:** ABSTAIN **Brief Title:** Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder **Official Title:** Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder #### Organization Study ID Info **ID:** 25536 #### Organization **Class:** OTHER **Full Name:** Oregon Health and Science University ### Status Module #### Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-19 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Portland VA Medical Center #### Lead Sponsor **Class:** OTHER **Name:** Milky Kohno #### Responsible Party **Investigator Affiliation:** Oregon Health and Science University **Investigator Full Name:** Milky Kohno **Investigator Title:** Assistant Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to identify sex-specific biomarkers that confer greater susceptibility for Alcohol Use Disorder (AUD) and differentiate how treatment response varies by sex in people with Alcohol Use Disorder. The main questions it aims to answer are: * How does trauma affect emotion regulation, inflammation, and limbic function, and what are the sex-dependent effects of NTX (Naltrexone) on these aspects? * What is the mechanism of Naltrexone (NTX), and how does it potentially moderate reductions in alcohol use through changes in or interactions between emotion regulation, inflammation, or limbic system function? Participants will * Be consented and will undergo comprehensive screening for eligibility criteria * Complete behavioral assessments and neuropsychological assessments, as well as neurocognitive assessments and neuroimaging measures * Provide urine samples for a urine drug screen (UDS) and urine pregnancy test (for women), and have blood and a cheek swab collected and stored in the repository * Take a study drug once daily for 12 weeks and track drug usage and effects in a study journal * Undergo weekly assessment calls and bi-weekly medical follow-up safety exams Researchers will compare naltrexone to placebo in AUD to see if naltrexone is effective in reducing alcohol cravings and promoting abstinence. Researchers will also compare baseline measures between AUD and Healthy Controls. **Detailed Description:** A twelve-week randomized placebo-controlled trial of naltrexone (NTX) will be conducted in one hundred people with alcohol use disorder (AUD), fifty of which will be women. Fifty healthy participants will serve as controls for baseline measures. We will use validated measures to comprehensively assess trauma exposure including: military sexual trauma (MST), physical or sexual assault, combat exposure, intimate partner violence, and other traumatic events. Emotion regulation will be assessed with the Cognitive Emotion Regulation questionnaire and Difficulty in Emotion Regulation scale. Functional magnetic resonance imaging at rest and during an emotion regulation task will assess limbic system connectivity and reactivity. Inflammation will be indexed with a multiplex panel assay of peripheral inflammatory markers. Days of alcohol use and average weekly standard drinks will be assessed at each time-point. ### Conditions Module **Conditions:** - Alcohol Use Disorder **Keywords:** - Naltrexone ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Drug: Naltrexone Half of the study participants with AUD will take an oral tablet of 50 mg naltrexone once daily for one week followed by 11 weeks of 100 mg naltrexone orally, once daily. Drug: Placebo oral tablet The other half of study participants will receive an identical looking placebo in tablet form and take the medication using an identical schedule as the real drug. Drug type will be randomized. **Intervention Names:** - Drug: Naltrexone **Label:** Alcohol Use Disorder (AUD) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Baseline measures will be taken but controls will not continue to the drug trial. **Label:** Healthy Controls **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Alcohol Use Disorder (AUD) **Description:** 12-week randomized double blinded placebo-controlled drug trial titrating drug/placebo dose after 1 week. **Name:** Naltrexone **Other Names:** - Revia **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Drinking days and average number of weekly standard drinks will be measured at baseline and at follow-up **Measure:** Change from baseline in alcohol use (number of drinking days, amount used per day) **Time Frame:** Baseline and Week 12 **Description:** Plasma samples will be analyzed using a customized, high-sensitivity magnetic bead multiplex assay Luminex system. Samples will be prepared and analyzed to measure peripheral immune markers: interleukin (IL)-1-beta, IL-6, IL-10, tumor necrosis factor (TNF)-alpha, brain-derived neurotrophic factor (BDNF), monocyte chemotactic protein (MCP)-1 and neural cell adhesion molecule (NCAM). Intra-and inter-assay coefficients of variation, as indices of within-and between-assay precision, respectively, will be calculated to examine the reliability of cytokine measurements. **Measure:** Changes from baseline in peripheral immune biomarkers associated with inflammation **Time Frame:** Baseline and Week 12 **Description:** Resting-state functional magnetic resonance imaging (rs-fMRI) will be used to assess changes in limbic system connectivity. Correlation coefficients of low-frequency oscillations in the fMRI blood oxygenation level dependent (BOLD) signal between regions and between large-scale resting-state networks in the brain will be z-score transformed. A score of 0 indicates no change while higher or lower scores indicate increased or decreased connectivity, respectively. **Measure:** Changes in limbic functional connectivity **Time Frame:** Baseline and Week 12 **Description:** The task will assess emotional reactivity and regulation to negative and stressful images. Each event (cue, neutral-look, negative-look, negative-reappraise and rating scale of negative affect) will be modeled using a canonical hemodynamic response function with a time derivative. The contrasts of interest will be Negative-look vs Neutral-look and Negative-look vs Negative-reappraise. Amygdala BOLD signal estimates will be extracted to calculate percent-change. **Measure:** Changes from baseline in BOLD signal brain activation during an emotion regulation fMRI task **Time Frame:** Baseline and Week 12 **Description:** DERS is a 36-item self-report questionnaire scored on a 5-point scale from 1 (almost never) to 5 (almost always), with total score ranging from 36 to 180. It measures emotion regulation difficulties across six dimensions: 1. Non-acceptance of emotional responses, 2. Difficulties engaging in goal-directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to effective emotion regulation strategies, 6. Lack of emotional clarity. Higher scores suggest greater difficulties in emotion regulation. **Measure:** Changes from baseline in emotion regulation assessed with the Difficulty in Emotion Regulation Scale (DERS) **Time Frame:** Baseline and Week 12 **Description:** CERQ is a 36-item self-report questionnaire that identifies cognitive emotion regulation or cognitive coping strategies used after having experienced negative events or situations. Scores can identify individual strategies to compare with normed scores from various populations. The nine cognitive emotion regulation strategies are measured on a 5-point Likert scale ranging from 1 to 5, with scores being obtained by calculating the mean scores belonging to a particular subscale. Higher subscale scores indicate greater use of a specific cognitive strategy. **Measure:** Changes from baseline in emotion regulation assessed with the Cognitive Emotion Regulation Questionnaire (CERQ) **Time Frame:** Baseline and Week 12 #### Secondary Outcomes **Description:** The Brief Alcohol Craving Scale, a 10-item self-report assessment of craving, will be used. Participants will be prompted with a statement regarding alcohol cravings and will choose an answer ranging between "strongly disagree" and "strongly agree." **Measure:** Change from baseline in craving (include craving measures/questionnaires) **Time Frame:** Baseline and Week 12 **Description:** Department of Veterans Affairs Military Sexual Trauma Screening consists of two questions used nationally within the Veterans Heath Administration (VHA) to screen for MST. Response options are yes, no, or decline to respond. Trauma Assessment for Adults (TAA) is a 17-item self-report on combat exposure, physical or sexual assault, surviving serious accidents and other threatening life events. Life Stressor Checklist-Revised (LSC-R) includes self-report measures relevant to women such as abortion or caregiver duties, in addition to 30 life events related to natural disasters, physical or sexual assault, death of a relative, incarceration and financial hardships. Childhood Maltreatment questionnaire is 70 items in five dimensions: emotional, physical, and sexual abuse, and physical and emotional neglect. A 7-point scale will be used to indicate level of trauma **Measure:** Differences in baseline trauma exposure (composite score) **Time Frame:** Baseline and Week 12 **Description:** The Standard Neuropsychological Battery will be used **Measure:** Change from baseline in neuropsychological testing scores **Time Frame:** Baseline and Week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-60 years old * Veteran enrolled in VHA healthcare Alcohol Group: * must meet diagnosis for recent alcohol-use disorder (DSM-V) * willing to return for follow-up visits and can participate for 12-weeks Control Group: * must not meet DSM-V criteria for a use disorder other than nicotine Exclusion Criteria: * Clinically significant neurological, endocrine, hepatic, or systemic disease that would compromise safe participation or confound outcomes * Left-handedness * Axis-1 psychiatric diagnoses other than anxiety, depression or post-traumatic stress disorder * Recreational or prescriptive use of psychotropic medications * Recreational or prescriptive use of opioid medications or have a past or current history of abuse or dependence on opioids * MRI contraindications (e.g. metal in body) * Positive urine drug screen, except for nicotine and marijuana, on test days * Women who are pregnant or breastfeeding * Participants on hormonal therapy or treatments other than pregnancy contraceptives * Autoimmune or neurodegenerative diseases that present with neuroinflammation (multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, Parkinson's) * Current participation in an investigational drug study * Alcohol group: \< 5 days and \> 3 weeks of abstinence from alcohol * Alcohol group: Liver disease requiring medication or medical treatment, and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit of normal, gastrointestinal or renal disease that would significantly impair absorption, metabolism or excretion of study drug, or require medical treatment. * Non-english speaker **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jazryn Nagum **Phone:** 503-721-7964 **Role:** CONTACT #### Locations **Location 1:** **City:** Portland **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jazryn Nagum - **Phone:** 503-721-7964 - **Role:** CONTACT **Country:** United States **Facility:** VA Portland Health Care System **State:** Oregon **Status:** RECRUITING **Zip:** 97239 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000004327 - Term: Drinking Behavior - ID: D000019973 - Term: Alcohol-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: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC25 - Name: Substance Related Disorders ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M3774 - Name: Alcohol Drinking - Relevance: HIGH - As Found: Alcohol Use - ID: M3783 - Name: Alcoholism - Relevance: HIGH - As Found: Alcohol Use Disorder - ID: M7502 - Name: Drinking Behavior - Relevance: LOW - As Found: Unknown - ID: M21842 - Name: Alcohol-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: D000007249 - Term: Inflammation - ID: D000000437 - Term: Alcoholism - ID: D000000428 - Term: Alcohol Drinking ### Intervention Browse Module - Ancestors - ID: D000000427 - Term: Alcohol Deterrents - ID: D000009292 - Term: Narcotic Antagonists - 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: AlcDet - Name: Alcohol Deterrents - Abbrev: NarcAntag - Name: Narcotic Antagonists - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M12222 - Name: Naltrexone - Relevance: HIGH - As Found: Coronary Artery - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M12243 - Name: Narcotic Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009271 - Term: Naltrexone ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426290 **Acronym:** PREDI-CHIRBA **Brief Title:** Prediction of Response to Bariatric Surgery in Patients With Severe Obesity **Official Title:** Prediction of Response to Bariatric Surgery Treatment in Patients Suffering From Severe Obesity, Based on the Scales of the MMPI-2-RF Questionnaire Carried Out Preoperatively #### Organization Study ID Info **ID:** CHMY-2021-06 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier de Moulins Yzeure ### Status Module #### Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **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:** Centre Hospitalier de Moulins Yzeure #### 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 an retrospective and prospective (ambispective) study with data collection from volunteer patients who passed an MMPI-2-RF (Minnesota Multiphasic Personality Inventory-2-Restructured form) questionnaire in the preoperative phase of a bariatric surgery project. The evolution of their BMI will be correlated to psychological dimensions collected in patient questionnaires, before and after bariatric surgery. The presence of possible risk factors such as depression, anxiety, eating disorders, quality of life, satisfaction and the perception of body, could make it possible to establish adapted therapies before surgery, in order to attenuate or eliminate the presence of these factors, and improve BMI evolution and bariatric surgery success. **Detailed Description:** A first phase of data collection will concern data from the MMPI-2-RF questionnaire as well as clinical data, collected during preoperative consultations. For the second phase, post-operative data will be collected, during a routine follow-up consultation in the nutrition Department, where specific psychological questionnaires are taken by patients. ### Conditions Module **Conditions:** - Body Weight Changes ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** OTHER #### Enrollment Info **Count:** 360 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Following questionnaires will be done : Patient Health Questionnaire (PHQ-9) Generalized Anxiety Disorder (GAD-7) Three Factor Eating Questionnaire (TFEQ-R21) Quality of life for obesity and dietetic questionnaire (EQVOD) Body Esteem Scale (BES) Figure Rating Scale (auto-questionnaire) **Name:** post-surgery psychological evaluation **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Depressive dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of depressive symptomatology dimension on the evolution of BMI. **Time Frame:** At inclusion psychological consultation #### Secondary Outcomes **Description:** Anxiety dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI **Time Frame:** At inclusion psychological consultation **Description:** Eating behaviour dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of eating behavior dimension on the evolution of BMI **Time Frame:** At inclusion psychological consultation **Description:** Quality of life dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of quality of life dimension on the evolution of BMI **Time Frame:** At inclusion psychological consultation **Description:** satisfaction and body perception dimensions assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI **Time Frame:** At inclusion psychological consultation **Description:** Using the MMPI-2-RF preoperative questionnaire **Measure:** Determine typical profiles of patients who have finally denied surgery apart from medical contraindications **Time Frame:** At inclusion psychological consultation **Description:** Using the MMPI-2-RF preoperative questionnaire **Measure:** Identify the risk factors for abandonment or difficulties after the intervention, in order to establish appropriate preoperative treatments before surgery **Time Frame:** At inclusion psychological consultation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Having been treated in the Nutrition department for severe obesity and considered for bariatric surgery because having met the criteria validating bariatric surgery: * Having passed the MMPI-2-RF questionnaire between January 1, 2014 and December 31, 2023 in the preoperative phase, as part of psychological follow-up * Having benefited from bariatric surgery or patients who have abandoned the surgery plan for a reason other than a medical contraindication. * Informed of the study, having agreed to participate and not having opposed the use of their data Exclusion Criteria: * Subjects who generated an invalid MMPI-2-RF questionnaire, according to the test validity criteria (verified by the principal investigator) * Subjects who expressly objected to the use of their data for this study * Subjects who have not undergone bariatric surgery due to a medical contraindication. * Patient unable to understand the study or complete the post-operative phase visit * Persons under guardianship or curators or under legal protection **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with severe obesity : BMI \> 40 kg/m2 or \> 35 kg/m2 associated with at least one comorbidity likely to be improved after surgery. * Failure of well-conducted medical, nutritional, dietetic and psychotherapeutic monitoring for 6-12 months * Lack of sufficient weight loss or failure to maintain weight loss ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Virginie ALLASSEUR, psychologist **Phone:** 33478357884 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sophie PAGNON, CRA **Phone:** 33470357822 **Role:** CONTACT #### Locations **Location 1:** **City:** Moulins **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** psychologist - **Phone:** 33478357884 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Sophie PAGNON, CRA - **Phone:** 33470357822 - **Role:** CONTACT ***Contact 3:*** - **Name:** Virginie ALLASSEUR - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Centre hospitalier Moulins-Yzeure **Status:** RECRUITING **Zip:** 03000 #### Overall Officials **Official 1:** **Affiliation:** Centre Hospitalier de Moulins Yzeure **Name:** Virginie ALLASSEUR, psychologist **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Body Weight - ID: M12702 - Name: Obesity, Morbid - Relevance: HIGH - As Found: Severe Obesity - ID: M5115 - Name: Body Weight Changes - Relevance: HIGH - As Found: Body Weight Changes - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009767 - Term: Obesity, Morbid - ID: D000001835 - Term: Body Weight - ID: D000001836 - Term: Body Weight Changes ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426277 **Acronym:** PROVEN-DIA **Brief Title:** Effectiveness of the Brazilian Diabetes Prevention Program **Official Title:** Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study) #### Organization Study ID Info **ID:** PROVEN-DIA ECR #### Organization **Class:** OTHER **Full Name:** Beneficência Portuguesa de São Paulo ### Status Module #### Completion Date **Date:** 2029-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-03-19 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beneficência Portuguesa de São Paulo #### 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 multicenter controlled randomized trial is to assess the effectiveness of Brazilian Diabetes Prevention Program (face-to-face or e-health) in incidence of T2D with, at least, 1590 adults at high risk of developing T2D during 3-yr follow-up. Our primary outcomes are the incidence of T2D, MVPA (min/week), prevalence of physical inactivity, quality of life, BALANCE DI, CDHI, body weight (kg), and biomarkers of glycemia. In addition, social, cultural, educational and geographical factors at community levels will also be analyzed throughout the follow-up to verify their association with the incidence of T2D. **Detailed Description:** This is a multicenter controlled randomized trial coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program). ### Conditions Module **Conditions:** - Prediabetic State - Pre Diabetes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 1590 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Brazilian Diabetes Prevention Program will be delivered face-to-face, including guidance for improving diet and lifestyle (especially physical activity in daily life), as well as stimulating self-care. **Intervention Names:** - Behavioral: Brazilian Diabetes Prevention Program (face-to-face care) **Label:** Brazilian Diabetes Prevention Program (face-to-face care) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Brazilian Diabetes Prevention Program (remote care) will be delivered either through telephone or video calls (using several media and software application), including guidance for improving diet and lifestyle (especially physical activity in daily life), as well as stimulating self-care. **Intervention Names:** - Behavioral: Brazilian Diabetes Prevention Program (remote care) **Label:** Brazilian Diabetes Prevention Program (remote care) **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Diet prescription for weight loss. **Intervention Names:** - Behavioral: Diet **Label:** Diet Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Brazilian Diabetes Prevention Program (face-to-face care) **Description:** A Program structured in 28 visits (in group and individual) and 21 contacts (through phone calls or video calls) to guide the improvement of diet quality, self-care, and regular practice of physical activity **Name:** Brazilian Diabetes Prevention Program (face-to-face care) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Diet Group **Description:** Hypocaloric diet prescription **Name:** Diet **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Brazilian Diabetes Prevention Program (remote care) **Description:** A Program structured in 49 contacts delivered through telehealth (through phone calls or video calls between professional and participant) to guide the improvement of diet quality, self-care, and regular practice of physical activity **Name:** Brazilian Diabetes Prevention Program (remote care) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** to analyze the incidence of type 2 diabetes mellitus **Measure:** Incidence of type 2 diabetes mellitus **Time Frame:** 36 months #### Secondary Outcomes **Description:** to compare mean HbA1c(%) obtained through laboratory exams/tests between groups **Measure:** Mean value of Glycated Hemoglobin level (HbA1c in %) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare mean fasting blood glucose (mg/dL) obtained through laboratory exams/tests between groups **Measure:** Mean value of Fasting Blood Glucose (mg/dL) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals with controlled blood glucose (\<126mg/dl) obtained through laboratory exams/tests without the use of hypoglycemic medication **Measure:** Number of Participants with controlled Fasting blood glucose (<126mg/dL) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals with HbA1c (\<6.4%) obtained through laboratory exams/tests without the use of hypoglycemic medication **Measure:** Number of Participants with controlled Glycated Hemoglobin level (<6.4%) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare mean weight (kg) between groups **Measure:** body weight **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals who are physically active (\>150 minutes of moderate to vigorous physical activity) and inactive (\<150 minutes of moderate to vigorous physical activity) between groups **Measure:** Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained thourgh International Physical Activity Questionnaire short form **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare mean time in minutes of practice of moderate/vigorous physical activity over a week between groups **Measure:** Minutes spent on moderate-to-vigorous physical activity **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals engaging in moderate or vigorous physical activity and sedentary behavior **Measure:** Moderate-to-vigorous physical activity and sedentary behavior **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals who engage in 150 minutes or more of physical activity per week **Measure:** Physical activity **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of sedentary individuals **Measure:** Sedentary behavior **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare mean score of Brazilian Cardioprotective Nutritional Program dietary index (BALANCE DI) between groups Minimum: 0 Maximum: 40 When higher the score, better the quality of diet **Measure:** Quality of diet (Mean score of the Brazilian Cardioprotective Nutritional Program dietary index) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the mean caloric intake (kcal) from ultra-processed foods obtained through two 24-hour Dietary Recall applied within a period of fifiteen days **Measure:** Mean of kcal from ultra processed food intake **Time Frame:** 6, 12, 24 and 36 months **Description:** to analyze the quality of life based on delta value of the eight domains (Functional capacity, Physical aspects, Pain, General health status, Vitality, Social aspects, Emotional aspects and Mental health) When higher the score, better the quality of life related to the assessed domain **Measure:** Delta value (Change score from baseline to 6, 12, 24 and 36 months) for each domain of Quality of life obtained through Short Form Health Survey (SF-36) **Time Frame:** 6, 12, 24 and 36 months **Description:** To compare the cost of interventions. To estimate healthcare system costs, we will consider only direct medical costs, which include screening costs, intervention costs, and costs of healthcare service utilization. To estimate social costs, we will consider not only direct medical costs but also non-medical direct costs, such as transportation, food, and accommodation expenses reported by participants when seeking medical assistance, as well as time spent traveling to and participating in group sessions. Additionally, we will include indirect costs, calculated based on the assumption that each necessary hospitalization results in a loss of 9 hours of paid work and each outpatient visit results in a loss of half a day (4.5 hours) of paid work **Measure:** Cost **Time Frame:** 36 months **Description:** To analyze the correlation between years of study and the incidence of type 2 diabetes **Measure:** Scholarity **Time Frame:** 36 months **Description:** T2DM incidence across Brazillian five geographic regions (South, Southeast, Midwest, West, and Northwest) **Measure:** Geo-Stratified Analysis **Time Frame:** 36 months **Description:** Association between T2DM incidence and individual Low or high income (accessed by ABEP - Critério Brasil 2022 questionnaire) **Measure:** Household income **Time Frame:** 36 months **Description:** correlation between neighborhood value (as assessed using the Gini index) and incidence of type 2 diabetes (DM2) **Measure:** Neighbourhood value **Time Frame:** 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * Be 18 years or older (no maximum age for being eligible) * Have a body mass index (BMI) between 25 and 34,9kg/m² * Have, at least, one electronic device (includes any of the following devices): * Computer * Laptop/notebook * Tablet * Smartphone * Have access to internet (broadband, 3G, 4G, 5G, among others) * Without previous nutritional counseling (within 6 months prior to the recruitment/randomization/intervention) * Living near the research center (at maximum 60 minutes of walking) * Had a blood test result in the prediabetes range within the last three months prior to the recruitment/randomization/intervention (includes any of these tests and results): * Hemoglobin levels (HbA1c): 5.7-6.4% * Fasting blood glucose: 100-125 mg/dL * Blood glucose 2 hours after an oral glucose tolerance: 140-199 mg/dL Exclusion Criteria * Diagnosis of Diabetes Mellitus * In secondary prevention for Cardiovascular Disease (myocardial infarction, unstable angina or stroke in the past six months) * Exclusion for underlying disease or condition likely to limit life span and/or increase risk of interventions o Cardiovascular disease * Congestive Heart Failure (New York Heart Association Functional Class \> 2) * Uncontrolled hypertension * Lung disease (asthma or Chronic Obstructive Pulmonary Disease) * Gastrointestinal disease * Renal disease * Major psychiatric disorder * Anemia (hematocrit \< 36.0% in men or \< 33.0% in women) * Weight loss of \> 10% in past 6 months for any reason, except post-partum weight loss * Excessive alcohol intake * Medication use (antihypertensives, antibiotics, corticoids, antipsychotic, antineoplastic agents, phenytoin, amphetamines, and prescript weight-loss drugs) * Likely to move away from participating clinics in next 5 years * Another household member is a participant or staff member in the study * Unable or unwilling to give informed consent (subject refused to sign the Free and Informed Consent Form) * Current participation in another Randomized Clinical Trial whose main purpose interferes with any of the interventions and primary outcomes of this study (for instance, food consumption and physical activity level) * Participant of the pilot Randomized Clinical Trial ( Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia), NCT05689658) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14117 - Name: Prediabetic State - Relevance: HIGH - As Found: Prediabetic State - ID: M20295 - Name: Glucose Intolerance - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000011236 - Term: Prediabetic State ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426264 **Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA] **Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info **ID:** ATTN201- CT010b #### Organization **Full Name:** [Redacted] ### Status Module **Delayed Posting:** True #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** WITHHELD #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Name:** [Redacted] #### Responsible Party **Old Name Title:** [Redacted] **Old Organization:** [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426251 **Brief Title:** Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty **Official Title:** A Randomized Trial of Photobiomodulation Effect in Patients Receiving Total Knee Arthroplasty #### Organization Study ID Info **ID:** 111-036-F #### Organization **Class:** OTHER **Full Name:** National Taiwan University Hospital Hsin-Chu Branch ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2022-08-02 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Taiwan University Hospital Hsin-Chu Branch #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Photobiomdoulation is the use of near-infrared light to relieve pain, stimulate healing and reduce inflammation. Swelling and inflammation is a common condition after orthopedics surgeries over extremity and spine. This study aim to evaluate the effect of photobiomodulation over patients after Total Knee Arthroplasty. **Detailed Description:** Patients aged over 20 after Total Knee Arthroplasty in our institution would be candidate for recruitment. The patients will be randomized to receive routine post operative care or photobiomodulation therapy. The swelling extent and subjective outcome will be recorded. ### Conditions Module **Conditions:** - Inflammation - Osteoarthritis - Post Operative Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This group of patient will receive photobiomodulation pads on the part of surgical site and the machine will emit near-infrared light. **Intervention Names:** - Device: Photobiomodulation **Label:** intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** This group of patient will have photobiomodulation pads on the body surface as intervention group, but the machine will not emit near-infrared light. **Intervention Names:** - Device: Photobiomodulation **Label:** control group **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - control group - intervention group **Description:** Photobiomodulation therapy will be given daily start on the first day after surgery to post operative day 6 **Name:** Photobiomodulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** bioimpedance of the surgical site will be measured for evaluation of swelling change **Measure:** the change of bioimpedance **Time Frame:** the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks #### Secondary Outcomes **Description:** patient reported pain score, from 0 to 100 points **Measure:** pain score (visual analogue score) **Time Frame:** once daily since post operative day1 to day6 **Description:** active range of motion of knee **Measure:** active range of motion of knee **Time Frame:** once daily since post operative day1 to day6 **Description:** the distance that the patient could walk within 2 minutes **Measure:** 2 minute walk test **Time Frame:** once daily since post operative day1 to day6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * total knee arthroplasty Exclusion Criteria: * open injury * pregnancy * wound without primary closure * infection * previous surgery over surgical site * skin defect **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hsiang-Chieh Hsieh **Phone:** 886972654075 **Role:** CONTACT #### Locations **Location 1:** **City:** Hsinchu **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hsiang-Chieh Hsieh - **Phone:** +886972654075 - **Role:** CONTACT **Country:** Taiwan **Facility:** National Taiwan University Hospital, Hsin-Chu Branch **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** National Taiwan University Hospital Hsin-Chu Branch **Name:** Hsiang-Chieh Hsieh **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** de Rezende MU, Varone BB, Martuscelli DF, Ocampos GP, Freire GMG, Pinto NC, de Sousa MVP. Pilot study of the effect of therapeutic photobiomodulation on postoperative pain in knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):159-161. doi: 10.1016/j.bjane.2021.07.040. Epub 2021 Nov 17. **PMID:** 34800495 **Citation:** Vassao PG, Renno AC, Smith BN, Bennett GB, Murphy M, Liebert A, Chow R, Laakso EL. Pre-Conditioning and Post-Operative Photobiomodulation Therapy by a Novel Light Patch System for Knee Arthroplasty: A Protocol for a Phase 1 Study. Photobiomodul Photomed Laser Surg. 2020 Apr;38(4):206-214. doi: 10.1089/photob.2019.4751. Epub 2020 Mar 18. **PMID:** 32186975 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000011183 - Term: Postoperative Complications - 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: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post Operative Pain - ID: M12926 - Name: Osteoarthritis - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - 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: D000007249 - Term: Inflammation - ID: D000010149 - Term: Pain, Postoperative ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426238 **Brief Title:** Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment **Official Title:** Comparison of Self-reported and Experimental Pain Outcomes Between Clear Aligners and Fixed Appliances in Patients Undergoing Orthodontic Treatment #### Organization Study ID Info **ID:** CIRB_23010 #### Organization **Class:** OTHER **Full Name:** Midwestern University ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Midwestern 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:** Pressure Pain Threshold (PPT) is defined as the minimum force applied to an area that is perceived as pain. PPT is considered an objective measurement tool to assess pain levels. Studies have assessed the difference in pain levels between clear aligners and fixed appliances using subjective pain scales. No study has utilized PPT to evaluate the difference in pain between aligners and fixed braces at different time points. This study will aim to compare the self- reported and experimental pain perception between the clear aligner and fixed appliance therapies during the phase of crown alignment and to assess how long pain is perceived in the following five days from the adjustment of the appliance. ### Conditions Module **Conditions:** - Pain **Keywords:** - Pressure pain threshold - Clear aligners - Orthodontic appliance - Adolescents - Self-reported pain ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 38 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Self-reported pain will be assessed using a Visual Analogue Scale with anchors from 0 (=no pain) to 10 (=worst imaginable pain) **Measure:** Self-reported pain intensity **Time Frame:** At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks **Description:** Pressure Pain Threshold will be measured through an algometer on masseter and temporals muscles **Measure:** Pressure Pain Threshold **Time Frame:** At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks #### Secondary Outcomes **Description:** Self-perceived anxiety and depression measured through the Patient Health Questionnaire, PHQ-4 (from 0 to 12, with higher score identifying higher anxiety and depression) **Measure:** Anxiety and depression symptoms **Time Frame:** At two timepoints through study completion: at baseline, and at 8-12 weeks **Description:** Self-reported pain catastrophizing measured trough Pain Catastrophizing Scale, PCS (from 0 to 52, with values \>30 identifying clinically meaningful pain catastrophizing) **Measure:** Pain catastrophizing **Time Frame:** At two timepoints through study completion: at baseline, and at 8-12 weeks **Description:** Semi-structural interview through questionnaire **Measure:** Past pain experience **Time Frame:** At T0: Baseline (pre-intervention) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * consecutive consented patients (\> 14 years old) beginning an orthodontic treatment on both arches, either with aligners or fixed appliance at the Midwestern University, Multidisciplinary Clinic; * patients in possession of an email address and Internet connection. Exclusion Criteria: * patients with generalized systemic conditions known to affect the overall body pain and pressure pain threshold assessment (e.g., fibromyalgia, autoimmune conditions such as multiple sclerosis, rheumatoid arthritis), * untreated dental caries. **Minimum Age:** 14 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients starting an orthodontic treatment (clear aligners or fixed braces) at the Multispecialty Clinic of Midwestern University ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Linda Sangalli, DDS, MS, PhD **Phone:** 630-515-7369 **Role:** CONTACT #### Locations **Location 1:** **City:** Downers Grove **Contacts:** ***Contact 1:*** - **Name:** Linda Sangalli, DDS, MS, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Linda Sangalli, DDS, MS, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Jahnavi Rao, DDS, MS - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Midwestern University **State:** Illinois **Status:** RECRUITING **Zip:** 60515 ## 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: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426225 **Brief Title:** Spinal Or General Anesthesia For Umblical Hernia Surgery **Official Title:** Should General Anesthesia or Spinal Aneshtesia With Ketofol Sedation Be Applied in Umblical Hernia Operations ? #### Organization Study ID Info **ID:** 1646 #### Organization **Class:** OTHER **Full Name:** Ankara City Hospital Bilkent ### Status Module #### Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara City Hospital Bilkent #### Responsible Party **Investigator Affiliation:** Ankara City Hospital Bilkent **Investigator Full Name:** Nargiz Mammadova **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:** In this study, the investigators compared spinal anesthesia under ketofol (ketamine-propofol combination) sedation with general anesthesia in terms of intraoperative and postoperative hemodynamics, respiratory parameters and cost in patients undergoing umbilical hernia operation. the investigator aimed to provide the most appropriate and hemodynamically stable option for the patient, to decrease the complication rates and to reduce the associated costs. **Detailed Description:** This study was carried out at the Ministry of Health Ankara City Hospital Operating Room, after receiving ethics committee approval.Preoperative evaluation was performed before the operation in cases undergoing elective umbilical hernia surgery.Complications and side effects are explained in detail.Verbal and written consents were obtained from the subjects who agreed to participate in the study.In patients undergoing umbilical hernia surgery, general anesthesia and spinal anesthesia under propofol and ketamine (ketamine-propofol combination) sedation were compared in terms of intraoperative and postoperative hemodynamics, aldrete score, pain score, respiratory parameters, and cost. The patients, who had fasted for 8 hours before the operation, were taken to the operating room without premedication. In all cases, a peripheral venous catheter cannulated on the dorsal part of the hand (20G, Plusflon i.v. Cannula, India) .Standard monitoring was applied. Group1. As premedication 0.03mg/kg midazolam was administered . For spinal anesthesia, 15 mg heavy-bupivacaine, sedation was provided with ketofol. ketamine:propofol mixture was prepared as 1:1 5mg/ml propofol and 5mg/ml ketamine 1 mg/kg ketofol administered i.v. Group2 . As premedication 0.03mg/kg midazolam was administered.In general anesthesia to all patients after induction 3 mg/kg propofol, 0.6 mg/kg rocuronium and 1 mcg/kg fentanyl Bispectral index and non-invasive blood pressure was monitored, a urinary catheter was placed. Anesthesia was maintained with sevoflurane and fentanyl to keep BIS values between 40-60. ### Conditions Module **Conditions:** - Umbilical Hernia - Spinal Aneshtesia - General Anesthesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** As premedication 0.03mg/kg midazolam was administered. During general anesthesia, 3 mg/kg propofol, 0.6 mg/kg rocuronium and 1 mcg/kg fentanyl were administered to all patients for induction. **Intervention Names:** - Other: General Anesthesia **Label:** General Anesthesia **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** As premedication 0.03mg/kg midazolam was administered. After premedication Spinal Anesthesia applied. Group will be sedated with ketofol after spinal anesthesia. Ketamine:propofol mixture will be prepared as 1:1 5mg/ml propofol and 5mg/ml ketamine. Surgery will begin when the Ramsey sedation scale reaches 3. **Intervention Names:** - Other: Spinal Aneshtesia **Label:** Spinal Anesthesia **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - General Anesthesia **Description:** General Anesthesia Applied Group 2 Patients. **Name:** General Anesthesia **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Spinal Anesthesia **Description:** Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients. **Name:** Spinal Aneshtesia **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** During Perioperative Period Heart rate was measured **Measure:** Heart Rate **Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute **Description:** non invasive blood pressure measurement **Measure:** systolic blood pressure **Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute **Description:** non invasive blood pressure measurement **Measure:** diastolic blood pressure **Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute **Description:** non invasive blood pressure measurement **Measure:** mean arterial blood pressure **Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute **Description:** Length of hospital stay was recorded. **Measure:** hospital stay **Time Frame:** From hospital admission to discharge **Description:** Bill amount during hospitalization **Measure:** Cost **Time Frame:** From hospital admission to discharge #### Secondary Outcomes **Description:** postoperative numeric rating scale was evaluated, 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable **Measure:** Postoperative NRS **Time Frame:** Postoperative 30.minute, Postoperative 12. hour **Description:** Postoperative Aldrete score was evaluated. **Measure:** Postoperative Aldrete Score **Time Frame:** Postoperative first 1 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I-II patients between the ages of 18 and 65 who would undergo Umbilical hernia surgery were included in the study. Exclusion Criteria: * who do not accept the procedure * serious cardiovasculer disease ,renal, hematological (bleeding diathesis, under anticoagulant therapy, those with hemoglobin value below 10 g/dl) disease, hepatic disease, cerebrovascular, neurological or psychiatric diseases, * those who are contraindicated for spinal anesthesia, * Those who are allergic to one of the local anesthetics to be used, with drug and alcohol addiction, * pregnant or breastfeeding * using drugs and analgesics effective on the central nervous system were excluded from the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nargiz Mammadova **Phone:** +905356570987 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** KROBOT, R. i PREMUŽIĆ, J. (2013). Comparison of general and spinal anaesthesia in patients undergoing open ventral hernia repair. Periodicum biologorum, 115 (2), 225-229. Preuzeto s https://hrcak.srce.hr/105984 **Citation:** Germano P, Siboni S, Milito P, Mautone G, Resta M, Bonavina L. Ventral hernia repair under neuraxial anesthesia. Eur Surg. 2022;54(1):54-58. doi: 10.1007/s10353-021-00731-x. Epub 2021 Jul 20. **PMID:** 34306042 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000006555 - Term: Hernia, Ventral - ID: D000046449 - Term: Hernia, Abdominal ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M9625 - Name: Hernia - Relevance: HIGH - As Found: Hernia - ID: M9632 - Name: Hernia, Umbilical - Relevance: HIGH - As Found: Umbilical Hernia - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M9633 - Name: Hernia, Ventral - Relevance: LOW - As Found: Unknown - ID: M25675 - Name: Hernia, Abdominal - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006554 - Term: Hernia, Umbilical - ID: D000006547 - Term: Hernia ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PsychDr - Name: Psychotropic Drugs ### Intervention Browse Module - Browse Leaves - ID: M8418 - Name: Fentanyl - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Imaging - ID: M1666 - Name: Rocuronium - Relevance: LOW - As Found: Unknown - ID: M11845 - Name: Midazolam - Relevance: LOW - As Found: Unknown - ID: M10674 - Name: Ketamine - Relevance: LOW - As Found: Unknown - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426212 **Acronym:** 3-TEICO **Brief Title:** Use of Teicoplanin on a Three-weekly Administration in the Infectious Diseases Unit **Official Title:** Use of Teicoplanin on a Three-weekly Administration in the Complex Outpatient Macroactivity Regimen of Infectious Diseases Unit in the Alessandro Manzoni Hospital (Lecco, Italy) #### Organization Study ID Info **ID:** 3-TEICO #### Organization **Class:** OTHER **Full Name:** Azienda Ospedaliera di Lecco ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **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:** Azienda Ospedaliera di Lecco #### Responsible Party **Investigator Affiliation:** Azienda Ospedaliera di Lecco **Investigator Full Name:** Stefania Piconi **Investigator Title:** Director of Infectious Diseases Unit **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Teicoplanin is an antibiotic belonging to the class of glycopeptides, in use since 1986. Like its older "classmate" vancomycin, it inhibits protein synthesis by interfering with the synthesis of peptidoglycan, and is active on Gram-positive bacteria such as Staphilococcus spp (including MRSA), Streptococcus spp and Enterococcus spp (both faecalis and faecium). Teicoplanin is characterized by poor gastrointestinal absorption, which requires intramuscular or intravenous administration; has a binding to plasma proteins greater than 90%; and a high volume of distribution. It reaches high levels in deep tissues (bone, abdomen, lung, kidney, heart) on the contrary it has poor penetration at the central nervous system level; it is approved for the treatment of skin and soft tissue infections, osteo-articular infections, pneumonia, endocarditis, complicated urinary tract infections, peritonitis and bacteremia associated with the aforementioned clinical conditions. Furthermore, teicoplanin has a markedly long half-life (between 30 and 180h) which allows it to be administered even every 48-72h. Dose and duration of treatment should be adjusted according to the location and severity of the infection and based on patient characteristics such as renal function. The possibility of carrying out therapeutic drug monitoring (TDM) allows maintaining plasma levels adequate for the treatment of deep infections (e.g. \>20 mg/l for endocarditis) and avoiding overdose. Thanks to the possibility of administering teicoplanin on a three-weekly schedule, patient access to hospital is further reduced. The investigators therefore propose a retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme by comparing its use in the treatment of deep infections (deep seated infections - DSIs) and superficial infections (non-deep seated infections - NDSIs). ### Conditions Module **Conditions:** - Comparison of Teicoplanin Used Three Times a Week in DSIs vs NDISs ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Use of teicoplanin three times a week **Label:** patients with deep infections (deep seated infections - DSIs) #### Arm Group 2 **Intervention Names:** - Drug: Use of teicoplanin three times a week **Label:** patients with superficial infections (non deep seated infections - NDSIs). ### Interventions #### Intervention 1 **Arm Group Labels:** - patients with deep infections (deep seated infections - DSIs) - patients with superficial infections (non deep seated infections - NDSIs). **Description:** retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme comparing its use in the treatment of deep infections (deep seated infections - DSIs) and superficial infections (non-deep seated infections - NDSIs). **Name:** Use of teicoplanin three times a week **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Describe the clinical characteristics of patients and outcome (recovery vs therapeutic failure intended as death, need for modification of antibiotic therapy or recurrence of infection) of the study population. **Measure:** Describe the clinical characteristics and outcome of the study population. **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \>18 years; * Patients with documented Gram-positive infection sensitive to teicoplanin; * Patients who have received at least 4 doses of teicoplanin on a three-weekly schedule, as monotherapy or associated with other antibiotics Exclusion Criteria: * Hospitalized patients * Patients who have received less than 4 doses of teicoplanin for any cause. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The data of patients with deep seated infections - DSIs or non deep seated infections - NDSIs treated from January 2021 to October 2023 in the Manzoni hospital in Lecco will be collected from the medical records in order to record the clinical outcomes understood as clinical resolution vs therapeutic failure, change of therapy or recurrence of infection. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Stefania Piconi, MD **Phone:** +390341489890 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Silvia Pontiggia, MS **Phone:** +390341253678 **Role:** CONTACT #### Locations **Location 1:** **City:** Lecco **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stefania Piconi, MD - **Phone:** +390341489890 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Silvia Pontiggia, MS - **Phone:** +390341253678 - **Role:** CONTACT **Country:** Italy **Facility:** Stefania Piconi **Status:** RECRUITING **Zip:** 23900 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### 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: HIGH - As Found: Infectious Disease - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infectious Disease - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections ### 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: M19621 - Name: Teicoplanin - Relevance: HIGH - As Found: Soda - 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: D000017334 - Term: Teicoplanin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426199 **Acronym:** TMJ **Brief Title:** Chitosan-Hyaluronate Gel Mixture Vs Hyaluronic for Internal Derangement **Official Title:** Arthroscope-Guided Intra-Articular Injection of Chitosan-Hyaluronate Gel Mixture Versus Hyaluronic Acid in the Treatment of TMJ Internal Derangement: A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** 12345asdfg #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-17 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Misr International University **Class:** UNKNOWN **Name:** University of Nizwa #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is designed to assess the impact of injecting sodium hyaluronic acid versus a chitosan-hyaluronate hybrid gel into the upper compartment of the temporomandibular joint (TMJ) as a treatment for anterior disc displacement without reduction. The study will include patients diagnosed with Stage III or IV TMJ internal derangement (anterior disc displacement without reduction), as classified by Wilkes, with diagnoses confirmed through clinical symptoms and MRI evaluations. Participants will be randomly divided into two groups, both undergoing TMJ arthroscopy. In the first group, 2 ml of chitosan-hyaluronic acid hybrid gel will be injected into the affected joints, whereas in the second group, 2 ml of hyaluronic acid (HA) will be administered. The study will compare and analyze outcomes in both groups, focusing on pain during TMJ function, clicking sounds, the extent of maximum mouth opening, and maximum lateral jaw movement. **Detailed Description:** This study will be a prospective randomized controlled clinical study on a convenience sample of patients who will be selected from the Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine, Suez University. Patients selected are whom will be diagnosed with TMJ internal derangement (anterior disk displacement without reduction Stage III, Stage IV Wilkes classification) based on clinical symptoms and MRI evaluations. Inclusion criteria will be adults aged between 25 - 50 years old, sufficient clinical and magnetic resonance imaging (MRI) data that could be obtained before and after the treatment. The exclusion criteria will be hematological or neurological diseases, inflammation or connective tissue diseases, head and neck malignancies, history of treatment of TMJ disease or history of craniofacial surgery not related to internal derangement treatment, insufficient clinical and MRI data. Participants will be selected based on established criteria. A total sample size of 20 (10 in each group) was calculated to detect an effect size of about 1.33-1.34, with a power (1-β error) of 0.8 (80%) using a two-sided hypothesis test, with a significance level (α error) 0.05 for data \[13\]. All patients will undergo a preoperative clinical evaluation including Pain level on forced mouth opening using visual analogue scale (VAS), assessment of mean lateral jaw movements, assessment of TMJ clicking, assessment of maximum mouth opening (MMO), deviation of mandibular midline during mouth opening and closure. All patients will do a Magnetic resonance imaging (MRI) to evaluate the disc displacement.All patients will undergo conservative treatment as the first line of treatment in all TMJID cases. All patients will be under general anesthesia. For both groups, the operation will be under GA and The skin surface of the pre-auricular region will be disinfected with povidone iodine solution. For both groups, TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. In the first group, the injection of 2 ml of chitosan-hyaluronic acid hybrid gel into affected joints, while 2 ml of HA will be injected in to affected joints in the second group. Needles will be removed after the injection sites and covered its sites with gauze dressing. Postoperative care and instructions: 1. Medications: Brufen\* as a nonsteroidal anti-inflammatory drug (NSAIDs) relieving muscle pain and swelling. Myofen\* as a muscle relaxant especially for people who grind or clench their teeth help to relax tight jaw muscles. 2. Application hot \& cold packs: All patients will be instructed to apply an ice pack to the side of his face and temple area for about 10 minutes. Also, simple stretching exercises for his or her jaw should be done. Application a warm towel or pack to the side of his face for about 5 minutes five times daily for 4 days. 3. Soft diet: Soft food such as yogurt, mashed potatoes, cheese, soup, fish, cooked fruits and vegetables, beans, and grains should be eaten. In addition, food should be cut into small pieces. Avoid hard and crunchy foods like hard rolls, raw carrots, thick and large foods that need your mouth to open wide to fit the foods. Also, chewy sticky foods (like caramels and taffy) avoided too for next 10 days. ### Conditions Module **Conditions:** - TMJ Disc Disorder **Keywords:** - TMD - Hyaluronic acid - Chitosan - Arthroscopy - Intra Articular Injection - TMJ ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Arthroscope-guided intra-articular injection of Hyaluronic Acid in patients with TMJ anterior disc displacement without reduction. **Intervention Names:** - Drug: Hyaluronic Acid **Label:** Intra-Articular Injection of Hyaluronic Acid **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Arthroscope-guided intra-articular injection of chitosan-hyaluronate gel mixture in patients with TMJ anterior disc displacement without reduction **Intervention Names:** - Drug: Chitosan-Hyaluronate Gel Mixture **Label:** Intra-Articular Injection of chitosan-hyaluronate gel mixture **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intra-Articular Injection of chitosan-hyaluronate gel mixture **Description:** The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Chitosan-Hyaluronate Gel Mixture into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing. **Name:** Chitosan-Hyaluronate Gel Mixture **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Intra-Articular Injection of Hyaluronic Acid **Description:** The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Hyaluronic acid into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing. **Name:** Hyaluronic Acid **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Self-pain and function of the jaw assessment, with Visual Analogue Scale (VAS), ranging from 0 to 10 scales. This scale will be used for self-evaluation of the patients, to evaluate pain level and jaw dysfunction and compared with preoperative degree. Patients will be asked about the pain severity \& dysfunction according to the VAS. **Measure:** Joint Pain **Time Frame:** 3 months **Description:** Maximum lateral excursion, the distance from midline of upper \& lower jaw will be measured with a digital caliper in mm. **Measure:** lateral excursion **Time Frame:** 3 months **Description:** measured by asking the patients to open and closed his mouth several times and clicking was recorded as present (early clicking, late clicking) or absent. **Measure:** TMJ sounds **Time Frame:** 3 months **Description:** Maximum mouth opening (MMO), between upper \& lower incisors will be measured during maximum opening with a digital caliber in mm. **Measure:** Maximum mouth opening **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients were diagnosed with TMJ internal derangement (anterior disk displacement without reduction Stage III, Stage IV Wilkes classification) based on clinical symptoms and MRI evaluations. 2. Age 25 - 50 years old. Exclusion Criteria: 1. Hematological or neurological diseases. 2. Inflammation or connective tissue diseases. 3. Head and neck malignancies. 4. History of treatment of TMJ disease or history of craniofacial surgery not related to ID treatment. 5. Insufficient clinical and MRI data. **Maximum Age:** 50 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nehal IA Shobair, PhD **Phone:** 00201063666985 **Phone Ext:** 0 **Role:** CONTACT #### Locations **Location 1:** **City:** Suez **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mahmoud A Elfarmawy, PhD - **Phone:** 01001464971 - **Phone Ext:** 0 - **Role:** CONTACT ***Contact 2:*** - **Name:** Nehal I Shobair, PhD - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Mahmoud A Elfarmawy, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Mayson H Alkhatib, PhD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Ahmed AA Al-Saadi, Msc - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Mohammed A Al-Saadi, PhD - **Role:** SUB_INVESTIGATOR **Country:** Egypt **Facility:** Suez University **Status:** RECRUITING **Zip:** 41522 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000276 - Term: Adjuvants, Immunologic - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000055675 - Term: Viscosupplements - ID: D000020011 - Term: Protective Agents - 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: D000002614 - Term: Chelating Agents - ID: D000064449 - Term: Sequestering Agents - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Coag - Name: Coagulants - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: HIGH - As Found: Users - ID: M25928 - Name: Chitosan - Relevance: HIGH - As Found: Broad - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M28295 - Name: Viscosupplements - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - 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: M28883 - Name: Lipid Regulating Agents - Relevance: LOW - As Found: Unknown - ID: M5860 - Name: Chelating Agents - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown - ID: T377 - Name: Chitosan - Relevance: HIGH - As Found: Broad ### Intervention Browse Module - Meshes - ID: D000048271 - Term: Chitosan - ID: D000006820 - Term: Hyaluronic Acid ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426186 **Brief Title:** Effect of Right-stellate Ganglion Block in Preventing on Postoperative Nausea and Vomiting **Official Title:** Effect of Right-stellate Ganglion Block in Preventing Postoperative Nausea and Vomiting in Gynecological Laparoscopic Patients #### Organization Study ID Info **ID:** PONV-Gynecological surgery #### Organization **Class:** OTHER **Full Name:** The Second Affiliated Hospital of Chongqing Medical University ### Status Module #### Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-08 **Type:** ACTUAL **Status Verified Date:** 2023-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-14 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Second Affiliated Hospital of Chongqing Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Postoperative nausea and vomiting is one of the common postoperative complications. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk operations such as gynecological laparoscopy is higher. Postoperative nausea and vomiting can lead to perioperative complications and seriously affect the prognosis of patients. Although various preventive and therapeutic measures have been adopted in clinic, the incidence of perioperative nausea and vomiting is still high. Therefore, it is of great clinical significance to explore more effective and feasible methods to prevent the occurrence of PONV. Stellate ganglion block has been proved to be widely used in clinic and can play a positive role in multiple organs and systems of the whole body. In clinical work, stellate ganglion block is more widely used in the treatment of various pain, autonomic nerve disorders and other diseases. However, there are few clinical studies on whether stellate ganglion block can be used as an effective and feasible means to prevent postoperative nausea and vomiting and the related mechanisms to prevent the possible occurrence of nausea and vomiting. Therefore, this project aims to explore the preventive effect of stellate ganglion block on postoperative nausea and vomiting in gynecological laparoscopic surgery patients, and to explore its possible mechanism. **Detailed Description:** Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as gynecologic laparoscopy is higher. The pathogenesis of postoperative nausea and vomiting is very complex, including central, peripheral receptors and multiple nerve pathways. When peripheral receptors are stimulated, the signal passes through the afferent nerve to the vomiting center, causing nausea and vomiting. The emetic chemical receptors are rich in many receptors, which can directly feel various toxins, metabolites or drugs in the blood and cerebrospinal fluid, project signals to the nerve center and then spread to the cerebral cortex, causing nausea and vertigo, or transmit signals along the vagus nerve, glossopharyngeal nerve, spinal nerve, etc. to the digestive tract, diaphragm and abdominal wall muscles, resulting in the opening of the sphincter in the upper esophagus and strong contraction of the diaphragm. Abdominal muscles contract, so that the stomach pressure increases, stomach contents through the digestive tract is expelled from the body, vomiting. There are many factors affecting postoperative nausea and vomiting in gynecological laparoscopic surgery, including patient factors, anesthetic factors and surgical factors. Firstly, gender as an independent risk factor for postoperative nausea and vomiting is widely recognized by researchers, and a large number of studies have confirmed that the incidence of postoperative nausea and vomiting is higher in females, and the possible mechanism is caused by different hormone levels. Secondly, some studies believe that the type of surgery is also a risk factor for postoperative nausea and vomiting, but there is some controversy. In general, laparoscopic surgery patients have a higher incidence of postoperative nausea and vomiting. Finally, the mode of anesthesia and anesthesia-related drugs are also one of the risk factors affecting PONV. Compared with other anesthesia methods, the incidence of PONV was increased under general anesthesia, and the combination of intravenous anesthesia and intraoperative opioid application also increased the incidence of postoperative nausea and vomiting. Stellate ganglion block has been proved to be widely used in clinic and can play a positive role in multiple organs and systems of the whole body. In clinical work, stellate ganglion block is more widely used in the treatment of various pain, autonomic nerve disorders and other diseases. However, there are few clinical studies on whether stellate ganglion block can be used as an effective and feasible means to prevent postoperative nausea and vomiting and the related mechanisms to prevent the possible occurrence of nausea and vomiting. Therefore, this study will explore the preventive effect of stellate ganglion block on postoperative nausea and vomiting in gynecological laparoscopic patients, and hope to explore its possible mechanism, so as to provide more effective and feasible methods for clinical prevention of postoperative nausea and vomiting and improve patients' medical comfort and satisfaction. ### Conditions Module **Conditions:** - Postoperative Nausea and Vomiting ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Right-stellate ganglion block was given 30 minutes before anesthesia induction **Intervention Names:** - Procedure: Right-stellate ganglion block **Label:** Right-stellate ganglion block **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No treatment was given 30 minutes before anesthesia induction **Label:** Blank control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Right-stellate ganglion block **Description:** The experimental group was given right stellate ganglion block 30 minutes before anesthesia **Name:** Right-stellate ganglion block **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Postoperative nausea and vomiting is evaluated by follow-up **Measure:** The incidence of postoperative nausea and vomiting **Time Frame:** From end of surgery to 24 hours after surgery #### Secondary Outcomes **Description:** Postoperative nausea and vomiting is evaluated by investigator's follow-up **Measure:** Incidence of nausea and vomiting during preemptive analgesia **Time Frame:** From 0-10 min after preemptive analgesia **Description:** ntensity of nausea and vomiting (the scale is Rhodes index of nausea and vomiting)is evaluated by numerical rating scale (0-10), which higher socre represents more severe the nausea and vomiting **Measure:** Intensity of nausea and vomiting during preemptive analgesia **Time Frame:** From 0-10 min after preemptive analgesia **Description:** Intensity of nausea and vomiting is evaluated by numeric rating scale (0-10), which higher socre represents more uncomfortable **Measure:** Intensity of nausea and vomiting during hospitalization **Time Frame:** From end of surgery to 24 hours after surgery **Description:** Mean arterial pressure in mmHg,heart rate in bpm,oxygen saturation（%） **Measure:** Hemodynamic parameters **Time Frame:** Before stellate ganglion block and From 0-30 min after Satellite Ganglion Blocks **Description:** Postoperative pain intensity is assessed by numeric rating scale (0-10), which higher socre represents more uncomfortable **Measure:** Postoperative pain intensity **Time Frame:** From end of surgery to 24 hours after surgery **Description:** Gastrointestinal function is is assessed by the evacuation time **Measure:** Recovery of gastrointestinal function **Time Frame:** From end of surgery to 24 hours after surgery **Description:** Sleep quality is is assessed by numeric rating scale (0-10), which higher socre represents better sleep quality **Measure:** Sleep quality **Time Frame:** From end of surgery to 1 day after surgery **Description:** Satisfaction score and postoperative analgesia satisfaction score is assessed by numeric rating scale (0-10), which higher socre represents more comfortable **Measure:** Satisfaction score and postoperative analgesia satisfaction score **Time Frame:** From end of surgery to hospital discharge with about 5 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥18 years and ≤ 70 years 2. American Society of Anesthesiologists(ASA) physical status classification I-Ill. 3. Voluntary participation and ability to understand and sign the informed consent form 4. Patients undergoing gynecological laparoscopic surgery elective general anesthesia Exclusion Criteria: 1. Patients with obesity(BMI\>30kg/m2) 2. Contraindicated to stellate ganglion block 3. Patients who cannot cooperate with the study for any reason,or whom the investigator deems unsuitable for inclusion in this trial. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ling Dan, BD **Phone:** 13983072922 **Phone Ext:** 86 **Role:** CONTACT #### Locations **Location 1:** **City:** Chongqing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ling Dan, BD - **Phone:** 86 13983072922 - **Role:** CONTACT **Country:** China **Facility:** The Second Affiliated Hospital of Chongqing Medical University **State:** Chongqing **Status:** RECRUITING **Zip:** 400000 #### Overall Officials **Official 1:** **Affiliation:** The Second Affilated Hospital of Chongqing Medical University **Name:** ling Dan, BD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** all IPD that underlie results in a publication **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M12273 - Name: Nausea - Relevance: HIGH - As Found: Nausea - ID: M17582 - Name: Vomiting - Relevance: HIGH - As Found: Vomiting - ID: M22074 - Name: Postoperative Nausea and Vomiting - Relevance: HIGH - As Found: Postoperative Nausea and Vomiting - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009325 - Term: Nausea - ID: D000014839 - Term: Vomiting - ID: D000020250 - Term: Postoperative Nausea and Vomiting ### 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: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426173 **Brief Title:** Effect of Resistance Training in Patients on the Waiting List for Heart Transplant **Official Title:** Effect of Resistance Training on Functional Capacity, Quality of Life and Cardiac Biomarkers in Patients on the Waiting List for Heart Transplant: a Randomized and Controlled Clinical Trial #### Organization Study ID Info **ID:** CAAE: 77806024.4.0000.0068 #### Organization **Class:** OTHER **Full Name:** University of Sao Paulo General Hospital ### Status Module #### Completion Date **Date:** 2026-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Conselho Nacional de Desenvolvimento Científico e Tecnológico #### Lead Sponsor **Class:** OTHER **Name:** University of Sao Paulo General Hospital #### Responsible Party **Investigator Affiliation:** University of Sao Paulo General Hospital **Investigator Full Name:** Rafael M. Ianotti, PT **Investigator Title:** Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor) **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 longitudinal, randomized, and blinded clinical trial aims to: * Evaluate the effects of resistance training on the functional capacity, quality of life, and cardiac biomarkers of hospitalized patients with heart failure (HF) on the waiting list for heart transplantation (HTx). * Evaluate the associations between Fried's frailty classification and functional capacity responses to resistance training. The protocol will have a total duration of 12 weeks. **Detailed Description:** Heart failure (HF) presents a significant challenge to contemporary healthcare systems. As HF progresses, heart transplantation (HTx) becomes the primary treatment option to enhance survival rates. Patients awaiting HTx often endure extended hospitalizations and rely on continuous inotropic support. This scenario exacerbates bed rest and potentially worsening functional capacity. Resistance training has shown promise in mitigating the detrimental effects of immobility, however, limited research has explored its impact on HF patients on the HTx waiting list. Objectives: * To evaluate the effects of resistance training on functional capacity, quality of life, and cardiac biomarkers in hospitalized patients with HF on the HTx waiting list. * To assess the associations between Fried's frailty phenotype and functional capacity responses to resistance training, hemodynamic behavior during the protocol, and the incidence of adverse events during the protocol implementation. Methods: A total of 50 patients hospitalized on the HTx waiting list will be recruited for this study. Participants will be randomly assigned to one of two groups: the resistance training group (TG) and the control group (CG). Assessments will occur at three time points: baseline (T0), at 6 weeks (T1), and at 12 weeks (T2) of resistance training. Clinical parameters will be evaluated, including the six-minute walk test and the Short Physical Performance Battery. Peripheral muscle strength will be measured using a dynamometer, and inspiratory muscle strength will be assessed through maximum inspiratory pressure. Quality of life will be evaluated using the Kansas City Cardiomyopathy Questionnaire-12. Additionally, cardiac biomarkers, such as exhaled air ketone and brain natriuretic peptide levels in venous blood samples, will be analyzed. ### Conditions Module **Conditions:** - Heart Failure - Heart Transplant **Keywords:** - heart failure - resistance training - cardiac rehabilitation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized controlled trial ##### Masking Info **Masking:** SINGLE **Masking Description:** The researcher responsible for conducting the functional assessment will be blinded to the randomization and allocation groups. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive the standard treatment provided by the hospital inpatient unit alongside the resistance training program. **Intervention Names:** - Other: Resistance Training Program - Other: Standard Treatment Group **Label:** Resistance Training Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will receive the standard treatment provided by the hospital inpatient unit. **Intervention Names:** - Other: Standard Treatment Group **Label:** Standard Treatment Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Resistance Training Group **Description:** The resistance training program will be individualized and divided into four stages of increasing complexity. It will be conducted for approximately 40 minutes per day, three times a week, for 12 weeks, under supervision. Each patient will begin the program at the stage corresponding to their functional capacity. The resistance load will be set at 50% of the maximum resistance (1RM) obtained in the initial assessment. Throughout all stages of the exercise program, the target intensity will range from light (≤ 12) to moderate (≤ 15) on the Borg scale. **Name:** Resistance Training Program **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Resistance Training Group - Standard Treatment Group **Description:** Patients will receive the standard treatment provided by the hospital inpatient unit, which includes guidance on reducing sedentary time, encouragement to walk, and performance of active and breathing exercises when necessary. **Name:** Standard Treatment Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible. **Measure:** To investigate changes in physical performance measured by Six-Minute Walk Test. **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** The SPPB consists of three additional tests assessing balance, mobility, and strength. Each test is scored from 0 (indicating a worse outcome) to 4 (indicating a better outcome) points. At the completion of all tests, the total score ranges from 0 to 12 points. **Measure:** To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB). **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Maximum inspiratory pressure (measured in cmH2O) **Measure:** To investigate changes in respiratory muscle strength: **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Handgrip test (measured in KgF) **Measure:** To investigate changes in peripheral muscle strength. **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Kansas City Cardiomyopathy Questionnaire-Short Version. The total score ranges from 0 (indicating a worse outcome) to 100 (indicating a better outcome) points. **Measure:** To investigate changes in quality of life: **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Ketones in exhaled air (measured in μg/L) **Measure:** Enhancing the investigation of changes in cardiac biomarker ketones **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Brain natriuretic peptide in venous blood sample (picogram per milliliter, pg/ml) **Measure:** Enhancing the investigation of changes in cardiac biomarker brain natriuretic peptide **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). #### Secondary Outcomes **Description:** The Fried's frailty phenotype scale ranges from 0 to 5 points, where: 0 points denote non-frailty, up to 2 points denote pre-frailty, and ≥3 points denote frailty **Measure:** To investigate changes Fried's frailty phenotype **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Measure:** To investigate changes in heart rate( bpm) **Time Frame:** Immediately before and after each session exercise training.(3 times per week, during 12 weeks) **Measure:** To investigate changes in blood pressure (mmHg) **Time Frame:** Immediately before and after each session exercise training (3 times per week, during 12 weeks) **Description:** Borg Rating of Perceived Exertion (0-lower, up to 10- highest) **Measure:** To investigate changes in perceived exertion sensation: **Time Frame:** Immediately before and after each session exercise training.(3 times per week, during 12 weeks) **Description:** Hemodynamic instability ( MAP \< 60 mmHg or \>120 mmHg) **Measure:** To investigate the occurrence of adverse events:Hemodynamic instability **Time Frame:** In each intervention period (3 days a week for 12 weeks) **Description:** Heart rate ( HR \< 50 bpm or \> 120 bpm). **Measure:** To investigate the occurrence of adverse events:Arrhythmia **Time Frame:** In each intervention period (3 times per week for 12 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients included in heart transplant list ≤1 month * hemodynamically stable in the last 48 hours defined as mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg and - Heart rate (HR) ≥ 60 bpm and ≤ 120 mmHg. * dobutamine dose ≤ 10 mcg/kg/min Exclusion Criteria: * heart failure of arrhythmogenic and/or restrictive etiology * presence of uncontrolled acute arrhythmias * cognitive, orthopedic, or neuromotor changes that prevent functional tests from being carried out **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Juliana A Nascimento, PT, PhD **Phone:** +55 11 30618529 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rafael M Ianotti, PT **Phone:** +55 11 26615319 **Role:** CONTACT #### Locations **Location 1:** **City:** Sao Paulo **Country:** Brazil **Facility:** Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo **Zip:** 05403-000 #### Overall Officials **Official 1:** **Affiliation:** University of Sao Paulo **Name:** Juliana A Nascimento, PT, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo **Name:** Rafael M Ianotti, PT **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426160 **Acronym:** TOPAC **Brief Title:** Tocilizumab for Painful Chronic Pancreatitis **Official Title:** Tocilizumab for Painful Chronic Pancreatitis: A Randomised, Placebo-Controlled, Double-blinded, Investigator Initiated Trial (TOPAC Trial) #### Organization Study ID Info **ID:** F2024-054 #### Organization **Class:** OTHER **Full Name:** Aalborg University Hospital #### Secondary ID Infos **ID:** 2023-510084-35-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Aarhus University Hospital **Class:** OTHER **Name:** University of Aarhus **Class:** OTHER **Name:** Viborg Regional Hospital **Class:** OTHER **Name:** Stanford University **Class:** OTHER **Name:** Haukeland University Hospital #### Lead Sponsor **Class:** OTHER **Name:** Soren Schou Olesen #### Responsible Party **Investigator Affiliation:** Aalborg University Hospital **Investigator Full Name:** Soren Schou Olesen **Investigator Title:** Professor, MD, Ph.D. **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:** This placebo-controlled study will investigate the effect of tocilizumab (an anti-interleukin-6 receptor antibody) on symptom burden, physical functioning, and quality of life in patients with chronic pancreatitis. **Detailed Description:** Recent independent research has emphasized the crucial role of immune cell infiltration and its interaction with pancreatic stellate cells in driving the inflammatory process and fibrogenesis in chronic pancreatitis (CP). The cytokine Interleukin 6 (IL-6) has been identified as a key mediator in this process, and preclinical studies have indicated that inhibiting IL-6 signaling can lead to favorable therapeutic outcomes. Consequently, targeting IL-6 signaling therapeutically holds great promise as a disease-modifying treatment for CP. Until now, there have been no placebo-controlled trials in humans to test immune-modulating treatments for CP. However, there have been some promising results in preclinical studies. For example, administering an anti-IL-6 receptor antibody to an animal model of CP reduced pancreatitis-related pain, indicating a potential therapeutic effect. Blocking IL-6 signaling in an in-silico model of CP was also shown to have disease-modifying effects. Recent anecdotal evidence indicates that using tocilizumab to treat patients with COVID-19 and concomitant pancreatitis can decrease inflammation and pain in the pancreas. Additionally, blocking IL-6 signaling has been demonstrated to have anti-fibrotic effects in patients with systemic sclerosis. Taken together, these findings suggest that targeting IL-6 signaling could be a promising approach for reducing inflammation and fibrogenesis in CP. Tocilizumab (RoActemra) is an anti-IL-6 receptor antibody currently used to treat several inflammatory diseases. Objectives: The investigators hypothesize that treatment with tocilizumab, compared with a placebo, will reduce symptom burden (CP-related pain) and improve physical functioning and quality of life in patients with CP. In addition, the investigators hypothesize that the clinical effects will be linked to a decrease in pancreatic inflammation and fibrosis as well as systemic inflammation. The investigators also hypothesize that the pain-relieving effect of tocilizumab will lead to the normalization of pain processing in CP patients. To test these hypotheses, the project is organized into four sub-studies. Sub-study 1 (main study - randomized placebo-controlled trial): The objective of sub-study 1 is to conduct an investigator-initiated phase 2b double-blinded, placebo-controlled, randomized clinical trial to investigate the clinical effect of tocilizumab on patient-reported outcomes. Sub-study 2 (inflammatory biomarkers): The objective of sub-study 2 is to investigate the effects of tocilizumab on systemic inflammation using blood-based immune and fibrosis markers. Sub-study 3 (quantitative imaging biomarkers): The objective of sub-study 3 is to investigate the effect of tocilizumab on pancreatic inflammation and fibrosis using Magnetic Resonance Imaging (MRI) of the pancreas. Sub-study 4 (pain processing): The objective of sub-study 4 is to investigate the effect of tocilizumab on pain processing using Pancreatic Quantitative Sensory Testing (P-QST) and electrophysiological methods (EEG and ECG). ### Conditions Module **Conditions:** - Pancreatitis, Chronic **Keywords:** - Inflammation - Pancreatic diseases - Digestive System Diseases ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomised, placebo-controlled, double-blinded investigator-initiated trial ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 8 mg / kg Tocilizumab will be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %) **Intervention Names:** - Drug: Tocilizumab 20 MG/ML [Actemra] **Label:** Tocilizumab **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 100 ml sodium chloride 9 mg/mL (0.9 %). **Intervention Names:** - Drug: Sodium Chloride 0.9% Inj **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Tocilizumab **Description:** Tocilizumab 8 mg/kg every four weeks for 24 weeks. **Name:** Tocilizumab 20 MG/ML [Actemra] **Other Names:** - RoActemra - Actemra **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo (Sodium chloride) every four weeks for 24 weeks. **Name:** Sodium Chloride 0.9% Inj **Other Names:** - Natriumchloride 0.9 % Inj **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** The investigators plan to use an O-link multiplex platform to examine changes in soluble inflammatory biomarker levels, including several cytokines and chemokines. **Measure:** Levels of soluble inflammation biomarker **Time Frame:** The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24) **Description:** The investigators plan to use an O-link multiplex platform to examine changes in soluble fibrosis biomarker levels, from baseline at 24 weeks. **Measure:** Levels of soluble fibrosis biomarker **Time Frame:** The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24) **Description:** Macrophage activation biomarkers will be analyzed using enzyme-linked immunosorbent assays (ELISAs) levels, from baseline at 24 weeks. **Measure:** Levels of soluble Biomarker of Macrophage Activation **Time Frame:** The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24) **Description:** For the key inflammatory mediator, found in above mentioned analysis, the investigators will confirm the analyses using ELISAs levels from baseline at 24 weeks. **Measure:** Levels of key Inflammatory Mediator **Time Frame:** The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24) **Description:** The between and within-group difference of diffusion-weighted imaging for inflammation using multiparametric pancreatic MRI at baseline and after 24 weeks. **Measure:** Pancreatic inflammation (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The between and within-group difference of fibrosis detection using T1 mapping multiparametric pancreatic MRI parameters at baseline and after 24 weeks. **Measure:** Pancreatic fibrosis (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The between and within-group difference of conventional anatomic imaging using multiparametric pancreatic MRI at baseline and after 24 weeks. **Measure:** Pancreatic morphology (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The between and within-group difference of pancreatic duct morphology using Magnetic resonance cholangiopancreatography (MRCP) at baseline and after 24 weeks. **Measure:** Pancreatic duct morphology (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The between and within-group difference of biliary duct morphology using MRCP at baseline and after 24 weeks. **Measure:** Biliary duct morphology (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The pancreatic quantitative sensory testing (P-QST) is used to characterize pain processing and comprises different experimental pain stimuli: PinPrick test: A pinprick stimulator 256 mN (MRC Systems GmbH, Germany) will be used to perform the pinprick test. The patient is asked to rate the pain sensitisation using the VAS score after a single pinprick stimulus and after ten repetitive stimuli (applied with an interstimulus interval of 1 second). Two test areas are assessed: the dominant forearm and the anterior TH10 dermatome. The score is reported on a VAS score from 0 to 10. Higher scores indicate higher pain tolerance. **Measure:** P-QST: PinPrick (Temporal summation) **Time Frame:** The intervention period is 24 weeks (performed at weeks 0 and 24) **Description:** The P-QST is used to characterize pain processing and comprises different experimental pain stimuli: Pain pressure test: Pressure algometry is performed with a handheld pressure algometer (Type2, Somedic production AB, Sweden) and performed in four dermatomes and five locations: C5 (the clavicle), TH10 (the back and abdomen), L1 (the anterior superior iliac spine), and L4 (straight thigh). The probe has a surface area of 1cm2. Pressure will be increased at a rate of 30 kPa/sec until prespecified thresholds (i.e., pain detection threshold (PDT) and pain tolerance threshold (PTT)) are reached. The assessment parameters are the imposed pressure (kPa) at the PDT and PTT. **Measure:** P-QST: Pain Pressure thresholds **Time Frame:** The intervention period is 24 weeks (performed at weeks 0 and 24) **Description:** The P-QST is used to characterize pain processing and comprises different experimental pain stimuli: Cold pressor test: The patient's hand is immersed in cold water (approximately two degrees Celsius) for 120 seconds. At 40, 80, and 120 seconds, the patient is asked to rate the pain sensation using a VAS score. If the patient cannot keep their hand in the water for 120 seconds, the duration is noted, and the VAS score at the time they withdraw their hand is used as the maximum score. The assessment parameters are the cold pressor endurance time (seconds) and the evoked pain responses on a visual analog scale (VAS) score, 0 = no pain and 10 = worst pain imaginable. Lower values indicate higher pain tolerance. **Measure:** P-QST: Cold Pressor **Time Frame:** The intervention period is 24 weeks (performed at weeks 0 and 24) **Description:** The P-QST is used to characterize pain processing and comprises different experimental pain stimuli: Conditioned pain modulation test is conducted using a pain pressure algometer, and the PTT is assessed at 15 cm above the patella in the L4 dermatome on the nondominant side before and after the cold pressor test is performed. The imposed pain pressure tolerance threshold is reported as kPa, with a minimum of 0, and no upper limit. Higher scores indicate higher pain tolerance. **Measure:** P-QST: Conditioned Pain Threshold **Time Frame:** The intervention period is 24 weeks (performed at weeks 0 and 24) **Description:** While performing the P-QST, the investigators measure EEG and ECG before and after the cold pressor test. A standard EEG electrode Cap Kit (EEG Electrode Cap Kit - OpenBCI Online Store) with ten electrodes is employed for these measurements.The Texas Instrument ADS1299 biopotential measurements system will be used for EEG and ECG recordings. This system is already being used in mobile brain-computer interfaces, and its signals are comparable to those of standard systems that can work in hospital settings. The EEG signals are transmitted wirelessly to an Android mobile telephone and stored for further processing. The results will be used to model connectivity between brain centres as well as the dominating centres of the brain. EEG power will be assessed in the Delta, Theta, Alpha, Beta, and Gamma bands between 1 and 70 Hertz. Finally, inverse modelling will be conducted to explore the dominating centres of brain activity. **Measure:** Electroencephalography (EEG) analysis **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0 and 24) **Description:** Four conventional ECG electrodes (Neurolink 700) is employed for these measurements. The ECG signals are transmitted wirelessly to an Android mobile telephone and stored for further processing. Frequency domains of heart variablity will be assessed using ECG,this involve Fast Fourier transformation of the Blackman Harris window included very low frequency (VLF), low frequency (LF), high frequency (HF), total power (TP), and the ratios LF/HF. **Measure:** Electrocardiographic (ECG) frequency domain **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0 and 24) **Description:** Four conventional ECG electrodes (Neurolink 700) is employed for these measurements. The ECG signals are transmitted wirelessly to an Android mobile telephone and stored for further processing. Time domains of heart variablity will be assessed using ECG, this involve determining the mean RR interval, standard deviation of RR interval, heartbeat rate (HR), and root mean squared difference of successive normal RR intervals (RMSSD). **Measure:** ECG time domain **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0 and 24) #### Primary Outcomes **Description:** The between-group difference (tocilizumab vs. placebo) of the change from baseline in the COMPAT-SF score at 24 weeks. The COMPAT-SF score is noramlized on a 0-100 score. Higher scores indicate a higher degree of pain. **Measure:** The Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Questionnaire **Time Frame:** The intervention period is 24 weeks (assessed every 4 weeks from baseline to finalization) #### Secondary Outcomes **Description:** The between-group difference in the Global Quality of Life Score from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ-C30) questionnaire at 24 weeks. The global quality of life score range from 0 to 100. A high score on the Global Quality of Life score represents a high level of life quality. **Measure:** Global Quality of Life Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Physical Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The physical functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning. **Measure:** Physical Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Role Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The role functional score ranges from 0 to 100 A high score on the functional scales represents a high level of daily functioning. **Measure:** Role Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Cognitive Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The cognitive functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning. **Measure:** Cognitive Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Emotional Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The emotional functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning. **Measure:** Emotional Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Social Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The social functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning. **Measure:** Social Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Symptom Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The symptom burden score ranges from 0 to 100. A high score for the symptom items represents a high level of symptomatology. **Measure:** Symptom Burden Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Pain severity score from baseline in the modified Brief Pain Inventory at 24 weeks. The pain severity score is rated on a visual analogue scale (VAS), 0 = no pain, 10 = worst pain imaginable), based on four pain severity items. Higher scores reflect more severe pain. **Measure:** Pain severity Score (modified BPI) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Pain Interference score from baseline in the modified Brief Pain Inventory at 24 weeks. The pain interference score is rated on a VAS, 0 = no pain, 10 = worst pain imaginable, based on seven pain interference items. Higher scores reflect more pain interference with daily life. **Measure:** Pain Interference Score (modified BPI) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Average Daily Pain score from baseline in the modified Brief Pain Inventory at 24 weeks. The average daily pain score ranges is rated on a VAS-scale, 0-10, 0 = no pain, and 10 = worst pain imaginable. **Measure:** Average Daily Pain Score (modified BPI) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in the PGIC questionnaire, a self-reporting seven-point rating scale (points from 1-7) on how the participant experiences treatment change from baseline at 24 weeks. Higher score corresponds to improvement. **Measure:** Patient's Global Impression of Change (PGIC) Questionnaire **Time Frame:** The intervention period is 24 weeks (assessed at week 24) **Description:** The between-group difference in the CP prognosis score from baseline at 24 weeks. The CP prognosis score ranges from 5-15 points. Higher scores indicates higher risk of readmission to hospital. **Measure:** CP Prognosis Score **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0 and 24) **Description:** Opioid use (yes, no, binary answer) continuously through the entire study **Measure:** Number of patient using prescription opioids for pain control **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) **Description:** The between and within-group difference of opioid dose (continuous variable in mg of moprhine equivalent) in patients, from baseline at 24 weeks. **Measure:** Daily opioid dose for patients using prescription opiods **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) **Description:** Weak analgesic use (yes, no, binary answer) continuously through the entire study **Measure:** Number of patient using weak analgesics for pain control **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) **Description:** The between and within-group difference of weak analgesic dose (continuous variable in mg) in patients, from baseline at 24 weeks. **Measure:** Daily weak analgesics dose for patients **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) **Description:** The frequency of adverse events from baseline at 24 weeks. **Measure:** Frequency of adverse events (Patient Diary) **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signed informed consent. * Probable or definitive diagnosis of CP according to the M-ANNHEIM criteria. This entails a typical clinical history of CP, including recurrent pancreatitis or abdominal pain in combination with the following additional criteria: * A definitive diagnosis of CP is established by one or more of the following additional criteria: * i) Pancreatic calcification * ii) Moderate or marked ductal lesions (according to the Cambridge classification) * iii) Exocrine pancreatic insufficiency, defined as pancreatic steatorrhea markedly reduced by enzyme supplementation * iv) Histological verification of CP * A probable diagnosis of CP is established by one or more of the following additional criteria: * i) Mild ductal alterations (according to the Cambridge classification) * ii) Recurrent or persistent pseudocysts * iii) Pathological test of pancreatic exocrine function (such as faecal elastase-1 test, secretin test, secretin-pancreozymin test) * iv) Diabetes mellitus * Abdominal pain of presumed pancreatic origin (i.e., upper abdominal pain radiating to the back). * Evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months. An inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following criteria: * i) Plasma amylase levels elevated 2-fold or more than the participant's usual amylase level. * ii) Elevated plasma levels of CRP 2-fold the upper normal level without suspicion of other sources such as infection. * iii) Signs of pancreatic inflammation on cross-sectional imaging. * ≥ 18 years of age * The participant must be able to read and understand the informed consent forms. * The participant is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures. Exclusion Criteria: * End-stage CP indicated by severe pancreatic atrophy defined as segmented pancreas volume \<20 ml on the latest available cross-sectional imaging examination (Computed Tomography (CT) or MRI). * Pancreatic duct obstruction by a stricture and/or stone amendable to endoscopic or surgical treatment. Patients with previous pancreatic duct decompression procedures are allowed to participate. * Ongoing alcohol or substance abuse. The patient must document abstinence from alcohol and substance abuse for the preceding six months prior to study enrolment. Recreational alcohol consumption within the safety limits recommended by the National Danish Health Authorities (i.e., max. ten units of alcohol per week) is allowed. * Active or recurrent infections. * Untreated ulcers in the gastrointestinal tract (however, those who have undergone proper treatment and one month has elapsed with no recurrence of symptoms will not be excluded). * Known hypersensitivity to Tocilizumab. * Positive test for Tuberculosis during screening * Positive test for Hepatitis during screening * Severe liver disease, indicated by ALT with \>5 upper normal limits. * Thrombocytopenia (platelet count \< 50 x 109/L). * Neutropenia (neutrophil count \<2 x 109/L). * Pregnancy and no contraception use, fertile women (\<55 years) must provide a urine sample for pregnancy test upon inclusion. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rasmus Hagn-Meincke, MD **Phone:** 004597663520 **Role:** CONTACT #### Locations **Location 1:** **City:** Aalborg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rasmus Hagn-Meincke, MD - **Phone:** 004597663520 - **Role:** CONTACT **Country:** Denmark **Facility:** Centre for Pancreatic Diseases and Mech-Sense research laboratory, Aalborg University Hospital **State:** Nordjylland **Zip:** 9000 #### Overall Officials **Official 1:** **Affiliation:** Mech-Sense, Department of Gastroenterology, Aalborg University Hospital **Name:** Søren S Olesen, MD, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Access to the data is available upon reasonable request. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000002908 - Term: Chronic Disease - 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 - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M13115 - Name: Pancreatitis - Relevance: HIGH - As Found: Pancreatitis - ID: M26260 - Name: Pancreatitis, Chronic - Relevance: HIGH - As Found: Pancreatitis, Chronic - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010195 - Term: Pancreatitis - ID: D000050500 - Term: Pancreatitis, Chronic ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426147 **Brief Title:** L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients) **Official Title:** A Randomised, Double-blind, Placebo-controlled Trial of L-Citrulline Oral Supplementation to Improve Short and Long-term Outcomes of Admitted Febrile Paediatric Patients With Biomarker-determined High-risk of Adverse Outcomes #### Organization Study ID Info **ID:** EChiLiBRiST CT2 #### Organization **Class:** OTHER **Full Name:** Barcelona Institute for Global Health ### Status Module #### Completion Date **Date:** 2027-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-01-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Barcelona Institute for Global Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** In low and middle-income countries, children admitted to hospital are not similarly ill, and do not all have a comparable prognosis. In fact, understanding at first encounter their risk of developing adverse outcomes (including mortality) could allow a more focused management and the tailoring of specific interventions to decrease in hospital mortality, and post discharge adverse longer-term outcomes. This clinical trial, part of the EChiLiBRiST larger project ("Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival") has the two-fold objective of: 1. Assessing whether a POINT-OF-CARE rapid triaging test (PoC RTT) based on the quantitative measurement at the bedside of the "prognostic" biomarker sTREM-1 (soluble-triggering receptor expressed on myeloid cells 1) can reliably identify those admitted children with a higher risk of adverse outcomes; and 2. Assessing whether the therapeutic intervention (the L-arginine precursor, L-Citrulline, key in the nitric oxide biosynthesis), administered orally for 28 days to those children aged 1-\<60 months identified as "moderate-to-high risk" by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo. This second objective will be assessed in a prospective multi-country, multi-site, individually randomised, two-arm, placebo-controlled, double blind clinical trial involving \~888 children 1-\<60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels. The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo (200-300mg/kg/day depending on weight-band; for 28 days) in reducing adverse outcomes in children with severe disease. The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia. **Detailed Description:** Children admitted to hospital and meeting the study eligibility criteria who are 0-\<60 months of age will be eligible for study inclusion, and for initial biomarker screening using the study-designed rapid triaging PoC test, based on the measurement of sTREM-1. Study participants aged 1m-\<5 years of age with sTREM-1 values classified as moderate (i.e., "yellow") or high-risk (i.e., "red") in the traffic light risk-stratification system will be randomly allocated (1:1) to receive L-Cit intervention or placebo. All study participants will be followed for 6 months, with study visits at the study hospitals or at home or via phone communication after discharge at day 3, day 5, day 7, day 28, and month 6. The study primary outcome will be "adverse disease outcome", defined as a composite of mortality, incident neurological sequelae, major adverse kidney event at discharge, need for organ support, clinical shock, coma, severe respiratory distress or need for readmission within 28 days after recruitment. ### Conditions Module **Conditions:** - Infectious Disease - Infections - Child, Only ### 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:** 2200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1 or 2 sachets every 12 hours (200-300mg/kg/day depending on weight-band) for 28 days **Intervention Names:** - Dietary Supplement: L-citrulline **Label:** L-citrulline **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 1 or 2 sachets every 12 hours (depending on weight-band) for 28 days **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - L-citrulline **Description:** 1 or 2 sachets every 12 hours (200-300mg/kg/day depending on weight-band) for 28 days **Name:** L-citrulline **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** 1 or 2 sachets every 12 hours (depending on weight-band) for 28 days **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** Concentration of circulating mediators of host immune and endothelial function, inflammation, intestinal barrier function, and neuronal damage at baseline, D3 and D7 **Measure:** Concentration of circulating mediators of host immune and endothelial function, inflammation, intestinal barrier function, and neuronal damage **Time Frame:** Up to day 7 **Description:** Levels of lactate at baseline and D3 **Measure:** Lactate levels **Time Frame:** Up to day 3 **Description:** Levels of markers of kidney function (creatinine, urea, saliva urea nitrogen (SUN), uNGAL etc.) at baseline, D3, D7 and at discharge **Measure:** Levels of markers of kidney function **Time Frame:** Up to day 7 **Description:** Prognostic performance of PoC-RTT measured sTREM-1 values at baseline among children (0-\<60 months of age) with adverse outcomes up to D28. **Measure:** PoC-RTT prognostic performance **Time Frame:** Up to day 28 **Description:** Prognostic performance of a larger panel of prognostic biomarkers (circulating markers of endothelial function, inflammation, intestinal barrier function, and neuronal damage) at baseline. **Measure:** Prognostic performance of a larger panel of biomarkers **Time Frame:** At baseline #### Primary Outcomes **Description:** Proportion of participants with "adverse disease outcome" defined as a composite of (i.e., the occurrence between D0 and D28 after recruitment of at least one -or more- of the following adverse outcomes): * Mortality * Incident neurological sequelae * Major adverse kidney event at discharge (MAKE-DC, defined as a severe AKI event between 2-7 days or a discharge eGFR\<60mL/min per 1.73m2) * Need for organ support * Clinical shock * Coma * Severe respiratory distress * Need for readmission within the first 28 days post-recruitment (after having been discharged) **Measure:** Adverse disease outcome **Time Frame:** Up to day 28 #### Secondary Outcomes **Description:** Proportion of participants with mortality between day 0 and day 28 after recruitment and/or up to hospital discharge. **Measure:** Mortality **Time Frame:** Up to day 28 **Description:** Proportion of participants with incident neurological sequelae between day 0 and day 28 after recruitment and/or up to hospital discharge. **Measure:** Incident neurological sequelae **Time Frame:** Up to day 28 **Description:** Proportion of participants with major adverse kidney event at discharge (MAKE-DC, defined as a severe AKI event between 2-7 days or a discharge eGFR\<60mL/min per 1.73m2) **Measure:** Major adverse kidney event **Time Frame:** Up to day 28 **Description:** Proportion of participants with need for organ support **Measure:** Need for organ support **Time Frame:** Up to day 28 **Description:** Proportion of participants with clinical shock **Measure:** Clinical shock **Time Frame:** Up to day 28 **Description:** Proportion of participants with severe respiratory distress **Measure:** Severe respiratory distress **Time Frame:** Up to day 28 **Description:** Proportion of participants with coma **Measure:** Coma **Time Frame:** Up to day 28 **Description:** Proportion of participants with need for readmission within the first 28 days post-recruitment (after having been discharged) **Measure:** Need for readmission **Time Frame:** Up to day 28 **Description:** Median duration of antibiotic treatment up to day 28 **Measure:** Median duration of antibiotic treatment **Time Frame:** Up to day 28 **Description:** Proportion of participants with oxygen requirement up to D28 and/or up to hospital discharge **Measure:** Oxygen requirement **Time Frame:** Up to day 28 **Description:** Proportion of participants with radiological pneumonia among children with RTI up to D28 and/or up to hospital discharge **Measure:** Radiological pneumonia **Time Frame:** Up to day 28 **Description:** Proportion of participants with hypoxemia (Sat 02\<90% irrespective of supplementary oxygen in absence of cyanotic heart disease) up to D28 and/or up to hospital discharge **Measure:** Hypoxemia (Sp02 <90%) **Time Frame:** Up to day 28 **Description:** Length of hospitalisation up to D28 and/or up to hospital discharge **Measure:** Lenght of hospitalisation **Time Frame:** Up to day 28 **Description:** Proportion of participants with mortality up to M6 **Measure:** Mortality **Time Frame:** Up to month 6 **Description:** Proportion of participants with secondary consultations or hospitalisations up to M6 **Measure:** Secondary consultation or hospitalisations **Time Frame:** Up to month 6 **Description:** Proportion of participants with serious adverse events up to month 6 **Measure:** Proportion of participants with serious adverse events **Time Frame:** Up to month 6 **Description:** Proportion of participants with suspected unexpected serious adverse reactions up to M6. **Measure:** Proportion of participants with suspected unexpected serious adverse reactions **Time Frame:** Up to month 6 **Description:** Proportion of participants with adverse events up to D30. **Measure:** Proportion of participants with adverse events **Time Frame:** Up to day 30 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Enrolled in the initial prognostic screening component. * Sick children with fever (axillary temperature\>37.5ºC) or a history of fever (within the preceding 72h) or with suspected severe disease. * 1m-\<60 months of age. * With an indication for admission, or having already been admitted to hospital due to their illness. * With an sTREM-1 PoC result classifying their disease as of "moderate-high risk" ("yellow" or "red") upon study recruitment and within D3. * Residents in the study area or willing to be contacted and traced during the study duration. * Willing to sign an informed consent document. * Willing to undergo and adhere to study procedures as explained in the IC document. Exclusion Criteria: * Admission to hospital for social reasons (and not on account of their disease). * Children for which informed consent document has not been signed. * Known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet. * Concurrent participation in any other clinical trial. * Patient under NPO or "nothing by mouth" prescription . * Contraindication for the insertion of a nasogastric tube (NGT) of for the enteral administration of drugs through the NGT in children who cannot tolerate by mouth. * Critically sick patient whose prognosis is considered by the clinical researcher as fatal outcome in the following hours after screening. * Any other condition determined by the investigators that makes it unlikely that the participant would complete the follow up until day 28 of study. **Maximum Age:** 60 Months **Minimum Age:** 0 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Quique Bassat, Prof **Phone:** 93 227 92 12 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Barbara Baro, PhD **Phone:** 93 227 92 12 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Barcelona Institute for Global Health **Name:** Quique Bassat, Prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** On request to any interested professional **Description:** This clinical trial, as part of the wider EChiLiBRiST project, is committed to EU-funded Horizon 2021 aims to improve and maximize access to and reuse of research data generated by the Project. Biological samples and data will be shared using material and data transfer agreements with the collaborating institutions. The full protocol will be available on request to any interested professional and may be published in peer-reviewed journals or deposited in an online repository. A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the the analysis is completed and no later than five years after the publication of the trial. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the data analysis is completed and no later than five years after the publication of the trial. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infectious Disease - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infectious Disease - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426134 **Acronym:** KISSeS **Brief Title:** Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS **Official Title:** Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders #### Organization Study ID Info **ID:** NL83836.018.23 #### Organization **Class:** OTHER **Full Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Parnassia Groep **Class:** OTHER **Name:** The University of Texas at Dallas **Class:** OTHER **Name:** University of Alberta **Class:** UNKNOWN **Name:** EnLiSense #### Lead Sponsor **Class:** OTHER **Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) #### Responsible Party **Investigator Affiliation:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) **Investigator Full Name:** Karin Huizer **Investigator Title:** Principal Investigator; MD, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD). The main questions it aims to answer are: Does a ketone drink improve information processing in patients with SSD/BD? Other questions it aims to answer are: Does a ketone drink improve cognitive functioning in patients with SSD/BD? Does a ketone drink improve metabolism and inflammation in patients with SSD/BD? Research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over'). Participants will: 1. drink a ketone drink and (after a wash-out period) an isocaloric control drink; after each drink: * EEG to determine information-processing parameters (PPI and P300) * cognitive tests * visual analog scale of mood, energy levels, ability to focus * indirect calorimetry to determine use of energy substrate * blood draws 2. for 5 consecutive days: * wear a continuous glucose monitor (CGM) * wear a non-invasive passive sweat biomarker sensor (EnLiSense device) * register a diet and nicotine diary * saliva sampling (max. 4x/day, only on both intervention days) ### Conditions Module **Conditions:** - Schizophrenia and Related Disorders - Psychosis - Bipolar and Related Disorders - Manic Episode - Depressive Episode ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1x50 g dGK ketone drink **Intervention Names:** - Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) **Label:** dGK **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 1x isocaloric carbohydrate control drink **Intervention Names:** - Other: Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride **Label:** isocaloric carb control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - dGK **Description:** 1x50g ingestion of pure dGK **Name:** (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) **Other Names:** - delta G Ketones (dGK) **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - isocaloric carb control **Description:** Isocaloric carbohydrate control (active control) **Name:** Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride **Other Names:** - Maurten Drink Mix 160 **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** PPI: an event-related potential (ERP) representing information processing (known to be disrupted in schizophrenia and bipolar disorder). The PPI task is an auditory paradigm featuring a total of 10 trials split evenly into two conditions: prepulse (PP) and non-prepulse (NP) in blocks. Startle pulses are 100dB at 40 ms, which is shown to provide significant startle visible in EEG126. Prepulse stimuli are 70 dB and 50 ms in duration, presented 50ms prior to the startle pulse. There is a 12 to 18 (avg: 15 s) interstimulus interval. All stimuli are white-noise blips. A calibrated apparatus is used to present the stimuli. Total estimated time is 20 min. **Measure:** Prepulse Inhibition (PPI) - change dGK vs isocaloric control **Time Frame:** measured 45 minutes (Tmax) after ingestion of intervention 1 (dGK) and 45 minuts after ingestion of intervention 2 (isocaloric carb control) #### Secondary Outcomes **Description:** The P300 task consists of 160 stimuli in the oddball paradigm and requires the subjects to press a button on detection of the rare target (32/160). The common nontarget stimuli are 500 Hz, 100 ms duration. The rare target stimuli are 700 Hz. Both are 100 ms duration at 80 dB with variable interstimulus interval of 1.2 to 1.5 s. Preceded by 10 practice trials. This task has minimal burden and requires about 10 minutes. **Measure:** P300 Event Related Potential (change dGK vs isocaloric control) **Time Frame:** measured 65-75 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after PPI. **Description:** 15WT is a measure of verbal/episodic memory. The 15WT consists of 15 words, which have to be learned during three trials. After every trial the respondent is asked to recall as many words as possible. After a distraction period of 20 minutes, the respondent is asked to name the words they have learned before, again. Immediate recall after 1 test: maximum 15 words (minimum 0) Immediate recall after 3 test: maximum 45 words (minimum 0). Retention score after 20 minutes: 1. percentage of correctly remembered words in the delayed recall-trial, relative to the number of words correctly remembered in the third immediate recall-trial 2. percentage of correctly remembered words in the delayed recall-trial, relative to the maximum score in the immediate recall-trials Higher 15WT scores indicate better verbal/episodic memory, lower scores the opposite. **Measure:** Cognitive test: 15 Word Test (15WT) - change dGK vs isocaloric control **Time Frame:** measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after P300. **Description:** TMT-A is a measure of (visual) attention. TMT-A outcome is the duration of time required to finalize test (including the time needed for the correction of errors prompted by the examiner), with a maximum of 5 minutes. The average TMT-A score in healthy adults is 29 seconds; a deficient score is greater than 78 seconds. Higher scores on TMT-A indicate worse (visual) attention. **Measure:** Cognitive test: Trail Making Test A (TMT-A) - change dGK vs isocaloric control **Time Frame:** measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after P300. **Description:** TMT-B is a measure of (frontal) executive functioning. TMT-B outcome is the duration of time required to finalize test (including the time needed for the correction of errors prompted by the examiner), with a maximum of 5 minutes. Average TMT-B score is 75 seconds; a deficient score is greater than 273 seconds. Higher scores on TMT-B indicate worse (frontal) executive functioning. **Measure:** Cognitive test: Trail-Making Test B (TMT-B) - (change dGK vs isocaloric control) **Time Frame:** measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after TMT-A. **Description:** DST is a measure for working memory. DST outcome is the maximum number of sequential digits correctly reproduced. In average healthy adults, the digit span is around 7 +/- 2. Minimum score is 0, maximum score is 9. Lower DST score indicate worse working memory. **Measure:** Cognitive test: Digit Span Test (DST) (change dGK vs isocaloric control) **Time Frame:** measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after TMT-B. **Description:** visual analog scale (VAS) is used with a scale of 0 to 10 to measure patient-experiences effects of the interventions on their mood (0=extremely depression, 10 = extremely happy/euforic), energy level (0=completely exhauster, 10= extremely energetic) and ability to focus (0=completely unable to focus, 10=perfect focus). **Measure:** Patient experience outcome on Mood, energy level, focus (change dGK vs isocaloric control) **Time Frame:** measured circa 120 minutes after ingestion of intervention 1 (dGK) and circa 120 minutes after ingestion of intervention 2 (isocaloric carb control) **Description:** sequential blood sampling through intravenous line: concentration (pg/ml) of inflammatory biomarkers relevant for immune function: * IL-1b * IL-6 * IL-8 * IL-10 * TNF-a * IFN-g * hsCRP Comparison between dGK and isocaloric control at the same time points (see below). **Measure:** Immune function: blood markers (change dGK vs isocaloric control) **Time Frame:** first blood sample before ingestion (dGK or isocaloric control) (T0), then every 20 minutes in first hour after ingestion; afterwards every 30 minutes (max. 3 hours) **Description:** RNA expression analysis (immune panel nCounter, Nanostring) in whole blood: comparison dGK vs isocaloric control only at T0 plus 90 minutes. **Measure:** Immune function: blood RNA markers (change dGK vs isocaloric control) **Time Frame:** first blood sample before ingestion (dGK or isocaloric control) (T0), next at T0+90 minutes **Description:** continuous measurement of IL-6 (pg/ml) in passive sweat (EnLiSense device) **Measure:** Immune function: passive sweat IL-6 (change dGK vs isocaloric control) **Time Frame:** Full 5 days of the study **Description:** continuous measurement of TNF-a (pg/ml)in passive sweat (EnLiSense device) **Measure:** Immune function: passive sweat TNF-a (change dGK vs isocaloric control) **Time Frame:** Full 5 days of study **Description:** Resting energy expenditure (REE) is measured by gaseous exchange (indirect calorimetry). Oxygen consumption and CO2 production are measured during 20 minutes using a ventilated hood system (Q-NRG, Cosmed). Subjects lie flat on their backs and breathe into a canopy for 20 minutes. REE and Respiratory Quotient (RQ) are calculated with these measurements. The RQ represents the ratio of CO2 exhaled to the amount of 02 consumed by the individual and represents whole body substrate oxidation (glucose, fat and protein oxidation). **Measure:** Metabolic function: Indirect Calorimetry (change dGK vs isocaloric control) **Time Frame:** circa 90-120 minutes after ingestion of intervention 1 (dGK) and intervention 2 (isocaloric control); directly after finalizing cognitive tests. **Description:** Sequential blood sampling through intravenous line, to determine the plasma and serum concentrations of: * Glucose * Ketones * acylcarnitine profile * growth hormone (GH) * superoxide dismutase (SOD) * gluthione S-transferase (GST) * soluble intercellular adhesion molecule 1 (sICAM1) Comparison between dGK and isocaloric control at the same time points (see below). **Measure:** Metabolic function: blood biomarkers - change dGK vs isocaloric control **Time Frame:** first blood sample before ingestion (both dGK and isocaloric control) (T0), then every 20 minutes in first hour after ingestion; afterwards every 30 minutes (max. 3 hours) **Description:** continuous glucose monitor (CGM; Abbott Libre Sense); continuous concentration in mM. **Measure:** Metabolic function: continuous glucose monitor (CGM) - change dGK vs isocaloric control **Time Frame:** Full 5 days of the study. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a first-episode psychosis (underlying schizophrenia-spectrum disorder), or patients with a (hypo)manic or depressive episode (underlying bipolar disorder) * Age \>= 18 years old * Receiving standard care (including antipsychotic and mood stabilizing medication) * Mentally competent to give informed consent: Exclusion Criteria: * Substance use as cause of psychosis or (hypo)mania * Substance use (other than nicotine) in the week prior to study onset * Intellectual disability * Diabetes mellitus (type 1 or type 2) * Metabolic disease impacting ketone metabolism (NB: these are rare disorders diagnosed during childhood) * Liver disease * Kidney disease * Cardiovascular disease * Pregnancy * Breastfeeding **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Karin Huizer, MD/PhD **Phone:** +31683048776 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nico Beveren, van, MD/PhD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Parnassia Groep **Name:** Karin Huizer, MD/PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000019964 - Term: Mood Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### 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 - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Disorder - ID: M15376 - Name: Schizophrenia - Relevance: HIGH - As Found: Schizophrenia - ID: M2598 - Name: Mania - Relevance: HIGH - As Found: Manic Episodes - ID: M226 - Name: Bipolar and Related Disorders - Relevance: HIGH - As Found: Bipolar and Related Disorders - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M10687 - Name: Ketosis - Relevance: LOW - As Found: Unknown - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood 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: D000087122 - Term: Mania - ID: D000012559 - Term: Schizophrenia - ID: D000001714 - Term: Bipolar Disorder - ID: D000068105 - Term: Bipolar and Related Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426121 **Brief Title:** Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product **Official Title:** Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product #### Organization Study ID Info **ID:** IDS-23CNBAC01 #### Organization **Class:** INDUSTRY **Full Name:** Becton, Dickinson and Company ### Status Module #### Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **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:** Becton, Dickinson and Company #### 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:** This study is a multi-center, randomized clinical validation. Subjects should be fully informed of this protocol and related risks, and can only be enrolled into this study after signing the informed consent form. Blood collection of the subjects at the same puncture point at a single site will be injected into the test vial and the control vial respectively, and the vials will be transferred to the BACTEC system for culture and the results will be observed. After the BACTEC system incubation completion, the vials will be subcultured. Strains grown on plates will be identified using appropriate methods and, if possible, at the species level. ### Conditions Module **Conditions:** - Blood Culture of Microorganisms ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Additional blood sample collected compared to clinical routine care **Intervention Names:** - Diagnostic Test: test Aerobic/F Culture Vials **Label:** BD BACTEC™ Plus Aerobic/F Culture Vials(test) #### Arm Group 2 **Description:** clinical routine care **Intervention Names:** - Diagnostic Test: control Aerobic/F Culture Vials **Label:** BD BACTEC™ Plus Aerobic/F Culture Vials(control) ### Interventions #### Intervention 1 **Arm Group Labels:** - BD BACTEC™ Plus Aerobic/F Culture Vials(test) **Description:** an additional blood sample will be collected compared to clinical routine of blood culture, inoculated into the test culture vial, and compared with the blood culture results of the control vial collected from the same site and the same puncture point **Name:** test Aerobic/F Culture Vials **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - BD BACTEC™ Plus Aerobic/F Culture Vials(control) **Description:** according to the clinical routine of blood culture, this blood sample should be collected and inoculated into the control vial, and its culture result will be collected **Name:** control Aerobic/F Culture Vials **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The consistency rate of the test vials and the control vials BACTEC™ system test results, including the overall consistency rate, positive consistency rate, and negative consistency rate **Measure:** consistency rate **Time Frame:** 8 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subject is willing to provide written informed consent to sponsor. * Blood specimens * Patients with suspected blood infection that have one or more of the following characteristics : a) Body temperature \> 38°C or body temperature \<36°C; b) chills; c) increased peripheral blood leukocyte count (count \> 10.0×109/L, especially if there is a "left shift") or decrease (count \< 3.0×109/L); d) Respiratory rate \> 20 beats/min or arterial partial pressure of carbon dioxide (PaCO2) \<32mmHg; e) Heart rate\> 90 beats/min; f) mucocutaneous hemorrhage; g) coma; h) Multi-organ dysfunction; i) decreased blood pressure; j) Elevated inflammatory response parameters such as C-reactive protein or hypersensitive C-reactive protein, procalcitonin (PCT), 1,3-β-D-glucan (G test), etc. Exclusion Criteria: * Subjects have been enrolled in this study and samples have been collected * Patients with severe and very severe anemia (last hemoglobin \<60g/L within seven days) * Females with known pregnancy **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** patients with suspected blood infection who are at risk of sepsis ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** namei hu **Phone:** +86 15800702757 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426108 **Acronym:** LBIARHMI **Brief Title:** Interventions to Control Hypersensitivity Pain in Teeth With Insisive Molar Hypomineralization **Official Title:** Association of Low-intensity Laser and a Remineralizing Agent in Controlling the Pain of Incisor Molar Hypomineralization in Children: a Randomized, Placebo-controlled, Triple-blind Clinical Trial #### Organization Study ID Info **ID:** 63035222.3.0000.5419 #### Organization **Class:** OTHER **Full Name:** University of Sao Paulo #### Secondary ID Infos **Domain:** UNIVERSITY OF SAO PAULO RIBEIRÃO PRETO FACULTY OF DENTISTRY **ID:** FORP-USP **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-03-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Sao Paulo #### Responsible Party **Investigator Affiliation:** University of Sao Paulo **Investigator Full Name:** Lucas Masaru Marubayashi **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Molar incisor hypomineralization (MIH) manifests as a qualitative, demarcated defect in tooth enamel of systemic origin, predominantly affecting one or more permanent first molars, and potentially extending to the incisors. One significant challenge in managing this enamel anomaly is hypersensitivity, leading to discomfort and pain in affected patients. Low-intensity laser therapy, alone or combined with other modalities, appears promising in alleviating pain associated with MIH. This study aims to assess the efficacy of low-intensity laser therapy using varied parameters, in conjunction with a remineralizing agent, for pain management in children with molar incisor hypomineralization. Participants aged 6 to 12 years will be recruited, with a total of 88 teeth diagnosed with MIH, presenting a sensitivity score ≤3 on the Visual Analog Scale (VAS) and a score ≤1 on the Schiff Cold Air Sensitivity Scale (SCASS). The teeth will be randomly assigned to one of four groups (n=22 each): Group I (GI): L-1J + VF, Group II (GII): L-1J + VP, Group III (GIII): L-2J + VF, and Group IV (GIV): L-2J + VP. Here, 'L' denotes low-intensity laser application at different parameters (1J and 2J), combined with either fluoride varnish (VF) or a placebo varnish (VP). Interventions and assessments will be conducted initially, after 48 hours, and at 1 and 2 weeks post-treatment. Patients will undergo re-evaluation at 2, 4, 8, and 12 weeks following interventions. Statistical analyses will be performed with a 95% confidence level (α = 0.05). **Detailed Description:** A randomized clinical trial will be carried out involving children aged 6 to 12 years, with a total of 88 teeth diagnosed with MIH, presenting a sensitivity score ≤3 on the visual analogue scale (VAS) and a score ≤1 on the Schiff Cold Air Sensitivity Scale (SCASS). ). Inclusion criteria will require the presence of at least one erupted permanent molar with an occlusal surface free of gingival tissue, demonstrating IMH with sensitivity. Additionally, participants must provide informed consent forms signed by parents or guardians, along with consent forms signed by children. Exclusion criteria include decayed teeth, atypical carious lesions, teeth that have other enamel defects such as fluorosis, enamel hypoplasia, amelogenesis imperfecta or enamel malformations associated with syndromes, ongoing orthodontic treatment, cognitive disorders in patients, desensitizing treatments recent use in the last 3 months, previous use of anti-inflammatory and/or analgesic medications, teeth diagnosed with MIH presenting post-eruptive dentin fractures, atypical restorations, atypical caries, sensitivity scores \>3 on the visual analogue scale (VAS) and scores \> 1 on the Schiff Cold Air Sensitivity Scale (SCASS). For the diagnosis of MIH, the investigators will employ the criteria outlined by the European Academy of Pediatric Dentistry, which includes assessment of demarcated opacities, post-eruptive enamel defects, atypical restorations, teeth lost due to MIH, and incompletely erupted teeth. The sample size was determined based on the anticipated outcome of pain reduction following treatment, with an expected 60% reduction. Calculation was conducted with a confidence level of 95% and a power of 80%. Following the application of the inclusion and exclusion criteria, each group will consist of a total of 88 teeth, randomly assigned to one of four groups: GI, GII, GIII, and GIV. The interventions for each group will be as follows: GI: Low-Intensity Laser 1J (10 seconds) + Fluoride Varnish. GII: Low-Intensity Laser 1J (10 seconds) + Placebo. GIII: Low-Intensity Laser 2J (20 seconds) + Fluoride Varnish. GIV: Low-Intensity Laser 2J (20 seconds) + Placebo. To administer laser therapy, the investigators will utilize a low-intensity infrared diode laser (Therapy EC, DMC Equipamentos Ltda., São Carlos, Brazil) operating in continuous mode, emitting at a wavelength of 808 nm with a power output of 100 mW. The dosage will be set at either 1 or 2 Joules, with a fluence of 35 J/cm\^2. Both the operator and the patient will wear personal protective equipment (PPE) during the procedure. The tooth will be irradiated perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion. Activation time will be either 10 or 20 seconds, corresponding to 1 or 2 Joules respectively, depending on the assigned group. To ensure consistency, even if the laser is activated for 1 Joule (equivalent to 10 seconds), the laser tip will be maintained in place for a standardized duration of 20 seconds, the maximum activation time, as confirmed by a stopwatch in all applications to ensure reliability. As an adjunct to LBI, the investigators will use a fluoride varnish (FV) and a placebo varnish (PV) without the active ingredient, ensuring that they are in identical packaging with the same taste and texture. Both will maintain the same method of application. The FV used will be Duraphat® (22,600 ppm F, Colgate). The application of both FV and PV will be conducted according to each respective group. Application will be facilitated using a microbrush, spreading it over the entire lesion area for 30 seconds. After the interventions, patients will be instructed not to consume hard foods and to refrain from brushing their teeth for at least four hours following varnish application, adhering to the manufacturer's recommendations. Following all tests, the data will undergo normality analysis (Shapiro-Wilk test) and homoscedasticity assessment (Levene's test) to determine the suitability of parametric statistics. Therefore, for all variables, one-way ANOVA will be employed, followed by Tukey's post-hoc test for group comparisons. Demographic data will be evaluated using Pearson's chi-square test. Friedman's test may be utilized for multiple comparisons (sensitivity assessments), and the Wilcoxon test for paired comparisons. Analyses will be conducted using the statistical software SPSS 12.0 (SPSS Inc., Chicago, IL, USA). All tests will be performed at a 95% confidence level (α = 0.05). ### Conditions Module **Conditions:** - Molar Incisor Hypomineralization **Keywords:** - Molar Incisor Hypomineralization - low-intensity Laser - Dental hypersensitivity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized placebo controlled triple blind clinical trial ##### Masking Info **Masking:** SINGLE **Masking Description:** Triple blind **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 88 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 1 Joule (equivalent to 10 seconds). In conjunction with the laser therapy, a fluoride varnish (Duraphat®, containing 22,600 ppm F, manufactured by Colgate) will be utilized as an adjuvant. Application will be facilitated using a microbrush, ensuring coverage over the entire extent of the lesion for 30 seconds. Following the interventions, patients will be advised to refrain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish, adhering to the manufacturer's guidelines. **Intervention Names:** - Drug: Fluoride Varnishes - Radiation: Low-Intensity Laser 1J **Label:** Low-Intensity Laser 1J + Fluoride Varnish **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The tooth will be subjected to low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 1 Joule (equivalent to 10 seconds). As an adjunct to the laser therapy, a placebo varnish, devoid of the active ingredient (fluoride), will be utilized. The varnish will be applied with the assistance of a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be advised to abstain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish. **Intervention Names:** - Drug: Varnishes placebo - Radiation: Low-Intensity Laser 1J **Label:** Low-Intensity Laser 1J + Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, utilizing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicularly in contact with the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 2 Joules (equivalent to 20 seconds). As an adjunct to the laser therapy, a fluoride varnish (Duraphat®, containing 22,600 ppm F, manufactured by Colgate) will be utilized. The varnish application will be facilitated using a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be instructed to refrain from consuming hard foods and to postpone tooth brushing for at least four hours after applying the varnish, in accordance with the manufacturer's recommendations. **Intervention Names:** - Drug: Fluoride Varnishes - Radiation: Low-Intensity Laser 2J **Label:** Low-Intensity Laser 2J + Fluoride Varnish **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the third cervical region of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 2 Joules (equivalent to 20 seconds). As an adjunct to the laser therapy, a placebo varnish, devoid of the active ingredient (fluoride), will be utilized.The varnish will be applied with the assistance of a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be advised to abstain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish. **Intervention Names:** - Drug: Varnishes placebo - Radiation: Low-Intensity Laser 2J **Label:** Low-Intensity Laser 2J + Placebo. **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Low-Intensity Laser 1J + Fluoride Varnish - Low-Intensity Laser 2J + Fluoride Varnish **Description:** the investigators will utilize a fluoride varnish with a concentration of 22,600 ppm F. The application will be facilitated using a microbrush, ensuring thorough coverage over the entire length of the lesion for a duration of 30 seconds. Following application, the varnish will be finished with water to create a film on the tooth surface. After completing the interventions, patients will receive instructions to refrain from consuming hard foods and to postpone tooth brushing for at least four hours, adhering to the manufacturer's recommendations. **Name:** Fluoride Varnishes **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Low-Intensity Laser 1J + Placebo - Low-Intensity Laser 2J + Placebo. **Description:** the investigators will apply a placebo varnish without the active ingredient (fluoride), ensuring that it is packaged identically to the fluoride varnish and has the same taste and texture, thus maintaining consistency in application. The varnish will be applied using a microbrush, spreading it evenly over the entire length of the lesion for a duration of 30 seconds. Following the interventions, patients will receive instructions to avoid consuming hard foods and to delay tooth brushing for at least four hours after applying the varnish. **Name:** Varnishes placebo **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Low-Intensity Laser 1J + Fluoride Varnish - Low-Intensity Laser 1J + Placebo **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion. **Name:** Low-Intensity Laser 1J **Type:** RADIATION #### Intervention 4 **Arm Group Labels:** - Low-Intensity Laser 2J + Fluoride Varnish - Low-Intensity Laser 2J + Placebo. **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion. **Name:** Low-Intensity Laser 2J **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Applying the low intensity laser of 1 joule (10 seconds) in infrared light in continuous mode, using a wavelength of 808 nm, power of 100 mW, dose of 1 or 2 Joules and fluence of 35 J/cm2. As an adjuvant to fluoride varnish (22,600 ppm F), we expect an improvement in hypersensitivity assessed by the visual analogue scale, ranging from 0 (no pain) to 10 (worst possible pain), so that applications performed after 48 hours will decrease, and in 1 and 2 weeks post-treatment, remaining stable during follow-ups at 2, 4, 8 and 12 weeks after interventions. This expectation arises from the known mechanisms of laser action in controlling inflammation and providing analgesia. Furthermore, we also anticipate that fluoride varnish will exert its remineralizing effects, contributing to the overall treatment of the disease. **Measure:** Gradual change of hypersensitivity on the visual analogue scale. **Time Frame:** Gradual reduction after 48 hours, and at 1 and 2 weeks post-treatment and remaining stable during follow-ups of 2, 4, 8, and 12 weeks following interventions #### Secondary Outcomes **Description:** Applying the low intensity laser of 1 joule (10 seconds) in infrared light in continuous mode, using a wavelength of 808 nm, power of 100 mW, dose of 1 or 2 Joules and fluence of 35 J/cm2. As an adjuvant to fluoride varnish (22,600 ppm F), we expect improvement in hypersensitivity assessed by the Schiff Cold Air Sensitivity Scale, ranging from 0 (the child does not respond to the stimulus) to 3 (the child responds to the stimulus, moves away and requests immediate suspension of the stimulation), so that it decreases with applications carried out after 48 hours, and at 1 and 2 weeks post-treatment, remaining stable during follow-ups at 2, 4, 8 and 12 weeks after the interventions. This expectation arises from the known mechanisms of laser action in controlling inflammation and providing analgesia. Furthermore, we also anticipate that fluoride varnish will exert its remineralizing effects, contributing to the overall treatment of the disease. **Measure:** Gradual change of hypersensitivity on the Schiff Cold Air Sensitivity Scale **Time Frame:** Gradual reduction after 48 hours, and at 1 and 2 weeks post-treatment and remaining stable during follow-ups of 2, 4, 8, and 12 weeks following interventions ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children aged 6 to 12 years old * Teeth diagnosed with MIH, exhibiting at least one erupted permanent molar with the occlusal surface devoid of gingival tissue and showing sensitivity associated with MIH with sensitivity score ≤3 on the Visual Analogue Scale (VAS) and score ≤1 on the Self-Consensus Assessment scale symptoms and signs (SCASS). * Children who have the cognitive ability to answer the tests. * Children who obtained authorization from their parents or guardians, through a signed free and informed consent form. Exclusion Criteria: * Decayed or restored teeth. * Teeth with other enamel defects, such as fluorosis, enamel hypoplasia, amelogenesis imperfecta or enamel malformations associated with syndromes, as well as those undergoing orthodontic treatment. * Patients with cognitive impairments that prevent responsiveness to the test. * Children who have undergone desensitizing treatment in the last 3 months. * Children who use anti-inflammatory and/or analgesic medications before starting treatment. * Teeth that have a sensitivity score \>3 on the visual analogue scale (VAS) and a score \>1 on the Schiff Cold Air Sensitivity Scale (SCASS). **Healthy Volunteers:** True **Maximum Age:** 12 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lucas M Marubayashi **Phone:** +5544988491230 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC. Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 2020 May;30(3):323-333. doi: 10.1111/ipd.12602. Epub 2019 Dec 23. **PMID:** 31808584 #### See Also Links **Label:** Related Info **URL:** https://pubmed.ncbi.nlm.nih.gov/31808584/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases - ID: D000094603 - Term: Dental Enamel Hypomineralization - ID: D000094602 - Term: Developmental Defects of Enamel - ID: D000014071 - Term: Tooth Abnormalities - ID: D000018640 - Term: Stomatognathic System Abnormalities - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Hypersensitivity - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M3067 - Name: Molar Hypomineralization - Relevance: HIGH - As Found: Molar Incisor Hypomineralization - ID: M16853 - Name: Toothache - Relevance: LOW - As Found: Unknown - ID: M6941 - Name: Dental Enamel Hypoplasia - Relevance: HIGH - As Found: Molar Incisor Hypomineralization - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M3066 - Name: Dental Enamel Hypomineralization - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M16826 - Name: Tooth Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20727 - Name: Stomatognathic System Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000094604 - Term: Molar Hypomineralization - ID: D000003744 - Term: Dental Enamel Hypoplasia - ID: D000006967 - Term: Hypersensitivity ### Intervention Browse Module - Ancestors - ID: D000002327 - Term: Cariostatic Agents - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M8587 - Name: Fluorides - Relevance: HIGH - As Found: Genetic - ID: M140080 - Name: Listerine - Relevance: LOW - As Found: Unknown - ID: M15771 - Name: Sodium Fluoride - Relevance: LOW - As Found: Unknown - ID: M8588 - Name: Fluorides, Topical - Relevance: HIGH - As Found: Highest - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005459 - Term: Fluorides - ID: D000005460 - Term: Fluorides, Topical ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426095 **Brief Title:** A Comparative Analysis of the Efficacy of Instructional Videos and Live Demonstrations in Crown Preparation Training for Preclinical Dental Students **Official Title:** Exploring Pedagogical Approaches: A Comparative Analysis of the Efficacy of Instructional Videos and Live Demonstrations in Crown Preparation Training for Preclinical Dental Students #### Organization Study ID Info **ID:** AIDM/ERC/01/2023/02 #### Organization **Class:** OTHER **Full Name:** Altamash Institute of Dental Medicine ### Status Module #### Completion Date **Date:** 2024-01-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-11 **Type:** ACTUAL #### Start Date **Date:** 2023-01-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Altamash Institute of Dental Medicine #### Responsible Party **Investigator Affiliation:** Altamash Institute of Dental Medicine **Investigator Full Name:** Dr Maria Shakoor **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** finding the optimal balance between traditional live demonstrations and instructional videos remains a subject of ongoing discussion in dental education. Moreover, integrating a hybrid model that combines the strengths of both methods may offer a comprehensive approach to crown preparation training. Therefore, this study aims to address this ongoing discussion by investigating the relative effectiveness of traditional live demonstrations, instructional videos, and a hybrid model that merges both approaches. Through an evaluation of dental students' satisfaction and performance with video tutorials and hands-on demonstrations, this research endeavors to shed light on how different instructional methods influence knowledge acquisition within the practical environment. **Detailed Description:** A randomized controlled single-blind trial was conducted at the Department of Prosthodontics, Altamash Institute of Dental Medicine for a duration of 12 months from 12th Jan' 2023 till 11th Jan' 2024. Prior approval was obtained from the Ethical Review Committee of Altamash Institute of Dental Medicine (AIDM/ERC/01/2023/02). written consent was obtained from all participants, A simple random sampling technique was used for the recruitment of participants. . a total of ninety-six final-year BDS students were enrolled in the study. Before allocation, all participants attended a comprehensive lecture on crown preparation principles delivered via a PowerPoint presentation. Following the lecture, participants were randomly assigned to one of three groups: Group A (instructional video), Group B (live demonstrations), or Group C (hybrid) Participants in Group A will view an instructional video, group B will attend live demonstrations. Participants in Group C received a dual approach, combining instructional video guidance with live demonstrations. Before the intervention, all participants across the three groups underwent a pretest consisting of five questions. These questions were designed to gauge participants' readiness and perceptions regarding crown preparation training. Responses were recorded using a Likert scale ranging from 1 to 5, where 1 represented "strongly disagree" and 5 represented "strongly agree". Following the lecture and demonstrations, participants were provided with an assessment questionnaire comprising six questions aimed at evaluating their comprehension and knowledge regarding porcelain-fused-to-metal tooth preparation. ### Conditions Module **Conditions:** - Medical Education - Dental - Dental Crown Preparation - Instructional Methods - Training Effectiveness **Keywords:** - Medical Education - Instruction video - Live Demonstrations ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 96 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in Group A received access to a specially prepared pre-recorded instructional video detailing the step-by-step process of porcelain-fused-to-metal tooth preparation for molars **Intervention Names:** - Behavioral: Group A (instructional video), **Label:** instructional video **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** live demonstrations of the same procedure conducted by the same experienced Prosthodontist to ensure consistency in teaching quality and technique. **Intervention Names:** - Behavioral: Group B (live demonstration) **Label:** live demonstrations **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** both video and live demonstrations will be given **Intervention Names:** - Behavioral: Group C (hybrid) **Label:** hybrid **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - instructional video **Description:** Participants in Group A received access to a specially prepared pre-recorded instructional video detailing the step-by-step process of porcelain-fused-to-metal tooth preparation for molars. **Name:** Group A (instructional video), **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - live demonstrations **Description:** Participants in Group B were provided with live demonstrations of the same procedure conducted by the same experienced Prosthodontist to ensure consistency in teaching quality and technique **Name:** Group B (live demonstration) **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - hybrid **Description:** Group C received a dual approach, combining instructional video guidance with live demonstrations. **Name:** Group C (hybrid) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Proficiency in Crown Preparation: Assessed by a standardized scoring chart evaluating key areas such as preparation axis, axial reduction, anatomic reduction, occlusal convergence, occlusal reduction depth, morphology, quality of axial/occlusal line angles, finish line location, form, continuity, and surface texture. Each area is scored to give a total proficiency score out of 20. Measurements will be taken immediately following the intervention period." **Measure:** Proficiency in Crown Preparation after instructional Videos and Live Demonstrations i **Time Frame:** 12 months **Description:** Before the intervention, all participants across the three groups underwent a pretest consisting of five questions. These questions were designed to gauge participants' readiness and perceptions regarding crown preparation training. Specifically, the questions addressed stress levels during preparation, the duration of preclinical training, the effectiveness of lectures and training, and readiness for clinical practice. Responses were recorded using a Likert scale ranging from 1 to 5, where 1 represented "strongly disagree" and 5 represented "strongly agree". **Measure:** students perception about the demonstration techniques of the three groups **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Fourth-year students of Bachelor of Surgery who voluntarily agreed to participate were included in the study. Exclusion Criteria: * Exclusion criteria include students who do not provide consent, those absent from tutorials, individuals with prior experience in crown preparation, or students with medical conditions affecting participation. **Healthy Volunteers:** True **Maximum Age:** 26 Years **Minimum Age:** 24 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Karachi **Country:** Pakistan **Facility:** Altamash Institute of dental medicine **Zip:** 75500 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426082 **Acronym:** DEBATE **Brief Title:** Deciphering a Novel and Unique Brown Adipose Tissue Depot in Women **Official Title:** Deciphering the Molecular and Secretory Functions of a Novel and Unique Brown Adipose Tissue Depot in Women #### Organization Study ID Info **ID:** PID2022-141442OA-I00 #### Organization **Class:** OTHER **Full Name:** Universidad de Almeria ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2023-10-11 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Leiden University Medical Center **Class:** OTHER **Name:** ETH Zurich (Switzerland) #### Lead Sponsor **Class:** OTHER **Name:** Universidad de Almeria #### Responsible Party **Investigator Affiliation:** Universidad de Almeria **Investigator Full Name:** Borja Martínez Tellez **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:** Type of Study: Clinical Trial Goal: The goal of this clinical trial is to investigate specific brown and beige fat cells in the dorsocervical area of young, lean adult women. Participant Population/Health Conditions: The study will involve 40 young, lean adult women. Main Questions: The main questions this study aims to answer are: * Are there active brown or beige adipocytes in the subcutaneous fat of the dorsocervical area (i.e., iBAT)? * What is the secretory function of these adipocytes? * How do traditional interventions like cold exposure, as well as new approaches like Beta-2 agonist stimulation and exercise, affect the thermogenesis of these fat cells at the cellular and molecular levels? Participants Will: Be randomized into one of four groups: thermoneutral exposure, cold exposure, aerobic exercise, or Beta-2 agonist treatment. Follow their assigned regimen for 4 weeks. Provide tissue samples from the dorsocervical area and abdomen before and after the 4-week intervention. Undergo analysis of these samples using advanced techniques to understand the presence and activity of brown and beige fat cells. Comparison Group: Researchers will compare the effects of different interventions (thermoneutral exposure, cold exposure, aerobic exercise, Beta-2 agonist treatment) on the presence and thermogenesis of brown and beige fat cells in the dorsocervical area. **Detailed Description:** Cardiometabolic diseases affect almost 50% of the population in the Western World. While lifestyle plus pharmacological interventions may provide short-term benefits, more research is needed to understand the long-term effectiveness and underlying molecular mechanisms. Brown adipose tissue (BAT) is a thermogenic tissue that combusts large amounts of glucose and lipids to generate heat and secretes signalling molecules known as 'batokines' that can influence cardiometabolic health. Previous research has shown that BAT is active in adults, primarily in the supraclavicular region, as demonstrated by the uptake of 18F-Fluorodeoxyglucose. Recently, it has been demonstrated that a rare subpopulation of brown adipocytes increases their abundance at higher temperatures and can regulate the thermogenesis of neighbouring adipocytes. Thus, it is plausible that classical (e.g., cold exposure) and novel interventions (i.e., Beta-2 stimulation and exercise) that can activate BAT, would induce a remodelling in the brown/beige subpopulation adipocytes that govern whole tissue thermogenesis. These unstudied changes in human BAT physiology could potentially explain how BAT activation could enhance cardiometabolic health. However, despite over a decade of research, our understanding of the role of BAT in human physiology in humans is limited. This lack of knowledge may be mainly explained because i) obtaining biological samples of human BAT is very difficult and ii) the seasonal variation strongly influences the current gold standard (PET-CT scan). Given the pilot data found in this proposal, young, lean adult women may have a novel and undescribed thermogenic active BAT depot at the dorsocervical area (i.e., interscapular BAT=iBAT). Based on that, the main hypothesis is that there are brown and/or beige adipocytes present within the subcutaneous adipose tissue of the dorsocervical area (i.e., iBAT) that have a unique composition of adipocyte subpopulations and specific secretory functions. Additionally, the specific subpopulations of brown and/or beige adipocytes related to thermogenesis in iBAT can be increased through exposure to cold temperatures, Beta-2 agonist stimulation, and exercise in young, lean women. Thus, the main objective of this study is to investigate whether the subcutaneous fat in the dorsocervical area contains active brown and/or beige adipocytes (i.e., iBAT), understand its secretory function, and study the impact of traditional (e.g. cold exposure) and new interventions (e.g. Beta-2 agonist and exercise) on iBAT thermogenesis at the cellular and molecular levels. Thus, the DEBATE project will carry out a randomized controlled trial where 40 young, lean adult women will be randomized into a thermoneutral exposure group (2 hours/day at 32ºC; 5 days/week) or a cold exposure group (2 hours/day at 18ºC; 5 days/week) or an aerobic exercise group (5 days/week at 65% heart rate reserve for 60 minutes) or a Beta-2 agonist group (salbutamol 12 mg/day. 7 days week). Before and after the 4-week intervention, iBAT tissue samples from the dorsocervical area and subcutaneous white adipose tissue (scWAT) from the abdomen will be collected. In these biological samples, the investigators will apply a set of cutting-edge omics (e.g., single nucleus RNA-seq) that will allow us to investigate whether iBAT is present and metabolically active in adults. The investigators will also conduct a set of in vitro experiments to discover the secretory function of this novel depot. ### Conditions Module **Conditions:** - Cardiometabolic Diseases **Keywords:** - brown adipose tissue - cold exposure - hot exposure - dorsocervical fat - exercise ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study will consist of a randomized controlled trial in which forty young, lean women will be assigned to a control group (n=10; receiving a thermoneutral exposure 2 hours/day at 32ºC; 5 days/week) or a cold exposure group (n=10; receiving 2 hours/day at 18ºC; 5 days/week) or aerobic exercise group (n=10; receiving 5 days/week at 65% heart rate reserve for 60 minutes each training session) or an ADBR2 agonist ingestion (n=10; salbutamol 12 mg/day. 7 days week). ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** n=10; receiving a thermoneutral exposure 2 hours/day at 32ºC; 5 days/week; Total 4 weeks **Intervention Names:** - Behavioral: Thermoneutral condition **Label:** Thermoneutral condition **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** n=10; receiving 2 hours/day at 18ºC; 5 days/week; Total 4 weeks **Intervention Names:** - Behavioral: Cold condition **Label:** Cold condition **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** n=10; salbutamol 12 mg/day. 7 days week. Total 4 weeks **Intervention Names:** - Drug: Salbutamol **Label:** Salbutamol **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** n=10; receiving 5 days/week at 65% heart rate reserve for 60 minutes each training session. Total 4 weeks **Intervention Names:** - Behavioral: Aerobic exercise condition **Label:** Aerobic exercise **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Thermoneutral condition **Description:** Participants will be exposed 2 hours/day at 32ºC for 5 days/week **Name:** Thermoneutral condition **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Cold condition **Description:** Participants will be exposed 2 hours/day at 18ºC for 5 days/week **Name:** Cold condition **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Aerobic exercise **Description:** Participants will perform aerobic exercise training 5 days/week at 65% heart rate reserve for 60 minutes each training session **Name:** Aerobic exercise condition **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Salbutamol **Description:** Participants will take salbutamol 12 mg/day. 7 days week **Name:** Salbutamol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Investigators will quantify the level UCP1 expression by qPCR in white adipose tissue biopsies obtained before and after the intervention **Measure:** Change in UCP1 expression in the dorsocervical area **Time Frame:** 2 years #### Secondary Outcomes **Description:** Change in fat percentage (% of fat) **Measure:** Body composition (BIA, Tanita) **Time Frame:** 2 years **Description:** Change in VO2max (ml/kg/min) **Measure:** Cardiorespiratory fitness test (indirect calorimetry and monarch bike) **Time Frame:** 2 years **Description:** Change in LDL-C (mg/dL) **Measure:** LDL quantification in blood **Time Frame:** 2 years **Description:** Change in HDL-C (mg/dL) **Measure:** HDL quantification in blood **Time Frame:** 2 years **Description:** Change in Glucose (mg/dL) **Measure:** Glucose quantification in blood **Time Frame:** 2 years **Description:** Change in Insulin (µIU/mL) **Measure:** Insulin quantification in blood **Time Frame:** 2 years **Description:** Change in Triglycerides (mg/dL) **Measure:** Triglycerides quantification in blood **Time Frame:** 2 years **Description:** Change in CRP (mg/L) **Measure:** C-reactive protein quantification in blood **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-22 years of age women. * BMI between ≥18 and \<25 kg/m2 * Are willing to be randomized to either of these 4 groups. * Must be sedentary (i.e., do not perform exercise or go to the gym). * Participants should have regular menstrual cycles. * Must be willing to adhere to all study procedures, including attendance at all study visits. * Must be willing to have biological samples stored for future research. * Must accept the use of the Period Calendar and Google Fit Apps on their mobile phones. Exclusion Criteria: * Diabetes mellitus (determined based on fasting glucose levels defined by ADA criteria). * Any other active endocrine disease (thyroid disease, any signs of Cushing's syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia). * Any cardiac disease (i.e., ischemic cardiac disease, arrhythmias, severe heart failure). * Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g., beta-blockers, antidepressants, corticosteroids). * Use of medication shown to increase risk of hypokalemia after salbutamol administration (e.g., xanthine derivatives, steroids and diuretics). * Clinically relevant abnormalities in clinical chemistry or electrocardiogram (ECG) at screening (to be judged by the study physician). * A first-degree family member with sudden cardiac death. * Any chronic renal or hepatic disease. * Any other contra-indications for the use of salbutamol or propranolol. * Abuse of alcohol or other substances. * Smoking. * Current participation in another research projects that may influence the current research project. * Use of beta-adrenergic receptor agonists (e.g., asthma). * Polycystic ovary syndrome. * Diagnosed psychotic conditions. **Healthy Volunteers:** True **Maximum Age:** 22 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Borja Martinez Tellez, PhD **Phone:** +34 950215334 **Phone Ext:** +34 **Role:** CONTACT #### Locations **Location 1:** **City:** Almería **Country:** Spain **Facility:** Universidad de Almería **Zip:** 04131 ### IPD Sharing Statement Module **Access Criteria:** Everybody **Info Types:** - STUDY_PROTOCOL - ICF - CSR **IPD Sharing:** YES **Time Frame:** 5 years after publishing the data **URL:** https://www.sportresearchgroup.es/ ### References Module #### References **Citation:** Martinez-Tellez B, Sanchez-Delgado G, Alcantara JMA, Acosta FM, Amaro-Gahete FJ, Osuna-Prieto FJ, Perez-Bey A, Jimenez-Pavon D, Llamas-Elvira JM, Gil A, Aguilera CM, Rensen PCN, Ruiz JR. Evidence of high 18 F-fluorodeoxyglucose uptake in the subcutaneous adipose tissue of the dorsocervical area in young adults. Exp Physiol. 2019 Feb;104(2):168-173. doi: 10.1113/EP087428. Epub 2018 Dec 18. **PMID:** 30468689 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - 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: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000058666 - Term: Adrenergic beta-2 Receptor Agonists - ID: D000000318 - Term: Adrenergic beta-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3767 - Name: Albuterol - Relevance: HIGH - As Found: Residual - 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: M17869 - Name: Tocolytic Agents - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3670 - Name: Adrenergic beta-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000420 - Term: Albuterol ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426069 **Brief Title:** Assessment of Masticatory Performance in Periodontitis **Official Title:** Assessment of Masticatory Performance in Various Stages of Periodontitis #### Organization Study ID Info **ID:** JANVIPERIO2024 #### Organization **Class:** OTHER **Full Name:** Postgraduate Institute of Dental Sciences Rohtak ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### 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:** True ### Description Module **Brief Summary:** The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health.This clinical trial aims to assess the status of masticatory performance among patients with stage I, stage II, stage III and stage IV periodontitis, along with those with healthy periodontium. **Detailed Description:** Periodontal disease manifestations include gingival bleeding, halitosis, tooth mobility and loss of teeth in advanced cases. The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health. Loss of periodontium leads to reduced ability of tooth to withstand masticatory loads. Thus, biting abilities of subjects with healthy periodontium are significantly greater than those of chronic periodontitis patients. Even though the new periodontitis classification includes masticatory dysfunction in stage 4, but clinical periodontal parameters do start influencing objective masticatory efficiency in early stages. Since the masticatory function is an important point for the classification of periodontitis, standardized procedures with corresponding reference values are needed to consider these parameters in the assessment of periodontitis and to be able to make specific therapy recommendations. This clinical trial aims to assess the changes in masticatory performance among periodontitis patients of all stages and healthy individuals using test methods easily applicable in daily practice. ### Conditions Module **Conditions:** - Periodontitis, Chronic - Chewing Problem - Inflammation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 555 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Periodontally Healthy #### Arm Group 2 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Stage I Periodontitis #### Arm Group 3 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Stage II Periodontitis #### Arm Group 4 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Stage III Periodontitis #### Arm Group 5 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Stage IV Periodontitis ### Interventions #### Intervention 1 **Arm Group Labels:** - Periodontally Healthy - Stage I Periodontitis - Stage II Periodontitis - Stage III Periodontitis - Stage IV Periodontitis **Description:** Masticatory efficiency will be assessed for each group. **Name:** Masticatory efficiency assessment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software. **Measure:** Objective masticatory performance **Time Frame:** Baseline #### Secondary Outcomes **Description:** Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks. **Measure:** Subjective masticatory performance **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adult patients with age group 30-50 years diagnosed with generalized periodontitis 2. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars. Exclusion Criteria: * Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases) * Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis) * Grade C periodontitis (evaluated indirectly by radiographic bone loss/age criteria) * Smoking or substance abuse * Pregnant and lactating women **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 30 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** A total of 555 patients will be recruited from the out patient department of periodontics, PGIDS, Rohtak based on the inclusion and exclusion criteria. The study design will be explained to eligible candidates and all study participants will be required to provide informed consent. Subjects will be grouped based on stage of periodontitis and a healthy control group. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rajinder K Sharma, MDS **Phone:** 09416358222 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Janvi Janvi, BDS **Phone:** 09416183623 **Role:** CONTACT #### Locations **Location 1:** **City:** Rohtak **Country:** India **Facility:** Post Graduate Institute of Dental Sciences **State:** Haryana **Zip:** 124001 #### Overall Officials **Official 1:** **Affiliation:** PGIDS Rohtak **Name:** Janvi Janvi, BDS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - 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: BC07 - Name: Mouth and Tooth Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M28044 - Name: Chronic Periodontitis - Relevance: HIGH - As Found: Periodontitis, Chronic - 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: 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: D000010518 - Term: Periodontitis - ID: D000055113 - Term: Chronic Periodontitis - ID: D000007249 - Term: Inflammation ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426056 **Brief Title:** Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer: A Multicentre, Single-arm, Phase II Trial. **Official Title:** Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer:A Multicentre, Single-arm, Phase II Trial. #### Organization Study ID Info **ID:** M2024240 #### Organization **Class:** OTHER **Full Name:** Peking University Third Hospital ### Status Module #### Completion Date **Date:** 2028-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Jilin Provincial Tumor Hospital **Class:** OTHER **Name:** Affiliated Hospital of Hebei University **Class:** OTHER **Name:** Hebei Medical University Fourth Hospital #### Lead Sponsor **Class:** OTHER **Name:** Peking University Third Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced cervical cancer. ### Conditions Module **Conditions:** - Cervical Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Radiation Therapy Concurrently With Nab-Paclitaxel Plus Cisplatin ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 64 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week). **Intervention Names:** - Radiation: radiotherapy - Drug: Nab paclitaxel - Drug: Cisplatin **Label:** Experimental group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. **Name:** radiotherapy **Other Names:** - RT **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - Experimental group **Description:** Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week). **Name:** Nab paclitaxel **Other Names:** - paclitaxel for injection (albumin bound) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Experimental group **Description:** Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week). **Name:** Cisplatin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** ORR(objective response rate)=CR (complete response)+PR(partial response)/all participants **Measure:** ORR (objective response rate) **Time Frame:** the 1, 3, 6, 9, 12 months after the end of the treatment #### Secondary Outcomes **Description:** adverse events **Measure:** AE **Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment **Description:** objective response rate **Measure:** OS **Time Frame:** the 1, 2, and 3 years after the end of the treatment **Description:** progression-free survival **Measure:** PFS **Time Frame:** the 1, 2, and 3 years after the end of the treatment **Description:** duration of response **Measure:** DOR **Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment **Description:** disease control rate **Measure:** DCR **Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment **Description:** clinical benefit rate **Measure:** CBR **Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * (1) Stage IB3 to IVA disease based on the 2018 International Federation of Gynecology and Obstetrics (FIGO) system; * (2) Eastern Cooperative Oncology Group at 2 or less; * (3) Life expectancy of greater than 3 months; * (4) Left ventricular ejection fraction at ≥55%; * (5) Neutrophil count at ≥1500/mm\^3, platelet count at ≥100,000/mm\^3 or hemoglobin at ≥9.0 g/dL; * (6) Serum creatinine at \<1.5 times the upper limit of the normal reference range; * (7) Alanine transaminase or aspartate aminotransferase at \>2.5 times the upper limit of the normal reference range; * (8) Non pregnant or lactating women; * (9) Women of childbearing age willing to adopt reliable contraceptive measures; * (10) Sign informed consent form. Exclusion Criteria: * (1) Individuals who have previously received chemotherapy with albumin bound paclitaxel; * (2) Individuals who have previously received abdominal or pelvic radiation therapy; * (3) Individuals who have received neoadjuvant chemotherapy or targeted, immunotherapy, and other anti-tumor treatments prior to concurrent chemoradiotherapy and chemotherapy; * (4) Individuals with central nervous system diseases or brain metastases； * (5) Other malignant tumors other than cervical cancer have appeared within the past 5 years; * (6) Previously experienced sensory or motor neuropathy (Grade ≥ 2) ; * (7) The researchers evaluate that the uncontrolled serious medical diseases that will affect the ability of the participants to receive the treatment of the clinical trial, such as complicated with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc; * (8) known to be allergic to paclitaxel; * (9) Received other experimental drugs or participated in clinical studies for other anti-cancer treatment purposes within 30 days of the first chemotherapy administration; * (10) Serious infections occurring within 4 weeks prior to the start of research treatment, including but not limited to complications of infection requiring hospitalization, bacteremia, or severe pneumonia; * (11) Human immunodeficiency virus (HIV) positive individuals; * (12) Uncontrolled or active viral hepatitis or infection with human immunodeficiency virus; * (13) Researchers determine that it is not suitable to participate in this study. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ping Jiang, doctor **Phone:** 86010-82266699 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Peking University Third Hospital **Name:** Ping Jiang, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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 ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000068196 - Term: Albumin-Bound Paclitaxel ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426043 **Brief Title:** A Prospective Study on the Treatment of Recurrent/Refractory/Intolerable NSAA With Lusutrombopag **Official Title:** An Exploratory Study on the Efficacy and Safety of Lusutrombopag in the Treatment of Recurrent/Refractory/Intolerable NSAA #### Organization Study ID Info **ID:** LNA-2024 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **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:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Investigator Affiliation:** Peking Union Medical College Hospital **Investigator Full Name:** Bing Han **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:** In a prospective, single-arm study, the efficacy and safety of Lusutrombopag in the treatment of relapsed/refractory/intolerable non-severe aplastic anemia (NSAA) were explored. **Detailed Description:** The enrolled patients: were given Lusutrombopag at 3mg/qd orally for 12 weeks (the starting dose of lusutrombopag was 3mg, taken once daily. After 2 weeks of continuous administration, the dose was increased by 3mg every 2 weeks based on the platelet count and safety of the subjects. The dose was gradually increased to 9mg/d over a total of 12 weeks). The treatment duration was at least 3 months. When the platelet increase was \<20×10\^9/L, the daily dose was increased by 3mg, up to a maximum of 9mg/day. When the platelet increase was ≥50×109/L and ≤200×10\^9/L, the dose was maintained at the previous level. When the platelet count was ≥200×10\^9/L and ≤400×10\^9/L, the daily dose was reduced by 3mg. When the platelet count was \>400×10\^9/L, the drug could be suspended, and the dose was reduced by 3mg when the platelet count decreased to \<200×10\^9/L. In this case, if the lowest dose of 3mg/day was used, the drug could be suspended. Responders continued treatment for 6 months. Other TPO-RA therapies were not allowed during the study period. ### Conditions Module **Conditions:** - Aplastic Anemia **Keywords:** - Non-severe aplastic anemia - Lusutrombopag - Refractory - Recurrent ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Administer lusutrombopag at 3mg/qd orally for 12 weeks (lusutrombopag starting dose is 3mg, once daily. After 2 weeks of continuous administration, the dose can be increased by 3mg every 2 weeks based on the platelet count and safety of the subject. The dose can be gradually increased to 9mg/d over a total of 12 weeks). The course should be at least 3 months. When the platelet increase is \<20×10\^9/L, the daily dose can be increased by 3mg up to a maximum of 9mg/day; when the platelet increase is ≥50×10\^9/L and ≤200×10\^9/L, the dose can be maintained; when the platelet count is ≥200×10\^9/L and ≤400×10\^9/L, the daily dose can be reduced by 3mg; when the platelet count is \>400×10\^9/L, the drug can be suspended and resumed when the platelet count decreases to \<200×10\^9/L, with the daily dose reduced by 3mg. In this case, if the lowest dose of 3mg/day is used, the drug can be suspended. Responders continue treatment until 6 months. **Intervention Names:** - Drug: Lusutrombopag **Label:** Lusutrombopag **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lusutrombopag **Description:** Administer lusutrombopag at 3mg/qd orally for 12 weeks (lusutrombopag starting dose is 3mg, once daily. After 2 weeks of continuous administration, the dose can be increased by 3mg every 2 weeks based on the platelet count and safety of the subject. The dose can be gradually increased to 9mg/d over a total of 12 weeks). The course should be at least 3 months. When the platelet increase is \<20×109/L, the daily dose can be increased by 3mg up to a maximum of 9mg/day; when the platelet increase is ≥50×10\^9/L and ≤200×10\^9/L, the dose can be maintained; when the platelet count is ≥200×10\^9/L and ≤400×10\^9/L, the daily dose can be reduced by 3mg; when the platelet count is \>400×10\^9/L, the drug can be suspended and resumed when the platelet count decreases to \<200×10\^9/L, with the daily dose reduced by 3mg. In this case, if the lowest dose of 3mg/day is used, the drug can be suspended. Responders continue treatment until 6 months. **Name:** Lusutrombopag **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Proportion of patients who achieved complete response, partial response and hematological response **Measure:** Overall response rate at 3 months **Time Frame:** 3 month **Description:** Proportion of patients who achieved complete response, partial response and hematological response **Measure:** Overall response rate at 6 months **Time Frame:** 6 month #### Secondary Outcomes **Description:** Proportion of patients with adverse eventsProportion of patients with adverse events **Measure:** adverse event rate at 3 months **Time Frame:** 3 month **Description:** Proportion of patients with adverse events **Measure:** adverse event rate at 6 months **Time Frame:** 6 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participants must be at least 18 years old, male or female. 2. Participants must be diagnosed with NSAA and have a refractory/relapsed/intolerable response to standard-dose cyclosporine (CsA). The definition of refractory/relapsed is patients who have been treated with sufficient doses of cyclosporine (3-5mg/kg) for at least 6 months without response or relapse. The definition of intolerable is patients who cannot tolerate CsA and have stopped treatment due to significant side effects. 3. Participants must meet the following criteria at enrollment: platelets \<30×109/L. 4. Baseline liver and kidney function must be within 2 times of normal range. 5. No active infection; no pregnancy or breastfeeding. 6. Participants must agree to sign the informed consent form. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Exclusion Criteria: 1. Other causes of pancytopenia, such as myelodysplastic syndrome (MDS). 2. Evidence of clonal hematopoietic system bone marrow disease (MDS, AML) with cytogenetics. 3. PNH clone ≥50%. 4. Received hematopoietic stem cell transplant (HSCT) prior to enrollment. 5. Received ATG treatment within 6 months prior to enrollment. 6. Infection or bleeding that cannot be controlled with standard therapy. 7. Allergic to ruxolitinib. 8. Active HIV, HCV, or HBV infection, cirrhosis, or portal hypertension. 9. Any malignant tumor within 5 years, or local basal cell carcinoma of the skin. 10. History of thromboembolic events, myocardial infarction, or stroke (including antiphospholipid syndrome) and current use of anticoagulants. 11. Pregnant or breastfeeding (lactating) women. 12. Participated in another clinical trial within 3 months. **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bing Bing, PhD **Phone:** 13601059938 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** QLin Hu, PhD **Phone:** 15810785167 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** QLin Hu, PhD - **Phone:** 15810785167 - **Role:** CONTACT ***Contact 2:*** - **Name:** Bing Bing, PhD - **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:** Bing Bing, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Young NS. Aplastic Anemia. N Engl J Med. 2018 Oct 25;379(17):1643-1656. doi: 10.1056/NEJMra1413485. No abstract available. **PMID:** 30354958 **Citation:** Ruan J, Zuo W, Chen M, Yang C, Han B. Eltrombopag is effective in patients with relapse/refractory aplastic anemia-report from a single center in China. Ann Hematol. 2020 Dec;99(12):2755-2761. doi: 10.1007/s00277-020-04266-1. Epub 2020 Sep 17. Erratum In: Ann Hematol. 2020 Nov 2;: **PMID:** 32944791 **Citation:** Katsube T, Wajima T, Fukuhara T, Kano T. Effects of Food and Calcium Carbonate on the Pharmacokinetics of Lusutrombopag, a Novel Thrombopoietin Receptor Agonist. Clin Ther. 2019 Sep;41(9):1747-1754.e2. doi: 10.1016/j.clinthera.2019.06.004. Epub 2019 Jul 11. **PMID:** 31303281 **Citation:** Hidaka H, Kurosaki M, Tanaka H, Kudo M, Abiru S, Igura T, Ishikawa T, Seike M, Katsube T, Ochiai T, Kimura K, Fukuhara T, Kano T, Nagata T, Tanaka K, Kurokawa M, Yamamoto K, Osaki Y, Izumi N, Imawari M. Lusutrombopag Reduces Need for Platelet Transfusion in Patients With Thrombocytopenia Undergoing Invasive Procedures. Clin Gastroenterol Hepatol. 2019 May;17(6):1192-1200. doi: 10.1016/j.cgh.2018.11.047. Epub 2018 Nov 28. **PMID:** 30502505 **Citation:** Wan Z, Chen M, Han B. Avatrombopag, a promising novel thrombopoietin receptor agonist for refractory/relapsed/intolerant non-severe aplastic anemia: a phase 2 single-arm clinical trial. Ann Med. 2023 Dec;55(1):2224044. doi: 10.1080/07853890.2023.2224044. **PMID:** 37318085 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000080983 - Term: Bone Marrow Failure Disorders - ID: D000001855 - Term: Bone Marrow Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M4071 - Name: Anemia, Aplastic - Relevance: HIGH - As Found: Aplastic Anemia - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2241 - Name: Bone Marrow Failure Disorders - Relevance: LOW - As Found: Unknown - ID: M13118 - Name: Pancytopenia - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: T460 - Name: Aplastic Anemia - Relevance: HIGH - As Found: Aplastic Anemia ### Condition Browse Module - Meshes - ID: D000000741 - Term: Anemia, Aplastic ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426030 **Brief Title:** Validation of Czech Language Versions of Questionnaires for ALS Patients' Functional Status and Biomarker Long-term Follow-up **Official Title:** Validation of Czech Language Versions of Questionnaires Most Frequently Used for Functional Status Monitoring in Patients With Amyotrophic Lateral Sclerosis and the Long-term Follow-up of Biomarkers of the Disease in These Patients. #### Organization Study ID Info **ID:** VALID-ALS-QUEST-CZ #### Organization **Class:** OTHER **Full Name:** Masaryk University ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-17 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Brno University Hospital **Class:** OTHER **Name:** University Hospital, Motol **Class:** OTHER **Name:** University Hospital, Martin **Class:** OTHER **Name:** University Hospital Bratislava #### Lead Sponsor **Class:** OTHER **Name:** Masaryk 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:** Questionnaires and scales used to assess the clinical status and quality of life of patients with amyotrophic lateral sclerosis (ALS) are an important tool to monitor the disease progression and current needs of patients. The use of these tools (and in particular their combination) allows to cover the whole spectrum of potential patient difficulties and thus significantly facilitates the process of individualisation and optimisation of care. The aim of the study was to create and validate the Czech language versions of the following questionnaires or scales: (1) ALSFRS-R (ALS Functional Rating Scale - Revised Version) and (2) ALSFRS-EX (EXtended, i.e. extended, version of the same scale), both in the self-assessment version (incl. (3) the ALSAQ-40 (ALS Assessment Questionnaire including 40 questions), (4) the DYALS (Dysphagia in ALS), and (5) the Borg Dyspnoea Rating Scale. All questionnaires were translated using the forward-backward translation method. The scales and questionnaires were administered to ALS patients repeatedly at one-week intervals, first in writing during routine patient follow-up at the Neuromuscular Centre of the University Hospital Brno, and during repeated administrations by telephone. **Detailed Description:** The first step of the study (before patient recruitment began) was the linguistic validation of all the scales and questionnaires used. Initially, Czech language versions were created using the forward-backward translation method. These created versions were then discussed by an expert panel consisting of 2 amyotrophic lateral sclerosis experts and 2 translators (one native speaker bilingual for both Czech and English, one professional translator specialized in medical English). Patients potentially meeting the entry criteria will be informed about the purpose and conduct of the study and will sign an informed consent if they agree to participate in the study. The first administration of all questionnaires (including the self-assessment version of the ALSFRS-R, ALSFRS-Ex, ALSAQ-40, DYALS and Borg Scale for lying, standing and moving positions) will be performed as part of the patient's routine clinical follow-up at the neuromuscular centre. The other two administrations of the questionnaires will be done by telephone one and two weeks after inclusion, respectively. The one-week interval was chosen in line with the approach of similar foreign validation studies of other languages, so that there is a high probability of no significant change in the patient's clinical condition between repeated administrations and, on the other hand, that the patient no longer remembers in detail the answers from the previous administration. At the first telephone readministration (after one week), patients will complete the full range of questionnaires as they did at the first administration of the questionnaires at the centre. The second telephone readministration (after an additional week) will involve completion of the ALSFRS-R and -EX questionnaires only and will use the standard version of both questionnaires administered by an assessor certified to use this scale. For patients with significantly limited verbal communication skills, it is acceptable to have the patient's caregiver mediate the responses during the telephone administration and/or to send the completed questionnaires during the follow-up administrations by mail or electronically (e-mail). In these cases, patients will be invited to complete the readministration questionnaires by email or telephone (depending on their preference) at a time that would be consistent with normal telephone readministrations for other patients (to maintain an identical time interval between readministrations). Similarly, for patients with limited ability to grasp writing instruments, it will be permissible to complete questionnaires in collaboration with the caregiver, but always on the basis of patient-reported data. At the first administration of all questionnaires (including the self-assessment version of the ALSFRS-R questionnaire) at the centre, the patient will be asked to complete the questionnaires without further clarification from the investigator. Similarly, during the first telephone readministration involving only the self-assessment questionnaires, the individual questions and the options included in them will be read to the patient only, with no opportunity for the patient to ask additional questions, in order to maintain the self-assessment nature of all tests used. The standard (non-self-assessment) version of the ALSFRS-R questionnaire will be administered at the second telephone follow-up by TRICALS (Treatment Research Initiative to Cure ALS, an organisation authorised to use the questionnaire in a certified manner) certified assessors and will be administered in accordance with the training provided by this initiative. Initial and repeat administrations will be conducted by different raters. Evaluators conducting telephone readministrations will not be aware of patients' initial test results at the first administration or their clinical status. The procedures for working with human subjects were approved by the Ethics Committee of the Brno University Hospital on 11.05.2023, reference number 06-110522/EK, project number 85/22. Statistical data processing will be performed using SPSS 29 statistical software (IBM Corporation, 2020, Armonk, New York, USA). ### Conditions Module **Conditions:** - Amyotrophic Lateral Sclerosis **Keywords:** - Amyotrophic lateral sclerosis - ALS - ALSFRS-R - ALSFRS-EX - ALSAQ-40 - Borg scale - Frontal assessment battery - Scale - Questionnaire ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Content Validity: Ensures the questionnaire comprehensively covers the construct it intends to measure. **Measure:** Questionnaire validity (ALSFRS-R(-EX), ALSAQ-40, DYALS) **Time Frame:** 01.09.2024 **Description:** Test-Retest Reliability: Intraclass Correlation Coefficient (ICC) Pearson or Spearman Correlation Coefficient Cohen's Kappa (κ) Bland-Altman Plot **Measure:** Questionnaire reproducibility (Czech versions of ALSFRS-R(-EX), ALSAQ-40, DYALS) **Time Frame:** 01.09.2024 **Description:** Test-Retest Reliability: Intraclass Correlation Coefficient (ICC) Pearson or Spearman Correlation Coefficient Cohen's Kappa (κ) Bland-Altman Plot **Measure:** Agreement between self reported and non-self reported version of ALSFRS-R **Time Frame:** 01.09.2024 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. diagnosed amyotrophic lateral sclerosis (ALS) meeting the EMG (electromyographic) criteria: * Gold Coast criteria or * at least clinically probable ALS according to Awaji-Shima criteria 2. willing and able to comply with all protocol procedures Exclusion Criteria: * none **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** ALS patients in colaborating Centres - University Hospital Brno (CZ), Motol University Hospital (CZ), Martin University Hospital (SK), University Hospital Bratislava (SK) - who are willing to participate in study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Adam Betik, MD **Phone:** +420532232503 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Eva Vlckova, doc,MD,PhD **Phone:** +420532233221 **Role:** CONTACT #### Locations **Location 1:** **City:** Brno **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Adam Betik, MD - **Phone:** +420532232503 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Eva Vlckova, doc,MD,PhD - **Phone:** +420532233221 - **Role:** CONTACT **Country:** Czechia **Facility:** University Hospital Brno **State:** Czech Republic **Status:** RECRUITING **Zip:** 62500 #### Overall Officials **Official 1:** **Affiliation:** Masaryk University, University Hospital Brno. **Name:** Eva Vlckova, doc,MD,PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000057177 - Term: TDP-43 Proteinopathies - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M18879 - Name: Motor Neuron Disease - Relevance: HIGH - As Found: Lateral Sclerosis - ID: M4024 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M28759 - Name: TDP-43 Proteinopathies - Relevance: LOW - As Found: Unknown - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T349 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis - ID: T4699 - Name: Primary Lateral Sclerosis - Relevance: HIGH - As Found: Lateral Sclerosis ### Condition Browse Module - Meshes - ID: D000016472 - Term: Motor Neuron Disease - ID: D000000690 - Term: Amyotrophic Lateral Sclerosis - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426017 **Brief Title:** Impact of FTO Gene Variation on Body Composition, Lipid Profile, Insulin Resistance, Advanced Glycation End-Products and Ghrelin Levels in Response to Hypocaloric, Protein Rich-Diet **Official Title:** Impact of FTO Gene Variation on Body Composition, Lipid Profile, Insulin Resistance, Advanced Glycation End-Products and Ghrelin Levels in Response to Hypocaloric, Protein Rich-Diet #### Organization Study ID Info **ID:** ASRB001624/IF/IBMS #### Organization **Class:** OTHER **Full Name:** Khyber Medical University Peshawar ### Status Module #### Completion Date **Date:** 2024-07-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Khyber Medical University Peshawar #### Responsible Party **Investigator Affiliation:** Khyber Medical University Peshawar **Investigator Full Name:** Bibi Hajira **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:** Obesity is a widespread disease that basically develops from unhealthy lifestyle and genetics. The Fat-mass and obesity associated (FTO) gene affects appetite and energy intake of the body, thus elevating fat mass and body weight. The single nucleotide polymorphism (SNP) rs9939609 of the FTO gene is a common variant in different ethnic groups, and its A allele is associated with increased body mass and waist circumference. Hence, the carriers of rs9939609 SNP are prone to weight gain if a healthy diet and lifestyle are not maintained. Similarly, high levels of serum cholesterol and triglycerides, while low levels of high-density lipoproteins are observed in carriers of rs9939609 AA genotype. For individuals having FTO rs9939609 A allele, consumption of hypocaloric diets (1500 kcal/day) consisting of high protein foods up to 25-30% of total daily energy intake might help reduce body weight. However, weight loss tends to vary in individuals after consuming the same diet under similar environmental conditions, so it is important to know the effect of different genotypes that might cause this variation. The study aimed to genotype overweight and obese adults for FTO rs9939609 polymorphism and to determine the effect of this polymorphism on body weight, BMI, waist and hip circumferences, lipid profile, insulin sensitivity, ghrelin levels, inflammatory markers and advanced glycation end-products in these individuals after consumption of a hypocaloric, high-protein diet for 4 weeks. ### Conditions Module **Conditions:** - Obesity - Insulin Resistance - Dyslipidemias - Advance Glycation - Inflammation **Keywords:** - Satiety - Food Intake - High protein diet - Obesity - FTO rs9939609 - Ghrelin - Carboxymethyl lysine - Interleukin-6 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** It will be a quasi-experimental study, where 110 individuals with obesity will be allocated into three allele groups i.e. TT, AT and AA based on minor allele frequency. Each participant in the study will go through intervention of high protein, low calorie diet for four weeks. BMI, waist to hip ratio, body composition, lipid profile, fasting glucose level, insulin resistance, advanced glycation end-products will measure at the start and end of the study while hunger hormone will be measured at the start, mid and end of the study. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 110 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 3 meals/day consumed by the participants with daily caloric intake of 800 kcal. 40-60% of the total calories added from both animal and plant proteins. 30% of the total calories added from fats. 20% of the total calories added from carbohydrates. **Intervention Names:** - Other: High Protein Low Calorie Dietary Intervention **Label:** High Protein Low Calorie Diet **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - High Protein Low Calorie Diet **Description:** High Protein Diet: Diet consisting of 40-60% total energy from proteins, \<20% total energy from carbohydrates and \<30% total energy from fats. **Name:** High Protein Low Calorie Dietary Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Body Weight **Time Frame:** Day 0 and day 29 **Measure:** Body Composition **Time Frame:** Day 0 and day 29 **Measure:** Lipid Profile **Time Frame:** Day 0 and day 29 **Measure:** Waist Circumference **Time Frame:** Day 0 and day 29 **Measure:** Hip Circumference **Time Frame:** Day 0 and day 29 **Measure:** HOMA-IR **Time Frame:** Day 0 and day 29 **Measure:** Carboxymethyl lysine levels (CML **Time Frame:** Day 0 and day 29 **Measure:** Interleukinin-6 **Time Frame:** Day 0 and day 29 **Measure:** Hunger Hormone- Ghrelin **Time Frame:** Day 1(Fasting and postprandial), Day 7(Fasting and postprandial) and Day 28(Fasting and postprandial). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1Overweight (BMI ≥ 25kg/m2) and obese (BMI ≥ 30kg/m2) individuals. * Both genders. * Age 18-50 years. Exclusion Criteria: * Children, pregnant and lactating women * Individuals taking medication for weight loss or undergoing any other weight loss dietary intervention. * Individuals having lost more than 5 pounds in the past three-month period. * Patients with any psychiatric disorders, heart, liver, kidney disease, diabetes or abnormal thyroid function. **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:** Dr Bibi Hajira, PhD **Phone:** 03015287833 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Dr Muhammad Omar Malik, PhD **Phone:** 03335196243 **Role:** CONTACT #### Locations **Location 1:** **City:** Peshawar **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bibi Hajira, PhD - **Phone:** 0301-5287833 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Omar Malik, PhD - **Phone:** 0333-5196243 - **Role:** CONTACT ***Contact 3:*** - **Name:** Bibi Hajira, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Omar Malik, PhD - **Role:** SUB_INVESTIGATOR **Country:** Pakistan **Facility:** Khyber Medical University **State:** KPK **Status:** RECRUITING **Zip:** 25100 **Location 2:** **City:** Peshawar **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dr Bibi Hajira, PhD - **Phone:** 03015287833 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Dr Muhammad Omar Malik, PhD - **Phone:** 03335196243 - **Role:** CONTACT ***Contact 3:*** - **Name:** Dr Bibi Hajira, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Dr Muhammad Omar, PhD - **Role:** SUB_INVESTIGATOR **Country:** Pakistan **Facility:** Trial Room Institute of Basic Medical Sciences **State:** KPK **Status:** RECRUITING **Zip:** 25100 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Rexrode KM, Carey VJ, Hennekens CH, Walters EE, Colditz GA, Stampfer MJ, Willett WC, Manson JE. Abdominal adiposity and coronary heart disease in women. JAMA. 1998 Dec 2;280(21):1843-8. doi: 10.1001/jama.280.21.1843. **PMID:** 9846779 **Citation:** McMillan DC, Sattar N, McArdle CS. ABC of obesity. Obesity and cancer. BMJ. 2006 Nov 25;333(7578):1109-11. doi: 10.1136/bmj.39042.565035.BE1. No abstract available. **PMID:** 17124223 **Citation:** Karra E, O'Daly OG, Choudhury AI, Yousseif A, Millership S, Neary MT, Scott WR, Chandarana K, Manning S, Hess ME, Iwakura H, Akamizu T, Millet Q, Gelegen C, Drew ME, Rahman S, Emmanuel JJ, Williams SC, Ruther UU, Bruning JC, Withers DJ, Zelaya FO, Batterham RL. A link between FTO, ghrelin, and impaired brain food-cue responsivity. J Clin Invest. 2013 Aug;123(8):3539-51. doi: 10.1172/JCI44403. Epub 2013 Jul 15. **PMID:** 23867619 **Citation:** Zou ZC, -J Mao L, Shi YY, Chen JH, Wang LS, Cai W. Effect of exercise combined with dietary intervention on obese children and adolescents associated with the FTO rs9939609 polymorphism. Eur Rev Med Pharmacol Sci. 2015 Dec;19(23):4569-75. **PMID:** 26698254 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000052439 - Term: Lipid Metabolism Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M10370 - Name: Insulin Resistance - Relevance: HIGH - As Found: Insulin Resistance - ID: M26181 - Name: Dyslipidemias - Relevance: HIGH - As Found: Dyslipidemia - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007333 - Term: Insulin Resistance - ID: D000050171 - Term: Dyslipidemias - ID: D000007249 - Term: Inflammation ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: T11 - Name: Lysine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06426004 **Acronym:** NPH **Brief Title:** Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland **Official Title:** Community Interventions to Address Health Disparities in the Care of Normal Pressure Hydrocephalus (NPH) in Maryland #### Organization Study ID Info **ID:** IRB00028028 #### Organization **Class:** OTHER **Full Name:** Johns Hopkins Bloomberg School of Public Health ### Status Module #### Completion Date **Date:** 2030-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2025-04-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Johns Hopkins Bloomberg School of Public Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study aims to estimate Normal Pressure Hydrocephalus (NPH) prevalence and evaluate health equity gaps in Baltimore and Maryland based on zip codes and race, with a focus on the Black community. Interventions will include educational elements about NPH and three layers targeting patients, Primary Care Providers, and community health workers to enhance care access. Short-term outcomes will measure referrals to specialists, while long-term outcomes will assess healthcare utilization. The study aims to identify and reduce racial disparities in NPH care access, informing intervention strategies for NPH and other surgical areas. **Detailed Description:** This proposal responds to an established need for developing an evidence-based and community-informed approach to address health disparities in specialty surgical clinics where barriers to accessing care are multiplied along each level of the referral pathway. The study will focus on Normal Pressure Hydrocephalus (NPH) related care - a clinical syndrome characterized excess cerebrospinal fluid (CSF) in the brain resulting in symptoms of falls, dementia, and urinary incontinence, that is treated surgically by shunting to remove excess fluid from the brain. This disorder afflicts an estimated about 750,000 Americans, and prevalence increases with age. Limited information regarding racial and socioeconomic contributing factors associated with diagnosis and treatment is available. Studies show NPH goes underdiagnosed in the USA. In the first part of the study the investigators will estimate NPH prevalence, the health equity gap in Baltimore and greater Maryland (MD), the health equity gap based on Zip Code as a marker of sociodemographic community status, and the health equity gap based on race, looking at the Black community, which comprises over 60% of the Baltimore and 30% in MD population. In the second part of the study, the investigators will develop three layers of interventions that involve educational elements about NPH and evaluate which provides the most benefit including referrals to NPH related care. 1) Patients identified from the first part of the study with possible NPH symptoms will receive intervention 2) Patients, and the Primary Care Providers (PCPs) receive intervention, and 3) patients, and PCP receive intervention and with additional community health workers (CHWs) assisting providers with managing the patient care including referrals, addressing socioeconomic barriers, transportation to receive care. The success of these interventions will be evaluated by short-term outcomes such as referrals to specialists including neurologists and neurosurgeons every 6 months, and long-term outcomes such as healthcare utilization including screening for shunt surgery within 12 months. This study aims to identify racial disparities in access to NPH care and intervention outcomes will evaluate the effect of different interventions on reducing racial disparities and to help developing a referral system to address the needs of most vulnerable population and Zip Codes in Baltimore and greater MD. Using the results of this study will help to identify gaps, understand the best intervention, and develop intervention strategies not only for NPH but potentially other surgical areas. ### Conditions Module **Conditions:** - Normal Pressure Hydrocephalus - Hakim Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL **Intervention Model Description:** The investigators will develop three layers of interventions that involve educational elements about NPH and evaluate which provides the most benefit including referrals to NPH related care. 1) Patients identified from the first part of the study with possible NPH symptoms will receive intervention 2) Patients, and the Primary Care Providers (PCPs) receive intervention, and 3) patients, and PCP receive intervention and with additional community health workers (CHWs) assisting providers with managing the patient care including referrals, addressing socioeconomic barriers, transportation to receive care. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 660 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients and the patient's family will receive NPH-related education. **Intervention Names:** - Other: patients will receive NPH education - Other: primary care physicians (PCPs) will receive professional NPH education - Other: A community health worker will assist PCP **Label:** Patients and the patient's family **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Primary Care Provider (PCP) will receive NPH education. **Intervention Names:** - Other: primary care physicians (PCPs) will receive professional NPH education - Other: A community health worker will assist PCP **Label:** PCPs Training **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** A community health worker (CHW) will assist PCP. **Intervention Names:** - Other: A community health worker will assist PCP **Label:** CHWs assist PCPs **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients and the patient's family **Description:** Patients will benefit from the Hydrocephalus Association's (HA) educational strategy for idiopathic normal pressure hydrocephalus (iNPH) emphasizes patient collaboration in the development of educational materials specifically for this condition. HA has a library of assets that include PowerPoint presentations, videos, and online and print educational materials. There will be also in-person outreach resulting recruitment, website (the study website and HA website), webform (with a symptom of gait, dementia, and bladder symptoms), YouTube videos. The investigators will also go to the communities like senior centers, health fair, and churches, then we will give a talk about iNPH. These resources will be carefully adjusted to suit low-income demographics, guided by feedback from Baltimore audiences and HA's iNPH volunteers. **Name:** patients will receive NPH education **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - PCPs Training - Patients and the patient's family **Description:** A comprehensive professional development program for PCPs and CHWs, featuring presentations, educational videos, webinars, and tools on iNPH diagnosis, treatment, and care management. Provider Continuing Medical Education (CME) credits will be offered for in-person lectures, aiming to equip PCPs with the skills needed to address iNPH in low-income settings effectively **Name:** primary care physicians (PCPs) will receive professional NPH education **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - CHWs assist PCPs - PCPs Training - Patients and the patient's family **Description:** A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care. **Name:** A community health worker will assist PCP **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** referrals for physical therapy, occupational therapy, psychiatry, neurology - movement disorder specialist, neurology neuropathy specialist, orthopedic surgery, neurosurgery- spine specialist, neuropsychologist **Measure:** number of referrals **Time Frame:** 12 months and 24 months #### Primary Outcomes **Description:** number of referrals for suspicion of NPH to neurologists or neurosurgeons **Measure:** number of referrals **Time Frame:** 6 months **Description:** number of screenings for shunt surgery **Measure:** number of screenings **Time Frame:** 12 months **Description:** number of screenings for shunt surgery **Measure:** number of screenings **Time Frame:** 24 months #### Secondary Outcomes **Description:** number of patients who have received a consultation **Measure:** number of NPH's consultations **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * People over 65 years old who have completed the Annual Wellness Survey (AWV) survey * have a clinical profile in the Hopkins Epic data sets * live in Maryland Exclusion Criteria: * People under 65 years old will be excluded if they have not completed the AWV survey * do not live in Maryland Community Health Worker (CHW) Inclusion Criteria: * certified Community Health Workers from Maryland * completed accredited training by the Maryland Department of Health Primary Care Physician inclusion criteria: * must have patients in Johns Hopkins University AWV **Healthy Volunteers:** True **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hossein Zare, MS, PhD **Phone:** 4106147246 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mark G Luciano, PhD, FACS **Role:** CONTACT #### Locations **Location 1:** **City:** Baltimore **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hossein Zare, MS, PhD - **Phone:** 410-614-7246 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mark G Luciano, PhD, FACS - **Role:** CONTACT ***Contact 3:*** - **Name:** Hossein Zare, MS, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Mark G Luciano, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Sevil Yasar, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 6:*** - **Name:** Darrell Gaskin, MS, PhD - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** Taiwo Akindahunsi, MD - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** Michelle Spencer, MS - **Role:** SUB_INVESTIGATOR ***Contact 9:*** - **Name:** Jiangxia Wang, MA, MS - **Role:** SUB_INVESTIGATOR ***Contact 10:*** - **Name:** Amanda Garzon, MIA - **Role:** SUB_INVESTIGATOR ***Contact 11:*** - **Name:** Roger Clark - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Johns Hopkins University and Hospital **State:** Maryland **Zip:** 21205 **Location 2:** **City:** Baltimore **Country:** United States **Facility:** Johns Hopkins University **State:** Maryland **Zip:** 21205 #### Overall Officials **Official 1:** **Affiliation:** Johns Hopkins Bloomberg School of Public Health **Name:** Hossein Zare, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The study protocol and analytic plan will be freely available. In addition to analytical files, the Stata, Statistical Analysis System (SAS), R codes and programs and data dictionary will be available to researchers approved by one of the study's Principal Investigators to receive data. All papers must include an acknowledgment section that includes the funding source. **Info Types:** - SAP - CSR **IPD Sharing:** YES **Time Frame:** The investigators will release the data 2 years after finishing up the study on April 2030. ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M9907 - Name: Hydrocephalus - Relevance: HIGH - As Found: Hydrocephalus - ID: M9908 - Name: Hydrocephalus, Normal Pressure - Relevance: HIGH - As Found: Normal Pressure Hydrocephalus - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006849 - Term: Hydrocephalus - ID: D000006850 - Term: Hydrocephalus, Normal Pressure ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425991 **Acronym:** MajesTEC-10 **Brief Title:** A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma **Official Title:** A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma #### Organization Study ID Info **ID:** 64007957MMY1008 #### Organization **Class:** INDUSTRY **Full Name:** Janssen Research & Development, LLC #### Secondary ID Infos **Domain:** Janssen Research & Development, LLC **ID:** 64007957MMY1008 **Type:** OTHER **Domain:** EUCT number **ID:** 2023-508426-10-00 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2027-01-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Janssen Research & Development, LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change). ### Conditions Module **Conditions:** - Relapsed or Refractory Multiple Myeloma **Keywords:** - 1-3 prior lines ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. **Intervention Names:** - Drug: Teclistamab **Label:** Arm A: Pre-change Teclistamab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. **Intervention Names:** - Drug: Teclistamab **Label:** Arm B: Post-change Teclistamab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm A: Pre-change Teclistamab - Arm B: Post-change Teclistamab **Description:** Teclistamab will be administered subcutaneously. **Name:** Teclistamab **Other Names:** - JNJ-64007957 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose). **Measure:** Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab **Time Frame:** Cycle 1 (28 days cycle): Predose to Day 7 postdose **Description:** AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose). **Measure:** Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose **Time Frame:** Cycle 1 (28 days cycle): Predose to Day 7 postdose **Description:** Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration. **Measure:** Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1 **Time Frame:** Cycle 3 (28 days cycle): Day 1 #### Secondary Outcomes **Description:** Number of participants with ADAs to teclistamab will be reported. **Measure:** Number of Participants with Anti-drug Antibodies (ADAs) **Time Frame:** Up to approximately 3 years **Description:** Percentage of participants with CR or better response will be reported. CR or better response rate is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria. **Measure:** Percentage of Participants With Complete Response (CR) or Better Response **Time Frame:** Up to approximately 3 years **Description:** An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event. **Measure:** Number of Participants with Adverse Events (AEs) by Severity **Time Frame:** Up to approximately 3 years **Description:** SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important. **Measure:** Number of Participants with Serious Adverse Events (SAEs) **Time Frame:** Up to approximately 3 years **Description:** Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported. **Measure:** Number of Participants with Abnormal Laboratory Results **Time Frame:** Up to approximately 3 years **Description:** Percentage of participants with overall response (PR or better) will be reported. Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria. **Measure:** Percentage of Participants With Overall Response (Partial Response [PR] or Better) **Time Frame:** Up to approximately 3 years **Description:** Percentage of participants with VGPR or better response will be reported. VGPR or better response rate is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria. **Measure:** Percentage of Participants With Very Good Partial Response (VGPR) or Better Response **Time Frame:** Up to approximately 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio * Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line * Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria * Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2 * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study Exclusion Criteria: * Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients * Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed * Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required * Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Study Contact **Phone:** 844-434-4210 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Janssen Research & Development, LLC **Name:** Janssen Research & Development, LLC Clinical Trial **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu **IPD Sharing:** YES **URL:** https://www.janssen.com/clinical-trials/transparency ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010265 - Term: Paraproteinemias - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12058 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: HIGH - As Found: Multiple Myeloma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma ### Condition Browse Module - Meshes - ID: D000009101 - Term: Multiple Myeloma - ID: D000054219 - Term: Neoplasms, Plasma Cell ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425978 **Acronym:** CellularMatrix **Brief Title:** Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit **Official Title:** The Efficacy of the Use of Cellular Matrix / A-CP-HA Kit (Combination of Autologous Platelet-rich Plasma and Non-cross-linked Hyaluronic Acid) Compared to Local Estrogen Therapy (Blissel, Estriol 50 Micrograms/g Vaginal Gel) in Women With Genitourinary Syndrome of Menopause. A Randomized Controlled Trial, With a Second Blind Observer. #### Organization Study ID Info **ID:** FSD-CEL-2023-11 #### Organization **Class:** OTHER **Full Name:** Institut Universitari Dexeus #### Secondary ID Infos **ID:** 2023-507200-31-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Regen Lab SA #### Lead Sponsor **Class:** OTHER **Name:** Fundación Santiago Dexeus Font #### 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 randomized, controlled, non-inferiority trial, that will be performed on 192 women on Menopause (absence of menstruation for at least 12 months), with diagnostic of genitourinary syndrome of menopause (SGM) and a vaginal health index \<15 points, that are sexually active. Patients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatment with two dose of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) separated for a month, and control group that will receive the standard treatment for SGM, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel). Both groups will be follow-up for 3 and 6 month afther treatment, a blind observer will assess the application of the validated scale (VHIS, VHI), and the investigators will do the FSD, symptom record, maturation index, follow-up photography and evaluation of adverse events and treatment compliance and adherence. **Detailed Description:** This study is a randomized, controlled, non-inferiority trial, with a second blind observer, comparing effectiveness of the use of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) to the standard line of treatment, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) in women with genitourinary syndrome of menopause (SGM). Duration of the study estimated is 24 months. A total of 192 menopausal women, with absence of menstruation for at least 12 months, ≤70 years old, that are sexually active and who report symptoms and signs of SGM, with a vaginal health index \<15 points. Patients will be excluded if are in treatment with systemic or local hormonal treatment in the last 3 months, Tamoxifen or Aromatase inhibitor treatments. Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida). Contraindication for vaginal estrogen therapy. Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases. Women who have had pelvic surgery within 6 months. Patients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatment with two dose of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid), separated for a month, and control group that will receive the standard treatment for SGM, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel). Patients will interviewed about their medical history, age of menopause, symptoms related and history of treatments. Evaluation of the Vaginal Health Index (VHIS), Vulvar Health Index (VHI), vaginal pH, and vaginal maturation index (vaginal cytology). The intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia and dysuria) will be measured using a 5-cm visual analog scale (VAS), and a valuation of Female Sexual Distress (FSD) score. Photographic monitoring during all phases of the procedure. Routine laboratory test serology will requested for both groups (valid up to 3 months). Both groups will be follow-up for 3 and 6 month afther treatment, a blind observer will assess the application of the validated scale (VHIS, VHI), and the investigators will do the FSD, symptom record, maturation index, follow-up photography and evaluation of adverse events and treatment compliance and adherence. ### Conditions Module **Conditions:** - Genitourinary Syndrome of Menopause ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 192 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) is a sterile tube designed for use in the preparation of a mixture of PRP and hyaluronic acid, tube is under vacuum allowing the withdrawal of 6 ml of blood and contains: 2 ml of hyaluronic acid gel (20mg/ml, 40 mg per tube) in phosphate buffer. Not crosslinked, hyaluronic acid is obtained from bacterial fermentation, 3 g of inert cell-selector gel, and 0.6 ml of anticoagulant (sodium citrate 4%). Centrifuged at 1,500 g, 3,000 rpm for 5 min. Platelet recovery of more than 70%, granulocyte depletion of 94.3% and red blood cells of 99.5% are achieved. **Intervention Names:** - Drug: Cellular Matrix / A-CP-HA Kit **Label:** Cellular Matrix / A-CP-HA Kit **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Blissel, estriol 50 micrograms/g vaginal gel **Intervention Names:** - Drug: Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) **Label:** Local estrogen therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cellular Matrix / A-CP-HA Kit **Description:** For infiltration, a prior preparation of the region with anesthetic cream is performed, procaine 25 mg/g + lidocaine 25 mg/g (Emla 5% cream) in the vulvar area and vaginal introitus. Occlusion of the area with plastic film is performed for 20 minutes. After asepsis and antisepsis, infiltration is performed with mesotherapy needles 31G 4mm, using the technique of superficial "point-to-point" mesotherapy microinjections, in the vestibule and the first 3 cm of the posterior wall of the vagina. **Name:** Cellular Matrix / A-CP-HA Kit **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Local estrogen therapy **Description:** Blissel®, Estriol vaginal gel 50 micrograms/g, daily application for 15-21 days in a row, then two times a week for 24 weeks (6 months). Application instructions will be explained to the patients. The gel should be applied in the vagina using an applicator with the marked dose, the full applicator should be inserted into the vagina and emptied, preferably at night. **Name:** Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Improvement is defined as having a higher score than the baseline in the Vaginal Health Index (VHIS) **Measure:** Percentage of patients with improved symptomatology. **Time Frame:** at 6 months after treatment #### Secondary Outcomes **Description:** defined as percentage of patients scoring ≥ 15 in the VHIS **Measure:** Healing percentage **Time Frame:** at 6 months after treatment **Measure:** Evolution of Vaginal Health Index **Time Frame:** at 3-months and 6-months follow-up **Measure:** Evolution of Vulvar Health Index **Time Frame:** at 3-months and 6-months follow-up **Measure:** Evolution of vaginal pH **Time Frame:** at 3-months and 6-months follow-up **Measure:** Evolution of Vaginal maturation index (vaginal cytology) **Time Frame:** at 3-months and 6-months follow-up **Description:** measured using a 5-cm visual analog scale (VAS) **Measure:** Evolution of intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) **Time Frame:** at 3-months and 6-months follow-up **Measure:** Incidence of adverse events and serious adverse events **Time Frame:** at 3-months and 6-months follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women ≤70 years old * Women that are sexually active * Women who report symptoms and signs of SGM, with a vaginal health index (VHIS - Bachmann score) \< 15 points. * Women who understand the Spanish language * Willing to participate in the study and sign informed consent. Exclusion Criteria: * Systemic or local hormonal treatment in the last 3 months * Tamoxifen or Aromatase inhibitor treatments * Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida) Contraindication for vaginal estrogen therapy * Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases. * Women who have had pelvic surgery within 6 months. * Women who are unwilling or unable to give informed consent and/or do not comply with the study requirements. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Antonella de Ponte Davi, MD **Phone:** 0034932274700 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ignacio Rodríguez, MSc **Phone:** 0034932274700 **Phone Ext:** 22029 **Role:** CONTACT #### Locations **Location 1:** **City:** Barcelona **Country:** Spain **Facility:** Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus **Zip:** 08037 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### See Also Links **Label:** Related Info **URL:** http://www.dexeus.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - 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: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: T6036 - Name: Menopause - Relevance: HIGH - As Found: Menopause ### Condition Browse Module - Meshes - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Ancestors - ID: D000006728 - Term: Hormones - 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 - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M8116 - Name: Estrogens - Relevance: HIGH - As Found: Nasal spray - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown - ID: M21320 - Name: Citric Acid - Relevance: LOW - As Found: Unknown - ID: M1837 - Name: Sodium Citrate - Relevance: LOW - As Found: Unknown - ID: M14216 - Name: Procaine - Relevance: LOW - As Found: Unknown - ID: M1801 - Name: Lidocaine, Prilocaine Drug Combination - 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: T382 - Name: Citrate - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004967 - Term: Estrogens ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425965 **Brief Title:** Effect of Hybrid Simulation Method on Advanced Life Support Application of Nursing Students **Official Title:** Effect of Hybrid Simulation Method on Advanced Life Support Application of Nursing Students #### Organization Study ID Info **ID:** 641752 #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) ### Status Module #### Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Yagmur Sen **Investigator Title:** Research Assistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The use of simulation in nursing education is an effective way to provide professional skills and enrich learning experiences while protecting patient safety. When the literature is examined, it is seen that simulation is frequently used in advanced life support training. The aim of the study is to examine the effects of advanced life support training in adults, which will be carried out with high-reality simulator/model simulation, web-based simulation and hybrid simulation methods, on the knowledge and skills of nursing students. It has been determined that training provided with hybrid simulation contributes to the professional development of students by creating individualized and interactive learning environments, and that students can more easily transfer the knowledge they have acquired in the educational environment to clinical practice. As a hybrid simulation method in the study; It is planned to use a combination of high-reality simulator/model, which has been proven to be effective in the development of psychomotor skills, and the web-based simulation method, which is effective in creating permanent learning by allowing students to repeat more. In the literature; It has been stated that the level of knowledge and skills gradually decreases after 6-10 weeks of advanced/basic life training. It is anticipated that the web-based simulation method will be effective in providing permanent learning as it gives learners the opportunity to repeat during/after the training. Based on these assumptions, it is planned to develop an adult advanced life support training program consisting of theory and practice, in which the development of students' professional skills is supported through hybrid simulation applications, and the students are provided with the opportunity to repeat. Since the study tests 3 different interventions, it is anticipated that it will lay the groundwork for subsequent studies and provide comprehensive information about simulation-based education practices. ### Conditions Module **Conditions:** - Advanced Life Support - Simulation Training - Nursing Education **Keywords:** - simulation - Advanced life support - Nursing education - Nursing student - Web-based simulation - High fadility ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The first group will receive advanced life support training with a high reality simulator. **Intervention Names:** - Other: Advanced life support training with high reality simulator **Label:** Intervention Group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The second group will receive advanced life support training with web-based simulation method. **Intervention Names:** - Other: Advanced life support training with web-based simulation **Label:** Intervention Group 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The third group will receive advanced life support training with a hybrid simulation method using both high reality simulator and web-based simulation. **Intervention Names:** - Other: Advanced life support training with hybrid simulation **Label:** Intervention Group 3 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Group 1 **Description:** The training consists of theoretical and practical training and lasts 3 hours a day, 5 days, for a total of 15 hours. The first 3 days of the training are theoretical, 1 day is laboratory practice and 1 day is evaluation. Theoretical courses start with introductions and sharing the content of the training and aim to provide the basic professional knowledge and skills required for advanced life support practice (diagnosis of cardiac arrest, ensuring airway patency, monitoring, cardiac rhythm diagnosis, drugs used during advanced life support and advanced life support algorithm). The laboratory application of the training is carried out with a high reality simulator in line with the information (15 min), scenario implementation (15 min) and debriefing sessions (30 min), respectively. **Name:** Advanced life support training with high reality simulator **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Intervention Group 2 **Description:** The training consists of theoretical and practical training and lasts 3 hours a day, 5 days, for a total of 15 hours. The first 3 days of the training are theoretical, 1 day is laboratory practice and 1 day is evaluation. Theoretical courses start with introductions and sharing the content of the training and aim to provide the basic professional knowledge and skills required for advanced life support practice (diagnosis of cardiac arrest, ensuring airway patency, monitoring, cardiac rhythm diagnosis, drugs used during advanced life support and advanced life support algorithm). The laboratory application of the training is carried out by web-based simulation method. Students participate in the web-based simulation application developed by the researcher. **Name:** Advanced life support training with web-based simulation **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Intervention Group 3 **Description:** The training consists of theoretical and practical training and lasts 3 hours a day, 5 days, for a total of 15 hours. The first 3 days of the training are theoretical, 1 day is laboratory practice and 1 day is evaluation. Theoretical courses start with introductions and sharing the content of the training and aim to provide the basic professional knowledge and skills required for advanced life support practice (diagnosis of cardiac arrest, ensuring airway patency, monitoring, cardiac rhythm diagnosis, drugs used during advanced life support and advanced life support algorithm). The laboratory application of the training is carried out with the hybrid simulation method in which high reality simulator and web-based simulation method are applied together. Students first apply the web-based simulation developed by the researcher. Then they perform the practice on the high reality simulator. **Name:** Advanced life support training with hybrid simulation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It was developed by the researchers in line with the literature to determine the level of knowledge of the participants about advanced life support practice. **Measure:** Advanced Life Support Knowledge Test **Time Frame:** before training, immediately after training, 1 month after training, 3 months after training **Description:** It was developed by the researcher based on the European Resuscitation Council 2021 Advanced Life Support Algorithm. **Measure:** Advanced Life Support Skill Checklist **Time Frame:** before training, immediately after training, 1 month after training, 3 months after training #### Secondary Outcomes **Description:** The scale was developed by Jeffries and Rizzolo in 2006. The Turkish validity and reliability study of the scale was conducted by Ünver et al. in 2015. The scale aims to determine students' satisfaction and self-confidence towards learning in simulation environment. The scale consists of two sub-dimensions, "Satisfaction with Current Learning" and "Confidence in Learning", and a total of 12 items. The scale is a 5-point Likert scale (1: Strongly disagree, 2: Disagree, 3: Undecided, 4: Agree, 5: Strongly Agree) and each item is scored as 1 being the lowest and 5 being the highest. The higher the total score obtained from the scale, the higher the student satisfaction and self-confidence in learning. **Measure:** Student Satisfaction and Self-confidence in Learning Scale **Time Frame:** immediately after training **Description:** The scale was developed by Jeffries and Rizzolo in 2006 and the Turkish validity and reliability study was conducted by Ünver et al. in 2015. The scale consists of 20 items and 2 sections. The first part measures simulation design elements, and the second part measures how important the simulation application is for students. An increase in the total score obtained in the first part of the scale indicates that the best simulation design elements are applied in the simulation application; an increase in the total score obtained from the second part indicates that the importance given by the student to the simulation experience is high. **Measure:** Simulation Design Scale **Time Frame:** immediately after training **Description:** In this study, a semi-structured interview form developed by the researchers in line with the literature was used to determine the opinions of the students participating in the Advanced Life Support in Adults Training Program about the training program. The form consists of questions aimed at determining the theoretical content of the training program, the effectiveness of teaching methods (web-based simulation, simulation with high reality simulator, hybrid simulation), the effects of the training on learning retention, and suggestions for improving the training program. **Measure:** Semi-structured Interview Form **Time Frame:** immediately after training ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * To complete first aid, internal medicine nursing, surgical nursing courses, * Volunteering to participate in the research. * Having experienced the simulation application before Exclusion Criteria: * Fail the specified courses (taking FF) * Not having taken first aid course/training before * Not having experienced the simulation application before. Disqualification criteria: * Being absent for more than 20% of the theoretical part of the planned advanced life support training * Not participating in the laboratory applications of the planned advanced life support training * Not having completed the planned web-based simulation application **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yagmur Sen **Phone:** +905061258462 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yagmur Sen - **Phone:** +905061258462 - **Role:** CONTACT **Country:** Turkey **Facility:** Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing **State:** Şişli **Status:** RECRUITING **Zip:** 34381 ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425952 **Acronym:** EquiCMT **Brief Title:** Impact of Sensory, Motor and Vestibular Deficit on the Postural Stability of CMT Patients **Official Title:** Impact of Sensory, Motor and Vestibular Deficit on the Postural Stability of CMT Patients #### Organization Study ID Info **ID:** OSRSCP-EquiCMT #### Organization **Class:** OTHER **Full Name:** IRCCS San Raffaele ### Status Module #### Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** IRCCS San Raffaele #### Responsible Party **Investigator Affiliation:** IRCCS San Raffaele **Investigator Full Name:** Stefano Previtali **Investigator Title:** Head Neuromuscular Repair Unit **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Charcot-Marie-Tooth (CMT), a therapeutically orphan neuromuscular disease affecting one in 2,500 people, represents a challenge to the medical and scientific communities. Physiotherapeutic-rehabilitative strategies play a crucial role in the management of CMT, particularly addressing balance impairment, a key disabling symptom. However, clinical studies in this field are limited. Our study aims to investigate the impact of strengh and somatosensory deficits on static and dynamic balance in CMT patients. The Investigators also aim to explore the involvement of the vestibular system and its correlation with postural instability. Furthermore, the Investigators seek to evaluate relationships between neurochemical biomarkers offering valuable insights for future targeted clinical studies. **Detailed Description:** A total of 60 patients will be recruited. To ensure adequate representation of the subgroups of interest, 10 patients with CMT1A (PMP22 gene duplication) and 10 patients with CMT2, regardless of their genotype, will be included. Additionally, three control groups, each comprising 10 subjects, will be included. The first group will consist of patients with motor symptoms, including those with hereditary motor neuropathy (HMN, 10 patients) or distal myopathy (MD, 10 patients). The second group will include patients with solely sensory symptoms, genetic neuropathies, or purely sensory acquired neuropathies such as HSN and neuropathies from anti-MAG antibodies. Finally, the third group will be composed of 10 healthy subjects. Each control subject will have comparable level of disability (motor or somatosensory), age, and gender to the enrolled CMT patients. All participants must meet the following inclusion criteria to take part in the study: * Age 18 years or older * Subject has documented diagnosis of one of the following diseases (except from healthy controls): * Hereditary sensory-motor neuropathy (CMT) confirmed by genetic analysis * Hereditary motor neuropathy (HMN) confirmed by genetic analysis * Hereditary sensory neuropathy (HSN) confirmed by genetic analysis * Hereditary distal myopathy (MD) confirmed by genetic analysis * Acquired sensory neuropathy: anti-MAG antibody neuropathy confirmed by neurophysiological, clinical and serological assessment. The presence of any one of the following exclusion criteria will lead to the exclusion of the subject: * Inability to maintain an upright position without assistance * Presence of systemic, neurological (except for the neuropathies and hereditary myopathies under study), psychiatric, orthopedic or rheumatological diseases that may affect evaluation * Mini Mental State Examination (MMSE)14 score less than 28 * History of alcohol or substance abuse * Partecipation in intensive motor rehabilitation programs in the last three months. ### Conditions Module **Conditions:** - Hereditary Neuropathy **Keywords:** - CMT neuropathy - equilibrium ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients with sensory-motor genetic neuropathy **Label:** CMT patients #### Arm Group 2 **Description:** Patients with motor genetic neuropathy **Label:** Motor patients #### Arm Group 3 **Description:** Patients with sensory neuropathy **Label:** Sensory patients #### Arm Group 4 **Description:** Patients with distal myopathy **Label:** Myopathic patients ### Outcomes Module #### Primary Outcomes **Description:** How sensory and motor deficit influence the postural equilibrium **Measure:** Postural equilibrium **Time Frame:** 12 months #### Secondary Outcomes **Description:** how vestibular system influence the postural equilibrium **Measure:** Vestibular equilibrium **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * CMT or HMN or sensory neuropathy or distal myopathy Exclusion Criteria: * unable to stand * other neurological, psychiatric, or orthopedic disorders * MMSE \<28 * alcohol abuse * intensive rehabilitation program **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 10 CMT1A patient, 10 CMT2, 10 HMN, 10 sensory neuropathies, 10 distal myopathies, 10 healthy controls. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Stefano C Previtali, MD **Phone:** 00390226433036 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Benedetta Sorrenti, MD **Phone:** 00390226433036 **Role:** CONTACT #### Locations **Location 1:** **City:** Milano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stefano C Previtali, MD - **Phone:** 00390226433036 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Benedetta Sorrenti, MD - **Phone:** 00390226433036 - **Role:** CONTACT **Country:** Italy **Facility:** Dept. of Neurology, IRCCS Ospedale San Raffaele **Status:** RECRUITING **Zip:** 20132 #### Overall Officials **Official 1:** **Affiliation:** IRCCS Ospedale San Raffaele **Name:** Stefano C Previtali, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425939 **Brief Title:** Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance **Official Title:** Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance #### Organization Study ID Info **ID:** PEP-2401 #### Organization **Class:** INDUSTRY **Full Name:** PepsiCo Global R&D ### Status Module #### Completion Date **Date:** 2024-09-30 **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:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** PepsiCo Global R&D #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Heart rate variability (HRV) is a measure of the variation in time between each heartbeat. It is an indirect and ubiquitous biomarker of performance readiness and recovery measured by most consumer-grade wearable fitness trackers. However, there is little documented on the relationship between HRV, training load, and performance measures in the Real-World. Whoop wrist-worn activity trackers have been validated against the gold-standard Electrocardiography (ECG) for HRV and HR measurements. Whoop leverages photoplethysmography (PPG) technology to continuously track (HR, HRV, respiratory rate, energy expenditure) and provides, daily, individual insights, trends, and coaching to improve strain, sleep, and recovery. Research has demonstrated that heart rate variability (HRV) guided training may be more optimal compared to predetermined training for aerobic exercise improvements. The purpose of this study is to assess the feasibility of providing personalized training recommendations based on HRV measured by a consumer-grade wearable (Whoop) in a real-world setting to better understand the HRV relationship with performance. **Detailed Description:** The purpose of this study is to determine if Training Intensity (%HRmax in min.) during Low HRV periods acutely (below HRV baseline next day and consecutive days) and chronically (weeks below previous weeks HRV baseline) will have a negative relationship with Post-Test Performance Metrics as measured by Force Plates, which could lead to personalized training recommendations using HRV. The Investigators conducted a pilot study using Whoop devices to monitor 50 subjects for 3 months and observed that individuals had High Training Load (above their baseline) on Low HRV days (below their baseline) on over 200 days. The Investigators hypothesize seeing similar High Training Load on Low HRV days during this study and would like to understand that relationship with Performance Primary objective: To determine if Training Intensity (%HRmax in min.) during Low HRV periods acutely (below HRV baseline next day and consecutive days) and chronically (weeks below previous weeks HRV baseline) will have a negative relationship with Post-Test Performance Metrics as measured by Force Plates. Secondary Objective : Measure and determine if subjective journal entries (mood, anxiety, recovery, etc.) are related to HRV, RHR, Sleep Quantity, and Sleep Efficiency. ### Conditions Module **Conditions:** - Heart Rate Variability - Exercise **Keywords:** - exercise performance - HRV - training load - Whoop - wrist worn tracker - exercise recovery ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy adults moderately trained in resistance exercises **Intervention Names:** - Other: Force plate assessment - Device: Whoop wrist band **Label:** Single group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Single group **Description:** On Day 1, Day 45 and Day 90: 3x drop jumps, 2 min rest, 3x counter movement jumps, 2 min rest, 3x dynamic push-ups **Name:** Force plate assessment **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Single group **Description:** Whoop wrist worn activity tracker (not a medical device) collects continuous data via smartphone app. This is a marketed device. This is not a device study. **Name:** Whoop wrist band **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** % HRmax (in minutes) measured by force plates **Measure:** Training Intensity **Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90) **Description:** Reactive Strength Index in cm/s using force plates **Measure:** Performance **Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90) **Description:** W/kg using force plates **Measure:** Peak Power Output **Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90) **Description:** (cm) using force plates **Measure:** Jump Height **Time Frame:** Change from baseline (Day1) to mid-study (Day 45) and end of study (Day 90) **Description:** (N)) using force plates **Measure:** Dynamic Push Ups Peak Force **Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90) #### Secondary Outcomes **Description:** True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin **Measure:** Correlation of subjective measures to Heart Rate Variability (HRV) **Time Frame:** Daily for 90 days **Description:** True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin **Measure:** Correlation of subjective measures to resting heart rate (RHR) **Time Frame:** Daily for 90 days **Description:** True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin **Measure:** Correlation of subjective measures to sleep quantity **Time Frame:** Daily for 90 days **Description:** True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin **Measure:** Correlation of subjective measures to sleep efficiency **Time Frame:** Daily for 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Actively participating in resistance training 2-4 times per week. 2. Age 21-50 years, male and female. 3. Subject is willing to refrain from vigorous exercise (light physical activity only) 24 hours prior to visit(s). 4. Subject is willing to avoid alcohol consumption 24 hours prior to visit(s). 5. Subject is willing to provide consent. 6. Subject is able to continuously wear a wrist-worn device, including during sleep, except when submerged underwater (i.e., swimming, bathing). Exclusion Criteria: 1. Individual has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the project/study protocol, which might confound the interpretation of the project/study results or put the person at undue risk. 2. Those with a medical history that would interfere with the results of this study. 3. Under the care of a physician. 4. Skin sensitivities. 5. Sleep disorders. 6. Using prescription medications that would impact sleep. 7. If female, you are not pregnant, planning to get pregnant or currently breast feeding. 8. Smoker. 9. Not able to wear wrist-worn device continuously. 10. Lack of proficiency in English. 11. Lack of proficiency or access to the internet and email address. 12. Participation in another clinical trial within the past 30 days. 13. Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Corey Ungaro, PhD **Phone:** 815-382-3213 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Eric Freese, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Corey Ungaro, PhD - **Phone:** 815-382-3213 - **Role:** CONTACT **Country:** United States **Facility:** PepsiCo R&D, Gatorade Sports Science Institute **State:** Illinois **Status:** RECRUITING **Zip:** 60607 **Location 2:** **City:** Frisco **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Anthony Wolfe, M.S. - **Phone:** 469-920-2862 - **Role:** CONTACT **Country:** United States **Facility:** PepsiCo R&D, Gatorade Sports Science Institute **State:** Texas **Status:** RECRUITING **Zip:** 75034 #### Overall Officials **Official 1:** **Affiliation:** PepsiCo, Inc. Sports Science **Name:** Corey Ungaro, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425926 **Brief Title:** Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors **Official Title:** A Phase 1/2, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of GIM-531 as a Single Agent and in Combination With Anti-PD-1 in Advanced Solid Tumors #### Organization Study ID Info **ID:** GIM531-CT01 #### Organization **Class:** INDUSTRY **Full Name:** Georgiamune Inc ### Status Module #### Completion Date **Date:** 2026-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Georgiamune Inc #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531 exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs). **Detailed Description:** GIM531-CT01 is a Phase 1/2 open label, first-in-human, multicenter study. The Phase 1 portion will include a dose escalation with GIM-531 administered as a single agent. Additionally, there will be a dose expansion portion at the safety-cleared dose levels with participants allocated 1:1 within the proposed therapeutic range to accrue additional data for determining the safety profile, pharmacokinetics (PK) profile, pharmacodynamic (PD) effects and early anti-tumor activity of GIM-531. In Phase 2, GIM-531will be administered to participants with advanced/metastatic cutaneous melanoma who have progressed following treatment with an anti-PD-1 therapy. ### Conditions Module **Conditions:** - Melanoma Stage IV - Solid Tumor **Keywords:** - PD-1 resistance - PD-1 resistant/refractory ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** GIM-531 administered orally daily **Intervention Names:** - Drug: GIM-531 **Label:** Phase 1 Single Agent **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** GIM-531 administered orally daily in combination with anti-PD-1 therapy **Intervention Names:** - Drug: GIM-531 - Drug: Anti-PD-1 monoclonal antibody **Label:** Phase 2 Combination Treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Phase 1 Single Agent - Phase 2 Combination Treatment **Description:** GIM-531 administered orally daily **Name:** GIM-531 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Phase 2 Combination Treatment **Description:** Continued treatment with anti-PD-1 therapy **Name:** Anti-PD-1 monoclonal antibody **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading **Measure:** Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerability **Time Frame:** Through study completion, an average of 1 year **Description:** To identify dose limiting toxicities with GIM-531 **Measure:** Dose limiting toxicities (DLT) with GIM-531 **Time Frame:** 21 days #### Secondary Outcomes **Description:** To preliminarily evaluate the Cmax in patients with advanced solid tumors **Measure:** Maximum plasma concentration (Cmax) **Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose **Description:** To preliminarily evaluate Tmax in patients with advanced solid tumors **Measure:** Time to maximum plasma concentration (Tmax) **Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose **Description:** To preliminarily evaluate the AUC in patients with advanced solid tumors **Measure:** Area under the plasma concentration versus time curve (AUC) **Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose **Description:** To identify objective response rate in patients with advanced solid tumors **Measure:** Objective response rate (ORR) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate BOR in patients with advanced solid tumors **Measure:** Best overall response (BOR) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate DOR in patients with advanced solid tumors **Measure:** Duration of response (DOR) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate DCR in patients with advanced solid tumors **Measure:** Disease control rate (DCR) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate PFS in patients with advanced solid tumors **Measure:** Progression-free survival (PFS) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate OS in patients with advanced solid tumors, including 12 month OS **Measure:** Overall survival (OS) rates **Time Frame:** From study enrollment until death from any cause (OS rate assessed at 12 months) **Description:** To analyze tumor expression of immunological markers **Measure:** Tumor expression of immunological markers **Time Frame:** Cycle 1 Days 1, 2 and 8; Cycle 2 Days 1 and 8; Cycle 3 Day 1 (each Cycle is 14 days) ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: * Written informed consent * Cytologically or histologically confirmed locally advanced or metastatic solid tumor that has progressed on standard therapy or for which no standard therapy exist; or be intolerant of standard therapy * Have not received an experimental drug within 4 weeks or 5 half-lives (whichever is shorter) of Screening or already be enrolled in a clinical study * ECOG performance status 0-1 * Laboratory and ECG assessments within 28 days of enrollment including acceptable cardiac, renal, and hepatic functions * Agree to baseline core needle biopsy or archival (within 12 months of screening) tumor submission; Note: Participants whose only site(s) of disease are in areas considered moderate or high risk for biopsy complications may be enrolled without a fresh biopsy upon Sponsor approval. * Non pregnant participants; female participants of child bearing potential with non-sterile partners agree to use an effective form of contraception from the time of first dose of study drug (or 14 days prior to first dose for oral contraception) until 7 months after the last dose of study drug. Effective forms of contraception include hormonal (injection or oral), double barrier method, or intrauterine device. Non-sterile male participants with sexual partners of childbearing potential agree to use a barrier contraception method and agree to not donate sperm from the time of first dose of study drug until 4 months after the last dose of study drug. * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 Phase 2 Specific Inclusion Criteria (in addition to above inclusion criteria): * Have confirmed unresectable Stage III or metastatic Stage IV cutaneous melanoma that has radiographically progressed (as confirmed by imaging assessed by the Investigator) on an approved first-line single-agent or combination anti-PD-1 therapy * Receiving anti-PD-1 therapy as their first line of treatment at the time of enrollment and amenable to continuing anti-PD-1 therapy during the study Key Exclusion Criteria: * Ongoing \>Grade 1 toxicity from prior therapy according to Common Terminology Criteria for Adverse Events v5.0 (Note: Grade 2 alopecia and Grade 2 sensory neuropathy are not exclusionary) * Has melanoma with documented BRAF mutation (Phase 2 only) * Has known brain metastases, except participants with the following: * Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the first administration of study drug; Note: Participants receiving steroids for brain metastases must be either off steroids or on a stable, or decreasing dose, of \<10 mg daily of prednisone (or equivalent) in order to be eligible for enrollment; and * No ongoing neurological symptoms related to the anatomic location of the brain metastases. Note: Neurological symptoms that are considered sequelae to treatment for brain metastases are allowed. * Has known structural cardiac disease * Has known serious arrythmia, serious dysrhythmia, history of long QT syndrome, or clinically relevant cardiac conduction abnormalities * Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * At time of screening, is receiving systemic steroid therapy (greater than or equal to 10 mg/day of prednisone or equivalent) or is taking any immunosuppressive therapy; Note: Use of topical, inhaled, nasal, or ophthalmic steroids is allowed. * Has active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) * Has a history of, or currently has, an acquired or primary (congenital) immunodeficiency; * Has had prior anti-cancer treatment with chemotherapeutic agents or immune modulating agents within \<4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study drug. * Has received a live vaccine within 30 days of first dose of study drug; * Has had or has planned major surgery within 2 weeks of the first dose of study drug; * Inability to swallow an oral dose of a medication (eg, oral capsules) * Is taking medications that are considered strong inducers or inhibitors of CYP2C8 or CYP3A4/5, P-glycoprotein (P-gp), breast cancer resistant protein (BCRP), or sensitive substrates of P-gp and BCRP (Appendix C) that cannot be discontinued at least 1 week prior to first dose of study drug and for the duration of the study. * Is taking drugs that modify gastric pH, such as proton-pump inhibitors (PPIs) or H2 blockers. Antacids such as calcium carbonate or aluminum hydroxide-based products are permitted. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jayadev Sureddi, CBCC CRO **Phone:** (661) 616-6453 **Role:** CONTACT #### Locations **Location 1:** **City:** Bakersfield **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nicole Ward - **Phone:** 661-862-8548 - **Role:** CONTACT **Country:** United States **Facility:** Comprehensive Blood and Cancer Center **State:** California **Status:** RECRUITING **Zip:** 93309 **Location 2:** **City:** Billings **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Matt Adler - **Phone:** 406-238-6894 - **Role:** CONTACT **Country:** United States **Facility:** Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana **State:** Montana **Status:** RECRUITING **Zip:** 59102 ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: 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: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000008545 - Term: Melanoma ### 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: M4230 - Name: Antibodies, Monoclonal - Relevance: HIGH - As Found: Chemotherapy - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000906 - Term: Antibodies - ID: D000000911 - Term: Antibodies, Monoclonal ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425913 **Brief Title:** Effects of Cold and Kinesio Taping in Individuals With Rotator Cuff Tendonitis **Official Title:** Short-Term Effects of Cold Therapy and Kinesio Taping on Pain and Upper Extremity Functionality in Individuals With Rotator Cuff Tendonitis: A Randomized Study #### Organization Study ID Info **ID:** 71306642 #### Organization **Class:** OTHER **Full Name:** Bezmialem Vakif University ### Status Module #### Completion Date **Date:** 2023-02-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-02-26 **Type:** ACTUAL #### Start Date **Date:** 2021-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **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:** Bezmialem Vakif University #### Responsible Party **Investigator Affiliation:** Bezmialem Vakif University **Investigator Full Name:** Elif Durgut **Investigator Title:** Asst. Prof **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Rotator cuff tendonitis (RCT) is one of the most common shoulder pathologies, causing pain, limitation of shoulder joint movements, and impaired function. Patient education, medical treatment, corticosteroid injections, physiotherapy rehabilitation approaches are the most common treatment options applied to alleviate the symptoms of RCT. Despite these various treatment methods, there are currently no specific guidelines regarding the most appropriate and effective intervention for RCT treatment. This is mainly because adequate, high-quality studies are lacking in RCT management. To the best of our knowledge, no studies have evaluated the effects of Kinesio Taping (KT), which has become a popular approach in recent years, and Cold Therapy (CT), which has often been used as a therapeutic agent since immemorial, on individuals with RCT. In this regard, this study aimed to investigate and compare the short-term effects of KT and CT on pain and upper extremity functionality in individuals with RCT. ### Conditions Module **Conditions:** - Rotator Cuff Tendinitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Participants were unaware of their group assignments. A therapist who was unaware of the intervention protocol and assigned groups performed the assessment procedures **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** KT was applied to the symptomatic shoulder of participants. **Intervention Names:** - Other: Kinesio Taping (KT) - Other: standardized home exercise program **Label:** Kinesio Taping **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Ice packs were applied to the symptomatic shoulder of participants. **Intervention Names:** - Other: Cold Therapy (CT) - Other: standardized home exercise program **Label:** Cold Therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Kinesio Taping **Description:** KT was applied to the symptomatic shoulder at the end of the baseline assessment by a certificated physiotherapist with over ten years of experience in Kinesio taping. After three days, participants were re-evaluated. KT application has been made according to the protocol for rotator cuff impingement or tendonitis including inhibition and correction techniques. **Name:** Kinesio Taping (KT) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Cold Therapy **Description:** The initial application was administered by the physiotherapist. In a sitting position, a pack was wrapped in a thin towel and placed on the affected shoulder joint, including the painful locations. During the application, the participant was closely observed for discomfort or adverse reactions (redness, burning, numbness, itching, ...). The cold application was continued for 20 minutes.After the first application, participants were instructed to apply ice for 20 minutes five times a day for three days at home or work. **Name:** Cold Therapy (CT) **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Cold Therapy - Kinesio Taping **Description:** All participants performed standardized home exercise program, including shoulder isometric and stretching exercises were . A physiotherapist taught the exercise program until the participants were able to exercise accurately on their own. All participants were instructed to perform the exercises three times a day for three days. **Name:** standardized home exercise program **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Numerical Rating Scale (NRS): The pain severity was assessed using the NRS, for which a subject was asked to rate his/her perceived pain. A 11-point NRS from 0 to 10 which 0 means no pain and 10 means the worst possible pain was scored during night, rest, and activity. **Measure:** Pain intensity **Time Frame:** At baseline and after three days of the applications **Description:** Disability of the Arm, Shoulder and Hand (DASH) Questionnaire): DASH is a self-reported questionnaire designed for evaluating the functional level of upper extremity. It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items). Each item is scored between 1 and 5. A score of 1 indicates no strain, and a score of 5 indicates inability to perform the specified activity. **Measure:** Function **Time Frame:** At baseline and after three days of the applications **Description:** Shoulder Pain and Disability Index (SPADI): The SPADI is a self-administered questionnaire developed to measure the pain and disability associated with shoulder pathology in people with shoulder pain of musculoskeletal, neurogenic, or undetermined origin. It consists of 13 items that assess two domains: a 5-item subscale that measures pain and an 8-item subscale that measures disability. The items of both domains were scored on a numerical rating scale ranging from 0 to 10, where 0=no pain/no disability and 10= worst pain imaginable/so difficult required help. **Measure:** Function **Time Frame:** At baseline and after three days of the applications #### Secondary Outcomes **Description:** Range of Motion (ROM): The active range of motion (ROM) of the affected shoulder, including flexion, abduction, external rotation, and internal rotation, was assessed using a universal goniometer following the protocol reported by the American Academy of Orthopaedic Surgeons (AAOS) **Measure:** Range of Motion **Time Frame:** At baseline and after three days of the applications **Description:** Jamar® hydraulic hand dynamometer were used to assess hand-grip strength of the affected side. **Measure:** Grip strength **Time Frame:** At baseline and after three days of the applications ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * RCT diagnosis * Excluding other shoulder pathologies by magnetic resonance imaging (MRI) and specific tests Exclusion Criteria: * Glenohumeral joint dislocation/subluxation; * Acromioclavicular sprain; * Rotator cuff tear; * Glenohumeral joint instability; * Calcific tendinitis of the shoulder; * Acromioclavicular joint pathologies, * Hyperlaxity; * Any fracture in the shoulder; * Diabetes, thyroid and any vascular or rheumatologic disease; * Glenohumeral joint deformities; * Superior labrum anteroposterior (SLAP) lesion; * Shoulder pain lasting more than six months; * History of shoulder surgery; * Intra-articular steroid injection **Maximum Age:** 60 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Bezmialem Vakıf University **Zip:** 34060 ### IPD Sharing Statement Module **Description:** IPD will not be shared **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000013708 - Term: Tendon Injuries - ID: D000014947 - Term: Wounds and Injuries - ID: D000012421 - Term: Rupture - ID: D000070599 - Term: Shoulder Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M27013 - Name: Tendinopathy - Relevance: HIGH - As Found: Tendinitis - ID: M624 - Name: Rotator Cuff Injuries - Relevance: HIGH - As Found: Rotator Cuff Tendinitis - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M15241 - Name: Rupture - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000052256 - Term: Tendinopathy - ID: D000070636 - Term: Rotator Cuff Injuries ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425900 **Brief Title:** A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients **Official Title:** Histologic and LCMS Evaluation of the Sebaceous Gland Changes Induced by Clascoterone Cream 1% #### Organization Study ID Info **ID:** DCS-115-22 #### Organization **Class:** INDUSTRY **Full Name:** Sun Pharmaceutical Industries Limited ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sun Pharmaceutical Industries Limited #### 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:** to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment ### Conditions Module **Conditions:** - Acne Vulgaris ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Winlevi (Clascoterone) cream 1% **Label:** Winlevi (Clascoterone ) cream 1% **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Winlevi (Clascoterone ) cream 1% **Description:** Dosed twice daily (BID) **Name:** Winlevi (Clascoterone) cream 1% **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** The primary efficacy endpoint is the histologic demonstration of reduced facial sebaceous gland size when comparing baseline to 3 months of clascoterone cream 1 % treatment. **Time Frame:** Week 12 #### Secondary Outcomes **Measure:** The secondary efficacy endpoint is the changes in sebum composition when comparing baseline to 3 months of clascoterone cream 1 % treatment. **Time Frame:** Week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Female or male subjects age 18-35 years. 2. Subjects of all Fitzpatrick skin types. 3. Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity. 4. Subjects with oily facial skin. 5. Subjects who agree to use only the study product and nothing else to the face. 6. Subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face. 7. Subjects agree not to introduce any new skin care products during the study. 8. No known medical conditions that, in the investigator's opinion, may interfere with study participation. 9. Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects." 10. Subjects are dependable and able to follow directions and willing to comply with the schedule of visits. 11. Subjects in generally good physical and mental health. Exclusion Criteria: 1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics. 2. Subjects who are not willing to use the assigned study product to their face as instructed. 3. Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry. 4. Subjects who have used any OTC products on the face for 2 weeks. 5. Subjects with clinically significant unstable medical disorders. 6. Subjects who are unwilling or unable to comply with the requirements of the protocol. 7. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. 8. Subjects currently participating in any other clinical trial. **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Head Clinical development **Phone:** 9122 66455645 **Role:** CONTACT #### Locations **Location 1:** **City:** High Point **Country:** United States **Facility:** Dermatology Consulting Services, PLLC **State:** North Carolina **Zip:** 27262 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017486 - Term: Acneiform Eruptions - ID: D000012871 - Term: Skin Diseases - ID: D000012625 - Term: Sebaceous Gland Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3512 - Name: Acne Vulgaris - Relevance: HIGH - As Found: Acne Vulgaris - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M19751 - Name: Acneiform Eruptions - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15439 - Name: Sebaceous Gland Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000152 - Term: Acne Vulgaris ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425887 **Brief Title:** Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter **Official Title:** Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter #### Organization Study ID Info **ID:** Smartwatch vs Holter study #### Organization **Class:** OTHER **Full Name:** Chinese University of Hong Kong ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chinese University of Hong Kong #### Responsible Party **Investigator Affiliation:** Chinese University of Hong Kong **Investigator Full Name:** Tam Tsz Kin **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 lifetime risk for development of atrial fibrillation, the commonest sustained arrhythmia in adults, is estimated to be 24%-27% for individuals of 40 years or older. Previous work showed that annual new diagnosis of AF is 11000-26000 in Hong Kong. Other arrhythmia such as supraventricular arrhythmia or premature beats were also common and of clinical significance. 12-lead ECG is a first line investigation for patients with suspected paroxysmal arrhythmia, but it has a low diagnostic yield with its 10-30 seconds recordings. 24-hour Holter exam is the usual next step of diagnosis. The diagnostic yield of Holter varies according to indication but is generally low at 1%-12%. This is because paroxysmal arrhythmia may not happen every day. In addition, even if arrhythmia is picked up in Holter, patient may not register the symptom, making the symptom arrhythmia correlation problematic. Despite limitations, the demand for Holter exam is still high. In Prince of Wales Hospital, a tertiary referral centre with a catchment of about 1 million populations, the waiting time for a routine Holter exam is 3 years. Smartwatch has gained popularity over past years as an adjunct to smartphone. Latest generations of smartwatch were equipped with wearer-initiated ECG rhythm strip recording capabilities. Smartwatch has evolved to become a health tracker with arrhythmia detection capabilities. It was found to be a useful tool for atrial fibrillation screening in general population. Other arrhythmias, such as supraventricular tachycardia, premature beats, and abnormal ECG patterns associated with sudden cardiac death could also be detected with smartwatch ECG recordings. Apple Heart study was the largest study utilizing smartwatch for arrhythmia detection. The general population was screened for atrial fibrillation using irregular pulse algorithm. The study found a 84% concordance rate between irregular pulse notification and ECG patches. Therefore, investigators propose to conduct a study to compare its diagnostic yield with Holter, in patients with suspected arrhythmia and see if smartwatch recording following a systematic protocol for four-weeks will have better arrhythmia diagnosis yield than a 24-hour Holter exam. ### Conditions Module **Conditions:** - Arrythmia ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 185 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** not interventional **Name:** Smart watch **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Compare the percentage of patients with significant arrhythmia diagnosed, between smartwatch rhythm recording and 24-hour Holter arm Significant arrhythmia is defined as the presence of any one of the following * Sustained supraventricular tachycardia (\>=30 seconds) * Atrial fibrillation (\>=30 seconds) * Ventricular tachycardia of more than 3 consecutive beats * Significant AV block (defined as 2nd degree Mobitz type II or 3rd degree heart block) * HR less than 40 while awake. * Pause \> 2 seconds while awake (for both smartwatch and Holter), or \>3 seconds while asleep (for Holter only) * Premature ventricular complex with an overall burden of more than 10% **Measure:** Comparison **Time Frame:** through study completion, an average of 1 month #### Secondary Outcomes **Description:** describe the detection rate of smartwatch for various arrhythmia **Measure:** Detection rate **Time Frame:** through study completion, an average of 1 month **Description:** describe patients' preference on using which modality (smartwatch or Holter) to record their arrhythmia, by means of a questionnaire **Measure:** Preference **Time Frame:** through study completion, an average of 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All patients referred for out-patient Holter exam from age 18 - 80 years old 2. The following indications for Holter exam will be allowed for recruitment * Palpitation * Pre-syncope * Dizziness Exclusion Criteria: 1. Patients with a prior ECG diagnosis to explain the symptom 2. Primary symptom is syncope 3. Patient who has no clear indication for Holter exam 4. Pregnant ladies 5. Patients who failed to make a successful recording despite teaching attempts. 6. Patients who cannot read English or Chinese version of consent. 7. Anticipation of non-compliance with recording protocol. 8. Patients who do not have a compatible smart phone (Android 9.0 or newer, or iOS15 or newer) 9. Patients under custody **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients being referred for out-patient Holter exam will be reviewed for eligibility. Individuals aged 18 to 80 with indications for Holter including palpitation, pre-syncope \& dizziness without meeting any exclusions will be invited to participate in this study. ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - 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: M4453 - Name: Arrhythmias, Cardiac - Relevance: HIGH - As Found: Arrhythmia - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001145 - Term: Arrhythmias, Cardiac ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425874 **Brief Title:** The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery **Official Title:** The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery: an Observational Cohort Study #### Organization Study ID Info **ID:** SYSKY-2024-147-01 #### Organization **Class:** OTHER **Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Status Module #### Completion Date **Date:** 2035-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2035-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **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:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University **Investigator Full Name:** Chen Kai **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:** Breast-conserving surgery is the standard treatment for young breast cancer patients, while mastectomy with breast reconstruction is an alternative for those who are not eligible for Breast-conserving surgery. Several studies have compared the quality of life and patient satisfaction among individuals receiving different types of surgery (Breast-conserving surgery, mastectomy alone, or mastectomy with reconstruction). For example, Meghan R. demonstrated that patients undergoing Breast-conserving surgery experience a higher quality of life compared to those undergoing mastectomy with breast reconstruction, whereas J. Dauplat's study showed that patients who undergo mastectomy with breast reconstruction report a higher quality of life than those who undergo mastectomy alone. However, the investigators hypothesize that the advantages of a specific type of surgery over another, such as Breast-conserving surgery versus breast reconstruction, may vary among patients with different socioeconomic factors. For instance, the benefits of breast reconstruction over Breast-conserving surgery might be more pronounced in young patients who require a more socially active lifestyle. Additionally, the benefits of one type of surgery over another may also vary at different time points during post-operative follow-up. Furthermore, it is worth noting that most current studies have been conducted in Caucasian populations. In contrast to Caucasians, Asians typically have smaller breast volumes, potentially leading to more significant defects after Breast-conserving surgery and possibly poorer aesthetic outcomes. Therefore, a study focusing on Asian young breast cancer populations is necessary. **Detailed Description:** This study is a prospective, observational cohort study aiming to enroll 1000 young Chinese breast cancer patients and assign them to three arms: Breast-conserving surgery, mastectomy alone, and mastectomy with breast reconstruction, based on their clinical decisions and preferences. Clinicopathological features (age,Tumor, Node, Metastasis stages, pathological features, etc.), socioeconomic determinants (education level, income, insurance status, marital status, occupational status, personality, etc.), treatment information (neoadjuvant chemotherapy or not, post-operative complications), and survival (local recurrence, metastasis) will be recorded. All patients will be followed at 6 and 12 months for the first year after diagnosis, then yearly thereafter for an additional 9 years (for a total follow-up of at least 10 years following diagnosis). During the post-operative follow-up, quality of life, psychological well-being, decision regret, surgical information, treatment costs, and surveillance-follow-up will be recorded. The primary endpoint of this study is the quality of life, assessed using the Breast-Q and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Secondary endpoints include decisional conflict scale, decision regret scales, and the Hospital Anxiety and Depression Scale (HADS). The primary and secondary endpoints will be compared among the three arms, and the impact of socioeconomic determinants at baseline on these endpoints will also be investigated. Additionally, the investigators aim to explore the potential of a novel subtyping method for young breast cancer patients using selected socioeconomic determinants. ### Conditions Module **Conditions:** - Breast Cancer - Surgery - Quality of Life ### 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 **Intervention Names:** - Procedure: Breast-conserving surgery **Label:** Breast-conserving surgery #### Arm Group 2 **Intervention Names:** - Procedure: Mastectomy **Label:** Mastectomy #### Arm Group 3 **Intervention Names:** - Procedure: Mastectomy with reconstruction **Label:** Mastectomy with reconstruction ### Interventions #### Intervention 1 **Arm Group Labels:** - Breast-conserving surgery **Description:** Breast-conserving surgery **Name:** Breast-conserving surgery **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Mastectomy **Description:** Mastectomy without reconstruction **Name:** Mastectomy **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Mastectomy with reconstruction **Description:** Any type of reconstruction(include implant and autologous) **Name:** Mastectomy with reconstruction **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Exploring the Influence of Socioeconomic, Psychological, and Clinicopathological Features on Primary and Secondary Outcomes. **Measure:** Influence of Socioeconomic, Psychological, and Clinicopathological Factors on Outcomes **Time Frame:** Pre-operation and 10 years #### Primary Outcomes **Description:** Utilizing the BREAST-Q questionnaire, this measure assesses women's self-reported satisfaction with their breasts and associated quality of life, encompassing psychosocial, sexual, and physical well-being. Scores range from 0 (worst) to 100 (best), with higher scores indicating a more favorable outcome.Assessment is conducted preoperatively and 10 years postoperatively. **Measure:** Participant's breast satisfaction assessed by BREAST-Q questionnaire version 2.0 **Time Frame:** Pre-operation and 10 years **Description:** Assessed through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), this self-administered questionnaire consists of 30 items designed to evaluate the health-related quality of life among cancer patients. For questions 1 to 28, a 4-point scale is used, ranging from 1 ("Not at all") to 4 ("Very much"), with lower scores indicating a more positive outcome. Questions 29 and 30 employ a 7-point scale, with scores ranging from 1 ("Very poor") to 7 ("Excellent"), where higher scores signify a better outcome.Assessment is conducted 10 years postoperatively. **Measure:** Participant's health-related quality of life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) **Time Frame:** 10 years #### Secondary Outcomes **Description:** Administered pre-operation, this tool evaluates the patient's conflict regarding the decision for surgery. Each item is rated on a Likert Scale with five responses, ranging from 0 ("Not at All") to 4 ("Extremely"), resulting in a total score ranging from 0 (Less conflicted) to 100 (Highly conflicted).Assessment is conducted preoperatively. **Measure:** Participant's decisional conflict assessed by Decisional Conflict Scale questionnaire **Time Frame:** Pre-Operative **Description:** Conducted during follow-up sessions, this assessment captures the patient's sentiments and remorse regarding the treatment-related decision to undergo surgery. Five items specifically inquire about feelings of regret. Scores range from 0 to 100, with a higher score indicating a greater level of decision-related regret.Assessment is conducted 10 years postoperatively. **Measure:** Participant's decision regret assessed by Decision Regret Scale questionnaire **Time Frame:** 10 years **Description:** Administered during follow-ups, this scale measures the patient's psychological change. The HADS comprises two 7-item subscales assessing depression and anxiety symptoms separately. Higher scores indicate greater levels of depression and/or anxiety.Assessment is conducted preoperatively and 10 years postoperatively. **Measure:** Participant's anxiety and depression assessed by Hospital Anxiety and Depression Scale questionnaire **Time Frame:** Pre-operation and 10 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 18 and 50 years old. * The surgery time and procedure have been confirmed, and the surgical informed consent and research informed consent forms have been signed. * Informed consent obtained from patient. * Unilateral Breast Cancer. * Good health,the patient is able to tolerate general anesthesia and surgery, with an ECOG performance status of ≤2 points. * No history of breast/axillary radiation therapy. * Willing and capable of complying with the study protocol visits, treatment plans, and other research procedures. Exclusion Criteria: * Bilateral breast cancer. * Inflammatory breast cancer. * Stage IV breast cancer. * Physical examination and imaging suggest tumor infiltration into the skin, pectoralis major muscle, and other adjacent tissues. * Patients unable to tolerate surgery due to coagulation abnormalities. * In patients without evidence of breast cancer in the contralateral breast, requesting contralateral prophylactic mastectomy. * In patients who have undergone surgical treatment for breast cancer (including mastectomy, breast-conserving surgery, and mastectomy with implant reconstruction), requesting secondary breast surgery. * Patients with a history or current diagnosis of other malignancies, excluding thyroid cancer. * The conditions considered unsuitable for inclusion by researchers. **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Young breast cancer women. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kai Chen, MD **Phone:** 15920164730 **Phone Ext:** 86 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Name:** Kai Chen, MD - **Role:** CONTACT **Country:** China **Facility:** Sun Yat-sen Memorial Hospital,Sun Yat-sen University **State:** Guangdong **Status:** RECRUITING ### IPD Sharing Statement Module **Description:** The study protocol and the raw and clean data for analysis will be shared among the participated researchers. Non-researchers could obtain relevant informations from the researchers upon reasonable requests. **IPD Sharing:** NO ### References Module #### References **Citation:** Dominici L, Hu J, Zheng Y, Kim HJ, King TA, Ruddy KJ, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Wong JS, Partridge AH, Rosenberg SM. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAMA Surg. 2021 Oct 1;156(10):e213758. doi: 10.1001/jamasurg.2021.3758. Epub 2021 Oct 13. Erratum In: JAMA Surg. 2021 Oct 1;156(10):989-990. **PMID:** 34468718 **Citation:** Hanson SE, Lei X, Roubaud MS, DeSnyder SM, Caudle AS, Shaitelman SF, Hoffman KE, Smith GL, Jagsi R, Peterson SK, Smith BD. Long-term Quality of Life in Patients With Breast Cancer After Breast Conservation vs Mastectomy and Reconstruction. JAMA Surg. 2022 Jun 1;157(6):e220631. doi: 10.1001/jamasurg.2022.0631. Epub 2022 Jun 8. **PMID:** 35416926 **Citation:** Diao K, Lei X, He W, Jagsi R, Giordano SH, Smith GL, Caudle A, Shen Y, Peterson SK, Smith BD. Patient-reported Quality of Life After Breast-conserving Surgery With Radiotherapy Versus Mastectomy and Reconstruction. Ann Surg. 2023 Nov 1;278(5):e1096-e1102. doi: 10.1097/SLA.0000000000005920. Epub 2023 May 26. **PMID:** 37232937 **Citation:** Rosenberg SM, Dominici LS, Gelber S, Poorvu PD, Ruddy KJ, Wong JS, Tamimi RM, Schapira L, Come S, Peppercorn JM, Borges VF, Partridge AH. Association of Breast Cancer Surgery With Quality of Life and Psychosocial Well-being in Young Breast Cancer Survivors. JAMA Surg. 2020 Nov 1;155(11):1035-1042. doi: 10.1001/jamasurg.2020.3325. **PMID:** 32936216 **Citation:** Riba LA, Gruner RA, Alapati A, James TA. Association between socioeconomic factors and outcomes in breast cancer. Breast J. 2019 May;25(3):488-492. doi: 10.1111/tbj.13250. Epub 2019 Apr 15. **PMID:** 30983100 **Citation:** Flanagan MR, Zabor EC, Romanoff A, Fuzesi S, Stempel M, Mehrara BJ, Morrow M, Pusic AL, Gemignani ML. A Comparison of Patient-Reported Outcomes After Breast-Conserving Surgery and Mastectomy with Implant Breast Reconstruction. Ann Surg Oncol. 2019 Oct;26(10):3133-3140. doi: 10.1245/s10434-019-07548-9. Epub 2019 Jul 24. **PMID:** 31342397 **Citation:** Dauplat J, Kwiatkowski F, Rouanet P, Delay E, Clough K, Verhaeghe JL, Raoust I, Houvenaeghel G, Lemasurier P, Thivat E, Pomel C; STIC-RMI working group. Quality of life after mastectomy with or without immediate breast reconstruction. Br J Surg. 2017 Aug;104(9):1197-1206. doi: 10.1002/bjs.10537. Epub 2017 Apr 12. **PMID:** 28401542 ## 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: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425861 **Brief Title:** A First in Human Trial Evaluating THB335 in Healthy Participants **Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of THB335 in Healthy Participants #### Organization Study ID Info **ID:** THB335-101 #### Organization **Class:** INDUSTRY **Full Name:** Third Harmonic Bio, Inc. ### Status Module #### Completion Date **Date:** 2025-03-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Third Harmonic Bio, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a double blind, randomized, placebo-controlled, Phase 1 study in two parts: single ascending doses and food effect (Part 1) and multiple ascending doses (Part 2). **Detailed Description:** THB335 is a highly potent and selective inhibitor of the receptor tyrosine kinase KIT that is expressed on mast cells. The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and food effect profile of THB335 administered orally in healthy participants. ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Single dose of THB335 fasted **Intervention Names:** - Drug: THB335 single dose **Label:** THB335 single dose **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Single dose of THB335 fasted and then fed **Intervention Names:** - Drug: THB335 fasted/fed **Label:** THB335 fasted and fed **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 14 days of multiple ascending doses of THB335 **Intervention Names:** - Drug: THB335 multiple dose **Label:** THB335 multiple dose **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Single dose of placebo capsule, fasted **Intervention Names:** - Drug: Single dose placebo **Label:** Single dose placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Description:** Single dose of placebo capsule fasted and then fed **Intervention Names:** - Drug: Placebo fasted/fed **Label:** Fasted and fed placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 6 **Description:** 14 days of multiple doses of placebo capsule **Intervention Names:** - Drug: Multiple dose placebo **Label:** Multiple dose placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - THB335 single dose **Description:** Single dose as oral capsule **Name:** THB335 single dose **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Single dose placebo **Description:** Single dose as oral capsule **Name:** Single dose placebo **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - THB335 fasted and fed **Description:** Single dose fasted and fed as oral capsule **Name:** THB335 fasted/fed **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Fasted and fed placebo **Description:** Single dose fasted and fed as oral capsule **Name:** Placebo fasted/fed **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - THB335 multiple dose **Description:** Multiple ascending doses oral capsule **Name:** THB335 multiple dose **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Multiple dose placebo **Description:** Multiple doses oral capsule **Name:** Multiple dose placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Number of Participants with Treatment-Related Adverse Events **Time Frame:** Part 1 Day 1 through Day 9 (end of study), and Part 2 Day 1 through Day 29 (end of study) #### Secondary Outcomes **Measure:** Maximum observed plasma concentration (Cmax) **Time Frame:** Part 1, and Part 2 on Day 1. Part 2 on Day 14 **Measure:** Time to Cmax (Tmax) **Time Frame:** Part 1, and Part 2 on Day 1. Part 2 on Day 14 **Measure:** Area under the plasma concentration-time curve (AUC) **Time Frame:** Part 1, and Part 2 on Day 1. Part 2 on Day 14 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations * Males or females, of any race, between 18 and 65 years of age, inclusive. * Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures * Body weight of ≥ 50.0 kg for men and ≥ 45.0 kg for women and Body Mass Index (BMI) of 17.5-32.0 kg/m2 (inclusive) at Screening Exclusion Criteria: * Significant history or clinical manifestation of cancer or any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder * Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study * A positive urine drug screen/alcohol breath test * The participant currently smokes, vapes, or uses nicotine-containing products. **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:** Third Harmonic Bio **Phone:** 617-915-6680 **Role:** CONTACT #### Locations **Location 1:** **City:** Miami **Contacts:** ***Contact 1:*** - **Name:** Principle Investigator - **Role:** CONTACT **Country:** United States **Facility:** QPS Miami **State:** Florida **Status:** RECRUITING **Zip:** 33143 #### Overall Officials **Official 1:** **Affiliation:** QPS Holdings LLC **Name:** Principal Investigator **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425848 **Acronym:** HF2 Registry **Brief Title:** HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry **Official Title:** Hemodynamic Frontiers in Heart Failure Registry #### Organization Study ID Info **ID:** STUDY00147383 #### Organization **Class:** OTHER **Full Name:** University of Kansas Medical Center ### Status Module #### Completion Date **Date:** 2030-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2030-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-10-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-02-29 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Kansas Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research. **Detailed Description:** Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional. ### Conditions Module **Conditions:** - Heart Failure **Keywords:** - Pulmonary Artery (PA) pressure monitor ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** OTHER #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 3 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who underwent PA pressure implantation from January 1, 2019 will be identified for registry participation. Patients who were implanted before November 8, 2022 will be considered enrolled in the retrospective arm of the registry and may not need to consent if consent waiver is granted by the institutional IRB (Institutional Review Board). **Intervention Names:** - Device: Observational **Label:** Retrospective arm #### Arm Group 2 **Description:** Patients will be identified as eligible for PA pressure sensor implant by a heart failure cardiologist. Patients will consent for device implant and procedure (right heart catheterization) as per standard of care. Patients may also consent to registry participation as per local institutional guidelines and requirements. **Intervention Names:** - Device: Observational **Label:** Prospective arm ### Interventions #### Intervention 1 **Arm Group Labels:** - Prospective arm - Retrospective arm **Description:** We are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors. **Name:** Observational **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Hemodynamic data such as mean PA pressure in mmHg, PA systolic pressure in mmHg, PA diastolic pressures in mmHg, will be collected at the time of implant of PA pressure sensor and at 3 months, 6 months, 12 months, 24 months and 36 months post implant. **Measure:** Change in hemodynamics **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant. **Description:** Echo data such as Left Ventricular Ejection Fraction (LVEF) percentage will be collected at implant and at 3 months, 6 months, 12 months, 24 months and 36 months if available. **Measure:** Changes in Echocardiogram (ECHO) **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** Medications changes such as type of diuretics, will be collected after implant and at 3 months, 6 months, 12 month, 24 months and 36 months. We are not collecting any doses or frequencies. **Measure:** Medication changes **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** Sodium levels, reported as millimoles per liter (mmol/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant. **Measure:** Sodium **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** Potassium level, reported as milliequivalents per liter (mEq/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant. **Measure:** Potassium **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** Hemoglobin concentration (Hb) reported as grams of hemoglobin per deciliter of blood (g/dL). Labs will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Measure:** Hemoglobin **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** BNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Measure:** B-type natriuretic peptide (BNP) **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** NT-proBNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Measure:** aminoterminal pro B-type natriuretic peptide (NT-proBNP) **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization. 2. Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II). Exclusion Criteria: 1. Patients less than 18 years of age. 2. Pregnant women at the scheduled time of PA pressure sensor implant. 3. Patients unable or unwilling to have continuity of care in the heart failure clinic. **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients who have been or will be implanted with PA pressure sensor. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kartik Munshi, MPH **Phone:** 913-945-6445 **Role:** CONTACT #### Locations **Location 1:** **City:** La Jolla **Contacts:** ***Contact 1:*** - **Name:** Timothy Jordan, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Thomas Heywood, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Scripps Health **State:** California **Status:** RECRUITING **Zip:** 92037 **Location 2:** **City:** Bloomington **Contacts:** ***Contact 1:*** - **Name:** Maya Guglin, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Maya Guglin, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Indiana University **State:** Indiana **Status:** RECRUITING **Zip:** 47401 **Location 3:** **City:** Kansas City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kartik Munshi, MPH - **Role:** CONTACT ***Contact 2:*** - **Name:** Hirak Shah, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Kansas Medical Center **State:** Kansas **Status:** RECRUITING **Zip:** 66160 **Location 4:** **City:** Maplewood **Contacts:** ***Contact 1:*** - **Name:** Terrie-Ann Benjamin, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Terrie-Ann Benjamin, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Fairview Health **State:** Minnesota **Status:** NOT_YET_RECRUITING **Zip:** 55109 **Location 5:** **City:** Minneapolis **Contacts:** ***Contact 1:*** - **Name:** Sarah Schwager, RN - **Role:** CONTACT ***Contact 2:*** - **Name:** Mosi Bennett, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Minneapolis Heart Institute Foundation/ Allina Health **State:** Minnesota **Status:** RECRUITING **Zip:** 55407 **Location 6:** **City:** Kansas City **Contacts:** ***Contact 1:*** - **Name:** Timothy Fendler, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Timothy Fendler, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Saint Luke's Health System **State:** Missouri **Status:** RECRUITING **Zip:** 64131 **Location 7:** **City:** Raleigh **Contacts:** ***Contact 1:*** - **Name:** Elizabeth Volz, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Elizabeth Volz, MS - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of North Carolina/ Rex Hospital, Inc. **State:** North Carolina **Status:** RECRUITING **Zip:** 27607 **Location 8:** **City:** Portland **Contacts:** ***Contact 1:*** - **Name:** Christy Lenhart, RN - **Role:** CONTACT ***Contact 2:*** - **Name:** Jacob Abraham, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Providence Heart Institute **State:** Oregon **Status:** RECRUITING **Zip:** 97225 **Location 9:** **City:** Columbia **Contacts:** ***Contact 1:*** - **Name:** Suzanne Amaker - **Role:** CONTACT ***Contact 2:*** - **Name:** Patrick McCann, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Prisma Health **State:** South Carolina **Status:** RECRUITING **Zip:** 29203 **Location 10:** **City:** Sioux Falls **Contacts:** ***Contact 1:*** - **Name:** Orvaar Jonsson, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Orvaar Jonsson, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Sanford Health **State:** South Dakota **Status:** RECRUITING **Zip:** 57104 **Location 11:** **City:** Austin **Contacts:** ***Contact 1:*** - **Name:** Kunjan Bhatt, MS - **Role:** CONTACT ***Contact 2:*** - **Name:** Kunjan Bhatt, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Austin Heart **State:** Texas **Status:** RECRUITING **Zip:** 78756 **Location 12:** **City:** Houston **Contacts:** ***Contact 1:*** - **Name:** Saba Khan - **Role:** CONTACT ***Contact 2:*** - **Name:** Ashrith Guha, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Arvind Bhimaraj, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Houston Methodist DeBakey Heart and Vascular Center **State:** Texas **Status:** RECRUITING **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** University of Kansas Medical Center **Name:** Hirak Shah, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425835 **Acronym:** VR **Brief Title:** Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments **Official Title:** Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study) #### Organization Study ID Info **ID:** UMonastir2024 #### Organization **Class:** OTHER **Full Name:** University of Monastir ### Status Module #### Completion Date **Date:** 2026-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-03-14 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Monastir #### Responsible Party **Investigator Affiliation:** University of Monastir **Investigator Full Name:** Pr. Semir Nouira **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:** Study and evaluate the effectiveness of virtual reality in pain management. **Detailed Description:** Study and evaluate the effectiveness of virtual reality in pain management.This is an open prospective observational study carried out at Urgences Fattouma Bourgiba Monastir. For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned. * If initial VAS \>5 and intolerable: patients will immediately use painkillers and will be excluded from the study. * If initial VAS \<=5 or \> 5 but tolerable: Only VR glasses are used as an analgesic. If during the procedure the patient describes intolerable pain: the VAS will be noted, and the patient will use a rescue analgesic (intranasal ketamine or other at the discretion of the attending physician). The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol. The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care. The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted. ### Conditions Module **Conditions:** - Pain and Anxiety - Dislocation - Suture ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol. The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care. The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted. **Name:** VR device **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** occurrence of adverse events, tolerance to glasses, patient satisfaction (Likert Satisfaction Scale) and max VAS during the procedure. **Measure:** occurrence of adverse events and patient satisfaction **Time Frame:** 3 hours #### Primary Outcomes **Description:** frequency of success (%) (use of emergency analgesics) **Measure:** frequency of success **Time Frame:** 30 minutes #### Secondary Outcomes **Description:** reduction in pain assessed by the visual analog scale (mm) **Measure:** reduction of pain **Time Frame:** 30 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 09 and 24 years * suturing a wound * changing a dressing * lumbar puncture, * peripheral venous line * blood test * intramuscular injection * reduction of a fracture * casting or plastering. Exclusion Criteria: * impaired consciousness * epilepsy * wound/infection covering the helmet area * headache * intellectual/mental retardation * nausea, vomiting * patient already included in the protocol * pain requiring immediate medical attention. analgesic (VAS \>5 and described as intolerable). **Maximum Age:** 24 Years **Minimum Age:** 9 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned. * If initial VAS \>5 and intolerable: patients will immediately use painkillers and will be excluded from the study. * If initial VAS\<=5 or \> 5 but tolerable: Only VR glasses are used as an analgesic. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** NOUIRA Semir, PR **Phone:** 73106000 **Phone Ext:** 216 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** GANNOUN IMEN, ARC **Phone:** 73106000 **Phone Ext:** 216 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - 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 - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M7385 - Name: Joint Dislocations - 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: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425822 **Acronym:** CLASS-VA **Brief Title:** Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias **Official Title:** Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias #### Organization Study ID Info **ID:** EC-2023-281 #### Organization **Class:** OTHER **Full Name:** Universitair Ziekenhuis Brussel ### Status Module #### Completion Date **Date:** 2027-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **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:** Universitair Ziekenhuis Brussel #### Responsible Party **Investigator Affiliation:** Universitair Ziekenhuis Brussel **Investigator Full Name:** Andrea Sarkozy **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a CHA2DS2-VASc score ≥ 2 points. The study cohort will be compared to a historical cohort of patients with diagnosed atrial fibrillation in a propensity-matched fashion. The main questions it aims to answer are: * Are the left atrial electroanatomical changes a consequence or a precursor to the development of atrial fibrillation? * Are the left atrial electroanatomical findings different between patients with atrial fibrillation and those at high risk of developing it? * What is the prognostic impact of left atrial pathologic changes in patients without diagnosed atrial fibrillation in terms of cardiovascular outcomes? ### Conditions Module **Conditions:** - Atrial Remodeling ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Inclusion criteria: * Age ≥ 18 years old. * Absence of a prior history of atrial fibrillation or flutter. * Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2. Exclusion criteria: * Presence of thrombus in the left atrial appendage. * Complications related to the index procedure. * Insufficient quality of the left atrial electroanatomical map. **Intervention Names:** - Diagnostic Test: Left atrial electroanatomical mapping **Label:** Left atrial mapping group in patients without atrial fibrillation ### Interventions #### Intervention 1 **Arm Group Labels:** - Left atrial mapping group in patients without atrial fibrillation **Description:** Left atrial electroanatomical mapping (substrate and functional mapping) **Name:** Left atrial electroanatomical mapping **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Other Outcomes **Description:** Episodes diagnosed via a single-lead ECG tracing or a complete 12-lead ECG lasting at least 30 seconds, or AHRE episodes detected by any cardiac implantable electronic device (CIED), lasting at least 5 minutes. **Measure:** Incidence of atrial fibrillation during follow-up. **Time Frame:** 12 months **Description:** Only type 1 myocardial infarctions, those related to acute coronary obstruction, will be considered. **Measure:** Incidence of myocardial infarction during follow-up **Time Frame:** 12 months **Description:** Stroke will be defined as any objective evidence of permanent brain, spinal cord, or retinal cell death resulting from a vascular cause, substantiated by pathological or imaging evidence, with or without accompanying clinical symptoms. **Measure:** Incidence of stroke during follow-up **Time Frame:** 12 months **Description:** Transient ischemic attack will be defined as a sudden, focal neurological deficit of presumed vascular origin lasting less than 24 hours. **Measure:** Incidence of transient ischemic attack incidence during follow-up **Time Frame:** 12 months #### Primary Outcomes **Description:** Substrate characterization will involve measuring Low Voltage (LV) and Transition Voltage (TV) Zones (LV zone voltage cut-off of \<0.5mV; TV zone voltage limits within 0.5 and 1mV). These zones will be considered if they encompass an area of at least 1cm², containing ≥3 neighboring points within ≤10mm distance. The total LVZ and TVZ surfaces will be expressed as a percentage relative to the total surface area of the left atrium (excluding the pulmonary veins and the mitral annulus). A comparative analysis of substrate characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation). **Measure:** Substrate characterization of the left atrium. **Time Frame:** 18 months **Description:** Functional analysis will rely on identifying deceleration zones characterized by isochronal crowding, defined as having ≥3 isochrones within a 1cm radius, using an 8-color scale of left atrial isochronal activation mapping. A comparative analysis of functional characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation). **Measure:** Functional characterization of the left atrium. **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Absence of a prior history of atrial fibrillation or flutter. * Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2. Exclusion criteria: * Presence of thrombus in the left atrial appendage. * Complications related to the index procedure. * Insufficient quality of the left atrial electroanatomical map. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Consecutive patients undergoing ventricular arrhythmias ablations in whom transeptal access is needed for the ablation of the targeted arrhythmia. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Andrea Sarkozy, MD, PhD **Phone:** 0032 02476 3657 **Role:** CONTACT #### Locations **Location 1:** **City:** Jette **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Andrea Sarkozy, MD, PhD - **Phone:** 0032 02476 3657 - **Role:** CONTACT **Country:** Belgium **Facility:** Universitair Ziekenhuis Brussel **State:** Brussels **Status:** RECRUITING **Zip:** 1090 #### Overall Officials **Official 1:** **Affiliation:** Universitair Ziekenhuis Brussel **Name:** Andrea Sarkozy, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020763 - Term: Pathological Conditions, Anatomical ### 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: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M30384 - Name: Atrial Remodeling - Relevance: HIGH - As Found: Atrial Remodeling - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000064752 - Term: Atrial Remodeling ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425809 **Brief Title:** Predictors of Muscle Injury Risk in Non-professional Football Players **Official Title:** Predictors of Muscle Injury Risk in Non-professional Football Players From the Principality of Asturias. An Ambispective Cohort Study. #### Organization Study ID Info **ID:** Pred-Fut #### Organization **Class:** OTHER **Full Name:** University of Oviedo ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **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:** University of Oviedo #### Responsible Party **Investigator Affiliation:** University of Oviedo **Investigator Full Name:** Ruben Cuesta Barriuso **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:** Background. Football accounts for 30% of all sports injuries. Muscle injuries in football are the most common non-traumatic and non-contact injuries. A comprehensive approach to injury prevention must consider the design of the footwear and the environmental conditions in which the match is played. Objective. To assess the risk of injury as a function of footwear and field of play in non-professional football players and to identify the best predictive model of muscle injury in these athletes. Method. Ambispective cohort study. Ninety-seven players will be recruited. The primary variable will be the number of lower limb muscle injuries in the last 3 seasons. Secondary and modifying variables will be: age, body mass index, boot type, pitch turf, training load and field position. Potential confounding variables will be motivation for choice of footwear, date of muscle injuries, time playing in the category and presence in the starting team. The analysis will calculate the risk of adverse effects in these patients and assess the influence of confounders and trend analysis on the primary variable, stratified by potential confounders. Expected outcomes. To calculate the risk of muscle injury as a function of anthropometric variables, and footwear and turf type. To identify the predictive model of muscle injuries in football players. ### Conditions Module **Conditions:** - Sport Injury **Keywords:** - Muscular Diseases - Football - Risk - Secondary Prevention - Physiotherapy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 97 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Data collection will take place between May and June 2024. This will be done through a self-questionnaire format with closed questions where no data will be collected that allow the identification of the subject (name, surname, or national identity document). The coding of the data collected and its analysis will be carried out under the supervision of the principal investigator, in accordance with current data protection regulations, scrupulously complying with the anonymous collection of clinical data, and without collecting any data that could allow the identification of the patients whose data are collected. **Intervention Names:** - Other: Observation **Label:** Observational group ### Interventions #### Intervention 1 **Arm Group Labels:** - Observational group **Description:** The data collection will be carried out by the two researchers, in accordance with current data protection regulations, scrupulously complying with the anonymous collection of clinical data, and without collecting any data that could allow the identification of the athletes whose data are collected. The members of the research group will not have access to personal data that could facilitate the identity of any person on the basis of the data collected. The data collected in this study, anonymised from the outset, will be exported to an Excel file. Access to the Excel file will require password access and will be managed from a computer of the University of Oviedo (Department of Surgery and Medical-Surgical Specialities). **Name:** Observation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary variable, the number of lower limb muscle injuries in the last 3 seasons, will be assessed as a quantitative variable. **Measure:** Asses the number of lower limb muscle injuries in the last 3 competition seasons **Time Frame:** Screening visit #### Secondary Outcomes **Description:** The secondary variable, age (in years completed), will be assessed as a quantitative variable. **Measure:** Assess the age **Time Frame:** Screening visit **Description:** The secondary variable, body mass index (in kg/m2), will be assessed as a quantitative variable. **Measure:** Assess the body mass index **Time Frame:** Screening visit **Description:** The secondary variable, type of training and competition boot (rubber cleat/metal cleat), will be assessed as a nominal qualitative variable. **Measure:** Assess the type of training and competition boot in the last 3 competition seasons **Time Frame:** Screening visit **Description:** The secondary variable, type of training and competition pitch (sand pitch / artificial turf pitch / natural grass pitch), will be assessed as a nominal qualitative variable. **Measure:** Assess the type of training and competition pitch in the last 3 competition seasons **Time Frame:** Screening visit **Description:** The secondary variable, type of muscle injury (fibrillar / musculotendinous / strain), will be assessed as an ordinal qualitative variable. **Measure:** Assess the type of muscle injury in the last 3 competition seasons **Time Frame:** Screening visit **Description:** The secondary variable, weekly training load (hours/week), will be assessed as a quantitative variable. **Measure:** Assess the weekly training load in the last 3 competition seasons **Time Frame:** Screening visit **Description:** The secondary variable, position on the field (goalkeeper / defender / midfielder / striker), will be assessed as an ordinal qualitative variable. **Measure:** Assess the position on the field in the last 3 competition seasons **Time Frame:** Screening visit ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Federated, non-professional football players. * Competing in category 3 RFEF (group 2). * Who compete in the territorial delimitation of the Principality of Asturias. * Subjects who have not undergone previous musculoskeletal surgery in the seasons under study. * Who were federated at least one year before the study period. Exclusion Criteria: * Players who have not participated in competition, during the seasons under study, for a period of more than 6 months due to a musculoskeletal injury. **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** MALE **Standard Ages:** - ADULT **Study Population:** Population: Non-professional football players from the Principality of Asturias, where the aim is to identify the risk of muscle injuries in these players and to identify the predictive model of muscle injuries based on anthropometric and sporting variables. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rubén Cuesta-Barriuso, PhD **Phone:** 607547274 **Role:** CONTACT #### Locations **Location 1:** **City:** Oviedo **Country:** Spain **Facility:** University of Oviedo **State:** Asturias **Zip:** 33006 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M4570 - Name: Athletic Injuries - Relevance: HIGH - As Found: Sport Injury - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries - ID: D000001265 - Term: Athletic Injuries ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M5953 - Name: Chlorhexidine - Relevance: LOW - As Found: Unknown - ID: M344731 - Name: Chlorhexidine gluconate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425796 **Acronym:** ADIPREG **Brief Title:** Adiposity and Iron Requirements in Pregnancy **Official Title:** Impact of Maternal Adiposity on Maternal Iron Status and Requirements: a Randomised Intervention Study #### Organization Study ID Info **ID:** FCBMS-23-259 #### Organization **Class:** OTHER **Full Name:** University of Ulster ### Status Module #### Completion Date **Date:** 2026-01-19 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-19 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Northern Health & Social Care Trust (NHSCT) **Class:** UNKNOWN **Name:** Solvotrin Therapeutics - Active Iron #### Lead Sponsor **Class:** OTHER **Name:** University of Ulster #### 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 aims to explore how body fat influences the response to either 25 or 50 mg of daily iron supplements during pregnancy. We will conduct a double-blind randomized controlled intervention study involving 312 pregnant women recruited from antenatal clinics in the Northern Trust Area. Participants will be randomly assigned to receive either 25 or 50 mg of iron per day from 12 weeks of pregnancy until delivery, using the Active Iron supplement brand. Blood samples will be collected at 12, 28 and 36 weeks gestation and umbilical cord blood will be collected at delivery. Anthropometric measurements will be taken at each visit, and participants will complete questionnaires on various aspects of health and lifestyle, mental health, gastrointestinal symptoms, and compliance. **Detailed Description:** The main aim of this study is to investigate the influence of adiposity on the difference in response to 25 or 50 mg of daily iron supplementation during pregnancy. The primary aim is to determine the influence of maternal adiposity on adjusted maternal ferritin concentrations in response to 25 mg or 50 mg iron supplementation in pregnancy. The secondary outcomes of this study include: investigating the impact of maternal body fat on various maternal iron biomarkers (such as haemoglobin, soluble transferrin receptor, hepcidin, transferrin saturation, and other haematological markers) in response to either 25 mg or 50 mg iron supplementation during pregnancy, evaluating changes in adjusted ferritin concentrations and other iron markers throughout pregnancy relative to the dosage of iron supplementation received, determining the effect of maternal body fat on neonatal iron biomarkers in response to maternal iron supplementation, assessing changes in markers of inflammation in response to iron supplementation during pregnancy, and examine changes in mental health scores in response to iron supplementation during pregnancy. This is a double-blind randomised controlled intervention study, in which 312 pregnant women with singleton pregnancy, without current complications, aged ≥ 18 years and BMI ≥ 18.5 kg/m2 will be recruited. Participants who are taking multivitamins will be included. They will be asked to discontinue any current supplementation. Pregnant women with anaemia, iron deficiency, high risk of iron overload, history of bariatric surgery, who are planning home birth, are currently involved in another research study, and those who cannot speak or understand English language will be excluded. Blood samples and anthropometric and body composition measurements will be taken at different points in the pregnancy (12, 28, 36 gestational weeks) and an umbilical cord blood sample at the time of birth. Blood concentrations of iron and inflammation markers will be analysed. General, dietary intake and lifestyle information will be collected, through a Health and Lifestyle questionnaire and a 4-day diary. Additionally, participants will complete a questionnaire about their mental health and gastrointestinal symptoms. The compliance of the supplementation will be evaluated at each timepoint. Additionally, participants will receive a telephone call to evaluate possible adverse effects and compliance of the supplementation between the timepoints (18, 24 and 32 weeks of gestation). In the event that a participant has been prescribed iron treatment, anaemia diagnosis at any time during pregnancy or the occurrence of any adverse outcome such as miscarriage, the participant will be withdrawn from the study. Electronic forms prepared in RedCap will be used to collect data. ### Conditions Module **Conditions:** - Iron Deficiency Anemia of Pregnancy **Keywords:** - Iron status - Iron Supplements - Pregnancy - Anaemia - Maternal obesity - Maternal Overweight - Body composition - Ferritin - Inflammation - Mental Health - Neonatal anaemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double Blind: two or more parties are unaware of the intervention assignment **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 312 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Iron 25 (total 25 mg/d of iron): 2 supplements of 12.5 mg of elemental iron + 1 multivitamin supplement; **Intervention Names:** - Dietary Supplement: Adiposity and Iron Requirements in Pregnancy (ADIPREG) **Label:** Iron 25 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Iron 50 (total 50 mg/d of iron): 2 supplements of 25 mg of elemental iron + 1 multivitamin supplement). **Intervention Names:** - Dietary Supplement: Adiposity and Iron Requirements in Pregnancy (ADIPREG) **Label:** IRON 50 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - IRON 50 - Iron 25 **Description:** Iron 25 arm will receive: two iron supplements containing 12.5 mg of elemental iron + 1 multivitamin supplement (they will receive a total of 3 supplements per day). Iron 50 arm will receive: two 25 mg elemental iron supplements + 1 multivitamin supplement (they will receive a total of 3 supplements per day). The multivitamin supplement will contain folic acid, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, vitamin C and vitamin D. In summary, each participant will receive 3 supplements per day and instructed to take the 3 supplements together, in the morning, with breakfast. Supplements will be given to the participants when they attend for their clinic appointment. The intervention will begin at 12 gestational weeks and continue until the baby is delivered. **Name:** Adiposity and Iron Requirements in Pregnancy (ADIPREG) **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Assessed via ELISA analyses for ferritin concentration **Measure:** Adjusted maternal ferritin concentrations in response to iron supplementation (ng/mL) **Time Frame:** 16, 24 and 28 weeks after baseline #### Secondary Outcomes **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Hemoglobin (g/L) **Time Frame:** 16, 24 and 28 weeks after baseline **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Red blood cell count (RBC) (10^12/L) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Mean cell haemoglobin (MCH) (pg **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Mean cell volume (MCV) (fl) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Mean cell haemoglobin concentrations (MCHC) (g/dL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Red cell distribution width (RDW) (%) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via immunoturbidimety assay **Measure:** Transferrin (g/L) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via colorimetic assay **Measure:** Serum iron (umol/L) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via ELISA **Measure:** sTfR (ug/mL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via ELISA **Measure:** Hepcidin (pg/mL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via ELISA **Measure:** C-reactive protein (mg/mL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via sandwich immunoassay **Measure:** Pro- anti- inflammatory biomarkers: IL-1 β, IL-6, IL-10, IL-22, IL-17, TNF- α, IFN- γ (fg/mL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via methylation analyses **Measure:** Genetic variants of interest in relation to obesity and iron metabolism in response to iron supplementation. **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** CORE 10 questionnaire will be completed by each participant at each timepoint: CORE stands for "Clinical Outcomes in Routine Evaluation." The CORE-10 is a 10-item assesses psychological distress over the past week. The resulting score can be divided into categories with increasing severity: Healthy (0-5), low (6-10), mild (11-14), moderate (15-19), moderate-to-severe (20-24), and severe (25 and above). The score of this questionnaire will be collected as a numeric variable. **Measure:** Mental health score in response to iron supplementation **Time Frame:** 16, 24 and 28 weeks after baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria:- Pregnant women * Age ≥ 18 years * BMI ≥18.5 kg/m2 * Without current pregnancy complications (for example, severe bleeding, Diabetes Mellitus, hyperemesis gravidarum, ectopic and molar pregnancies) * At least 12 Gestational Week * Singleton pregnancy confirmed with the first ultrasound scan * Participants who are currently taking multivitamins will be included. They will be asked to discontinue any current supplementation. Exclusion Criteria: * Hb \<110 g/L * SF \<30 μg/L * High risk of iron overload (Hb \>150 g/L, transferrin saturation \>45% or SF\> 150 μg/L) * Participants with history of haematological, renal, liver, autoimmune disorders, malabsorptive syndromes * Participants with history of bariatric surgery * Participants who take steroids or anti-inflammatory treatments or drugs that affect gut absorption (proton-pump inhibitors) * Planned home births * Participants currently involved in another research study * Multiple pregnancy * Participants who do not speak English **Gender Based:** True **Gender Description:** only female participants are being studied **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mary T McCann, PhD **Phone:** +4402870123969 **Role:** CONTACT #### Locations **Location 1:** **City:** Coleraine **Country:** United Kingdom **Facility:** Ulster University,Human Intervention Studies Unit, **State:** Co. Londonderry **Zip:** BT521SA #### Overall Officials **Official 1:** **Affiliation:** University of Ulster **Name:** Mary McCann, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006402 - Term: Hematologic Diseases - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000000747 - Term: Anemia, Hypochromic ### 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: BC15 - Name: Blood and Lymph Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M4070 - Name: Anemia - Relevance: HIGH - As Found: Anemia - ID: M20857 - Name: Anemia, Iron-Deficiency - Relevance: HIGH - As Found: Iron Deficiency Anemia - ID: M2781 - Name: Iron Deficiencies - Relevance: HIGH - As Found: Iron Deficiency - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M2040 - Name: Obesity, Maternal - Relevance: LOW - As Found: Unknown - ID: M4081 - Name: Anemia, Neonatal - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M21177 - Name: Iron Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M4077 - Name: Anemia, Hypochromic - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000740 - Term: Anemia - ID: D000018798 - Term: Anemia, Iron-Deficiency - ID: D000090463 - Term: Iron Deficiencies ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Hemat - Name: Hematinics - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Vi - Name: Vitamins - Abbrev: Mi - Name: Mineral ### Intervention Browse Module - Browse Leaves - ID: M4513 - Name: Ascorbic Acid - Relevance: LOW - As Found: Unknown - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown - ID: M12476 - Name: Niacinamide - Relevance: LOW - As Found: Unknown - ID: M12465 - Name: Niacin - Relevance: LOW - As Found: Unknown - ID: M12479 - Name: Nicotinic Acids - Relevance: LOW - As Found: Unknown - ID: M17550 - Name: Vitamin D - Relevance: LOW - As Found: Unknown - ID: M6003 - Name: Cholecalciferol - Relevance: LOW - As Found: Unknown - ID: M23026 - Name: Vitamin B 6 - Relevance: LOW - As Found: Unknown - ID: M14583 - Name: Pyridoxal - Relevance: LOW - As Found: Unknown - ID: M14589 - Name: Pyridoxine - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M13124 - Name: Pantothenic Acid - Relevance: LOW - As Found: Unknown - ID: M17548 - Name: Vitamin B 12 - Relevance: LOW - As Found: Unknown - ID: M9934 - Name: Hydroxocobalamin - Relevance: LOW - As Found: Unknown - ID: M16595 - Name: Thiamine - Relevance: LOW - As Found: Unknown - ID: M15085 - Name: Riboflavin - Relevance: LOW - As Found: Unknown - ID: T477 - Name: Vitamin C - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T455 - Name: Nicotinamide - Relevance: LOW - As Found: Unknown - ID: T453 - Name: Niacin - Relevance: LOW - As Found: Unknown - ID: T454 - Name: Niacinamide - Relevance: LOW - As Found: Unknown - ID: T456 - Name: Nicotinic Acid - Relevance: LOW - As Found: Unknown - ID: T471 - Name: Vitamin B3 - Relevance: LOW - As Found: Unknown - ID: T437 - Name: Ascorbic Acid - Relevance: LOW - As Found: Unknown - ID: T442 - Name: Cholecalciferol - Relevance: LOW - As Found: Unknown - ID: T479 - Name: Vitamin D3 - Relevance: LOW - As Found: Unknown - ID: T440 - Name: Calciferol - Relevance: LOW - As Found: Unknown - ID: T474 - Name: Vitamin B6 - Relevance: LOW - As Found: Unknown - ID: T459 - Name: Pyridoxal - Relevance: LOW - As Found: Unknown - ID: T461 - Name: Pyridoxine - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T451 - Name: Methylcobalamin - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown - ID: T472 - Name: Vitamin B5 - Relevance: LOW - As Found: Unknown - ID: T476 - Name: Vitamin B12 - Relevance: LOW - As Found: Unknown - ID: T441 - Name: Cobalamin - Relevance: LOW - As Found: Unknown - ID: T444 - Name: Cyanocobalamin - Relevance: LOW - As Found: Unknown - ID: T341 - Name: Iron Supplement - Relevance: LOW - As Found: Unknown - ID: T464 - Name: Thiamin - Relevance: LOW - As Found: Unknown - ID: T465 - Name: Thiamine - Relevance: LOW - As Found: Unknown - ID: T469 - Name: Vitamin B1 - Relevance: LOW - As Found: Unknown - ID: T463 - Name: Riboflavin - Relevance: LOW - As Found: Unknown - ID: T470 - Name: Vitamin B2 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425783 **Brief Title:** Warmed Blood Transfusion in Premature Infants **Official Title:** Warmed Blood Transfusion in Premature Babies Less Than 34 Weeks of Gestational Age: a Randomized Controlled Trial #### Organization Study ID Info **ID:** SYNEO-03 #### Organization **Class:** OTHER **Full Name:** Goztepe Prof Dr Suleyman Yalcın City Hospital ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **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:** Goztepe Prof Dr Suleyman Yalcın City Hospital #### Responsible Party **Investigator Affiliation:** Goztepe Prof Dr Suleyman Yalcın City Hospital **Investigator Full Name:** Sibel Sevuk Ozumut **Investigator Title:** pediatric clinic chief assistant, MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Premature babies have to deal with many problems from the moment they are born due to the immature of their organs. Their clinical condition is unstable, especially in the first few weeks, and they are greatly affected by environmental factors. During this period, blood transfusion may be needed for many reasons such as intraventricular hemorrhage and necrotizing enterocolitis. In addition, multiple blood draws to evaluate irregular metabolic, hematological and biochemical findings result in anemia and the need for blood transfusion. There are many algorithms regarding blood transfusion indications and transfusion limits in premature babies. However, there are no strict rules regarding the application of warming before blood transfusion, but it is recommended by some guidelines. Especially in unstable babies such as advanced premature babies, it is recommended to give blood by heating it at physiological temperature to avoid important complications such as hypothermia, coagulopathy and rhythm disturbances. Premature babies, whose hemodynamic and metabolic balance is very sensitive, may go into hypothermia when blood and products stored at +4C⁰ are given without heating. In routine practice, blood transfusion is performed without heating. The concern here is that hemolysis may develop by heating the blood. Studies have shown that hemolysis occurs when blood is heated above 46C⁰. In this study, physiological heating is planned. In vitro neonatal experimental modeling has shown that there is no hemolysis with physiological heating. The aim of the researchers is; While protecting fragile, extremely premature babies from the complications of cold transfusion, the aim is to compare the transfusion groups with and without physiological heating in terms of hemolysis, metabolic balance and cerebral tissue oxygenation. **Detailed Description:** This trial is planned to be randomized and controlled. Erythrocyte transfusion (ET) will be applied to premature babies born below the 34th gestational week, based on the limit values specified by TND, during Level 3 routine intensive care treatment and follow-up. They will be divided into two groups of 20 babies each: control and study groups. The control group will receive erythrocyte transfusion without heating, which is routinely applied. Heated ET will be performed on the study group by physiological warming between 34-36C⁰. Procedures to be applied for the working group: 1. ET requirement will be determined in line with the TND guide. It will be transfused at a standard dose of 20 ml/kg. Before ET is performed, blood gas and HTC, K and blood temperature before entering the heater will be measured and recorded. 2. The erythrocyte suspension will be heated between 34-36 C⁰, which is the determined physiological temperature. 3. Before giving it to the baby, 2 ml of blood will be taken through a triple tap and its hematocrit and K value (blood gas) will be checked. It will be given to the baby after the temperature is checked with a body fluid thermometer and determined to be within the appropriate range and if hemolysis is not observed. 4. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K. As standard for all babies during transfusion; Heart rate, blood pressure, saturation and body temperatures will be monitored. It was planned to investigate whether there was a difference in terms of hypothermia and hemolysis between the groups with and without Physiological Heating. It will be examined whether heated blood has an effect on cerebral tissue perfusion by NIRS monitoring ### Conditions Module **Conditions:** - Transfusion Related Complication - Premature **Keywords:** - premature infants - warmed blood transfusion - hypothermia - hemolysis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** randomized controlled, parallel group. A single center ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double blind **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** It was planned to transfuse the blood at +4C temperature brought from the blood bank center in 3 hours. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K. **Label:** Blood Transfusion **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Blood will be warmed before transfusion. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K. **Intervention Names:** - Procedure: Warmed Blood Transfusion **Label:** Blood transfusıon **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Blood transfusıon **Description:** The erythrocyte suspension will be heated between 34-36 C⁰, which is the determined physiological temperature. Before giving it to the baby, 2 ml of blood will be taken through a triple tap and its hematocrit and K value (blood gas) will be checked. It will be given to the baby after the temperature is checked with a body fluid thermometer and determined to be within the appropriate range and if hemolysis is not observed. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K. **Name:** Warmed Blood Transfusion **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The baby's body temperature will be measured and recorded before, during and after heated and unheated blood transfusions. It will be determined whether transfusion of unwarmed blood causes lower body temperature. **Measure:** Effect of heated blood transfusion on body temperature in premature babies **Time Frame:** 6 hours **Description:** Cerebral tissue oxygenation will be measured with Near infrared spectroscopy (NIRS) monitoring in both transfusion applications. The data recorded on the NIRS device will be transferred to the computer and compared. The effect of warming the blood on cerebral tissue oxygenation will be demonstrated. **Measure:** Effects of warming blood in blood transfusion on cerebral tissue oxygenation **Time Frame:** 8 hours **Description:** After the heated and unheated blood transfusion ends, the hematocrit levels of the babies will be compared to determine which model is more effective. **Measure:** Effect of heated and unheated blood transfusion on hematocrit level **Time Frame:** 8 hours #### Secondary Outcomes **Description:** After the blood is brought to physiological body temperature, a sample will be taken before giving it to the baby. The presence of hemolysis will be evaluated by measuring the potassium level in blood heated at 34-36 C. At the end of the blood transfusion, potassium will be measured in the blood taken from the baby. **Measure:** Effect of warming blood on potassium level **Time Frame:** 6 hours **Description:** After blood transfusion, LDH will be measured by taking blood samples from the babies in both groups. A measurement of LDH above 700 will be defined as hemolysis. **Measure:** Effect of warming blood on LDH level **Time Frame:** 6 hours **Description:** At the end of heated and unheated blood transfusion, blood gas and blood lactate levels will be measured. It will be compared which transfusion application increases the lactate level more. **Measure:** Effect of heated blood on blood lactate level **Time Frame:** 8 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Premature babies less than 34 weeks of gestation Babies requiring ES transfusions while receiving treatment in the NICU Exclusion Criteria: * babies with severe congenital anomalies **Maximum Age:** 3 Months **Minimum Age:** 1 Hour **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Goztepe Prof Dr. Suleyman Yalcın City Hospital **State:** N/A (n/a) **Zip:** 34730 #### Overall Officials **Official 1:** **Affiliation:** Istanbul Medeniyet University **Name:** Fahri Ovalı, Prof **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Bailey SM, Mally PV. Near-Infrared Spectroscopy to Guide and Understand Effects of Red Blood Cell Transfusion. Clin Perinatol. 2023 Dec;50(4):895-910. doi: 10.1016/j.clp.2023.07.006. Epub 2023 Aug 17. **PMID:** 37866855 **Citation:** Poder TG, Nonkani WG, Tsakeu Leponkouo E. Blood Warming and Hemolysis: A Systematic Review With Meta-Analysis. Transfus Med Rev. 2015 Jul;29(3):172-80. doi: 10.1016/j.tmrv.2015.03.002. Epub 2015 Mar 24. **PMID:** 25840802 **Citation:** Hulse W, Bahr TM, Fredrickson L, Canfield CM, Friddle K, Pysher TJ, Ilstrup SJ, Ohls RK, Christensen RD. Warming blood products for transfusion to neonates: In vitro assessments. Transfusion. 2020 Sep;60(9):1924-1928. doi: 10.1111/trf.16007. Epub 2020 Aug 10. **PMID:** 32776545 **Citation:** Dani C, Pratesi S, Fontanelli G, Barp J, Bertini G. Blood transfusions increase cerebral, splanchnic, and renal oxygenation in anemic preterm infants. Transfusion. 2010 Jun;50(6):1220-6. doi: 10.1111/j.1537-2995.2009.02575.x. Epub 2010 Jan 22. **PMID:** 20113454 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - 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: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Premature - ID: M10085 - Name: Hypothermia - Relevance: LOW - As Found: Unknown - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - 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: D000047928 - Term: Premature Birth ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425770 **Brief Title:** Digital vs Conventional Impression in Capturing the Emergence Profile Around Maxillary Anterior Implant-supported Crowns **Official Title:** Investigating the Accuracy of Conventional vs Digital Impressions and Conventional vs 3D Fabricated Casts in Capturing the Emergence Profile Around Maxillary Anterior Single Implant-supported Crowns #### Organization Study ID Info **ID:** 129/2023 #### Organization **Class:** OTHER **Full Name:** Semmelweis University ### Status Module #### Completion Date **Date:** 2026-02-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-05 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Semmelweis University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25). **Detailed Description:** Correct design of the peri-implant emergence profile (EP) is crucial for maintaining the health of the supracrestal complex and long-term success of the implant implant-prosthodontics. After its formation with a provisional restoration, its shape needs to be transferred to the final restoration via conventional elastomeric or digital (direct/indirect) impression taking. Our aims are to investigate around maxillary anterior single implants in patients with thick gingival phenotype: 1. the accuracy of direct digital impression vs indirect digital impression vs conventional elastomeric impression in capturing the EP and implant position 2. the accuracy of 3D printed cast with conventional gingival mask vs conventional epoxy-resin cast with gingival mask in replicating the EP and implant position 3. the amount of soft tissue collapse at 0,2,10,20 minutes following the removal of the provisional restoration in case of direct EP scanning ### Conditions Module **Conditions:** - Dental Implants, Single-Tooth - Dental Impression Technique **Keywords:** - Peri-Implant Emergence Profile - Dental Impression Technique - Dental Implants, Single-Tooth - Esthetics, Dental - Crowns - Denture, Partial, Fixed - Computer-Aided Design ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created **Intervention Names:** - Procedure: conventional impresion and cast **Label:** conventional cast **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration **Intervention Names:** - Procedure: indirect digital impression and 3D printed cast **Label:** indirect digital impression and 3D printed cast **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration **Intervention Names:** - Procedure: direct digital impression **Label:** direct digital impression **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - indirect digital impression and 3D printed cast **Description:** the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration **Name:** indirect digital impression and 3D printed cast **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - direct digital impression **Description:** the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration **Name:** direct digital impression **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - conventional cast **Description:** conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created **Name:** conventional impresion and cast **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** pink esthetic score of the definitive restoration **Measure:** Pink esthetic score/PES **Time Frame:** at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up **Description:** white esthetic score of the definitive restoration **Measure:** White esthetic score/WES **Time Frame:** at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up **Description:** functional implant prosthodontic score of the definitive restoration **Measure:** functional implant prosthodontic score/FIPS **Time Frame:** at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up #### Primary Outcomes **Description:** The absolute mean deviation between the emergence profiles replicated with different impression techniques along the whole surface of the EP **Measure:** 3D RMS - root mean square difference **Time Frame:** at impression taking, 0,2,10,20 mins #### Secondary Outcomes **Description:** Vertical height change of the buccal gingiva marginal level measured at the mesial and distal papilae and mid-facial levels **Measure:** Linear vertical soft tissue change **Time Frame:** at impression taking, 0,2,10,20 mins **Description:** Horizontal thickness change of the buccal and palatal gingiva at three levels at each third of the distance between the implant platform and the marginal gingiva. **Measure:** Linear horizontal soft tissue change **Time Frame:** at impression taking, 0,2,10,20 mins **Description:** The absolute mean deviation between the emergence profiles replicated with different impression techniques along vertical and horizontal cross-sections. **Measure:** 2D RMS - root mean square difference **Time Frame:** at impression taking, 0,2,10,20 mins **Description:** Patient evaluation of the different types of impression methods on a visual analoge scale based questionnaire **Measure:** Patient reported outome measures - evaluation of the impression method **Time Frame:** at the end of each session of the digital and conventional impression taking ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult above 18 yo * No systematic deseases * Good oral hygene (FMPS \< 25%) * Stable occlusion * Thick phenotype * Single missing maxilary anterior (FDI #15-25 position) tooth replaced with osseointegrated bone level impant * Correctly formed soft tissue with CAD/CAM temporary abutment for min. 3 months * Neighbouring teeth in place and in good condition * Patient voluntarily accepts and signs the patient leaflets for the trial Exclusion Criteria: * Active periodontitis * Peri-implant inflammation **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:** Krisztina Mikulás, PhD **Phone:** +3614591500 **Phone Ext:** 59115 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Xinyi Qian **Phone:** +3614591500 **Phone Ext:** 59313 **Role:** CONTACT #### Locations **Location 1:** **City:** Budapest **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Krisztina Mikulás, PhD - **Phone:** 3614591500 - **Phone Ext:** 59115 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Xinyi Qian - **Phone:** 3614591500 - **Phone Ext:** 59313 - **Role:** CONTACT **Country:** Hungary **Facility:** Semmelweis University, Department of Prosthodontics **State:** Pest **Status:** RECRUITING **Zip:** 1088 #### Overall Officials **Official 1:** **Affiliation:** Department of Prosthodontics, Semmelweis University **Name:** Krisztina Mikulás, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Li J, Chen Z, Wang M, Wang HL, Yu H. Dynamic changes of peri-implant soft tissue after interim restoration removal during a digital intraoral scan. J Prosthet Dent. 2019 Sep;122(3):288-294. doi: 10.1016/j.prosdent.2018.07.020. Epub 2019 Mar 15. **PMID:** 30885583 **Citation:** Xiong J, Sun W, Huang B, Ji W, Shi B. Effect of the implant-supported provisional restoration on the accuracy of digital peri-implant mucosa replication-A clinical study. Clin Oral Implants Res. 2022 Jun;33(6):598-606. doi: 10.1111/clr.13921. Epub 2022 Mar 26. **PMID:** 35290685 **Citation:** Monaco C, Scheda L, Baldissara P, Zucchelli G. Implant Digital Impression in the Esthetic Area. J Prosthodont. 2019 Jun;28(5):536-540. doi: 10.1111/jopr.12991. Epub 2018 Dec 3. **PMID:** 30357992 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000015853 - Term: Cysteine Proteinase Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M15630 - Name: Silicon - Relevance: LOW - As Found: Unknown - ID: M40889 - Name: Calpastatin - Relevance: HIGH - As Found: Electric - ID: M14343 - Name: Protease 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: T4 - Name: Cysteine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000033668 - Term: Calpastatin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425757 **Brief Title:** Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia **Official Title:** Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia #### Organization Study ID Info **ID:** IRB-2024-315(IIT) #### Organization **Class:** OTHER **Full Name:** Zhejiang Cancer Hospital ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **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:** Xie Kangjie #### Responsible Party **Investigator Affiliation:** Zhejiang Cancer Hospital **Investigator Full Name:** Xie Kangjie **Investigator Title:** Clinical Professor **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:** Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia **Detailed Description:** This study was a single-center, interventional clinical study. Patients with different plasma albumin levels were selected before surgery and induced by a single injection of Ciprofol at a depth of 0.3 mg/kg. 2ml of venous blood was collected before and 0.5, 1, 2, 3, 5, 8, 15, 30min, 1h, 2h and 4h after administration. The pharmacokinetics of Ciprofol were studied by measuring the concentration of Ciprofol in blood. ### Conditions Module **Conditions:** - Hypoproteinemia - Pharmacokinetics - Ciprofol ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Blood albumin concentration≤30g/L **Intervention Names:** - Drug: ciprofol **Label:** Severe Hypoproteinemia **Type:** OTHER #### Arm Group 2 **Description:** Blood albumin concentration 30g/L-40g/L **Intervention Names:** - Drug: ciprofol **Label:** Moderate Hypoproteinemia **Type:** OTHER #### Arm Group 3 **Description:** Blood albumin concentration \>40g/L **Intervention Names:** - Drug: ciprofol **Label:** Normal plasma albumin **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Moderate Hypoproteinemia - Normal plasma albumin - Severe Hypoproteinemia **Description:** Patients who intended to undergo elective surgery under general anesthesia were induced by a single intravenous injection of 0.3mg/kg and ciprofol, and the experimental drug was manually injected by CVC within 30s. 2ml of venous blood was collected before and after administration 0.5min, 1min, 2min, 3min, 5min, 8min, 15min 30min, 1h, 2h and 4h respectively. The concentration of cyclopofol in blood was measured **Name:** ciprofol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Blood concentration of ciprofol **Measure:** Blood concentrations at different time points after a single injection **Time Frame:** Before administration, after administration 0.5 minute, 1 minute, 2 minutes, 3 minutes, 5 minutes, 8 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours #### Secondary Outcomes **Description:** The time it takes for the blood concentration of a drug to reach the clinically active concentration level from zero **Measure:** Onset time of ciprofol in patients with hypoproteinemia **Time Frame:** Day 1 **Description:** From the time the drug was administered to the time the patient lost consciousness **Measure:** Effect time of ciprofol in patients with hypoproteinemia **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with moderate to severe hypoproteinemia (albumin \< 30g/L, protein detection time uniformly within three days before surgery） * Weight greater than 45kg, BMI20-24 * The ASA rating is Class I or Class II Exclusion Criteria: * Severe liver dysfunction * Severe renal dysfunction * Patients with ASA grade III and above * Known allergy to eggs, soy products, opioids and their relief drugs, propofol * Emergency surgery **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** XIE Kangjie, doctoral **Phone:** 13516721870 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** XIE Kangjie, MD - **Phone:** 13516721870 - **Role:** CONTACT **Country:** China **Facility:** Zhejiang Cancer Hospital **State:** Zhejang **Status:** RECRUITING **Zip:** 310000 #### Overall Officials **Official 1:** **Affiliation:** Zhejiang Cancer Hospital **Name:** XIE Kangjie, doctoral **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10069 - Name: Hypoproteinemia - Relevance: HIGH - As Found: Hypoproteinemia - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007019 - Term: Hypoproteinemia ### 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: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425744 **Brief Title:** Impact of Pilates and Myofascial Release on Women's Chronic Low Back Pain **Official Title:** The Effect of Self-Myofascial Release and Pilates Reformer Exercise on Pain, Muscle Function and Quality of Life in Women With Chronic Low Back Pain #### Organization Study ID Info **ID:** SYU 2022-07-014 #### Organization **Class:** OTHER **Full Name:** Sahmyook University ### Status Module #### Completion Date **Date:** 2022-11-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-10-30 **Type:** ACTUAL #### Start Date **Date:** 2022-08-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sahmyook University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to find out if Reformer Pilates and self-myofascial release are effective for pain and muscle function in women with chronic low back pain. Investigators will also look at changes in quality of life. The main questions for the study are Can Reformer Pilates and self-myofascial release reduce pain in participants? Can Reformer Pilates and self-myofascial release change muscle function in participants? The researchers want to compare the effects of Reformer Pilates and self-myofascial release in women with chronic low back pain. Participants will be Group 1 Perform Reformer Pilates and self-myofascial release exercises twice a week for 6 weeks, for a total of 12 sessions. Group 2 Perform Reformer Pilates exercises twice a week for 6 weeks, for a total of 12 sessions. Participants will visit the Pilates Centre for an examination before and once after starting the programme. All groups perform a home exercise training programme for 15 minutes three times a week. ### Conditions Module **Conditions:** - Low Back Pain **Keywords:** - low back pain - Pilates - Myofasical Release - Pain - Flexibility ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The experimental 1 group perform self-myofascial release and Pilates exercises. **Intervention Names:** - Other: self-myofascial release combined reformer Pilates **Label:** experimental 1 group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The experimental 2 group perform pilates exercise using reformer. **Intervention Names:** - Other: Reformer Pilates **Label:** experimental 2 group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - experimental 1 group **Description:** The self-myofascial release combined reformer Pilates group performs 10 minutes of self-myofascial release using the BALLance© method before beginning 20 minutes of Reformer Pilates. The 6-week program includes warm-up and breathing, main supine exercises 1 and 2, and movements targeting the sacroiliac and hip joints. All Pilates exercises are designed in a variety of positions including supine, prone, sitting and standing. All participants attend twice a week for 6 weeks, for a total of 12 sessions. And all participants performed home exercise program follows the guidelines of Geroge et al (2021) and includes myofascial release and Pilates Reformer exercises, as well as stretching exercises beneficial for chronic low back pain. The home exercises are performed three times a week for 15 minutes, and exercise materials are distributed. **Name:** self-myofascial release combined reformer Pilates **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - experimental 2 group **Description:** The reformer Pilates group will do 30 minutes of Pilates on the Reformer. All Pilates exercises are designed in a variety of positions including supine, prone, sitting and standing. All participants also attend twice a week for 6 weeks, for a total of 12 sessions. The home exercise program follows the guidelines of Geroge et al (2021) as well as stretching exercises beneficial for chronic low back pain. The home exercises are performed three times a week for 15 minutes, and exercise materials are distributed. **Name:** Reformer Pilates **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Pain severity is measured using a visual analogue scale, where participants mark the level of back pain they feel on a line between 0 mm and 100 mm(0: no pain, 10: worst pain imaginable). Measurement unit is in mm, with higher scores considered more painful **Measure:** Pain severity **Time Frame:** From enrollment to the end of treatment at 6 weeks **Description:** The Korean version of the Oswestry Disability Index (KODI) is used to assess functional impairment due to low back pain. This assessment consists of 10 items, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and travel, with each item scored on a scale of 0 to 5 for a total of 50 points. The KODI score is given as a percentage (%) of the total score. Scores are categorised as mild disability (0-20%), moderate disability (21-40%), severe disability (40-60%) and disability affecting all aspects of life (\>60%), with high test-retest reliability (r=0.92). **Measure:** Functional disability caused by low back pain **Time Frame:** From enrollment to the end of treatment at 6 weeks #### Secondary Outcomes **Description:** Flexibility is measured using the sit-to-stand reach test (SRT), which assesses the flexibility of the lower back and hamstrings. The score is the most distant point (cm) reached with the fingertips. The best of three trials should be recorded. Participants sit with their feet on a box, knees straight, and reach as far forward as possible. The posture is maintained for five seconds and the reach distance is recorded over three trials and averaged. The longer the distance in centimeters, the more flexible it is. **Measure:** Flexibility of lower back and hamstring **Time Frame:** From enrollment to the end of treatment at 6 weeks **Description:** Muscular endurance is assessed using the supine bridge test (SBT), which requires participants to raise their pelvis to form a straight line from shoulder to knee. The time taken to hold the position is recorded in seconds (sec) and averaged over three trials. The longer time hold is the higher muscular endurance. **Measure:** Muscular endurance **Time Frame:** From enrollment to the end of treatment at 6 weeks **Description:** The European Quality of Life 5-Dimensional 5-Level Version (EQ-5D-5L) questionnaire is used to assess quality of life. This standardised tool assesses five dimensions: mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression. General health status is measured using a visual analogue scale (EQ-5D VAS). Scores on the EQ-5D index range from -0.59 to 1, with 1 being the best health. In the absence of a scoring algorithm, a summed scale score was also calculated for both versions to provide additional information about the contribution of the two additional 5L response categories. **Measure:** Quality of life questionnaire **Time Frame:** From enrollment to the end of treatment at 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * People who have had chronic low back pain for 12 weeks or more * Have a Korean Oswestry Disability Index (KODI) score of 17% or higher Exclusion Criteria: * Patients with low back pain due to trauma, neurological lesions of the lower extremities, herniated disc lesions, hip, pelvic or abdominal surgery * Patients who have received radiation or injections within the last 3 months, * Pregnant women or patients who have given birth within the last year **Maximum Age:** 50 Years **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Goyang-si **Country:** Korea, Republic of **Facility:** Pilates Dasom **State:** Gyeonggi-do **Zip:** 10592 ### IPD Sharing Statement Module **Description:** only IPD used in the results publication **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Back Pain - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425731 **Brief Title:** Dance and Energy Expenditure Among Adults With Parkinson's **Official Title:** Characterizing Dance-related Physical Activity Behaviors Among Adults Living With Parkinson's Disease for Automated Analyses of Energy Expenditure #### Organization Study ID Info **ID:** 23-10-30 #### Organization **Class:** OTHER **Full Name:** Northeastern University ### Status Module #### Completion Date **Date:** 2025-07-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-26 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Mark Morris Dance Group #### Lead Sponsor **Class:** OTHER **Name:** Northeastern 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:** The first purpose of the study is to develop and test new methods for quantifying dance among adults with a diagnosis of Parkinson's using various kinds of cameras, wearable activity monitors, and questionnaires. The second reason we are conducting the study is to better understand the relationship between the intensity of dance classes specifically designed for adults with Parkinson's and individual-level factors like the kinds of routine activities one does beyond dancing and one's health status. Participants in the study may be asked to engage in any of the following activities: * complete a small number of assessments on their physical and cognitive functioning * complete their routine group-based dance classes, specifically designed for adults with a diagnosis of Parkinson's, while being recorded Depending upon the group that a participant joins, one may also be asked to: * wear an activity monitor on their waist while engaged in their daily business as usual for nine (9) days * complete an iDXA scan * describe their perceptions on how the use of technology can integrated into their dancing **Detailed Description:** Parkinson's Disease (PD) is a neurodegenerative disorder that affects an estimated 1 million people in the United States, with the onset of symptoms typically occurring after the age of 50 years old. Adults living with PD experience motor impairments such as postural and gait instability, resting tremor, bradykinesia, and muscular rigidity; cognitive impairment, with an estimated 40% of individuals with PD presenting symptoms of at least mild cognitive impairment; and depression. Furthermore, PD symptom severity is known to increase with age.5 Research has shown that exposures to physical activity (PA) may delay the symptomatic progression of PD, and a recent meta-analysis revealed that engaging in dance, when compared to other modes of PA behavior, confers especial protective benefits across motor and cognitive outcomes. Surprisingly, the PA dose administered across some studies of dance has gone unmeasured and is therefore unknown. This is because various modes of dance are known to elicit different PA intensities, and PA intensity is further influenced by intra-individual factors. Because accurate measures of PA intensity are essential for determining an optimal PA dose within dose-response research, additional research that accurately quantifies the absolute and relative intensities of dance behaviors is needed to advance research on dance and health among adults living with PD. Of the PD sequela that appear sensitive to dance exposures, studies have demonstrated protective benefits across motor symptoms, in addition to cognitive and mental health outcomes, after 3 - 12 months of participation in dance. However, little is known about the PA intensities of the dance behaviors that led to these reported outcomes, which therefore limits present understanding of the dose of dance required to yield reproducible results. Dance for PD (Collaborator: Leventhal), a codified dance program for adults living with PD, has been well-studied. During a Dance for PD class, participants dance, with music, while in a chair, standing, and while ambulatory. With wide acceptability, Dance for PD offers an ideal experimental paradigm in which to systematically monitor and quantify the intensity of dance behaviors among adults with PD. Wearable sensors and cameras can be used to estimate PA intensities at individual and group levels. Building upon our prior work, our group is currently collecting camera, wearable sensor, and cardiopulmonary data in an ongoing clinical trial (PI: McCullough) to train algorithms that predict PA intensity during solo, free-form dance behavior. Preliminary results show healthy adults ages 18 to 75, with and without prior dance training, who intend to dance free-form at light-to-moderate intensities engage in dance at an average 4.4-6.0 metabolic equivalent (METs) (i.e., moderate-to-vigorous PA intensities). Age and body mass index are inversely associated with METs, and dancing with music is positively associated with METs. Dance for PD sessions include a range of structured and free-form activities performed with music; their codified framework affords participants multiple opportunities to modulate their PA behavior and intensity in community- and home-based settings. In view of our preliminary results that show multiple factors may impact the PA intensity of dance behavior, additional research is needed to better understand the dose of PA received during Dance for PD sessions. Therefore, we aim to: 1a) Train PA classifiers to detect the absolute and relative PA intensities of Dance for PD sessions within a cohort of N=30 Dance for PD participants in a community-based setting. To test this aim, 2D/3D cameras and triaxial accelerometers will be used to continuously record behavioral and kinematic data during group-based Dance for PD sessions. Indirect calorimeters and wireless heart rate sensors will be used to continuously monitor oxygen uptake and heart rate during multiple Dance for PD sessions. Oxygen uptake and heart rate data will serve as the ground truth, with signal features derived from the camera and wearable sensor data as key predictors. Hypothesis: Sensor-derived signal features can respectively be used to train algorithms to accurately classify the PA intensity of dance during Dance for PD sessions at both individual and group levels. 1b) Estimate associations between PA intensities observed during Dance for PD sessions and respective individual-level factors. To test this aim, estimates of the absolute and relative intensities of Dance for PD (aim 1) exposures will be respectively adjusted for body fat percentage, PD motor symptom severity, years since PD diagnosis, free-living activity, cognitive function, sex, and age. Hypothesis: Adjusting for clinical, demographic, anthropometric, and behavioral covariates will improve the accuracy of PA intensity classifiers. 2) Characterize the relative intensity of Dance for PD sessions within home-based settings. To test this aim, N=30 adults will wear heart rate monitors while engaged in Dance for PD sessions at home. Heart rate data will be used to calculate the relative intensity of home-based Dance for PD sessions. Hypothesis: Engaging in Dance for PD at home will elicit light to moderate intensity physical activity bouts. ### Conditions Module **Conditions:** - Parkinson Disease ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants are prospectively assigned to participate in one of two study conditions that respectively seek to test different interventions and outcomes. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will engage in Dance for PD classes in-person in their usual fashion, and within a group-based setting, for a total of three sessions. Oxygen uptake, heart rate and perceived exertion will be measured throughout specific Dance for PD classes. **Intervention Names:** - Other: Fasting **Label:** Dance for PD (in-person) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will engage in Dance for PD classes online in their usual fashion, and within a group-based setting, for a total of two sessions. Heart rate and perceived exertion will be measured throughout the Dance for PD classes. **Intervention Names:** - Other: No Intervention **Label:** Dance for PD (virtual/remote) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dance for PD (in-person) **Description:** Participants (Dance for PD, in-person only) will engage in one of their routine weekly dance sessions while a portable indirect calorimeter is used for energy expenditure analysis. Before this session, participants will be asked to fast for at least 4-hours. In this way, participants in this study arm will engage in a self-controlled study design wherein they complete a 4-hour fast before engaging in an oxygen uptake assessment during their routine dance classes. During the 4-hour fasting period, participants will be asked to refrain from eating any food and drinking any beverages except for water. **Name:** Fasting **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Dance for PD (virtual/remote) **Description:** No Intervention **Name:** No Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The rate of oxygen uptake during a 60-min dance session **Measure:** Oxygen uptake **Time Frame:** The outcome measure will be assessed after the intervention (i.e., after fasting: no food for at least 4 hours prior to a single dance session) and during the intervention (i.e., participants will continue to fast during the 60-minute dance session). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults (18-85 years old) * Diagnosis of idiopathic PD (as confirmed by a neurologist), who are at a Hoehn and Yahr stage \<=3 (i.e., physically independent, some postural instability, mild to moderate bilateral involvement or less severe symptoms; Bhidayasiri et al., 2012), and who are * enrolled in Dance for PD® classes at the time of recruitment as a participant Exclusion Criteria: * Adults with a score of \>3 on the Hoehn \& Yahr scale (i.e., those presenting with severely disabling disease, but still able to walk or stand unassisted or those who are confined to a bed or wheelchair unless aided; Bhidayasiri et al., 2012) * history of a prior neurological condition that is not PD, including epilepsy * pregnant or trying to become pregnant * those with contraindications to exercise as determined by the Physical Activity Readiness Questionnaire for Everyone (PARQ+) * currently smoke cigarettes or use tobacco products * have a pacemaker or other implanted medical device * have been hospitalized due to a psychological disorder within the last 5 years * have a respiratory disease (including chronic obstructive pulmonary disease- COPD, asthma, pulmonary high blood pressure) * have a metabolic condition (including type 1 diabetes, type 2 diabetes, pre-diabetes, chronic kidney disease, or liver problems) * have a kidney condition, a heart condition, history of stroke or cancer * experienced a blackout, fainted, or lost consciousness as a result of a head injury or had diagnosed concussion within the last 12 months * take a medication that affects cardiovascular responses to exercise * prospective participants with a diagnosis of PD who score \< 17 on the Telephone Interview for Cognitive Status (TICS-30) * currently residing outside of the United States **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:** Aston K McCullough, PhD, MS, MA **Phone:** 6173738893 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gregory Cloutier - **Phone:** 617-373-8009 - **Role:** CONTACT ***Contact 2:*** - **Name:** Aston K McCullough, PhD, MS, MA - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Northeastern University **State:** Massachusetts **Status:** RECRUITING **Zip:** 02115 ### IPD Sharing Statement Module **Description:** The data set that will be generated in this study will contain identifiable information in the form of video data, which will be instrumental to the primary and secondary aims of the study. Though we do not plan to share any of the raw video or audio data, we may share signal features extracted from human activity detected in the video data; and we may share audio transcripts. **IPD Sharing:** UNDECIDED ## 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: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425718 **Brief Title:** Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries **Official Title:** Comparison of Transversalis Fascia Plane Block and Surgical Site Local Anesthetic Infiltration in Elective Cesarean Section Surgeries #### Organization Study ID Info **ID:** MarmaraClinical #### Organization **Class:** OTHER **Full Name:** Marmara University ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Marmara 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:** Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, multimodal analgesia strategies with peripheral nerve blocks are preffered with greater safety in elective Cesarean section surgeries. The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis fascia plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia. **Detailed Description:** After Cesarean sections, several factors play a role in the formation of postoperative pain, including parietal stimulation originating from the surgical incision, visceral stimulation originating from the peritoneum, and manipulation of intra-abdominal structures. To enhance patients' rehabilitation during the postoperative period, promote lactation and infant care, and reduce hospital stays, the most appropriate postoperative analgesia method should be selected. Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, regional anesthesia techniques are preferred with greater safety in elective Cesarean section surgeries. In the postoperative period, multimodal analgesia strategies can be used for pain control, and one of these strategies is postoperative peripheral nerve blocks. Ultrasound guided transversalis fascia plane block is one of the preferred methods for postoperative analgesia in cesarean section patients. The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia. ### Conditions Module **Conditions:** - Opioid Use - Postoperative Pain **Keywords:** - opioid use - postoperative pain - transversalis plane block ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Bilateral Transversalis Fascia Plane Block (with %0.25 bupivacaine, 20 ml for each side) and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes) **Intervention Names:** - Procedure: Postoperative pain management technique **Label:** Transversalis Fascia Plane Block **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Local anesthetic infiltration will be applied to the surgical incision area with 0.25% 20 ml bupivacaine and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes) **Intervention Names:** - Procedure: Postoperative pain management technique **Label:** Surgical Site Local Anesthetic Infiltration **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Surgical Site Local Anesthetic Infiltration - Transversalis Fascia Plane Block **Description:** Patients who will undergo cesarean section under spinal anesthesia will be included. Comparing postoperative pain and opioid consumption in groups **Name:** Postoperative pain management technique **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous tramadol consumption will be recorded via PCA device, then it will be documented in mg/kg units. **Measure:** Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device **Time Frame:** 48 hours #### Secondary Outcomes **Description:** In a Numerical Rating Scale (NRS), patients are asked to choose from 1 to 10. 1: no pain 10: worst pain experienced **Measure:** Postoperative pain assessment with Numeric Rating Scale (NRS) **Time Frame:** 48 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients over 18 years old * ASA II-III patients undergoing elective cesarean section Exclusion Criteria: * ASA IV patients * Patients with known neurologic or psychiatric disorders * Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease * Patients with alcohol or drug addiction * Mentally disabled patients * Patients with BMI\>30 * Patients who develop massive bleeding or coagulopathy **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Beliz Bilgili **Phone:** +905362187927 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Marmara University **Name:** Beliz Bilgili **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M16901 - Name: Tramadol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425705 **Brief Title:** Impact of Silymarin Adjunct Therapy on Proteinuria in Type 2 Diabetic Patients on RAS Inhibitors **Official Title:** Evaluating the Outcome of Silymarin as an Adjunct Therapy to Renin-Angiotensin System Inhibitors in Proteinuric Type 2 Diabetic Patients #### Organization Study ID Info **ID:** LahoreGeneralH1 #### Organization **Class:** OTHER_GOV **Full Name:** Lahore General Hospital ### Status Module #### Completion Date **Date:** 2023-07-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-10 **Type:** ACTUAL #### Start Date **Date:** 2022-02-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Lahore General Hospital #### Responsible Party **Investigator Affiliation:** Lahore General Hospital **Investigator Full Name:** Muhammad Irfan Jamil **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Given the inadequacies of existing pharmacological interventions for diabetic nephropathy, this study is predicated on the hypothesis that silymarin, having shown promise in mitigating hyperglycemia in diabetic patients without nephropathy and displaying renal protective effects in animal models, merits a thorough and systematic investigation. The current body of research on silymarin, particularly human trials, is limited by small cohorts and the preliminary nature of its outcomes. This research aims to evaluate the efficacy of silymarin as an adjunctive treatment in patients with Type 2 diabetes mellitus (T2DM) already on renin-angiotensin system inhibitors, focusing on its potential to reduce proteinuria and improve renal function. The ultimate objective is to amass more definitive evidence that could potentially inform a new therapeutic approach in the management of diabetic nephropathy. **Detailed Description:** After securing the approval from the Ethical Review Board of hospital, this study was conducted in the Nephrology Department, Lahore General Hospital, Lahore. All patients diagnosed with Type 2 Diabetes Mellitus was assessed based on the previously defined inclusion and exclusion criteria. Informed consent was obtained from all eligible participants who agreed to participate in the study. Baseline Data Collection: Upon enrollment, demographic and clinical information including age, gender, duration of diabetes, baseline renal function tests, current medication use, and baseline measures of HBA1c, FBS, RBS and proteinuria were collected. This information was provided a comprehensive profile of each participant at the start of the study. Treatment Allocation: Patients was randomly assigned into two groups using a lottery method: * Group A: received 140 mg of silymarin administered orally three times daily, alongside their standard treatment with renin-angiotensin system inhibitors. * Group B: received placebo capsule three times a day alongside their standard treatment with renin-angiotensin system inhibitors. Monitoring and Follow-up Assessments: Participants was assessed for outcomes after at one month and 3 months to monitor changes in proteinuria and renal function. Specific tests were included: * Measurement of Urinary Albumin-Creatinine Ratio (UACR): Participants were required to provide 24-hour urine specimens at one month and three months into the study. To ensure that the urine samples are not affected by external factors, patients was instructed to maintain their usual physical activities and avoid strenuous exercises the evening before the assessment days. Proteinuria was quantified using immunoturbidimetry. * Assessment of Serum Creatinine and Calculation of eGFR to Monitor Renal Function: The estimated glomerular filtration rate (eGFR) was calculated using the CKD-EPI formula at one month and three months. These assessments were help to monitor any changes in renal function over the course of the study. * Measurement of HbA1c levels after 3 months. The data was recorded meticulously using standardized data collection forms. Data was analyzed using SPSS version 26.0. Baseline characteristics of participants (age, gender, duration of diabetes, baseline renal function tests, HbA1c, FBS, RBS) were summarized using means and standard deviations for continuous variables, and frequencies and percentages for categorical variables. Changes in UACR, eGFR, and HbA1c from baseline to one month and three months were compared between Group A (silymarin) and Group B (placebo) using independent t-tests or Mann-Whitney U tests, depending on the normality of the data. Analysis of Covariance (ANCOVA) was used to adjust for any baseline imbalances and potential confounders between the two groups. Repeated measures ANOVA were employed to analyze changes over time within and between treatment groups for UACR, eGFR, and HbA1c levels, accounting for within-subject correlation over the assessment periods. All statistical tests were two-sided, and a p-value of less than 0.05 was considered statistically significant. ### Conditions Module **Conditions:** - Type 2 Diabetes Mellitus **Keywords:** - Proteinuria - Type 2 Diabetes Mellitus - Renin-Angiotensin System ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 70 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Received 140 mg of silymarin administered orally three times daily, alongside their standard treatment with renin-angiotensin system inhibitors. **Intervention Names:** - Drug: Silymarin **Label:** Group Silymarin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Received placebo capsule three times a day alongside their standard treatment with renin-angiotensin system inhibitors. **Intervention Names:** - Drug: Placebo **Label:** Group Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group Silymarin **Description:** 140 mg of silymarin administered orally three times daily, alongside their standard treatment with renin-angiotensin system inhibitors. **Name:** Silymarin **Other Names:** - Milk thistle extract **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group Placebo **Description:** placebo capsule three times a day alongside their standard treatment with renin-angiotensin system inhibitors. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** It was measured quantitatively by comparing the urinary albumin-creatinine ratio (UACR) in mg/g between initial recruitment and subsequent follow-up visits at one and three months. **Measure:** Change in the urinary albumin-creatinine ratio (UACR) from baseline **Time Frame:** Outcomes monitored at one and three-month intervals **Description:** eGFR was calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula, which incorporates serum creatinine, age, sex, and race. The outcome measure was the change in eGFR in mL/min/1.73 m² at one month and three months compared to the baseline value. **Measure:** Change in estimated glomerular filtration rate (eGFR) from baseline **Time Frame:** Outcomes monitored at one and three-month intervals **Description:** It was measured quantitatively by comparing the HbA1c levels in percentage (%) between initial recruitment and subsequent follow-up visit after three months. **Measure:** Change in HbA1c levels from baseline **Time Frame:** Outcomes monitored after three-month. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 35-70 years. * Both male and female with Type II diabetes. * Overt proteinuria defined by urinary albumin excretion \> 300 mg/24 hr. in 2 consecutive determinations despite treatment with highest FDA recommended doses of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker for at least 6 months. * Treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin (If a SGLT2 inhibitors is used, stable dose for at least 3 months). * Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins. * Patients using stable dose of Non-Dihydropyridine Calcium Channel Blockers for at least 6 months as antihypertensive. * Presence of diabetic retinopathy. * Signing informed consent. Exclusion Criteria: * Type I diabetes. * Advanced chronic kidney disease defined by estimated GFR \< 30 ml/min/1.73 m2 * Severely uncontrolled diabetes defined by HbA1C \> 10%. * Uncontrolled hypertension defined by SBP \>140 mmHg or DBP \>90 mmHg despite antihypertensive therapy. * Patients with organ transplant history. * Secondary forms of hypertension with defined etiology other than diabetes mellitus. * Other renal diseases. * Chronic Heart Failure with NYHA class III or IV. * Active infection. * Pregnancy. Use of one of the following medications within 2 months prior to enrollment in the study: * Non-steroidal anti-inflammatory agents. * Antioxidants supplements including vitamin E, vitamin C, N-acetyl- cysteine (NAC), Pentoxifylline, Lipoic acid, Fish-oil extracts (omega-3 fatty acids), Soy extracts (isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts. * Active malignancy. * History of drug or alcohol dependency. * Psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol. **Maximum Age:** 70 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** Lahore General Hospital, Lahore **State:** Punjab **Zip:** 54000 #### Overall Officials **Official 1:** **Affiliation:** Lahore General Hospital, Lahore **Name:** Muhammad Irfan Jamil, MBBS, FCPS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** will be shared on special request **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000014555 - Term: Urination Disorders - 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: D000020924 - Term: Urological Manifestations ### 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: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes Mellitus - ID: M14368 - Name: Proteinuria - Relevance: HIGH - As Found: Proteinuria - 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: M17305 - Name: Urination Disorders - 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: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011507 - Term: Proteinuria - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Fl - Name: Flavonoid - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M15643 - Name: Silymarin - Relevance: HIGH - As Found: Blended - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T43 - Name: Silymarin - Relevance: HIGH - As Found: Blended - ID: T229 - Name: Milk Thistle - Relevance: HIGH - As Found: CD33 ### Intervention Browse Module - Meshes - ID: D000012838 - Term: Silymarin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425692 **Brief Title:** Work Package 3 Education for ICU Clinicians in Basic Palliative Care **Official Title:** Enhancing Palliative Care in ICU (EPIC) - Work Package 3 #### Organization Study ID Info **ID:** 2023-2676 #### Organization **Class:** OTHER **Full Name:** Heinrich-Heine University, Duesseldorf ### Status Module #### Completion Date **Date:** 2029-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-01 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Heinrich-Heine University, Duesseldorf #### 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 EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. The project is the first European intervention study on palliative care in the ICU using a systems- based approach with proactive patient identification, checklist and blended learning designed to meet the specific needs of ICU staff. EPIC's vision is to contribute to a change in awareness from a narrow focus on prolonging life to a more holistic approach to care. The development of blended learning for intensive care staff is the task of Work Package (WP) 3. The aim is to improve the attitude, understanding and self-confidence of ICU staff. Blended learning is to be developed and implemented for this purpose. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. Due to the international character of the project, it is to be developed in English with subtitles in the local languages. In addition a workshop with patient and family advisors will be conducted. **Detailed Description:** Background Around 10% of all deceased people in the population die after being admitted to an intensive care unit (ICU). These patients may have distressing symptoms and may receive more intensive life-prolonging treatment than they would have chosen themselves. This can lead to family stress, but also to mental distress among intensive care staff. The EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. The project is the first European intervention study on palliative care in the ICU using a systems-based approach with proactive patient identification, checklist and blended learning designed to meet the specific needs of ICU staff. EPIC's vision is to contribute to a change in awareness from a narrow focus on prolonging life to a more holistic approach of care. Objectives of Work Package (WP) 3 The aim is to improve the attitude, understanding and self-confidence of ICU-staff. Blended learning will be developed and implemented for this purpose. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. Due to the international character of the project, it is to be developed in English with subtitles in the local languages. In addition a workshop with patient and family advisors should conducted. Development and implementation of blended learning The blended learning program is to be completed by all ICU staff participating in the study during the crossover period of 4 weeks prior to the intervention. The curriculum will be developed in close collaboration with another work package. The main aim is to teach the standardized EPIC procedures using the following questions: 1. Why is palliative care necessary? 2. When to call for a specialist palliative care consultation? 3. How to message palliative care? 4. What are the critical elements of palliative care in the ICU? Participants first complete the eLearning programme. This is made available to them via the data-secured open-source platform: BeST, Charite. Participants will then take part in interactive online workshops moderated by the investigators involved in the study. The workshop curriculum also focuses on communication skills training and open questions after the eLearning. Two workshops of 90 minutes each will be offered to allow all ICU staff to participate. In addition, a pocket card for symptom assessment, communication and care planning will be developed and handed out at each workshop. Evaluation of the impact of the training The evaluation of blended learning takes place at different times. On one hand, the validated CPD Response Questionnaire, a 12-item questionnaire to assess the impact of CPD activities on changes in clinical behavioral intentions, will be used. CPD activities can be used as a way of indicating that new knowledge can lead to changes in practice. Which changes the investigators want to measure will become apparent during the development of the curriculum. The comparative self-assessment (CSA) gain is used to evaluate the specific learning effects in relation to the increase in knowledge, attitudes and skills. Here, the participants assess their own increase in knowledge in the post/this assessment. The information is assessed using German school grades (1 = very good, 6 = unsatisfactory). Subsequently, the learning gain on the levels of attitude and knowledge can be calculated as CSA Gain \[%\] = ((MWpre-MWpost)/(Mwpre-1)) x 100. The learning objectives will be based on the curriculum to be developed, so the questionnaire will also be submitted as an amendment. Both questionnaires will be made available to participants via a link and/or QR code using SoSci Survey tool. The CPD is to be surveyed before and after blended learning and after six months, and the CSA gain after blended learning and also after six months. The questionnaires are available in English and will be translated back and forth according to the state of the art. Reminders for the follow-up questionnaires will be sent to the participants by e-mail. Results will be communicated to the investigators at other sites and used to update the curriculum after the intervention study has ended. Conducting and evaluation of the patients and family workshop A co-workshop will be held with patients and relatives to integrate their perspectives and needs in terms of skills and knowledge of professional caregivers. This will then also be evaluated, whereby the content to be developed will provide the items of the evaluation. The evaluation is also collected as an online questionnaire via SoSci. ### Conditions Module **Conditions:** - ICU - Staff Attitude - Learning - Palliative Care, Patient Care **Keywords:** - multi-center study - ICU staff - EU-Horizon ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Blended learning for ICU staff and online webinars. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. **Intervention Names:** - Behavioral: Education **Label:** Education on basic palliative care **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Education on basic palliative care **Description:** Education on basic palliative care via e-learning + webinar to deepen knowledge. **Name:** Education **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The comparative self-assessment (CSA) gain is used to evaluate the specific learning effects in relation to the increase in knowledge, attitudes and skills \[2\]. Here, the participants assess their own increase in knowledge in the post/this assessment. The information is assessed using german school grades (1 = very good, 6 = unsatisfactory). Subsequently, the learning gain on the levels of attitude and knowledge can be calculated as "Comparative Self-Assessment Gain" (CSA Gain \[%\] = ((MWpre- MWpost)/(Mwpre-1)) x 100) using specific outcome evaluation. **Measure:** CSA-gain **Time Frame:** e-Learning: 45 minutes, CSA-gain immediately after e-learning and 6 months post e-learning. **Description:** 12-item questionnaire to assess the impact of CPD activities on changes in clinical behavioural intentions **Measure:** CPD Response Questionnaire ("Continuing professional development") **Time Frame:** Right before starting the 45-minute e-learning session + immediately after the completion of one of the offered online workshops (to be held on two Thursdays per month for 5 years) + 6 months post blended learning. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥18 years * ICU staff and participants of the EPIC intervention study (physician, nurse) * participants of patients and family workshops * agreement to participate in the study Exclusion Criteria: * \&lt;18 years * rejection of study participation. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Martin Neukirchen, MD **Phone:** GER 0049-211-08700 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Raupach T, Munscher C, Beissbarth T, Burckhardt G, Pukrop T. Towards outcome-based programme evaluation: using student comparative self-assessments to determine teaching effectiveness. Med Teach. 2011;33(8):e446-53. doi: 10.3109/0142159X.2011.586751. **PMID:** 21774642 **Citation:** Legare F, Freitas A, Turcotte S, Borduas F, Jacques A, Luconi F, Godin G, Boucher A, Sargeant J, Labrecque M. Responsiveness of a simple tool for assessing change in behavioral intention after continuing professional development activities. PLoS One. 2017 May 1;12(5):e0176678. doi: 10.1371/journal.pone.0176678. eCollection 2017. **PMID:** 28459836 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425679 **Acronym:** ExerMOT4Health **Brief Title:** Cost-effectiveness and Efficacy of Different Physical Exercise Interventions (ExerMOT4Health) **Official Title:** Cost-effectiveness and Efficacy of Physical Exercise on Mental and Physical Health in Older Adults: Role of Motivational Strategies and Digital Technology #### Organization Study ID Info **ID:** PID2021-123688OB-C31 #### Organization **Class:** OTHER **Full Name:** University of Cadiz ### Status Module #### Completion Date **Date:** 2025-01-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2025-01-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Institute of Biomedical research and innovation of Cádiz (INIBICA) **Class:** OTHER **Name:** Universidad de Almeria **Class:** OTHER_GOV **Name:** Ministerio de Ciencia e Innovación, Spain **Class:** UNKNOWN **Name:** Agencia Estatal de Investigación, Spain **Class:** OTHER **Name:** European Regional Development Fund #### Lead Sponsor **Class:** OTHER **Name:** University of Cadiz #### Responsible Party **Investigator Affiliation:** University of Cadiz **Investigator Full Name:** Ana Carbonell Baeza **Investigator Title:** PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Online exercise has increased in popularity during the pandemic, but there is no evidence of its feasibility and benefits in older people and the influence of motivational strategies. The main aims of this project are: i) To analyze the influence of applying or not motivational strategies during different physical exercise interventions (face-to-face and online) on the effect on mental health, physical health and adherence, according to sex/gender; ii) To analyze and compare the cost-effectiveness and efficacy of face-to-face and online exercise interventions on mental health, physical health and adherence, according to sex/gender. Participants will be 104 community-dwelling older adults (60-75 years) who will be randomized assigned to control, supervised face to face, supervised face to face plus motivation, synchronous online supervised exercise or synchronous online supervised exercise groups. The control group will carry out the usual activities they have been doing, and the intervention groups will participate for 24 weeks in multicomponent exercise intervention. Study assessments will be made before starting the intervention, at the end and after 24 weeks of follow-up. Primary variables will be changes in mental and physical health, assessed by the Trail Making Test, the Yesavage Geriatric Depression Scale, and lower extremity power measured by the sit to stand test. Secondary outcomes will include other parameters of mental and physical health, blood markers, physical activity, and cost-effectiveness analysis. The dropout rate, the attendance at the sessions, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will also be recorded. The results of this project will provide insight into the mental and physical health effects and feasibility of face-to-face and synchronous online supervised physical exercise interventions, and identify older adults' perceptions of the safety, barriers and facilitators of these interventions for future application and transfer to community settings. **Detailed Description:** Scientific evidence has demonstrated the effects of multicomponent physical exercise on the mental and physical health of community-dwelling older people. Despite this, the interest of some older people in exercise is low and even a low percentage of older people practice it with sufficient frequency and intensity to obtain benefits in their mental and physical health. Recent studies have demonstrated the importance of using motivational strategies to generate adherence to exercise, but there are still no studies with community-dwelling older adults. Furthermore, the Covid-19 pandemic has shown that face-to-face physical exercise is not always possible, so it is necessary to have alternatives in case situations of social isolation and mobility restrictions return. It is also important to note that many older people have difficulty traveling to a sports center or living in rural environments, which makes it difficult to practice exercise regularly. Online exercise has increased in popularity during the pandemic, but there is no evidence of its feasibility and benefits in older people. The specific aims of this study are: 1. To analyze the influence of applying or not motivational strategies during supervised face-to-face and synchronous online physical exercise interventions on the effect on mental health, physical health and adherence, according to sex/gender in the community setting. 2. To analyze and compare the cost-effectiveness and efficacy of supervised face-to-face and synchronous online exercise interventions vs usual lifestyle on mental health, physical health and adherence, according to sex/gender in the community setting, in short and long term (follow up). 3. To design and evaluate the feasibility of supervised face-to-face and synchronous online exercise interventions and to identify older adults' perceptions of safety, barriers and facilitators of supervised face-to-face and synchronous online physical exercise interventions for future application and transfer to the community setting. 4. To create audio-visual resources that explain how to implement safe face-to-face and synchronous online supervised physical exercise interventions in older men and women that promote adherence, based on scientific evidence, in the community setting. Participants (N=104 community-dwelling older adults aged 60-75 years) will be randomized assigned to: 1) control, 2)supervised face to face, 3) supervised face to face plus motivation, 4) synchronous online supervised exercise or 5) synchronous online supervised exercise groups. The control group will carry out the usual activities they have been doing, and the intervention groups will participate for 24 weeks in 3 sessions/week of multicomponent exercise intervention, being performed from home (online groups) or at a sport center, according to the assigned group. Each session will last 60 minutes and will include 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. Study assessments will be made before starting the intervention, at the end and after 24 weeks of follow-up. Primary variables will be changes in mental and physical health, assessed by the Trail Making Test, the Yesavage Geriatric Depression Scale, and lower extremity power measured by the sit-to-stand test. Secondary outcomes will include other parameters of mental and physical health, blood markers, physical activity, and cost-effectiveness analysis. We will also record the dropout rate, the attendance at the sessions, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality. ### Conditions Module **Conditions:** - Physical Inactivity - Healthy Aging - Older Adult **Keywords:** - Aging - Exercise - Physical activity - Supervised - Home-based - Multidomain training - Multicomponent training - Physical health - Mental health - Quality of life - Physical function - Cost-effectiveness ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Supervised synchronous online exercise intervention without motivational strategies **Label:** Supervised synchronous online exercise intervention without motivational strategies **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Supervised synchronous online exercise intervention with motivational strategies **Label:** Supervised synchronous online exercise intervention with motivational strategies **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Behavioral: Supervised face to face exercise intervention without motivational strategies **Label:** Supervised face to face exercise intervention without motivational strategies **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Behavioral: Supervised face to face exercise intervention with motivational strategies **Label:** Supervised face to face exercise intervention with motivational strategies **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Participants will be advised to maintain their usual lifestyle. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Supervised synchronous online exercise intervention without motivational strategies **Description:** Participants will carry out an online synchronic supervised physical exercise intervention through their computer/tablet or mobile phone at home. The exercise professional will supervise the participant's execution online. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised face to face groups. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks.. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks **Name:** Supervised synchronous online exercise intervention without motivational strategies **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Supervised synchronous online exercise intervention with motivational strategies **Description:** Participants will carry out an online synchronic supervised physical exercise intervention through their computer/tablet or mobile phone at home. The exercise professional will supervise the participant's execution online and will also apply motivational strategies based on self-determination theory. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised face to face groups. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. **Name:** Supervised synchronous online exercise intervention with motivational strategies **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Supervised face to face exercise intervention without motivational strategies **Description:** Participants will attend the sports facilities and perform the training in small groups, being supervised by an exercise professional. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the online synchronic supervised groups, but is performed in a sports center. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. **Name:** Supervised face to face exercise intervention without motivational strategies **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Supervised face to face exercise intervention with motivational strategies **Description:** Participants will attend the sports facilities and perform the training in small groups, being supervised by an exercise professional who will also apply motivational strategies. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the online synchronic supervised groups, but is performed in a sports center. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. **Name:** Supervised face to face exercise intervention with motivational strategies **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Trail-Making Test Part A and B will be administered. Part A is based on number sequencing, participants link numbers from 1 to 25 in ascending order. Part B focuses on alternating numbers and letters in ascending order. The completion time will be registered in seconds (the lower duration, the best performance). **Measure:** Neuropsychological Performance **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** The short 15-item version of the Yesavage Geriatric Depression Scale will be used. This is a questionnaire used to screen for depression in older people. This scale consists of 15 items with a yes/no answer pattern, being the minimum score 0 and the maximum 15. The cut-off point for Depression is 5 or more. **Measure:** Depression **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Lower limb muscle performance will be assessed using the 30-seconds Chair Sit to Stand (30-s CST) test. The number of standing up in 30 seconds will be counted. A higher score, better performance. **Measure:** Lower-body muscular function **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) #### Secondary Outcomes **Description:** Grip strength will be measured with a digital hand-held dynamometer on both arms (Takei TKK5401, Tokyo, Japan). The test was performed in both standing and sitting positions, in both cases with the arm fully extended. A higher score, better performance. **Measure:** Upper-body muscular function **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Maximum gait speed will be evaluated by measuring the time used to walk 3, 4, 6 and 10 meters linear distance at maximum pace without running. Gait speed is calculated by dividing the distance into registered walking time. A higher speed (or lower registered time) better performance. **Measure:** Maximum walking speed (3, 4, 6 and 10-m) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Usual gait speed will be evaluated by measuring the time used to walk 3, 6 and 10 meters linear distance at usual pace. Gait speed is calculated by dividing the distance into registered walking time. A higher speed (or lower registered time) better performance. **Measure:** Usual walking speed (3, 6 and 10-m) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** It consists of three parts: the ability to stand with feet together in side-to-side, semi-tandem, and tandem positions (balance), 4-meters walk test (speed), and 5 times sit-to-stand (muscle power). Each part is scored from 0 to 4, with a total SPPB score of 12 points, a higher score, better performance. **Measure:** Short Physical Performance Battery (SPPB) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** SFT battery includes 30-second chair stand test (lower-body strength), 30-second arm curl test (upper-body strength), 6-minute walk test (aerobic endurance), Chair sit-and-reach test (lower-body flexibility), Back scratch test (upper-body flexibility) and 8-foot up-and-go test (agility and dynamic balance). **Measure:** Senior Fitness Test (SFT) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Systolic and diastolic blood pressure will be assessed in a seated position, twice, 2 minutes apart, after 5 minutes at rest, using a digital upper arm blood pressure monitor (OMRON M6, Spain). Blood pressure will be assessed at the level of the right atrium, with the participant's back supported and uncrossed legs with both feet on the floor. **Measure:** Resting blood pressure **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Heart rate will be assessed in a seated position twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute), using a digital upper arm blood pressure monitor (OMRON M6, Spain). **Measure:** Resting heart rate **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Height will be measured with a stadiometer (Seca 213, Hamburg, Germany). Body mass will be measured using a body composition analyzer (InBody 770, Biospace, California, USA). The participant will be barefoot and wearing as minimally clothed as possible. Body mass index will be calculated as body mass (kg) divided by height (m) squared (kg·m-2). **Measure:** Anthropometry **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Waist and hip perimeters will be measured in upright position in accordance with the ISAK guidelines with a circumference tape (Lukfin, W606PM) following the standardized protocol, as well as calf perimeter in a sitting position. **Measure:** Body perimeters **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Body Composition will be measured using a body composition analyzer (InBody 770, Biospace, California, USA), following the standardized protocol. Fat mass (kg and %), fat free mass (kg and %) and skeletal muscle mass (kg and %) will be obtained. **Measure:** Body composition **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** The EuroQol-5D questionnaire will be used for assessing the health-related quality of live of the participants, including five dimensions and a visual analogue scale. The 5 dimensions included in the descriptive system are (1) mobility, (2) self-care, (3) usual activities, (4) pain/discomfort, and (5) anxiety/depression. Responses will be coded according to the three-level scale for each dimension. A utility value will be assigned to each combination of responses. This index provides a quantitative measure of each individual's health-related quality of life, where 0 represents the worst possible health and 1 represents the best possible health.The EQ-VAS scale consists of asking participants to indicate their current health status from 0 ("worst imaginable health status") to 100 ("best imaginable health status"). **Measure:** Health-related quality of life **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score ranged from 0 to 30, and the highest score indicates better performance. **Measure:** Cognitive Performance- The Montreal Cognitive Assessment **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The Stroop Color and Word Test (SCWT) is divided into three conditions, the first condition consists of reading color names printed in black ink, in the second condition the participant will read colors printed in an "X", and the third condition consists of naming the ink color instead of reading the word. All conditions contain 100 words, and time is limited to 45 seconds for each condition. The total number of correct words for each condition will be recorded, indicating that the higher the number of correct words, the better the performance. **Measure:** Cognitive Performance-The Stroop Color and Word Test (SCWT) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Digit Span test of the Wechsler Adult Intelligence Scale III (WAIS III). Participants will be asked to recall a list of numbers in the order given (forward or backwards). The test is finished when for the same item, the participant fails two attempts. A total number of correct answers will be registered for each condition, ranging from 0 to 30, with the highest scores being the best performance. **Measure:** Cognitive Performance- Digit Span test of the Wechsler Adult Intelligence Scale III **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The test consists of drawing a clock with a given time (11:10). The total score is the sum of the scores given to dial, numbers and clock faces, ranging from 0 to 10 with the highest scores being the best performance. **Measure:** Cognitive Performance-Clock Drawing Test (CDT). **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Digit Symbol Substitution Test. The participant will fill in a series of coded symbols for 90 and 120 seconds. The total number of responses as well as errors are recorded. In this test, the higher the score, the better the performance. **Measure:** Cognitive Performance- Digit Symbol Substitution Test **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The Zung Anxiety Self-Assessment Scale will be used to assess anxiety symptoms. It consists of 20 items with a 4-point response scale ranging from 1 (not at all or hardly ever) to 4 (most or all of the time), obtaining a maximum score of 80. The higher the score, the higher anxiety. **Measure:** Anxiety **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Physical activity and sedentary behavior will be assessed by accelerometry ((Actigraph GT3X, MTI, USA). The devices will be placed on the subject's non-dominant wrist using a watch strap for 8 days. **Measure:** Physical activity and sedentary behavior patterns assessed by accelerometry. **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Physical activity and sedentary behavior will be assessed by the International Physical Activity Questionnaire-Short form (IPAQ). This questionnaire ask about the time spent on vigorous, moderate, walking and sitting activities in the last 7 days. **Measure:** Physical activity and sedentary behavior patterns by questionnaire **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The number of hours of sleep will be assessed by accelerometry ((Actigraph GT3X, MTI, USA). The devices will be placed on the subject's non-dominant wrist using a watch strap for 8 days. **Measure:** Sleep assessed by accelerometry **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The Pittsburgh Sleep Quality Index consists of 19 self-assessed questions and 5 partner-assessed questions. The 19 items are combined to form seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), each with a range of 0 to 3 points. The total score ranges from 0 to 21, where 0 points represents no difficulties and 21 points represents severe difficulties and worse sleep quality. **Measure:** Sleep assessed by questionnaire **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Blood samples will be collected in the morning after an overnight fast and at least 24 h after the last exercise session. After collection, tubes will be centrifuged at 3500 rpm for 10 min. Serum obtained for each participant will be stored in aliquots at -80 °C until analysis. Serum BDNF (ng/mL) will be quantified using a sandwich enzyme-linked immunosorbent assay (ELISA). Human BDNF Quantikine Immunoassay (R\&D Systems, Minneapolis, MN) will be performed according to the manufacturer's instructions. **Measure:** Serum BDNF **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Blood samples will be collected in the morning after an overnight fast and at least 24 h after the last exercise session. After collection, tubes will be centrifuged at 3500 rpm for 10 min. Serum obtained for each participant will be stored in aliquots at -80 °C until analysis. A commercial enzyme-linked immunosorbent assay (ELISA) will be performed to measure α-klotho serum concentration (pg/ml) according to the manufacturer's protocol (Human soluble α-Klotho Assay Kit JP27998, Immuno-Biological Laboratories Co., Ltd., Gunma, Japan). The quantification will be performed spectrophotometrically using a FLUOstar OPTIMA Microplate Reader (ThermoFisher Scientific, Waltham, MA, USA) and Optima Control software version 2.20. **Measure:** Serum α-Klotho **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Glucose, uric acid, urea, creatinine, bilirubin, sodium, potassium, chloride, calcium, phosphorus, total proteins, albumin, cholesterol, cholesterol-HDL, cholesterol-LDL (calculated), triglycerides, aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyltransferase (GGT),alkaline phosphatase, lactate dehydrogenase (LDH), creatine kinase (CK,) will be measured using routinary clinical techniques. **Measure:** Routinary blood serum analysis **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** It consists of the analysis following parameters: red blood cell count, hemoglobin concentration, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, white blood cell count, differential white blood cell count, platelet count and mean platelet volume **Measure:** Hemogram **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Motivators and barriers to exercise will be measured using the Exercise Benefits/Barriers Scale. It is a 43-item instrument with a four-response Likert-type scale; Twenty-nine items are related to the benefits, while the remaining 14 are barriers. - The total score of the instrument can range from 43 to 172 points, with higher scores indicating a more positive perception of exercise. **Measure:** Motivators and barriers to exercise **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The Behavioral Regulation during Exercise Questionnaire (BREQ-3) comprises 23 items (4 for intrinsic regulation, 4 for integrated regulation, 3 for identified regulation, 4 for introjected regulation, 4 for external regulation and 4 for amotivation) that measure the stages of the self-determination theory with respect to motivation to exercise. Participants will answer each item on a 5-point scale ranging from 0 (not true for me) to 4 (very true for me). Higher scores on identified regulation, integrated regulation and intrinsic motivation are generally considered indicative of a more self-determined and healthy motivation towards exercise. On the other hand, higher scores on amotivation, external regulation and introjected regulation generally indicate less self-determined motivation. **Measure:** Motivation to exercise according to self-determination theory **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** The Basic Psychological Needs in Exercise Scale (BPNES) is composed of 12 items assessing the satisfaction of the three basic psychological needs in physical exercise contexts: competence, autonomy and relationship with others. A 5-point likert scale is used: (1) Do not agree at all, (2) Somewhat agree, (3) Somewhat agree, (4) Strongly agree, and (5) Strongly agree.using : (1) I don't agree at all, (2) I agree a little bit, (3) I somewhat agree, (4) I agree a lot, and (5) I completely agree. For each need, a minimum score of 4 points and a maximum of 20 points can be obtained. The score for the total questionnaire would be a minimum of 12 points and a maximum of 60 points. A higher score reflects a better satisfaction of basic psychological needs. **Measure:** Basic Psychological Needs in Exercise **Time Frame:** Baseline (week 0), Post-intervention (week 25) and follow-up (week 48) **Description:** The Satisfaction with Life Scale is a 5-item instrument with a Likert-type scale ranging from 1 to 5 points, and measures overall subjective happiness through statements in which participants rate themselves. The higher the score, the higher the satisfaction with life. **Measure:** Satisfaction with Life **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Age, sex, marital status, educational level, socioeconomic status, employment status, self-rated health, family history of Alzheimer, pathologies diagnosed, number of falls during the previous year, consumption of medicines, and tobacco and alcohol consumption will be determined by this questionnaire **Measure:** Sociodemographic characteristics questionnaire **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** A cost-effectiveness analysis will be performed to assess the expenses associated with each intervention group, utilizing the EQ-5D questionnaire to evaluate changes in health states.The analysis will focus on the following key metrics, the Quality-Adjusted Life-Year (QALY) and the Incremental Cost-Effectiveness Ratio (ICER). The Cost-Utility analysis examines an intervention's cost-effectiveness by considering expenses and the impact on patients' quality of life. QALYs provide a comprehensive measure of both the quantity and quality of life, calculated by multiplying the utility weights assigned to each health state by the time spent in that state. The cost per QALY gained is determined by dividing the total intervention costs by the total QALYs gained. The ICER compares the cost-effectiveness of two interventions by evaluating the difference in costs and effects (QALYs gained). A positive ICER indicates that Intervention A is more expensive and less effective than Intervention B **Measure:** Cost-Effectiveness Analysis **Time Frame:** Through intervention completion (24 weeks) **Description:** Adherence to physical training program will be recorded by the trainers. It will be calculated as a percentage (\[sessions completed/total sessions expected\] x 100), where 0 % indicates total non-adherence and 100 % indicates full adherence to the exercise intervention. **Measure:** Adherence to physical training program **Time Frame:** Through intervention completion (week 24) **Description:** During the 24-week follow-up, the investigators will assess through an ad-hoc self-reported questionnaire whether or not participants exercised during the follow up period (24 weeks), the exercise modality performed, if the exercise was supervised center-based and/or unsupervised/supervised home-based, the number of weekly exercise sessions performed, the average time and the subjective intensity perceived (light, moderate or vigorous). **Measure:** Exercise during follow-up period **Time Frame:** Follow-up (week 48) **Description:** Participants in the supervised synchronous online exercise and control groups will record in a diary their falls and adverse events during and outside exercise sessions. In the supervised face to face groups, supervisors will register the incidence of falls during exercise sessions an participants will register them outside the exercise sessions using the diary. **Measure:** Falls and adverse events **Time Frame:** Through intervention completion (24 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * People from both sexes aged 60-75 years. * Not to have diseases and disabilities that limit to be part of exercise interventions or avoid measurements. * Not perform supervised moderate to vigorous physical activity \>30 minutes and \>3 days/week. * To be able to communicate without problems. * To be able to read and understand the aim of the project and informed consent form. * To have a smartphone, tablet or computer with internet connection. Exclusion Criteria: * Acute or terminal illness. * Myocardial infarction, coronary artery bypass grafting, angioplasty, angina, or other cardiac conditions in the past year. * Uncontrolled medical problems that the general practitioner considers would preclude patients from undertaking the exercise program (e.g., acute systemic illness such as pneumonia, acute rheumatoid arthritis, and acute or unstable heart failure). * Conditions requiring a specialized physical exercise program (e.g., uncontrolled epilepsy, significant neurological disease or impairment, inability to maintain an upright seated position or unable to move independently, multiple sclerosis, cancer, Parkinson's, Alzheimer's, or chronic obstructive pulmonary disease). * General practitioner-diagnosed hypertension that has not been controlled. * Uncontrolled Type I or Type II Diabetes. * History of major psychiatric illness including schizophrenia, generalized anxiety disorder, or depression according to the DSM-5. * Three or more self-reported falls in the last year. * Not wanting to complete the study or be assigned to the control group; * Be participating in another research study that may influence this project. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Almería **Country:** Spain **Facility:** Universidad de Almeria **State:** Almeria **Zip:** 04120 **Location 2:** **City:** Puerto Real **Country:** Spain **Facility:** University of Cadiz **State:** Cadiz **Zip:** 11519 #### Overall Officials **Official 1:** **Affiliation:** University of Cadiz **Name:** Ana Carbonell Baeza, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Universidad de Almeria **Name:** Pablo Jorge Marcos Pardo, PhD **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: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425666 **Brief Title:** Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy **Official Title:** European Prospective Multicentre, Open Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial) #### Organization Study ID Info **ID:** Uni-Koeln-5135 #### Organization **Class:** OTHER **Full Name:** University of Cologne #### Secondary ID Infos **Domain:** ESCRS (European society of Cataract and Refractive Surgeons) **ID:** ORG-100006227 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Clinical Trials Centre Cologne **Class:** UNKNOWN **Name:** ESCRS (European Society of Cataract and Refractive Surgeons) #### Lead Sponsor **Class:** OTHER **Name:** University of Cologne #### Responsible Party **Investigator Affiliation:** University of Cologne **Investigator Full Name:** Björn Bachmann **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:** The purpose of this study is to investigate whether there is a difference in best spectacle corrected visual acuity (BSCVA) in patients treated with one of the following two surgeries: (1) cataract surgery with preservation of the diseased endothelial cells ("cataract surgery only experimental intervention, investigational therapy/ arm 1); (2) cataract surgery combined with removal of the diseased endothelial cells and the attached Descemet's membrane followed by transplantation of a healthy endothelial cell layer with attached Descemet's membrane ("triple-DMEK"(""cataract surgery only", control intervention comparator therapy/ arm 2) **Detailed Description:** After signing the informed consent, patients are screened for eligibility for the trial regarding in- and exclusion criteria. Different tests will be performed like ocular examination including slit lamp examination, fundus examination, IOP measurement, BSCVA, Pentacam imaging, contrast sensivity test and Macula-OCT, vital signs. Once all inclusion criteria and none of the exclusion criteria are met, the patient will be enrolled into the trial and will receive a subject-ID. If Screening and Baseline assessments cannot be performed on the same day, a Baseline Visit can take place up to 7 days after enrolment of the subject into the clinical trial. At the Baseline Visit different tests will be performed like a Fluorescein stain test. In addition, subjects have to complete vision related quality of life questionnaires. After all investigations are completed, the subject will be randomised and distributed to the respective treatment groups. Patients who are enroled in arm 1 undergo exclusively a cataract surgery, in the comparator therapy (arm 2) patients undergo triple-DMEK (cataract surgery and DMEK) The post-operative Visit will take place 22 weeks ± 14 days after the surgical intervention where different test have to be performed. The duration of the clinical trial for every individual subject will be up to 24 weeks. ### Conditions Module **Conditions:** - Cataract Surgery - Cataract and Fuchs Endothelial Corneal Dystrophy **Keywords:** - Fuchs´ Endothelial Corneal Dystrophy Krachmer grade 3 and 4 - nuclear cataract - Nuclear opalescence (NO) grades 2 - Nuclear opalescence (NO) grades 3 - Central corneal thickness ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Masking Description:** After screening and enrollement subjects will be randomly allocated to the trial groups (cataract surgery versus triple-DMEK, allocation rate 1:1) **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After randomisation the investigational therapy (arm 1), patients undergo a cataract surgery (cataract surgery with preservation of the diseased endothelial cells). The cataract surgery will take approximately 10-20 minutes. The follow-up period after surgery will be 22 weeks ± 14 days. **Intervention Names:** - Procedure: Intervention group /arm 1 (Cataract surgery alone) **Label:** Experimental intervention /arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** After randomisation, patients in the comparator therapy (arm 2) undergo triple-DMEK which is a cataract surgery combined with DMEK (removal of the diseased endothelial cells followed by transplantation of a healthy endothelial cell layer). Triple-DMEK takes approximately 5-10 minutes longer than cataract surgery. The follow-up period after surgery will be 22 weeks ± 14 days. **Intervention Names:** - Procedure: Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK) **Label:** Control intervention /arm2 **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental intervention /arm 1 **Description:** Cataract surgery (experimental intervention / arm 1) is performed using a small incision technique. The main incision will be localized between 11 and 12 o'clock and will have a width of 2.4 to 2.8 mm. A tunnel suture will only be placed if there is leakage from the incisions. A thin dispersive viscoelastic is applied to the endothelium for protection before phacoemulsification. A hydrophobic acrylic monofocal IOL will be implanted into the bag. **Name:** Intervention group /arm 1 (Cataract surgery alone) **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Control intervention /arm2 **Description:** After cataract surgery DMEK is continued using the surgeon's standard technique for graft implantation and unfolding in triple-DMEK. In all cases the graft will be implanted using the same main incision as for IOL implantation. Once the DMEK graft is unrolled and attached to the posterior corneal stroma the complete anterior chamber will be filled with SF6 20%. **Name:** Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Best spectacle corrected visual acuity (BSCVA) is messured with EDTRS-charts (transformed to logMAR) **Measure:** The primary objective of the study is to investigate whether there is a difference in best spectacle corrected visual acuity (BSCVA) in patients who receive one of the following two surgeries: (arm 1) cataract surgery alone and (arm 2) triple-DMEK **Time Frame:** 22 weeks +/- 14 days after surgery #### Secondary Outcomes **Description:** Specific measurement variable: ETDRS charts (transformed to logMAR); Analysis metric (participant level): Difference BSCVA at follow-up - BSCVA at baseline \[logMAR - no dimension\]; Method of aggregation (summary measure for each study group): Mean difference **Measure:** Change in visual acuity (BSCVA) **Time Frame:** Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Total score of Freiburg Vision Test "FrACT"; Analysis metric (participant level): Value \[logCS (Weber)\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Contrast sensitivity **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Total score of objective scattering index (OSI); Analysis metric (participant level): Value \[OSI - no dimension\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Optical quality measured by HD-analyzer **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Total score of Modulation transfer function (MTF) cut-off; Analysis metric (participant level): Value \[c/deg\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Optical quality measured by HD-analyzer **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Total score of Strehl ratio; Analysis metric (participant level): Value \[no dimension\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Optical quality measured by HD-analyzer **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Deviation from target refraction \[D\], mean error \[ME\], mean absolute error \[MAE\]; Analysis metric (participant level): Value (D, ME and/or MAE) \[D\]); Method of aggregation (summary measure for each study group): Mean **Measure:** Refractive accuracy:spherical equivalent **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Corneal densitometr (grayscale unit GSU) (Anterior, central, posterior and total layer); Analysis metric (participant level): Value \[GSU\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Corneal topography/ tomography **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Corneal densitometry (grayscale unit GSU) (Anterior, central, posterior and total layer); Analysis metric (participant level): Difference value at follow-up - baseline value \[GSU\]; Method of aggregation (summary measure for each study group): Mean difference **Measure:** Change in Corneal topography/tomography parameters **Time Frame:** At baseline and 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: CCT measured by Pentacam \[μm\]; Analysis metric (participant level): Difference CCT at follow up - CCT baseline \[µm\]; Method of aggregation (summary measure for each study group): Mean difference **Measure:** Change in central corneal thickness (CCT) **Time Frame:** At baseline and 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: CME visualized by SD-OCT; Analysis metric (participant level): Value \[yes/no\]; Method of aggregation (summary measure for each study group): Proportion **Measure:** Cystoid macular edema **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Measured by SD-OCT; Analysis metric (participant level): Difference value at follow-up - baseline value \[µm\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Change in central retinal thickness **Time Frame:** At baseline and at 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Catquest-9SF (all centers) and V-Fuchs (Germany only); Analysis metric (participant level): Total score \[no dimension\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Quality of life after surgery **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Catquest-9SF (all centers) and V-Fuchs (Germany only); Analysis metric (participant level): Difference in total score \[no dimension\] (follow-up-- baseline) \[no dimension\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Change in quality of life **Time Frame:** At baseline and at 22 weeks +/- 14 days after initial surgery **Description:** Analysis metric (participant level): Value \[mmHg\] **Measure:** Change in intraocular pressure (IOP) from baseline **Time Frame:** At baseline and at 22 weeks +/- 14 days after initial surgery **Description:** Analysis metric (participant level): Value \[yes/no\] **Measure:** Postoperative endothelial decompensation **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Analysis metric (participant level): Value \[yes/no\] **Measure:** Additional ocular surgeries **Time Frame:** 22 weeks +/- 14 days after initial surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with FECD and nuclear cataract in study eye 2. Male and female patients ≥18 years of age 3. Subject must be able to understand and read the national language. 4. Written informed consent prior to any study-related procedures 5. Nuclear opalescence (NO) grades 2 and 3 according to the lens opacities classification system III (LOCS III) 6. Krachmer grade (3 \[2-5 mm diameter area with confluent guttae\]; 4 \[ \> 5 mm diameter area with confluent guttae\] without edema identified by slit lamp examination) 7. Central corneal thickness (CCT) measured with Pentacam below 620 µm between 8:00 am and 01:00 pm 8. BSCVA logMAR \< 0,7 and \> 0,1 9. No previous cataract surgery or triple-DMEK on the opposite side 10. Pentacam Quality specification: "OK" 11. For women below age of 60 negative urine pregnancy test Exclusion Criteria: 1. Patients with ocular and/or systemic comorbidity affecting vision or clinically proven anterior and/or posterior segment disease other than FECD and cataract (exclusion of macular disease or edema by OCT) 2. Iris synechiae, pupil diameter \<6 mm after dilatation, pseudoexfoliation syndrome, subluxated lens, previous history of ocular trauma/surgery or inflammatory disease 3. Subjective diurnal changes in visual acuity with worse visual acuity in the morning 4. Corneal (epithelial) edema visible at slit lamp examination 5. Preoperative anterior chamber depth below 2 mm 6. Participation in other interventional trials parallel or within the last 4 weeks 7. Systemic use of Alpha-1-Adrenozeptor-Antagonists, immunosuppressive therapy or chemotherapy) 8. Pregnant women and nursing mothers 9. Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator 10. Legally incapacitated persons 11. Persons held in an institution by legal or official order **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Björn Bachmann, Prof. **Phone:** 0049-221 478-87476 **Role:** CONTACT #### Locations **Location 1:** **City:** Aarhus N **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jesper Hjortdal, Prof. - **Phone:** 78 45 46 44, 23346770 - **Phone Ext:** 0045 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jesper Hjortdal, Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Department of Ophthalmology, Aarhus University Hospital **State:** Midtjylland **Zip:** DK- 8200 **Location 2:** **City:** Köln **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Björn Bachmann, Prof. - **Phone:** 0049-2214784308 - **Role:** CONTACT ***Contact 2:*** - **Name:** Björn Bachmann, Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** Klinik für Ophthalmologie des Universitätsklinikums Köln **State:** NRW **Zip:** 50937 **Location 3:** **City:** Nijmegen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Siamak Nobacht, Dr. - **Phone:** 653613048 - **Phone Ext:** 0031 - **Role:** CONTACT ***Contact 2:*** - **Name:** Siamak Nobacht, Dr. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Radboud-Universität Nijmegen **State:** Gelderland **Zip:** GA 6525 **Location 4:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** José Luis Güell, Dr. - **Phone:** 934 000 700 - **Phone Ext:** 0034 - **Role:** CONTACT ***Contact 2:*** - **Name:** José Luis Güell, Dr. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva **Zip:** 08035 #### Overall Officials **Official 1:** **Affiliation:** University Hospital Cologne **Name:** Björn Bachmann, Prof. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007905 - Term: Lens Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000003316 - Term: Corneal Diseases - ID: D000015785 - Term: Eye Diseases, Hereditary - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M5638 - Name: Cataract - Relevance: HIGH - As Found: Cataract - ID: M6540 - Name: Corneal Dystrophies, Hereditary - Relevance: HIGH - As Found: Corneal Dystrophy - ID: M8761 - Name: Fuchs' Endothelial Dystrophy - Relevance: HIGH - As Found: Fuchs Endothelial Corneal Dystrophy - ID: M10917 - Name: Lens Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M6539 - Name: Corneal Diseases - Relevance: LOW - As Found: Unknown - ID: M18339 - Name: Eye Diseases, Hereditary - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002386 - Term: Cataract - ID: D000003317 - Term: Corneal Dystrophies, Hereditary - ID: D000005642 - Term: Fuchs' Endothelial Dystrophy ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425653 **Brief Title:** Exercise With Scleroderma Functional Outcomes **Official Title:** The Effect of Exercise Program Applied to Patients With Scleroderma on Functional Outcomes: A Randomized Controlled Trial #### Organization Study ID Info **ID:** 20-9T/25 #### Organization **Class:** OTHER **Full Name:** Trakya University ### Status Module #### Completion Date **Date:** 2021-12-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-02-05 **Type:** ACTUAL #### Start Date **Date:** 2021-02-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Scientific and Technological Research Council of Turkey #### Lead Sponsor **Class:** OTHER **Name:** Trakya University #### Responsible Party **Investigator Affiliation:** Trakya University **Investigator Full Name:** Gizem Özbudak **Investigator Title:** Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study aims to investigate the effects of an exercise program applied to patients with scleroderma on functional outcomes (hand and mouth functional results and quality of life). **Detailed Description:** Systemic sclerosis (scleroderma) is a significant, rare autoimmune connective tissue disease characterized by autoantibodies, fibrosis of the skin and internal organs, microvascular injury and vascular damage due to endothelial cell activation (Sepulveda et al., 2019; Rosendahl et al., 2022). The term "scleroderma" is derived from two Greek words "sklero" and "derma" meaning hard skin (Bielacka et al., 2017; Singh et al., 2019). The global prevalence of scleroderma is estimated to be between 0.3 and 40 per 100,000 population (Alhendi et al., 2020; Benz et al., 2021; Sierakowska et al., 2019). The occurrence of systemic sclerosis in women is three to five times and in some literature up to eight times higher than in men. The disease incidence peaks between the ages of 30 and 65 (Sierakowska et al., 2019; Hughes et al., 2020; Alhendi et al., 2020). Impairment of hand functions is one of the most significant disabilities in patients with scleroderma and is commonly observed (Gregory et al., 2019; Mugii et al., 2019). The skin of the hand thickens with manifestations including fingertip ulcers, swelling of the fingers, raynaud's phenomenon and subcutaneous calcium deposition (Abreu et al., 2023). Deformities such as loss of flexion in the metacarpophalangeal joints, loss of extension in the proximal and distal interphalangeal joints, loss of abduction, flexion of the thumb and wrist movement can occur, leading to contractures and severe impairment of hand functions (Bongi \& Rosso, 2016; Vannajak et al., 2014). Besides hand function impairment, another significant issue in scleroderma is the fibrotic involvement of the connective tissue of the face and mouth. Patients tend to lose facial expression. Sclerosis of the skin around the lips and mouth area causes a reduction in mouth opening (microstomia) and width (microcheilia) in 43% to 80% of cases (Puzio et al., 2019; Uras et al., 2019). Rehabilitation strategies which play a crucial role in the management of scleroderma, include psychoeducational interventions, exercise therapy, application of physical methods, assistive devices and orthoses; joint protection and energy conservation approaches, dietary interventions and comprehensive multidisciplinary team care programs (Schouffoer et al., 2011). Among these interventions daily hand exercises are specifically mentioned to improve hand movement and function, and also mouth and facial exercises positively affect mouth opening function (Gregory et al., 2019). Hand rehabilitation enhances hand movement, functionality and strength, as well as participation in daily life activities such as self-care, housework, work and recreational activities, thereby improving quality of life (Bongi \& Rosso, 2016). Exercises that stretch the mouth and increase mouth opening are reported to prevent the progression of microstomia and reduce limitations in mouth opening (Puzio et al., 2019; Yuen et al., 2012). Some approaches and techniques involving active exercises for managing microstomia are suggested, indicating success with the performance of mandibular movements (Puzio et al., 2019). Programs that include hand and oral rehabilitation interventions are needed to prevent hand deformities and oral dysfunctions, ensure positive body perception, provide coping strategies and maintain quality of life (Schouffoer et al., 2011; Vannajak et al., 2014). However, individuals with a rare disease such as scleroderma face many challenges, including lack of knowledge about the disease, difficulties in accurate diagnosis and limited treatment and support options. Professional support services that are usually provided to individuals with more common diseases are not available for scleroderma patients (Delisle et al., 2019). Scleroderma is a chronic disease that affects multiple systems and can present numerous symptoms and complications, impacting individuals physically, psychologically and socially. Therefore, the care of patients with scleroderma requires an interdisciplinary holistic health approach that encompasses both physical and emotional support. The rarity of scleroderma, the fact that many patients live far from physical therapy and rehabilitation clinics or the necessity of continuous participation in a program necessitates the implementation of nurse-led home programs (Murphy et al., 2018). ### Conditions Module **Conditions:** - Scleroderma, Systemic - Scleroderma, Diffuse - Scleroderma, Limited - Hand Rheumatism - Mouth Movement Impaired **Keywords:** - exercise - hand and mouth functional outcomes - nursing - scleroderma - quality of life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** In the control group the standard protocol was applied. The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 44 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the control group the standard protocol was applied. The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization **Intervention Names:** - Other: Exercise Program **Label:** Exercise Program **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. **Label:** Standart Protocol **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Exercise Program **Description:** In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization **Name:** Exercise Program **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** The mouth opening measurements at the final follow-up of the intervention and control group patients included in the study are compared in Table 3. A statistically significant difference was found between the final follow-up mouth opening measurement values of the groups (p\<0.05) **Measure:** Oral functional results of the participants **Time Frame:** After 12 weeks **Description:** The final follow-up scores of the World Health Organization Quality of Life (WHOQOL) Scale averages for the patients in the intervention and control groups who participated in the study were compared. When all subdomains of the scale were evaluated, it was determined that there was a statistically significant difference between the final follow-up total score averages for the physical, psychological, social and environmental domains of the patients in both the intervention and control groups (p\<0.05) **Measure:** Quality of life results of the participants **Time Frame:** After 12 weeks #### Primary Outcomes **Description:** Of the patients included in the study, 50.0% (22 patients) were in the intervention group and 50.0% (22 patients) were in the control group. 95.5% of the intervention group were women and 4.5% were men, with the control group also comprising 95.5% women and 4.5% men patients. The mean age of the all patients was 51.70 ± 11.11 years. 63.6% of patients in the intervention group and 59.1% of patients in the control group were diagnosed with diffuse cutaneous scleroderma. The mean duration of scleroderma diagnosis of all the patients was 9.54 ± 6.73 years for the intervention group and 9.4 ± 6.20 years for the control group. The majority in both groups (63.6% in the intervention group / 95.5% in the control group) were nonsmokers. Table 1 compares the demographic and disease characteristics of the groups. Groups were similar with regard to the demographic and disease characteristics. **Measure:** Demographic and disease characteristics of the participants **Time Frame:** After 12 weeks #### Secondary Outcomes **Description:** Upon examining the final follow-up hand functional outcomes of the intervention and control group patients, it has been observed that there is a statistically significant difference between the groups in terms of the average total score of the Duruöz Hand Scale for all sub-dimensions including kitchen, dressing, cleaning, workplace and other activities, as well as the overall average total score (p\<0.05) **Measure:** Hand functional outcomes of the participants **Time Frame:** After 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The inclusion criteria were being aged between 18 to 70 years, having no communication problems, being able to speak Turkish and agreeing to participate in the study. Exclusion Criteria: * . The exclusion criteria were not having the ability to regularly perform hand and mouth exercises, having undergone hand surgery in the last six months, having open wounds or contractures on the hand, having hand and mouth functional disorders due to reasons other than scleroderma, having no teeth, having all upper and lower teeth as dentures and being included in a rehabilitation program in the last three months. **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:** Edirne **Country:** Turkey **Facility:** Gizem Özbudak #### Overall Officials **Official 1:** **Affiliation:** Trakya University **Name:** Gizem Özbudak, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Ege University **Name:** Serap Özer, PhD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Ege University **Name:** Figen Yargucu Zihni, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Sierra-Sepulveda A, Esquinca-Gonzalez A, Benavides-Suarez SA, Sordo-Lima DE, Caballero-Islas AE, Cabral-Castaneda AR, Rodriguez-Reyna TS. Systemic Sclerosis Pathogenesis and Emerging Therapies, beyond the Fibroblast. Biomed Res Int. 2019 Jan 23;2019:4569826. doi: 10.1155/2019/4569826. eCollection 2019. **PMID:** 30809542 **Citation:** Rosendahl AH, Schonborn K, Krieg T. Pathophysiology of systemic sclerosis (scleroderma). Kaohsiung J Med Sci. 2022 Mar;38(3):187-195. doi: 10.1002/kjm2.12505. Epub 2022 Mar 2. **PMID:** 35234358 **Citation:** Kowal-Bielecka O, Fransen J, Avouac J, Becker M, Kulak A, Allanore Y, Distler O, Clements P, Cutolo M, Czirjak L, Damjanov N, Del Galdo F, Denton CP, Distler JHW, Foeldvari I, Figelstone K, Frerix M, Furst DE, Guiducci S, Hunzelmann N, Khanna D, Matucci-Cerinic M, Herrick AL, van den Hoogen F, van Laar JM, Riemekasten G, Silver R, Smith V, Sulli A, Tarner I, Tyndall A, Welling J, Wigley F, Valentini G, Walker UA, Zulian F, Muller-Ladner U; EUSTAR Coauthors. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis. 2017 Aug;76(8):1327-1339. doi: 10.1136/annrheumdis-2016-209909. Epub 2016 Nov 9. **PMID:** 27941129 **Citation:** Singh D, Parihar AK, Patel S, Srivastava S, Diwan P, Singh MR. Scleroderma: An insight into causes, pathogenesis and treatment strategies. Pathophysiology. 2019 Jun;26(2):103-114. doi: 10.1016/j.pathophys.2019.05.003. Epub 2019 May 18. **PMID:** 31130325 **Citation:** Alhendi FJ, Werth VP, Sollecito TP, Stoopler ET. Systemic sclerosis: Update for oral health care providers. Spec Care Dentist. 2020 Sep;40(5):418-430. doi: 10.1111/scd.12492. Epub 2020 Jul 6. **PMID:** 33448431 **Citation:** Benz K, Baulig C, Knippschild S, Strietzel FP, Hunzelmann N, Jackowski J. Prevalence of Oral and Maxillofacial Disorders in Patients with Systemic Scleroderma-A Systematic Review. Int J Environ Res Public Health. 2021 May 14;18(10):5238. doi: 10.3390/ijerph18105238. **PMID:** 34069099 **Citation:** Sierakowska M, Doroszkiewicz H, Sierakowska J, Olesinska M, Grabowska-Jodkowska A, Brzosko M, Leszczynski P, Pawlak-Bus K, Batko B, Wiland P, Majdan M, Bykowska-Sochacka M, Romanowski W, Zon-Giebel A, Jeka S, Ndosi M. Factors associated with quality of life in systemic sclerosis: a cross-sectional study. Qual Life Res. 2019 Dec;28(12):3347-3354. doi: 10.1007/s11136-019-02284-9. Epub 2019 Sep 3. **PMID:** 31482431 **Citation:** Hughes M, Pauling JD, Armstrong-James L, Denton CP, Galdas P, Flurey C. Gender-related differences in systemic sclerosis. Autoimmun Rev. 2020 Apr;19(4):102494. doi: 10.1016/j.autrev.2020.102494. Epub 2020 Feb 13. **PMID:** 32062031 **Citation:** Gregory WJ, Wilkinson J, Herrick AL. A randomised controlled trial of wax baths as an additive therapy to hand exercises in patients with systemic sclerosis. Physiotherapy. 2019 Sep;105(3):370-377. doi: 10.1016/j.physio.2018.08.008. Epub 2018 Sep 5. **PMID:** 30318128 **Citation:** Mugii N, Matsushita T, Oohata S, Okita H, Yahata T, Someya F, Hasegawa M, Fujimoto M, Takehara K, Hamaguchi Y. Long-term follow-up of finger passive range of motion in Japanese systemic sclerosis patients treated with self-administered stretching. Mod Rheumatol. 2019 May;29(3):484-490. doi: 10.1080/14397595.2018.1466635. Epub 2018 May 15. **PMID:** 29667474 **Citation:** Marcatto de Abreu MF, Landim S, Yuamoto FY, Lins C, Magalhaes EP, Etchebehere M. Screening tool development for hand surgery referrals in systemic sclerosis. Clinics (Sao Paulo). 2023 Aug 17;78:100270. doi: 10.1016/j.clinsp.2023.100270. eCollection 2023. **PMID:** 37597472 **Citation:** Maddali-Bongi S, Del Rosso A. Systemic sclerosis: rehabilitation as a tool to cope with disability. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):162-169. Epub 2016 Jul 4. **PMID:** 27384349 **Citation:** Vannajak K, Boonprakob Y, Eungpinichpong W, Ungpansattawong S, Nanagara R. The short-term effect of gloving in combination with Traditional Thai Massage, heat, and stretching exercise to improve hand mobility in scleroderma patients. J Ayurveda Integr Med. 2014 Jan;5(1):50-5. doi: 10.4103/0975-9476.128859. **PMID:** 24812476 **Citation:** Puzio A, Przywara-Chowaniec B, Postek-Stefanska L, Mrowka-Kata K, Trzaska K. Systemic sclerosis and its oral health implications. Adv Clin Exp Med. 2019 Apr;28(4):547-554. doi: 10.17219/acem/76847. **PMID:** 30079996 **Citation:** Uras C, Mastroeni S, Tabolli S, Masini C, Pallotta S, Teofoli P, Rocco G, Mazzanti C, Abeni D. A comparison between two educational methods in the rehabilitation of the microstomia in systemic sclerosis: a randomized controlled trial. Clin Rehabil. 2019 Nov;33(11):1747-1756. doi: 10.1177/0269215519858395. Epub 2019 Jun 19. **PMID:** 31216880 **Citation:** Schouffoer AA, Ninaber MK, Beaart-van de Voorde LJ, van der Giesen FJ, de Jong Z, Stolk J, Voskuyl AE, Scherptong RW, van Laar JM, Schuerwegh AJ, Huizinga TW, Vlieland TP. Randomized comparison of a multidisciplinary team care program with usual care in patients with systemic sclerosis. Arthritis Care Res (Hoboken). 2011 Jun;63(6):909-17. doi: 10.1002/acr.20448. **PMID:** 21312348 **Citation:** Yuen HK, Marlow NM, Reed SG, Mahoney S, Summerlin LM, Leite R, Slate E, Silver RM. Effect of orofacial exercises on oral aperture in adults with systemic sclerosis. Disabil Rehabil. 2012;34(1):84-9. doi: 10.3109/09638288.2011.587589. Epub 2011 Sep 27. **PMID:** 21951278 **Citation:** Delisle VC, Gumuchian ST, El-Baalbaki G, Korner A, Malcarne VL, Pelaez S, Carrier ME, Pepin M, Thombs BD; Scleroderma Support Group Project Advisory Team. Training and support needs of scleroderma support group facilitators: the North American Scleroderma Support Group Facilitators Survey. Disabil Rehabil. 2019 Oct;41(20):2477-2482. doi: 10.1080/09638288.2018.1467970. Epub 2018 Apr 26. **PMID:** 29696997 **Citation:** Murphy SL, Barber MW, Homer K, Dodge C, Cutter GR, Khanna D. Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1653-1660. doi: 10.1002/acr.23522. **PMID:** 29381834 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15412 - Name: Scleroderma, Systemic - Relevance: HIGH - As Found: Scleroderma - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: HIGH - As Found: Scleroderma - ID: M15045 - Name: Rheumatic Diseases - Relevance: HIGH - As Found: Rheumatism - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M25562 - Name: Scleroderma, Limited - Relevance: HIGH - As Found: Scleroderma, Limited - ID: M15411 - Name: Scleroderma, Localized - Relevance: HIGH - As Found: Scleroderma - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown - ID: T5565 - Name: Systemic Scleroderma - Relevance: HIGH - As Found: Scleroderma - ID: T3490 - Name: Localized Scleroderma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012216 - Term: Rheumatic Diseases - ID: D000012595 - Term: Scleroderma, Systemic - ID: D000045743 - Term: Scleroderma, Diffuse - ID: D000012594 - Term: Scleroderma, Localized - ID: D000045745 - Term: Scleroderma, Limited ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425640 **Acronym:** 24h-MBs_T1D **Brief Title:** 24-hour Movement Behaviors in Adults With Type 1 Diabetes **Official Title:** INTERPLAY WITHIN THE DAY: Optimizing Intra-day Glucose Control by Intervening on the Day-to-day 24-hour Movement Behavior Patterns in Adults With Type 1 Diabetes Mellitus. #### Organization Study ID Info **ID:** ONZ-2023-0611 #### Organization **Class:** OTHER **Full Name:** University Hospital, Ghent ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-01 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University Ghent #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Ghent #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Only 24.9% of the Belgian adults (25-50 years) with type 1 diabetes mellitus (T1DM) achieve a good glucose control. This can be explained by the challenging day-to-day diabetes management which places a substantial burden on this population. However, a tight glycemic control is fundamental in order to prevent the development of acute and chronic complications. Despite the added value of continue glucose monitors to glucose control, optimizing daily glucose levels is still problematic in adults with T1DM. In addition to self-monitoring of blood glucose, a healthy lifestyle with sufficient physical activity (PA), limited sedentary behavior (SB) and sufficient sleep time and quality is crucial for a good glucose control. A recent shift in health promotion stresses the importance of considering all these behaviors (i.e. PA, SB and sleep) in one 24-hour day instead of focusing on one behavior in isolation. The aim of this study is to investigate the association between the day-by-day 24h-MB patterns of adults (25-50 years) with T1DM and their intra-day glucose control (i.e. time in range and coefficient of variation) on the one hand. On the other hand, associations between he 24-h MB patterns and explanatory variables and cardiometabolic health markers will be investigated. To gain insight into the 24-hour behavior of adults with type 1 diabetes, 150 adults with type 1 diabetes will wear an Actigraph accelerometer, for 14 consecutive days. Daily glucose control will be measured using the participant's continuous glucose meter. Information about the explanatory variables and cardiometabolic health will be obtained by means of a questionnaire, diary and a few measurements (blood pressure, weight, length, Advanced Glycation Endproducts, hip-and waist circumference) during a one-off visit to one of the recruitment- and testing centers namely University hospital of Ghent or University hospital of Antwerp. The results of this cross-sectional study will inform future interventions focusing on the 24-hour movement behaviors in adults with T1DM. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 1 **Keywords:** - 24-hour movement behaviors - Glycemic control ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adults with type 1 diabetes (25-50 years) will wear an accelerometer to objectively measure their 24-hour movement behaviors. An online questionnaire and food diary will be completed to gain insight into the explanatory variables of 24-hour movement behaviors. Information on glucose control will be collect through the continuous glucose monitor of the participant. **Intervention Names:** - Behavioral: 24-hour movement behavior **Label:** Adults with type 1 diabetes ### Interventions #### Intervention 1 **Arm Group Labels:** - Adults with type 1 diabetes **Description:** Cross-sectional observational study investigating the 24-hour movement behaviors and glucose control **Name:** 24-hour movement behavior **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Following demographics will be questioned in a self-developed questionnaire: age, sex, ethnicity, smoking status, educational level, profession, family situation. **Measure:** Demographics **Time Frame:** Through study completion, an average 1 year **Description:** Health-related variables that will be questioned are height, weight, timing of T1DM diagnosis, insulin delivery system (CSII versus multiple daily injections), insulin and other medication. **Measure:** Health-related variables **Time Frame:** Through study completion, an average 1 year **Description:** Two questionnaires will be used to measure HRQOL: the Short Form 36 health survey questionnaire (SF-36) and the Diabetes Quality of life questionnaire-brief (DQOLQ-brief). The SF-36 will measure the general HLQOL. The DQOLQ-brief will assesses diabetes-related QOL. **Measure:** Health-related quality of life **Time Frame:** Through study completion, an average 1 year **Description:** The Hospital Anxiety and Depression Scale is a short (14-item) and easy to use questionnaire. The questionnaire consists of two subscales: one evaluates anxiety (7 items) and the other depression (7 items). **Measure:** Depression an anxiety **Time Frame:** Through study completion, an average 1 year **Description:** The patient education and knowledge (PEAK) questionnaire will be used to assess diabetes knowledge. Diabetes knowledge is determined based on 10-items (i.e. knowledge about insulin titration, correction factor, carbohydrate counting, PA and interpretation of glucose trends) with scores ranging from 0 (no diabetes knowledge) to 10 (excellent diabetes knowledge). **Measure:** Diabetes knowledge **Time Frame:** Through study completion, an average 1 year **Description:** Health literacy will be assessed using the validated Newest-Vital Sign-D (NVS-D) questionnaire. The NVS-D is a six items questionnaire which assesses an individual ability to find, understand and apply information. **Measure:** Health literacy **Time Frame:** Through study completion, an average 1 year **Description:** Diabetes self-management will be assessed using the diabetes self-management questionnaire revised (DSMQ-R). The DSMQ-R is a multidimensional validated questionnaire with 27-items regarding essential self-management practices (e.g. glucose monitoring, physical activity, cooperation with diabetes team) for T1DM. **Measure:** Diabetes self-management **Time Frame:** Through study completion, an average 1 year **Description:** newly developed and reliable questionnaire to assess explanatory variables 24h-MBs in adults will collect information on behavioral factors. The behavioral factors are based on the integrated behavior change (IBC) model. This model combines different behavioral change theories, i.e. the theory of planned behavior, the self-determination theory, and the dual system theory. The following behaviors will be questioned: autonomous motivation, attitude, internal behavioral control (i.e. habits, skills), external behavioral control (i.e. barriers) and self-efficacy. The validated barriers to physical activity in T1DM (BAPD-1) questionnaire will assess external behavioral control factors for physical activity. **Measure:** Behavioral factors **Time Frame:** Through study completion, an average 1 year **Description:** A newly developed and reliable questionnaire to assess explanatory variables of 24-h movement behaviors in adults will collect information on socio-environmental factors and physical environmental factors. The socio-environmental factors are subjective norm, social modelling and social support. The physical environmental factors are electronic devices at home, sleep environment, neighbourhood and work environment. **Measure:** Environmental factors **Time Frame:** Through study completion, an average 1 year **Description:** Each accelerometer will be supplemented by a diary in which the participant will be asked to give context-related information about PA (e.g. type of sport, active transportation) and sleep (e.g. sleep quality). **Measure:** Context-related information about physical activity **Time Frame:** Through study completion, an average 1 year **Description:** Dietary intake, an important and indispensable component of diabetes management, will be measured with a 14-day food diary completed during the same period of wearing the ActiGraph. Since a written food diary is time consuming and can result in reporting errors (i.e. underreporting due to difficulties in estimating portion sizes), the Digitaal Dagboek application (https://digitaaldagboek.be/) will be used to register daily food intake. **Measure:** Food intake **Time Frame:** Through study completion, an average 1 year #### Primary Outcomes **Description:** All the movement behaviors performed within one day (i.e. PA, SB and sleep) will be objectively measured using an Actigraph wGT3X-BT accelerometer. The participants will wear the accelerometer for 14 consecutive days. At daytime, the accelerometer will be worn at the right hip, at night the accelerometer will be switched to the non-dominant wrist. **Measure:** 24-hour movement behaviors **Time Frame:** Through study completion, an average 1 year **Description:** Coefficient of variation is a measure for intra-day glucose control and will be measured by the continuous glucose monitor of the participants. Raw CGM data of 14 consecutive days will be downloaded from the receiver of the participants with the programme compatible with their CGM (i.e. Libreview, Dexcom studio, Glooko). **Measure:** Coefficient of variation (in %) **Time Frame:** Through study completion, an average 1 year **Description:** Time in range is a measure for intra-day glucose control and will be measured by the continuous glucose monitor of the participants. Raw CGM data of 14 consecutive days will be downloaded from the receiver of the participants with the programme compatible with their CGM (i.e. Libreview, Dexcom studio, Glooko). **Measure:** Time in range **Time Frame:** Through study completion, an average 1 year #### Secondary Outcomes **Description:** Waist circumference will be measured twice with a measuring tape (Seca 201). **Measure:** Waist circumference (in cm) **Time Frame:** Through study completion, an average 1 year **Description:** Hip circumference will be measured twice with a measuring tape (Seca 201). **Measure:** Hip circumference (in cm) **Time Frame:** Through study completion, an average 1 year **Description:** Blood pressure will be measured twice with an interval of one minute with an automatic OMRON M6 Comfort device after 10 minutes of rest. **Measure:** Blood pressure (in mmHg) **Time Frame:** Through study completion, an average 1 year **Description:** AGE's, a predictive value for the development of diabetic and cardiovascular complications, will be measured with a skin AGE-reader (Diagnoptics Technologies, Groningen, the Netherlands). **Measure:** Advanced glycation endproducts **Time Frame:** Through study completion, an average 1 year **Description:** LDL-cholesterol will be obtained through the participants' most recent blood results. **Measure:** LDL-cholesterol (in mg/dl) **Time Frame:** Through study completion, an average 1 year **Description:** HDL-cholesterol will be obtained through the participants' most recent blood results. **Measure:** HDL-cholesterol (in mg/dl) **Time Frame:** Through study completion, an average 1 year **Description:** Triglycerides will be obtained through the participants' most recent blood results. **Measure:** Triglycerides (in mg/dl) **Time Frame:** Through study completion, an average 1 year **Description:** Total cholesterol will be obtained through the participants' most recent blood results. **Measure:** Total cholesterol (in mg/dl) **Time Frame:** Through study completion, an average 1 year **Description:** Average HbA1c over the last 10 years (or from diagnosis if diagnosis was less than 10 years ago) will be collected through the patient file. **Measure:** Long-term glucose regulation (in % or mmol/mol) **Time Frame:** Through study completion, an average 1 year **Description:** Information about medication intake will be collected through the patient file. **Measure:** Medication intake **Time Frame:** Through study completion, an average 1 year **Description:** Information about C-peptide level will be collected through the patient file. **Measure:** C-peptide level **Time Frame:** Through study completion, an average 1 year **Description:** Information about comorbidities will be collected through the patient file. **Measure:** Co-morbidities **Time Frame:** Through study completion, an average 1 year **Description:** Weight will be collected through the patient file. **Measure:** Weight (in kg) **Time Frame:** Through study completion, an average 1 year **Description:** The mean glucose of 14 consecutive days will be derived from the participant's raw CGM data. **Measure:** Mean glucose **Time Frame:** Through study completion, an average 1 year **Description:** The standard deviation of glucose, a measure of the spread in glucose readings around the average glucose, will be derived from the participant's raw CGM data. **Measure:** Standard deviation **Time Frame:** Through study completion, an average 1 year **Description:** Mean amplitude of glycemic excursions, a glucose variability metric, will be derived from the participant's raw CGM data. **Measure:** Mean amplitude of glycemic excursions **Time Frame:** Through study completion, an average 1 year **Description:** Continuous overall net glycemic action, a measure of glycemic variability, will be derived from the participant's raw CGM data. **Measure:** Continuous overall net glycemic action **Time Frame:** Through study completion, an average 1 year **Description:** Percent of measurements below 70 mg/dl, a measure that gives insight in the time in hypoglycemia, will be derived from the participant's raw CGM data. **Measure:** Percent of measurements below 70 mg/dl (in %) **Time Frame:** Through study completion, an average 1 year **Description:** Percent of measurements above 180 mg/dl, a measure that gives insight in the time in hyperglycemia, will be derived from the participant's raw CGM data. **Measure:** Percent of measurements above 180 mg/dl (in %) **Time Frame:** Through study completion, an average 1 year **Description:** Mean of daily differences, a measure that gives insight in the between-days glycemic variability, will be derived from the participant's raw CGM data. **Measure:** Mean of daily differences **Time Frame:** Through study completion, an average 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults between 25 and 50 years * Diagnosed with T1DM for a minimum of two years * Minimal daily insulin dose of 10 units * Using a continuous glucose monitor * Most recent HbA1c between 6% and 9.5% Exclusion Criteria: * Using a hybrid closed loop insulin pump * Shift workers * Known cardiovascular disease (e.g. peripheral arterial disease causing intermittent claudication reducing walking distance to \<500 meters, history of cerebrovascular accidents with residual impact on motoric function or heart failure NYHA class 3 and 4) * Physical disabilities that disturb daily functioning (e.g. amputations, paralysis) * Other conditions affecting normal movement behaviors (e.g. active treatment for malignancies, diabetic nephropathy stage 4 or 5, chronic obstructive pulmonary disease stage 3 or 4 or asthma stage 3 or 4) * Visual impairment (e.g. retinopathy with loss of vision or blindness) * Hypoglycemia unawareness (i.e. self-reporting of biochemical hypoglycemia unaccompanied by symptoms, loss of autonomic symptoms (e.g. hunger, sweating) as initial sign of hypoglycemia) * Symptomatic peripheral neuropathy(i.e. loss of sensations, pain, exaggerated sensitivity to painless stimuli, paresthesia, ulceration injuries or amputations) * Professional or semi-professional top athletes * Participating in another supervised healthy lifestyle or drug intervention **Maximum Age:** 50 Years **Minimum Age:** 25 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** A total of 150 adults (25-50 years) with T1DM will be recruited in this study. Participants will be recruited through visits at diabetologists at University hospital of Ghent and Antwerp, diabetes educators, dieticians, general practitioners and community health centres. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lotte Bogaert, PhD **Phone:** 093323638 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Marieke De Craemer, Professor **Phone:** 09 332 52 08 **Role:** CONTACT #### Locations **Location 1:** **City:** Ghent **Contacts:** ***Contact 1:*** - **Name:** Bruno Lapauw, Professor - **Role:** CONTACT **Country:** Belgium **Facility:** University Hospital Ghent **State:** East Flanders **Zip:** 9000 **Location 2:** **City:** Antwerp **Contacts:** ***Contact 1:*** - **Name:** Eveline Dirinck, Professor - **Role:** CONTACT **Country:** Belgium **Facility:** University Hospital Antwerp **Zip:** 2650 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Ghent **Name:** Bruno Lapauw, Professor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University Hospital, Antwerp **Name:** Eveline Dirinck, Professor **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** University Ghent **Name:** Marieke De Craemer, Professor **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 1 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425627 **Brief Title:** Spinal Versus General Anesthesia on Postoperative Pulmonary Complications **Official Title:** Spinal Versus General Anesthesia on Postoperative Pulmonary Complications in Elderly Patients With Delayed Operation of Hip Fracture #### Organization Study ID Info **ID:** TongjiHospital102114 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2026-05-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tongji Hospital #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Tianzhu Liu **Investigator Title:** M.D. **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 was to investigate the difference in postoperative pulmonary complications (PPCs) between spinal anesthesia and general anesthesia in patients undergoing delayed hip surgery. **Detailed Description:** In this study, the difference of 30 min arterial partial pressure of oxygen after operation was used as the main outcome index. By means of pulmonary ultrasound, pulmonary function monitoring and other physical and biochemical examinations, the difference of postoperative pulmonary complications between spinal anesthesia and general anesthesia in patients with delayed operation of hip fracture longer than 48 hours was compared. ### Conditions Module **Conditions:** - Pulmonary Complication - Anesthesia - Hip Fractures **Keywords:** - Hip fracture - delayed surgery - pulmonary complication - spinal anesthesia - general anesthesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients underwent real-time ultrasound guided spinal anesthesia. The maximum attempts of skin piercings are 3, and the total redirections of each skin piercings should not exceed 6 times. General anesthesia was considered if three skin piercings were unsuccessful. **Intervention Names:** - Procedure: spinal anesthesia **Label:** spinal anesthesia **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Rapid sequential induction was performed with sufentanil 0.5 ug /kg, etomidate 0.3 mg /kg, cisatracurium 0.15 mg /kg, and then laryngeal mask was applyed. Parameter settings: tidal volume: 6-10 mL/kg, 1.5 \~ 2.0% sevoflurane inhalation, remifentanil 0.1 \~ 0.2 ug/ kg.min-1. Mechanical driving pressure was applyed by PEEP titration method. **Intervention Names:** - Procedure: general anesthesia **Label:** general anesthesia **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - spinal anesthesia **Description:** An intrathecal anesthetic technique. **Name:** spinal anesthesia **Other Names:** - lumbar anesthesia **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - general anesthesia **Description:** An intravenous (combined with inhalation) anesthetic technique. **Name:** general anesthesia **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Documented side effects associated with the intervention by an unwitting third party **Measure:** Adverse outcomes **Time Frame:** up to one month #### Primary Outcomes **Description:** PaO2 was measured by arterial blood gas analysis **Measure:** Arterial partial pressure of oxygen, PaO2 **Time Frame:** 30 minutes after surgery #### Secondary Outcomes **Description:** PaO2 was measured by arterial blood gas analysis **Measure:** Arterial partial pressure of oxygen, PaO2 **Time Frame:** 30 minutes before surgery **Description:** FVC was measured by Spirometer (SP70B) **Measure:** Forced vital capacity, FVC **Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery **Description:** FEV1 was measured by Spirometer (SP70B) **Measure:** Forced expiratory volume in 1 second, FEV1 **Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery **Description:** PEF was measured by Spirometer (SP70B) **Measure:** Peak expiratory flow, PEF **Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery **Description:** PEF 25, 75, and 25-75 were measured by Spirometer (SP70B) **Measure:** PEF 25, 75, and 25-75 **Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery **Description:** Bedside measurements using portable ultrasound **Measure:** Lung Ultrasound Score (LUS) **Time Frame:** 30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery **Description:** Pulmonary complications (PPCs) include: (1) Evidence of pneumonia, pneumothorax, atelectasis and pleural effusion indicated by postoperative pulmonary ultrasound, chest film or chest CT; ② After surgery, the patient developed bronchospasm, ARDS, O2 requirement (nasal catheter or mask), non-invasive ventilation requirement, or unplanned endotracheal intubation/mechanical ventilation for more than 1 day; ③ The increase of inflammatory biochemical indexes 24 h after surgery suggested systemic inflammatory response (blood routine, C-reactive protein CRP, procalcitonin PCT and IL-6, IL-1β, TNF-α). **Measure:** Postoperative pulmonary complications **Time Frame:** up to one month **Description:** The Harris scale was used to score. Range:0-100. A total Harris hip score below 70 points was considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent. **Measure:** Hip mobility (Harris hip score, HHS) **Time Frame:** up to one month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients ≥ 65 years old * ASA Class I \~ III * Surgical repair of femoral neck, intertrochanteric or subtrochanteric fractures * The time from diagnosis to surgery is more than 48 hours Exclusion Criteria: * Unable to walk about 3 meters or across a room without assistance before the fracture * Emergency surgery * Chronic obstructive pulmonary disease (COPD), congestive heart failure, asthma, anemia (Hb \< 90 g/L), hypoalbuminemia (ALB \< 35g/L) * Abnormal coagulation function * Severe aortic stenosis * Injection site infection or increased intracranial pressure * Patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization * The written informed consent of the patient or his/her representative cannot be obtained **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tianzhu Liu, M.D. **Phone:** 13098866448 **Role:** CONTACT #### Locations **Location 1:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tianzhu Liu, M.D. - **Phone:** 13098866448 - **Role:** CONTACT ***Contact 2:*** - **Name:** Tianzhu Liu, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Tianzhu Liu **State:** Hubei **Status:** RECRUITING **Zip:** 430000 #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital **Name:** Tianzhu Liu, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000005264 - Term: Femoral Fractures - ID: D000025981 - Term: Hip Injuries - ID: D000007869 - Term: Leg Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M9696 - Name: Hip Fractures - Relevance: HIGH - As Found: Hip Fracture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M8402 - Name: Femoral Fractures - Relevance: LOW - As Found: Unknown - ID: M23105 - Name: Hip Injuries - Relevance: LOW - As Found: Unknown - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050723 - Term: Fractures, Bone - ID: D000006620 - Term: Hip Fractures ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Imaging - ID: M1673 - Name: Sevoflurane - Relevance: LOW - As Found: Unknown - ID: M19684 - Name: Sufentanil - Relevance: LOW - As Found: Unknown - ID: M1696 - Name: Remifentanil - Relevance: LOW - As Found: Unknown - ID: M237638 - Name: Cisatracurium - Relevance: LOW - As Found: Unknown - ID: M8190 - Name: Etomidate - Relevance: LOW - As Found: Unknown - ID: M117729 - Name: Dsuvia - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425614 **Acronym:** COLTRANE **Brief Title:** COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial **Official Title:** Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery: A Randomized Clinical Trial #### Organization Study ID Info **ID:** CHUBX 2022/22 #### Organization **Class:** OTHER **Full Name:** University Hospital, Bordeaux ### Status Module #### Completion Date **Date:** 2026-02-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-02-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-01-12 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Bordeaux #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding. Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products. Among them, the processing of shed blood and residual cardiopulmonary bypass circuit volume with autotransfusion device is routinely used. Conventional centrifugation-based autotransfusion devices actually available only recover red blood cells while platelets and coagulation factors are almost totally lost. Consequently, large amounts of intraoperative cell salvage could significantly alter perioperative haemostasis. The SAME autotransfusion device (i-SEP, France) is a new and innovative filtration-based autotransfusion device able to recover erythrocytes, leukocytes but also platelets. By offering the opportunity to re-infuse to patients their own platelets in addition red blood cells, significantly improve perioperative haemostasis with this new device is expected. The purpose of the COLTRANE trial is to compare the quality of the perioperative haemostasis in cardiac surgical patients for whom intraoperative cell salvage will be performed using either the SAME autotransfusion device or conventional centrifugation-based device. Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay, the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients. The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection. **Detailed Description:** The SAME device is a new and innovative filtration-based autotransfusion device able to recover both erythrocytes and platelets. A multicentre single-arm clinical feasibility and safety trial conducted by our group, using SAME device on 50 cardiac surgical patients reported erythrocyte yield per cycle of 89%, post-treatment hematocrit of 43% with an excellent washing performance. In addition, the device recovered 52% of platelets, that were found unaltered by the device as demonstrated by a limited platelet activation and a strong response to thrombin-pathway stimulation assessed by flow cytometry. By offering the opportunity to re-infuse to the patients their own platelets in addition to their RBC, this new device might significantly improve perioperative haemostasis and thus decrease the need for blood products. It is well established that severe postoperative bleeding and blood products transfusion lead to increase morbidity and mortality. Consequently, an improvement of postoperative outcomes and a decrease in intensive care unit (ICU) and hospital length of stay may be expected. The fact that patients receive their own platelets should limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection. Consequently, a reduction of infectious complication may be also expected. The purpose of COLTRANE trial is to test the hypothesis that the intraoperative use of the filtration-based SAME autotransfusion device could improve perioperative haemostasis thereby reducing the proportion of patients exhibiting clinically significant perioperative bleeding (moderate to massive bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification). ### Conditions Module **Conditions:** - On-pump Cardiac Surgery - High Risk for Bleeding - Autotransfusion **Keywords:** - cardiac surgery - bleeding - autotransfusion - cardiopulmonary bypass - perioperative haemostasis - Universal Definition of Perioperative Bleeding - filtration-based autotransfusion - centrifugation-based autotransfusion ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Multicentre clinical trial, Randomized, Comparative, controlled, single blinded, superiority design, two groups. ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 570 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** new filtration-based autotransfusion (SAME I-SEP device) **Intervention Names:** - Procedure: Autotransfusion **Label:** Autotransfusion by filtration **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** centrifugation-based autotransfusion (routinely used in cardiac surgery centers) **Intervention Names:** - Procedure: Autotransfusion **Label:** Autotransfusion by centrifugation **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Autotransfusion by centrifugation - Autotransfusion by filtration **Description:** ANTIFIBRINOLYTIC THERAPY : tranexamic acid as antifibrinolytic therapy : dose after anaesthesia induction followed by continuous intravenous infusion until end INTRAOPERATIVE MANAGEMENT : * Routine monitoring : five lead-ECG, pulse oximeter, non-invasive arterial pressure will be instituted. A peripheral venous catheter and an arterial catheter * The general anaesthesia : * propofol and Remifentanil or sufentanil both simultaneously administered . * monitoring of the bispectral index * Triple lumen central venous catheter * Heparinization (300 UI/kg) * Aortic and right auricular cannulations TRANSFUSION PROTOCOL : * During CPB, PRBC transfusion if necessary * In the postoperative period if necessary In bleeding patients: The perioperative use of blood products will be managed according to results of conventional haemostasis tests or viscoelastic point of care tests when available in the center. **Name:** Autotransfusion **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** * Hospital incomes will correspond to the Groupe Homogène de Séjour (GHS) of each patient * Hospital expenditure (in-hospital stay, operating room occupancy, transfusions, treatment of infections) valued in the perspective of hospital centers, using data from the national cost studies with common methodology and from analytical accounting. * The difference between hospital incomes and hospital expenditures for each patient will be used to estimate the cost-benefit of the filtration-based autotransfusion SAME device as compared to centrifugation-based autotransfusion devices. **Measure:** COST-BENEFIT **Time Frame:** Day 30 /+2 days **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: haemoglobin level and plasma free haemoglobin will be performed Blood samples will be also collected from the patient just before surgery as well as 6+/-2 hours after surgery to measure plasma free haemoglobin level. **Measure:** Haemoglobin and plasma free haemoglobin **Time Frame:** just before surgery as well as 6+/-2 hours after surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: hematocrit level will be performed. **Measure:** Hematocrit **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: complete blood count will be performed **Measure:** Complete blood count **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: unfractionated heparin anti-Xa level will be performed **Measure:** Unfractionated heparin anti-Xa **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: fibrinogen level will be performed **Measure:** Fibrinogen **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: triglycerides level will be performed **Measure:** Triglycerides **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: total proteins level will be performed **Measure:** Total proteins **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: potassium level will be performed **Measure:** Potassium **Time Frame:** During the surgery **Description:** Patients in whom the salvaged blood from mediastinal shed and residual cardiopulmonary bypass circuit volume will be processed and not reinfused before protamine infusion will be included in this ancillary study. Blood samples will be collected from the patient just before and immediately after re-infusion of the processed blood and sent to the haematology laboratory to perform viscoelasticity assessment Quantra QPlus™ **Measure:** Blood viscoelasticity assessment **Time Frame:** just before and immediately after re-infusion, pré-treatment and just after traitement by the autotransfusion device **Description:** Patients in whom the salvaged blood from mediastinal shed and residual cardiopulmonary bypass circuit volume will be processed and not reinfused before protamine infusion will be included in this ancillary study. Blood samples will be collected from the patient just before and immediately after re-infusion of the processed blood and sent to the haematology laboratory to complete blood count. **Measure:** Complete bloof count **Time Frame:** just before and immediately after re-infusion, pré-treatment and just after traitement by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for INF-γ assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** INF-γ profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for IL-1β assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** IL-1β-γ profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for Il-6 assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** Il-6 profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for IL-8 assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** IL-8 profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for IL-10 assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** IL-10 profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for TNFα assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** TNFα profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device #### Primary Outcomes **Description:** The proportion of patients with clinically significant (moderate to massive) perioperative bleeding according to the Universal Definition for Perioperative Bleeding. **Measure:** Perioperative bleeding **Time Frame:** At the end of Day 1 #### Secondary Outcomes **Description:** Total blood loss from chest tubes within 12 and 24 postoperative hours and up to chest tubes removal (maximum 5 postoperative days) **Measure:** total blood loss **Time Frame:** Hours 12, Hours 24, up to 5 after operatives days **Description:** Surgical re-exploration for excessive bleeding within 5 postoperative days **Measure:** surgical re-exploration **Time Frame:** Day 0-Day 5, **Description:** Delayed sternal closure **Measure:** Sternal closure **Time Frame:** Hours 12 **Description:** Perioperative use of blood products and/or plasma derivatives within 2 postoperative days including PRBC, PLT, FFP, fibrinogen concentrate, PCCs, rFVIIa **Measure:** Overall quality of perioperative haemostasis : Use of blood **Time Frame:** Day 0-Day 2, **Description:** Coagulation tests (PT, aPTT, fibrinogen level) preoperatively, at the end of the surgery (+ thrombin time or ACT ), at arrival in ICU and at POD1, 3 and 5 **Measure:** Perioperative biological hemostasis **Time Frame:** Pre-inclusion - Day 5 **Description:** Complete blood count preoperatively, at the end of the surgery, at arrival in ICU and at POD1, 3 and 5. **Measure:** Complete blood count **Time Frame:** Pre-inclusion - Day 5 **Description:** calculated ICU and hospital free days **Measure:** ICU and hospital length of stay **Time Frame:** End of study or early termination- Day 30 **Description:** Cardiovascular: need for inotropes and/or vasopressors intravenous infusion \>24 hours, need for short-term mechanical circulatory support, occurrence of atrial fibrillation and/or ventricular fibrillation/tachycardia, high grade atrioventricular bloc, myocardial infarction, tamponade, symptomatic thromboembolic events. Respiratory: duration of mechanical ventilation, re-intubation, ARDS according the Berlin criteria, need for VV ECMO Renal: Kidney Disease Improving Global Outcomes stage (KDIGO) ≥2; need for renal replacement therapy. Serum electrolytes and renal function preoperatively, at arrival in ICU and at POD1, 3 and 5. Neurology: transient and permanent stroke, epilepsy, confusion Infectious: mediastinitis, septic shock, pneumopathy and bacteremia Abdominal: mesenteric ischemia, upper and/or lower gastrointestinal bleeding. Liver function tests preoperatively, at arrival in ICU and at POD1, 3 and 5. 30-day all-cause mortality **Measure:** Early postoperative morbidity within 30 postoperative days **Time Frame:** Day 30 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Adult patients (≥18 yr) affiliated or beneficiary of a social security scheme and undergoing on-pump cardiac surgery at high risk for bleeding with autotranfusion indication defined as: * Primary or redo combined cardiac procedures (2 valves or more, valve(s) and coronary artery bypass grafting(s)) * Primary or redo ascending aorta surgery * Primary or redo isolated coronary artery bypass grafting (iCABG) involving 3 or more grafts using the internal mammary artery * Free, informed and written consent signed by the participant and the investigator Exclusion Criteria: * Preoperative therapy by P2Y12 receptor inhibitors (within 5 preoperative days for clopidogrel, ticagrelor or ticlopidine, within 7 preoperative days for prasugrel, and within one preoperative hour for cangrelor) * Preoperative treatment by active anticoagulant drug (within 5 preoperative days for VKA, 4 days for dabigatran, 3 days for rivaroxaban and apixaban, 24 hours for therapeutic LMWH, 36 hours for therapeutic fondaparinux, 12 hours for prophylactic LMWH, 24 hours for prophylactic fondaparinux, 4 hours for unfractionated heparin Sepsis * Malignant tumor * Immunocompromised patients (steroids, immunosuppressive drugs, ongoing treatment for solid tumor or hematologic malignancy, primary immunodeficiency disorders, AIDS) * Emergency cardiac surgery * Heart transplantation * Implantation or patients under ventricular assist device (VAD) * Patients with two or more previous sternotomy * Surgery procedure requiring circulatory arrest and/or profound hypothermia (\<32°C) * Active infective endocarditis * Cardiac surgical procedure for benign or malignant cardiac tumors * Patients with known acquired or constitutional coagulopathy requiring specialist management * End stage renal disease * Preoperative haemoglobin level less than 10 g/dL * Preoperative platelet count \< 100 G/L * Persons participating in another interventional research including a period of exclusion that is still ongoing * Pregnant or breastfeeding women * Persons placed under judicial protection * Patients deprived of liberty **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alexandre Ouattara, MD, PhD **Phone:** 0557656866 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Antoine Beurton, MD **Phone:** 0557677147 **Role:** CONTACT #### Locations **Location 1:** **City:** Bordeaux **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexandre Ouattara, MD, PhD - **Phone:** 0557656866 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Antoine BEURTON - **Phone:** 0557656866 - **Phone Ext:** +33 - **Role:** CONTACT **Country:** France **Facility:** CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire **Zip:** 33076 **Location 2:** **City:** Bron **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jean-Luc FELLAHI, MD, PhD - **Phone:** 0472118933 - **Role:** CONTACT **Country:** France **Facility:** HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation **Zip:** 69677 **Location 3:** **City:** Montpellier **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Philippe GAUDARD, MD - **Phone:** 0467336733 - **Role:** CONTACT **Country:** France **Facility:** CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve **Zip:** 34295 **Location 4:** **City:** Nantes **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bertrand ROZEC, MD, PhD - **Phone:** 0240165304 - **Role:** CONTACT **Country:** France **Facility:** CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque **Zip:** 44093 **Location 5:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aude Carillion, MD - **Phone:** 0184827387 - **Role:** CONTACT **Country:** France **Facility:** Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale **Zip:** 75651 **Location 6:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sophie Provenchere, MD - **Phone:** 0140258355 - **Role:** CONTACT **Country:** France **Facility:** Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation **Zip:** 75877 **Location 7:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bernard Cholley, MD, PhD - **Phone:** 0156092515 - **Role:** CONTACT **Country:** France **Facility:** Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation **Zip:** 75908 **Location 8:** **City:** Rennes **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexandre Mansour, MD - **Phone:** 0299289153 - **Role:** CONTACT **Country:** France **Facility:** CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV **Zip:** 35033 **Location 9:** **City:** Strasbourg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Paul-Michel MERTES, MD, PhD - **Phone:** 0369550444 - **Role:** CONTACT **Country:** France **Facility:** CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale **Zip:** 67091 **Location 10:** **City:** Toulouse **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** François Labaste, MD - **Phone:** 0561322822 - **Role:** CONTACT **Country:** France **Facility:** CHU Toulouse, Hôpital Rangueil, Service Anesthésie **Zip:** 31400 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Bordeaux **Name:** Alexandre Ouattara, MD, PhD **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: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Bleeding ### Condition Browse Module - Meshes - ID: D000006470 - Term: Hemorrhage ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M16902 - Name: Tranexamic Acid - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown - ID: M19684 - Name: Sufentanil - Relevance: LOW - As Found: Unknown - ID: M1696 - Name: Remifentanil - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M4252 - Name: Antifibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M117729 - Name: Dsuvia - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425601 **Brief Title:** A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy **Official Title:** The Impact of Chest Drain Type on Pain, Drainage Efficacy and Short Term Outcome Following VATS Lobectomy for Lung Cancer: A Prospective Randomized Study Comparing Silicone Versus PVC Drains #### Organization Study ID Info **ID:** 0120-445/2019/8 #### Organization **Class:** OTHER **Full Name:** University Medical Centre Ljubljana ### Status Module #### Completion Date **Date:** 2023-08-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-08-10 **Type:** ACTUAL #### Start Date **Date:** 2020-09-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Medical Centre Ljubljana #### Responsible Party **Investigator Affiliation:** University Medical Centre Ljubljana **Investigator Full Name:** Boris Greif, MD **Investigator Title:** Head of Thoracic Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer. The main questions it aims to answer are: * silicone chest drains are less painful compared to standard PVC drains? * is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome. ### Conditions Module **Conditions:** - Postoperative Pain - Postoperative Complications **Keywords:** - VATS - lung lobectomy - postoperative pain - chest drain - analgesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For postoperative pleural space drainage a silicone coaxial drain of size French 24 (Redax Coaxial Drain, Redax S.p.A., Poggio Rusco Mantova, Italy) was used **Intervention Names:** - Device: SIL drain **Label:** Silicone (SIL) group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** For postoperative pleural space drainage a standard polyvinyl chloride drain of size French 24 (Argyle, Covidien, Mansfield, USA) was used **Intervention Names:** - Device: PVC drain **Label:** PVC group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Silicone (SIL) group **Description:** Silicone chest tube used for pleural space drainage after VATS lobectomy **Name:** SIL drain **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - PVC group **Description:** Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy **Name:** PVC drain **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome. **Measure:** Analgesics consumption **Time Frame:** 2 days **Description:** Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome. **Measure:** Need for peroral analgesia after the chest tube removal **Time Frame:** 2 days **Description:** Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome. **Measure:** Maximal inspiratory pressure **Time Frame:** 2 days **Description:** Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome. **Measure:** Maximal expiratory pressure **Time Frame:** 2 days **Description:** Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome. **Measure:** Visual analogue scale **Time Frame:** 2 days #### Secondary Outcomes **Description:** The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome. **Measure:** Duration of chest drainage **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome. **Measure:** Pneumothorax rate on the day of surgery **Time Frame:** First day **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome. **Measure:** Pneumothorax rate after chest tube removal **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome. **Measure:** Pleural effusion rate on the day of surgery **Time Frame:** First day **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome. **Measure:** Pleural effusion rate after chest tube removal **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of clinically expressed subcutaneous emphysema (frequency in number). Higher scores mean a worse outcome. **Measure:** Subcutaneous emphysema rate **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of prolonged air leak over 5 days (frequency in number). Higher scores mean a worse outcome. **Measure:** Prolonged air leak rate **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of reintervention (thoracentesis or chest drainage) after chest tube removal (frequency in number). Higher scores mean a worse outcome. **Measure:** Reintervention rate **Time Frame:** 1 month **Description:** Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome. **Measure:** Duration of hospital stay **Time Frame:** 1 month **Description:** Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome. **Measure:** Respiratory complication rate **Time Frame:** 1 month **Description:** Early postoperative course was analyzed by assessing the rate of readmission in the first month after drain removal (frequency in number). Higher scores mean a worse outcome. **Measure:** Readmission rate **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * primary lung cancer eligible for VATS lobectomy by tumor board meeting Exclusion Criteria: * age under 18 years * high risk of post-operative complications (ASA \> 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) ≤ 40%, cycle ergometry with oxygen consumption (VO2 max) \< 15 ml/kg/min) * tumors growing in parietal pleura * extended lung resection diffuse * previous surgery in the same hemithorax * chronic pain * chronic use of analgesics or sedatives * surgical revision * inability to participate in the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ljubljana **Country:** Slovenia **Facility:** University Medical Centre Ljubljana **Zip:** 1000 #### Overall Officials **Official 1:** **Affiliation:** UMC Ljubljana **Name:** Boris Greif **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - 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: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: HIGH - As Found: Postoperative Complications - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative - ID: D000011183 - Term: Postoperative Complications ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425588 **Brief Title:** Craniofacial Dimensions as Determinants of the Fitted Performance of Common Face Masks (FACEFIT 2.0) **Official Title:** Craniofacial Dimensions as Determinants of the Fitted Performance of Common Face Masks (FACEFIT 2.0) #### Organization Study ID Info **ID:** 24-0349 #### Organization **Class:** OTHER **Full Name:** University of North Carolina, Chapel Hill #### Secondary ID Infos **Domain:** EPA **ID:** FACEFIT 2.0 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Environmental Protection Agency (EPA) #### Lead Sponsor **Class:** OTHER **Name:** University of North Carolina, Chapel Hill #### 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 examines the role of craniofacial dimensions and self-evaluation thereof in the protection afforded by masks commonly worn by the public as protection against aerosol contaminants. The effectiveness of instructions for self-evaluation of craniofacial dimensions will be tested against standard digital and manual craniometric methods. Approximately 500 (18-70 year old) subjects of any gender. After consenting to participate in the study, subjects will use a short self-assessment questionnaire to measure their craniofacial dimensions, and have their face measured using standard anthropological techniques and a 3D camera. They will then enter a chamber containing an atmosphere of aerosolized salt particles where the fitted filtering efficiency of 2 types of face masks will be measured briefly. Participation time is approximately 60 minutes. **Detailed Description:** Wearing a face mask is a primary protection strategy against airborne infectious agents as well as toxic aerosols such as wildfire smoke. Despite the ubiquitous presence of masks in public life in recent years, the average person has a poor understanding of factors that influence the fitted performance of the face coverings that they wear. This problem is exacerbated by the lack of mask fit testing available to the public outside of occupational settings subject to regulation. As a result, the vast majority of the population currently wears masks with limited knowledge of their efficacy or the means to acquire it. A simple, validated method to quantitatively self-assess individual craniofacial dimensions relative to that of the general population will permit members of the public to make informed decisions about the types of mask that they wear in specific risk situations, and whether to use fit enhancements to optimize their fitted performance. In addition to limiting the morbidity associated with exposure to poor air quality, an individualized improvement in the efficacy of mask will have a multiplicative effect in the prevention of the transmission of infectious vectors. Subjects who are not excluded from the initial screening will be scheduled for consenting at the EPA Human Studies Facility (HSF). At the start of the visit, the study protocol will be outlined, and informed consent obtained to initiate enrollment into the study. There will be one session in this study. Consenting subjects will proceed immediately to the participation phase. Consenting: There will be one (1) study consent form (form FF2.0 1). This consent form must be signed by the participant and the study team member obtaining informed consent. The subjects may ask any questions they have regarding their participation in the study at any time prior to or during their participation. Persons with child-bearing potential will be required to self-administer a pregnancy test in a private bathroom. Those who self-administer a pregnancy test will have to confirm the results on the consent form in order to proceed to the study phase. Behavioral questionnaire: Subjects will complete a short questionnaire (Form FF2.0 2) that asks about their predisposition to wear a face mask under a variety of scenarios. This information will be used to guide public health communications during air quality emergencies. Assessment of self-evaluation instructions for craniofacial measurements: Subjects will use instructions presented in a self-evaluation form (Form FF2.0 3) to measure their own craniofacial dimensions using the rulers provided and a mirror. Subjects will receive no assistance with completing the self-assessment form. At intervals of approximately, 10-40 subjects, measurements obtained in the self-evaluation will be compared to the craniofacial measurements obtained by a study team member. The results of the comparison will be used to guide revisions of the instruction in the self-evaluation form in an iterative manner. The protocol will be amended accordingly to update changes to the self-evaluation instructions. Craniofacial measurements: A 3 D scan of the subjects' face and head will be obtained by aligning the head inside of an oval shown on a tablet screen. The image takes about 3 seconds to generate and subjects will be asked to move their head slightly. In addition, manual measurement of 4-8 craniofacial dimensions will be taken by a study team member using calipers and a tape measure. Lung Function Test. Participants will complete a breathing test (peak flow meter) before and after the facemask testing. Study personnel will coach the participant to take a full breath in and then blow it out as hard and fast as they can. They may be asked to do this up to five times. This test measures the volume of air they can blow out (exhale) quickly after taking a very deep breath. This is a method to measure lung function before and after the testing procedure for safety purposes. The investigators will stop the study and not complete the mask fit testing if the participant's peak expiratory flow (as measured with the peak flow meter) is not ≥ 80.0% of their predicted value based on their age, height, and weight. Assessment of filtering face piece (FFP) use: The range of variability that exists in the subject population while wearing two different types of face coverings will be assessed. Masks will consist of a KN95 mask and a surgical/procedure mask. The fitted filtration efficiency of each mask will be measured using aerosolized sodium chloride particles (mean aerodynamic diameter 0.040 microns) emitted by a particle generator. During the fit testing, the concentration of aerosolized saline particles emitted by a TSI Particle Generator will be approximately 5000-30000 particles/cc of air. The temperature in the chamber will vary between 20 and 30 oC, the relative humidity will be maintained at approximately 50 %. The subject will remain seated in the chamber and complete a modified version the Occupational Safety and Health Administration Quantitative Fit Testing Protocol (Modified Ambient Aerosol CNC Quantitative Fit Testing Protocol for Filtering Facepiece TableA-2-RESPIRATORS). The subject will then move their head from left to right, taking two breaths at each extreme for 30 seconds. This will be followed by moving the head up and down, taking two beaths at each extreme for 30 seconds. The procedure will be repeated after the addition of a clip to the ear-loops of the mask behind the neck of the subject. In total, the testing time for the 2 masks with and without clip will be approximately 6 minutes. ### Conditions Module **Conditions:** - Healthy **Keywords:** - Healthy subjects - Mask - Mask fit - Fitted Filtration Efficiency - Self-Evaluation - Craniofacial Morphology - 3D imaging ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants will be fit tested while completing a modified version of the OSHA fit test. **Intervention Names:** - Other: Surgical/Procedure Mask Fit Testing - Other: KN95 Mask Fit testing **Label:** Mask Testing **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mask Testing **Description:** All participants will wear a surgical/procedure mask and be fit tested using a modified version of the OSHA quantitative fit testing procedure. **Name:** Surgical/Procedure Mask Fit Testing **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Mask Testing **Description:** All participants will wear a KN95 mask and be fit tested using a modified version of the OSHA quantitative fit testing procedure. **Name:** KN95 Mask Fit testing **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** A mask fit procedure will be performed based on an OSHA (Occupational Safety and Health Administration)- approved protocol during the baseline visit. The efficiency of masks will be determined by a percentage of particle number measured behind the facemask over the particle number in the ambient air. Mask fit efficiency values from different levels of mask fit instructions will be compared. **Measure:** Fitted Filtration Efficiency **Time Frame:** During fitting procedure (90 seconds for each condition) **Description:** Cranial morphology will be assessed using a self-evaluation that guides participants on how to measure five dimensions of their head/face including: nose length, nose arc, face width, neck circumference, and ear breadth. Participants will record their measurement for each cranial/facial features using the instructions provided on the self-evaluation form. Investigators will then use the five recorded values to cluster each participant into one of four categories of overall face and head shape/size. **Measure:** Cranial Morphology- Self Evaluation **Time Frame:** The self-evaluation will take approximately ten minutes and be filled out once during the study visit (Day 1). #### Secondary Outcomes **Description:** Calipers will be used to measure craniofacial features of each subject. Trained personnel (wearing gloves) will need to touch areas of the subject's face and scalp to ensure proper caliper measurements are collected. Measurements to be collected include: nose length, face width, neck circumference, and ear breadth. All measurements have a common unit (cm). **Measure:** Cranial Morphology- Caliper Measurement **Time Frame:** The craniometric assessment will take approximately 5 minutes and be completed before the fit testing procedure. **Description:** Subjects will self-administer a 3D scan of their face by aligning their head inside of an oval shown on the camera screen, triggering the camera shutter. The image takes about 3 seconds to generate and subjects will be asked to remain still during this time. The acquired facial images will be analyzed using digital image analysis software. The images will be analyzed to measure the participant's nose gap area. **Measure:** Cranial Morphology- 3D Imaging **Time Frame:** The 3D imaging will take approximately 5 minutes and be completed before the fit testing procedure. **Description:** Subjects will take a brief questionnaire regarding their masking behavior and perceptions of masks. The questionnaire will also ask participants to rate how big/small they think their head length, width, and size is compared to adults of the same age/gender. The survey is comprised of 34 questions that fall into the following sections: sociodemographic information, mask perception, experience with mask usage, knowledge of particulate matter vs. volatile organic compounds, and perception of face shape and size. All questions consist of four or five point likert scales corresponding to ordinal scores (No Impact to Significant Impact, 1-5)(Most Likely to Least Likely, 1-4). All questions correspond to the participant's knowledge or perception and are recorded on an ordinal scale and thus the survey has no "directionality". **Measure:** FaceFit 2.0 Face Filtering PIece Usage Survey **Time Frame:** This survey will take about five minutes and be completed before the mask fit testing. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-70 years old healthy of any gender and ethnicity. 2. Subjects must be ambulatory and tolerate enclosed spaces. 3. Subjects must report being in good health 4. Subjects must pass COVID-19 screening questions and have had at least a primary COVID-19 vaccination series. 5. Individuals with a BMI (kg/m2) that is greater than 16.0 and less than 50.0 Exclusion Criteria: 1. Persons who are pregnant, attempting to become pregnant or breastfeeding 2. Persons who are unable to read English well enough to follow written instructions or a questionnaire. 3. Persons who have facial hair. 4. Individuals who have had an acute respiratory illness within 6 weeks. 5. Individuals who have active allergies. 6. Those who are not feeling well. 7. Anyone who is unable to walk unassisted, stand or sit still for 15 minutes at a time. 8. Anyone who suffered a heart attack, cardiac arrest or stroke in the past 6 months. 9. Anyone who has been hospitalized overnight or sought urgent medical care in the last 30 days. 10. Anyone who has an unspecified illness, which in the judgment of the medical staff, might increase the risk associated with this study will be a basis for exclusion. 11. Those who are pregnant, attempting to become pregnant or breastfeeding. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Robin Kaminski **Phone:** (919) 966-0604 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Patrice Ratliffe **Phone:** (919)-966-0607 **Role:** CONTACT #### Locations **Location 1:** **City:** Chapel Hill **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Patrice Ratliffe - **Phone:** 919-966-0607 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** James Samet, PhD - **Phone:** 919-966-0665 - **Role:** CONTACT ***Contact 3:*** - **Name:** James Samet, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** U.S. Environmental Protection Agency Human Studies Facility **State:** North Carolina **Zip:** 27514 #### Overall Officials **Official 1:** **Affiliation:** U.S. Environmental Protection Agency **Name:** James Samet, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Data will be available at the U.S. EPA Science Hub. **Description:** Deidentified individual data will be shared through the U.S. EPA's ScienceHub database. ScienceHub is used to upload and store datasets associated with journal articles. Non-sensitive datasets are then made publicly accessible via the Environmental Dataset Gateway in fulfillment of the EPA's requirement to adhere to the Office of Management and Budget's Open Data Policy. **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** The data will be available to the public after the conclusion of the study and the publication of the manuscripts. **URL:** http://catalog.data.gov/dataset/epa-sciencehub ## 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: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425575 **Brief Title:** Resolution of Pudendal Neuralgia in Chronic Pelvic Pain Using a Novel Biologic Therapy **Official Title:** Resolution of Pudendal Neuralgia in Chronic Pelvic Pain Using a Novel Biologic Therapy #### Organization Study ID Info **ID:** 18D.719 #### Organization **Class:** OTHER **Full Name:** Thomas Jefferson University ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-10-31 **Type:** ACTUAL #### Start Date **Date:** 2019-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-02-21 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Cooper Health System #### Lead Sponsor **Class:** OTHER **Name:** Thomas Jefferson University #### Responsible Party **Investigator Affiliation:** Thomas Jefferson University **Investigator Full Name:** Thomas N. Tulenko **Investigator Title:** Adjunct Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This goal of this study is to determine whether a novel biologic, i.e., an "amniotic suspension allograft" (ASA) will reduce pain and improve quality of life (QoL) in women stricken with chronic pelvic pain (CPP). The main questions it aims to answer are: * Weather pain in the genitalia is reduced with treatment * Weather bladder or urination pain is reduced with treatment * Weather any adverse events occur following treatment Patient responses to pain and QoL will be collected before and 6-12 months after treatment. **Detailed Description:** This is an observational study and is driven by the hypothesis that novel biologic, i.e., an "amniotic suspension allograft" (ASA) will reduce pain and improve quality of life in women stricken with chronic pelvic pain (CPP). This clinical trial is performed in a hospital-based practice at Thomas Jefferson University in which all patients over the age of 18 presenting with clinically defined CPP will be accepted into the study and therefore all patients will be treated with the ASA; no patients with CPP will be excluded from the study. This small study is not funded so the patients will not be randomized and there will not be any "control" subjects receiving placebo instead of the ASA product. Upon arriving to the hospital, but just prior to treatment, all patients will be asked to fill out a consent form and a pre-procedure questionnaire regarding pain, discomfort and quality of life issues they've been experiencing prior to treatment. They will then be brought into the operating room, placed in the lithotomy position, and briefly anesthetized (15-30 min). Once anesthetized, the urogynecologist will feel for an opening in the pelvic bone (ischium) by inserting her fingers into the vagina. The opening (Alcock's canal) in the ischium exposes the pudendal nerve which carries pain signals from the vagina and nearby tissues to the brain's pain centers. Once the medial aspect of Alcock's canal is clearly identified by the doctor's fingers, a 6 inch pudendal trumpet needle will be advanced through the vaginal wall and guided and placed near the pudendal nerve in Alcock's canal. A solution of the ASA along with sterile saline and the anesthetic marcaine (5 cc total) will be injected so as to infiltrate the pudendal nerve with this mixture. Marcaine is used to help suppress any acute pain that may occur in the few hours after treatment. Both the left and right pudendal nerves will be thusly treated. When the patients awaken, they will receive a drink of choice and light snack like gram crackers or biscuits. When fully awake the patients will be allowed to leave the hospital accompanied with a companion, but not allowed to drive until the full effects of the anesthesia has worn off several hours later. From beginning to end, this procedure takes approximately one hour. To determine the extent to which any pain relief and quality of life have improved, or not, answers to a follow-up questionnaire will be solicited from each participating patient by telephone approximately 6 to 12 months after treatment. The questionnaire contains 14 questions addressing pain and discomfort, urination and impact of symptoms and takes about 10 minutes to compete. To protect patient privacy the data will be entered into an Excel spreadsheet with the patients' names replaced by a number and date of birth replaced with just their age. The data will be digitized, analyzed and statistical significance will be evaluated buy a biostatistician. This study has been approved by the institutional review board (protocol number: 18D.719) prior to beginning. ### Conditions Module **Conditions:** - Chronic Pelvic Pain Syndrome **Keywords:** - pudendal neuralgia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** the amniotic suspension allograft consists of fresh amniotic fluid into which micronized amniotic membrane has been added as a suspension. **Name:** Amniotic suspension allograft **Other Names:** - Rheo, Flowgraft **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Pain in structures of the genitalia, rectum and pain during sexual activity **Measure:** Overall Pain and overall quality of life **Time Frame:** Between 6 and 12 months after treatment #### Secondary Outcomes **Description:** Symptoms relating to interstitial cystitis **Measure:** Bladder pain and urination frequency **Time Frame:** Between 6 and 12 months after treatment **Description:** Zero pain relief **Measure:** Adverse events **Time Frame:** Between 6 and 12 months after treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: All patients 18 years of age or older who present with chronic pelvic pain - Exclusion Criteria: 1. Under 18 years of age 2. Malignancy defined as terminal - **Gender Based:** True **Gender Description:** All patients with clinically demonstrable chronic pelvic pain who are 18 years or older.. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All women presenting with chronic pelvic pain who are over 18 and without terminal disease ### Contacts Locations Module #### Locations **Location 1:** **City:** Philadelphia **Country:** United States **Facility:** Thomas Jefferwson University Hospital **State:** Pennsylvania **Zip:** 19107 #### Overall Officials **Official 1:** **Affiliation:** Thomas Jefferson University **Name:** Thomas N Tulenko, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009408 - Term: Nerve Compression Syndromes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuralgia - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M19918 - Name: Pelvic Pain - Relevance: HIGH - As Found: Pelvic Pain - ID: M29660 - Name: Pudendal Neuralgia - Relevance: HIGH - As Found: Pudendal Neuralgia - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M12352 - Name: Nerve Compression Syndromes - Relevance: LOW - As Found: Unknown - ID: M5853 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: M18092 - Name: Hereditary Sensory and Motor Neuropathy - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T4805 - Name: Pudendal Neuralgia - Relevance: HIGH - As Found: Pudendal Neuralgia - ID: T1081 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: T2761 - Name: Hereditary Motor and Sensory Neuropathy - Relevance: LOW - As Found: Unknown - ID: T2766 - Name: Hereditary Neuropathy With Liability to Pressure Palsies - Relevance: LOW - As Found: Unknown - ID: T5067 - Name: Roussy Levy Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009437 - Term: Neuralgia - ID: D000060545 - Term: Pudendal Neuralgia - ID: D000017699 - Term: Pelvic Pain ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425562 **Acronym:** AM-IOS **Brief Title:** The Potential Added Value of Impulse Oscillometry in Asthma Monitoring **Official Title:** The Potential Added Value of Impulse Oscillometry in Asthma Monitoring #### Organization Study ID Info **ID:** 24151_AM-IOS #### Organization **Class:** OTHER **Full Name:** Universitair Ziekenhuis Brussel ### Status Module #### Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Vrije Universiteit Brussel #### Lead Sponsor **Class:** OTHER **Name:** Universitair Ziekenhuis Brussel #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this longitudinal observational study is to learn if impulse oscillometry (IOS) has an added value in asthma monitoring in adult asthma patients who are prescribed a change in asthma maintenance therapy. The main questions it aims to answer are: * Is there a difference in the change in IOS parameters and FEV1 respectively, stratified according to change in asthma control test? * Is there a difference in the change in IOS parameters and FEV1 respectively, stratified according to change in other questionnaire such as the asthma control questionnaire and the asthma quality of life questionnaire. * Are the proposed minimal clinically important differences (MCIDs) valid for short follow-up periods (3 - 6 months)? Participants will undergo lung function testing (full lung function, multiple breath nitrogen washout, impulse oscillometry) and questionnaires (asthma control test, asthma control questionnaire, asthma quality of life questionnaire), once during the baseline visit and once during the follow-up visit three to six months later. ### Conditions Module **Conditions:** - Asthma **Keywords:** - impulse oscillometry - asthma monitoring ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### 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:** Lung function tests (full lung function, multiple breath nitrogen washout, impulse oscillometry) and questionaires (asthma control test, asthma control questionnaire, asthma quality of life questionnaire) will be conducted, once at baseline and once 3 - 6 months later during follow-up. **Intervention Names:** - Other: Full lung function - Other: Multiple breath nitrogen washout - Other: Impulse oscillometry **Label:** Adult asthma patients **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Adult asthma patients **Description:** This includes spirometry, body plethysmography and single breath gas transfer test. These are all non-invasive physiological measurements / lung function tests. Measures flow volumes, lung volumes and gas transfer respectively. **Name:** Full lung function **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Adult asthma patients **Description:** Non-invasive physiological measurement / lung function test. 100% oxygen is inhaled and the nitrogen concentration in the lungs is measured. This test gives information on the ventilation distribution in the lungs. **Name:** Multiple breath nitrogen washout **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Adult asthma patients **Description:** Non-invasive physiological measurement / lung function test. This technique superimposes sound waves on tidal breathing. The patient can breathe normally trough the device, no forced respiratory maneuvers are required. It gives information on the reactance and resistance of the lung. **Name:** Impulse oscillometry **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Frequency dependance of resistance (FDR) is an impulse oscillometry parameter. FDR is expressed in kPa/(L.s). A lower FDR indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score. **Measure:** Change in frequency dependance of resistance (FDR) stratified according to change in asthma control test (ACT) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score. **Measure:** Change in area of reactance (AX) stratified according to change in asthma control test (ACT) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score. **Measure:** Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control test (ACT) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up #### Secondary Outcomes **Description:** Frequency dependance of resistance (FDR) is an impulse oscillometry parameter. FDR is expressed in kPa/(L.s). A lower FDR indicates a clinically better outcome. The ACQ-6 is a questionnaire which consists of 6 questions, each evaluated on a 7-point Likert-Scale. The total score score is divided by 6 yielding a mean score ranging from 0.0 to 6.0, where a lower score is clinically better than a higher score. **Measure:** Change in frequency dependence of resistance (FDR) stratified according to change in asthma control questionnaire (ACQ-6) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome. The ACQ-6 is a questionnaire which consists of 6 questions, each evaluated on a 7-point Likert-Scale. The total score score is divided by 6 yielding a mean score ranging from 0.0 to 6.0, where a lower score is clinically better than a higher score. **Measure:** Change in area of reactance (AX) stratified according to change in asthma control questionnaire (ACQ-6) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome. The ACQ-6 is a questionnaire which consists of 6 questions, each evaluated on a 7-point Likert-Scale. The total score score is divided by 6 yielding a mean score ranging from 0.0 to 6.0, where a lower score is clinically better than a higher score. **Measure:** Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control questionnaire (ACQ-6) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Frequency dependance of resistance (FDR) is an impulse oscillometry parameter. FDR is expressed in kPa/(L.s). A lower FDR indicates a clinically better outcome. The AQLQ is a questionnaire which consists of 32 questions, each evaluated on a 7-point Likert-Scale. The total score is divided by 32 yielding a mean score ranging from 1.0 to 7.0, where a lower score is clinically worse than a higher score. **Measure:** Change in frequency dependence of resistance (FDR) stratified according to change in asthma quality of life questionnaire (AQLQ) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome.The AQLQ is a questionnaire which consists of 32 questions, each evaluated on a 7-point Likert-Scale. The total score is divided by 32 yielding a mean score ranging from 1.0 to 7.0, where a lower score is clinically worse than a higher score. **Measure:** Change in area of reactance (AX) stratified according to change in asthma quality of life questionnaire (AQLQ) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome.The AQLQ is a questionnaire which consists of 32 questions, each evaluated on a 7-point Likert-Scale. The total score is divided by 32 yielding a mean score ranging from 1.0 to 7.0, where a lower score is clinically worse than a higher score. **Measure:** Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma quality of life questionnaire (AQLQ) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** MCIDs over 1 year have been published for IOS parameters. For frequency dependence of resistance (FDR) the MCID is defined as a decline of FDR greater or equal to 0.06 kPa/(L.s). Change of FDR ≥ 0.06 kPa/(L.s) or not **Measure:** Change in frequency dependence of resistance (FDR) over the 3-6 months observation period compared to proposed minimal clinically important differences (MCIDs) (calculated for a one year interval) for FDR. **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** MCIDs over 1 year have been published for IOS parameters. For area of reactance (AX) the MCID is defined as a decline of AX greater or equal to 0.65 kPa/L. Change of AX ≥ 0.65 kPa/L or not **Measure:** Change in area of reactance (AX) over the 3-6 months observation period compared to proposed minimal clinically important differences (MCIDs) (calculated for a one year interval) for AX. **Time Frame:** Once at baseline and 3 - 6 months later during follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult asthma patients with a scheduled consultation at the outpatient hospital to whom a step-up or step-down of their pharmacological asthma treatment is prescribed Exclusion Criteria: * Unstable asthma (defined as need for oral corticosteroids or (respiratory) antibiotic course in the 4 weeks before inclusion or any major medical issue in the 4 weeks before inclusion) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Shane Hanon, Prof. Dr. MD. **Phone:** 02 477 6841 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425549 **Acronym:** BE TOGETHER **Brief Title:** A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis **Official Title:** A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis #### Organization Study ID Info **ID:** PS0021 #### Organization **Class:** INDUSTRY **Full Name:** UCB Pharma #### Secondary ID Infos **Domain:** WHO universal trial number (UTN) **ID:** U1111-1293-2383 **Type:** OTHER **Domain:** CTIS (EU CT) **ID:** 2023-503859-10-00 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2030-11-08 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-08-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** UCB Biopharma SRL #### 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 primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO). ### Conditions Module **Conditions:** - Moderate to Severe Plaque Psoriasis **Keywords:** - bimekizumab - BKZ - ustekinumab - paediatric study participants - children - adolescents - Psoriasis - PSO - Plaque Psoriasis - Paediatric Psoriasis ### 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:** 168 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study participants randomized to this arm receive bimekizumab dosage regimen 1 at pre-specified timepoints during the Initial Treatment Period (16 weeks). They continue to receive bimekizumab dosage regimen 2 in the Maintenance Period (32 weeks). Under certain conditions study participants may be offered to continue on bimekizumab dosage regimen 2 in the Open-label Extension (OLE) Period (104 weeks). **Intervention Names:** - Drug: bimekizumab - Drug: placebo **Label:** bimekizumab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Study participants randomized to this arm receive ustekinumab at pre-specified timepoints during the Initial Treatment Period (16 weeks) and during the Maintenance Period. Under certain conditions participants may switch to bimekizumab dosage regimen 1 (16 weeks) and continue with bimekizumab dosage regimen 2 in the last 16 weeks of the Maintenance Period. Under certain conditions study participants may be offered to participate in the OLE Period also receiving bimekizumab dosage regimen 2. **Intervention Names:** - Drug: bimekizumab - Drug: ustekinumab - Drug: placebo **Label:** ustekinumab **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - bimekizumab - ustekinumab **Description:** Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study. **Name:** bimekizumab **Other Names:** - BKZ - UCB4940 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - ustekinumab **Description:** Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study. **Name:** ustekinumab **Other Names:** - USTE **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - bimekizumab - ustekinumab **Description:** Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding. **Name:** placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** Psoriasis Area Severity Index 90 (PASI90) response at Week 16 **Time Frame:** Week 16 **Description:** The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline. **Measure:** Investigator´s Global Assessment (IGA) 0/1 response at Week 16 **Time Frame:** Week 16 #### Secondary Outcomes **Description:** The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** PASI75 response at Week 4 **Time Frame:** Week 4 **Description:** A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** PASI100 response at Week 16 **Time Frame:** Week 16 **Description:** The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** PASI90 response at Week 48 **Time Frame:** Week 48 **Description:** The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline. **Measure:** IGA 0/1 response at Week 48 **Time Frame:** Week 48 **Description:** A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** PASI100 response at Week 48 **Time Frame:** Week 48 **Description:** The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear \[0\] with at least a two-category improvement from Baseline. **Measure:** IGA 0 response at Week 16 **Time Frame:** Week 16 **Description:** The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear \[0\] with at least a two-category improvement from Baseline. **Measure:** IGA 0 response at Week 48 **Time Frame:** Week 48 **Description:** An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. **Measure:** Incidence of treatment-emergent adverse events (TEAE)s **Time Frame:** From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) **Description:** An serious adverse event (SAE) must meet 1 or more of the following criteria: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly/birth defect * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. **Measure:** Incidence of serious TEAEs **Time Frame:** From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) **Description:** An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. **Measure:** Incidence of TEAEs leading to discontinuation of Investigational Medicinal Product (IMP) **Time Frame:** From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) **Description:** An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent withdrawal from study. **Measure:** Incidence of TEAEs leading to withdrawal from the study **Time Frame:** From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) **Description:** Safety topics of interest are infections (serious, opportunistic, fungal, and tuberculosis), inflammatory bowel disease, and injection site reactions. **Measure:** Incidence of TEAEs predefined as safety topics of interest **Time Frame:** From Baseline (Week 0) to Week 48 and to End of Safety Follow-up (up to Week 164) **Description:** Blood pressure will be measured in millimeters of mercury (mmHg). **Measure:** Change from Baseline in vital signs (systolic blood pressure) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Blood pressure will be measured in millimeters of mercury (mmHg). **Measure:** Change from Baseline in vital signs (diastolic blood pressure) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Pulse rate will be measured in beats per minute (beats/min). **Measure:** Change from Baseline in vital signs (pulse rate) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Clinically significant findings or worsening of previous findings since the physical examination at Baseline will be reported as TEAEs. **Measure:** Incidence of clinically significant physical examination findings reported as TEAEs **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Growth assessment, as assessed by the change from Baseline in height. **Measure:** Change from Baseline in height (growth assessment) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Growth assessment, as assessed by the change from Baseline in weight. **Measure:** Change from Baseline in weight (growth assessment) **Time Frame:** From Baseline (Week 0) up to Week 48. **Description:** Platelets will be measured in number of platelets per liter (10\^9/L). **Measure:** Change from Baseline in hematology parameters (platelet count) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Erythrocytes will be measured in number of red blood cells per liter (10\^12/L). **Measure:** Change from Baseline in hematology parameters (erythrocytes) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Hemoglobin will be measured in grams per liter (g/L). **Measure:** Change from Baseline in hematology parameters (hemoglobin) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Hematocrit will be measured in volume percentage (%) of red blood cells in blood. **Measure:** Change from Baseline in hematology parameters (hematocrit) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase will be measured in units per liter (U/L). **Measure:** Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes will be measured in number of white blood cells per liter (10\^9/L). **Measure:** Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L). **Measure:** Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Clinical chemistry parameters will be measured in micromols per liter (μmol/L). **Measure:** Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol). **Measure:** Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 16 **Time Frame:** Week 16, compared to Baseline **Description:** The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol). **Measure:** Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 48 **Time Frame:** Week 48, compared to Baseline **Description:** The CHAQ is a questionnaire designed to capture physical function in children and adolescents with juvenile rheumatoid arthritis. The CHAQ comprises 2 indices, Disability and Discomfort. The Disability Index assesses the degree of difficulty experienced over the past week across 30 items in the following 8 categories of the daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The Disability Index ranges from 0 (no disability) to 3 (maximum disability). Discomfort is determined by the presence of pain, as measured by a 100-mm visual analogue scale (VAS). In addition, a final global assessment item asks study participants to rate how they are doing by placing a mark on a 100 mm VAS. **Measure:** Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile PsA prior to Baseline **Time Frame:** Week 16, compared to Baseline **Description:** The Peak Pruritus NRS measures the worst level of itching in the past 24 hours on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). **Measure:** Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16 **Time Frame:** Week 16, compared to Baseline **Description:** Plasma bimekizumab concentrations prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration **Measure:** Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period **Time Frame:** From Baseline to End of OLE Period (up to 144 weeks) **Description:** Anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration **Measure:** Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period **Time Frame:** From Baseline to End of OLE Period (up to 144 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Study participant must be 6 to \<18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation * Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit * Study participant meets the following at both the Screening and Baseline Visits: 1. Body surface area (BSA) affected by PSO ≥10% 2. . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4) 3. . Psoriasis Area and Severity Index (PASI) score ≥12 OR PASI score ≥10 plus at least 1 of the following: i) Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement * Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling * Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening Exclusion Criteria: * Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17 * Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO * Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD * History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated * Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) * Study participant has previously received bimekizumab * Study participant has previously received ustekinumab * Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments * Study participant has the presence of active suicidal ideation, or positive suicide behavior * Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded * Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study **Maximum Age:** 17 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** UCB Cares **Phone:** 1-844-599-2273 (USA) **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** UCB Cares **Phone:** 001 844 599 2273 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** 001 844 599 2273 **Name:** UCB Cares **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. **Description:** Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion. **URL:** https://Vivli.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017444 - Term: Skin Diseases, Papulosquamous - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14422 - Name: Psoriasis - Relevance: HIGH - As Found: Psoriasis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19713 - Name: Skin Diseases, Papulosquamous - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011565 - Term: Psoriasis ### Intervention Browse Module - Ancestors - ID: D000003879 - Term: Dermatologic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M460 - Name: Ustekinumab - Relevance: HIGH - As Found: Manufactured - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069549 - Term: Ustekinumab ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425536 **Brief Title:** Efficacy of Remineralizing Products Used in Molar Grooves: Evaluation With Diagnodent Pen and Diagnocam **Official Title:** Efficacy of Remineralizing Products Used in Molar Grooves: RCT With Evaluation With Diagnodent Pen and Diagnocam #### Organization Study ID Info **ID:** 2024-MOLARGROOVES #### Organization **Class:** OTHER **Full Name:** University of Pavia ### Status Module #### Completion Date **Date:** 2025-01-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Pavia #### Responsible Party **Investigator Affiliation:** University of Pavia **Investigator Full Name:** Andrea Scribante **Investigator Title:** Associate Professor, Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate the efficacy of enamel remineralization by biomimetic hydroxyapatite contained in microRepair-based Biorepair Total Protection toothpaste compared to the use of Bio Enamel Caries and Erosion toothpaste based on Fluoro-Hydroxyapatite and BioActive Complex, evaluated with Diagnodent Pen and Diagnocam. **Detailed Description:** The recruited patients will be divided into: Group 1: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Biorepair Total Protection toothpaste 2 times/day Gruppo 2: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Curasept Biosmalto Caries and Erosion toothpaste 2 times/day For both groups, Diagnodent Pen will be used to evaluate the degree of demineralization, while Diagnocam will be used as qualitative evaluation. Other clinical indices to be collected are: plaque index (PI), bleeding index (BOP), basic erosive wear examination (BEWE), Schiff Air Index (SAI). The time frames of the study are: * T0: baseline * T1: after 1 month * T2: after 3 months * T3: after 6 months ### Conditions Module **Conditions:** - Enamel Caries ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Home use **Label:** Biorepair Total protection toothpaste **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Home use **Label:** Biosmalto Caries and Erosion **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Biorepair Total protection toothpaste - Biosmalto Caries and Erosion **Description:** Home use twice a day **Name:** Home use **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Scores (according to the manufacturer): 0 - 12: Normal prophylaxis (such as fluoride toothpaste) 13 - 24: Intensive prophylaxis (e.g. fluoridation, remineralisation) \> 25: Minimally invasive restorative procedures, composite filling materials and intensive prophylaxis (e.g. remineralisation, Air Abrasion, SONICflex micro), conventional restoration with large lesions, depending on risk assessment and findings. **Measure:** Change in Diagnodent Pen value **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** Qualitative evaluation. **Measure:** Change in Diagnocam value **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** 0: the subject did not respond to air blasting; 1. the subject responded to air blasting; 2. the subject responded to air blasting and requested discontinuation; 3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful. **Measure:** Change in Schiff Air Index **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%. **Measure:** Change in Bleeding on Probing **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100 **Measure:** Change in Plaque Index **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** Scoring criteria (Barlet et al., 2008): 0: no erosive tooth wear; 1. initial loss of surface texture; 2. distinct defect, hard tissue loss \< 50% of the surface area; 3. hard tissue loss ≥ 50% of the surface area. **Measure:** Change in Basic Erosive Wear Examination **Time Frame:** Study begin, 1, 3 and 6 months after the baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * First permanent molars erupted and completely healthy * Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen Exclusion Criteria: * Patients with Diagnodent-stimulated value \> 25 * Patients with groove sealings of sealed permanent first molars or composite restorations * First molars with extensive demineralizations (Molar Incisor Hypomineralization, fluorosis, white/brown spots) **Healthy Volunteers:** True **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:** Andrea Scribante, DDS, PhD **Phone:** +39 0382516223 **Role:** CONTACT #### Locations **Location 1:** **City:** Pavia **Country:** Italy **Facility:** Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia **State:** Lombardy **Zip:** 27100 #### Overall Officials **Official 1:** **Affiliation:** University of Pavia **Name:** Andrea Scribante, DDS, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data will be available upon motivated request to the Principal Investigator. **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425523 **Acronym:** THRIVE **Brief Title:** Transforming Health and Resilience In Vulnerable Environments: Mental Health, Psychosocial Support, and Climate-Smart Farming in Nakivale **Official Title:** Strengthening Resilience to Climate Change by Improving Mental Health: Evidence From a Randomized Intervention in Southwestern Uganda #### Organization Study ID Info **ID:** NAK-SH/HGI-2024 #### Organization **Class:** OTHER **Full Name:** Uppsala University #### Secondary ID Infos **Domain:** Formas - a Swedish Research Council for Sustainable Development **ID:** 2022-01573_Formas **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS) **Class:** INDUSTRY **Name:** Vivo international e.V. **Class:** OTHER **Name:** Bielefeld University **Class:** OTHER **Name:** Kabale University **Class:** OTHER **Name:** University of Turku **Class:** UNKNOWN **Name:** Max Planck Institute for Research on Collective Goods **Class:** UNKNOWN **Name:** University of North Carolina at Charlotte #### Lead Sponsor **Class:** OTHER **Name:** Uppsala 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:** The study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. It is a cluster-randomized controlled trial involving 900 pairs consisting of refugee mothers and their children aged 36-59 months, living in Nakivale refugee settlement in Uganda. The mothers will be randomly assigned to one of three groups: * Control group: Mothers will receive Enhanced Usual Care (EUC). * HGI group: Mothers will receive the Home Gardening Intervention, consisting of training and supplies for home gardening. * HGI/SH+ group: Mothers will receive both the Home Gardening Intervention and the Self-Help Plus mental health intervention. The main goal is to see if the gardening program alone can reduce food insecurity after 12 months compared to the EUC control group. It also aims to see if reducing psychological distress by adding the mental health component boosts the effects of the gardening intervention. Secondary goals are to look at impacts on dietary diversity, child malnutrition, and mothers' mental health levels across all three groups. The study also gathers survey data on participant mothers' migration history, social capital, exposure to potentially traumatic events, exposure to natural hazards and environmental stressors, mental health, and parenting style. Both mothers and their children will furthermore play incentivized economic games to measure their economic preferences (time, risk, social preferences). Additionally, the study will assess childrens' wellbeing and functioning. Children will also be asked to carry out gamified tasks designed to measure their cognitive development. ### Conditions Module **Conditions:** - Psychological Distress - Malnutrition, Child - Dietary Deficiency - Mental Health - Malnutrition **Keywords:** - Self-Help Plus - Home Gardening Intervention - Uganda - Refugee - Nakivale - Mental health - Child develpment - Food security - Climate change adaptation - Climate smart agriculture - Farming intervention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Three-arm, parallel-group, 1:1:1 allocation, superiority, cluster-randomized controlled trial (cRCT) ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 900 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Enhanced Usual Care **Intervention Names:** - Behavioral: Enhanced Usual Care (EUC) **Label:** EUC **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Home Gardening Intervention **Intervention Names:** - Behavioral: Home Gardening Intervention (HGI) - Behavioral: Enhanced Usual Care (EUC) **Label:** HGI **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Self-Help Plus in combination with Home Gardening Intervention **Intervention Names:** - Behavioral: Home Gardening Intervention (HGI) - Behavioral: Self-Help Plus (SH+) - Behavioral: Enhanced Usual Care (EUC) **Label:** SH+/HGI **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HGI - SH+/HGI **Description:** The Home Gardening Intervention (HGI) provides refugee participants with agricultural inputs and training (field prep., sowing, water management, pest control, weeding, etc.) through a participatory field school approach with a curriculum derived from best practices in agro-ecology. The program includes active monitoring during a 12-month period. The training involves nutrition education on cooking methods and the importance of dietary diversity using garden produce as well as guidance on surplus management and market support. The overall goal of the intervention is to enable climate-resilient farming for improved food security and dietary diversity that is sustainable long-term. **Name:** Home Gardening Intervention (HGI) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - SH+/HGI **Description:** Self-Help Plus (SH+) is a 5-session group intervention developed by the WHO and based on Acceptance and Commitment Therapy, delivered by trained local facilitators. It provides tools to manage stress and adversity through pre-recorded audio lessons and a self-help book. Sessions include individual exercises and group discussions. SH+ aims to decrease psychological distress. It has shown effectiveness among refugees in Uganda and elsewhere. **Name:** Self-Help Plus (SH+) **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - EUC - HGI - SH+/HGI **Description:** The Enhanced Usual Care (EUC) control condition involves a single 15-minute psychoeducation session providing information on managing overthinking and utilizing available mental health services in the settlement. These services include psychosocial support from community health workers and clinical mental health services (counseling and medications) provided weekly at local primary care centers by a visiting team. **Name:** Enhanced Usual Care (EUC) **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Both mothers and their children will play a set of incentivized economic games to measure economic preferences. Risk-taking will be measured using a "bomb-task." Time preferences will be measured using an investment task. Prosociality will be assessed using a series of dictator games. **Measure:** Economic preferences **Time Frame:** 12 months **Description:** Children's cognitive skills will be assessed using a battery of gamified tasks. Spatial cognition will be measured using 3d blocks and 2d shapes. Mathematics ability will be assessed using free counting, give-n, number comparison, and addition/subtraction tasks. Theory of mind will be measured using surprise content and surprise outcome tasks. Gaze following will be measured using TANGO. Language skills will be assessed using TIFALDI. **Measure:** Cognitive skills **Time Frame:** 12 months **Description:** Social capital will be measured using survey items asking about group membership, involvement in citizenship activities, and trust. **Measure:** Social capital **Time Frame:** 12 months **Description:** Positive parenting will be assessed using the 6-item Positive Parenting Subscale of the Alabama Parenting Questionnaire (APQ). This subscale focuses on the frequency of positive interactions between parents and children. Each item is rated on a scale from 1 (never) to 5 (always), with higher scores indicating more frequent use of positive parenting practices. **Measure:** Positive parenting **Time Frame:** 12 months **Description:** Child maltreatment will be measured using the 11-Item Discipline Module of the Multiple Indicator Cluster Survey (MICS). MICS is a household survey developed by UNICEF. It consists of eleven Yes/No questions that inquire about the different disciplinary actions taken by the caregiver in the past month. The total score can range from 0 to 11, with higher scores indicating the use of more types of disciplinary actions. **Measure:** Maltreatment **Time Frame:** 12 months **Description:** Posttraumatic stress will be measured using the Post-Traumatic Checklist 6-item Civilian Version (PCL-C). It has 6 items rated from 1 to 5, measuring key PTSD symptoms. Total score ranges from 6 to 30, with scores above 14 indicating potential PTSD. **Measure:** Posttraumatic stress **Time Frame:** 12 months **Description:** Stress will be assessed with the Perceived Stress Scale 4-item version (PSS-4). The PSS-4 is a brief self-report measure of perceived stress. It consists of four questions that ask about feelings and thoughts during the last month. Each item is rated on a scale from 0 (Never) to 4 (Very often), with items 2 and 3 reverse scored. The total score, ranging from 0 to 16, is obtained by adding the scores of all items. Higher scores indicate higher perceived stress. **Measure:** Stress **Time Frame:** 12 months **Description:** Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a widely-utilized questionnaire that gauges the severity of depression in individuals. It consists of nine items, each corresponding to a symptom of depression. The responses are scored on a scale ranging from 0 (not at all) to 3 (nearly every day), with the total score indicating the depression level. The scale's range is 0-27, reflecting varying degrees of depression severity from mild to severe. **Measure:** Depression **Time Frame:** 12 months **Description:** Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a brief measure designed to assess the severity of generalized anxiety disorder symptoms. It includes seven items that evaluate key symptoms such as nervousness, excessive worry, and fear. Respondents rate how often they have been bothered by each symptom over the past two weeks on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with higher scores indicating more severe anxiety. **Measure:** Anxiety **Time Frame:** 12 months **Description:** Psychological flexibility will be measured using the Acceptance and Action Questionnaire - version 2 (AAQ-2). The AAQ-2 consists of seven items scored on a 7-point Likert scale ranging from 1 (never true) to 7 (always true). The total score can range from 7 to 49, with higher scores indicating greater psychological inflexibility. **Measure:** Psychological flexibility **Time Frame:** 12 months **Description:** Functional impairment will be assessed using a 15-item verion of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS-II). The WHODAS-II is a standardized instrument for measuring health and disability across various domains of functioning. It covers six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is rated for difficulty over the past 30 days on a 5-point scale from 0 (none) to 4 (extreme or cannot do). The scores can be summed to provide a profile of functioning and disability. **Measure:** Functional impairment **Time Frame:** 12 months **Description:** Subjective wellbeing will be measured using the WHO-5 Well-Being Index. the WHO-5 is a concise self-report tool that measures an individual's subjective well-being. It contains five questions that assess positive mood, vitality, and general interests. The responses are scored on a scale from 0 (at no time) to 5 (all of the time), and the total score is then multiplied by 4 to give a final score ranging from 0 to 100. A score of 0 indicates very poor well-being, while 100 represents excellent well-being. **Measure:** Subjective wellbeing **Time Frame:** 12 months **Description:** Child wellbeing and functioning will be assessed using one of two versions of the Kiddy-KINDL questionnaire, depending on the child's age. For children aged 3 to 4 years, the parent version consists of 24 items that cover six subscales: physical well-being, psychological well-being, self-worth, family, friends, and functioning in everyday life (school or preschool/kindergarten). The items are scored on a 5-point Likert scale from 1 (never) to 5 (all the time), and a total score is calculated to reflect overall health-related quality of life. For children aged 4 years and above, there is a self-report version of the Kiddy-KINDL which contains 12 items. This version also uses a 5-point Likert scale for responses, and it similarly assesses various dimensions of a child's well-being. **Measure:** Child wellbeing and functioning **Time Frame:** 12 months #### Primary Outcomes **Description:** Food insecurity will be assessed using the Food Insecurity Experience Scale (FIES). The FIES was developed by the FAO, and consists of 8 questions regarding the availability of sufficient food in the past thirty days. The questions form a scale calibrated against a global reference from the 2014-2016 Gallup World Poll for comparability across countries. Responses are analyzed as a scale using Item Response Theory (IRT) models, ensuring comparability of food insecurity prevalence rates. **Measure:** Food insecurity **Time Frame:** 12 months #### Secondary Outcomes **Description:** Dietary diversity will be assessed using the Household Dietary Diversity Score (HDDS). The HDDS is a measure of food consumption that reflects a household's access to a variety of foods. It's based on households' self-reporting of the 12 food groups consumed in the previous 24 hours. **Measure:** Dietary diversity **Time Frame:** 12 months **Description:** Child malnutrition will be assessed using the Height-for-Age Z-score (HAZ). The HAZ is a standard statistical measurement that represents how a child's height compares to a reference population of the same age and sex. It's used to assess long-term nutritional status and can indicate chronic malnutrition or stunting. A HAZ score below -2 is considered stunted, indicating that the child is significantly shorter than the average height for their age. A score above +2 would suggest the child is taller than the average height for their age. **Measure:** Child malnutrition **Time Frame:** 12 months **Description:** Psychological distress will be measured using the Kessler Psychological Distress Scale (K6). The K6 is a concise tool used to screen for psychological distress. It assesses general psychological distress through six questions that inquire about symptoms of depression and anxiety experienced in the past month. Each of the six questions is scored from 0 (none of the time) to 4 (all of the time), providing a total score range from 0 to 24. Higher scores indicate greater psychological distress. **Measure:** Psychological distress **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria (mothers): * Psychological distress (score 5 or above on K-6) * Ability to speak and understand Kiswahili * Have a child aged 36-59 months * Availability of plot of land for farming * Access of water for farming * Written informed consent to enter the study Exclusion Criteria (mothers): * Imminent risk of suicide * Observable signs of psychosis * Manic behaviors * Intellectual disability Inclusion criteria (children): * Age 36-59 months * Written parental consent to enter the study * Assent to enter the study Exclusion criteria (children): * Intellectual disability * Not living with mother **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jonathan Hall, PhD **Phone:** +46709948737 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Phaidon Vassiliou, M.A. **Phone:** +46703726681 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Uppsala University **Name:** Jonathan Hall, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2. **PMID:** 31981556 **Citation:** Al Daccache M, Abi Zeid B, Hojeij L, Baliki G, Bruck T, Ghattas H. Systematic review on the impacts of agricultural interventions on food security and nutrition in complex humanitarian emergency settings. BMC Nutr. 2024 Apr 19;10(1):60. doi: 10.1186/s40795-024-00864-8. **PMID:** 38641632 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25306 - Name: Malnutrition - Relevance: HIGH - As Found: Malnutrition - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M18049 - Name: Child Nutrition Disorders - Relevance: HIGH - As Found: Malnutrition, Child ### Condition Browse Module - Meshes - ID: D000044342 - Term: Malnutrition - ID: D000015362 - Term: Child Nutrition Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425510 **Brief Title:** Using Technology to Improve Function for Older Latinos With Disabilities in Underserved Areas **Official Title:** Tech Enabled Functional Health: Bridging Primary Care Gaps for Older Latinos With Functional Disabilities in Underserved Communities #### Organization Study ID Info **ID:** 2405230330 #### Organization **Class:** OTHER **Full Name:** University of Puerto Rico ### Status Module #### Completion Date **Date:** 2027-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2025-02-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Puerto Rico #### 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 project aims to test a culturally appropriate assistive technology (AT) intervention called VIVE-AT to help older Latinos with disabilities improve their function and quality of life. The researchers will first refine the VIVE-AT program based on feedback from a Community Advisory Board and focus groups with older Latinos with disabilities. Then, 76 older Latinos with disabilities will be recruited from a primary care clinic serving low-income communities in Puerto Rico. They will be randomly assigned to either receive the VIVE-AT intervention in the primary care clinic or be placed on a waitlist with regular phone calls. All participants will continue to receive standard care at the clinic. **Detailed Description:** Functional disabilities (FDs), defined as difficulties in performing daily activities, constitute a significant public health problem associated with increased dependency, poor health outcomes, diminished quality of life, institutionalization, and premature death. Older Latinos residing in Puerto Rico (PR) are disproportionately affected by FDs, with one of the highest rates of FDs (58%) in the US and its territories. Research has demonstrated positive outcomes from employing assistive technology (AT) devices, such as jar openers, sock aids, and canes, among older adults with FDs, thereby enhancing their functioning, participation, and capacity to remain at home or in the community for a longer period. However, Latinos are among the least likely to utilize AT. Given the dearth of culturally competent assistive technology interventions for Latinos, along with the scarcity of rehabilitation professionals and assistive technology services in primary healthcare facilities, this project leverages preliminary data from a prior study that assessed the feasibility of the Viviendo las Ventajas de la Asistencia Tecnológica; (VIVE-AT for short; Living the Advantages of Assistive Technologies) intervention. The specific aims of this project are to: 1. refine the protocol of the VIVE-AT to align with the unique needs of the primary health care clinic; 2. assess the efficacy of the VIVE-AT in comparison to a waitlist control arm, in decreasing FDs and improving the quality of life among Latinos aged ≥65 years post-intervention and at six months; 3. evaluate whether proposed mechanisms of change in FDs, specifically knowledge of AT, motivation for using AT, self-efficacy for using AT, and use of AT, account for the reduction in FDs post-intervention. To achieve these aims, the interdisciplinary team of this project will first refine the intervention based on recommendations from participants in the feasibility study, as well as input from the Community Advisory Board and older Latinos with FDs through iterative focus groups (Aim 1). Subsequently, 76 older Latinos with physical FDs recruited from a primary health care facility serving low-income communities in PR will be randomly assigned to either the VIVE-AT intervention group (n=38) or a waitlist + attention calls controlled condition group (n=38) to assess its efficacy and mechanisms of change (Aims 2 and; 3). All participants will receive standard usual care at the primary health care center. Participants in the intervention group will attend a weekly, two-hour group session for 6 weeks, facilitated by trained healthcare workers, focusing on self-management of FDs through the use of AT. Additionally, participants will receive up to five AT devices tailored to their specific FI needs, along with training on their usage. All participants will be assessed at baseline, post-intervention, and six months after intervention. The goals of the VIVE-AT are to encourage participants to use AT devices to self-manage their FDs and improve their quality of life. Our approach will contribute to scientific knowledge and inform a subsequent scalable multisite Hybrid Type I RCT, designed to evaluate its effectiveness in reducing physical FDs among older Latinos in primary healthcare settings in the U.S. and P.R. ### Conditions Module **Conditions:** - Aging - Disability Physical **Keywords:** - self help devices - behavioral intervention - assistive technology - primary health care - community health workers ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Social Cognitive Theory ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 76 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The VIVE-AT program consists of a six-week, once-a-week, 2-hour group educational intervention guided by the social cognitive model. It is facilitated by primary care and community health workers in a primary healthcare clinic. The intervention aims to teach older Latinos self-management strategies to increase the adoption and use of assistive technology devices that enhance their function in daily activities. VIVE-AT is designed to support behavioral change by providing up to five assistive technology devices to participants, along with information, instruction, demonstration, action planning, and guided practice in using the devices. **Intervention Names:** - Behavioral: Viviendo las Ventajas de la Asistencia Tecnológica **Label:** Viviendo las ventajas de la Asistencia Tecnológica (VIVE-AT) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in the waitlist control group will receive weekly attention calls providing general health advice during the 6-week intervention period. They will also receive usual care for the initial 6 months post-randomization, followed by crossover to the VIVE-AT intervention. **Intervention Names:** - Other: Attention calls **Label:** Waitlist Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Viviendo las ventajas de la Asistencia Tecnológica (VIVE-AT) **Description:** It comprises 2-hours small group sessions of 8-10 participants, once a week, for six weeks of participatory discussions, experiential learning, multimodal instructions, and demonstration and practice with selected ATDs. The content of the VIVE-AT weekly sessions is as follows: Week 1 - Introduction to ATDs, funding and resources; Week 2 - ATDs for self-care and toilet use; Week 3 - ATDs for mobility; Week 4 - ATDs for dressing; Week 6 - ATDs for cooking and home tasks. Each session is designed with the following components: monitoring of participants\&#39; weekly goals, providing information on ATDs, resources, and services, reflection on the advantages and disadvantages of using these ATDs, hands-on practice with selected ATDs, goal setting, and addressing barriers to using ATDs. Group sessions will incorporate visual aids, including modeling and videos of older individuals using ATDs accessed through an AT web app in a tablet provided by this project. **Name:** Viviendo las Ventajas de la Asistencia Tecnológica **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Waitlist Control **Description:** Ten minutes attention calls, once a week for six weeks to the waitlist control participants will offer general health advice on topics like nutrition, exercise, sleep, stress, and social connections. These calls emphasize participant well-being without touching upon the specific VIVE-AT content, maintaining a clear distinction from the intervention group. **Name:** Attention calls **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** The percent of eligible OL who were enrolled (goal: ≥ 80%) **Measure:** Participation rates **Time Frame:** At the end of the intervention (6 weeks) **Description:** The percent of OL who complete the study measures at the end of the intervention and at 6 months post intervention (goal: ≥ 80%). **Measure:** Retention rates **Time Frame:** At the end of the intervention (6weeks) and at 6 months post-intervention **Description:** The percent of participants who drop out or are lost to follow-up at the end of the intervention and at 6 months post-intervention, with reasons recorded when known (goal: ≤ 20%). **Measure:** Attrition rates **Time Frame:** At the end of the intervention (6 weeks) and 6 months post-intervention **Description:** The percent of participants completing at least 4 of 6 group sessions (goal: ≥ 80%). **Measure:** Completion rates **Time Frame:** At 6 months post-intervention **Description:** This questionnaire is based on the key dimensions outlined in the Theoretical Framework of Acceptability, which include affect, burden, perceived effectiveness, ethicality, coherence, opportunity costs, and self-efficacy. It features open-ended questions to further explore suggested improvements, identify successful components, and understand contextual issues that influenced the implementation of the intervention in primary care clinic, all based on the Practical Robust Implementation and Sustainability Model (PRISM). The goal is to achieve a mean satisfaction level of ≥ 80%. **Measure:** Acceptability as Assessed by Acceptability: Assessment will be conducted using the Intervention Acceptability and Implementation Questionnaire **Time Frame:** At the end of the intervention (6 weeks) **Description:** We will document the total intervention costs, costs per participant, and marginal costs per incremental change in physical functional disabilites PROMIS-HAQ T-score. Resource use associated with the programs will be valued at competitive market rates. Costs will be estimated and evaluated in constant dollars using the Prospective Payment System Index. Major resource categories will be examined, including costs of identifying and recruiting participants and intervention preparation, direct interventionist labor costs, interventionist training and supervision costs, and program materials, supplies, office space, and storage space costs. We will separate research-based costs from intervention costs. Emergency room visit frequency, costs, and reasons, as well as institutional costs, including hospitalizations and institutionalization will be tracked. The number, direct costs, and type of visits to primary care physicians, both internal and external to the primary care clinic, will be doc **Measure:** Cost **Time Frame:** Baseline, during the intervention, at the end of the intervention (6 weeks), and at 6 months post-intervention #### Primary Outcomes **Description:** This is a patient-reported outcome measure design to assess physical FDs in adults across the categories of dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, errands, and chores. It comprises 20 items on a 5-point Likert-type scale, ranging from 5 "without difficulty" to 1 "unable to do". **Measure:** Physical Function as Assessed by the PROMIS Short Form v2.0 - Physical Function 24a (PROMIS-HAQ) **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** This is a 10 items health-related quality of life measure with five domains: physical health, pain, fatigue, mental health, and social health, along with an overall health assessment. It also includes two subscales: Global Mental Health (GMH) and Global Physical Health (GPH). **Measure:** Quality of Life as Assessed by PROMIS Scale v1.2 - Global Health **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention #### Secondary Outcomes **Description:** The ATUAS assess participants knowledge of 44 assistive technology devices. Participants are presented with photographs and names of the devices and asked if they possess each item. If the answer is 'No,' further questions will determine whether they use it (code 2) or not (code 1), are aware of its existence (code 3), or neither (code 4). Responses will be recoded into two categories: used (code 2) and not used (codes 1, 3, and 4) to calculate ATD usage. **Measure:** Use of Assistive Technology Devices as Assessed by Assistive Technology Awareness Scale (ATUAS) **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** The ATUAS assess participants knowledge of 44 assistive technology devices. Participants are presented with photographs and names of the devices and asked if they possess each item. If the answer is 'No,' further questions will determine whether they use it (code 2) or not (code 1), are aware of its existence (code 3), or neither (code 4). Assistive technology knowledge is assessed by recoding the answer for each assistive technology into two categories: aware (codes 1, 2, 3) versus not aware (code 4). **Measure:** Assistive Technology Knowledge as Assessed by Assistive Technology Use and Awareness Scale (ATUAS) **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** The AADS consists of 12 items designed to measure older adults' attitudes (motivation) including the substitution of care, the financial aspect of care, and the effect on privacy. It utilizes a Likert scale with 5 points, ranging from 5 (totally agree) to 1 (totally disagree), with interval scores ranging from 12 to 60. A high score indicates a positive attitude. **Measure:** Motivation to Use Assistive Technology as Assessed by Attitudes Towards Assistive Device Scale (AADS) **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** This measure consists of three items presenting increasing levels of intention (motivation) to use assistive technology devices. It employs a 5-point Likert scale, ranging from 1 (I do not have the intention to do this at all) to 5 (I certainly have the intention to do this). The total score ranges from 3 to 15; higher scores indicating a strong intention to use asssitive technology devices. **Measure:** Intention to Use Assistive Technology as Assessed by Intention to Use Assistive Device Scale **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** This measure measures assesses self-efficacy for using assistive technology devices with three items, each representing increasing barriers. The interval scale ranges from 3 to 15; higher score indicates higher self-efficacy. **Measure:** Self-efficacy as Assessed by Self-efficacy Regarding Assistive Device Use **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Spanish speaking Latino adults ≥65 years * With a physical function impairment (PROMIS-HAQ T-Score ≤45) * Living independently in the community (not requiring supervision to perform their daily living activities) * Self-reported ability to participate in a 6 weeks of group intervention * Having no plans to move for the next 12 months Exclusion Criteria: * Currently residing in a nursing or group home * Receiving home healthcare services * Having a significant cognitive impairment as evidenced by a score ≤23 in the Mini Mental State Examination (MMSE) **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Elsa M Orellano-Colón, Ph.D. **Phone:** 787-758-2525 **Phone Ext:** 4200 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Milagros I Figueroa-Ramos, Ph.D. **Phone:** 787-758-2525 **Phone Ext:** 1986 **Role:** CONTACT #### Locations **Location 1:** **City:** San Juan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Elsa M Orellano-Colón, Ph.D. - **Phone:** 787-758-2525 - **Phone Ext:** 4200 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Milagros I Figueroa-Ramos, Ph.D. - **Phone:** 787-758-2525 - **Phone Ext:** 1986 - **Role:** CONTACT ***Contact 3:*** - **Name:** Elsa M Orellano-Colón, Ph.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Puerto Rico **Facility:** University of Puerto Rico Medical Sciences Campus **Zip:** 00936-5067 ### IPD Sharing Statement Module **Access Criteria:** The study's IPD would be accessible to the academic community and the public. This repository serves as a digital storage site for the scientific and creative work produced by the University of Puerto Rico. They will be able to access all shared study materials, data, and metadata. To access the repository, users can visit the DIRe.UPR website at https://repositorio.upr.edu. The repository allows searching and browsing of the content, which includes faculty research works. **Description:** De-identified quantitative data which can be publicly shared will be formatted for widely available statistical packages such as R, SPSS, STATA, and SAS. All shared study materials, data, and metadata will be made publicly available through the University of Puerto Rico Institutional Repository available at the Repositorio Digital Institucional de la Universidad de Puerto Rico (DIRe.UPR) website at https://repositorio.upr.edu. Data will be assigned a Digital Object Identifier (DOI) and will be searchable via the University of Puerto Rico Institutional Repository and other search engines. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** Data and metadata will be deposited into the repository at the time of publication or by the end of the project period, whichever comes first. Data will be preserved for three years following the end of the grant period. **URL:** https://repositorio.upr.edu/ ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M251802 - Name: Imidacloprid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425497 **Acronym:** PTV-DSAaKT **Brief Title:** DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY **Official Title:** DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY #### Organization Study ID Info **ID:** sperimentazioni PTV 92.24 #### Organization **Class:** OTHER **Full Name:** University of Rome Tor Vergata ### Status Module #### Completion Date **Date:** 2024-05-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-31 **Type:** ACTUAL #### Start Date **Date:** 2010-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Rome Tor Vergata #### Responsible Party **Investigator Affiliation:** University of Rome Tor Vergata **Investigator Full Name:** Roberta Angelico **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels. **Detailed Description:** Retrospective observational monocentric study at the U.O.C. of Hepatobiliary Surgery and Transplants of Tor Vergata Polyclinic. All kidney transplant patients in the indicated study period will be enrolled and followed at the U.O.C. clinic. For each patient, demographic, transplant and post-transplant data will be collected. In the latter, data relating to dnDSA will be registered, searching for a possible triggering cause at the anamnestic level. The dosage of dnDSA is performed in common clinical practice in a routine manner in all patients undergoing kidney transplant, using the method "Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI\> 1000)". The blood dosage of the immunosuppressor is measured during routine checks and a comparison is made between Tacrolimus-based immunosuppressive therapy and other immunosuppressive therapy, highlighting the differences in the risk of developing dnDSA and in graft and patient survival. ### Conditions Module **Conditions:** - Kidney Transplant; Complications - Immunosuppression ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 600 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study population will be composed by patients who underwent a kidney transplant, single or double, from a deceased or living donor, from 01/01/2010 to 07/31/2023 at the U.O.C. of the Hepatobiliary Surgery and Transplants of the Tor Vergata Polyclinic, with at least one year of post-transplant follow-up. **Intervention Names:** - Other: The dosage of dnDSA **Label:** Kidney transplant patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Kidney transplant patients **Description:** Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI\> 1000) **Name:** The dosage of dnDSA **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Define the incidence of development of dnDSA in patients undergoing kidney transplantation. **Measure:** Development of dnDSA in kidney transplant patients **Time Frame:** • Pre-transplant • Baseline (I PODs) • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old #### Secondary Outcomes **Description:** Graft survival At 5 and 10 years **Measure:** Graft survival **Time Frame:** 5 and 10 years **Description:** Patient survival at 5 and 10 years **Measure:** Patient survival **Time Frame:** 5 and 10 years **Description:** Blood dosage levels of post-transplant immunosuppressive drugs (tacrolemia, ciclosporinemia, everolemia, sirolemia); **Measure:** Blood dosage levels of post-transplant immunosuppressive drugs **Time Frame:** • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old **Description:** Donor-recipient HLA mismatch **Measure:** Donor-recipient HLA mismatch **Time Frame:** Pre-transplant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients,both male and female over the age of 18 * Patients with at least one year of follow-up Exclusion Criteria: * Combined liver-kidney or pancreas-kidney transplants * Re-transplants * Patients with follow-up less than one year **Minimum Age:** 19 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population will be composed by patients who underwent a kidney transplant, single or double, from a deceased or living donor, from 01/01/2010 to 07/31/2023 at the U.O.C. of the Hepatobiliary Surgery and Transplants of the Tor Vergata Polyclinic, with at least one year of post-transplant follow-up. ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Università degli Studi di Roma "Tor Vergata" **Name:** Roberta Angelico, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### 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 ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425484 **Brief Title:** The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation. **Official Title:** The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation. #### Organization Study ID Info **ID:** USM/JEPeM/kk/23010129 #### Organization **Class:** OTHER **Full Name:** Universiti Sains Malaysia ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-31 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universiti Sains Malaysia #### Responsible Party **Investigator Affiliation:** Universiti Sains Malaysia **Investigator Full Name:** Rhendra Hardy Mohamad Zaini **Investigator Title:** Prof Madya **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 compare effectiveness between epidural combined with TAP block versus epidural alone in gynaecology operation participant .The main question\[s\] it aims to answer are: * what is the pain score for both groups * what is the requirement of epidural infusion between the 2 groups Participants will be given general anesthesia for the operation with the epidural insertion prior to induction. Patient will be randomized into epidural plus TAP block or epidural alone for the study. The US TAP block will be given at the end of operation prior to extubation. Researchers will compare pain score, epidural infusion requirment between the two groups. **Detailed Description:** The research is a prospective randomized control study. It is blinded study as accessor is blinded whereby the acute pain service (APS) team will be reviewing patient postoperatively. Study size of 46 subjects based on repeated measure ANOVA between factor , alpha value 0.05% with 80% power study, a dropout 10%. Divided into 2 groups ; Group E - epidural alone, Group T - epidural plus bilateral US TAP block. Perioperatively, epidural catheter will be inserted then induction for general anesthesia given. Intraoperatively anesthesia maintain with inhalation agent. Prior to extubation, bilateral TAP block is provided using portable US guidance. At this location, the 3 layers of anterior abdominal wall is visualized for the truncal block. Post operatively, participant will be given epidural cocktail bupivacaine 0.1% + fentanyl 2mcg/ml infusion for next 24hrs. The APS team will review patient post operatively in ward and all data will be recorded. Participation of patient's during study is approximately 2 days duration. ### Conditions Module **Conditions:** - Gynecologic Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Total sample size of 46 subjects, divided into 2 groups epidural alone (Group E) and epidural with bilateral US TAP block (Group T) ##### Masking Info **Masking:** SINGLE **Masking Description:** APS team will be assessing participants pain score in the ward and documented the data. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group epidural with bilateral US TAP block **Intervention Names:** - Other: Bilateral US TAP block **Label:** Group T **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Group epidural alone **Intervention Names:** - Other: Bilateral US TAP block **Label:** Group E **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group E - Group T **Description:** epidural plus bilateral US guided TAP block **Name:** Bilateral US TAP block **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** To compare the pain score between 2 groups (epidural with bilateral TAP block) and epidural alone for gynaecology operation. **Measure:** Pain score between epidural plus bilateral TAP block and epidural alone **Time Frame:** Post operatively, until day 2 post operation. #### Secondary Outcomes **Description:** To compare the postoperative epidural infusion requirement between bilateral US guided TAP block plus epidural versus epidural alone. **Measure:** To compare the epidural infusion requirement between the 2 groups ( Group T and Group E) **Time Frame:** Post operatively, until day 2 post operation. **Description:** To evaluate time taken for early mobilization between group Epidural with TAP block and epidural alone after the operation . **Measure:** To evaluate time of early mobilization between 2 groups ( Group T and Group E) **Time Frame:** Post operatively, until day 2 post operation. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Elective major laparotomy gynaecology procedure. * Age 18 years and above * ASA I, II, III Exclusion Criteria: * Prolonged INR * Allergic to LA * History of chronic pain * Psychological disorder/addict to opioid or benzodiazepine * Any contraindication for epidural or TAP block procedure * Pregnancy **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rhendra Hardy Mohd Zain **Phone:** +6097676104 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Suki Ismet **Phone:** +6097676105 **Role:** CONTACT #### Locations **Location 1:** **City:** Kubang Kerian **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Munirah Abdul Majid - **Phone:** +6097673000 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Suki Ismet - **Phone:** +6097676105 - **Role:** CONTACT **Country:** Malaysia **Facility:** Universiti Sains Malaysia **State:** Kelantan **Status:** RECRUITING **Zip:** 16150 #### Overall Officials **Official 1:** **Affiliation:** University Sains Malaysia **Name:** Munirah Abdul Majid **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University Sains Malaysia **Name:** W.Mohd Nazaruddin W. Hassan **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ganapathy S, Sondekoppam RV, Terlecki M, Brookes J, Das Adhikary S, Subramanian L. Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):797-804. doi: 10.1097/EJA.0000000000000345. **PMID:** 26426576 **Citation:** Yoshida T, Furutani K, Watanabe Y, Ohashi N, Baba H. Analgesic efficacy of bilateral continuous transversus abdominis plane blocks using an oblique subcostal approach in patients undergoing laparotomy for gynaecological cancer: a prospective, randomized, triple-blind, placebo-controlled study. Br J Anaesth. 2016 Dec;117(6):812-820. doi: 10.1093/bja/aew339. **PMID:** 27956680 **Citation:** Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31. **PMID:** 29226150 **Citation:** Iyer SS, Bavishi H, Mohan CV, Kaur N. Comparison of Epidural Analgesia with Transversus Abdominis Plane Analgesia for Postoperative Pain Relief in Patients Undergoing Lower Abdominal Surgery: A Prospective Randomized Study. Anesth Essays Res. 2017 Jul-Sep;11(3):670-675. doi: 10.4103/0259-1162.206856. **PMID:** 28928569 **Citation:** Wu Y, Liu F, Tang H, Wang Q, Chen L, Wu H, Zhang X, Miao J, Zhu M, Hu C, Goldsworthy M, You J, Xu X. The analgesic efficacy of subcostal transversus abdominis plane block compared with thoracic epidural analgesia and intravenous opioid analgesia after radical gastrectomy. Anesth Analg. 2013 Aug;117(2):507-13. doi: 10.1213/ANE.0b013e318297fcee. Epub 2013 Jun 6. **PMID:** 23744953 **Citation:** Huepenbecker SP, Cusworth SE, Kuroki LM, Lu P, Samen CDK, Woolfolk C, Deterding R, Wan L, Helsten DL, Bottros M, Mutch DG, Powell MA, Massad LS, Thaker PH. Continuous epidural infusion in gynecologic oncology patients undergoing exploratory laparotomy: The new standard for decreased postoperative pain and opioid use. Gynecol Oncol. 2019 May;153(2):356-361. doi: 10.1016/j.ygyno.2019.02.017. Epub 2019 Feb 22. **PMID:** 30798950 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8943 - Name: Genital Diseases, Female - Relevance: HIGH - As Found: Gynecologic Disease - 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: D000005831 - Term: Genital Diseases, Female ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425471 **Brief Title:** A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery **Official Title:** A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery #### Organization Study ID Info **ID:** HSC-MS-22-1019 #### Organization **Class:** OTHER **Full Name:** The University of Texas Health Science Center, Houston ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Texas Health Science Center, Houston #### Responsible Party **Investigator Affiliation:** The University of Texas Health Science Center, Houston **Investigator Full Name:** Jimmy Espinoza **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery **Detailed Description:** Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes ### Conditions Module **Conditions:** - In Utero Procedure Affecting Fetus or Newborn ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: KARL STORZ fetoscope arm **Label:** KARL STORZ fetoscope arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - KARL STORZ fetoscope arm **Description:** The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS) **Name:** KARL STORZ fetoscope arm **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Gestational age at delivery in patients requiring percutaneous in-utero surgery **Time Frame:** at time of delivery (about 10 weeks after in utero surgery) #### Secondary Outcomes **Measure:** Number of successful procedures with completion of laser ablation of the abnormal vessels. **Time Frame:** within 24 hours of in utero surgery **Description:** This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree. This is not a validated scale and does not have an official title. The minimum value is strongly disagree and the maximum value is strongly agree. Higher scores mean better outcomes. **Measure:** Improved visualization as assessed by the Likert scale **Time Frame:** within 24 hours of in utero surgery **Description:** This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree **Measure:** Improved angle for laser visualization as assessed by the Likert scale **Time Frame:** within 24 hours of in utero surgery **Description:** This is a 4 item questionnaire and each is scored from 1(poor) to 5(excellent) for a maximum score of 20 higher score indicating better outcome **Measure:** Improved ease of use of the new fetoscope as assessed by a questionnaire **Time Frame:** within 24 hours of in utero surgery **Description:** Time from from operative cannula insertion until it is removed **Measure:** Operative time in minutes **Time Frame:** end of surgery ( about 1 hour form start of surgery) **Measure:** Number of fetuses alive prior to hospital discharge **Time Frame:** time of discharge (about 48 hours after surgery) **Description:** Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption **Measure:** Total number of maternal patients that present with short term morbidity **Time Frame:** from end of surgery to within 10 weeks after surgery **Measure:** Total number of patients that have maternal and/or fetal perioperative complications **Time Frame:** from end of surgery to within 10 weeks after surgery **Measure:** The number of participants that develop twin-anemia-polycythemia sequence (TAPS) **Time Frame:** from end of surgery to within 10 weeks after surgery **Measure:** Total number of live births **Time Frame:** from time of in utero surgery till delivery (about 10 weeks after surgery) **Description:** Short-term morbidities include, but are not limited to, premature delivery (\<37 weeks), the need for extracorporeal membrane oxygenation (ECMO), neurological abnormalities found by MRI or ultrasound, gastrointestinal problems, oxygen support, infection and other problems associated with prematurity, including but not limited to, necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, and neonatal sepsis. **Measure:** Total number of short-term morbidities **Time Frame:** from time of in utero surgery till delivery (about 10 weeks after surgery) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant woman * The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition * Patient of the baby provides signed informed consent that details the maternal and fetal risks involved with the procedure Exclusion Criteria: * Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia * Allergy or previous adverse reaction to a study medication specified in this protocol * Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy * Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation * Suspicion of a major recognized syndrome by ultrasound or MRI * Maternal BMI \>40 kg/m2 * High risk for fetal hemophilia **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jimmy Espinoza, MD, MSc,FACOG **Phone:** (713) 500-5859 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Elisa Garcia **Phone:** 713-500-6347 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jimmy Espinoza, MD, MSc,FACOG - **Phone:** (713) 500-5859 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Elisa Garcia - **Phone:** 713-500-6347 - **Role:** CONTACT **Country:** United States **Facility:** The University of Texas health Science Center at Houston **State:** Texas **Status:** RECRUITING **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** The University of Texas Health Science Center, Houston **Name:** Jimmy Espinoza, MD, MSc,FACOG **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425458 **Brief Title:** Transitioning Youth Out of Homelessness 2.5 (TYOH 2.5) **Official Title:** Transitioning Youth Out of Homelessness 2.5: A Co-Designed Strengths-Based Leadership Program for Young People Transitioning Out of Homelessness #### Organization Study ID Info **ID:** 24-072 #### Organization **Class:** OTHER **Full Name:** Unity Health Toronto ### Status Module #### Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Covenant House Toronto **Class:** UNKNOWN **Name:** StepStones for Youth **Class:** UNKNOWN **Name:** The Resource Association for Teens (RAFT) #### Lead Sponsor **Class:** OTHER **Name:** Unity Health Toronto #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The idea for this study came from the research team's current study called Transitioning Youth Out of Homelessness (TYOH) 2.0, which provides coaching and a leadership guide to youth transitioning out of homelessness. Based on feedback from youth and coaches involved in that study, the research team plans to make small changes to the leadership guide and see if it works better as an in-person, four-week leadership program. All participants in this study will be invited to attend an in-person, four-week leadership program. There will be two programs running at the same time: one in St. Catharines and one in Toronto. The goal is to have 15 participants in each program. The main purpose of the study is to learn what participants think of the program. The second purpose is to see if there are changes in identity capital (feeling a sense of purpose and confidence in achieving goals) and knowledge about things that are covered in the program, when the research team compares participants' answers at the beginning and at the end of the program. **Detailed Description:** This project builds on the research team's current community-based randomized clinical trial (Transitioning Youth Out of Homelessness 2.0) utilizing coaching and a co-designed leadership guide to target identity capital (purpose, control, self-efficacy, and self-esteem) for youth transitioning out of homelessness (all participants are also receiving rent subsidies). Based on preliminary feedback from study youth and coaches involved in the intervention arm, the research team will modify the leadership guide and pilot it in the form of an in-person, four-week leadership program (vs. independent learning in the current study). The overarching objective of this mixed methods pilot project is to co-develop and test a strengths-based leadership program targeting identity capital for youth (16-24 years of age) transitioning out of homelessness. Specifically, the objectives are to: 1. Modify the leadership guide being used in the research team's current study so it can be delivered as an in-person leadership program. 2. Co-develop and pilot a four-week, strengths-based leadership program for young people transitioning out of homelessness. 3. Determine the feasibility and acceptability of the leadership guide when delivered as a four-week, in-person program (as opposed to independent learning in the current study). 4. Examine whether self-reported measures of identity capital and knowledge of program material show improvement immediately post-program compared to baseline. 5. Explore whether there are differences in outcomes by sub-groups (e.g., gender, age, identification as 2SLGBTQ+, child welfare involvement) and/or program participation levels. If this modified delivery of the leadership guide shows promise, the research team plans to incorporate it into a national scale-up alongside rent subsidies and coaching. ### Conditions Module **Conditions:** - Homelessness - Youth **Keywords:** - Identity Capital - Youth - Coach - Self-Efficacy - Self-Esteem - Control - Purpose - Socioeconomic Inclusion - Homelessness - Transition ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Young people transitioning out of homelessness will attend a four-week, strengths-based leadership program. Two four-week leadership programs (15 youth per program) will be led by coaches from the research team's current TYOH 2.0 study with youth advisors participating as paid leadership interns. **Intervention Names:** - Behavioral: Co-Designed Strengths-Based Leadership Program **Label:** Co-Designed Strengths-Based Leadership Program **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Co-Designed Strengths-Based Leadership Program **Description:** Please see arm description. **Name:** Co-Designed Strengths-Based Leadership Program **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** A baseline demographic questionnaire will be utilized (T1), session attendance will be tracked throughout the intervention (T1-T2), and focus group findings will be examined (T2). The baseline demographic questionnaire is a 18-item self-report measure that was developed for this study and explores domains related to: age; gender; race/ethnicity; sexual orientation; immigration status; child welfare involvement; homelessness entrenchment; education; social support; financial support; and food security. **Measure:** Explore whether there are differences in outcomes by sub-groups (e.g., gender, age, identification as 2SLGBTQ+, child welfare involvement) and/or program participation levels. **Time Frame:** Assessed at T1 (first day of intervention) and T2 (last day of intervention). #### Primary Outcomes **Description:** Quantitative measures consisting of recruitment/enrolment/attendance/dropout metrics will be utilized. The recruitment rate will be estimated as the proportion of contacted individuals who express interest in participating in the study (T0). The enrolment rate will be calculated as the proportion of recruited individuals who are eligible and consent to participate in the study (T0). Session attendance and dropout rates will be tracked throughout the intervention (T1-T2). **Measure:** Intervention feasibility and acceptability as assessed by recruitment/enrolment/attendance/dropout metrics. **Time Frame:** Assessed at T0 (pre-intervention), T1 (first day of intervention) and T2 (last day of intervention). **Description:** This 4-item anonymous questionnaire will be used to collect information about participants' view of the leadership program, the impact of the program on them, and their view of the individuals running the program. **Measure:** Intervention feasibility and acceptability as assessed by a composite program feedback questionnaire. **Time Frame:** Assessed at T2 (last day of intervention). **Description:** Focus group discussions will explore intervention feasibility and acceptability (T2). **Measure:** Intervention feasibility and acceptability as informed by focus groups. **Time Frame:** Assessed at T2 (last day of intervention). #### Secondary Outcomes **Description:** The MAPS20 is a 20-item validated self-report measure that explores domains related to identity capital: self-esteem; purpose in life; internal locus of control; self-efficacy/ego strength. Score range: 20-120; score of less than 71 indicates risk/vulnerability of being overwhelmed by any adverse circumstances (internal consistency of four sub-scales α = .61-.75; T1/T2). **Measure:** Change in self-reported measures of identity capital as assessed by the Multi-Measure Agentic Personality Scale (MAPS20). **Time Frame:** Assessed at T1 (first day of intervention) and T2 (last day of intervention). **Description:** The composite knowledge assessment scale is 16-item self-report measure that was developed for this study and explores domains related to self-leadership, such as: mindfulness; core values; purpose; goal setting; growth mindset; identity; and courage (T1/T2). **Measure:** Change in self-reported knowledge of program material as assessed by a composite knowledge assessment scale. **Time Frame:** Assessed at T1 (first day of intervention) and T2 (last day of intervention). ### Eligibility Module **Eligibility Criteria:** Eligible young people aged 16-24 years who have transitioned out of homelessness (e.g., no longer living in a shelter or couch surfing), defined as 3 consecutive months within the past 12 months, will be identified by community partners (note: for the purpose of this study, youth living in foster care will be considered homeless). This age mandate was chosen because this is the age group served by the community partners. The research team has chosen to target the first year of exiting homelessness because collective experience has shown that this can be a particularly precarious time for youth in terms of mental health challenges and risk of (re)experiencing homelessness (even if youth have attempted exits in the past). Inclusion Criteria: * Be able to provide free and informed consent. * Be able to understand English (leadership program and data collection will be conducted in English). * Have experienced homelessness (e.g., unstable housing arrangements including shelter stays, foster care, and couch surfing) for 3 consecutive months in the past 12 months. * Be able to consistently attend the four-week leadership program. Exclusion Criteria: * Enrolled in a program or study with similar features to the TYOH 2.5 leadership program. **Healthy Volunteers:** True **Maximum Age:** 24 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Naomi S Thulien, NP-PHC, PhD **Phone:** 416-360-4000 **Role:** CONTACT #### Locations **Location 1:** **City:** Toronto **Country:** Canada **Facility:** Unity Health Toronto **State:** Ontario ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Côté, J. (2016). The identity capital model: A handbook of theory, methods, and findings. #### See Also Links **Label:** Describes the Multi-Measure Agentic Personality Scale (MAPS20), which is being utilized in the current study. **URL:** https://ir.lib.uwo.ca/sociologypub/38/ ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06425445 **Brief Title:** Quantitative Assessment of Orofacial Muscle Function in FSHD **Official Title:** Development of a New Clinical Tool for the Assessment of Orofacial Muscles in Patients Affected by Facioscapulohumeral Muscular Dystrophy: a Preliminary Study. #### Organization Study ID Info **ID:** P2024/031 #### Organization **Class:** OTHER **Full Name:** University of Mons ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Mons #### Responsible Party **Investigator Affiliation:** University of Mons **Investigator Full Name:** Alexandre Legrand **Investigator Title:** Professor and Dean of the Faculty of Medicine and Pharmacy **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 goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals, using maximal expiratory pressures (MEPs). Our hypothesis is the following: - The pressure drop observed when using circular mouthpieces (versus ovoid mouthpieces) is a reflection of orofacial dysfunction in FSHD affected individuals ### Conditions Module **Conditions:** - Facioscapulohumeral Muscular Dystrophy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds **Label:** Affected participants **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Procedure: Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds **Label:** Healthy participants **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Affected participants - Healthy participants **Description:** Participants perform forced static expiratory maneuvers sustained over a five second period **Name:** Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The pressure drop (PD) is defined as the pressure difference between a reference ovoid-shaped mouthpiece and variously-sized circular mouthpieces, divided by the reference pressure. It is a relative value that is expected to reflect the magnitude of orofacial muscle dysfunction in FSHD affected individuals. **Measure:** The pressure drop **Time Frame:** The pressure drop will be assessed for each study participant at visit 1 and subsequently at visit 2 (3 months later). The measurements as such, should take about 30 minutes for each participant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Genetic diagnosis of FSHD type 1 and/or type 2 Exclusion Criteria: * Pregnant women * Presence of other associated neuromuscular conditions * Any unstable interfering clinical situation **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eliot Rudy Mbolo Ebubu (PhD candidate, MD, study investigator) **Phone:** 0032485114738 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Alexandre Legrand (PhD, MD, principal investigator) **Phone:** 0032475471353 **Role:** CONTACT #### Locations **Location 1:** **City:** Mons **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Eliot Rudy Mbolo Ebubu (PhD candidate, MD, study investigator) - **Phone:** 0032485114738 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Alexandre Legrand (PhD, MD, principal investigator) - **Phone:** 0032475471353 - **Role:** CONTACT **Country:** Belgium **Facility:** University of Mons **State:** Hainaut **Status:** RECRUITING **Zip:** 7000 #### Overall Officials **Official 1:** **Affiliation:** University of Mons **Name:** Alexandre Legrand (PhD, MD, principal investigator) **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020966 - Term: Muscular Disorders, Atrophic - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12093 - Name: Muscular Dystrophies - Relevance: HIGH - As Found: Muscular Dystrophy - ID: M22188 - Name: Muscular Dystrophy, Facioscapulohumeral - Relevance: HIGH - As Found: Facioscapulohumeral Muscular Dystrophy - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M22697 - Name: Muscular Disorders, Atrophic - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T3963 - Name: Muscular Dystrophy - Relevance: HIGH - As Found: Muscular Dystrophy - ID: T2182 - Name: Facioscapulohumeral Muscular Dystrophy - Relevance: HIGH - As Found: Facioscapulohumeral Muscular Dystrophy ### Condition Browse Module - Meshes - ID: D000009136 - Term: Muscular Dystrophies - ID: D000020391 - Term: Muscular Dystrophy, Facioscapulohumeral ### Misc Info Module - Version Holder: 2024-05-31