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## Protocol Section ### Identification Module NCT ID: NCT06440668 Brief Title: Management of Chronic Non-Cancer Pain With Non-Pharmacological Therapies Official Title: Management of Chronic Non-Cancer Pain With Non-Pharmacological Therapies: Randomized Clinical Trial. #### Organization Study ID Info ID: 2-2024 #### Organization Class: OTHER Full Name: Hospital San Juan de Dios del Aljarafe de Sevilla ### Status Module #### Completion Date Date: 2025-10-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-05 Type: ACTUAL Last Update Submit Date: 2024-06-04 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-05-31 Type: ESTIMATED #### Start Date Date: 2024-06-10 Type: ESTIMATED Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-14 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Hospital San Juan de Dios del Aljarafe de Sevilla #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: A randomized controlled clinical trial will be conducted, involving a psychoeducational activity as the intervention. There will be a control group of patients with non-cancer chronic pain who will continue their usual treatment. The trial will end after 3 months. Pain, well-being, medication management, mood, self-esteem, and quality of life will be compared just before starting the workshop with the status at the end of the workshop (one month later) to assess the immediate effect, and three months later to evaluate the medium-term effect. These measurements will be taken in both the control and intervention groups. Additionally, for the intervention group, a follow-up will be conducted six months after the workshop ends to assess the long-term effect duration. This study does not allow blinding of patients or professionals conducting the intervention, but the person analyzing the data to compare the effect produced in the control and intervention groups will be blinded. Therefore, it is an observer-blind evaluation. Detailed Description: Intervention Group: Workshop. This group starts and completes the workshop (attend at least 4 out of the 5 sessions). Complete all the initial documentation, at the end of the workshop, and at the 3-month mark. Perform daily tracking of the 3 mandatory activities throughout the duration of the workshop. Control Group: Traditional treatment. This group meets the inclusion criteria but does not participate in the workshop. They complete all documentation at the beginning, at one month, and at three months. These patients will continue with the usual treatment prescribed by their doctor. Intervention: Chronic Pain Management Workshop with Non-Pharmacological Therapies. Psychoeducational and self-care training, pain management, and emotional control, conducted in groups and aimed at patients with non-cancer chronic pain. Workshop Methodology and Facilities: It will take place at HSJDA over 5 afternoons, with each session lasting 3.5 hours. Sessions will be held once a week for 5 consecutive weeks. The sessions will include oral presentations supported by PowerPoint, videos, activities to be performed in the classroom by the patients to apply different techniques, testimonies from individuals known for personal overcoming, experiences from patients of previous workshops, and the application of the explained tools. In the first session, a WhatsApp group will be created with the participants of each workshop, coordinated by a volunteer patient, who will directly contact the workshop director. The director will send reinforcement information from the workshop sessions, such as videos and songs, through this group. Patients can ask questions via the group, which will be directed from the patient coordinator to the workshop director for resolution. They can also report any issues regarding attendance to a session. This group will remain active for up to 6 months to serve as reinforcement and a support group for the patients. At the end of each session, patients will be given some homework for the week, as well as a tracking sheet to record 3 activities they must perform daily and an assessment of pain control using the main technique (to be filled out daily until the workshop ends). In the last session, there will be a review of all the tools presented in previous sessions, questions will be answered, and patients will evaluate the workshop (satisfaction, most useful aspects, etc.), as well as its impact on pain control and other aspects (quality of life, self-esteem, mood, etc.). They can also provide suggestions for improvement and free-text comments. At the end of the workshop, patients will receive a guide reinforcing what was explained in the workshop so they can continue applying the tools and recommendations after the workshop ends. Patient Recruitment: Patients will be referred by healthcare professionals from the following services or areas: Rehabilitation, Traumatology, Internal Medicine, Gynecology, etc. Primary Care: Health Centers in the Aljarafe Area belonging to the Aljarafe-Sevilla Norte Health District. Associations of patients with conditions associated with non-cancer chronic pain. Sample Selection: Each referred patient will be interviewed by phone by the workshop director to confirm they meet the inclusion criteria. If they do, they will be informed about the workshop, invited to participate in the study, and if they accept, they will be sent the information sheet and informed consent via email, to be returned signed by email. All those who accept will be added to the list of workshop candidate patients registered in Excel. Participants will be assigned to each group (control and intervention) using the Excel "RAND" function, which assigns a random number to each patient, then sorted from smallest to largest, with the first half forming the control group and the other half forming the intervention group. Sample Size: Each workshop will include a maximum of 20 patients. A 20% dropout rate is expected (patients missing two or more sessions), so approximately 16 patients are expected to complete each workshop. Using G\POWER software, the sample size calculation was performed using an independent samples t-test to compare means of two groups (control and experimental), considering a significance level of 0.05, power of 0.80, and an effect size of 0.5 (conservative size), resulting in a sample size of 128 patients (64 in each group). Workshops will be conducted until the required sample size is recruited. Considering a 20% dropout rate, 4 workshops will be needed, recruiting 80 patients (20 per workshop), expecting 80% to complete the workshops, resulting in 64 patients, meeting the minimum sample size required. Workshop Follow-up: Both control and experimental groups will undergo 3 measurements: initial, one month (workshop end), and three months, completing the clinical trial. Additionally, the experimental group will have a follow-up one month after completion (two months from the start), presenting group results (anonymized) and a brief personalized report of their results. Another follow-up will occur at six months to assess if the workshop effect persists long-term, with the scales administered again. Statistical Analysis: With the documentation collected at the beginning of the study, the random allocation will be ratified, checking the comparability of all variables that may influence the final outcome. Descriptive statistics will be performed in each group: Continuous quantitative variables: mean and SD (if they follow a normal distribution); median and quartiles (if they do not follow a normal distribution). Categorical variables: Absolute and relative frequencies (%). The normality of the variables will be checked with the Kolmogorov-Smirnov test. 95% confidence intervals will be calculated for means and percentages. At the end of the study, an intention-to-treat analysis will be performed. The Statistical Package for Social Sciences (SPSS) Version 27.0 will be used. To compare the main and secondary dependent variables between the control and intervention groups, hypothesis testing will be performed: Student's t-test and ANOVA (for quantitative variables that follow a normal distribution), Mann-Whitney U and Kruskal-Wallis (for those with a non-normal distribution) when comparing 2 or more groups, respectively. To compare related variables (before and after) both within the control group and within the intervention group, paired t-tests will be used for normally distributed data, and the Wilcoxon test for non-normally distributed data. The correlation between outcome variables will also be assessed using Pearson's or Spearman's correlation coefficient, depending on whether the variables compared follow a normal distribution or not. The normality of quantitative variables will be checked using the Kolmogorov-Smirnov test. For qualitative variables, the Chi-square test or Fisher's test (if expected frequencies are low) will be used to compare independent variables, and the McNemar test to compare related variables. Finally, a multivariate analysis will be conducted to develop an explanatory model with the main variables that influence the outcomes. The Odds Ratio of the associations with their confidence intervals will be calculated. Bioethical considerations. This project, has received favorable approval from the Research Ethics Committee of the University Hospitals Virgen Macarena and Virgen del Rocío at its meeting on 20/07/2023, under record CEI_07/2023. Internal Code: 1181-N-23. Researchers involved in this project will ensure compliance with current regulations and legislation governing research involving human subjects (Declaration of Helsinki and its update in Fortaleza (Brazil), Oviedo Declaration, Good Clinical Practice Guide of the ICH -CPMP/ICH/135/95-, Law 41/2002 of November 14, regulating patient autonomy, Law 14/2007 of July 3, on biomedical research). Individuals participating in this project must have provided written consent once they have been adequately informed and their questions have been addressed. Researchers will ensure the anonymity and the confidentiality of participants' data (recommendations of REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 27, 2016; Directive 95/46/EC and Organic Law 3/2018, of December 5, on Personal Data Protection and guarantee of digital rights. Two databases (DB) will be worked with and kept in different files. In DB-1, the NID (patient identification number) will be related to personal data. The NID is a unique number for each patient. In DB-2, the NID will be related to patients' clinical data. ### Conditions Module Conditions:* - Chronic Pain Syndrome - Sensitization, Central - Quality of Life - Patient Empowerment Keywords: - Chronic Pain Syndrome - Sensitization, Central - Quality of Life - Patient Empowerment ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Randomised controlled clinical trial ##### Masking Info Masking: SINGLE Masking Description: The statistician who analyse the data is unaware of the group to which each patient belonged. Who Masked: - INVESTIGATOR Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 128 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Psychoeducational and self-care training, pain management, and emotional control, conducted in groups and aimed at patients with non-cancer chronic pain. Therapies applied: relaxation, meditation, cognitive-behavioral therapy, acceptance and commitment therapy, coaching, healthy eating, physical exercise, improving self-esteem, forgiveness technique. This group starts and successfully completes the workshop. A patient is considered to have successfully completed if they: Attend at least 4 out of the 5 sessions; complete all the initial documentation, at the end of the workshop, and at the 3-month mark; perform daily tracking of the 3 mandatory activities throughout the duration of the workshop. Intervention Names: - Behavioral: Chronic Pain Management Workshop with Non-Pharmacological Therapies Label: Workshop Type: EXPERIMENTAL #### Arm Group 2 Description: This group meets the inclusion criteria but does not participate in the workshop. They complete all documentation at the beginning, at one month, and at three months. These patients will continue with the usual treatment prescribed by their doctor. Label: Traditional treatment Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Workshop Description: 1st Session: Welcome. Expectations. Pathophysiological mechanism of pain. Influence of emotions on pain intensity. Activities: My limiting beliefs; Affirmations in front of the mirror; Mental analgesia. / 2nd: Pain and its impact on the patient's life. Forgiveness and self-forgiveness. Ho'oponopono technique. Self-esteem. Activities: Labels that limit us; Reading "When I Loved Myself for Real"; Self-healing meditation; Life purpose. / 3rd: Tips to slow down aging. Promotion of healthy habits; Metta meditation; Motivation for change. / 4th: Active participation in my own healing. How to face illness. Creative visualization. Activity:Energy wheel. / 5th: Review of the tools. Resolving doubts. Workshop evaluation and scales. Guide with the tools presented. Activities: Final farewell. / At the end of each session, the homework assignments are explained, and at the beginning of the next, they are reviewed. Sessions 2, 3, 4 5: Experience of a previous workshop patient. Name: Chronic Pain Management Workshop with Non-Pharmacological Therapies Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Pain measured with the "visual analogue scale" (scale: 0-10) Measure: Pain last week Time Frame: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group). Description: self-assessment at the end of the workshop on whether they have replaced a higher-tier analgesic with a lower one, decreased the dosage, reduced the frequency, or stopped taking analgesics or anxiolytics/antidepressants. Measure: Analgesic regimen Time Frame: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group). Description: Numerical visual scale from 0 (minimum) to 10 (maximum). Higher scores indicate greater well-being. Measure: Well-being Time Frame: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group). Description: Rosenberg Self-esteem Scale, ranging from 9 (minimum) to 36 (maximum).Higher scores indicate greater Self-esteem Measure: Self-esteem Time Frame: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group). Description: Hospital Anxiety and Depression Scale (HADS). It consists of 14 items with two subscales (anxiety and depression), each with scores from 0 to 3. Cut-off points: \<8 normal, 8-10 possible cases, and \>10 for cases in both subscales. Measure: Anxiety and Depression Time Frame: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group). Description: Brief Resilience Scale (BRS). Scale from 6 (minimum) to 30 (maximum). Higher scores indicate greater resilience. Measure: Resilience Time Frame: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group). Description: Measured with the EuroQol-5D questionnaire. Scale from 0 to 1 (maximum) (with the possibility of negative values). Higher scores indicate greater health-related quality of life. Measure: Health-related quality of life Time Frame: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group). Description: The number of emergency episodes and outpatient visits for pain or associated symptoms (anxiety, depression, insomnia) will be quantified, both in primary care (at their health center) and hospitalized. Measure: Number of emergency episodes and outpatient visits Time Frame: 3 measurements: The scale will be administered just before starting the workshop, at 3 months, and at 6 months (this only in the intervention group). #### Secondary Outcomes Description: Satisfaction with the workshop: Clarity of the presented content; Appropriateness of the exercises and activities performed; Usefulness of the workshop for managing my pain; Usefulness of the workshop for managing my illness; To what extent would you recommend this workshop?; Overall satisfaction. Suggestions for improvement are also collected. Scale from 0 to 10. Measure: Satisfaction with the workshop Time Frame: 1 measurement: The scale will be administered just at the end (last day of the workshop, after 4 weeks) (this only in the intervention group). Description: In the 3rd session, we work on a self-assessment of certain habits (nutrition, physical exercise, relaxation/meditation, "me time") and ask participants to choose one or two to improve and make the change. At the end of the workshop, we ask them if they have made any habit changes and what those changes were, through the self-assessment questionnaire they complete at the end of the workshop. This is measured as Yes/No. Measure: Improving habits Time Frame: 2 measurements: In the 3rd session and just at the end (last day of the workshop, after 4 weeks) (this only in the intervention group). ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients aged 18 years or older, * Residing in the areas served by HSJDA, * With non-cancer chronic pain already diagnosed and treated for at least 6 months but not relieved by the usual treatment, * Who have explicitly and in writing expressed their desire to participate in the workshops and the study through the Informed Consent document, * And who complete the initial documentation necessary for their evaluation. Exclusion Criteria: * Patients in the diagnostic phase, * Patients with pain exclusively associated with cancer pathology, * Patients with a life expectancy of less than one year, * Patients with severe cognitive or mental illnesses that prevent them from understanding both the content of the workshops and the measurement instruments. Healthy Volunteers: True Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Bollullos de la Mitación Contacts: *Contact 1:* - Email: mariavictoria.ruiz@sjd.es - Name: María Victoria MV Ruiz Romero, PhD - Phone: 664396621 - Role: CONTACT *Contact 2:* - Email: consuelomaria.pereira@sjd.es - Role: CONTACT *Contact 3:* - Name: Consuelo CM Pereira-Delgado, Dr - Role: SUB_INVESTIGATOR *Contact 4:* - Name: Ana A Porrúa Del Saz, Graduate - Role: SUB_INVESTIGATOR *Contact 5:* - Name: Begoña B Gómez Hernández, Graduate - Role: SUB_INVESTIGATOR *Contact 6:* - Name: Blanca María BM Martínez-Monrobé, Graduate - Role: SUB_INVESTIGATOR Country: Spain Facility: María Victoria RUIZ ROMERO State: Sevilla Zip: 41110 ### IPD Sharing Statement Module Description: We will not be shared with other researchers individual participant data. IPD Sharing: NO ### References Module #### References Citation: Ruiz Romero MV, Lobato Parra E, Porrua Del Saz A, Martinez Monrobe MB, Pereira Delgado CM, Gomez Hernandez MB. [Management of chronic non-oncologic pain by multicomponent programs using non-pharmacologic therapies: A systematic review of the literature]. J Healthc Qual Res. 2024 May-Jun;39(3):168-187. doi: 10.1016/j.jhqr.2024.02.004. Epub 2024 Mar 30. Spanish. PMID: 38556371 Citation: Ruiz Romer MV, Porrua Del Saz A, Gomez Hernandez MB, Lobato Parra E, Soler Jimenez A, Pereira Delgado C. [Impact of a multicomponent program with nonpharmacological therapies for patients with chronic pain]. J Healthc Qual Res. 2024 Mar-Apr;39(2):109-119. doi: 10.1016/j.jhqr.2024.01.005. Epub 2024 Feb 23. Spanish. PMID: 38402091 Citation: Ruiz Romero MV, Lopez Tarrida AC, Porrua Del Saz A, Gomez Hernandez MB, Martinez Monrobe MB, Sanchez Villar E, Cruz Valero C, Pereira Delgado C. [Efectividad de una intervencion multimodal para la mejora de la atencion al dolor cronico.]. Rev Esp Salud Publica. 2023 Sep 6;97:e202309071. Spanish. PMID: 37921370 Citation: Ruiz-Romero MV, Guerra-Martin MD, Alvarez-Tellado L, Sanchez-Villar E, Arroyo-Rodriguez A, Sanchez-Gutierrez MC. [Non-drug treatments for chronic non-malignant pain]. An Sist Sanit Navar. 2022 Aug 30;45(2):e1011. doi: 10.23938/ASSN.1011. No abstract available. Spanish. PMID: 36040235 ## 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: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M29442 - Name: Chronic Pain - Relevance: HIGH - As Found: Chronic 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: HIGH - As Found: Chronic - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000059350 - Term: Chronic Pain ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440655 Acronym: PRF Brief Title: The Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients Official Title: A Randomized, Split-head Comparison Study of the Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients : A Pilot Study #### Organization Study ID Info ID: COA no. Si286/2023 #### Organization Class: OTHER Full Name: Siriraj Hospital ### Status Module #### Completion Date Date: 2024-09-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-06-30 Type: ESTIMATED #### Start Date Date: 2023-05-30 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-02-06 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Siriraj Hospital #### Responsible Party Investigator Affiliation: Siriraj Hospital Investigator Full Name: Rattapon Thuangtong Investigator Title: Associate Professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The goal of this clinical trial is to compare between platelet-rich fibrin and platelet-rich plasma in female pattern hair loss . The main question\[s\] it aims to answer are: * efficacy between platelet-rich fibrin and platelet-rich plasma * safety between platelet-rich fibrin and platelet-rich plasma Participants will be divided into 2 side of treatment with composed of 1. Platelet rich plasma 2. Platelet rich fibrin Detailed Description: Subject was treated both platelet-rich fibrin and platelet-rich plasma for 3 times which 1 month interval then will be followed up at 4 months and 6 months after last treatment ### Conditions Module Conditions: - Female Pattern Hair Loss - Platelet-Rich Plasma - Platelet-rich Fibrin Keywords: - female pattern hair loss - platelet-rich plasma - platelet-rich fibrin ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP Intervention Model Description: All subject were injected with PRP and PRF at baseline, 4 weeks and 8 weeks with split-head of sides of injection. ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 10 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: All patients were treated with both platelet rich fibrin and platelet rich plasma but each side of head (left or right) was split with * one side of head was injected with platelet rich plasma at week 0,4 and 8 (total 3 times) * another side of head was injected with platelet rich fibrin at week 0,4 and 8 (total 3 times) Intervention Names: - Device: Platelet rich plasma - Device: Platelet rich fibrin Label: PRF and PRP Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - PRF and PRP Description: Subjects were treated by Platelet rich plasma in each side of head (Left or right) Name: Platelet rich plasma Other Names: - PRP Type: DEVICE #### Intervention 2 Arm Group Labels: - PRF and PRP Description: Subjects were treated by Platelet rich fibrin in each side of head (Left or right) Name: Platelet rich fibrin Other Names: - PRF Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Average counts and density of hair per 1.5mm\^2 Measure: Trichoscan Time Frame: baseline(week0), 4 months after last treatment(week20), 6 months after last treatment(week28) #### Secondary Outcomes Description: Evaluation of improvement through picture by doctor Measure: The 7-point of doctor subjective global assessment Time Frame: baseline(week0),1 month after first treatment(week4), 1 months after second treatment(week8), 4 months after last treatment(week20), 6 months after last treatment(week28) Description: Evaluation of improvement through picture by patient Measure: The 7-point of patient subjective global assessment Time Frame: baseline(week0),1 month after first treatment(week4), 1 months after second treatment(week8), 4 months after last treatment(week20), 6 months after last treatment(week28) Description: pain during intervention Measure: Visual analog scale Time Frame: baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Age 20-55 years * Female * Subject who was diagnosed with Female pattern hair loss in Ludwig Classification 2 (part width 2-4 centimeters) by Dermatologist Exclusion Criteria: * Pregnancy or Lactation subjects * Subject with history of platelet dysfunction, low platelet, anemia, cirrhosis, cancer, or immunocompromised host * Subject who are active smoking and alcoholism * Subject who has dermatitis, scar or infection at intervention area * Subject who has history of allergy to anesthesia drug * Subject who taking NSAIDs, Hormonal drug, anticoagulants drug * Subject who has psychiatric condition diagnosed by psychiatrist * Subject who are not allowed to take a photo Maximum Age: 55 Years Minimum Age: 20 Years Sex: FEMALE Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: rattaponthuangtong@yahoo.com Name: Rattapon Thuangtong, Asst. Prof. Phone: +66815533305 Role: CONTACT Contact 2: Email: noldtawat.vir@gmail.com Name: Noldtawat Viriyaskultorn, MD Phone: +66819228736 Role: CONTACT #### Locations Location 1: City: Bangkok Noi Contacts: *Contact 1:* - Email: noldtawat.vir@gmail.com - Name: Noldtawat Viriyaskultorn, M.D. - Phone: +66819228736 - Role: CONTACT *Contact 2:* - Email: rattaponthuangtong@yahoo.com - Name: Rattapon Thuangtong, M.D. - Phone: +66815533305 - Role: CONTACT *Contact 3:* - Name: Rattapon Thuangtong, M.D. - Role: PRINCIPAL_INVESTIGATOR Country: Thailand Facility: Faculty of Medicine Siriraj Hospital, Mahidol University State: Bangkok Status: RECRUITING Zip: 10700 Location 2: City: Bangkok Noi Contacts: *Contact 1:* - Email: noldtawat.vir@gmail.com - Name: Noldtawat Viriyaskultorn, M.D. - Phone: 0819228736 - Role: CONTACT *Contact 2:* - Email: rattaponthuangtong@yahoo.com - Name: Rattapon Thuangtong, M.D. - Phone: +66815533305 - Role: CONTACT *Contact 3:* - Name: Rattapon Thuangtong, M.D. - Role: PRINCIPAL_INVESTIGATOR Country: Thailand Facility: Medicine Siriraj Hospital, Mahidol University State: Bangkok Status: RECRUITING Zip: 10700 #### Overall Officials Official 1: Affiliation: Mahidol University Name: Rattapon Thuangtong, Asst. Prof. Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: Prohibited from laws (and/or rules, regulations, contracts). Fear of inappropriate use of data IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007039 - Term: Hypotrichosis - ID: D000006201 - Term: Hair Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3846 - Name: Alopecia - Relevance: HIGH - As Found: Hair Loss - ID: M3847 - Name: Alopecia Areata - Relevance: HIGH - As Found: Hair Loss - ID: M10089 - Name: Hypotrichosis - Relevance: LOW - As Found: Unknown - ID: M9293 - Name: Hair Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000505 - Term: Alopecia - ID: D000000506 - Term: Alopecia Areata ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440642 Brief Title: The Effect of the Steep Trendelenburg Position on Intraocular Pressure Official Title: The Effect of the Steep Trendelenburg Position on Intraocular Pressure ın Patients Undergoing Total Laparoscopic Hysterectomy #### Organization Study ID Info ID: 2023/51,1/250/33 #### Organization Class: OTHER_GOV Full Name: Dr. Lutfi Kirdar Kartal Training and Research Hospital ### Status Module #### Completion Date Date: 2024-07-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-07-31 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-23 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER_GOV Name: Dr. Lutfi Kirdar Kartal Training and Research Hospital #### Responsible Party Investigator Affiliation: Dr. Lutfi Kirdar Kartal Training and Research Hospital Investigator Full Name: İrem DURMUS 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: A total of 50 patients aged between 18-60 years, classified as American Society of Anesthesiologists (ASA) I-II, undergoing elective total laparoscopic hysterectomy in the steep trendelenburg position (STP) will be included in the study. Preoperatively, an ophthalmologist will perform an eye examination on the patients, and intraocular pressure will be measured using a non-contact computerized tonometer (Topcon CT-800, Japan). Central corneal thickness and iridocorneal angle will be measured using a topography device (Sirius Topography, CSO, Italy), and the thickness of the retinal nerve fiber layer (RNFL) will be measured using an optical coherence tomography (OCT) device (DRI OCT Triton, Topcon, Japan). Patients' demographic data and operation durations will be recorded. Intraocular pressure (IOP) will be measured in the supine position after intubation (T1), during pneumoperitoneum (T2), in the steep Trendelenburg position (23°, head down) (T3), at the end of the operation when pneumoperitoneum is terminated (T4), after returning to the supine position (T5), and 10 minutes after returning to the supine position (T6). Simultaneously with IOP measurements, the patients' hemodynamic data (Blood pressure, heart rate, end-tidal CO2, partial saturation) will be recorded. Detailed Description: This study is planned to be conducted in the operating room of Kartal Dr. Lütfi Kırdar City Hospital between June 2024 and July 2024. A total of 50 patients aged between 18-60 years, classified as ASA I-II, undergoing elective total laparoscopic hysterectomy in the steep Trendelenburg position will be included in the study. Patients who are under 18 years or over 60 years, classified as ASA III or above, or have pre-existing eye conditions causing intraocular pressure changes such as glaucoma or ocular hypertension, cranial tumors, or any conditions that may be affected by increased intracranial pressure will not be included in the study. All patients will undergo a preoperative evaluation the day before surgery, and written informed consent will be obtained for participation in the study. Patients who agree to participate will have an eye examination performed by an ophthalmologist preoperatively. Intraocular pressure (IOP) will be measured using a non-contact computerized tonometer (Topcon CT-800, Japan). Central corneal thickness and iridocorneal angle will be measured using a topography device (Sirius Topography, CSO, Italy), and the thickness of the retinal nerve fiber layer (RNFL) will be measured using an optical coherence tomography (OCT) device (DRI OCT Triton, Topcon, Japan). Sure, here is the translation of your text into English: --- The anesthesia protocol will be standardized for the drugs used during the procedure. Standard anesthesia induction will be provided with 2 mg IV midazolam, 3 mg/kg IV propofol, 100 mcg IV fentanyl, and 0.8 mg/kg IV rocuronium. Sevoflurane at 1 Minimum Alveolar Concentration (MAC) will be used for anesthesia maintenance. While the patient is in the supine position, intraperitoneal CO2 insufflation will be used to create pneumoperitoneum. The patients will then be placed in the steep Trendelenburg position (25 degrees from horizontal) at the maximum Trendelenburg angle (STP). All procedures will be performed in the same operating room, on the same table, and at the same angle. Intraperitoneal pressure will be maintained at 15 mm Hg throughout the surgery. At the end of the operation, patients will be awakened and transferred to the recovery unit. In the recovery unit, patients will be monitored for at least 30 minutes. Intraocular pressure (IOP) will be measured in the supine position using a contact handheld tonometer (TONO-PEN AVIA, Reichert, USA). The Tono-pen is chosen for its speed, the ability to measure across multiple patients with single-use latex tip covers, ease of use, accuracy, and reliability in various positions. Five consecutive measurements will be taken for each eye. If the variability between consecutive measurements exceeds 5%, the measurements will be repeated. The average of the five measurements will be taken for each measurement. All measurements will be performed by the same ophthalmologist. All surgical operations will be conducted in the morning or early afternoon to prevent diurnal variations in IOP. All surgeries will be performed by the same surgical team. The demographic data of the patients and the durations of the operations will be recorded. IOP will be measured in the supine position after intubation (T1), during pneumoperitoneum (T2), when placed in STP (23° head down) (T3), at the end of the operation when pneumoperitoneum is terminated (T4), after being placed back in the supine position (T5), and 10 minutes after being placed back in the supine position (T6). Simultaneously with IOP measurements, the patients' hemodynamic data (blood pressure, heart rate, end-tidal CO2, partial saturation) will be recorded. ### Conditions Module Conditions: - Laparoscopic Surgery - Intraocular Pressure ### Design Module #### Design Info Observational Model: CASE_CONTROL Time Perspective: PROSPECTIVE #### Enrollment Info Count: 50 Type: ESTIMATED Patient Registry: True Study Type: OBSERVATIONAL Target Duration: 2 Months ### Arms Interventions Module #### Arm Group 1 Description: Patients Undergoing Laparoscopic Hysterectomy Intervention Names: - Device: tonopen Label: steep trendelenburg ### Interventions #### Intervention 1 Arm Group Labels: - steep trendelenburg Description: Intraoculer pressure will be measured in the supine position after intubation (T1), during pneumoperitoneum (T2), when placed in steep trendelenburg posıtıon (T3), at the end of the operation when pneumoperitoneum is terminated (T4), after being placed back in the supine position (T5), and 10 minutes after being placed back in the supine position (T6). Name: tonopen Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: the primary aim of the study is to evaluate patients' intraoculer pressure change during laparoscopic hysterectomy, position of steep trendelenburg Measure: Evaluate patients' intraoculer pressure Time Frame: during surgery and 10 minutes after the end of the operation ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * electively laparoscopic hysterectomy surgery with steep trendelenburg position * ASA I-II * Between 18-60 years old Exclusion Criteria: * Those under 18 or over 60 years old, * ASA III and above, * pre-existing eye conditions such as glaucoma, ocular hypertension, or other conditions affecting intraocular pressure * those with conditions such as cranial tumors Maximum Age: 60 Years Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: FEMALE Standard Ages: - ADULT Study Population: The study will include 50 patients aged between 18 and 60 years with ASA I-II who will undergo elective total laparoscopic hysterectomy in the steep trendelenburg position. ### Contacts Locations Module #### Central Contacts Contact 1: Email: irem.durmus89@gmail.com Name: İrem DURMUŞ, MD, Specialist Phone: 05449306949 Role: CONTACT ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440629 Acronym: RA-DRUM Brief Title: Effect of Proactive Therapeutic Drug Monitoring on Maintenance of Sustained Disease Control in Adults With Rheumatoid Arthritis on a Subcutaneous TNF Inhibitor: The Rheumatoid Arthritis Therapeutic DRUg Monitoring Trial (RA-DRUM) Official Title: A Multi-center, Open, Randomized, 18-month, Parallel-group, Superiority Study to Compare the Effect of Proactive Therapeutic Drug Monitoring Versus Standard of Care With Regards to Maintenance of Sustained Disease Control Without Flare in Adults With Rheumatoid Arthritis Treated With a Subcutaneous Tumor Necrosis Factor Inhibitor #### Organization Study ID Info ID: EU CT No 2023-510184-35-00 #### Organization Class: OTHER Full Name: Diakonhjemmet Hospital ### Status Module #### Completion Date Date: 2027-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-06-03 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2027-12-31 Type: ESTIMATED #### Start Date Date: 2024-06-15 Type: ESTIMATED Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-23 Study First Submit QC Date: 2024-06-03 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Oslo University Hospital Class: OTHER Name: Karolinska University Hospital Class: OTHER Name: Queen Mary University of London Class: OTHER Name: Medical University of Vienna Class: OTHER Name: Alesund Hospital Class: OTHER Name: St. Olavs Hospital Class: OTHER_GOV Name: Helse Stavanger HF Class: OTHER Name: Drammen sykehus Class: OTHER Name: University Hospital of North Norway Class: OTHER Name: Førde Hospital Trust Class: OTHER Name: Hospital of Southern Norway Trust Class: OTHER Name: Haukeland University Hospital Class: OTHER Name: Ostfold Hospital Trust Class: OTHER Name: Lillehammer Hospital for Rheumatic Diseases Class: OTHER Name: Martina Hansen's Hospital Class: OTHER Name: Haugesund Rheumatism Hospital Class: OTHER Name: Betanien Hospital Class: UNKNOWN Name: Helgeland Hospital Trust Class: OTHER Name: Nordlandssykehuset HF #### Lead Sponsor Class: OTHER Name: Diakonhjemmet Hospital #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Is US Export: False Oversight Has DMC: True ### Description Module Brief Summary: The goal of this clinical trial is to compare therapeutic drug monitoring (TDM) versus Standard of care in patients with rheumatoid arthritis treated with a subcutaneous tumor necrosis factor inhibitor (adalimumab). The main question it aims to answer is: Is TDM superior to standard of care in order to maintain sustained disease control without flares? Participants will be followed with blood sampling every second month, measuring serum drug levels and anti-drug antibodies of the TNFi. In the TDM-group, the researchers will adjust the dosage of the TNFi based on knowledge on optimal therapeutic ranges. In the Standard of care group, the TNFi will be administered according to standard of care without knowledge of serum drug levels or anti-drug antibodies. Detailed Description: There is a considerable variation in serum drug levels among rheumatoid arthritis (RA) patients on tumor necrosis factor inhibitors (TNFi), and a high number develop neutralizing anti-drug antibodies (ADAb). Sub-therapeutic drug levels and ADAb formation are major contributors to TNFi treatment failure and disease flare. Proactive therapeutic drug monitoring (TDM), i.e., individualized drug dosing based on regular assessments of serum drug levels and ADAb, has the potential to optimize the efficacy and safety of TNFi treatment. The aim of the RA-DRUM trial is to assess whether TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with the SC TNFi adalimumab. Participants will be randomized to: * Administration of TNFi based on proactive TDM (TDM group) * Administration of TNFi based on standard of care without knowledge of serum drug levels or ADAb status (Standard of care group) Participants will be followed for 18 months with on-site visits at baseline, 4, 8, 12 and 18 months and digital visits at 2, 6, 10, 14, and 16 months. Blood sampling for serum drug levels and anti-drug antibodies will be done at all visits. ### Conditions Module Conditions: - Rheumatoid Arthritis Keywords: - Rheumatoid arthritis - Therapeutic drug monitoring - Tumor necrosis factor inhibitor ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Masking Description: The joint assessor will be blinded. Primary Purpose: TREATMENT #### Enrollment Info Count: 350 Type: ESTIMATED Phases: - PHASE4 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: In the TDM-group, the TNFi dose will be adjusted in order to keep the drug level within the therapeutic range Intervention Names: - Drug: Therapeutic drug monitoring (TDM) of adalimumab Label: TDM-group Type: EXPERIMENTAL #### Arm Group 2 Description: In the Standard of Care group, TNFi will be administered according to standard of care without knowledge of serum drug levels or ADAb Label: Standard of Care group Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - TDM-group Description: In the TDM-group, the adalimumab dose will be adjusted according to the following algorithms in order to keep the drug level within the therapeutic range: * Serum drug level within therapeutic range : keep dose * Low drug levels, ADAb undetectable or low levels : Decrease dosing interval by one week to a maximum of 40 mg/week * Low drug levels, ADAb high levels : Switch to another therapy * High drug levels : Increase dosing interval by one week up to a maximum of 6 weeks Name: Therapeutic drug monitoring (TDM) of adalimumab Type: DRUG ### Outcomes Module #### Other Outcomes Description: The EQ-5D is a utility instrument for measurement of health-related quality of life. It consists of 5 dimensions. Each dimension is scored on a level from 1 to 5: LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme The health state is referred to by a 5-digit code, e.g. state 11111 indicates no problems on any of the five dimensions, while state 55555 indicate extreme problems on all of the five dimensions. Measure: European Quality of Life 5 Dimensions (EQ-5D) Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 18 months Description: The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8- scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index (SF-6D). It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. Accordingly, the SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments. Measure: 36-Item Short-form health survey (SF-36) Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 18 months Description: The Work Productivity and Activity Impairment (WPAI) questionnaire is a tool that assesses impairments in both work and daily activities. It consists of six items that determine employment status and measure absenteeism caused by health issues, presenteeism, and overall health-related impairment in both paid work and regular activities over the preceding 7 days. The questionnaire yields four outcomes: i) the percentage of work time missed due to health; ii) the percentage of impairment experienced while working due to health in the past 7 days; iii) the percentage of overall work impairment; iv) activity impairment resulting from health issues. Participants will be asked to answer the Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis V2.0. Measure: Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI:RA) Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 18 months Description: The RA-FQ was developed by the Omeract group to identify and measure flares in patients with RA. It encompasses pain, physical impairment, fatigue, stiffness, and participation, and the score is calculated as the sum of responses for the 5 items (maximum 50). Measure: Rheumatoid arthritis flare questionnaire (RA-FQ) Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 18 months Description: At each visit (every two months), the participant will fill out a questionnaire assessing compliance in into the eCRF. Measure: Adherence Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 18 months Description: Registration of co-medication will be made at each clinical visit. Measure: Co-medication Time Frame: 4, 8, 12, and 18 months Description: C-reactive protein (CRP) will be measured at all clinical visits. Measure: Consentration of C-reactive protein (CRP) Time Frame: 4, 8, 12, and 18 months Description: Erythrocyte sedimentation rate (ESR) will be measured at all clinical visits. Measure: Erythrocyte sedimentation rate (ESR) Time Frame: 4, 8, 12, and 18 months #### Primary Outcomes Description: A flare defined as either of the following: A combination of an increase in Disease Activity Score using 28 joints C-reactive protein (DAS28-CRP) \> 1.2, or \> 0.6 if DAS28-CRP ≥ 3.2, AND 2 swollen joints on examination of 44 joints OR Consensus between patient and physician that a disease flare has occurred, leading to a major change\* in treatment \Please see protocol for the definition of a major change in treatment (due to word restrictions) Measure:* Sustained disease control over the follow-up period of 18 months without flare Time Frame: 4, 8, 12, 18 months #### Secondary Outcomes Description: The DAS28-CRP composite score includes the 28 tender and swollen joint counts, CRP and a Patient Global Assessment of Disease activity (PGA). The DAS28-CRP is calculated as follows: DAS28-CRP = 0.56\√ (tender joints 28) + 0.28\√ (swollen joints 28) + 0.36\ln(CRP (mg/L)+1) + 0.014\PGA + 0.96 High disease activity is defined as a DAS28-CRP value \> 5.1, moderate disease activity as DAS28-CRP \> 3.2 - 5.1, low disease activity as a DAS28-CRP-value of 2.6 - 3.2, and remission as DAS28-CRP \< 2.6 PGA is measured on a 100 mm VAS according to the question: "Considering all the ways your arthritis has affected you, how did you feel your arthritis was over the last week?" (on a 0-100mm Visual Analogue Scale (VAS) with with 0 = excellent and 100 = very poor). Measure: Disease activity assessed by Disease Activity Score using 28 joints C-reactive protein (DAS28-CRP) Time Frame: 4, 8, 12, and 18 months Description: 44 joint count are included in the original Disease Activity Score (DAS) and in addition to the joints included in DAS28 it includes the MTP joints and the sternoclavicular joints for a more comprehensive valuation of the participants' joints. Measure: Disease activity measured by 44 joint count Time Frame: 4, 8, 12, and 18 months Description: PGA is measured on a 100 mm VAS according to the question: "Considering all the ways your arthritis has affected you, how did you feel your arthritis was over the last week?" (on a 0-100mm Visual Analogue Scale (VAS) with with 0 = excellent and 100 = very poor). Measure: Patient Global assessment of disease activity (PGA) Time Frame: 4, 8, 12, and 18 months Description: EGA is measured on a NRS according to the question "Please rate the patient's overall (global) disease activity", with 0 = best and 10 = worst. Measure: Evaluators Global Assessment of Disease Activity (EGA) Time Frame: 4, 8, 12, and 18 months Description: CDAI includes the 28 tender and swollen joint counts, Patient Global Assessment of Disease activity (PGA) and Evaluators Global Assessment of Disease Activity (EGA) The formula for CDAI is: swollen joints 28 + tender joints 28 + (PGA (VAS 0-100)/10) + EGA (NRS 0-10). PGA is measured on a 100 mm VAS according to the question: "Considering all the ways your arthritis has affected you, how did you feel your arthritis was over the last week?" (on a 0-100mm Visual Analogue Scale (VAS) with with 0 = excellent and 100 = very poor). EGA is measured on a NRS according to the question "Please rate the patient's overall (global) disease activity", with 0 = best and 10 = worst. Measure: Disease activity assessed by Clinical Disease Activity Index (CDAI) Time Frame: 4, 8, 12, and 18 months Description: SDAI includes the 28 tender and swollen joint counts, Patient Global Assessment of Disease activity (PGA) and Evaluators Global Assessment of Disease Activity (EGA) and C-reactive protein (CRP). The formula for SDAI is: swollen joints 28 + tender joints 28 + (PGA(VAS 0-100)/10) + EGA(NRS 0-10) + (CRP (mg/dL)/10). PGA is measured on a 100 mm VAS according to the question: "Considering all the ways your arthritis has affected you, how did you feel your arthritis was over the last week?" (on a 0-100mm Visual Analogue Scale (VAS) with with 0 = excellent and 100 = very poor). EGA is measured on a NRS according to the question "Please rate the patient's overall (global) disease activity", with 0 = best and 10 = worst. Measure: Disease activity assessed by Simple Disease Activity Index (SDAI) Time Frame: 4, 8, 12, and 18 months Description: The ACR/EULAR remission criteria defines a patient in remission when either 1. the patient is in Boolean 2.0 remission with each of the variables tender joint count, swollen joint count and CRP having a value of ≤1 and Patient Global Assessment of Disease activity (PGA) having a value ≤ 2 (PGA on a Visual Analogue Scale (VAS)100mm/10 with 0=best and 100= worst, CRP in mg/dl) OR 2. the SDAI score is ≤ 3.3 Measure: Remission assessed by American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) remission criteria Time Frame: 4, 8, 12, and 18 months Description: The RAID questionnaire includes seven domains with the following relative weights: pain (0.21), functional disability (0.16), fatigue (0.15), emotional well-being (0.12), sleep (0.12), coping (0.12) and physical well-being (0.12) each rated on an Numeric Rating Scale (NRS) (0-10 with 0=best and 10=worst). The rates of each domain are weighted and summed to form a score in the range of 0-10 Measure: Rheumatoid Arthritis Impact of Disease (RAID) Time Frame: 4, 8, 12, and 18 months Description: The MHAQ includes eight items covering the physical function of patients with inflammatory joint diseases. Each item is scored on a categorical 0-3 scale (0=best and 3= worst) and the sum score is divided by 8 to form the MHAQ score 0.0 to 3.0 Measure: Evaluation of physical function measured by Modified Health Assessment Questionnaire (MHAQ) Time Frame: 4, 8, 12, and 18 months Description: Assessments of AE Measure: Number and type of adverse events (AE) Time Frame: 4, 8, 12, and 18 months Description: Drug survival assessed by survival analyses Measure: Drug survival Time Frame: 4, 8, 12, and 18 months Description: Assessments of drug consumption Measure: Drug consumption Time Frame: 18 months Description: ADAb will be assessed in all serum samples with adalimumab levels \<3mg/L. Measure: Occurrence of anti-drug antibodies (ADAb) Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 18 months Description: Serum drug levels will be assessed at all visits, both clinical and digital. Measure: Serum drug levels Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 18 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. A clinical diagnosis of RA 2. ≥ 18 and under 75 years of age at screening 3. On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months 4. In low disease activity or remission (DAS28-CRP under 3.2) and indication for continuation of treatment according to the treating physician 5. Subject capable of understanding and signing an informed consent form Exclusion Criteria: 1. Major comorbidities, such as previous malignancies within the last 5 years, uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, significant renal or hepatic disease, and/or other diseases or conditions which either contraindicate treatment with SC TNFi or make adherence to the protocol difficult 2. Hypersensitivity to sc TNFi (adalimumab). 3. Pregnancy, or subject considering becoming pregnant during the study period 4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult 5. Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months 6. Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily). 7. Active participation in any other interventional study. 8. In need of live vaccines during the study period. Maximum Age: 74 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: ingrid.jyssum@gmail.com Name: Ingrid Jyssum, PhD, MD Phone: +4722451500 Role: CONTACT Contact 2: Email: s.w.syversen@gmail.com Name: Silje W Syversen, PhD, MD Phone: +4722451500 Role: CONTACT #### Locations Location 1: City: Vienna Contacts: *Contact 1:* - Email: helga.lechner-radner@meduniwien.ac.at - Name: Helga Lechner-Radner, PhD, MD - Phone: +43 1 40400-43010 - Role: CONTACT *Contact 2:* - Name: Helga Lechner-Radner, PhD, MD - Role: PRINCIPAL_INVESTIGATOR Country: Austria Facility: Medical University Vienna Zip: A-1090 Location 2: City: Oslo Contacts: *Contact 1:* - Email: ingrid.jyssum@gmail.com - Name: Ingrid Jyssum, PhD, MD - Phone: +4722451500 - Role: CONTACT *Contact 2:* - Email: s.w.syversen@gmail.com - Name: Silje W Syversen, PhD, MD - Phone: +4722451500 - Role: CONTACT *Contact 3:* - Name: Ingrid Jyssum, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Diakonhjemmet sykehus State: N-0319 Zip: 0319 Location 3: City: Bergen Contacts: *Contact 1:* - Email: anne.kristine.hjorteseth.halse@helse-bergen.no - Name: Anne- Kristine Halse, MD, PhD - Phone: +4755975000 - Role: CONTACT *Contact 2:* - Name: Anne- Kristine Halse, MD, PhD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Haukeland University Hospital Zip: 5009 Location 4: City: Bodø Contacts: *Contact 1:* - Email: Sonja.Pedersen@nordlandssykehuset.no - Name: Sonja Pedersen, MD - Phone: +4775534000 - Role: CONTACT *Contact 2:* - Name: Sonja Pedersen, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Nordland Hospital Trust Zip: 8005 Location 5: City: Drammen Contacts: *Contact 1:* - Email: filsko@vestreviken.no - Name: Fillip Skovlund, MD - Phone: +4703525 - Role: CONTACT *Contact 2:* - Name: Fillip Skovlund, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Drammen Hospital Zip: 3004 Location 6: City: Førde Contacts: *Contact 1:* - Email: pawel.franciszek.mielnik@helse-forde.no - Name: Pawel F Mienik, MD, PhD - Phone: +4757839000 - Role: CONTACT *Contact 2:* - Name: Pawel F Mienik, MD, PhD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Førde Hospital Trust Zip: 6812 Location 7: City: Haugesund Contacts: *Contact 1:* - Email: svanaug.skorpe@hsr.as - Name: Svanaug Skorpe, MD - Phone: +4752805000 - Role: CONTACT *Contact 2:* - Name: Svanaug Skorpe, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Haugesund Rheumatism Hospital Zip: 5528 Location 8: City: Kristiansand Contacts: *Contact 1:* - Email: Jintana.Bunpan.Andersen@sshf.no - Name: Jintana B Andersen, MD, PhD - Phone: +4738073000 - Role: CONTACT *Contact 2:* - Name: Jintana B Andersen, MD, PhD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Hospital of Southern Norway Trust Zip: 4615 Location 9: City: Lillehammer Contacts: *Contact 1:* - Email: Eldri.Kveine.Strand@revmatismesykehuset.no - Name: Eldri K Strand, MD - Phone: +4761279500 - Role: CONTACT *Contact 2:* - Name: Eldri K Strand, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Lillehammer Hospital for Rheumatic Diseases Zip: 2609 Location 10: City: Mo I Rana Contacts: *Contact 1:* - Email: Petya.Stefanova.Galabova@helgelandssykehuset.no - Name: Petya S Galabova, MD - Phone: +4775660000 - Role: CONTACT *Contact 2:* - Name: Petya S Galabova, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Helgeland Hospital Trust Zip: 8613 Location 11: City: Moss Contacts: *Contact 1:* - Email: annhau@so-hf.no - Name: Anne J Haugen, MD, PhD - Phone: +4769860000 - Role: CONTACT *Contact 2:* - Name: Anne J Haugen, MD, PhD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Østfold Hospital Trust Zip: 1535 Location 12: City: Sandvika Contacts: *Contact 1:* - Email: Anne.Bull.Haaversen@mhh.no - Name: Anne B Haaversen, MD - Phone: +4767500800 - Role: CONTACT *Contact 2:* - Name: Anne B Haaversen, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Martina Hansen's Hospital Location 13: City: Skien Contacts: *Contact 1:* - Email: stillum@hotmail.com - Name: Christine Stillum, MD - Phone: +4735900700 - Role: CONTACT *Contact 2:* - Name: Christine Stillum, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Betanien Hospital Zip: 3722 Location 14: City: Stavanger Contacts: *Contact 1:* - Email: kjartan.bryne@sus.no - Name: Kjartan Bryne, MD - Phone: +4751518000 - Role: CONTACT *Contact 2:* - Name: Kjartan Bryne, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Stavanger University Hospital Zip: 4019 Location 15: City: Tromsø Contacts: *Contact 1:* - Email: trude.jannecke.bruun@unn.no - Name: Trude J Bruun, MD - Phone: +4777626000 - Role: CONTACT *Contact 2:* - Name: Trude J Bruun, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: University Hospital of North Norway Zip: 9019 Location 16: City: Trondheim Contacts: *Contact 1:* - Email: mari.hoff@stolav.no - Name: Mari Hoff, MD, PhD - Phone: +4772573000 - Role: CONTACT *Contact 2:* - Name: Mari Hoff, MD, PhD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: St.Olavs Hospital Zip: 7030 Location 17: City: Ålesund Contacts: *Contact 1:* - Email: Astrid.Jordet.Langhammer@helse-mr.no - Name: Astrid B Langhammer, MD - Phone: +4770105000 - Role: CONTACT *Contact 2:* - Name: Astrid B Langhammer, MD - Role: PRINCIPAL_INVESTIGATOR Country: Norway Facility: Ålesund Hospital Zip: 6017 Location 18: City: Stockholm Contacts: *Contact 1:* - Email: aikaterini.chatzidionysiou@ki.se - Name: Aikaterini Chatzidionysiou, MD, PhD - Role: CONTACT *Contact 2:* - Name: Aikaterini Chatzidionysiou, MD, PhD - Role: PRINCIPAL_INVESTIGATOR Country: Sweden Facility: Karolinska University Hospital Zip: 141 86 Location 19: City: London Contacts: *Contact 1:* - Email: m.bombardieri@qmul.ac.uk - Name: Michele Bombardieri, MD, PhD - Role: CONTACT *Contact 2:* - Name: Michele Bombardieri, MD, PhD - Role: PRINCIPAL_INVESTIGATOR Country: United Kingdom Facility: Queen Mary State: Sw15 5pn Zip: SW15 5PN #### Overall Officials Official 1: Affiliation: Diakonhjemmet Hospital Name: Espen A Haavardsholm, Phd, MD Role: STUDY_DIRECTOR ### IPD Sharing Statement Module Access Criteria: The data will only be made available after submission of a project plan outlining the reason for the request and any proposed analyses, and will have to be approved by the RA-DRUM steering group. Project proposals can be submitted to the corresponding author. Data sharing will have to follow appropriate regulations. Description: A de-identified patient data set can be made available to researchers upon reasonable request. Info Types: - STUDY_PROTOCOL - SAP - ICF IPD Sharing: YES Time Frame: 10 years after publishing ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-19 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 855666 - Type Abbrev: Prot - Upload Date: 2024-05-29T09:37 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: HIGH - As Found: Rheumatoid Arthritis - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000001172 - Term: Arthritis, Rheumatoid ### Intervention Browse Module - Ancestors - ID: D000079424 - Term: Tumor Necrosis Factor Inhibitors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M326 - Name: Adalimumab - Relevance: HIGH - As Found: Where - ID: M2052 - Name: Tumor Necrosis Factor Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068879 - Term: Adalimumab ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440616 Brief Title: Benefit of Spectral Information in Patients Suspected for Lung Cancer Official Title: Benefit of Spectral Information Provided by Photon Counting CT in Patients Suspected for Lung Cancer #### Organization Study ID Info ID: H- 23045674 #### Organization Class: OTHER Full Name: Copenhagen University Hospital at Herlev ### Status Module #### Completion Date Date: 2027-06-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-06-01 Type: ESTIMATED #### Start Date Date: 2024-05-24 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-27 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Rigshospitalet, Denmark Class: OTHER Name: Aarhus University Hospital #### Lead Sponsor Class: OTHER Name: Copenhagen University Hospital at Herlev #### Responsible Party Investigator Affiliation: Copenhagen University Hospital at Herlev Investigator Full Name: Michael Brun Andersen Investigator Title: Associate Professor, PhD 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: Purpose The aim of the study is to investigate the utilization of photon counting CT (PCCT) and the spectral information provided to determine the impact of spectral information on follow-up examinations. As secondary aims we will compare conventional CT, CT + 18Flouro-deoxy-glucose (18F-FDG) positron emission tomography (PET) and PCCT + 18F-FDG PET for the tumor-node-metastasis (TNM) staging of lung cancer patients. PCCT with and without spectral information to assess the need for additional work-up,TNM classification, and sensitivity/specificity for malignant lesions. Patients will be randomized for reading with or without spectral information available within a clinical setting. The clinical readings are performed as a structured reports of all significant findings. Including both malignant and benign findings. Furthermore, in case additional follow-up/work-up is needed based on the guidelines on incidental findings by the American College of Radiology (ACR), this will be reported as well. If lesions suspicious of pulmonary malignancy is present, a provisional TNM classification is provided based on the scan findings. After 3 months, the patient record is reviewed where additional examinations that can be attributed to the PCCT scan are recorded. The financial impact is calculated by a health economist based on the findings. PET/CT, conventional CT and PCCT combined with PET will be assessed retrospectively for comparison. Endpoints are number of supplementary examinations and cost savings. Sensitivity and specificity for any malignant finding. The T, N and M stages are assessed separately as diagnostic measures by the McNemar's test with a reference standard from the Danish Lung cancer register. The number of malignant lesions will be determined by reviewing the patient records incl. pathology assessment if available 12 months after inclusion of the last patient. ### Conditions Module Conditions: - Lung Neoplasm Malignant Keywords: - Computed tomography - Spectral CT ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: DIAGNOSTIC #### Enrollment Info Count: 1000 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Reported without access to spectral information in a normal clinical practice. Supplemental examinations suggested as per the ACR white papers for incidental findings. Label: CT images without spectral information available Type: NO_INTERVENTION #### Arm Group 2 Description: Reported with access to spectral information in a normal clinical practice. Supplemental examinations suggested as per the ACR white papers for incidental findings. Intervention Names: - Device: Spectral CT images generated by a photon counting CT scanner Label: CT images with spectral information available Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - CT images with spectral information available Description: The reading radiologist will in the experimental arm have access to spectral CT images in the form of low virtual monoenergetic images, virtual non-contrast images, iodine maps and effective atomic number. In the non-interventional arms the reading radiologist will only have access to conventional CT images. Name: Spectral CT images generated by a photon counting CT scanner Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Determine the number of suggested follow-up examinations based on the initial CT scan to learn the significance of spectral information in a clinical setting. Measure: Number of follow up examinations Time Frame: Baseline #### Secondary Outcomes Description: Determine the accuracy of T, N, and M stage based on PCCT, conventional CT, PET/CT and PET/PCCT. Retrospective assessment 24 months after primary scan. Measure: T, N, and M stage Time Frame: 24 months Description: Determine the number of found malignant lesions in each arm. Reference standard will be follow up or pathology within a minimum of one year of the scan. That means 12 months after the end of the inclusion period. Measure: Number of malignant lesions Time Frame: 24 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients suspected of lung cancer refered to Copenhagen University Hospital as per the guidelines from the danish national health authorities from either the general practitioner or from the department of pulmonology. * Informed consent Exclusion Criteria: * Patients who cannot tolerate intravenous iodinated contrast * Already verified lung cancer from another institution * Comorbidities that exclude the patient from receiving treatment * Lack of reference standard in the form of either histology or follow-up * Known extrapulmonary malignancy * Technical limitations within the scans/reconstructions * other Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: michael.brun.andersen@regionh.dk Name: Michael B Andersen, PhD Phone: 38 68 38 68 Phone Ext: +45 Role: CONTACT #### Locations Location 1: City: Herlev Contacts: *Contact 1:* - Email: michael.brun.andersen@region.dk - Name: Michael B Andersen, PhD - Phone: 38 68 38 68 - Phone Ext: +45 - Role: CONTACT Country: Denmark Facility: Copenhagen University Hospital Herlev State: Capital Region Status: RECRUITING Zip: 2730 #### Overall Officials Official 1: Affiliation: Copenhagen University Hospital, Herlev-Gentofte Name: Michael B Andersen, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Neoplasms - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10488 - Name: Iodine - Relevance: LOW - As Found: Unknown - ID: M229695 - Name: Cadexomer iodine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440603 Brief Title: EKLF Gene Expression in β-thalassemia Official Title: Erythroid Krüppel Like Factor (EKLF) Gene Expression in β-thalassemia Patients #### Organization Study ID Info ID: β-thalassemia #### Organization Class: OTHER Full Name: Assiut University ### Status Module #### Completion Date Date: 2027-07-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-31 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: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-19 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Rofaida Hassan Ahmed #### Responsible Party Investigator Affiliation: Assiut University Investigator Full Name: Rofaida Hassan Ahmed Investigator Title: Principle investigator Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: 1. Studying the effect of expression pattern of EKLF gene in β-thalassemic patients. 2. Detecting the correlation between the gene expression of EKLF and the clinical phenotype of β-thalassemic patients. Detailed Description: β-thalassemia is a common inherited disorder caused by absent or reduced synthesis of the hemoglobin subunit beta (beta globin chain) , it has 3 clinical types; minor which is a carrier state, intermedia and major which are differentiated by blood transfusion dependency and lab findings. In β-thalassemia, insufficient production of the β-globin molecule results in an excess of free α-globin chains that can precipitate within erythroid precursors, impairing their maturation and leads to death of these precursors and ineffective production of erythroid cells. As a result, a significant anaemia occurs and the consequent expansion of erythroid precursors can lead to secondary problems in bones and other organs. These mutations are primarily point mutations that affect transcriptional control, translation, and splicing of the beta haemoglobin gene and gene expression. The frequency of beta-thalassemia mutations varies by regions of the world with the highest prevalence in the Mediterranean, the Middle East, and Southeast and Central Asia. Approximately 68000 children are born with beta-thalassemia. Its prevalence is 80-90 million carriers, around 1.5% of the global population. Erythroid Krüppel-like factor (EKLF or KLF1) is a transcriptional regulator that plays a major role in lineage-restricted control of gene expression. KLF1 expression and activity are tightly controlled in a temporal and differentiation stage-specific manner. The mechanisms by which KLF1 is regulated encompass a range of biological processes, including control of KLF1 RNA transcription, protein stability, localization, and posttranslational modifications. Intact KLF1 regulation is essential to correctly regulate erythroid function by gene transcription and to maintain hematopoietic lineage homeostasis by ensuring a proper balance of erythroid/megakaryocytic differentiation. In turn, KLF1 regulates erythroid biology by a wide variety of mechanisms, including gene activation and repression by regulation of chromatin configuration, transcriptional initiation and elongation, and localization of gene loci to transcription factories in the nucleus. Previous studies have shown that EKLF plays a critical role in regulating the developmental switch between fetal and adult haemoglobin expression, both by direct activation of β-globin and indirect repression of γ-globin gene expression in adult erythroid progenitors via regulation of Bcl11a and ZBTB7a and PUM1. PUM1 is a direct posttranscriptional regulator of β-globin switching, whose expression is regulated by the erythroid master transcription factor erythroid Krüppel-like factor (EKLF/KLF1), peaks during erythroid differentiation, binds γ-globin messenger RNA (mRNA), and reduces γ-globin (HBG1) mRNA stability and translational efficiency, which culminates in reduced γ-globin protein levels. So, EKLF is too important in erythropoiesis and Hb switching that there are clinical trials nowadays depending on the molecules that targeted by EKLF (eg:Bcl11a, ZBTB7a and PUM1) and their role in Hb switching in treatment of thalassemia and other haemolytic anaemias as sickle cell anaemia. ### Conditions Module Conditions: - β-thalassemia ### Design Module #### Bio Spec Description: Ethylenediamine tetra-acetic acid (EDTA) peripheral blood samples 3- Reverse transcription-quantitative polymerase chain reaction (RT-qPCR) for detection of EKLF: * The method of total RNA extraction: TRIZOL and TRIZOL LS. * The purity and concentration of the RNA will be measured using Nano Drop 2000 instument. * cDNA will be done with primers using thr Goscript Reverse Transcription System Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: CASE_CONTROL Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 150 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Age and sex matched healthy Control Intervention Names: - Diagnostic Test: PCR Label: Group I #### Arm Group 2 Description: 50 patients with β-thalassemia major Intervention Names: - Diagnostic Test: PCR Label: Group 2 #### Arm Group 3 Description: 50 patients with β-thalassemia intermedia Intervention Names: - Diagnostic Test: PCR Label: Group 3 ### Interventions #### Intervention 1 Arm Group Labels: - Group 2 - Group 3 - Group I Description: Reverse transcription-quantitative polymerase chain reaction (RT-qPCR) for detection of EKLF: * The method of total RNA extraction: TRIZOL and TRIZOL LS. * The purity and concentration of the RNA will be measured using Nano Drop 2000 instument. * cDNA will be done with primers using thr Goscript Reverse Transcription System Name: PCR Type: DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes Description: study the expression pattern of EKLF gene by Real-time polymerase chain reaction (RT-qPCR) in β-thalassemic patients Measure: study the expression pattern of EKLF gene in β-thalassemic patients, work by measuring mRNA levels Time Frame: Baseline #### Secondary Outcomes Description: study the correlation between the gene expression of EKLF and the clinical phenotype of β-thalassemic patients. Measure: study the correlation between the gene expression of EKLF and the clinical phenotype of β-thalassemic patients. Time Frame: Baseline ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * patients with β-thalassemia (major and intermedia). * patients are of both sexes (male or female) at any age Exclusion Criteria: * patients with any other types of hemolytic anaemia Healthy Volunteers: True Maximum Age: 80 Years Minimum Age: 5 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT Study Population: Patients \> 5 years diagnosed with β-thalassemia including both thalassemia major and intermedia ### Contacts Locations Module #### Central Contacts Contact 1: Email: mahaseb_rofaida@yahoo.com Name: Rofida Hassan Phone: +2 1019935111 Role: CONTACT Contact 2: Email: emannasr2000@yahoo.com Name: Eman Naser Eldin Phone: 01002677890 Role: CONTACT #### Overall Officials Official 1: Affiliation: Assiut University Name: Eman Naser Eldin Role: STUDY_DIRECTOR Official 2: Affiliation: Assiut University Name: Sherif Helmy Role: STUDY_DIRECTOR Official 3: Affiliation: Assiut University Name: Reem Elagoz Role: STUDY_DIRECTOR ### References Module #### References Citation: Sankaran VG, Orkin SH. The switch from fetal to adult hemoglobin. Cold Spring Harb Perspect Med. 2013 Jan 1;3(1):a011643. doi: 10.1101/cshperspect.a011643. PMID: 23209159 Citation: Cao A, Galanello R. Beta-thalassemia. Genet Med. 2010 Feb;12(2):61-76. doi: 10.1097/GIM.0b013e3181cd68ed. PMID: 20098328 Citation: Origa R. beta-Thalassemia. Genet Med. 2017 Jun;19(6):609-619. doi: 10.1038/gim.2016.173. Epub 2016 Nov 3. PMID: 27811859 Citation: Yien YY, Bieker JJ. EKLF/KLF1, a tissue-restricted integrator of transcriptional control, chromatin remodeling, and lineage determination. Mol Cell Biol. 2013 Jan;33(1):4-13. doi: 10.1128/MCB.01058-12. Epub 2012 Oct 22. PMID: 23090966 Citation: Borg J, Papadopoulos P, Georgitsi M, Gutierrez L, Grech G, Fanis P, Phylactides M, Verkerk AJ, van der Spek PJ, Scerri CA, Cassar W, Galdies R, van Ijcken W, Ozgur Z, Gillemans N, Hou J, Bugeja M, Grosveld FG, von Lindern M, Felice AE, Patrinos GP, Philipsen S. Haploinsufficiency for the erythroid transcription factor KLF1 causes hereditary persistence of fetal hemoglobin. Nat Genet. 2010 Sep;42(9):801-5. doi: 10.1038/ng.630. Epub 2010 Aug 1. PMID: 20676099 Citation: Elagooz R, Dhara AR, Gott RM, Adams SE, White RA, Ghosh A, Ganguly S, Man Y, Owusu-Ansah A, Mian OY, Gurkan UA, Komar AA, Ramamoorthy M, Gnanapragasam MN. PUM1 mediates the posttranscriptional regulation of human fetal hemoglobin. Blood Adv. 2022 Dec 13;6(23):6016-6022. doi: 10.1182/bloodadvances.2021006730. PMID: 35667093 Citation: Siatecka M, Soni S, Planutis A, Bieker JJ. Transcriptional activity of erythroid Kruppel-like factor (EKLF/KLF1) modulated by PIAS3 (protein inhibitor of activated STAT3). J Biol Chem. 2015 Apr 10;290(15):9929-40. doi: 10.1074/jbc.M114.610246. Epub 2015 Feb 24. PMID: 25713074 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000745 - Term: Anemia, Hemolytic, Congenital - ID: D000000743 - Term: Anemia, Hemolytic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000006453 - Term: Hemoglobinopathies - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16557 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - ID: M19408 - Name: beta-Thalassemia - Relevance: HIGH - As Found: Β-thalassemia - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M4073 - Name: Anemia, Hemolytic - Relevance: LOW - As Found: Unknown - ID: M4075 - Name: Anemia, Hemolytic, Congenital - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9539 - Name: Hemoglobinopathies - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T5622 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - ID: T737 - Name: Beta-thalassemia - Relevance: HIGH - As Found: Β-thalassemia ### Condition Browse Module - Meshes - ID: D000013789 - Term: Thalassemia - ID: D000017086 - Term: beta-Thalassemia ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440590 Brief Title: Supra-Pectineal QLS Plating Vs Infra-pectineal Plating in Management of Quadrilateral Plate Fractures Official Title: Supra-Pectineal Quadrilateral Buttress Plating Versus Infra-pectineal Plating in Management of Quadrilateral Plate Fractures: A Randomized Controlled Trial #### Organization Study ID Info ID: FMASU R66/2023 #### Organization Class: OTHER Full Name: Ain Shams University ### Status Module #### Completion Date Date: 2024-07-15 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-06-03 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2024-04-15 Type: ACTUAL #### Start Date Date: 2023-04-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-26 Study First Submit QC Date: 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Ain Shams University #### Responsible Party Investigator Affiliation: Ain Shams University Investigator Full Name: Islam Moussa Investigator Title: lecturer of orthopedic surgery Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The investigators conducted such a prospective randomized controlled study aiming to reach a satisfactory outcome and to compare supra-pectineal QL buttress plating versus infra-pectineal for management of anterior column with or without posterior hemi-transverse component and quadrilateral plate involvement. Detailed Description: Our hypothesis was that supra-pectineal quadrilateral buttress plating provides much more rigid fixation and a strong buttress for medial wall migration, also it could correlate with a better functional and radiological outcome. However, there is a lack of knowledge in the prospective assessment of functional and radiological outcomes and follow up of postoperative complications of supra-pectineal quadrilateral buttress plating versus infra-pectineal plating in fixation of QLS and to our knowledge, it will be the first study to include such measures of outcome together in a prospective randomized fashion. ### Conditions Module Conditions: - Evaluation of QL Buttress Plating in QLP Fracture Fixation Keywords: - quadrilateral plate fractures - anterior column fractures - associated both column fractures - infra-pectineal plating - supra-pectineal quadrilateral buttress plating ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. The investigators prospectively carried out this study on 30 patients with quadrilateral plate fractures between February 2022 and June 2023 that met our inclusion criteria. The independent doctor allocated the 30 cases to two groups: Group A (15 cases): supra-pectineal quadrilateral buttress plating, group B (15 cases): Infra-pectineal plating ##### Masking Info Masking: SINGLE Masking Description: Double (Investigator, Outcomes Assessor) Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. Who Masked: - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 30 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients treated by supra-pectineal quadrilateral buttress plating through anterior intrapelvic approach Intervention Names: - Procedure: suprapectineal quadrilateral buttress plating Label: supra-pectineal quadrilateral buttress plating Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: Patients treated by infra-pectineal conventional plating applied on the medial wall through anterior intrapelvic approach Intervention Names: - Procedure: Infra-pectineal plating Label: Infrapectineal plating Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - supra-pectineal quadrilateral buttress plating Description: 15 cases will undergo anatomical supra-pectineal quadrilateral plate Name: suprapectineal quadrilateral buttress plating Type: PROCEDURE #### Intervention 2 Arm Group Labels: - Infrapectineal plating Description: 15 cases will undergo conventional manually contoured infra-pectineal plate Name: Infra-pectineal plating Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: Clinical assessment was done via Modified Merle d'Aubigné scoring system that was calculated at each follow-up visit (out of 18) and presented the mean value; the score evaluates three factors: pain, mobility \& ability to walk. the score maximum being 18 (excellent) and minimum 6 (poor) Measure: Rate of Excellent, very good, Good, Average or Poor functional outcomes using Modified Merle d'Aubigné scoring system Time Frame: one-year post-operative Description: Radiological assesment was done according to the grading of Matta and Tornetta, The investigators classified the results into: Anatomical, congruent \& incongruent; based on the restoration of the five anatomical lines (iliopectineal line, ilioischial line, acetabular dome, posterior wall \& anterior wall) \& best judged on the anteroposterior view. Measure: Rate of Anatomical, Congruent or Incongruent Radiological Outcomes using Matta & Tornetta radiological principles Time Frame: 1 year postoperative Description: Residual displacement was measured in millimeters and compared between the two study groups Measure: Amount of residual displacement Time Frame: immediate post-operative and throughout study completion #### Secondary Outcomes Description: The investigators focused the evaluation of Postoperative complications on the local complications related to fixation principles and technique: LLD, AVN of the hip joint, wound infection, residual malunion or non-union of the quadrilateral plate, and loss of reduction Measure: post-operative complications' rate Time Frame: 1-year post-operative Description: The mean blood loss was calculated and compared between the two study groups, it was measured intraoperative and postoperative from suction drains Measure: Mean intraoperative blood loss Time Frame: up to 4 days post-operative Description: The mean operation time was calculated in minutes and compared between the two study groups Measure: Mean operative time Time Frame: it was calculated intra-operative ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Anterior column fracture acetabulum with QLS involvement * Anterior column posterior hemi-transverse fracture acetabulum with QLS involvement * Age between 16-60 years' old Exclusion Criteria: * Open fractures * Associated pelvic ring injuries that require intervention * Associated internal organ injuries that require intervention * Age less than 14 years and older than 60 years Healthy Volunteers: True Maximum Age: 60 Years Minimum Age: 16 Years Sex: ALL Standard Ages: - CHILD - ADULT ### Contacts Locations Module #### Locations Location 1: City: Cairo Country: Egypt Facility: Ain Shams university State: Abassia Zip: 1234 #### Overall Officials Official 1: Affiliation: no funding recieved Name: Islam S Moussa, MD Role: STUDY_CHAIR ### IPD Sharing Statement Module Access Criteria: full access Description: i plan to share it with other researchers Info Types: - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE IPD Sharing: YES Time Frame: one year ## Derived Section ### Condition Browse Module - Ancestors - 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: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050723 - Term: Fractures, Bone ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440577 Brief Title: Craving & Decision-Making Official Title: Decision Neuroscience of Craving #### Organization Study ID Info ID: Pro2018002176 #### Organization Class: OTHER Full Name: Rutgers, The State University of New Jersey #### Secondary ID Infos ID: R01DA054201 Link: https://reporter.nih.gov/quickSearch/R01DA054201 Type: NIH ### Status Module #### Completion Date Date: 2026-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2026-12 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: NIH Name: National Institute on Drug Abuse (NIDA) #### Lead Sponsor Class: OTHER Name: Rutgers, The State University of New Jersey #### Responsible Party Investigator Affiliation: Rutgers, The State University of New Jersey Investigator Full Name: Anna B. Konova, PhD 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: Craving is the strong desire for something, such as for substances in drug addiction and food or other activities in everyday life. Recent work suggests craving can influence how people make decisions and assign value to choice options available to them, yet the neural mechanisms underlying these interactions between craving and valuation remain unknown. To address this, this study uses cognitive decision-making tasks that measure how much individuals will pay (from a study endowment) to have everyday consumer items or snack foods when they crave something specific (opioids or a specific snack, respectively). First, the study will identify the neural mechanisms for how drug craving (craving for opioids) interacts with valuation for consumer items that have associations with drug use or not in people receiving treatment for opioid use disorder (OUD). This will be evaluated in the activity patterns and interactions among brain regions involved in craving and value assignment during decision-making. Then, the study will examine for parallel mechanisms for how food craving (craving for a specific snack) interacts with valuation for snack food items that have similar features to the craved snack or not in people receiving treatment for OUD and non-psychiatric community control participants. ### Conditions Module Conditions: - Decision Making Keywords: - Craving - Decision Making - Opioid Use Disorder - Dietary Choice ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: SINGLE_GROUP Intervention Model Description: Men and women with OUD receiving medications for OUD treatment will complete both the Consumer Items Willingness-to-Pay Task and Snack Foods Willingness-to-Pay Task at two separate task sessions. Non-psychiatric community control participants will complete the Snack Foods Willingness-to-Pay Task. ##### Masking Info Masking: NONE Primary Purpose: BASIC_SCIENCE #### Enrollment Info Count: 160 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Men and women with OUD receiving medications for OUD treatment will complete a decision-making task during functional magnetic resonance imaging (fMRI) in which they indicate their willingness-to-pay for everyday consumer items that have associations with drug use or not. Interleaved with blocks of the task, participants will briefly observe stimuli that can produce a change in their psychological state and drug craving, via two psychological/behavioral interventions: Audio-visual stimuli (Neutral-Relaxing) and Audio-visual stimuli (Drug). Intervention Names: - Behavioral: Audio-visual stimuli (Neutral-Relaxing) - Behavioral: Audio-visual stimuli (Drug) Label: Consumer Items Willingness-to-Pay Task Type: EXPERIMENTAL #### Arm Group 2 Description: Men and women with OUD receiving medications for OUD treatment and control participants from the community will complete a decision-making task during functional magnetic resonance imaging (fMRI) in which they indicate their willingness-to-pay for snack food items that vary in their features (savory, sweet, etc.). Interleaved with blocks of the task, participants will briefly observe stimuli that can produce a change in their psychological state and food craving, via two psychological/behavioral interventions: Audio-visual stimuli (Non-Food) and Audio-visual stimuli (Food). Intervention Names: - Behavioral: Audio-visual stimuli (Non-Food) - Behavioral: Audio-visual stimuli (Food) Label: Snack Foods Willingness-to-Pay Task Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Consumer Items Willingness-to-Pay Task Description: Audio instruction for participant to allow themselves to experience their feelings followed by 3-min passive viewing of images of neutral everyday objects (e.g., tools, dirt) and their use (construction, gardening). Name: Audio-visual stimuli (Neutral-Relaxing) Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - Consumer Items Willingness-to-Pay Task Description: Audio instruction for participant to allow themselves to experience their feelings followed by 3-min passive viewing of images of drug paraphernalia (e.g., syringe, tourniquet, heroin) and preparation. Name: Audio-visual stimuli (Drug) Type: BEHAVIORAL #### Intervention 3 Arm Group Labels: - Snack Foods Willingness-to-Pay Task Description: Audio instruction for participant to focus their attention on the experimenter followed by 3-min audio-guided viewing of the experimenter opening/unwrapping an everyday object (e.g., box of crayons) and taking out its contents. Name: Audio-visual stimuli (Non-Food) Type: BEHAVIORAL #### Intervention 4 Arm Group Labels: - Snack Foods Willingness-to-Pay Task Description: Audio instruction for participant to focus their attention on the experimenter followed by 3-min audio-guided viewing of the experimenter opening/unwrapping a snack (e.g., chocolate bar, bag of chips) and taking out its contents. Name: Audio-visual stimuli (Food) Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: The amount that a participant would be willing to pay for different available choice options. This is measured during the decision-making tasks in which participants are shown images of consumer items or snack foods and report how much they would be willing to pay to have the different items in that moment. Measure: Willingness-to-pay Time Frame: during the task Description: Functional MRI data will be analyzed to measure changes in blood-oxygen-level-dependent (BOLD) signal in specific regions of interest based on prior research (ventral striatum, ventromedial prefrontal cortex, amygdala, and insula) as participants make willingness-to-pay decisions during each task. Measure: fMRI-BOLD activity measured during willingness-to-pay decisions Time Frame: during the task ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * At least 18 years of age * Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures * Minimum of 6th grade reading level Additional inclusion criteria for participants with OUD: * Primary diagnosis of OUD encompassing heroin and/or painkiller use * Receiving medications for OUD treatment on an outpatient basis * At least 12-month history of opioid use Exclusion Criteria: * Unable to speak or read English * Active psychosis or mania * Current or past schizophrenia diagnosis * History of intellectual disability or developmental or neurological disorder, seizures or epilepsy, or loss consciousness lasting more than 30 minutes * Severe medical conditions requiring hospitalization or that, in the opinion of the study staff could compromise study participation * MRI contraindications (claustrophobia, nonremovable piercings, certain metal in the body etc.) or pregnancy Additional exclusion criteria for community control participants: * Positive urine drug screen * Current or past problematic substance use other than nicotine, and alcohol abuse confined to college or military service * Current or past bipolar disorder diagnosis * Use of central nervous system medications within the past 6 weeks (e.g., antidepressants, Ritalin) Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: anna.konova@rutgers.edu Name: Anna Konova, PhD Phone: 732-235-4335 Role: CONTACT #### Locations Location 1: City: Piscataway Contacts: *Contact 1:* - Name: Anna Konova, PhD - Role: CONTACT Country: United States Facility: Rutgers, The State University of New Jersey State: New Jersey Status: RECRUITING Zip: 08854 #### Overall Officials Official 1: Affiliation: Rutgers, The State University of New Jersey Name: Anna Konova, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M7127 - Name: Heroin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440564 Brief Title: Laser Disinfection in Periprosthetic Joint Infection Official Title: Laser Disinfection as Biofilm-Disrupter in Periprosthetic Joint Infection (PJI) #### Organization Study ID Info ID: 1087/2021 #### Organization Class: OTHER Full Name: Medical University of Vienna ### Status Module #### Completion Date Date: 2025-05-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2024-05-01 Type: ACTUAL #### Start Date Date: 2021-11-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-24 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Paracelsus Medical University #### Lead Sponsor Class: OTHER Name: Medical University of Vienna #### Responsible Party Investigator Affiliation: Paracelsus Medical University Investigator Full Name: Lukas Kriechbaumer 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 eradication of biofilms from infected implants is still an unsolved challenge. The high-energy light beam of an Er:YAG laser causes rapid heating and explosive ablation of tissue. In this study we test the suitability of this laser for the removal of biofilms from infected implant surfaces. Detailed Description: Infections after joint arthroplasties represent a devastating and progressively escalating complication with increased morbidity and mortality. The eradication of biofilms from infected implants is still an unsolved challenge. The high-energy light beam of an Er:YAG laser causes rapid heating and explosive ablation of tissue. In this study the investigators test the suitability of this laser for the removal of biofilms from infected implant surfaces. Methods In this prospective study, acute or early hematogenous periprosthetic joint infections (PJIs) will be treated with the modified procedure of Debridement, Antibiotics, Laser irradiation and Implant Retention (DALIR). The investigators compare the completeness of biofilm removal from the implant surface with mechanical cleansing alone and the additional use of Er:YAG laser light. Therefore, the investigators will obtain swab cultures from the implants on three distinct occasions: post-arthrotomy, subsequent to mechanical cleansing, and after Er:YAG laser irradiation. The investigators also compare the success rate of the DALIR procedure with the international literature. Results The investigators expect, that the prevalence of viable microorganisms obtained from implant surfaces through swab cultures will be considerably diminished after additional Er:YAG laser therapy in comparison to only mechanical cleaning with LavaSurge®. The investigators hope to reach a higher healing rate in relation to comparable studies. Conclusion If the hypothese is correct, the investigators will recommend the use of Er:YAG laser irradiation as an additional tool for disinfection of metal implants in PJIs whenever a DAIR procedure seems to be beneficial. ### Conditions Module Conditions: - Periprosthetic Joint Infections Keywords: - Er:YAG laser - biofilm removal - periprosthetic joint infections (PJI) - DAIR - laser disinfection ### 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: In addition to the standard DAIR procedure, laser light is used to disrupt the biofilm from implant surfaced. Intervention Names: - Procedure: Er:YAG Laser irradiation Label: Er:YAG Laser intervention Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Er:YAG Laser intervention Description: The presented DALIR procedure differs in so far from a standard treatment that after exposure all accessible metal implant surfaces and the adjacent soft tissue is irradiated manually with the Er:YAG laser all over line-by-line with an intended overlap of approximately 10% at constant spot diameter. Name: Er:YAG Laser irradiation Other Names: - Mechanical cleaning with LavaSurge® Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: Primary outcome is the comparison of biofilm removal from the implant surface with mechanical cleansing alone (LavaSurge® administered with Pulsavac®) and the additional use of Er:YAG laser light. This is demonstrated by taking microbiological swabs from the implant surface before and after laser treatment. Measure: Biofil Eradication Time Frame: 14 days #### Secondary Outcomes Description: Secondary outcome is infection eradication at 1 year following the DALIR procedure. Success of a DALIR procedure will be determined by the absence of antibiotic administration, lack of clinical indications of infection, and absence of infection related subsequent surgical procedures. Measure: Healing Rate Time Frame: 1 year ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients with periprosthetic joint infection (PJI) that will be treated with a debridement, antibiotics, and implant retention (DAIR) procedure Exclusion Criteria: * When a DAIR procedure seems not beneficial in a PJI case. Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Salzburg Country: Austria Facility: University Clinic of Orthopedics and Trauma Surgery (Paracelus Medical University Salzburg, Austria) Zip: 05020 #### Overall Officials Official 1: Affiliation: Paracelsus Medical University Name: Lukas K Kriechbaumer, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M4478 - Name: Arthritis, Infectious - Relevance: HIGH - As Found: Joint Infection - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000001170 - Term: Arthritis, Infectious ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440551 Brief Title: Puerto Rican Obesity Intervention for Men Official Title: Puerto Rican Obesity Intervention for Men #### Organization Study ID Info ID: 0048231 #### Organization Class: OTHER Full Name: Medical College of Wisconsin ### Status Module #### Completion Date Date: 2026-05-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-31 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: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-04-26 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Medical College of Wisconsin #### Responsible Party Investigator Affiliation: Medical College of Wisconsin Investigator Full Name: Lisa Sanchez-Johnsen 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: The goal of this clinical trial is to address the high rates of overweight/obesity in Puerto Rican (PR) men. The main question it aims to answer is whether virtual culturally relevant classes supporting physical activity and healthy eating for Puerto Rican men at different levels of acculturation to the US culture, will help these men achieve clinically meaningful weight loss. The purpose of this project is to assess whether a virtual intervention tailored for Puerto Rican men that includes information about healthy eating, physical activity, sedentary behavior is feasible and acceptable compared to a general health (GH) intervention. It is also to determine whether this intervention leads to healthier eating, increased physical activity, less sedentary behavior (low activity), and clinically meaningful weight loss. Hypothesis 1: Test the feasibility (recruitment, retention, adherence, fidelity) and acceptability (treatment components, intervention leaders, telehealth modality, technology and equipment, intervention satisfaction, satisfaction with randomized study, and measures) of a randomized 4-month synchronous telehealth lifestyle intervention led by a community health promoter and behavioral health specialist, who will receive either: TeleSalud HE-PA/SB" or TeleSalud GH in 48 PR men. Hypothesis 2: Demonstrate proof -of-concept by achieving a clinically significant weight reduction of ≥ 5% of baseline weight in the TeleSalud HE-PA/SB intervention after 4 months and at the end of the 4-month maintenance compared to the TeleSalud General Health intervention. Researchers will compare this to a group that will receive information about general health topics - not healthy eating or physical activity. * Participants in both groups will meet via virtually for 4 months (twice per week for 3 months and once per week for 1 month). * Participants will then meet one per month for a maintenance session for the next 4 months. ### Conditions Module Conditions: - Obesity Keywords: - Diet - Physical Activity - Puerto Rican ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 48 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will attend virtual classes on increasing healthy eating, increasing physical activity, and decreasing sedentary behaviors. Intervention Names: - Behavioral: TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) Label: Healthy Eating and Physical Activity - Intervention Type: EXPERIMENTAL #### Arm Group 2 Description: Participants will attend virtual classes on general health topics. Intervention Names: - Behavioral: TeleSalud General Health Intervention Label: General Health Topics - Control Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Healthy Eating and Physical Activity - Intervention Description: Participants will meet via telehealth for 4 months (twice a week for 3 months and then once per week for 1 month) for a TeleSalud HE-PA/SB Class, after which they will attend one maintenance meeting per month for 4 months. Weekly, Day 1 (Healthy Eating \& PA-SB Class): Participants will receive a 50-min. healthy eating class. Physical Activity- Sedentary Behavior (PA-SB) Class: By discussing barriers and strategies to overcome barriers, this will help to increase self-efficacy. We will engage in Latino-centered moderate impact (increasing to vigorous) aerobics with Latino or salsa movements and music for 45-50 minutes. Aspects of kickboxing aerobics will be integrated. Goal: Exercise a minimum of 150-250 min./ week of moderate intensity. Weekly, Day 2: PA-SB identical PA-SB to Day 1. Maintenance (Months 5-8): Meetings once/ month for 70 min. for HE/PA-SB class, including 25 min. to discuss diet and PA-SB barriers. Goal: Exercise a minimum of 150-250 min./week. Name: TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - General Health Topics - Control Description: Weekly: Participants will meet via telehealth for 4 months (twice a week for 3 months and then once per week for 1 month) for a TeleSalud General Heath Class, after which they will attend one maintenance meeting per month for 4 months. Participants will meet and discuss general health topics (not diet or PA). Examples of the general health topics are: Back Pain, Muscle Strains, Alcohol Use, Stress \& Coping, Oral and Dental Health, Safety Tips, Emergency Preparedness. The content is relevant to Latinos, and information is focused on Latino men. Maintenance (Months 5-8): Participants will meet via telehealth once/ month for 70 min. to discuss general health topics. To enhance motivation to complete the study and assessments, this group will receive a copy of the TeleSalud HE-PA/SB intervention manual and related materials after the maintenance period ends. Name: TeleSalud General Health Intervention Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Delivery will be measured by an adherence checklist. It will monitor consistency and accuracy in the delivery of the intervention. Measure: Acceptability- Fidelity: Delivery Time Frame: 4 months, 8 months Description: Receipt will be measured by participants' self-reports of understanding and knowledge acquisition of content for both groups. Measure: Acceptability- Fidelity: Receipt Time Frame: 4 months, 8 months Description: Enactment will be measured by participants' self-report of changes in behavior based on targets of treatment (e.g., Healthy Eating, Physical Activity, and Sedentary Behavior, General Health.) Measure: Acceptability- Fidelity: Enactment Time Frame: 4 months, 8 months Description: Perceived helpfulness/ effectiveness of various treatment components (12 questions, on a 5- point Likert scale: not at all to extremely effective) will be assessed. The average of the treatment component questions will be used as the overall dependent measure of the acceptability of the treatment components. Measure: Acceptability- Helpfulness of Treatment Components Time Frame: 4 months, 8 months Description: Perceived helpfulness/ effectiveness of the intervention leaders (6 questions, on a 5-point Likert scale: not at alll to extremely helpful) will be assessed. The average of the questions will be used as the overall dependent measures of the acceptability of the intervention leaders. Measure: Acceptability- Helpfulness/ Effectiveness of the Intervention Leaders Time Frame: 4 months, 8 months Description: Acceptability- Assessed by an intervention satisfaction questionnaire (14 questions, on a 5- point Likert scale: not at all satisfied to extremely satisfied). Measure: Acceptability- Intervention Satisfaction Time Frame: 4 months, 8 months Description: Perceived helpfulness/ effectiveness of the telehealth modality, technology and equipment (3 questions, on 5-point Likert scale: not at all to extremely effective) will be assessed. The average of the telehealth components questions will be used as the overall dependent measure of the acceptability of the telehealth components. Measure: Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and Equipment Time Frame: Baseline, 4 months, 8 months Description: Acceptability- Assessed by a questionnaire assessing satisfaction with being in a study with random assignment to groups (14 questions, on a 5-point Likert scale: not at all satisfied to extremely satisfied). Measure: Acceptability- Satisfaction with Random Assignment to Groups Time Frame: Baseline, 4 months, 8 months Description: Changes in number of servings of fruits will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool. Measure: Dietary Intake: Number of Servings of Fruits Time Frame: Baseline, 4 months, 8 months Description: Change in number of servings of vegetables will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool. Measure: Dietary Intake: Number of Servings of Vegetables Time Frame: Baseline, 4 months, 8 months Description: Changes in percent of calories from saturated fat will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. Measure: Dietary Intake: Percent of Calories from Saturated Fat Time Frame: Baseline, 4 months, 8 months Description: Changes in total energy intake will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. Measure: Dietary Intake: Total Energy Intake Time Frame: Baseline, 4 months, 8 months Description: Feasibility- Adherence- Monthly: Will be measured by the frequency of attendance at each session on a monthly basis. Measure: Feasibility- Adherence- Monthly Attendance Time Frame: 4 months, 8 months Description: Feasibility- Adherence- Number of Make-Up Sessions: Will be assessed by frequency/counts of number of make-up sessions. Measure: Feasibility- Adherence- Number of Make-Up Sessions Time Frame: 4 months, 8 months Description: Feasibility- Adherence- Number of Missed Sessions Overall: Will be assessed by frequency/ counts of the number of missed sessions overall (no make-up sessions). Measure: Feasibility- Adherence- Number of Missed Sessions Overall Time Frame: 4 months, 8 months Description: Feasibility- Adherence- Weekly Attendance: Will be measured by the frequency of attendance at each session on a weekly basis. Measure: Feasibility- Adherence- Weekly Attendance Time Frame: 4 months, 8 months Description: Recruitment feasibility assessed by the number of participants enrolled. Measure: Feasibility- Recruitment- Number Enrolled Time Frame: Pre-Intervention Description: Recruitment feasibility assessed by counts of the number of contacts. Measure: Feasibility- Recruitment- Number of Contacts Time Frame: Pre-Intervention Description: Recruitment feasibility assessed by the rate of consenting. Measure: Feasibility- Recruitment- Rate of Consenting Time Frame: Pre-Intervention Description: Recruitment feasibility assessed by the rate of enrollment. Measure: Feasibility- Recruitment- Rate of Enrollment Time Frame: Pre-Intervention Description: Recruitment feasibility assessed by the rate of screening. Measure: Feasibility- Recruitment- Rate of Screening Time Frame: Pre-Intervention Description: Feasibility assessed by tracking the method of recruitment. Measure: Feasibility- Recruitment- Recruitment Method Time Frame: Pre-Intervention Description: Recruitment feasibility assessed by rate of response. Measure: Feasibility- Recruitment- Response Rate Time Frame: Pre-Intervention Description: Recruitment feasibility assessed by tracking the type of contact. Measure: Feasibility- Recruitment- Type of Contact Time Frame: Pre-Intervention Description: Retention assessed by counts and frequency of the number who completed the interventions. Measure: Feasibility- Retention- Number Completed the intervention Time Frame: 4 months, 8 months Description: Recruitment feasibility assessed by the count of number of individuals screened. Measure: Feasibility- Recruitment- Number Screened Time Frame: Pre-Intervention Description: Retention- assessed by counts of the number of classes attended. Measure: Feasibility- Retention- Number of Classes Attended Time Frame: 4 months, 8 months Description: Retention assessed by the percent of participants who completed the interventions. Measure: Feasibility- Retention- Percent Completed the Interventions Time Frame: 4 months, 8 months Description: Retention assessed by percent of classes attended. Measure: Feasibility- Retention- Percent of Classes Attended Time Frame: 4 months, 8 months Description: Recruitment feasibility assessed by the number of participants who consented. Measure: Feasibility- Recruitment- Number Consented Time Frame: Pre-Intervention Description: A triaxial wrist accelerometer (ActiGraph wGT3XBT) will measure objective physical activity. They will used the accelerometer during waking hours for 7 days on their non-dominant wrist. Measure: Objective Physical Activity (Accelerometer) Time Frame: Baseline, 4 months, 8 months Description: The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity. Measure: Subjective Physical Activity (International Physical Activity Questionnaire) Time Frame: Baseline, 4 months, 8 months Description: The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity. Measure: Subjective Sedentary Behavior (International Physical Activity Questionnaire) Time Frame: Baseline, 4 months, 8 months #### Secondary Outcomes Description: Body Mass Index (BMI) will be assessed by objectively measured height and weight. Measure: Body Mass Index Time Frame: Baseline, 4 months, 8 months Description: Outcome expectations will be assessed by the Outcome Expectations for Diet Questionnaire. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention. Measure: Outcome Expectations for Diet Questionnaire Time Frame: Baseline, 4 months, 8 months Description: Outcome expectations for Exercise will be assessed by the Exercise Outcomes on the Outcomes Expectations Questionnaire. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention. Measure: Exercise Outcomes on the Outcomes Expectations Questionnaire Time Frame: Baseline, 4 months, 8 months Description: Self-efficacy will be assessed by the Self-Efficacy for Dietary Behaviors. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention. Measure: Self-Efficacy for Dietary Behaviors Time Frame: Baseline, 4 months, 8 months Description: Self-efficacy will be assessed by the Exercise Confidence Survey. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention. Measure: Exercise Confidence Survey Time Frame: Baseline, 4 months, 8 months Description: Social Support will be assessed by the Social Support and Exercise Survey and the Social Support and Eating Habits Survey. These measures will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention. Measure: Social Support and Eating Habits Survey Time Frame: Baseline, 4 months, 8 months Description: Social Support will be assessed by the Social Support and Exercise Survey and the Social Support and Eating Habits Survey. These measures will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention. Measure: Social Support and Exercise Survey Time Frame: Baseline, 4 months, 8 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Male of Puerto Rican descent over 35 years. * BMI ≥25 by anthropometrically measured weight and height. * Physically able to exercise (via the EASY tool or, if needed, able to receive medical clearance to participate in the study). * Has access to secure computer or tablet in a private location with reliable internet connection to support video streaming * Ability to understand and speak English and Spanish. Exclusion Criteria: * Does not understand/speak English or Spanish. * Plans to move from the Illinois area during the study. * Currently in a formal weight management program. * Current or planned use of weight control or loss medication prescribed by a doctor. * Currently exercising \>1 time/week. * Unable to attend study times. * Serious medical problems or medications that would make protocol compliance difficult or dangerous, e.g., unable to engage in moderate \& eventually vigorous exercise, uncontrolled diabetes (A1C \> 9) or hypertension (systolic \>160 or diastolic \>100), hypoglycemia, heart attack in the past six months, unstable angina, life-threatening arrhythmias, cancer that required treatment in the last 5 years (except non-melanoma skin cancers that have been cured). * Current alcohol abuse (\>35 alcoholic drinks/week); score of yes to \> 2 questions on the CAGE alcohol scale. * Current recreational or illegal drug use. Healthy Volunteers: True Minimum Age: 35 Years Sex: MALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: LSanchezJohnsen@mcw.edu Name: Lisa Sanchez-Johnsen, PhD Phone: 414-955-8057 Role: CONTACT Contact 2: Email: krifelj@mcw.edu Name: Kelly Rifelj, MPA Phone: 4146517352 Role: CONTACT #### Locations Location 1: City: Milwaukee Contacts: *Contact 1:* - Email: lsanchezjohnsen@mcw.edu - Name: Lisa Sanchez-Johnsen, PhD - Role: CONTACT Country: United States Facility: Medical College of Wisconsin State: Wisconsin Zip: 53226 #### Overall Officials Official 1: Affiliation: Medical College of Wisconsin Name: Lisa Sanchez-Johnsen, PhD Role: PRINCIPAL_INVESTIGATOR ## 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: 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 ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440538 Brief Title: Rebuilding Inter-limb Transfer in Cervical SCI Official Title: Improving Upper Limb Rehabilitation by Rebuilding Inter-limb Transfer of Motor Gains in Cervical SCI #### Organization Study ID Info ID: 23-415 #### Organization Class: OTHER Full Name: The Cleveland Clinic ### Status Module #### Completion Date Date: 2025-07-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-06-03 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-07-30 Type: ESTIMATED #### Start Date Date: 2024-02-15 Type: ACTUAL Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2023-10-10 Study First Submit QC Date: 2024-06-03 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: The Craig H. Neilsen Foundation #### Lead Sponsor Class: OTHER Name: The Cleveland Clinic #### Responsible Party Investigator Affiliation: The Cleveland Clinic Investigator Full Name: Ela B. Plow Investigator Title: Associate Proffesor Type: PRINCIPAL_INVESTIGATOR ### 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 this study in people living with cervical Spinal Cord Injury (SCI) is to examine the effects of paired neurostimulation (i.e., PCMS) combined with contralateral motor training on inter-limb transfer of ballistic motor and hand dexterity skills. Detailed Description: Cervical spinal cord injury (SCI) is the most common and severe type of SCI that can lead to paralysis of the trunk and all four limbs, also known as tetraplegia. People with tetraplegia place a high priority on regaining upper limb motor function to be independent in daily life. Despite intensive therapies, upper limb motor gains are slow to emerge, especially in chronic cases. A critical barrier to effective and efficient upper limb rehabilitation in cervical SCI lies in the motor deficits of inter-limb transfer. Inter-limb transfer refers to a natural innate process within the human neuromotor system that motor skills acquired in one limb can transfer to the opposite, untrained limb, and is believed to play a key role in maximizing and accelerating post-injury recovery. Inter-limb transfer however is deficient following cervical SCI due to a breakdown of inter-limb neural connections at the cortical and spinal levels. Prior studies in uninjured people reveal that one can upregulate inter-limb neural mechanisms and hence augment inter-limb transfer effects by giving neurostimulation to augment corticomotoneuronal pathways to the untrained arm just before motor training in the contralateral arm. This study aims to rebuild inter-limb transfer of motor gains in chronic cervical SCI using a novel non-invasive neurostimulation method called paired corticospinal-motor neuronal stimulation (PCMS). We will test the central hypothesis that PCMS given to an untrained hand immediately before the visuomotor ballistic motor training at the other hand will improve inter-limb transfer of ballistic motor and dexterity skills to the untrained hand, based on potentiation of inter-limb neural mechanisms. ### Conditions Module Conditions: - Cervical Spinal Cord Injury Keywords: - Cervical Spinal Cord Injury - Upper limb - Motor Training - Brain Stimulation - Peripheral Nerve Stimulation - Hand Dexterity - Inter-limb transfer - Motor learning ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 17 Type: ESTIMATED Phases: - EARLY_PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Device: PCMS + Contralateral Motor Training Label: PCMS + Contralateral Motor Training Type: EXPERIMENTAL #### Arm Group 2 Intervention Names: - Device: PCMS + Rest Label: PCMS + Rest Type: ACTIVE_COMPARATOR #### Arm Group 3 Intervention Names: - Device: Sham PCMS + Contralateral Motor Training Label: Sham PCMS + Contralateral Motor Training Type: SHAM_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - PCMS + Contralateral Motor Training Description: PCMS + Contralateral Motor Training will involve delivering 360 pairs of TMS-PNS pulses (30min, 0.2 Hz) to the weaker first dorsal interosseous (FDI) muscle immediately before a session of ballistic index finger abduction training at the opposite, stronger FDI muscle. Name: PCMS + Contralateral Motor Training Type: DEVICE #### Intervention 2 Arm Group Labels: - PCMS + Rest Description: PCMS + Rest will involve delivering 360 pairs of TMS-PNS pulses (30min, 0.2Hz) to the weaker FDI followed by a 30-min rest. Name: PCMS + Rest Type: DEVICE #### Intervention 3 Arm Group Labels: - Sham PCMS + Contralateral Motor Training Description: 360 TMS pulses will be delivered at a location 10-cm posterior to the participant's head (into the air, 0.2Hz) and no PNS pulses will be generated, followed by a session of 30-min ballistic index finger abduction training at the opposite, stronger FDI muscle. Name: Sham PCMS + Contralateral Motor Training Type: DEVICE ### Outcomes Module #### Other Outcomes Description: A TMS safety questionnaire will be asked at the end of each TMS testing session Measure: TMS safety questionnaire Time Frame: Post paired TMS and PNS stimulation, assessed for approximately 4-6 hours Description: CUE-T is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients Measure: Capabilities of Upper Extremity Test(CUE-T) Time Frame: Baseline Description: COPM is used to measure participation restrictions of Spinal Cord Injury Subjects Measure: Canadian Occupational Performance Measure (COPM) Time Frame: Baseline Description: GRASSP is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients Measure: Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Time Frame: Baseline Description: SCIM is a spinal cord injury measure that identifies activity limitations of self-care Measure: Spinal Cord Independence Measure(SCIM) Time Frame: Baseline Description: The LTPAQ-SCI is an SCI-specific, self-report assessment of LTPA that measures the number of minutes of mild, moderate, and heavy exercises performed throughout a typical week. Measure: Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) Time Frame: Baseline Description: Questionnaire to ascertain the handedness of a participant in activities of daily living (ADL). Measure: Edinburgh Handedness Inventory Time Frame: Baseline #### Primary Outcomes Description: Participants perform 10 trials of ballistic index finger abduction with a accelerometer attached to index finger to capture the peak acceleration during the movement. Measure: Change in ballistic acceleration Time Frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours Description: Transcranial magnetic stimulation will be used to test cortical output from both hemispheres and will be measured as motor evoked potentials(MEPS) of the First Dorsal Interosseous (FDI) muscle. Measure: Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS) Time Frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours Description: Peripheral Nerve stimulation will be performed to collect the spinal F-wave amplitude of the First Dorsal Interosseous (FDI) muscle. Measure: Change in excitability of spinal physiology (F-wave) Time Frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours #### Secondary Outcomes Description: The NHPT is used to measure finger dexterity measured in time to complete the test or amount of pegs placed in 100 sec. Measure: Change in Nine Hole Peg Test (NHPT) Time Frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours Description: The investigator will calculate the index finger(2nd digit) velocity smoothness using the number of local maxima of frontal plane finger velocities during the peg transfer phase using kinematic sensors place on the fingers. Measure: Change in finger velocity smoothness during NHPT Time Frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Neurological Level of Injury C4, C5, C6, C7, C8 * American Spinal Injury Association Impairment Scale (AIS) C-D * greater than or equal to 1 year time post injury * residual motor sparing of bilateral FDI muscles, defined as medical research council (MRC) grade 2 to 5 Exclusion Criteria: * contraindications to transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) including pacemaker, metal in the skull, seizure history, pregnancy, etc. * history of alcohol and/or drug abuse * current usage of medications that can potentially lower the seizure threshold such as bupropion, amphetamines, etc. * history of other neurological conditions such as stroke, Parkinson's, and traumatic brain injury (TBI) * active pressure ulcers to avoid disruption of ongoing medical treatments * participation of on-going upper-limb therapies to minimize confounding effects * excessive tone/spasticity (Modified Ashworth Scale \[MAS\] \>3) and severe contractures or soft tissue shortening at elbow/wrist/fingers Healthy Volunteers: True Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: olaughk@ccf.org Name: Kyle J O'Laughlin, MS Phone: 216-445-6728 Role: CONTACT Contact 2: Email: LIUJ19@ccf.org Name: Jia Liu, PhD Phone: 216-445-6728 Role: CONTACT #### Locations Location 1: City: Cleveland Contacts: *Contact 1:* - Email: olaughk@ccf.org - Name: Kyle J O'Laughlin, MS - Phone: 216-445-7841 - Role: CONTACT *Contact 2:* - Email: plowe2@ccf.org - Name: Ela Plow, PhD - Phone: 216-445-4589 - Role: CONTACT *Contact 3:* - Name: Ela Plow, PhD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Lerner Research Institute; Cleveland Clinid Foundation State: Ohio Status: RECRUITING Zip: 44195 #### Overall Officials Official 1: Affiliation: The Cleveland Clinic Name: Ela Plow, PhD Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000020196 - Term: Trauma, Nervous System - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15916 - Name: Spinal Cord Injuries - Relevance: HIGH - As Found: Spinal Cord Injury - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013119 - Term: Spinal Cord Injuries ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440525 Brief Title: A Phase 2 Study of RSLV-132 in Females With Primary Sjögren's Syndrome Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Primary Sjögren's Syndrome (pSS) With Moderate to Severe Symptom Burden #### Organization Study ID Info ID: 132-06 #### Organization Class: INDUSTRY Full Name: Resolve Therapeutics ### Status Module #### Completion Date Date: 2026-07 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-05 Type: ESTIMATED #### Start Date Date: 2024-09-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Resolve Therapeutics #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Oversight Has DMC: False ### Description Module Brief Summary: The goal of this clinical study is to learn if RSLV-132 improves the symptoms of pSS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are: * Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain? * Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's? * What are the blood levels of RSLV-132 over time? * What is the immune (antibody) response in the body to RSLV-132? * What is the safety profile of RSLV-132? Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS. Participants will: Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device ### Conditions Module Conditions: - Primary Sjögren Syndrome ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: QUADRUPLE Who Masked: - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 106 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Intravenous infusions of 10 mg/kg RSLV-132 solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment Intervention Names: - Drug: RSLV-132 Label: RSLV-132 Type: EXPERIMENTAL #### Arm Group 2 Description: Intravenous infusions of placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment Intervention Names: - Drug: Placebo Label: Placebo Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - RSLV-132 Description: Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1) Name: RSLV-132 Type: DRUG #### Intervention 2 Arm Group Labels: - Placebo Description: 0.9% sodium chloride solution Name: Placebo Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument Measure: Assessment of cardinal symptoms of Sjogren's Time Frame: Measured daily from at least 7 days prior to first dose until 169 days after the first dose #### Secondary Outcomes Description: Change from baseline in the Patient Reported Outcomes Measurement Information System Fatigue Short Form 10a (PROMIS SF10a) on Day 169 Measure: Tiredness/fatigue assessment Time Frame: Measured from before the first dose until Day 169 Description: Serum concentrations of RSLV-132 using an assay measuring RNAse enzyme activity Measure: RSLV-132 pharmacokinetics Time Frame: Measured from before the first dose until Day 211 Description: Presence of antibodies to RSLV-132 measured using an immunoassay Measure: RSLV-132 immunogenicity Time Frame: Measured from before the first dose until Day 211 Description: Incidence of serious and non-serious adverse events Measure: Adverse events Time Frame: From the first dose of Investigational Product until Day 211 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Providing written informed consent * Weight at least 45 kg * Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS * Diagnosis in the last 10 years * Positive anti-Ro/SSA antibody test * Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale * Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures Exclusion Criteria: * Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments * Uncontrolled hypothyroidism or severe fibromyalgia * New medications or change in medications in the last 4 weeks for pSS symptoms * Receipt of other prohibited medications * Apheresis or blood donation * Allergic reaction to RSLV-132 or biologic therapy * Clinically significant infection in last 30 days * Participation in another clinical study * Malignancy in last 5 years * Positive test for HIV or hepatitis * Major surgery in last 30 days or anticipated surgery during the study * Pregnancy or breast feeding * Laboratory blood tests outside of specified ranges * Other medical conditions or medications that would make the participant unsuitable Maximum Age: 65 Years Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: jp@resolvebio.com Name: James Posada Phone: (208) 727-7010 Role: CONTACT ### References Module #### References Citation: Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26. PMID: 27785888 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000001172 - Term: Arthritis, Rheumatoid - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000014987 - Term: Xerostomia - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000007766 - Term: Lacrimal Apparatus Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M15664 - Name: Sjogren's Syndrome - Relevance: HIGH - As Found: Sjogren's Syndrome - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M17724 - Name: Xerostomia - Relevance: LOW - As Found: Unknown - ID: M15285 - Name: Salivary Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M18040 - Name: Dry Eye Syndromes - Relevance: LOW - As Found: Unknown - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012859 - Term: Sjogren's Syndrome - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10122 - Name: Immunoglobulin G - Relevance: LOW - As Found: Unknown - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440512 Brief Title: The Effect of Chocolate on Vascular Function of Endurance Runners Official Title: The Effect of Chocolate on Vascular Function of Endurance Runners #### Organization Study ID Info ID: EC-161/2023 #### Organization Class: OTHER Full Name: Aristotle University Of Thessaloniki ### Status Module #### Completion Date Date: 2024-11-20 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-09-01 Type: ESTIMATED #### Start Date Date: 2024-06-10 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-22 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Aristotle University Of Thessaloniki #### Responsible Party Investigator Affiliation: Aristotle University Of Thessaloniki Investigator Full Name: Evangelia Kouidi Investigator Title: Professor, Director of the Laboratory of Sports Medicine Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The aim of this study is to examine the effects of chocolate on the vascular function of endurance runners through a crossover study involving male runners consuming both dark and white chocolate. Detailed Description: Participants will be male endurance runners who will receive both black and white chocolate interventions. Arterial stiffness, cardiovascular parameters, respiratory parameters, and running performance will be assessed before and after each intervention period. The study will involve a two-week intervention period for each type of chocolate, with a washout period in between. The primary outcome measure will be arterial stiffness, while secondary outcome measures will include cardiovascular and respiratory parameters, as well as running performance. The study is expected to provide insights into the effects of chocolate consumption on vascular function in endurance athletes. ### Conditions Module Conditions: - Vascular Function Keywords: - arterial stiffness - aerobic fitness - chocolate - polyphenols - endurance runners ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER Intervention Model Description: This study employs a crossover design to investigate the effects of chocolate consumption on vascular function of endurance runners. Participants will undergo multiple treatment periods where they will receive either dark chocolate or white chocolate, followed by washout periods to minimize carryover effects. The order of treatment administration will be randomized to mitigate potential sequence effects. Outcome measures will be assessed at the end of each treatment period to evaluate the impact of chocolate consumption on vascular function, athletic performance and other relevant outcomes. ##### Masking Info Masking: NONE Masking Description: Τhe study does not use the method of blind evaluation due to the nature of the interventions, which are easily identifiable by the participants Primary Purpose: BASIC_SCIENCE #### Enrollment Info Count: 50 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Intervention period 1:The group will consume 50 grams of dark chocolate daily for two weeks. Washout period: Two-weeks Intervention period 2: The group will consume 40 grams of white chocolate daily for two weeks. Intervention Names: - Other: Dark chocolate Intervention - Other: White chocolate Intervention Label: A Chocolate Arm Type: EXPERIMENTAL #### Arm Group 2 Description: Intervention period 1:The group will consume 40 grams of white chocolate daily for two weeks. Washout period: Two-weeks Intervention period 2: The group will consume 50 grams of dark chocolate daily for two weeks Intervention Names: - Other: Dark chocolate Intervention - Other: White chocolate Intervention Label: B Chocolate Arm Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - A Chocolate Arm - B Chocolate Arm Description: The intervention involves daily consumption of 50 grams of dark chocolate for a period of two weeks. The dark chocolate is provided in tablet form, and participants are instructed to consume it daily. Name: Dark chocolate Intervention Type: OTHER #### Intervention 2 Arm Group Labels: - A Chocolate Arm - B Chocolate Arm Description: The intervention involves daily consumption of 40 grams of white chocolate for a period of two weeks. The dark chocolate is provided in tablet form, and participants are instructed to consume it daily. Name: White chocolate Intervention Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Measurement of the velocity of the pressure wave between the carotid and femoral arteries, expressed in meters per second (m/s) Measure: CF-PWV (Carotid-Femoral Pulse Wave Velocity) Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate). Description: Measurement of arterial stiffness, calculated as the difference between the first and second systolic peaks of the arterial waveform, expressed as a percentage (%) Measure: AIx (Augmentation Index) Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate). Description: Total duration of exercise during cardiopulmonary exercise testing, measured in minutes. Measure: Exercise Time in Cardiopulmonary Exercise Testing Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate). Description: Maximum amount of oxygen consumed per minute during incremental exercise, expressed in milliliters per kilogram per minute (mL/kg/min) Measure: VO2max (Maximal Oxygen Uptake) Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate). Description: Total time taken to complete a 5-kilometer run, measured in minutes and seconds. Measure: 5km Time Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate). Description: Average speed during a 5-kilometer run, expressed in kilometers per hour (km/h). Measure: 5km Speed Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate). ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Gender: Male * Age: 25-55 years * Healthy status * Active endurance runner * Regular physical activity (at least 3 times per week) * Availability on specific days and times for research sessions * Willingness and consistency Exclusion Criteria: * Allergies or Intolerances: Participants with known allergies or intolerances to chocolate or any of its ingredients. * Cardiovascular Diseases: Participants with known cardiovascular diseases or history of cardiac episodes. * Metabolic Disorders: Individuals with diabetes or other metabolic disorders that may affect glucose and insulin metabolism. * Contradictory Diet: Individuals following specific diets that may affect the study, such as high or low flavonoid diets. * Medication Use: Individuals taking medications that affect vascular function, such as antihypertensives or anticoagulants. * Smoking: Smokers or individuals who have quit smoking within the last six months. * Substance Abuse: Individuals with a history of alcohol or substance abuse. * Patients with Chronic Diseases: Individuals with serious chronic diseases that may affect the study outcomes. * Participation in Other Studies: Individuals participating in other clinical trials or research that may affect the study outcomes. * Physical Condition: Individuals who are not regular runners or who do not exercise regularly at a level similar to other participants. Healthy Volunteers: True Maximum Age: 55 Years Minimum Age: 25 Years Sex: MALE Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: zvordos@hotmail.com Name: Zacharias Vordos, PhD Phone: +306977136712 Role: CONTACT Contact 2: Email: adeligia@phed.auth.gr Name: Asterios Deligiannis, Professor Phone: +302310992181 Role: CONTACT #### Locations Location 1: City: Thessaloniki Contacts: *Contact 1:* - Email: kouidi@phed.auth.gr - Name: Evangelia Kouidi, Professor - Role: CONTACT Country: Greece Facility: Laboratory of Sports Medicine Zip: 57001 #### Overall Officials Official 1: Affiliation: Aristotle University Of Thessaloniki Name: Evangelia Kouidi, Professor Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440499 Brief Title: Screening of Congenital Anomalies of Kidney Official Title: Prenatal Ultrasonographic Screening of Congenital Anomalies of Kidney and Urinary Tract During the Third Trimester of Pregnancy #### Organization Study ID Info ID: congenital anomalies of kidney #### Organization Class: OTHER Full Name: Assiut University ### Status Module #### Completion Date Date: 2025-04-05 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-30 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-03-05 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-04 Type: ACTUAL Study First Submit Date: 2024-05-24 Study First Submit QC Date: 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Assiut University #### Responsible Party Investigator Affiliation: Assiut University Investigator Full Name: Mohamed Salah Investigator Title: Assiut University Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: To evaluate the role of ultrasound in prenatal diagnosis of congenital anomalies of kidney and urinary system in third trimester of pregnancy. Primay outcomes: To determine incidence of congenital anomalies in kidney and urinary system in Third Timerter by ultrasound. ### Conditions Module Conditions: - Kidney Congenital Anomalies ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 250 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 Description: Us Name: US Type: DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes Measure: To determine sensitivity, spacificy, the +ve PP &-ve P.P of ultrsound screening for renal anomalies. Time Frame: 1 year ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * • Singleton pregnancy. * Healthy women Aged between 20 to 40 years old. * Third trimester Exclusion Criteria: * • Multiples pregnancies. * Maternal D.M or HTN * Patients\' refusal to participate. Healthy Volunteers: True Sampling Method: PROBABILITY_SAMPLE Sex: FEMALE Standard Ages: - CHILD - ADULT - OLDER_ADULT Study Population: pregnant ### Contacts Locations Module #### Central Contacts Contact 1: Email: m.salah250@yahoo.com Name: m.salah250@yahoo.com screening of congenital anomalies of kidney Phone: 201065574768 Role: CONTACT ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Al-Hamed MH, Sayer JA, Alsahan N, Tulbah M, Kurdi W, Ambusaidi Q, Ali W, Imtiaz F. Novel loss of function variants in FRAS1 AND FREM2 underlie renal agenesis in consanguineous families. J Nephrol. 2021 Jun;34(3):893-900. doi: 10.1007/s40620-020-00795-0. Epub 2020 Jul 8. PMID: 32643034 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12 - Name: Congenital Abnormalities - Relevance: HIGH - As Found: Congenital Anomalies ### Condition Browse Module - Meshes - ID: D000000013 - Term: Congenital Abnormalities ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440486 Brief Title: Assessment of Probiotics on Inflammation and Metabolism in Type 2 Diabetes. Official Title: Based on a Randomized, Double-blind, Controlled Trial, Evaluate the Effects of Probiotics on Inflammation and Metabolism in Patients With Type 2 Diabetes Mellitus. #### Organization Study ID Info ID: WK2024008 #### Organization Class: INDUSTRY Full Name: Wecare Probiotics Co., Ltd. ### Status Module #### Completion Date Date: 2024-12-15 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-09-15 Type: ESTIMATED #### Start Date Date: 2024-06-15 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-27 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Wecare Probiotics Co., Ltd. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This clinical study aims to explore the effects of probiotics on inflammatory and metabolic indicators in patients with type 2 diabetes. By assessing the potential of probiotics to modify these markers, the study seeks to identify an economical and effective strategy for the prevention and treatment of type 2 diabetes. ### Conditions Module Conditions: - Type 2 Diabetes ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - INVESTIGATOR Primary Purpose: TREATMENT #### Enrollment Info Count: 80 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will receive a probiotic strip (3g/strip) daily alongside their standard clinical treatment for a continuous 12-week period. Intervention Names: - Dietary Supplement: Probiotics Label: Probiotics Type: EXPERIMENTAL #### Arm Group 2 Description: Participants will take a daily placebo strip (3g/strip) in addition to their regular clinical treatment over a continuous 12-week period. Intervention Names: - Dietary Supplement: Probiotics Label: Maltodextrin Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Maltodextrin - Probiotics Description: Serum and fecal samples were collected at the beginning and end of the study to evaluate the effects of probiotic consumption on immune markers, metabolites, and gut microbiota before and after administration. Name: Probiotics Type: DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes Description: Blood samples will be collected from patients with type 2 diabetes mellitus (T2DM), centrifuged to obtain serum, and analyzed for tumor necrosis factor-alpha (TNF-α), interleukins 6 (IL-6), 10 (IL-10), and 18 (IL-18), IL-1β, and interferon-gamma (IFN-γ) to assess the impact of probiotics on T2DM patients. Measure: Inflammatory markers Time Frame: 12 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Signed an informed consent form before the study and has a thorough understanding of the content, process, and possible adverse reactions of the study; 2. Age 18 (inclusive) and above, gender not limited; 3. Diagnosed with type 2 diabetes mellitus; 4. Not diagnosed with cardiovascular, kidney, or any other diabetic complications. Exclusion Criteria: 1. Age over 75 years old; 2. Use of exogenous insulin or patients with cardiovascular disease and other complications; 3. Patients who are currently using α-glucosidase inhibitors; 4. Patients who have a habit of taking probiotics or are currently taking probiotics; 5. Pregnant or lactating women; 6. Subjects deemed unsuitable for participation in this clinical study by the investigators due to other reasons. Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: liukang@nsmc.edu.cn Name: Kang Liu, Doctor Phone: 15808432375 Phone Ext: ＋86 Role: CONTACT #### Locations Location 1: City: Nanchong Contacts: *Contact 1:* - Email: liukang@nsmc.edu.cn - Name: Kang Liu - Phone: 15808432375 - Role: CONTACT Country: China Facility: Nanchong Central Hospital State: Sichuan Zip: 637000 ### 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 - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 - ID: D000007249 - Term: Inflammation ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440473 Brief Title: Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin Official Title: Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin #### Organization Study ID Info ID: Pro00078950 #### Organization Class: OTHER Full Name: Rao Dermatology ### Status Module #### Completion Date Date: 2024-07-28 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-06-28 Type: ESTIMATED #### Start Date Date: 2024-05-28 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Rao Dermatology #### Responsible Party Investigator Affiliation: Rao Dermatology Investigator Full Name: Babar Rao Investigator Title: Principal Investigator and Owner 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: The goal of this study is to visualize the deposition of topical 0.3% roflumilast (Zoryve) compared to vehicle using Line-Field Optical Coherence Tomography (LC-OCT) in vivo in healthy skin. We hypothesize that the application of topical 0.3% roflumilast (Zoryve) will result in distinct patterns of deposition within the epidermal and dermal layers compared to the vehicle. Specifically, we anticipate observing deeper penetration and more uniform distribution of roflumilast within the skin layers, indicative of enhanced efficacy, as visualized by LC-OCT imaging. Detailed Description: Primary Objective Compare the deposition of Zoryve and the vehicle in the epidermal and dermal layers using LC-OCT. Primary Endpoint The primary endpoint of this study is a visual qualitative analysis of LC-OCT images conducted by an expert confocalist, Babar Rao MD. This analysis aims to assess the penetration of the active drug product compared to the vehicle. Subjects will be instructed to apply topical 0.3% Zoryve once daily for seven consecutive days to a predetermined 2x2cm area on the dorsal surface forearm, as defined by the investigator. Additionally, participants will apply a topical cream vehicle provided by Zoryve to the dorsall side of the opposite forearm. Therefore, one forearm, will be designated for application of Zoryve, while the other forearm will the designated for application of the topical cream vehicle supplied by Zoryve. Subjects will apply the topical vehicle and roflumilast, daily, for 7 consecutive days. LC-OCT imaging will be conducted on both arms at various time points: baseline (T0A), 15 minutes (T0B), 1 hour (T0C), 8-12 hours (T0D), 24 hours (T0E), seven days after application (T7), and seven days after not applying cream (T14). LC-OCT imaging will follow a predefined image acquisition protocol, with investigators designating 2x2cm areas for imaging. The imaging protocol will include capturing 2D vertical photos, 3D photos, and 2D vertical videos per imaging site. Participants will be instructed to photograph the imaging sites to aid in the accurate application of the active drug product or vehicle cream base. ### Conditions Module Conditions: - Healthy Skin ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: SINGLE_GROUP ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: BASIC_SCIENCE #### Enrollment Info Count: 3 Type: ESTIMATED Phases: - PHASE4 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: Roflumilast Label: Roflumilast Type: ACTIVE_COMPARATOR #### Arm Group 2 Intervention Names: - Other: Vehicle (Roflumilast 0.3% vehicle cream) Label: Vehicle Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Roflumilast Description: Roflumilast 0.3% cream Name: Roflumilast Type: DRUG #### Intervention 2 Arm Group Labels: - Vehicle Description: Vehicle (Roflumilast 0.3% vehicle cream) Name: Vehicle (Roflumilast 0.3% vehicle cream) Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The primary endpoint of this study is a visual qualitative analysis of LC-OCT images conducted by an expert confocalist, Babar Rao MD. This analysis aims to assess the penetration of the active drug product compared to the vehicle. Measure: LC-OCT Time Frame: 14 days ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Healthy subjects over 18 years of age from the outpatient dermatology clinic, Rao Dermatology. All subjects must have provided written informed consent. Exclusion Criteria: * Subjects with a history of immune-mediated skin conditions will be excluded from participation. Additionally, participants who have received systemic therapy within the last 60 days will not be eligible. Those using topical therapy must have discontinued their current treatment for a minimum of seven days prior to enrollment. Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: Rafiqbassem@gmail.com Name: Bassem Rafiq, BS Phone: 2403974368 Role: CONTACT #### Locations Location 1: City: Atlantic Highlands Contacts: *Contact 1:* - Email: Rafiqbassem@gmail.com - Name: Bassem Rafiq - Phone: 240-397-4368 - Role: CONTACT *Contact 2:* - Name: Babar K Rao, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Rao Dermatology State: New Jersey Status: RECRUITING Zip: 07716 ### IPD Sharing Statement Module Description: Results to be reported as pulled data IPD Sharing: NO ### References Module #### References Citation: Pixley JN, Schaetzle T, Feldman SR. A Review of Topical Roflumilast for the Treatment of Plaque Psoriasis. Ann Pharmacother. 2023 Aug;57(8):966-969. doi: 10.1177/10600280221137750. Epub 2022 Nov 24. PMID: 36420929 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440460 Acronym: ISWAY Brief Title: Intergenerational Study of War-Affected Youth Official Title: Social and Biological Mechanisms Driving the Intergenerational Impact of War on Child Mental Health: Implications for Developing Family-Based Interventions #### Organization Study ID Info ID: 22.115.01 #### Organization Class: OTHER Full Name: Boston College ### Status Module #### Completion Date Date: 2026-11-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2026-06-01 Type: ESTIMATED #### Start Date Date: 2024-05-27 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: University of Makeni Class: OTHER Name: Caritas Freetown Class: OTHER Name: Tulane University Class: OTHER Name: Kenema Government Hospital #### Lead Sponsor Class: OTHER Name: Boston College #### Responsible Party Investigator Affiliation: Boston College Investigator Full Name: Theresa Betancourt Investigator Title: Salem Professor in Global Practice Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: War-related violence is a leading driver of mental disorders and illness affecting children in low- and middle-income countries (LMICs). Parents exposed early in life to war-related violence and loss are at risk for mental health problems and may pass risks to their offspring. The study posits that war-related trauma alters the stress-response circuitry in ways that endure into adulthood and affect the next generation. This will be the first investigation in a 20-year longitudinal study to examine mechanisms that link parental war-related trauma exposure and subsequent mental health problems to risk for mental disorders in offspring. This study will extend the first intergenerational study of war in Sub-Saharan Africa (R01HD073349) to focus on children (aged 7-24) born to war-affected parents. Assessments of behavioral and biological indicators of the Research Domain Criteria (RDoC)-linked constructs of self-regulation and stress reactivity will be collected, including autonomic nervous system reactivity, inflammation, and telomere length as well as sophisticated observations of parent-child interactions and synchrony. These measures will be utilized to identify potentially modifiable risk and protective processes both to inform the development of screening tools to identify families at risk for poor child mental health and to be deployed as active ingredients of interventions to reduce transmission of mental health problems to children of war-affected parents. This follow-up study involves the following activities: 1. Pilot to assess measure performance and field test study protocols. 1. Translation and adaptation of newly selected measures 2. Pilot study of new child and adult measures with 36 caregivers and 60 children in a district of Sierra Leone unlinked to participants to test the feasibility and validity of new tools. 2. Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24. 1. Household tracking and re-enrollment of 145 households that were formerly enrolled in LSWAY (T1: 2002, T2: 2004, T3: 2008, T4: 2016). 2. Quantitative (full sample) and qualitative (subsample) data collection with 145 households who were enrolled in T4 LSWAY, including war-affected youth who are now parents, their intimate partners, and their children aged 7-24. Through these activities we will test three overarching hypotheses: 1. Childhood war-related trauma exposure will be associated with mental difficulties (anxiety, depression, post-traumatic stress, disruptions of emotion regulation). 2. Poor mental health in war-affected parents will be associated with emotional and behavioral disruptions in biological offspring. 3. Risk and protective factors across the social ecology may serve as intervention targets to mitigate the effects of parental war-related trauma on behavioral disruptions and stress physiology, both within and across generations. Detailed Description: The Intergenerational Study of War-Affected Youth (ISWAY) entails a fifth wave of data collection in a 22-year study of war-affected youth in Sierra Leone (the Longitudinal Study of War-Affected Youth, or LSWAY), the first of its kind in Sub-Saharan Africa. LSWAY findings drawn from four waves of data collection (T1:2002, T2: 2004, T3: 2008, T4:2016/17) that indicate that a healthy transition to adulthood among war-affected youth was linked to engagement in prosocial behavior and community involvement, while problems with hostility, poor emotion regulation, and social withdrawal created barriers to achieving healthy and productive lives. Community stigma and poor family acceptance compounded these barriers. Our preliminary analyses of offspring of war-affected youth-first enrolled at T4-indicate that harsh paternal parenting was associated with offspring poor mental health and maternal parenting (harsh and warm) predicted offspring disruptions in emotion regulation and mental health. We theorize such associations are linked to biological mechanisms, but research to date has been limited to cross-sectional data on the health and mental health of biological offspring. ISWAY will examine how social and biobehavioral mechanisms operate among war-affected parents to shape parenting and the mental health of offspring. The study's guiding framework blends a biobehavioral and ecological model of risk and resilience with the Stress Adjustment Paradigm.The Multisystemic Model of Child Development holds that both behavioral and biological mechanisms are influenced by risk and protective factors at different levels of the social ecology and that exposure to trauma may lead to disruptions in individual stress reactivity and emotion regulation. The Stress-Adjustment Paradigm posits that traumatic life events lead to individual outcomes that are shaped by risk and protective processes across the social ecology. Taken together, these theories propose that both past trauma and current social stressors (e.g., underemployment, stigma) have implications for understanding the mechanisms linking past parental trauma to parent-child interactions and the mental health of subsequent generations. Adult stress reactivity, including ANS reactivity, may manifest in similar ways among offspring. Biological markers of inflammation and telomere length may also be linked in war-affected parents and their offspring. An integrated model suggests that several important protective processes and resources may operate to mitigate these intergenerational disruptions such as social support and access to other attachment figures in the household who have strong self-regulation. Helping parents who have experienced severe trauma build self-regulation skills and extending social support networks may be critical components of preventive interventions. ISWAY entails an enriched follow-up of the parents and their offspring focusing on the RDoC-related constructs that may underlie self-regulation (negative/positive valence systems, arousal systems, social processes). Collecting and analyzing both behavioral and biological/physiological data will deepen understanding of mechanisms that may contribute to increased risk of mental health difficulties in offspring. This will be amplified by an exploration of modifiable risk and protective factors across the social ecology (individual, family, and community levels) to prioritize as intervention targets for addressing intergenerational risks to the mental health of offspring of war-affected parents. ### Conditions Module Conditions: - Anxiety Disorders - Anxiety State - Depressive Disorder - Mood Disorders - Trauma and Stressor Related Disorders - Social Skills - Violence, Non-accidental Keywords: - Early Child Development - Sierra Leone - Observational Study - Longitudinal - Emotion Regulation - Self Regulation - Mental Health - Stress - Trauma - Quality of Life - Stress Biomarkers - Biological Embedding - Parenting ### Design Module #### Bio Spec Description: Whole blood Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 804 Type: ESTIMATED Study Type: OBSERVATIONAL ### Outcomes Module #### Primary Outcomes Description: Diagnostic tool for depression and anxiety in caregivers Measure: Hopkins Symptom Checklist Time Frame: May-December 2024 Description: Diagnostic tool for depression in children Measure: Center for Epidemiological Studies Depression Scale-Child Time Frame: May-December 2024 Description: Diagnostic tool for post-traumatic stress disorder in caregivers Measure: UCLA PTSD Index-Revised Time Frame: May-December 2024 Description: Caregiver report on child's internalizing and/or externalizing Measure: Child Behavior Checklist Time Frame: May-December 2024 Description: Caregiver self-report and child self-report on emotion regulation Measure: Difficulties in Emotion Regulation Scale Time Frame: May-December 2024 Description: Child self-report of externalizing, internalizing, and prosocial attitudes and behaviors Measure: Oxford Measure of Psychosocial Adjustment Offspring Time Frame: May-December 2024 Description: Observation of child and caregiver cognitive functioning Measure: Rapid Assessment of. Cognitive and Emotional Regulation (RACER) Time Frame: May-December 2024 Description: Observation of child's Measure: Kaufman Assessment Battery for Children Time Frame: May-December 2024 Description: Caregiver and adult child self-report on parenting behaviors Measure: SWAY Parenting Time Frame: May-December 2024 Description: Caregiver self-report of child discipline practices and behaviors Measure: Adapted UNICEF Multiple Indicator Cluster Survey Child Discipline Module Time Frame: May-December 2024 Description: Caregiver self-report and child report on caregiver on caregiver attitudes and behaviors directed at child Measure: Parenting Acceptance and Rejection Questionnaire Time Frame: May-December 2024 Description: Coding system for observation of caregiver-child interactions Measure: Coding Interactive Behavior Time Frame: May-December 2024 Description: Observation of child's early literacy skills Measure: Early Grade Reading Assessment Early Grade Reading Assessment Time Frame: May-December 2024 Description: Observation of child's early numeracy skills Measure: Early Grade Math Assessment Time Frame: May-December 2024 Description: Measure of caregiver and child's autonomic response to stress via respiratory sinus arrhythmia (RSA) Measure: Autonomic Stress Reactivity Time Frame: May-December 2024 Description: Measure of caregiver and child's telomere length Measure: Telomere Length Time Frame: May-December 2024 Description: Measure of caregiver and child's inflammatory markers (e.g., C-reactive protein) Measure: Inflammation Time Frame: May-December 2024 Description: Caregiver and child self-report on daily hardships Caregiver and child self-report on daily hardships Caregiver and child self-report on daily hardships Measure: Post-War Adversities Scale Time Frame: May-December 2024 Description: Caregiver and adult child self-report on perceived stress Measure: Perceived Stress Scale Time Frame: May-December 2024 Description: Caregiver, child, and adult child self-report on traumatic childhood experience Measure: Childhood Trauma Questionnaire Time Frame: May-December 2024 #### Secondary Outcomes Description: Caregiver and child self-report of coping skills Measure: Brief COPE Scale Time Frame: May-December 2024 Description: Child-self report of beliefs involving norms around aggressive behavior Measure: Normative Beliefs about Aggression Scale Time Frame: May-December 2024 Description: Caregiver self-report of post-traumatic growth Measure: Post-Traumatic Growth Inventory Time Frame: May-December 2024 Description: Child and caregiver self-report of risk behaviors Measure: Adapted Youth Risk Behavior Survey Time Frame: May-December 2024 Description: Child and caregiver self-report of functioning Measure: WHO Disability Adjustment Scale Time Frame: May-December 2024 Description: Child self-report of school functioning Measure: Child Rating Scale Time Frame: May-December 2024 Description: Caregiver self-report on intimate partner violence Measure: Conflict Tactics Scale Time Frame: May-December 2024 Description: Caregiver and adult child self-report on intimate partner relationships Measure: Dyadic Adjustment Scale Time Frame: May-December 2024 Description: Caregiver and adult child report on demographic and household information Measure: Demographic and Health Survey (DHS) Sierra Leone Time Frame: May-December 2024 Description: Caregiver and child self-report on perceived community acceptance Measure: Perceived Community Acceptance Time Frame: May-December 2024 Description: Caregiver and adult child self-report on community engagement Measure: Community Politics & Participation Time Frame: May-December 2024 Description: Caregiver, child, and adult child self-report on social cohesion, disorder, and control Measure: Collective Efficacy Scale Time Frame: May-December 2024 Description: Caregiver, child, and adult child self-report on negative community interactions Measure: Everyday Discrimination Scale Time Frame: May-December 2024 Description: Caregiver, child, and adult child self-report on social support Measure: Inventory of Socially Supportive Behaviors Time Frame: May-December 2024 Description: Caregiver, child, and adult child self-report of perceived norms related to gender and masculinity Measure: Gender Equitable Men scale Time Frame: May-December 2024 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * being a war-affected young adult (referred to as the index participant) previously interviewed at one or more waves of the Longitudinal Study of War Affected Youth (LSWAY) who still resides in Sierra Leone * being a cohabitating intimate partner of the index participant; or (c) being a cohabitating biological child (aged 7-24) of the index participant. Exclusion criteria are (a) not being sampled in a prior LSWAY wave * being a cohabitating biological child (aged 7-24) of the index participant Exclusion Criteria: * not being sampled in a prior LSWAY wave * not being a biological child or intimate partner of the index cohort participant * being in acute crisis (active suicidality or psychosis) Minimum Age: 7 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT Study Population: The study population consists of participants who were formerly enrolled in T4 of LSWAY, including index subjects (i.e., war-affected youth), their caregivers, and biological offspring who meet the eligibility criteria. In addition, focus group participants, who were not part of the LSWAY cohort from prior study waves, will be recruited from the 5 largest districts in which LSWAY participants reside. These participants will be sampled in order to understand community experiences regarding the social context of parenting in Sierra Leone, including challenges and perceptions of social norms and their effect on everyday life in Sierra Leone. ### Contacts Locations Module #### Locations Location 1: City: Freetown Country: Sierra Leone Facility: Caritas Freetown #### Overall Officials Official 1: Affiliation: Boston College Name: Theresa S Betancourt Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: HIGH - As Found: Mood Disorders - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: HIGH - As Found: Trauma and Stressor Related Disorders - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders - ID: D000003866 - Term: Depressive Disorder - ID: D000019964 - Term: Mood Disorders - ID: D000068099 - Term: Trauma and Stressor Related Disorders ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440447 Acronym: EXPEDITE Brief Title: EXploring Patterns of Use and Effects of Adult Day Programs to Improve Trajectories of Continuing carE Official Title: EXploring Patterns of Use and Effects of Adult Day Programs to Improve Trajectories of Continuing carE (EXPEDITE) #### Organization Study ID Info ID: 563198b #### Organization Class: OTHER Full Name: York University ### Status Module #### Completion Date Date: 2027-06-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-30 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-06-30 Type: ESTIMATED #### Start Date Date: 2024-08-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-16 Study First Submit QC Date: 2024-05-30 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Carswell Family Foundation Class: UNKNOWN Name: Alzheimer Society of York Region #### Lead Sponsor Class: OTHER Name: York University #### Responsible Party Investigator Affiliation: York University Investigator Full Name: Matthias Hoben Investigator Title: Associate Professor, Helen Carswell Chair in Dementia Care Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This study seeks to understand the impact of Canada's adult day program on attendees and non-attendees, especially those with dementia and other co-morbidities. A retrospective cohort study will be conducted, including older adults in the community who do or do not attend adult day programs in Alberta, British Columbia, and Manitoba, Canada. The objectives are to (1) compare patterns of day program use (including non-use) by Canadian province (Alberta, British Columbia, Manitoba), and time, (2) compare characteristics of older adults by day program use pattern (including non-use), province, and time, and (3) to examine whether those who are exposed to day programs, compared to a propensity-score matched comparison group of non-exposed older adults in the community, enter long-term care homes at later times (primary outcome), are less likely to have depressive symptoms, physical and cognitive change, and have lower use of primary, acute, and emergency care (secondary outcomes). Detailed Description: Adult day programs provide critical supports to both, older adults living in the community, and their family/friend caregivers. This is essential because ensuring high-quality care in the community for as long as possible and avoiding or delaying long-term care home admissions are key priorities of older adults, their caregivers, and healthcare systems. While most older adults in Canada receive care in the community, about 10% of newly admitted nursing home residents have relatively low care needs that could be met in the community with the right supports. Caregivers provide most of the care in the community, which puts them at high risk for caregiver burden. Day programs intend to mitigate these issues by providing respite to caregivers. However, research on the effectiveness of day programs is inconsistent. Generally, the methodological quality of studies is poor, and especially Canadian research is lacking. The research objectives are to (1) explore changes in patterns of day program use (including non-use) between provinces and over time, (2) compare characteristics of older adults with different day program use patterns (including non-use), and (3) assess whether day program attendees compared to a propensity score matched control group of non-attendees have better outcomes. This retrospective cohort study will use population-based clinical and health administrative data of older adults (65+ years) who received publicly subsidized continuing care in the community in Alberta, British Columbia, and Manitoba between January 01, 2012 and December 31, 2024. Patterns of day program use (i.e., variations in time to attend a day program for the first time, and frequency and duration of attendance) and how these patterns vary by province and over time will be assessed. Characteristics of older adults with different patterns of day program use (e.g., no, low, medium, high) will be compared. Characteristics of the participants will include age, sex, dementia status, frailty level, comorbidity status, socioeconomic status, availability of a caregiver, and caregiver distress. Finally, propensity-matched comparison group (by region, age, gender, cognitive/physical impairment, type/duration of community care received previously) of older adults who have not attended a day program will be created. Time-to-event models and general estimating equations will assess whether day program attendees compared to non-attendees enter continuing care facilities later (primary outcome); use emergency, acute, or primary care less frequently; experience less cognitive and physical decline; and have better mental health (secondary outcomes). Models will include day program exposure as an independent variable and will be adjusted for province, participant demographics, medical and functional conditions, caregiver availability/distress, other community services received (e.g., home care, in-home respite), and (if appropriate) matching variables. ### Conditions Module Conditions: - Adult Day Programs - Continuing Care - Old Age; Dementia - Family/Friend Caregivers Keywords: - Adult day programs - Older adults - Program evaluation - Cohort studies - Health administrative data ### Design Module #### Design Info Observational Model: COHORT Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 500000 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Older adults (65+ years) attending an adult day program in Alberta, British Columbia, or Manitoba Intervention Names: - Other: Adult day program use Label: Day program attendees #### Arm Group 2 Description: Older adults with an initial Resident Assessment Instrument - Home Care (RAI-HC), who are not attending a day program in Alberta, British Columbia, or Manitoba Intervention Names: - Other: Other community care (non-attendees) Label: Non-attendees ### Interventions #### Intervention 1 Arm Group Labels: - Day program attendees Description: Day program use patterns will be determined, using Latent Class Analysis. Three continuous variables will be categorized as low, low-moderate, high-moderate, high, using sample distribution quartiles: (1) Time between first RAI-HC assessment and first attendance of a day program, (2) average number of hours of day program attendance (i.e., total number of hours spent in a day program divided by the number of times attended), and (3) total number of days a person attended a day program. Name: Adult day program use Type: OTHER #### Intervention 2 Arm Group Labels: - Non-attendees Description: Any publicly funded continuing care services in the community, other than adult day programming (e.g., home care, in-home respite). Community care participants will be propensity score matched with day program participants, using RAI-HC variables on day program eligibility (to ensure similarity of non-attendees to day program attendees). Matching variables will include: physical functioning, cognition, behavioural symptoms, bladder/bowel continence, availability of a caregiver, and caregiver distress. The investigators will also include variables on health and social characteristics (e.g., age, sex, type/duration of publicly funded community care received before the matching index date, deprivation indices). Name: Other community care (non-attendees) Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Data will come from provincial continuing care registries, which document the start date of any publicly funded continuing care service a person receives, the end date of this service, and the type of service. The outcome will be the time between a person's first RAI-HC assessment and admission to a long-term care home (i.e., an assisted living home or nursing home). Measure: Time to admission to a long-term care homes Time Frame: From date of home care admission until the date of admission to a long-term care home or loss to follow up (i.e., death, move out of province), whichever came first, assessed up to 12 years (between Jan 31, 2012 and Dec 31, 2024) #### Secondary Outcomes Description: To determine the presence or absence of depressive symptoms, the validated RAI-HC Depression Rating Scale (DRS) will be used. DRS scores range from 0-14, and a cut-point of 3 or higher represents clinically meaningful depressive symptoms. Measure: Symptoms of depression Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first Description: Change in physical functioning will be captured, using the validated RAI-HC Activities of Daily Living Hierarchy (ADLh) scale. The scale ranges from 0 (no impairment) to 6 (maximum impairment), and the outcome will be dichotomous, indicating any increase (versus no change or a decrease) between the previous and follow up measurement in this scale. Measure: Presence or absence of physical decline Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first Description: Change in cognition will be captured, using the validated RAI-HC Cognitive Performance Scale (CPS). The scale ranges from 0 (no impairment) to 6 (maximum impairment), and the outcome will be dichotomous, indicating any increase (versus no change or a decrease) between the previous and follow up measurement in this scale. Measure: Presence or absence of cognitive decline Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first Description: The National Ambulatory Care Report System (NACRS) captures all emergency department visits and diagnoses. The outcome will be the yearly average number of a person's emergency department visits. Measure: Emergency room registrations Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first Description: The Discharge Abstract Database (DAD) includes information on all inpatient hospital stays, including diagnoses and length of stay. The outcome will be the yearly average number of a person's hospital stays. Measure: Hospital stays Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first Description: Care provider claims data includes health service claims submitted for payment by primary care providers (e.g., general practitioners, nurse practitioners, geriatricians, geriatric psychiatrists, neurologists, therapists). The outcome will be the yearly average number of a person's primary care provider visits. Measure: Primary care provider visits Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first ### Eligibility Module Eligibility Criteria: Inclusion criteria: * Persons aged 65 years and over * Initial RAI-HC assessment completed * Attendance of an adult day program (for cohort 1) * Receipt of any community-based continuing care services, other than adult day program (cohort 2) Exclusion criteria: - No receipt of any community-based continuing care service Minimum Age: 65 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - OLDER_ADULT Study Population: The study focuses on community care systems in Alberta, British Columbia, and Manitoba, all of which assess day program eligibility using comparable processes, criteria, and assessments (i.e. RAI-HC). The yearly average number of completed RAI-HC assessments is \~20,000-30,000 in Alberta, \~34,000-39,000 in British Columbia, and \~10,000 in Manitoba. The estimated number of day program attendees is \>20,000/year (\>200,000 within the study period), each with multiple assessments. ### Contacts Locations Module #### Central Contacts Contact 1: Email: mhoben@yorku.ca Name: Matthias Hoben, Dr rer medic Phone: +1 437-335-1338 Role: CONTACT #### Overall Officials Official 1: Affiliation: York University Name: Matthias Hoben, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: The health administrative data used in this study are owned by the respective provincial health authorities. Provincial data policies do not allow public sharing of these data. The research team will work with an in-house health system data analyst in each of the provinces to carry out the analyses. Data are required to stay within the respective province and within the province's protected and secure data repository. IPD Sharing: NO ### References Module #### References Citation: European Commission. The 2018 ageing report: Economic and budgetary projections for the 28 EU member states (2016-2070). Luxembourg: European Commission; 2018. Report No.: 79. Available from: https://economy-finance.ec.europa.eu/publications/2018-ageing-report-economic-and-budgetary-projections-eu-member-states-2016-2070_en#files [accessed Sep 2, 2022] Citation: Federal/provincial/territorial ministers responsible for seniors. Core community supports to age in community. Ottawa: Government of Canada; 2019. Available from: https://www.canada.ca/en/employment-social-development/corporate/seniors/forum/core-community-supports.html [accessed Sep 2, 2022] Citation: MacDonald B-J, Wolfson M, Hirdes JP. The future co$t of long-term care in Canada. Toronto, ON: National Institute on Aging; 2019. Available from: https://www.nia-ryerson.ca/reports [accessed Sep 2, 2022] Citation: Thomas KS, Applebaum R. Long-term services and supports (LTSS): A growing challenge for an aging America. Public Policy & Aging Report 2015;25(2):56-62. doi: 10.1093/ppar/prv003 Citation: Whitman DB. Unsolved mysteries in aging policy. Public Policy & Aging Report 2015;25(2):67-73. doi: 10.1093/ppar/prv006 Citation: 2022 Alzheimer's disease facts and figures. Alzheimers Dement. 2022 Apr;18(4):700-789. doi: 10.1002/alz.12638. Epub 2022 Mar 14. PMID: 35289055 Citation: Prince MJ, Wimo A, Guerchet MM, Ali GC, Wu Y-T, Prina M. World Alzheimer Report 2015 - The Global Impact of Dementia: An analysis of prevalence, incidence, cost and trends. London: Alzheimer's Disease International; 2015. Available from: https://www.alzint.org/resource/world-alzheimer-report-2015/ [accessed Sep 2, 2022 Citation: Public Health Agency of Canada. Dementia in Canada. Ottawa: Public Health Agency of Canada; Available from: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/dementia.html [accessed Sep 2, 2022] Citation: Nguyen H, Manolova G, Daskalopoulou C, Vitoratou S, Prince M, Prina AM. Prevalence of multimorbidity in community settings: A systematic review and meta-analysis of observational studies. J Comorb. 2019 Aug 22;9:2235042X19870934. doi: 10.1177/2235042X19870934. eCollection 2019 Jan-Dec. PMID: 31489279 Citation: The Academy of Medical Sciences. Multimorbidity: a priority for global health research. London: The Academy of Medical Sciences; 2018. Available from: https://acmedsci.ac.uk/policy/policy-projects/multimorbidity [accessed Sep 2, 2022] Citation: Canadian Institute for Health Information (CIHI). Quick stats - Home Care Reporting System (HCRS) profile of clients in home care 2020-2021. Available from: https://www.cihi.ca/en/quick-stats [accessed Sep 2, 2022] Citation: Morgan T, Ann Williams L, Trussardi G, Gott M. Gender and family caregiving at the end-of-life in the context of old age: A systematic review. Palliat Med. 2016 Jul;30(7):616-24. doi: 10.1177/0269216315625857. Epub 2016 Jan 26. PMID: 26814213 Citation: Quesnel-Vallée A, Willson A, Reiter-Campeau S. Health inequalities among older adults in developed countries: Reconciling theories and policy approaches. In: George L, Ferraro K, editors. Handbook of aging - social sciences 8th ed. London: Elsevier; 2016. Citation: Quesnel-Vallée A, Farrah J-S, Jenkins T. Population aging, health systems, and equity: Shared challenges for the United States and Canada. In: Settersten Jr. RA, Angel JL, editors. Handbook of sociology of aging New York, Dordrecht, Heidelberg, London: Springer; 2011. Citation: McGrail K. Long-term care as part of the continuum. Healthc Pap. 2011;10(4):39-43; discussion 58-62. doi: 10.12927/hcpap.2011.22190. PMID: 21593615 Citation: Sinha S, Dunning J, Wong I, Nicin M, Nauth S. Enabling the future provision of long-term care in Canada. Toronto, ON: National Institute on Aging; 2019. Available from: https://www.nia-ryerson.ca/reports [accessed Sep 2, 2022] Citation: Federal/provincial/territorial ministers responsible for seniors. Report on housing needs of seniors. Ottawa: Government of Canada; 2019. Available from: https://www.canada.ca/en/employment-social-development/corporate/seniors/forum/report-seniors-housing-needs.html [accessed Sep 2, 2022] Citation: Spasova S, Baeten R, Coster S, Ghailani D, Peña-Casas R, Vanhercke art. Challenges in long-term care in Europe - A study of national policies 2018. Brussels: European Commission; 2018. Available from: https://ec.europa.eu/social/main.jsp?langId=en&catId=1135&newsId=9185&furtherNews=yes [accessed Sep 2, 2022] Citation: Goncalves J, Weaver F, Konetzka RT. Measuring State Medicaid Home Care Participation and Intensity Using Latent Variables. J Appl Gerontol. 2020 Jul;39(7):731-744. doi: 10.1177/0733464818786396. Epub 2018 Jul 6. PMID: 29978735 Citation: Wysocki A, Butler M, Kane RL, Kane RA, Shippee T, Sainfort F. Long-Term Services and Supports for Older Adults: A Review of Home and Community-Based Services Versus Institutional Care. J Aging Soc Policy. 2015;27(3):255-79. doi: 10.1080/08959420.2015.1024545. PMID: 25942005 Citation: Royal Bank of Canada. 2013 RBC retirement myths & realities poll: most appealing living arrangements for boomers. 2013. Available from: http://www.rbc.com/newsroom/news/2013/20131024-myths-realities.html [accessed Sep 2, 2022] Citation: American Association of Retired Persons (AARP). 2018 home and community preferences: A national survey of adults age 18-plus. Washington, DC: AARP Research; 2018. 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PMID: 8199334 ## 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: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6904 - Name: Dementia - Relevance: HIGH - As Found: Dementia - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003704 - Term: Dementia ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440434 Brief Title: Effects of Morningness on Night Split Shift Performance Official Title: Effects of Morningness on Night Split Shift Performance #### Organization Study ID Info ID: M3447 #### Organization Class: OTHER Full Name: University of Bergen ### Status Module #### Completion Date Date: 2024-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-06-02 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2024-05-24 Type: ESTIMATED #### Start Date Date: 2024-04-19 Type: ACTUAL Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-14 Study First Submit QC Date: 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University of Bergen #### Responsible Party Investigator Affiliation: University of Bergen Investigator Full Name: Ståle Pallesen 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 is to investigate if the morningness-eveningness dimension mediates sleep and function on spilt night shifts (midnight-4am and 4am-8am). Does those with high score of morningness function relatively better on the last compared to the first split shift? Participants will: Record their sleep from 2 days prior to 2 days following the split shift During the shifts complete questionnaires assessing mood, sleepiness and perceived performance as well as complete cognitive tests: Psychomotor vigilance test, digit symbol substitution test, working memory scanning test, reversal learning test, and visual search test Detailed Description: A sample of 28 students will be recruited and exposed to two conditions in a randomized, controlled, crossover study. They will be assessed with subjective (sleep diary) and objective sleep measures (sleep radar) for 2 days before the night shift, during the night shift and 2 days following the night shift. The simulated night shifts will last from midnight to 8am and will be divided into two halves (midnight-4am and 4am-8am), denoted as split-shift, and for each participant separated by at least 1 week. Based on the Horne-Östberg Morningness-Eveningness Questionnaire (median spilt) two groups are created, from which participants will be randomized to the two orders of the spilt-shift. Each hour on each shift the participants will complete: Positive and Negative Affect Schedule (PANAS), Karolinska Sleepiness Scale, perceived performance and the following cognitive tests: Psychomotor vigilance test, Digit symbol substitution test, Working memory scanning test, Reversal learning test, and Visual search test. Data will be analyzed with linear mixed models with three fixed factors: Group (low vs. high morningness), shift (midnight-4am vs. 4am-8am), and hour and one random factor (participant). ### Conditions Module Conditions: - Shift-work Disorder ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER Intervention Model Description: A 2 (midnight-4am vs.4am-8am) within factor x 2 (below vs. above median on morningness) between factor experimental design ##### Masking Info Masking: NONE Masking Description: Randomly allocated to order of night shifts (midnight-4am vs.4am-8am) Primary Purpose: BASIC_SCIENCE #### Enrollment Info Count: 30 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Behavioral: Time of night shift Label: Early night shift (midnight-4am) Type: ACTIVE_COMPARATOR #### Arm Group 2 Intervention Names: - Behavioral: Time of night shift Label: Late night shift (4am - 8am) Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Early night shift (midnight-4am) - Late night shift (4am - 8am) Description: Early vs. late night split night shift Name: Time of night shift Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Total sleep (sleep diary and radar). Higher values indicates more sleep Measure: Total sleep time Time Frame: Total sleep time between 6pm day before shift start to 6pm the day the shift end for both early night shift (midnight-04am) and late night shift (04am-08am) Description: Reaction time (mean 1/RT) and number of lapses (RTs≥500 ms). For mean 1/RT higher values are associated with best performance, on lapses higher values are associated with worst performance Measure: Psychomotor Vigilance Test (PVT) Time Frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift) Description: Assessment of state sleepiness, range 1-9 (higher scores indicate worse state) Measure: Karolinska Sleepiness Scale (KSS) Time Frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift) #### Secondary Outcomes Description: Sleep efficiency (diary and radar). Range from 0-100%. Higher scores indicate best state Measure: Sleep efficiency (percentage of time in bed one sleeps) Time Frame: Between 6pm day before shift start to 6pm the day the shift end for both early night shift (midnight-04am) and late night shift (04am-08am) Description: Assessment of mood/affect. Range 10-50. On positive mood subscale higher scores indicate best state, on negative mood state, higher scores indicate worst state Measure: Positive and Negative Affect Schedule (PANAS) Time Frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift) Description: Self-rated performance on cognitive tests. Range 1-10. Higher scores indicate best performance rating Measure: Self-rated performance Time Frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift) Description: Test where one match symbols to numbers as fast as possible. Range 0-100. Higher scores indicate best performance Measure: Digital Symbol Substitution Test Time Frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift) Description: Test presenting list of words. Then words are presented and subjects decide if word was present or not in list presented. The accuracy and RTs for positive trials (where probe was present in list) will be used as dependent variables. Higher accuracy and lower reaction time are associated with best performance Measure: Working Memory Scanning Test (probed recall) Time Frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift) Description: Test measuring the ability to differentiating between "go-stimuli" and "no-go stimuli" before and after reversal of go and no-go stimuli. Discriminability (hit rate/false alarm rate) and response bias before and after reversal are recorded. Higher discriminability indicates better performance, higher response bias indicate worse performance Measure: Reversal Learning Test Time Frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift) Description: Multiple objects are presented, and from among them a target is identified. The task of the subject is finding the target. Outcomes are reaction time (RT) and accuracy. Lower reaction times and higher accuracy are associated with best performance Measure: Visual Search Test Time Frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * 18-40 years old * no incorrectable vision problems Exclusion Criteria: \* regular use of sleep medication Healthy Volunteers: True Maximum Age: 40 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Locations Location 1: City: Bergen Country: Norway Facility: University of Bergen Zip: 5020 ### IPD Sharing Statement Module Description: If legel in terms of data protection regulations data will be shared IPD Sharing: UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440421 Brief Title: Understanding Food Choices in Bahrain Official Title: Evaluating Promising Food Labelling Interventions Using Bahrain e-Mart #### Organization Study ID Info ID: #0002004615 #### Organization Class: OTHER Full Name: Duke-NUS Graduate Medical School ### Status Module #### Completion Date Date: 2024-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-06-02 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-12 Type: ESTIMATED #### Start Date Date: 2024-07 Type: ESTIMATED Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-24 Study First Submit QC Date: 2024-05-30 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: World Bank Class: UNKNOWN Name: Ministry of Industry and Commerce, Bahrain Class: OTHER_GOV Name: Ministry of Health, Bahrain #### Lead Sponsor Class: OTHER Name: Duke-NUS Graduate Medical School #### Responsible Party Investigator Affiliation: Duke-NUS Graduate Medical School Investigator Full Name: Soye Shin 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: Using a two-arm randomized controlled trial (RCT) and an intercept survey, the investigators aim to evaluate the effects of the Multiple-Traffic Light (MTL) front-of-pack (FOP) food labels in Bahrain, on diet quality of grocery shoppers in the Kingdom of Bahrain. The investigators will use an experimental online grocery store, called Bahrain e-Mart, which is similar in design to commercial web-based grocery stores to test these labels. Participants will complete an online shopping experiment on Bahrain e-Mart such that those assigned to the control arm and those assigned to the intervention arm would be exposed to food and beverage products with no FOP labels and with MTL labels, respectively. Participants will randomly be assigned to one of the following arms and asked to complete a one-time shop. Arm 1 (Control): Participants will experience a default version of Bahrain e-Mart which replicates the traditional shopping experience of online grocery stores with no FOP labels. Arm 2 (MTL): Same as Arm 1 Bahrain e-Mart except that Multiple-Traffic Light (MTL) labels are displayed on all food and beverage products. The investigators hypothesize the following: Hypothesis 1: Diet quality, as measured by weighted (by the number of servings) average of all purchased products' Multiple Traffic Light scores for the shopping trip, will be greater in Arm 2 as compared to Control. Multiple Traffic Light is a nutrition labelling system wherein each nutrient attribute constituting this label is assigned different colours according to whether the amount of that nutrient is low (green), medium (amber) or high (red). Hypothesis 2: Diet quality, as measured by weighted (by the number of servings) average of all purchased products' Nutri-Score points for the shopping trip, will be greater in Arm 2 as compared to Control. Relying on the British Food Standard Agency Nutrient Profiling System, the Nutri-Score (NS) point system assigns points to each product based on levels of 7 nutrients (calories, saturated fats, sugar, salt, fibre, protein and percentage of fruits, vegetables, and nuts) per 100g or 100 ml to assess overall nutritional quality. The final NS points range from 0 to 55, with 0 being the least healthy score and 55 the healthiest. Hypothesis 3: The weighted (by the number of servings) average calories (kcal), sugar (g), sodium (mg), total fat (g), and saturated fat (g) per serving will be less in Arm 2 as compared to Control. Detailed Description: Experimental design \& procedures The aim of this study is to use a 2-arm randomized controlled trial with an online grocery store (Bahrain e-Mart), to rigorously evaluate the effect of the Multiple Traffic Light front-of-pack (MTL FOP) labels displayed on all food and beverage products, on diet quality. Multiple Traffic Light (MTL) Labels The investigators will test one type of front-of-pack (FOP) label known as MTL. The MTL label includes per serving size information and grades each nutrient i.e., energy, sugar, fat, saturated fat, and sodium separately based on recommended thresholds. Green signifies a healthy amount of that nutrient; red signifies an unhealthy amount, and amber signifies that the nutrient levels fall between healthy and unhealthy amounts. Additionally, the label also shows how much of a person's daily allowance for a particular nutrient is met by consuming one serving of the product. Lastly, MTL includes the absolute values of each nutrient per serving of a product and the percentage of an adult's daily reference intake that is met by consuming a serving of this product. Overview of Randomised Control Trial (RCT) Design To test these labels, the investigators used two different versions of Bahrain e-Mart. Each participant was randomly assigned to one of the following arms and asked to complete a one-time shop. Arm 1 (Control): Participants will experience a default version of Bahrain e-Mart which replicates the traditional shopping experience of online grocery stores with no FOP labels. Arm 2 (MTL): Same as Arm 1 Bahrain e-Mart except that Multiple-Traffic Light (MTL) labels are displayed on food and beverage products. Multiple Traffic Light is a nutrition labelling system wherein each nutrient attribute constituting this label (i.e. sugar, saturated fat, fat, and sodium) is assigned different colours according to whether the amount of that nutrient is low (green), medium (amber) or high (red). To collect shopping data as close as possible to shoppers' actual grocery carts, the investigators set a minimum spending value per person per week and adjusted the total minimum spending value depending on household size. Additionally, participants will have to shop from at least 4 different Bahrain e-Mart categories to successfully checkout their cart. Finally, participants will be informed that they may win rebates ranging from 25% to 100% on their grocery order. This will be done by implementing an electronic prize wheel that the participants will spin after successfully checking out their cart. Every participant will have an equal chance of winning. If they win any of the rebates, they will be expected to conduct a grocery shop in a market/supermarket of their choice to purchase the same items ordered on the Bahrain e-Mart grocery store website. The maximum rebate they can get after spinning the wheel will be based on their drawn rebate rate and the total order amount on Bahrain e-Mart (e.g., If participants win a 50% rebate and the total order amount on Bahrain e-Mart was BD 40, the maximum rebate they can get would be BD 20). If the exact same item cannot be found, they are allowed to purchase a similar item as a replacement instead. Replacements are subject to the guidelines provided in the participant information sheet and consent form that they must sign prior to enrolment and randomisation into either of the study arms. Subject related procedures Participants will be recruited if they are Kingdom of Bahrain residents aged 21 years or older, can speak and write Arabic or English and are primary weekly shoppers for their households. Recruitment will be done by a market research company utilising in-person intercept surveys. This survey aims to recruit participants across 4 cities and 20 locations (e.g., shopping malls). The Duke-NUS team is not directly involved in data collection. Participants will be intercepted in-person by the interviewer and be briefed about the study. Those who are interested will first be invited to select their preferred language (i.e. English or Arabic) and then complete the online screener questionnaire using a tablet. All eligible participants will then be asked to enter their mobile number in a textbox field and will be required to give consent for the investigators to use their personal data for registration purposes, that is, to verify via OTP that their mobile number has never been entered into the system before. This ensures that the participant is not a duplicate participant and has not attempted to join the study before. Participants who decide to withdraw from the study after screener completion and provision of their mobile number will be ineligible to participate in the study again. Participants will subsequently be asked to read an information sheet and provide their consent to enroll in this study by entering their name and email address in a textbox field. Upon consent, participants will be redirected to complete a baseline questionnaire to collect demographic and health characteristics, which should take approximately 10 minutes to complete. The baseline questionnaire includes a question as to whether any household members have a medical condition, such as diabetes or hypertension, which requires limiting the types of foods they eat. Investigators ask this question to allow for testing whether the intervention differentially influence these households, with the expectation that households with less healthy patients may obtain greater benefits from purchasing baskets with higher mean Nutri-Scores. Since the objective of this (RCT is to quantify the effectiveness of the intervention on diet quality, a precursor to non-communicable diseases (NCDs), the collection of household health indicators is reasonable. Upon completion of the baseline survey, participants will be randomly assigned to one of the 2 shopping conditions (Arm 1 \[Control\] or Arm 2) and redirected to Bahrain e-Mart to log in and begin shopping immediately. Participants will be informed that the shop must be completed with the aim of purchasing enough groceries for all members of their household for a week. If they have a household size of 8 members or less, they are required to spend a minimum of BD 10 (≈USD 26) for each member of their household, and their expenditure should not exceed twice the total minimum. For instance, if they have 4 members their minimum expenditure should be BD 10 X 4 = BD 40 and their maximum expenditure should be BD 40 x 2 = BD 80. However, if they have a household size of more than 8 members, they are required to spend a minimum of BD 80 and a maximum of BD 160. Additionally, participants must select products from at least 4 different Bahrain e-Mart Store categories (e.g. Dairy and eggs, fruits and vegetables etc.). The interviewer will stand at a distance to allow participants to complete their shop privately up until the prize wheel, unless the participant raises any questions. The time spent completing the shop is expected to be approximately 15-20 minutes. Subsequently, participants will be required to complete a post-study survey which should take around 3-5 minutes to complete. Upon completion of the post-study survey, participants will spin a random electronic prize wheel. Depending on the results of the prize wheel, their shopping trip may or may not involve actual purchases. Participants may win rebates ranging from 25% to 100% based on their total order amount on Bahrain e-Mart. To claim their rebate, participants are expected to email the market research company ONE image of their purchased grocery items and ONE clear image of the itemized grocery receipt for verification within 14 days from the time of study completion, which is after the participant spins the prize wheel. If no claims have been received via email within the stipulated time, the rebate will be forfeited. Please note that participants will still receive BD 2.5 via online transfer as stated in the participant information sheet. Once the market research company validates the two images above, the study reimbursement and rebate amount will be transferred to the participant via online transfer. This will be done within 24 working hours of the company receiving the images. If the prize wheel lands on "BD 2.5", then no further action is required. The study reimbursement will be transferred to the participant via online transfer immediately upon study completion. The study reimbursement of BD 2.5 will be given to all participants, regardless of the outcome of the prize wheel. The prize wheel only determines the additional rebates that participants may win. All individuals who provided their consent to join this study will be emailed a copy of the full information sheet and consent form as well as the debriefing sheet when they complete the study (i.e., after participant has spun the wheel of rebate) or if they choose to withdraw from the study. This is the same for participants who land on "BD2.5". The interviewer will remind participants to review the debriefing sheet on their own. Analysis Plan An ordinary least square model will be used to compare the primary and secondary outcome variables between the MTL arm and the control arms. The model will be adjusted for potential confounders including age, gender, household size, education level, income, and prevalence of diet-related health conditions that may affect the outcomes. ### Conditions Module Conditions: - Diet, Healthy Keywords: - Front of pack labels - Diet quality - Online grocery shopping - Kingdom of Bahrain - Multiple traffic light labels ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: TRIPLE Who Masked: - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: HEALTH_SERVICES_RESEARCH #### Enrollment Info Count: 432 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will experience a default version of Bahrain e-Mart which replicates the traditional shopping experience of online grocery stores with no FOP labels. Label: Control Arm (Arm 1) Type: NO_INTERVENTION #### Arm Group 2 Description: Same as Arm 1 Bahrain e-Mart except that Multiple-Traffic Light (MTL) labels are displayed on food and beverage products. Intervention Names: - Behavioral: MTL Labels Label: MTL Labels (Arm 2) Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - MTL Labels (Arm 2) Description: The MTL label developed by the United Kingdom (UK) Food Standards Agency (FSA) includes per serving size information and grades each nutrient i.e., energy, sugar, fat, saturated fat, and sodium separately based on recommended thresholds. Green signifies a healthy amount of that nutrient; red signifies an unhealthy amount, and amber signifies that the nutrient levels fall between healthy and unhealthy amounts. Additionally, the label also shows how much of a person's daily allowance for a particular nutrient is met by consuming one serving of the product. Lastly, MTL includes the absolute values of each nutrient per serving of a product and the percentage of an adult's daily reference intake that is met by consuming a serving of this product. These will be displayed on all food and beverage products shown on this version of Bahrain e-Mart. Name: MTL Labels Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Diet quality measured by the weighted (by the number of servings) average of all purchased products' Multiple Traffic Light scores for the shopping trip. Multiple Traffic Light is a nutrition labelling system wherein each nutrient attribute constituting this label is assigned different colours according to whether the amount of that nutrient is low (green), medium (amber) or high (red). MTL Scores are calculated by assigning values to the 4 nutrients that constitute Multiple Traffic Light labels i.e., sugar, fat, saturated fat, and sodium wherein each nutrient classified with a green colour is assigned a score of 3, amber ones are assigned a score of 2 and red ones are assigned a score of 1. Then, the resulting average is computed for each product on the store. Measure: Value of Multiple Traffic Light Score Time Frame: After completion of data collection, an average of about 5 months #### Secondary Outcomes Description: Secondary diet quality measured by taking the weighted (by the number of servings) average of all purchased products' Nutri-Score points for the shopping trip. Relying on the British Food Standard Agency Nutrient Profiling System, the Nutri-Score (NS) point system assigns points to each product based on levels of 7 nutrients (calories, saturated fats, sugar, salt, fibre, protein and percentage of fruits, vegetables, and nuts) per 100g or 100 ml to assess overall nutritional quality. The final NS points range from 0 to 55, with 0 being the least healthy score and 55 the healthiest. Measure: Value of Nutri-Score points Time Frame: After completion of data collection, an average of about 5 months Description: Calories per serving. Measure: Quantity of calories that MTL labels display Time Frame: After completion of data collection, an average of about 5 months Description: Grams of sugars per serving. Measure: Quantity of sugars that MTL labels display Time Frame: After completion of data collection, an average of about 5 months Description: Milligrams of sodium per serving. Measure: Quantity of sodium that MTL labels display Time Frame: After completion of data collection, an average of about 5 months Description: Grams of saturated fat per serving. Measure: Quantity of saturated fat that MTL labels display Time Frame: After completion of data collection, an average of about 5 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * People who are residents of the Kingdom of Bahrain * Age of 21 and above, * Arabic OR English speakers and readers, and * A weekly primary grocery shopper for their households can participate in this study. Exclusion Criteria: * People who are not residents of the Kingdom of Bahrain * Under 21 years of age, * Cannot speak or read Arabic AND English, or * Are not weekly primary grocery shoppers for their households cannot participate in this study. Healthy Volunteers: True Minimum Age: 21 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: michelle.chow@duke-nus.edu.sg Name: Michelle TN Chow, BSc Phone: +65 6516 1276 Role: CONTACT Contact 2: Email: jyotika.puri@duke-nus.edu.sg Name: Jyotika Puri, BSocSc Phone: +65 6601 6442 Role: CONTACT #### Overall Officials Official 1: Affiliation: Duke-NUS Graduate Medical School Name: Soye Shin, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440408 Acronym: PVS-WSS Brief Title: Calculating Wall Shear Stress in Infant Pulmonary Veins Official Title: Calculating Wall Shear Stress in Pulmonary Veins of Infants Using Cardiac Magnetic Resonance Imaging: A Pilot Study #### Organization Study ID Info ID: IRB 23-021612 #### Organization Class: OTHER Full Name: Children's Hospital of Philadelphia ### Status Module #### Completion Date Date: 2026-03 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-30 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-09 Type: ESTIMATED #### Start Date Date: 2024-09 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-24 Study First Submit QC Date: 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Children's Hospital of Philadelphia #### Responsible Party Investigator Affiliation: Children's Hospital of Philadelphia Investigator Full Name: Ryan Callahan, MD Investigator Title: Assistant Professor of Pediatrics Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Oversight Has DMC: False ### Description Module Brief Summary: The purpose of this study is to better understand pediatric pulmonary vein stenosis (PVS), which is the narrowing of blood vessels that connect the lungs to the heart. PVS is a life-threatening disease without a clear cause. The investigators think patients who develop PVS have an increased Wall Shear Stress (WSS) level in the pulmonary veins, which is the force placed on the walls of the veins. This study will determine if WSS can be calculated in the pulmonary veins of infants using Ferumoxytol enhanced Cardiac Magnetic Resonance Imaging (FcMRI). If possible, the investigators aim to use FcMRI to better screen patients at risk of PVS and to help guide therapy in patients with PVS. Detailed Description: Background: The mechanism of pediatric intraluminal pulmonary vein stenosis (PVS) remains unknown. It is hypothesized that elevated wall shear stress (WSS) as a result of excessive pulmonary blood flow (left to right shunts) and/or pulmonary vein distortion from surrounding anatomy contributes to the neo-intimal proliferation. Calculating WSS in pediatric pulmonary veins using ferumoxytol enhanced cardiac magnetic resonance (FcMRI) has not been reported and would represent a novel method of evaluation. Objectives: The primary objective is to determine the feasibility of calculating WSS in infant pulmonary veins using FcMRI. The secondary objective is to determine the magnitude and variability of WSS in pulmonary veins among high-risk patients and normal controls. Study Design: Prospective, interventional, single center, feasibility study Setting/Participants: Single center study at The Children's Hospital of Philadelphia. High-risk infants (n = 10) will include two groups of patients; (1) infants with moderate to severe bronchopulmonary dysplasia (BPD) and (2) infants with postoperative repair of total anomalous pulmonary venous connection (TAPVC). Group 1 participants will be infants who are undergoing an MRI as part of clinical care for other issues (i.e., MRI brain for hypoxic ischemia encephalopathy), with the research FcMRI being performed following the clinical care MRI. Group 2 participants will be infants who are undergoing FcMRI as part of clinical care. Controls (n = 10) will be pediatric patients without intracardiac defects who are undergoing FcMRI as part of clinical care (i.e., evaluation of anomalous coronary, aortopathy, vascular ring). Study Procedures, Interventions and Measures: Participants will undergo FcMRI and have the WSS calculated in each pulmonary vein (right upper, right lower, left upper, left lower) using several methodologies. Patients will be followed for 12 months following cMRI monitoring for a new diagnosis of PVS. ### Conditions Module Conditions: - Pulmonary Vein Stenosis Keywords: - Cardiac Magnetic Resonance Imaging - Wall Shear Stress ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: DIAGNOSTIC #### Enrollment Info Count: 20 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: A one time dose of Ferumoxytol will be administered prior to the cMRI in order to enhance the images. A dose of 4 mg/kg (max dose 510 mg) administered at a concentration of 8 mg/mL (in saline) will be used for this study. If the volume being administered is less than 6 mL, this is diluted with 3 mL of normal saline prior to administration. The drug is given over 15 minutes intravenously through a central or peripheral line. The drug is given at least 15 minutes prior to cardiac imaging. Intervention Names: - Drug: Ferumoxytol Label: Ferumoxytol enhanced cMRI Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Ferumoxytol enhanced cMRI Description: Ferumoxytol will be used as a contrast agent for the cMRI Name: Ferumoxytol Other Names: - Feraheme Type: DRUG ### Outcomes Module #### Primary Outcomes Description: WSS (dyn/cm2) will be reported in each pulmonary vein using multiple modalities with data from the cMRI. This includes computational fluid dynamics, 4D-Flow and 4\Mu\v/r, where Mu is the viscosity of blood, r is the vessel radius, and v is the average velocity of blood. Measure: Wall Shear Stress level in infant pulmonary veins using cMRI Time Frame: 12 months ### Eligibility Module Eligibility Criteria: Normal (Controls) Subjects Inclusion Criteria 1. Males or Females less than 18 years of age. 2. Weight \> 3 kg. 3. Undergoing cMRI with ferumoxytol as part of clinical care. 4. Structurally normal heart (by echocardiography) with exception of small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies. 5. Parental/guardian permission (informed consent). Normal (Controls) Subjects Exclusion Criteria 1. Congenital heart disease (except small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies). 2. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 3. Patient not receiving ferumoxytol as part of their cMRI due to a known hypersensitivity to the drug, or a known diagnosis of iron overload. High-Risk Subject Inclusion Criteria 1. Males or Females less than 12 months of age. 2. Diagnosis of moderate to severe BPD (group 1) or TAPVC s/p repair (group 2). 3. Weight \> 3 kg. 4. Undergoing non-contrast MRI for clinical reasons (group 1) or undergoing cMRI with ferumoxytol as part of clinical care (group 2). 5. Parental/guardian permission (informed consent). High-Risk Subject Exclusion Criteria 1. Congenital heart disease with single ventricle physiology. 2. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 3. Patient has a contraindication to ferumoxytol such as a known hypersensitivity to the drug, or a known diagnosis of iron overload. Maximum Age: 18 Years Sex: ALL Standard Ages: - CHILD - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: callahanr2@chop.edu Name: Ryan Callahan, MD Phone: 267-426-2957 Role: CONTACT #### Locations Location 1: City: Philadelphia Contacts: *Contact 1:* - Email: callahanr2@chop.edu - Name: Ryan Callahan, MD - Phone: 267-426-2957 - Role: CONTACT Country: United States Facility: Children's Hospital of Philadelphia State: Pennsylvania Zip: 19104 #### Overall Officials Official 1: Affiliation: Children's Hospital of Philadelphia Name: Ryan Callahan, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Hammer PE, McEnaney K, Callahan R, Baird CW, Hoganson DM, Jenkins KJ. The Role of Elevated Wall Shear Stress in Progression of Pulmonary Vein Stenosis: Evidence from Two Case Studies. Children (Basel). 2021 Aug 25;8(9):729. doi: 10.3390/children8090729. PMID: 34572161 Citation: Misra S, Fu AA, Misra KD, Glockner JF, Mukhopadhyay D. Wall shear stress measurement using phase contrast magnetic resonance imaging with phase contrast magnetic resonance angiography in arteriovenous polytetrafluoroethylene grafts. Angiology. 2009 Aug-Sep;60(4):441-7. doi: 10.1177/0003319709335908. Epub 2009 Jul 21. PMID: 19625275 Citation: Kamada H, Nakamura M, Ota H, Higuchi S, Takase K. Blood flow analysis with computational fluid dynamics and 4D-flow MRI for vascular diseases. J Cardiol. 2022 Nov;80(5):386-396. doi: 10.1016/j.jjcc.2022.05.007. Epub 2022 Jun 17. PMID: 35718672 Citation: Callahan R, Gauvreau K, Marshall AC, Sena LM, Baird CW, Ireland CM, McEnaney K, Bjornlund EC, Mendonca JT, Jenkins KJ. Outcomes in Establishing Individual Vessel Patency for Pediatric Pulmonary Vein Stenosis. Children (Basel). 2021 Mar 10;8(3):210. doi: 10.3390/children8030210. PMID: 33802089 Citation: Nguyen KL, Yoshida T, Kathuria-Prakash N, Zaki IH, Varallyay CG, Semple SI, Saouaf R, Rigsby CK, Stoumpos S, Whitehead KK, Griffin LM, Saloner D, Hope MD, Prince MR, Fogel MA, Schiebler ML, Roditi GH, Radjenovic A, Newby DE, Neuwelt EA, Bashir MR, Hu P, Finn JP. Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. Radiology. 2019 Dec;293(3):554-564. doi: 10.1148/radiol.2019190477. Epub 2019 Oct 22. PMID: 31638489 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M700 - Name: Stenosis, Pulmonary Vein - Relevance: HIGH - As Found: Pulmonary Vein Stenosis - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T4823 - Name: Pulmonary Vein Stenosis - Relevance: HIGH - As Found: Pulmonary Vein Stenosis ### Condition Browse Module - Meshes - ID: D000071078 - Term: Stenosis, Pulmonary Vein ### Intervention Browse Module - Ancestors - ID: D000006397 - Term: Hematinics - ID: D000057947 - Term: Parenteral Nutrition Solutions - ID: D000019999 - Term: Pharmaceutical Solutions ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M26996 - Name: Ferrosoferric Oxide - Relevance: HIGH - As Found: 1.3 - ID: M9485 - Name: Hematinics - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M28934 - Name: Parenteral Nutrition Solutions - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000052203 - Term: Ferrosoferric Oxide ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440395 Acronym: HCIS Brief Title: Small Steps for Big Changes - Healthy Cities Implementation Science Official Title: Small Steps for Big Changes: Implementing an Evidence-Based Diabetes Prevention Program Into Diverse Urban Communities #### Organization Study ID Info ID: H23-01930 #### Organization Class: OTHER Full Name: University of British Columbia ### Status Module #### Completion Date Date: 2029-09 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-06 Type: ESTIMATED Last Update Submit Date: 2024-06-04 Overall Status: RECRUITING #### Primary Completion Date Date: 2029-09 Type: ESTIMATED #### Start Date Date: 2024-06-03 Type: ACTUAL Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-13 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Collaborators Class: OTHER_GOV Name: Canadian Institutes of Health Research (CIHR) Class: OTHER_GOV Name: Public Health Agency of Canada (PHAC) Class: OTHER Name: McMaster University Class: OTHER Name: Memorial University of Newfoundland Class: OTHER Name: Brock University Class: OTHER Name: Arthritis Research Centre of Canada #### Lead Sponsor Class: OTHER Name: University of British Columbia #### Responsible Party Investigator Affiliation: University of British Columbia Investigator Full Name: Mary Jung Investigator Title: Associate Professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Small Steps for Big Changes (SSBC) is a diet and exercise counselling program that significantly reduces the risk of developing Type 2 Diabetes (T2D). In partnership with YMCAs in Canada spanning 8 provinces, the aim of this study is to scale-up program delivery and evaluate the implementation and effectiveness of SSBC. To evaluate implementation, the number of staff trained/patients enrolled, attendance, sessions delivered as planned, delivery costs, and number of sites continuing to deliver the program will be examined. To evaluate program effectiveness, changes in patient health (e.g., T2D status, blood glucose, weight, exercise, diet) will be measured over 2 years following program completion. Detailed Description: In partnership with YMCAs in Canada spanning 8 provinces (overseeing 44 distinct community facilities/sites), the investigators will adapt and deliver our evidence-based diabetes prevention program, Small Steps for Big Changes. The purpose of this project is to evaluate the implementation and effectiveness of SSBC across diverse urban communities. Specifically, the investigators aim to: 1. Evaluate the implementation and sustainability of the program by examining the number of staff trained/patients enrolled, attendance, sessions delivered as planned, delivery costs, and number of sites continuing to deliver the program. 2. Examine clinical-effectiveness of the program on: T2D status (self-report and HbA1c; primary outcomes), cardiorespiratory fitness, anthropometric (weight, waist circumference, resting heart rate), health behaviours (exercise, diet). 3. Examine cost-effectiveness of the program on: healthcare resource utilization, and health-related quality of life (secondary outcomes). Research Design: A hybrid type 2 implementation-effectiveness study design (Curran et al., 2012) with multi/mixed methods will be used to evaluate the implementation and effectiveness of SSBC. SSBC program: SSBC will be administered and facilitated by the community facility trainers at YMCA locations. SSBC consists of 6 sessions delivered over 4 consecutive weeks, with each session comprising brief (20-30 mins) counselling that support participants self-regulatory skills to promote independence and long-term adherence to healthy dietary behaviours and regular exercise, followed by 20-30 mins of supervised aerobic exercise. ### Conditions Module Conditions: - PreDiabetes Keywords: - Implementation Science - Exercise Behaviour - Diet Behaviour - Adherence - Health Behaviour Change ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 4400 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Diabetes Prevention Program (one-treatment group) The diabetes prevention program is a 4-week program that will introduce participants to a regular healthy behaviours that includes exercise and simple dietary strategies. There is no randomization to this program - all individuals enrolled will partake in the same program and will be followed up for 24 months after the program has concluded. Intervention Names: - Behavioral: Behavioural: Small Steps for Big Changes Diabetes Prevention Program Label: Small Steps for Big Changes: Diabetes Prevention Program ### Interventions #### Intervention 1 Arm Group Labels: - Small Steps for Big Changes: Diabetes Prevention Program Description: The 4-week behaviour change program will introduce participants to a regular healthy lifestyle including exercise and dietary changes for reducing sugar intake, reducing refined/processed carbohydrate intake, increasing vegetable consumption. The 4-week program will include six supervised exercise sessions and three exercise sessions performed independently (e.g., at home or outside of the YMCA). The supervised session will include brief behavioural counselling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercising and dietary changes. Name: Behavioural: Small Steps for Big Changes Diabetes Prevention Program Type: BEHAVIORAL ### Outcomes Module #### Other Outcomes Description: Organizational readiness for change measured by the Organizational Readiness for Implementing Change (Shea et al., 2014) Measure: Organizational readiness Time Frame: 0 weeks Description: Change in 24-hour movement will be examined using a 4-item measure to collect information on time spent in activity, sitting and sleeping in hours and minutes Measure: Change in 24-hour movement Time Frame: 0, 4, 52, 104 weeks Description: Measured at level of Iliac crest in centimetres by the coach Measure: Change in waist circumference Time Frame: 0, 4, 52, and 104 weeks Description: Patients' self-compassion will be assessed at baseline using the short form self-compassion scale (Raes et al., 2011). This 12-item measure has participants rate the extent to which they engage in certain behaviours on a 5-point response scale from 1 (almost never) to 5 (almost always). Sub scales can be computed by adding item scores. A total self-compassion score is computed. Measure: Baseline self-compassion Time Frame: 0 weeks #### Primary Outcomes Description: Self reported HbA1c% Measure: Type 2 diabetes status Time Frame: 0, 12, and 24 months post intervention Description: Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants Measure: Change in HbA1c Time Frame: 0, 12 and 24 months post intervention Description: Proportion and representativeness of coaches and implementation support team obtained through program records Measure: Adoption of SSBC Time Frame: 0, 52, 104, 156, 208 weeks Description: Proportion of patients' enrolled and completing the intervention, proportion of implementation staff trained and retained. Demographics of the patients and staff Measure: Reach of SSBC Time Frame: 0, 52, 104, 156, 208 weeks Description: Number of SSBC sessions delivered by coaches (0-6) will be gathered through coach checklists Measure: Dose Delivered Time Frame: During delivery of the intervention Description: Frequency with which clients recieve each core component and quality of counselling skills measured using session checklists. Measure: Fidelity of SSBC delivery Time Frame: During delivery of the intervention Description: Number and type of adaptations made prior to delivery of SSBC and during SSBC delivery. Number of adaptations needed for sustainment and during sustainment. Adaptation information will be gathered through meeting minutes with site leads, annual reports from delivery sites and through interviews with coaches and site leads. Measure: Adaptations of SSBC Time Frame: Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks) Description: Patient acceptability and satisfaction will be assessed using the 1-item net promoter score, overall satisfaction measure developed in house and the theoretical framework of acceptability measure. Interviews will be conducted with a subsample of patients at each site (2-3 per site) after completing SSBC. Staff satisfaction and burden will be assessed using brief surveys a various points through the program delivery with coaches (baseline, after 5, 10, 20 clients) and site leads (baseline and at the end of SSBC delivery). Satisfaction and acceptability will also be examined among staff using qualitative interviews. Measure: Receptivity to SSBC among patients' and staff Time Frame: 4, and 52 weeks (patients), during delivery (staff) Description: Costs incurred for implementing SSBC at the delivery sites will be collected through annual reporting from the delivery sites. Measure: Cost of Delivering SSBC Time Frame: 104, 156, 208 weeks Description: The proportion of individuals who convert their one-month free pass to a facility membership and the retention of this membership over time will be calculated. This information will be collected from annual reports from delivery sites and client surveys. Measure: Membership rates Time Frame: 104, 156, 208 weeks #### Secondary Outcomes Description: Measured in pounds Measure: Change in body weight Time Frame: 0, 4, 52, and 104 weeks Description: Distance walked in the six minute walk test will be conducted at sites with access to a walking track. Measure: Change in cardiorespiratory fitness Time Frame: 0, 4, 52, and 104 weeks Description: The Godin Leisure Time Physical Activity Questionnaire will be used to examine physical activity behaviour. Respondents report the frequency of strenuous, moderate, and mild physical activity for bouts of 15 or more minutes during a 7-day period. The scores are multiplied by weigths and summed into an overall score reports in metabolic equivalents of task (METs)/minutes of physical activity per week. Measure: Change in physical activity behaviour using the Godin Leisure Time Physical Activity Questionnaire Time Frame: 0, 4, 52, and 104 weeks Description: The 2-item Physical Activity Vital Signs measure will be used to collect information on physical activity behaviour. Two questions are self-reported: 1) "How many days during the past week have you performed physical activity where your heart beats faster and your breathing is harder than normal for 30 minutes or more?" and 2) "How many days in a typical week do you perform activity such as this?" The responses are reported as days during the past week over days in a typical week, with scores ranging from 0 to 7 for each question. Measure: Changes in physical activity using the 2-item Physical Activity Vital Signs measure Time Frame: 0, 4, 52, and 104 weeks Description: Assessed using the brief food frequency questionnaire. Participants are asked about their intake of five foods within the past week: fruits, vegetables, sweets, bread and rice/pasta. Items are rated on a 6-point scale. The questionnaire also uses a composite score for refined carbohydrates (sum of bread and rice/pasta). Measure: Change in dietary intake Time Frame: 0, 4, 52, and 104 weeks Description: Aspects of the larger social, political and economic environment that may influence delivery of the adapted intervention will be assessed by interview. These interviews will also gather qualitative data potential factors that impact delivery of SSBC at the site including context, acceptability, adaptability, feasibility, compatibility, cost, culture, complexity and self efficacy. These interviews will be conducted among coaches and managerial staff. Measure: Determinants of intervention implementation Time Frame: 52 weeks Description: Data will be collected on the number of sites continuing delivery, the number of coaches continuing delivery, the number of clients run through SSBC and the number of implementation strategies that are utilized. This data will be gathered through program records. Focus groups will be conducted at each site over the 2-year sustainability phase to gather information on the contextual factors that impact sustainment outcomes. Measure: Sustainability outcomes and determinants Time Frame: 104, 156 and 208 weeks Description: The EQ-5D-5L consists of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Participants are asked to indicate their level of functioning (from 1 "no problems" to 5 "extreme problems") on each of the five dimensions of the EQ-5D-5L. The EQ-5D-5 L describes 3125 distinct health states, with 11111 representing the best and 55555 the worst possible health states. The Canadian EQ-5D-5 L scoring algorithm will be applied to generate index scores which range from - 0.148 for the worst (55555) to 0.949 for the best (11111) health states. Measure: Change in health-related quality of life (EQ-5D-5L Profile) Time Frame: 0, 4, 52, and 104 weeks Description: Health status will be assessed with the EQ-5D-5L visual analogue scale. Participants report on their health on a visual analogue scale from 0 (worst health) to 100 (best health) Measure: Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale) Time Frame: 0, 4, 52, and 104 weeks Description: The extent to which participants use medical services will be assessed using the Health Resource Utilization Survey. The information will be combined with the EQ-5D-5L health related quality of life profiles to calculate the cost-effectiveness of the program. Measure: Change in health resource utilization Time Frame: 0, 52, and 104 weeks ### Eligibility Module Eligibility Criteria: Patients Inclusion Criteria: * Community-dwelling adults aged 18 years or older * able to read and speak English * has prediabetes assessed by one of the following means: (a) physician-diagnosed prediabetes, (b) HbA1c values between 5.7 - 6.4% (American Diabetes Association, 2012), (c) an American Diabetes Association risk questionnaire score indicating increased risk (\>5) * Individuals who have previously been diagnosed with type 2 diabetes but who are in remission (defined as achieving glycated hemoglobin (A1C) of \< 6.4% without any diabetes-related medications for a minimum of 3 months) will be eligible to participate. Exclusion Criteria: - Patients currently diagnosed type 2 diabetes with an HbA1c of 6.5% or greater. Organizational partners Inclusion criteria: - Senior leadership and/or management of our Canadian YMCA delivery partner organizations Exclusion criteria: N/A Site leads/managers Inclusion criteria: - YMCA staff who manage/coordinate programs (e.g., general manager of health programs) for each site willing to act as SSBC site lead champion. Exclusion criteria: N/A Coaches Inclusion criteria: Site staff certified as SSBC coaches to deliver the program. Exclusion criteria: N/A Healthy Volunteers: True Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: The investigators aim to recruit a community-based sample of adults at risk of type 2 diabetes ### Contacts Locations Module #### Locations Location 1: City: Edmonton Contacts: *Contact 1:* - Email: jody.kyle@northernalberta.ymca.ca - Name: Jody Kyle - Role: CONTACT *Contact 2:* - Name: Linda Li - Role: SUB_INVESTIGATOR Country: Canada Facility: Castle Downs Family YMCA State: Alberta Status: NOT_YET_RECRUITING Zip: T5X 6A3 Location 2: City: Kelowna Contacts: *Contact 1:* - Email: mary.jung@ubc.ca - Name: Mary E June, PhD - Phone: 250-807-8419 - Role: CONTACT *Contact 2:* - Name: Mary E Jung, PhD - Role: PRINCIPAL_INVESTIGATOR Country: Canada Facility: Health and Exercise Psychology Laboratory State: British Columbia Status: RECRUITING Zip: V1V 1V7 Location 3: City: Prince George Contacts: *Contact 1:* - Email: alyssa.oconnor@bc.ymca.ca - Name: Alyssa O'Connor - Phone: 250 562 9341 - Phone Ext: 2116 - Role: CONTACT *Contact 2:* - Name: Linda Li - Role: SUB_INVESTIGATOR Country: Canada Facility: Prince George Family YMCA State: British Columbia Status: NOT_YET_RECRUITING Zip: V2L 4V7 Location 4: City: Surrey Contacts: *Contact 1:* - Email: alyssa.oconnor@bc.ymca.ca - Name: Alyssa O'Connor - Phone: 604.320-5846 - Role: CONTACT *Contact 2:* - Name: Linda Li - Role: SUB_INVESTIGATOR Country: Canada Facility: Tong Louie Family YMCA State: British Columbia Status: NOT_YET_RECRUITING Zip: V3S 7S6 Location 5: City: Brandon Contacts: *Contact 1:* - Email: lon.cullen@ymanitoba.ca - Name: Lon Cullen - Role: CONTACT *Contact 2:* - Name: Diana Sherifali - Role: SUB_INVESTIGATOR Country: Canada Facility: YMCA of Brandon Health and Fitness Centre State: Manitoba Status: NOT_YET_RECRUITING Zip: R7A 3X2 Location 6: City: Winnipeg Contacts: *Contact 1:* - Email: casie.nishi@ymanitoba.ca - Name: Casie Nishi - Phone: 204-831-2972 - Role: CONTACT *Contact 2:* - Name: Diana Sherifali - Role: SUB_INVESTIGATOR Country: Canada Facility: Elmwood-Kildonan State: Manitoba Status: NOT_YET_RECRUITING Zip: R2K 2M6 Location 7: City: Saint John Contacts: *Contact 1:* - Email: S.Fitzgerald@saintjohny.ca - Name: Sherry Fitzgerald - Role: CONTACT *Contact 2:* - Name: Katie Wadden - Role: SUB_INVESTIGATOR Country: Canada Facility: Saint John Regional Y State: New Brunswick Status: NOT_YET_RECRUITING Zip: E2K 3E2 Location 8: City: Saint John's Contacts: *Contact 1:* - Email: sherry.squires@nl.ymca.ca - Name: Sherry Squires - Role: CONTACT *Contact 2:* - Name: Katie Wadden - Role: SUB_INVESTIGATOR Country: Canada Facility: Ches Penney Family YMCA State: Newfoundland and Labrador Status: NOT_YET_RECRUITING Zip: A1A 5G6 Location 9: City: Halifax Contacts: *Contact 1:* - Email: joy.chiekwe@halifax.ymca.ca - Name: Joy Chiekwe - Role: CONTACT *Contact 2:* - Name: Katie Wadden - Role: SUB_INVESTIGATOR Country: Canada Facility: John W. Lindsay YMCA State: Nova Scotia Status: NOT_YET_RECRUITING Zip: B3J 3Y3 Location 10: City: Kitchener Contacts: *Contact 1:* - Email: Crystal.Hughes@ytr.ymca.ca - Name: Crystal Hughes - Phone: (613) 921-4159 - Role: CONTACT *Contact 2:* - Name: Diana Sherifali - Role: SUB_INVESTIGATOR Country: Canada Facility: YMCA 3 Rivers State: Ontario Status: NOT_YET_RECRUITING Zip: N2G 3C5 Location 11: City: Scarborough Contacts: *Contact 1:* - Email: Samantha.Casmey@YMCAGTA.ORG - Name: Samantha Casmey - Role: CONTACT *Contact 2:* - Name: Diana Sherifali - Role: SUB_INVESTIGATOR Country: Canada Facility: YMCA of Greater Toronto - Scarborough Health and Fitness Centre State: Ontario Status: NOT_YET_RECRUITING Zip: M1B 3C6 Location 12: City: Regina Contacts: *Contact 1:* - Email: Steve.compton@regina.ymca.ca - Name: Steve Compton - Role: CONTACT *Contact 2:* - Name: Linda Li - Role: SUB_INVESTIGATOR Country: Canada Facility: YMCA of Regina Health, Fitness and Aquatics Centre State: Saskatchewan Status: NOT_YET_RECRUITING Zip: S4X 2P9 ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14117 - Name: Prediabetic State - Relevance: HIGH - As Found: Prediabetes - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M20295 - Name: Glucose Intolerance - 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: D000011236 - Term: Prediabetic State ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440382 Acronym: SCREEN Brief Title: Scottish Cervical Screening and Ethnicity Project Official Title: Scottish Cervical Screening and Ethnicity Project #### Organization Study ID Info ID: AC19033 #### Organization Class: OTHER Full Name: University of Edinburgh ### Status Module #### Completion Date Date: 2022-12-31 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: COMPLETED #### Primary Completion Date Date: 2022-08-01 Type: ACTUAL #### Start Date Date: 2019-03-01 Type: ACTUAL Status Verified Date: 2020-02 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-21 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University of Edinburgh #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: To identify important ethnic inequalities in cervical cancer screening participation in Scotland, and explore possible reasons for these. Detailed Description: The 2011 Census database was linked, via the Community Health Index number, with the Scottish Cervical Screening Programme data to generate anonymised individual level information on cervical screening participation rates by self-reported ethnic group in Scotland. The cohort comprised women (aged 20 to 70) who were living in Scotland in April 2011 and took part in the 2011 Scottish census, and who were invited to participate in the Scottish Cervical Screening Programme between January 2012 and December 2018. All ethnic groups were compared to the population of White Scottish women. Qualitative interviews were carried out with 50 women (South Asian, East European, Chinese, Black African / Caribbean, or White Scottish). ### Conditions Module Conditions: - Cervical Cancer ### Design Module #### Design Info Observational Model: CASE_CONTROL Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 600000 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: eligible women in Scotland invited to cervical screening Label: screening invitees #### Arm Group 2 Description: 50 women from diverse ethnic groups Label: interview study ### Outcomes Module #### Primary Outcomes Measure: % women who attend cervical screening Time Frame: within 6 months of date of invitation ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * screening invitees through national programme Exclusion Criteria: * not invited to cervical screening Maximum Age: 70 Years Minimum Age: 20 Years Sampling Method: PROBABILITY_SAMPLE Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT Study Population: women (aged 20 to 70) who were living in Scotland in April 2011 and took part in the 2011 Scottish census, and who were invited to participate in the Scottish Cervical Screening Programme between January 2012 and December 2018 ### Contacts Locations Module #### Locations Location 1: City: Edinburgh Country: United Kingdom Facility: University of Edinburgh ### 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 ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440369 Acronym: PACaR Brief Title: Physical Activity and Cardiovascular Risk Official Title: Effets d'un Programme d'Exercice aérobie Sur cycloergomètre Chez le Patient Atteint d'Insufisance Rénale Chronique ou Polyarthrite Rhumatoïde #### Organization Study ID Info ID: UnivFranche-Comte #### Organization Class: OTHER Full Name: University of Franche-Comté ### Status Module #### Completion Date Date: 2026-12-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-05 Type: ACTUAL Last Update Submit Date: 2024-06-04 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-10-30 Type: ESTIMATED #### Start Date Date: 2024-09-01 Type: ESTIMATED Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-21 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University of Franche-Comté #### Responsible Party Investigator Affiliation: University of Franche-Comté Investigator Full Name: Daniele Peres Investigator Title: Sponsor-Investigator Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: Physical activity (PA) is essential for the prevention and treatment of chronic conditions. Despite its benefits, global physical inactivity is prevalent, contributing to chronic diseases and premature mortality. For patients with chronic kidney disease (CKD) and rheumatoid arthritis (RA), PA is particularly beneficial as it improves endothelial health, reduces cardiovascular risk, diminishes inflammation, and enhances quality of life. Given the chronic inflammation and immune system dysregulation in CKD and RA, PA may mitigate these effects and improve patient outcomes. The primary objective of this study is to evaluate the effects of a personalized aerobic exercise program on cardiovascular risk in patients with CKD or RA. The secondary objectives are to assess the effects on inflammation and immunosenescence; investigate the relationship between inflammation, immunosenescence, and various health outcomes; compare the impacts of chronic PA and PA guidance on cardiovascular risk, disease activity, lifestyle habits, cognitive functions, and quality of life. This study presents an interventional design. A total of 105 subjects are expected to participate in this study, including 45 CKD patients and 45 RA patients. Participants will be stratified by PA level and cardiovascular risk (SCORE 2 scale) and then randomized into three groups: Control Group: 15 CKD and 15 RA patients; Therapeutic Education Group: 15 CKD and 15 RA patients; and Experimental Group: 15 CKD and 15 RA patients. The inclusion criteria are: age \> 50 years; diagnosed with CKD or RA; glomerular filtration rate between 45 and 29 ml/min/1.73 m² for CKD; DAS-28 score ≥ 2.6 for RA; medical clearance for PA; informed consent and affiliation with French social security. The exclusion criteria are: unstable corticosteroid therapy or \>10 mg prednisone/day; uncontrolled hypertension; pregnancy; cognitive impairment preventing adherence to the program; inability to perform PA; legal incapacity or anticipated poor cooperation; lack of health insurance and participation in an incompatible study. The primary efficacy criterion of this study is changes in endothelial function (macrovascular arterial stiffness) and the secondary efficacy criteria are: endothelial function (microvascular hyperemia test); levels of inflammation and immunity (blood tests); physical activity levels and quality of life (questionnaires); disease-related functional impairment; disease activity and cognitive function. Patient screening will begin with the identification of eligible patients in the Nephrology and Rheumatology departments. Day 0 will be the selection visit for participant information and consent. A week after Day 0, the inclusion visit and initial assessment (arterial stiffness, endothelial function, disease impact, and blood markers for immunosenescence and inflammation, blood pressure, heart rate, PA level, quality of life, and cognitive functions) will be conducted for all patients. Next, only the patients in the experimental group will carry out a 47-minute cycling intermittent exercise session, perceived exertion assessment, and post-exercise reassessment. They will redo the assessments after the exercise. They will have another 16 sessions of supervised exercise by a health professional and a final session identical to the first for reassessment. Patients in the physical activity guidance group will not undertake a physical exercise program but will receive one call per week to discuss the physical activities performed and get answers to their questions on the subject. The control group will continue with their usual lifestyle habits. Detailed Description: To address the primary objective, arterial stiffness in the experimental group will be analyzed and compared with the control group and the physical activity orientation group. To address the secondary objectives, various variables related to quality of life, cognitive functions, and disease activity will be compared between different patient groups. The levels of inflammation and immunosenescence and the relationship between these two dimensions will be analyzed before and after the exercise program in the experimental group of RA and CKD patients, with patients serving as their own controls. The first contact with CKD patients will be in the Nephrology Department, and for RA patients, in the Rheumatology Department during their regular medical visits. Initially, investigators will screen potential patients for participation. The screening process involves a thorough evaluation of medical characteristics, health history, and other pre-established criteria to identify subjects who meet the specific inclusion criteria of this study. The evaluations described in the initial assessment will be conducted, and all enrolled subjects will undergo a resting ECG, with the investigator recording data for each subject. Patient treatments will not be interrupted during the entire protocol period. All patients will be evaluated twice: once during the inclusion visit and again after 6 weeks. During the inclusion visit, the patient will complete questionnaires, then rest in a lying position for 10 minutes. An initial evaluation lasting about 10 minutes will be conducted in a lying position, including measurements of blood pressure, heart rate, reactive hyperemia (to evaluate endothelial function), and pulse wave velocity (PWV). The total duration will be 25 minutes. After then, for control group patients and physical activity orientation group patients, the session ends here. For experimental group patients, the patient will then perform physical activity on a cycle ergometer for 47 minutes. The same assessments will be conducted at the end of the session For invasive measures, venous blood samples will be taken from the elbow crease by a clinical research nurse. A total of 2 dry tubes of 5 ml and 2 EDTA purple tubes of 5 ml will be collected at the beginning and end of the rehabilitation protocol (6 weeks), totaling 40 ml. For experimental groups, an additional blood sample will be taken during follow-up, 6 weeks after the end of the rehabilitation program, totaling 60 ml for these groups. Endothelial function will be assessed by measuring pulse wave velocity and reactive hyperemia. Arterial compliance (central and peripheral) will be assessed by measuring the pulse wave velocity on the carotid-femoral and carotid-radial segments, respectively, using the Complior (Complior SP®, Artech Medical, Pantin, France). Reactive hyperemia will be assessed with ENDOPAT (Itamar Medical®, Caesarea, Israel), which quantifies peripheral vasodilatory response non-invasively via electronic finger cuffs following blood flow occlusion. Hemodynamic parameters will be evaluated by measuring heart rate and blood pressure with the Finapres during assessments. Heart rate monitoring during cycling in experimental groups will use the Polar A300 heart rate monitor. Blood pressure will be measured before and after exercise with the Omron. The interventions during the 6 weeks for the experimental group - exercise sessions will be conducted in the nephrology or rheumatology departments, supervised by an adapted physical activity professional, scheduled for three weekly 47-minute sessions over 6 weeks (18 sessions). Exercise intensity will be adjusted based on individual heart rate reserve, starting at 40% and progressing to 70% by the final session. Each session includes a warm-up, main exercise phase, and active recovery. The interventions during the 6 weeks for the PA orientation group - Every week, for around ten minutes, patients in the PA orientation group will be contacted by telephone. The main objective of this exchange is to provide targeted advice on physical activity, its role, its objectives as well as its different ways of carrying it out. The second objective is to provide each week a personalized objective for each patient which can evolve over the weeks in order to increase levels of physical activity as far as possible. Call Procedure are: establishing a diagnosis carried out using questionnaires distributed beforehand (level of physical activity, quality of life); contribution of advice and explanation around physical activity: The evaluator (adapted physical activity teacher) will provide knowledge about PA, its roles and objectives, recommendations, and different ways of practice; lifestyle exchange (personalized): An exchange between the professional and the patient to understand the patient's lifestyle habits; setting a therapeutic objective: Propose an objective around physical activity based on the patient's needs and lifestyle and answer patient questions: Reflective listening and open-ended questions will facilitate the exchange. ### Conditions Module Conditions: - Rheumatoid Arthritis - Chronic Kidney Diseases - Endothelial Dysfunction - Arterial Stiffness - Exercise ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Control group (CG): Patients will continue their lifestyle. Physical activity orientation group (G0-AP): Patients will be encouraged to practice physical activity and will benefit from telephone calls for instructions regarding this practice. They will be contacted by telephone each week, for a total of 6 calls, each lasting approximately 10 minutes. Training group (GE): Patients will begin the individualized PA program during the inclusion visit and will continue it for 6 weeks, at a rate of 3 sessions per week (for a total of 18 sessions). At the end, patients will be able to resume their usual activities and will be evaluated again 6 weeks after stopping the program. The training program will be supervised by a physical activity instructor adapted and carried out at the CHRU, in the Nephrology or Rheumatology Department depending on the patient's pathology. ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 105 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients will begin the individualized physical activity program during the inclusion visit and will continue it for 6 weeks, with 3 sessions per week (for a total of 18 sessions). At the end, patients will be able to resume their usual activities and will be evaluated again 6 weeks after stopping the program. The training program will be supervised by a physical activity instructor adapted and carried out at the CHRU, in the Nephrology or Rheumatology Department depending on the patient's pathology. Intervention Names: - Other: Training group Label: Training group Type: EXPERIMENTAL #### Arm Group 2 Description: Patients will be encouraged to engage in physical activity and will receive phone calls for instructions regarding this practice. They will be contacted by telephone each week, for a total of 6 calls, each lasting approximately 10 minutes. Intervention Names: - Other: Physical activity orientation group Label: Physical activity orientation group Type: ACTIVE_COMPARATOR #### Arm Group 3 Label: Control group Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Training group Description: The patient will perform an intermittent exercise which consists of nine 5-minute cycles with a succession of work (top: 1 minute; bottom: 4 minutes). The high-intensity work phase will be adjusted so as to achieve a target Heart Rate (HR) corresponding to resting HR + 80% reserve HR (reserve HR = (200 - age) - resting HR). The low-intensity work phase will be adjusted to achieve a target maximum HR corresponding to resting HR + 60% reserve HR. In total duration, the exercise presents a submaximal intensity, commonly used in exercise rehabilitation studies carried out with various pathologies. It is an intensity capable of promoting benefits on the cardiovascular aspect without representing a severe intensity for the patient. In order to adapt the training and guarantee patient safety, the first exercise session will be carried out with an alternation between a high-intensity work phase of resting HR + 70% reserve HR and a work phase. at low intensity of resting HR + 50% reserve HR. Name: Training group Type: OTHER #### Intervention 2 Arm Group Labels: - Physical activity orientation group Description: Every week, for around ten minutes, patients in the AP orientation group will be contacted by telephone. The main objective of this exchange is to provide targeted advice on physical activity, its role, its objectives as well as its different ways of carrying it out. The second objective is to provide each week a personalized objective for each patient which can evolve over the weeks to increase levels of physical activity as far as possible. During each call, the evaluator will practice reflective listening, ask open-ended questions to facilitate the exchange, value and summarize the patient. Name: Physical activity orientation group Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The evaluation of central and peripheral arterial compliance will be carried out by measuring the pulse wave velocity on the carotid-femoral and carotid-radial segments respectively. These evaluations are carried out using the Complior device (Complior SP®, Artech Medical, Pantin, France). This system is equipped with an interface between the piezoelectric sensors and the laptop which is used to save the recordings. The search for the best site at the radial, femoral and carotid levels will be done by palpation. Once the sites have been identified, the operator will mark them using a hypoallergenic marker so as to find the same measurement positions during the session (for the experimental and healthy group). The sensors will be held in place with a velcro system or by the operator. After checking the quality of the signal and after leaving the subject to rest for a few minutes, the operator can record the signal. Measure: Pulse wave velocity Time Frame: Assessment on the same day of the inclusion visit and 6 consecutive weeks later. Description: The evaluation of the hyperemic reaction will be carried out by ENDOPAT (Itamar Medical®, Caesarea, Israel). This tool quantifies the peripheral vasodilator response (reactive hyperemia) via an electronic finger cot in a non-invasive manner, following occlusion of vascular flow. The measuring device is made up of two probes with an inflation system placed on the index finger of each hand. On the side of the finger tested, after measuring the basal flow, a cuff positioned at the level of the arm is inflated above the systolic pressure for 5 minutes, then released creating a reflex vasodilation measured by the ENDOPAT. Endothelial function is calculated by the relationship between the average amplitude of reactive hyperemia over a 1 minute period starting 1.5 minutes after cuff deflation and the baseline level. Measure: Reactive hyperemia Time Frame: Assessment on the same day of the inclusion visit and 6 consecutive weeks later. #### Secondary Outcomes Description: Venous blood samples will be used to measure CD4 and CD8 concentrations and IL6 concentrations; CRP; TNF-α. Measure: Inflammation level Time Frame: Assessment on the same day of the inclusion visit and 6 consecutive weeks later. Description: The Short Form 36 (SF-36) health survey questionnaire is the most commonly used generic instrument to assess health-related quality of life in the general population. This questionnaire validated in French was developed by Ware and Sherbourne in 1992 based on the Medical Outcome Study. The questionnaire consists of 36 questions assessing the following 8 dimensions: physical activity, physical limitations, physical pain, perceived state of health, life and relationships with others, limitations due to physical state , mental health and finally a comparison with the state of health perceived one year previously. This questionnaire was selected because of its speed of administration (around ten minutes), its self-administrability and its ease of use. The range is 0 to 100 points, where higher scores indicate better physical functioning. Measure: Level of quality of life Time Frame: Assessment on the same day of the inclusion visit and 6 consecutive weeks later. Description: The PA level will be measured by the short version of the "International Physical Activity Questionnaire - IPAQ". This questionnaire makes it possible to assess overall physical activity and the level of sedentary lifestyle during the last seven days of patients. The IPAQ questionnaire therefore focuses on the practice of intense, moderate activities, walking, and the time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or again during transport. The short version of the IPAQ questionnaire validated in French includes 7 questions. The questionnaire thus makes it possible to classify the subject according to 3 activity levels: inactive, moderate and high. This questionnaire was selected because of its speed of administration (less than 10 minutes) and its ease of use. The range varies depending on the person's activities, with higher scores indicating higher levels of physical activity. Measure: Level of physical activity Time Frame: Assessment on the same day of the inclusion visit and 6 consecutive weeks later. Description: They will be measured continuously at the finger using the photoplethysmographic method on the non-dominant side (Finapres, Finapres Medical Systems, Amsterdam). The Finapres method is a non-invasive technique that measures beat-to-beat variations in blood pressure and heart rate. It was validated against intra-arterial recordings as well as the traditional blood pressure monitor Measure: Systolic pressure (mmHg) and diastolic pressure (mmHg) Time Frame: Assessment on the same day of the inclusion visit and 6 consecutive weeks later. Description: They will be measured continuously at the finger using the photoplethysmographic method on the non-dominant side (Finapres, Finapres Medical Systems, Amsterdam). The Finapres method is a non-invasive technique that measures beat-to-beat variations in blood pressure and heart rate. It was validated against intra-arterial recordings as well as the traditional blood pressure monitor Measure: Heart rate (HR, bpm) Time Frame: Assessment on the same day of the inclusion visit and 6 consecutive weeks later. ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Healthy subject (man or woman) over 50 years old, without diagnosis of chronic disease. * Patient (man or woman) over 50 years old, with a diagnosis of CKD or RA without other risk factors related to the disease. * Have a medical certificate of no contraindication to AP. * Have a glomerular filtration rate between 45 and 29 ml/min/1.73 m2, corresponding to non-dyalized stages III and IV for patients with CKD. * Have a DAS-28 score ≥ 2.6 points for patients with RA. * Signature of informed consent. * Affiliation to a French social security scheme or beneficiary of such a scheme. Exclusion Criteria: * unstabilized corticosteroid therapy and/or \>10 mg of prednisone/day; * unbalanced high blood pressure; * pregnant women ; * alteration of higher functions making understanding and adherence to a conditioning program impossible; * inability to perform physical exercise, whatever the origin (neurological, central or peripheral, cardiac, vascular or respiratory or musculoskeletal). * Legal incapacity or limited legal capacity * Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator * Subject without health insurance * Subject being in the period of exclusion from another study or provided for by the "national volunteer file". Healthy Volunteers: True Minimum Age: 50 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16759 - Name: Tin Fluorides - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440356 Brief Title: Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia Official Title: Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia: A Randomised, Placebo-controlled Trial #### Organization Study ID Info ID: UGaziantep1986 #### Organization Class: OTHER Full Name: University of Gaziantep ### Status Module #### Completion Date Date: 2024-03-30 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-03-30 Type: ACTUAL #### Start Date Date: 2024-01-23 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-21 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University of Gaziantep #### Responsible Party Investigator Affiliation: University of Gaziantep Investigator Full Name: İREM KARAGOZOGLU Investigator Title: Assist. Prof. Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The aim of this study was to compare the effectiveness of two different photobiomodulation (PBM) therapies as an alternative to medical treatment to reduce pain and improve quality of life in patients with trigeminal neuralgia (TN). Detailed Description: The aim of this study was to compare the effectiveness of two different photobiomodulation (PBM) therapies as an alternative to medical treatment to reduce pain and improve quality of life in patients with trigeminal neuralgia (TN). A total of 45 patients with mean age of 46.09 years (26 female, 19 male) were randomly divided into three groups. The first group received PBM therapy with a new generation diode laser (NGD laser). In the second group, low-level Nd:YAG laser was applied along the affected nerve line and the placebo group received the same protocol with Nd:YAG laser without the device switched on. The scores were recorded before and after the treatment using the Brief Pain Inventory-facial (BPI-facial) scale. ### Conditions Module Conditions: - Trigeminal Neuralgia ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 45 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: In the first group, a NGD laser with dual wavelength, infrared and LED features, operating at a depth of 50 mm, which can be applied regionally, was used. In the second group, a neodymium-doped yttrium aluminium garnet laser was used. After the laser unit has been switched on, the LLLT preset has been selected. Patients in the third group received emission-free laser treatment. In the same procedure with the Nd:YAG laser, a placebo treatment was performed with the device on, laser beams visible but not active. Intervention Names: - Other: laser therapy Label: Treatment protocol Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Treatment protocol Description: low level laser therapy applied Name: laser therapy Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Brief Pain Inventory-facial scale is a validated, self-reported scale assessing the average pain intensity over the past 24 hour period. The scores range from 0: no pain, 10: the worst pain you can imagine change= week 4 score-baseline score Measure: Change from baseline in pain intensity on the 10 point Brief Pain Inventory-facial scale at week 4. Time Frame: baseline and week 4 Description: Brief Pain Inventory-facial scale is a validated, self-reported scale assessing the interference in general activities over the past 24 hour period. The scores range from 0: no inhibition, 10: complete inhibition change= week 4 score-baseline score Measure: Change from baseline in interference in general activities on the 10 point Brief Pain Inventory-facial scale at week 4. Time Frame: baseline and week 4 #### Secondary Outcomes Description: Brief Pain Inventory-facial scale is a validated, self-reported scale assessing the interference in face specific activities over the past 24 hour period. The scores range from 0: no inhibition, 10: complete inhibition change= week 4 score-baseline score Measure: Change from baseline in interference in face specific activities on the 10 point Brief Pain Inventory-facial scale at week 4. Time Frame: baseline and week 4 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients diagnosed with idiopathic trigeminal neuralgia as defined by the International Headache Society (2). * Patients diagnosed with idiopathic trigeminal neuralgia and receiving medical treatment (carbamazepine, etc.) * Patients with unilateral, severe, sudden onset of facial pain along the branches of the trigeminal nerve. * Patients who have not previously received any interventional treatment for TN. * Patients recently diagnosed and started on a first dose of carbamazepine and its derivatives Exclusion Criteria: * • Patients diagnosed with type 2 (atypical, symptomatic) trigeminal neuralgia as defined by the International Headache Society (2). * Patients with etiologies such as tumour, multiple sclerosis or neurovascular compression on radiography. * Pregnant women * Patients with systemic diseases such as diabetes, cardiovascular disease, hypertension, etc. * Patients who have been previously diagnosed and treated with any type of TN therapy. Healthy Volunteers: True Maximum Age: 65 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Şehi̇tkami̇l Country: Turkey Facility: İrem Karagözoğlu State: Gazi̇antep Zip: 27310 ### 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: D000020433 - Term: Trigeminal Nerve Diseases - ID: D000005156 - Term: Facial Neuralgia - ID: D000005155 - Term: Facial Nerve Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000003389 - Term: Cranial Nerve Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuralgia - ID: M17029 - Name: Trigeminal Neuralgia - Relevance: HIGH - As Found: Trigeminal Neuralgia - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22229 - Name: Trigeminal Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: M8299 - Name: Facial Neuralgia - Relevance: LOW - As Found: Unknown - ID: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown - ID: M8298 - Name: Facial Nerve 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: M6605 - Name: Cranial Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: T5717 - Name: Trigeminal Neuralgia - Relevance: HIGH - As Found: Trigeminal Neuralgia ### Condition Browse Module - Meshes - ID: D000014277 - Term: Trigeminal Neuralgia - ID: D000009437 - Term: Neuralgia ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440343 Brief Title: Effects of Acute Carbohydrate Intake Intra-training in Crosstraining Official Title: Effects of Acute Carbohydrate Intake Intra-training in Crosstraining Athletes: a Randomized, Placebo-controlled Crossover Study #### Organization Study ID Info ID: CROSSCARB #### Organization Class: OTHER Full Name: Universidad de Granada ### Status Module #### Completion Date Date: 2024-09 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2024-07 Type: ESTIMATED #### Start Date Date: 2024-05-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-21 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Universidad de Granada #### Responsible Party Investigator Affiliation: Universidad de Granada Investigator Full Name: Lucas Jurado-Fasoli Investigator Title: Principal Investigator Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: This study aims to investigate the effect of acute carbohydrate intake during a crosstraining session on exercise-induced muscle damage and the recovery of crosstraining athletes. Detailed Description: Carbohydrate intake during exercise could decrease the subjective perceived exertion and promote recovery during high-intensity and intermittent exercises such as crosstraining. Nevertheless, despite extensive research on carbohydrate ingestion during exercise across different sports disciplines, its effects have not been investigated in crosstraining sessions. 23 male trained crosstraining athletes will ingest carbohydrates (60g of maltodextrin + fructose, 2:1 ratio) or placebo during a one-and-a-half-hour crosstraining session. The session will consist of a warm-up, a weightlifting part, a strength part, a WOD, and an AMRAP. The rating of perceived exertion (RPE) will be assessed using the validated Borg scale at the beginning of the session, after each part of the training, and at the end of the session. DOMS will be assessed using a visual analog scale at 24 and 48 hours after the crosstraining session. ### Conditions Module Conditions: - Recovery Keywords: - Sports drink - performance - concurrent exercise - nutrition - recovery ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER ##### Masking Info Masking: QUADRUPLE Who Masked: - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: OTHER #### Enrollment Info Count: 25 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: 60g of maltodextrin + fructose, 2:1 ratio Intervention Names: - Dietary Supplement: Carbohydrates Label: Carbohydrates Type: EXPERIMENTAL #### Arm Group 2 Description: Preparation of colorants, sweeteners, aromas and acidulants Intervention Names: - Dietary Supplement: Placebo Label: Placebo Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Carbohydrates Description: 60g of maltodextrin + fructose, 2:1 ratio Name: Carbohydrates Type: DIETARY_SUPPLEMENT #### Intervention 2 Arm Group Labels: - Placebo Description: Placebo Name: Placebo Type: DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes Description: Countermovement jump Measure: Exercise-induced muscle damage and recovery Time Frame: 1 hour 30 minutes Description: Delayed-onset muscle soreness (DOMS) scale (0-10 arbitrary units Measure: Exercise-induced muscle damage and recovery Time Frame: 1 hour 30 minutes #### Secondary Outcomes Description: Capillar lactate levels Measure: Metabolic markers Time Frame: 1 hour 30 minutes Description: Capilar glucose levels Measure: Metabolic markers Time Frame: 1 hour 30 minutes Description: Rate of perceived exertion scale Measure: Subjective fatigue Time Frame: 1 hour 30 minutes Description: Feeling scale Measure: Feeling sensations Time Frame: 1 hour 30 minutes Description: Weight used in the crosstraining session Measure: Performance Time Frame: 1 hour 30 minutes Description: Repetitions performed in the crosstraining session Measure: Performance Time Frame: 1 hour 30 minutes Description: Rounds performed in the crosstraining session Measure: Performance Time Frame: 1 hour 30 minutes ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Age: 18-35 years. * Body mass index: 18.5-30 kg/m2. * Ability to understand the instructions, objectives, and study protocol. * Minimum of 3 years of experience in crosstraining, with at least 6 hours of weekly training over the past 3 months. * Resident on the island of Tenerife. Exclusion Criteria: * History of a significant adverse cardiovascular event, renal insufficiency, cirrhosis, eating disorder, weight control surgical intervention, or type 2 diabetes mellitus. * Any chronic condition in which the intake of nutritional supplements is not advisable. * Any condition that, in the investigator's judgment, would impair the ability to participate in the study or represent a personal risk to the participant. * Use of medications that may affect the study results. * Unstable body weight for 3 months prior to the start of the study (\> 4 kg loss or gain in - weight). * Active tobacco abuse or illicit drug use, or history of treatment for alcohol abuse. * On a special diet or prescribed for other reasons (e.g., celiac disease). Healthy Volunteers: True Maximum Age: 35 Years Minimum Age: 18 Years Sex: MALE Standard Ages: - ADULT ### Contacts Locations Module #### Locations Location 1: City: Granada Country: Spain Facility: University of Granada ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440330 Acronym: DECODE Brief Title: Define Predictors for Posttransplant Diabetes Mellitus Study Official Title: Define Predictors for Posttransplant Diabetes Mellitus Study #### Organization Study ID Info ID: 5469 #### Organization Class: OTHER Full Name: University Hospital, Antwerp ### Status Module #### Completion Date Date: 2026-09-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: RECRUITING #### Primary Completion Date Date: 2026-06-30 Type: ESTIMATED #### Start Date Date: 2023-09-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-21 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Universitair Ziekenhuis Brussel Class: OTHER Name: University Ghent Class: OTHER Name: Universitaire Ziekenhuizen KU Leuven Class: UNKNOWN Name: HUB Class: OTHER Name: Université Catholique de Louvain Class: OTHER Name: Centre Hospitalier Universitaire de Liege #### Lead Sponsor Class: OTHER Name: University Hospital, Antwerp #### 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 primary aim of this prospective, multicentre study is to develop an accurate and convenient tool to predict the risk of PTDM at 3 months post-transplant, based on information on the day of transplantation (day 0). In order to create such model, we will start by identifying individual predictor variables at the day of transplantation and subsequently explore the optimal combination of these predictors in multivariable models. Secondary objectives include: * Compare the performance of the model based on predictor variables at day 0 with existing models for prediction of PTDM (Chakkera, San Antonio Diabetes Prediction Model and Framingham Offspring Study Diabetes Mellitus algorithm) * Explore the glucose level evolution during the first 2 weeks after transplantation using continuous glucose monitoring, and its relationship with baseline patient characteristics and immunosuppressant drug use. * Evaluate the added value of incorporating information on glucose levels in the first and second weeks post-transplant to improve the PTDM prediction model. * Identify predictors for early post-transplant hyperglycemia (first 2 weeks post-transplantation) * Explore the correlation between early post-transplant hyperglycemia (fasting glycemia, pre-dinner glycemia) and PTDM at 3 months ### Conditions Module Conditions: - Post-transplant Diabetes Mellitus - Kidney Transplant; Complications ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 330 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 Description: continuous glucose monitoring will be used during the first 14 days post-transplantation Name: continuous glucose monitoring Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Post-transplant diabetes mellitus diagnosis based on the need for glucose lowering therapy or 2h-OGTT value of \>=200mg/dL Measure: Post-transplant diabetes mellitus Time Frame: at 10-13 weeks post-transplantation ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Adult patients (≥18 years) with end stage kidney disease undergoing kidney transplantation with a deceased or living donor * Signed informed consent * Initial therapy with at least tacrolimus and corticosteroids Exclusion Criteria: * Patients with a diagnosis of diabetes mellitus (either type 1 or type 2) prior to kidney transplantation * Treatment with GLP1-RA for weight losing purposes * Patients receiving a multi-organ transplantation * ABO incompatibility Healthy Volunteers: True Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Kidney transplant recipients without known pre-existing diabetes. ### Contacts Locations Module #### Central Contacts Contact 1: Email: yassine.laghrib@uza.be Name: Yassine Laghrib, MD Phone: +3238213435 Role: CONTACT #### Locations Location 1: City: Edegem Contacts: *Contact 1:* - Email: yassine.laghrib@uza.be - Name: Yassine Laghrib, MD - Phone: +3238213435 - Role: CONTACT Country: Belgium Facility: UZA State: Antwerpen Status: RECRUITING Zip: 2650 ### 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: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440317 Acronym: PLAQSIRIS Brief Title: Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane Official Title: Investigation of Immunothrombosis in Intensive Care Patients With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane #### Organization Study ID Info ID: CHUBX 2023/93 #### Organization Class: OTHER Full Name: University Hospital, Bordeaux ### Status Module #### Completion Date Date: 2025-07 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-06 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-04-25 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: Baxter Healthcare Corporation #### 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: False ### Description Module Brief Summary: Sepsis remains a global scourge. Before the SARS-CoV-2 pandemic, the World Health Organization estimated approximately 49 million cases annually, resulting in 11 million deaths. Defined by dysregulated host response to infection, sepsis leads to vital organ failure. Renal dysfunction affects about half of ICU patients, necessitating extracorporeal renal replacement therapy in approximately 10% of cases, alongside coagulation system involvement typified by thrombocytopenia. Immunothrombotic phenomena are pivotal in sepsis pathophysiology, activating coagulation and disrupting immune responses. Microcirculatory impairment, mediated by neutrophils, monocytes, and platelets, worsens vital organ perfusion. Excessive production of Neutrophil Extracellular Traps (NETs) is implicated in microcirculatory compromise during sepsis. ### Conditions Module Conditions: - Sepsis Keywords: - Intensive Care - Immunothrombosis - NETs - Neutrophils - Platelets ### Design Module #### Bio Spec Description: Blood samples will be collected in citrate and EDTA tubes before and after the membrane on the day of initiating renal replacement therapy (Day 0), the day after starting therapy (Day 1), and 5 days after (Day 5). Extraction of peripheral blood mononuclear cells (PBMCs) will be done. Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 30 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units. Intervention Names: - Device: Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane) Label: Hemofiltration membranes (the oXiris® membrane and the HF1400 ® membrane) ### Interventions #### Intervention 1 Arm Group Labels: - Hemofiltration membranes (the oXiris® membrane and the HF1400 ® membrane) Description: The PRISMAFLEX® or PRISMAX® control unit (pre- and post-dilution with a prescribed treatment dose \> 25 ml/kg/h) with regional citrate anticoagulation and a substitution solution by PHOXILLUM will be used regardless of the type of membrane used (the oXiris membrane and the HF 1400 membrane), also as part of routine care provided in the ICU. Name: Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane) Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Dosages of platelet activation markers, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane Measure: Immunothrombosis : Concentration of platelet activation markers Time Frame: 12 months after inclusion day #### Secondary Outcomes Description: Dosages of Neutrophil Extracellular Traps, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane Measure: NETosis : Concentration of Neutrophil Extracellular Traps Time Frame: 12 months after inclusion day Description: Dosages of monocyte (CD14+), before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane Measure: Monocyte activation : Concentration of monocyte (CD14+) Time Frame: 12 months after inclusion day ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients aged 18 years and older * Admitted to the intensive care unit with septic shock, defined as an increase in the Sequential Organ Failure Assessment (SOFA) score of at least 2 points due to infection, requiring vasopressor drugs to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and a lactate level \> 2 mmol/L (18 mg/dL) despite adequate fluid resuscitation * Requiring renal replacement therapy according to consensus indications: * KDIGO stage 3 acute kidney injury with oliguria or anuria persisting for more than 72 hours * Urea \> 40 mmol/L * Plasma potassium \> 5.5 mmol/L despite medical treatment * pH \< 7.15 (pure metabolic acidosis with PaCO2 \< 30 mmHg or mixed acidosis with PaCO2 \> 50 mmHg without the possibility of improving alveolar ventilation) * Acute pulmonary edema secondary to hydrosaline overload resulting in severe hypoxemia (oxygen flow \> 5 L/min or FiO2 \> 50% during mechanical ventilation to maintain SaO2 \> 95%) despite diuretic therapy * Receiving continuous renal replacement therapy with a high-adsorption membrane (oXiris membrane) or a conventional membrane (HF1400 membrane) Exclusion Criteria: * Known history of constitutional thrombopathy (Bernard Soulier disease, Glanzmann thrombasthenia, Gray's syndrome or dense granule disease) * Myelodysplastic or myeloproliferative syndrome * Autoimmune thrombocytopenic purpura * Acute leukemia * Hemorrhagic shock * Platelet transfusion within 7 days prior to inclusion * Antiplatelet therapy with clopidogrel or ticagrelor within 5 days prior to inclusion, prasugrel or dipyridamole within 7 days prior to inclusion * Active HIV infection or hepatitis B or C * Pregnant woman * Not affiliated to a social security system or not benefiting from such a system Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units ### Contacts Locations Module #### Central Contacts Contact 1: Email: antoine.dewitte@u-bordeaux.fr Name: Antoine DEWITTE, Dr Phone: 05 57 65 68 66 Phone Ext: +33 Role: CONTACT Contact 2: Email: sara.cronier@chu-bordeaux.fr Name: Sarah CRONIER Phone: 05 57 65 68 66 Phone Ext: +33 Role: CONTACT #### Locations Location 1: City: Pessac Contacts: *Contact 1:* - Email: antoine.dewitte@u-bordeaux.fr - Name: Antoine DEWITTE, Dr - Phone: 05 57 65 68 66 - Phone Ext: +33 - Role: CONTACT *Contact 2:* - Email: sarah.cronier@chu-bordeaux.fr - Name: Sarah CRONIER - Phone: 05 57 65 68 66 - Phone Ext: +33 - Role: CONTACT Country: France Facility: Hopital Haut-Lévêque Zip: 33604 #### Overall Officials Official 1: Affiliation: ImmunoConcEpT, Bordeaux University Name: Maria MAMANI, Pr Role: STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes - ID: D000013927 - Term: Thrombosis - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001778 - Term: Blood Coagulation Disorders - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions ### Condition Browse Module - Browse Leaves - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M15577 - Name: Shock - Relevance: LOW - As Found: Unknown - ID: M2804 - Name: Thromboinflammation - Relevance: HIGH - As Found: Immunothrombosis - ID: M15580 - Name: Shock, Septic - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M16686 - Name: Thrombosis - Relevance: LOW - As Found: Unknown - ID: M7784 - Name: Embolism - Relevance: LOW - As Found: Unknown - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - 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: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000090882 - Term: Thromboinflammation ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - 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: T382 - Name: Citrate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440304 Acronym: TheraCRAB Brief Title: Therapeutic Options for CRAB Official Title: Therapeutic Strategies for Carbapenem-Resistant Acinetobacter Baumannii Infections: Study Protoco #### Organization Study ID Info ID: CRAB01 #### Organization Class: OTHER Full Name: Clinical Hospital Centre Zagreb ### Status Module #### Completion Date Date: 2027-02 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-12 Type: ESTIMATED #### Start Date Date: 2024-11 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-21 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Clinical Hospital Centre Zagreb #### Responsible Party Investigator Affiliation: Clinical Hospital Centre Zagreb Investigator Full Name: Ivan Šitum, MD Investigator Title: Principal invesigator 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: CRAB infections in ICUs are on the rise, leading to higher morbidity, mortality, and healthcare costs due to resistance to most antibiotics, including carbapenems. The main resistance mechanisms include carbapenemases, efflux pumps, and changes in the bacterial cell wall. Current treatments include polymyxins (Colistin, Polymyxin B), which are effective but can lead to resistance, aminoglycosides (Amikacin, Gentamicin), which are limited by resistance, and tetracyclines (Tigecycline, Eravacycline), which are effective against CRAB. Fosfomycin is effective in combination treatments, and combination therapy (e.g., colistin with sulbactam, fosfomycin, or eravacycline) can enhance outcomes. Research shows promise for combination therapies, improving treatment efficacy and reducing mortality. New regimens are being studied to find optimal combinations. Individualized dosing is crucial, considering patient-specific factors like age, weight, and renal function. Adjustments depend on infection site and comorbidities. Strict infection control and antimicrobial stewardship programs (ASPs) are essential. ASPs focus on optimizing antibiotic use and reducing resistance through education and surveillance. Future directions include continued research for new drugs or combinations and strategies to overcome resistance and improve treatment efficacy. Study goals include achieving negative samples after 10 days of therapy, 30-day survival, discharge rates, reduced SOFA scores, and improved clinical and radiological findings. A randomized study will compare colistin combined with fosfomycin, ampicillin/sulbactam, and eravacycline. In summary, treating CRAB infections is complex, requiring combination therapy, individualized dosing, and strict infection control measures. Detailed Description: The primary goal was the negativization of positive samples (surveillance or diagnostic) after 10 d of therapy. In addition to the control samples with the same name, 4.,7. and the 10th day after starting therapy. The secondary objectives were 30-day survival, discharge from the ICU, discharge from the hospital, reduction in SOFA score, rate of reinfection, and frequency of complications (deterioration of renal function). Reduction of CRP, PCT, Leukocytes, improvement of the clinical picture, improvement of radiological findings (such as X-ray of the lungs), and reduction of elevated body temperature. P: Surgical patients who require treatment in the ICU with a positive sample (surveillance or diagnostic) for A. baumannii, with clinical signs of infection (temperature \>38.5, CPR \>50, L \>10000) (in which no infection can be explained by another cause?) I + C - 3 groups: 1. Colistin+Fosfomycin, 2. Colistin+Unasin 3. Colistin+Xerava O, negative sample positive; LOS, ICU; LOS, hospital; Reduction of SOFA score. Hypothesis The combination of fosfomycin with colistin and eravacycline with colistin led to faster negative samples than the combination of ampicillin/sulbactam with colistin in intensive care unit patients diagnosed with carbapenem-resistant A. baumannii. After obtaining approval from the ethics committee of KBC Zagreb, this study will be conducted at the UHC Zagreb, Department of Anesthesiology and ICU. Patients will be randomly divided according to a predetermined randomization table Upon arrival of a positive microbiological finding on A. baumannii, the Fosfo group will receive fosfomycin 8 g every 8 h, together with a colistin bolus of 6 million IJ, followed by 3 million IJ every 8 h. After the first day, the dose was adjusted according to kidney and liver function. Therapy was administered for 10 days. Upon arrival of a positive microbiological finding on A. baumannii, the Unasin group will receive a bolus dose of ampicillin/sulbactam 2 g + 1 g and a continuous infusion of 8 g + 4 g over 24 h together (maximum daily dose 12 g/day) with a colistin bolus of 6 mil IJ, followed by 3 mil IJ every 8 h. After the first day, the dose was adjusted according to kidney and liver function. Therapy was performed for 10 days Upon arrival of a positive microbiological finding for A. baumannii, the Xerava group will receive eravacycline at a dose of 1 mg/kg every 12 h for 60 min together with colistin bolus 6 mil IU, and then 3 mil IU every 8 h. After the first day, the dose was adjusted according to kidney and liver function. Therapy was administered for 10 days. After the first positive microbiological finding for A. baumannii, the test was repeated on days 4th, 7th and 10th days from the start of therapy. The Charlson Comorbidity Index was calculated for each patient upon inclusion in the study. The SOFA score was calculated daily for each patient over 10 days. Patient data from a hospital information system were used in this study. Demographic data, comorbidities, habits (alcohol and cigarettes), Charlson comorbidity index, SOFA score, allergies, and the type of positive sample will be recorded. The Charlson Comorbidity Index was calculated for each patient upon inclusion in the study. The SOFA score was calculated daily for each patient over 10 days. Patients were included in the study after the arrival of a microbiological test positive for A. baumannii. A routine antimicrobial susceptibility test will be performed when the microbiological findings are positive for A. baumannii. The sensitivity of all A. baumannii strains included in the study, regardless of the group to which they belonged (Fosfo, Unasin, and Xerava), fosfomycin, and eravacycline, was determined during microbiological analysis of all A. baumannii strains included in the study. After the first positive microbiological finding for A. baumannii, the test was repeated on days 4th, 7th and 10th days from the start of therapy. For each patient included in the study, inflammatory parameters (leukocytes, CRP, and procalcitonin) and the number of days and discharge from the ICU and hospital as well as 30-day mortality and cause of death, complications (AKI and ALF), and reinfection were monitored. For a test power of 80% and the use of an independent t-test for the primary objective and x2 test for the secondary objective with a statistical significance of 0.05, it was necessary to include 108 patients, three groups, and 36 subjects per group. The test for power calculation was G Power Version 3.1.9.6). The results were processed using IBM SPSS Statistics v27. ### Conditions Module Conditions: - Infections, Bacterial - Sepsis Bacterial Keywords: - Carbapenem-resistant Acinetobacter baumannii (CRAB) - Intensive Care Unit (ICU) infections - Polymyxins (colistin) - Combination antimicrobial therapy - Antimicrobial resistance mechanisms - Fosfomycin - Eravacyclin - Ampicillin/sulbactam ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 108 Type: ESTIMATED Phases: - PHASE4 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Upon arrival of a positive microbiological finding on A. baumannii, the Fosfo group will receive fosfomycin 8 g every 8 h, together with a colistin bolus of 6 million IJ, followed by 3 million IJ every 8 h. After the first day, the dose was adjusted according to kidney and liver function. Therapy was administered for 10 days. Intervention Names: - Drug: Fosfomycin Label: Fosfo Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: Upon arrival of a positive microbiological finding on A. baumannii, the Unasin group will receive a bolus dose of ampicillin/sulbactam 2 g + 1 g and a continuous infusion of 8 g + 4 g over 24 h together (maximum daily dose 12 g/day) with a colistin bolus of 6 mil IJ, followed by 3 mil IJ every 8 h. After the first day, the dose was adjusted according to kidney and liver function. Therapy was performed for 10 days Intervention Names: - Drug: Unasyn Label: Unasin Type: ACTIVE_COMPARATOR #### Arm Group 3 Description: Upon arrival of a positive microbiological finding for A. baumannii, the Xerava group will receive eravacycline at a dose of 1 mg/kg every 12 h for 60 min together with colistin bolus 6 mil IU, and then 3 mil IU every 8 h. After the first day, the dose was adjusted according to kidney and liver function. Therapy was administered for 10 days. Intervention Names: - Drug: Eravacycline Label: Xerava Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Fosfo Description: Patients will be randomly divided according to a predetermined randomization table Upon arrival of a positive microbiological finding on A. baumannii, patient will be randomised to one of groups (Colistin with Unasyn OR Colistin with Xerava OR Colistin with Fosfomycin Name: Fosfomycin Other Names: - Fosfomycin with Colistin Type: DRUG #### Intervention 2 Arm Group Labels: - Xerava Description: Patients will be randomly divided according to a predetermined randomization table Upon arrival of a positive microbiological finding on A. baumannii, patient will be randomised to one of groups (Colistin with Unasyn OR Colistin with Xerava OR Colistin with Fosfomycin Name: Eravacycline Other Names: - Eravacycline with Colistin Type: DRUG #### Intervention 3 Arm Group Labels: - Unasin Description: Patients will be randomly divided according to a predetermined randomization table Upon arrival of a positive microbiological finding on A. baumannii, patient will be randomised to one of groups (Colistin with Unasyn OR Colistin with Xerava OR Colistin with Fosfomycin Name: Unasyn Other Names: - Unasyn with Colistin Type: DRUG ### Outcomes Module #### Other Outcomes Description: patients survived 30 days after randomisation Measure: 30 day Survival Time Frame: 30day #### Primary Outcomes Description: Rate of negativisation of (surveillance or diagnostic) microbiological sample; Measure: Negativisation Time Frame: 10 days #### Secondary Outcomes Description: Days spent in ICU total after randomisation Measure: Length of stay in ICU Time Frame: 90 days Description: Days spent in hospital total after randomisation Measure: Length of stay in hospital Time Frame: 90 days Description: Change in initial SOFA score from randomisation day, from 0 points to 24 Measure: Reduction of Sequential Organ Failure Assessment (SOFA) score Time Frame: 10 days ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Surgical patients (abdominal, vascular, and polytraumatized patients) * older than 18 years * who require postoperative treatment in the ICU * A positive sample (surveillance or diagnostic) for A. baumannii with signs of systemic infection. * Infection is defined as a diagnostic microbiologically positive sample for A. baumannii and a surveillance microbiologically positive sample for A. baumannii with signs of systemic infection (CRP, L, and body temperature) * Colonisation is a positive surveillance microbiological sample for A. baumannii in the absence of signs of systemic infection (CRP, L, and body temperature). Exclusion Criteria: * Allergy to medicines * Positive surveillance swabs for A. baumannii without signs of systemic infection * Positive findings (surveillance or diagnostic) for carbapenem-sensitive A. baumannii * Refusal to participate in the research Maximum Age: 90 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: ivsitum@gmail.com Name: Ivan Šitum Phone: 0915143620 Role: CONTACT #### Overall Officials Official 1: Affiliation: UHC Zagreb Name: Ivan Šitum Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Šitum I, Mamić G, Džaja N, Hrvoić L, Lovrić D, Siroglavić M, et al. Upala pluća povezana s mehaničkom ventilacijom uzrokovana bakterijom Acinetobacter baumannii u razdoblju pandemije COVID-19. Medicina Fluminensis : Medicina Fluminensis [Internet]. 2023 Jun 1 [cited 2024 Apr 30];59(2):139-48. Available from: http://hrcak.srce.hr/medicinamedicinafluminensis Citation: Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities \| A.R. & Patient Safety Portal [Internet]. [cited 2024 May 2]. Available from: https://arpsp.cdc.gov/story/cra-urgent-public-health-threat Citation: Shields RK, Paterson DL, Tamma PD. Navigating Available Treatment Options for Carbapenem-Resistant Acinetobacter baumannii-calcoaceticus Complex Infections. Clin Infect Dis. 2023 May 1;76(Suppl 2):S179-S193. doi: 10.1093/cid/ciad094. PMID: 37125467 Citation: Isler B, Doi Y, Bonomo RA, Paterson DL. New Treatment Options against Carbapenem-Resistant Acinetobacter baumannii Infections. Antimicrob Agents Chemother. 2018 Dec 21;63(1):e01110-18. doi: 10.1128/AAC.01110-18. Print 2019 Jan. PMID: 30323035 Citation: Viehman JA, Nguyen MH, Doi Y. Treatment options for carbapenem-resistant and extensively drug-resistant Acinetobacter baumannii infections. Drugs. 2014 Aug;74(12):1315-33. doi: 10.1007/s40265-014-0267-8. PMID: 25091170 Citation: Dalfino L, Stufano M, Bavaro DF, Diella L, Belati A, Stolfa S, Romanelli F, Ronga L, Di Mussi R, Murgolo F, Loconsole D, Chironna M, Mosca A, Montagna MT, Saracino A, Grasso S. Effectiveness of First-Line Therapy with Old and Novel Antibiotics in Ventilator-Associated Pneumonia Caused by Carbapenem-Resistant Acinetobacter baumannii: A Real Life, Prospective, Observational, Single-Center Study. Antibiotics (Basel). 2023 Jun 14;12(6):1048. doi: 10.3390/antibiotics12061048. PMID: 37370367 Citation: Paul M, Carrara E, Retamar P, Tangden T, Bitterman R, Bonomo RA, de Waele J, Daikos GL, Akova M, Harbarth S, Pulcini C, Garnacho-Montero J, Seme K, Tumbarello M, Lindemann PC, Gandra S, Yu Y, Bassetti M, Mouton JW, Tacconelli E, Rodriguez-Bano J. European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines for the treatment of infections caused by multidrug-resistant Gram-negative bacilli (endorsed by European society of intensive care medicine). Clin Microbiol Infect. 2022 Apr;28(4):521-547. doi: 10.1016/j.cmi.2021.11.025. Epub 2021 Dec 16. PMID: 34923128 Citation: Rodrigues RD, Garcia RCL, Bittencourt GA, Waichel VB, Garcia ECL, Rigatto MH. Antimicrobial Therapy Duration for Bloodstream Infections Caused by Pseudomonas aeruginosa or Acinetobacter baumannii-calcoaceticus complex: A Retrospective Cohort Study. Antibiotics (Basel). 2023 Mar 8;12(3):538. doi: 10.3390/antibiotics12030538. PMID: 36978405 Citation: Reina R, Leon-Moya C, Garnacho-Montero J. Treatment of Acinetobacter baumannii severe infections. Med Intensiva (Engl Ed). 2022 Dec;46(12):700-710. doi: 10.1016/j.medine.2022.08.007. Epub 2022 Oct 19. PMID: 36272902 Citation: Acinetobacter in Healthcare Settings \| HAI \| CDC [Internet]. [cited 2024 Apr 30]. Available from: https://www.cdc.gov/hai/organisms/acinetobacter.html Citation: Nartey YA, Donkor AB, Siaw ADJ, Ekor OE, Jimah BB. Carbapenem-Resistant Acinetobacter baumannii Bloodstream Infection in a Ghanaian Patient with Unilateral Diaphragmatic Eventration and HIV Type 1 Infection. Case Rep Infect Dis. 2023 Oct 12;2023:9930291. doi: 10.1155/2023/9930291. eCollection 2023. PMID: 37867582 Citation: Kim SH, Wi YM, Peck KR. Clinical Effectiveness of Tetracycline-Class Agents Based Regimens in Patients With Carbapenem-Resistant Acinetobacter baumannii Bacteremia: A Single-Center Retrospective Cohort Study. J Korean Med Sci. 2023 Aug 28;38(34):e263. doi: 10.3346/jkms.2023.38.e263. PMID: 37644679 Citation: Jung SY, Lee SH, Lee SY, Yang S, Noh H, Chung EK, Lee JI. Antimicrobials for the treatment of drug-resistant Acinetobacter baumannii pneumonia in critically ill patients: a systemic review and Bayesian network meta-analysis. Crit Care. 2017 Dec 20;21(1):319. doi: 10.1186/s13054-017-1916-6. PMID: 29262831 Citation: Pogue JM, Zhou Y, Kanakamedala H, Cai B. Burden of illness in carbapenem-resistant Acinetobacter baumannii infections in US hospitals between 2014 and 2019. BMC Infect Dis. 2022 Jan 6;22(1):36. doi: 10.1186/s12879-021-07024-4. PMID: 34991499 Citation: Seok H, Choi WS, Lee S, Moon C, Park DW, Song JY, Cheong HJ, Kim J, Kim JY, Park MN, Kim YR, Lee HJ, Kim B, Pai H, Jo YM, Kim JH, Sohn JW. What is the optimal antibiotic treatment strategy for carbapenem-resistant Acinetobacter baumannii (CRAB)? A multicentre study in Korea. J Glob Antimicrob Resist. 2021 Mar;24:429-439. doi: 10.1016/j.jgar.2021.01.018. Epub 2021 Feb 8. PMID: 33571708 Citation: Gatti M, Viaggi B, Rossolini GM, Pea F, Viale P. An Evidence-Based Multidisciplinary Approach Focused on Creating Algorithms for Targeted Therapy of Infection-Related Ventilator-Associated Complications (IVACs) Caused by Pseudomonas aeruginosa and Acinetobacter baumannii in Critically Ill Adult Patients. Antibiotics (Basel). 2021 Dec 28;11(1):33. doi: 10.3390/antibiotics11010033. PMID: 35052910 Citation: Ozger HS, Cuhadar T, Yildiz SS, Demirbas Gulmez Z, Dizbay M, Guzel Tunccan O, Kalkanci A, Simsek H, Unaldi O. In vitro activity of eravacycline in combination with colistin against carbapenem-resistant A. baumannii isolates. J Antibiot (Tokyo). 2019 Aug;72(8):600-604. doi: 10.1038/s41429-019-0188-6. Epub 2019 Apr 26. PMID: 31028352 Citation: Abdallah M, Olafisoye O, Cortes C, Urban C, Landman D, Quale J. Activity of eravacycline against Enterobacteriaceae and Acinetobacter baumannii, including multidrug-resistant isolates, from New York City. Antimicrob Agents Chemother. 2015 Mar;59(3):1802-5. doi: 10.1128/AAC.04809-14. Epub 2014 Dec 22. PMID: 25534744 Citation: Monogue ML, Thabit AK, Hamada Y, Nicolau DP. Antibacterial Efficacy of Eravacycline In Vivo against Gram-Positive and Gram-Negative Organisms. Antimicrob Agents Chemother. 2016 Jul 22;60(8):5001-5. doi: 10.1128/AAC.00366-16. Print 2016 Aug. PMID: 27353265 Citation: Zhanel GG, Baxter MR, Adam HJ, Sutcliffe J, Karlowsky JA. In vitro activity of eravacycline against 2213 Gram-negative and 2424 Gram-positive bacterial pathogens isolated in Canadian hospital laboratories: CANWARD surveillance study 2014-2015. Diagn Microbiol Infect Dis. 2018 May;91(1):55-62. doi: 10.1016/j.diagmicrobio.2017.12.013. Epub 2017 Dec 22. PMID: 29338931 Citation: Ni W, Shao X, Di X, Cui J, Wang R, Liu Y. In vitro synergy of polymyxins with other antibiotics for Acinetobacter baumannii: a systematic review and meta-analysis. Int J Antimicrob Agents. 2015 Jan;45(1):8-18. doi: 10.1016/j.ijantimicag.2014.10.002. Epub 2014 Oct 24. PMID: 25465524 Citation: Grabein B, Graninger W, Rodriguez Bano J, Dinh A, Liesenfeld DB. Intravenous fosfomycin-back to the future. Systematic review and meta-analysis of the clinical literature. Clin Microbiol Infect. 2017 Jun;23(6):363-372. doi: 10.1016/j.cmi.2016.12.005. Epub 2016 Dec 9. PMID: 27956267 Citation: Assimakopoulos SF, Karamouzos V, Eleftheriotis G, Lagadinou M, Bartzavali C, Kolonitsiou F, Paliogianni F, Fligou F, Marangos M. Efficacy of Fosfomycin-Containing Regimens for Treatment of Bacteremia Due to Pan-Drug Resistant Acinetobacter baumannii in Critically Ill Patients: A Case Series Study. Pathogens. 2023 Feb 9;12(2):286. doi: 10.3390/pathogens12020286. PMID: 36839558 Citation: Nwabor OF, Terbtothakun P, Voravuthikunchai SP, Chusri S. Evaluation of the Synergistic Antibacterial Effects of Fosfomycin in Combination with Selected Antibiotics against Carbapenem-Resistant Acinetobacter baumannii. Pharmaceuticals (Basel). 2021 Feb 25;14(3):185. doi: 10.3390/ph14030185. PMID: 33668905 Citation: Mohd Sazlly Lim S, Heffernan A, Naicker S, Wallis S, Roberts JA, Sime FB. Evaluation of Fosfomycin-Sulbactam Combination Therapy against Carbapenem-Resistant Acinetobacter baumannii Isolates in a Hollow-Fibre Infection Model. Antibiotics (Basel). 2022 Nov 9;11(11):1578. doi: 10.3390/antibiotics11111578. PMID: 36358238 Citation: Warrier AR, Sneha R, Wilson A, Prakash S. 654. Clinical efficacy and safety of high dose Ampicillin sulbactam among patients with CRAB infections: A case series. Open Forum Infect Dis [Internet]. 2022 Dec 15 [cited 2024 Apr 30];9(Supplement_2). Available from: https://dx.doi.org/10.1093/ofid/ofac492.706 Citation: Saelim W, Changpradub D, Thunyaharn S, Juntanawiwat P, Nulsopapon P, Santimaleeworagun W. Colistin plus Sulbactam or Fosfomycin against Carbapenem-Resistant Acinetobacter baumannii: Improved Efficacy or Decreased Risk of Nephrotoxicity? Infect Chemother. 2021 Mar;53(1):128-140. doi: 10.3947/ic.2021.0007. 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PMID: 35175509 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: HIGH - As Found: Infection, Bacterial - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000001424 - Term: Bacterial 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 - Abbrev: Hemat - Name: Hematinics ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M6319 - Name: Colistin - Relevance: HIGH - As Found: Phase III Trial - ID: M8700 - Name: Fosfomycin - Relevance: HIGH - As Found: 6.5 - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4003 - Name: Ampicillin - Relevance: LOW - As Found: Unknown - ID: M16193 - Name: Sulbactam - Relevance: LOW - As Found: Unknown - ID: M13997 - Name: Polymyxins - Relevance: LOW - As Found: Unknown - ID: M207969 - Name: Sultamicillin - Relevance: HIGH - As Found: Vaginal examination ### Intervention Browse Module - Meshes - ID: D000003091 - Term: Colistin - ID: D000005578 - Term: Fosfomycin - ID: C000035444 - Term: Sultamicillin ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440291 Acronym: Roman3 Brief Title: Cardioneuroablation for Reflex Syncope and Exercise Capacity Official Title: Effects of caRdioneurOablation on Exercise perforMance in Patients With Reflex Asystolic syNcope: The Roman 3 Study #### Organization Study ID Info ID: 501-1-10-14-24 #### Organization Class: OTHER Full Name: Centre of Postgraduate Medical Education ### Status Module #### Completion Date Date: 2025-09-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-09-01 Type: ESTIMATED #### Start Date Date: 2023-05-02 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Centre of Postgraduate Medical Education #### Responsible Party Investigator Affiliation: Centre of Postgraduate Medical Education Investigator Full Name: Prof. Piotr Kulakowski 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: Cardioneuroablation (CNA) is a new promising method to treat reflex syncope which is due to vagally-induced functional sinus arrest or atrio-ventricular block (AVB). Although the procedure is effective in \> 80% of patients, there are potential adverse effects associated with the lack of vagal protection. One of them is increased sinus rate and possible worsening of exercise capacity. However, it is not known how often this happens. Moreover, the most accurate tool to asses exercise capacity - cardiopulmonary exercise testing (CPET), has not yet been used in this group of patients. Therefore, the aim of the study is to assess one-year effects of CNA-induced total vagal denervation on cardiorespiratory fitness in patients undergoing CNA due to reflex asystolic syncope. The study group consists of patients undergoing CNA in our institution. All patients give informed written consent to undergo CNA and to participate in the study (Ethics Committee approval # 22/2024). CNA is performed according to standard protocol used in our institution. A symptom-limited cardiopulmonary exercise (CPET) is performed twice, at baseline (1-2 days before CNA) and after one year of follow-up. Standard CPET parameters are measured. Quality of life is measured using a dedicated questionnaire. Also, a control group of healthy volunteers will undergo CPET to answer the question whether subjects with reflex syncope differ in exercise capacity from healthy people. Detailed Description: Introduction Cardioneuroablation (CNA) is a new promising method to treat reflex syncope which is due to vagally-induced functional sinus arrest or atrio-ventricular block (AVB). The goal of the procedure is to ablate post-ganglionic endings of the parasympathetic part of the autonomic nervous system (ANS), located in ganglionated plexi (GP) in the epicardial fat and in the myocardium. Although both sympathetic and parasympathetic nerves are localized in GPs, the latter ones only barely regenerate. Therefore, CNA-induced damage to the parasympathetic part of GP is greater and more durable than that of the sympathetic part of ANS. Because increased vagal activity is one of the main mechanisms leading to reflex sinus arrest or atrio-ventricular (AV) block, targeting this part of ANS by CNA may prevent recurrences of reflex syncope. Indeed, it has been shown that CNA may be effective in approximately 80-90% of very symptomatic subjects with reflex syncope. Lack or diminished parasympathetic drive to the heart may be, however, associated with adverse effects. The main complication which is seen shortly and up to one year after CNA is heart rhythm acceleration which may be symptomatic in approximately one-third of patients. In the majority of patients sinus rate gradually slows down over a period of 3-12 months due to partial parasympathetic reinnervation, however, approximately 6-7% of patients remain severely symptomatic and require heart rate slowing agents. Other complaints such as decreased exercise capacity or effort dyspnea can occur in up to 14% of patients and they are usually attributed to faster than needed sinus rate at rest and during exercise. Although in the vast majority of patients, the above mentioned symptoms are rather mild and do not decrease the patient's acceptance of CNA, in some may decrease the quality of life. Thus, a detailed assessment of the effects of CNA on exercise performance is clinically important. However, to date, no study addressed this issue. There are several methods to assess exercise performance with cardiopulmonary exercise testing (CPET) being the most accurate and reference tool. It measures cardiorespiratory fitness and physiological responses to aerobic exercise in many conditions. CPET provides a comprehensive evaluation of the respiratory, circulatory, and metabolic responses to exercise that cannot be accurately measured by less precise methods such as standard exercise stress test. Therefore, we have chosen CPET to evaluate the effects of CNA on exercise performance in our patients. Aim To assess one-year effects of CNA-induced total vagal denervation on cardiorespiratory fitness in patients undergoing CNA due to reflex asystolic syncope. To compare cardiorespiratory fitness between subjects with reflex syncope and healthy volunteers. Hypothesis. Cardioneuroablation significantly decreases cardiopulmonary fitness in patients with reflex asystolic syncope. There are no differences between patients with syncope and healthy people in cardiorespiratory fitness at baseline whereas post-CNA results of CPET are significantly worse in syncope patients versus controls Methods Patients. The study group will consist of consecutive patients undergoing CNA in our institution. Patients are referred for CNA if they have severe, recurrent symptoms due to reflex syncope with ECG documented asystole \>3 seconds, especially if associated with injury, or recurrent presyncope with persistent reflex bradycardia. The patients have to have a history of ineffective prior non-pharmacological treatment and a positive baseline atropine test (sinus rate acceleration \> 30% and no AV block following 2 mg of intravenous atropine). All patients gave informed written consent to undergo CNA and to participate in the study (Ethics Committee approval # 22/2024). Control group. This group will consist of healthy volunteers without cardiovascular and other chronic disorders, age- and gender-matched with the CNA group. This group will not undergo CNA. Cardioneuroablation. The procedure is performed under general anesthesia with muscle relaxation using a 3.5 mm irrigated tip catheter (Navistar ThermoCool SmartTouch) with contact force module and electroanatomical system Carto 3 (Biosense Webster, US). The ablation index is set at 500 except coronary sinus (CS) where the target value is 350. Intracardiac echocardiography (ICE) (Acuson SC2000, Siemens, Germany, AcuNav™ Ultrasound Catheter, Biosense Webster, US) is also used throughout the whole procedure and serves for guiding ablation, including identification of presumed GP areas. The extra cardiac vagal stimulation (ECVS) is performed using two diagnostic catheters positioned in the right and left jugular veins utilizing neurostimulator designed by Dr Pachon (Sao Paulo, Brazil) (pulse amplitude of 1 V/kg body weight up to 70 V, 50 ms width, 50 Hz frequency, delivered over 5 sec). Complete bilateral vagal denervation of both sinus and AV nodes (no sinus arrest, slowing of sinus rate no more than 10% compared with baseline and no AV block with PR interval no longer than at baseline), documented on ECVS, is the end-point of CNA. Ablation is usually started in the left atrium (LA) at the anterior antrum of the right pulmonary vein where the superior paraseptal GP (SPSGP) is located, followed by ablation of the inferior paraseptal GP (IPSGP) at the floor of LA). Next, these GPs are ablated from the right atrium (RA). If the intraprocedural endpoints of CNA are not achieved by ablation of paraseptal GPs, additional applications in the LA at the sites of superior and postero-lateral LA GPs are performed, followed by applications in CS. At the end of the procedure, atropine test is performed in order to assess the residual, if present, vagal nerve activity. The value of \< 10% of increase in sinus rate following atropine injection (2 mg iv) will be taken as successful vagal denervation. Cardiopulmonary exercise testing A symptom-limited cardiopulmonary exercise (CPET) will be performed twice, at baseline and after one year of follow-up, both in the syncope and control patients. Exercise tests will be performed on a treadmill with a cardio-pulmonary system Reynolds Medical. The same load protocol will be used twice for the same patient. All patients will be encouraged to exercise at maximal effort (≥8 points using the 10-point Borg scale). During the exercise test, the patient's clinical status will be monitored. The systolic and diastolic blood pressure will be recorded every 3 minutes of exercise. Heart rate, heart rate reserve (predicted and achieved), chronotropic index and percentage of maximum predicted heart rate at peak exercise will be calculated (3). The maximum predicted heart rate will be calculated as 220-age in years. The heart rate recovery in 1 minute will be assessed. A 12-lead electrocardiogram will be recorded. ECG and heart rate parameters: ischemia, arrhythmia, or conduction disturbances during exercise and recovery will be accessed according to the American Heart Association recommendations. Ventilatory and gas exchange parameters will be assessed during the test. The peak oxygen uptake (VO2) will be averaged from the highest 30 s of exercise. Maximum predicted oxygen uptake will be calculated according to the Wasserman/Hansen equations. The anaerobic threshold will be calculated using a dual-method approach (V-slope and ventilatory equivalent methods). Other analyzed cardiopulmonary exercise testing parameters will include oxygen uptake to work rate increment ratio (∆O2/∆WR), ventilatory efficiency (VE/VCO2 slope), and breathing reserve at peak exercise, calculated as the percentage of maximum voluntary ventilation: \[(maximum voluntary ventilation - minute ventilation at peak exercise) / maximum voluntary ventilation\] × 100. All exercise tests will be supervised and analyzed according to current guidelines. Quality of life. Quality of life will be measured using a dedicated questionnaire: The Impact of Syncope on Quality-of-Life Questionnaire University of Calgary. This questionnaire consists of 9 questions with 6 choices and 3 questions with 5 choices. The overall maximum score is 57. The higher the score the poorer the quality of life is. Statistical analysis. The results are presented as mean±SD or numbers and percentages. Differences between variables are analysed using paired two-sided student t-test for normally distributed continuous variables or U Mann Whitney for not-normally distributed variables. The Chi square test (with Yates correction if appropriate) or exact Fisher test are used to compare qualitative parameters. A Pearson correlation coefficient is used to assess association between CPET values and QoL results. A p value \< 0.05 is considered significant. ### Conditions Module Conditions: - Syncope, Vasovagal Keywords: - syncope ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 100 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Cardioneuroablation procedure as described in the Methods section of the study Intervention Names: - Procedure: Cardioneuroablation Label: cardioneuroablation Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - cardioneuroablation Description: Cardioneuroablation procedure performed according to the protocol Name: Cardioneuroablation Type: PROCEDURE ### Outcomes Module #### Other Outcomes Description: The Impact of Syncope on Quality-of-Life Questionnaire University of Calgary (points) Measure: Quality of Life Time Frame: 12 months #### Primary Outcomes Description: peak Vo2 = maximum amount of oxygen that body can absorb and use during exercise (ml/kg/min) Measure: peak Vo2 Time Frame: 12 months #### Secondary Outcomes Description: (peak heart rate-resting heart rate)/(220-age-resting heart rate) (%) Measure: chronotropic index Time Frame: 12 months Description: metabolic equivalent of task (kcal/kg/min) Measure: METs Time Frame: 12 months Description: maximal heart rate during exercise (beats/min) Measure: HR peak Time Frame: 12 months Description: heart rate reserve = the difference between peak heart rate during exercise and heart rate soon after stopping exercise. Measure: HR reserve Time Frame: 12 months Description: duration of exercise in minutes and seconds Measure: exercise duration Time Frame: 12 months Description: heart rate recorded one minute after completion exercise test (beats/min) Measure: HR 1 minute after exercise Time Frame: 12 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * severe, recurrent symptoms due to reflex syncope or recurrent presyncope due to slow heart rate * ECG documented asystole \>3 seconds * ineffective prior non-pharmacological treatment * positive baseline atropine test (sinus rate acceleration \> 30% and no atrio-ventricular block following 2 mg of intravenous atropine) * signed written informed consent Exclusion Criteria: * serious comorbidities precluding general anaesthesia and cardioneuroablation * non-functional sinus arrest or atrio-ventricular block (negative atropine test) * lack of consent to participate in the study Healthy Volunteers: True Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: kulak@kkcmkp.pl Name: Piotr Kulakowski, PhD Phone: 604455081 Role: CONTACT Contact 2: Email: sikorska.agnieszka.anna@gmail.com Name: Anieszka Sikorska, PhD Phone: 604106455 Role: CONTACT #### Locations Location 1: City: Warsaw Contacts: *Contact 1:* - Email: kulak@kkcmkp.pl - Name: Piotr Kulakowski, MD PhD - Phone: +48 22 51 52 757 - Role: CONTACT *Contact 2:* - Email: agnieszka.sikorska.anna@gmail.com - Name: Agnieszka Sikorska, MD PhD - Phone: +48 22 51 52 757 - Role: CONTACT Country: Poland Facility: Department of Cardiology, Postgraduate Medical School, Grochowski Hospital Status: RECRUITING Zip: 04-073 #### Overall Officials Official 1: Affiliation: Department of Cardiology, Postgraduate Medical School, Grochowski Hospital Name: Roman Piotrowski, PhD Role: STUDY_DIRECTOR ### IPD Sharing Statement Module Access Criteria: personal e-mail contact Description: To share data on a reasonable request from other researchers in this filed Info Types: - STUDY_PROTOCOL - SAP - ICF - CSR IPD Sharing: YES Time Frame: 24 months ### References Module #### References Citation: Pachon JC, Pachon EI, Pachon JC, Lobo TJ, Pachon MZ, Vargas RN, Jatene AD. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005 Jan;7(1):1-13. doi: 10.1016/j.eupc.2004.10.003. PMID: 15670960 Citation: Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28. PMID: 21712276 Citation: Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.2022.08.011. Epub 2022 Aug 28. PMID: 36114133 Citation: Kulakowski P, Baran J, Sikorska A, Krynski T, Niedzwiedz M, Soszynska M, Piotrowski R. Cardioneuroablation for reflex asystolic syncope: Mid-term safety, efficacy, and patient's acceptance. Heart Rhythm. 2024 Mar;21(3):282-291. doi: 10.1016/j.hrthm.2023.11.022. Epub 2023 Nov 29. PMID: 38036236 Citation: Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available. PMID: 20585013 Citation: Rose MS, Koshman ML, Ritchie D, Sheldon R. The development and preliminary validation of a scale measuring the impact of syncope on quality of life. Europace. 2009 Oct;11(10):1369-74. doi: 10.1093/europace/eup106. PMID: 19797151 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014474 - Term: Unconsciousness - ID: D000003244 - Term: Consciousness Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000054971 - Term: Orthostatic Intolerance - ID: D000054969 - Term: Primary Dysautonomias - ID: D000001342 - Term: Autonomic Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M9411 - Name: Heart Arrest - Relevance: LOW - As Found: Unknown - ID: M16353 - Name: Syncope - Relevance: HIGH - As Found: Syncope - ID: M21417 - Name: Syncope, Vasovagal - Relevance: HIGH - As Found: Syncope, Vasovagal - ID: M17224 - Name: Unconsciousness - Relevance: LOW - As Found: Unknown - ID: M6468 - Name: Consciousness Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M27981 - Name: Orthostatic Intolerance - Relevance: LOW - As Found: Unknown - ID: M4643 - Name: Autonomic Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M27979 - Name: Primary Dysautonomias - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013575 - Term: Syncope - ID: D000019462 - Term: Syncope, Vasovagal ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440278 Acronym: HHH-2 Brief Title: Healthy Heart Habits-2 Official Title: Multisite Feasibility of BA-HD: An Integrated Depression and Behavioral Risk Factor Reduction Coaching Program Following Acute Coronary Syndrome #### Organization Study ID Info ID: R34HL165716-01A1 Link: https://reporter.nih.gov/quickSearch/R34HL165716-01A1 Type: NIH #### Organization Class: OTHER Full Name: The Miriam Hospital ### Status Module #### Completion Date Date: 2025-07-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-04-30 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: The Miriam Hospital #### Responsible Party Investigator Affiliation: The Miriam Hospital Investigator Full Name: Emily C. Gathright, PhD Investigator Title: Research Scientist Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: Sixty adults who have experienced acute coronary syndrome within the past 2-12 months from three states (Rhode Island, North Carolina, Minnesota) will be randomized to either (1) a coaching program for depressed mood and health behavior change (Behavioral Activation for Health and Depression; BA-HD), or (2) Enhanced Usual Care. This study will evaluate the feasibility and acceptability of study procedures and BA-HD, and establish protocol and measurement harmonization across three sites in preparation for a future multi-site efficacy trial. Detailed Description: Acute coronary syndrome (ACS) represents a significant public health burden, with the most recent estimates suggesting that over 1 million U.S. adults experience ACS per year. As individuals are acutely surviving ACS more often, the associated disease burden is increasing for both the healthcare system and the individual living post-ACS. Poor engagement in health behaviors post-ACS contributes to risk for recurrent ACS and mortality. Modifiable behavioral contributors include smoking, medication non-adherence, physical inactivity, and poor diet. Approximately 20% of post-ACS adults experience depression and depression is associated with worse engagement in critical health behaviors, which in turn, increases subsequent progression of cardiovascular disease. Treatment of depression alone improves, but does not eliminate, behavioral nonadherence. Behavioral Activation is a robust counseling treatment for depression with evidence of improvements in depressive symptoms across varied populations (including those with medication conditions). BA seeks to improve mood by increasing environmental reinforcement through collaborative, values-guided setting of "activation goals." The goal setting focus and structure of BA allows for seamless integration of health behavior targets and thus offers a potential framework to integrate depression and health behavior treatment. BA-HD may be a useful strategy to depression and multiple health behavior improvement post-ACS. However, this possibility requires further testing. The purpose of this study is to examine the feasibility and acceptability of a multisite pilot randomized controlled trial and test the initial potential effects of the intervention (BA-HD) on cardiovascular health and depressive symptoms relative to an Enhanced Usual Care control condition. Participants will be randomly assigned to either 12 weeks of tele-delivered BA-HD) or Enhanced Usual Care (i.e., one session of depression and heart disease education and provision of community mental health resources). Primary endpoints are feasibility of multisite recruitment procedures (e.g., recruitment rates at each site), feasibility of intervention and control procedures (e.g., percent of enrolled participants who complete the study), study retention (e.g., percent of participants who complete 3 month follow-up), and acceptability of intervention content and intervention delivery and control procedures. We hypothesize that the intervention content and delivery will be 1) feasible and 2) acceptable. We will also examine changes in cardiovascular health, depressive symptoms, medication adherence, affect, and quality of life. ### Conditions Module Conditions: - Acute Coronary Syndrome ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 60 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Behavioral: Behavioral Activation for Health and Depression (BA-HD) Label: Behavioral Activation for Health and Depression Type: EXPERIMENTAL #### Arm Group 2 Intervention Names: - Other: Enhanced Usual Care Label: Enhanced Usual Care Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Behavioral Activation for Health and Depression Description: BA-HD includes 8 - 10 sessions delivered over 10-12 weeks. Sessions use behavioral activation techniques to connect patient core values with goal-setting targeting activities that improve mood, alongside personalized adjustments to cardiovascular health behaviors (i.e., tobacco cessation, medication adherence, physical activity, diet, and sleep). Educational materials and commercially available tools like activity trackers, pillboxes, and portion control aids will accompany the goal-setting process to facilitate behavior change. Name: Behavioral Activation for Health and Depression (BA-HD) Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - Enhanced Usual Care Description: Patients will receive depression and heart disease education, as well as a list of local mental health resources. Name: Enhanced Usual Care Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Number of participants randomized per month of recruitment Measure: Recruitment feasibility Time Frame: Baseline Description: Proportion of randomized participants who complete the 6 month assessment. Measure: Study retention Time Frame: Week 26 Description: Dose of treatment received (i.e., session attendance) Measure: Treatment engagement Time Frame: Week 13 Description: Client Satisfaction Questionnaire-8; Scores range from 8-32 with higher scores indicating greater treatment satisfaction. Measure: Treatment Acceptability Time Frame: Week 13 #### Secondary Outcomes Description: Life's Essential 8 (LE8) Score; The LE8 classifies cardiovascular (CV) health across eight CV risk metrics: diet, physical activity, nicotine exposure, sleep health, weight, blood pressure, total cholesterol, and hemoglobin A1C. Each individual LE8 component is assigned a value ranging from 0 to 100. A total score is created by averaging each component score. Higher total scores reflect better overall CV health. Measure: Cardiovascular Health Time Frame: Week 13, Week 26 Description: Patient Health Questionnaire-9; Scores range from 0 to 27; higher scores indicate greater depressive symptoms. Measure: Depressive symptoms Time Frame: Week 13, Week 26 Description: Minutes spent in moderate to vigorous physical activity from 7 day Actigraph wear Measure: 7 Day Moderate to Vigorous Physical Activity Time Frame: Week 13, Week 26 Description: Minutes spent in moderate to vigorous physical activity over 7 days based on report from a 7 Day Physical Activity Recall interview Measure: Self-Reported Moderate to Vigorous Physical Activity Time Frame: Week 13, Week 26 Description: Mediterranean Eating Pattern for Americans Questionnaire; Scores range from 0-16 with higher scores indicating greater consistency with mediterranean style diet Measure: Self-Reported Diet Time Frame: Week 13, Week 26 Description: Self-report of no smoking, not even a puff, for 7 days; then Bio-chemically confirmed by carbon monoxide in a breath sample Measure: 7-day point prevalence abstinence from smoking Time Frame: Week 13, Week 26 Description: Average hours of sleep per night over 7 nights assessed via 7 day Actigraph wear Measure: Sleep duration Time Frame: Week 13, Week 26 Description: Self-reported hours of sleep per night from the Pittsburgh Sleep Quality Index Measure: Self-reported sleep duration Time Frame: Week 13, Week 26 Description: Body weight (kilograms)/ Height (meters squared) Measure: Body Mass Index Time Frame: Week 13, Week 26 Description: Systolic and diastolic blood pressures (mmHg) Measure: Blood pressure Time Frame: Week 13, Week 26 Description: mg/dL; measured via point of care testing Measure: Non-HDL cholesterol Time Frame: Week 13, Week 26 Description: %; measured via point of care testing Measure: Hemoglobin A1C Time Frame: Week 13, Week 26 Description: DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to cholesterol medication; scores range from 1-5. Measure: Medication adherence (cholesterol regimen) Time Frame: Week 13, Week 26 Description: DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to blood pressure medication; scores range from 1-5 Measure: Medication adherence (blood pressure regimen) Time Frame: Week 13, Week 26 Description: DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to both oral and injectable medication (assessed separately) to manage blood glucose; scores range from 1-5 Measure: Medication adherence (blood glucose regimen) Time Frame: Week 13, Week 26 Description: Composite of hospitalization for unstable angina, urgent coronary revascularization, and non-fatal myocardial infarction determined via participant inquiry and confirmed through electronic medical record review Measure: Major Adverse Cardiac Events Time Frame: Week 26 Description: Electronic medical record review Measure: All-cause mortality Time Frame: Week 26 Description: A health behavior engagement composite score will be created that follows the LE8 scoring structure. LE8 component scores will be summed for physical activity, diet, combustible tobacco exposure, and sleep. Medication adherence will also be assigned a score ranging from 0 to 100 based on scaled DOSE-Nonadherence scores. Measure: Health Behavior Engagement Composite Time Frame: Week 13, Week 26 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Medical chart-documented ACS (diagnosis of unstable angina, ST or non-ST elevation myocardial infarction) occurrence within the past 2-12 months. * Post-ACS depressed mood defined as a Patient Health Questionnaire(PHQ)--9 score ≥ 10 upon screening, * Non-adherence to and willingness to implement changes to ≥1 health behavior based on screening of: 1. Smoking/Tobacco exposure, 2. Physical Activity, 3. Diet, 4. Sleep health, 5. Medication adherence * English-language fluency * Resides within 90 minutes (driving time) of each site with no plans to relocate beyond that range during study participation * Access to a telephone and/or videoconferencing capability * Has primary care provider * Address at which packages can be received Exclusion Criteria: * Chart indication of significant cognitive impairment (e.g., chart-documented dementia), Current exacerbation of serious mental illness, * Suicidality, * Hearing impairment that prevents telephone/video communication for intervention and assessment purposes, * Current hospice care, and * Current engagement in cardiac rehabilitation or other regular counseling treatment targeting depression or health behavior change Maximum Age: 80 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: Emily.Gathright@lifespan.org Name: Emily Gathright, PhD Phone: 401-793-8271 Role: CONTACT Contact 2: Email: KWalaska@Lifespan.org Name: Kristen Walaska, BS Phone: 401-793-8022 Role: CONTACT #### Locations Location 1: City: Minneapolis Contacts: *Contact 1:* - Name: Andrew Busch - Role: CONTACT *Contact 2:* - Name: Andrew Busch, PhD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Hennepin Healthcare Research Institute State: Minnesota Status: RECRUITING Zip: 55415 Location 2: City: Greenville Contacts: *Contact 1:* - Name: Matthew Whited, PhD - Role: CONTACT *Contact 2:* - Name: Matthew Whited, PhD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: ECU Health State: North Carolina Status: NOT_YET_RECRUITING Zip: 27835 Location 3: City: Providence Contacts: *Contact 1:* - Email: Emily.Gathright@lifespan.org - Name: Emily Gathright, PhD - Role: CONTACT *Contact 2:* - Email: kwalaska@lifespan.org - Name: Kristen Walaska, BS - Role: CONTACT Country: United States Facility: The Miriam Hospital State: Rhode Island Status: RECRUITING Zip: 02903 #### Overall Officials Official 1: Affiliation: The Miriam Hospital Name: Emily Gathright, PhD Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: Hennepin Healthcare Research Institute Name: Andrew Busch, PhD Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - 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: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M27545 - Name: Acute Coronary Syndrome - Relevance: HIGH - As Found: Acute Coronary Syndrome - ID: M10543 - Name: Ischemia - 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: D000054058 - Term: Acute Coronary Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440265 Acronym: AM-PAC Brief Title: Validity and Reliability of Korean Version of AM-PAC Inpatient Short Form (Low Function) in Critically Ill Patients Official Title: Validity and Reliability of Korean Version of Activity Measure for Post Acute Care (AM-PAC) Inpatient Short Form (Low Function) in Critically Ill Patients #### Organization Study ID Info ID: 2301-085-1395 #### Organization Class: OTHER Full Name: Seoul National University Hospital ### Status Module #### Completion Date Date: 2024-04-04 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-04-04 Type: ACTUAL #### Start Date Date: 2023-03-31 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-04-26 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Seoul National University Hospital #### Responsible Party Investigator Affiliation: Seoul National University Hospital Investigator Full Name: Sung Eun Hyun Investigator Title: assistant professor (MD, PhD), Department of Rehabilitation Medicine Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The Activity Measure for Post Acute Care (AM-PAC) inpatient short form (low function) evaluates the level of assistance a patient requires another person to provide for distinct functional mobility and daily activities. The objective of the study was to translate and cross-culturally adapt the AM-PAC (low function) into Korean version and assess its reliability and validity . Independent raters assessed 38 patients from ICU using the Korean version of AM-PAC, respectively. Intra-class correlation coefficients (ICCs) and Bland-Altman's plots were used to evaluate reliability, and Cronbach's alpha for internal consistency. Validity was evaluated using Spearman's correlation analysis with other physical function assessment tools (functional status score for the ICU(FSS-ICU), Medical Research Council-sum score(MRC-SS), hand grip strength) and other unrelated factors (body mass index, glucose level). Detailed Description: The Activity Measure for Post Acute Care (AM-PAC) inpatient short form (low function) evaluates the level of assistance a patient requires another person to provide for distinct functional mobility and daily activities. The objective of the study was to translate and cross-culturally adapt the AM-PAC (low function) into Korean version and assess its reliability and validity. An expert committee in intensive care unit (ICU) rehabilitation supervised the forward and backward translation process and to finalize the Korean version of AM-PAC (low function). First evaluation of AM-PAC basic mobility and daily activity inpatient short forms was conducted on the first rehabilitation treatment day in ICU by the primary therapist. Subsequently, follow-up evaluations are conducted at 2 weeks and 4 weeks until the patient is discharged. Paired raters observed and recorded the scores independently. Each therapist was unaware of the other rater's scores, and they did not communicate verbally during the assessment. Starting with the first evaluation in the ICU, the same inter-rater reliability evaluation was performed in week 2 and week 4. Raters assessed 38 patients from Medical ICU using the Korean version of AM-PAC. Intra-class correlation coefficients (ICCs) and Bland-Atman's plots were used to evaluate reliability, and Cronbach's alpha for internal consistency. Then, convergent validity was evaluated using Spearman's correlation analysis between AM-PAC score and other physical function assessment tools (FSS-ICU, MRC-sum score, hand grip strength), and divergent validity was evaluated using correlation analysis between AM-PAC score and BMI or serum glucose level. ### Conditions Module Conditions: - Post Intensive Care Syndrome - Intensive Care Unit Acquired Weakness Keywords: - ICU acquired weakness - Post intensive care syndrome - AM-PAC ### Design Module #### Design Info Observational Model: CASE_ONLY Time Perspective: PROSPECTIVE #### Enrollment Info Count: 38 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 Description: The Activity Measure for Post-Acute Care(AM-PAC) "6-clicks" instruments have advantages in that they are simple and quick to complete, easy to use within usual care and has been validated in the entire hospital population. It has gained broad adoption in acute care hospital and, although it includes items for people at lower levels of function, there is a concern of a floor effect in ICU measurement. So, new AM-PAC items are developed to measure physical function at the lowest level and added 2 new items to AM-PAC inpatient mobility short form. It lowered the floor effect and increased statistical power, measurement breath, and sensitivity. 2 new items * Turning head * Following simple instructions Name: AM-PAC inpatient short form (low function) Type: OTHER ### Outcomes Module #### Primary Outcomes Description: two-way, mixed effect intra-class correlation coefficient (ICC) and Bland Altman's plot between each independent, blinded rater's AM-PAC scores Measure: Inter-rater reliability Time Frame: enrollment day, 2week, 4week Description: Convergent validity using Spearman's correlation analysis between AM-PAC score and FSS-ICU, MRC-sum score, hand grip strength; Divergent validity using Spearman's correlation analysis between AM-PAC score and body mass index(BMI) and serum glucose level which are irrelevant with functional status. Measure: Concurrent Validity Time Frame: enrollment day, 2week, 4week ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * All patients above 18 years who were admitted to the Medical ICU and were expected to remain in the ICU for at least two days, were eligible for inclusion. Exclusion Criteria: * Patients who were medically unstable to start rehabilitation in ICU or when mobilization was contraindicated by the medical team were excluded Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: all patients above 18 years who were admitted to the Medical ICU and who are candidates of ICU rehabilitation, receiving the best care to recover from critical illness ### Contacts Locations Module #### Locations Location 1: City: Seoul Country: Korea, Republic of Facility: Seoul National University Hospital Zip: 03080 #### Overall Officials Official 1: Affiliation: Seoul National University Hospital Name: Sung Eun Hyun, MD,PhD Role: STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020969 - Term: Disease Attributes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critically Ill - ID: M4554 - Name: Asthenia - Relevance: HIGH - As Found: Weakness - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness - ID: D000001247 - Term: Asthenia ### 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: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440252 Brief Title: Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults Official Title: The Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults: a Randomised, Double-blind, Placebo-controlled Crossover Study #### Organization Study ID Info ID: ALVCIR #### Organization Class: INDUSTRY Full Name: RDC Clinical Pty Ltd ### Status Module #### Completion Date Date: 2025-06-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-03-31 Type: ESTIMATED #### Start Date Date: 2024-06-30 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-17 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: RDC Clinical Pty Ltd #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: This is a randomized, double-blind, placebo-controlled, 2 arm crossover study conducted over 11 weeks, with participants randomised to a product for 4 weeks, followed by a 3-week washout period before completing the second product for 4 weeks, to study the effectiveness of a grape seed extract on circulatory measures in healthy adults. ### Conditions Module Conditions: - Circulatory; Change ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - INVESTIGATOR Primary Purpose: TREATMENT #### Enrollment Info Count: 150 Type: ESTIMATED Phases: - PHASE3 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Grape seed extract 600mg per day - 1 capsule per day Intervention Names: - Drug: Grape Seed Extract Label: Grape Seed Extract Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: Maltodextrin - 1 capsule per day Intervention Names: - Drug: Maltodextrin Label: Maltodextrin Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Grape Seed Extract Description: One daily dose of 1 capsule containing 600mg grape seed extract Name: Grape Seed Extract Type: DRUG #### Intervention 2 Arm Group Labels: - Maltodextrin Description: One daily dose of 1 capsule Name: Maltodextrin Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Change in Diastolic blood pressure (arm) as measured by blood pressure machine Measure: Change in Diastolic blood pressure (arm) Time Frame: Baseline, week 4, week 8, week 11 #### Secondary Outcomes Description: Change in Systolic blood pressure (arm) as measured by blood pressure machine Measure: Change in Systolic blood pressure (arm) Time Frame: Baseline, week 4, week 8, week 11 Description: Change in Peripheral systolic and diastolic blood pressure (leg) as measured by blood pressure machine Measure: Change in Peripheral systolic and diastolic blood pressure (leg) Time Frame: Baseline, week 4, week 8, week 11 Description: Change in HGB as measured by FBC via blood test Measure: Change in HGB Time Frame: Baseline, week 4, week 8, week 11 Description: Change in WBC as measured by FBC via blood test Measure: Change in WBC Time Frame: Baseline, week 4, week 8, week 11 Description: Change in RBC as measured by FBC via blood test Measure: Change in RBC Time Frame: Baseline, week 4, week 8, week 11 Description: Change in Platelet Aggregation as measured by FBC via blood test Measure: Change in Platelet Aggregation Time Frame: Baseline, week 4, week 8, week 11 Description: Change in eNOS as measured via blood test Measure: Change in (endothelial nitric oxide synthase) eNOS Time Frame: Baseline, week 4, week 8, week 11 Description: Change in NO as measured via blood test Measure: Change in endogenous nitric oxide (NO) Time Frame: Baseline, week 4, week 8, week 11 Description: Change in Tibial artery structure via Laser Doppler Flowmetry Measure: Change in Tibial artery structure Time Frame: Baseline, week 4, week 8, week 11 Description: Change in blood flow of the right leg via Laser Doppler Flowmetry Measure: Change in blood flow of the right leg Time Frame: Baseline, week 4, week 8, week 11 Description: Change in oxygen saturation as measured by pulse oximeter Measure: Change in oxygen saturation Time Frame: Baseline, week 4, week 8, week 11 Description: Change in resting pulse rate as digital blood pressure and resting pulse rate machine Measure: Change in resting pulse rate Time Frame: Baseline, week 4, week 8, week 11 Description: Change in weight as measure by digital scales Measure: Change in weight Time Frame: Baseline, week 4, week 8, week 11 Description: Change in BMI as measured by weight and height calculation Measure: Change in Body Mass Index (BMI) Time Frame: Baseline, week 4, week 8, week 11 Description: Change in waist and hip circumference as measured by tape measure Measure: Change in waist and hip circumference Time Frame: Baseline, week 4, week 8, week 11 Description: Change in 36-Item Short Form Health Survey (SF-36) as self-reported Measure: Change in 36-Item Short Form Health Survey (SF-36) Time Frame: Baseline, week 4, week 8, week 11 Description: Change in E/LFT as measured via blood test Measure: Change in E/LFT Time Frame: Baseline, week 4, week 8, week 11 Description: Change in triglycerides as measured via blood test Measure: Change in triglycerides Time Frame: Baseline, week 4, week 8, week 11 Description: Change in cholesterol as measured via blood test Measure: Change in cholesterol Time Frame: Baseline, week 4, week 8, week 11 Description: Change in blood glucose as measured via blood test Measure: Change in blood glucose Time Frame: Baseline, week 4, week 8, week 11 Description: Change in adverse events as reported by participant Measure: Change in adverse events Time Frame: Baseline, week 4, week 8, week 11 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Adults 25 years or older * Generally healthy * BMI 18 - 35kg/m2 * Able to provide informed consent * Have prehypertensive blood pressure (systolic 120-139 mmHg and/or diastolic 80-89 mmHg) * Agree to not change current diet and/or exercise frequency or intensity during entire study period * Agree to not participate in another clinical trial while enrolled in this trial Exclusion Criteria: * Those with a history of myocardial infarction, angina or bleeding disorders * Those who have uncontrolled thyroid diseases * Currently taking dietary supplements for circulation (e.g. fatty acids, CoQ10, L-arginine, red ginseng, ginseng, natto, ginkgo) or use of these in the last 1 month * Currently taking inflammation or circulatory associated medications (e.g. Pentoxifylline and vasodilators like nitroglycerin) or use of these in the last 1 month * Currently taking statins medication including atorvastatin (e.g. Lipitor, Lorstat), fluvastatin (e.g. Lescol or Vastin), pravastatin (e.g. Pravachol, Cholstat), rosuvastatin (e.g. Cavstat, Crestor) or simvastatin (e,g, Lipex, Zocor, Zimstat). * Currently taking Coumadin, Marevan (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy, or substrates of P-glycoprotein including (but not limited to) calcium channel blockers, cyclosporin, digoxin, erythromycin and protease inhibitors(1). * Have a serious illness(2) e.g. mood disorders such as bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions * Have an unstable illness(3) (i.e., changing medication/treatment) * Malignancy or treatment for malignancy within the previous 2 years (this excludes non-melanoma (e.g. BCC and SCC) skin cancers not requiring radiation or chemotherapy) * Active smokers, nicotine use or drug (prescription or illegal substances) abuse * Chronic past and/or current alcohol use (\>14 alcoholic drinks week) * Allergic to any of the ingredients in active or placebo formula * Pregnant or lactating woman or women trying to conceive * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion * Participated in another trial in the past 1 month 1. Any participant that begins taking antiplatelet medication during the trial will be excluded from the study 2. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. 3. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. Minimum Age: 25 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: amanda@rdcglobal.com.au Name: Amanda Rao, PhD Phone: +61 414 488 559 Role: CONTACT Contact 2: Email: david@rdcglobal.com.au Name: David Briskey, PhD Phone: +61 421 784 077 Role: CONTACT #### Locations Location 1: City: Brisbane Country: Australia Facility: RDC Clinical Pty Ltd State: Queensland Zip: 4006 #### Overall Officials Official 1: Affiliation: RDC Clinical Pty Ltd Name: Amanda Rao, PhD Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - 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: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M28517 - Name: Grape Seed Extract - Relevance: HIGH - As Found: Acetic acid - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T173 - Name: Grape - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000056604 - Term: Grape Seed Extract ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440239 Brief Title: A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s) Official Title: A Phase 1/Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of PMS-101 Administration in Patients With Burn(s) #### Organization Study ID Info ID: PMS-101-A001 #### Organization Class: INDUSTRY Full Name: Primoris Therapeutics ### Status Module #### Completion Date Date: 2025-11-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-11-30 Type: ESTIMATED #### Start Date Date: 2024-10-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-22 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Primoris Therapeutics #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: For Phase 1, researchers will explore the safety, and tolerability of PMS-101 and determine the recommended Phase 2 dose (RP2D) using the donor site. For Phase 2a, researchers will compare PMS-101 to a standard-of-care to see if PMS-101 works to treat mid-dermal burns. Detailed Description: Phase 1 is a single arm, open label, non-randomised study designed to assess the safety, tolerability and efficacy of 2 planned dose levels of PMS-101. The decision to continue dosing in Cohort 2(higher level dose) at the planned dosage regimen will be made by the Safety Review Committee (SRC) following the review of the safety and tolerability data of the participants in Cohort 1(lower level dose). The tolerability assessment of all the enrolled participants will be completed to determine the RP2D. Phase 2a is a double arm, open label, randomised study designed to assess the safety and efficacy of the dose recommended after the tolerability assessments of all participants enrolled in Phase 1 study. ### Conditions Module Conditions: - Burns - Burn Degree Second ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 40 Type: ESTIMATED Phases: - PHASE1 - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: PMS-101 Intervention Names: - Drug: PMS-101 Label: Investigational Product Type: EXPERIMENTAL #### Arm Group 2 Description: Standard of care or treatment Intervention Names: - Other: Standard treatment Label: Control Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - Investigational Product Description: PMS-101 Name: PMS-101 Type: DRUG #### Intervention 2 Arm Group Labels: - Control Description: Standard treatment according to physicians Name: Standard treatment Type: OTHER ### Outcomes Module #### Primary Outcomes Measure: Tolerability assessed by dose-limiting toxicity (Phase 1) Time Frame: Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56 Measure: Time to complete healing of wound site (Phase 2a) Time Frame: Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56, Day84 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. The combined TBSA of all burns is 10% or less. 2. Nonsmoker and must not have used any tobacco products within 2 months prior to Screening. 3. Phase 1 only: Participants with TBSA \< 10% who will undergo autologous skin grafting. 4. Phase 2a only: Participants with dermal burns who are within 5 days from the date of wound and will be enrolled. 5. Phase 1 only: Those who have confirmed at least 1 donor wound site with an even distribution of depth and extent of maximum 1% TBSA as judged by the Investigator. 6. Phase 2a only: Those who have confirmed at least 2 dermal burn sites with similar depth and extent of 50 cm2 or more each as judged by the Investigator. Exclusion Criteria: 1. Those who are allergic to or have experienced hypersensitivity to any components of the IP or its excipients such as gelatin or hyaluronic acid ingredients. 2. Those with the following conditions for burns at the time of Screening in clinical trials: 1. Those who have suffered chemical or electrical burns (for Phase 2a only). 2. Persons requiring tracheal intubation or tracheostomy due to severe inhalation burns. 3. Those with burn wounds accompanied by trauma such as fractures or lacerations. 4. Persons with purulent infection of burn wounds. 5. Those who require treatment such as artificial mechanical ventilation, extracorporeal membrane oxygen therapy, or dialysis due to other concomitant diseases or conditions. 3. History of or active bleeding or coagulation diseases (eg, hemophilia, von Willebrand's disease, thrombocytopenia, disseminated intravascular coagulation). 4. History of or active autoimmune diseases (eg, systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, Behcet's disease, and/or multiple sclerosis. 5. History of or active cardiovascular disease including clinically significant arrhythmias, uncontrolled hypertension, coronary artery disease (CAD), and/or prolonged QT interval (QTc \> 450 msec for males and \> 470 msec for females). 6. History of or active ischemic, hemorrhagic, or anatomical neurovascular disease including, but not limited to, trans ischemic attack, cerebrovascular accident, arterio-venous malformation, or brain aneurysm. 7. History of or active peripheral vascular disease such as deep vein thrombosis, pulmonary embolism, chronic venous insufficiency, claudication, or lymphedema. 8. History of active pulmonary diseases including chronic obstructive pulmonary disease, pulmonary fibrosis, moderate-to-severe sleep apnea, and moderate-to-severe asthma. 9. Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas. 10. History of immunosuppressive, chemotherapeutic, or radiation treatment within the last 12 months prior to Screening. 11. History of type 1 diabetes or active type 2 diabetes. 12. History of severe endocrine disorders such as Cushing's disease, hypogonadism, and growth hormone deficiency. 13. History or presence of severe active acute or chronic liver disease (eg, cirrhosis), hepatic insufficiency defined as Child Pugh Class A or higher, nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), general hepatic disease including serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × the upper limit of normal. 14. Uncontrolled psychiatric disease including major depressive disorder, bipolar, anxiety disorder, or eating disorders such as bulimia. 15. Those with serious diseases or condition that the Investigator believes may affect wound healing, such as a malnourished, clinically significant vitamin and/or mineral deficiencies. 16. Positive test for HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at the initial Screening Visit. 17. History of systemic active infectious diseases (eg, sepsis, tuberculosis) at the initial Screening Visit. 18. Those who have a history of malignant tumor or lymphoproliferative disease or have received an organ transplant within 5 years of initial Screening Visit. 19. Participants who have received systemic steroids, immunosuppressants, antiplatelet agents or anticoagulants within 1 week before application of this clinical trial drug. 20. History of abnormal wound healing such as keloids or hypertrophic scars. 21. History of significant drug abuse within 12 months prior to Screening or positive urine drug test at Screening. 22. Chronic kidney disease Stages 1 to 5. Maximum Age: 70 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: jo.maitz@skingineering.com.au Name: Joanneke Maitz, Dr Phone: +61408865606 Role: CONTACT #### Overall Officials Official 1: Affiliation: The Concord Repatriation General Hospital Name: Joanneke Joanneke, Dr Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - 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: M5326 - Name: Burns - Relevance: HIGH - As Found: Burn - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002056 - Term: Burns ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440226 Acronym: RRF Brief Title: Testing Methods to Increase the Frequency of Lucid Dreaming Official Title: Behaviors Of Boredom, Memory, and Wakefulness, and Their Relation to Determining the Frequency of Lucid Dreaming #### Organization Study ID Info ID: ReserologyRF #### Organization Class: OTHER Full Name: Reserology Research Foundation #### Secondary ID Infos Domain: Reserology Research Foundation ID: Grantee 000010000 Type: OTHER ### Status Module #### Completion Date Date: 2024-05-02 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-04-26 Type: ACTUAL #### Start Date Date: 2024-01-09 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-21 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Abdulraheem Mohamed Gouda #### Responsible Party Investigator Affiliation: Reserology Research Foundation Investigator Full Name: Abdulraheem Mohamed Gouda Investigator Title: Research Director 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 investigates the impact of lucid dreaming on individuals and explores methods to increase the likelihood of inducing lucid dreams intentionally. This study explores the impact of lucid dreaming on individuals, examining how this unique state of consciousness affects mental and emotional well-being. It further explores various methods aimed at increasing the likelihood of intentionally inducing lucid dreams. By analyzing scientific literature and experimental findings, the research highlights the potential therapeutic and creative benefits of lucid dreaming. Additionally, the study offers practical techniques designed to enhance the frequency of lucid dreams, such as maintaining a dream journal, eye movement before sleep, and recall of memories. These approaches provide individuals with tools to harness the power of lucid dreaming for personal growth and self-discovery.This study highlights the potential benefits of lucid dreaming and provides practical techniques for enhancing its frequency. Detailed Description: This detailed study explores the profound impact of lucid dreaming on individuals and assesses various techniques designed to intentionally induce lucid dreams. Lucid dreaming, where dreamers are aware that they are dreaming and can often control their dreams' content, has long intrigued both the scientific community and the general public due to its potential for deep psychological insight and self-improvement. The primary objective of the research was to investigate methods that could significantly increase the likelihood of inducing lucid dreams. In continuation, the study explores various methodologies aimed at increasing the probability of individuals intentionally inducing lucid dreams. Techniques such as targeted memory reactivation, where dreamers set intentions before sleep, are scrutinized for their effectiveness. The research examines how these methods align with neuroscientific understandings of sleep phases, particularly REM sleep when lucid dreaming most frequently occurs. The correlation between sleep quality, dream recall frequency, and the propensity to experience lucid dreams is highlighted, proposing that enhancing one's sleep hygiene could indirectly foster the conditions suitable for lucid dreaming. Analyzing extensive scientific literature and experimental data, the study discusses the uses of lucid dreaming as a cognitive tool. It examines scenarios that promote problem-solving and creative thinking through conscious navigation and manipulation of dream content. This allows individuals to rehearse skills, resolve conflicts, and explore creative avenues that may not be accessible in waking life. Lastly, these approaches offer individuals practical tools to harness the power of lucid dreaming for personal growth and self-discovery. The study emphasizes the importance of intentionality in entering the lucid dreaming state and maintaining a mindset conducive to this during waking hours. The capacity to engage in lucid dreaming is presented as a meaningful pursuit that can contribute to one's mental health and creative expression, fostering a deeper understanding and appreciation of this complex cognitive phenomenon. ### Conditions Module Conditions: - Sleep Wake Disorders Keywords: - sleep - sleep disorder - lucid dreaming - dreams - sleep hygiene ### Design Module #### Bio Spec Description: All records of participants and randomly selected individuals are kept. Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: OTHER Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 101 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Detailed in study, no dosages, no drugs used. Label: Placebo Group #### Arm Group 2 Description: Detailed in study, no dosages, no drugs used. Intervention Names: - Behavioral: Eye Movement Technique - Behavioral: Memory Recall of Previous Night's Thoughts - Behavioral: Recall of Previous Lucid Dreams Label: Actual Group #### Arm Group 3 Description: Detailed in study, no dosages, no drugs used. Label: Standard Assessment Group ### Interventions #### Intervention 1 Arm Group Labels: - Actual Group Description: Participants were instructed to move their eyes as much as possible with their eyes closed just before falling asleep. This technique aimed to mimic the Rapid Eye Movement (REM) sleep phase, which is often associated with more vivid and memorable dreams. Name: Eye Movement Technique Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - Actual Group Description: Another intervention involved asking participants to recall and think about their thoughts or events from the previous night before going to sleep. This method engaged cognitive processes related to memory and reflection, potentially setting the stage for increased awareness during sleep. Name: Memory Recall of Previous Night's Thoughts Type: BEHAVIORAL #### Intervention 3 Arm Group Labels: - Actual Group Description: Participants were also asked to recall their lucid dreams from previous nights. This intervention seemed to activate memory and awareness related to dreaming, which significantly increased the likelihood of experiencing lucid dreams the following night. Name: Recall of Previous Lucid Dreams Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Measuring the likelihood of lucid dreaming with the implementation of the methods mentioned in the behavioural section of this study. Measure: Testing the likelihood of Lucid Dreaming in Participants Time Frame: 4 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Normal blood pressure, Healthy weight, no record of sleep apnea, no difficulty sleeping, ages between 18-30 only. Exclusion Criteria: * Overweight(muscle being taken into consideration, not using BMI), high or low blood pressure, Maximum Age: 30 Years Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT Study Population: Young, healthy, individuals with no previous record of medical sleep conditions. ### Contacts Locations Module #### Locations Location 1: City: London Country: United Kingdom Facility: Reserology Research Zip: DN3 6GB #### Overall Officials Official 1: Affiliation: Reserology Research Foundation Name: Abdelraheem Mohamed Role: STUDY_CHAIR ### IPD Sharing Statement Module Description: Privacy reasons as requested by participants when signed up contractually. IPD Sharing: NO ### References Module #### References Citation: Greenwald B, Lombard LA, Watanabe TK. Managing sleepiness after traumatic brain injury. PM R. 2011 May;3(5):480-5. doi: 10.1016/j.pmrj.2011.04.010. No abstract available. PMID: 21570037 #### See Also Links Label: Main publication area URL: http://Reserology.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Wake Disorders - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012893 - Term: Sleep Wake Disorders ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2024-06-03 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2024-06-03 - Reset Date: Unknown - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440213 Brief Title: A Study to Determine the Safety and Tolerability of a Range of Doses of PeptiControl in Pre-diabetic Individuals Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Determine the Safety and Tolerability of a Range of Doses of PeptiControl in Pre-diabetic Individuals. #### Organization Study ID Info ID: NRS/230703/PF/PDI #### Organization Class: INDUSTRY Full Name: Nuritas Ltd ### Status Module #### Completion Date Date: 2024-11-22 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-11-22 Type: ESTIMATED #### Start Date Date: 2024-05-20 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-04-30 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Nuritas Ltd #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: A randomised, double blind, placebo controlled parallel study to examine the effects of a dose range of PeptiControl, a plant-based ingredient, in pre-diabetic males and females. Detailed Description: The primary aim of this study is to evaluate safety and establish the effective dose to see acute effects in males and females with elevated fasting blood glucose. PeptiControl will be supplemented 30 minutes before lunch as a single oral dose of either 2610mg, 870mg or 435mg/day. A placebo group will also be included who will receive microcrystalline cellulose. Capsule number will be matched across all study arms to retain double blinding. This trial incorporates continuous glucose monitoring (CGM) as wearable technology to measure blood glucose and time in range of the participants for the duration of the study. The trial will be conducted over 12 days, which includes a 2 day run-in period to gather baseline CGM data, followed by 6 days of PeptiControl supplementation and 4 days follow up on safety and blood glucose tracking post supplementation. The primary endpoint will measure safety and tolerability via adverse event reporting and occurrence of hypoglycemic episodes evaluated by time below target range (70 - 180 mg/dL) during CGM throughout the intervention. Secondary endpoints investigated during the trial will include safety of a dose range as assessed by a safety blood panel, glucose metabolism and insulin sensitivity, time in range, aspects of cognition and memory and hunger, satiety and fullness as assessed by VAS questionnaires. ### Conditions Module Conditions: - Pre Diabetes - Overweight ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Randomized, double-blind, placebo-controlled, parallel group study ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - INVESTIGATOR Primary Purpose: TREATMENT #### Enrollment Info Count: 124 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: 6 capsules, 30 minutes prior to lunch every day for 6 days Intervention Names: - Dietary Supplement: PeptiControl™ (Low - Dose 435 mg/day) Label: PeptiControl™ (Low - Dose 435 mg/day) Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: 6 capsules, 30 minutes prior to lunch every day for 6 days Intervention Names: - Dietary Supplement: PeptiControl™ (Mid - Dose 870 mg/day) Label: PeptiControl™ (Mid - Dose 870 mg/day) Type: ACTIVE_COMPARATOR #### Arm Group 3 Description: 6 capsules, 30 minutes prior to lunch every day for 6 days Intervention Names: - Dietary Supplement: PeptiControl™ (High - Dose 2610 mg/day) Label: PeptiControl™ (High - Dose 2610 mg/day) Type: ACTIVE_COMPARATOR #### Arm Group 4 Description: 6 capsules, 30 minutes prior to lunch every day for 6 days Intervention Names: - Dietary Supplement: Placebo Microcrystalline Cellulose Label: Placebo Microcrystalline Cellulose Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - PeptiControl™ (Low - Dose 435 mg/day) Description: Plant protein hydrolysate Name: PeptiControl™ (Low - Dose 435 mg/day) Type: DIETARY_SUPPLEMENT #### Intervention 2 Arm Group Labels: - PeptiControl™ (Mid - Dose 870 mg/day) Description: Plant protein hydrolysate Name: PeptiControl™ (Mid - Dose 870 mg/day) Type: DIETARY_SUPPLEMENT #### Intervention 3 Arm Group Labels: - PeptiControl™ (High - Dose 2610 mg/day) Description: Plant protein hydrolysate Name: PeptiControl™ (High - Dose 2610 mg/day) Type: DIETARY_SUPPLEMENT #### Intervention 4 Arm Group Labels: - Placebo Microcrystalline Cellulose Description: Placebo MCC micro-crystalline cellulose Name: Placebo Microcrystalline Cellulose Type: DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes Description: The hypoglycemic events will be monitored and recorded from the day of IP initiation (Day 0) until the end of study (Day 10). The tolerability of different doses of PeptiControl™ will be assessed on the basis of the hypoglycemic episodes evaluated by time below target range (70 - 180 mg/dL) during CGM throughout the study in each arm. Measure: To investigate the safety and tolerability of a range of doses of PeptiControl™ as assessed by occurrence of hypoglycemic episodes evaluated by time below target range (70 - 180 mg/dL) during Continuous Glucose Monitoring (CGM) Time Frame: Day 0 to Day 10 #### Secondary Outcomes Description: Blood samples will be taken from participants pre and post consumption of PeptiControl and analysed in a safety blood panel assessing liver, kidney and lipid markers for the identification of any changes from baseline. Measure: To explore the safety of a range of doses of PeptiControl™ as assessed by a safety blood panel comparing baseline and post dose parameters. Time Frame: Day 0 and Day 6 Description: Thirty minutes post IP consumption, participants will consume a glucose solution (comprising of 75g glucose in approximately 250 ml water). Blood samples will then be collected at 15, 30, 60, 90, 120 and 180 mins for the assessment of blood glucose concentrations Measure: To assess the efficacy of range of doses of PeptiControl™ on blood glucose concentrations when given 30 minutes prior to Oral Glucose Tolerance Test (OGTT) compared to placebo Time Frame: Day 0 Description: The glucose iAUC will be derived from the OGTT. This assessment will be conducted at 0, 15, 30, 60, 90, 120 and 180 mins after glucose solution consumption Measure: To assess the efficacy of range of doses of PeptiControl™ on Glucose metabolism as assessed by incremental Area Under Curve (iAUC) Time Frame: Day 0 Description: Pancreatic efficiency will be evaluated by fasting serum insulin levels in blood Fasting insulin: Normal range - 2.6-24.9 μU/mL (17.8-173 pmol/L) Measure: To assess the efficacy of range of doses of PeptiControl™ on Pancreatic efficiency Time Frame: Day 0 and Day 6 Description: Continuous glucose monitoring device automatically calculates the time in the blood glucose target range (70 - 180 mg/dl) as well as above and below the target range Measure: To assess the efficacy of range of doses of PeptiControl™ Time in range via CGM (Continuous Glucose Monitoring). Time Frame: Starting from day -2 and worn continuously until day 10 with readings taken at day -2, day 0, day 6, day 10 Description: Insulin sensitivity will be assessed by HOMA-IR. The HOMA - IR score will be calculated using the formula: fasting insulin (mU/L) x fasting glucose (mmol/L)/22.5. Fasting insulin: Normal range - 2.6-24.9 μU/mL (17.8-173 pmol/L) Fasting Glucose: Normal range - 4.11-6.05 mmol/L(74-109 mg/dL) Measure: To assess the efficacy of range of doses of PeptiControl™ on Insulin sensitivity as assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). Time Frame: Day 0 and Day 6 Description: Working memory will be assessed using the Validated Paired Associate Learning test by Creyos. Measure: To assess the efficacy of range of doses of PeptiControl™ on Working memory as assessed by Paired Associate Learning test Time Frame: Day 0, Day 6, and Day 10 Description: Selective attention will be assessed using the Double Trouble/Stroop test by Creyos Measure: To assess the efficacy of range of doses of PeptiControl™ on Selective attention as assessed by Stroop test. Time Frame: Day 0, Day 6, and Day 10 Description: The VAS will be 100 mm in length with words anchored at each end expressing the most positive and the most negative rating. It will assess five components: hunger, satiety, fullness, prospective food consumption and desire to eat. Measure: To assess the efficacy of range of doses of PeptiControl™ on Hunger, satiety and fullness as assessed by the Visual Analog Scale (VAS) Time Frame: Day 0, Day 6, and Day 10 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Males and Females (30-60 years of age) * Individuals with Body Mass Index (BMI) more than or equal to 25 and less than or equal to 33.0 kg/m² * Individuals with fasting blood glucose (FBG) more than or equal to 100 mg/dL and less than or equal to 125 mg/dL after 8-10 hours fasting. * Individual must be a non-smoker or an ex-smoker (5 years or more). * Have a stable body weight (less than or equal to 4.5 kgs change) in the last 3 months (as self-reported by the individual). * Be willing to maintain existing dietary habits and physical activity levels throughout the study period. * Individual must be willing to wear a continuous glucose monitor during the specific time in the study * Individual must be willing to attend all site visits and follow protocols for that visit, e.g., arrive fasting and provide blood samples. * Individuals who have given their signed Informed Consent. Exclusion Criteria: * Individuals having fasting blood glucose levels less than 100 mg/dL or more than 125 mg/dL. * Individuals having BMI outside the range of 25 - 33 kg/m². * Individuals who are presently dieting, or who were using medications affecting body weight or who had experienced a change in weight of more than 4.5 kg or a change in physical activity within the six months preceding the screening visit. * Individuals diagnosed with Type I Diabetes mellitus. * Individuals diagnosed with Type II Diabetes mellitus and currently on medication. * Individuals with Triglyceride levels more than 200 mg/dL, and/or liver function tests (AST, ALT) levels 1.5 times than the normal range, and/or kidney function test (serum creatinine) levels 1.5 times than the normal range. * Individuals with low haemoglobin or haematocrit (i.e., lower than normal ranges \[less than 12.0 g/dL hemoglobin levels in women and less than 13.0 g/dL hemoglobin levels in men\]) * Individuals having a significant acute or chronic co-existing illnesssuch as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrine disorder, immunological disorder, metabolic disease, or any condition which contraindicates, in the investigator's judgement, entry to the study or which poses a significant risk to the individual. * Individuals diagnosed with hypertension (systolic blood pressure more than 140 mm Hg and/or diastolic blood pressure more than 90 mm Hg) and currently on medication. * Individuals who have unstable medical conditions or who are on chronic medication that has not been at a stable dose for at least 1 month. * Consumption of more than the recommended alcohol guidelines i.e., more than 21 alcohol units/week for males and more than 14 alcohol units/week for females. * Currently or recently (within 3 months of study entry) taking any medication, which in the opinion of the investigator, could interfere with the outcome of the study, including insulin, acetylsalicylic acid, thyroxine, beta blockers, or hypolipidemic agents. * Individuals on any medications associated with weight loss such as medication for the treatment of deficit hyperactivity, medication associated with weight gain like antipsychotics, or glucocorticoids, and/or immunosuppressants. * Have a known allergy or sensitivity to any compounds in the test material's active or inactive ingredients or placebo. * Individuals having a history of drug or alcohol abuse. * Individuals who have a history of neurological disorders or significant psychiatric illness, who are cognitively impaired and/or who are unable to give informed consent. * Present or recent use (within 3 months of pre-screening) of dietary supplements that may affect the level of blood glucose, e.g., chromium, dietary fibres, and non-digestible carbohydrates e.g., fructooligosaccharides chicory inulin, mulberry leaf extract. * Females who are pregnant, lactating or wish to become pregnant during the study. * Individuals with evidence of a clinically unstable disease (such as depression), as determined by medical history, physical examination, that, in the Investigator and medical monitors opinion, preclude entry into the study. * Breast feeding women. * Immune compromised individuals. * Individuals who have participated in a clinical study with an investigational product (IP) within 90 days before pre-screening, or who plan to participate in another study during the study period. Healthy Volunteers: True Maximum Age: 60 Years Minimum Age: 30 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: mohan.niamh@nuritas.com Name: Niamh Mohan, PhD Phone: 014301290 Role: CONTACT #### Locations Location 1: City: Nashik Contacts: *Contact 1:* - Name: Nilesh Tuplondhe - Role: CONTACT *Contact 2:* - Name: Nilesh Tuplondhe, MBSS, MD - Role: PRINCIPAL_INVESTIGATOR Country: India Facility: Chopda Medicare & Research Centre State: Maharashtra Status: RECRUITING Zip: 422005 Location 2: City: Nashik Contacts: *Contact 1:* - Name: Sagar Mandlik - Role: CONTACT *Contact 2:* - Name: Sagar Mandlik, MBBS, MD - Role: PRINCIPAL_INVESTIGATOR Country: India Facility: Vakretund Hospital State: Maharashtra Status: RECRUITING Zip: 422010 Location 3: City: Pune Contacts: *Contact 1:* - Name: Ravindra Kulkarni - Role: CONTACT *Contact 2:* - Name: Ravindra Kulkarni, MBBS, MD - Role: PRINCIPAL_INVESTIGATOR Country: India Facility: Ashwin Medical Foundation State: Maharashtra Status: RECRUITING Zip: 411033 Location 4: City: Pune Contacts: *Contact 1:* - Name: Vishwajeet Gaikwad - Role: CONTACT *Contact 2:* - Name: Vishwajeet Gaikwad, MBBS, MD - Role: PRINCIPAL_INVESTIGATOR Country: India Facility: Imperial Multispeciality Hospital State: Maharashtra Status: RECRUITING Zip: 411062 #### Overall Officials Official 1: Affiliation: Ashwin Medical Foundation Pune, Maharashtra, India, 411033 Name: Dr. Ravindra Kulkarni, MBBS,DNB,MD Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: Imperial Multispecialty Hospital Pune, Maharashtra, India, 411062 Name: Dr. Vishwajeet Gaikwad, MBBS, MD Role: PRINCIPAL_INVESTIGATOR Official 3: Affiliation: Chopda Medicare & Research centre Nashik, Maharashtra, India, 422005 Name: Dr. Nilesh Tuplondhe, MBBS, MD Role: PRINCIPAL_INVESTIGATOR Official 4: Affiliation: Vakratund Hospital Pvt. Ltd Nashik, Maharashtra, India, 422010 Name: Dr. Sagar Mandlik, MBBS, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M14117 - Name: Prediabetic State - Relevance: HIGH - As Found: Pre-diabetes - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - ID: M20295 - Name: Glucose Intolerance - 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 - 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: D000050177 - Term: Overweight - ID: D000011236 - Term: Prediabetic State ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440200 Brief Title: Exploring the Health Effects of Group Game-based Activities on Individuals With Chronic Mental Illness Official Title: Applying Group Game-based Activities to Improve the Health of Patients With Chronic Mental Illness #### Organization Study ID Info ID: 202401209RINE #### Organization Class: OTHER Full Name: National Taiwan University Hospital ### Status Module #### Completion Date Date: 2024-08-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2024-07-18 Type: ESTIMATED #### Start Date Date: 2024-01-18 Type: ACTUAL Status Verified Date: 2024-03 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-03-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: National Taiwan University Hospital #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This study aims to explore the health effects of group games for patients with chronic mental illness. The goal of this clinical intervention study is to compare the efficacy of group games in two ways (experimental group/ group game-based or control group) to improve the health of patients with chronic mental illness. The main questions it aims to answer are: The efficacy of applying group game-based activities to increase interest and improve the physical fitness of patients with chronic mental illness. Also, the goal of this clinical interventional study is to clarify the positive benefits of psychological and social aspects. Subjects will be asked to complete the questionnaire and physical ability examination after filling out the consent of this study. Participants will be randomly divided into two groups. Participants in the experimental group will accept the group game-based activities for 12 weeks (twice per week, 22 times). In contrast, Participants in the control group will accept the activities the psychiatric day wards and halfway house offer as usual. After 12 weeks of intervention, The Participants in both groups will be asked to fill out the questionnaire and physical ability examination. One month later, Participants in both groups will be asked to fill out the questionnaire and physical ability examination again. The study will last for 4 months. The time points for completing the questionnaire are listed following: Baseline/ pre-intervention test(T1), First post-intervention test (T2, 12 weeks later) and Second post-intervention test (T3, 4 weeks later). The researchers will compare the difference in effectiveness between the two groups. Detailed Description: This study is a randomized controlled study. Researchers use a random assignment. One is an experimental group (group game-based), and the other is a control group(activities as usual). This Parallel two-group pre-test, first post-test and second post-test are designed to conduct a 12-week interventional study regarding group game-based activities for patients with chronic mental illness. A total of 3 questionnaires will be collected to compare the differences between the two groups to clarify the efficacy of group game-based activities. The investigators will discuss the outcome and the change in physiological values, physical ability, depression rating scale, quality of life and the motivation of group game-based activities. Once the participants fill out the consent form, they will be asked to conduct the pre-test questionnaire including physiological values, physical ability, depression rating scale and quality of life. Then, the random numbers table will be used to divide subjects into the experimental group or the control group. The experimental group will accept group game-based activity twice a week lasting 12 weeks. There will be many motion-sensing games in the group game-based activities. The games designed for activities can provide somatosensory control including tactual, visual and auditory feedback. On the contrary, Participants in the control group will accept the activities the psychiatric day wards and halfway house offer as usual. After 12 weeks, subjects in two groups will be asked to complete the first post-test questionnaire and physical examination(T2) which physiological values, physical ability, depression rating scale quality of life and motivation of group game-based activities will be included. Then, they will be asked to do the second post-test after 4 weeks without any intervention to investigate the long-term effect of the group game-based activities. The content of the questionnaire and physical examination will be the same as T2. ### Conditions Module Conditions: - Chronic Mental Illness - Schizophrenia - Psychiatry Keywords: - group game-based activities - physiological values - depression rating scales - quality of life ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: OTHER #### Enrollment Info Count: 100 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: The group game-based activity will be twice a week lasting 12 weeks. There will be many motion sensing games in the group game-based activities. The games designed for activities can provide somatosensory control and visual and auditory feedback. Intervention Names: - Behavioral: group gamed-based activity Label: group gamed-based activites Type: EXPERIMENTAL #### Arm Group 2 Description: The activities will be the psychiatric day wards and half-way house offered as usual. Label: control group Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - group gamed-based activites Description: Participants in interventional group will play the active-type software with Switch game console which develops by Nintendo company. Team building, cooperation, cohesion, sense of belonging and sense of achieving will be emphasized. Name: group gamed-based activity Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Height in meters. Measure: Height Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) Description: Weight in kilograms. Weighing machine will be used. Measure: Ｗeight Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) Description: Body Mass Index(BMI), Weight and height will be combined to report BMI in kg/m\^2. Measure: BMI Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) Description: The measuring tape will pass through the middle point between the upper edge of the left and right intestinal bones and the lower edge of the ribs. The Length of the measuring tape will be the results of Ｗaist circumference. Measure: Ｗaist circumference Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) Description: The measuring tape will pass through the high point of buttocks. The Length of the measuring tape will be the results of Ｗaist circumference. Measure: Buttocks circumference Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) Description: Time in second. To measuring time of walking at comfortable for 10 meters. Measure: 10-meter walking time at comfortable Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) Description: Time in second. Investigators will measure the time of walking at maximum for 10 meters. Measure: 10-meter walking time at maximum Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) Description: Time in second. First, The patient will sit on a chair. Second, he/she will stand up and go for 3 meters. At last, he/she will turn around and go back to have a sit. Investigators will measure time of the process. Measure: Get up and Go test Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) Description: Time in second. First, The patient will sit on a chair. Second, he/she will stand up and sit down immediately. The patients will be asked to do this process for 5 times. Measure: 5 times sit-to-stand-test Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) Description: Investigators will measure patients' body fat percentage by the body fat machine produced by Inbody company. Measure: Body fat percentage Time Frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16) #### Secondary Outcomes Description: The abbreviation of patient health questionnaire-9 is PHQ-9. The total number of questions is 9. The minimum and maximum values are 0 and 27 respectively. Then, the higher scores mean a worse outcome. Measure: Patient health questionnaire-9 Time Frame: Depression rating scale will be done at T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16). motivation of group game-based activities will be at T2=first post-test(Week 12) and T3=second post-test(Week 16). Description: The abbreviation of World Health Organization Quality-of-Life Scale is WHOQOL-BREF. The total number of questions is 28. The minimum and maximum values are 28 and 140 respectively. Then, the higher scores mean a better outcome. Measure: World Health Organization Quality-of-Life Scale Time Frame: The questionnaire of quality of life will be done at T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16). motivation of group game-based activities will be at T2=first post-test(Week 12) and T3=second post-test(Week 16). Description: The total number of questions is 13. The content of the questionnaire includes whether the games is easy, the games can bring happiness and deserve to play, etc. Measure: Chinese version of interactive video games questionnaire on satisfaction and feasibility Time Frame: Motivation of group game-based activities will be done at T2=first post-test(Week 12) and T3=second post-test(Week 16). ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Adults whose age is above 18 * Patients who diagnosed with schizophrenia spectrum disorders or bipolar disorders * At present, you can go out, make friends, take care of your daily life, fully exercise your rights, and have full capacity as an adult, and have not been restricted by any legal declaration, so you do not need to obtain the consent of your legal representative to sign to participate in this study. Exclusion Criteria: * Those who have obvious limb movement disorders, such as congenital disability or hemiplegia after stroke, etc., which make them unable to participate in the group's game activities * Those who are unwilling or unable to complete the signing of the written consent form. Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Taipei Country: Taiwan Facility: National Taiwan University Hospital Zip: 100225 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15376 - Name: Schizophrenia - Relevance: HIGH - As Found: Schizophrenia - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: HIGH - As Found: Mental Illness - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - 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: D000012559 - Term: Schizophrenia - ID: D000001523 - Term: Mental Disorders ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440187 Acronym: HN17-11 Brief Title: Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11 Official Title: Phase II Study of Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11 #### Organization Study ID Info ID: KCSG-HN-17-11 #### Organization Class: OTHER Full Name: Seoul National University Hospital ### Status Module #### Completion Date Date: 2021-04-30 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: COMPLETED #### Primary Completion Date Date: 2021-04-30 Type: ACTUAL #### Start Date Date: 2018-06-08 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2018-06-06 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Seoul National University Hospital #### Responsible Party Investigator Affiliation: Seoul National University Hospital Investigator Full Name: Bhumsuk Keam 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: NPC is a highly chemo-sensitive cancer. Platinum-containing doublet chemotherapy is regarded as the standard treatment for patients with recurrent or metastatic NPC, even though it has never been directly compared with supportive care. Until now, no randomized trials have defined the optimum regimens. At present, cisplatin plus continuous intravenous infusion of fluorouracil is widely used in patients with recurrent or metastatic nasopharyngeal carcinoma, with a response rate of 40-65%. Gemcitabine single is active and tolerable agent for recurred or metastatic NPC. Response rate (RR) was 34% and progression-free survival (PFS) was 5.0 months . Moreover, gemcitabine reduces the frequency of CD11b+GR1+ myeloid suppressor cells. Gemcitabine-induced apoptosis of established tumours may enhance the dendritic cell dependent cross-presentation of tumor antigens to T cells. Gemcitabine can function in synergy with CD40 stimulation of T cells. Hence, theoretically gemcitabine can have synergistic effect with PD-1/PD-L1 blocking agent. Immunotherapy with immune checkpoint inhibitors has gradually emerged as a promising treatment modality for head and necks squamous cell carcinoma and NPC. Detailed Description: Based on these evidences which suggest a function for PD-1/PD-L1 in NPC and potential synergistic effect with gemcitabine, the use of nivolumab in recurred/metastatic NPC is reasonable and valuable. So we design this phase II study of nivolumab and gemcitabine in recurred/metastatic NPC which is common cancer in Asian. ### Conditions Module Conditions: - Recurrent or Metastatic Nasopharyngeal Carcinom ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP Intervention Model Description: gemcitabine + nivolumab ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 38 Type: ACTUAL Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Nivolumab administration on D1 and D15 every cycle, with 3mg/kg with gmecitabine co-administration on D1 and D15 every cycle, with 1250mg/m2 Intervention Names: - Drug: Gemcitabine+ nivolumab Label: gemcitabine+ nivolumab Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - gemcitabine+ nivolumab Description: Gemcitabine+ nivolumab q 2wks Name: Gemcitabine+ nivolumab Other Names: - Experimental group Type: DRUG ### Outcomes Module #### Primary Outcomes Description: the percentage of patients who have not experienced disease progression or death from any cause from the start of treatment. Measure: Progression free survival Time Frame: From the first date of treatment to the date occurring disease progression or death from any cause ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Histologically confirmed nasopharyngeal carcinoma 2. Recurred after local treatment or metastatic disease. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent 3. Received at least one line of palliative chemotherapy 4. Presence of at least one measurable target lesion for further evaluation according to RECIST 1.1 criteria. Progressive lesions after radiation therapy can also be a target lesion. However, patients who were refractory to initial CCRT with platinum therapy (recurred within 6 months) were excluded. 5. 20 years or older 6. ECOG performance status 0, 1 7. Adequate organ function ANC ≥ 1500/ μL Platelets ≥100,000/ μL Hemoglobin ≥ 9.0 g/dL Serum creatinine ≤1.5 x ULN Serum bilirubin ≤1.5 x ULN AST, ALT, ≤3.0 x ULN (regardless of liver metastasis) 8. A patient with the willingness to comply with the study protocol during the study period and capable of complying with it 9. A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages. Exclusion Criteria: 1. A patient with no measurable disease 2. A patient with previous active or passive immunotherapy or immune check point blocking agents or gemcitabine. 3. Active HBV (HBV DNA is positive) or HCV (HCV RNA is detected) or HIV infection. (inactive HBsAg carrier with prophylactic antiviral treatment can be enrolled) 4. A pregnant or lactating patient 5. A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential) 6. A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study 7. A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of skin, early gastric cancer, and cervical carcinoma in situ. 8. A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications. 9. A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial infarction within past 12 months. 10. Ongoing cardiac arrhythmia of grade ≥2, atrial fibrillation of any grade, or QTc interval\>450msec for males or \>470msec for female. 11. A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs 12. A patient with organ transplantation requiring immunosuppressive therapy Healthy Volunteers: True Minimum Age: 20 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Seoul Country: Korea, Republic of Facility: Department of Internal Medicine, Seoul National University Hospital Zip: 110-744 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000009303 - Term: Nasopharyngeal Neoplasms - ID: D000010610 - Term: Pharyngeal Neoplasms - ID: D000010039 - Term: Otorhinolaryngologic Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009302 - Term: Nasopharyngeal Diseases - ID: D000010608 - Term: Pharyngeal Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrent - ID: M1730 - Name: Nasopharyngeal Carcinoma - Relevance: HIGH - As Found: Nasopharyngeal Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M12254 - Name: Nasopharyngeal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13517 - Name: Pharyngeal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12962 - Name: Otorhinolaryngologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12253 - Name: Nasopharyngeal Diseases - Relevance: LOW - As Found: Unknown - ID: M13515 - Name: Pharyngeal Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: T4047 - Name: Nasopharyngeal Carcinoma - Relevance: HIGH - As Found: Nasopharyngeal Carcinoma ### Condition Browse Module - Meshes - ID: D000077274 - Term: Nasopharyngeal Carcinoma - ID: D000012008 - Term: Recurrence ### Intervention Browse Module - Ancestors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000082082 - Term: Immune Checkpoint Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2985 - Name: Gemcitabine - Relevance: HIGH - As Found: Activity - ID: M1854 - Name: Nivolumab - Relevance: HIGH - As Found: Prospective - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000093542 - Term: Gemcitabine - ID: D000077594 - Term: Nivolumab ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440174 Acronym: VALUE Brief Title: Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE) Official Title: Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE): a Multi-methods Study #### Organization Study ID Info ID: CAN1794 #### Organization Class: OTHER Full Name: University Hospital Southampton NHS Foundation Trust ### Status Module #### Completion Date Date: 2026-06-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-06 Type: ESTIMATED Last Update Submit Date: 2024-06-05 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-09-30 Type: ESTIMATED #### Start Date Date: 2024-05-27 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-08 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: OTHER_GOV Name: National Institute for Health Research, United Kingdom #### Lead Sponsor Class: OTHER Name: University Hospital Southampton NHS Foundation Trust #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: This is an observational trial that will look at patients undergoing endoscopic ultrasound (EUS) in patients with oesophageal cancer and to determine the proportion of cases in which EUS changes disease management in these patients. Detailed Description: Over 9,000 patients are diagnosed with oesophageal cancer in the United Kingdom (UK) annually. The prognosis of these patients is poor, with an overall 5-year survival rate of 15%. Most patients (60%) present with advanced disease and palliation is the only treatment option. Accordingly, oesophageal cancer has considerable unmet research need. The VALUE trial is a prospective observational study investigating EUS in the modern era of oesophageal cancer staging. A quantitative study component will examine how often and why EUS changes treatment decisions after initial staging with CT and PET-CT. A qualitative study component will explore both clinician and patient attitudes and opinions towards the utility of EUS in the staging pathway. EUS is an invasive procedure combining upper gastrointestinal endoscopy with ultrasonography. An ultrasound probe located at the end of the endoscope allows direct visualisation of the oesophageal wall layers and adjacent tissues providing local assessment of the depth of tumour invasion and lymph nodes. This assessment informs local tumour (T-) and node (N-) staging which are important prognostic indicators of survival. Patients undergoing EUS require sedation and there are risks of complication. EUS is a specialist investigation requiring many years of dedicated training to perform competently. VALUE aims to recruit patients with oesophageal cancer who are deemed to have potentially curable disease and who are fit for, and wish to have, radical treatment, and who receive EUS as part of their standard of care staging pathway. Patients with a range of disease status (T1-T4; N0-N3) will be considered for recruitment to allow diverse consideration of the reasons whether EUS impacts treatment decisions in current clinical practice. VALUE will also recruit clinicians who regularly care for oesophageal cancer patients in a multi-disciplinary setting to gather their opinions regarding the use of EUS in this patient population. A systematic review, updating a prior review, found that current evidence concerning the impact of EUS on the management and outcome of oesophageal cancer patients in modern staging with PET-CT was of limited quality. In total, 18 studies with 11,836 patients were included. Overall, 2,805 patients (23.7%) underwent EUS compared to 9,031 (76.3%) without. However, only 19.7% of all patients also had PET-CT for staging. Reported change of management by EUS varied widely from 0% to 56%. EUS use in oesophageal cancer patients across the NHS is also reported to vary widely. Considerable variation in EUS practice was found in a survey of oesophageal cancer multi-disciplinary team (MDT) leads across the UK. Eighty-seven of 97 UK NHS trusts responded. 29% recommended EUS for all potentially curable patients whereas 46% requested EUS after PET-CT on a case-by-case basis. 20% reported both a lack of utility and concerns about treatment delay. Overall, 63% and 43% routinely use EUS for radiotherapy and surgical planning, respectively. Further, data from the National Oesophago-Gastric Cancer Audit (NOGCA) all describe the reported decline in EUS use from 62% of all patients in 2013, to 39% in 2019, and 18.6% to 2021. In 2020/21, EUS was used in 23.6% of patients who had a curative treatment plan. The Cancer of Oesophagus or Gastricus-New Assessment of Technology of Endosonography (COGNATE) trial randomised patients between EUS with CT, and CT alone. EUS led to improved quality-adjusted survival. However, since COGNATE, oesophageal cancer staging has been transformed by PET-CT, a cross-sectional nuclear imaging test usually performed prior to EUS. PET-CT has greater sensitivity for distant metastases than CT, and therefore identifies more patients unsuitable for radical treatment, meaning that local staging with EUS becomes less critical in these patients. This conclusion is supported by data from a large retrospective cohort study by Findlay et al which included 953 patients, of which 798 had EUS, and 918 had PET-CT. The authors found that patient management was changed by EUS in 11% of cases, but when probability thresholds were calculated, the utility of EUS in the majority of patients (71.8% staged T2-T4a) was minimal (0.4%), concluding that the risk of EUS exceeded its benefit. However, these data have not been validated outside of this single-centre study but does question the value of EUS in the modern staging pathway. In summary, the use of PET-CT for oesophageal cancer staging is increasing, and use of EUS declining, which supports the modern tendency of clinicians to favour non-invasive cross-sectional imaging. However, evidence supporting the basis for this recent change in practice is limited. There will also be a qualitative part of the trial where a qualitative researcher will interview 30 patients who consent to this in the patient information sheet and 30 clinicians who can carry out EUS, and ask both for their opinions and thoughts on the procedure. ### Conditions Module Conditions: - Oesophageal Cancer ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 180 Type: ESTIMATED Patient Registry: True Study Type: OBSERVATIONAL Target Duration: 6 Months ### Arms Interventions Module ### Interventions #### Intervention 1 Description: EUS is an invasive procedure combining upper gastrointestinal endoscopy with ultrasonography. An ultrasound probe located at the end of the endoscope allows direct visualisation of the oesophageal wall layers and adjacent tissues providing local assessment of the depth of tumour invasion and lymph nodes. This assessment informs local tumour (T-) and node (N-) staging which are important prognostic indicators of survival. Patients undergoing EUS require sedation and there are risks of complication. EUS is a specialist investigation requiring many years of dedicated training to perform competently. Name: endoscopic ultrasound Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: to determine if using EUS after CT-PET changes management. Measure: Number of patients who change treatment management Time Frame: this decision will be made at baseline. #### Secondary Outcomes Description: The voluntary one to one interview which patients will consent to on the informed consent form, will be used to identify factors that patients consider when deciding whether EUS should be used. This will take place on Microsoft Teams, hosted by the SCTU qualitative researcher. The interview will be recorded and accurately transcribed and once this has taken place, the interview will be deleted. The anonymised transcript can be stored for up to 10 years with the University of Southampton research data management policy. Measure: Number of clinicians and patients who will share their opinions on EUS by a one to one interview with a qualitative researcher. Time Frame: This will take place up to 6 weeks following the EUS at one to one interviews. Description: to determine the reasons why EUS changed management. Measure: Number of patients who changed their treatment management following EUS. Time Frame: this decision will be made at baseline. Description: to determine the time from diagnosis to treatment decision before and after EUS. Measure: Number of patients who decided on their treatment. Time Frame: this decision will be made at baseline. ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Patients aged 16 or above with first diagnosis of biopsy-confirmed oesophageal cancer. 2. Referred for EUS examination as part of standard of care investigations. 3. Tumour location in the oesophagus, or gastro-oesophageal junction (Siewert types I-III) 4. MDT decision that patient is potentially curable with radical treatment (e.g., endoscopic treatment, surgery +/- neoadjuvant therapy, or definitive chemoradiotherapy) 5. Prior staging with CT and PET-CT 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 7. Clinical staging of T1-T4, N0-N3, M0 disease 8. Adenocarcinoma or squamous cell carcinoma (SCC) histopathological cell type Exclusion Criteria: 9. Recurrent or residual disease 10. Distant metastatic disease detected before EUS. 11. Previous oesophagectomy or oesophageal radiotherapy 12. Unable to undergo EUS examination. 13. Concurrent malignancy e.g., second primary tumour 14. Other histopathological cell type Minimum Age: 16 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT Study Population: Patients will be recruited through MDTs at participating secondary care centres in the UK. Those deemed suitable will be approached by their care team to take part. ### Contacts Locations Module #### Central Contacts Contact 1: Email: value@soton.ac.uk Name: Ben Lindfield Phone: 023 8120 5154 Role: CONTACT #### Locations Location 1: City: Bournemouth Contacts: *Contact 1:* - Email: natalie.agius@uhd.nhs.uk - Name: Natalie Agius - Role: CONTACT *Contact 2:* - Name: Andrew Cowie - Role: PRINCIPAL_INVESTIGATOR Country: United Kingdom Facility: Royal Bournemouth Hospital Status: NOT_YET_RECRUITING Location 2: City: Cambridge Contacts: *Contact 1:* - Email: tara.evans@nhs.net - Name: Tara Evans - Role: CONTACT *Contact 2:* - Name: Massimiliano di Pietro - Role: PRINCIPAL_INVESTIGATOR Country: United Kingdom Facility: Cambridge University NHS Foundation Trust Status: NOT_YET_RECRUITING Location 3: City: Cardiff Contacts: *Contact 1:* - Email: christopher.cotterill-jones@wales.nhs.uk - Name: Christopher Cotterill-Jones - Role: CONTACT *Contact 2:* - Name: Kieran Foley - Role: PRINCIPAL_INVESTIGATOR Country: United Kingdom Facility: Velindre University NHS Trust Status: NOT_YET_RECRUITING Location 4: City: Glasgow Contacts: *Contact 1:* - Email: lucy.bullimore@ggc.scot.nhs.uk - Name: Lucy Bullimore - Role: CONTACT *Contact 2:* - Name: Eliana Saffouri - Role: PRINCIPAL_INVESTIGATOR Country: United Kingdom Facility: Glasgow Royal Infirmary Status: NOT_YET_RECRUITING Location 5: City: Hull Contacts: *Contact 1:* - Email: debbie.callaghan3@nhs.net - Name: Debbie Callaghan - Role: CONTACT *Contact 2:* - Name: Rajarshi Roy - Role: PRINCIPAL_INVESTIGATOR Country: United Kingdom Facility: Castle Hill Hospital Status: RECRUITING Location 6: City: London Contacts: *Contact 1:* - Email: aaron.gyamfi@nhs.net - Name: Aaron Gyamfi - Role: CONTACT *Contact 2:* - Name: Christopher Peters - Role: PRINCIPAL_INVESTIGATOR Country: United Kingdom Facility: Imperial College Healthcare NHS Trust Status: NOT_YET_RECRUITING Location 7: City: Southampton Contacts: *Contact 1:* - Email: andreia.soaresvieira@uhs.nhs.uk - Name: Andreia Vieira - Role: CONTACT *Contact 2:* - Name: Nadeem Tehami - Role: PRINCIPAL_INVESTIGATOR Country: United Kingdom Facility: University Hospital Southampton Status: RECRUITING Location 8: City: Truro Contacts: *Contact 1:* - Email: sally.thomas23@nhs.net - Name: Sally Thomas - Role: CONTACT *Contact 2:* - Name: Dushyant Shetty - Role: PRINCIPAL_INVESTIGATOR Country: United Kingdom Facility: Royal Cornwall Hospital Status: NOT_YET_RECRUITING #### Overall Officials Official 1: Affiliation: Chief Investigator, based at Velindre University NHS Trust Name: Kieran Foley 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: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Oesophageal Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck 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: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Oesophageal Cancer ### Condition Browse Module - Meshes - ID: D000004938 - Term: Esophageal Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440161 Brief Title: Association of Intraoperative Haemodynamic and Postoperative Complications in Type A Aortic Dissection Surgery Official Title: Association of Intraoperative Haemodynamic Instability With Postoperative Mortality, Renal Injury, and Stroke in Type A Aortic Dissection Surgery: A Retrospective Cohort Analysis #### Organization Study ID Info ID: KY20230918-KS-02 #### Organization Class: OTHER Full Name: Nanjing First Hospital, Nanjing Medical University ### Status Module #### Completion Date Date: 2024-03-01 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-01-01 Type: ACTUAL #### Start Date Date: 2023-10-01 Type: ACTUAL Status Verified Date: 2023-09 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-06 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Nanjing First Hospital, Nanjing Medical University #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Background To determine whether venous congestion is an important predictor of postoperative kidney injury and other adverse events after type A aortic dissection (TAAD). Methods Authors collected data of adults who underwent surgery for TAAD between January 2016 and July 2023. Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP). The primary outcomes were acute kidney injury (AKI) and acute injury disease (AKD). The secondary outcomes encompassed death and stroke. Restricted cubic spline regression model was used to adjust for confounding factors and multiple comparisons. Detailed Description: Type A aortic dissection (TAAD) is a catastrophic cardiac macrovascular disease with a striking in-hospital mortality rate of 22%-31%. Among the myriad of complications following TAAD surgeries, acute kidney injury (AKI) is one of the most prevalent, boasting an incidence of 40-55%. Notably, this incidence surpasses that observed in other cardiovascular procedures, such as coronary artery bypass grafting (CABG), which ranges from 10-20%, and aortic valve replacement (AVR) at 17-23%. Furthermore, the occurrence of AKI post-TAAD surgeries has been linked with escalated in-hospital, short-term, and long-term mortalities, as well as significant complications. Preoperatively, patients with TAAD usually have poorly controlled blood pressure, long-term hypertension can cause chronic kidney damage. In some cases, involving renal artery origins, renal perfusion insufficiency may exist preoperatively. Intraoperatively, the kidneys need to undergo a complete ischemic phase of deep hypothermic circulatory arrest (DHCA), inflammatory reactions associated with cardiopulmonary bypass (CPB), and a large number of blood and fluid transfusions could potentially cause renal dysfunction. Patients are at high risk for postoperative surgical site infection following TAAD procedure, further exacerbating acute kidney injury. The myriad factors mentioned above collectively exacerbate the elevated occurrence of kidney injury following Type A Aortic Dissection (TAAD) surgeries when juxtaposed with other cardiac surgical procedures. Pathological anatomy and surgical procedure intricacies pose formidable challenges in mitigation. Consequently, the pursuit of precise intraoperative hemodynamic management objectives aimed at maximizing organ perfusion has emerged as a focal point in contemporary research endeavours. A study encompassing 5,127 patients undergoing CABG and cardiac valvular surgery underscored the role of venous congestion duration and severity as independent postoperative AKI/AKD risk determinants. However, the relationship between intraoperative hemodynamic in TAAD surgeries and ensuing AKI/AKD remains elusive. There's a paucity of comprehensive evaluations, primarily due to a dearth of long-term data from expansive TAAD cohorts. The investigators' primary objective was to discern the correlation between intraoperative hypotension and venous congestion durations and magnitudes at varied thresholds during TAAD surgeries and the subsequent risks of postoperative AKI/AKD. As a secondary objective, the investigators sought to elucidate the association between intraoperative hemodynamic and major adverse events, including stroke and mortality. The investigators hypothesize that both intraoperative hypotension and venous congestion are paramount predictors for postoperative AKI and AKD following TAAD surgeries. ### Conditions Module Conditions: - Acute Kidney Injury Keywords: - Acute Kidney Injury - Intraoperative Hypotension - Venous Congestion - Acute Kidney Disease - Type A Aortic Dissection ### Design Module #### Design Info Observational Model: COHORT Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 543 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 Description: After the induction of anaesthesia, a central venous or pulmonary artery catheter was positioned. Based on prior studies, thresholds for central venous pressure were set at 10, 12, 16, and 20 mm Hg. Venous congestion was quantified by time exceeding each CVP threshold and the area under the curve (AUC) surpassing each CVP threshold in mmHg × min. Assessments were limited to pre- and post-CPB periods, as the venous drainage cannulate generated negative CVP during CPB. An arterial catheter was installed upon room admission. Continuous arterial blood pressure monitoring commenced after exposure to atmospheric pressure and calibration to zero. The MAP was determined using the formula: 2/3 × diastolic blood pressure + 1/3 × systolic blood pressure. Data were logged by automated software every minute. Established thresholds for MAP were 55, 65, and 75 mm Hg. Hypotension was quantified as (1) time under each MAP threshold in minutes and (2) the AUC below each MAP threshold in mmHg × min. Name: Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP). Type: OTHER ### Outcomes Module #### Primary Outcomes Description: AKI diagnosis adhered to the Kidney Disease Improvement Global Prognosis Organization (KDIGO) criteria. Measure: The Incidence of AKI Time Frame: After the surgery，up to 7 days Description: AKD staging was determined based on the Acute Disease Quality Initiative (ADQI) Working Group consensus, using available Scr values from 8 to 90 days post-surgery. Measure: The Incidence of AKD Time Frame: After the surgery，longer than 7 days but within 90 days #### Secondary Outcomes Description: The days of stay in hospital Measure: The days of stay in hospital Time Frame: perioperatively Description: The days of stay in ICU Measure: The days of stay in ICU Time Frame: after surgery Description: The incidence of in-hospital mortality Measure: The incidence of in-hospital mortality Time Frame: after surgery Description: The incidence of 30-day all-cause mortality Measure: The incidence of 30-day all-cause mortality Time Frame: after surgery Description: Stroke diagnosis adhered to National Institute of Neurological Disorders and Stroke rt PA Stroke study Group Measure: The incidence of stroke Time Frame: after surgery ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1) Eligible patients were adults, aged 18 or older. Exclusion Criteria: 1. Lacking preoperative serum creatinine (Scr) values 2. Insufficient hemodynamic or laboratory data 3. Exhibiting a preoperative Scr level ≥133 μmol/L 4. Patients with renal insufficiency before surgery 5. Patients on preoperative dialysis Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Eligible patients underwent surgery for TAAD. ### Contacts Locations Module #### Locations Location 1: City: Nanjing Country: China Facility: Nanjing First Hospital State: Jiangsu Zip: 210000 #### Overall Officials Official 1: Affiliation: The First Affiliated Hospital with Nanjing Medical University Name: Ya-li Ge Role: STUDY_DIRECTOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051437 - Term: Renal Insufficiency - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000094665 - Term: Dissection, Blood Vessel - ID: D000000783 - Term: Aneurysm - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000094683 - Term: Acute Aortic Syndrome - ID: D000001018 - Term: Aortic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M28998 - Name: Acute Kidney Injury - Relevance: HIGH - As Found: Acute Kidney Injury - ID: M4114 - Name: Aortic Dissection - Relevance: HIGH - As Found: Aortic Dissection - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M10072 - Name: Hypotension - Relevance: LOW - As Found: Unknown - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M3081 - Name: Dissection, Blood Vessel - Relevance: LOW - As Found: Unknown - ID: M4113 - Name: Aneurysm - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M3085 - Name: Acute Aortic Syndrome - Relevance: LOW - As Found: Unknown - ID: M4334 - Name: Aortic Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000058186 - Term: Acute Kidney Injury - ID: D000000784 - Term: Aortic Dissection ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440148 Brief Title: Relationship Between Circulating Sclerostin and Bone Lesions in Patients With Mastocytosis Official Title: Role of Sclerostin in Mastocytosis Bone Disease #### Organization Study ID Info ID: SCLERMAST01 #### Organization Class: OTHER Full Name: Medical University of Lublin ### Status Module #### Completion Date Date: 2026-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-05-01 Type: ACTUAL #### Start Date Date: 2019-09-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-06 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Medical University of Lublin #### Responsible Party Investigator Affiliation: Medical University of Lublin Investigator Full Name: Aneta Szudy Szczyrek Investigator Title: Doctor of Medicine Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Mastocytosis is very rare and highly heterogeneous group of disorders, characterized by the accumulation of clonal mast cells which can infiltrate several organs and tissues. Bones are the most frequent localization of systemic mastocytosis. The aim of our research was to explain the potential role of sclerostin in the pathogenesis of bone disease in mastocytosis. Detailed Description: Mastocytosis is a heterogeneous group of disorders, characterized by the accumulation of clonal mast cells which can infiltrate several organs, such as the skin, bone marrow or liver. The skeleton is the most frequent localization of systemic mastocytosis (SM). Bone involvement occurs in approximately 70% of SM patients. Pathogenesis of mastocytosis bone disease is poorly understood. The aim of our research is to explain the potential role of sclerostin, a recently discovered bone tissue protein, in the pathogenesis of bone changes in patients with mastocytosis. The study group consists of adult patients with mastocytosis divided according to their clinical variants of disease (aggressive systemic mastocytosis - ASM, systemic mastocytosis with an associated hematological neoplasms SM-AHN, smouldering systemic mastocytosis - SSM, indolent systemic mastocytosis - ISM and cutaneous mastocytosis - CM; and group of healthy volunteers. The concentration of sclerostin, bioactive sclerostin and expression of the SOST gene in human plasma and HMC-1.2 human mast cell culture supernatants is assessed. The Real-Time PCR method is used to evaluate the expression of sclerostin at the mRNA level, while the concentration of the sclerostin protein and its bioactive form is assessed using the enzyme immunoassay ELISA method. The obtained results are correlated with selected demographic, clinical, laboratory and radiological findings. Low-dose CT scan is used to assess bone changes. These preliminary results could serve that sclerostin may be a new therapeutic target in patients with mastocytosis. ### Conditions Module Conditions: - Mastocytosis - Bones Keywords: - Bones - Mastocytosis - Osteolysis - Osteosclerosis - Sclerostin ### Design Module #### Bio Spec Description: The studied material is approximately 2.5 ml of peripheral blood collected into plasma gel tubes. The samples are centrifuged at 3000 rpm for 10 min, plasma is pipetted into tubes. Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: CASE_CONTROL Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 50 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 Description: Pathogenesis of mastocytosis bone disease Name: SCLEROSTIN Type: BIOLOGICAL ### Outcomes Module #### Primary Outcomes Description: The Primary Outcome Measures concern: * the measurements of plasma levels of sclerostin and its bioactive form in patients with mastocytosis and healthy volunteers * the measurements of levels of sclerostin and its bioactive form in HMC-1.2 human mast cells unstimulated and stimutaled with Il-6 Measure: plasma sclerostin measurements (in pmol/l) SOST gene expression by Real-Time PCR dimensions of osteolytic lesions on low-dose computed tomography (in mm) dimensions of osteosclerotic lesions on low-dose computed tomography (in mm) Time Frame: 1 year Description: The Primary Outcome Measures concern: - the measurements of the dimensions of osteolytic bone lesions on low-dose computed tomography in patients with mastocytosis Measure: dimensions of osteolytic lesions (in mm) Time Frame: 1 year Description: The Primary Outcome Measures concern: - the measurements of the dimensions of osteosclerotic bone lesions on low-dose computed tomography in patients with mastocytosis Measure: dimensions of osteosclerotic lesions (in mm) Time Frame: 1 year ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Age \> 18 years * Mastocytosis defined according to WHO criteria * Known KIT mutation status Exclusion Criteria: * History of organ transplant * Inability to give informed consent * Pregnancy, Breastfeeding * Vulnerable Patient, defined as: patient with another uncontrolled severe disease; patient under juridical protection Healthy Volunteers: True Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: The study group consists of adult patients diagnosed with mastocytosis, divides according to the clinical variants: aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), indolent systemic mastocytosis (ISM), smoldering systemic mastocytosis (SSM) and cutaneous mastocytosis (CM). The diagnosis of mastocytosis should be established based on biopsy of the affected organ (bone marrow trephine biopsy, skin affected by the disease), following the 2022 WHO classification. The control group comprised 30 healthy volunteers matched with the study group in terms of age and gender. ### Contacts Locations Module #### Central Contacts Contact 1: Email: aneta.szudy-szczyrek@umlub.pl Name: Aneta Szudy-Szczyrek, MD., PhD. Phone: +48815345468 Role: CONTACT #### Locations Location 1: City: Lublin Contacts: *Contact 1:* - Email: aneta.szudy-szczyrek@umlub.pl - Name: Aneta Szudy-Szczyrek, MD., PhD. - Role: CONTACT Country: Poland Facility: Department of Hematooncology and Bone Marrow Transplantation State: Lubelskie Status: RECRUITING Zip: 20-081 #### Overall Officials Official 1: Affiliation: Medical University of Lublin Name: Aneta A Szudy-Szczyrek, MD., PhD. Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009372 - Term: Neoplasms, Connective Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000090362 - Term: Mast Cell Activation Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M11399 - Name: Mastocytosis - Relevance: HIGH - As Found: Mastocytosis - ID: M12937 - Name: Osteolysis - Relevance: LOW - As Found: Unknown - ID: M12949 - Name: Osteosclerosis - Relevance: LOW - As Found: Unknown - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M2776 - Name: Mast Cell Activation Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3626 - Name: Mastocytosis - Relevance: HIGH - As Found: Mastocytosis - ID: T5148 - Name: Sclerosteosis - Relevance: HIGH - As Found: Sclerostin ### Condition Browse Module - Meshes - ID: D000008415 - Term: Mastocytosis ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440135 Brief Title: Ziftomenib Maintenance Post Allo-HCT Official Title: An Open Label Phase I Study of Ziftomenib as Maintenance Therapy Following Allogeneic Hematopoietic Cell Transplantation #### Organization Study ID Info ID: 24-096 #### Organization Class: OTHER Full Name: Massachusetts General Hospital ### Status Module #### Completion Date Date: 2027-09-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-09-01 Type: ESTIMATED #### Start Date Date: 2024-08-31 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-03-05 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Massachusetts General Hospital #### Responsible Party Investigator Affiliation: Massachusetts General Hospital Investigator Full Name: Zachariah Michael DeFilipp Investigator Title: Principal Investigator Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Oversight Has DMC: True ### Description Module Brief Summary: The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT. The name of the study drug involved in this study is: • Ziftomenib Detailed Description: This is a prospective, multi-center, open-label, phase I study of ziftomenib as maintenance therapy following allogeneic hematopoietic cell transplantation (HCT). This study is testing whether ziftomenib, combined with the standard allo-HCT treatment, is safe and effective in treating blood cancer. This study will test if ziftomenib improves outcomes after allo-HCT. The study drug is given after the allo-HCT, in combination with standard treatment and aftercare. This study consists of 2 parts: Part A (Dose Escalation): The investigators are looking to find the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated. Once determined, this highest dose will then be used in the dose expansion part of the study. Part B (Expansion Cohort): Participants will be treated at the respective dose as determined during Part A(Dose Escalation). Ziftomenib administered after allo-HCT may work to enhance graft-versus-leukemia effects, selectively target residual leukemic cells, or suppress leukemic stem cells, among other mechanisms. The U.S. Food and DrugAdministration (FDA) has not currently approved ziftomenib as a treatment for any disease but it is being studied in Phase 1/2 interventional clinical trials for participants with relapsed or refractory acute myelogenous leukemia. The estimated length of the study is 2 years. Participants will begin treatment 30 to 90 days after allo-HCT, and treatment will continue for up to 12 months. Then they will be followed for 12 to 24 months after study treatment ends. It is expected that about 22 people will take part in this research study. ### Conditions Module Conditions: - Acute Myeloid Leukemia - Acute Myeloid Leukemia in Remission - NPM1 Mutation - KMT2A Rearrangement Keywords: - Acute Myeloid Leukemia - Allogeneic hematopoietic cell transplantation (HCT) - Allo-HCT - NPM1 Mutation - KMT2A Rearrangement ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 22 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will begin treatment 30 to 90 days after allo-HCT and only after disease remission is confirmed, and treatment will continue for up to 12 months. All participants will receive ziftomenib. Participants will undergo allo-HCT as a part of their standard care. Participants will undergo the following procedures: * Screening * Allo-HCT (standard care), including pre and post-treatment as a part of standard care * 30 - 90 days after allo-HCT, participants will take the study drug orally once per day for up to 12 28-day cycles * End of treatment visit * Follow-up data will be collected every 3 months for 24 months from the start of treatment Intervention Names: - Drug: Ziftomenib Label: Ziftomenib Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Ziftomenib Description: Taken orally once per day Name: Ziftomenib Other Names: - KO-539 Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Defined as the highest dose level at which 1 or 0 of 6 patients experience a Dose Limiting Toxicity (DLT). Toxicities will be graded and documented according to NCI CTCAE version 5.0. A non-hematologic DLT is any grade 3 adverse event (AE) lasting \>72 hours or any grade greater than or equal to 4 AE that is at least possibly related to the study drug with exceptions. Any ≥ grade 2 non-hematologic toxicity that the participant finds intolerable or renders the participant unable to take 75% or more of the assigned doses (e.g. multiple dose interruptions) during the first cycle will be considered a DLT. Measure: Maximum Tolerated Dose (Dose Escalation) Time Frame: 28 days #### Secondary Outcomes Description: Defined as ziftomenib-related toxicities detected and categorized according to severity. Toxicities will be graded and documented according to NCI CTCAE version 5.0. Measure: Occurrence of ziftomenib-related toxicities Time Frame: Day 0 to last treatment dose, up to 336 days Description: Defined as cumulative incidence of acute GVHD from start of ziftomenib in subjects receiving maintenance therapy after allogeneic HCT. Clinical stage and grade of acute graft-versus-host-disease (GVHD) is based on MAGIC Criteria (Harris 2016). The incidence of acute GVHD grade II-IV and grade III-IV will be estimated for each treatment group using the cumulative incidence estimate, treating death prior to acute GVHD as a competing event. Measure: Incidence of acute Graft versus Host Disease (GVHD) during treatment Time Frame: Day 0 to end of treatment visit, up to 366 days (336 days of treatment + 30 days end of treatment) Description: The incidence of chronic GVHD will be estimated for each treatment group using the cumulative incidence estimate, treating death prior to chronic GVHD as a competing event. Chronic GVHD will be assessed as per the 2014 National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease (Jagasia 2015). Measure: Incidence of chronic Graft versus Host Disease (GVHD) during treatment Time Frame: Day 0 to end of treatment visit, up to 366 days (336 days of treatment + 30 days end of treatment) Description: The incidence of non-relapse mortality will be estimated for each treatment group using the cumulative incidence estimate, treating disease relapse or progression as a competing event. AML treatment response is based on 2022 ELN recommendations (Dohner 2022). Measure: Non-relapse mortality (NRM) Time Frame: Day 0 to end of treatment visit, up to 1086 days (336 days of treatment + 30 days end of treatment + 24 months follow-up)) Description: Leukemia-Free Survival is defined as the time from first dose of study drug to the earlier of leukemia relapse or death due to any cause. Participants alive and leukemia-free are censored at the date of last disease evaluation. AML treatment response is based on 2022 ELN recommendations (Dohner 2022). Measure: Leukemia-Free Survival (LFS) Time Frame: Day 0 to end of treatment visit, up to 1086 days (336 days of treatment + 30 days end of treatment + 24 months follow-up)) Description: Overall Survival is defined as the time from first dose of study drug to the date of death due to any cause. Participants who are alive at the analysis / cutoff date will be censored at the last contact date. Measure: Overall Survival (OS) Time Frame: Day 0 to end of treatment visit, up to 1086 days (336 days of treatment + 30 days end of treatment + 24 months follow-up)) Description: GVHD, relapse-free survival is defined as the time from first dose of study drug to the earlier of grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, leukemia relapse or death due to any cause. Participants alive and without one of these three events are censored at the date of last disease evaluation. AML treatment response is based on 2022 ELN recommendations (Dohner 2022). Measure: GVHD-free, relapse-free survival (GRFS) Time Frame: Day 0 to end of treatment visit, up to 1086 days (336 days of treatment + 30 days end of treatment + 24 months follow-up)) Description: Defined as proportion of subjects who successfully screen for study prior to transplantation but who do not reach the maintenance phase due to transplant-related morbidity or mortality. Measure: Proportion of successfully screened that do not reach study treatment Time Frame: 30 days (Screening to Day 0) Description: Characterize the pharmacokinetics (PK) of ziftomenib and metabolites when ziftomenib is given as maintenance therapy after allogeneic HCT by measuring the plasma concentration of ziftomenib and metabolites. Measure: Plasma Concentration of ziftomenib and metabolites Time Frame: Up to 62 days (Cycle 1 Day 1 - Cycle 3 Day 1 (+/- 5 days) Description: Assess PK drug-drug interaction between ziftomenib and oral systemic immunosuppressive agents performed by measuring plasma concentrations. Measure: Plasma Concentration of oral immunosuppressive agents and ziftomenib Time Frame: Up to 34 days (Day -7 to -14 after HCT prior to co-administration and on Cycle 1 Day 1 and Day 15 (+/- 5 days) of co-administration) Description: The severity/intensity of adverse events will be graded based upon the subject's symptoms according to the current active minor version of the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0). All participants will be followed and assessed for adverse events 30 days after removal from protocol therapy or until death, whichever occurs first. Measure: Number of Participants with Treatment-Related Adverse Events Time Frame: Day 0 to end of treatment visit, up to 366 days (336 days of treatment + 30 days end of treatment) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * 18 years or older. * Pathologically confirmed diagnosis of acute myeloid leukemia (AML). * Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening. * Complete remission (CR): * no circulating blasts in peripheral blood and \<5% blasts in bone marrow * no extramedullary disease * platelet count ≥100 x 10(9)/L and/or absolute neutrophil count ≥1000/µL * Complete remission with incomplete count recovery (CRi): * no circulating blasts in peripheral blood and \<5% blasts in bone marrow * no extramedullary disease * platelet count \<100 x 10(9)/L and/or absolute neutrophil count \<1000/µL * Presence of at least one of the following molecular mutations: * KMT2A rearrangement * Eligibility and enrollment will be based on local mutational testing. * The presence of a KMT2A rearrangement (excluding partial tandem duplication \[PTD\]) at the time of initial diagnosis or any other time thereafter is sufficient. * Participants may receive additional treatment for AML between consent and transplant. * NPM1 mutation * Eligibility and enrollment will be based on local mutational testing. * For participants being transplanted in CR1, the presence of a NPM1 mutation at screening is necessary for the purposes of eligibility. * For participants being transplanted in greater than or equal to CR2, the presence of a NPM1 mutation at the time of consent is not necessary for eligibility and its presence at the time of initial diagnosis or any other time thereafter is sufficient. * Participants may receive additional treatment for AML between consent and transplant. * Treatment with a menin inhibitor prior to transplant is permitted. However, patients who experienced AML relapse or progression while being treated with a menin inhibitor prior to transplant are ineligible. * Will undergo first allogeneic HCT for their malignancy. * Transplantation will be performed with the use of conventional myeloablative (MAC) or reduced intensity conditioning (RIC). * HCT Donor will be one of the following: * 5/6 or 6/6 (HLA-A, B, DR) matched related donor * 7/8 or 8/8 (HLA-A, B, DR, C) matched unrelated donor. Matching in the unrelated setting must be at the allele level. * Haploidentical related donor, defined as ≥ 3/6 (HLA-A, B, DR) matched * ≥ 4/6 (HLA-A, B, DR) umbilical cord blood (UCB). Matching in the UCB setting is at the antigen level. Recipients may receive either one or two UCB units. In the case of 2 UCB units, both units must have been at least 4/6 matched with the recipient. * Any non-investigational GVHD prophylaxis regimen is allowed. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Participants must have normal organ and function as defined below: * AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 3x institutional upper limit of normal (ULN) * Total bilirubin \< 1.5 x institutional ULN (with the exception of subjects with a history of Gilbert's syndrome, for which the total bilirubin must be \< 5 x ULN) * Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula) * LVEF must be ≥50%, as measured by MUGA scan or echocardiogram. * Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing. * The effects of ziftomenib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 6 months after the last dose of treatment. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of other malignancy(ies) unless * the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or * the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up * the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin * Known diagnosis of active hepatitis B or hepatitis C * Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \< 50%, as measured by multigated acquisition (MUGA) scan or echocardiogram) * Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome * Systemic uncontrolled infection * Known dysphagia, short-gut syndrome, gastroparesis, or other condition(s) that limits the ingestion or gastrointestinal absorption of drugs administered orally * Uncontrolled hypertension (systolic blood pressure \[BP\] \> 180 mmHg or diastolic BP \> 100 mmHg) * QTc interval (i.e., Friderica's correction \[QTcF\]) ≥ 480 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening * Uncontrolled intercurrent illness that would limit compliance with study requirements. * Persons who are pregnant or lactating. Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: zdefilipp@mgh.harvard.edu Name: Zachariah DeFilipp, MD Phone: (617) 726-5765 Role: CONTACT #### Locations Location 1: City: Boston Contacts: *Contact 1:* - Email: zdefilipp@mgh.harvard.edu - Name: Zachariah DeFilipp, MD - Phone: 617-726-5765 - Role: CONTACT Country: United States Facility: Massachusetts General Hospital State: Massachusetts Zip: 02114 #### Overall Officials Official 1: Affiliation: Massachusetts General Hospital Name: Zachariah DeFilipp, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Access Criteria: MGH - Contact the Partners Innovations team at http://www.partners.org/innovation Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Zachariah DeFilipp, MD. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. Info Types: - STUDY_PROTOCOL - SAP - ICF IPD Sharing: YES Time Frame: Data can be shared no earlier than 1 year following the date of publication ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: HIGH - As Found: Myeloid Leukemia - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000015470 - Term: Leukemia, Myeloid, Acute ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440122 Brief Title: The Incidence and Outcomes of Metabolically Active Brown Adipose Tissue (aBAT) in Patients With Pheochromocytoma or Paraganglioma (PPGLs) Official Title: The Incidence and Outcomes of Metabolically Active Brown Adipose Tissue (aBAT) in Patients With Pheochromocytoma or Paraganglioma (PPGLs) #### Organization Study ID Info ID: GafREC-Endo203 #### Organization Class: OTHER Full Name: King's College Hospital NHS Trust ### Status Module #### Completion Date Date: 2024-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-09-30 Type: ESTIMATED #### Start Date Date: 2024-05-31 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-21 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: King's College Hospital NHS Trust #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: White adipose tissue (WAT) and brown adipose tissue (BAT) form the main adipose tissue subtypes in humans and several animals. BAT, owing to its unique metabolic function, has been of increased focus and interest in metabolic research (1). BAT forms the major organ of non-shivering thermogenesis in the body, and is dependent on the large concentration of mitochondria and increased uncoupling protein-1 (UCP-1) activity present in this type of tissue (2). There are numerous triggers for the metabolic activation of BAT including cold temperature, low body mass index (BMI), adrenergic agonists, and elevated concentration of thyroid hormones (3). BAT is found more abundantly in fetuses and infants, with significant regression into adulthood. The main areas where BAT can be found are the neck, mediastinum, axilla, retroperitoneum, and abdominal wall (4). Clinical research suggests that activation and thermogenesis in BAT are mediated by noradrenaline release from the sympathetic nervous system (5). With the increasing use of fluorodeoxyglucose positron emission tomography (18FDG-PET) imaging, there has been an increased detection rate of activated brown adipose tissue (aBAT); this may affect diagnoses and lead to false-positive reporting (6). Phaeochromocytomas/paragangliomas (PPGLs) are chromaffin-cell-derived endocrine tumors that emerge from the adrenal medulla or extra-adrenal ganglia. High FDG accumulation has been commonly noted in aBAT in patients with catecholamine-producing tumours, with subsequent resolution of these findings after resection of the tumour (7). This finding is likely related to the increased glucose transport related to noradrenaline excess (4). BAT has traditionally been considered to mainly express β3-adrenoreceptors; however, in vitro studies have indicated that activated β2-adrenoreceptors may be the main driving force behind thermogenesis (8). Studies reviewing PPGLs have shown an aBAT detection rate of 7.8% to 42.8% on FDG-PET imaging, correlating with elevated catecholamine levels but without clear correlation to germline mutations (9-12). In one study, this imaging finding was associated with a statistically significant reduction in overall survival (12). Standardisation for the 'standardised uptake value' (SUV) cut-offs for aBAT on FDG-PET are lacking, but these are often reported between 1.0 and 2.0 (13); in previous studies of PPGL, a cut-off value of \>1.5 has been employed (10, 12). Research on the clinical implications of aBAT in patients with PPGL remains scarce. The main objectives of this study were to gain further insights into BAT activation rates in patients with PPGLs and how this may relate to patient demographics, biochemistry, radiological features, mutational status, and outcomes. The main hypotheses were that aBAT rates would be significantly linked to the severity of catecholamine excess and could be considered a poor prognostic feature. Detailed Description: References: 1. Santhanam P, Solnes L, Hannukainen JC, Taïeb D. Adiposity-related cancer and functional imaging of brown adipose tissue. Endocr Pract. 2015;21(11):1282-90. 2. Fenzl A, Kiefer FW. Brown adipose tissue and thermogenesis. Horm Mol Biol Clin Investig. 2014;19(1):25-37. 3. Marlatt KL, Ravussin E. Brown adipose tissue: An update on recent findings. Curr Obes Rep. 2017;6(4):389-96. 4. Iyer RB, Guo CC, Perrier N. Adrenal pheochromocytoma with surrounding brown fat stimulation. AJR Am J Roentgenol. 2009;192(1):300-1. 5. Bartness TJ, Vaughan CH, Song CK. Sympathetic and sensory innervation of brown adipose tissue. Int J Obes (Lond). 2010;34 Suppl 1(S1):S36-42. 6. Nedergaard J, Bengtsson T, Cannon B. Unexpected evidence for active brown adipose tissue in adult humans. Am J Physiol Endocrinol Metab. 2007;293(2):E444-52. 7. Terada E, Ashida K, Ohe K, Sakamoto S, Hasuzawa N, Nomura M. Brown adipose activation and reversible beige coloration in adipose tissue with multiple accumulations of 18F-fluorodeoxyglucose in sporadic paraganglioma: A case report. Clin Case Rep. 2019;7(7):1399-403. 8. Blondin DP, Nielsen S, Kuipers EN, Severinsen MC, Jensen VH, Miard S, et al. Human brown adipocyte thermogenesis is driven by β2-AR stimulation. Cell Metab. 2020;32(2):287-300.e7. 9. Wang Q, Zhang M, Ning G, Gu W, Su T, Xu M, et al. Brown adipose tissue in humans is activated by elevated plasma catecholamines levels and is inversely related to central obesity. PLoS One. 2011;6(6):e21006. 10. Puar T, van Berkel A, Gotthardt M, Havekes B, Hermus ARMM, Lenders JWM, et al. Genotype-dependent brown adipose tissue activation in patients with pheochromocytoma and paraganglioma. J Clin Endocrinol Metab. 2016;101(1):224-32. 11. Hadi M, Chen CC, Whatley M, Pacak K, Carrasquillo JA. Brown fat imaging with (18)F-6-fluorodopamine PET/CT, (18)F-FDG PET/CT, and (123)I-MIBG SPECT: a study of patients being evaluated for pheochromocytoma. J Nucl Med. 2007;48(7):1077-83. 12. Abdul Sater Z, Jha A, Hamimi A, Mandl A, Hartley IR, Gubbi S, et al. Pheochromocytoma and paraganglioma patients with poor survival often show brown adipose tissue activation. J Clin Endocrinol Metab. 2020;105(4):1176-85. 13. Sampath SC, Sampath SC, Bredella MA, Cypess AM, Torriani M. Imaging of brown adipose tissue: State of the art. Radiology. 2016;280(1):4-19. ### Conditions Module Conditions: - Pheochromocytoma - Paraganglioma Keywords: - Brown Adipose Tissue - FDG-PET - Activation - Pheochromocytoma - Paraganglioma ### Design Module #### Design Info Observational Model: COHORT Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 100 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Diagnostic Test: FDG-PET Scan Label: Patients with pheochromocytoma or paraganglioma and positive brown adipose tissue on FDG-PET #### Arm Group 2 Intervention Names: - Diagnostic Test: FDG-PET Scan Label: Patients with pheochromocytoma or paraganglioma and negative brown adipose tissue on FDG-PET ### Interventions #### Intervention 1 Arm Group Labels: - Patients with pheochromocytoma or paraganglioma and negative brown adipose tissue on FDG-PET - Patients with pheochromocytoma or paraganglioma and positive brown adipose tissue on FDG-PET Description: Positive for activated brown adipose tissue (SUVmax \>1.5) FDG-PET scan Name: FDG-PET Scan Type: DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes Measure: Number of patients with pheochromocytoma and metabolically active brown adipose tissue on FGD-PET scan Time Frame: through study completion, an average of 1 year Measure: Number of patients with paraganglioma and metabolically active brown adipose tissue on FGD-PET scan Time Frame: through study completion, an average of 1 year #### Secondary Outcomes Description: We are going to assess if patients with metabolically active adipose tissue and pheochromocytoma or paraganglioma present with germ-line mutations (VHL) or whether this occurs in patients with sporadic tumours Measure: Metabolically active brown adipose tissue and presence of germ-line mutations (NHL) in patients with pheochromocytoma and paraganglioma Time Frame: through study completion, an average of 1 year Description: We are going to assess if patients with metabolically active adipose tissue and pheochromocytoma or paraganglioma present with germ-line mutations (NF-1) or whether this occurs in patients with sporadic tumours Measure: Metabolically active brown adipose tissue and presence of germ-line mutations (NF-1) in patients with pheochromocytoma and paraganglioma Time Frame: through study completion, an average of 1 year Description: We are going to assess if patients with metabolically active adipose tissue and pheochromocytoma or paraganglioma present with germ-line mutations (MEN) or whether this occurs in patients with sporadic tumours Measure: Metabolically active brown adipose tissue and presence of germ-line mutations (MEN) in patients with pheochromocytoma and paraganglioma Time Frame: through study completion, an average of 1 year ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients with confirmed pheochromocytoma or paraganglioma who have undergone a FDG-PET as part of staging process. Exclusion Criteria: * Patients with any other neoplasm other than pheochromocytoma or paraganglioma Maximum Age: 80 Years Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Any patients with confirmed pheochromocytoma or paraganglioma treated at King's College Hospital NHS Foundation Trust Endocrinology department who underwent an FDG-PET scan. ### Contacts Locations Module #### Central Contacts Contact 1: Email: g.dimitriadis@nhs.net Name: Georgios K Dimitriadis Phone: 0777615084 Role: CONTACT #### Locations Location 1: City: London Contacts: *Contact 1:* - Email: laura.freer2@nhs.net - Name: Laura Freer - Role: CONTACT Country: United Kingdom Facility: King's College Hospital NHS Foundation Trust State: United Kingdom Of Great Britain And Northern Ireland Status: RECRUITING Zip: SE5 9RS #### Overall Officials Official 1: Affiliation: King's College Hospital NHS Trust Name: Georgios Dimitriadis Role: PRINCIPAL_INVESTIGATOR ### References Module #### References Citation: Santhanam P, Solnes L, Hannukainen JC, Taieb D. ADIPOSITY-RELATED CANCER AND FUNCTIONAL IMAGING OF BROWN ADIPOSE TISSUE. Endocr Pract. 2015 Nov;21(11):1282-90. doi: 10.4158/EP15870.RA. Epub 2015 Aug 17. PMID: 26280202 Citation: Fenzl A, Kiefer FW. Brown adipose tissue and thermogenesis. Horm Mol Biol Clin Investig. 2014 Jul;19(1):25-37. doi: 10.1515/hmbci-2014-0022. PMID: 25390014 Citation: Marlatt KL, Ravussin E. Brown Adipose Tissue: an Update on Recent Findings. Curr Obes Rep. 2017 Dec;6(4):389-396. doi: 10.1007/s13679-017-0283-6. PMID: 29101739 Citation: Iyer RB, Guo CC, Perrier N. Adrenal pheochromocytoma with surrounding brown fat stimulation. AJR Am J Roentgenol. 2009 Jan;192(1):300-1. doi: 10.2214/AJR.08.1166. No abstract available. PMID: 19098214 Citation: Bartness TJ, Vaughan CH, Song CK. Sympathetic and sensory innervation of brown adipose tissue. Int J Obes (Lond). 2010 Oct;34 Suppl 1(0 1):S36-42. doi: 10.1038/ijo.2010.182. PMID: 20935665 Citation: Nedergaard J, Bengtsson T, Cannon B. Unexpected evidence for active brown adipose tissue in adult humans. Am J Physiol Endocrinol Metab. 2007 Aug;293(2):E444-52. doi: 10.1152/ajpendo.00691.2006. Epub 2007 May 1. PMID: 17473055 Citation: Terada E, Ashida K, Ohe K, Sakamoto S, Hasuzawa N, Nomura M. Brown adipose activation and reversible beige coloration in adipose tissue with multiple accumulations of 18F-fluorodeoxyglucose in sporadic paraganglioma: A case report. Clin Case Rep. 2019 Jun 11;7(7):1399-1403. doi: 10.1002/ccr3.2259. eCollection 2019 Jul. PMID: 31360497 Citation: Blondin DP, Nielsen S, Kuipers EN, Severinsen MC, Jensen VH, Miard S, Jespersen NZ, Kooijman S, Boon MR, Fortin M, Phoenix S, Frisch F, Guerin B, Turcotte EE, Haman F, Richard D, Picard F, Rensen PCN, Scheele C, Carpentier AC. Human Brown Adipocyte Thermogenesis Is Driven by beta2-AR Stimulation. Cell Metab. 2020 Aug 4;32(2):287-300.e7. doi: 10.1016/j.cmet.2020.07.005. PMID: 32755608 Citation: Wang Q, Zhang M, Ning G, Gu W, Su T, Xu M, Li B, Wang W. Brown adipose tissue in humans is activated by elevated plasma catecholamines levels and is inversely related to central obesity. PLoS One. 2011;6(6):e21006. doi: 10.1371/journal.pone.0021006. Epub 2011 Jun 20. PMID: 21701596 Citation: Puar T, van Berkel A, Gotthardt M, Havekes B, Hermus AR, Lenders JW, van Marken Lichtenbelt WD, Xu Y, Brans B, Timmers HJ. Genotype-Dependent Brown Adipose Tissue Activation in Patients With Pheochromocytoma and Paraganglioma. J Clin Endocrinol Metab. 2016 Jan;101(1):224-32. doi: 10.1210/jc.2015-3205. Epub 2015 Nov 17. PMID: 26574955 Citation: Hadi M, Chen CC, Whatley M, Pacak K, Carrasquillo JA. Brown fat imaging with (18)F-6-fluorodopamine PET/CT, (18)F-FDG PET/CT, and (123)I-MIBG SPECT: a study of patients being evaluated for pheochromocytoma. J Nucl Med. 2007 Jul;48(7):1077-83. doi: 10.2967/jnumed.106.035915. Epub 2007 Jun 15. PMID: 17574980 Citation: Abdul Sater Z, Jha A, Hamimi A, Mandl A, Hartley IR, Gubbi S, Patel M, Gonzales M, Taieb D, Civelek AC, Gharib AM, Auh S, O'Mara AE, Pacak K, Cypess AM. Pheochromocytoma and Paraganglioma Patients With Poor Survival Often Show Brown Adipose Tissue Activation. J Clin Endocrinol Metab. 2020 Apr 1;105(4):1176-85. doi: 10.1210/clinem/dgz314. PMID: 31903484 Citation: Sampath SC, Sampath SC, Bredella MA, Cypess AM, Torriani M. Imaging of Brown Adipose Tissue: State of the Art. Radiology. 2016 Jul;280(1):4-19. doi: 10.1148/radiol.2016150390. PMID: 27322970 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13578 - Name: Pheochromocytoma - Relevance: HIGH - As Found: Pheochromocytoma - ID: M13149 - Name: Paraganglioma - Relevance: HIGH - As Found: Paraganglioma - 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: T4530 - Name: Pheochromocytoma - Relevance: HIGH - As Found: Pheochromocytoma - ID: T4409 - Name: Paragangliomas 1 - Relevance: HIGH - As Found: Paraganglioma - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010673 - Term: Pheochromocytoma - ID: D000010235 - Term: Paraganglioma ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440109 Brief Title: The Effect of Therapeutic Touch and Emotional Freedom Technique (EFT) on Postpartum Mood and Fatigue in Postpartum Women Official Title: The Effect of Therapeutic Touch and Emotional Freedom Technique (EFT) on Postpartum Mood and Fatigue in Postpartum Women #### Organization Study ID Info ID: A-TURAN-001 #### Organization Class: OTHER Full Name: KTO Karatay University ### Status Module #### Completion Date Date: 2024-09-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-09-30 Type: ESTIMATED #### Start Date Date: 2024-05-30 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-08 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: KTO Karatay 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: Therapeutic touch (TD) is a non-pharmacological/integrated treatment method used to balance the body by regulating the imbalanced energy field in the individual or resolving blockages in energy flow. Emotional freedom technique (EFT) is a psychophysiological intervention that combines elements of somatic stimulation using acupuncture points. This research will be conducted as a randomized controlled experimental study to determine the effect of TD and EFT intervention on postpartum mood and fatigue in postpartum women. The research will be conducted between November 2023 and November 2024 with women who gave birth normally and are registered at Karakulak Family Health Center in Konya. This research; It was planned to be carried out with three groups: TD intervention, EFT intervention and control group. The population of the research consists of women who gave birth vaginally and those who gave birth vaginally in the relevant hospital. A pilot study was conducted with 15 people to calculate the sample size. The number of samples was determined as 60 by post hoct analysis in the G\Power 3.1.9.4 program, in line with the pilot study results. Data will be collected with the Personal Information Form, Brief Mood Introspection Scale, Visual Similarity Scale for Fatigue, and Unit of Subjective Experience (SUE). The analysis of the data obtained from the research will be carried out in the Social Sciences Statistical Package (SPSS) 25.0 package program. The critical significance value will be taken as 0.05. Therapeutic touch and EFT interventions are thought to be methods that can be used to improve women's health because they are easy to apply, have no side effects, and are non-drug practices that midwives/nurses can apply independently. ### Conditions Module Conditions:* - Fatigue - Emotion Regulation Keywords: - emotional freedom technic - therapeutic touch - fatigue - mood state level ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - OUTCOMES_ASSESSOR Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 60 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: The application will be carried out in line with EFT application protocols. In this regard, women's home visits will be completed with 6 meetings, once every week. Each EFT session will last 15 minutes Intervention Names: - Other: Emotional freedom technique (EFT) Label: EFT intervention Type: EXPERIMENTAL #### Arm Group 2 Description: The application will be carried out in line with TD application protocols. In this regard, women's home visits will be completed with 6 meetings, once every week. Each TD session will last 15 minutes Intervention Names: - Other: Therapeutic touch (TD) Label: TD intervention Type: EXPERIMENTAL #### Arm Group 3 Description: No intervention will be made. Women in the intervention groups will be followed for 6 weeks and receive standard care. The final test will be administered at the end of the sixth week Label: Control grup Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - EFT intervention Description: İntervention groups will be followed for six months and one of the six EFT therapies will be applied, one session every week. Name: Emotional freedom technique (EFT) Type: OTHER #### Intervention 2 Arm Group Labels: - TD intervention Description: İntervention groups will be followed for six months and one of the six TD therapies will be applied, one session every week. Name: Therapeutic touch (TD) Type: OTHER ### Outcomes Module #### Primary Outcomes Description: SUE scale and vital signs will be taken from the participants before and after each session. Measure: Postpartum 3rd-5th. EFT intervention will be applied to women who are between Time Frame: six weeks Description: SUE scale and vital signs will be taken from the participants before and after each session. Measure: Postpartum 3rd-5th. TD intervention will be applied to women who are between Time Frame: six weeks Description: The researcher will not perform any intervention on women in this group. After the pre-tests are completed, women in this group will be called by phone during the interview weeks for the intervention group, their postpartum needs will be questioned and support will be provided when necessary. The implementation of the final tests will be completed in the sixth week. Measure: 3rd-5th postpartum Pre- and post-test will be given to women between Time Frame: six weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Having a vaginal birth at term * Being primiparous * Postpartum 3rd-5th. to be in the days * Being able to speak and understand Turkish * Being 18 years or older * Having a single and viable fetus * Volunteering to participate in research * Not having experienced TD or EFT treatment before Exclusion Criteria: * A psychiatric diagnosis has been made, * Having a chronic systemic disease, * The newborn's need for treatment * Having postpartum complications in the mother or baby * Those who have sensitivity or problems with touch, * Wounds, infections, etc. in places that need to be touched. existence of situations, * Women who have any disability that would prevent communication (deafness, hearing impairment, etc., use of languages other than Turkish) will be excluded from the research. Healthy Volunteers: True Maximum Age: 60 Years Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8364 - Name: Fatigue - Relevance: HIGH - As Found: Fatigue ### Condition Browse Module - Meshes - ID: D000005221 - Term: Fatigue ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440096 Brief Title: Complete Blood Count-derived Indexes in Inflammatory Modic Changes Official Title: Harran University Hospital Department of Physical Medicine and Rehabilitation #### Organization Study ID Info ID: YÖMAVD #### Organization Class: OTHER Full Name: Sanliurfa Mehmet Akif Inan Education and Research Hospital ### Status Module #### Completion Date Date: 2024-01-05 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-01-05 Type: ACTUAL #### Start Date Date: 2023-03-30 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Veysel Delen, MD #### Responsible Party Investigator Affiliation: Sanliurfa Mehmet Akif Inan Education and Research Hospital Investigator Full Name: Veysel Delen, MD Investigator Title: Harran University Hospital Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Some indicators generated from hemogram such as neutrophil/lymphocyte (NLR) have been suggested as biomarkers of systemic inflammation. Type I Modic changes (MCs) have inflammatory nature histologically and are more painful clinically than type II MCs. Therefore, we hypothesized that patients with type I MCs may have increased inflammatory biomarkers and low back pain than those with type II MCs. The aim of this study was to test this hypothesis. Detailed Description: Patients and Methods: A total of 48 patients with MCs (type I/type II=24/24) were included in this study. Their demographic, clinical and hematologic characteristics were recorded. A 10 cm Visual Analog Scale (VAS) was used to detect low back pain intensity. Systemic inflammatory biomarkers including NLR, monocyte/lymphocyte (MLR), platelet/lymphocyte (PLR), neutrophil/lymphocyte\platelet (NLPR), systemic inflammatory index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI) were derived from whole blood cell count. Keywords: Neutrophil-to-lymphocyte ratio, inflammation, Modic changes, back pain. ### Conditions Module Conditions:* - Modic Changes ### Design Module #### Design Info Observational Model: OTHER Time Perspective: CROSS_SECTIONAL #### Enrollment Info Count: 48 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: 24 patients with type I Modic changes Intervention Names: - Diagnostic Test: hemogram Label: Modic changes type I #### Arm Group 2 Description: 24 patients with type II Modic changes Intervention Names: - Diagnostic Test: hemogram Label: Modic changes type II ### Interventions #### Intervention 1 Arm Group Labels: - Modic changes type I - Modic changes type II Description: hemogram Name: hemogram Type: DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes Description: blood-based Measure: Hemogram-derived inflammation indexes Time Frame: 10 minutes ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Inclusion criteria were male or female with type I or type II MCs, aged ≥18 and ≤64 years old, and accepted informed consent to participation. Exclusion Criteria: * type III MCs and a combination of MCs' types were excluded. In addition, acute low back pain, spinal deformities, inflammatory diseases, cancers, heart diseases, stroke, lactation, pregnancy, psychiatric disorders, and extreme obesity (BMI≥40 kg/m²) were also excluded. Maximum Age: 64 Years Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT Study Population: Male or female patients with type I or type II Modic changes, aged ≥18 and ≤64 years old ### Contacts Locations Module #### Locations Location 1: City: Şanlıurfa Country: Turkey Facility: Harran University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Şanlıurfa ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440083 Brief Title: Pre-warning Risk Scoring System for Sudden Cardiac Death Official Title: Pre-warning Risk Scoring System for Sudden Cardiac Death #### Organization Study ID Info ID: SYSKY-2023-177-01 #### Organization Class: OTHER Full Name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Status Module #### Completion Date Date: 2027-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-05 Type: ACTUAL Last Update Submit Date: 2024-06-03 Overall Status: RECRUITING #### Primary Completion Date Date: 2027-12-31 Type: ESTIMATED #### Start Date Date: 2023-03-02 Type: ACTUAL Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### 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: Jingfeng Wang 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 observational study is to identify potential indicators for pre-warning of sudden cardiac death (SCD), including clinical biochemistry markers, electrocardiogram, echocardiography, MRI and CT imaging values, genetic markers and so on, and further construct a series of multi-parameter assessments of SCD early screening. Detailed Description: In the past few decades, evidence-based drug and surgical treatment strategies have significantly improved the prevention of sudden cardiac death (SCD), however, a large number of patients with cardiovascular disease still face high risk of SCD, the prognosis of these high-risk SCD patients are still uncertain. Therefore, clinical physicians might need to move towards a multi-parameter assessment of SCD risk pre-warning. Several parameters for risk stratification of arrhythmia, including clinical biochemistry markers, electrocardiogram, echocardiography, imaging, and genetic markers, are crucial for accurate assessment of SCD risk stratification. In addition, the integration of cardiac magnetic resonance parameters and specific CT and ECG information is a future research trend for implementing risk stratification of malignant arrhythmias. In order to further explore the possibility of early warning of SCD, this study aims to include subjects with potential SCD risks, collect relevant potential SCD warning indicators, and then construct an SCD prewarning score system. Afterwards, the investigators will continuously improve the SCD warning score system based on follow-up information, and ultimately summarize an effective set of SCD warning scores and apply them to clinical practice, striving to achieve early warning of SCD and benefiting more people at risk of SCD. ### Conditions Module Conditions: - Sudden Cardiac Death Keywords: - Sudden Cardiac Death - Cohort study ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 100000 Type: ESTIMATED Study Type: OBSERVATIONAL ### Outcomes Module #### Primary Outcomes Description: Identify participants who die by cardiovascular diseases during follow-up period Measure: Sudden cardiac death Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up #### Secondary Outcomes Description: Identify participants who die during follow-up period Measure: All-causes death Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up Description: Identify participants who with recurrence of cardiovascular disease during follow-up period Measure: Recurrence of cardiovascular disease Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up Description: Identify participants who suffer sudden cardiac arrest during follow-up period Measure: Cardiac arrest Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up Description: Identify participants who suffer incident major cardiovascular events during follow-up period Measure: Major cardiovascular events Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up ### Eligibility Module Eligibility Criteria: Inclusion Criteria: The subjects with the following diagnosis of one or more cardiovascular diseases: 1. Coronary heart disease If there is a history of coronary heart disease or a new diagnosis of coronary heart disease, or with a report of coronary angiography that indicates at least one vascular stenosis\>50%. Diagnosis includes chronic coronary syndrome (stable angina, ischemic cardiomyopathy, and occult coronary heart disease) and acute coronary syndrome (unstable angina, ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction). 2. Heart failure Individuals with a history of heart failure or newly diagnosed heart failure, including heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction (LVEF) ≤40%)、intermediate heart failure (HFmrEF, LVEF 41%-49%，with evidence of spontaneous or excitable increase in left ventricular filling pressure), and ejection fraction preserving heart failure (HFpEF, LVEF≥50%, there is evidence of spontaneous or excitable increase in left ventricular filling pressure). 3. Genetically related cardiomyopathy or arrhythmia Cardiomyopathy includes hypertrophic cardiomyopathy (DCM), dilated cardiomyopathy (HCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), inflammatory cardiomyopathy (myocarditis, sarcoidosis, Chagas disease). Hereditary arrhythmias include long QT syndrome, short QT syndrome, Brugada syndrome, idiopathic ventricular fibrillation, catecholamine sensitive polymorphic ventricular tachycardia (CPVT), early repolarization syndrome, etc. 2) Sign an informed consent form. Exclusion Criteria: 1. Age\<16 years old; 2. Refusal to the follow-up visits; 3. Individuals with severe mental disorders who are unable to express their wishes; 4. Other obvious physical diseases and abnormal laboratory test results; 5. Patients deemed unsuitable for participation in this study by the supervising physician. Healthy Volunteers: True Maximum Age: 90 Years Minimum Age: 16 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT Study Population: Participants with potential high-risk of sudden cardiac death. ### Contacts Locations Module #### Central Contacts Contact 1: Email: zhyul@mail.sysu.edu.cn Name: Yuling Zhang, M.D.,Ph.D. Phone: +862081332360 Role: CONTACT Contact 2: Email: lmhuan@mail.sysu.edu.cn Name: Maohuan Lin, M.D.,Ph.D. Phone: +862081332360 Role: CONTACT #### Locations Location 1: City: Guanzhou Contacts: *Contact 1:* - Email: zhyul@mail.sysu.edu.cn - Name: Yuling Zhang, Doctor - Phone: +862081332360 - Role: CONTACT *Contact 2:* - Email: lmhuan@mail.sysu.edu.cn - Name: Maohuan Lin, Doctor - Phone: +862081332360 - Role: CONTACT Country: China Facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University State: Guangdong Status: RECRUITING Zip: 510120 #### Overall Officials Official 1: Affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Name: Jingfeng Wang, M.D.,Ph.D. Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000006323 - Term: Heart Arrest - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000003645 - Term: Death, Sudden ### 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: M19118 - Name: Death, Sudden, Cardiac - Relevance: HIGH - As Found: Sudden Cardiac Death - ID: M6845 - Name: Death - Relevance: HIGH - As Found: Cardiac Death - ID: M6847 - Name: Death, Sudden - Relevance: LOW - As Found: Unknown - ID: M9411 - Name: Heart Arrest - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016757 - Term: Death, Sudden, Cardiac - ID: D000003643 - Term: Death ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440070 Brief Title: Ultrasound-Guided Curved Needle Thread Carpal Tunnel Release: Efficacy and Safety of a Single-Center, Single-Arm Clinical Trial Official Title: B-ultrasound-guided Bending Needle and Thread Loop Carpal Tunnel Ligament Release in Carpal Tunnel Syndrome :Efficacy and Safety of a Single-Center, Single-Arm Clinical Trial #### Organization Study ID Info ID: SYSKY-2024-287-02 #### Organization Class: OTHER Full Name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Status Module #### Completion Date Date: 2026-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2026-12-31 Type: ESTIMATED #### Start Date Date: 2024-01-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Carpal tunnel syndrome is a set of symptoms and signs caused by compression of the median nerve within the carpal tunnel. The prevalence in the general population is about 3.72%, with a rising trend, making it the most common peripheral nerve entrapment syndrome. Compared to conservative treatment, surgical treatment has definite efficacy and lower recurrence rates, making it the ultimate choice for relieving median nerve compression. However, open surgery has disadvantages such as large trauma, long postoperative recovery period, and scar formation, while wrist arthroscopic surgery, although minimally invasive, is technically challenging, requires expensive specialized equipment, and has low cost-effectiveness, limiting its clinical application. Therefore, based on clinical and life experience, our team innovatively developed the "Ultrasound-guided Needle Release of the Transverse Carpal Ligament." This technique avoids the risks of large trauma and scar formation associated with traditional open surgery, significantly shortens surgical and postoperative recovery times, and is more minimally invasive and cost-effective compared to wrist arthroscopic surgery, thus having high clinical value for promotion. This study aims to validate the effectiveness and safety of this innovative procedure through a single-arm interventional clinical study, providing a theoretical basis for further clinical application. ### Conditions Module Conditions: - Carpal Tunnel Syndrome - Surgery - Ultralsound-Guide ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 69 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Procedure: Loop Carpal Tunnel Release Label: Loop Carpal Tunnel Release group Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Loop Carpal Tunnel Release group Description: Under the guidance of ultrasound, needles are inserted above and below the transverse carpal ligament, respectively, to form a loop around the ligament. Finally, the ligament is cut by pulling the looped thread. Name: Loop Carpal Tunnel Release Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: The Boston Carpal Tunnel Questionnaire (BCTQ) is considered an effective tool for assessing the severity of symptoms and functional status in carpal tunnel syndrome. It is divided into two parts: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS consists of 11 questions that evaluate the severity, frequency, and duration of symptoms. The FSS comprises 8 questions that assess the impact of the syndrome on daily life activities. Each question is scored from 0 (no symptoms or no impact) to 5 (most severe). The total score of the questionnaire is the average score of all questions. Measure: Changes in BCTQ scale scores compared to preoperative values at 6 months postoperatively Time Frame: 6 months post-operation #### Secondary Outcomes Description: The change in Quick Disabilities of the Arm, Shoulder and Hand (quickDASH) scores from preoperative to 2 weeks, 3 months, and 6 months postoperative. Researchers will ask the enrolled patients the questionnaire either in person, over the phone, or online, then record the answers, summarize, and document the scores. Measure: quickDASH scale score Time Frame: preoperative, 2 weeks, 3 months, and 6 months postoperative Description: The change in grip strength from before the surgery to 6 months postoperative. Researchers will explain the use of the dynamometer to the patients, assist them in measuring their grip strength, and record the dynamometer readings. Measure: Grip strength Time Frame: before the surgery, 6 months postoperative Description: The change in pinch strength from before the surgery to 6 months postoperative. Researchers will explain the use of the dynamometer to the patients, assist them in measuring their pinch strength, and record the dynamometer readings. Measure: Pinch strength Time Frame: before the surgery, 6 months postoperative Description: The comparison of the cross-sectional area of the median nerve at the proximal entrance of the carpal tunnel under ultrasound between preoperative and 6 months postoperative. This will be examined and reported by the Ultrasound Department of our hospital. Measure: the cross-sectional area of the median nerve at the proximal entrance of the carpal tunnel under ultrasound Time Frame: before the surgery, 6 months postoperative Description: The time to return to work after surgery is defined as the number of days from the day of surgery to the first day the patient returns to their preoperative job or is able to fully resume daily activities. This is self-assessed by the patient, and researchers will ask and record the information at 1, 2, and 4 weeks postoperative. Measure: Time to return to work Time Frame: 1, 2, and 4 weeks postoperative ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Aged between 40 and 70 years; 2. Exhibiting symptoms consistent with carpal tunnel syndrome (e.g., finger numbness, tingling, weakness, or pain; symptoms aggravated by repetitive or sustained gripping; symptoms worsening at night) and signs (sensory impairment or weakness in the hand; positive Tinel's sign or Phalen's test for the median nerve); 3. Meeting the diagnostic criteria for typical or possible carpal tunnel syndrome based on the Katz hand diagram for carpal tunnel syndrome \[14\]; 4. Ultrasound indicating thickening of the transverse carpal ligament, compressing the median nerve; 5. Ineffective conservative treatment (e.g., immobilization, oral NSAIDs, local corticosteroid injections) for more than 3 months; 6. Signing the informed consent form. Exclusion Criteria: 1. Ultrasound examination reveals bifurcation of the median nerve or the presence of a persistent median artery at the carpal tunnel entrance, or compression at the carpal tunnel caused by cysts, tumors, or fracture fragments; 2. Systemic infection or local infection at the surgical site; 3. Severe coagulation disorders; 4. Previous carpal tunnel syndrome surgery on the affected side for this operation; 5. Patients with uncontrolled epilepsy, cervical radiculopathy, or diabetic peripheral neuropathy; 6. Allergy to local anesthetics; 7. Inability to complete the questionnaire due to language or cognitive impairments; 8. Patients with severe heart, lung, liver, or brain diseases; 9. Patients with mental illnesses; 10. Participation in other clinical trials within the last three months; 11. Pregnant or breastfeeding women. Maximum Age: 70 Years Minimum Age: 40 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: houjingyi246@126.com Name: Jingyi Hou Phone: 15920530546 Role: CONTACT #### Locations Location 1: City: Guangzhou Contacts: *Contact 1:* - Email: houjingyi246@126.com - Name: Jingyi Hou - Phone: 15920530546 - Role: CONTACT Country: China Facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University State: Guangdong Status: RECRUITING Zip: 510235 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000020423 - Term: Median Neuropathy - ID: D000020422 - Term: Mononeuropathies - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009408 - Term: Nerve Compression Syndromes - ID: D000012090 - Term: Cumulative Trauma Disorders - ID: D000013180 - Term: Sprains and Strains - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M5603 - Name: Carpal Tunnel Syndrome - Relevance: HIGH - As Found: Carpal Tunnel Syndrome - ID: M6867 - Name: Decompression Sickness - Relevance: LOW - As Found: Unknown - ID: M22219 - Name: Median Neuropathy - Relevance: LOW - As Found: Unknown - ID: M22218 - Name: Mononeuropathies - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: 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: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M14930 - Name: Cumulative Trauma Disorders - Relevance: LOW - As Found: Unknown - ID: M15974 - Name: Sprains and Strains - Relevance: LOW - As Found: Unknown - 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: D000002349 - Term: Carpal Tunnel Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440057 Brief Title: Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma. Official Title: A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma. #### Organization Study ID Info ID: ZG006-003 #### Organization Class: INDUSTRY Full Name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd ### Status Module #### Completion Date Date: 2026-07 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-05 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This is a multicenter, open-label phase I/II study, divided into 2 parts: Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2. Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma. ### Conditions Module Conditions: - Neuroendocrine Carcinoma ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: SEQUENTIAL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 78 Type: ESTIMATED Phases: - PHASE1 - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg. Intervention Names: - Biological: ZG006 Label: Dose Escalation Type: EXPERIMENTAL #### Arm Group 2 Description: Participants will receive the RP2D identified in Dose Escalation Study . Intervention Names: - Biological: ZG006 Label: Dose Expansion Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Dose Escalation - Dose Expansion Description: ZG006 will be administered as an intravenous (IV) infusion. Name: ZG006 Type: BIOLOGICAL ### Outcomes Module #### Primary Outcomes Description: ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria. Measure: Objective response rate (ORR) Time Frame: Up to approximately 2 years #### Secondary Outcomes Description: The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 Measure: Number of participants with adverse events (AEs) Time Frame: Up to approximately 2 years ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form; * Male or female 18\~75 years of age; * Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; * Life expectancy ≥ 3 months. Exclusion Criteria: * Participants were deemed unsuitable for participating in the study by the investigator for any reason. Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: ningsd@zelgen.com Name: Shangdi Ning Phone: +86-0512-57309965 Role: CONTACT #### Locations Location 1: City: Beijing Contacts: *Contact 1:* - Email: jmxu2003@163.com - Name: Jianming Xu - Phone: 13910866712 - Role: CONTACT Country: China Facility: Chinese PLA General Hospital State: Beijing Zip: 100853 #### Overall Officials Official 1: Affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd Name: Jason Wu Role: STUDY_CHAIR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000000230 - Term: Adenocarcinoma - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M28323 - Name: Small Cell Lung Carcinoma - Relevance: HIGH - As Found: Small Cell Lung Cancer - ID: M20423 - Name: Carcinoma, Neuroendocrine - Relevance: HIGH - As Found: Neuroendocrine Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - 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: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T5271 - Name: Small Cell Lung Cancer - Relevance: HIGH - As Found: Small Cell Lung Cancer - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000055752 - Term: Small Cell Lung Carcinoma - ID: D000018278 - Term: Carcinoma, Neuroendocrine ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440044 Brief Title: Recurrence and Bleeding in Colorectal Cancer Patients With Cancer-associated Venous Thrombembolism Official Title: Recurrence and Bleeding in Colorectal Cancer Patients With Cancer-associated Venous Thrombembolism #### Organization Study ID Info ID: 2024ZSLYEC-226 #### Organization Class: OTHER Full Name: Sixth Affiliated Hospital, Sun Yat-sen University ### Status Module #### Completion Date Date: 2024-06-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2023-12-31 Type: ACTUAL #### Start Date Date: 2019-01-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Sixth Affiliated Hospital, Sun Yat-sen University #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Is US Export: False Oversight Has DMC: True ### Description Module Brief Summary: Patients with colorectal cancer (CRC) have a higher risk of both venous thromboembolism (VTE) and major bleeding (MB). Patients with CRC are underrepresented in the major trials examining treatment of cancer-associated VTE with anticoagulant. Detailed Description: Patients with colorectal cancer (CRC) have a higher risk of both venous thromboembolism (VTE) and major bleeding (MB). Specifically, a subsequent analysis of the Hokusai study showed that the excess in MB was confined to patients with gastrointestinal cancer. In the RIETE registry, patients with gastrointestinal or genitourinary cancers experienced more bleeding outcomes while patients with brain or lung cancer experienced more thrombotic outcomes. However, in a subgroup analysis of the Caravaggio trial, major gastrointestinal bleeding in patients with CRC was low and similar in both apixaban and LMWH groups. Patients with CRC are underrepresented in the major trials examining treatment of CAT with anticoagulant. Despite concerns that DOACs pose a significant bleeding risk in CRC patients, many patients with CRC are treated with apixaban or rivaroxaban in clinical practice. Balancing risks of thrombosis recurrence and bleeding can be challenging and requires a nuanced, individualized approach to decision making to improve prognosis in this population. The aim of this study is to identify risk factors for recurrence and bleeding in CRC patients with VTE. Deaths, regardless of the mechanism, will also be included in the one year all-cause mortality outcome. ### Conditions Module Conditions: - Thrombosis, Venous - Colo-rectal Cancer - Major Bleed - Bleeding Keywords: - Venous Thrombembolism；Colorectal Cancer；Major Bleeding；Clinical Relevant Non Major Bleeding ### Design Module #### Design Info Observational Model: COHORT Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 2000 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients with adverse anticoagulant outcomes in the study period. Adverse anticoagulant outcomes include venous thromboembolism recurrence, major bleeding, and clinical relevant non major bleeding. Intervention Names: - Other: Data collection Label: Patients with adverse anticoagulant outcomes #### Arm Group 2 Description: Patients without any adverse anticoagulant outcomes in the study period. Intervention Names: - Other: Data collection Label: Patients without any adverse anticoagulant outcomes ### Interventions #### Intervention 1 Arm Group Labels: - Patients with adverse anticoagulant outcomes - Patients without any adverse anticoagulant outcomes Description: A prospectively maintained database query of all patients with CRC and VTE was initially performed, and then each patient's electronic record was reviewed for inclusion criteria. Name: Data collection Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Recurrent DVT had to be confirmed by duplex ultrasonography, venography, CT, or MRI. Recurrent PE was confirmed by CT, MRI, conventional pulmonary angiography, or VQ (ventilation/perfusion) imaging. Fatal PE had to be based on objective diagnostic testing, autopsy, or death that could not be attributed to a documented cause and for which PE/DVT could not be ruled out (unexplained death). Incidental VTE recurrence had to be identified via surveillance-related imaging. To be classified as a recurrent event, a new filling defect had to be evident on the second study, not appreciated on the original images, or an interval study clearly showing thrombus resolution. Measure: recurrent VTE including deep vein thrombosis (DVT) and pulmonary embolism (PE) Time Frame: From the date of index VTE to VTE recurrence Description: MB was defined as overt bleeding plus a hemoglobin decrease of ≥ 2 g/dL after the incident, requirement for transfusion of ≥ 2 units of packed read blood cells, or intracranial, intraspinal, intraocular, pericardial, retroperitoneal, intramuscular causing compartment syndrome, or fatal bleeding. Measure: Major Bleeding (MB) Time Frame: From the date of index VTE to MB occurrence Description: CRNMB was defined as overt bleeding not meeting the criteria for MB but associated with medical intervention, unscheduled contact with a member of the health care team, temporary cessation of the treatment, or impairment of activities of daily life. Measure: Clinical Relevant Non Major Bleeding (CRNMB) Time Frame: From the date of index VTE to CRNMB occurrence #### Secondary Outcomes Description: Deaths, regardless of the mechanism, were included in the all-cause mortality outcome Measure: All cause mortality Time Frame: One year follow up since index VTE identified ### Eligibility Module Eligibility Criteria: Inclusion Criteria: Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment. Briefly, CRC patients with VTE treated with an anticoagulant (rivaroxaban or LMWH) for at least six months were identified. Patients diagnosed with PE and/or DVT via any radiologic imaging method, such as CT or ultrasound, were considered to have VTE. No formal predefined protocol or prospective screening plan for occult VTE was implemented. Both symptomatic individuals, diagnosed through symptom-prompted diagnostic imaging, and asymptomatic individuals, identified via imaging studies conducted for other medical purposes (e.g., cancer restaging), were included. VTE was considered cancer-related if the patient had a diagnosis of CRC within six months before or after the VTE diagnosis, any cancer treatment within the previous six months, or recurrent/metastatic cancer regardless of treatment. Exclusion Criteria: Participation in this study required active anticoagulant treatment. Apart from this, there were no specific exclusion criteria. Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment at The Sixth Affiliated Hospital, Sun Yat-sen University from January 2019 to January 2023. ### Contacts Locations Module #### Central Contacts Contact 1: Email: lixyan5@mail.sysu.edu.cn Name: xiaoyan li Phone: 13609066172 Role: CONTACT #### Locations Location 1: City: Guangzhou Contacts: *Contact 1:* - Email: lixyan5@mail.sysu.edu.cn - Name: xiaoyan li - Phone: 13609066172 - Role: CONTACT Country: China Facility: the Sixth Affiliated Hospital of Sun Yat-Sen University State: Guangdong Status: RECRUITING Zip: 510655 #### Overall Officials Official 1: Affiliation: Sixth Affiliated Hospital, Sun Yat-sen University Name: xiaoyan li Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000020969 - Term: Disease Attributes - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Bleeding - ID: M16686 - Name: Thrombosis - Relevance: HIGH - As Found: Thrombosis - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M22071 - Name: Venous Thrombosis - Relevance: HIGH - As Found: Thrombosis, Venous - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M7784 - Name: Embolism - Relevance: LOW - As Found: Unknown - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000013927 - Term: Thrombosis - ID: D000020246 - Term: Venous Thrombosis - ID: D000006470 - Term: Hemorrhage - ID: D000012008 - Term: Recurrence ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440031 Acronym: CaMaPi Brief Title: CaMaPi for Adolescents/Young People With a History of Self-harm and Suicidal Ideation in Jos, Nigeria Official Title: Culturally-adapted Manual-assisted Psychological Intervention (CaMaPi) for Adolescents/Young People With a History of Self-harm and Suicidal Ideation in Jos, Nigeria #### Organization Study ID Info ID: 0000-0001-5034-0335f #### Organization Class: OTHER Full Name: Nottingham Trent University ### Status Module #### Completion Date Date: 2025-09-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-06-30 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: University of Manchester Class: OTHER Name: Jos University Teaching Hospital Class: OTHER Name: Teesside University #### Lead Sponsor Class: OTHER Name: Nottingham Trent University #### Responsible Party Investigator Affiliation: Nottingham Trent University Investigator Full Name: Dr Dung Jidong, PhD Investigator Title: Dr Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: Suicide and self-harm are global disease burden that contributes significantly to years of lost life and mortality. Detailed Description: Self-harm and suicidal ideation represent a significant global public health concern (Knipe et al., 2022), affecting about 14.6 million people yearly (Nichols et al., 2021). Globally, over 700 000 people die by suicide annually (World Health Organization -- WHO, 2023). Suicide is the fourth leading cause of death among 15-29-year-olds, and 77% of global suicides occur in low- and middle-income countries, including Nigeria (WHO, 2023). The psychological impact of suicidal ideation includes continuing high tendencies of self-harm (Jidong et al., 2024). Despite the increasing rates of suicide and self-harm in Nigeria, this topic is understudied, with no culturally appropriate or sustainable psychological interventions. ### Conditions Module Conditions: - Self-harm - Suicidal Ideation ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: TREATMENT #### Enrollment Info Count: 32 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Behavioral: CaMaPi Label: CaMaPi Type: EXPERIMENTAL #### Arm Group 2 Intervention Names: - Other: TAU Label: TAU Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - CaMaPi Description: CaMaPi is a manually assisted brief psychological intervention that is based on the principles of Cognitive Behaviour Therapy (CBT). The intervention includes psycho-education and a comprehensive cognitive behavioural assessment of the suicidal ideation and self-harm attempt using virtual stories of four young people to be delivered in 8-10 sessions for over three months Name: CaMaPi Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - TAU Description: Treatment as Usual (TAU) is routine care, such as diagnosis, assessment, psychotherapy, monitoring and any form of intervention (e.g., medication prescription) available at the collaborating service. Name: TAU Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Primary outcome measure would be assessed using the Service Satisfaction Scale Measure: Change in acceptance and satisfaction with the intervention Time Frame: Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention #### Secondary Outcomes Description: Secondary outcome measure would be assessed using the Beck Scale for Suicide Ideation Measure: Change in suicidal ideation Time Frame: Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention Description: Secondary outcome measure would be assessed using the Beck Hopelessness Scale Measure: Change in hopelessness Time Frame: Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention Description: Secondary outcome measure would be assessed using the EQ-5D-5L quality of health scale Measure: Change in Health Status Time Frame: Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention Description: Secondary outcome measure would be assessed using an adapted Suicide Attempt Self-Injury Interview Measure: Change in repetition rate's of self-harm Time Frame: Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention Description: Secondary outcome measure would be assessed using Client Service Receipt Inventory Measure: Change in use of health services Time Frame: Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention Description: Secondary outcome measure would be assessed using Kessler Psychological Distress Scale Measure: Change in psychological distress Time Frame: Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients aged 16-24 years presenting to the participating services, and emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals. * Participants will have to be living within the catchment area of the participating practices, services and hospitals. * Not needing inpatient psychiatric treatment. Exclusion Criteria: * Severe mental illness (such as Psychotic disorder). * Conditions limiting engagement with assessment/intervention. * Temporary resident unlikely to be available for follow up. 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: dung.jidong@mamnchester.ac.uk Name: Dung Jidong, PhD Phone: 07448930519 Phone Ext: +44 Role: CONTACT ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013405 - Term: Suicide - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M29364 - Name: Suicidal Ideation - Relevance: HIGH - As Found: Suicidal Ideation - ID: M19089 - Name: Self-Injurious Behavior - Relevance: HIGH - As Found: Self-harm - ID: M16191 - Name: Suicide - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059020 - Term: Suicidal Ideation - ID: D000016728 - Term: Self-Injurious Behavior ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440018 Acronym: INSPIRE Brief Title: INSPIRE: A Multi-Cancer Early Detection Study Official Title: INSPIRE: Integrating Circulating DNA Methylation and Fragmentomics to Scan and Pinpoint Cancer Signals Effectively #### Organization Study ID Info ID: multiple #### Organization Class: INDUSTRY Full Name: Singlera Genomics Inc. ### Status Module #### Completion Date Date: 2025-02-28 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-02-28 Type: ESTIMATED #### Start Date Date: 2024-06-20 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Fudan University Class: UNKNOWN Name: Hubei Cancer Hospital, Huazhong University of Science and Technology Class: OTHER Name: China-Japan Friendship Hospital Class: OTHER Name: Shanxi Provincial Cancer Hospital Class: UNKNOWN Name: Xuhui Central Hospital, Fudan University Class: UNKNOWN Name: Shanghai Electric Power Hospital Class: UNKNOWN Name: East Hospital, Tongji University Class: UNKNOWN Name: The First Affiliated Hospital of Xi' an Jiaotong University Class: UNKNOWN Name: GaoZhou People's Hosipital Class: OTHER_GOV Name: Anhui Provincial Hospital Class: OTHER Name: Beijing Friendship Hospital #### Lead Sponsor Class: INDUSTRY Name: Singlera Genomics 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: This research constitutes a multi-centric, case-control designed investigation aimed at developing and implementing a blinded validation of a machine learning-powered, multi-cancer early detection model. This is to be achieved through the prospective collection of blood specimens from newly diagnosed cancer patients and individuals devoid of a confirmed cancer diagnosis Detailed Description: Cancerous tissues, their adjacent non-cancerous tissues, along with white blood cells (WBCs) and normal tissue samples will be utilized to identify potential methylation candidate markers and investigate variations in methylation patterns among patients diagnosed with distinct cancer types. Building upon previous research and current study, a comprehensive methylation signature panel tailored specifically to cancer patients will be established. We will prospectively collect blood samples from newly diagnosed cancer patients and non-cancer individuals to analyze and identify specific cancer signals via the detection of cfDNA methylation patterns. Following a rigorous and comprehensive research framework, a machine learning-driven model will be developed and validated through blinded testing in an independent cohort. The study aims to enroll approximately 2,650 cancer patients, with a focus on including early-stage cases to enhance the model's sensitivity in detecting cancers with favorable prognoses. Furthermore, around 2,400 control subjects, matched with cancer patients by age and gender and screened negative for cancer through routine tests, will participate as healthy or benign-condition volunteers in model development. Lastly, samples from an additional 300 patients with other tumors will be gathered to conduct interference testing, ensuring the robustness of the model's performance. ### Conditions Module Conditions: - Lung Cancer - Gastric Cancer - Liver Cancer - Colorectal Cancer - Pancreatic Cancer - Esophageal Cancer - Breast Cancer - Cervical Cancer - Ovarian Cancer - Endometrial Cancer - Bladder Cancer - Prostate Cancer - Cholangiocarcinoma ### Design Module #### Bio Spec Description: Tissue and blood samples Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: CASE_CONTROL Time Perspective: PROSPECTIVE #### Enrollment Info Count: 5350 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants newly diagnosed with cancer, belonging to one of thirteen distinct cancer types. Label: Case arm #### Arm Group 2 Description: Healthy or benign condition participants with no cancer diagnosis subsequent to routine cancer screening tests. Label: Control arm ### Outcomes Module #### Primary Outcomes Measure: The AUC, sensitivity, specificity and tissue origin accuracy of the multi-cancer early detection model in detecting cancer or non-cancer Time Frame: 12 months #### Secondary Outcomes Measure: The performance of the multi-cancer early detection model in early stage cancer and precancerous lesion cases Time Frame: 12 months Measure: The performance of the multi-cancer early detection model in different subgroups (such as age, gender, cancer pathological classification, and clinical stage) Time Frame: 12 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria for Case Arm Participants: * 40-75 years old * Clinically and/or pathologically diagnosed cancer * No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc. * Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria for Case Arm Participants: * Pregnancy or lactating women * Known prior or current diagnosis of other types of malignancies comorbidities * Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug; * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to screen * Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide * Failure to collect blood on time according to plan * The blood sample does not meet the requirements Inclusion Criteria for Control Arm Participants: * 40-75 years old * Without confirmed cancer diagnosis * Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria for Control Arm Participants: * Pregnancy or lactating women * No previous history of malignancy in other sites * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to screen * Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide * Unsuitable for this trial determined by the researchers Maximum Age: 75 Years Minimum Age: 40 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: A consenting professional will invite participants, including cancer patients and healthy controls, from the main center and affiliated hospitals, to take part in a comprehensive case-control study. ### Contacts Locations Module #### Central Contacts Contact 1: Email: zhixi.su@singlera.com Name: Zhixi Su, PHD Phone: +862180113170 Phone Ext: 1022 Role: CONTACT Contact 2: Email: rliu@singlera.com Name: Rui Liu Phone: +862180113170 Phone Ext: 1027 Role: CONTACT ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014594 - Term: Uterine Neoplasms - ID: D000014591 - Term: Uterine Diseases - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12974 - Name: Ovarian Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16064 - Name: Stomach Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14335 - Name: Prostatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5030 - Name: Urinary Bladder Neoplasms - Relevance: LOW - As Found: Unknown - ID: M20426 - Name: Cholangiocarcinoma - Relevance: HIGH - As Found: Cholangiocarcinoma - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11113 - Name: Liver Neoplasms - Relevance: LOW - As Found: Unknown - ID: M19235 - Name: Endometrial Neoplasms - Relevance: HIGH - As Found: Endometrial Cancer - ID: M17315 - Name: Urogenital Neoplasms - 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: M8943 - Name: Genital Diseases, Female - 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: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T4387 - Name: Pancreatic Cancer - Relevance: HIGH - As Found: Pancreatic Cancer - ID: T4352 - Name: Ovarian Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Esophageal Cancer - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: LOW - As Found: Unknown - ID: T755 - Name: Bile Duct Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016889 - Term: Endometrial Neoplasms - ID: D000018281 - Term: Cholangiocarcinoma ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06440005 Brief Title: A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors Official Title: A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors Including Triple-Negative Breast Cancer and Pancreatic Adenocarcinoma #### Organization Study ID Info ID: AGX101-001 #### Organization Class: INDUSTRY Full Name: Angiex, Inc. ### Status Module #### Completion Date Date: 2027-05 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-30 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-05 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-26 Study First Submit QC Date: 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Angiex, 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: AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously. Dosing of AGX101 will be repeated once every 3 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug. ### Conditions Module Conditions: - Cancer - Advanced Cancer - Locally Advanced Carcinoma - Metastatic Solid Tumor - Triple Negative Breast Cancer - Pancreas Cancer - Pancreatic Adenocarcinoma Keywords: - ADC - Antibody Drug Conjugate - AGX101 ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: SEQUENTIAL Intervention Model Description: A mTPI-2 design (Guo et al, 2017) with a target DLT rate of at most 30% will be applied for dose-escalation and expansion to determine the AGX101 RP2D. ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 80 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses. Intervention Names: - Drug: AGX101 Label: Dose Escalation Phase Type: EXPERIMENTAL #### Arm Group 2 Description: AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type. Intervention Names: - Drug: AGX101 Label: Dose Expansion Phase Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Dose Escalation Phase - Dose Expansion Phase Description: Antibody Drug Conjugate Name: AGX101 Other Names: - ADC Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of AGX101 will be characterized Measure: Acceptable maximum tolerated dose for participants Time Frame: 21 days following the first dose of AGX101 (Day 1 through Day 21) Description: Evaluation of the incidence, severity, and duration of adverse events Measure: Number of participants with adverse events Time Frame: Screening through end of treatment, approximately 6 months and up to 3 years #### Secondary Outcomes Description: Determination of the terminal elimination half-life (t½) Measure: Terminal elimination half life (PK) Time Frame: 22 days following the first dose of AGX101 (Day 1 through Day 22) Description: Determination of the AUC in 1 dosing interval Measure: AUC (PK) Time Frame: 22 days following the first dose of AGX101 (Day 1 through Day 22) Description: Determination of the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state Measure: Cmax (PK) Time Frame: 22 days following the first dose of AGX101 (Day 1 through Day 22) Description: Incidence and titers of ADA will be measured Measure: Number of Participants with Antidrug Antibodies (ADA) to AGX101 Time Frame: Approximately 6 months and up to 3 years Description: Determination the objective response rate (ORR) Measure: Efficacy as measured by Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator Time Frame: Approximately 6 months and up to 3 years Description: Determination of the duration of response (DoR) Measure: Efficacy as measured by Duration of Response (DoR) Assessed by Investigator Time Frame: Approximately 6 months and up to 3 years Description: Determination of the disease control rate (DCR) Measure: Efficacy as measured by Disease Control Rate (DCR) Time Frame: Approximately 6 months and up to 3 years Description: Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS). Measure: Efficacy as measured by Proportion of Participants with Progression Free Survival (PFS) According to RECIST v1.1 Evaluated by the Investigator Time Frame: Approximately 6 months and up to 3 years Measure: Efficacy as measured by Duration of Treatment Time Frame: Approximately 6 months and up to 3 years Measure: Overall Survival Time Frame: Approximately 6 months and up to 3 years ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Histologically confirmed unresectable, locally advanced, or metastatic solid tumors including triple-negative breast cancer (TNBC) and pancreatic ductal adenocarcinoma (PDAC). * Refractory to or relapsed after all standard therapies known to provide proven clinical benefit, unless the patient is not a candidate for standard treatment, there is no standard treatment, or the patient refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit * Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor * Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): Systemic cytotoxic chemotherapy: ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C); Biologic therapy (eg, antibodies): ≥ 3 weeks; Small molecule therapies: ≥ 5 × half-life * Have an ECOG performance status of 0 to 1 * Have adequate organ function * LVEF ≥ 50%, as determined on cardiac ECHO or cardiac multiple-gated acquisition (MUGA) scan * Highly effective contraception for both male and female patients throughout the study Exclusion Criteria: * Colorectal cancer and non-small-cell lung cancer with predominant squamous histology (ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed and approved by Sponsor * Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable and/or asymptomatic CNS metastases allowed) * Have not recovered to ≤ Grade 1 or baseline from all AEs due to previous therapies (patients with ≤ Grade 2 neuropathy, endocrine-related irAEs, or other AEs may be eligible after discussion with the Sponsor) * Has an active vasculitis that has required systemic treatment in the past 2 years prior to starting study treatment * Significant (ie, ≥ Grade 2) ocular disturbances * Variceal bleeding within 6 months prior to treatment, currently untreated or incompletely treated varices with bleeding, or who otherwise are at a high risk of bleeding * Any other concurrent antineoplastic treatment except for allowed local radiation of lesions for palliation (to be considered non-target lesions after treatment) and hormone ablation * Uncontrolled or life-threatening symptomatic concomitant disease, including known symptomatic HIV positive with an AIDS defining opportunistic infection within the last year, known symptomatic active hepatitis B or C, or known active tuberculosis * Has undergone a major surgery within 3 weeks prior to starting study treatment or has inadequate healing or recovery from complications of surgery prior to starting study treatment * Has received prior radiotherapy within 2 weeks prior to starting study treatment * Has or had a potentially life-threatening second malignancy requiring systemic treatment within the last 3 years, or which would impede evaluation of treatment response * Clinically significant cardiovascular disease * Patients on a potent CYP3A inhibitor or CPY3A inducer who cannot be changed to another medication * Has an active infection requiring concurrent systemic antibiotic therapy * A woman of child-bearing potential (WOCBP) who has a positive pregnancy test prior to treatment * Is breastfeeding or expecting to conceive or father children within the projected duration of the study Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: clinical@angiex.com Name: Paul Jaminet, PhD Phone: 617-576-1753 Role: CONTACT #### Locations Location 1: City: Nashville Contacts: *Contact 1:* - Email: becky.beaman@scri.com - Name: Rebecaa Beaman - Role: CONTACT *Contact 2:* - Name: Meredith P Pelster, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Sarah Cannon Research Center State: Tennessee Status: RECRUITING Zip: 37203 Location 2: City: San Antonio Contacts: *Contact 1:* - Email: abetancourt@nextoncology.com - Name: Amanda Betancourt - Role: CONTACT *Contact 2:* - Name: Ismael Rodriguez Rivera, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: NEXT Oncology State: Texas Status: RECRUITING Zip: 78229 #### Overall Officials Official 1: Affiliation: Medical Lead Name: Glen Weiss, MD Role: STUDY_DIRECTOR ## 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 - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: HIGH - As Found: Triple Negative Breast Cancer - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Pancreas Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T4387 - Name: Pancreatic Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000064726 - Term: Triple Negative Breast Neoplasms - ID: D000010190 - Term: Pancreatic Neoplasms ### 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: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439992 Brief Title: Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl Official Title: Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD) #### Organization Study ID Info ID: FSA-PIB AD #### Organization Class: OTHER Full Name: Washington University School of Medicine ### Status Module #### Completion Date Date: 2025-11 Type: ESTIMATED #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-29 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-11 Type: ESTIMATED #### Start Date Date: 2023-11-07 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-04-22 Study First Submit QC Date: 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Washington University School of Medicine #### Responsible Party Investigator Affiliation: Washington University School of Medicine Investigator Full Name: Tammie L. S. Benzinger, MD, PhD Investigator Title: Professor of Radiology and Neurological Surgery Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Oversight Has DMC: True ### Description Module Brief Summary: The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging. Detailed Description: The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan. Second, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18F-Fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. Amyloid is a protein related to dementia of Alzheimer's disease. 11C-PIB PET imaging and MRI of the brain will also be completed in the same participants and the data will be compared with 18F-Fluselenmayl. 11C-PIB and 18F-Fluselenamyl both bind to beta-amyloid plaques. Finally, a comparison of the normal control participants to patients with Alzheimer's disease will be completed. ### Conditions Module Conditions: - Alzheimer Disease ### Design Module #### Bio Spec Description: Whole blood for future use Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: CASE_CONTROL Time Perspective: PROSPECTIVE #### Enrollment Info Count: 60 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Healthy participants with normal cognition will be recruited and receive the following interventions: Drug: \[18F\]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET-certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush. Drug: \[11C\]-Pittsburgh Compound (\[11C\]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET-certified professional will prepare and administer the \[11C\]-PIB tracer. Participants will receive the PIB injection followed by a 10 ml 0.9% sodium chloride (normal saline) flush. Intervention Names: - Drug: 18F-Fluselenamyl Label: Healthy participants #### Arm Group 2 Description: Participants with mild cognitive impairment will be recruited and receive the following interventions: Drug: \[18F\]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET-certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush. Drug: \[11C\]-Pittsburgh Compound (\[11C\]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET-certified professional will prepare and administer the \[11C\]-PIB tracer. Participants will receive the PIB injection followed by a 10 ml 0.9% sodium chloride (normal saline) flush. Intervention Names: - Drug: 18F-Fluselenamyl Label: Participants with mild cognitive impairment ### Interventions #### Intervention 1 Arm Group Labels: - Healthy participants - Participants with mild cognitive impairment Description: Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer 18F-Fluselenamyl and will undergo an 18F-Fluselenamyl PET/CT scan of the head and neck. Name: 18F-Fluselenamyl Other Names: - 18F-FSA Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 8 healthy volunteers (4 males and 4 females) for up to a maximum of 4.5 hours immediately following intravenous (IV) injection of 10 mCi ± 20% of \[18F\]-Fluselenamyl (dosage range calculated from rodent dosimetry data extrapolated to humans). The primary outcome measure is to quantify each organ's radiation exposure (rad/mCi). Measure: To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers. Time Frame: Through study completion, an average of 1 year Description: To assess the sensitivity of \[18F\]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct a comparative analysis of PET imaging data using \[11C\]-PIB imaging in the same participants. Measure: PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment. Time Frame: Through study completion, an average of 2 years ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Male or Female, any race * Age ≥ 18 years * Healthy volunteers or volunteers with Alzheimer's disease Exclusion Criteria: * Has hypersensitivity to 18F-Fluselenamyl or any of its excipients ; * Has hypersensitivity to 11C-PIB or any of its excipients ; * Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ; * Unwilling or unable to undergo PET scans tracer injections ; * Unwilling or unable to undergo MRI (Aim 2 and Aim 3) * Any condition that, in the Investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer); * Women who are currently pregnant or breast-feeding; * Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. Healthy Volunteers: True Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Aim 1: Dosimetry group - 8 healthy adult normal volunteers (4 M, and 4 F) will undergo whole-body PET/CT imaging to assess the safety, dosimetry, and metabolism of 18F-FSA. Aim 2: Proof of Concept group - 36 participants (18 healthy and 18 participants with mild cognitive impairment) will undergo 18F-FSA imaging of the brain and neck, 11C-PIB imaging of the brain and neck, MRI, and Cognitive testing. Aim 3: Performance group- Aim 2 participants will be invited for additional imaging. Aim 3A- 10 participants from Aim 2 will undergo repeat 18F-FSA imaging \~ 1 month after baseline imaging Aim 3B- 18 participants from Aim 2 will have a longitudinal follow-up visit \~ 18 months after the initial study. They will undergo repeat 18F-FSA, 11C-PIB, MRI, and Cognitive testing. ### Contacts Locations Module #### Central Contacts Contact 1: Email: jayashree.r@wustl.edu Name: Jayashree Rajamanickam Phone: 314 273 6140 Role: CONTACT Contact 2: Email: kelleyj@wustl.edu Name: Kelley Jackson Role: CONTACT #### Locations Location 1: City: Saint Louis Contacts: *Contact 1:* - Email: jayashree.r@wustl.edu - Name: Jayashree Rajamanickam - Phone: 314-273-6140 - Role: CONTACT *Contact 2:* - Email: kelleyj@wustl.edu - Name: Kelley Jackson - Phone: 314 362 3613 - Role: CONTACT Country: United States Facility: Washington University School of Medicine State: Missouri Status: RECRUITING Zip: 63110 #### Overall Officials Official 1: Affiliation: Washington University School of Medicine Name: Tammie Benzinger, MD., PhD Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003704 - Term: Dementia - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000024801 - Term: Tauopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3885 - Name: Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease - ID: M4021 - Name: Amyloidosis - Relevance: LOW - As Found: Unknown - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M23002 - Name: Tauopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease ### Condition Browse Module - Meshes - ID: D000000544 - Term: Alzheimer Disease ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439979 Acronym: RAYS Brief Title: Rural Adult and Youth Sun Protection Study Official Title: Rural Adult and Youth Sun Protection Study - Rural Baseball R01 #### Organization Study ID Info ID: 00173007 #### Organization Class: OTHER Full Name: University of Utah ### Status Module #### Completion Date Date: 2030-04 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-29 Overall Status: RECRUITING #### Primary Completion Date Date: 2029-08 Type: ESTIMATED #### Start Date Date: 2024-04-08 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-13 Study First Submit QC Date: 2024-05-29 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Georgetown University Class: OTHER Name: West Virginia University #### Lead Sponsor Class: OTHER Name: University of Utah #### Responsible Party Investigator Affiliation: University of Utah Investigator Full Name: Yelena Wu Investigator Title: Associate Professor, Department of Dermatology; Investigator Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: The purpose of this study is to help prevent skin cancer by improving the use of sun protective behaviors among youths living in rural communities in Utah and West Virginia. Detailed Description: Children living in rural and under-served communities are at high risk for skin cancer; however, there are no evidence-based sun safety interventions showing durable effects for this vulnerable pediatric population. The objective of this proposal is to rigorously test a novel, multi-level approach to skin cancer prevention among young rural children that is delivered through developmental baseball leagues. To attain this objective, the investigators will conduct a two-arm cluster-randomized trial with the primary outcome being multi-behavior sun protection change among children. ### Conditions Module Conditions: - Melanoma (Skin) - Skin Cancer Keywords: - Rural - Melanoma, Skin cancer - Prevention - Underserved communities - Youth - Sports ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: RAYS uses a 2-arm cluster-randomized trial in 2 rural US states (Utah and West Virginia) matched for high skin cancer burden and rurality. This parallel model includes an intervention arm, which will include sun-safety education and skin cancer prevention, and the control arm which will focus on general sports-related injury prevention. Leagues enrolled in the study will be randomized to one of the two arms. ##### Masking Info Masking: SINGLE Masking Description: Masking will only be used for participants in the study. Investigators will know which arm of the study each participant has been randomized to. Who Masked: - PARTICIPANT Primary Purpose: PREVENTION #### Enrollment Info Count: 843 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: The RAYS arm is the intervention being tested, which will include skin cancer prevention education and providing participants with sun-safety supplies. Intervention Names: - Behavioral: RAYS Intervention Label: RAYS Intervention Type: EXPERIMENTAL #### Arm Group 2 Description: The Control arm of the study will not receive any skin cancer prevention information or sun-safety materials but will only receive general injury prevention information. Label: Control Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - RAYS Intervention Description: Developmental baseball leagues will be randomly assigned to RAYS vs. control. Outcomes include directly-observed child sun safety behaviors after controlling for environmental ultra-violet radiation (UVR), with parent-reported child sun protection and other related endpoints at 1 year. Name: RAYS Intervention Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who applied sunscreen at any time during the practice or game. This tallied number will create a percentage of the team that applied sunscreen. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention. "How many wearing sunscreen?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior. Measure: Directly observed child sunscreen application Time Frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered) Description: Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who wore a hat at any time during the practice or game. This tallied number will create a percentage of the team that wore a hat. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention. "How many wore a hat?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior. Measure: Directly observed child hat wearing Time Frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered) Description: Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who wore a long-sleeved shirt at any time during the practice or game. This tallied number will create a percentage of the team that wore protective long-sleeved shirts. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention. "How many wore long sleeves?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior. Measure: Directly observed child wearing long sleeves Time Frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered) Description: Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who spent time in shade or under an umbrella at any time during the practice or game. This tallied number will create a percentage of the team that spent time in shade/under umbrella. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention. "How many in shade/under umbrella?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior. Measure: Directly observed child shade seeking Time Frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered) #### Secondary Outcomes Description: A random sample of parents will report on their child's use of sun protection using the Sun Habits Survey, a well-established and valid measure. These same parents will be asked to complete questionnaires at baseline, end-of-season, and at 1 year follow-up. "On a warm and sunny day, how often did your child...Use sunscreen with a sun protective factor (SPF) of 30+?" All parent-reported items will be assessed on a 5-point Likert-type scale ("Never" to "Always"). Measure: Parent-reported child sun protection behaviors Time Frame: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline Description: Parents will report on the number of sunburns their child experienced during baseball and not during baseball at baseline, post-intervention and one-year post-baseline. Parents will report on child behaviors using items from the Sun Habits Survey. "How many times did your child have a red OR painful sunburn that lasted a day or more? In the past month? In the past 12 months?" Minimum value = 0, maximum value = 5 or more. A low number indicates a better outcome. Measure: Parent-report child sunburn Time Frame: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline ### Eligibility Module Eligibility Criteria: Parent inclusion criteria: i. Adults who currently have children ages 3 and older years of age playing on participating sports teams in leagues serving rural areas in Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems) ii. Live and/or work in rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems) Coach/leader inclusion criteria: i. Adults who serve as coaches or leaders of recreational sports (i.e. baseball/softball, soccer, flag football, etc.) teams or developmental programs serving children ages 3 and older ii. Live and/or work in rural areas of Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems) Participant inclusion criteria for minor participants (ages 3 and older) are as follows: i. Live in rural communities and/or participate in sports leagues serving rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems). Participant inclusion criteria for key informant interviews are as follows: i. Adults who serve as leaders or who are affiliated with sports leagues or community groups serving rural youths and/or adults who currently have minor children 3 years of age or older playing on participating sports teams and/or adults who live and/or work in rural communities in Utah or West Virginia ((≥4 as defined by the RUCA or RUCC systems) Local sports leagues will be eligible to participate if they convene recreational sports (i.e. baseball/softball) teams or developmental programs (i.e. T-ball and coach pitch) for children ages 3 and older. Exclusion Criteria: * Adults and children who do not speak or read English will be excluded. * For individuals asked to complete surveys, individuals who have a medical or other condition (e.g., developmental delay) that would preclude their completion of these surveys will be excluded. Healthy Volunteers: True Maximum Age: 7 Years Minimum Age: 3 Years Sex: ALL Standard Ages: - CHILD ### Contacts Locations Module #### Central Contacts Contact 1: Email: yelena.wu@utah.edu Name: Yelena P Wu, PhD Phone: 8015850303 Role: CONTACT Contact 2: Email: kate.welch@hci.utah.edu Name: Kate M Welch, BS Phone: 8015850303 Role: CONTACT #### Locations Location 1: City: Salt Lake City Contacts: *Contact 1:* - Email: yelena.wu@utah.edu - Name: Yelena P Wu, PhD - Phone: 801-585-0303 - Role: CONTACT *Contact 2:* - Email: kate.welch@hci.utah.edu - Name: Kate M Welch, BS - Phone: 8015850303 - Role: CONTACT *Contact 3:* - Name: Yelena P Wu, PhD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: University of Utah State: Utah Status: RECRUITING Zip: 84132 Location 2: City: Morgantown Contacts: *Contact 1:* - Email: dboatman@hsc.wvu.edu - Name: Dannell Boatman, MS - Phone: 304-293-8409 - Role: CONTACT *Contact 2:* - Email: rays-wv@hsc.wvu.edu - Name: Zack Jarrett, MS - Phone: 304-293-8409 - Role: CONTACT *Contact 3:* - Name: Dannell Boatman, MS - Role: PRINCIPAL_INVESTIGATOR *Contact 4:* - Name: Zack Jarrett, MS - Role: SUB_INVESTIGATOR Country: United States Facility: West Virginia University State: West Virginia Status: NOT_YET_RECRUITING Zip: 26501 #### Overall Officials Official 1: Affiliation: University of Utah Name: Yelena P Wu, PhD Role: PRINCIPAL_INVESTIGATOR ### 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: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018326 - Term: Nevi and Melanomas - 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: M15681 - Name: Skin Neoplasms - Relevance: HIGH - As Found: Skin Cancer - 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: 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: D000008545 - Term: Melanoma - ID: D000012878 - Term: Skin Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439966 Brief Title: Expanded Access to ABBV-787 Official Title: Expanded Access to ABBV-787 #### Organization Study ID Info ID: C25-244 #### Organization Class: INDUSTRY Full Name: AbbVie ### Status Module #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: AVAILABLE Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: AbbVie #### Responsible Party Type: SPONSOR ### Description Module Brief Summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-787 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. ### Conditions Module Conditions: - Acute Myeloid Leukemia Keywords: - Expanded Access - Pre-approval Access - Compassionate Use - Special Access Program - Named Patient Basis - Special Access Scheme ### Design Module #### Expanded Access Types Individual: True Study Type: EXPANDED_ACCESS ### Arms Interventions Module ### Interventions #### Intervention 1 Description: Intravenous (IV) Infusion Name: ABBV-787 Type: DRUG ### Eligibility Module Eligibility Criteria: Inclusion Criteria: - The participant must not be eligible for an ABBV-787 clinical trial. Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: abbvieclinicaltrials@abbvie.com Name: ABBVIE CALL CENTER Phone: 844-663-3742 Role: CONTACT #### Overall Officials Official 1: Affiliation: AbbVie Name: ABBVIE INC. Role: STUDY_DIRECTOR ### References Module #### See Also Links Label: Related Info URL: https://www.abbvieclinicaltrials.com/study/?id=C25-244 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: LOW - As Found: Unknown - ID: M10955 - Name: Leukemia, Myeloid - Relevance: LOW - As Found: Unknown - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439953 Brief Title: Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation Official Title: Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation #### Organization Study ID Info ID: Irrimax Trial #### Organization Class: OTHER Full Name: Lifespan ### Status Module #### Completion Date Date: 2026-05 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-05 Type: ACTUAL Last Update Submit Date: 2024-06-03 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-05 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Jared Fridley #### Responsible Party Investigator Affiliation: Lifespan Investigator Full Name: Jared Fridley Investigator Title: Neurosurgeon, Associate Professor Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: False Oversight Has DMC: False ### Description Module Brief Summary: Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. When used as a powder, topical application of vancomycin has demonstrated increased risk of symptomatic seroma formation, which is an adverse outcome that often requires bedside or intra-operative aspiration. Broad-spectrum antiseptic agents, such as Irrisept, offer bacteriocidal properties to eliminate hardware inoculation, thereby minimizing the risk of deep space infection, while obviating the risk of seroma development. Detailed Description: Spinal instrumentation remains the standard of care in the treatment of various traumatic, oncologic, and degenerative spinal pathologies, often requiring the implantation of hardware to stabilize the bony column. In the setting of an aging patient population and expanding indications for instrumentation in younger patients, the number of spinal operations performed has risen substantially within the past decade. Although these procedures have proven to enhance patient quality of life, spinal instrumentation is not without post-operative complication, most notable of which are surgical site infection, seroma formation, and wound breakdown. Such complications can result in notable negative sequelae. Recurrent seroma may compress underlying neurologic structures or increase pressure along the incision, thereby precipitating wound dehiscence and inoculation of the surgical site with pathogenic organisms. Deep space infections often result in prolonged hospitalization, long-term suppressive antibiotic therapy, hardware removal, and permanent disability, which increases cost burden at the patient and hospital level. As such, preventative strategies to reduce the rate of complications following spinal instrumentation remain paramount. Within recent years, attention has turned to various irrigation methods to terminally sterilize prosthetic devices and wound beds, thereby minimizing bacterial colonization and biofilm formation that would otherwise predispose infection. Irrisept (Irrimax Corporation, Gainesville, Florida) is a solution comprised of 0.05% chlorhexidine gluconate in 99.95% sterile water administered through a proprietary, low-pressure lavage mechanism that has demonstrated efficacy as a bacteriocidal agent in orthopedic hip and knee arthroplasty procedures. Whereas other antiseptic irrigation solutions, such as vancomycin-saline lavage, are routinely used to prevent surgical site infection, relative inertness against gram negative organisms and potential predisposition toward seroma formation render them non-ideal for use in spine surgery. Despite the utility of dilute chlorhexidine gluconate as a prophylactic irrigant, there exist gaps in knowledge with regard to the efficacy of Irrisept to prevent post-operative complications following spinal instrumentation. The central hypothesis of this proposal is that prophylactic use of Irrisept irrigation will result in fewer surgical site infections, clinically significant seromas, and gram negative or atypical infections when compared to standard of care irrigation (vancomycin-saline solution with or without topical vancomycin powder). Proposed is a prospective, randomized controlled trial comparing rates of post-operative complications following use of Irrisept irrigation alone versus vancomycin-saline lavage with or without topical vancomycin powder (standard of care) in patients aged 18 years or older who undergo posterior cervical, thoracic, lumbar, and/or sacral spinal instrumentation for various indications (deformity, malignancy, degenerative pathology, and trauma) at Rhode Island Hospital. ### Conditions Module Conditions: - Post-Op Complication - Spine Surgery - Site Infection - Surgical Site Infection - Spinal Instrumentation - Index Spinal Instrumentation - Layer-by-Layer Closure - Locoregional Flap-Based Closure ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: PREVENTION #### Enrollment Info Count: 200 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation. Intervention Names: - Device: Chlorhexidine gluconate solution Label: Irrisept Irrigation Type: EXPERIMENTAL #### Arm Group 2 Description: Patients scheduled to undergo spinal instrumentation will receive intra-operative irrigation using vancomycin-saline irrigation. Intervention Names: - Drug: Vancomycin Label: Vancomycin-saline Irrigation Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Irrisept Irrigation Description: Evaluating the prophylactic use of Irrisept irrigation alone Name: Chlorhexidine gluconate solution Other Names: - Irrisept irrigation Type: DEVICE #### Intervention 2 Arm Group Labels: - Vancomycin-saline Irrigation Description: Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin Name: Vancomycin Other Names: - Vancomycin-saline Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Development of infection after index spinal instrumentation Measure: Occurrence of surgical site infection Time Frame: 90 days post-operatively #### Secondary Outcomes Description: Capture mortality rates after index spinal instrumentation Measure: Mortality Time Frame: 12 months post-operatively Description: Capture duration of index hospitalization after index spinal instrumentation Measure: Duration of index hospitalization Time Frame: 12 months post-operatively Description: Capture 30-day readmission rates after index spinal instrumentation Measure: Occurrence of 30-day readmission Time Frame: 30 days post-operatively Description: Capture all incidences of wound dehiscence after index spinal instrumentation Measure: Occurrence of wound dehiscence Time Frame: 12 months post-operatively Description: Capture the time interval to closed suction drain removal after index spinal instrumentation Measure: Time to closed suction drain removal Time Frame: 12 months post-operatively Description: Capture the presence of atypical micro-organisms after index spinal instrumentation Measure: Presence of atypical micro-organisms on wound fluid laboratory culture Time Frame: 12 months post-operatively Description: Consider associated total costs of spinal instrumentation after index spinal instrumentation by comparing total surgical costs and post-surgical outcome expenses of those with and without Irrisept irrigation use Measure: Cost of spine surgery care from surgery to 12-month post-operative follow up Time Frame: 12 months post-operatively ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Age: 18+ years old * Indications: deformity, oncologic, degenerative, trauma * Standard layer-by-layer closure * Locoregional flap-based closure Exclusion Criteria: * Acute/chronic open wounds (spine or non-spine) * On-going non-spinal infection within 30 days of index operation * Concurrent antibiotic use (for spine or non-spine infections) * History of prior spinal infection * Allergy to vancomycin or chlorhexidine * Suspicion for osteomyelitis * Other surgery within 90 days post-operatively fromm index * Concurrent enrollment in other trial Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: AChernysh@lifespan.org Name: Alexander Chernysh Phone: 401-444-9868 Role: CONTACT Contact 2: Email: owen.leary@lifespan.org Name: Owen Leary Phone: 401-6068388 Role: CONTACT #### Locations Location 1: City: Providence Contacts: *Contact 1:* - Email: AChernysh@Lifespan.org - Name: Alexander Chernysh - Phone: 401-444-9868 - Role: CONTACT *Contact 2:* - Name: Jared S. Fridley, MD - Role: PRINCIPAL_INVESTIGATOR *Contact 3:* - Name: Albert S. Woo, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Rhode Island Hospital State: Rhode Island Zip: 02903 #### Overall Officials Official 1: Affiliation: Rhode Island Hospital Name: Jared S. Fridley, MD Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: Rhode Island Hospital Name: Albert S. Woo, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ### References Module #### References Citation: Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338. PMID: 20371784 Citation: Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. 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PMID: 19398246 Citation: Torres KA, Konrade E, White J, Tavares Junior MCM, Bunch JT, Burton D, Jackson RS, Birlingmair J, Carlson BB. Irrigation techniques used in spine surgery for surgical site infection prophylaxis: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2022 Aug 26;23(1):813. doi: 10.1186/s12891-022-05763-2. PMID: 36008858 Citation: Yao R, Tan T, Tee JW, Street J. Prophylaxis of surgical site infection in adult spine surgery: A systematic review. J Clin Neurosci. 2018 Jun;52:5-25. doi: 10.1016/j.jocn.2018.03.023. Epub 2018 Mar 30. PMID: 29609860 Citation: Kapadia BH, Zhou PL, Jauregui JJ, Mont MA. Does Preadmission Cutaneous Chlorhexidine Preparation Reduce Surgical Site Infections After Total Knee Arthroplasty? Clin Orthop Relat Res. 2016 Jul;474(7):1592-8. doi: 10.1007/s11999-016-4767-6. PMID: 26956247 Citation: Johnson AJ, Kapadia BH, Daley JA, Molina CB, Mont MA. Chlorhexidine reduces infections in knee arthroplasty. J Knee Surg. 2013 Jun;26(3):213-8. doi: 10.1055/s-0032-1329232. Epub 2012 Nov 12. PMID: 23288739 Citation: Lung BE, Le R, Callan K, McLellan M, Issagholian L, Yi J, McMaster WC, Yang S, So DH. Chlorhexidine gluconate lavage during total joint arthroplasty may improve wound healing compared to dilute betadine. J Exp Orthop. 2022 Jul 10;9(1):67. doi: 10.1186/s40634-022-00503-w. PMID: 35819733 Citation: Ghobrial GM, Cadotte DW, Williams K Jr, Fehlings MG, Harrop JS. Complications from the use of intrawound vancomycin in lumbar spinal surgery: a systematic review. Neurosurg Focus. 2015 Oct;39(4):E11. doi: 10.3171/2015.7.FOCUS15258. PMID: 26424335 Citation: Youssef JA, Orndorff DG, Scott MA, Ebner RE, Knewitz AP. Sterile Seroma Resulting from Multilevel XLIF Procedure as Possible Adverse Effect of Prophylactic Vancomycin Powder: A Case Report. Evid Based Spine Care J. 2014 Oct;5(2):127-33. doi: 10.1055/s-0034-1386754. PMID: 25364326 Citation: Mallet C, Meissburger V, Caseris M, Happiette A, Chinnappa J, Bonacorsi S, Simon AL, Ilharreborde B. Does the use of intrawound povidone-iodine irrigation and local vancomycin powder impact surgical site infection rate in adolescent idiopathic scoliosis surgery? Eur Spine J. 2022 Nov;31(11):3020-3028. doi: 10.1007/s00586-022-07340-6. Epub 2022 Aug 1. PMID: 35913622 Citation: Schroeder JE, Girardi FP, Sandhu H, Weinstein J, Cammisa FP, Sama A. The use of local vancomycin powder in degenerative spine surgery. Eur Spine J. 2016 Apr;25(4):1029-33. doi: 10.1007/s00586-015-4119-3. Epub 2015 Aug 7. PMID: 26249032 Citation: Lemans JVC, Oner FC, Wijdicks SPJ, Ekkelenkamp MB, Vogely HC, Kruyt MC. The efficacy of intrawound vancomycin powder and povidone-iodine irrigation to prevent surgical site infections in complex instrumented spine surgery. Spine J. 2019 Oct;19(10):1648-1656. doi: 10.1016/j.spinee.2019.05.592. Epub 2019 May 31. PMID: 31158503 Citation: Cohen LE, Fullerton N, Mundy LR, Weinstein AL, Fu KM, Ketner JJ, Hartl R, Spector JA. Optimizing Successful Outcomes in Complex Spine Reconstruction Using Local Muscle Flaps. Plast Reconstr Surg. 2016 Jan;137(1):295-301. doi: 10.1097/PRS.0000000000001875. PMID: 26710033 Citation: Rinkinen JR, Weitzman RE, Clain JB, Lans J, Shin JH, Eberlin KR. Locoregional Flap Closure for High-risk Multilevel Spine Surgery. Plast Reconstr Surg Glob Open. 2020 Apr 21;8(4):e2751. doi: 10.1097/GOX.0000000000002751. eCollection 2020 Apr. PMID: 32440420 Citation: Hochberg J, Ardenghy M, Yuen J, Gonzalez-Cruz R, Miura Y, Conrado RM, Pait TG. Muscle and musculocutaneous flap coverage of exposed spinal fusion devices. Plast Reconstr Surg. 1998 Aug;102(2):385-9; discussion 390-2. doi: 10.1097/00006534-199808000-00013. PMID: 9703074 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000014946 - Term: Wound Infection ### 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: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M16310 - Name: Surgical Wound Infection - Relevance: HIGH - As Found: Surgical Site Infection - ID: M14065 - Name: Postoperative Complications - Relevance: HIGH - As Found: Post-Op Complication - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M1112 - Name: Surgical Wound - Relevance: LOW - As Found: Unknown - ID: M17684 - Name: Wound Infection - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000013530 - Term: Surgical Wound Infection - ID: D000011183 - Term: Postoperative Complications ### Intervention Browse Module - Ancestors - ID: D000000891 - Term: Anti-Infective Agents, Local - ID: D000000890 - Term: Anti-Infective Agents - ID: D000004202 - Term: Disinfectants - ID: D000003879 - Term: Dermatologic Agents - ID: D000000900 - Term: Anti-Bacterial Agents ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M5953 - Name: Chlorhexidine - Relevance: HIGH - As Found: tDCS - ID: M344731 - Name: Chlorhexidine gluconate - Relevance: HIGH - As Found: Fascia - ID: M17388 - Name: Vancomycin - Relevance: HIGH - As Found: Pattern - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4215 - Name: Anti-Infective Agents, Local - Relevance: LOW - As Found: Unknown - ID: M7383 - Name: Disinfectants - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002710 - Term: Chlorhexidine - ID: C000010882 - Term: Chlorhexidine gluconate - ID: D000014640 - Term: Vancomycin ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439940 Brief Title: Pilot Test for an Early Diagnosis Kit for Breast Cancer Based on Liquid Biopsies Official Title: Pilot Test for an Early Diagnosis Kit for Breast Cancer Based on Liquid Biopsies #### Organization Study ID Info ID: 459 EMnP0S0 / 21 #### Organization Class: INDUSTRY Full Name: Oncoliq US Inc ### Status Module #### Completion Date Date: 2025-03-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-12-31 Type: ESTIMATED #### Start Date Date: 2021-07-14 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Oncoliq US 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: Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test aims to improve the accuracy of cancer detection, thereby reducing patient mortality and healthcare costs. To develop this test, the discovery and validation phases have been completed. In addition, Machine learning and AI were used to determine the algorithm for breast cancer detection. The overall objective of this protocol is to implement a pilot test to enroll 1,000 women without a previous cancer diagnosis who are attending their annual medical check-up. To achieve this, we will develop the following specific objectives: Enroll women over age 35 who attend the gynecological annual check-up. Test the plasma of the enrolled volunteers for specific miRNA biomarkers using RT-qPCR. Perform an analysis based on artificial intelligence techniques in collaboration with IMAGO Systems (USA) on mammogram images. Compare the results obtained from the clinical check-up (BiRad from mammogram), IMAGO Systems and RT-qPCR (Oncoliq breast test). Conduct a 5-year follow-up on volunteers with pathological results from Oncoliq breast test. Participants who meet the inclusion and exclusion criteria and agree to take part in the protocol will be required to sign both pages of the Informed Consent Form and complete the Annex and Survey. Subsequently, a small blood sample of 3-5 mL will be drawn via venipuncture. ### Conditions Module Conditions: - Breast Cancer Female - Breast Cancer - Breast Carcinoma Keywords: - early diagnosis - early detection - cancer - breast cancer - miRNAs - liquid biopsies - pilot study - pilot test - liquid biopsy - Oncoliq - machine learning - AI - RT-qPCR ### Design Module #### Bio Spec Description: Plasma samples Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 364 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Diagnostic Test: Blood sample extraction Label: Women aged 50 to 70 who attend the gynecological annual check-up ### Interventions #### Intervention 1 Arm Group Labels: - Women aged 50 to 70 who attend the gynecological annual check-up Description: We do not alter the patient\'s regular gynecological check-up in any way. The patient will undergo a mammogram and a blood draw. We will then separate a small aliquot of blood for the purposes of the research protocol. Name: Blood sample extraction Type: DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes Measure: BIRADS mammography Time Frame: From July 14 2021 to December 31 2024 #### Secondary Outcomes Measure: miRNAs detection with RT-qPCR Time Frame: From March 2023 to December 2024 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients over 35 years old who visit the gynecological clinic for their annual mammographic check-up Exclusion Criteria: * Personal history of cancer Healthy Volunteers: True Minimum Age: 35 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT Study Population: This protocol includes female volunteers over 35 years old with no personal history of oncological disease who visit the gynecology unit at \&#34;Hospital Posadas\&#34; for a gynecological and mammographic check-up. ### Contacts Locations Module #### Central Contacts Contact 1: Email: drstigliano@yahoo.com.ar Name: Javier Stigliano, MD specialist in mastology Phone: +54 9 11 5952-7959 Role: CONTACT #### Locations Location 1: City: El Palomar, Morón Contacts: *Contact 1:* - Email: drstigliano@yahoo.com.ar - Name: Javier Stigliano, MD specialist in mastology - Phone: +549 11 5952 7959 - Role: CONTACT *Contact 2:* - Name: Javier Stigliano, MD specialist in mastology - Role: PRINCIPAL_INVESTIGATOR Country: Argentina Facility: Hospital Nacional Profesor Alejandro Posadas State: Buenos Aires Status: RECRUITING Zip: B1684 ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## 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: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - 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 ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439927 Brief Title: New Method to Close Nasal Septal Perforation Official Title: Nasal Septal Perforation Closure Using a 3-dimensional Fabricated Polycaprolactone Nasal Mesh #### Organization Study ID Info ID: self sponsored #### Organization Class: OTHER Full Name: Helwan University ### Status Module #### Completion Date Date: 2025-05 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-06-01 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-02 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Helwan University #### Responsible Party Investigator Affiliation: Helwan University Investigator Full Name: Mohamed Hossam Sebaey Investigator Title: Assistant lecturer of otorhinolaryngology 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 investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. Endoscopic examination for septal mucosa status will be done monthly for a three months follow up period. ### Conditions Module Conditions: - Nasal Perforated Septum Keywords: - nasal septal perforation ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 23 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Device: Polycaprolactone nasal mesh Label: Polycaprolactone nasal mesh Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Polycaprolactone nasal mesh Description: a 3-dimensional fabricated Polycaprolactone nasal mesh Name: Polycaprolactone nasal mesh Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Endoscopic evaluation of nasal septal mucosa status will be classified as complete bilateral healing, complete unilateral healing, no healing, and perforation. Measure: Mean Change in Post-operative healing of septal perforation Time Frame: for a three months follow up period #### Secondary Outcomes Description: The following complications will be evaluated on a present/absent basis:hematoma-infection-allergy Measure: Postoperative complications Time Frame: for a three months follow up period ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients undergoing nasal septal perforation repair surgery. Exclusion Criteria: * Patients with known allergy to polycaprolactone. * Pregnancy or lactation. Maximum Age: 58 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: mohamed.h757@hotmail.com Name: Mohamed H Sebaey, Master degree Phone: 01008306356 Role: CONTACT #### Locations Location 1: City: Cairo Contacts: *Contact 1:* - Email: mohamed.h757@hotmail.com - Name: Mohamed H Sebaey, master degree - Phone: 01008306356 - Role: CONTACT Country: Egypt Facility: Faculty of Medicine, Helwan University #### Overall Officials Official 1: Affiliation: Helwan University Name: Mohamed H Sebaey, master degree Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M29804 - Name: Nasal Septal Perforation - Relevance: HIGH - As Found: Nasal Septal Perforation - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000061270 - Term: Nasal Septal Perforation ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439914 Brief Title: First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy Official Title: IFN-y PET Imaging: Bench to Bedside #### Organization Study ID Info ID: 2023-092 #### Organization Class: OTHER Full Name: Barbara Ann Karmanos Cancer Institute ### Status Module #### Completion Date Date: 2027-06 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 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: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Nerissa T. Viola #### Responsible Party Investigator Affiliation: Barbara Ann Karmanos Cancer Institute Investigator Full Name: Nerissa T. Viola Investigator Title: Principle Investigator Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Is US Export: False ### Description Module Brief Summary: The goal of this clinical trial is to investigate the use of \[89Zr\]Zr-DFO-emapalumab as an IFN-γ PET imaging agent to detect lesions and response to therapy among treatment-naïve non-small cell lung cancer (NSCLC) patients. PET scans following the imaging agent will be completed prior to and about 30 days after starting immunotherapy. Detailed Description: Participants will be enrolled into the clinical trial once confirmed eligible. Screening activities include, standard of care blood work, medical history and a physical exam. -Within 14 days of starting immunotherapy, participants will complete PET scans 1-2 hours post-tracer administration, again on the day following tracer administration, and 3-5 days after the tracer administration. This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans. ### Conditions Module Conditions: - Non Small Cell Lung Cancer ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: DIAGNOSTIC #### Enrollment Info Count: 6 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Radiotracer \[89Zr\]Zr-DFO-emapalumab injection Intervention Names: - Drug: [89Zr]Zr-DFO-emapalumab Label: [89Zr]Zr-DFO-emapalumab Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - [89Zr]Zr-DFO-emapalumab Description: Radiotracer \[89Zr\]Zr-DFO-emapalumab administration followed by 3 PET Scans (day 0, day 1 and day 3-5) within 14 days of starting immunotherapy and repeated once 25-45 days after immunotherapy started Name: [89Zr]Zr-DFO-emapalumab Other Names: - Zirconium Zr 89-DFO-emapalumab Type: DRUG ### Outcomes Module #### Other Outcomes Description: Descriptively summarize the percent change from baseline to post-immunotherapy by PET response Measure: change of SUVpeak by PET response Time Frame: Up to Day 45 Description: Descriptively summarize the percent change from baseline to post-immunotherapy by PET response Measure: change of SUVmean by PET response Time Frame: Up to Day 45 Description: Descriptively summarize the percent change from baseline to post-immunotherapy by PET response Measure: change of SUVmax by PET response Time Frame: Up to Day 45 #### Primary Outcomes Description: Descriptively summarize at baseline and post-immunotherapy treatments. Measure: peak Standard Uptake Value (SUVpeak) Time Frame: Up to Day 45 Description: Descriptively summarize at baseline and post-immunotherapy treatments. Measure: mean Standard Uptake Value (SUVmean) Time Frame: Up to Day 45 Description: Descriptively summarize at baseline and post-immunotherapy treatments. Measure: maximum Standard Uptake Value (SUVmax) Time Frame: Up to Day 45 #### Secondary Outcomes Description: Descriptively summarize the percent change from baseline to post-immunotherapy treatments. Measure: change of SUVpeak Time Frame: Up to Day 45 Description: Descriptively summarize the percent change from baseline to post-immunotherapy treatments. Measure: change of SUVmean Time Frame: Up to Day 45 Description: Descriptively summarize the percent change from baseline to post-immunotherapy treatments. Measure: change of SUVmax Time Frame: Up to Day 45 ### Eligibility Module Eligibility Criteria: Inclusion * Prior histologic or cytologic diagnosis of non-small cell lung cancer. * FDG PET done within 2 months of the baseline imaging, as part of standard-of-care. * measurable disease by RECIST 1.1 with at least one lesion of at least 2 cm in a region of the body that can be imaged by PET (e.g.,outside of the liver) * must be able to lie still for the tests. Their girth and weight must be suitable to enter the gantry, which varies per tomograph. * must be \>18 years old. * Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center. * Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST, and ALT) must be done within 28 days prior to PET imaging Exclusion * No prior immunotherapy for current stage of NSCLC (Non Small Cell Lung Cancer). Immunotherapy in neoadjuvant or adjuvant setting and have recurrence at least 12 months following completion of immunotherapy are eligible after discussion with the principle investigator. * Pregnant or breast feeding individuals. Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: violan@karmanos.org Name: Nerissa T Viola, PhD Phone: 3135768309 Role: CONTACT #### Locations Location 1: City: Detroit Contacts: *Contact 1:* - Email: violan@karmanos.org - Name: Nerissa T Viola, PhD - Phone: 313-576-8309 - Role: CONTACT *Contact 2:* - Name: Nerissa T Viola, PhD - Role: PRINCIPAL_INVESTIGATOR *Contact 3:* - Name: Anthony F Shields, MD, PhD - Role: SUB_INVESTIGATOR *Contact 4:* - Name: Hirva Mamdani, M.D. - Role: SUB_INVESTIGATOR *Contact 5:* - Name: Dipesh Uprety, M.D. - Role: SUB_INVESTIGATOR *Contact 6:* - Name: Ammar Sukari, M.D. - Role: SUB_INVESTIGATOR *Contact 7:* - Name: Tarik Hadid, MD, MPH, MS - Role: SUB_INVESTIGATOR *Contact 8:* - Name: Otto Muzik, PhD - Role: SUB_INVESTIGATOR *Contact 9:* - Name: Huailei Jiang, PhD - Role: SUB_INVESTIGATOR Country: United States Facility: Karmanos Cancer Institute State: Michigan Zip: 48201 #### Overall Officials Official 1: Affiliation: Barbara Ann Karmanos Cancer Institute Name: Nerissa T Viola, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M10407 - Name: Interferons - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439901 Acronym: OPTI-DEPIST Brief Title: Optimizing Bronchopulmonary Cancer Screening Official Title: Optimizing the Implementation of Bronchopulmonary Cancer Screening in the Ile de France Region (OPTI-DEPIST-MUT) #### Organization Study ID Info ID: IC 2023-11 #### Organization Class: OTHER Full Name: Institut Curie ### Status Module #### Completion Date Date: 2032-06-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2031-06-30 Type: ESTIMATED #### Start Date Date: 2024-06-30 Type: ESTIMATED Status Verified Date: 2024-04 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Institut Mutualiste Montsouris #### Lead Sponsor Class: OTHER Name: Institut Curie #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The aim of this study is to evaluate the feasibility of performing a first screening for bronchopulmonary cancer by thoracic scanner in a French cohort within a dedicated, effective and strutured network in the pilot centers participating in the study. Detailed Description: The organization of bronchopulmonary cancer screening in the Ile de France region, within the Mutualité and its affiliated health centers, is based on a clear, simple and functional process: * Definition of eligibility criteria for screening, based on those of the NELSON study, * Referral and consultation by a health center physician trained in these criteria, * Referral and performance of a chest CT scan according to the same recommendations, * Structured centralized reading and interpretation of CT scan images, * Referral to a multidisciplinary team (CITT), if bronchopulmonary cancer is suspected, * Referral to a tobaccology unit in a health center for smokers who have not stopped smoking, * Organization of follow-up and continuation of the screening program. ### Conditions Module Conditions: - Bronchopulmonary Disease - Diagnoses Disease Keywords: - bronchopulmonary cancer - screening - primary prevention ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP Intervention Model Description: Multicentre, Interregional , feasibility study ##### Masking Info Masking: NONE Primary Purpose: DIAGNOSTIC #### Enrollment Info Count: 500 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Screening CTscans according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years), Intervention Names: - Other: Screening - Other: Inclusion - Other: Chest CT scan and follow-up Label: Screening for primary prevention of bronchopulmonary cancer Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - Screening for primary prevention of bronchopulmonary cancer Description: A first step to identify and recruit people eligible for screening, Name: Screening Type: OTHER #### Intervention 2 Arm Group Labels: - Screening for primary prevention of bronchopulmonary cancer Description: A second step for inclusion of participants, with an online self-questionnaire and information, and an inclusion visit to the health center, Name: Inclusion Type: OTHER #### Intervention 3 Arm Group Labels: - Screening for primary prevention of bronchopulmonary cancer Description: A third step with an initial CT scan, with dual interpretation and appropriate management of participants, including follow-up care. Name: Chest CT scan and follow-up Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Rate of completion of a first bronchopulmonary cancer screening among people who have joined the program (i.e. registered on the program's web platform and met the inclusion criteria). Measure: Rate of first CT scan for bronchopulmonary cancer screening Time Frame: 36 months #### Secondary Outcomes Description: Ratio of the number of eligible people (meeting all inclusion and inclusion criteria and no non-inclusion criteria) to the total number of people registered on the web platform. Measure: Eligibility rate among people registering on the web platform Time Frame: 36 months Description: Ratio of the number of people who have completed the inclusion visit to the total number of eligible people registered on the web platform Measure: Rate of completion of the inclusion visit among people registered on the web platform, Time Frame: 36 months Description: Ratio of the number of people who had their 1-year screening scan CT among those eligible for a 1-year scan Measure: Rate of completion of screening scans at 1 year according to NELSON trial schedule Time Frame: 48 months Description: Ratio of the number of people who had their 3-year screening scan CT among those eligible for a 3-year scan Measure: Rate of completion of screening scans at 3 years according to NELSON trial schedule Time Frame: 72 months Description: Ratio of the number of people who had their 5.5-year screening scan CT among those eligible for a 5.5-year scan Measure: Rate of completion of screening scans at 5.5 years according to NELSON trial schedule Time Frame: 102 months Description: Demographic characteristics at inclusion will be compared between people who have or have not had at least one nodule detected on one of the 4 scans. Measure: Correlation of demographic characteristics and the detection of a nodule during the 4 scans Time Frame: 102 months Description: The pourcentage will be estimated by dividing the observed population by the population at risk Measure: Complications related to complementary explorations of positive screenings Time Frame: 102 months Description: The rate of newly non-smoking subjects will be calculated for each type of approach by dividing the number of newly non-smoking subjects by the number of subjects people included in the study. Measure: Smoking cessation rates during the screening program Time Frame: 102 months Description: Number of bronchopulmonary cancers detected at an early stage (stage I or stage II) to the total number of people who underwent a CT scan at inclusion Measure: Rate of early-stage bronchopulmonary cancers identified Time Frame: 102 months Description: The rate of false-positive screening will be calculated by people who have at least one positive screening scan, but whose histology has not confirmed their malignancy, to the number people who had a scan Measure: Rate of positive screening without bronchopulmonary cancer Time Frame: 102 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Participant aged 50 to 74. * Resident in the Île-de-France region. * Active smoker or quit smoker for 10 years or less: 1. more than 10 cigarettes a day for more than 30 years, 2. more than 15 cigarettes a day for more than 25 years. * The participant has been informed and has signed the consent form. * Social Security System affiliation. * Willingness to participate in a smoking cessation program, if currently smoking. Exclusion Criteria: * Active cancer or a history of cancer in remission for less than 5 years (except basal cell carcinoma of th skin or epithelioma in situ of the uterine cervix). * Presence of symptoms suggestive of bronchopulmonary cancer. Participants with these symptoms require immediate diagnostic investigations and are therefore not eligible for screening. * Weight \>= 140 kg. * Severe comorbidity contraindicating therapeutic options or invasive thoracic diagnostic investigations. * Inability to climb two flights of stairs without stopping. * A thoracic CT scan performed within the previous year. * Persons deprived of liberty or under guardianship. * Impossibility to undergo the medical monitoring of the trial for geographical, social or psychological reasons. Maximum Age: 74 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: catherine.daniel@curie.fr Name: Catherine DANIEL, MD Phone: +33 1 44 32 40 00 Role: CONTACT Contact 2: Email: nicolas.girard@curie.fr Name: Nicolas GiRARD, PhD Phone: +33 1 44 32 40 00 Role: CONTACT ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439888 Acronym: LySATRA Brief Title: Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer Official Title: Pan-lesions SBRT Combined With Lymphocyte Support Through ATRA-driven Blockade of MDSC in Patients With Oligo-metastatic Solid Cancer #### Organization Study ID Info ID: 2022-500680-13-00 #### Organization Class: OTHER Full Name: Gustave Roussy, Cancer Campus, Grand Paris #### Secondary ID Infos Domain: CSET number (Gustave Roussy ID) ID: 2022/3511 Type: OTHER ### Status Module #### Completion Date Date: 2026-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2026-08 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Gustave Roussy, Cancer Campus, Grand Paris #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: The goal of this clinical trial is to assess safety of pan-metastases directed SBRT combined with ATRA and the lympho-protective efficacy of ATRA upon radiation-induced lymphopenia. This is a French bicentric, open label, phase I/II clinical study that will comprise two parts. Part I will evaluate the safety of the combination based on a single-arm safety run design, while Part II will be randomized (ratio 1:1) and will study SBRT with or without ATRA. Patients enrolled will be treated with: * SBRT to all lesions more than 1.5cm, on week days (from Monday to Friday), over a maximum of 2 weeks, * With or without (for part II patients randomized in the control arm) ATRA therapy: ATRA 150 mg/m\^2/day for 3 days every 3 weeks for a maximum of 4 cycles (about 3 months), starting on the first day of radiation therapy. The expected rate of patients who will have lymphopenia of grade 2 or higher in the control arm at 6 weeks post-radiotherapy is 50%. At a one-sided level of statistical significance of 0.07, the randomization of 52 patients (26 patients in each arm) will provide 85% power to detect a decrease in this rate to 15% in the SBRT+ATRA arm, using Fisher's exact test. Detailed Description: Ablative radiotherapy - also called stereotactic body radiation therapy (SBRT) - can achieve durable control of tumor lesions and appears as a highly promising strategy to extend overall survival of patients with oligo-metastatic diseases. Radiotherapy has recognized immunomodulatory effects: it triggers immunogenic cell death and reprogramming of the tumor immune microenvironment, which eventually results in a systemic antitumor response following focal radiation treatment. This is called the abscopal effect (distant out-of-the-field lesions that shrink after focal irradiation). Unfortunately, evidences show that this is directly counteracted by the toxic effects of radiotherapy on cytotoxic lymphocytes, which are highly radiosensitive. Recent data support the fact that radiation-induced lymphopenia is mostly driven by the deregulation of the myeloid-lymphoid imbalance following radiation therapy, with aberrant myelopoiesis and high levels of tumor infiltration by myeloid-derived suppressive cells (MDSC). In preclinical models, pharmacological blockade of MDSC combined with radiation therapy successfully abrogated radiation-induced lymphopenia and significantly improved survival outcomes. All trans retinoic acid (ATRA, also known as tretinoin) is a vitamin A derivative that has a market authorization for the treatment of acute promyelocytic leukemia as it efficiently induces differentiation of abnormal promyelocytes. Similarly, several clinical studies report that ATRA can differentiate MDSCs into mature myeloid cells, with a positive effect on the count of activated cluster of differentiation 8 (CD8+) lymphocytes. This clinical trial will provide the clinical proof-of-concept that adding ATRA to pan-metastases SBRT is safe in humans, prevents severe and prolonged lymphopenia and therefore, may foster a radiation-induced systemic anticancer immune response sufficient to increase survival in patients with cancer at the oligo-metastatic stage. ### Conditions Module Conditions: - Oligometastatic Disease - Solid Tumor, Adult ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 58 Type: ESTIMATED Phases: - PHASE1 - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Part I will allow to evaluate the safety of pan-metastases directed SBRT combined with ATRA in N=6 patients. * SBRT to all lesions more than 1.5cm, on Monday up to Friday, over a maximum of 2 weeks, * ATRA 150 mg/m2/day given orally for 3 days every 3 weeks for a maximum of 4 cycles (about 3 months), starting on the same day as SBRT. Intervention Names: - Drug: all-trans retinoic acid - Radiation: Stereotactic Body Radiation Therapy Label: Part I : Stereotactic Body Radiation Therapy + All-trans retinoic acid Type: EXPERIMENTAL #### Arm Group 2 Description: Part II will allow to evaluate the lympho-protective efficacy of ATRA upon radiation-induced lymphopenia. The experimental arm consists in : * SBRT to all lesions more than 1.5cm, on Monday up to Friday, over a maximum of 2 weeks, * ATRA 150 mg/m2/day given orally for 3 days every 3 weeks for a maximum of 4 cycles (about 3 months), starting on the same day as SBRT. Intervention Names: - Drug: all-trans retinoic acid - Radiation: Stereotactic Body Radiation Therapy Label: Part II : Stereotactic Body Radiation Therapy + All-trans retinoic acid Type: EXPERIMENTAL #### Arm Group 3 Description: Part II will allow to evaluate the lympho-protective efficacy of ATRA upon radiation-induced lymphopenia. The control arm consists in : - SBRT to all lesions more than 1.5cm, on Monday up to Friday, over a maximum of 2 weeks Intervention Names: - Radiation: Stereotactic Body Radiation Therapy Label: Part II : Stereotactic Body Radiation Therapy alone Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Part I : Stereotactic Body Radiation Therapy + All-trans retinoic acid - Part II : Stereotactic Body Radiation Therapy + All-trans retinoic acid Description: per os treatment, started from the same day as SBRT, during 3 successive days, every 3 weeks, for a maximum of 4 cycles Name: all-trans retinoic acid Other Names: - Tretinoin - VESANOID Type: DRUG #### Intervention 2 Arm Group Labels: - Part I : Stereotactic Body Radiation Therapy + All-trans retinoic acid - Part II : Stereotactic Body Radiation Therapy + All-trans retinoic acid - Part II : Stereotactic Body Radiation Therapy alone Description: Standard of Care, planned over 1 or 2 weeks, every lesions must be irradiated Name: Stereotactic Body Radiation Therapy Type: RADIATION ### Outcomes Module #### Primary Outcomes Description: Dose-limiting toxicity (DLT) is defined as an adverse event reported during the first three weeks of treatment that is possibly related to study intervention and fulfills any one of the DLT criteria using CTCAE Version 5.0 Measure: Dose-limiting toxicities (DLT) Time Frame: from the first intake to 3 weeks after the treatment initiation Description: Rate of patients with lymphopenia grade 2 or higher at 6 weeks after treatment completion (as absolute lymphocyte count less than 800/mm3 (CTCAE V5.0)) Measure: Lympho-protective efficacy Time Frame: At 6 weeks after SBRT completion #### Secondary Outcomes Description: Control rates on the treated lesions Measure: Control rates Time Frame: from 6 weeks to 1 year after SBRT Description: Objective response rate Measure: Objective response rate Time Frame: from 6 weeks to 1 year after SBRT Description: Duration of response Measure: Duration of response Time Frame: from 6 weeks to 1 year after SBRT Description: Progression-free survival Measure: Progression-free survival Time Frame: from 6 weeks to 1 year after SBRT ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Adult male or female patients (older than 18 years of age at inclusion); * Histologically or cytologically proven solid cancer at the oligo-metastatic stage amenable to pan-lesion SBRT, as defined by: 1. 2 to 5 tumor lesions measurable as per RECIST V1.1 (including primary) with a largest diameter comprised between 1.5 and 5 cm, 2. The disease can be either genuinely oligo-metastatic, oligo-progressive, or an induced oligo-metastatic disease, 3. All tumor lesions that match criterion I2a must be eligible to SBRT in terms of location and radiotherapy constraints, 4. SBRT to all lesions must be feasible over a two-week period, 5. Whatever the primary tumor type; * Patients must agree to comply with biopsy and blood sampling for research purpose; * Minimal wash-out periods from last administration of treatments to the first day of SBRT must be: 1. Systemic chemotherapy including cytotoxic, immunotherapy, targeted therapy, hormone therapy, any investigational agent during the last 4 weeks, 2. Immunosuppressive medication during the last 4 weeks, with the exceptions of intranasal, topical, and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceeding 10 mg/day of prednisone, or an equivalent corticosteroid, 3. Live attenuated vaccination during the last 4 weeks, 4. Major surgery during the last 4 weeks; * World Health Organization (WHO) 0 or 1 and Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1; * Patients must have adequate organ function defined as follows: 1. White blood cell count of equal to or higher than 1,500/mm\^3, 2. Lymphocyte count of equal to or higher than 800/mm\^3, 3. Platelet count of equal to or higher than 100,000/mm\^3, 4. Hemoglobin higher than 9 g/dL, 5. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) equal to or less than 2.5 upper level norm (or if liver metastases are present must be equal to or less than 5x upper level norm) 6. Serum creatinine clearance higher than 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance; * Female patients must either be of non-reproductive potential or must have a negative serum pregnancy test within 3 days prior to the initiation of the study drug. Fertile men with a female partner of childbearing potential must agree to use male condom plus spermicide and childbearing potential women must have agreed to use at least one highly effective contraceptive method during treatment on this trial and for up to 1 month after the last dose of ATRA; Pregnancy testing and contraception counseling should be repeated monthly throughout the period of ATRA treatment. * Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol; * Patients must be affiliated to a social security system or beneficiary of the same Exclusion Criteria: * Evidence of disease rapidly progressing at the time of screening according to the two last best-fitted imaging modalities (CT-scans, MRI, positron emission tomography), at the discretion of the investigator and the multidisciplinary board (RCP); * Any evidence of brain metastasis; * Any situation where irradiation of the target site(s) would imply re-irradiation of a formerly irradiated tumor site; * Bone metastasis located in a femoral bone if risk of pending fracture is high; * Liver metastasis adjacent to the stomach or small bowel and liver metastasis that leads to a volume of uninvolved liver less than 700 cc; * Patients with any concurrent severe condition (grade 3 or beyond according to CTCAE V5.0) and/or uncontrolled medical condition that could compromise participation in the study; * Any psychiatric illness or social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent; * Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Patients with a completely treated prior malignancy who are no longer treated (including maintenance therapy) and no evidence of disease for at least 2 years are eligible; * Chronic treatment with systemic corticosteroids or another immunosuppressant including, but not limited to systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent, methotrexate, azathioprine, and tumor necrosis factor-α (TNF-α) blockers. Use of immunosuppressive medications for the management of investigational product-related Adverse Events or in subjects with contrast allergies is acceptable. The use of topical, inhaled and intranasal corticosteroids is permitted; * Patients with tumor(s) that invade major vessels, as shown unequivocally by imaging studies; * Patients with central lung metastasis (i.e within 2 cm from hilum) that are cavitary as shown unequivocally by imaging studies; * Persisting significant toxicities related to prior treatments i.e. Grade 2 and higher adverse event according to CTCAE V5.0 criteria, except for alopecia and biological values defined in inclusion criteria I6; * Known allergy or hypersensitivity to the study drug. The study drug is contraindicated in patients with soy or peanut allergy; * Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); * Patients at risk of QT prolongation (including patients with hypokaliemia, baseline QT/corrected QT interval more than 470 ms (for women) and more than 450 ms (for men)); * Pregnant or breastfeeding women; * Persons deprived of their freedom or under guardianship, or for whom it would be impossible to undergo the medical follow-up required by the trial, for geographic, social or psychological reasons. Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: lisa.schmidt@gustaveroussy.fr Name: Lisa SCHMIDT, MSc Phone: +33 (0)1 42 11 42 11 Role: CONTACT Contact 2: Email: daphne.morel@gustaveroussy.fr Name: Daphné MOREL, PharmD Phone: +33 (0)1 42 11 42 11 Role: CONTACT #### Locations Location 1: City: Lyon Contacts: *Contact 1:* - Email: gwenaelle.garin@lyon.unicancer.fr - Name: Gwenaëlle GARIN-FOURNIER, PhD - Phone: +33 (0)4 26 55 68 24 - Role: CONTACT *Contact 2:* - Name: Vincent GREGOIRE, PhD, MD - Role: PRINCIPAL_INVESTIGATOR Country: France Facility: Centre Léon Bérard Status: NOT_YET_RECRUITING Zip: 69000 Location 2: City: Villejuif Contacts: *Contact 1:* - Email: eric.deutsch@gustaveroussy.fr - Name: Eric DEUTSCH, PhD, MD - Phone: +33 (0)1 42 11 42 11 - Role: CONTACT *Contact 2:* - Name: Eric DEUTSCH, PhD, MD - Role: PRINCIPAL_INVESTIGATOR Country: France Facility: Gustave Roussy Status: RECRUITING Zip: 94800 #### Overall Officials Official 1: Affiliation: Gustave Roussy, Cancer Campus, Grand Paris Name: Eric DEUTSCH, PhD, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007641 - Term: Keratolytic Agents - ID: D000003879 - Term: Dermatologic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16965 - Name: Tretinoin - Relevance: HIGH - As Found: Significance - ID: M10667 - Name: Keratolytic Agents - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014212 - Term: Tretinoin ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439875 Brief Title: Effects of L-arginine and Liposomial Vitamin C on Severe Copd Patients Undergoing Pulmonary Rehabilitation. Official Title: Effects of the Association of L-arginine and Liposomal Vitamin C on Fatigue in COPD Patients With Chronic Respiratory Failure After Rehabilitation Intervention #### Organization Study ID Info ID: CTSM109-23 #### Organization Class: OTHER Full Name: Istituti Clinici Scientifici Maugeri SpA ### Status Module #### Completion Date Date: 2025-07-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-06-03 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-05-01 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-04 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Istituti Clinici Scientifici Maugeri SpA #### 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 hypothesis that is being tested is that the supplementation of L-arginine plus Vitamin C to multidisciplinary pulmonary rehabilitation (PR) in patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD) and chronic respiratory failure can have a favorable influence on fatigue and on clinical indicators related to endothelial function, potentially mitigating the cardiovascular (CV) disease burden in this clinical context. Detailed Description: The primary objective of this project is to assess the effects of L-arginine plus Vitamin C supplementation on the physical outcomes in a group of COPD patients with chronic respiratory failure who underwent a 28-day PR program. Eligible participants will be randomized using a random number generator in a 1:1 ratio to receive a twice-daily oral supplementation with either a combination of 1.66 g l-arginine plus 500 mg liposomal vitamin C (Bioarginina® C, Farmaceutici Damor, Naples, Italy) or a placebo for 28 days. Vials containing the active supplement or the placebo will be supplied by Farmaceutici Damor and will be made indistinguishable in appearance. All patients will undergo an intensive multidisciplinary PR program based on endurance and strength training. The main outcome of the study is the fatigue severity scale (FSS) total score after rehabilitation. Secondary outcomes include: 6-minute walking distance, forced expiratory volume in the first second (FEV1), COPD assessment test (CAT) score, endothelial function assessed through flow-mediated dilation (FMD), and muscular strength assessed through handgrip measurement. Anthropometric, clinical, and functional characteristics of the study participants will be reported as mean ± standard deviation (SD) or median (interquartile range, IQR) for continuous variables and as absolute values (percentages) for categorical variables. Changes from baseline for continuous variables will be expressed as deltas (values at 28 days minus the values at baseline), and differences between the interventional groups will be evaluated using the Student's t-test for normally distributed variables or the Mann-Whitney U test for skewed variables. ### Conditions Module Conditions: - Chronic Obstructive Pulmonary Disease - Respiratory Failure Keywords: - COPD - pulmonary rehabilitation - L-arginine - fatigue - respiratory failure ### 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: 102 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants in this arm of the study will have an oral supplementation of l-arginine and liposomial vitamin C on a daily basis for 28 days. Intervention Names: - Dietary Supplement: effect of L-arginine and liposomial vitamin C on pulmonary rehabilitation Label: L-arginine (arm 1) Type: EXPERIMENTAL #### Arm Group 2 Description: This arm will be given a placebo comparator on a daily basis for 28 days. Intervention Names: - Other: placebo Label: Placebo (arm 2) Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - L-arginine (arm 1) Description: Patients with a certified diagnosis of COPD and chronic respiratory failure will be randomized in a 1:1 ratio into the interventional arm or the placebo controller arm. All patients will undergo multidisciplinary intensive pulmonary rehabilitation for 28 days. The patients in the interventional group will receive a twice-daily oral supplementation with either a combination of 1.66 g l-arginine plus 500 mg liposomal vitamin C Name: effect of L-arginine and liposomial vitamin C on pulmonary rehabilitation Type: DIETARY_SUPPLEMENT #### Intervention 2 Arm Group Labels: - Placebo (arm 2) Description: Patients in this arm will undergo multidisciplinary intensive pulmonary rehabilitation without any dietary supplementation. Name: placebo Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The Fatigue Severity Scale (FSS) is a 9-item scale that measures the severity of fatigue and how much it affects the person's activities and lifestyle in patients with a variety of disorders. The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity. More common way of scoring: mean of all the scores with minimum score being 1 and maximum score being 7. Mean (SD) FSS scores for healthy individuals; 2.3 (0.7). Cut-off score of 4 or more considered indicative of problematic fatigue. Measure: Fatigue Severity Scale Time Frame: at baseline and after 28 days of intensive pulmonary rehabilitation #### Secondary Outcomes Description: The six minute walking test (6MWT) is a strong predictor of survival and outcome in PR. The patient is asked to walk on a flat surface for six minutes. The total distance walked, peripheral saturation, heart rate, dyspnea and muscular fatigue are assessed before starting the test and at the end. The distance walked varies with age and might be affected by non-respiratory diseases such as musculoscheletal and cardiovascular diseases. A distance walked inferior to the 80% of the theoretical distance is considered to be abnormal, as well as the presence of desaturations defined as a peripheral oxygen saturation \< 90%. Dyspnea and fatigue are assessed through the modified Borg's scale, which ranges from 0 (= no symptom) to 10 (the most intense sensation imaginable). Measure: Six minute walking test (6MWT) Time Frame: at baseline and after 28 days of intensive pulmonary rehabilitation Description: The participant is coached to perform as many full stands as possible within 30 seconds, starting from and returning to a complete sitting position. It is possible to assess a wide variety of ability levels with scores ranging from 0 for those who can not complete one stand to a score greater than 20 for more fit individuals. Measure: Sit to stand test (STST) Time Frame: at baseline and after 28 days of intensive pulmonary rehabilitation Description: CAT is designed to measure the impact of COPD on a person's life, and how this changes over time. CAT explores eight different domains, and for each one the participant may indicate a score ranging from 0 to 5. A score of 0 means that there is no impairment in that area. A score of 5 means severe impairment.The overall score will therefore range from 0 to 40. Higher scores indicate that COPD has a greater impact on the patient's overall health and well-being. Measure: COPD Assessment Test (CAT) Time Frame: at baseline and after 28 days of intensive pulmonary rehabilitation Description: MRC uses to assess the degree of baseline functional disability due to dyspnoea. It ranges from 0 to 4. A value = 0 indicates no significant dyspnea. A value = 1 indicates dyspnea ony for heavy efforts, A value = 2 indicates dyspnea for moderate efforts. A value = 3 indicates dyspnea for mild efforts. A value = 4 indicates dyspnea at rest. Measure: Medical Research Council (MRC) for dyspnea test Time Frame: at baseline and after 28 days of intensive pulmonary rehabilitation Description: FMD evaluates the alterations of the diameter of the brachial artery in response to an induced ischemic stimulus. FMD has been widely used in clinical research and allows the studying of the influence of diseases and treatment interventions on endothelial function. Measure: Flow-mediated dilation (FMD); Time Frame: at baseline and after 28 days of intensive pulmonary rehabilitation Description: Fractional exhaled nitric oxide (FeNO) is an endogenous gaseous molecule which can be measured in human breath. Higher FeNO values have been linked airway inflammation. A cut-off of 25 parts per billion (ppb) has been suggested in order to discriminate between a normal exam (FeNO \< 25 ppb) and an altered one (FeNO \> or = 25 ppb). Measure: Fractional exhaled nitric oxide (FeNO) Time Frame: at baseline and after 28 days of intensive pulmonary rehabilitation Description: Muscle strength will be measured with a handgrip device, which consists of a handle-shaped dynamometer which is able to calculate the handgrip's strength (expressed in Newton units). Measure: Muscle Strength Time Frame: at baseline and after 28 days of intensive pulmonary rehabilitation ### Eligibility Module Eligibility Criteria: Inclusion criteria: * COPD patients of both sexes complicated by respiratory failure (PaO2 inferior to 60 mmHg while breathing room air) * aged between 40 and 90 years selected from the inpatient/outpatient population admitted to perform a PR program in 12 Italian rehabilitation hospitals. Exclusion criteria: * consuming any ergogenic supplement in the last 2 months; * severe acute exacerbations in the 3 months before enrolment; * clinical instability (pH inferior to 7.35, hemodynamic instability, tachypnea at rest); * lung restrictive diseases; * primitive pulmonary hypertension; * recent lung thromboembolic events; * orthopaedic clinical conditions interfering with exercise; * coronary heart disease; * cardiac failure with reduced ejection fraction; * major cardiac arrhythmias; * neuromuscular diseases; * mini mental state examination (MMSE) \<24; * any prior or current medical problem that would limit the subject participation Maximum Age: 90 Years Minimum Age: 40 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: mauro.maniscalco@icsmaugeri.it Name: Mauro Maniscalco Phone: +39 0824909350 Role: CONTACT Contact 2: Email: pasquale.ambrosino@icsmaugeri.it Name: Pasquale Ambrosino Phone: +39 0824909351 Role: CONTACT #### Locations Location 1: City: Telese Terme Contacts: *Contact 1:* - Email: mauro.maniscalco@icsmaugeri.it - Name: mauro maniscalco - Phone: +390824909350 - Role: CONTACT Country: Italy Facility: Istituti Clinici Scientifici Maugeri State: Benevento Zip: 82037 #### Overall Officials Official 1: Affiliation: IRCCS Maugeri Telese Name: mauro maniscalco Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000012120 - Term: Respiration Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Respiratory Failure - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: HIGH - As Found: Obstructive Pulmonary Disease - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: HIGH - As Found: Chronic Obstructive Pulmonary Disease - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive - ID: D000012131 - Term: Respiratory Insufficiency ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M4513 - Name: Ascorbic Acid - Relevance: LOW - As Found: Unknown - ID: T437 - Name: Ascorbic Acid - Relevance: LOW - As Found: Unknown - ID: T477 - Name: Vitamin C - Relevance: HIGH - As Found: Adjusted - ID: T1 - Name: Arginine - Relevance: HIGH - As Found: Every 21 days ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439862 Acronym: QUALIVUP Brief Title: Study of the Quality of Life in School Aged-children With Posterior Urethral Valves Official Title: Quality of Life in School Aged-children With Posterior Urethral Valves #### Organization Study ID Info ID: 69HCL24_0181 #### Organization Class: OTHER Full Name: Hospices Civils de Lyon ### Status Module #### Completion Date Date: 2025-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-12-31 Type: ESTIMATED #### Start Date Date: 2025-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Hospices Civils de Lyon #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Posterior urethral valves (PUV) are the most common congenital obstructive lesion of the urethra, affecting from 1 per 3000 to 1 per 8000 live births. Valve ablation usually resolves the obstruction in PUV but patients still may suffer of deterioration in renal and urinary functions. Renal insufficiency is the most feared long-term complication. Up to 50 % of the patients will develop chronic kidney disease (CKD), and up to 20 % will develop end-stage renal disease (ESRD) and ultimately will require kidney transplantation. PUV is the first urological cause of ESRD. Progression towards CKD depends on febrile urinary tract infections (UTIs), severity of a vesicoureteral reflux and bladder dysfunction. Bladder dysfunction is due to an overactive and small poorly compliant bladder during infancy. Detrusor overactivity usually decreases in childhood and bladder capacity increases. The most common symptom of this bladder dysfunction is urinary incontinence. 60 % of children are continent at the age of 5 years old and 90 % at 10 years old. In case of persistent bladder dysfunction, medical treatment (anticholinergics, alpha-blockers) may be introduced, or even intermittent catheterizations. Current scientific literature has very few studies on quality of life (QoL) in patients with PUV, mostly in adult patients and very small cohorts. Men treated for PUV in childhood had a good quality of life compared to the normative population, except for sleeping, eating and sexual activity. It seemed that the more severe the urological and nephrological functions were, the lower the QoL was. Children were only asked about intermittent urinary catheterization, and family point of view has never been collected. However, QoL and long-term evolution represent the first concerns of parents-to-be in prenatal counseling, or after diagnosis in an infant with PUV. Hence, the aim of the study is to investigate the quality of life in school-aged children who had been treated for PUV in their first year of life, as measured by the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0). ### Conditions Module Conditions: - Quality of Life - Posterior Urethral Valve - Renal Insufficiency - Chronic Renal Disease - End Stage Renal Disease - Bladder Dysfunction - Urinary Incontinence Keywords: - Quality of life - Posterior Urethral Valves - Children - Adolescents - Family ### Design Module #### Design Info Observational Model: CASE_ONLY Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 65 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 Description: Male children aged 6 to 17 years old treated for PUV in their first year of life between 2006 and 2018 in Lyon, and managed in the Femme-Mère-Enfant Hospital in Lyon Name: Children with PUV Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The PedsQL 4.0 measures health-related quality of life in healthy children and those with acute and chronic health conditions. It consists of parallel child self-report and parent proxy-report formats, with 23 items and 5 response selections that range from "never" to "almost always". Parent proxy-report assesses parent's perceptions of their child's HRQOL. The items for each of the forms are essentially identical, differing in developmentally appropriate language, or first or third person tense. Items are reverse-scored and linearly trans-formed to a 0 to 100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed. Measure: Score of the PedsQL 4.0 (Pediatric Quality of Life Inventory Version 4.0) Generic Core Scales Time Frame: At inclusion ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Male patients and their parents/relatives * Aged 6 to 17 years old * Treated for PUV in their first year of life between 2006 and 2018 * Managed in the Femme-Mère-Enfant Hospital in Lyon Exclusion Criteria: * Children with pre-existing severe cognitive and physical disability (physician's rating) from other condition * Children enable to complete QoL questionnaire due to mental or communication impairment Maximum Age: 17 Years Minimum Age: 6 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: MALE Standard Ages: - CHILD Study Population: Children with PUV will be selected inside the database of the pediatric surgery department of the Femme-Mère-Enfant Hospital in Lyon ### Contacts Locations Module #### Central Contacts Contact 1: Email: valeska.bidault@chu-lyon.fr Name: BIDAULT Valeska, MD Phone: 04 27 85 57 94 Role: CONTACT #### Locations Location 1: City: Bron Contacts: *Contact 1:* - Email: valeska.bidault@chu-lyon.fr - Name: BIDAULT Valeska, MD - Phone: 04 27 85 57 94 - Role: CONTACT *Contact 2:* - Email: claire.lo@chu-lyon.fr - Name: LO Claire, MD - Role: CONTACT Country: France Facility: Femme-Mère-Enfant Hospital #### Overall Officials Official 1: Affiliation: Hospices Civils de Lyon Name: BIDAULT Valeska, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - 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: D000059411 - Term: Lower Urinary Tract Symptoms - ID: D000020924 - Term: Urological Manifestations - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Renal Disease - ID: M17299 - Name: Urinary Incontinence - Relevance: HIGH - As Found: Urinary Incontinence - ID: M7936 - Name: Enuresis - Relevance: LOW - As Found: Unknown - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: Chronic Renal Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: HIGH - As Found: Renal Insufficiency - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Renal Disease - 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: M29464 - Name: Lower Urinary Tract Symptoms - Relevance: LOW - As Found: Unknown - ID: M22659 - Name: Urological Manifestations - 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 - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life - ID: T4654 - Name: Posterior Urethral Valves - Relevance: HIGH - As Found: Posterior Urethral Valves ### Condition Browse Module - Meshes - ID: D000014549 - Term: Urinary Incontinence - ID: D000007674 - Term: Kidney Diseases - ID: D000007676 - Term: Kidney Failure, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000051436 - Term: Renal Insufficiency, Chronic ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439849 Acronym: TRIANGLE Brief Title: A Single Patient Compassionate Use Clinical Trial for the Use of L-S-Gboxin (Lyophilized Form of S-Gboxin) for the Treatment Diffuse Midline Glioma, H3 K27/28-altered (DMG), Including Diffuse Intrinsic Pontine Glioma (DIPG) Official Title: A Single Patient Compassionate Use Clinical Trial for the Use of L-S-Gboxin (Lyophilized Form of S-Gboxin) for the Treatment Diffuse Midline Glioma, H3 K27/28-altered (DMG), Including Diffuse Intrinsic Pontine Glioma (DIPG) #### Organization Study ID Info ID: 21DN24S #### Organization Class: OTHER Full Name: Petrov, Andrey ### Status Module #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: AVAILABLE Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Petrov, Andrey #### Responsible Party Type: SPONSOR ### Description Module Brief Summary: F. 50y.o. 77kg, DS confirmed 18 Nov. 2022 Received treatment: 11 courses of TMZ (240mg) Radiotherapy 30 courses of 1.8Gr (total 54 Gr, TMZ 140 mg on RT). Bevacizumab intravenously -400 mg -0-14-28-42 (December-February 2023). Severe side effects. The attending physician discontinued bevacizumab after 4 courses. In remission for 11 months. According to the results of the MRI dated April 28, 2024, continued growth. Neurological status is good. Reflexes are not impaired. To date, treatment options have been exhausted. Participation of the patient in Clinical Trials is impossible. As of April 2024, negative dynamics. The patient signed an informed consent agreement. Information on taking L-S-Gboxin (Lyophilisate) as part of a compassionate program - explained. Written consent of the attending physician for the patient's participation in the Compassion Program (TRIANGLE) with L-S-Gboxi (Lyophilisate) - received. (medical documentation will be available on clinicaltrials.gov within a month from the date of publication - patient's consent to publish the medical history and examination results has been obtained) Detailed Description: TREATMENT PLAN Оn days 1 to 3 of treatment, the patient will receive a sublingual form of the lyophilized form of L-S-Gboxin at a dose of 5 mg/kg. If there is no toxicity, on days 4 to 14 the patient will receive a sublingual form of the lyophilized form of S-Gboxin at a dose of 10 mg/kg. The first course of treatment is 14 days. On day 20, MRI + PET-CT monitoring is carried out to assess the dynamics of tumor growth. Based on the results of the examination plan, the attending physician and the main investigator make a decision on the continuation of treatment and the duration of the second course of therapy. ### Conditions Module Conditions: - DIPG Brain Tumor - Diffuse Brainstem Glioma - H3 K27M - H3 K28M - GBM Keywords: - S-Gboxin - S-Gboxin (lyophilized form) ### Design Module #### Expanded Access Types Individual: True Study Type: EXPANDED_ACCESS ### Arms Interventions Module ### Interventions #### Intervention 1 Description: S-Gboxin (lyophilized form of S-Gboxin) for the treatment diffuse midline glioma with H3 K27M / H3 K28M mutation Name: S-Gboxin Other Names: - lyophilized form of S - Gboxin - 3-(2-(((1R,2S,5R)-2-isopropyl-5-methylcyclohexyl)oxy)-2-oxoethyl)-1-methyl-2-(3-(trifluoromethyl)phenyl)-1H-benzo[d]imidazol-3-ium iodide Type: DRUG ### Eligibility Module Eligibility Criteria: Inclusion Criteria: unacceptable for single patient Exclusion Criteria: * unacceptable cardiotoxicity * cerebrospinal fluid dissemination * systemic infection or viral disease, other associated symptoms that may jeopardize the patient's safety (at the discretion of the treating physician) Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: apetrov@swissbio.zuerich Name: Andrey Petrov, Dr Phone: +41766165523 Role: CONTACT Contact 2: Email: Erweiterte-Zugriffsprogramme@mail.ch Name: Oliever Parteny Role: CONTACT ### References Module #### See Also Links Label: OXPHOS URL: https://www.nature.com/articles/ncomms4103 Label: Gboxin URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6655586/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000001932 - Term: Brain Neoplasms - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000020295 - Term: Brain Stem Neoplasms - ID: D000015192 - Term: Infratentorial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9020 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: M5209 - Name: Brain Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2159 - Name: Diffuse Intrinsic Pontine Glioma - Relevance: HIGH - As Found: Diffuse Intrinsic Pontine Glioma - ID: M20446 - Name: Neoplasms, Neuroepithelial - 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: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M18937 - Name: Central Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - 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: M22108 - Name: Brain Stem Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17898 - Name: Infratentorial Neoplasms - Relevance: LOW - As Found: Unknown - ID: T2519 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: T1865 - Name: Diffuse Intrinsic Pontine Glioma - Relevance: HIGH - As Found: Diffuse Intrinsic Pontine Glioma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005910 - Term: Glioma - ID: D000080443 - Term: Diffuse Intrinsic Pontine Glioma ### Intervention Browse Module - Ancestors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10488 - Name: Iodine - Relevance: LOW - As Found: Unknown - ID: M121171 - Name: Imidazole - Relevance: HIGH - As Found: Long-term Follow-up - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000029899 - Term: Imidazole ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439836 Brief Title: Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy Official Title: Phase 1 Trial of CA-4948 in Combination With Pembrolizumab to Overcome Resistance to PD-1/PD-L1 Blockade in Metastatic Urothelial Cancer #### Organization Study ID Info ID: NCI-2024-04436 #### Organization Class: NIH Full Name: National Cancer Institute (NCI) #### Secondary ID Infos Domain: CTRP (Clinical Trial Reporting Program) ID: NCI-2024-04436 Type: REGISTRY Domain: Mount Sinai Hospital ID: 10636 Type: OTHER Domain: CTEP ID: 10636 Type: OTHER ### Status Module #### Completion Date Date: 2025-10-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-05 Type: ACTUAL Last Update Submit Date: 2024-06-04 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-10-01 Type: ESTIMATED #### Start Date Date: 2024-08-30 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-31 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: NIH Name: National Cancer Institute (NCI) #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Is US Export: False Oversight Has DMC: False ### Description Module Brief Summary: This phase I trial tests the safety, side effects, best dose, and effectiveness of emavusertib (CA-4948) in combination with pembrolizumab in treating patients with urothelial cancer that has spread from where it first started to other places in the body (metastatic) and that has a resistance to PD-1/PD-L1 immune checkpoint inhibitors. CA-4948, a kinase inhibitor, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving CA-4948 in combination with pembrolizumab may be safe, tolerable and/or effective in treating patients with metastatic urothelial cancer that is resistant to PD-1/PD-L1 immune checkpoint inhibitors. Detailed Description: PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose of the combination of CA-4948 plus pembrolizumab in patients with immune checkpoint blockade (ICB)-resistant metastatic urothelial cancer (Dose Escalation Cohort). II. To determine the safety of the combination of CA-4948 plus pembrolizumab in patients with ICB-resistant metastatic urothelial cancer (Dose Escalation Cohort and Dose Expansion Cohort). SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To measure the objective response (complete response \[CR\] or partial response \[PR\]) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 9 weeks and the best overall response (CR or PR) as defined by RECIST 1.1 at any time while on study. III. To determine progression-free survival, overall survival, and duration of response. IV. To assess whether CA-4948 plus pembrolizumab leads to on-treatment increases in 2IR scores (as defined by ribonucleic acid \[RNA\] sequencing) in paired tumor biopsies. EXPLORATORY OBJECTIVES: I. To assess the clinical benefit rate with pembrolizumab plus CA-4948 therapy. II. To assess the "C-reactive protein (CRP) response rate" as defined by the proportion of patients achieving a ≥ 1.5 fold reduction in CRP at 9 weeks. III. To explore the association between the 2IR score as defined by bulk-ribonucleic acid (RNA) sequencing of pre-treatment tumor tissue and objective response rate, clinical benefit rate, progression-free survival, and/or overall survival. IV. To explore whether CA-4948 plus pembrolizumab leads to on-treatment changes in the cellular and/or molecular composition of the tumor microenvironment (TME). V. To explore the association between the quantity and spatial localization of SPP1+ monocytes-macrophages (MoMacs) defined by multiplex immunohistochemistry on pre-treatment tumor tissue and objective response rate, clinical benefit rate, progression-free survival, and/or overall survival. VI. To explore the association between the cellular and molecular composition of the TME defined by spatial RNA sequencing on pre-treatment tumor tissue and objective response rate, clinical benefit rate, progression-free survival, and/or overall survival. VII. To explore on-treatment changes in high-sensitivity (hs) CRP and cytokines and chemokines in peripheral blood and their association with objective response rate, clinical benefit rate, progression-free survival, and/or overall survival. VIII. To explore the association between PD-L1 expression on pre-treatment tumor tissue and objective response rate, clinical benefit rate, progression-free survival, and/or overall survival. IX. To explore the association between the CXCL9:SPP1 ratio as defined by bulk-RNA sequencing of pre-treatment tumor tissue and objective response rate, clinical benefit rate, progression-free survival, and/or overall survival. X. To assess whether CA-4948 plus pembrolizumab leads to on-treatment increases in the CXCL9:SPP1 ratio (as defined by RNA sequencing) in paired tumor biopsies. OUTLINE: This is a dose-escalation study of CA-4948 in combination with pembrolizumab followed by a dose-expansion study. Patients receive CA-4948 orally (PO) twice daily (BID) on days 1-21 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) throughout the study. Additionally, patients may undergo a tumor biopsy on study. After completion of study treatment, patients are followed up every 3 months for 2 years. ### Conditions Module Conditions: - Metastatic Urothelial Carcinoma - Unresectable Urothelial Carcinoma ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 25 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients receive CA-4948 orally PO BID on days 1-21 and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, CT, MRI, or PET throughout the study. Additionally, patients may undergo a tumor biopsy on study. Intervention Names: - Procedure: Biopsy - Procedure: Biospecimen Collection - Procedure: Computed Tomography - Biological: Emavusertib - Procedure: Magnetic Resonance Imaging - Biological: Pembrolizumab - Procedure: Positron Emission Tomography Label: Treatment (CA-4948, pembrolizumab) Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Treatment (CA-4948, pembrolizumab) Description: Undergo tumor biopsy Name: Biopsy Other Names: - BIOPSY_TYPE - Bx Type: PROCEDURE #### Intervention 2 Arm Group Labels: - Treatment (CA-4948, pembrolizumab) Description: Undergo blood sample collection Name: Biospecimen Collection Other Names: - Biological Sample Collection - Biospecimen Collected - Specimen Collection Type: PROCEDURE #### Intervention 3 Arm Group Labels: - Treatment (CA-4948, pembrolizumab) Description: Undergo CT Name: Computed Tomography Other Names: - CAT - CAT Scan - Computed Axial Tomography - Computerized Axial Tomography - Computerized axial tomography (procedure) - Computerized Tomography - Computerized Tomography (CT) scan - CT - CT Scan - tomography Type: PROCEDURE #### Intervention 4 Arm Group Labels: - Treatment (CA-4948, pembrolizumab) Description: Given PO Name: Emavusertib Other Names: - AU 4948 - AU-4948 - CA 4948 - CA-4948 - CA4948 - Interleukin-1 Receptor-associated Kinase 4 Inhibitor CA-4948 - IRAK4 Inhibitor CA-4948 Type: BIOLOGICAL #### Intervention 5 Arm Group Labels: - Treatment (CA-4948, pembrolizumab) Description: Undergo MRI Name: Magnetic Resonance Imaging Other Names: - Magnetic Resonance - Magnetic Resonance Imaging (MRI) - Magnetic resonance imaging (procedure) - Magnetic Resonance Imaging Scan - Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance - MR - MR Imaging - MRI - MRI Scan - MRIs - NMR Imaging - NMRI - Nuclear Magnetic Resonance Imaging - sMRI - Structural MRI Type: PROCEDURE #### Intervention 6 Arm Group Labels: - Treatment (CA-4948, pembrolizumab) Description: Given IV Name: Pembrolizumab Other Names: - BCD-201 - GME 751 - GME751 - Keytruda - Lambrolizumab - MK-3475 - Pembrolizumab Biosimilar BCD-201 - Pembrolizumab Biosimilar GME751 - Pembrolizumab Biosimilar QL2107 - QL2107 - SCH 900475 Type: BIOLOGICAL #### Intervention 7 Arm Group Labels: - Treatment (CA-4948, pembrolizumab) Description: Undergo PET Name: Positron Emission Tomography Other Names: - Medical Imaging, Positron Emission Tomography - PET - PET Scan - Positron emission tomography (procedure) - Positron Emission Tomography Scan - Positron-Emission Tomography - proton magnetic resonance spectroscopic imaging - PT Type: PROCEDURE ### Outcomes Module #### Other Outcomes Description: CBR will be defined as the proportion of patients achieving a CR or PR per RECIST 1.1 criteria at 9 weeks or stable disease at 9 weeks accompanied by a 1.5 or greater reduction in hrCRP. CBR will be reported along with a corresponding two-sided 95% Wilson CI and p-value will be reported from Binomial exact test. Measure: Clinical benefit rate (CBR) Time Frame: At 9 weeks Description: CRP response rate will be defined as achieving a ≥ 1.5 fold reduction in CRP at 9 weeks. The CRP response rate will be reported along with a corresponding two-sided 95% Wilson CI and p-value will be reported from Binomial exact test. Linear mixed models will also be fitted for comparisons between patients achieving and not achieving an objective response and between patients achieving and not achieving clinical benefit. Random effects with autoregressive model of order 1 will be incorporated to describe the correlation of repeated measures. Univariable PH Cox regression models for PFS and OS will also be fitted with hsCRP levels either at baseline or as a time-dependent continuous covariate. Measure: High-sensitivity C-reactive protein (hsCRP) Time Frame: At 9 weeks Description: Linear mixed models will also be used for comparisons between patients achieving and not achieving an objective response and between patients achieving and not achieving clinical benefit. Random effects with autoregressive model of order 1 will be incorporated to describe the correlation of repeated measures. Residual plots will be used to check model assumptions. Univariable PH Cox regression models for PFS and OS will also be fitted with cytokine and chemokine levels either at baseline or as time-dependent continuous covariates. Schoenfeld residuals will be used to check PH assumption. P-values will be adjusted by false discovery rate of 5%. Measure: Cyotkines and chemokines Time Frame: At baseline and up to 2 years after last dose of study treatment Description: A paired t-test will be used to test whether there are a reduction of SPP1+ MoMacs and an increase in intra-tumoral T cells from baseline to on-treatment time points. Univariable logistic regression models will be fitted for ORR and CBR as response variables with either marker levels at baseline or change in marker levels as continuous covariates. PH Cox regression models for PFS and OS will also be fitted with marker levels either at baseline or as time-dependent continuous covariates. Schoenfeld residuals will be used to check PH assumption. P-values will be adjusted by false discovery rate of 5%. Measure: Multiplex immunohistochemistry markers Time Frame: At baseline and up to 2 years after last dose of study treatment Description: Univariable logistic regression models will be fitted for ORR and CBR as response variables with PD-L1 expression as continuous covariate. Univariable PH Cox regression models for PFS and OS will be fitted with PD-L1 expression as continuous covariate. Schoenfeld residuals will be used to check PH assumption. Measure: PD-L1 expression Time Frame: Up to 2 years after last dose of study treatment Description: A paired t-test will be used to test whether there are a decrease in SPP1+ CD68+ cells and an increase in C1QC+ CD68+ cells from baseline to on-treatment time points. Univariable logistic regression models will be fitted for ORR and CBR as response variables with either TME markers at baseline or change in TME marker levels as continuous covariates. PH Cox regression models for PFS and OS will be fitted with TME markers either at baseline or as time-dependent continuous covariates. Schoenfeld residuals will be used to check PH assumption. P-values will be adjusted by false discovery rate of 5%. Measure: Tumor microenvironment (TME) markers Time Frame: At baseline and up to 2 years after last dose of study treatment #### Primary Outcomes Description: Adverse events (AEs) will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Occurrence of DLTs along with with count and percentage of subjects experiencing DLTs will be summarized. Safety of the combination regimen will be summarized by the number of adverse events as well as by the number and percentage of subjects experiencing the adverse events in both dose escalation and expansion cohorts. The safety summary will include count and percentage for overall and by AE type, seriousness, severity, attribution, anticipated or not. Furthermore, toxicity index will be calculated as a summary index for each patient to summarize multiple AEs. Measure: Dose limiting toxicities (DLTs) Time Frame: Up to completion of cycle 1 Description: The RP2D may be determined to be the highest dose level, the maximum tolerated dose, or it may be a lower dose based on the consensus of the investigators, Cancer Therapy Evaluation Program and pharmaceutical company collaborators. Measure: Recommended phase 2 dose (RP2D) Time Frame: Up to completion of cycle 1 Description: AEs will be graded using NCI CTCAE v 5.0. Safety will be summarized by the number of AEs as well as by the number and percentage of subjects experiencing the AEs in both the dose escalation and dose expansion phases of the study. The safety summary will include count and percentage for overall and by AE type, seriousness, severity, attribution, anticipated or not. Toxicity will be calculated as a summary index for each patient to summarize multiple AEs. Measure: Incidence of AEs Time Frame: Up to 30 days after last dose of study treatment #### Secondary Outcomes Description: ORR will be defined as the proportion of patients achieving a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria at 9 weeks. The number of confirmed responses will be reported along with a corresponding two-sided 95% Wilson confidence interval (CI) and p-value will be reported from Binomial exact test. Measure: Objective response rate (ORR) Time Frame: At 9 weeks Description: PFS will be defined as the time from initial treatment to any progression or death from any cause, whichever occurs first. Kaplan-Meier estimates of median PFS time will be presented together with two-sided 95% CIs calculated according to Brookmeyer and Crowley. The frequency (number and percentage) of participants with an event (progression or death) and censoring reasons will be presented (alive, withdrawal of consent, lost to follow-up). Measure: Progression-free survival (PFS) Time Frame: At initial treatment to progression or death up to 2 years after last dose of study treatment Description: OS will be defined as the duration from the first date of study treatment to the date of death. Kaplan-Meyer estimates of median OS will be presented together with two-sided 95% CIs calculated according to Brookmeyer and Crowley. the frequency of participants with an event and censoring reasons will be presented. Measure: Overall survival (OS) Time Frame: At start of study treatment to death up to 2 years after last dose of study treatment Description: DOR will be defined as the time from date of the first documentation of response to the first documentation of progression of disease or death due to any cause in the absence of documented progression of disease. Kaplan-Meier estimates of median DOR time will be presented together with two-sided 95% CIs calculated according to Brookmeyer and Crowley. The frequency of participants with an event and censoring reasons will be presented. Measure: Duration of response (DOR) Time Frame: At first response to progression or death up to 2 years after last dose of study treatment Description: The 2IR score will be calculated using the mean expression levels of the adaptive immune response and pro-tumorigenic inflammation gene signatures from the baseline and on-treatment transcriptome profile derived for each subject. A paired t-test will be used to test whether there is an increase in 2IR score from baseline to on-treatment time points. Univariable logistic regression models will be fitted for response variables with either 2IR score at baseline and change in 2IR score as continuous covariates. Proportional hazard (PH) Cox regression models for PFS and OS will also be fitted with 2IR score either at baseline or as time-dependent continuous covariates. Measure: 2IR scores Time Frame: At baseline and up to 2 years after last dose of study treatment ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients must have histologically confirmed urothelial cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * Age ≥ 18 years * Because no dosing or adverse event data are currently available on the use of CA-4948 in combination with pembrolizumab in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) within 28 days prior to registration * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count (ANC) ≥ 1,500/mcL * Platelets ≥ 100,000/mcL * Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L * Criteria must be met without packed red blood cell (pRBC) transfusion within the prior 2 weeks. Participants can be on stable dose of erythropoietin (≥ approximately 3 months) * Creatine phosphokinase (CPK) \< grade (Gr) 2 ( \</= 2.5 upper limit of normal \[ULN\]) * Measured or calculated creatinine clearance (CrCl) ≥ 30 mL/min for patient with creatine levels ≥ 1.5 x institutional ULN * Creatinine clearance (CrCl) should be calculated per institutional standard * Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) ≤ 3 x ULN * Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x ULN * International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants * Activated partial thromboplastin time (aPTT) ≤1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Ability to provide at least 20 unstained slides or formalin-fixed paraffin-embedded (FFPE) block plus 1 hematoxylin and eosin (H\&E) slide from prior archival invasive urothelial cancer specimen (and/or ability to undergo baseline tumor biopsy in patients in the expansion cohort) * Measurable metastatic or unresectable disease * Must have received prior treatment with a PD-1 or PD-L1 inhibitor * Must have received at least one of the following (may have been administered concurrently or sequentially with PD-1/PD-L1 inhibitor): * Platinum-based chemotherapy * Enfortumab vedotin * Primary resistance to PD-1/PD-L1 blockade as defined by Society for Immunotherapy of Cancer (SITC) consensus definitions: * For patients who received single-agent PD-1/PD-L1 blockade in the adjuvant setting: * Must have received ≥ 6 weeks of treatment with PD-1/PD-L1 blockade * Recurrence while on treatment or within ≤ 3 months after completion of therapy * For patients who received single-agent PD-1/PD-L1 blockade in the metastatic setting: * Must have received ≥ 6 weeks of treatment with PD-1/PD-L1 blockade * Progression within ≤ 6 months of initiating treatment with single-agent PD-1/PD-L1 blockade with best response of stable disease * For patients who received single-agent PD-1/PD-L1 blockade in the switch-maintenance setting: * Must have received ≥ 6 weeks of treatment with PD-1/PD-L1 blockade * Progression within ≤ 6 months of initiating treatment with single-agent PD-1/PD-L1 blockade * For patients who received an antibody-drug conjugate or cytotoxic chemotherapy plus PD-1/PD-L1 blockade combination * Must have received ≥ 6 weeks of treatment with PD-1/PD-L1 blockade * Progression within ≤ 12 months of initiating treatment * An eligibility form will be developed to include documentation of the dates of prior PD-1/PD-L1 blockade and a redacted radiology report confirming best response of stable disease for \< 6 months or progressive disease) * Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female patients of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient * Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Patients who have received messenger ribonucleic acid (mRNA) COVID-19 and influenza vaccines will be allowed * Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan, for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen * Patients should be willing and able to swallow pills * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants Exclusion Criteria: * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) Note: Patients with grade ≤ 2 neuropathy or grade ≤ 2 alopecia are an exception to this criterion and may qualify for the study. Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug * Grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade * History of allergic reactions attributed to compounds of similar chemical or biologic composition to CA-4948 and/or pembrolizumab * Patients with uncontrolled intercurrent illness, including but not limited to interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit compliance with study requirements * Patients who are receiving any other investigational agents * Patients with carcinomatous meningitis * Patients with malabsorption syndrome or other conditions that would interfere with intestinal absorption * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator * Has received a live vaccine within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted * Pregnant women are excluded from this study because pembrolizumab is a monoclonal antibody with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab, breastfeeding should be discontinued if the mother is treated with pembrolizumab. These potential risks may also apply to other agents used in this study * Has known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] RNA \[qualitative\] is detected) * Has a known history of active tuberculosis (TB) Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials Official 1: Affiliation: MOUNT SINAI HOSPITAL Name: Matthew D Galsky Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page. IPD Sharing: YES URL: https://grants.nih.gov/policy/sharing.htm ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5551 - Name: Carcinoma, Transitional Cell - Relevance: HIGH - As Found: Urothelial Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T5693 - Name: Transitional Cell Carcinoma - Relevance: HIGH - As Found: Urothelial Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002295 - Term: Carcinoma, Transitional Cell ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Mg/m2 - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000582435 - Term: Pembrolizumab ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439823 Brief Title: Controlled Study of Upper and Lower Limb Movements in Patients With Neurological Pathologies Official Title: Controlled Study of Upper and Lower Limb Movements in Patients With Neurological Pathologies to Validate Signal Analysis Algorithms for Wearable Devices Using Magneto-inertial Technology #### Organization Study ID Info ID: MoCAP #### Organization Class: OTHER Full Name: Centre Hospitalier Régional de la Citadelle ### Status Module #### Completion Date Date: 2028-08 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: RECRUITING #### Primary Completion Date Date: 2028-08 Type: ESTIMATED #### Start Date Date: 2022-08-24 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: SYSNAV #### Lead Sponsor Class: OTHER Name: Laurent Servais #### Responsible Party Investigator Affiliation: Centre Hospitalier Régional de la Citadelle Investigator Full Name: Laurent Servais Investigator Title: Professor Laurent Servais Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The main aim of the study is to validate the algorithms developed to analyze the signals from the various sensors contained in the magneto-inertial control units and reconstruct upper and lower limb movements under different normal and pathological conditions. ### Conditions Module Conditions: - Neuromuscular Diseases ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: BASIC_SCIENCE #### Enrollment Info Count: 200 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients and controls will be examined by a neuropediatric or neurologist. they will perform upper and lower limb assessments in a walking laboratory. this study comprises a single session per patient/control subject. Intervention Names: - Device: ActiMyo®/Syde® Label: Patient with neuromuscular disease or control subjects Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Patient with neuromuscular disease or control subjects Description: Subjects will be equipped with magneto-inertial sensors (ActiMyo®/Syde®) and passive reflective markers belonging to the MoCap® motion capture system. Name: ActiMyo®/Syde® Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Validate the algorithms developed to analyze the signals from the various sensors contained in magneto-inertial control units and reconstruct upper and lower limb movements. Measure: step length and distance Time Frame: 36 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Subjects over 2 years old * Male or female * Control subjects with no neurological pathology or gait or osteoarticular disorders OR Patients with a neurological condition affecting movement and whose diagnosis is confirmed by a neurologist. * Signed informed consent and, in the case of minors, informed consent signed by the person with parental authority/guardian Exclusion Criteria: * Any other previous or present pathology having an impact on current motor or balance function * Recent surgery or trauma to upper or lower limbs, or major surgery or trauma within 6 months of inclusion. * For control subjects, athlete of at least national level. * Pregnant or breast-feeding women Healthy Volunteers: True Minimum Age: 2 Years Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: laurie.medard@citadelle.be Name: Laurie Medard Phone: 003243218222 Role: CONTACT #### Locations Location 1: City: Liège Contacts: *Contact 1:* - Email: laurie.medard@citadelle.be - Name: Laurie Medard - Phone: 003243218222 - Role: CONTACT Country: Belgium Facility: CHR citadelle State: Liege Status: RECRUITING Zip: 4000 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12411 - Name: Neuromuscular Diseases - Relevance: HIGH - As Found: Neuromuscular Diseases ### Condition Browse Module - Meshes - ID: D000009468 - Term: Neuromuscular Diseases ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439810 Acronym: MYDNITE Brief Title: Diagnostic Utility of Mycobacterium Tuberculosis Cell-free DNA Official Title: Diagnostic Utility of Mycobacterium Tuberculosis Cell-free DNA (MTB cfDNA) in Tuberculous and Non-tuberculous Pleural Effusion #### Organization Study ID Info ID: PF_MTB cfDNA #### Organization Class: OTHER Full Name: Chinese University of Hong Kong ### Status Module #### Completion Date Date: 2026-06-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-12-31 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### 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: Ka Pang Chan Investigator Title: Doctor (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: Tuberculosis (TB) is one of the major global health threats and is the second leading infectious cause of death after COVID-19 in 2022. Extrapulmonary TB (EPTB), amongst which tuberculous pleuritis (TBP) is one of the most common subtypes, poses additional obstacles to global TB control due to its difficulty in diagnosis. The diagnosis of TBP is challenging. The ideal way of confirming TBP is by direct detection of TB bacteria or its specific component in the pleural space. However, the performance of available diagnostic tests is far from satisfactory, and no single test can achieve multiple diagnostic goals simultaneously, including high detection sensitivity, high specificity to exclude other diseases, low invasiveness and detection of drug resistance. The inability to diagnose TBP early leads to unnecessary invasive pleural procedures and delayed curative treatment. There is a pressing need for a better diagnostic test to diagnose TBP confidently. When TB bacteria die or break down, the DNA materials shed into the pleural space, forming Mycobacterium tuberculosis cell-free DNA (MTB cfDNA), which may aid in diagnosing TBP. However, only limited literature explored this aspect, and the sensitivity rates reported were still suboptimal due to the scarcity of DNA materials in the pleural fluid. Based on a small patient cohort, our group has recently developed a new laboratory assay measuring MTB cfDNA to overcome this problem, with a superior diagnostic performance to conventional tests. This assay can potentially capture the genes harbouring drug resistance towards anti-TB medications. There are three aims in this research proposal. First, the diagnostic accuracy of the new MTB cfDNA assay in diagnosing TBP will be determined using a large cohort containing pleural fluid samples of various causes from countries with different TB burdens. Second, the clinical and laboratory factors determining the pleural fluid MTB cfDNA level will be identified. Third, the ability of the assay to capture different anti-TB drug-resistance genes will be explored. This new diagnostic method will significantly enhance the pickup rate of TBP, benefit patients with less invasive procedures, shorter hospital stays and timely treatment. Detailed Description: Tuberculosis (TB) remains a key infectious disease burden globally. According to the Global TB Report by the World Health Organization (WHO) in 2023, TB is the second leading infectious cause of death after COVID-19 in 2022. Extrapulmonary TB, amongst which tuberculous pleuritis (TBP) is one of the most common subtypes, poses additional obstacles to global TB control due to its difficulty in diagnosis. There is a large geographical variation in the incidence of TBP, with the proportion of TBP among all TB patients ranging from 2.2% to 31.4%. An increasing incidence of TBP was noted in two large retrospective Chinese cohort studies. The paucibacillary nature of TBP leads to its diagnostic challenge. Despite being a gold standard diagnostic test, the diagnostic sensitivity of pleural fluid Mycobacterium tuberculosis (MTB) culture is suboptimal. It varies between 7.0% and 75.0%, depending on the culture medium and HIV status. Its long turnaround time of around 4 to 8 weeks also impairs its clinical practicality. Commercial PCR techniques, such as Xpert MTB/RIF or Xpert Ultra, are rapid and specific tests with positive results. However, their utilities are limited by suboptimal sensitivity. Pleural biopsy for histology and combined histology / culture might raise the sensitivity to 66% and 79%, but this procedure is more invasive than thoracentesis. Pleural fluid adenosine deaminase (ADA) is the most commonly studied biomarker, with diagnostic sensitivity and specificity of 0.93 and 0.90 at a cutoff of 40 U/L. Its cutoff range may vary with patient characteristics (age, comorbid illness). The difficulty in diagnosing TBP, therefore, leads to delayed initiation of anti-TB treatment. Empirical anti-TB treatment may be initiated based on compatible clinical presentations without confirmatory diagnostic microbiological results, bearing the risk of treatment toxicities (e.g. hepatotoxicity). This suggests an unmet clinical need for a better diagnostic tool for TBP. Detecting MTB cell-free DNA (cfDNA) in the pleural fluid may solve the above problems. It is a potential diagnostic tool with minimal invasiveness and, most importantly, a direct confirmation of MTB in the pleural space. However, previous PCR-based methods reported suboptimal sensitivity for diagnosing TBP, of about 40-80%. The sensitivity may be limited by the low level of MTB cfDNA and the single-gene target (IS6110 or devR) in the detection. With the advancement of next-generation sequencing (NGS) technology, the detection of microbial cfDNA by metagenomic NGS (mNGS) has been applied in infectious disease diagnostics. Chang et al. have previously evaluated the use of mNGS in blood and urine samples for tuberculosis diagnostics. They revealed that such methodology is limited by the low MTB concentration and the background of contaminating non-tuberculous mycobacterial (NTM) DNA, which shares similar sequences to the pathogenic MTB. Our group has recently developed a new laboratory assay measuring the MTB cfDNA levels. We hypothesise that the new MTB cfDNA assay has better diagnostic performance than conventional microbiological methods in discriminating pleural effusions due to TBP from non-TBP. Since the development cohort only contains a limited number of pleural fluid samples, a large-scale confirmatory study containing pleural effusions with a wide spectrum of causes is required to confirm its clinical utility before being introduced in clinical practice. This study has three major aims. First, the diagnostic accuracy of the new MTB cfDNA assay in diagnosing TBP will be determined using a large cohort containing pleural fluid samples of various causes from countries with different TB burdens. Second, the clinical and laboratory factors determining the pleural fluid MTB cfDNA level will be identified. Third, the ability of the assay to capture different anti-TB drug-resistance genes will be explored on pleural fluid from DR-TB endemic areas. ### Conditions Module Conditions: - Tuberculosis, Pleural Keywords: - Tuberculosis - Tuberculous pleuritis - cell-free DNA ### Design Module #### Bio Spec Description: Pleural fluid for cell-free DNA extraction Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: CASE_CONTROL Time Perspective: PROSPECTIVE #### Enrollment Info Count: 400 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients with definite or probable tuberculous pleuritis Intervention Names: - Diagnostic Test: Mycobacterium tuberculosis (MTB) cell-free DNA (cfDNA) Label: Tuberculous pleuritis #### Arm Group 2 Description: Patients without tuberculous pleuritis Intervention Names: - Diagnostic Test: Mycobacterium tuberculosis (MTB) cell-free DNA (cfDNA) Label: Non-tuberculous pleuritis ### Interventions #### Intervention 1 Arm Group Labels: - Non-tuberculous pleuritis - Tuberculous pleuritis Description: Comparing the diagnostic accuracy between MTB cfDNA and PCR on diagnosing tuberculous pleuritis Name: Mycobacterium tuberculosis (MTB) cell-free DNA (cfDNA) Other Names: - Mycobacterium tuberculosis PCR Type: DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes Description: to evaluate the diagnostic accuracy of the new MTB cfDNA assay in a randomly selected cohort of pleural effusions containing TBP and non-TBP aetiologies. Measure: diagnostic accuracy of the new MTB cfDNA assay Time Frame: 24 months #### Secondary Outcomes Description: Diagnostic performance of the new MTB cfDNA assay with MTB PCR in diagnosing MTB culture-positive and MTB culture-negative TBP Measure: Diagnostic performance of the new MTB cfDNA assay Time Frame: 24 months Description: Clinical and laboratory factors may affect MTB cfDNA levels in pleural fluid Measure: Clinical factors that may affect the levels of MTB cfDNA in TBP Time Frame: 24 months Description: Diagnostic performance of the new MTB cfDNA assay in capturing drug resistance genes towards anti-TB medications Measure: Diagnostic performance of the new MTB cfDNA assay (drug resistant TB) Time Frame: 24 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * New-onset pleural effusion planning for thoracentesis * Age 18 years or above * Able to give informed consent Exclusion Criteria: * History of TBP or intrapleural therapy (including talc and fibrinolytic) in the ipsilateral pleural space. Patients with a history of TB outside the pleural space completed anti-TB treatment can be included * History of surgical intervention (including decortication, pleurodesis, lung resection) in the ipsilateral pleural space * Concomitant use of at least two anti-TB medications (including isoniazid, rifampicin, pyrazinamide, ethambutol, amikacin, streptomycin, levofloxacin, moxifloxacin, linezolid) for more than consecutive 7 days in the past 3 months * Consent not obtained from the participants Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Patients with definite or probably TBP will be recruited as positive control. Patients without TBP will be recruited as negative control ### Contacts Locations Module #### Central Contacts Contact 1: Email: chankapang@cuhk.edu.hk Name: Ka Pang Chan, MBChB Phone: 35052211 Role: CONTACT #### Overall Officials Official 1: Affiliation: Prince of Wales Hospital Name: Ka Pang Chan, MBChB Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009164 - Term: Mycobacterium Infections - ID: D000000193 - Term: Actinomycetales Infections - ID: D000016908 - Term: Gram-Positive Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000092225 - Term: Tuberculosis, Extrapulmonary - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000010995 - Term: Pleural Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M17127 - Name: Tuberculosis - Relevance: HIGH - As Found: Tuberculosis - ID: M17146 - Name: Tuberculosis, Pleural - Relevance: HIGH - As Found: Tuberculosis, Pleural - ID: M13886 - Name: Pleural Effusion - Relevance: LOW - As Found: Unknown - ID: M12119 - Name: Mycobacterium Infections - Relevance: LOW - As Found: Unknown - ID: M13888 - Name: Pleurisy - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19252 - Name: Gram-Positive Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M2910 - Name: Tuberculosis, Extrapulmonary - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M13885 - Name: Pleural Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014376 - Term: Tuberculosis - ID: D000014396 - Term: Tuberculosis, Pleural ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439797 Acronym: ECT MDD Brief Title: Inflammatory Markers as Predictors of the Efficacy of Electroconvulsive Therapy (ECT) in Major Depression Patients Official Title: Inflammatory Markers as Predictors of the Efficacy of Electroconvulsive Therapy (ECT) in Major Depression Patients #### Organization Study ID Info ID: 5040-18-SMC #### Organization Class: OTHER Full Name: The Chaim Sheba Medical Center ### Status Module #### Completion Date Date: 2020-07-09 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: COMPLETED #### Primary Completion Date Date: 2020-07-09 Type: ACTUAL #### Start Date Date: 2018-11-29 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Hebrew University of Jerusalem #### Lead Sponsor Class: OTHER Name: The Chaim Sheba Medical Center #### Responsible Party Investigator Affiliation: Tel Aviv University Investigator Full Name: Revital Amiaz Investigator Title: Head of Psychiatry Department B, The Chaim Sheba Medical Center Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Background: ECT is an effective treatment indicated for patients with treatment resistant depression. Although most patients display some degree of recovery, 32-52% do not respond or remit at all. Considering the possible side effects and the considerably high cost of treatment, it is important to identify sub-populations that would benefit the most from ECT. In the current study we sought to identify predictive molecular markers in the blood of depressed patients who are responsive to ECT. Methods: Patients, ages 18-70, with the diagnosis of treatment-resistant depression will be recruited. Participants will undergo psychiatric and psychological assessments, before (baseline) and 12 weeks after ECT initiation. Assessments will include the Montgomery-Asberg Depression Rating Scale (MADRAS), Clinical Global Improvement and Severity Scales (CGI-S, CGI-I), Inventory of Depressive Symptomatology (IDS), and the State-Trait Anxiety Inventory (STAI). Blood samples for serum and isolation of peripheral blood mononuclear cells (PBMCs)will be collected at baseline and the 12-week end-of-treatment time points for molecular analysis. Detailed Description: Despite impressive progress in our understanding of the molecular, cellular and circuit-level correlates of major depression, the biological mechanisms that causally underlie this disorder remain unclear, hindering the development of effective novel therapeutic procedures. One possible reason for this situation is that almost all research in this area focuses on the involvement of abnormalities in neuronal functioning, whereas the involvement of non-neuronal brain cells, particularly microglia, has not been thoroughly investigated. Recent studies indicate that impairments of the normal structure and function of microglia, caused by either intense inflammatory activation or by decline and senescence of these cells, can lead to depression and associated impairments in neuroplasticity and neurogenesis. Accordingly, we argued that at least some forms of depression can be considered as microgliopathies, in which either microglial activation or microglial decline and suppression constitute the direct etiology of the depressive syndrome. This implies that depression cannot be treated uniformly but should rather be treated by a personalized medical approach based on the microglial status of the individual depressed patient (Yirmiya et al., TiNS, 2015). In the current proposal we aim to lay foundations for a thorough examination of the personalized medical approach to depression, by examining the benefits of personalized utilization of anti-depressive procedures based on screening for inflammatory/ microglial markers, and by developing state-of-the-art tools for microglia manipulations that will allow to directly examine the causal role of these cells in various animal models of depression. We specifically aim to develop a personalized approach to the utilization of electroconvulsive therapy (ECT), because our preliminary findings in a mouse model of depression associated with impaired microglia functioning conclusively show that ECT-induced microglia activation is causally related to the anti-depressive effects of this treatment. We propose to utilize a translational approach, assessing the inflammatory/microglia-related molecular factors (measured before treatment) that predict and contribute to the efficacy of ECT in major depression patients. Specifically, we expect that ECT will be more beneficial in patients with low expression of inflammatory/microglia-related genes, and thus based on the findings of this experiment we shall be able to devise a molecular screening for the suitability of ECT (and possibly other anti-depressant procedures) for the individual depressed patient. Furthermore, we aim to establish the transcriptomic effects of ECT, with a particular emphasis on inflammatory-related pathways. We expect differential transcriptomic effects of ECT in patients with high vs. low baseline inflammatory status. The results should significantly contribute to our knowledge regarding the molecular mechanisms that underlie the therapeutic effects of ECT in specific sub-groups of depressed patients. In parallel studies we aim to develop molecular tools for selective and region-specific microglia activation or inhibition and to use these tools for: 1) examining the effects of these manipulations in animal models of depression that involve either hyper-or hypo-activity of microglia. 2) defining the causal role of microglia in mediating the anti-depressive effects of ECT in a depression model associated with low microglia status. These studies should complement the clinical part in humans, by providing definitive evidence for the inverted U-shape pattern of relations between inflammatory status and depression, which constitutes the basis for the personalized medical approach to this disease. ### Conditions Module Conditions: - Major Depressive Disorder - Healty Controls ### Design Module #### Design Info Observational Model: CASE_CONTROL Time Perspective: PROSPECTIVE #### Enrollment Info Count: 18 Type: ACTUAL Study Type: OBSERVATIONAL ### Outcomes Module #### Primary Outcomes Description: Patients, ages 18-70, with the diagnosis of treatment-resistant depression will recruited. Participants will undergo psychiatric and psychological assessments, before (baseline) and 12 weeks after ECT initiation. Assessments included the Montgomery-Asberg Depression Rating Scale (MADRAS), Clinical Global Improvement and Severity Scales (CGI-S, CGI-I), Inventory of Depressive Symptomatology (IDS), and the State-Trait Anxiety Inventory (STAI). Blood samples for serum and isolation of peripheral blood mononuclear cells (PBMCs) will be collected at baseline and the 12 weeks end-of-treatment time points for molecular analysis. Measure: Inflammatory Markers as Predictors of the efficacy of Electroconvulsive Therapy (ECT) in Major Depression Patients. Time Frame: Before ECT treatment and after 12 treatments, After 3 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Capable and willing to provide informed consent. Able to adhere to the treatment schedule. Are treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF (antidepressant treatment history form) instruction guidelines. Exclusion Criteria: * Diagnosis of an autoimmune disease. History of disturbances with bone marrow functioning. History of Oncologic Diseases. History of drug abuse or alcoholism in the last 6 months. Suffering from another diagnosis on axis 1, including schizophrenia, and geriatric depression. Patients with any current unstable medical illness. Any condition involving fluid retention, pulmonary infiltrates, congestive heart failure, respiratory symptoms or disease, cardiac symptoms or disease, and renal or hepatic dysfunction Patients taking lithium or corticosteroids. Pregnancy or not using a reliable method of birth control. Neurodegenerative diseases (i.e: Alzheimer's disease, Parkinson's disease). Participation in a current interventional clinical study or interventional clinical study within 30 days before this study. Maximum Age: 70 Years Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Major Depressive Disorder with treatment-resistant disorder referred to the ECT clinic ### Contacts Locations Module #### Locations Location 1: City: Ramat Gan Country: Israel Facility: Revital Amiaz State: RI Zip: 52621 ## 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: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - 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: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439784 Acronym: VERIOS Brief Title: Contribution of the VERITON-CT Camera in Prostate Bone Radiostereotaxy Official Title: Contribution of 99mTc-HDP Whole-body SPECT/CT Imaging by VERITON-CT CZT Camera in Stereotactic Radiotherapy Treatment of Bone Metastases of Prostate Cancer #### Organization Study ID Info ID: CHB23.06 #### Organization Class: OTHER Full Name: Centre Henri Becquerel ### Status Module #### Completion Date Date: 2027-06-15 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-06-15 Type: ESTIMATED #### Start Date Date: 2024-06-15 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Centre Henri Becquerel #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Stereotactic radiotherapy enables bone metastases to be treated with highly precise irradiation beams, enabling small targets to be irradiated. Planning requires the use of cross-sectional imaging such as computed tomography (CT) or magnetic resonance imaging (MRI). Bone scintigraphy with Tc99m-labelled biphosphonates (T1/2=6h) is indicated in the extension assessment of prostate cancers. Thanks to the advent of single-photon emission computed tomography (SPECT) based on CZT detectors; whole-body SPECT is now compatible with clinical constraints. We propose to study the value of using whole-body SPECT for planning stereotactic radiotherapy of metastatic prostate cancer. This is a prospective, single-center, non-randomized study involving 30 patients. Patients will benefit from routine examinations (CT scan, MRI) including a bone SPECT/CT in treatment position performed on the VERITON-CT (Spectrum Dynamics, Haifa, Israel). Planning based on whole-body SPECT images will be carried out remotely from the patient's point of care. The examination will be interpreted by the nuclear physician, and planning will be based on the dosimetric CT scanner, as in standard management. Virtual replanning will be carried out at distance from treatment, incorporating SPECT imaging. Treatment plans with and without SPECT will be compared quantitatively and qualitatively. The feasibility of SPECT imaging in the treatment position will be assessed, enabling lesion location imaging and dosimetric scanning to be performed in a single examination. All therapeutic management and clinical follow-up will be carried out as part of routine care. Detailed Description: This is a prospective, single-center, non-randomized study. After a decision in a multidisciplinary consultation meeting, the patient will be offered to join the study. All therapeutic care and clinical follow-up is carried out as part of routine care. Patients will benefit from routine examinations (CT scan, MRI) including a SPECT/CT scan of the bone in the treatment position. Three hours after injection of 9 MBq/kg of 99mTc-HDP, CT imaging followed by whole-body SPECT/CT will be performed on the VERITON-CT (Spectrum Dynamics, Haifa, Israel). In order to make the images in the treatment position, the molding of the BodyFIX (Elekta) compression system that is used to reposition the patient between sessions will be made on the examination bed of the VERITON. It is a mattress that stiffens due to air vacuums. It will be placed on an external radiotherapy tray as for the dosimetry scanner. If it is not possible to take the images under these conditions, the patient will benefit from an examination in the standard position. The images will then be interpreted by a nuclear physician who will identify the targets and define the contours from the SPECT/CT data using the segmentation tools available in the Syngo.via visualization software (Siemens Healthineers, Erlangen, Germany). The images and contours will be anonymized in order to allow blind virtual replanning, at least 6 months before the planning. Non-anonymized images alone will be transmitted as a standard examination, but cannot be incorporated into the treatment plan, as is currently the case. The patient will benefit from a standard dosimetry scanner for treatment planning. The molding of the mattress made during the SPECT/CT scan of the bone will be reused for the dosimetric scanner. The therapeutic procedure will then follow the local protocol and in line with national recommendations. Whole-body SPECT/CT imaging will then be performed at 3 and 6 months on the conventional examination bed. The targets identified during the reference whole-body SPECT/CT will be reused in order to measure the evolution of the SUV quantification. ### Conditions Module Conditions: - Prostatic Cancer Keywords: - whole body SPECT/CT - bone scintigraphy - stereotaxic bone radiation therapy ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: OTHER #### Enrollment Info Count: 30 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patient will endergo whole body SPECT/CT in treatment position Intervention Names: - Other: whole body SPECT/CT Label: whole body SPEC/CT Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - whole body SPEC/CT Description: Patient will unergo a whole body SPECT/CT in treatment position Name: whole body SPECT/CT Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Let m1 be the mean of a dosimetric index from whole-body 99mTc-HDP-SPECT/CT imaging and m2 the mean of the same dosimetric index from standard imaging, the null hypothesis will be "H0: m1 ≠ m2" and the alternative hypothesis "H1: m1 = m2". Thus, if we reject the null hypothesis at the risk of 5% then we will highlight the equivalence between m1 and m2. The statistical approach to set up such tests is called TOST and will require the definition of appropriate and relevant equivalence limits. Measure: Equivalency of the two treatment plans in quantitative terms Time Frame: 3 years #### Secondary Outcomes Description: The consortium of radiation therapists will decide which treatment plan will be most beneficial for the patient. The proportion of patients whose SPECT/CT-based plan was chosen will be an indicator of the qualitative impact that this imaging can have on the treatment plan. This proportion will also be associated with its 95% confidence interval for accuracy. Measure: Equivalency of the two treatment plans in qualitative terms Time Frame: 3 years Description: The number of patients who have been able to benefit from 99mTc-HDP-SPECT/CT imaging in a treatment position usable in dosimetric planning will be the main indicator of feasibility. Depending on the results of the feasibility of this imaging in the treatment position, we can deduce different conclusions: If the feasibility is demonstrated (25/30 patients) and the primary outcome does not show a difference between the two treatment plans, we will conclude that 99mTc-HDP-SPECT/CT imaging in the treatment position can be substituted for the standard simulation CT scanner. If feasibility is not demonstrated and the primary outcome does not show a difference between the two treatment plans, we will conclude that 99mTc-HDP-SPECT /CT imaging in the treatment position does not contribute to dosimetry planning. Measure: Feasibility of SPECT/CT imaging in treatment position Time Frame: day of SPECT/CT ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Age ≥ 18 years, * Good general health WHO ≤ 1 * Informed and signed consent prior to any specific study procedure. * Patient affiliated to the social security system * Bone metastases from prostate cancer * Indication for bone stereotactic radiotherapy Exclusion Criteria: * Presence of active cancer in the previous three years * Protected adults (under guardianship or curatorship) * Unable to undergo medical monitoring for geographical, social or psychological reasons * Unable to decubitus (orthopnea, etc.), * Hypersensitivity to HDP or to one of the excipients of the radiopharmaceutical. * History of radiotherapy of the volume to be treated by stereotaxy. Minimum Age: 18 Years Sex: MALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: arnaud.dieudonne@chb-unicancer.fr Name: Arnaud Dieudonne, PhD Phone: +33232082254 Role: CONTACT Contact 2: Email: doriane.richard@chb-unicancer.fr Name: Doriane Richard, PhD Phone: +33232082985 Role: CONTACT #### Locations Location 1: City: Rouen Contacts: *Contact 1:* - Email: arnaud.dieudonne@chb.unicancer.fr - Name: Arnaud Dieudonne, PhD - Phone: +33232082254 - Role: CONTACT Country: France Facility: Centre Henri Becquerel Zip: 76038 #### Overall Officials Official 1: Affiliation: Centre Henri Becquerel Name: Arnaud Dieudonne, PhD Role: STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostatic Cancer - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439771 Brief Title: A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC Official Title: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With Locally Advanced or Metastatic Breast Cancer With TNBC, HR-Positive, HER2-Zero-expression or HER2-Low-expression #### Organization Study ID Info ID: YL202-CN-202-01 #### Organization Class: INDUSTRY Full Name: MediLink Therapeutics (Suzhou) Co., Ltd. ### Status Module #### Completion Date Date: 2028-07-29 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-07-30 Type: ESTIMATED #### Start Date Date: 2024-07-31 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-16 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: MediLink Therapeutics (Suzhou) Co., Ltd. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True ### Description Module Brief Summary: This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression ### Conditions Module Conditions: - Locally Advanced or Metastatic Breast Cancer ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 180 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: YL202 is provided as the lyophilized powder, 200 mg/vial. Triple-negative breast cancer (TNBC) patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. Intervention Names: - Drug: YL202 should be intravenously infused Label: Experimental: Corhort A Type: EXPERIMENTAL #### Arm Group 2 Description: YL202 is provided as the lyophilized powder, 200 mg/vial. HR-positive breast cancer with HER2-Zero-expression and HER2-Low-expression patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. Intervention Names: - Drug: YL202 should be intravenously infused Label: Experimental: Corhort B Type: EXPERIMENTAL #### Arm Group 3 Description: YL202 is provided as the lyophilized powder, 200 mg/vial. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC (excluding HER2+ patients, ie, HER2 IHC 3+ or IHC 2+/ISH+ patients) will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. Intervention Names: - Drug: YL202 should be intravenously infused Label: Experimental: Corhort C Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Experimental: Corhort A - Experimental: Corhort B - Experimental: Corhort C Description: For each patient, YL202 should be intravenously infused over 60±10 min. Name: YL202 should be intravenously infused Type: DRUG ### Outcomes Module #### Primary Outcomes Description: ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). Measure: ORR assessed according to RECIST v1.1 Time Frame: By the end of trial date, approximately within 36 months Measure: Determination of the recommended dose of YL202 in the pivotal clinical study Time Frame: By the end of trial date, approximately within 36 months #### Secondary Outcomes Measure: Progression-free survival (PFS) assessed according to RECIST v1.1 Time Frame: By the end of trial date, approximately within 36 months Measure: Clinical benefit rate (CBR) assessed based on RECIST v1.1 Time Frame: By the end of trial date, approximately within 36 months Measure: Depth of response (DpR) assessed based on RECIST v1.1 Time Frame: By the end of trial date, approximately within 36 months Measure: Disease control rate (DCR) assessed based on RECIST v1.1 Time Frame: By the end of trial date, approximately within 36 months Measure: Duration of response (DOR) assessed based on RECIST v1.1 Time Frame: By the end of trial date, approximately within 36 months Measure: Time to response (TTR) assessed based on RECIST v1.1 Time Frame: By the end of trial date, approximately within 36 months Measure: Evaluate the overall survival (OS) Time Frame: By the end of trial date, approximately within 36 months Measure: Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment Time Frame: Approximately within 36 months Description: steady-state area under curve (AUC) Measure: Characterize the PK parameter AUC Time Frame: Approximately within 36 months Description: peak concentration (Cmax) Measure: Characterize the PK parameter Cmax Time Frame: Approximately within 36 months Description: trough concentration (Ctrough) Measure: Characterize the PK parameter Ctrough Time Frame: Approximately within 36 months Description: clearance (CL) Measure: Characterize the PK parameter CL Time Frame: Approximately within 36 months Description: volume of distribution (Vd) Measure: Characterize the PK parameter Vd Time Frame: Approximately within 36 months Description: half-life (t1/2) Measure: Characterize the PK parameter t1/2 Time Frame: Approximately within 36 months Measure: Incidence of anti-YL202 antibody Time Frame: Approximately within 36 months Measure: Evaluate the corelaton between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate Time Frame: Approximately within 36 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form. 2. Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system \[Version 8\]) who are not candidates for curative surgery or radiotherapy. 3. Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,. 4. Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression. 5. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC. 6. Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 7. Have Adequate organ and bone marrow function within 7 days prior to the first dose. 8. Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug. 9. Have a expected survival ≥ 3 months. 10. Have ability and willingness to comply with protocol-specified visits and procedures. Exclusion Criteria: 1. Have prior treatment with an agent targeting HER3. 2. Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor. 3. Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an interventional study. 4. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug. 5. Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study. 6. Have prior allogeneic bone marrow transplant or prior solid organ transplant. 7. Have received treatment with systemic steroids. 8. Have received any live vaccine within 4 weeks prior to the first dose of study drug or intend to receive a live vaccine during the study. 9. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression. 10. Brain metastases with the exceptions. 11. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease. 12. Have clinically significant concomitant pulmonary diseases. 13. Have a diagnosis of Gilbert's syndrome. 14. Have pleural effusion, abdominal effusion. 15. Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose. 16. Have serious infection. 17. Patients with human immunodeficiency virus (HIV) infection. 18. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 19. Have any other primary malignancy within 5 years prior to the first dose of study drug. 20. Have unresolved toxicities from prior anticancer therapy. 21. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies. 22. Lactating women, or women who are confirmed to be pregnant by pregnancy test within 3 days prior to the first dose. Maximum Age: 75 Years Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Name: r Role: CONTACT #### Locations Location 1: City: Shanghai Contacts: *Contact 1:* - Email: RA@medilinkthera.com - Name: Coordinator Clinical operation director - Role: CONTACT Country: China Facility: Fudan University Shanghai Cancer Center State: Shanghai Zip: 250117 ## 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 ### 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 ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439758 Brief Title: Effects of First-Line Oral Hypoglycemics in Bone Markers of Treatment Naïve Saudi Adults With Type 2 Diabetes Official Title: Effects of First-Line Oral Hypoglycemics in Bone Markers of Treatment Naïve Saudi Adults With Type 2 Diabetes #### Organization Study ID Info ID: IRB log Number: 2024-6 #### Organization Class: OTHER Full Name: King Saud University ### Status Module #### Completion Date Date: 2025-12-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-08-01 Type: ESTIMATED #### Start Date Date: 2024-08-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-20 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: King Saud University #### Responsible Party Investigator Affiliation: King Saud University Investigator Full Name: Mohammed Ali Almosfer Investigator Title: Principal Investigator Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Both diabetes mellitus and osteoporosis are prevalent diseases with crucial associated mortality and morbidity. There is no clear relevance between bone diseases and diabetes mellitus. Previous research indicates that diabetes and complications related to this disease can contribute to bone disease and DM can also determine bone health. Both kinds of diabetes mellitus bring fracture risk, the most substantial clinical osteoporosis endpoint, which has crucial impact on mortality and morbidity including quality of life of an individual. Although research shows that there is association between Type 1 diabetes (T1DM) and decreased bone mineral density (BMD) values, patients with Type 2 diabetes (T2DM) have either normal or higher than expected BMD values usually. General Objective: To determine the influence of first-line anti-DM therapies in bone turnover markers and metabolism among T2DM naïve Saudi adults. Specific objectives: * To investigate the differences in the 3- and 6-month effects of metformin alone, lifestyle intervention alone and combination (metformin + lifestyle modification) on bone markers in T2DM naïve Saudi adults. * To investigate the differences in the 3- and 6-month effects of metformin alone, lifestyle intervention alone and combination (metformin + lifestyle modification) on metabolism in T2DM naïve Saudi adults. Detailed Description: Design and Setting The present investigation is a multi-center intervention study to be conducted in Hail, Saudi Arabia. The primary endpoint of the study is changes in bone markers. Participants Consenting Saudi adults, males, and females, aged 25-65 years with newly diagnosed T2DM will be included. T2DM diagnosis will be done by collaborating primary care physicians following the American Diabetes Association (ADA) and World Health Organization (WHO) criteria: Fasting plasma glucose ≥7.0mmol/l or ≥126mg/dl. Fasting is defined as no caloric intake for at least 8 hours OR • 2-h PG ≥200 mg/dl (11.1 mmol/L) during OGTT. The test should be performed as described by WHO, using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water. OR • Hba1c ≥6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and Complications (Trial) DCCT assay. OR • In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dl (11.1 mmol/L). Exclusion Criteria * Non-Saudis and those outside the age range (less than 25 years and above 65 years old). * Those with comorbidities and existing complications (osteoporosis, uncontrolled hypertension, atherosclerosis, renal and liver abnormalities, morbidly obese, psychologically incapacitated). * Known cases of T2DM who are already on medications. * Participants who will be unable to commit to the treatment allocated for 6 months, either for personal reasons or physician's advice. Intervention Participants will be assigned to receive, for 6 months either A) Metformin 500mg/day, B) Lifestyle Modification or C) Metformin + Lifestyle Modification. The lifestyle modification management was based on a T2DM prevention program for people with prediabetes and includes weight reduction to 5% from baseline, moderate exercise (150min/week), reduction of fat intake and increased fiber intake (15g/1000kcal). Monitoring will be done at baseline, after 3 months and after 6 months. Below is the schematic diagram of the study: Figure 1: Schematic diagram of the intervention study. Data Collection A generalized questionnaire will be administered to patients at baseline which includes demographics, medical history and risk for osteoporosis. Anthropometrics Height (cm) and weight (kg) will be measured with the participant wearing light clothing. Waist (cm) and hip (cm) circumferences will be measured using standard tape measure. Blood pressure (mmHg) will be measured using a digital sphygmomanometer twice at 15min interval and the average will be recorded. Sample Collection Fasting blood samples will be collected from participants at baseline and follow-up visits. Routine blood tests (Glucose/HbA1c, liver function tests, renal function tests, and lipid profile) will be done at primary healthcare will be measured using the ARCHITECT c4000 clinical chemistry analyzer and Abbott Afinion HbA1c analyzer. For the bone markers (CTX, PINP, Sclerostin, and Osteocalcin) will be sent to the Chair for Biomarkers of Chronic Diseases (CBCD) in King Saud University, Riyadh, Saudi Arabia for testing using the enzyme-linked immunosorbent assay (ELISA). CTX and PINP will be measured using Cobas e411 immunoassay analyzer. Sclerostin, and Osteocalcin (NMID)will be measured using commercially available assays. Sample size calculation Mori et al. (2017) have reported the significant decrease in CTX after 3-months in participants consuming metformin as compared to participants consuming pioglitazone with the effect size of 0.40. In our study, to determine the significant change in BTM with the effect size of 0.30 with the power of 80% the required total sample size would be 111 at 95% CI divided in 3 groups (N=37 per group). We intend to recruit 40 participants or more per group to account for dropouts. Data Analysis Data analysis will be done using SPSS (version 21, Chicago, IL, USA). Statistical analysis will be performed using Intent-to-Treat analysis. All normally distributed data will be presented as mean and standard deviations, while non-normally distributed data will be presented as median and interquartile range. Categorical data will be presented as frequencies and percentages (%). Analysis of Variance (ANOVA) and Kruskal Wallis tests will be used to compare significant baseline differences between groups. Log transformation will be used to transform non-normal variables prior to repeated measure analysis of variance ANOVA, which will be used to obtain within group differences. Logistic regression analysis showing odds of improvement in bone markers as well as other variables of interest in groups will be calculated. A p-value \<0.05 was considered statistically significant. ### Conditions Module Conditions: - Diabetes Type 2 - Osteoporosis ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - CARE_PROVIDER Primary Purpose: TREATMENT #### Enrollment Info Count: 111 Type: ESTIMATED Phases: - PHASE4 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Intervention Names: - Drug: Metformin Label: Metformin Type: EXPERIMENTAL #### Arm Group 2 Description: The effect is when a person's physical or mental health appears to improve after changing their diary system. Intervention Names: - Behavioral: Lifestyle Label: Lifestyle Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Metformin Description: Metformin 1000 mg/day for 6 months Name: Metformin Type: DRUG #### Intervention 2 Arm Group Labels: - Lifestyle Description: Dietary lifestyle modifications Name: Lifestyle Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Changes in CTX (pg/mL) Measure: Changes in bone marker CTX post intervention Time Frame: 6 months Description: Changes in PINP (ug/L) Measure: Changes in bone marker PINP post intervention Time Frame: 6 months Description: Changes in Sclerostin (pmol/L) Measure: Changes in bone marker Sclerostin post intervention Time Frame: 6 months Description: Changes in Osteocalcin (ng/mL) Measure: Changes in bone marker Osteocalcin post intervention Time Frame: 6 months #### Secondary Outcomes Description: changes in Lipid profile (HDL, total cholesterol, Triglycerides), Urea, and fasting Glucose (all mmol/L) Measure: Changes in fasting glucose, urea, and lipid profile post intervention Time Frame: 6 months Description: Changes in Creatinine (umol/L) Measure: Changes in Creatinine post intervention Time Frame: 6 months Description: Changes in AST, and ALT (U/L) Measure: Changes in Liver profile post intervention Time Frame: 6 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Consenting Saudi adults, males, and females, aged 25-65 years with newly diagnosed T2DM will be included. * T2DM diagnosis will be done by collaborating primary care physicians following the American Diabetes Association (ADA) and World Health Organization (WHO) criteria (ADA, 2022): * Fasting plasma glucose ≥7.0mmol/l or ≥126mg/dl. Fasting is defined as no caloric intake for at least 8 hours OR * 2-h PG ≥200 mg/dl (11.1 mmol/L) during OGTT. The test should be performed as described by WHO, using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water. OR •Hba1c ≥6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and Complications (Trial) DCCT assay. OR •In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dl (11.1 mmol/L). Exclusion Criteria: * Non-Saudis and those outside the age range (less than 25 years and above 65 years old). * Those with comorbidities and existing complications (osteoporosis, uncontrolled hypertension, atherosclerosis, renal and liver abnormalities, morbidly obese, psychologically incapacitated). * Known cases of T2DM who are already on medications. * Participants who will be unable to commit to the treatment allocated for 6 months, either for personal reasons or physician's advice. Maximum Age: 65 Years Minimum Age: 25 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: 444105548@student.ksu.edu.sa Name: Mohammed Al Almosfer, PhD Phone: 00966540771115 Role: CONTACT Contact 2: Email: ssabico@ksu.edu.sa Name: Shaun B Sabico, M.D. PhD Phone: 00966114675939 Role: CONTACT #### Overall Officials Official 1: Affiliation: King Saud Name: Nassir Mo Al-dagari, PhD Role: STUDY_DIRECTOR ### 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 - ID: D000001851 - Term: Bone Diseases, Metabolic - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal 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: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Type 2 - ID: M12947 - Name: Osteoporosis - Relevance: HIGH - As Found: Osteoporosis - 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: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5130 - Name: Bone Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010024 - Term: Osteoporosis - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11667 - Name: Metformin - Relevance: HIGH - As Found: Assessment - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008687 - Term: Metformin ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439745 Acronym: cN0PTC Brief Title: More Than 50% of the Patients With Clinically Unifocal T1b/Small T2 Node Negative Papillary Thyroid Carcinoma Scheduled for Thyroid Lobectomy May Require Completion Thyroidectomy if the Nodal Status is Evaluated Official Title: More Than 50% of the Patients With Clinically Unifocal T1b/Small T2 Node Negative Papillary Thyroid Carcinoma Scheduled for Thyroid Lobectomy May Require Completion Thyroidectomy if the Nodal Status is Evaluated #### Organization Study ID Info ID: 6584 #### Organization Class: OTHER Full Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Status Module #### Completion Date Date: 2024-02-01 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-09-01 Type: ACTUAL #### Start Date Date: 2014-09-01 Type: ACTUAL Status Verified Date: 2024-03 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-03-07 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: In absence of nodal metastases or aggressive features, thyroid lobectomy (TL) should be preferred over total thyroidectomy (TT) for small unifocal, papillary thyroid carcinoma(PTC). However, occult, despite non-microscopic (\>2 mm), nodal metastases may be present inclinically node-negative (cN0) PTC. Among 4216 thyroidectomies for malignancy (2014-2023), 110 (2.6%) TL plus ipsilateral central neck dissections (I-CND) were scheduled for unifocal cT1b/small cT2 (\<3 cm) cN0 PTCs. Nodes frozen section examination (FSE) was performed: when positive, completion thyroidectomy (CT) was accomplished during the same procedure. In presence of aggressive pathologic features, CT was suggested within 6 months from index operation. Detailed Description: Papillary thyroid carcinoma (PTC) is the most common type of thyroid cancer. Although its incidence has increased in recent decades, the prognosis is excellent due to the indolent nature of disease. Despite that, recurrence rate of PTC remains common. Nowadays, the correct extent of thyroidectomy remains controversial. However, several studies demonstrated no significant differences in terms of disease-free survival (DFS) and loco-regional recurrence (LRR) in differentiated thyroid carcinoma (DTC) \> 1cm after thyroid lobectomy (TL) vs thyroid lobectomy (TT). In absence of preoperative high-risk features (HRFs), the most recent NCCN and ATA guidelines consider unifocal 1-4 cm PTC eligible for TL. However, many of HRFs are highlighted only after histological examination: positive lymph nodes, aggressive tumor subtype, multifocality, microscopic extrathyroidal extension (ETE), positive margin and lymphovascular invasion (LVI). Recent retrospective series showed that up to 59% of preoperative low risk PCT were upgraded to higher risk category after histological examination. Current recommendations could potentially increase the need for reoperation, in terms of completion thyroidectomy (CT) and subsequent administration of RAI in order to reduce the risk of LRR. Among the HRFs, no preoperative clinical parameter is a predictor of nodal disease. However, occult lymph node metastases (LNMs) may be found in 31-62% of patients subjected to prophylactic CND (p-CND). The risk of complications (hypoparathyroidism and laryngeal nerve injury) is the main matter against prophylactic bilateral CND in unifocal node negative PCT. According to a recent systematic review, basing on prevalence of occult central LNM by tumor size, ipsilateral central neck dissection (I-CND) may be justified in all PTC patients. Since isolated contralateral metastases are rare, a routine use of frozen section examination (FSE) of I-CND may allow a more accurate staging with a reduction of morbidity. Although p-CND is not usually recommended in patients with clinically unifocal cT1b/T2 node negative PTC, we supposed that the evaluation of LN status through FSE of I-CND may contribute significantly to risk stratification and consequently to modulate the extension of surgical treatment. In this retrospective study we aim to evaluate the result of this strategy to identify intraoperatively patients who may benefit from total thyroidectomy (TT) with bilateral CND (B-CND), reducing the need of second step CT and, theoretically, the risk of LRR. Among 4176 patients who underwent thyroidectomy for malignancy between September 2014 and September 2023 at Fondazione Policlinico Universitario A. Gemelli - Rome, we identified X patients scheduled for thyroid lobectomy (TL) plus ipsilateral central neck dissection (I-CND) for clinically intrathyroidal unifocal cT1b/small cT2 node negative papillary thyroid carcinoma (PTC). Every patient was informed of the risks and benefits of TL and TT, based on available guidelines. Inclusion criteria were: age\>18; classic papillary carcinoma and variants; clinically unifocal and intrathyroidal PTC; clinical tumor size \>1 cm and ≤3 cm; no clinical evidence of LN involvement. Exclusion criteria were: age \< 18 years; prior head or neck irradiation; family history of thyroid carcinoma; clinical evidence of multifocality, extrathyroidal extension or LN metastases; follow-up \< 6 months. ### Conditions Module Conditions: - Papillary Thyroid Cancer - Papillary Carcinoma - Thyroid Cancer - Thyroid Carcinoma - Thyroid Cancer, Papillary - Lymph Node Metastasis ### Design Module #### Design Info Observational Model: COHORT Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 314 Type: ACTUAL Study Type: OBSERVATIONAL ### Outcomes Module #### Primary Outcomes Description: Evaluation of patients with papillary thyroid carcinoma with histopathology risk factors (such as nodal metastases, aggressive variants, lympho-angioinvasion, extranodal extension, multifocalty, positive resection status) who may require completion thyroidectomy. Measure: evaluation of patients requiring total thyroidectomy Time Frame: September 2014-September 2023 #### Secondary Outcomes Description: Evaluation of recurrence of the disease among the patients' cohort Measure: evaluation of disease recurrence Time Frame: September 2014-September 2023 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * age\>18 * classic papillary carcinoma and variants * clinically unifocal and intrathyroidal PTC * clinical tumor size \>1 cm and ≤3 cm * no clinical evidence of LN involvement Exclusion Criteria: * age \< 18 * prior head or neck irradiation * family history of thyroid carcinoma * clinical evidence of multifocality * extrathyroidal extension or LN metastases * follow-up \< 6 months. Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Patients who underwent surgical treatment of papillary thyroid carcinoma at the Surgical Division of Endocrine and Metabolic Surgery of Fondazione Policlinico Universitario A. Gemelli IRCCS between September 2014 and September 2023. ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009362 - Term: Neoplasm Metastasis - ID: D000009385 - Term: Neoplastic Processes - ID: D000010335 - Term: Pathologic Processes - ID: D000004700 - Term: Endocrine System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000000231 - Term: Adenocarcinoma, Papillary - ID: D000000230 - Term: Adenocarcinoma - ID: D000018307 - Term: Neoplasms, Squamous Cell ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M16723 - Name: Thyroid Neoplasms - Relevance: HIGH - As Found: Thyroid Carcinoma - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M5547 - Name: Carcinoma, Papillary - Relevance: HIGH - As Found: Papillary Carcinoma - ID: M1729 - Name: Thyroid Cancer, Papillary - Relevance: HIGH - As Found: Thyroid Cancer, Papillary - ID: M11204 - Name: Lymphatic Metastasis - Relevance: HIGH - As Found: Lymph Node Metastasis - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M3586 - Name: Adenocarcinoma, Papillary - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: T4401 - Name: Papillary Thyroid Carcinoma - Relevance: HIGH - As Found: Papillary Thyroid Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000008207 - Term: Lymphatic Metastasis - ID: D000077273 - Term: Thyroid Cancer, Papillary - ID: D000002291 - Term: Carcinoma, Papillary - ID: D000013959 - Term: Thyroid Diseases ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439732 Acronym: HERMES Brief Title: Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery Official Title: Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery #### Organization Study ID Info ID: 6704 #### Organization Class: OTHER Full Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Status Module #### Completion Date Date: 2026-07-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-07-01 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-22 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS #### Responsible Party Investigator Affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Investigator Full Name: RUSSO ANDREA Investigator Title: principal investigator Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Is US Export: False ### Description Module Brief Summary: In this study investigators will study the association between the use of an hemodynamic monitoring system and the anesthetic consumption in patients following major abdominal surgery. Investigators will randomise patients for a control group and an intervention group. Patients belonging to intervention group will be monitored with a non-invasively continue system (Acumen IQ cuff sensor), while the control group will be monitored with a non-invasive intermittent pressure system. The total amount of mL of Sevoflurane will be registered in both groups and the difference will be considered as the aim of our study ### Conditions Module Conditions: - Hypotension During Surgery Keywords: - Anestethic comsumption - hemodynamic monitoring ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: TREATMENT #### Enrollment Info Count: 84 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: In this group we will use a continuous non-invasive hemodynamic monitoring system (Acumen IQ cuff) Intervention Names: - Device: Acumen IQ cuff Label: Intervention Type: EXPERIMENTAL #### Arm Group 2 Description: In this group we will use the oscillometric non-invasive blood pressure monitoring system Label: Control Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Intervention Description: Use of Acumen IQ cuff for haemodynamic monitoring Name: Acumen IQ cuff Type: DEVICE ### Outcomes Module #### Primary Outcomes Measure: Reduction in Anesthetic consumption Time Frame: During surgery #### Secondary Outcomes Measure: number hypotensive episodes Time Frame: during surgery Measure: duration hypotensive episodes Time Frame: during surgery ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * over 18 years of age * signature of informed medical consent Exclusion Criteria: * BMI\> 30 * eGFR\<30 * NYHA III-IV * severe cardiac valvular diseases * absence of informed medical consent Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: russoandreamd@gmail.com Name: Andrea Russo, MD Phone: 0630154507 Role: CONTACT Contact 2: Name: Andrea Russo, MD Role: CONTACT #### Overall Officials Official 1: Affiliation: Fondazione Policlinico universitario Agostino Gemelli Name: Andrea Russo, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular 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: M10072 - Name: Hypotension - Relevance: HIGH - As Found: Hypotension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007022 - Term: Hypotension ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439719 Brief Title: Plaque Composition in T2DM With and Without Microvascular Complications Official Title: Differences in Plaque Composition Evaluated Through Coronary Tomography in Subjects With Type 2 Diabetes With and Without Microvascular Complications #### Organization Study ID Info ID: 6561 #### Organization Class: OTHER Full Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Status Module #### Completion Date Date: 2026-05-27 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-05-27 Type: ESTIMATED #### Start Date Date: 2024-05-27 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Adults with diabetes mellitus have 2-3 times fold increased cardiovascular (CV) risk compared to adults without diabetes, and the risk rises with the worsening of glycaemic control. Adults with type 2 diabetes mellitus (T2DM) and microvascular complications (DMCs) have a higher risk of CV complications than subjects without DMCs. 2023 European Society of Cardiology (ESC) guidelines stated that individuals with T2DM with target organ damage (TOD), defined as presence of microvascular disease in at least three different sites (e.g., microalbuminuria (stage A2) plus retinopathy plus neuropathy), should be considered into a very high CV risk category. Coronary artery calcium score (CACS) is a measure of the amount of calcium deposits in the coronary arteries obtained through a CT coronary imaging. CACS has become a widely available and accurate tool for determining the risk of major CV events. The specific role of DMCs in determining the features of coronary plaques is not completely known. A recent study showed how T2DM subjects with obstructive coronary artery disease (CAD) with DMCs at their first coronary event present a more "stable" coronary atherosclerosis features at OCT-imaging, as they have a higher prevalence of fibrous plaques and healed plaques with larger calcifications compared to those with T2DM and no DMCs. In this study only subjects with obstructive CAD (defined as a stenosis ≥50% in the left main coronary artery or any stenosis ≥70% or fractional flow reserve \<0.80 in any other major epicardial vessel) were enrolled. Therefore, further research to evaluate differences in CACS in T2DM subjects with no previous history of CAD with and without DMCs is required. Aim of our study was to evaluate the presence of differences in the distribution and tomographic features of coronary plaques in T2DM subjects with no previous history of CAD with at least one DMCs, focusing on the degree of plaque calcification calculated by the CACS. Detailed Description: Subjects with T2DM who performed CT coronary imaging, as per clinical routine practice. They will be, therefore, divided into two groups: * Group A: subjects with T2DM with at least one DMC, as defined: • Retinopathy, defined as any diabetes related eye disease (macular oedema, severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy) or previous history of retinal photocoagulation therapy and/or intravitreal injections of anti- vascular endothelial growth factor (VEGF) agents. * Neuropathy, including any diabetes-related neurological complication (diabetic peripheral neuropathy, diabetic autonomic neuropathy). * Nephropathy, defined as the presence of albuminuria (urinary albumin \> 30 mg/g creatinine) and/or an estimated glomerular filtration rate \< 60 mL/min/1.73 m2 * Group B: subjects with T2DM without DMCs. Following data will be collected Anthropometric parameters * Sex * Year of birth * Height, expressed in m * Weight, expressed in Kg * BMI, calculated as weight divided by height squared Vital signs * Blood pressure, expressed in mmHg; * Heart rate, expressed in bpm; * VFA (Visceral fat area - cm2); * SFA (subcutaneous fat area - cm2). Medical history * Date of diagnosis of diabetes, at least the year; * Comorbidities; * Year of diagnosis of comorbidities. * Smoking habits, defined as "current smoker", "former smoker", "never smoked" Medications * Diabetes medications; * Dose of each diabetes medications; * Year of start for each diabetes medications; * Concomitant medications; * Dose of each concomitant medications; * Year of start for each concomitant medication. Cardiovascular risk scores • SCORE2-Diabetes \[12\] Blood Tests data collection * HbA1c * Serum Creatinine * Total Cholesterol * LDL Cholesterol * HDL Cholesterol * Triglycerides * Transaminases * Microalbuminuria Blood sample collection • CRP Cardiovascular Autonomic Tests Following Cardiovascular autonomic tests will be performed: * Deep breathing: The patient sits quietly and breathes deeply at six breaths a minute (five seconds in and five seconds out) for one minute. An electrocardiogram is recorded throughout the period of deep breathing, with a marker used to indicate the onset of each inspiration and expiration. * Valsalva manoeuvre: The test is performed by the patient blowing into a mouth- piece connected to an aneroid manometer or a modified sphygmomanometer and holding it at a pressure of 40 mm Hg for 15 seconds while a continuous electrocardiogram is recorded. The manoeuvre is performed three times with one- minute intervals between. * Lying to standing: The test is performed by measuring the patient's blood pressure with a sphygmomanometer while he is lying down quietly and again when he stands up. The postural fall in blood pressure is taken as the difference between the systolic blood pressure lying and the systolic blood pressure standing \[13\]. Neuropathy evaluation * Michigan Neuropathy Screening Instrument (MNSI-Q) questionnaire \[14\] * COMPASS31 questionnaire \[15\] * Diabetic Neuropathy Index (DNI) questionnaire \[16\] * DN4 questionnaire \[17\] * Monofilament examination Ophthalmologic evaluation • Non mydriatic Ocular fundus photography Coronary CTA parameters collection * Total EAT * EAT of atrio_ventricular sulcus * EAT of anterior interventricular artery, both as volume and thickness * EAT of right coronary artery * EAT of circumfl ex coronary artery * EAT Volume Index (cm3/m2) * Perivascular FAI (-30 -190 UH) * CACS (Agatston score, Volume and mass) * Plaque grading/stenosis (Minimum, mild, intermediate, Severe), using CAD-RADS 2.0 * Plaque characteristics non-calcific, mixed and calcific plaque, evaluating any high-risk plaque profile ### Conditions Module Conditions: - Diabetes Mellitus, Type 2 ### Design Module #### Design Info Observational Model: CASE_CONTROL Time Perspective: PROSPECTIVE #### Enrollment Info Count: 244 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: T2DM with microvascular complications Intervention Names: - Procedure: Blood sample collection Label: T2DM with microvascular complications #### Arm Group 2 Description: T2DM without microvascular complications Intervention Names: - Procedure: Blood sample collection Label: T2DM without microvascular complications ### Interventions #### Intervention 1 Arm Group Labels: - T2DM with microvascular complications - T2DM without microvascular complications Description: Collection of blood sample Name: Blood sample collection Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: Differences in coronary calcium score between subjects with diabetes with and with our microvascular complications Measure: Coronary artery calcium score Time Frame: 24 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Informed consent signed before any activity related to the study 2. Age 40 - 70 years, both sexes 3. Diagnosis of T2DM ≥5 years 4. CT coronary imaging performed in 60 days before enrollment Exclusion Criteria: 1. Previous diagnosis of type 1 diabetes, late autoimmune diabetes of the adults (LADA), diabetes secondary to pancreatitis 2. Malignant disease 3. Acute/chronic inflammatory disease 4. Severe obesity Maximum Age: 70 Years Minimum Age: 40 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Subjects with T2DM who performed CT coronary imaging, as per clinical routine practice. They will be, therefore, divided into two groups: * Group A: subjects with T2DM with at least one DMC * Group B: subjects with T2DM without DMCs ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439706 Brief Title: HPV Self-sampling for Underscreened Latinas Official Title: Assessing the Feasibility and Acceptability of Juntas Contra el Virus Del Papiloma Humano, an HPV Self-sampling Intervention for Underscreened Latinas #### Organization Study ID Info ID: 23-1027 #### Organization Class: OTHER Full Name: Fox Chase Cancer Center ### Status Module #### Completion Date Date: 2025-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-09-30 Type: ESTIMATED #### Start Date Date: 2023-10-04 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Pennsylvania Breast Cancer Coalition #### Lead Sponsor Class: OTHER Name: Fox Chase Cancer Center #### Responsible Party Investigator Affiliation: Fox Chase Cancer Center Investigator Full Name: Carolyn Fang, PhD Investigator Title: Associate Director of Population Science 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 learn if women of Hispanic/Latina ethnicity are willing to self-collect a cervico-vaginal sample for HPV testing. The main question the study will answer is: • Does a brief educational intervention increase the feasibility and acceptability of HPV self-sampling among Hispanic/Latina women? The study team will compare whether including a brief educational intervention with a mailed HPV self-sampling kit is more acceptable than receiving a mailed HPV self-sampling kit alone. Participants will be asked to complete surveys at study entry (baseline) and then randomized to receive only the HPV self-sampling kit, or the kit plus a small group education that meets with a bilingual health educator. Participants will then be contacted about one-month later to complete a follow-up survey. The study team will also measure the number of participants in each group who self-collect a sample and mail it in for HPV testing. Detailed Description: We will recruit a sample of underscreened Latinas (n=100) who will be randomly assigned to either the educational intervention (n=50) or a control condition (n=50). Feasibility will be measured through study enrollment and intervention completion (defined as the proportion of women who self-collect a sample). Acceptability of intervention materials and self-sampling procedures will be measured using self-report surveys at follow-up assessments. ### Conditions Module Conditions: - Uterine Cervical Neoplasm ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: SCREENING #### Enrollment Info Count: 100 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants receive an HPV self-sampling kit in the mail with instructions on how to self-collect a sample and return it to the lab for testing. Intervention Names: - Behavioral: HPV Self-Sampling Label: Mailed Kit Only Control Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: Participants receive information about cervical cancer risks and screening guidelines in a small-group format with a bilingual health educator. Participants also receive an HPV self-sampling kit in the mail with instructions on how to self-collect a sample and return it to the lab for testing. Intervention Names: - Behavioral: HPV Self-Sampling - Behavioral: Group Education Label: Education Plus Mailed Kit Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Education Plus Mailed Kit - Mailed Kit Only Control Description: HPV self-sampling kit Name: HPV Self-Sampling Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - Education Plus Mailed Kit Description: Small-group education led by bilingual health educator Name: Group Education Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: The number of participants who attend at least one session in the intervention arm Measure: Feasibility Time Frame: 1 month #### Secondary Outcomes Description: The number of participants who return a self-collected sample Measure: Participation in screening Time Frame: 1 month ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Self-reported Hispanic/Latina ethnicity * Assigned female sex at birth * Age 30-65, consistent with guidelines for HPV DNA testing for cervical cancer screening * Speak and read English or Spanish * Computer or other device with internet connection * Overdue for cervical cancer screening (e.g., no cytology-based screening within the past 3 years; no hrHPV testing either alone or in combination with cytology in the past 5 years). Exclusion Criteria: * Prior diagnosis of cervical cancer or abnormality (e.g., dysplasia) * Had a hysterectomy/removal of the cervix * Compromised immune system (e.g., known HIV) * Women who self-report that they are pregnant or are within three months after a pregnancy Healthy Volunteers: True Maximum Age: 65 Years Minimum Age: 30 Years Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: carolyn.fang@fccc.edu Name: Carolyn Fang, PhD Phone: 2157284062 Role: CONTACT #### Locations Location 1: City: Philadelphia Contacts: *Contact 1:* - Email: carolyn.fang@fccc.edu - Name: Carolyn Fang, PhD - Phone: 215-728-4062 - Role: CONTACT Country: United States Facility: Fox Chase Cancer Center State: Pennsylvania Status: RECRUITING Zip: 19111 #### Overall Officials Official 1: Affiliation: Fox Chase Cancer Center Name: Carolyn Fang, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: De-identified data and associated documentation can be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. All procedures will be compliant with NIH regulations on the distribution of unique research resources. 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: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Uterine Cervical Neoplasms - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002583 - Term: Uterine Cervical Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439693 Brief Title: The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer Official Title: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study: #### Organization Study ID Info ID: 24-223 #### Organization Class: OTHER Full Name: Dana-Farber Cancer Institute #### Secondary ID Infos Domain: TBCRC ID: TBCRC065 Type: OTHER ### Status Module #### Completion Date Date: 2033-03-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2030-03-30 Type: ESTIMATED #### Start Date Date: 2024-11 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Translational Breast Cancer Research Consortium Class: OTHER Name: Johns Hopkins University #### Lead Sponsor Class: OTHER Name: Dana-Farber Cancer Institute #### Responsible Party Investigator Affiliation: Dana-Farber Cancer Institute Investigator Full Name: Heather A. Parsons, MD Investigator Title: Principle Investigator 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: The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants. The names of the study drugs involved in this study are: * Paclitaxel (a type of anti-microtubule agent) * Docetaxel (a type of anti-microtubule agent) * Nab-Paclitaxel (a type of anti-microtubule agent) * Trastuzumab (a type of IgG1 kappa monoclonal antibody) * Pertuzumab (a type of monoclonal antibody) * Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate) * Tucatinib (Tyrosine Kinase HER2 Inhibitor) * Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate) Detailed Description: This is an open-label phase II single-arm study to test the efficacy of a regimen of human epidermal growth factor receptor 2 (HER2)-targeted study drugs in participants with HER2-Positive metastatic Breast Cancer (HER2+ MBC). The U.S. Food and Drug Administration (FDA) has approved all the study drugs as a treatment option for metastatic, HER2+ breast cancer. In this study, investigators are planning to give a series of treatments in a row without waiting for disease worsening and then stopping HER2 treatment. The research study procedures include screening for eligibility, study treatment visits, blood tests, tumor biopsies, questionnaires, Computed Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, echocardiograms, and electrocardiograms. Participation in this research study is expected to last about 93 weeks (12 weeks for Part A, 18 weeks for Part B, 12 weeks for Part C, and 51 weeks for Part D) for study treatment and approximately three months to ten years for follow up. It is expected that about 72 people will take part in this research study. Seagen Inc. is supporting this study by providing the study drug, tucatinib, and funding. ### Conditions Module Conditions: - Breast Cancer Female - Breast Cancer - Breast Cancer Metastatic - Estrogen Receptor-positive Breast Cancer - HER2-positive Breast Cancer - Stage IV Breast Cancer Keywords: - Breast Cancer - Breast Cancer Female - Breast Cancer Metastatic - Estrogen Receptor-Positive Breast Cancer - HER2-positive Breast Cancer - Stage IV Breast Cancer ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 72 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will complete: * Screening visit with tumor biopsy and imaging. * Imaging on Day I of cycles for Parts A through D. * Part A: * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab (or biosimilar) 1X daily * Day 1 of 21 day cycle: Predetermined dose of Pertuzumab 1X daily * Predetermined dose of Taxane (Paclitaxel, Docetaxel, or Nab-Paclitaxel) * Part B: --Day 1 of 21 day cycle: Predetermined dose of trastuzumab deruxtecan 1X daily * Part C: * Day 1 of 21 day cycle: Predetermined dose of T-DM1 1X daily * Days 1 through 21 of 21 day cycle: Predetermined dose of Tucatinib 2X daily * Part D: * Imaging every 9 weeks * Days 1 through 21 of 21 day cycle: Predetermined dose of Tucatinib 2X daily * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab (biosimilar or SC) 1X daily * Day 1 of 21 day cycle: Predetermined dose of Pertuzumab (or PHESGO) 1X daily * Follow Up: visits every 12 weeks with imaging every 9 weeks. Intervention Names: - Drug: Nab-Paclitaxel - Drug: Paclitaxel - Drug: Docetaxel - Drug: Phesgo - Drug: T-DM1 - Drug: Pertuzumab - Drug: Trastuzumab Deruxtecan - Drug: Trastuzumab Subcutaneous Subcutaneous - Drug: Tucatinib - Drug: Trastuzumab Label: HER2+ Breast Cancer Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - HER2+ Breast Cancer Description: Anti-microtubule agent, via intravenous (into the vein) infusion per institutional guidelines. Name: Nab-Paclitaxel Other Names: - Abraxane - ABI-007 - Albumin-bound paclitaxel Type: DRUG #### Intervention 2 Arm Group Labels: - HER2+ Breast Cancer Description: Anti-microtubule agent, via intravenous infusion per institutional guidelines. Name: Paclitaxel Other Names: - Taxol Type: DRUG #### Intervention 3 Arm Group Labels: - HER2+ Breast Cancer Description: Anti-microtubule agent, via intravenous infusion per institutional guidelines. Name: Docetaxel Other Names: - Taxotere Type: DRUG #### Intervention 4 Arm Group Labels: - HER2+ Breast Cancer Description: Pertuzumab plus trastuzumab plus hyaluronidase-zzxf, 10 or 15mL single-dose vial, via subcutaneous (under the skin) injection per protocol. Name: Phesgo Other Names: - pertuzumab plus trastuzumab plus hyaluronidase-zzxf - RG6264 - RO7198574 Type: DRUG #### Intervention 5 Arm Group Labels: - HER2+ Breast Cancer Description: HER2-targeted antibody-drug conjugate, 16 or 100 mg single-use vials, via intravenous infusion per institutional guidelines. Name: T-DM1 Other Names: - ado-trastuzumab emtansine - Kadcyla Type: DRUG #### Intervention 6 Arm Group Labels: - HER2+ Breast Cancer Description: Recombinant humanized monoclonal antibody, 20mL single-use vial, via intravenous infusion per institutional guidelines. Name: Pertuzumab Type: DRUG #### Intervention 7 Arm Group Labels: - HER2+ Breast Cancer Description: HER2-directed antibody drug conjugate, 100mg vial, via intravenous infusion per institutional guidelines. Name: Trastuzumab Deruxtecan Other Names: - Enhertu - fam-trastuzumab deruxtecan-nxki - T-DXd - DS-8201a Type: DRUG #### Intervention 8 Arm Group Labels: - HER2+ Breast Cancer Description: Humanized IgG1 kappa monoclonal antibody, 6mL vial, via subcutaneous injection per institutional guidelines. Name: Trastuzumab Subcutaneous Subcutaneous Other Names: - Herceptin Hylecta - Trastuzumab and hyaluronidase-oysk Type: DRUG #### Intervention 9 Arm Group Labels: - HER2+ Breast Cancer Description: Tyrosine Kinase HER2 Inhibitor, 50 or 150mg tablet taken orally per institutional guidelines. Name: Tucatinib Type: DRUG #### Intervention 10 Arm Group Labels: - HER2+ Breast Cancer Description: Humanized IgG1 kappa monoclonal antibody, 150 mg single-dose vial, via intravenous infusion per institutional guidelines. Name: Trastuzumab Type: DRUG ### Outcomes Module #### Primary Outcomes Description: DFS4 is the probability estimate 4 years based on Kaplan-Meier Method. DFS is defined the time from registration to disease progression (including death from any cause) or resumption of anti-cancer therapy (not including endocrine therapy). Participants that are alive, progression free and off all anti-cancer therapy are censored at the date of their last disease evaluation. Measure: Disease Free Survival at 4 Years (DFS4) Time Frame: Up to 4 years #### Secondary Outcomes Description: Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant. Measure: Median Overall Survival (OS) Time Frame: Up to 5 years Description: Objective response rate (ORR), defined as best overall response of either complete or partial response, will be assessed among participants who start protocol therapy and have measurable disease at screening. Radiographic response will be assessed using RECIST 1.1 criteria as defined in section 11.1. The objective response rate by RECIST 1.1 (CR + PR) will be reported with 95% exact confidence interval. ORR will be calculated as best cumulative response achieved with each Part of therapy, taking as baseline, the measurements taken prior to C1D1 of Part A of therapy, and as best cumulative response at the completion of Part D of therapy. Measure: Objective Response Rate (ORR) Time Frame: Up to 54 months Description: The percentage of participants who experienced a maximum grade 3-5 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms. Measure: Grade 3-5 Treatment-Related Toxicity Rate Time Frame: Up to 54 months Description: Sequential therapy includes (A) taxane, trastuzumab, pertuzumab, (B) trastuzumab deruxtecan, (C) ado-trastuzumab emtansine, tucatinib, and (D) trastuzumab, pertuzumab, tucatinib. The proportion of participants who complete each part of therapy will be tabulated as the complete rate. Measure: Complete Rate of Each Treatment Part Time Frame: Up to 54 months Description: Sequential therapy includes (A) taxane, trastuzumab, pertuzumab, (B) trastuzumab deruxtecan, (C) ado-trastuzumab emtansine, tucatinib, and (D) trastuzumab, pertuzumab, tucatinib. The reasons of non-completion will be tabulated. Measure: Non-Completion reasons of each part of the sequential therapy Time Frame: Up to 54 months Description: DFS4 is defined as primary outcome 1. Participants will be categorized by MRD status (detectable nv non-detectable). Measure: DFS4 by Minimal Residual Disease (MRD) status Time Frame: Up to 4 years ### Eligibility Module Eligibility Criteria: Inclusion criteria: * Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma. Patients must have stage IV breast carcinoma at diagnosis (i.e., de novo metastatic) with unequivocal evidence of metastasis on imaging. * Diagnosis of HER2-positive invasive breast carcinoma and 3+ by immunohistochemistry on both breast and metastatic biopsies, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines. HER2 status must be determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory (central testing not required). Patients with HER2 1+ or 2+ disease which is HER2 FISH positive are not eligible to enroll. * No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab/pertuzumab/taxane (THP) within 6 weeks from treatment start. Prior endocrine therapy for non-invasive breast carcinoma or non-cancerous lesions is allowed if it has been completed at least 5 years prior to study entry. * Age ≥18 years. Because no dosing or adverse event data are currently available on the use of trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, T-DM1 and tucatinib in Participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 * Left ventricular ejection fraction (LVEF) ≥50%, as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 12 weeks prior to first dose of study treatment, or within 12 weeks before starting THP for patients who start metastatic therapy prior to study entry. * Participants must meet the following organ and marrow function as defined below within 28 days prior to registration: * Hgb ≥9.0 g/dL * Absolute Neutrophil Count ≥ 1,000 /mm3 * Platelets ≥100,000/mm3 * Total bilirubin ≤ 1.5 x ULN (institutional) or direct bilirubin within normal limits in patients with a history of Gilbert\'s syndrome. * AST and ALT ≤ 2.5 x ULN (institutional) or ≤ 5 x ULN for participants with documented liver metastases * Serum creatinine ≤ 1.5 x ULN (institutional) OR calculated GFR ≥60mL/min * Participants with concurrent human immunodeficiency virus (HIV) infection are eligible provided the following criteria are met: * CD4+ T-cell (CD4+) counts \> 350 cells/uL * No history of AIDS-defining opportunistic infection within 12 months prior to enrollments * Any medication used in an ART regimen must have no known interaction with the agents used in the study treatment regimen. * Participants with active or chronic Hepatitis B or C are eligible provided they meet the liver function criteria described in 3.1.7 and are not on a medication with a known liver function criteria described in 3.1.7 and are not on a medication with a known interaction with the agents used in the study treatment regimen. The following guidance applies: * patients with chronic HBV infection with active disease who meet the FDA criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy. * patients with a history of HCV infection should have completed curative antiviral treatment. HCV viral load must be below the limit of quantification. * patients who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible. * Participants with brain metastases identified at diagnosis or at time of screening are eligible if the following criteria are met: * Known, untreated brain metastases must undergo definitive local therapy - as determined by treating physician - prior to study entry. * Treated brain metastases must be clinically stable since treatment. Restaging brain MRI is not required to deem eligibility if local therapy was given within 28 days from first dose of study treatment. Patients are eligible if time from local therapy and first dose of study treatment is: * 7 days for stereotactic radiosurgery (SRS); * 14 days for whole-brain radiation therapy (WBRT); * 28 days for surgical resection. * Patients who have already started THP prior to study entry and have brain metastasis detected at screening MRI are eligible after completion of definitive local therapy- as determined by treating physician. Systemic treatment can be interrupted as determined by the treating physician and after discussion with the Sponsor Investigator. * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible (i.e., adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer). * This study involves agents that have known genotoxic, mutagenic and teratogenic effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her Partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of study therapy. * Women of childbearing potential must have had a negative pregnancy test within 14 days of registration. Childbearing potential is defined as: those who have not been surgically sterilized and/or have had a menstrual period in the past 12 months or who have been on ovarian suppression in the past year. * Ability to understand and the willingness to sign a written informed consent document indicating awareness of the investigational nature and the risks of this study * Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion criteria: * Prior history of invasive breast carcinoma * Treatment with any other investigational agents for this condition. * Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 28 days of study entry or an anticipated need for major surgery during the study. * Extracranial palliative radiotherapy within 7 days prior to enrollment. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, trastuzumab emtansine, tucatinib. * Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV). * Subjects must not have any of the following: * Any untreated brain lesion on screening MRI, unless approved by the Sponsor Investigator * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \>2 mg of dexamethasone (or equivalent). * Known or concurrent leptomeningeal disease on screening MRI * Poorly controlled (\>1/week) generalized or complex partial seizures * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the Sponsor-Investigator. * History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * History of other lung disease, such as: * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrolment, severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, pleural effusion etc.). * Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. * Prior pneumonectomy. * Active or uncontrolled clinically serious infection * Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications * Have ongoing ≥ Grade 2 diarrhea of any etiology * Participants receiving any medications or substances that are inhibitors or inducers of CYP2C8 and/or CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. * Pregnant women are excluded from this study because of potential for teratogenic or abortifacient effects of study drugs. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued prior to enrollment. Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: HeatherA_parsons@dfci.Harvard.edu Name: Heather Parsons, MD, MPH Phone: 617-632-3800 Role: CONTACT #### Locations Location 1: City: Boston Contacts: *Contact 1:* - Email: HeatherA_parsons@dfci.Harvard.edu - Name: Heather Parsons, MD, MPD - Phone: 617-632-3800 - Role: CONTACT *Contact 2:* - Name: Heather Parsons, MD, MPH - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Dana-Farber Cancer Institute State: Massachusetts Zip: 02215 #### Overall Officials Official 1: Affiliation: Dana-Farber Cancer Institute Name: Heather Parsons, MD, MPH Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. Info Types: - STUDY_PROTOCOL - SAP IPD Sharing: YES Time Frame: Data can be shared no earlier than 1 year following the date of publication ## 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 ### 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 ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast 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 - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000922 - Term: Immunotoxins - ID: D000018796 - Term: Immunoconjugates - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Analg - Name: Analgesics - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M1668 - Name: Docetaxel - Relevance: HIGH - As Found: Physical - ID: M289243 - Name: Pertuzumab - Relevance: HIGH - As Found: Present - ID: M325 - Name: Trastuzumab - Relevance: HIGH - As Found: Quality - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M2102 - Name: Ado-Trastuzumab Emtansine - Relevance: HIGH - As Found: Ertapenem - ID: M349698 - Name: Tucatinib - Relevance: HIGH - As Found: Cleaned - ID: M233243 - Name: Trastuzumab deruxtecan - Relevance: HIGH - As Found: Peginterferon Alfa-2a - ID: M8116 - Name: Estrogens - Relevance: LOW - As Found: Unknown - ID: M147959 - Name: Taxane - Relevance: LOW - As Found: Unknown - ID: M3595 - Name: Adenosine - 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 - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M4241 - Name: Immunotoxins - Relevance: LOW - As Found: Unknown - ID: M20855 - Name: Immunoconjugates - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000077143 - Term: Docetaxel - ID: D000080044 - Term: Ado-Trastuzumab Emtansine - ID: D000068196 - Term: Albumin-Bound Paclitaxel - ID: D000068878 - Term: Trastuzumab - ID: C000485206 - Term: Pertuzumab - ID: C000705452 - Term: Tucatinib - ID: C000614160 - Term: Trastuzumab deruxtecan ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439680 Brief Title: HASCV-R" Health Programme: a RCT Official Title: The Effect of " HASCV-R" Training Program on Women's Health Promotion and Protective Behaviors: A Randomized Controlled Experimental Study #### Organization Study ID Info ID: 05/24 #### Organization Class: OTHER Full Name: Bozok University ### Status Module #### Completion Date Date: 2023-11-15 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-09-15 Type: ACTUAL #### Start Date Date: 2023-05-15 Type: ACTUAL Status Verified Date: 2023-09 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Bozok University #### Responsible Party Investigator Affiliation: Bozok University Investigator Full Name: Mehmet KORKMAZ Investigator Title: Phd. Mehmet Korkmaz 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 randomized controlled trial: is to determine the effect of " HASCV-R " health programme on the health promoting and protective behaviours of the women. The main question it aims to answer are: • Does the HASCV-R program, positively affect the health promoting and protective behaviours of women? The health program was given to the women in the experimental group in five sessions of 40 minutes each for five weeks. The program was implemented to 45 women. After obtaining consent from women, Data were gathered with all participants at the available time and places. The data were collected from the control and experimental groups at two different times, prior to the program was implemented and 3 months after the program was implemented. Detailed Description: Positive health behaviors aimed at improving health refer to individuals' conscious efforts to protect and improve their own health and the health of other individuals. Examples of positive health behaviors include eating adequate and balanced nutrition, paying attention to sleep patterns, doing physical activity, staying away from stress, having regular health checks, and communicating effectively and positively with people. In order for individuals to acquire positive health behaviors, they need to have an idea about all of these behaviors and turn the knowledge they have acquired into behavior. Health professionals undoubtedly have a large share in the formation of this health awareness, as well as in the treatment of diseases, as well as in protecting health and avoiding risky health behaviors. It is seen that in developed societies, the planning, implementation and evaluation stages of health promotion programs in health services are carried out by professional nurses. The group that will ensure the development of health, informing and guiding healthy behaviors are nurses who provide professional care in health institutions. There are training programs to improve women's health in the literature, but there is no training program that is both health-promoting and health-protective. Considering the impact of nurses on health education and creating behavioral change, their knowledge on this subject and their ability to transfer this to public health is of great importance. In addition, considering that a healthy lifestyle has become so important today, the unique value of the study is that the training program to be developed includes behaviors that promote and protect women's health. This research was planned to evaluate the effect of the "HASCV-R" training program on women's health-promoting and protective behaviors. ### Conditions Module Conditions: - Health Behavior Keywords: - Health behaviors - health promotion - Women's health ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: SEQUENTIAL Intervention Model Description: double-blind randomised controlled pretest-posttest experimental research ##### Masking Info Masking: NONE Primary Purpose: PREVENTION #### Enrollment Info Count: 90 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Experimental: experimental This study was carried out with the women living in Tokat province. Trainings and measurement tools in the HASCV-R programme was implemented in the Hanımeli culture and art centers. Intervention Names: - Other: HASCV-R" Health Programme Label: experimental Type: EXPERIMENTAL #### Arm Group 2 Description: control Intervention Names: - Other: HASCV-R" Health Programme Label: control Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - control - experimental Description: HASCV-R program "Healthy nutrition, Active life, Ways to cope with Stress, Cancer and cancer screening, Vaccination - Reproductive health" Training programme Name: HASCV-R" Health Programme Type: OTHER ### Outcomes Module #### Primary Outcomes Description: This form, developed by the researchers based on the literature, includes the socio-demographic characteristics of the women such as age, education status, income status, etc.) Measure: Questionnaire form Time Frame: prior to the program was implemented and 3 months after the program was implemented #### Secondary Outcomes Description: Evaluates the extent to which the individual keeps himself active in daily life, regular exercise behaviours and behaviours related to meeting physiological needs such as eating and drinking. Measure: Health Promoting and Protective Behaviours Scale Time Frame: prior to the program was implemented and 3 months after the program was implemented Description: It was developed to determine the reproductive health protective attitudes and behaviours of married women. Measure: Scale for Determining Reproductive Health Protective Attitudes of Married Women Time Frame: prior to the program was implemented and 3 months after the program was implemented ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * volunteering to participate in the study, * be between the ages of 18 and 49, * being a women, * no communication barriers (to communicate with any problem such as hearing problem, speech impediment), * to be married Exclusion Criteria: being younger than 18 or over 49, * be man, * ınability to communicate with any problem such as hearing problem, speech impediment, * living single, * refusing to participate in the study Gender Based: True Healthy Volunteers: True Maximum Age: 49 Years Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT ### Contacts Locations Module #### Locations Location 1: City: Yozgat Country: Turkey Facility: Yozgat Bozok University ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439667 Acronym: Tele-foot X Brief Title: VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING Official Title: VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING #### Organization Study ID Info ID: H-52991 #### Organization Class: OTHER Full Name: Baylor College of Medicine ### Status Module #### Completion Date Date: 2028-01-03 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2028-01-03 Type: ESTIMATED #### Start Date Date: 2024-09-03 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: BioSensics #### Lead Sponsor Class: OTHER Name: Baylor College of Medicine #### Responsible Party Investigator Affiliation: Baylor College of Medicine Investigator Full Name: Bijan Najafi, PhD Investigator Title: Professor of Surgery Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to the clinician to improve patient's perfusion to the lower extremity, improve diabetic wound healing and prevent muscle loss in the lower extremity.This is a cross sectional and comparative feasibility study. It is designed to explore acceptability, feasibility and proof of concept/ . Detailed Description: Foot ulceration is the most common and costly late complication of diabetes, with morbidity and mortality being worse than many cancers. It is estimated that up to one-third of people with diabetes will develop a diabetic foot ulcer (DFU) in their lifetime. Non-healing DFUs are a leading cause of hospitalization, amputation, disability, and death among people with diabetes. In the United States, one-third of all diabetes-related costs are spent on diabetic foot care, with two-thirds of the costs incurred in inpatient settings, constituting a substantial economic burden to society. Therefore, every means possible should be used to try to heal DFU and prevent amputation. In this regard, there is a significant body of evidence related to the clinical benefits of exercise for people with DFU, including improving blood flow and oxygen supply, muscle loss prevention, and joint mobility. Despite this evidence, exercise is not part of the standard care for wound healing, mainly because there is no solution for promoting and managing home-based exercise programs for people with DFU. To address the gaps described above, we propose an interactive foot and ankle tele-exercise platform called "Tele-FootX". This platform allows clinicians to remotely and virtually supervise exercise tasks and coach patients to perform evidence-based foot and ankle exercises inspired by the validated Buerger-Allen (BA), while also educating and monitoring the patients adherence to the exercise program. ### Conditions Module Conditions: - Diabetic Foot Ulcer Keywords: - Diabetic Foot Ulcer - Ambulatory in the home without the aid of another person - Able to provide written informed consent ### Design Module #### Design Info Observational Model: OTHER Time Perspective: OTHER #### Enrollment Info Count: 15 Type: ESTIMATED Study Type: OBSERVATIONAL ### Outcomes Module #### Primary Outcomes Description: We will design an interactive game-based exercise platform using foot-mounted sensors and make it suitable for people with DFU by including game-based exercises inspired by the Buerger-Allen exercise program Measure: Design interactive game-based platform Time Frame: 4 weeks #### Secondary Outcomes Description: We will demonstrate the acceptability, feasibility, safety, and proof of concept effectiveness of the Tele-FootX in improving lower extremity perfusion by recruiting 15 participants with DFU. We will examine the perceived benefit, ease of use, technology acceptance, usability, and technology anxiety from the point of view of the 15 participants with DFU recruited in Aim 2, as well as 10 health care professionals with expertise in DFU management. To evaluate user experience, we interviewed participants to describe their experience using the sensor-based exergame technology with an adapted questionnaire called Technology Acceptance Model (TAM). Each TAM item will be graded using a 5-point Likert response question. Measure: This study is designed to explore acceptability, feasibility safety, and proof of concept effectiveness of the Tele-FootX. Time Frame: 4 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Male or Female - 18 years or older - Diabetic Foot Ulcer - Ambulatory in the home without the aid of another person - Able to provide written informed consent Exclusion Criteria: * Wound present for more than one year -HbA1c \> 12% -ABI of index limb is \<0.60 and/or they are being considered for revascularization within the course of the study -Ulcer involving bone or tendon -Ulcer not caused by diabetes -Fully confined to a wheelchair -Any condition limiting the ability to engage in Tele-FootX exercise routine such as major cognitive decline, and major visual or hearing problem -Unable or unwilling to attend prescribed clinic visits Healthy Volunteers: True Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Convenient and selected based on available resources to demonstrate feasibility and the proof of concept effectiveness. ### Contacts Locations Module #### Locations Location 1: City: Houston Contacts: *Contact 1:* - Email: bijan.najafi@bcm.edu - Name: Bijan Najafi, PhD - Phone: 713-798-7536 - Role: CONTACT *Contact 2:* - Email: maria.noun@bcm.edu - Name: Maria Noun, BS - Phone: 713-798-7538 - Role: CONTACT Country: United States Facility: Baylor College of Medicine State: Texas Zip: 77030 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003925 - Term: Diabetic Angiopathies - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000007871 - Term: Leg Ulcer - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases - ID: D000003929 - Term: Diabetic Neuropathies - ID: D000005534 - Term: Foot Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M19933 - Name: Diabetic Foot - Relevance: HIGH - As Found: Diabetic Foot - ID: M18919 - Name: Foot Ulcer - Relevance: HIGH - As Found: Foot Ulcer - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M7120 - Name: Diabetic Angiopathies - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M10883 - Name: Leg Ulcer - Relevance: LOW - As Found: Unknown - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7124 - Name: Diabetic Neuropathies - Relevance: LOW - As Found: Unknown - ID: M8658 - Name: Foot Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000017719 - Term: Diabetic Foot - ID: D000016523 - Term: Foot Ulcer ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439654 Acronym: ALLTOP Brief Title: Atlantic Lipid Lowering Treatment Optimization Program Official Title: Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Complex Dyslipidemias #### Organization Study ID Info ID: 2096455 #### Organization Class: OTHER Full Name: Atlantic Health System ### Status Module #### Completion Date Date: 2027-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2027-05-31 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: Regeneron Pharmaceuticals #### Lead Sponsor Class: OTHER Name: Atlantic Health System #### Responsible Party Investigator Affiliation: Atlantic Health System Investigator Full Name: Robert Fishberg 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: Hypercholesterolemia is recognized as the major driver for cardiovascular morbidity and mortality. To help address this in our community, Atlantic Medical Group (AMG) formed a lipid workgroup chaired by Robert D. Fishberg, MD, and Jeffrey N. Feldman, MD. The overarching goal of the lipid workgroup is to enhance the treatment of lipid disorders in those patients with abnormal lipid levels by improving access to resources at the primary care practice level and specialty level. We aim to develop a model for primary and secondary prevention that integrates guidelines for treatment at the practice level. Our primary objective is to identify high-risk patients by utilizing the electronic health record and partnering with patients' primary care providers to provide comprehensive medical management. Detailed Description: This study will screen patients with LDL-C \>160 mg/dL and with evidence of familial hypertension, reach out (using secure chat) to the attending practitioner of such patients and inform the practitioner of our comprehensive services to address FH. A study team member will inform the practitioner that one of the study team plans to reach out to their patient to inform the patient of the study. Unless one of the study team receives notification by the practitioner that they want to opt out of this service for their patients, and do not want further interaction, the patient will be informed of the study and the consent process. The research question is: Will an innovative comprehensive outreach approach, in conjunction with the primary care provider, reduce LDL-C levels in individuals with familial hypercholesteremia below individual baseline values, ideally at a level at or below 100 mg/dL. ### Conditions Module Conditions: - Familial Hypercholesterolemia - Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia - Apolipoprotein B 100, Familial Defective - High Density Lipoprotein Deficiency - Low-Density-Lipoid-Type Hyperlipoproteinemia Keywords: - treatment optimization; familial hypercholesterolemia; complex dyslipidemia ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP Intervention Model Description: This is a prospective quantitative study of individuals with FH to examine the benefit of comprehensive supportive care to lower elevated LDL-C and sustain healthy levels through 36 months from baseline enrollment. We propose to demonstrate improvement in lipid parameters and outcomes in patients referred to the study. Specifically, we will target patients with documented hypercholesterolemia, hypertriglyceridemia, prior myocardial infarction, and personal or family history of coronary artery disease, who may be living with undiagnosed/untreated familial hypercholesterolemia FH. ##### Masking Info Masking: NONE Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 250 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Most recent LDL-C result Intervention Names: - Other: Supportive care Label: LDL-C Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - LDL-C Description: The study model will utilize the accepted standard of care while implementing key enhancements to proactively reach high-risk patients as early as possible. Wrap around comprehensive care is defined as database screening, outreach, encouraging genetic testing for participants and their family members, and provide ongoing education, medical management (e.g., adherence to FDA-approved medications), routine laboratory testing, specialist referrals, Epic referrals to integrated care support such as pharmacy, nutrition, social work, and community health), and routine follow-up either in-person or using virtual visits. Consultations with pharmacists, nutritionists and genetic counselors or specialists to manage co-morbidities may be requested. Name: Supportive care Type: OTHER ### Outcomes Module #### Primary Outcomes Description: LDL-C \<100 mg/dL after at least six months of therapy Measure: Proportion of patients with LDL-C maintenance<100 Time Frame: 6 months from enrollment in study #### Secondary Outcomes Description: LDL-C \<75 mg/DL Measure: Proportion of patients with LDL-C reaching <75 Time Frame: 6 months from enrollment in study Description: LDL-C \< 55mg/DL Measure: Proportion of patients with LDL-C reaching <55 Time Frame: 6 months from enrollment in study ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * LDL-C ≥160 mg/dL * Untreated LDL-C ≥190 with family history of CAD * Prior MI and currently without optimized lipid-lowering therapy * Family history of CAD in first degree relative * Personal history of CAD * Untreated triglycerides \>500 * Elevated Lp(a) and/or high calcium scores * Consenting individuals Exclusion Criteria: * Individuals who are pregnant * Individuals who are incarcerated * Individuals with a terminal illness * Individuals who do not consent Maximum Age: 120 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: robert.fishberg@atlantichealth.org Name: Robert D Fishberg, MD Phone: 973-467-0005 Role: CONTACT Contact 2: Email: jeffrey.feldman@atlantichealth.org Name: Jeffrey N Feldman, MD Phone: 908-686-9330 Role: CONTACT #### Locations Location 1: City: Clark Contacts: *Contact 1:* - Email: robert.fishberg@atlantichealth.org - Name: Robert D Fishberg, MD - Phone: 973-467-0005 - Role: CONTACT *Contact 2:* - Email: jeffrey.feldman@atlantichealth.org - Name: Jeffrey N Feldman, MD - Phone: 908-686-9330 - Role: CONTACT *Contact 3:* - Name: Robert D Fishberg, MD - Role: PRINCIPAL_INVESTIGATOR *Contact 4:* - Name: Jeffrey N Feldman, MD - Role: SUB_INVESTIGATOR *Contact 5:* - Name: Deatrah Dubose, NP - Role: SUB_INVESTIGATOR *Contact 6:* - Name: Matthew Proute, MD - Role: SUB_INVESTIGATOR *Contact 7:* - Name: Nosagie Ohonba, MD - Role: SUB_INVESTIGATOR *Contact 8:* - Name: Tiffany Haynes, MD - Role: SUB_INVESTIGATOR *Contact 9:* - Name: Anusha Ramasray, MD - Role: SUB_INVESTIGATOR Country: United States Facility: Atlantic Medical Group State: New Jersey Zip: 07066 Location 2: City: Springfield Contacts: *Contact 1:* - Email: robert.fishberg@atlantichealth.org - Name: Robert D Fishberg, MD - Phone: 973-467-0005 - Role: CONTACT *Contact 2:* - Email: jeffrey.feldman@atlantichealth.org - Name: Jeffrey N Feldman, MD - Phone: 908-686-9330 - Role: CONTACT *Contact 3:* - Name: Jeffrey N Feldman, MD - Role: SUB_INVESTIGATOR *Contact 4:* - Name: Deatrah Dubose, NP - Role: SUB_INVESTIGATOR *Contact 5:* - Name: Matthew Proute, MD - Role: SUB_INVESTIGATOR *Contact 6:* - Name: Nosagie Ohonba, MD - Role: SUB_INVESTIGATOR *Contact 7:* - Name: Tiffany Haynes, MD - Role: SUB_INVESTIGATOR *Contact 8:* - Name: Anusha Ramasray, MD - Role: SUB_INVESTIGATOR *Contact 9:* - Name: Robert D Fishberg, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Atlantic Medical Group State: New Jersey Zip: 07081 #### Overall Officials Official 1: Affiliation: Atlantic Health System Name: Robert D Fishberg, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: De-identified data will be disseminated in aggregate. IPD Sharing: NO ### References Module #### References Citation: Writing Committee; Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Covington AM, DePalma SM, Minissian MB, Orringer CE, Smith SC Jr, Waring AA, Wilkins JT. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022 Oct 4;80(14):1366-1418. doi: 10.1016/j.jacc.2022.07.006. Epub 2022 Aug 25. No abstract available. Erratum In: J Am Coll Cardiol. 2023 Jan 3;81(1):104. PMID: 36031461 Citation: Myers KD, Farboodi N, Mwamburi M, Howard W, Staszak D, Gidding S, Baum SJ, Wilemon K, Rader DJ. Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes. Circ Cardiovasc Qual Outcomes. 2019 Aug;12(8):e005404. doi: 10.1161/CIRCOUTCOMES.118.005404. Epub 2019 Jul 23. PMID: 31331194 Citation: Khera AV, Won HH, Peloso GM, Lawson KS, Bartz TM, Deng X, van Leeuwen EM, Natarajan P, Emdin CA, Bick AG, Morrison AC, Brody JA, Gupta N, Nomura A, Kessler T, Duga S, Bis JC, van Duijn CM, Cupples LA, Psaty B, Rader DJ, Danesh J, Schunkert H, McPherson R, Farrall M, Watkins H, Lander E, Wilson JG, Correa A, Boerwinkle E, Merlini PA, Ardissino D, Saleheen D, Gabriel S, Kathiresan S. Diagnostic Yield and Clinical Utility of Sequencing Familial Hypercholesterolemia Genes in Patients With Severe Hypercholesterolemia. J Am Coll Cardiol. 2016 Jun 7;67(22):2578-89. doi: 10.1016/j.jacc.2016.03.520. Epub 2016 Apr 3. PMID: 27050191 Citation: Amrock SM, Duell PB, Knickelbine T, Martin SS, O'Brien EC, Watson KE, Mitri J, Kindt I, Shrader P, Baum SJ, Hemphill LC, Ahmed CD, Andersen RL, Kullo IJ, McCann D, Larry JA, Murray MF, Fishberg R, Guyton JR, Wilemon K, Roe MT, Rader DJ, Ballantyne CM, Underberg JA, Thompson P, Duffy D, Linton MF, Shapiro MD, Moriarty PM, Knowles JW, Ahmad ZS. Health disparities among adult patients with a phenotypic diagnosis of familial hypercholesterolemia in the CASCADE-FH patient registry. Atherosclerosis. 2017 Dec;267:19-26. doi: 10.1016/j.atherosclerosis.2017.10.006. Epub 2017 Oct 6. PMID: 29080546 Citation: Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1. PMID: 26330422 Citation: Alam L, Fishberg R, Echeverry T, Feldman J. Screening for familial hypercholesterolemia using Epic Secure Chat in comparison to Epic Letter as educational outreach. Journal of Clinical Lipidology. 2022;16(1):e20-e21. doi.org/10.1016/j.jacl.2021.09.029 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000008052 - Term: Lipid Metabolism, Inborn Errors - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M10059 - Name: Hypolipoproteinemias - Relevance: HIGH - As Found: Lipoprotein Deficiency - ID: M9988 - Name: Hypercholesterolemia - Relevance: HIGH - As Found: Hypercholesterolemia - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: HIGH - As Found: Hyperlipoproteinemia - ID: M10000 - Name: Hyperlipidemias - Relevance: HIGH - As Found: Hyperlipoproteinemia - ID: M9989 - Name: Hyperlipoproteinemia Type II - Relevance: HIGH - As Found: Familial Hypercholesterolemia - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M11054 - Name: Lipid Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T2217 - Name: Familial HDL Deficiency - Relevance: HIGH - As Found: High Density Lipoprotein Deficiency - ID: T2942 - Name: Hypolipoproteinemia - Relevance: HIGH - As Found: Lipoprotein Deficiency ### Condition Browse Module - Meshes - ID: D000006938 - Term: Hyperlipoproteinemia Type II - ID: D000007009 - Term: Hypolipoproteinemias - ID: D000006937 - Term: Hypercholesterolemia - ID: D000006951 - Term: Hyperlipoproteinemias - ID: D000006949 - Term: Hyperlipidemias ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439641 Acronym: SOMMICI Brief Title: Prevalence and Factors Associated With Sleep Disorders in Inflammatory Bowel Disease Official Title: Prevalence and Factors Associated With Sleep Disorders in Inflammatory Bowel Disease: a Cross-sectional Study at Reims University Hospital #### Organization Study ID Info ID: PO24032* #### Organization Class: OTHER Full Name: CHU de Reims ### Status Module #### Completion Date Date: 2025-09 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-06 Type: ESTIMATED #### Start Date Date: 2024-07 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: CHU de Reims #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Inflammatory bowel diseases (IBD) including Crohn's disease (CD) and ulcerative colitis (UC), are an inflammatory disease that can affect the entire digestive tract from the mouth to the anus for CD and the entire colon and rectum for UC. They mainly affect adolescents and young adults. These pathologies evolve in relapses interspersed with phases of remission. Sometimes associated with extraintestinal manifestations (joint, dermatological, ophthalmological or biliary systems), chronic inflammation of the digestive tract and the resulting symptoms (abdominal pain, diarrhea, rectal syndrome, etc.) lead to a significant alteration in the quality of life of patients in all spheres of activity (professional, sexual, social). Sleep is a basic neurophysiological state, the normal total duration of which in humans is between six and ten hours per day. It is an essential element of the circadian rhythm in humans, influencing certain cellular functions and in particular the synthesis of cytokines and pro-inflammatory molecules (Nobel Prize in Medicine awarded to Jeffrey C. Hall, Michael Rosbash and Michael W. Young in 2017). Sleep disturbances and disruption of the circadian rhythm lead to metabolic and immunological dysfunctions, which may be involved in chronic inflammatory conditions through changes in the immune response. In the field of IBD, many studies suggest poor sleep quality in patients with IBD. While there seems to be a link between sleep disorders and impaired quality of life with a socio-professional impact in these patients, the links between IBD activity, its treatment and sleep disorders are poorly studied, with discordant results in previous studies. In order to enrich our knowledge on this topic, the investigators wish to study the prevalence and risk factors associated with sleep disorders in IBD patients in order to improve patients' quality of life Detailed Description: Objectives: The main objective of this work is to assess the prevalence of sleep disorders during IBD. The secondary objectives are: * Identify factors associated with sleep disorders * To assess the association between sleep disturbances and IBD severity and activity * To study the prevalence and weight of each of the 7 components of PSQI in the subgroup of patients with sleep disorders and their associated factors (clinical, activity and severity of inflammatory digestive disease, fatigue, quality of life and functional disability). Material and Methods: Study Type: Interventional cross-sectional study in a hospital cohort Population/patients: Consecutive inclusion of all adult patients capable of consenting, followed for IBD in the hepato-gastroenterology department of the Reims University Hospital, a tertiary center with expertise in IBD. Inclusion Criteria: - Adult patients with Crohn's disease (CD) or ulcerative colitis (UC) presenting for consultation or hospitalization in Gastroenterology unit. Non-inclusion criteria: * Patients under legal protection * Patients without social security coverage * Pregnant women Exclusion Criteria: - Patients with an already identified sleep pathology Investigation Plan: Participation in the research will be offered to any eligible patient followed in Gastroenterology at the Reims University Hospital. If the patient agrees to participate in the research, he will be included in the study after receiving the information and signing the informed consent. Once consent has been obtained, the patient will answer several (n=5) questionnaires, 3 self-questionnaires and 2 face-to-face questionnaires. If the patient wishes, he or she will be able to answer the 2 face-to-face questionnaires during a telephone interview, these questionnaires having been validated face-to-face as well as in a telephone interview. The disease activity questionnaire will be either the "Clinical Mayo score" in UC or the "HBI" in CD. * Specific self-questionnaires are the "Pittsburgh Sleep Quality Index" for sleep quality, "Functional Assessment of Chronic Illness Therapy by FACIT-F" for fatigue, and "Functional Disability by IBD-DI". They will be given to the patient at the end of the consultation and then retrieved after being completed. * Specific face-to-face questionnaires are the "IBDQ" for quality of life, "HBI" or "Mayo clinical score" for disease activity will be completed during the consultation with the gastroenterologist, as part of the usual management. * Clinical, biological, radiological, endoscopic and pathological data will be collected via the computerized patient file, and supplemented if necessary by a specifically developed standardized questionnaire. These data are essential to assess the extent of inflammatory digestive disease. The extent considered is the maximum extent of the disease in the patient's history, in fact no ad integrum restitution of the mucosa exists during the course of the patient's evolution. The data will be pseudonymized and filled in by the first letter of the first and last name followed by a subsequent inclusion number. Judging Criteria: * Primary: Percentage of patients with a sleep disorder according to the PSQI questionnaire. * Secondary outcomes will be: * Disease activity according to HBI score for CD or clinical MAYO score for UC * Fatigue according to FACIT-F score (Fatigue) * Quality of life according to the IBDQ score (Inflammatory Bowel Disease Questionnaire) * Functional disability according to IBD-DI (Inflammatory Bowel Disease - Disabilty Index) score Investigation Plan: Patients will be included in the consultation of physicians who are experts in IBD and hospitalization. The study will be explained to them by the expert gastroenterologist and after their inclusion they will complete the various questionnaires on their own and with a clinical research assistant for the face-to-face questionnaire (IBDQ) or over the phone with the clinical research assistant if they prefer. Calculation of the number of patients to include: This study is purely descriptive. All eligible patients will be notified of this study. The gastroenterology department of the Reims University Hospital is a reference centre with expertise in IBD. The active queue is 1500 IBD patients seen in consultation or hospitalized in the gastroenterology department of the Reims University Hospital and the investigators hope to include at least 300 of them (20% of the entire active queue) over 1 year. Statistics: Data will be described using mean and standard deviation or median and interquartile range for quantitative variables and using size and percent for qualitative variables. Normal-distributed continuous variables will be compared using Student's test. Variables with a non-normal distribution will be compared using the Mann-Whitney test. Discrete variables will be compared using Fisher's exact test or chi2, depending on the conditions of application. The search for associated factors will be carried out by logistic regression. Results and perspectives: The purpose of this study is to estimate the prevalence of sleep disorders in the IBD population at Reims University Hospital, and to determine the potential factors associated with these sleep disorders, whether they are related to patients or digestive disease. A better knowledge of the prevalence of these disorders could allow for appropriate management of affected patients, with a significant benefit on the quality of life of these patients. ### Conditions Module Conditions: - Inflammatory Bowel Diseases - Crohn Disease - Ulcerative Colitis - Sleep Disorder Keywords: - Inflammatory Bowel Diseases - Crohn's Disease - Ulcerative Colitis - Sleep Disorders ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: DIAGNOSTIC #### Enrollment Info Count: 300 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: patients with IBD Intervention Names: - Other: Ulcerative colitis Disease Activity Index Label: Patients with Inflammatory bowel diseases Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - Patients with Inflammatory bowel diseases Description: QUESTIONNAIRE - Score between 0 to 12, the higher is the worse Name: Ulcerative colitis Disease Activity Index Type: OTHER ### Outcomes Module #### Primary Outcomes Measure: Pittsburgh Sleep Quality Index Questionnaire Time Frame: Only one time at inclusion ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Adult patients with Crohn's disease (CD) or ulcerative colitis (UC) presenting for consultation or hospitalization in Gastroenterology unit Exclusion Criteria: * Patients with an identified sleep pathology Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Reims Country: France Facility: Chu Reims Zip: 51092 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6638 - Name: Crohn Disease - Relevance: HIGH - As Found: Crohn's Disease - ID: M6320 - Name: Colitis - Relevance: HIGH - As Found: Colitis - ID: M6321 - Name: Colitis, Ulcerative - Relevance: HIGH - As Found: Ulcerative Colitis - ID: M10444 - Name: Intestinal Diseases - Relevance: HIGH - As Found: Bowel Disease - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: HIGH - As Found: Inflammatory Bowel Disease - ID: M22242 - Name: Parasomnias - Relevance: HIGH - As Found: Sleep Disorders - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Disorders - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003424 - Term: Crohn Disease - ID: D000003092 - Term: Colitis - ID: D000003093 - Term: Colitis, Ulcerative - ID: D000007410 - Term: Intestinal Diseases - ID: D000015212 - Term: Inflammatory Bowel Diseases - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000020447 - Term: Parasomnias ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439628 Brief Title: ARISE-A Chinese Real-world Study of Rimegepant for the Acute Treatment of Migraine Official Title: A Chinese Real-world Study of Rimegepant for the Acute Treatment of Migraine #### Organization Study ID Info ID: 89127781 #### Organization Class: OTHER Full Name: Chinese PLA General Hospital ### Status Module #### Completion Date Date: 2027-03 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-01 Type: ESTIMATED #### Start Date Date: 2024-08 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2023-12-13 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Chinese PLA General Hospital #### Responsible Party Investigator Affiliation: Chinese PLA General Hospital Investigator Full Name: Shengyuan Yu Investigator Title: Director Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True ### Description Module Brief Summary: Research question and objectives Primary endpoint • To evaluate the effectiveness of Rimegepant in the acute treatment of migraine as measured by most severe pain, onset of pain relief, satisfaction with pain relief, and satisfaction with return to normal function post-dose. Secondary Objectives * To evaluate the effectiveness of Rimegepant in the acute treatment of migraine as measured by onset of associated symptoms relief. * To evaluate the long-term effect of Rimegepant treatment on the treatment satisfaction and global impression of change at months 3，6 and 12. Exploratory Objective * To evaluate the long-term effectiveness of Rimegepant by evaluating the changes from baseline in any decrease in MMD with any intensity in those participants with baseline MMD ≥6 days. * To evaluate the long-term effectiveness of Rimegepant by evaluating the changes from baseline of any decrease of MHD. * To evaluate the long-term effectiveness of Rimegepant by evaluating any decrease of mean number of moderate to severe migraine days per month in those participants with baseline MMD ≥6 days * To evaluate the changes from baseline in the percentage of MOH and chronic migraine transformation to episodic migraine during Rimegepant long-term (PRN) use. * To evaluate the changes from baseline of Rimegepant usage, other migraine-related medication usage and MO during Rimegepant long-term (PRN) use. * To evaluate the changes from baseline on quality of life, function, depression and anxiety at months 3, 6 and 12. * To evaluate the association between the timing of Rimegepant dosing (dosing at pain free while with any prodrome symptoms/ dosing at pain free while with any aura symptoms / dosing at mild pain/ dosing at moderate pain/ dosing at severe pain) and the acute treatment effectiveness of Rimegepant. * To evaluate the acute treatment effectiveness of Rimegepant in migraine participants with a history of insufficient response or intolerable to NSAIDs /Triptans /Combination analgesic. * To evaluate the acute treatment effectiveness of combination use of Rimegepant plus NSAIDs/Triptans/Combination analgesic in participants with insufficient response to monotherapy. * To evaluate the acute treatment effectiveness of Rimegepant in migraine participants with prior treatment failure of more than two triptans. Study design This is a single arm, prospective, multi-center, observational registry study with participants receiving Rimegepant for the acute treatment of migraine in a real-world setting. Each participant will receive treatment and care according to standard clinical practice. About 3,000 adult migraine participants will be enrolled continuously at 70 to 73 sites with a headache clinic or headache center in China in approximately 16 consecutive months or until reaching the target sample size.. The index date for a participant will be the date of enrollment. The maximum follow-up period per participant after enrollment is 12 months. At the Baseline Visit, the demographics information, socioeconomic characteristics, and medical and migraine history will be collected from the enrolled participants. For the acute treatment effectiveness evaluation, data on Rimegepant treating single migraine attack including the timing of dosing, most severe pain, onset time of pain relief, onset time of associated symptoms relief, satisfaction with pain relief and satisfaction with function improvement are expected to be captured within 3 months after enrollment through a digital platform. If none of these data are captured within 3 months, the participant will be marked as failed in the study and will not be followed up further. For the long-term effectiveness evaluation, participants will use an eDiary to record headache and migraine occurrence, and use a digital platform to collect Rimegepant and other migraine-related medication usage days every month. At study visits, participants will complete the Migraine-Specific Quality-of-Life Questionnaire (MSQ) v2.1, Migraine Disability Assessment (MIDAS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder -7 (GAD-7), Patient Global Impression of Change (PGI-C) and the Satisfaction with Medication (SM) scale at months 3, 6 and 12 via electronic patient reported outcomes (ePROs). The previous four scales will be completed by participants at baseline visit. ### Conditions Module Conditions: - Migraine ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 3000 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: Rimegepant Label: Rimegepant treatment group ### Interventions #### Intervention 1 Arm Group Labels: - Rimegepant treatment group Description: patients take rimegepant to treat migraine attack as needed Name: Rimegepant Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Pain severity post-dose will be measured on Visual Analogue Scale (VAS) (0=No pain, 10=worst pain). Measure: The average scores of the most severe pain post-dose measured by VAS scale to evaluate the effectiveness of Rimegepant in the acute treatment of migraine Time Frame: within 48 hours post-dose of rimegepant Description: Onset of pain relief is defined as the earliest time point after dosing at which the participant feels that the medication has started working to relieve the pain. If the participant remains pain free both at and after dosing, the time should be recorded as 0 Measure: The onset time of pain relief post-dose to evaluate the effectiveness of Rimegepant in the acute treatment of migraine Time Frame: within 48 hours post-dose of rimegepant Description: Satisfaction with pain relief will be measured via 7-point SM scale Measure: The percentage of patients satisfied with pain relief post-dose to evaluate the effectiveness of Rimegepant in the acute treatment of migraine Time Frame: within 48 hours post-dose of rimegepant Description: Satisfaction with pain relief will be measured via 7-point SM scale Measure: The percentage of patients satisfied with return to normal function post-dose to evaluate the effectiveness of Rimegepant in the acute treatment of migraine Time Frame: within 48 hours post-dose of rimegepant ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Male or female participants aged ≥ 18 years-old 2. Primary diagnosis of migraine according to ICHD-3 3. Migraine attacks present for more than 1 year 4. Rimegepant is prescribed for the acute treatment of migraine by physician 5. Written informed consent must be obtained before participant is enrolled Exclusion Criteria: * Participants meeting any of the following criteria will not be included in the study: 1. Severe impairment of speech, vision, memory or cognition, or other factors that affect communication and ability to complete questionnaires and follow-up 2. Lack of necessary digital tools to complete questionnaires on a digital platform 3. History of hypersensitivity reaction to Rimegepant or to any of its components 4. Participants with severe hepatic impairment or end-stage renal disease 5. Any situation that the investigator believes may affect the patient's participation in the study Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: The study will recruit male and female participants in China, 18 years of age or older with migraine (with or without aura), diagnosed according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)21. Participants must be prescribed with Rimegepant according to the clinical decision of the doctor and the willingness of the participants. ### Contacts Locations Module #### Central Contacts Contact 1: Email: yusy1963@126.com Name: Shengyuan Yu Phone: 8613501171068 Role: CONTACT ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous 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: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M9351 - Name: Headache - 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: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439615 Acronym: BLISS Brief Title: Baricitinib for the Lung Injury Following Spontaneous SAH Official Title: The Treatment Effect of Baricitinib for the Secondary Pulmonary Complications Following Spontaneous Subarachnoid Hemorrhage #### Organization Study ID Info ID: BAR-SAH #### Organization Class: OTHER Full Name: Tang-Du Hospital ### Status Module #### Completion Date Date: 2027-06-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-12-31 Type: ESTIMATED #### Start Date Date: 2024-08-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Tang-Du Hospital #### 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 present study is a randomized, parallel control, and double-blind trial designed to assess the efficacy of baricitinib in reducing the occurrence of pulmonary complications in patients with spontaneous subarachnoid hemorrhage (SAH). The research protocol incorporates an adaptive design, allowing for modifications to key elements such as the sample size enrolled during interim analysis. Detailed Description: Subarachnoid hemorrhage (SAH) is an acute cerebrovascular disorder resulting from the rupture of intracranial vessels, primarily caused by factors such as the rupture of intracranial aneurysms (accounting for approximately 75%-80% of SAH cases), arteriovenous malformations, and abnormal vasculature. Pulmonary complications, including pneumonia and acute respiratory distress syndrome (ARDS), frequently manifest in a significant number of subarachnoid hemorrhage (SAH) patients, significantly impacting their prognosis. The pathogenesis of these complications can be partially attributed to an exaggerated inflammatory response during the acute phase following SAH. The incidence of cerebrovascular spasm and mortality rates significantly increase in SAH patients with pulmonary complications, thereby resulting in a poorer long-term prognosis. However, the current strategy for preventing or managing pulmonary complications after SAH is not sufficiently effective. The JAK-STAT signaling pathway, a pivotal stress-induced inflammatory cascade triggered subsequent to SAH, is characterized by its rapid response to external stimuli. Baricitinib, a JAK inhibitor developed by Eli Lilly Company, exerts significant anti-inflammatory effects in diverse pathological processes and finds extensive application in patients with rheumatoid arthritis, COVID-19, and alopecia areata. However, it remains uncertain whether early administration of baricitinib can mitigate the incidence of secondary pulmonary complications and enhance the prognosis of SAH by suppressing the exaggerated inflammatory response during the acute phase following SAH. The current multicenter clinical trial is designed as a randomized, parallel control, and double-blind study to assess the efficacy of baricitinib in reducing pulmonary complications among patients with SAH. SAH Patients admitted to participating clinical centers with a Hunt-Hess score of Ⅲ-Ⅳ will undergo continuous screening based on predefined selection criteria. The enrolled subjects will be randomly allocated into an experimental group and a control group, receiving either Baricitinib (4mg/day for 3 days) in addition to conventional treatment or placebo in addition to conventional treatment, respectively. The primary outcome is the incidence of pneumonia within 14 days after SAH. While the secondary outcome including the incidence of ARDS and other pulmonary complications within 14 days, the incidence of serious adverse events within 14 days, the proportion of patients requiring assisted ventilation measures within 14 days, the mortality rate within 14/30/90 days, as well as the neurological outcome at 30/90 days. ### Conditions Module Conditions: - Spontaneous Subarachnoid Hemorrhage Keywords: - Spontaneous subarachnoid hemorrhage - Baricitinib - Inflammation - Complications - Acute respiratory distress syndrome - Pneumonia - Outcome ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - OUTCOMES_ASSESSOR Primary Purpose: PREVENTION #### Enrollment Info Count: 100 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will receive standard treatment and care according to the current management guidelines for SAH. Intervention Names: - Other: Standard treatment Label: Control group Type: SHAM_COMPARATOR #### Arm Group 2 Description: In addition to receiving standard treatment and care, baricitinib will be administrated orally (or crushed for nasogastric tube delivery) at a daily dosage of 4mg for three consecutive days following SAH. Intervention Names: - Drug: Baricitinib 4 MG - Other: Standard treatment Label: Baricitinib group Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Baricitinib group Description: Baricitinib will be administered orally (or crushed for nasogastric tube delivery) at a daily dosage of 4mg for three consecutive days following SAH. Name: Baricitinib 4 MG Other Names: - JAK Inhibitor Type: DRUG #### Intervention 2 Arm Group Labels: - Baricitinib group - Control group Description: Participants will receive standard treatment and care according to the current management guidelines for subarachnoid hemorrhage. Name: Standard treatment Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Proportion of patients who occur pneumonia within 14 days Measure: The incidence of pneumonia Time Frame: up to 14 days #### Secondary Outcomes Description: The incidence of ARDS within 14 days following SAH. Measure: The incidence of ARDS Time Frame: up to 14 days Description: The incidence of additional pulmonary complications, such as pulmonary edema, pulmonary embolism, and pleural effusion among patients within 14 days following SAH. Measure: The incidence of other pulmonary complications Time Frame: up to 14 days Description: The proportion of patients requiring assisted ventilation measures within 14 days following SAH. Measure: The incidence of assisted ventilation measures Time Frame: up to 14 days Description: The incidence of SIRS within 14 days following SAH. Measure: The incidence of Systemic Inflammatory Response Syndrome(SIRS) Time Frame: up to 14 days Description: The mortality rate within 14 days / 30 days / 90 days. Measure: Mortality rate Time Frame: up to 90 days Description: The incidence of SAE within 14 days following SAH. Measure: The incidence of serious adverse events (SAE) Time Frame: up to 14 days Description: The neurological functional scores evaluated by Modified Rankin Scale and Glasgow Outcome Scale at 30 days and 90 days after SAH. Measure: The neurological functional outcome Time Frame: up to 90 days Description: The Mini-Mental Status Exam (MMSE) scores at 90 days after SAH. Measure: The cognitive impairment after SAH Time Frame: up to 90 days ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Age ≥18 and ≤80 years old; 2. Diagnosed with spontaneous subarachnoid hemorrhage through imaging or lumbar puncture; 3. Hunt-Hess score of Ⅲ-Ⅳ; 4. Acute onset, admitted to the hospital within 24 hours of onset Exclusion Criteria: 1. Presence of lung diseases before initiation of study treatment such as chronic obstructive emphysema, bronchiectasis, lung cancer, tuberculosis, or a history of lung surgery; 2. Presence of autoimmune diseases, immune system dysfunction, or blood system dysfunction (absolute lymphocyte count (ALC) less than 0.5×109 cells/L, absolute neutrophil count (ANC) less than 1×109 cells/L, or hemoglobin value less than 8 g/dL) before the onset of the disease; 3. Secondary SAH (such as traumatic SAH), or combined craniocerebral trauma, intraparenchymal hemorrhage, or peripheral organ trauma; 4. Evidence of fever or infection already present at the time of admission; 5. History of previous craniocerebral surgery, previous cerebral hemorrhage, craniocerebral injury, cerebral infarction, intracranial tumor, or presence of neurological dysfunction before the onset of the disease; 6. Presence of contraindications for baricitinib treatment, including severe liver damage, renal dysfunction (creatinine clearance rate \<30ml/min), hypercholesterolemia, or known drug allergies; 7. Taking JAK inhibitors or other immunosuppressive drugs before the onset of the disease; 8. Expected survival time less than 2 weeks; 9. Females who are pregnant or breastfeeding; 10. Currently participating in other interventional clinical studies; 11. Patients who refuse to sign the consent form or refuse to accept follow-up. Maximum Age: 80 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: lhxiao@fmmu.edu.cn Name: Haixiao Liu, PhD MD Phone: +86-02984778359 Role: CONTACT Contact 2: Email: gesn8561@fmmu.edu.cn Name: Shunnan Ge, PhD MD Phone: +86-02984778359 Role: CONTACT #### Overall Officials Official 1: Affiliation: Department of Neurosurgery, Tangdu Hospital Name: Yan Qu, PhD MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Robba C, Busl KM, Claassen J, Diringer MN, Helbok R, Park S, Rabinstein A, Treggiari M, Vergouwen MDI, Citerio G. Contemporary management of aneurysmal subarachnoid haemorrhage. An update for the intensivist. Intensive Care Med. 2024 May;50(5):646-664. doi: 10.1007/s00134-024-07387-7. Epub 2024 Apr 10. PMID: 38598130 Citation: Chai CZ, Ho UC, Kuo LT. Systemic Inflammation after Aneurysmal Subarachnoid Hemorrhage. Int J Mol Sci. 2023 Jun 30;24(13):10943. doi: 10.3390/ijms241310943. PMID: 37446118 Citation: Kahn JM, Caldwell EC, Deem S, Newell DW, Heckbert SR, Rubenfeld GD. Acute lung injury in patients with subarachnoid hemorrhage: incidence, risk factors, and outcome. Crit Care Med. 2006 Jan;34(1):196-202. doi: 10.1097/01.ccm.0000194540.44020.8e. PMID: 16374174 Citation: Macmillan CS, Grant IS, Andrews PJ. Pulmonary and cardiac sequelae of subarachnoid haemorrhage: time for active management? Intensive Care Med. 2002 Aug;28(8):1012-23. doi: 10.1007/s00134-002-1382-7. Epub 2002 Jul 6. PMID: 12185419 Citation: RECOVERY Collaborative Group. Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet. 2022 Jul 30;400(10349):359-368. doi: 10.1016/S0140-6736(22)01109-6. Erratum In: Lancet. 2022 Oct 1;400(10358):1102. PMID: 35908569 Citation: Taylor PC, Laedermann C, Alten R, Feist E, Choy E, Haladyj E, De La Torre I, Richette P, Finckh A, Tanaka Y. A JAK Inhibitor for Treatment of Rheumatoid Arthritis: The Baricitinib Experience. J Clin Med. 2023 Jul 6;12(13):4527. doi: 10.3390/jcm12134527. PMID: 37445562 Citation: Ely EW, Ramanan AV, Kartman CE, de Bono S, Liao R, Piruzeli MLB, Goldman JD, Saraiva JFK, Chakladar S, Marconi VC; COV-BARRIER Study Group. Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial. Lancet Respir Med. 2022 Apr;10(4):327-336. doi: 10.1016/S2213-2600(22)00006-6. Epub 2022 Feb 3. Erratum In: Lancet Respir Med. 2022 Feb 11;: PMID: 35123660 Citation: Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen Morales L, Reyes Gonzaga J, Yakushin S, Ishii T, Emoto K, Beattie S, Arora V, Gaich C, Rooney T, Schlichting D, Macias WL, de Bono S, Tanaka Y. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345. PMID: 28199814 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020300 - Term: Intracranial Hemorrhages - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC01 - Name: Infections - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M28143 - Name: Lung Injury - Relevance: LOW - As Found: Unknown - ID: M14965 - Name: Respiratory Distress Syndrome - Relevance: LOW - As Found: Unknown - ID: M14964 - Name: Respiratory Distress Syndrome, Newborn - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M28144 - Name: Acute Lung Injury - Relevance: LOW - As Found: Unknown - ID: M16135 - Name: Subarachnoid Hemorrhage - Relevance: HIGH - As Found: Subarachnoid Hemorrhage - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Hemorrhage - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M22113 - Name: Intracranial Hemorrhages - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T4927 - Name: Respiratory Distress Syndrome, Infant - Relevance: LOW - As Found: Unknown - ID: T192 - Name: Acute Respiratory Distress Syndrome - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013345 - Term: Subarachnoid Hemorrhage - ID: D000006470 - Term: Hemorrhage ### Intervention Browse Module - Ancestors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1474 - Name: Janus Kinase Inhibitors - Relevance: HIGH - As Found: 290 - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000075242 - Term: Janus Kinase Inhibitors ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439602 Brief Title: Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients Official Title: A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout #### Organization Study ID Info ID: AR882-302 #### Organization Class: INDUSTRY Full Name: Arthrosi Therapeutics ### Status Module #### Completion Date Date: 2026-11 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: RECRUITING #### Primary Completion Date Date: 2026-11 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Arthrosi Therapeutics #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Oversight Has DMC: True ### Description Module Brief Summary: This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months ### Conditions Module Conditions: - Gout - Arthritis, Gouty - Hyperuricemia - Gout Chronic ### 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: 750 Type: ESTIMATED Phases: - PHASE3 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: AR882 50 mg taken once daily for 12 months Intervention Names: - Drug: AR882 50 mg Label: AR882 50 mg Type: EXPERIMENTAL #### Arm Group 2 Description: AR882 75 mg taken once daily for 12 months Intervention Names: - Drug: AR882 75 mg Label: AR882 75 mg Type: EXPERIMENTAL #### Arm Group 3 Description: AR882 matching placebo taken once daily for 12 months Intervention Names: - Drug: Placebo Label: Placebo Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - AR882 50 mg Description: Solid Oral Capsule Name: AR882 50 mg Type: DRUG #### Intervention 2 Arm Group Labels: - AR882 75 mg Description: Solid Oral Capsule Name: AR882 75 mg Type: DRUG #### Intervention 3 Arm Group Labels: - Placebo Description: Matching Solid Oral Capsule Placebo Name: Placebo Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL at month 6 Measure: Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 Time Frame: 24 weeks #### Secondary Outcomes Description: Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL for the 3-month period from the end of month 9 to the end of month 12 Measure: Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12 Time Frame: 12 weeks Description: Comparison of the treatment groups for the proportion of patients with no gout flares for the 3-month period from the end of month 9 to the end of month 12 Measure: No gout flares from the end of month 9 to the end of month 12 Time Frame: 12 weeks Description: Comparison of the treatment groups for monthly mean rate of gout flares for the 3-month period from the end of month 9 to the end of month 12 Measure: Monthly mean rate of gout flares by month 12 Time Frame: 12 weeks Description: Comparison of the treatment groups for the proportion of patients who experience a complete response, marked or partial response, of at least 1 target tophus at Month 12, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 12 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method Measure: Change in tophus burden by month 12 Time Frame: 48 weeks Description: Treatment Emergent Adverse Events and Serious Adverse Event incidence Measure: Incidence of Adverse Events Time Frame: 56 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * History of gout * Occurrence of ≥ 2 self-reported gout flares in the last 12 months * Body weight no less than 50 kg * Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL * Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL * Serum creatinine must be \< 3.0 mg/dL and estimated CLcr ≥ 30 mL/min Exclusion Criteria: * Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * Pregnant or breastfeeding * History of symptomatic kidney stones within the past 6 months Maximum Age: 85 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: AR882-302@Arthrosi.com Name: Director Clinical Operations Phone: +1 858-437-9123 Role: CONTACT #### Locations Location 1: City: Foley Country: United States Facility: Arthrosi Investigative Site (106) State: Alabama Status: NOT_YET_RECRUITING Zip: 36535 Location 2: City: Anchorage Country: United States Facility: Arthrosi Investigative Site (139) State: Alaska Status: NOT_YET_RECRUITING Zip: 99508 Location 3: City: Phoenix Country: United States Facility: Arthrosi Investigative Site (112) State: Arizona Status: NOT_YET_RECRUITING Zip: 85037 Location 4: City: Tempe Country: United States Facility: Arthrosi Investigative Site (114) State: Arizona Status: NOT_YET_RECRUITING Zip: 85281 Location 5: City: El Cajon Country: United States Facility: Arthrosi Investigative Site (131) State: California Status: NOT_YET_RECRUITING Zip: 92108 Location 6: City: Encinitas Country: United States Facility: Arthrosi Investigative Site (117) State: California Status: NOT_YET_RECRUITING Zip: 92024 Location 7: City: Rancho Cucamonga Country: United States Facility: Arthrosi Investigative Site (138) State: California Status: NOT_YET_RECRUITING Zip: 91730 Location 8: City: Aurora Country: United States Facility: Arthrosi Investigative Site (101) State: Colorado Status: NOT_YET_RECRUITING Zip: 80014 Location 9: City: Colorado Springs Country: United States Facility: Arthrosi Investigative Site (109) State: Colorado Status: NOT_YET_RECRUITING Zip: 80918 Location 10: City: Aventura Country: United States Facility: Arthrosi Investigative Site (118) State: Florida Status: RECRUITING Zip: 33180 Location 11: City: Clearwater Country: United States Facility: Arthrosi Investigative Site (149) State: Florida Status: NOT_YET_RECRUITING Zip: 33756 Location 12: City: Coral Gables Country: United States Facility: Arthrosi Investigative Site (115) State: Florida Status: RECRUITING Zip: 33134 Location 13: City: DeLand Country: United States Facility: Arthrosi Investigative Site (128) State: Florida Status: NOT_YET_RECRUITING Zip: 32720 Location 14: City: Edgewater Country: United States Facility: Arthrosi Investigative Site (143) State: Florida Status: NOT_YET_RECRUITING Zip: 32132 Location 15: City: Hollywood Country: United States Facility: Arthrosi Investigative Site (102) State: Florida Status: NOT_YET_RECRUITING Zip: 33024 Location 16: City: Miami Country: United States Facility: Arthrosi Investigative Site (103) State: Florida Status: NOT_YET_RECRUITING Zip: 33176 Location 17: City: Ormond Beach Country: United States Facility: Arthrosi Investigative Site (135) State: Florida Status: NOT_YET_RECRUITING Zip: 32174 Location 18: City: Boise Country: United States Facility: Arthrosi Investigative Site (133) State: Idaho Status: NOT_YET_RECRUITING Zip: 83713 Location 19: City: River Forest Country: United States Facility: Arthrosi Investigative Site (122) State: Illinois Status: NOT_YET_RECRUITING Zip: 48109 Location 20: City: New Orleans Country: United States Facility: Arthrosi Investigative Site (144) State: Louisiana Status: NOT_YET_RECRUITING Zip: 70115 Location 21: City: New Orleans Country: United States Facility: Arthrosi Investigative Site (108) State: Louisiana Status: NOT_YET_RECRUITING Zip: 70124 Location 22: City: Hagerstown Country: United States Facility: Arthrosi Investigative Site (150) State: Maryland Status: NOT_YET_RECRUITING Zip: 21740 Location 23: City: Ann Arbor Country: United States Facility: Arthrosi Investigative Site (121) State: Michigan Status: NOT_YET_RECRUITING Zip: 48109 Location 24: City: Detroit Country: United States Facility: Arthrosi Investigative Site (105) State: Michigan Status: NOT_YET_RECRUITING Zip: 48076 Location 25: City: Kansas City Country: United States Facility: Arthrosi Investigative Site (119) State: Missouri Status: RECRUITING Zip: 64151 Location 26: City: Binghamton Country: United States Facility: Arthrosi Investigative Site (100) State: New York Status: NOT_YET_RECRUITING Zip: 13905 Location 27: City: Brooklyn Country: United States Facility: Arthrosi Investigative Site (113) State: New York Status: NOT_YET_RECRUITING Zip: 11201 Location 28: City: Greensboro Country: United States Facility: Arthrosi Investigative Site (137) State: North Carolina Status: NOT_YET_RECRUITING Zip: 27410 Location 29: City: Shelby Country: United States Facility: Arthrosi Investigative Site (140) State: North Carolina Status: RECRUITING Zip: 28150 Location 30: City: Wilmington Country: United States Facility: Arthrosi Investigative Site (130) State: North Carolina Status: NOT_YET_RECRUITING Zip: 28403 Location 31: City: Cleveland Country: United States Facility: Arthrosi Investigative Site (148) State: Ohio Status: NOT_YET_RECRUITING Zip: 44195 Location 32: City: Dayton Country: United States Facility: Arthrosi Investigative Site (146) State: Ohio Status: NOT_YET_RECRUITING Zip: 45429 Location 33: City: Hatboro Country: United States Facility: Arthrosi Investigative Site (120) State: Pennsylvania Status: RECRUITING Zip: 19040 Location 34: City: Myrtle Beach Country: United States Facility: Arthrosi Investigative Site (147) State: South Carolina Status: NOT_YET_RECRUITING Zip: 29572 Location 35: City: Rapid City Country: United States Facility: Arthrosi Investigative Site (132) State: South Dakota Status: NOT_YET_RECRUITING Zip: 57702 Location 36: City: Amarillo Country: United States Facility: Arthrosi Investigative Site (110) State: Texas Status: NOT_YET_RECRUITING Zip: 79106 Location 37: City: Dallas Country: United States Facility: Arthrosi Investigative Site (104) State: Texas Status: NOT_YET_RECRUITING Zip: 75251 Location 38: City: Graham Country: United States Facility: Arthrosi Investigative Site (116) State: Texas Status: NOT_YET_RECRUITING Zip: 76450 Location 39: City: Lake Jackson Country: United States Facility: Arthrosi Investigative Site (126) State: Texas Status: NOT_YET_RECRUITING Zip: 77566 Location 40: City: Missouri City Country: United States Facility: Arthrosi Investigative Site (136) State: Texas Status: NOT_YET_RECRUITING Zip: 77459 Location 41: City: Plano Country: United States Facility: Arthrosi Investigative Site (129) State: Texas Status: NOT_YET_RECRUITING Zip: 75024 Location 42: City: Round Rock Country: United States Facility: Arthrosi Investigative Site (127) State: Texas Status: NOT_YET_RECRUITING Zip: 78681 Location 43: City: Tomball Country: United States Facility: Arthrosi Investigative Site (107) State: Texas Status: NOT_YET_RECRUITING Zip: 77375 Location 44: City: Tomball Country: United States Facility: Arthrosi Investigative Site (124) State: Texas Status: NOT_YET_RECRUITING Zip: 77377 Location 45: City: Bountiful Country: United States Facility: Arthrosi Investigative Site (142) State: Utah Status: NOT_YET_RECRUITING Zip: 98021 Location 46: City: Ogden Country: United States Facility: Arthrosi Investigative Site (145) State: Utah Status: NOT_YET_RECRUITING Zip: 84405 Location 47: City: Hampton Country: United States Facility: Arthrosi Investigative Site (111) State: Virginia Status: NOT_YET_RECRUITING Zip: 23666 Location 48: City: Winchester Country: United States Facility: Arthrosi Investigative Site (134) State: Virginia Status: RECRUITING Zip: 22601 Location 49: City: Bothell Country: United States Facility: Arthrosi Investigative Site (141) State: Washington Status: NOT_YET_RECRUITING Zip: 98021 Location 50: City: Botany Country: Australia Facility: Arthrosi Investigative Site (203) State: New South Wales Status: NOT_YET_RECRUITING Zip: 2019 Location 51: City: Westmead Country: Australia Facility: Arthrosi Investigative Site (201) State: New South Wales Status: NOT_YET_RECRUITING Zip: 2145 Location 52: City: Camberwell Country: Australia Facility: Arthrosi Investigative Site (200) State: Victoria Status: NOT_YET_RECRUITING Zip: 3124 Location 53: City: Auckland Country: New Zealand Facility: Arthrosi Investigative Site (300) Status: NOT_YET_RECRUITING Zip: 1010 Location 54: City: Auckland Country: New Zealand Facility: Arthrosi Investigative Site (302) Status: NOT_YET_RECRUITING Zip: 1010 Location 55: City: Hamilton Country: New Zealand Facility: Arthrosi Investigative Site (304) Status: NOT_YET_RECRUITING Zip: 3200 Location 56: City: Nelson Country: New Zealand Facility: Arthrosi Investigative Site (303) Status: NOT_YET_RECRUITING Zip: 7011 Location 57: City: Rotorua Country: New Zealand Facility: Arthrosi Investigative Site (301) Status: NOT_YET_RECRUITING Zip: 3010 #### Overall Officials Official 1: Affiliation: Arthrosi Therapeutics, Inc. Name: Robert Keenan, MD Role: STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000070657 - Term: Crystal Arthropathies - ID: D000012216 - Term: Rheumatic Diseases - ID: D000011686 - Term: Purine-Pyrimidine Metabolism, Inborn Errors - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000008659 - Term: Metabolic Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M9177 - Name: Gout - Relevance: HIGH - As Found: Gout - ID: M17915 - Name: Arthritis, Gouty - Relevance: HIGH - As Found: Arthritis, Gouty - ID: M24343 - Name: Hyperuricemia - Relevance: HIGH - As Found: Hyperuricemia - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M630 - Name: Crystal Arthropathies - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M14540 - Name: Purine-Pyrimidine Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006073 - Term: Gout - ID: D000015210 - Term: Arthritis, Gouty - ID: D000033461 - Term: Hyperuricemia ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439589 Brief Title: Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors Official Title: An Open-label, Multi-center Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors #### Organization Study ID Info ID: HRS2398-201-PD-L1 #### Organization Class: INDUSTRY Full Name: Shanghai Hengrui Pharmaceutical Co., Ltd. ### Status Module #### Completion Date Date: 2025-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-12 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Shanghai Hengrui Pharmaceutical Co., Ltd. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors. ### Conditions Module Conditions: - Advanced Solid Tumors ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 88 Type: ESTIMATED Phases: - PHASE1 - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: HRS2398 - Drug: Adebrelimab Label: HRS2398 given in combination with adebrelimab Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - HRS2398 given in combination with adebrelimab Description: HRS2398: Tablets, 40mg/tablet, oral Name: HRS2398 Type: DRUG #### Intervention 2 Arm Group Labels: - HRS2398 given in combination with adebrelimab Description: Adebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion Name: Adebrelimab Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: The number of subjects with dose-limiting toxicity (DLT) Time Frame: From first dose of study treatment until the end of Cycle 1（up to 28 days） Measure: Determination of Recommended Phase II dose (RP2D) Time Frame: From first dose of study treatment until the end of Cycle 1（up to 28 days） Measure: Objective Response Rate (ORR) Time Frame: From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months) #### Secondary Outcomes Measure: Disease Control Rate (DCR) Time Frame: From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months) Measure: Duration of Response (DoR) Time Frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months) Measure: Progression free Survival (PFS) Time Frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months) Measure: Overall Survival (OS) Time Frame: From time of first dose of objective disease progression until the date of death (up to 24 months) Measure: Time To Response(TTR) Time Frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. 2. Age 18\~75 years old. 3. Dose escalation phase: patients with clinically diagnosed or pathologically confirmed advanced solid tumors who have failed standard therapy (disease progression during or after treatment) or for whom no effective standard treatment regimen exists. 4. Dose Expansion and Efficacy Expansion Phase: Patients with advanced solid tumors who have received systemic immunotherapy and platinum-containing chemotherapy in the recurrent/metastatic settings. 5. At least one measurable lesion per RECIST v1.1 criteria. 6. ECOG PS score: 0-1. Exclusion Criteria: 1. Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy. 2. Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose. 3. Presence of any active, known autoimmune disease. Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: xin.xu@hengrui.com Name: Xin Xu Phone: 0518-82342973 Role: CONTACT Contact 2: Email: yuting.wang@hengrui.com Name: Yuting Wang Phone: 0518-82342973 Role: CONTACT #### Locations Location 1: City: Zhengzhou Contacts: *Contact 1:* - Name: Yanyan Liu - Role: PRINCIPAL_INVESTIGATOR Country: China Facility: Henan Cancer Hospital State: Henan Zip: 450003 ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439576 Brief Title: Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study) Official Title: China Faricimab Real World Evidence: Evaluation of Faricimab Effectiveness, Safety and Treatment Pattern, in Diabetic Macular Edema, Retinal Vein Occlusion and Neovascular Age-Related Macular Degeneration: The Farseeing Study #### Organization Study ID Info ID: ML45401 #### Organization Class: INDUSTRY Full Name: Hoffmann-La Roche ### Status Module #### Completion Date Date: 2027-11-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2027-11-30 Type: ESTIMATED #### Start Date Date: 2024-05-31 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Shanghai Roche Pharmaceutical Co., Ltd #### Lead Sponsor Class: INDUSTRY Name: Hoffmann-La Roche #### 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 Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. It is a primary data collection, non-interventional, prospective and retrospective, multi-center study designed to collect real-world, long-term data to gain clinical evidence on faricimab, by observing cohorts of patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) who are receiving treatment with faricimab. ### Conditions Module Conditions: - Diabetic Macular Edema - Neovascular Age-related Macular Degeneration - Retinal Vein Occlusion ### 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: - Drug: Faricimab Label: Cohort 1: Patients with nAMD #### Arm Group 2 Intervention Names: - Drug: Faricimab Label: Cohort 2: Patients with DME #### Arm Group 3 Intervention Names: - Drug: Faricimab Label: Cohort 3: Patients with RVO ### Interventions #### Intervention 1 Arm Group Labels: - Cohort 1: Patients with nAMD - Cohort 2: Patients with DME - Cohort 3: Patients with RVO Description: The dosing and treatment duration of the studied medicinal product is at the discretion of the physician in accordance with clinical practice and labeling in China. Name: Faricimab Other Names: - VABYSMO® Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score. Measure: Change in Visual Acuity from Baseline at Month 12 Time Frame: Baseline and Month 12 #### Secondary Outcomes Measure: Visual Acuity Over Time Time Frame: Baseline, Months 3, 6, 9, 12, 18, and 24 Measure: Change in Visual Acuity from Baseline Over Time Time Frame: Baseline, Months 3, 6, 9, 18, and 24 Measure: Central Subfield Thickness Over Time Time Frame: Baseline, Months 3, 6, 9, 12, 18, and 24 Measure: Change in Central Subfield Thickness from Baseline Over Time Time Frame: Baseline, Months 3, 6, 9, 12, 18, and 24 Measure: Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Time Frame: From Baseline to Month 24 Measure: Number of Treatments per Year Time Frame: Months 12 and 24 Measure: Percentage of Eyes with Treatment Switch by Reason for Switch Over Time Time Frame: Months 3, 6, 9, 12, 18, and 24 Measure: Percentage of Eyes with Treatment Regimen Switch (Fixed, Treat-and-Extend, As Needed, or Other) by Reason for Switch Over Time Time Frame: Months 3, 6, 9, 12, 18, and 24 Measure: Total Number of Visits per Year Time Frame: Months 12 and 24 Measure: Number of Visits With or Without Treatment per Year Time Frame: Months 12 and 24 Measure: Time Interval Between Treatments per Year Time Frame: Months 12 and 24 Measure: Percentage of Eyes Treated with Ocular Concomitant Medications or Therapy by Type and Frequency During the Study Time Frame: From Baseline until end of study (up to 3.5 years) Measure: Number of Participants Lost to Follow-Up More Than 6 Months at Months 12, 18, and 24 Time Frame: Months 12, 18, and 24 Measure: Percentage of Eyes According to the Last Treatment Interval at Months 3, 6, 12, 18, and 24 Time Frame: Months 3, 6, 12, 18, and 24 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Have signed the informed consent 2. Female and male Chinese patients, who had been diagnosed with nAMD, DME, or RVO by CFP, OCT, FFA, ICGA, or OCTA 3. ≥50 years old for patients with nAMD, ≥18 years old both for patients with DME and RVO, at the time of signing informed consent (or the first administration of faricimab, whichever occurs first) 4. Patients for whom the decision to receive treatment with faricimab is made prior to and independent from study participation 5. Patients have received at least one faricimab treatment (the first dose) in the study eye Exclusion Criteria: 1. Patients not receiving treatment for nAMD/DME/RVO with faricimab according to the standard of care and in line with the current summary of product characteristics (SPC) / labeling in China 2. Active ocular inflammation or suspected / active ocular infection in either eye 3. Received any other anti-VEGF treatment after faricimab 4. Received any steroid treatment within 6 months (180 days) before the first faricimab treatment in the study eye 5. Any participation in any other clinical trials currently 6. Patients could not provide the clinical data (visual acuity and OCT images) within 2 weeks (14 days) before receiving the initial faricimab injection Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: The study will recruit patients who are naïve to anti-VEGF therapy in the study eye and those who have previously been treated with anti-VEGF therapy in the study eye. Study participation of patients previously treated with other anti-VEGF agents will be capped at a maximum of 40% of each indication enrollment. ### Contacts Locations Module #### Central Contacts Contact 1: Email: global-roche-genentech-trials@gene.com Name: Reference Study ID Number: ML45401 https://forpatients.roche.com/ Phone: 888-662-6728 (U.S. Only) Role: CONTACT #### Locations Location 1: City: Shanghai Country: China Facility: Shanghai First People's Hospital Status: RECRUITING Zip: 200080 #### Overall Officials Official 1: Affiliation: Hoffmann-La Roche Name: Clinical Trials Role: STUDY_DIRECTOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012162 - Term: Retinal Degeneration - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000020246 - Term: Venous Thrombosis - ID: D000013927 - Term: Thrombosis - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000009901 - Term: Optic Nerve Diseases - ID: D000003389 - Term: Cranial Nerve Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11260 - Name: Macular Degeneration - Relevance: HIGH - As Found: Age-related Macular Degeneration - ID: M11261 - Name: Macular Edema - Relevance: HIGH - As Found: Macular Edema - ID: M15005 - Name: Retinal Vein Occlusion - Relevance: HIGH - As Found: Retinal Vein Occlusion - ID: M7657 - Name: Edema - Relevance: HIGH - As Found: Edema - ID: M13130 - Name: Papilledema - Relevance: HIGH - As Found: Edema, Retinal - ID: M28735 - Name: Wet Macular Degeneration - Relevance: HIGH - As Found: Neovascular Age-related Macular Degeneration - ID: M14997 - Name: Retinal Degeneration - Relevance: LOW - As Found: Unknown - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M16686 - Name: Thrombosis - Relevance: LOW - As Found: Unknown - ID: M22071 - Name: Venous Thrombosis - Relevance: LOW - As Found: Unknown - ID: M7784 - Name: Embolism - Relevance: LOW - As Found: Unknown - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M12832 - Name: Optic Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: M6605 - Name: Cranial Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: T4402 - Name: Papilledema - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010211 - Term: Papilledema - ID: D000008268 - Term: Macular Degeneration - ID: D000008269 - Term: Macular Edema - ID: D000057135 - Term: Wet Macular Degeneration - ID: D000012170 - Term: Retinal Vein Occlusion - ID: D000004487 - Term: Edema ### Intervention Browse Module - Ancestors - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M353201 - Name: Faricimab - Relevance: HIGH - As Found: 3D printing - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000723200 - Term: Faricimab ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439563 Brief Title: Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers Official Title: A Multicenter, Parallel, Double-blind, Randomized, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 Treatment in the Prevention of (NSAIDs)-Induced Peptic Ulcers #### Organization Study ID Info ID: JP-1366-304 #### Organization Class: INDUSTRY Full Name: Onconic Therapeutics Inc. ### Status Module #### Completion Date Date: 2027-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-29 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2027-08 Type: ESTIMATED #### Start Date Date: 2024-08 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-22 Study First Submit QC Date: 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Onconic Therapeutics Inc. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 mg. ### Conditions Module Conditions: - Peptic Ulcer ### 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: 364 Type: ESTIMATED Phases: - PHASE3 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: JP-1366 10 mg - Drug: Lanston Capsule 15 mg placebo Label: JP-1366 10 mg Type: EXPERIMENTAL #### Arm Group 2 Intervention Names: - Drug: Lanston Capsule 15 mg - Drug: JP-1366 10 mg placebo Label: Lanston Capsule 15 mg Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - JP-1366 10 mg Description: JP-1366 10 mg, tablet, orally once a day for up to 24 weeks Name: JP-1366 10 mg Type: DRUG #### Intervention 2 Arm Group Labels: - Lanston Capsule 15 mg Description: Lanston Capsule 15 mg orally once a day for up to 24 weeks Name: Lanston Capsule 15 mg Type: DRUG #### Intervention 3 Arm Group Labels: - Lanston Capsule 15 mg Description: JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks Name: JP-1366 10 mg placebo Type: DRUG #### Intervention 4 Arm Group Labels: - JP-1366 10 mg Description: Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks Name: Lanston Capsule 15 mg placebo Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: Cumulative proportion of subjects who developed peptic ulcers Time Frame: at 24 weeks after administration of investigational products #### Secondary Outcomes Measure: Proportion of subjects with gastric or duodenal endoscopic bleeding Time Frame: at 24 weeks after administration of investigational products ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Adult male/female aged 19 years or older as of the date of obtaining consent 2. Those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous administration of NSAIDs for 24 weeks or more 3. Those with one or more of the following risk factors for ulcer development at the time of screening 4. Subjects who fully understand this study and voluntarily signed the informed consent form. Exclusion Criteria: 1. Those who cannot undergo upper gastrointestinal endoscopy 2. At the time of screening, those who were confirmed to have active stage ulcers (A1, A2) or healing stage ulcers (H1, H2) in the stomach or duodenum according to the Sakita-Miwa Classification\* 3. Those with a confirmed history of malignant tumor within 5 years 4. Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract 5. Those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted): 6. Pregnant and lactating women or those with a positive pregnancy test result at screening 7. Those who participated in another study and were administered investigational products or had medical devices applied at least once within 4 weeks from the screening visit(Visit 0) Minimum Age: 19 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: onconictherapeutics@gmail.com Name: John KIM Phone: 0234540780 Role: CONTACT #### Locations Location 1: City: Seoul Contacts: *Contact 1:* - Name: Sang-Heon Lee - Phone: 0220305114 - Role: CONTACT Country: Korea, Republic of Facility: Konkuk University Medical Center ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000004378 - Term: Duodenal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M13348 - Name: Peptic Ulcer - Relevance: HIGH - As Found: Peptic Ulcer - ID: M17206 - Name: Ulcer - Relevance: HIGH - As Found: Ulcer - ID: M7552 - Name: Duodenal Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010437 - Term: Peptic Ulcer - ID: D000014456 - Term: Ulcer ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439550 Brief Title: Adjuvant Treatment With Serplulimab，Trastuzumab and SOX in the HER-2 Positive GC/GEJC Official Title: Adjuvant Treatment With Serplulimab，Trastuzumab and SOX in the of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC) #### Organization Study ID Info ID: HLX10IIT123 #### Organization Class: OTHER Full Name: The First Affiliated Hospital of Zhengzhou University ### Status Module #### Completion Date Date: 2026-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-12-31 Type: ESTIMATED #### Start Date Date: 2024-07-15 Type: ESTIMATED Status Verified Date: 2023-11 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: The First Affiliated Hospital of Zhengzhou University #### Responsible Party Investigator Affiliation: The First Affiliated Hospital of Zhengzhou University Investigator Full Name: Feng Wang Investigator Title: The First Affiliated Hospital of Zhengzhou University Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab，Trastuzumab and SOX in the adjuvant treatment of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC) ### Conditions Module Conditions: - HER2-positive Gastric Cancer ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 42 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Within 4 weeks after surgery, patients will be enrolled in the study and started on Serplulimab (300mg, q3w) + Trastuzumab (First dose 8mg/kg, maintenance 6mg/kg, q3w) + oxaliplatin (130mg/m2, q3w) + Tegafur (40mg/m2, bid d1-d14, q3w). Among them, oxaliplatin + Teggio can be used for 4-6 cycles according to the patient's tolerance, and Serplulimab + trastuzumab can be continued until 12 months or tumor recurrence or metastasis Intervention Names: - Drug: Serplulimab - Drug: Trastuzumab - Drug: Oxaliplatin + Tegafur Label: Serplulimab，Trastuzumab and SOX Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Serplulimab，Trastuzumab and SOX Description: 300mg, q3w Name: Serplulimab Type: DRUG #### Intervention 2 Arm Group Labels: - Serplulimab，Trastuzumab and SOX Description: First dose 8mg/kg, maintenance 6mg/kg, q3w Name: Trastuzumab Type: DRUG #### Intervention 3 Arm Group Labels: - Serplulimab，Trastuzumab and SOX Description: oxaliplatin (130mg/m2, q3w) + Tegafur (40mg/m2, bid d1-d14, q3w). Name: Oxaliplatin + Tegafur Other Names: - SOX Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Objective response rate according to RECIST 1.1 Measure: Disease progression free survival （DFS） Time Frame: 24 months after the last subject participating in #### Secondary Outcomes Description: Overall survival Measure: Overall survival (OS） Time Frame: 24 months after the last subject participating in Description: Objective response rate according to RECIST 1.1 Measure: Recurrence rate Time Frame: 24 months after the last subject participating in Description: Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE Measure: Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE Time Frame: through study completion, an average of 1 year ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Histologically confirmed gastric adenocarcinoma/esophagogastric junction adenocarcinoma, HER-3 + or HER-2 +, with Fish amplification; 2. Subjects must complete R0 resection before enrollment；If they received neoadjuvant therapy, it was required that the neoadjuvant therapy regimen should not contain anti-HER-2 targeted drugs; 3. Postoperative pathology: II-III; 4. Age 18-75 years old; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 6. Blood routine and biochemistry within 7 days before enrollment : a. Hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets ≥100×109/L (no blood transfusion within 14 days before treatment, no granulocyte colony-stimulating factor, no correction with other drugs); b. ALT and AST≤2.5 times the normal upper limit (ULN); ALP≤2.5 times ULN; c. Serum total bilirubin \<1.5 ULN (Gilbert syndrome patients with total bilirubin \<3 ULN can be enrolled); d. Serum creatinine \<1.5 ULN or estimated glomerular filtration rate ≥60ml/min/1.73m2; e. Serum albumin ≥30g/L; f. International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, unless the patient is receiving anticoagulant therapy and the PT value is within the intended treatment range of the anticoagulant; g. Activated partial thromboplastin time (APTT) ≤1.5 times ULN. 7. No serious concomitant diseases that make the survival time less than 5 years; 8. Voluntary and able to adhere to the program during the study; 9. Provide written informed consent form before entering the study, and the subjects has understood that he can withdraw from the study at any time during the study without any loss. Exclusion Criteria: 1. A history of any other malignancy in the past 5 years (except carcinoma in situ or basal cell carcinoma of the skin or squamous cell carcinoma of the skin)；Patients with small gastric stromal tumors and other tumors may be excluded if the researcher determines that other tumors will not affect the patient's life in the short term； 2. Participated in clinical trials of other drugs within four weeks; 3. Have any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects has vitiligo; asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included) 4. Requires systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration to treat a current condition. 5. Any active malignant tumour within 2 years, excluding the specific cancer being studied in this trial and the locally recurrent cancer that has been cured (such as basal cell or squamous cell skin cancer that has been removed, superficial bladder cancer cancer, cervical or breast cancer in situ); 6. Subjects with central nervous system metastasis or a history of central nervous system metastasis. With clinically suspected CNS metastasis, CT or MRI must be performed within 28 days before starting treatment to rule out CNS metastasis； 7. With unstable angina pectoris; Newly diagnosed angina pectoris within 3 months prior to screening or myocardial infarction events occurred within 6 months prior to screening; Arrhythmias (including QTcF: ≥ 450 ms for males and ≥ 470 ms for females) require long-term use of antiarrhythmic drugs and a New York Heart Association grade of ≥ II cardiac dysfunction; 8. Or urinary protein qualitative ≥2+, 24 hours urinary protein \> 1g 9. For female subjects: should be surgically sterilized, postmenopausal, or consent to use a medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests must be negative within 7 days before enrollment and must be non-lactating. Male subjects: patients who should be surgically sterilized or who have consented to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period; 10. Liver transplantation patients； 11. With infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other subjects require the use of corticosteroids; 12. Have a history of chronic autoimmune diseases, such as systemic lupus erythematosus; 13. Have a history of inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, and a history of chronic diarrhea diseases such as irritable bowel syndrome； 14. Have a history of sarcoidosis or tuberculosis； 15. With active HBV, HCV，and HIV infection； 16. Subjects with a history of psychotropic substance abuse and are unable to abstain or have mental disorders; 17) Thoracic or abdominal effusion with clinical symptoms that require clinical intervention; 18) A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 19) According to the judgment of the researcher,there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study. Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: fengw010@163.com Name: Feng Wang Phone: 13938244776 Role: CONTACT #### Overall Officials Official 1: Affiliation: The First Affiliated Hospital of Zhengzhou University Name: Feng Wang 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: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - 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: M1674 - Name: Oxaliplatin - Relevance: HIGH - As Found: Min - ID: M325 - Name: Trastuzumab - Relevance: HIGH - As Found: Quality - ID: M8760 - Name: Tegafur - Relevance: HIGH - As Found: Nail - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077150 - Term: Oxaliplatin - ID: D000068878 - Term: Trastuzumab - ID: D000005641 - Term: Tegafur ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439537 Acronym: ICIT: Recall Brief Title: ICIT: Recall A Multicentre Study of Consent For Hip Fractures Official Title: Improving Consent In Trauma: Recall (ICIT: Recall) A Multicentre Study of Consent For Hip Fractures #### Organization Study ID Info ID: AC23137 #### Organization Class: OTHER_GOV Full Name: NHS Lothian ### Status Module #### Completion Date Date: 2024-09 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-29 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-09 Type: ESTIMATED #### Start Date Date: 2024-07 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-06 Study First Submit QC Date: 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER_GOV Name: NHS Lothian #### Responsible Party Type: SPONSOR ### Oversight Module Oversight Has DMC: False ### Description Module Brief Summary: Hip fractures are a major cause litigation in patients undergoing trauma surgery. Common causes of litigation in hip operations are alleged incompetent surgery and development of pressure sources, both of which are associated with poor quality of consent. One aspect of poor consent is patients not being able to retain information discussed with them prior to their operation. There are many factors attributed to this, including pain in the acute setting, administration of sedating medications and the high rate of delirium in this patient cohort. However, even in individuals deemed to have capacity during the consent process, studies have shown that many were unable to explain what type of surgery they had or express knowledge of the potential complications. Importantly, the hip fracture patient demographic is very different from patients undergoing a planned procedure, in that they have had an acute injury following physical trauma, tend to be older and medically frailer. Research into the recall of patients undergoing gynaecological or abdominal surgeries further corroborate patients' poor recall of potential complications in the acute setting. Patients with hip fractures face a range of risks, some of which can result in a substantial mortality rate regardless of whether surgery is performed. The list of complications includes infections in the hip joint and wound, development of pressure sores, occurrence of pulmonary embolism (PE) and deep vein thrombosis (DVT), myocardial infarction, urinary tract infection, pneumonia, and potential procedural failures. As such, the ability of patients to remember the discussed complications is critical to their well-being and overall quality of life and remains an unmet clinical need. Detailed Description: Improving Consent In Trauma: Recall (ICIT Recall) will be a multicentre quality improvement project within the NHS clinical care setting. The aim of this study is to assess hip fracture patient's ability retain information regarding their injury, proposed operation, potential complications, and alternatives. following obtaining formal written consent. To that end, the project is intended to be a multicentre study, with interviews across a range of different health boards. The investigators also wish to listen to individual patients' experience of the surgical consent process through a follow-up interview once it has been over one week since their operation. Part (1), the structured face-to-face questionnaire was established to identify the extent of the problem and what patients find memorable or overlooked about the consent process. Part (2), the interview was designed to obtain qualitative data on what patients find important and to allow the participants to tell their story. The overarching objective of this project is to empower patients so that they are more involved and have a greater understanding of the operation that they have consented to. This includes simple measures such as providing a patient information leaflet or improving communication with the patient or close family members during their consent process. Sometimes, poor retention of information is unavoidable due to the significant pain and stress patients are under, and for this reason our aim is to improve the quality of consent for major procedures like hip operations. As part of the project, the investigators also wish to engage with and capture patient-cantered experiences through a further interview. The investigators aim to like to capture their experience of the consent process entirely from the patient's perspective. Patient stories are a powerful tool to promote culture change in patient care. Unlike surveys, patient stories allow a seamless flow of thoughts and feelings that can provide insight into their journey to recovery. Here, the aim is to highlight the importance of good communication and an overall clear consent process in promoting wellbeing. This aspect of care tends to be overlooked. Addressing this issue is particularly important in delivering compassionate care within the NHS. ### Conditions Module Conditions: - Hip Fractures - Hip Injuries Keywords: - hip fracture - consent - incapacity ### 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: Single-group cohort for all hip fracture patients who are candidates for an operation Intervention Names: - Other: Semi-structured questionnaire - Other: Post-operative interview Label: Single-group for all hip fracture patients ### Interventions #### Intervention 1 Arm Group Labels: - Single-group for all hip fracture patients Description: All patients recruited to the study will undergo a semi-structured questionnaire within 36 hours of admission Name: Semi-structured questionnaire Type: OTHER #### Intervention 2 Arm Group Labels: - Single-group for all hip fracture patients Description: All patients recruited to the study will undergo a semi-structured interview once they have reached post-operative day 7 or over Name: Post-operative interview Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Proportion of individuals admitted with hip fractures that do not have capacity to consent. The measurement tool will be the 4AT. Measure: Incapacity Time Frame: Within 36 hours of admission Description: Proportion of complications discussed initially in consenting individuals that were still retained by the time of interview (within 36 hours of admission). Measure: Retention of complications Time Frame: Within 36 hours of admission #### Secondary Outcomes Description: The personal experience of giving consent for hip fracture operations through semi-structured questionnaires. The measurement tool is a thematic analysis using a qualitative coding framework, whereas the unit of measure is the frequency and prevalence of themes Measure: Thematic analysis of narrative contents Time Frame: Post-operative day 7 to post-operative day 28 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Inpatient on trauma and orthopaedic wards * Is candidate for a hip fracture operation * Able to provide informed consent * Able to participate in a conversation (without the use of a translator) Exclusion Criteria: * Deemed to be too unwell or medically unstable to participate * Under Adult With Incapacity Act or other detaining orders * Patients scoring a 4AT score of 4 or more * Unable to provide consent Maximum Age: 110 Years Minimum Age: 50 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Participants listed for hip fracture surgery, after sustaining a hip fracture surgery under the care of participating surgeons at the Royal Infirmary of Edinburgh. Approximately 100 participants will be included in this prospective cohort study recruited through consecutive sampling. ### Contacts Locations Module #### Central Contacts Contact 1: Email: Nick.Clement@nhslothian.scot.nhs.uk Name: Nicholas Clement, MBBS, MD, PhD, FRCS (T&O) Phone: 0131 2426462 Role: CONTACT Contact 2: Email: tony.feng@nhs.scot Name: Tony Feng, MBChB, BSc (Hons) Phone: 07769661392 Role: CONTACT #### Locations Location 1: City: Edinburgh Contacts: *Contact 1:* - Email: nick.clement@nhslothian.scot.nhs.uk - Name: Nicholas Clement, PhD - Phone: +44 1312421000 - Role: CONTACT *Contact 2:* - Email: tony.feng@nhs.scot - Name: Tony Feng - Role: CONTACT Country: United Kingdom Facility: Royal Infirmary of Edinburgh State: Scotland Zip: EH16 4SA #### Overall Officials Official 1: Affiliation: NHS Lothian Name: Nicholas Clement, MBBS, MD, PhD, FRCS (T&O) Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Ring J, Talbot C, Cross C, Hinduja K. NHSLA litigation in hip fractures: Lessons learnt from NHSLA data. Injury. 2017 Aug;48(8):1853-1857. doi: 10.1016/j.injury.2017.06.009. Epub 2017 Jun 19. PMID: 28648408 Citation: Herrera-Perez M, Gonzalez-Martin D, Sanz EJ, Pais-Brito JL. Ethical Dilemmas with Regard to Elderly Patients with Hip Fracture: The Problem of Nonagenarians and Centenarians. J Clin Med. 2022 Mar 27;11(7):1851. doi: 10.3390/jcm11071851. PMID: 35407459 Citation: Zalmay P, Collis J, Wilson H. Patients Lacking the Capacity to Consent to Hip Fracture Surgery May Be Undergoing Major Operations Without Their Next of Kin Being Involved in Best-Interests Decisions: A Quality Improvement Report. Cureus. 2021 Dec 10;13(12):e20322. doi: 10.7759/cureus.20322. eCollection 2021 Dec. PMID: 35028219 Citation: Kalisvaart KJ, Vreeswijk R, de Jonghe JF, van der Ploeg T, van Gool WA, Eikelenboom P. Risk factors and prediction of postoperative delirium in elderly hip-surgery patients: implementation and validation of a medical risk factor model. J Am Geriatr Soc. 2006 May;54(5):817-22. doi: 10.1111/j.1532-5415.2006.00704.x. PMID: 16696749 Citation: Thiruchandran G, McKean AR, Rudran B, Imam MA, Yeong K, Hassan A. Improving consent in patients undergoing surgery for fractured neck of femur. Br J Hosp Med (Lond). 2018 May 2;79(5):284-287. doi: 10.12968/hmed.2018.79.5.284. PMID: 29727232 Citation: Probert N, Malik AA, Lovell ME. Surgery for fractured neck of femur - are patients adequately consented? Ann R Coll Surg Engl. 2007 Jan;89(1):66-9. doi: 10.1308/003588407X160846. PMID: 17316526 Citation: Bhangu A, Hood E, Datta A, Mangaleshkar S. Is informed consent effective in trauma patients? J Med Ethics. 2008 Nov;34(11):780-2. doi: 10.1136/jme.2008.024471. PMID: 18974409 Citation: Howard A, Webster J, Quinton N, Giannoudis PV. 'Hobson's choice': a qualitative study of consent in acute surgery. BMJ Open. 2020 Oct 8;10(10):e037657. doi: 10.1136/bmjopen-2020-037657. PMID: 33033090 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000005264 - Term: Femoral Fractures - 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: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M9696 - Name: Hip Fractures - Relevance: HIGH - As Found: Hip Fracture - ID: M23105 - Name: Hip Injuries - Relevance: HIGH - As Found: Hip Injuries - ID: M8402 - Name: Femoral Fractures - 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 - ID: D000025981 - Term: Hip Injuries ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439524 Brief Title: The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial Official Title: The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial #### Organization Study ID Info ID: 1111 #### Organization Class: OTHER Full Name: Main Line Health ### Status Module #### Completion Date Date: 2027-04 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-29 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-02-28 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-02-29 Study First Submit QC Date: 2024-05-29 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: Pfizer Class: INDUSTRY Name: Sumitomo Pharma America, Inc. #### Lead Sponsor Class: OTHER Name: Main Line Health #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Is US Export: True Oversight Has DMC: False ### Description Module Brief Summary: The goal of this clinical trial is to compare the overall quality of life of participants taking Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis to participants that do not take Rel-CT following the same surgery. Rel-CT is an FDA approved form of medical treatment for endometriosis. It is known to work in treating endometriosis pain. However, investigators do not know whether or not there is a benefit to beginning Rel-CT immediately following surgery. This study will test if patients who take Rel-CT after surgery have better quality of life and less chance the endometriosis comes back, requiring additional surgery. The main question it aims to answer is: - Does taking Rel-CT following excisional surgery for endometriosis result in higher Endometriosis Health Profile 30 (EHP-30) scores, indicating a positive impact on overall health-related quality of life and well-being? Participants will: * Be randomly assigned to one of two treatment groups. One treatment group will take study drug Rel-CT after having excisional surgery, and the other treatment group will just have the surgery alone. * Be asked to complete questionnaires, called the Endometriosis Health Profile 30 (EHP-30) at 4 timepoints. The first time is before surgery, then at follow-up visits at 1 month, 3 months, and 6 months. The survey has 30 questions that ask about pain, control, powerlessness, emotional well-being, social support, and self-image. Researchers will compare the two treatment groups (Rel-CT and non Rel-CT) to see if there is a change in EHP-30 scores. Detailed Description: The design of this study will be an unblinded randomized controlled trial of medical suppression with once daily Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis performed by high volume minimally invasive gynecologic surgeons. Women over the age of 18 scheduled to undergo a laparoscopic surgery for endometriosis will be screened and if agree and consented to participate will be randomized to either Rel-CT following surgery or no post-operative hormonal suppression using a block randomization with blocks 2 and 4. The surgeon will not have access to the randomization schedule to reduce selection bias. Inclusion criteria will include: 1) Patients over the age of 18 planning to undergo an elective laparoscopic/robotic procedure for known or suspected endometriosis. Exclusion criteria will include: 1) Patients with known contraindications to REL-CT; 2) Any form of hormonal suppression of endometriosis within 4-weeks of the index surgical procedure; 3) Primary language other than English/Spanish; 4) Patients without histologic evidence of endometriosis following their surgical procedure; 5) Patients interested in pregnancy within the 12 months following their surgical procedure. The primary outcome will be change in Endometriosis Health Profile 30 (EHP-30) score. A preoperative EHP-30 will be completed by all patients enrolled in the study within 4 weeks of their scheduled surgical procedure and then again postoperatively at 1 month, 3 months, and 6 months. Investigators expect that postoperative use of REL-CT will lead to a clinically meaningful improvement in EHP-30 scores compared to surgery alone. In addition, investigators will gather data on our secondary outcomes: These data could be very helpful in informing providers and patients of the utility of medical suppression of endometriosis using REL-CT following surgery. ### Conditions Module Conditions: - Endometriosis ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: The design of this study will be an unblinded randomized controlled trial of medical suppression with once daily Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis performed by high volume minimally invasive gynecologic surgeons. Researchers will use descriptive statistics to compare the demographics and clinical characteristics of the groups with chi-square and two-sample t-tests. The median differences in EHP-30 from baseline to 6 months will be compared between groups with Mann Whitney U test. The 95% confidence interval of the difference between group medians will be used to measure superiority. ##### Masking Info Masking: NONE Masking Description: Participants and providers will know if participants are assigned to the treatment arm to take Rel-CT or not. Primary Purpose: TREATMENT #### Enrollment Info Count: 110 Type: ESTIMATED Phases: - PHASE3 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, one tablet daily for 6 months Intervention Names: - Drug: 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate Label: Rel-CT Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: no study drug Label: no study drug Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Rel-CT Description: if randomized to study drug, participants will take one tablet Rel-CT daily following excisional surgery for endometriosis Name: 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate Other Names: - Relugolix Combination Therapy (Rel-CT) - Myfembree Type: DRUG ### Outcomes Module #### Primary Outcomes Description: The study will assess quality of life via change in total Endometriosis Health Profile 30 (EHP-30) scores following excisional surgery for endometriosis from baseline to 6 months postoperatively. Measure: This study aims to determine if immediate postoperative medical suppression with Regugolix combination therapy (Rel-CT) following excisional surgery for endometriosis is superior to surgery alone. Time Frame: 6 months #### Secondary Outcomes Description: Comparison of EHP-30 scores according to endometriosis stage of the participant of Rel-CT group to non Rel-Ct treatment group Measure: Change in EHP-30 scores between groups stratified by endometriosis stage Time Frame: 6 months Description: Comparison of EHP-30 survey subscales in treatment groups. Measure: Comparison of EHP-30 subscales Time Frame: 6 months Description: Need for surgical reintervention will be assessed between treatment groups. Measure: Reintervention rates between groups Time Frame: 6 months Description: Study drug adherence will be monitored and reported. Measure: Compliance rates for the study drug and office visits following surgery Time Frame: 6 months Description: Rate of concomitant adenomyosis will be collected and compared between two treatment groups. Measure: Rates of concomitant adenomyosis Time Frame: 6 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Women over the age of 18 planning to undergo an elective laparoscopic/ robotic procedure for known or suspected endometriosis. Exclusion Criteria: * Patients with known contraindications to Rel-CT * Patients taking any form of hormonal suppression of endometriosis within 4-weeks of the index surgical procedure * Primary language other than English/Spanish * Patients without histologic evidence of endometriosis following their surgical procedure * Patients interested in pregnancy within the 12 months following their surgical procedure * Surgical intervention more invasive than the planned laparoscopic or robotic excisional surgery, such as open abdominal surgical repair. Gender Based: True Gender Description: biological female at birth and meeting criteria for endometriosis Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: Klebanoffj@mlhs.org Name: Jordan Klebanoff, MD Phone: 610-896-4380 Role: CONTACT Contact 2: Email: WindawiS@mlhs.org Name: Sarah Windawi, MPH Phone: 484-476-8451 Role: CONTACT #### Locations Location 1: City: Wynnewood Contacts: *Contact 1:* - Name: Jordan Klebanoff, MD - Role: CONTACT Country: United States Facility: Main Line Health State: Pennsylvania Zip: 19096 #### Overall Officials Official 1: Affiliation: Main Line Health Name: Jordan Klebanoff, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Rindos NB, Fulcher IR, Donnellan NM. Pain and Quality of Life after Laparoscopic Excision of Endometriosis. J Minim Invasive Gynecol. 2020 Nov-Dec;27(7):1610-1617.e1. doi: 10.1016/j.jmig.2020.03.013. Epub 2020 Apr 6. PMID: 32272239 Citation: Zondervan KT, Becker CM, Missmer SA. Endometriosis. N Engl J Med. 2020 Mar 26;382(13):1244-1256. doi: 10.1056/NEJMra1810764. No abstract available. PMID: 32212520 Citation: Agarwal SK, Chapron C, Giudice LC, Laufer MR, Leyland N, Missmer SA, Singh SS, Taylor HS. Clinical diagnosis of endometriosis: a call to action. Am J Obstet Gynecol. 2019 Apr;220(4):354.e1-354.e12. doi: 10.1016/j.ajog.2018.12.039. Epub 2019 Jan 6. PMID: 30625295 Citation: Bafort C, Beebeejaun Y, Tomassetti C, Bosteels J, Duffy JM. Laparoscopic surgery for endometriosis. Cochrane Database Syst Rev. 2020 Oct 23;10(10):CD011031. doi: 10.1002/14651858.CD011031.pub3. PMID: 33095458 Citation: Burks C, Lee M, DeSarno M, Findley J, Flyckt R. Excision versus Ablation for Management of Minimal to Mild Endometriosis: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2021 Mar;28(3):587-597. doi: 10.1016/j.jmig.2020.11.028. Epub 2020 Dec 10. PMID: 33310168 Citation: Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469. PMID: 29420391 Citation: Roman H, Chanavaz-Lacheray I, Hennetier C, Tuech JJ, Dennis T, Verspyck E, Merlot B. Long-term risk of repeated surgeries in women managed for endometriosis: a 1,092 patient-series. Fertil Steril. 2023 Oct;120(4):870-879. doi: 10.1016/j.fertnstert.2023.05.156. Epub 2023 May 22. PMID: 37225069 Citation: Hornstein MD, Hemmings R, Yuzpe AA, Heinrichs WL. Use of nafarelin versus placebo after reductive laparoscopic surgery for endometriosis. Fertil Steril. 1997 Nov;68(5):860-4. doi: 10.1016/s0015-0282(97)00360-9. PMID: 9389816 Citation: Kaser DJ, Missmer SA, Berry KF, Laufer MR. Use of norethindrone acetate alone for postoperative suppression of endometriosis symptoms. J Pediatr Adolesc Gynecol. 2012 Apr;25(2):105-108. doi: 10.1016/j.jpag.2011.09.013. Epub 2011 Dec 11. PMID: 22154396 Citation: Yap C, Furness S, Farquhar C. Pre and post operative medical therapy for endometriosis surgery. Cochrane Database Syst Rev. 2004;2004(3):CD003678. doi: 10.1002/14651858.CD003678.pub2. PMID: 15266496 Citation: Giudice LC, As-Sanie S, Arjona Ferreira JC, Becker CM, Abrao MS, Lessey BA, Brown E, Dynowski K, Wilk K, Li Y, Mathur V, Warsi QA, Wagman RB, Johnson NP. Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associated pain: two replicate phase 3, randomised, double-blind, studies (SPIRIT 1 and 2). Lancet. 2022 Jun 18;399(10343):2267-2279. doi: 10.1016/S0140-6736(22)00622-5. Erratum In: Lancet. 2022 Aug 27;400(10353):660. PMID: 35717987 #### See Also Links Label: Estimating the Mean and Variance from the Median, Range, and the Size of a Sample URL: https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-5-13 ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-19 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 142176 - Type Abbrev: ICF - Upload Date: 2024-05-10T09:02 ## 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 ### Intervention Browse Module - Ancestors - ID: D000004967 - Term: Estrogens - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000080066 - Term: Contraceptive Agents, Hormonal - ID: D000003270 - Term: Contraceptive Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000003271 - Term: Contraceptive Agents, Female - ID: D000003278 - Term: Contraceptives, Oral, Hormonal - ID: D000003276 - Term: Contraceptives, Oral - ID: D000003280 - Term: Contraceptives, Oral, Synthetic - ID: D000000726 - Term: Androgen Antagonists - ID: D000006727 - Term: Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12577 - Name: Norethindrone - Relevance: HIGH - As Found: Meropenem - ID: M1841 - Name: Norethindrone Acetate - Relevance: HIGH - As Found: Neratinib - ID: M8108 - Name: Estradiol - Relevance: HIGH - As Found: Cell lymphoma - ID: M347494 - Name: Relugolix - Relevance: HIGH - As Found: University Students - ID: M266279 - Name: Estradiol 17 beta-cypionate - Relevance: LOW - As Found: Unknown - ID: M266280 - Name: Estradiol 3-benzoate - Relevance: LOW - As Found: Unknown - ID: M234941 - Name: Polyestradiol phosphate - Relevance: LOW - As Found: Unknown - ID: M8116 - Name: Estrogens - 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: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown - ID: M2116 - Name: Contraceptive Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M6495 - Name: Contraceptive Agents, Female - Relevance: LOW - As Found: Unknown - ID: M6500 - Name: Contraceptives, Oral - Relevance: LOW - As Found: Unknown - ID: M6502 - Name: Contraceptives, Oral, Hormonal - Relevance: LOW - As Found: Unknown - ID: M4059 - Name: Androgens - Relevance: LOW - As Found: Unknown - ID: M4057 - Name: Androgen Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009640 - Term: Norethindrone - ID: D000077563 - Term: Norethindrone Acetate - ID: D000004958 - Term: Estradiol - ID: C000561634 - Term: Relugolix ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439511 Acronym: Darwin Brief Title: Comparison of a Non Contact Vital Signs Application With Traditional Pulse Oximetry for Heart Rate Measurement Official Title: Comparison of a Non Contact Vital Signs Application (Darwin Edge rVSM) on a Smartphone With Traditional Pulse Oximetry for Heart Rate Measurement: a Prospective Clinical Study #### Organization Study ID Info ID: Darwin #### Organization Class: OTHER Full Name: Hôpital du Valais ### Status Module #### Completion Date Date: 2024-10-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-09-30 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-22 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: University of Lausanne Hospitals #### Lead Sponsor Class: OTHER Name: Hôpital du Valais #### 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 investigators want to test the accuracy of the Smartphone application Darwin Edge rVSM in measuring heart rate, as compared to traditional pulsoxymetry. The intervention is to look at the smartphone camera for approximately 30 seconds, and after that to compare the heart rate value with that obtained with a recording by pulsoxymetry. Detailed Description: Participants undergoing a routine perianesthetic consultation at the preanesthetic clinic will be recruited. as a part of routine clinical assessment their heart rate is measured with pulsoxymetry, a non invasive device worn at the fingertip for about 1 minute. this measurement will be compared to the values for heart rate that can be obtaine with the ''Darwin Edge rVSM'' mobile application. this application can be installed on any smartphone. the participant is required to look into the smartphone camera for about 30 seconds. environmental and lighning conditions will be kept stable. The investigators will do the measurements in 200 participants in order to obtaine values in a population characterized by a variety of phenotypes, in the perioperative setting. ### Conditions Module Conditions: - Heart ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: CROSSOVER Intervention Model Description: All participants will have heart rate measurement 1. by pulse oxymetry 2. by a smartphone application ##### Masking Info Masking: NONE Primary Purpose: DIAGNOSTIC #### Enrollment Info Count: 200 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Pulse oxymetry is one of the gold standards for non invasive measurement of heart rate. Intervention Names: - Device: Pulse oxymetry Label: Pulse oxymetry Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: This is a new smartphone application which can potentially measure heart rate in less than 30 seconds. Intervention Names: - Device: Darwin smartphone app Label: Smartphone app Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Smartphone app Description: The participant must look into the smartphone camera with the Darwin app for about 30 seconds. Name: Darwin smartphone app Type: DEVICE #### Intervention 2 Arm Group Labels: - Pulse oxymetry Description: Heart rate will be measured with pulsoe oximetry (gold standard) Name: Pulse oxymetry Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: accuracy of heart rate measurement Measure: Heart rate Time Frame: 1 minute ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Men or women older than 18 years old presenting to the preanesthetic assessment clinic of Valais Hospital * Subjects that have signed the informed consent form Exclusion criteria: * subjects with damaged/injured skin at the face * Subjects unable to remain still for 30 seconds Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: sina.grape@hopitalvs.ch Name: Sina Grape, MD, MBA Phone: 0041276038759 Role: CONTACT Contact 2: Email: sylva.elkazma@hopitalvs.ch Name: Sylva Kazma, MD Phone: 0041276038615 Role: CONTACT #### Overall Officials Official 1: Affiliation: Lausanne University Hospital Name: Patrick Schoettker, MD Role: STUDY_DIRECTOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439498 Brief Title: Frequency of Orthostatic Hypotension in Patients Who Underwent Colonoscopy Official Title: Frequency of Orthostatic Hypotension and Affecting Factors in Patients Who Underwent Colonoscopy With Procedural Sedoanalgesia #### Organization Study ID Info ID: 109-SBKAEK #### Organization Class: OTHER Full Name: Ankara University ### Status Module #### Completion Date Date: 2024-08-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2024-07-01 Type: ESTIMATED #### Start Date Date: 2024-05-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Ankara University #### Responsible Party Investigator Affiliation: Ankara University Investigator Full Name: Gülencan Yumuşak Ergin Investigator Title: Specialist Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Patients who will undergo colonoscopy accompanied by sedoanalgesia will be admitted at Aksaray Training and Research Hospital Gastroenterology Clinic between May and July 2024. Orthostatic hypotension will be evaluated after patients meet the discharge criteria in the postoperative recovery unit. Detailed Description: Patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included. Patients who will be excluded from the study; Patients with cognitive dysfunction for whom consent could not be obtained Patients who cannot walk Routine ASA (American Society of Anesthesiologist) monitoring will be applied when patients are taken to the procedure room. Patients will be monitored for oxygen saturation with an oxygen saturation probe, non-invasive blood pressure monitoring, and heart rate and rhythm monitoring with an electrocardiogram. Patients will be given oxygen support via nasal cannula or mask. Patients will be given maintenance intravenous fluids. Patients will receive moderate to deep sedation/analgesia. At the end of the procedure, patients will be taken to the postoperative recovery unit and monitored. Patients will be evaluated according to the Aldrete score and a discharge decision will be made. When the decision to discharge the patients is made, they will first be seated and vital signs will be monitored when they are first placed in a sitting position and at the 3rd minute in the sitting position. Then, the patients will be stood up and vital signs will be monitored when they first stand up and at the 3rd minute. It will be noted whether patients develop additional symptoms. Patients who do not have symptoms and are decided to be discharged will be taken to a second waiting room and will be monitored under observation for a while. ### Conditions Module Conditions: - Orthostatic Hypotension Keywords: - orthostatic hypotension - colonoscopy ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 150 Type: ESTIMATED Study Type: OBSERVATIONAL ### Outcomes Module #### Primary Outcomes Description: Non invasive blood pressure when sitting position Measure: Non invasive blood pressure when sitting position Time Frame: during first 3 minutes after sitting Description: Non invasive blood pressure when standing position Measure: Non invasive blood pressurewhen standing position Time Frame: during first 3 minutes after standing ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included. Exclusion Criteria: * Patients with cognitive dysfunction for whom consent could not be obtained Patients who cannot walk Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Patients who will undergo colonoscopy accompanied by sedoanalgesia will be admitted at Aksaray Training and Research Hospital Gastroenterology Clinic between May and July 2024. ### Contacts Locations Module #### Locations Location 1: City: Ankara Country: Turkey Facility: Ankara University School of Medicine #### Overall Officials Official 1: Affiliation: Ankara University Name: Gülencan YUMUŞAK ERGİN Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000054971 - Term: Orthostatic Intolerance - ID: D000054969 - Term: Primary Dysautonomias - ID: D000001342 - Term: Autonomic Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10072 - Name: Hypotension - Relevance: HIGH - As Found: Hypotension - ID: M10074 - Name: Hypotension, Orthostatic - Relevance: HIGH - As Found: Orthostatic Hypotension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M27981 - Name: Orthostatic Intolerance - Relevance: LOW - As Found: Unknown - ID: M4643 - Name: Autonomic Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M27979 - Name: Primary Dysautonomias - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007024 - Term: Hypotension, Orthostatic - ID: D000007022 - Term: Hypotension ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439485 Brief Title: Phase II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion Official Title: Phase II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion #### Organization Study ID Info ID: 2024-0106 #### Organization Class: OTHER Full Name: M.D. Anderson Cancer Center #### Secondary ID Infos Domain: NCI-CTRP Clinical Registry ID: NCI-2024-04693 Type: OTHER ### Status Module #### Completion Date Date: 2030-02-22 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2028-02-22 Type: ESTIMATED #### Start Date Date: 2024-11-29 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: Incyte Corporation #### Lead Sponsor Class: OTHER Name: M.D. Anderson Cancer Center #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Is US Export: False Oversight Has DMC: True ### Description Module Brief Summary: To learn if pemigatinib in combination with atezolizumab and bevacizumab can help to control cholangiocarcinoma. Detailed Description: Primary Objectives: • To assess the antitumor activity of the treatment combinations based on objective response rate (ORR) Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. This assessment will be confirmed in the next scheduled scan. Secondary Objectives: 1. To determine the safety and recommended phase 2 dose (RP2D) of the triple combination of pemigatinib with bevacizumab and atezolizumab in participants with FGFR-altered metastatic CCA. 2. To evaluate the duration of response in participants with best overall response of complete response (CR) or partial response (PR). 3. To evaluate PFS defined as the time from the start of study treatment to disease progression or death, whichever occurs first. 4. To evaluate the duration of OS defined as the time from the start of study treatment to death from any cause. 5. To evaluate the clinical benefit rate defined as the proportion of participants with best overall response of CR, PR, or stable disease. 6. To evaluate safety and endpoints 2-5 with the doublet of pemigatinib with atezolizumab. Exploratory Objectives: • To examine the change of the immune microenvironment on treatment by the combination using a validated immune biomarker panel and end-of-treatment genomic markers using cfDNA to study resistance to pemigatinib and response markers from trial medications. ### Conditions Module Conditions: - Advanced Cholangiocarcinoma - FGFR2 Fusion ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 25 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants enrolled in Part 1, the dose of pemigatinib the participant receive will depend on when the participant join this study. Up to 2 dose levels of pemigatinib will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the highest dose level of pemigatinib. A second group will receive a lower dose of pemigatinib than the group before it, if intolerable side effects are seen. Intervention Names: - Drug: Pemigatinib - Drug: Atezolizumab - Drug: Bevacizumab Label: Part 1 Type: EXPERIMENTAL #### Arm Group 2 Description: Participants in Part 2, you will receive pemigatinib at the recommended dose that was found in Part 1. Intervention Names: - Drug: Pemigatinib - Drug: Atezolizumab - Drug: Bevacizumab Label: Part 2 Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Part 1 - Part 2 Description: Given by PO Name: Pemigatinib Type: DRUG #### Intervention 2 Arm Group Labels: - Part 1 - Part 2 Description: Given by PO and IV Name: Atezolizumab Other Names: - MPDL3280A - TECENTRIQ Type: DRUG #### Intervention 3 Arm Group Labels: - Part 1 - Part 2 Description: Given by PO and IV Name: Bevacizumab Other Names: - Avastin™ - Anti-VEGF monoclonal antibody - rhuMAb-VEGF Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Measure: Safety and adverse events (AEs) Time Frame: Through study completion; an average of 1 year. ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Ability to understand and willingness to sign a written informed consent document for participation in this trial. Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation. * Age ≥18 years. * Has histologically confirmed metastatic or advanced unresectable cholangiocarcinoma. * Has disease that is measurable per the RECIST v1.1. * Has at least one measurable target lesion. * Has FGFR2 fusion or rearrangement in tumor tissue. Presence of the FGFR2 fusion and rearrangement should be determined by CLIA-validated genomic testing of a tumor tissue specimen (DNA-based or RNA-based). * Is refractory to, has demonstrated intolerance to, had received, or has refused access to, the 1st line systemic therapy including gemcitabine-based therapy with or without immunotherapy including durvalumab or pembrolizumab. Participants who discontinued available standard therapy due to toxicity must have continued evidence of measurable disease. * Has available a formalin-fixed, paraffin-embedded primary tumor sample. * Is able to take oral medication. * Is able to comply with protocol procedures and scheduled visits. * Has Eastern Cooperative Oncology Group performance status of 0 or 1 * Has adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: * Absolute neutrophil count (ANC) ≥ 1.0 × 109/L (1000/µL) without granulocyte colony-stimulating factor support * Platelet count ≥ 75 × 109/L (75,000/µL) without transfusion * Hemoglobin ≥ 80 g/L (8 g/dL) * Participants may be transfused to meet this criterion. * Aspartate amino transferate (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN), with the following exceptions: * Participants with documented liver metastases: AST and ALT ≤ 5 × ULN * Participants with documented liver or bone metastases: ALP ≤ 5 × ULN * Serum bilirubin ≤ 1.5 × ULN with the following exception: * Participants with known Gilbert disease: serum bilirubin ≤ 3 × ULN * Serum creatinine ≤ 1.5 × ULN * Serum albumin ≥ 25 g/L (2.5 g/dL) * For participants not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN * Has a negative human immunodeficiency virus (HIV) test at screening with the following exception: participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200 and have an undetectable viral load * Has a negative hepatitis B surface antigen (HBsAg) test at screening (unless participant has chronic HBV on anti-viral therapy) * Has a negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening (unless patient has chronic HBV on anti-viral therapy) * The HBV DNA test will be performed only for participant who have a negative HBsAg test and a positive total HBcAb test. * Participants with chronic HBV on antiviral therapy or HCV participants who have completed curative anti-viral therapy can be included. Requirements for contraception and pregnancy testing for a clinical trial should encompass all investigational medicinal products (IMPs) as well as protocol-mandated non-investigational medicinal products (NIMPs) such as background therapy, and the measures to be followed should be based on the medicinal product with the highest risk (see the protocol synopsis for definition of IMP and NIMP). Contraception requirements for marketed Roche IMPs or NIMPs should be based on recommendations in the Summary of Product Characteristics or, if there is no Summary of Product Characteristics, national prescribing information. Length of time required for abstinence or use of contraceptives should take into account the reproductive toxicity profile, including genotoxicity and teratogenicity, the size of the molecule, and the number of doses. In the absence of specific delayed-toxicity concerns or safety hypotheses, the following guidelines should be used: Options for female contraception are based on the Clinical Trial Facilitation Group "Recommendations related to contraception and pregnancy testing in clinical trials." Three options for female contraception are shown below. • For women of childbearing potential: agrees to remain abstinent (refrain from heterosexual intercourse) or to use contraceptive methods, and agrees to refrain from donating eggs, as defined below: * Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 6 months after the final dose of atezolizumab/pemigatinib/bevacizumab. Women must refrain from donating eggs during this same period. * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. * Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. Options for contraception in male patients with pregnant female partners and/or with female partners of childbearing potential are based on the Clinical Trial Facilitation Group "Recommendations related to contraception and pregnancy testing in clinical trials" and the Roche White Paper regarding contraception for males in clinical trials. Atezolizumab does not require male contraception or condom use; guidelines below apply to other protocol-mandated study treatments. • For men: agrees to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agrees to refrain from donating sperm, as defined below: * With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of atezolizumab/pemigatinib/bevacizumab to avoid exposing the embryo. Men must refrain from donating sperm during this same period. * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of preventing drug exposure. Exclusion Criteria: * Received prior chemotherapy, biologic therapy, immunotherapy, or investigational agent within 3 weeks prior to initiation of study medications. * Had previous treatment with selective FGFR inhibitors including erdafitinib, infigratinib, or futibatinib. * Had prior therapy with any VEGFR-targeting agent targeting including bevacizumab, ramucirumab, pazopanib, lenvatinib, and other anti-angiogenesis inhibitors. * Has a history and/or has current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung. Exceptions include calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcifications-these are allowed. * Has corneal or retinal disorder/keratopathy with current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, inflammation, or ulceration, keratoconjunctivitis, or diabetic retinopathy, confirmed by ophthalmic physician. Participants with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study. * Are currently receiving or are planning to receive during participation in this study, treatment with any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Moderate CYP3A4 inhibitors are not prohibited but should be avoided. Medications that increase serum phosphorus and/or calcium concentration are prohibited. Medications associated with hyperphosphatemia and/or hypercalcemia adverse events are searchable in the Leximcomp Online Pharmacy \& Formulary available on the Inside MD Anderson Clinical Tools SharePoint site. Participants are not permitted to receive enzyme-inducing anti-epileptic drugs, including carbamazepine, phenytoin, phenobarbital, and primidone. * Have consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges or products containing juice of these fruits within 7 days prior to first dose of study drug. * Had a Grade 3-4 gastrointestinal bleed within 3 months prior to enrollment. * Has a history of deep vein thrombosis, pulmonary embolism, or any other thromboembolism, including portal venous thrombosis within 3 months prior to enrollment. Venous port or catheter thrombosis, incidental asymptomatic pulmonary embolism diagnosed on imaging studies, or superficial venous thrombosis are not considered significant and are allowed. * Has current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants (including direct oral anticoagulants); thrombolytic agents for therapeutic (as opposed to prophylactic) purpose; use of aspirin (\> 325 mg/day); or use of clopidogrel (\> 75 mg/day). Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an INR \<1.5 × ULN and an aPTT within normal limits within 14 days prior to initiation of study treatment. * Had significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, transient ischemic attack or cerebrovascular accident); unstable arrhythmia; or unstable angina significant cardiovascular disease within 6 months prior to enrollment. * Has a history of uncontrolled or poorly-controlled hypertension (\>150 mmHg systolic or \>100 mmHg diastolic). * Has a history of hypertensive crisis or hypertensive encephalopathy. * Had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment. * Has undergone major surgery (including open biopsy, surgical resection, wound revision; or any other major surgery involving entry into a body cavity); or significant traumatic injury within 28 days prior to enrollment; or subcutaneous venous-access-device placement within 7 days prior to enrollment; or anticipates need for major surgical procedure, core biopsy, or other minor surgical procedures during the course of the study. o Note: Placement of a vascular access device should be at least 2 days prior to initiation of study treatment. * Is receiving chronic antiplatelet therapy, nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen), dipyridamole, clopidogrel, or similar agents. Once-daily aspirin use (≤325 mg/day) is allowed. * Is pregnant or breastfeeding. * Has had significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization. * Has a history of central nervous system disease or evidence of this disease upon physical or neurological examination. * Has a history of Grade ≥ 2 hemoptysis (defined as ≥ 2.5 mL of bright red blood per episode) within 1 month prior to screening. * Has a history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation). * Has a history of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to randomization. * Has a history of leptomeningeal disease. * Has uncontrolled tumor-related pain. * Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Participants should have recovered from the effects of radiation. There is no required minimum recovery period. * Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy, if appropriate, prior to enrollment. * Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (at a frequency of at least once monthly) o Participants with indwelling catheters (e.g., PleurX®) are allowed. Has uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL, or corrected serum calcium \> ULN). * Has current evidence of endocrine alterations of calcium/phosphate homeostasis, eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, and other disorders. * Has elevated phosphorus or abnormal serum calcium, or phosphorus, or calcium-phosphorus product ≥ 55 mg2/dL2: * Inorganic phosphorus \> 1.02 × ULN Has active or a history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 9 for full list), with the following exceptions: * Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study. Participants with controlled Type 1 diabetes mellitus (as determined by the treating physician) who are on an insulin regimen are eligible for the study. * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: * Rash must cover \< 10% of body surface area * Disease is well controlled at baseline and requires only low-potency topical corticosteroids * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet-A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months * Has a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis; or has evidence of active pneumonitis upon screening via computed tomography (CT) scan of the chest. * History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Has active tuberculosis. * Had a major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipates need for a major surgical procedure during the study. * Had a history of malignancy other than cholangiocarcinoma within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. * Had a severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. * Received treatment with therapeutic oral- or IV antibiotics within 2 weeks prior to initiation of study treatment. * Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. * Had a prior allogeneic stem cell or solid organ transplantation * Has any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the patient at high risk from treatment complications. * Received treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipates need for such a vaccine during treatment or within 5 months after the final dose of treatment. Receipt of SARS-CoV vaccine is allowed. * Received treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment. * Received treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, or anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipates a need for systemic immunosuppressive medication during study treatment, with the following exceptions: * Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained. * Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study. * Has a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. * Has a known hypersensitivity to Chinese hamster ovary-cell products or to any component of the atezolizumab formulation. * Has a known allergy or hypersensitivity to any component of the pemigatinib, bevacizumab, or atezolizumab formulations. * Is pregnant or breastfeeding or intends to become pregnant during study treatment or within 6 months after the final dose of study treatment. * Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. * Has a history of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 UI/weekly) to replenish the deficiency. Vitamin D supplements are allowed. Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: sslee1@mdanderson.org Name: Sunyoung Lee, MD,PHD Phone: (713) 792-8501 Role: CONTACT #### Locations Location 1: City: Houston Contacts: *Contact 1:* - Email: sslee1@mdanderson.org - Name: Sunyoung Lee, MD,PHD - Phone: 713-792-8501 - Role: CONTACT *Contact 2:* - Name: Sunyoung Lee, MD,PHD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: MD Anderson Cancer Center State: Texas Zip: 77030 #### Overall Officials Official 1: Affiliation: M.D. Anderson Cancer Center Name: Sunyoung Lee, MD,PHD Role: PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links Label: MD Anderson Cancer Center URL: http://www.mdanderson.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20426 - Name: Cholangiocarcinoma - Relevance: HIGH - As Found: Cholangiocarcinoma - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T755 - Name: Bile Duct Cancer - Relevance: HIGH - As Found: Cholangiocarcinoma ### Condition Browse Module - Meshes - ID: D000018281 - Term: Cholangiocarcinoma ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M246 - Name: Bevacizumab - Relevance: HIGH - As Found: Non- - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M349417 - Name: Atezolizumab - Relevance: HIGH - As Found: Done - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068258 - Term: Bevacizumab - ID: C000594389 - Term: Atezolizumab ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439472 Brief Title: Effectiveness of the Suboccipital Inhibition Technique in Forward Head Posture. Official Title: Effectiveness of the Suboccipital Inhibition Technique in Individuals With Forward Head Posture: Randomized Controlled Trial #### Organization Study ID Info ID: OST1_016 #### Organization Class: OTHER Full Name: Escola Superior de Tecnologia da Saúde do Porto ### Status Module #### Completion Date Date: 2024-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-04 Type: ACTUAL Last Update Submit Date: 2024-06-02 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-12 Type: ESTIMATED #### Start Date Date: 2024-09 Type: ESTIMATED Status Verified Date: 2024-06 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Escola Superior de Tecnologia da Saúde do Porto #### Responsible Party Investigator Affiliation: Escola Superior de Tecnologia da Saúde do Porto Investigator Full Name: Natália Maria Oliveira Campelo Investigator Title: Professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: In this randomized controlled experimental trial, it is aimed to verify the effectiveness of applying the suboccipital inhibition technique in altering forward head posture, increasing the craniovertebral angle and decreasing the angle between the chin, the external acoustic meatus and the sternal angle. Detailed Description: Forward head posture (FHP) is defined as misalignment of the head caused by anterior translation of the head in relation to the trunk, The incidence rate of this postural alteration is 66% in individuals between the ages of 20 and 50. In order to diagnose this alteration, two angles are used: the craniovertebral angle (CVA) and the angle between the chin, the external acoustic meatus and the sternal angle (AMME), with the CVA being the reference angle for diagnosing a FHP. According to the literature, when the CVA is less than 49.9º, there is a FHP. We decided to use the suboccipital inhibition technique, which according to Eileen DiGiovanna et al (2005), causes a decrease in muscle tension leading to their relaxation. This relaxation, according to Heredia Rizo et al (2012), has significant effects on increasing CVA, which in turn will decrease AMME, resulting in a positive change in FHP. ### Conditions Module Conditions: - Individuals With Forward Head Posture Keywords: - Forward head posture; Craniovertebral angle; Suboccipital muscles; Osteopathy. ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: DOUBLE Masking Description: Dual (participant, outcome assessor). Participants will be assigned codes, these codes will be randomized via the website https://www.invertexto.com/numeros-aleatorios, and randomly distributed into two groups, a control group and an experimental group, where only the principal investigator and the care provider will have access. The outcome assessors will also have no contact with the researcher and the participant during the intervention. Who Masked: - PARTICIPANT - OUTCOMES_ASSESSOR Primary Purpose: OTHER #### Enrollment Info Count: 50 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Experimental: Suboccipital Inhibition Technique Intervention Names: - Other: Suboccipital Inhibition Technique Label: Suboccipital Inhibition Technique Type: EXPERIMENTAL #### Arm Group 2 Description: Placebo Comparator: Sham Technique Intervention Names: - Other: Sham Technique Label: Sham Technique Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Suboccipital Inhibition Technique Description: The researcher will place their palms under the patient's head and use their fingers to contact the occipital condyles. Next, the researcher will place the 3rd and 4th fingers of each hand in the space between the occiput and the spinous process of C2. The metacarpophalangeal joints are at 90º flexion, with the base of the skull resting on their hands while they apply constant, non-painful pressure in a postero-anterior direction, keeping the 2nd, 3rd and 4th fingers together in extension. Afterwards, the researcher applies a light and gentle traction in a cephalad direction in order to relieve the suboccipital area. Once the suboccipital muscles have relaxed, the researcher gently removes the contact, leaving the participant's head resting on the table. This technique is performed for 4 minutes. Name: Suboccipital Inhibition Technique Type: OTHER #### Intervention 2 Arm Group Labels: - Sham Technique Description: The participant is instructed to lie down in the supine position while the mediator assumes a position at the head of the table and places their hands on the participant's shoulders. This technique is performed for 4 minutes. Name: Sham Technique Type: OTHER ### Outcomes Module #### Primary Outcomes Description: To obtain the craniovertebral angle, the SAPO postural assessment software will be used. This angle will be measured in the sagittal plane, with the participant sitting on a chair with their feet shoulder-width apart, resting on the floor, forearms relaxed over their legs, looking at a fixed point positioned on the wall 1 meter in front of their eyes. The SAPO software will determine the angle measurement. This procedure will be carried out 3 times in order to minimize the reading error. Measure: Craniovertebral angle Time Frame: Immediately after the intervention. Description: To obtain this angle, the SAPO postural assessment software will be used. This angle will be measured in the sagittal plane, with the participant sitting on a chair with their feet shoulder-width apart, resting on the floor, forearms relaxed over their legs, looking at a fixed point positioned on the wall 1 meter in front of their eyes. The SAPO software will determine the angle measurement. This procedure will be carried out 3 times in order to minimize the reading error. Measure: Angle between the chin, external acoustic meatus and the sternal angle. Time Frame: Immediately after the intervention. ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * male and female; * be over 18 years old; * have a craniovertebral angle of less than 49.9º. Exclusion Criteria: * have a craniovertebral angle greater than 49.9º; * be a 3rd or 4th year osteopathy student; * be an osteopath. Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: nmc@ess.ipp.pt Name: Natália MO Campelo, PhD Phone: 22 206 1000 Role: CONTACT #### Locations Location 1: City: Porto Contacts: *Contact 1:* - Email: nmc@ess.ipp.pt - Name: Natália MO Campelo, PhD - Phone: +35122 206 1000 - Role: CONTACT Country: Portugal Facility: Escola Superior de Saúde do Porto Zip: 4200-072 #### Overall Officials Official 1: Affiliation: Escola Superior de Saúde do Porto Name: Natália MO Campelo, PhD Role: PRINCIPAL_INVESTIGATOR ### References Module #### References Citation: Aggarwal, A., Nair, A., Palekar, TJ e Bhamare, D. (2022). Efeito da técnica de liberação suboccipital na postura anterior da cabeça: um estudo comparativo. Jornal Médico da Universidade Dr. DY Patil , 15 (4), 534-537. Citation: Contractor, ES, Shah, S. e Dave, P. (2019). Estudar o efeito imediato da técnica de energia muscular suboccipital no ângulo craniovertebral e no ângulo crânio-horizontal em indivíduos com postura de cabeça anteriorizada. Int J Health Sci Res , 9 (3), 83. Citation: Kim, BB, Lee, JH, Jeong, HJ e Cynn, HS (2016). Efeitos da liberação suboccipital com exercício de flexão craniocervical no alinhamento craniocervical e na atividade muscular cervical extrínseca em indivíduos com postura anterior da cabeça. Jornal de Eletromiografia e Cinesiologia , 30 , 31-37. Citation: Weber, P., Corrêa, ECR, Milanesi, JM, Soares, JC, & Trevisan, ME (2012). Postura craniocervical: análise cefalométrica e biofotogramétrica. Revista Brasileira de Ciências Orais , 11 (3), 416-421. Citation: DiGiovanna, E. L., Schiowitz, S., Dowling, D. J. (2005). Uma abordagem osteopática para diagnóstico e tratamento. Lippincott Williams & Wilkins. ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439459 Acronym: SDR-SVF Brief Title: Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation Official Title: Quantitative Measurements of the Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation #### Organization Study ID Info ID: Shanghai9th-SDR-SVF-ZT #### Organization Class: OTHER Full Name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University #### Secondary ID Infos Domain: Science and Technology Commission of Shanghai Municipality ID: 22MC1940300 Type: OTHER_GRANT Domain: Shanghai Municipal Key Clinical Specialty ID: shslczdzk00901 Type: OTHER_GRANT ### Status Module #### Completion Date Date: 2024-02-25 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-12-21 Type: ACTUAL #### Start Date Date: 2023-02-15 Type: ACTUAL Status Verified Date: 2023-01 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-27 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 study is a prospective, exploratory investigation aimed at exploring the efficacy of stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography. Detailed Description: This study is a prospective, exploratory investigation aimed at exploring the efficacy of stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography. The trial aims to include patients experiencing dermal exhaustion during the process of skin soft tissue expansion. We will extract SVF components from autologous adipose tissue and injected intradermally into the expanded skin. The changes of dermis of expanded skin were recorded before the treatment (baseline), and at 4 weeks and 8 weeks follow-up timepoints after SVF transplantation. More specifically, skin surface area was measured using laser 3D scan; skin thickness and texture were detected by Doppler ultrasound, VISIA skin analyzer and CK skin analyzer; skin blood perfusion was analyzed using indocyanine green angiography. ### Conditions Module Conditions: - Skin Regeneration Keywords: - skin expansion - stromal vascular fraction ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 8 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Subcutaneous fat was harvested from either the abdomen or the posterior inner thigh region and then digested with 600 U of collagenase (Shanghai Qiaoyuan Biological Pharmaceutical Co., Ltd, Shanghai, China) at 37°C and 150rpm for three hours. After enzymatic digestion, the lower aqueous phase liquid was aspirated to acquire the stromal vascular fraction (SVF). The SVF cell-pellet was washed and adjusted to 2×10\^6 cells/mL. The skin was marked with methylene blue and a total of 0.5ml (around 1×10\^6 cells) were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg. This procedure was repeated until adequate skin area was achieved for subsequent facial restoration surgery. Intervention Names: - Procedure: Stromal vascular fraction transplantation Label: Stromal vascular fraction transplantation Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Stromal vascular fraction transplantation Description: Stromal vascular fraction was extracted from subcutaneous fat harvested from either the abdomen or the posterior inner thigh region. The SVF cell-pellet was washed and was adjusted to 2×10\^6 cells/mL. The skin was marked with methylene blue and a total of 0.5ml (around 1×10\^6 cells) were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg. This procedure was repeated until adequate skin area was achieved for subsequent facial restoration surgery. Name: Stromal vascular fraction transplantation Type: PROCEDURE ### Outcomes Module #### Other Outcomes Description: Using the VISIA skin analyzer to visualize the distribution of dermal marks, which is an indication of dermal rupture. Briefly, photographs of the patient's expanded skin were taken from three standard angles: front, left side, and right side. Use the VISIA instrument to generate texture imaging of the expanded skin, selecting the expanded skin and surrounding normal skin as the region of interest. Employ the instrument's built-in red area analysis function to analyze the distribution of dermal marks in the expanded skin. Measure: Skin texture (dermal rupture) Time Frame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation Description: Using the elasticity probe (Cutometer® MPA 580) of CK Skin analyzer to measure the elasticity of the expanded skin. Represent skin softness through the skin viscoelasticity parameter R2 (R2 = Ua/Uf, where Ua is the total elastic and plastic recovery, and Uf is the total elastic and plastic deformation). An R2 value closer to 1 indicates better skin elasticity. The measurements were conducted at the center of the expanded skin and other four points (above, below, left, right) around the center. Each point is measured three times, and the average value is taken to represent the measurement for that point. Measure: Skin texture (elasticity) Time Frame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation Description: Indocyanine green (ICG) angiography was used to detect the blood perfusion of the expanded skin. Briefly, the detector of SPY imaging system was adjusted to approximately 20 cm from the surface of the flap. A white light photograph of the expanded skin was taken. Without changing the detector position, indocyanine green imaging was performed as follows: Inject 2 ml of ICG solution (2.5 mg/ml) intravenously and fluorescence signals from the expanded skin were collected by SPY imaging system. The integrated SPY-Q software was used for the analysis of the arterial and venous perfusion of the expanded flap. Measure: Skin perfusion Time Frame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation #### Primary Outcomes Description: Using Doppler ultrasound to measure the full-thickness of skin dermis of the expanded skin. The measurements were conducted at the center of the expanded skin and other four points (above, below, left, right) around the center. The average value is taken to represent the dermal thickness of the patient's expanded skin. Measure: Dermal thickness Time Frame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation #### Secondary Outcomes Description: Using the HSCAN771 handheld laser 3D scanner and the VIVID910 3D laser scanning system to measure the surface area of the expanded skin. Measure: Skin surface area Time Frame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * had undergone tissue expansion treatment; * show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis (\<2mm) with no improvement after suspending expansion for 2 weeks; * require further expansion to achieve the size for defect reconstruction. Exclusion Criteria: * Patients with serious underlying diseases such as cardiovascular or cerebrovascular disease, peripheral vascular disease, or impaired liver or kidney function; * Patients with a long history of smoking and alcohol use who have not quit smoking or drinking; * Patients allergic to iodine or iodine-containing preparations; * Patients with psychiatric disorders, lack of insight, or those who cannot accurately express themselves or cooperate; * Patients with contraindications for SVF transplantation, such as ulceration or infection of the expanded skin; * Patients with severely loose skin or insufficient subcutaneous fat tissue; * Patients who request to withdraw informed consent and exit the clinical trial. Maximum Age: 65 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Shanghai Country: China Facility: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine State: Huangpu Zip: 200011 ### IPD Sharing Statement Module Description: Any additional information regarding individual participants is available from the principle investigator of this study upon reasonable request. IPD Sharing: NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11726 - Name: Methylene Blue - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439446 Brief Title: Functionality and Family Characteristics in Children With Cerebral Palsy Official Title: The Effect of Family Characteristics on the Functional Level of Children With Cerebral Palsy of the Spastic Type With Walking Ability #### Organization Study ID Info ID: KAEU-T.ATAHAN-004 #### Organization Class: OTHER Full Name: Kirsehir Ahi Evran Universitesi ### Status Module #### Completion Date Date: 2024-05-25 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-31 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-05-05 Type: ACTUAL #### Start Date Date: 2023-06-06 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Kirsehir Ahi Evran Universitesi #### Responsible Party Investigator Affiliation: Kirsehir Ahi Evran Universitesi Investigator Full Name: Atahan TURHAN Investigator Title: Principal Investigator, Dr. Lecturer Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The aim of this study was to investigate the effect of family characteristics on functional level in children with Spastic Type Cerebral Palsy who are able to walk. ### Conditions Module Conditions: - Cerebral Palsy - Family Characteristics Keywords: - Functional Level ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 68 Type: ACTUAL Study Type: OBSERVATIONAL ### Outcomes Module #### Primary Outcomes Description: Gross motor function level was measured with Gross Motor Function Measure-66 (GMFM-66). GMFM-66 is a 66-item test developed to measure gross motor skills in children with cerebral palsy and can be evaluated in 5 different categories, including reaching and rolling, sitting, crawling and crawling, standing, walking, running and jumping. It is a 4-point Likert type scale. Higher scores on the test indicate higher gross motor skills. Measure: Gross Motor Function Level Time Frame: 36 week Description: Parents' self-reported quality of life functions such as physical, emotional, social, and cognitive were assessed with The PedsQL Family Impact Module. Total score range is 0-100. Higher scores on the scale indicate less anxiety. Measure: Parents' Quality of Life Time Frame: 36 week #### Secondary Outcomes Description: Gross motor functional classification was evaluated with the Gross Motor Function Classification System (GMFCS). GMFCS classifies children with Cerebral Palsy into 5 levels (1-5) based on their motor skills, functional abilities, assistive technologies, and wheelchair needs. Measure: Gross Motor Function Classification Time Frame: 36 week Description: Characteristic information about the family, such as the family's average monthly income, the number of people living in the family, and the region in which the family lived, was collected. Measure: Sociodemographic Form Time Frame: 36 week ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Diagnosed with hemiparetic and diparetic type CP * Between the ages of 5-15 * GMFCS level I, II and III * Volunteer individuals were included. Exclusion Criteria: * Having undergone a surgical operation within the last year, * Having contracture in the lower extremity, * Having had a fracture in the lower extremity in the last 6 months, * Botulinum Toxin A (BTX-A) administered in the last 6 months * Patients with cognitive, visual or hearing impairments that would prevent communication with their peers and siblings were excluded from the study. Maximum Age: 15 Years Minimum Age: 5 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD Study Population: This study was carried out at Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Patients who applied to the Physical Medicine and Rehabilitation Polyclinic with the diagnosis of CP were examined by a physical therapist. Parents of children who met the inclusion criteria were interviewed and informed about the study. ### Contacts Locations Module #### Locations Location 1: City: Kırşehir Country: Turkey Facility: Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M12085 - Name: Muscle Spasticity - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - 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: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002547 - Term: Cerebral Palsy ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439433 Brief Title: ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase IIc Clinical Trial of ALA-PDT in Patients With Cervical Intraepithelial Neoplasia Grade 2 (CIN2) in p16-positivity and High-risk HPV Infection #### Organization Study ID Info ID: FDZJYX-ALA-202001 #### Organization Class: INDUSTRY Full Name: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. ### Status Module #### Completion Date Date: 2024-03-06 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-12-20 Type: ACTUAL #### Start Date Date: 2021-05-31 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection. Detailed Description: A multi-center, randomized, double-blind, placebo-controlled phase IIc clinical trial of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection. ### Conditions Module Conditions: - Cervical Intraepithelial Neoplasia Grade 2 - Papillomavirus Infections - p16 Protein ### 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: 119 Type: ACTUAL Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: ALA 500mg Group Intervention Names: - Drug: Aminolaevulinic acid (500-mg bottle) Label: ALA A Group Type: EXPERIMENTAL #### Arm Group 2 Description: ALA 750mg Group Intervention Names: - Drug: Aminolaevulinic acid (750-mg bottle) Label: ALA B Group Type: EXPERIMENTAL #### Arm Group 3 Description: Placebo Group Intervention Names: - Drug: Placebo Label: Placebo Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - ALA A Group Description: once a week for 6 weeks Name: Aminolaevulinic acid (500-mg bottle) Other Names: - ALA 500mg Type: DRUG #### Intervention 2 Arm Group Labels: - ALA B Group Description: once a week for 6 weeks Name: Aminolaevulinic acid (750-mg bottle) Other Names: - ALA 750mg Type: DRUG #### Intervention 3 Arm Group Labels: - Placebo Description: once a week for 6 weeks Name: Placebo Type: DRUG ### Outcomes Module #### Other Outcomes Description: "Response" is defined as: pathology showed normal or only inflammatory changes or CIN1 Measure: Response rate of HPV16 and/or HPV18 positive patients at week 12 after last treatment Time Frame: Baseline and week 12 after treatments Description: "Response" is defined as: pathology showed normal or only inflammatory changes or CIN1 Measure: Response rate of HPV16 and/or HPV18 positive patients at week 24 after last treatment Time Frame: Baseline and week 24 after treatments #### Primary Outcomes Description: "Response" is defined as: pathology showed normal or only inflammatory changes or CIN1 Measure: Response rate at week 12 after last treatment Time Frame: Baseline and week 12 after treatments #### Secondary Outcomes Description: "Response" is defined as: pathology showed normal or only inflammatory changes or CIN1 Measure: Response rate at week 24 after last treatment Time Frame: Baseline and week 24 after treatments Description: "Cure" is defined as: pathology showed normal or only inflammatory changes Measure: Cure rate at week 12 after last treatment Time Frame: Baseline and week 12 after treatments Description: "Cure" is defined as: pathology showed normal or only inflammatory changes Measure: Cure response rate at week 24 after last treatment Time Frame: Baseline and week 24 after treatments Description: Proportion of patients with HPV clearance Measure: Clearance rate of HPV at week 12 after last treatment Time Frame: Baseline and week 12 after treatments Description: Proportion of patients with HPV clearance Measure: Clearance rate of HPV at week 24 after last treatment Time Frame: Baseline and week 24 after treatments ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Premenopausal women, 18-45 years of age * Satisfactory the colposcopy examination (cervical transformation zone types: Type 1 or 2) at screening, and CIN2 as verified by cervical biopsy and p16-positivity within the last 3 months * Intense desire to retain the cervical structure or function * High-risk (including probably/possibly carcinogenic) HPV-DNA (i.e. 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 or 82) positive within the last 3 months * Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study * Signed written informed consent Exclusion Criteria: * Atypical glandular cells (AGS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease * Invasive carcinoma possibility or lesions extending to the vaginal wall * Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination * Undiagnosed vaginal bleeding within the last 3 months * With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues * With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions or long-term glucocorticoid or immunosuppressants exposure; patients with malignant tumors within the last 5 years * Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase \> 3 upper limit of normal \[ULN\], or total bilirubin \> 1.5 ULN, or serum creatinine or blood urea nitrogen \> 1.5 ULN) * History of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months * Pregnancy or nursing * Participation in any clinical studies within the last 30 days * Poor compliance or inability to complete the trial * Subjects that the investigators judged to be not suitable to participate the study besides above Maximum Age: 45 Years Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT ### Contacts Locations Module #### Locations Location 1: City: Beijing Country: China Facility: Peking University Third Hospital State: Beijing Zip: 100191 Location 2: City: Zhengzhou Country: China Facility: The First Affiliated Hospital of Zhengzhou University State: Henan Zip: 450000 Location 3: City: Jinan Country: China Facility: Qilu Hospital of Shandong University State: Shandong Zip: 250012 Location 4: City: Shanghai Country: China Facility: The Obstetrics & Gynecology Hospital of Fudan University State: Shanghai Zip: 200011 Location 5: City: Shanghai Country: China Facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine State: Shanghai Zip: 200120 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000011230 - Term: Precancerous Conditions - 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 - ID: D000015229 - Term: Sexually Transmitted Diseases, Viral - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000004266 - Term: DNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000014412 - Term: Tumor Virus Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M23687 - Name: Papillomavirus Infections - Relevance: HIGH - As Found: Papillomavirus Infection - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5535 - Name: Carcinoma in Situ - Relevance: HIGH - As Found: Intraepithelial Neoplasia - ID: M5826 - Name: Uterine Cervical Dysplasia - Relevance: HIGH - As Found: Cervical Intraepithelial Neoplasia - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M14111 - Name: Precancerous Conditions - 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 - ID: M15558 - Name: Sexually Transmitted Diseases - Relevance: LOW - As Found: Unknown - ID: M17933 - Name: Sexually Transmitted Diseases, Viral - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M17162 - Name: Tumor Virus Infections - Relevance: LOW - As Found: Unknown - ID: T1074 - Name: Cervical Intraepithelial Neoplasia - Relevance: HIGH - As Found: Cervical Intraepithelial Neoplasia ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000030361 - Term: Papillomavirus Infections - ID: D000009369 - Term: Neoplasms - ID: D000002278 - Term: Carcinoma in Situ - ID: D000002578 - Term: Uterine Cervical Dysplasia ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439420 Acronym: CBT-I in PBT Brief Title: CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial Official Title: Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial #### Organization Study ID Info ID: MCC-23-20323 #### Organization Class: OTHER Full Name: Virginia Commonwealth University #### Secondary ID Infos Domain: Virginia Commonwealth University ID: HM20028336 Type: OTHER ### Status Module #### Completion Date Date: 2026-11-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-11-30 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Virginia Commonwealth 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 study seeks to investigate an evidence-based, manualized, behavioral health intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I), in individuals with primary brain tumors (PBT) and insomnia. Our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with PBT and insomnia in the behavioral health intervention, CBT-I, and investigate the potential benefits of CBT-I within this at-risk and understudied population. In the long term, the goals are to expand treatment options for neuro-oncology patients and improve their mission readiness and overall wellbeing. ### Conditions Module Conditions: - Primary Brain Tumor - Glioblastoma - Astrocytoma - Oligodendroglioma - Meningioma - Primary Central Nervous System (CNS) Lymphoma Keywords: - Brain Tumor - Insomnia - Glioma - Sleep ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 60 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Behavioral: Cognitive Behavioral Therapy for Insomnia Label: Telehealth Cognitive Behavioral Therapy for Insomnia Type: EXPERIMENTAL #### Arm Group 2 Label: Enhanced Treatment as Usual Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Telehealth Cognitive Behavioral Therapy for Insomnia Description: CBT-I is a non-pharmacological approach to treating sleep disturbance consisting of educational, behavioral, and cognitive intervention components with evidence-based strategies including sleep efficiency, stimulus control, and sleep hygiene modification. CBT-I includes at least 6 group sessions, each approximately 90 minutes in length, delivered over 6 weeks via telehealth. Name: Cognitive Behavioral Therapy for Insomnia Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Number of participants that consent to screening procedures Measure: Rate of consent to screening procedures Time Frame: Baseline (Day 1) Description: Number of participants that are eligible to enroll to the protocol Measure: Rate of those eligible enrolling Time Frame: Baseline (Day 1) Description: Number of participants that complete the baseline assessment Measure: Rate of baseline assessment completion Time Frame: Week 1 Description: The number of participants that complete the post-intervention assessment Measure: Rate of post-intervention assessment completion Time Frame: Week 6 Description: The number of participants that complete the follow-up assessment Measure: Rate of follow-up assessment completion Time Frame: Week 18 Description: The number of participants that do not complete the CBT-I intervention Measure: Rate of intervention attrition Time Frame: Week 6 Description: Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best Measure: Acceptability of quantity of assessments Time Frame: Week 18 Description: Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best Measure: Acceptability of timing of assessments Time Frame: Week 18 Description: Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best Measure: Acceptability of duration of assessments Time Frame: Week 18 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Primary brain tumor diagnosis (grade I-IV) * \>/=2weeks post-cranial resection (if applicable) * \>/=1 month post-radiation therapy (if applicable) * Able to understand, speak, and read English * Absence of major cognitive concerns * Meet Diagnostic and statistical manual of mental disorders version 5 (DSM-V) diagnostic criteria for insomnia * Reliable internet connection Exclusion Criteria: * Major communication difficulties that would prohibit effective intervention * Inability to attend weekly virtual group meetings * Inability to understand and provide informed consent * Currently a prisoner or residing in a correctional facility Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: livenow@vcu.edu Name: Mary Bridgman Phone: (804) 628-6799 Role: CONTACT #### Locations Location 1: City: Richmond Country: United States Facility: Virginia Commonwealth University State: Virginia Zip: 23298 #### Overall Officials Official 1: Affiliation: Virginia Commonwealth University Name: Ashlee Loughan, Ph.D Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: There are no plans to share individual participant data. IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000005910 - Term: Glioma - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009383 - Term: Neoplasms, Vascular Tissue - ID: D000008577 - Term: Meningeal Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M9020 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: M5209 - Name: Brain Neoplasms - Relevance: HIGH - As Found: Brain Tumor - ID: M9019 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: M4561 - Name: Astrocytoma - Relevance: HIGH - As Found: Astrocytoma - ID: M11562 - Name: Meningioma - Relevance: HIGH - As Found: Meningioma - ID: M12769 - Name: Oligodendroglioma - Relevance: HIGH - As Found: Oligodendroglioma - ID: M20446 - Name: Neoplasms, Neuroepithelial - 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: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M18937 - Name: Central Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - 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: M12328 - Name: Neoplasms, Vascular Tissue - Relevance: LOW - As Found: Unknown - ID: M11560 - Name: Meningeal Neoplasms - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown - ID: T2519 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: T2518 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: T3707 - Name: Meningioma - Relevance: HIGH - As Found: Meningioma - ID: T4232 - Name: Oligodendroglioma - Relevance: HIGH - As Found: Oligodendroglioma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005909 - Term: Glioblastoma - ID: D000001932 - Term: Brain Neoplasms - ID: D000001254 - Term: Astrocytoma - ID: D000008579 - Term: Meningioma - ID: D000009837 - Term: Oligodendroglioma ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439407 Brief Title: Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders Official Title: An Open-label, Randomized, Controlled, Exploratory Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders #### Organization Study ID Info ID: SAT014-KP-001 #### Organization Class: INDUSTRY Full Name: S-Alpha Therapeutics, Inc. ### Status Module #### Completion Date Date: 2024-08-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-27 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2024-08-31 Type: ESTIMATED #### Start Date Date: 2024-01-03 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-27 Study First Submit QC Date: 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: S-Alpha Therapeutics, Inc. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Failure to adapt to stress leads to functional impairments in various areas, including social, occupational, educational, and other significant domains, necessitating therapeutic intervention. Interventions through mobile app in the form of software can provide a new alternative for alleviating symptoms caused by psychological trauma by increasing accessibility to early intervention for trauma patients. This study aims to preliminarily assess the safety and feasibility of a psychological traum intervention by developing SAT-014 to help patients with trauma and stress-related disorder continue effective treatment in a stable environment. ### Conditions Module Conditions: - Posttraumatic Stress Disorder ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 20 Type: ACTUAL Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Device: SAT-014(Software as Medical Device) Label: SAT-014 Type: EXPERIMENTAL #### Arm Group 2 Intervention Names: - Device: SAT-014(Software as Medical Device) Label: Maintain previous treatment Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - Maintain previous treatment - SAT-014 Description: SAT-014(Software as Medical Device) + maintain previous treatment Name: SAT-014(Software as Medical Device) Type: DEVICE ### Outcomes Module #### Primary Outcomes Measure: Change in IES-R (Impact Event Scale-Revised) score Time Frame: Baseline, 3weeks, 6weeks, 10weeks Measure: Change in PCL-5 (PTSD Checklist-5) score Time Frame: Baseline, 3weeks, 6weeks, 10weeks Measure: Change in GAD-7 (Generalized Anxiety Disorder 7 item scale) score Time Frame: Baseline, 3weeks, 6weeks, 10weeks Measure: Change in BAI (Beck Anxiety Inventory) score Time Frame: Baseline, 3weeks, 6weeks, 10weeks Measure: Change in PHQ-9 (Patient Health Questionnaire-9; depression screening tool) score Time Frame: Baseline, 3weeks, 6weeks, 10weeks Measure: Change in QIDS-SR (Quick Inventory of Depressive Symptomatology-Self Report) score Time Frame: Baseline, 3weeks, 6weeks, 10weeks Measure: Change in CGI (Clinical Global Impression) score Time Frame: Baseline, 3weeks, 6weeks, 10weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Adults (19 years and older) 2. Have experienced clinically significant psychological trauma within the 6 months prior to screening visit 3. Met the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD) or Adjustment Disorder (AD) category as evaluated by MINI (Mini-International Neuropsychiatric Interview) 4. Score between 17 and 38 points on the IES-R (Impact of Event Scale-Revised) 5. Score of 4 or less on CGI (Clinical Global Impression) 6. Capable of complying the activity instructions provided the app Exclusion Criteria: 1. Have been diagnosed with schizophrenia, bipolar disorder, and psychotic disorder 2. Have been diagnosed with neurodevelopmental disorder, neurocognitive disorder, or organic mental disorder 3. Severe depression (PHQ-9 score of 20 or greater) 4. Comorbid with severe personality disorder 5. Diagnosed with substance use disorder excluding nicotine and caffeine and with severe alcohol use disorder 6. Have made a suicide attempt within 3 months and are judged to be at high risk for suicide by a psychiatrist 7. Pregnant or lactating 8. Currently participating in another clinical trial or have participated in another trial within 90 days from screening 9. Others deemed unsuitable for participation in this clinical trial at the discretion of the investigator due to ethical concerns or potential impact on the trial outcome Healthy Volunteers: True Minimum Age: 19 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Seoul Country: Korea, Republic of Facility: Samsung Medical Center ## Derived Section ### Condition Browse Module - Ancestors - ID: D000040921 - Term: Stress Disorders, Traumatic - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: HIGH - As Found: Trauma and Stress Related Disorders - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Posttraumatic Stress Disorder - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013313 - Term: Stress Disorders, Post-Traumatic - ID: D000068099 - Term: Trauma and Stressor Related Disorders ### 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: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439394 Brief Title: An Observational Study to Assess Optive MEGA-3 (OM3) on Dry Eye Symptoms and Quality of Life of Adult Participants With Mild to Moderate Dry Eye Disease (DED) Official Title: Patient Experience Study Evaluating Effect of OM3 on Dry Eye Symptoms and Quality of Life in Patients With Mild to Moderate Dry Eye Disease #### Organization Study ID Info ID: P25-006 #### Organization Class: INDUSTRY Full Name: AbbVie ### Status Module #### Completion Date Date: 2024-07-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-03 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-07-31 Type: ESTIMATED #### Start Date Date: 2024-05-31 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: AbbVie #### 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: Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate real-world experiences with Optive MEGA-3 (OM3) on relieving dry eye symptoms in adult participants with DED. OM3 is an over the counter (OTC) monograph drug indicated for the temporary relief of symptoms of eye dryness. Participants will administer 1 drop of OM3 on Day 1 for the acute phase of the study, then participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. Around 50 adult participants will be enrolled at one site in the United States. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site as per standard of care. ### Conditions Module Conditions: - Dry Eye Keywords: - Dry Eye - OM3 - Optive MEGA-3 - AGN-OMEGA3 ### 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: Participants will receive 1 drop of OM3 on Day 1. After Day 1, participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. Intervention Names: - Drug: Optive MEGA-3 (OM3) Label: OM3 ### Interventions #### Intervention 1 Arm Group Labels: - OM3 Description: Eye Drops Name: Optive MEGA-3 (OM3) Other Names: - Refresh MEGA-3 Type: DRUG ### Outcomes Module #### Primary Outcomes Description: The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the current moment using a scale ranging from '0 = strongly disagree' to '100 = strongly agree.' Measure: Acute Phase: Change from Baseline in Current Symptom Scores Time Frame: Day 1; Hour 8 Description: The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time to 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability to 100=complete disability). A negative number change from baseline represents an improvement. Measure: Chronic Phase: Change from Baseline in Ocular Surface Disease Index (OSDI) Score Time Frame: Day 15 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * During a routine visit, investigator will decide whether artificial tears are the appropriate treatment for potential participants with dry eyes and will then consider enrollment into this study. * Participant has at least one of the following signs of dry eye: * Three consecutive tear break-up time (TBUT) tests \<= 10 seconds in at least one eye at Screening Visit OR; * Grade 1 to 4 (modified National Eye Institute \[NEI\] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at Screening Visit. Exclusion Criteria: * Use of artificial tears in the last 24 hours. * Use of more than 4 drops of artificial tears per day in each eye. * Use of dry eye treatment other than artificial tears. Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Adult participants with dry eye disease who are eligible based on the inclusion and exclusion criteria. ### Contacts Locations Module #### Central Contacts Contact 1: Email: abbvieclinicaltrials@abbvie.com Name: ABBVIE CALL CENTER Phone: 844-663-3742 Role: CONTACT #### Locations Location 1: City: Memphis Country: United States Facility: Southern College of Optometry /ID# 262668 State: Tennessee Status: RECRUITING Zip: 38104-2211 #### Overall Officials Official 1: Affiliation: AbbVie Name: ABBVIE INC. Role: STUDY_DIRECTOR ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ### References Module #### See Also Links Label: Related Info URL: https://www.abbvieclinicaltrials.com/study/?id=P25-006 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007766 - Term: Lacrimal Apparatus Diseases - ID: D000007637 - Term: Keratoconjunctivitis - ID: D000003231 - Term: Conjunctivitis - ID: D000003229 - Term: Conjunctival Diseases - ID: D000007634 - Term: Keratitis - ID: D000003316 - Term: Corneal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M18040 - Name: Dry Eye Syndromes - Relevance: HIGH - As Found: Dry Eye - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: HIGH - As Found: Dry Eye - ID: M8271 - Name: Eye Diseases - Relevance: HIGH - As Found: Eye Disease - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10663 - Name: Keratoconjunctivitis - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown - ID: M6455 - Name: Conjunctivitis - Relevance: LOW - As Found: Unknown - ID: M6453 - Name: Conjunctival Diseases - Relevance: LOW - As Found: Unknown - ID: M10660 - Name: Keratitis - Relevance: LOW - As Found: Unknown - ID: M6539 - Name: Corneal Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000007638 - Term: Keratoconjunctivitis Sicca - ID: D000005128 - Term: Eye Diseases ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M12814 - Name: Ophthalmic Solutions - Relevance: LOW - As Found: Unknown - ID: T415 - Name: Omega 3 Fatty Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False
## Protocol Section ### Identification Module NCT ID: NCT06439381 Brief Title: Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps Official Title: A Multicenter, Randomized, Continuing Trial to Evaluate the Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps #### Organization Study ID Info ID: TQH2722-II-04 #### Organization Class: INDUSTRY Full Name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date Date: 2025-11 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-06-06 Type: ESTIMATED Last Update Submit Date: 2024-06-04 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-10 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2023-11 #### Study First Post Date Date: 2024-06-03 Type: ACTUAL Study First Submit Date: 2024-05-28 Study First Submit QC Date: 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: This is a multicenter, randomized, continuing, Phase II expansion trial to evaluate the safety, efficacy, and immunogenicity of two doses of TQH2722 in the long-term treatment of severe chronic sinusitis with or without nasal polyps. ### Conditions Module Conditions: - Chronic Rhinosinusitis ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 120 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: For Part A or Part B, 300mg/600mg of TQH2722 injection was administered every 2 weeks until week 22, combined with Mometasone furoate nasal spray of 100-200μg/ day until week 32. Intervention Names: - Drug: 300mg/600mg of TQH2722 injection Label: 300mg/600mg of TQH2722 injection in Part A or B Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - 300mg/600mg of TQH2722 injection in Part A or B Description: TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade. Name: 300mg/600mg of TQH2722 injection Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Frequency of treatment emergent adverse events (TEAE) occurring during treatment. Measure: Treatment emergent adverse events (TEAE) Time Frame: Up to 32 weeks #### Secondary Outcomes Description: The frequency of serious adverse events (SAEs) that occurred during treatment in subjects with chronic sinusitis with nasal polyps (CRSwNP) or chronic sinusitis without nasal polyps (CRSsNP). Measure: Serious adverse events (SAEs) Time Frame: Up to 32 weeks Description: Abnormal laboratory test indicators during treatment in subjects with chronic sinusitis with nasal polyps (CRSwNP) or chronic sinusitis without nasal polyps (CRSsNP). Measure: Abnormal laboratory test indicators Time Frame: Up to 32 weeks Description: Change in Lund Mackay score assessed by CT from baseline. The total score is 0-24 points, with the higher score meaning the more severe symptoms. Measure: Changes in Lund Mackay score assessed by CT from baseline Time Frame: Up to 24 weeks Description: The change in the University of Pennsylvania Smell Identification Test (UPSIT) from baseline (main study TQH2722-II-02 and baseline in this study, respectively) at each evaluation time point. Measure: Changes in the University of Pennsylvania Smell Identification Test (UPSIT) Time Frame: Up to 32 weeks Description: Changes in subjects' Nasal Total Symptom Score from baseline. The total score is 0-9 points, with the higher score meaning the more severe symptoms. Measure: Changes in Nasal Total Symptom Score from baseline Time Frame: Up to 32 weeks Description: Changes in the sinusitis Visual Analogue Scale (VAS) score from baseline were measured at each evaluation time point. The total score is 0-10 points, with the higher score meaning the more severe symptoms. Measure: Changes in the sinusitis Visual Analogue Scale (VAS) score from baseline Time Frame: Up to 32 weeks Description: Immunogenicity: The incidence of drug-resistant antibodies (ADA) and their titers, and the incidence of neutralizing antibodies (Nab) in subject. If the subject tests positive for ADA, neutralizing antibodies are added. Measure: Immunogenicity: The incidence of drug-resistant antibodies (ADA) and their titers, and the incidence of neutralizing antibodies (Nab). Time Frame: 0h (The first dose), D113, D169 and during withdrawal Description: Changes in nasal polyp scores of subjects with chronic sinusitis with nasal polyps (CRSwNP) at each evaluation time point were compared with baseline values (TQH2722-II-02 in the main study and baseline values in this study, respectively). Measure: Changes in nasal polyp scores of subjects with chronic sinusitis with nasal polyps (CRSwNP) in part A Time Frame: Weekends 0, 8, 16, 24 and 32 Description: Changes in Sino-nasal Outcome Test (SNOT-22) from baseline for subjects at each evaluation time point. Measure: Changes in Sino-nasal Outcome Test (SNOT-22) in part A Time Frame: Weekends 0, 8, 16, 24 and 32 Description: The changes in nasal congestion score (NCS) from baseline at each evaluation time point in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms. Measure: Changes in nasal congestion score (NCS) in part A from baseline Time Frame: Up to 32 weeks Description: Changes in subjects' nasal/posterior runny nose scores from baseline at each evaluation time point. The total score is 0-3 points, with the higher score meaning the more severe symptoms. Measure: Changes in nasal/posterior runny nose scores in part A from baseline Time Frame: Up to 32 weeks Description: The changeS in the anosmia score from baseline at each evaluation time point in part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms. Measure: Changes in the anosmia score in part A from baseline Time Frame: Up to 32 weeks Description: In Part B, the change of subjects' olfactory loss score from baseline (using the main study TQH2722-II-02 and the baseline value in this study, respectively) at each evaluation time point. The total score is 0-3 points, with the higher score meaning the more severe symptoms. Measure: Changes of olfactory loss score in part B from baseline Time Frame: Up to 32 weeks Description: In Part B, changes in subjects' nasal endoscopic modified Lund-Kennedy scores from baseline (using the main study TQH2722-II-02 and the baseline in this study, respectively) at each evaluation time point are measured. The total score is 0-24 points, with the higher score meaning the more severe symptoms. Measure: Changes in nasal endoscopic modified Lund-Kennedy scores in part B Time Frame: Weekends 0, 8, 16, 24 and 32 Description: In Part B, change from baseline in Sino-nasal Outcome Test (SNOT-22) for subjects at each evaluation time point. Measure: Changes in Sino-nasal Outcome Test (SNOT-22) in part B Time Frame: Weekends 0, 8, 16, 24 and 32 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Inclusion Criteria of Part A * Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test; * Age 18-75 years old (including the threshold), male or female; * Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria "a" or "b" : 1. Subjects completed prescribed treatment as required and completed Part A end of study (EOS) visit; 2. The subjects withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the subjects' early termination of the main study treatment have disappeared/no longer affected the subjects' participation in the continuation study as assessed by the investigators and sponsors. Note: If protocol window period requirements are met, examination results from subject's main study EOS/ early exit visit may be used as screening/baseline examination for this study. * Subjects had used a more stable dose of nasal glucocorticoids (INCS) for more than 4 weeks prior to screening (for subjects who had used other INCS prior to screening than intranasal Mometasone furoate nasal spray (MFNS), subjects were willing to switch to MFNS during the study); * Subjects agree not to have a family plan for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age. 2. Inclusion Criteria of Part B * Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test; * Age 18-75 years old (including the threshold), male or female; * Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria "a" or "b" : 1. Subjects completed prescribed treatment as required and completed Part B EOS visit; 2. The subjects withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the subjects' early termination of the main study treatment have disappeared/no longer affected the subjects' participation in the continuation study as assessed by the investigators and sponsors. Note: If protocol window period requirements are met, examination results from subject's main study EOS/ early exit visit may be used as screening/baseline examination for this study. * Subjects had used a more stable dose of nasal glucocorticoids (INCS) for more than 4 weeks prior to screening (for subjects who had used other INCS prior to screening than intranasal Mometasone furoate nasal spray (MFNS), subjects were willing to switch to MFNS during the study); * Subjects agree not to have a family plan for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age. Exclusion Criteria: * In the main study (TQH2722-II-02), a TQH2722-related SAE occurred or TQH2722-related AE led to the discontinuation of TQH2722 therapy, and after discussion between the investigator and sponsor, the subject was deemed unsuitable for continuation of TQH2722 therapy. * The subjects had poor compliance in the main study, and the researchers judged that they could not complete the continuing study. * During the main study (TQH2722-II-02), any severe progression or poorly controlled concomitant disease (such as asthma exacerbation requiring adjustment of background medication) is identified and the subject is deemed unfit to participate by the principal investigator; * Any of the following laboratory test values are abnormal during the screening period: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 upper limit of normal (ULN); 2. Total bilirubin \> 2 x ULN (except indirect bilirubin elevation secondary to Gilbert syndrome); 3. Creatinine \> 1.5×ULN; * Any medical condition, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major limb disorders, that the investigator believes is unstable and may affect the patient's safety throughout the study period, or affect the study results or their interpretation, or interfere with the patient's ability to complete the entire study process.For example, but not limited to: ischemic heart disease, left ventricular failure, arrhythmia, uncontrolled hypertension, uncontrolled hyperglycemia, cerebrovascular disease, etc.; * Patients with active autoimmune diseases (including, but not limited to, Hashimoto thyroiditis, Graves' disease, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis and other neuroinflammatory diseases, psoriasis vulgaris, rheumatoid arthritis); * Known or suspected immunosuppressed individuals, including but not limited to a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pulmonary cyst disease, aspergillosis), even if the infection has resolved; * Subjects with active malignant tumors or a history of malignant tumors:Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ who had completed curative treatment for at least 12 months prior to visit 1 could be enrolled in this study; patients with other malignancies could be enrolled if they had completed curative treatment for at least 5 years prior to visit 1; * A history of active pulmonary tuberculosis within 12 months prior to screening; * Active hepatitis was present at the screening stage, either hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and Hepatitis B Virus-DNA positive, or Hepatitis C Virus (HCV) antibody positive and HCV-RNA positive; or human immunodeficiency virus (Anti-HIV) positive, or treponema pallidum antibody (Anti-TP) positive (if the treponema pallidum serological test is positive, then further non-treponema pallidum serological test is performed, the latter is negative and the investigator determines that patients who have been infected with syphilis in the past but have been cured are eligible for inclusion); * Diagnosis of helminthic infection within 6 months prior to the screening period, failure to receive standard treatment or failure to respond to standard treatment; * Subjects who received the following treatments: 1. Had sinus surgery or nasal sinus surgery within 6 months prior to screening (visit 1). 2. Received monoclonal antibody therapy within 8 weeks or 5 half-lives prior to screening (whichever is longer); 3. Received immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, interferon gamma, azathioprine, methotrexate, mycophenolate and tacrolimus) within 8 weeks or 5 half-lives prior to screening, whichever is longer; 4. Use of other non-biological agents within 8 weeks or 5 half-lives (whichever is longer) prior to screening; 5. Intravenous immunoglobulin (IVIG) therapy and/or plasma exchange within 30 days prior to screening visit (Visit 1); 6. Subjects treated with leukotriene antagonists/modulators prior to screening (subjects treated with stable doses of leukotriene modulators for ≥30 days prior to screening can be enrolled); 7. Start allergen immunotherapy within 3 months prior to screening, or plan to start such therapy during the study period or plan to change the therapeutic dose during the study period; 8. Have received live attenuated vaccine within 4 weeks prior to screening or plan to receive live attenuated vaccine during the study period; 9. Chronic active or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasites, antivirals, or antifungals during the 4 weeks prior to screening, or a viral disease that may not have received antiviral treatment during the 4 weeks prior to screening;(Screening visits can be performed after the patient recovers from infection, but the systemic antibiotic washout period needs to be greater than 2 weeks). * Patients with asthma should be excluded if: a. forced expiratory volume in the first second (FEV1) ≤ 50% of the expected normal value, or b.Acute exacerbation of asthma within 90 days prior to screening requiring hospitalization (\>24 hours), or c.Are using a daily dose of fluticasone or equivalent inhaled glucocorticoids (ICS) greater than 1000mcg; * Subjects with asthma were initiated with inhaled corticosteroids within 4 weeks prior to the screening/induction period (for subjects who could receive a stable dose for at least 4 weeks prior to screening and whose assessed dose could be maintained throughout the study period, inhaled corticosteroids could be fluticasone propionate at a dose ≤1000μg or equivalent doses of other inhaled corticosteroids). * Subjects have concomitant medical conditions that prevent them from completing the screening period assessment or evaluating the primary efficacy endpoint, such as: 1. A deviated nasal septum leads to obstruction of at least one nostril 2. Persistent drug rhinitis; 3. The diagnosis was eosinophilic granulomatous vasculitis (Churg-Strauss syndrome), granulomatous polyvasculitis (Wegener's granuloma), Young's syndrome, Kartagener syndrome or other ciliary dyskinesia syndrome, cystic fibrosis; 4. Suspected or confirmed fungal rhinosinusitis on imaging; * Subjects with nasal malignancies and benign tumors (e.g., papilloma, hemangioma, etc.); * Subjects who are unable to use MFNS or are allergic or intolerant to Mometasone furoate nasal spray; * Subjects with a history of systemic allergy to any biological agent (except local injection site reactions); * Pregnant or lactating women; * Alcohol, drug and known drug dependence; * The subjects had poor compliance in the study and could not complete the study as judged by the researcher; * Any medical or psychiatric condition that, in the judgment of the investigator or sponsor medical reviewer, puts the subject at risk, interferes with participation in the study, or interferes with the interpretation of the study results. Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: dr.luozhang@139.com Name: Luo Zhang, Postdoctoral Phone: 13910830399 Role: CONTACT #### Locations Location 1: City: Beijing Contacts: *Contact 1:* - Email: dr.luozhang@139.com - Name: Luo Zhang, postdoctor - Phone: 13910830399 - Role: CONTACT *Contact 2:* - Email: wangcs830@126.com - Name: Chengshuo Wang, Doctor - Phone: 13911623569 - Role: CONTACT Country: China Facility: Beijing Tongren Hospital, Capital Medical University State: Beijing Zip: 100730 Location 2: City: Foshan Contacts: *Contact 1:* - Email: t_jun@fsyyy.com - Name: Juan Tang, Doctor - Phone: 13600307264 - Role: CONTACT Country: China Facility: The First People's Hospital of Foshan State: Guangdong Zip: 528000 Location 3: City: Shenzhen Contacts: *Contact 1:* - Email: luyongtian@263.net - Name: Yongtian Lu - Phone: 13602666223 - Role: CONTACT Country: China Facility: The Second People's Hospital of Shenzhen State: Guangdong Zip: 518035 Location 4: City: Nanning Contacts: *Contact 1:* - Email: daisyqs@163.com - Name: Song Qu - Phone: 13607887386 - Role: CONTACT Country: China Facility: Guangxi Medical University Cancer Hospital State: Guangxi Zip: 530021 Location 5: City: Shijiazhuang Contacts: *Contact 1:* - Email: luanfengly@163.com - Name: Feng Luan, Master - Phone: 18533112937 - Role: CONTACT Country: China Facility: Hebei Medical University Third Hospital State: Hebei Zip: 050000 Location 6: City: Cangzhou Contacts: *Contact 1:* - Email: lwwzcbj@163.com - Name: Weiwei Liu, Master - Phone: 13393275339 - Role: CONTACT Country: China Facility: Cangzhou Central Hospital State: Heibei Zip: 061017 Location 7: City: Zhengzhou Contacts: *Contact 1:* - Email: 13598895398@163.com - Name: Guangke Wang, Bachelor - Phone: 13598895398 - Role: CONTACT Country: China Facility: Henan Provincial People's Hospital State: Henan Zip: 450003 Location 8: City: Wuhan Contacts: *Contact 1:* - Email: Ylly80331@163.com - Name: Jianjun Chen, Doctor - Phone: 13659851719 - Role: CONTACT Country: China Facility: Union Hospital, Tongji Medical College, Huazhong University of science and technology State: Hubei Zip: 430022 Location 9: City: Wuhan Contacts: *Contact 1:* - Email: xy37138@163.com - Name: Yu Xu, Doctor - Phone: 15927088198 - Role: CONTACT Country: China Facility: Renmin Hospital of Wuhan University Hubei General Hospital State: Hubei Zip: 430060 Location 10: City: Changsha Contacts: *Contact 1:* - Email: 48961753@qq.com - Name: Xianfang Chen, Bachelor - Phone: 13637381190 - Role: CONTACT Country: China Facility: Loudi Central Hospital State: Hunan Zip: 417000 Location 11: City: Baotou Contacts: *Contact 1:* - Email: 13314721473@163.com - Name: Zhendong Xu, Bachelor - Phone: 13314721473 - Role: CONTACT Country: China Facility: Baotou Central Hospital State: Inner Mongolia Zip: 014000 Location 12: City: Nanjing Contacts: *Contact 1:* - Email: yonglong11a@163.com - Name: Yonglong Xiao, Doctor - Phone: 13951913764 - Role: CONTACT Country: China Facility: Nanjing Drum Tower Hospital State: Jiangsu Zip: 210008 Location 13: City: Changchun Contacts: *Contact 1:* - Email: entliu@163.com - Name: Hui Liu, Master - Phone: 15843076669 - Role: CONTACT Country: China Facility: Jilin Provincial People's Hospital State: Jilin Zip: 130021 Location 14: City: Yanji Contacts: *Contact 1:* - Email: jyd0091@126.com - Name: Yongde Jin, Master - Phone: 15526771005 - Role: CONTACT Country: China Facility: The Affiliated Hospital of Yanbian University State: Jilin Zip: 133002 Location 15: City: Shenyang Contacts: *Contact 1:* - Email: wangyanoto@aliyun.com - Name: Yan Wang, Doctor - Phone: 13840262419 - Role: CONTACT Country: China Facility: The First Hospital of China Medical University State: Liaoning Zip: 110002 Location 16: City: Shenyang Contacts: *Contact 1:* - Email: czw18940251770@163.com - Name: Zhiwei Cao, Doctor - Phone: 18940251770 - Role: CONTACT Country: China Facility: Shengjing Hospital Affiliated to China Medical University State: Liaoning Zip: 110004 Location 17: City: Shenyang Contacts: *Contact 1:* - Email: fugongbi@163.com - Name: Gongbi Fu, Master - Phone: 18002478636 - Role: CONTACT Country: China Facility: The Central Hospital of Shenyang Medical College State: Liaoning Zip: 110075 Location 18: City: Jinan Contacts: *Contact 1:* - Email: shili126@sina.com - Name: Li Shi, Doctor - Phone: 13791122810 - Role: CONTACT Country: China Facility: Shandong Second People's Hospital State: Shandong Zip: 250299 Location 19: City: Weihai Contacts: *Contact 1:* - Email: yongwuli@126.com - Name: XiaoJun Sui, Master - Phone: 18306305850 - Role: CONTACT Country: China Facility: Weihai Central Hospital State: Shandong Zip: 264499 Location 20: City: Yantai Contacts: *Contact 1:* - Email: songxicheng@126.con - Name: Xicheng Song, Doctor - Phone: 18005350077 - Role: CONTACT Country: China Facility: Yantai Yuhuangding Hospital State: Shandong Zip: 264000 Location 21: City: Zibo Contacts: *Contact 1:* - Email: Lwen.a@163.com - Name: Wen Liu, Bachelor - Phone: 18678185226 - Role: CONTACT Country: China Facility: Zibo Central Hospital State: Shandong Zip: 255036 Location 22: City: Shanghai Contacts: *Contact 1:* - Email: drlijiping@163.com - Name: Jiping Li, Doctor - Phone: 13764089841 - Role: CONTACT Country: China Facility: Renji Hospital Shanghai Jiaotong University School of Medical State: Shanghai Zip: 200127 Location 23: City: Taiyuan Contacts: *Contact 1:* - Email: cxb14001@163.com - Name: Xiangbin Chai, Doctor - Phone: 15135193199 - Role: CONTACT Country: China Facility: First Hospital of Shangxi Medical University State: Shangxi Zip: 030001 Location 24: City: Chengdu Contacts: *Contact 1:* - Email: Scheganghegang@163.com - Name: Gang He - Phone: 19938294970 - Role: CONTACT Country: China Facility: Chengdu Second People's Hospital State: Sichuan Zip: 610021 Location 25: City: Ürümqi Contacts: *Contact 1:* - Email: hzhang1106@163.com - Name: Hua Zhang - Phone: 13999984998 - Role: CONTACT Country: China Facility: The First Affiliated Hospital of Xinjiang Medical University State: Xinjiang Zip: 830011 Location 26: City: Taizhou Contacts: *Contact 1:* - Email: Drshu@126.com - Name: Hairong Shu, Bachelor - Phone: 13906597178 - Role: CONTACT Country: China Facility: Taizhou central hospital(Taizhou university hospital) State: Zhejiang Zip: 318000 Location 27: City: Wenling Contacts: *Contact 1:* - Email: zg112515@163.com - Name: Gang Zheng, Bachelor - Phone: 13666808800 - Role: CONTACT Country: China Facility: Wenling First People's Hospital State: Zhejiang Zip: 317599 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012220 - Term: Rhinitis - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000010254 - Term: Paranasal Sinus Diseases - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000011127 - Term: Polyps - ID: D000020763 - Term: Pathological Conditions, Anatomical ### 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: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14011 - Name: Polyps - Relevance: LOW - As Found: Unknown - ID: M3269 - Name: Rhinosinusitis - Relevance: HIGH - As Found: Rhinosinusitis - ID: M15657 - Name: Sinusitis - Relevance: HIGH - As Found: Sinusitis - ID: M12249 - Name: Nasal Polyps - Relevance: HIGH - As Found: Nasal Polyps - ID: M15049 - Name: Rhinitis - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M13167 - Name: Paranasal Sinus Diseases - Relevance: LOW - As Found: Unknown - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000096825 - Term: Rhinosinusitis - ID: D000012852 - Term: Sinusitis - ID: D000009298 - Term: Nasal Polyps ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AAll - Name: Anti-Allergic Agents - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M290 - Name: Mometasone Furoate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 Has Results: False