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## Protocol Section ### Identification Module NCT ID: NCT06416332 Brief Title: Development and Testing of a Tele-rehabilitation System for Adult Patients With Knee Osteoarthritis Official Title: Development and Implementation of a Tele -Rehabilitation System for Patients With Knee Osteoarthritis (Aged 40-70 Years, Kellgren Grade 1-3 and Lawrence ) #### Organization Study ID Info ID: 61123-27/06/2023 #### Organization Class: OTHER Full Name: University of West Attica ### Status Module #### Completion Date Date: 2024-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2024-09 Type: ESTIMATED #### Start Date Date: 2022-09-13 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-07 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University of West Attica #### Responsible Party Investigator Affiliation: University of West Attica Investigator Full Name: Theodora Plavoukou Investigator Title: PT,MSc,PhD(can)Physiotherapy Department of the University West Attica Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: DEVELOPMENT AND TESTING OF A TELEREHABILITION SYSTEM FOR PATIENTS WITH OSTEOARTHRITIS OF THE. KNEE (AGES 40-70 YEARS, GRADE 1-3, ACCORDING TO KELLGREN AND LAWRENCE) This study aims to develop and compare two methods of implementing a therapeutic exercise program for knee osteoarthritis: face-to-face sessions versus a telerehabilitation program. The telerehabilitation system will allow remote delivery of exercises with real-time monitoring and feedback. Measurement tools will assess various dimensions of knee osteoarthritis, ensuring comprehensive evaluation. Two experimental groups will receive either face-to-face or telerehabilitation sessions twice a week for eight weeks. Both groups will follow structured exercise programs, with the telerehabilitation group receiving remote instructions and feedback. Measurements will be taken before and after the intervention period, as well as at a three-month follow-up. Expected results include confirming and potentially enhancing findings regarding the effectiveness of remote rehabilitation for knee osteoarthritis. The study anticipates that telerehabilitation intervention could be equally or more effective than face-to-face intervention, ultimately providing a personalized, self-managed solution for managing chronic conditions like knee osteoarthritis. Detailed Description: The purpose of this study is to develop, investigate and compare the effectiveness of a new system of remote therapeutic exercise, using technological equipment, in relation to face to face therapeutic exercise, which is proposed by international guidelines, in patients with osteoarthritis of the knee. More specifically, the magnitude of the improvement of motor, kinematic and psychocognitive parameters, physical condition, functionality, quality of life and symptoms of the disease will be examined, using these two methods. It is fully understood and constitutes one of the objectives of this study , that the volume of this information should be transmitted to the patient and the physical therapist in the most understandable and simplified way possible. Finally, the effectiveness of the interventions will also be evaluated in relation to the ease of use and execution of the therapeutic exercise plan, as well as the degree of compliance of the patients with each intervention method. The aim of the present study is the development of an innovative telerehabilitation system and the comparison of two different methods of implementation of a therapeutic exercise program for knee osteoarthritis, and in particular a face to face live program and a remote application program. In order to implement remote intervention, a rehabilitation system for patients with knee osteoarthritis will be created, where therapeutic exercise will be provided through special software and technological equipment and the patients progress will be monitored remotely or in real time, whenever this is deemed necessary. . In this way, it is expected to create a remote but immediate rehabilitation environment, with easy access, which will provide flexibility, short response time and economy during its application by the patient. This study is a multicenter, single-blind, randomized, controlled prospective study with two parallel axes will be designed. The sample will come from the places where the study will be carried out and which are legal physical therapy laboratories.The participants of this study will be volunteers a considedered a sample of men and women, aged 40-70 years with radiographically and orthopedically diagnosed knee osteoarthritis, Kellgren grade 1-3 and Lawrence classification system of osteoarthritis. The Sample size was determined by the G- power test analysis based on the primary outcome measures selected and the effect size size which is reported in similar studies. According to a meta-analysis, the effect size for pain measures ( whether the measurements were made using questionnaires or algometers ) was equal to SMD =0.66, in all the measurement tools used . Finally, in a research, in which the isokinetic dynamometer was used as a measuring tool, the effect size for the strength of the subjects quadriceps muscle was equal to SMD =0.42. Thus, taking into account all the above and setting the level of statistical significance at α=0.05 and the power of the study at 80%, through the G- power analysis test the sample size was determined at 34 participants. Assuming a potential loss to follow-up of 20% of participants, the minimum sample size was calculated at 42 patients. The randomization process will be performed by an independent researcher. The allocation of participants will be done randomly through the use of the random.org program. Sealed envelopes will be given to participants prior to their allocation to research groups and each envelope will indicate the group to which each participant is allocated, as randomly assigned by the computer program. The study will have two experimental groups , group A : face to face therapeutic exercise and group B: telerehabilitation program. In group A: for face to face live therapeutic exercise the program and its progressivity will be determined and performed face to face according to the progress of the patient, with a frequency of sessions twice a week, session duration 45 minutes, following the recommended dosage of exercise according to clinical guidelines, while the total duration of the intervention will be eight weeks. You will be instructed to perform the program at home, 3 times a week. The standardized exercise program to be followed by this group will include : 1. Exercises to strengthen the hip and knee muscles through isometric contractions and resistance exercises using elastic bands. 2. Balance and neuromuscular coordination exercises. This standardized program will be structured following international guidelines and the gradual difficulty of the exercises will be confirmed through electromyographic activity of the respective muscle groups, following a pilot study, the results of which will be the mechanism for confirming the progression of the difficulty of each exercise, so that the patient can either proceed according to his progress to the next exercise, or return to a previous exercise if he experiences pain during its execution. Initially, patients will be informed about the pathogenesis and the proposed, according to the article, management of the disease. Then, there will be a documentation and explanation of the progressive therapeutic exercise program, as suggested by the international literature, while printed material will also be distributed. In group B: telerehabilitation program, the therapeutic exercise program will follow the same structure, which was mentioned above. The differentiation in the intervention of this group will be that the explanation of the exercises, their presentation, monitoring and information of the participants will be done through the telerehabilitation platform and special data processing software, as shown in diagram 1. The intervention time remains the same, with the physical therapist during these 45 minutes of the session , to evaluate the data on the patients progress by receiving the information through the software and to inform the patient of any changes in the progressivity of the exercise program. The other parameters of the intervention remain the same, as in the face to face live exercise. All participants will initially complete a questionnaire that will include their history and demographics. They will complete the study questionnaires and submit to the respective tests, the same procedure will be followed after the eight weeks and the end of the respective interventions in both intervention groups and the same procedure will be followed after the three months. The statistical processing will be done with SPSS (Statistical Package for the Social Science) software for Windows (version 25.0). A statistical analysis will be performed of the differences of each measurement, between the two interventions, as they will be recorded before the start of the intervention, eight weeks and three months later, using the MANOVA and Kruskal - Wallis test (for the non-parametric data). Data normality testing will be performed and the statistical significance level will be set at α = 0.05. With the completion of this research work, it is expected to confirm and increase the findings of previous studies in the international literature regarding the effect of remote rehabilitation through an innovative telerehabilitation system, for patients suffering from knee osteoarthritis, through a series of assessment tools that do not have so far been described in combination. Evidence is awaited that telerehabilitation intervention will be equally - or even more - effective than in-person intervention. The ultimate and final goal will be to create an optimal, personalized environment for self-management of such a chronic pathological entity as knee osteoarthritis, with the perspective that this intervention will be the optimal solution for managing chronic diseases . ### Conditions Module Conditions: - Knee Osteoarthritis - Knee Osteoarthritis \(OA\) - Telerehabilitation Keywords: - Exercise - knee osteoarthitis - tele-rehabilitation - physical therapy ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Parallel Assignment This a randomized controlled trial with first primary end point at 8 weeks and second primary end point at 3 months. Participants will be allocated randomly into one of two intervention groups. Group1 (Telerehabilitation) Group 2 (in person) ##### Masking Info Masking: DOUBLE Masking Description: The Investigator and outcomes assessor are blinded to patient allocation and data code. Who Masked: - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 34 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: In the live therapeutic exercise group (group A) the program and its progression will be determined and performed for life according to the patient's progress, with a frequency of sessions twice a week, a session duration of 45 minutes, following the recommended dosage of exercise according to with the clinical instructions, while the total duration of the intervention will be eight weeks. Intervention Names: - Other: group A: in face to face live therapeutic exercise Label: in face to face live group Type: EXPERIMENTAL #### Arm Group 2 Description: In the telerehabilitation program group (group B), the therapeutic exercise program will follow the same structure, with differences in the explanation of the exercises, their presentation, as well as the monitoring and information of the participants, as they will be done through a telerehabilitation platform and a special software data processing. The intervention time remains the same, with the physiotherapist in these 45 minutes of the session evaluating the data on the patient's progress by receiving the information through the software, and informing the patient of any changes in the progression of the exercise program. The remaining parameters of the intervention also remain the same, as in face to face live exercise. Intervention Names: - Other: group B: telerehabilitation program Label: telerehabilitation program group Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - in face to face live group Description: In group A: in face to face live therapeutic exercise the program and its progressivity will be determined and performed for life according to the progress of the patient, with a frequency of sessions twice a week, session duration 45 minutes, following the recommended dosage of exercise according to clinical guidelines, while the total duration of the intervention will be eight weeks. You will be instructed to perform the program at home, 3 times a week. The standardized exercise program to be followed by this group will include : 1. Exercises to strengthen the hip and knee muscles through isometric contractions and resistance exercises using elastic bands. 2. Balance and neuromuscular coordination exercises. Name: group A: in face to face live therapeutic exercise Type: OTHER #### Intervention 2 Arm Group Labels: - telerehabilitation program group Description: In group B: telerehabilitation program, the therapeutic exercise program will follow the same structure, which was mentioned above. The differentiation in the intervention of this group will be that the explanation of the exercises, their presentation, monitoring and information of the participants will be done through the telerehabilitation platform and special data processing software. The intervention time remains the same, with the physical therapist during these 45 minutes of the session , to evaluate the data on the patients progress by receiving the information through the software and to inform the patient of any changes in the progressivity of the exercise program. The other parameters of the intervention remain the same, as in person exercise. Name: group B: telerehabilitation program Type: OTHER ### Outcomes Module #### Primary Outcomes Description: "change" is being assessed for pain and stiffness of the knee joint with The WOMAC tool (Western Ontario and McMasters Universities Osteoarthritis Index), is a widely used measure. The questionnaire consists of 24 sections which are divided into three subscales . A five-point Likert (0-4) isosceles scale is used for calibration . Thus the pain subscale can be scored from 0-20, the stiffness 0-8 and the functionality 0-68. In addition to the Linkert scale, the VAS scale (visual analog scale) can be used. On a straight line of 10 cm, from 0 (no pain) to 10 (worst pain), the patient notes the pain he is experiencing at that moment. The WOMAC questionnaire is reliable and valid, the Greek version has been checked for its validity and reliability in a research. Measure: pain and stiffness of the knee joint Time Frame: [Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)] Description: "change" is being assessed for the muscle perfomance done with the help of the surface electromyogram with and the use of an isokinetic dynamometer, which are also considered as the gold standard standard . Measure: the muscle performance of the quadriceps muscle Time Frame: [Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)] #### Secondary Outcomes Description: "change" is being assessed for functionality with ASES.The Arthritis Self-Efficacy Scale (ASES) was developed to explain changes in the health of arthritis patients following educational interventions. KAA (Arthritis Self-Efficacy Scale - ASES) is the most frequently used and psychometrically tested tool specialized in arthritis. The KAA is a tool for assessing self -efficacy in patients with arthritis . The KAA includes 20 questions that assess three (3) factors: a) Pain self -efficacy - AP (5 questions), b) Functionality self-efficacy - AL (9 questions) and c) Other Symptoms self-efficacy - AAS (6 questions). Question scores range from 1 (not at all sure) to 10 (very sure) on a numerical scale, with continuous vertical lines representing whole numbers. The score of each factor results from the average of its individual questions. The scale should not be scored if more than 25% of the total questions have not been answered. The time to complete the KAA is estimated at 5-10 minutes. Measure: functionality Time Frame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)] Description: "change" is being assessed for Kinesiophobia with TSK.The TSK scale is a widely used tool that measures fear of movement or re-injury in various activities. It consists of 17 questions that can take four values from value 1: completely disagree to value 4: completely agree. The total score is calculated after reversing questions 4, 8, 12 and 16. The Greek version of the Tampa scale Scale of Kinesiophobia was measured in Greek and the validity and reliability indices of the Greek version were examined by the study , where they demonstrated a valid and reliable assessment tool whose internal validity (Cronbach's a=0.74) and reliability (ICC=0.78) demonstrate a tool capable of measuring patients' perception of fear of re-injury due to exercise or physical activity. Measure: Kinesiophobia Time Frame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up) Description: "change" is being assessed for Balance - Propriety is Time Up and Go Test .Time up and Go test: introduced in 1991 by Podsiadlo and Richarson as a measure of physical performance. Requires minimal equipment. The patient is asked to get up from a chair 45-50 cm high without sides, come to a standing position, travel as fast as possible a distance of three meters, turn and return to his original position. The total time of the test is related to the patient's level of functional ability. Measure: Balance - Propriety Time Frame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)] Description: for Anxiety - Depression is the Hospital Anxiety and Depression Scale (HADs) The Hospital Anxiety and Depression Scale (HADs): The HADs tool is a self-reported and calibrated scale measuring anxiety and depression. This scale consists of 14 questions, with a range of values from 0 to 3, which are divided into two subcategories. One subscale includes seven questions to screen for depression and the other with the same number of questions screens for anxiety disorders. The sum of the representative questions for each disease (0-21) forms an attempt to highlight the severity and quantification of anxiety and depression. The Hospital Anxiety and Depression Scale (HADS) is used to study anxiety and depression in hospital patients . The scale is completed by the examinee himself and consists of a total of 14 questions. Specifically, two factors are studied, anxiety (HADS-Anxiety - HADS-A) and depression (HADS-Depression - HADS-D), with each factor including 7 questions. Measure: Anxiety - Depression Time Frame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)] Description: change" is being assessed for Compliance with Diary of continuous recording of exercise time either in physical form or online Measure: Compliance Time Frame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)] ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Age 40-70 2. Ability to provide consent and good knowledge of the Greek language 3. Diagnosed, radiographically and by an orthopedic doctor, knee osteoarthritis grade 1-3, according to Kellgren and Lawrence classification system of osteoarthritis 4. Diagnosis of knee osteoarthritis and good general health Exclusion Criteria: 1. Participation in a systematic exercise program in the previous three months for the same problem 2. Participation in a physical therapy program in the previous three months for the same problem 3. Previous knee surgery within last three years 4. Medical contraindication to exercise 5. Systemic diseases or autoimmune in the acute phase of symptoms 6. Underlying severe neurological disease 7. Cognitive disability → inability to communicate 8. Red Flags (eg fractures (osteoporotic and non-osteoporotic), rapidly unexplained decrease in muscle strength, cardiorespiratory problems, etc.) - Maximum Age: 70 Years Minimum Age: 40 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Athens Country: Greece Facility: Physiotherapy Department, University of West Attica State: Agiou Spiridonos 28, 12243 Egaleo, Zip: 12243 #### Overall Officials Official 1: Affiliation: uniwa Name: Theodora Plavoukou, PhDc Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: uniwa Name: George Georgoudis, PhD Role: STUDY_DIRECTOR ### IPD Sharing Statement Module Access Criteria: It is to the authors discretion to share study data to other researchers. Description: Yes Only upon agreement by the authors that there will be no further changes and/ or analysis, results of the study will be published and shared. No patient data will be shared to be compliant with the latest GDPR code. Info Types: - STUDY_PROTOCOL - CSR IPD Sharing: YES Time Frame: 6 months after publication date and only upon agreement by the authors that there will be no further changes and/or analysis may data be shared. ### References Module #### References Citation: Skrepnik N, Spitzer A, Altman R, Hoekstra J, Stewart J, Toselli R. Assessing the Impact of a Novel Smartphone Application Compared With Standard Follow-Up on Mobility of Patients With Knee Osteoarthritis Following Treatment With Hylan G-F 20: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 May 9;5(5):e64. doi: 10.2196/mhealth.7179. PMID: 28487266 Citation: Saki, F., Bakhtiari Khou, S. and Ramezan, F. (2020). The Role of Digital Technologies as an Alternative for Face-to-Face Knee Rehabilitation: A Systematic Review. Physical Treatments: Specific Physical Therapy Journal, 10(4), pp.185-194 Citation: Naeemabadi, Mr., Fazlali, H., Najafi, S., Dinesen, B. and Hansen, J. (2020). Telerehabilitation for Patients With Knee Osteoarthritis: A Focused Review of Technologies and Teleservices. JMIR Biomedical Engineering, 5(1), p.e16991. Citation: Mecklenburg G, Smittenaar P, Erhart-Hledik JC, Perez DA, Hunter S. Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial. J Med Internet Res. 2018 Apr 25;20(4):e156. doi: 10.2196/jmir.9667. PMID: 29695370 Citation: Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6. Erratum In: Arthritis Rheumatol. 2021 May;73(5):799. PMID: 31908163 Citation: Johnson AJ, Palit S, Terry EL, Thompson OJ, Powell-Roach K, Dyal BW, Ansell M, Booker SQ. Managing osteoarthritis pain with smart technology: a narrative review. Rheumatol Adv Pract. 2021 Mar 16;5(1):rkab021. doi: 10.1093/rap/rkab021. eCollection 2021. PMID: 33928214 Citation: Byra J, Czernicki K. The Effectiveness of Virtual Reality Rehabilitation in Patients with Knee and Hip Osteoarthritis. J Clin Med. 2020 Aug 14;9(8):2639. doi: 10.3390/jcm9082639. PMID: 32823832 Citation: Bennell K, Nelligan RK, Schwartz S, Kasza J, Kimp A, Crofts SJ, Hinman RS. Behavior Change Text Messages for Home Exercise Adherence in Knee Osteoarthritis: Randomized Trial. J Med Internet Res. 2020 Sep 28;22(9):e21749. doi: 10.2196/21749. PMID: 32985994 Citation: Allen KD, Arbeeva L, Callahan LF, Golightly YM, Goode AP, Heiderscheit BC, Huffman KM, Severson HH, Schwartz TA. Physical therapy vs internet-based exercise training for patients with knee osteoarthritis: results of a randomized controlled trial. Osteoarthritis Cartilage. 2018 Mar;26(3):383-396. doi: 10.1016/j.joca.2017.12.008. Epub 2018 Jan 5. PMID: 29307722 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416319 Acronym: PreAct Brief Title: Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct) Official Title: Preoperative Physical Activity Improvement With the Use of Activity Trackers in Patients Undergoing Radical Cystectomy for Bladder Cancer: A Randomized Controlled Trial (PreAct) #### Organization Study ID Info ID: 2021-677 #### Organization Class: OTHER Full Name: Universitätsmedizin Mannheim ### Status Module #### Completion Date Date: 2026-03-14 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-03-14 Type: ESTIMATED #### Start Date Date: 2023-03-14 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-05 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Dr. Rolf M. Schwiete Foundation #### Lead Sponsor Class: OTHER Name: Universitätsmedizin Mannheim #### Responsible Party Investigator Affiliation: Universitätsmedizin Mannheim Investigator Full Name: Karl-Friedrich Kowalewski Investigator Title: Managing Senior Physician Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy. Detailed Description: The goal of the PreAct study is to test whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy with a daily activity goal and feedback on the achievement of this goal improves the participants' physical activity up to the day of radical cystectomy. In addition to the fitness tracker, we provide each patient with a smartphone. For each fitness tracker a separate account in a fitness application is set up for (e.g. name: tracker1.0 with the corresponding e-mail address and password). Neither the patients in the Daily activity Goal and Feedback arm nor the No Daily Activity Goal or Feedback arm receive the access data to the accounts. However, the patients in the intervention group receive the access PIN for the smartphone. On this smartphone a messaging service and the fitness application are installed. The patient thus receives, for example the wristband tracker1.0, which is registered with the corresponding access data in the fitness application of the smartphone given to them. For the entire preoperative period, the Bluetooth function on the smartphone must always stay activated so that the fitness application and the fitness tracker are continuously connected to each other. A detailed description of the timing and implementation of the intervention are described in "Study design" and "Arm and Interventions". ### Conditions Module Conditions: - Bladder Cancer - Bladder Neoplasm - Bladder Urothelial Carcinoma Keywords: - Cystectomy - Preoperative Exercise - Fitness Trackers - Exercise - Frailty ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Participants with an indication for radical cystectomy are included in this study. Recruitment, including eligibility criteria testing and randomized allocation to the intervention or control group, will take place on the day of premedication approximately 7 to 10 days prior to surgery. This period represents the prehabilitation period. ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 164 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: The participants in the Daily Activity Goal and Feedback arm receive a defined daily activity goal in the form of a defined number of steps, feedback on the achievement of this goal, and push-up notifications sent directly to the wristband to encourage them to remain active. Intervention Names: - Device: Daily Activity Goal and Feedback Label: Daily Activity Goal and Feedback Type: EXPERIMENTAL #### Arm Group 2 Description: The display of the fitness wristbands of the No Daily Activity Goal or Feedback arm is covered up. The participants in this arm neither receive a daily activity goal nor get feedback on the achievement of the activity goal/push-up notifications. Label: No Daily Activity Goal or Feedback Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Daily Activity Goal and Feedback Description: The daily activity target is a fixed number of steps. The exact number of steps is determined beforehand as part of the case number planning in a pilot study with ten participants and adjusted if necessary. The activity target we suggest is 8000 steps. In addition, the participants receive feedback several times a day about the steps needed to reach the goal and whether they have ultimately reached the daily goal. Name: Daily Activity Goal and Feedback Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery. Measure: Number of steps per day Time Frame: Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down. #### Secondary Outcomes Description: Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery. Measure: Total number of steps Time Frame: Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down. Description: The postoperative physical activity of the participants measured by the average number of steps per day and in total on postoperative days 1 to 3. Neither arm will receive a daily activity goal. However, the fitness trackers of the No Daily Activity Goal or Feedback arm are still covered. Measure: Postoperative physical activity Time Frame: Morning of postoperative day 4 at 7 PM Description: Postoperative complications measured by the Comprehensive Classification Index (CCI), on a scale from 0 (no complications) to 100 (death), (Slankamenac, Graf et al. 2013) and the Clavien-Dindo Classification (CDC), which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death (Clavien, Barkun et al. 2009): CDC ≥ 3a corresponding to a CCI ≥ 26.2 defined as "severe complications" including CDC = 5 and CCI = 100 defined as "patient's death" and the total number of complications Measure: Postoperative Complications Time Frame: On postoperative day 30 and 90 Description: In minutes, incision - surgical incision closure Measure: Operating time Time Frame: On the day of surgery Description: In millilitres Measure: Blod loss Time Frame: On the day of surgery Description: Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma Measure: Required transfusion of blood products Time Frame: On the day of surgery Description: Yes or no Measure: Feasibility of the planned urinary diversion Time Frame: On the day of surgery Description: If the planned urinary diversion is not feasible Measure: Conversion rate Time Frame: On the day of surgery Description: SF-36: Health-related quality of life (Scale 0 - 100: The higher the score, the lower the disability. A score of 100 corresponds to no disability) Measure: Patient Reported Outcome Measures (PROMs) Time Frame: On the day of randomization at the premedication appointment and on the day of discharge which is on average 2 weeks after the surgery and postoperative day 30 and 90 Description: LOS measured by the number of days spent in the hospital after surgery until discharge Measure: Length of hospital stay (LOS) Time Frame: On the day of discharge which is on average 2 weeks after the surgery Description: Readmissions due to a complication of the radical cystectomy Measure: Readmission rate Time Frame: On postoperative day 90 if occured Description: Reoperation due to a complication of the radical cystectomy Measure: Reoperation rate Time Frame: On postoperative day 90 if occured Description: Days spent in the ICU after surgery Measure: Length of stay in the intensive care unit (ICU) Time Frame: On postoperative day 90 if occured ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Planned radical cystectomy with bilateral pelvic lymphadenectomy and one of the different forms of urinary diversion (continent vs. incontinent; orthotopic vs. heterotopic) in patients with bladder cancer * Participants age ≥ 18 years and capacity to consent * Mobile participant who is not dependent on a walking aid * The participant declares his or her consent to participate in this study by signing and dating the informed consent form prior to the surgical procedure Exclusion Criteria: * Karnofsky performance status scale ≤ 70% (with 70%: Care for self. Unable to carry on normal activity or to do active work (Ambulatory and capable of all selfcare but unable to carry out any work activities). ) (Range: 0 - 100 percent with 0 percent "participant´s death" and 100 percent "no disabilities" * ASA Physical Status Classification: ASA \> 3 (3: A patient with severe systemic disease) * ASA 1, 2, 3 if acute or chronic diseases of the musculoskeletal system or the central nervous system are involved that result in a symptomatic restriction of motor and / or, in the last case, neurological function (healing ruptures and fractures, Parkinson's disease, multiple sclerosis, etc.) * Emergency intervention Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: karl-friedrich.kowalewski@umm.de Name: Karl-Friedrich Kowalewski, PD Dr. med. Phone: 0152-53404943 Role: CONTACT Contact 2: Email: johanneskilz@stud.uni-heidelberg.de Name: Johannes Kilz Phone: 0162-5297396 Role: CONTACT #### Locations Location 1: City: Mannheim Contacts: *Contact 1:* - Email: karl-friedrich-kowalewski@umm.de - Name: Karl-Friedrich Kowalewski, M.D., M.Sc. - Role: CONTACT *Contact 2:* - Name: Karl-Friedrich Kowalewski, M.D. - Role: PRINCIPAL_INVESTIGATOR Country: Germany Facility: Department of Urology, University Medical Center Mannheim, University of Heidelberg State: Baden-Württemberg Status: RECRUITING Zip: 68167 Location 2: City: München Contacts: *Contact 1:* - Email: maximilian.kriegmair@ukmp.de - Name: Maximilian C. Kriegmair, M.D. - Role: CONTACT Country: Germany Facility: Urologische Klinik München Planegg (UKMP) State: Bayern Status: RECRUITING #### Overall Officials Official 1: Affiliation: Department of Urology, University Medical Center Mannheim, Heidelberg University Name: Karl-Friedrich Kowalewski, PD Dr. med Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M1175 - Name: Frailty - Relevance: LOW - As Found: Unknown - ID: M5030 - Name: Urinary Bladder Neoplasms - Relevance: HIGH - As Found: Bladder Cancer - ID: M5551 - Name: Carcinoma, Transitional Cell - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T5693 - Name: Transitional Cell Carcinoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001749 - Term: Urinary Bladder Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416306 Brief Title: Treatment Targets in Spanish and English Bilingual Speech Intervention Official Title: Speech Intervention for Bilingual Children #### Organization Study ID Info ID: 01466758 #### Organization Class: OTHER Full Name: University of Iowa #### Secondary ID Infos Domain: University of Iowa ID: 202109072 Type: OTHER ID: R21DC021249 Link: https://reporter.nih.gov/quickSearch/R21DC021249 Type: NIH ### Status Module #### Completion Date Date: 2027-03-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2027-03-31 Type: ESTIMATED #### Start Date Date: 2024-05-08 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-07 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: NIH Name: National Institute on Deafness and Other Communication Disorders (NIDCD) #### Lead Sponsor Class: OTHER Name: Philip Combiths #### Responsible Party Investigator Affiliation: University of Iowa Investigator Full Name: Philip Combiths Investigator Title: Assistant Professor Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The goal of this clinical trial is to learn which speech treatment targets result in the greatest amount of speech learning in Spanish-English bilingual children with speech sound disorders. The main questions it aims to answer are: * Does linguistic complexity of the treatment target increase the amount of generalized learning within the treated language? * Does linguistic complexity of the treatment target increase the amount of generalized speech across languages? Researchers will compare intervention effects across treatment provided in English and Spanish to see if the effect differs according to the language of intervention. Participants will: * Attend between 12 and 18 45-minute speech intervention sessions in Spanish or English for up to 6 weeks * Attend assessment visits before and after intervention * Attend follow-up assessment visits 1 month and 2 months after intervention Detailed Description: This study is a single-subject experimental design with staggered multiple baselines examining speech intervention for Spanish-English bilingual children with speech sound disorders. The study includes two arms based on the language of intervention (Spanish or English). Within each arm are two conditions that manipulate the linguistic complexity of the speech treatment target (simple consonant singleton or complex consonant cluster). Participants will be pseudo-randomly assigned to these arms and conditions. The primary outcome is system-wide generalization; specifically, a) within-language and b) across-language generalization to untreated sounds. Accuracy data for the dependent variable will be derived from narrow phonetic transcription of participants' productions from speech probes in English and Spanish. The entire generalization probe is administered at each assessment visit (Pre, Post, and 1- and 2-Month Follow-Ups), and shorter subset probes targeting only monitored sounds are administered during Baselines and weekly during Treatment. ### Conditions Module Conditions: - Speech Sound Disorder Keywords: - speech - speech sound disorder - bilingual - treatment targets ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Two prospective treatment studies that share an identical study design, differing only in the language of treatment (Spanish or English). Both studies will employ a within- and across-subjects, single-subject experimental design (SSED) with multiple staggered baselines across two conditions (singleton consonant target vs. consonant cluster target). ##### Masking Info Masking: DOUBLE Masking Description: Outcomes will be determined from phonetic transcription of participants' speech during assessment sessions. All transcriptions will be completed by research assistants unaware of the condition (simple or complex treatment target), arm of the study (English or Spanish language of intervention) or phase of the intervention study (Pre, Post, or Follow-up). The participant will be unaware of the relative complexity of their treatment target (i.e., condition: simple or complex). Who Masked: - PARTICIPANT - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 16 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Treatment will be conducted entirely in Spanish, targeting Spanish speech sounds. Treatment will follow a drill-play format. Intervention Names: - Behavioral: Speech Intervention Label: Spanish Language Intervention Type: EXPERIMENTAL #### Arm Group 2 Description: Treatment will be conducted entirely in English, targeting English speech sounds. Treatment will follow a drill-play format. Intervention Names: - Behavioral: Speech Intervention Label: English Language Intervention Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - English Language Intervention - Spanish Language Intervention Description: The treatment will begin with imitation, whereby the child will produce target words following the study clinician's verbal model with 1:1 clinician feedback for the accuracy of the child's productions. This will include explicit articulatory instruction (i.e., verbal and visual cues) to elicit correct target forms. When a child achieves 75% accuracy following a verbal model across 2 consecutive sessions or completes the 9th session (whichever is first), treatment will shift to spontaneous production, in which the child will produce target words spontaneously or through elicitation without a verbal model. Treatment materials will be images of treatment target words, interactive games and stories, and a standard set of toys. Name: Speech Intervention Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Accuracy data for the dependent variable will be derived from narrow phonetic transcription of participants' productions from speech generalization probes in English and Spanish. Both protocols elicit \~300 word productions and sample each singleton consonant and consonant cluster in the respective language a minimum of three times in every permissible word position. The entire generalization probe is administered at each assessment visit (Pre, Post, and 1- and 2-Month Follow-Ups), and shorter subset probes targeting only monitored sounds are administered during Baselines and weekly during Treatment. All transcriptions will be completed by research assistants unaware of the condition (simple or complex treatment target), arm of the study (English or Spanish language of intervention) or phase of the intervention study (Pre, Post, or Follow-up). Measure: Comprehensive Probe or Monitored Sounds Probe Time Frame: At initial visit, 2-4 times across the 2 weeks prior to intervention, once per week during the 6-week intervention, within 1 week after intervention, 1 month after intervention, and 2 months after intervention ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Participants will be regularly exposed to English for at least 3 months in one of the following ways: a) an English-speaking caregiver or sibling who interacts with the child on a daily basis in English, b) attendance at an English-speaking daycare, preschool, or elementary school. * Caregivers will have reported concern with their child's speech development and/or reduced intelligibility on the Intelligibility in Context Scale in Spanish or English. * Participants will present with 5 or more consonants or clusters missing from their phonetic inventories in each language to confirm presence of a speech sound disorder and sufficient gaps in phonological knowledge to warrant treatment. Exclusion Criteria: * Participants receiving speech or language treatment elsewhere during their participation in this project. Maximum Age: 7 Years Minimum Age: 4 Years Sex: ALL Standard Ages: - CHILD ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003147 - Term: Communication Disorders - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M30694 - Name: Speech Sound Disorder - Relevance: HIGH - As Found: Speech Sound Disorder - ID: M6374 - Name: Communication Disorders - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000066229 - Term: Speech Sound Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416293 Acronym: WAVES Brief Title: Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians Official Title: Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians (Wechselseitiger Patienten-Arzt-Austausch in Der Versorgung Bei Brustkrebs Mit Dem Ziel Der Gemeinsamen Erarbeitung Neuer Patienten-orientierter Strukturen) #### Organization Study ID Info ID: 2.0 #### Organization Class: OTHER Full Name: University Hospital Augsburg ### Status Module #### Completion Date Date: 2027-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2026-12-31 Type: ESTIMATED #### Start Date Date: 2022-04-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-08 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Wuerzburg University Hospital Class: OTHER Name: Technical University of Munich Class: OTHER Name: LMU Klinikum Class: OTHER Name: University Hospital Regensburg Class: OTHER Name: University Hospital Erlangen Class: UNKNOWN Name: Bavarian Cancer Research Center (BZKF) #### Lead Sponsor Class: OTHER Name: University Hospital Augsburg #### Responsible Party Investigator Affiliation: University Hospital Augsburg Investigator Full Name: Nina Ditsch Investigator Title: Head of Breast Centre University Hospital Augsburg, Principal Investigator, Clinical Professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The aim of this BZKF project is to record the current care structure for breast cancer patients in order to use this as a basis for developing possible future models for improvement. The active involvement of representatives of regional and national patient organizations in the creation of a patient-based and patient-oriented survey ensures that the needs of patients are the focus. In addition to and in contrast to other projects, relevant questions are explicitly addressed not only to patients but also to physicians in order to identify and specify the interfaces between patient wishes/suggestions and to develop clinical consequences for care. The first objective is to survey the "current situation" by recording the current care structure for breast cancer. The focus is on the survey of both groups on patient-physician communication, time management and coping strategies. By planning the future harmonization of national data structures, the basis is created for the long-term goal of an improved "target", a concept developed jointly by physicians and patients for an improved communication and care structure that focuses on the patient. ### Conditions Module Conditions: - Breast Cancer Keywords: - Communication - patient-physician-relationship - questionnaire ### Design Module #### Design Info Observational Model: OTHER Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 2000 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients with diagnosis of breast cancer or DCIS Intervention Names: - Other: Questionnaire patients Label: BC Patients #### Arm Group 2 Description: Physicians treating patients with breast cancer Intervention Names: - Other: Questionnaire physicians Label: Physicians ### Interventions #### Intervention 1 Arm Group Labels: - BC Patients Description: Completion of a two-part questionnaire with a special focus on communication around the breast cancer diagnosis. Tumor stage and therapies received are also surveyed. The questionnaire can be answered online via a secure tool (REDCap) or in paper form. Name: Questionnaire patients Type: OTHER #### Intervention 2 Arm Group Labels: - Physicians Description: Completion of a questionnaire with a special focus on communication around the breast cancer diagnosis Name: Questionnaire physicians Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The primary aim of the questionnaire is to record the current reality of care for breast cancer patients with a focus on communication. Measure: Current state of care - patient view Time Frame: through study completion, an average of 3 years #### Secondary Outcomes Description: Secondarily, a comparison will be made with the physicians assessment of the same topics Measure: Current state of care - physician view Time Frame: through study completion, an average of 3 years ### Eligibility Module Eligibility Criteria: Inclusion Criteria (patients): * Breast cancer or DCIS * women and men aged 18 years and older Exclusion Criteria (patients): * women and men \< 18 years * no histologically confirmed breast cancer or DCIS diagnosis Inclusion Criteria (physicians): - Treatment of breast cancer patients Healthy Volunteers: True Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Women and men aged 18 years and older with breast cancer. Physicians treating breast cancer patients. ### Contacts Locations Module #### Central Contacts Contact 1: Email: nina.ditsch@uk-augsburg.de Name: Nina Ditsch, Prof. Phone: +49 821 400 15809 Role: CONTACT Contact 2: Email: melitta.koepke@uk-augsburg.de Name: Melitta Köpke, Dr. Phone: +49 821 400 165862 Role: CONTACT #### Locations Location 1: City: Augsburg Contacts: *Contact 1:* - Email: nina.ditsch@uk-agsburg.de - Name: Nina Ditsch, Prof. - Phone: +49 821 400 165809 - Role: CONTACT *Contact 2:* - Email: melitta.koepke@uk-augsburg.de - Name: Melitta Köpke, Dr. - Phone: +49 821 400 165862 - Role: CONTACT Country: Germany Facility: University Hospital Augsburg, Department of Gynecology and Obstetrics State: Bayern Status: RECRUITING Zip: 86156 #### Overall Officials Official 1: Affiliation: University Hospital Augsburg Name: Nina Ditsch, Prof. Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### 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: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416280 Acronym: CCASTING Brief Title: Inter-observer Reliability of the TRiP(Cast) Score in Patients With Trauma to a Lower Limb Requiring Immobilisation Official Title: Inter-observer Reliability of the Assessment of the Risk of Developing a Venous Thromboembolic Event, the TRiP(Cast) Score, in Patients With Trauma to a Lower Limb Requiring Immobilisation #### Organization Study ID Info ID: 24_0131 #### Organization Class: OTHER_GOV Full Name: University Hospital, Angers ### Status Module #### Completion Date Date: 2025-12-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-16 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-05-20 Type: ESTIMATED #### Start Date Date: 2024-05-16 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-06 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER_GOV Name: University Hospital, Angers #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: The aim of the study isto evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiP(cast) score in patients presenting with trauma to a lower limb requiring immobilisation, and of the clinicians' assessment using the physician's implicit probability (gestalt) compared with the use of the TRiP(cast) score. Detailed Description: Trauma to the lower limbs requiring orthopedic immobilisation (plaster cast or splint) is a frequent reason for seeking emergency care. Because of the venous stasis caused by immobilisation, hypercoagulability and vascular lesions induced by the trauma, these patients are at risk of developing a venous thromboembolic event (VTE). This risk is estimated at around 2% (95% CI 1.3 to 2.7). To reduce the risk of thrombosis, preventive anticoagulants, mainly low molecular weight heparins (LMWH) and fondaparinux, have been shown to be beneficial. However, not all patients have the same thromboembolic risk factors. A targeted strategy should therefore be used to avoid prescribing treatment to low-risk patients and to prescribe it to the sub-group of patients at high risk. The TRiP(cast) score has been developed and validated for this purpose. In the CASTING study (randomised stepped-wedge trial), patients not receiving thromboprophylaxis on the basis of a TRiP(cast) score \<7 had a 3-month rate of symptomatic thromboembolic events of 0.70% (95% CI: 0.21-1.17). Use of the TRiP(cast) score reduced the rate of anticoagulation prescriptions by 26% (24.5% versus 50.4%) without increasing the rate of thromboembolic events at 3 months. Since this study, French recommendations concerning the prescription of anticoagulation treatments have been updated. Since this study, French recommendations concerning the prescription of preventive anticoagulant treatment have been updated by the SFMU (French Society of Emergency Medicine) and the SFMV (French Society of Vascular Medicine). They were presented in June 2023 and are now applied in all emergency facilities. During the review for the publication of the CASTING study, it was discussed whether it would be useful to evaluate the reliability of this score. However, the reliability of the measurement and the reproducibility of the score have never been assessed. Given the importance of assessing the risk of venous thromboembolism in patients with lower-limb trauma when deciding whether or not to prescribe thromboprophylaxis, this assessment is essential. Although this score appears to be objective, there are still items where interpretation may be different. For example, the type of immobilisation cannot be transposed perfectly to all existing immobilisation methods. This study will also be carried out in other European countries. The types of immobilisation vary considerably from one country to another, and the interpretation of certain items could be different. The interpretation of patient characteristics may also vary. Furthermore, this score has never been compared with the clinician's implicit "gestalt" probability, which is used to define patients at risk of venous thromboembolic events. It is a real challenge when implementing scores to assess their added value compared with clinical intuition. The use of scores has an initial educational objective, but it is important to know whether clinical intuition would be sufficient to assess this venous thromboembolic risk. The aim of the study is to evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiP(cast) score in patients presenting with trauma to a lower limb requiring immobilisation, and of the clinicians' assessment using the physician's implicit probability (gestalt) compared with the use of the TRiP(cast) score. ### Conditions Module Conditions: - Venous Thromboembolism - Deep Vein Thrombosis - Pulmonary Embolism - Thromboprophylaxis - Lower Limb Trauma - Immobilisation Syndrome ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 302 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 Description: In patients presenting to the emergency department with trauma to a lower limb, the TRiP(cast) score is assessed in accordance with the recommendations. If the patient does not object. The attending physician will then be asked to fill in his implicit assessment of the risk of venous thromboembolism on a paper CRF and then to complete his assessment of the TRiP(cast) score. He will then be free to decide whether or not to anticoagulate the patient. At the same time, a doctor not involved in the patient's care will assess the TRiP(cast) score and record it on a paper CRF. The second doctor's assessment will be independent and will have no impact on the patient's management. The CRFs will then be analysed and stored. Data will be anonymised during data collection and each patient will be assigned an anonymity number. Name: Assessment of the TRiP(cast) score Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Outcome measure : The rate of agreement or "concordance" will be estimated by the Kappa coefficient. Measure: The primary aim is to assess the inter-observer reliability of venous thromboembolic risk assessment using the TRiP(cast) score in patients with lower limb trauma requiring immobilisation. Time Frame: Day 0 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Consultation in one of the emergency departments participating in the study, * Isolated trauma to a lower limb, * Rigid immobilisation (plaster or resin) or semi-rigid immobilisation for an expected duration of at least 7 days, * Patient over 18 years of age, * Patient affiliated to or benefiting from a social security scheme, * Patients who have signed a prior informed consent form Exclusion Criteria: * Patient taking anticoagulant treatment at the time of the trauma, * Trauma requiring hospitalisation for more than 48 hours, * Pregnant, breast-feeding or parturient patients, * Patient deprived of liberty by judicial or administrative decision, * Patient under compulsory psychiatric care, * Patient under legal protection, * Patients unable to give their free and informed consent Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Emergency department patients ### Contacts Locations Module #### Central Contacts Contact 1: Email: Delphine.Douillet@chu-angers.fr Name: Delphine DOUILLET Phone: (0)241353637 Phone Ext: +33 Role: CONTACT #### Locations Location 1: City: Angers Contacts: *Contact 1:* - Email: delphine.douillet@chu-angers.fr - Name: Delphine DOUILLET - Role: CONTACT Country: France Facility: DOUILLET Delphine Status: RECRUITING #### Overall Officials Official 1: Affiliation: University Hospital, Angers Name: Delphine DOUILLET Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Trauma - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M16686 - Name: Thrombosis - Relevance: HIGH - As Found: Thrombosis - ID: M14509 - Name: Pulmonary Embolism - Relevance: HIGH - As Found: Pulmonary Embolism - ID: M7784 - Name: Embolism - Relevance: HIGH - As Found: Embolism - ID: M16682 - Name: Thromboembolism - Relevance: HIGH - As Found: Thromboembolism - ID: M27780 - Name: Venous Thromboembolism - Relevance: HIGH - As Found: Venous Thromboembolism - ID: M22071 - Name: Venous Thrombosis - Relevance: HIGH - As Found: Deep Vein Thrombosis - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - 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: D000011655 - Term: Pulmonary Embolism - ID: D000013927 - Term: Thrombosis - ID: D000004617 - Term: Embolism - ID: D000013923 - Term: Thromboembolism - ID: D000054556 - Term: Venous Thromboembolism - ID: D000020246 - Term: Venous Thrombosis - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416267 Acronym: MBL RiskConseq Brief Title: Risk and Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL) Official Title: Immune Biomarkers, Genetic Risk, and the Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL) #### Organization Study ID Info ID: MBL_RiskCons #### Organization Class: OTHER Full Name: University of Haifa ### Status Module #### Completion Date Date: 2040-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2040-12 Type: ESTIMATED #### Start Date Date: 2024-08 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-07 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Clalit Health Services, Haifa and West Galilee Class: OTHER_GOV Name: Bnai Zion Medical Center #### Lead Sponsor Class: OTHER Name: University of Haifa #### Responsible Party Investigator Affiliation: University of Haifa Investigator Full Name: Geffen Kleinstern Investigator Title: Senior 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 proposal is to identify immune biomarkers, genetic risk, and the clinical consequences of low count monoclonal B-cell lymphocytosis (LC MBL), a common premalignant condition affecting up to 17% of European adults age\&gt;40. LC MBL is a precursor to chronic lymphocytic leukemia (CLL), characterized by a circulating population of clonal B-cells. It is relatively understudied, despite emerging evidence of clinical consequences such as increased risk for life-threatening infections and lymphoid malignancies. Studies reported that male sex, age, family history of CLL, and CLL-susceptibility genetic loci were associated with LC MBL risk. These findings were reported in European ancestry individuals and have not been generalized to other thnicities. This study will provide this missing knowledge using a unique multi-ethnic Israeli population of Jews and Arabs that have one of the highest and lowest age-standardized incidence rates of CLL in the world, respectively, and characterized with different genetic backgrounds. ### Conditions Module Conditions: - Monoclonal B-Cell Lymphocytosis - Chronic Lymphocytic Leukemia - Infections - Cancers - Cardiovascular Diseases - Alzheimer Disease - Dementia - Autoimmune Diseases - Parkinson Disease Keywords: - Monoclonal B cell Lymphocytosis - Genetic Risk - Outcomes - Infections - Cancers - CLL ### Design Module #### Bio Spec Description: Blood samples Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 1500 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Individuals over the age of 40 attending to the Clalit HMO clinics in the North of Israel for regular blood tests. Label: Clalit Health Services ### Outcomes Module #### Primary Outcomes Description: Blood samples will be screened for MBL using flow cytometry, while data on the various outcomes will be collected from electronic medical records from Clalit Health Services. Measure: Assess the relationship between LC MBL and life-threatening infections, hematologic malignancies, and solid tumors among Jews and Arabs in Israel Time Frame: From enrollment and 15 years of follow up Description: Blood samples will be screened for MBL using flow cytometry, while data on the various outcomes will be collected from electronic medical records from Clalit Health Services. Measure: Assess the relationship between LC MBL and cardiovascular diseases, autoimmune conditions, and Alzheimer among Jews and Arabs in Israel Time Frame: From enrollment and 15 years of follow up Description: DNA will be extracted from the blood sample and sequenced. Measure: Identify germline genetic factors that are associated with LC MBL risk among Jews and Arabs in Israel Time Frame: The first 5 years of the study Description: Blood samples will be screened for MBL using flow cytometry, ethnicity and sex will be determined using a demographic questionnaire Measure: Evaluate the prevalence of LC MBL by Jews and Arabs and by sex in Israel. Time Frame: The first 5 years of the study Description: Blood sample will be screened for MBL using flow cytometry, and immune biomarkers will be screened from plasma samples. Measure: Identify immune biomarkers that are associated with LC MBL risk Time Frame: The first 5 years of the study #### Secondary Outcomes Description: Other clinical conditions will be determined from electronic medical records from Clalit Health Services Measure: Assess the relationship between LC MBL and other clinical conditions Time Frame: From enrollment and 15 years of follow up ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Individuals over the age pf 40 Exclusion Criteria: * Individuals with lymphoproliferative disorder Healthy Volunteers: True Minimum Age: 40 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Jewish and Arab individuals over the age of 40 attending to the Clalit HMO clinics in the North of Israel for regular blood tests ### Contacts Locations Module #### Central Contacts Contact 1: Email: gkleinste@univ.haifa.ac.il Name: Geffen Kleinstern Phone: +972545715624 Role: CONTACT ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000003704 - Term: Dementia - ID: D000024801 - Term: Tauopathies - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000007945 - Term: Leukemia, Lymphoid - ID: D000007938 - Term: Leukemia - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000015448 - Term: Leukemia, B-Cell - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000007964 - Term: Leukocytosis - ID: D000007960 - Term: Leukocyte Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: HIGH - As Found: Autoimmune Diseases - ID: M3885 - Name: Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease - ID: M10945 - Name: Leukemia - Relevance: LOW - As Found: Unknown - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M18116 - Name: Leukemia, Lymphocytic, Chronic, B-Cell - Relevance: HIGH - As Found: Chronic Lymphocytic Leukemia - ID: M11215 - Name: Lymphocytosis - Relevance: HIGH - As Found: Lymphocytosis - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M23002 - Name: Tauopathies - 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: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M18115 - Name: Leukemia, B-Cell - 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: M10967 - Name: Leukocytosis - Relevance: LOW - As Found: Unknown - ID: M10963 - Name: Leukocyte Disorders - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: LOW - As Found: Unknown - ID: T1308 - Name: Chronic Lymphocytic Leukemia - Relevance: HIGH - As Found: Chronic Lymphocytic Leukemia ### Condition Browse Module - Meshes - ID: D000015451 - Term: Leukemia, Lymphocytic, Chronic, B-Cell - ID: D000010300 - Term: Parkinson Disease - ID: D000000544 - Term: Alzheimer Disease - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000008218 - Term: Lymphocytosis - ID: D000001327 - Term: Autoimmune Diseases ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416254 Brief Title: The Fibre Full Study Official Title: The Effects of a Diet Enriched With Dietary Fibre on Glycaemic Response, Gastrointestinal Tolerability, Satiety, and Microbiome Functionality (The Fibre Full Study). #### Organization Study ID Info ID: APC170 #### Organization Class: OTHER Full Name: University College Cork ### Status Module #### Completion Date Date: 2025-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-31 Type: ESTIMATED Last Update Submit Date: 2024-05-29 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-06 Type: ESTIMATED #### Start Date Date: 2024-03-28 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-03 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University College Cork #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This study will systematically investigate the effects of a diet with decreased energy density, reduced glycaemic index, and significantly increased dietary fibre, on post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight (Body Mass Index (BMI) 25-35kg/m2). Hypothesis: The investigators hypothesise that a diet enriched in fibre will be beneficial to post-prandial glycaemic response, well tolerated and satiating, as compared to the standard Western-style diet. Detailed Description: Participants: Healthy men and pre-menopausal, non-pregnant and non-lactating women, 18-45 years of age, with a Body Mass Index (BMI) between 25-34.9 kg/m2 will be recruited (n=20). Study Design: This exploratory study aims to investigate the effects of a fibre-enriched (FR) diet in adults with excess body weight in comparison to a control diet. This randomized, single-blinded, placebo-controlled intervention/trial with a crossover design compares the effects of consumption of fibre-enriched food staples delivered within a full meal plan (fibre-enriched diet plan) with a matched control meal plan (control diet plan). Participants stratified by age and BMI, will be randomly assigned to receive either the control diet or fibre-enriched (FR) diet for 8 days. After these 8 days, a washout period (13 day minimum) will commence, and participants will then crossover to the opposite diet. All foods and prepared meals within the menu plan will be provided to participants for both the control and FR diets. Participants are required to strictly adhere to their assigned meal plan for the 8-day period. Given the higher dietary fibre intake of the FR-diet, the study design incorporates a dose escalation of the fibre content to allow participants on the FR diet to adjust to the increase in dietary fibre intake (4-day reduced dose, wherein study foods contain only a portion of the required dose of fibre, and 4-day full dose, high fibre intake). The effect of the FR diet on satiety and overall food intake will be assessed. Participants on the FR diet and the control diet will be provided with non-fibre enriched snacks which they may consume at designated times each day, if they wish to and in ab libitum. These snacks will be an optional component of the menu plan. All food intakes will be monitored, and all leftovers will be returned to the research team. Additionally, dietary assessments will be completed at regular intervals. Study Treatments: * The FR diet consists of a full meal plan containing engineered common food products with decreased energy density and glycaemic index, in which a large proportion of refined carbohydrates are replaced with dietary fibre. * The control diet consists of a full meal plan with non-fibre enriched food products. Study Outcome measures will include post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight (BMI 25-35kg/m2). ### Conditions Module Conditions: - Overweight and Obesity Keywords: - Dietary fiber - glycemic control - gastrointestinal microbiome - microbiota - overweight - obesity - metabolism - satiety ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER Intervention Model Description: Crossover: Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study. ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: BASIC_SCIENCE #### Enrollment Info Count: 20 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: During the fibre-enriched arm, participants will receive the fibre-rich diet containing fibre-enriched foods provided through a full meal plan to be consumed throughout the day. Intervention Names: - Other: Fibre-enriched diet Label: Fibre-enriched Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: During the control arm, participants will receive a non-fibre enriched diet consisting of matched control foods provided through a full meal plan otherwise identical to the fibre-enriched arm. Intervention Names: - Other: Control diet Label: Control Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Fibre-enriched Description: The fibre-enriched diet contains fibre-enriched foods in which a portion of digestible carbohydrates are replaced with isolated dietary fibres. The fibre-enriched study foods are consumed as part of a full meal plan provided to participants. Name: Fibre-enriched diet Type: OTHER #### Intervention 2 Arm Group Labels: - Control Description: The control diet contains non-fibre-enriched study foods. The control study foods are consumed as part of a full meal plan provided to participants. Name: Control diet Type: OTHER ### Outcomes Module #### Other Outcomes Description: Changes in gut inflammatory marker concentration using established methods. Measure: Impact of a fibre-enriched diet on gut inflammatory marker concentration. Time Frame: Assessments may be conducted at baseline (pre-intervention), and then at the end of each 8 day intervention period. #### Primary Outcomes Description: Changes in glycaemic response using continuous interstitial glucose monitoring when consuming the fibre-enriched diet compared to a matched control diet. Measure: Impact of a fibre-enriched diet on glycaemic control Time Frame: Assessments will be conducted continuously over each 8-day intervention period Description: Differences in satiety assessed by analysis of Participant responses to the Satiety Labelled Intensity Magnitude (SLIM) scale and assessment of food consumption. The SLIM scale assesses perceived hunger/fullness using 11 phrases placed along a vertical line scale with "Greatest imaginable hunger" (score = -100) at the bottom and "Greatest imaginable fullness" at the top (score = +100). Measure: Differences in participant reported satiety when consuming the fibre-enriched diet compared to the matched control diet Time Frame: Throughout each 8-day intervention period assessed at specific time points during the day (e.g. pre- and post-meal consumption) #### Secondary Outcomes Description: Evaluation of the impact of the fibre-enriched diet on gastrointestinal tolerance, through monitoring of participant reported gastrointestinal symptoms. This will be assessed via a Gastrointestinal Symptom and Bowel Movement Questionnaire comprising eleven questions from The Gastrointestinal Symptom Rating Scale (GSRS) followed by the Bristol Stool Chart and bowel frequency and flatus questions. The GSRS utilizes a 7-point response scale to measure the level of discomfort associated with a given gastrointestinal symptom, ranging from "No discomfort at all" to "Very severe discomfort." Participants will also rate the form of their stool sample using the Bristol Stool Chart. Measure: Gastrointestinal tolerance to dietary fibre assessed by a Gastrointestinal Symptom and Bowel Movement Questionnaire Time Frame: Throughout each 8-day intervention period, assessed at specific time points (i.e. at baseline, 4 days (mid-point) and 8 days (end) of each dietary intervention) Description: Changes in gut microbiome composition and diversity between intervention periods through 16S ribosomal RNA (rRNA) gene sequencing of faecal samples. Measure: Impact of a fibre-enriched diet on gut microbiota composition Time Frame: Assessments may be conducted at baseline (pre-intervention), and then at 4 days (mid-point) and 8 days (end) of each study intervention period. Description: Changes in faecal metabolite concentrations determined through liquid chromatography-mass spectrometry (LC-MS) Measure: Effect of a fibre-enriched diet on gut microbiota function Time Frame: Assessments may be conducted at baseline (pre-intervention), and then at 4 days (mid-point) and 8 days (end) of each study intervention period. ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Be willing and able to give written informed consent. * Be between 18 and 45 years of age * Have a Body Mass Index (BMI) of 25-34.9kg/m2 (Overweight or Obese Class I) * Have had a stable body weight (≤5% change over the past three months) * Be in general good health as determined by the investigator through interview and vital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100 mm Hg (defined as Hypertension stage 2). * Be willing to avoid consuming dietary supplements, prebiotics, probiotics, or fibre-rich supplements within four weeks prior to the baseline visit, and until the end of the study. * Be willing to avoid physical exercise for the duration of the study (physical exercise defined as any physical activity that is planned to achieve a fitness goal) * Be willing to consume the investigational products daily for the duration of the study. Exclusion Criteria: * Pregnant, lactating, menopausal or post-menopausal women, or women who are planning to become pregnant over the study period. * Have had antibiotic treatment within three months prior to baseline. * Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of study results; to include: anti-inflammatory drugs, H2 blockers, antacid, proton pump inhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas, antibiotics, anti-coagulants, immunosuppressant medication. Participants should have a wash-out period of at least two-weeks for each of these medications except for antibiotics, which should not have been taken in the previous three months. Participants taking proton pump inhibitors and medications for chronic conditions (e.g., anti-hypertensive medication) will be allowed onto the study if the dose has been stable for at least two months prior to the study baseline visit. * Have a history or indication of drug and/or alcohol abuse at the time of enrolment. * Have a habitual alcohol consumption of \>2 alcoholic beverages/day (\>28g ethanol daily). * Follow a vegetarian or vegan diet * Have a typical fibre intake of \>30g per day * Have experienced major dietary changes within three months prior to the study baseline. * Plan major lifestyle changes (diet, physical activity, or travel) during the study period. * Have a clinically diagnosed eating disorder. * Have a food allergy or intolerance that would preclude study product intake (for example eggs, gluten, nuts, milk or any other food allergy or intolerance) * Have an active gastrointestinal disorder or previous gastrointestinal surgery * Have a significant active and medically-diagnosed acute or chronic co-existing illness including: metabolic, psychiatric, cardiovascular, endocrinological, immunological condition, gastrointestinal disease or any other condition which contraindicates, in the investigator's judgement, entry to the study (such as, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis A/B/C, HIV, cancer, diabetes etc) or a significant history of such diseases. * Are severely immunocompromised (e.g., HIV positive, transplant patient, on anti-rejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last 12 months). * Have a malignant disease or concomitant end-stage organ disease. * Have symptomatic respiratory or cardiac illness. * Experience alarm features such as sudden weight loss, rectal bleeding, a recent change in bowel habits, or significant abdominal pain within three months prior to baseline. * Individuals who, in the opinion of the investigator are poor attendees or unlikely for any reason to be able to comply with the study protocol. * Participants may not be receiving treatment involving experimental drugs. * If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study. * Individuals with pacemakers or implantable cardioverter defibrillators. * Individuals that regularly undertake rigorous exercise, defined by International Physical Activity Questionnaire with a score within category 3, Health Enhancing Physical Activity (HEPA) Active. * Individuals who smoke or vape regularly (i.e., daily or habitual use). Gender Based: True Gender Description: An equal number of male and female participants will be enrolled Healthy Volunteers: True Maximum Age: 45 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: fibrestudy@ucc.ie Name: Study Coordinator Phone: 086 199 2919 Role: CONTACT #### Locations Location 1: City: Cork Contacts: *Contact 1:* - Email: fibrestudy@ucc.ie - Name: Study Coordinator - Phone: 086 199 2919 - Role: CONTACT Country: Ireland Facility: University College Cork Status: RECRUITING #### Overall Officials Official 1: Affiliation: University College Cork Name: Jens Walter, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Armet AM, Deehan EC, Thone JV, Hewko SJ, Walter J. The Effect of Isolated and Synthetic Dietary Fibers on Markers of Metabolic Diseases in Human Intervention Studies: A Systematic Review. Adv Nutr. 2020 Mar 1;11(2):420-438. doi: 10.1093/advances/nmz074. PMID: 31342059 Citation: Baenziger PS, Frels K, Greenspan S, Jones J, Lovegrove A, Rose D, Shewry P, Wallace R. A stealth health approach to dietary fibre. Nat Food. 2023 Jan;4(1):5-6. doi: 10.1038/s43016-022-00674-w. No abstract available. PMID: 37118563 Citation: David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11. PMID: 24336217 Citation: Deehan EC, Walter J. The Fiber Gap and the Disappearing Gut Microbiome: Implications for Human Nutrition. Trends Endocrinol Metab. 2016 May;27(5):239-242. doi: 10.1016/j.tem.2016.03.001. Epub 2016 Apr 11. PMID: 27079516 Citation: Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16. Erratum In: Cell Metab. 2019 Jul 2;30(1):226. Cell Metab. 2020 Oct 6;32(4):690. PMID: 31105044 Citation: Ludwig DS, Ebbeling CB. The Carbohydrate-Insulin Model of Obesity: Beyond "Calories In, Calories Out". JAMA Intern Med. 2018 Aug 1;178(8):1098-1103. doi: 10.1001/jamainternmed.2018.2933. PMID: 29971406 Citation: Rouhani MH, Haghighatdoost F, Surkan PJ, Azadbakht L. Associations between dietary energy density and obesity: A systematic review and meta-analysis of observational studies. Nutrition. 2016 Oct;32(10):1037-47. doi: 10.1016/j.nut.2016.03.017. Epub 2016 Mar 31. PMID: 27238958 Citation: Sonnenburg ED, Sonnenburg JL. Starving our microbial self: the deleterious consequences of a diet deficient in microbiota-accessible carbohydrates. Cell Metab. 2014 Nov 4;20(5):779-786. doi: 10.1016/j.cmet.2014.07.003. Epub 2014 Aug 21. PMID: 25156449 Citation: Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001. PMID: 26590418 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050177 - Term: Overweight ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416241 Acronym: INTRAMED-CRVO Brief Title: Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion Official Title: Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion #### Organization Study ID Info ID: 699/2019 #### Organization Class: OTHER Full Name: University of Athens ### Status Module #### Completion Date Date: 2024-03-31 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: COMPLETED #### Primary Completion Date Date: 2020-12-31 Type: ACTUAL #### Start Date Date: 2017-01-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-08 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University of Athens #### Responsible Party Investigator Affiliation: National and Kapodistrian University of Athens Investigator Full Name: Irini Chatziralli Investigator Title: Associate Professor in Ophthalmology Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Is US Export: True Oversight Has DMC: False ### Description Module Brief Summary: Central retinal vein occlusion (CRVO) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. CRVO may cause visual impairment, especially due to macular edema (swelling of the macula due to fluid accumulation) and macular non-perfusion. Aflibercept has been found to improve visual acuity and reduce macular thickness in pivotal trials. The purpose of this study was to evaluate the efficacy and safety of intravitreal aflibercept in real-world, using a patient-fitted treatment regimen. Additionally, imaging parameters have been assessed before and after treatment with intravitreal aflibercept. ### Conditions Module Conditions: - Retinal Vein Occlusion - Vascular Occlusive Disease Keywords: - optical coherence tomography angiography - aflibercept - retinal vein occlusion - biomarkers ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 51 Type: ACTUAL Phases: - PHASE4 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: EYLEA 2 MG in 0.05 ML Injection Label: Eylea 2.0mg/0.05ml Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - Eylea 2.0mg/0.05ml Description: Intravitreal injection Name: EYLEA 2 MG in 0.05 ML Injection Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: Change in visual acuity as measured using ETDRS charts Time Frame: 5 years Measure: Change in retinal thickness as measured in μm using spectral domain optical coherence tomography Time Frame: 5 years #### Secondary Outcomes Measure: Change in microvascular parameters in OCT angiography (vessel density, FAZ area) Time Frame: 2 years Measure: Complications Time Frame: 5 years Measure: Change in endothelial dysfunctionafter aflibercept treatment, as measured by the perfused boundary region sublingual 5-25 μm Time Frame: 6 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Treatment naive center-involved macular edema secondary to CRVO for no longer than 3 months. * Patients \>18 years of age, who are diagnosed with macular edema secondary to CRVO who are scheduled to be treated with intravitreal aflibercept in real-life conditions * BCVA of Snellen of 20/40 to 20/200 in the study eye Exclusion Criteria: * Previous PRP or macular laser photocoagulation in the study eye. * Any prior ocular treatment in the study eye for macular edema secondary to CRVO. * Prior systemic anti-VEGF or corticosteroid therapy, within the last 3 months before enrollment to the study. * Any active or previous inflammation, ocular trauma * Uncontrolled glaucoma (IOP\>30 mmHg) Healthy Volunteers: True Maximum Age: 95 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008268 - Term: Macular Degeneration - ID: D000012162 - Term: Retinal Degeneration - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases - 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 ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M11261 - Name: Macular Edema - Relevance: HIGH - As Found: Macular Edema - ID: M7657 - Name: Edema - Relevance: LOW - As Found: Unknown - ID: M15005 - Name: Retinal Vein Occlusion - Relevance: HIGH - As Found: Retinal Vein Occlusion - ID: M11260 - Name: Macular Degeneration - Relevance: LOW - As Found: Unknown - ID: M14997 - Name: Retinal Degeneration - Relevance: LOW - As Found: Unknown - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - 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 ### Condition Browse Module - Meshes - ID: D000008269 - Term: Macular Edema - ID: D000012170 - Term: Retinal Vein Occlusion ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M257727 - Name: Aflibercept - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416228 Acronym: NCS Brief Title: Beetroot Juice NO Cold Study Official Title: Beetroot Juice Supplement for Boosting Mucosal Immunity - The NO Cold Study #### Organization Study ID Info ID: 23-108 #### Organization Class: OTHER Full Name: Southern Methodist University ### Status Module #### Completion Date Date: 2026-05-15 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2026-05-15 Type: ESTIMATED #### Start Date Date: 2024-04-02 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-29 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Baylor University #### Lead Sponsor Class: OTHER Name: Southern Methodist University #### Responsible Party Investigator Affiliation: Southern Methodist University Investigator Full Name: Thomas Ritz 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: Currently, there is a lack of evidence-based prevention strategies for respiratory infection and management of these conditions can be costly to the public. Airway nitric oxide provides a first line of defense against pathogens, and beetroot juice, a source of dietary nitrate, has been shown to elevate nitric oxide. The main objective of this project is to demonstrate that one week of supplementation with beetroot juice elevates airway nitric oxide during stressful periods in young adults and thereby can protect against respiratory viral infections. Detailed Description: Study Title Beetroot Juice Supplement for Boosting Mucosal Immunity: The NO Cold Study Objectives Aim 1: Demonstrate that a 7-day trial of daily beetroot juice or nitrate depleted placebo beetroot juice is feasible with acceptable retention and adherence during a period of real-life stress, using adherence monitoring of beetroot juice intake by cell phone recorded video; acceptable burdensomeness for participants and success of team coordination and study logistics should also be demonstrated. Aim 2: Generate initial estimates of effect size for a) elevations in exhaled nitric oxide (FENO) and b) the correlation between changes in FENO and both infection reduction and cold symptom reduction (biological signature). Aim 3: a) Examine if 2 daily doses of beetroot juice are more potent than 1 daily dose in elevating FENO, and b) investigate whether each beetroot juice dosage (1 dose and 2 doses) increases FENO more than the placebo. Exploratory aims: Explore sex as a moderator of all the Aims. Also explore effects of competitors/inhibitors of NO (arginase, asymmetric dimethylarginine) in a) reducing FENO under stress, and b) whether beetroot juice buffers any of these potential adverse effects on FENO; c) investigate whether effects of stress cortisol, which negatively impact NO, cold symptoms, and respiratory infections, are also buffered by beetroot juice. Design and Outcomes This is a double-blind, placebo controlled clinical trial to test the efficacy of beetroot juice as elevating airway NO, which is associated with reduced cold symptoms and respiratory viral infection rates, in undergraduate students aged 18-30. Interventions and Duration Participants will be receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice, 2 active daily doses of beetroot juice, or 2 daily doses of nitrate-depleted placebo beetroot. Cold symptoms will be explored by questionnaire at baseline (in a low stress period during the semester) and subsequently twice during the final exam period, once at an early stage of the finals (days 1-3 of the final exam period), and once at a later stage (days 4-6). A follow-up online questionnaire packet will be administered 3 days after the last final day. FENO, sampling for viral PCR, salivary cortisol, and exhaled breath condensate will be undertaken at baseline, early finals, and late finals (in-person assessments are not feasible at follow-up, because students leave campus after finals). Sample Size and Population The sample size is 150 students (n=66 at SMU site, n=84 at Baylor site). Female and male students 18-30 years old will be recruited from Baylor and SMU. The investigators will make an extra effort to guarantee equal representation of both genders. Participants can be from any ethnic or cultural background, as long as they can understand and read English adequately. The student population of both universities combined is diverse (28.5-38.5% minorities). The investigators will stratify by sex and by site, to randomize participants to receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice, 2 active daily doses of beetroot juice, or 2 daily doses of nitrate-depleted placebo beetroot juice (n=50 per group). ### Conditions Module Conditions: - Respiratory Tract Infections - Cold Symptoms - Exhaled Nitric Oxide ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Double blinded, placebo controlled study ##### Masking Info Masking: QUADRUPLE Masking Description: Both participating students and assessors will be blinded to the participants' group assignment. Since students and research staff will not know whether their beetroot juice is depleted or not, treatment conditions are double-blinded (juice "shots" will be pre-labeled by study statistician with a participant number based on the pre-study randomization, so neither the staff nor the participant know the contents). Students will also be assured of full blinding of course instructors, including the PIs and Co-Is, to names of study participants. Who Masked: - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: PREVENTION #### Enrollment Info Count: 150 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: 2 active (nitrate containing) doses of Beet-it Pro 400 Intervention Names: - Dietary Supplement: Beetroot juice Label: Two active doses of beetroot juice Type: EXPERIMENTAL #### Arm Group 2 Description: 1 active (nitrate containing) dose of Beet-it Pro 400 and one placebo (nitrate-depleted) dose of beetroot juice Intervention Names: - Dietary Supplement: Beetroot juice Label: One active dose of beetroot juice and one placebo dose of beetroot juice Type: ACTIVE_COMPARATOR #### Arm Group 3 Description: 2 placebo (nitrate-depleted) doses of beetroot juice Intervention Names: - Dietary Supplement: Beetroot juice Label: Two placebo doses of beetroot juice Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - One active dose of beetroot juice and one placebo dose of beetroot juice - Two active doses of beetroot juice - Two placebo doses of beetroot juice Description: Participants will take on dose in the morning and one in the afternoon, for 7 days during their final academic examinations Name: Beetroot juice Other Names: - Beet-it 400 Type: DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes Description: One-day food record via the Automated Self-Administered 24-Hour platform; control variable Measure: One-day Food Record Time Frame: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) Description: From Exhaled breath condensate or saliva, competitors/inhibitor of NO; exploratory mediator of FENO Measure: Arginase Time Frame: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) Description: From Exhaled breath condensate or saliva, competitors/inhibitor of NO; exploratory mediator of FENO Measure: Asymmetric dimethylarginine Time Frame: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) #### Primary Outcomes Description: The Fraction of NO in Exhaled Breath (FENO, in ppb) will be measured with an electrochemical gas analyzer (NIOX vero). Measure: Exhaled Nitric Oxide Time Frame: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) Description: Binary positive/negative test results for a panel of viral and bacterial respiratory pathogens. Measure: Viral Polymerase Chain Reaction Time Frame: Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period) Description: Assess symptoms of acute upper respiratory tract infections (common cold symptoms) by questionnaire Measure: Wisconsin Upper Respiratory Symptom Survey (WURSS) Time Frame: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period), 1-3 days after finishing beetroot shots (after final examinations) Description: Participants will upload a cell phone video of their intake for that day to a secure cloud folder, time stamp in comparison to assigned intake windows provides measure of adherence Measure: Adherence monitoring (feasibility) Time Frame: Every day during active beetroot shots (Days 1-7) Description: Follow-up questionnaire will be administered with the online follow-up survey. It explores experience with the best mode of reminder receipt (email or text message), whether the participants guessed their condition, and how burdensome 8 aspects of the study (including daily intake, video recording, upload, questionnaires, physiological assessment) were. Measure: Burdensomeness Time Frame: 1-3 days after finishing beetroot shots (after final examinations) #### Secondary Outcomes Description: Ad-hoc acute stress rating Measure: Acute stress Time Frame: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period), 1-3 days after finishing beetroot shots (after final examinations) Description: Cortisol, from saliva sampled with passive drool test Measure: Cortisol Time Frame: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) Description: Perceived Stress Scale (PSS) Measure: Perceived stress Time Frame: Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period) Description: Hospital Anxiety and Depression Scale (HADS) Measure: Mood Time Frame: Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period) Description: Measured after at least 10 min of acclimatization to the laboratory Measure: Blood pressure (systolic and diastolic blood pressure) and heart rate Time Frame: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: Individuals will be included: * SMU or Baylor University students * Ages of 18-30 years old. Exclusion Criteria: * Active smokers * Smoking cannabis or vape * Students with clinically significant asthma * COPD and emphysema * Allergic rhinitis * High levels of exhaled nitric oxide (FENO ≥40ppb) * Developing kidney stone * Clinically significant heart disease * Cerebrovascular disease * Thyroid dysfunction * Out-of-control diabetes * Significant current problems with schizophrenia, psychosis, mood disorders, suicidality, and drug or alcohol dependence or abuse Healthy Volunteers: True Maximum Age: 30 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: sspringfield@mail.smu.edu Name: Savannah Springfield, BA Phone: (214) 768-6441 Role: CONTACT Contact 2: Email: Danielle_Young@baylor.edu Name: Danielle Young, Ph.D. Phone: (254) 710-2236 Role: CONTACT #### Locations Location 1: City: Dallas Contacts: *Contact 1:* - Email: sspringfield@smu.edu - Name: Savannah Springfield, BA - Phone: 214-768-6441 - Role: CONTACT Country: United States Facility: Southern Methodist University State: Texas Status: RECRUITING Zip: 75206 Location 2: City: Waco Contacts: *Contact 1:* - Email: Danielle_Young@baylor.edu - Name: Danielle Young, Ph.D. - Phone: 254-710-2236 - Role: CONTACT Country: United States Facility: Baylor University State: Texas Status: RECRUITING Zip: 76796 #### Overall Officials Official 1: Affiliation: Southern Methodist University Name: Thomas Ritz, Ph.D. Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: Baylor University Name: Annie Ginty, Ph.D. Role: STUDY_DIRECTOR ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: HIGH - As Found: Respiratory Tract Infections - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012141 - Term: Respiratory Tract Infections ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416215 Acronym: PROMISE Brief Title: Promoting Positive Mental Health for Sustainable Eating Behaviors Official Title: Promoting Positive Mental Health for Sustainable Eating Behaviors: the PROMISE Study in Patients With Obesity #### Organization Study ID Info ID: PROMISE_BO_2024 #### Organization Class: OTHER Full Name: University of Bologna ### Status Module #### Completion Date Date: 2024-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-16 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-12-31 Type: ESTIMATED #### Start Date Date: 2024-01-30 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-09 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: IRCCS Azienda Ospedaliero-Universitaria di Bologna Class: OTHER Name: European Union #### Lead Sponsor Class: OTHER Name: University of Bologna #### Responsible Party Investigator Affiliation: University of Bologna Investigator Full Name: Elena Tomba Investigator Title: Associate Professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: The main aim of the present study is to assess the effects and the effectiveness of a psychological intervention based on the principles of well-being therapy (WBT) in promoting weight-loss, sustainable and healthy eating behaviors and an optimal psychological functioning in patients with obesity. Detailed Description: The primary objective of this pilot study is to assess the effects and the effectiveness, both post-treatment and at 1- and 3-month follow-ups, of a group intervention inspired by the principles of Well-Being Therapy (WBT), combined with a nutritional education, compared to treatment as usual (TAU), namely a Basic Nutritional Intervention (BNI) in a group setting, in terms of weight loss. The secondary objective is to evaluate the effects and effectiveness of this intervention, both post-treatment and at 1- and 3-month follow-ups, compared to BNI, in promoting healthy and sustainable eating behaviors and an optimal psychological functioning. This includes the promotion of balanced psychological well-being levels and functional eating styles, and the reduction of both psychological distress and dysfunctional justification cognitive mechanisms use. After being informed about the study and its potential risks, all patients giving written informed consent will be randomly assigned to either the experimental group or the control group. Both groups will participate in five weekly online group sessions of two hours each. ### Conditions Module Conditions: - Obesity ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 50 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Six weekly online sessions of two hours of a psychological intervention based on WBT elements and cognitive restructuring combined with a nutritional education. Intervention Names: - Other: Psychological intervention based on WBT and cognitive restructuring Label: Psychological intervention based on WBT and cognitive restructuring Type: EXPERIMENTAL #### Arm Group 2 Description: Six weekly online sessions of two hours of a nutritional education. Intervention Names: - Other: Basic Nutritional Intervention Label: Basic Nutritional Intervention Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Psychological intervention based on WBT and cognitive restructuring Description: Participants will engage in 6 weekly group session of two hours. One part will be held by a trained dietician and will focus on nutritional education, particularly emphasizing the adoption of healthy and sustainable eating behaviors. The remaining part will be dedicated to a group psychological intervention inspired by the principles of Well-Being Therapy and will be held by a trained psychologist. During these sessions, participants will be introduced to the six dimensions of psychological well-being and will be gradually provided with cognitive-behavioral strategies to enhance psychological well-being and seek a balance between the presented dimensions. Participants will be given cognitive-behavioral tools to recognize justification cognitive mechanisms and replace them with more functional cognitions. These objectives will also be achieved through the use of a food diary to highlight emotions and thoughts experienced during food intake. Name: Psychological intervention based on WBT and cognitive restructuring Type: OTHER #### Intervention 2 Arm Group Labels: - Basic Nutritional Intervention Description: Participants will receive treatment as usual (TAU) by participating in 6 weekly group sessions of two hours of a Basic Nutritional Intervention (BNI) held by a trained dietician. This course focuses on promoting healthier lifestyles through nutritional education, diet monitoring using a dedicated food diary, and recommendations for proper physical activity. Name: Basic Nutritional Intervention Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Body weight will be both self-evaluated by patients and will be verified by the medical staff during follow-up visits Measure: Change from baseline in weight-loss Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention #### Secondary Outcomes Description: The Sustainable and Healthy Dietary Behaviors (SHDB) is 30-item self-reported questionnaire on a 6-point Likert scale to assess sustainable and healthy dietary behaviors through five dimensions and the total score: food choices, storing, cooking, food consumption and food disposal. For each sub-scale and the total score, scores range from 0 to 6, with higher scores indicating more sustainable and healthy eating behaviors (better outcome). Measure: Change from baseline in the Sustainable and Healthy Dietary Behaviors (SHDB) questionnaire Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention Description: The Psychological Well-Being Scale (PWBs) is a 42-item self-reported questionnaire on a 6-point Likert scale that assesses psychological well-being through six dimensions: autonomy, personal growth, environmental mastery, purpose in life, acceptance and positive relations with others. For each dimension scores range from 14 to 84, with higher scores indicating higher levels on that specific PWB dimension (better outcome). Measure: Change from baseline in the Psychological Well-Being Scale (PWBs) Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention Description: The Dutch Eating Behavior Questionnaire (DEBQ) is 33-item self-reported questionnaire on a 5-point Likert scale to assess eating styles through three sub-scales: restrictive eating, emotional eating and external eating. For each sub-scale scores range from 1 to 5, with higher scores indicating higher levels on that specific dimension (worse outcome). Measure: Change from baseline in the Dutch Eating Behavior Questionnaire (DEBQ) Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention Description: The Depression and Anxiety Stress Scale (DASS-21) is a 21-item self-reported questionnaire on a 4-point Likert scale to assess psychological distress through three subscales: depression, anxiety and stress. For each sub-scale scores range from 0 to 56, with higher scores indicating higher levels on that specific dimension (worse outcome). Measure: Change from baseline in the Depression and Anxiety Stress Scale (DASS-21) Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention Description: An ad-hoc assessment index adapted from a previous study will be used to assess dysfunctional cognitive justification mechanisms through the presentation of three hypothetical scenarios that could pose dilemmas regarding the adherence to a healthy diet. Participants will be asked to assess their level of identification with the scenario (from 1 to 10) and to specify the type of justification most frequently used in similar situations. Measure: Change from baseline in the use of dysfunctional cognitive justification mechanisms assessed through an ad-hoc form Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention ### Eligibility Module Eligibility Criteria: INCLUSION CRITERIA Patients are included in the study if they: 1. are affiliated with the Clinical Nutrition and Metabolism Unit of Policlinico S. Orsola-Malpighi; 2. have a BMI ≥ 30; 3. are aged ≥ 18 years; 4. voluntarily agree to participate in the study; 5. have access to a computer and can use it independently. EXCLUSION CRITERIA Patients are excluded from the study if they: 1. do not sign the informed consent to participate in the study; 2. have limited knowledge of the Italian language; 3. have cognitive deficits; 4. meet the diagnostic criteria for one or more of the following psychiatric diagnoses: drug and/or alcohol abuse, psychotic disorders, neuro-cognitive disorders, suicidal behaviors; 5. participate in another weight loss study or program; 6. take weight loss medications; 7. engage in individual or group psychotherapeutic interventions; 8. have undergone weight loss surgery in the 16 months preceding the study and during the entire study period (approximately five months); 9. (only women) were/are pregnant or were/are planning pregnancy in the 16 months preceding the study and during the entire study period (approximately five months). Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: elena.tomba@unibo.it Name: Elena Tomba Phone: +390512091339 Role: CONTACT Contact 2: Email: sara.gostoli2@unibo.it Name: Sara Gostoli Role: CONTACT #### Locations Location 1: City: Bologna Contacts: *Contact 1:* - Email: marialetizia.petroni@unibo.it - Name: Maria Letizia Petroni - Role: CONTACT Country: Italy Facility: IRCCS-S. Orsola-Malpighi Hospital, University of Bologna, Status: RECRUITING #### Overall Officials Official 1: Affiliation: University of Bologna Name: Elena Tomba Role: STUDY_DIRECTOR Official 2: Affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna Name: Maria Letizia Petroni Role: PRINCIPAL_INVESTIGATOR ### References Module #### References Citation: GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12. PMID: 28604169 Citation: Aguera Z, Lozano-Madrid M, Mallorqui-Bague N, Jimenez-Murcia S, Menchon JM, Fernandez-Aranda F. A review of binge eating disorder and obesity. Neuropsychiatr. 2021 Jun;35(2):57-67. doi: 10.1007/s40211-020-00346-w. Epub 2020 Apr 28. PMID: 32346850 Citation: Alimoradi Z, Golboni F, Griffiths MD, Brostrom A, Lin CY, Pakpour AH. Weight-related stigma and psychological distress: A systematic review and meta-analysis. Clin Nutr. 2020 Jul;39(7):2001-2013. doi: 10.1016/j.clnu.2019.10.016. Epub 2019 Oct 31. PMID: 31732288 Citation: Bischoff SC, Boirie Y, Cederholm T, Chourdakis M, Cuerda C, Delzenne NM, Deutz NE, Fouque D, Genton L, Gil C, Koletzko B, Leon-Sanz M, Shamir R, Singer J, Singer P, Stroebele-Benschop N, Thorell A, Weimann A, Barazzoni R. Towards a multidisciplinary approach to understand and manage obesity and related diseases. Clin Nutr. 2017 Aug;36(4):917-938. doi: 10.1016/j.clnu.2016.11.007. Epub 2016 Nov 16. PMID: 27890486 Citation: Bottesi G, Ghisi M, Altoe G, Conforti E, Melli G, Sica C. The Italian version of the Depression Anxiety Stress Scales-21: Factor structure and psychometric properties on community and clinical samples. Compr Psychiatry. 2015 Jul;60:170-81. doi: 10.1016/j.comppsych.2015.04.005. Epub 2015 Apr 15. PMID: 25933937 Citation: Brantley PJ, Stewart DW, Myers VH, Matthews-Ewald MR, Ard JD, Coughlin JW, Jerome GJ, Samuel-Hodge C, Lien LF, Gullion CM, Hollis JF, Svetkey LP, Stevens VJ. Psychosocial predictors of weight regain in the weight loss maintenance trial. J Behav Med. 2014 Dec;37(6):1155-68. doi: 10.1007/s10865-014-9565-6. Epub 2014 Apr 11. PMID: 24722826 Citation: Castelnuovo G, Pietrabissa G, Manzoni GM, Corti S, Ceccarini M, Borrello M, Giusti EM, Novelli M, Cattivelli R, Middleton NA, Simpson SG, Molinari E. Chronic care management of globesity: promoting healthier lifestyles in traditional and mHealth based settings. Front Psychol. 2015 Oct 15;6:1557. doi: 10.3389/fpsyg.2015.01557. eCollection 2015. PMID: 26528215 Citation: Chu DT, Minh Nguyet NT, Dinh TC, Thai Lien NV, Nguyen KH, Nhu Ngoc VT, Tao Y, Son LH, Le DH, Nga VB, Jurgonski A, Tran QH, Van Tu P, Pham VH. An update on physical health and economic consequences of overweight and obesity. Diabetes Metab Syndr. 2018 Nov;12(6):1095-1100. doi: 10.1016/j.dsx.2018.05.004. Epub 2018 May 5. PMID: 29799416 Citation: da Luz FQ, Hay P, Touyz S, Sainsbury A. Obesity with Comorbid Eating Disorders: Associated Health Risks and Treatment Approaches. Nutrients. 2018 Jun 27;10(7):829. doi: 10.3390/nu10070829. PMID: 29954056 Citation: Dakanalis A, Zanetti MA, Clerici M, Madeddu F, Riva G, Caccialanza R. Italian version of the Dutch Eating Behavior Questionnaire. Psychometric proprieties and measurement invariance across sex, BMI-status and age. Appetite. 2013 Dec;71:187-95. doi: 10.1016/j.appet.2013.08.010. Epub 2013 Aug 30. PMID: 23994503 Citation: Fava GA. Well-being therapy: Treatment manual and clinical applications. Karger Medical and Scientific Publishers. 2016 Citation: Fava GA. Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5. No abstract available. PMID: 27043240 Citation: Fischer M, Oberander N, Weimann A. Four main barriers to weight loss maintenance? A quantitative analysis of difficulties experienced by obese patients after successful weight reduction. Eur J Clin Nutr. 2020 Aug;74(8):1192-1200. doi: 10.1038/s41430-020-0559-x. Epub 2020 Jan 30. PMID: 32001814 Citation: Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007 Feb 1;61(3):348-58. doi: 10.1016/j.biopsych.2006.03.040. Epub 2006 Jul 3. Erratum In: Biol Psychiatry. 2012 Jul 15;72(2):164. PMID: 16815322 Citation: Kantartzis K, Machann J, Schick F, Rittig K, Machicao F, Fritsche A, Haring HU, Stefan N. Effects of a lifestyle intervention in metabolically benign and malign obesity. Diabetologia. 2011 Apr;54(4):864-8. doi: 10.1007/s00125-010-2006-3. Epub 2010 Dec 21. PMID: 21174075 Citation: Kawasaki Y, Nagao-Sato S, Yoshii E, Akamatsu R. Integrated consumers' sustainable and healthy dietary behavior patterns: Associations between demographics, psychological factors, and meal preparation habits among Japanese adults. Appetite. 2023 Jan 1;180:106353. doi: 10.1016/j.appet.2022.106353. Epub 2022 Oct 26. PMID: 36309231 Citation: Lillis J, Kendra KE. Acceptance and Commitment Therapy for weight control: Model, evidence, and future directions. J Contextual Behav Sci. 2014 Jan;3(1):1-7. doi: 10.1016/j.jcbs.2013.11.005. PMID: 25419510 Citation: Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. PMID: 7726811 Citation: Mantzios M, Egan HH. On the Role of Self-compassion and Self-kindness in Weight Regulation and Health Behavior Change. Front Psychol. 2017 Feb 16;8:229. doi: 10.3389/fpsyg.2017.00229. eCollection 2017. No abstract available. PMID: 28261147 Citation: Manzoni GM, Cribbie RA, Villa V, Arpin-Cribbie CA, Gondoni L, Castelnuovo G. Psychological well-being in obese inpatients with ischemic heart disease at entry and at discharge from a four-week cardiac rehabilitation program. Front Psychol. 2010 Aug 3;1:38. doi: 10.3389/fpsyg.2010.00038. eCollection 2010. PMID: 21833207 Citation: Popkin BM, Ng SW. The nutrition transition to a stage of high obesity and noncommunicable disease prevalence dominated by ultra-processed foods is not inevitable. Obes Rev. 2022 Jan;23(1):e13366. doi: 10.1111/obr.13366. Epub 2021 Oct 10. PMID: 34632692 Citation: Ruini C, Ottolini F, Rafanelli C, Ryff CD, Fava GA. La validazione italiana delle Psychological Well-being Scales (PWB). Rivista di psichiatria. 2003; 38(3): 117-130. Citation: Ryff CD, Singer B. Psychological well-being: meaning, measurement, and implications for psychotherapy research. Psychother Psychosom. 1996;65(1):14-23. doi: 10.1159/000289026. PMID: 8838692 Citation: Sarwer DB, Allison KC, Wadden TA, Ashare R, Spitzer JC, McCuen-Wurst C, LaGrotte C, Williams NN, Edwards M, Tewksbury C, Wu J. Psychopathology, disordered eating, and impulsivity as predictors of outcomes of bariatric surgery. Surg Obes Relat Dis. 2019 Apr;15(4):650-655. doi: 10.1016/j.soard.2019.01.029. Epub 2019 Feb 23. PMID: 30858009 Citation: Sharma M. Behavioural interventions for preventing and treating obesity in adults. Obes Rev. 2007 Sep;8(5):441-9. doi: 10.1111/j.1467-789X.2007.00351.x. PMID: 17716301 Citation: Taylor C, Webb TL, Sheeran P. 'I deserve a treat!': justifications for indulgence undermine the translation of intentions into action. Br J Soc Psychol. 2014 Sep;53(3):501-20. doi: 10.1111/bjso.12043. Epub 2013 Jul 15. PMID: 23855962 Citation: Teixeira PJ, Going SB, Houtkooper LB, Cussler EC, Metcalfe LL, Blew RM, Sardinha LB, Lohman TG. Pretreatment predictors of attrition and successful weight management in women. Int J Obes Relat Metab Disord. 2004 Sep;28(9):1124-33. doi: 10.1038/sj.ijo.0802727. PMID: 15263921 Citation: Turton R, Chami R, Treasure J. Emotional Eating, Binge Eating and Animal Models of Binge-Type Eating Disorders. Curr Obes Rep. 2017 Jun;6(2):217-228. doi: 10.1007/s13679-017-0265-8. PMID: 28434108 Citation: Van Strien T, Frijters JE, Bergers GP, Defares PB. The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. International journal of eating disorders. 1986; 5(2): 295-315. Citation: Vallis M. Quality of life and psychological well-being in obesity management: improving the odds of success by managing distress. Int J Clin Pract. 2016 Mar;70(3):196-205. doi: 10.1111/ijcp.12765. Epub 2016 Feb 4. PMID: 26842304 Citation: Webber KH, Casey EM, Mayes L, Katsumata Y, Mellin L. A comparison of a behavioral weight loss program to a stress management program: A pilot randomized controlled trial. Nutrition. 2016 Jul-Aug;32(7-8):904-9. doi: 10.1016/j.nut.2016.01.008. Epub 2016 Jan 21. PMID: 27138110 Citation: Zhu B, Gostoli S, Benasi G, Patierno C, Petroni ML, Nuccitelli C, Marchesini G, Fava GA, Rafanelli C. Promoting weight loss and psychological well-being in patients with obesity: A sequential combination of behavioural lifestyle intervention and well-being therapy. Clin Psychol Psychother. 2023 Mar;30(2):422-435. doi: 10.1002/cpp.2806. Epub 2022 Dec 20. PMID: 36436883 ## Document Section ### Large Document Module #### Large Docs - Date: 2023-11-21 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 388430 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-09T04:23 ## 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 ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416202 Acronym: HybridRam Brief Title: Closed Loop Pumps vs. Traditional Open Loop Pumps in Managing Blood Glucose Levels in T1DM Patients Fasting in Ramadan. Official Title: Comparative Efficacy of Advanced Hybrid Closed Loop (AHCL) Therapy Versus Open-Loop Insulin Delivery (OLID) System in Type 1 Diabetes Management During Ramadan: A Randomized Controlled Trial #### Organization Study ID Info ID: IRB00010471 #### Organization Class: OTHER_GOV Full Name: King Fahad Medical City #### Secondary ID Infos Domain: Federal Wide Assurance NlH, US ID: FWA00018774 Type: OTHER ### Status Module #### Completion Date Date: 2024-06-29 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-20 Type: ACTUAL Last Update Submit Date: 2024-05-16 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2024-03-11 Type: ACTUAL #### Start Date Date: 2024-02-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-16 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER_GOV Name: King Fahad Medical City #### Responsible Party Investigator Affiliation: King Fahad Medical City Investigator Full Name: Nouf Aboalsamh Investigator Title: Principal Investigator Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: True Oversight Has DMC: True ### Description Module Brief Summary: Our proposed study aims to build upon the existing findings by conducting a first-of-its-kind randomized controlled trial (RCT) that directly compares Advanced Hybrid Closed Loop (AHCL) and open-loop insulin delivery (OLID) systems during Ramadan. This comparison is crucial for understanding the nuanced benefits and potential limitations of each system in the context of Ramadan fasting, a topic not yet explored in RCT settings. By undertaking this study, we intend to bridge this gap in research, providing valuable insights into the effectiveness of these contrasting insulin delivery methods. The outcomes of this research could significantly inform clinical recommendations for T1DM management during Ramadan, emphasizing the importance of personalized treatment approaches that are aligned with patient needs and technological advancements. Detailed Description: A Multi-center, randomized controlled trial will be conducted at King Fahad Medical City and Prince Sultan Military Medical City Participants were randomly assigned to either the control group (OLID) or one of the intervention groups (AHCL). Stratified randomization will be used according to age (\<18 and ≥18 years) and HbA1c (\<8.5% and ≥8.5%) to avoid overrepresentation of certain age or glycemic control groups. All groups will receive comprehensive diabetes education and extensive carbohydrate counting training. Continuous glucose monitoring (CGM) will be conducted using the Guardian 4 sensor or Dexcom G6 for the intervention group depending on the type of pump used. The control group will continue using their current CGM device. Data on glycemic control, hypoglycemic events, and patient satisfaction will be collected before and throughout Ramadan. Additionally, fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control. The investigators compared between groups in terms of the number of fasting days out of the entire month and the number of days in which participants break their fast due to diabetes-related reasons. Days when female participants do not fast due to their menstrual period will not be counted as days of fasting break for the purposes of this analysis. Sociodemographic data, laboratory investigations, and relevant clinical data will be collected from the Electronic Health Record (EHR). CGM metrics including Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), Glucose Management Indicator (GMI), and Coefficient of Variation (COV) will be gathered. Fructosamine levels will also be measured to assess the immediate past 2 weeks' glycemic control. A survey for diabetes distress and quality of life will be filled by the participants prior to the study. The same CGM metrics will be collected. Insulin data including total daily dose (TDD) and percentage of basal insulin and meal boluses will be obtained. Fructosamine levels will be measured again at the end of the study to compare with the baseline measurements. This will provide a detailed assessment of the glycemic control changes specifically during Ramadan. The quality of life and diabetes distress surveys will be refilled at the end of the study. HbA1c levels will also be collected at the end of the study for a comprehensive assessment of the glycemic control during Ramadan. Statistical Analysis: The sample size was calculated using the confidence interval method. Statistical analyses will include comparative evaluations of HbA1c levels, hypoglycemia incidence, and patient-reported outcomes. Assuming change in time of range by 12%, power: 80% and alpha error of 5%, sample size was calculated at 25 for each group. However, we are planning to include the maximum patients we could recruit to account for the possible patients drop out. ### Conditions Module Conditions: - Insulin Pump Therapy ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: A multi-center, randomized controlled trial will be conducted at King Fahad Medical City \& Prince Sultan Military Medical City. The study will involve two intervention groups and one control group: one receiving open-loop insulin delivery (OLID) and the others receiving Advanced Hybrid Closed Loop (AHCL) Therapy. Participants will be randomly assigned to either the control group (OLID) or one of the intervention groups (AHCL). Stratified randomization will be used according to age (\<18 and ≥18 years) and HbA1c (\<8.5% and ≥8.5%) to avoid overrepresentation of certain age or glycemic control groups. ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 75 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients with Type 1 Diabetes (T1D) on OLID, who observe Ramadan fasting. Intervention Names: - Other: Open Loop Insulin Delivery system Label: Open loop insulin delivery Type: OTHER #### Arm Group 2 Description: AHCL system (Medtronic MiniMed 780G or Tandem T-slim x2 pump). Intervention Names: - Device: Advanced hybrid closed loop insulin pump Label: Advanced Hybrid Closed loop system Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Advanced Hybrid Closed loop system Description: All groups will receive comprehensive diabetes education and extensive carbohydrate counting training. Continuous glucose monitoring (CGM) will be conducted using the Guardian 4 sensor or Dexcom G6 for the intervention group depending on the type of pump used. fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control. Name: Advanced hybrid closed loop insulin pump Other Names: - AHCL Type: DEVICE #### Intervention 2 Arm Group Labels: - Open loop insulin delivery Description: the control group will continue using their current CGM device. Data on glycemic control, hypoglycemic events, and patient satisfaction will be collected before and throughout Ramadan. Additionally, fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control. Name: Open Loop Insulin Delivery system Other Names: - OLID Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Assessment of the effectiveness and safety of Insulin Pump Therapy with AHCL vs OLID during fasting in terms of Time below range(glucose level \<50mg/dL) in percentage or Time above range in percent (glucose level \>180 mg/dL) and Time in range (75-180mg/dL) on CGM Measure: Frequencies of Hypoglycemic and Hyperglycemic events during Ramadan fasting in individuals with type 1 diabetes who use AHCL to control their blood glucose levels compared to those using conventional OLID methods. Time Frame: From enrollment to the end of treatment at 12 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Type 1 diabetes as per the American Diabetes Association classification for at least 1 year. * Age 14 to 70. * OLID therapy for at least 6 months. * Willingness and ability to adhere to the study protocol. Exclusion Criteria: * Pregnancy. * Using medications that affect blood glucose like steroids. * Patients who are not able to fast for the entire month of Ramadan due to medical or non-medical reasons. Maximum Age: 70 Years Minimum Age: 14 Years Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Riyadh Country: Saudi Arabia Facility: King Fahad Medical City State: Riyadh Province Zip: 11525 #### Overall Officials Official 1: Affiliation: King Fahad Medical City Name: Mohammed AlMehthel, Consultant Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Wannes S, Gamal GM, Fredj MB, Al Qusayer D, El Abed S, Sedky Y, Khalil M. Glucose control during Ramadan in a pediatric cohort with type 1 diabetes on MiniMed standard and advanced hybrid closed-loop systems: A pilot study. Diabetes Res Clin Pract. 2023 Sep;203:110867. doi: 10.1016/j.diabres.2023.110867. Epub 2023 Aug 4. PMID: 37544364 Citation: Elbarbary NS, Ismail EAR. Glycemic control during Ramadan fasting in adolescents and young adults with type 1 diabetes on MiniMed 780G advanced hybrid closed-loop system: A randomized controlled trial. Diabetes Res Clin Pract. 2022 Sep;191:110045. doi: 10.1016/j.diabres.2022.110045. Epub 2022 Aug 17. PMID: 35987309 Citation: Alamoudi R, Alsubaiee M, Alqarni A, Saleh Y, Aljaser S, Salam A, Eledrisi M. Comparison of Insulin Pump Therapy and Multiple Daily Injections Insulin Regimen in Patients with Type 1 Diabetes During Ramadan Fasting. Diabetes Technol Ther. 2017 Jun;19(6):349-354. doi: 10.1089/dia.2016.0418. Epub 2017 Mar 15. PMID: 28296467 Citation: Al Awadi FF, Echtay A, Al Arouj M, Sabir Ali S, Shehadeh N, Al Shaikh A, Djaballah K, Dessapt-Baradez C, Omar Abu-Hijleh M, Bennakhi A, El Hassan Gharbi M, El Sayed El Hadidy K, Abdul Kareem Khazaal F, Hassanein MM. Patterns of Diabetes Care Among People with Type 1 Diabetes During Ramadan: An International Prospective Study (DAR-MENA T1DM). Adv Ther. 2020 Apr;37(4):1550-1563. doi: 10.1007/s12325-020-01267-4. Epub 2020 Mar 6. PMID: 32144714 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: HIGH - As Found: Day 1 - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M17768 - Name: Zinc - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin - ID: C000557859 - Term: Insulin, Globin Zinc ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416189 Brief Title: Teeth Decrowding With and Without Fixed Appliances Official Title: The Decrowding Rate Post Premolar Extraction With and Without Fixed Appliance: Randomized Controlled Trial #### Organization Study ID Info ID: Ortho-0001 #### Organization Class: OTHER Full Name: Samer Mheissen ### Status Module #### Completion Date Date: 2024-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-08-30 Type: ESTIMATED #### Start Date Date: 2024-02-02 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-01-26 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Samer Mheissen #### Responsible Party Investigator Affiliation: Samer Mheissen Investigator Full Name: Samer Mheissen Investigator Title: Researcher Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: In orthodontics, the teeth tend to move to the extraction space. This tooth movement becomes of larger importance when there is a crowding. During the COVID lockdown period, It was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation. Detailed Description: In this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces. ### Conditions Module Conditions: - Tooth Crowding ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Two groups; one with fixed braces and one without fixed braces. ##### Masking Info Masking: DOUBLE Masking Description: The two groups will have lingual arches. However, patients without braces will not be informed about their braces before 5 months of trial initiation. Who Masked: - PARTICIPANT - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 40 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Fixed appliance would be bonded post teeth extraction (premolars). subsequently, leveling and alignment using sequence of archwires would be followed. The measurements would be done using models each month. Intervention Names: - Device: Fixed appliances Label: Braces Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: Extraction of premolars and only observing the case over time. The measurements would be done using models each month. Label: Without braces Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Braces Description: MBT Brackets 0.022 inch Name: Fixed appliances Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: The cumulative before extraction and space closure for 4 months (mean difference before and after).. Measure: Anterior teeth alignment every 4 weeks at each time point. Time Frame: 6 months #### Secondary Outcomes Description: The anchorage loss of molars will be measured over time using the models. Measure: Molar anchorage loss at each time point. Time Frame: 6 months Description: this will be measured by visual inspection intraorally. Measure: Gingival invagination Time Frame: 9 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: - Patients with permanent dentition between age group of 13 - 30 years. * Maxillary or mandibular crowding \>4.1mm and requiring extraction of maxillary first premolars or mandibular first premolars. The crowding will be measured using a caliper one cast models. * Fully erupted teeth from 1st molar to the 1st molar. * Patients with periodontally sound dentition. * Patients with good general health. No previous history of extraction or orthodontic tooth movement. Exclusion Criteria: * Cases requiring orthognathic surgery. * History of systemic and medical illness. * Contraindication of extraction. * Previous history of orthodontic treatment. * Poor oral hygiene. * Nickel allergy. Healthy Volunteers: True Maximum Age: 30 Years Minimum Age: 13 Years Sex: ALL Standard Ages: - CHILD - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: mheissen@yahoo.com Name: Samer Mheissen, orthodontics Phone: 00962795710426 Role: CONTACT Contact 2: Email: drhariskhan@gmail.com Name: Haris Khan, PhD Role: CONTACT #### Locations Location 1: City: Amman Contacts: *Contact 1:* - Email: hna987@hotmail.com - Name: Hanan Habarneh, DDS - Phone: +962 7 7233 6009 - Role: CONTACT Country: Jordan Facility: Medical Services Status: RECRUITING Zip: 00962 #### Overall Officials Official 1: Affiliation: Private Practice Name: Samer Mheissen, DDS Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Info Types: - STUDY_PROTOCOL - SAP IPD Sharing: YES Time Frame: 12 months ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11301 - Name: Malocclusion - Relevance: HIGH - As Found: Tooth Crowding - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008310 - Term: Malocclusion ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416176 Brief Title: The Effect of a Mindfulness-Based Stress Reduction Program in Patients With Multiple Sclerosis Official Title: The Effect of a Mindfulness-Based Stress Reduction Program On Fatigue, Self-Efficacy And Stress in Patients With Multiple Sclerosis: A Randomized Controlled Trial #### Organization Study ID Info ID: Acetinkaya002 #### Organization Class: OTHER Full Name: Halic University ### Status Module #### Completion Date Date: 2020-11-15 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: COMPLETED #### Primary Completion Date Date: 2020-10-01 Type: ACTUAL #### Start Date Date: 2020-07-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-08 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Halic University #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: The aim of this study is to investigate the effect of an mindfulness-based stress reduction (MBSR) program designed in accordance with the literature and the basic principles of the program on fatigue, self-efficacy and stress for individuals with multiple sclerosis (MS). Thirty members of the Multiple Sclerosis Society with multiple sclerosis were randomized as experimental and control groups. Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Outcome measurements consisted of Fatigue Impact Scale (FIS), Self-Efficacy Scale and Perceived Stress Scale. Detailed Description: The use of mindfulness-based interventions to reduce fatigue in individuals with MS is supported by meta-analytic evidence. A systematic review concluded that mindfulness-based interventions effectively improves the quality of life in MS patients. To characterize the best formatting, mechanisms of action, and outcomes in MS patients with a wider range of social, educational, and clinical backgrounds, more research is necessary. Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. Each meeting were planned as a 3-hour session that completes the mindfulness training procedures by doing an opening meditation of 30- 45 minutes about that week, after the information about the meeting topic of the week is discussed. Experiences after meditation were shared with the group. Each week, the meeting topic and meditation continued with different contents, and practice meditations on the subject were held every week and home exercises were given. Home practice meditations were performed by listening to the guide audio recording with headphones. All home exercises in the training content were followed up on a daily basis and recorded. The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Furthermore, the control group received an invitation to participate in an identical MBSR program session following the study's conclusion. ### Conditions Module Conditions: - Multiple Sclerosis - Mindfulness - Upper Motor Neuron Lesion Keywords: - Mindfulness - Multiple sclerosis - Fatigue - Self-efficacy ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: TREATMENT #### Enrollment Info Count: 30 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. Intervention Names: - Other: Mindfulness-Based Stress Reduction (MBSR) Program Label: Experimental group Type: EXPERIMENTAL #### Arm Group 2 Description: The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Furthermore, the control group received an invitation to participate in an identical MBSR program session following the study's conclusion. Label: Control group Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Experimental group Description: Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. Each meeting were planned as a 3-hour session that completes the mindfulness training procedures by doing an opening meditation of 30- 45 minutes about that week, after the information about the meeting topic of the week is discussed. Experiences after meditation were shared with the group. Each week, the meeting topic and meditation continued with different contents, and practice meditations on the subject were held every week and home exercises were given. Home practice meditations were performed by listening to the guide audio recording with headphones. All home exercises in the training content were followed up on a daily basis and recorded. Name: Mindfulness-Based Stress Reduction (MBSR) Program Type: OTHER ### Outcomes Module #### Primary Outcomes Description: It is a multidimensional fatigue scale that is frequently used in clinical and experimental investigations to assess the impact of fatigue on the body, mind, and social interactions. Measure: Fatigue Impact Scale Time Frame: at baseline and at week 8 Description: The scale, which does not belong to any subjective domain, measures the general perception of self-efficacy. Measure: Self-Efficacy Scale Time Frame: at baseline and at week 8 Description: The scale was developed by Cohen et al in 1983 . Consisting of 14 items in total, Perceived Stress Scale is designed to measure how stressful a person's life is perceived by certain situations. Measure: Perceived Stress Scale Time Frame: at baseline and at week 8 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * diagnosis of relapsing-remitting MS or progressive MS * over 18 years of age, * neurologist confirmed diagnosis of MS, * a score of less than or equal to 7.0 on the Expanded Disability Status Scale (EDSS). Exclusion Criteria: * comorbidities with life-threatening physical or mental health (such as active psychosis, suicidal ideation, or terminal or life-threatening co-occurring medical diseases), or disorders that are predicted to severely restrict participation and adherence (e.g., dementia, pregnancy, ongoing substance abuse); * individuals who are presently undergoing non-pharmacological psychological treatments or prior formal training in mindfulness Maximum Age: 65 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Istanbul Country: Turkey Facility: Halic University State: Eyüpsultan Zip: 34060 #### Overall Officials Official 1: Affiliation: Halic University Name: İrem Çetinkaya, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416163 Acronym: FIBRINOX-EXTRA Brief Title: FIBRotic Interstitial Lung Disease With Nocturnal hypOXaemia and EXercise Induced desaTuRAtion Official Title: A Prospective Observational Study Investigating Whether Nocturnal Hypoxaemia and Exercise Induced Desaturation Predict Functional Deterioration in Patients With Fibrotic Interstitial Lung Disease #### Organization Study ID Info ID: 329843 #### Organization Class: OTHER Full Name: Guy's and St Thomas' NHS Foundation Trust ### Status Module #### Completion Date Date: 2029-07-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2028-10-01 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-01-19 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: Boehringer Ingelheim #### Lead Sponsor Class: OTHER Name: Guy's and St Thomas' NHS Foundation Trust #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This is an observational clinical research study investigating patients with fibrotic interstitial lung disease (fILD), also known as pulmonary fibrosis. It is not known why some patients with fILD clinically deteriorate. This study will investigate whether measuring oxygen levels during sleep or exercise can help identify patients who are at increased risk of clinical deterioration. Detailed Description: This work will build upon the FIBRINOX study, previous clinical research conducted by the Guy's and St Thomas' ILD research team. The FIBRINOX study showed that patients with fILD and normal oxygen saturations at rest, but who desaturate whilst asleep or during exercise, have a significantly increased mortality and greater reduction in quality of life compared to patients who do not desaturate at night or during exercise. The reasons for these differences in mortality and health related quality of life are not known. Data suggests that worsening fILD and the development of pulmonary hypertension, a condition characterised by increased pressure in the pulmonary arteries that is associated with poorer outcomes, may be playing a role. This clinical research study will recruit approximately 160 patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease (fILD). Data from routinely performed investigations as part of tertiary ILD assessment will be systematically recorded. Investigations will include lung function tests, echocardiography, blood tests, a 6-minute walk test and overnight oximetry. Participants will also complete several quality-of-life questionnaires. These investigations will be performed at baseline, and again at 12 months, with all tests also repeated at 6 months except for an echocardiogram. After the initial 1 year study period, a 3 year post-recruitment mortality and right heart catheter check will be performed using the participants' medical records. Data will be collected from CT scans and right heart catheters if performed during the study period as part of the participants usual clinical care. This study is designed to establish whether patients with fILD who desaturate during sleep or exercise are more likely to experience functional decline, as well as confirm previous findings of increased mortality and worsening quality of life as demonstrated in the FIBRINOX study. The data generated by this observational study will help generate future hypotheses, research questions and clinical study. ### Conditions Module Conditions: - Interstitial Lung Disease - Fibrosis Lung - Pulmonary Hypertension ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 160 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: All participants will be in one group which is the collection of retrospective data Intervention Names: - Other: Prospective Label: Retrospective ### Interventions #### Intervention 1 Arm Group Labels: - Retrospective Description: Collection of prospective data all ready available for participant Name: Prospective Type: OTHER ### Outcomes Module #### Primary Outcomes Description: As measured by 6-minute walk test Measure: Change in 6-minute walk distance Time Frame: 52 weeks #### Secondary Outcomes Description: If death occurs during the study period, and the cause of death Measure: Mortality Time Frame: 52 and 156 weeks Description: Defined by: decline in forced vital capacity (FVC) \>10% or death Measure: Clinical deterioration Time Frame: 52 weeks Description: Decline in forced vital capacity Measure: Decline in FVC Time Frame: 52 weeks Description: Decline in total diffusing capacity of the lungs for carbon monoxide Measure: Decline in TLCO Time Frame: 52 weeks Description: Right heart catheter confirmed pulmonary hypertension Measure: Pulmonary hypertension Time Frame: 52 and 156 weeks Description: Arterialised capillary blood gas partial pressure of oxygen Measure: Change in arterialised capillary blood gas pO2 Time Frame: 52 weeks Description: Arterialised capillary blood gas oxygen saturations Measure: Change in arterialised capillary blood gas oxygen saturations Time Frame: 52 weeks Description: Arterialised capillary blood gas partial pressure of carbon dioxide Measure: Change in arterialised capillary blood gas pCO2 Time Frame: 52 weeks Description: Arterialised capillary blood gas partial pressure of bicarbonate Measure: Change in arterialised capillary blood gas HCO3 Time Frame: 52 weeks Description: Arterialised capillary blood gas pH Measure: Change in arterialised capillary blood gas pH Time Frame: 52 weeks Description: The number of days until the participant requires hospital admission for an acute worsening of their respiratory condition, not attributable to other causes Measure: Time to first acute exacerbation of fILD Time Frame: 52 weeks Description: The number of times the participant requires hospital admission for an acute worsening of their respiratory condition, not attributable to other causes Measure: Rate of acute exacerbation of fILD Time Frame: 52 weeks Description: Change in NT-proBNP/BNP level from baseline Measure: Change in NT-proBNP/BNP level Time Frame: 52 weeks Description: Change in troponin level from baseline Measure: Change in troponin level Time Frame: 52 weeks Description: Change in peak tricuspid regurgitation velocity (TRV) Measure: Change in peak TRV Time Frame: 52 weeks Description: Change in cardiac chamber size/area Measure: Change in cardiac chamber size/area Time Frame: 52 weeks Description: Change in cardiac chamber area Measure: Change in cardiac chamber area Time Frame: 52 weeks Description: Change in right ventricle to left ventricle basal diameter area ratio Measure: Change in RV/LV basal diameter area ratio Time Frame: 52 weeks Description: Change in main pulmonary artery to ascending aorta diameter ratio Measure: Change in MPA:AA diameter ratio Time Frame: 52 weeks Description: Change in tricuspid annular plane systolic excursion to systolic pulmonary artery pressure ratio Measure: Change in TAPSE/sPAP ratio Time Frame: 52 weeks Description: Change in score of European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) questionnaire Measure: Change in European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) questionnaire score Time Frame: 52 weeks Description: Change in score of King's Brief Interstitial Lung Disease (KBILD) questionnaire Measure: Change in King's Brief Interstitial Lung Disease (KBILD) questionnaire score Time Frame: 52 weeks Description: Change in score of Living with Pulmonary Fibrosis (L-IPF) questionnaire Measure: Change in Living with Pulmonary Fibrosis (L-IPF) questionnaire score Time Frame: 52 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Patients aged 18 year and over 2. Tertiary MDT diagnosis of FILD with \>10% fibrosis on CT chest as determined by the investigator. Underlying diagnoses to include but not limited to: idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), connective tissue disease-related interstitial lung disease (CTD-ILD), fibrotic organising pneumonia (FOP) and pulmonary sarcoidosis. 3. Able to provide informed written consent Exclusion Criteria: 1. The use of or any indication for long-term oxygen therapy (LTOT) 2. Known moderate or severe obstructive sleep apnoea with an apnoea/hypopnoea index (AHI) or oxygen desaturation index (ODI) over 15 events per hour 3. Radiological predominance of emphysema compared with fibrosis on CT chest 4. Inability to complete all health status questionnaires as set out in this protocol, with appropriate support 5. A confirmed diagnosis of pulmonary hypertension 6. Significant cardiovascular comorbidity including severe, uncontrolled hypertension, uncontrolled arrhythmia, recent acute coronary syndrome within 30 days prior to study enrolment, that could mean exercise testing poses a risk to patient health, in the opinion of the investigator 7. Musculoskeletal comorbidity that will preclude the participant's ability to reliably complete the complete 6-minute walk test (6MWT) 8. Participation in another research project which may confound this study's research findings Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease ### Contacts Locations Module #### Central Contacts Contact 1: Email: alexandra.lawrence@gstt.nhs.uk Name: Alexandra Lawrence, MBBS Phone: 02071887188 Phone Ext: 58207 Role: CONTACT Contact 2: Email: gillian.radcliffe@gstt.nhs.uk Name: Gillian Radcliffe, BSc Phone: 07395285492 Phone Ext: 88070 Role: CONTACT #### Locations Location 1: City: London Country: United Kingdom Facility: Guy's & St Thomas' NHS Foundation Trust Zip: SE1 9RT #### Overall Officials Official 1: Affiliation: Guys and St. Thomas NHS Foundation Hospital Name: Alex West, MBBS Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: No individual participant data will be shared or made available to researchers outside of the site research team where the patient is based, and GSTT ILD research team. IPD Sharing: NO ### References Module #### References Citation: Myall KJ, West AG, Martinovic JL, Lam JL, Roque D, Wu Z, Maher TM, Molyneaux PL, Suh ES, Kent BD. Nocturnal Hypoxemia Associates With Symptom Progression and Mortality in Patients With Progressive Fibrotic Interstitial Lung Disease. Chest. 2023 Nov;164(5):1232-1242. doi: 10.1016/j.chest.2023.05.013. Epub 2023 May 13. PMID: 37187434 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006973 - Term: Hypertension - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000005355 - Term: Fibrosis - ID: D000010335 - Term: Pathologic Processes - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - 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: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Lung Disease - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown - ID: M10027 - Name: Hypertension, Pulmonary - Relevance: HIGH - As Found: Pulmonary Hypertension - ID: M19813 - Name: Lung Diseases, Interstitial - Relevance: HIGH - As Found: Interstitial Lung Disease - ID: M14512 - Name: Pulmonary Fibrosis - Relevance: HIGH - As Found: Fibrosis Lung - ID: M4185 - Name: Hypoxia - Relevance: HIGH - As Found: Hypoxemia - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000006976 - Term: Hypertension, Pulmonary - ID: D000017563 - Term: Lung Diseases, Interstitial - ID: D000011658 - Term: Pulmonary Fibrosis - ID: D000000860 - Term: Hypoxia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416150 Brief Title: Reducing Urban Cervical Cancer Disparities Official Title: Reducing Urban Cervical Cancer Disparities Using a Tailored mHealth Intervention to Enhance Colposcopy Attendance #### Organization Study ID Info ID: 23-1035 #### Organization Class: OTHER Full Name: Fox Chase Cancer Center ### Status Module #### Completion Date Date: 2027-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2027-04 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-09 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Rutgers, The State University of New Jersey Class: OTHER Name: Thomas Jefferson University Class: OTHER Name: Temple University Class: OTHER Name: University of South Carolina #### Lead Sponsor Class: OTHER Name: Fox Chase Cancer Center #### 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 uses a hybrid Type 1 effectiveness-implementation trial to operationalize and assess the efficacy of the Health Enhancement Resource System (HERS) intervention. HERS aims to increase patient follow-up after abnormal test results through text message-based barriers counseling for women and supplemental telephone-based Health Coaching for women who miss their appointment. Detailed Description: Invasive cervical cancer is preventable with well-established screening and diagnostic tests. However, there is a large and persistent disparity gap in cervical cancer mortality rates among urban, underserved populations that continues to intensify. This gap is largely due to low follow-up after an abnormal test result leading to continued disease risk. The study team developed an efficacious, tailored telephone counseling intervention delivered by a health coach \[Tailored Communication for Cervical Cancer Risk (TC3)\] that increased attendance at follow-up appointments for initial colposcopy among urban, underserved women. This evidence-based intervention is available for dissemination and implementation through the National Cancer Institute's Evidence-based Cancer Control Programs database. However, TC3 was developed prior to the upsurge of smartphones and texting usage and is resource-intensive, requiring dedicated staff to interview and counsel patients before their appointment, limiting its scalability and sustainability. Therefore, this study proposes use of a hybrid type 1 effectiveness-implementation study design to assess the impact of a Health Enhancement Resource System (HERS)-adapted from TC3-on attending follow-up appointments after an abnormal cervical test result. Using a sequential, multiple assignment, randomized trial (SMART) design, a multi-site intervention study will be conducted at three high-volume, urban clinic sites in PA and NJ serving predominately low-income minority women: Fox Chase Cancer Center/Temple University Health System; Rutgers University, and Thomas Jefferson University. The study will target patients scheduled for first time or repeat colposcopy through (a) HERS text message-based barriers counseling and (b) supplemental telephone-based Health Coaching for women who miss their scheduled appointment. Participants scheduled for a colposcopy after an abnormal cervical test will be recruited and randomized in a 1:1 ratio to receive either Standard of Care or HERS (text message intervention). Participants randomized to Standard of Care who do not attend the scheduled colposcopy appointment will be assigned to receive HERS. Participants randomized to HERS who do not attend the scheduled colposcopy appointment will be rerandomized to receive either HERS (repeating the text message intervention) or HERS+HC (text plus health coaching). For the 12-month colposcopy appointment, participants will continue with the last intervention assignment they completed for the first colposcopy appointment (i.e., Standard of Care, HERS, or HERS+HC). Again, participants randomized to Standard of Care who do not attend the 12-month scheduled colposcopy appointment will be assigned to receive HERS. Participants randomized to HERS who do not attend the 12-month scheduled colposcopy appointment will be rerandomized to receive either HERS (repeating the text message intervention) or HERS+HC (text plus health coaching). Participants randomized to HERS+HC who do not attend the 12-month scheduled colposcopy appointment will be assigned to repeat HERS+HC. All participants will complete surveys at baseline survey and a 1-week post-appointment survey for both colposcopy appointments. Participants will also complete a barriers assessment. Standard of Care participants will complete the assessment via online survey while HERS and HERS+HC participants will complete the barriers assessment via text message as part of the HERS text message intervention. Qualitative interviews will be completed with providers at each site at pre-implementation and post-implementation. Additionally, a subset of participants will complete exit interviews after their 12-month colposcopy appointment. ### Conditions Module Conditions: - Cervical Cancer - Papilloma Viral Infection ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: SCREENING #### Enrollment Info Count: 546 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Start with Stage 1 Standard of Care; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 Standard of Care; patient attends 12-month follow-up appointment, no Stage 4 intervention. Intervention Names: - Behavioral: Stage 1 SOC - Behavioral: Stage 3 SOC Label: Stage 1 and 3 SoC Type: EXPERIMENTAL #### Arm Group 2 Description: Start with Stage 1 Standard of Care; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 Standard of Care; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Intervention Names: - Behavioral: Stage 1 SOC - Behavioral: Stage 3 SOC - Behavioral: Stage 4 HERS Label: Stage 1 and 3 SoC + Stage 4 HERS Type: EXPERIMENTAL #### Arm Group 3 Description: Start with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. Intervention Names: - Behavioral: Stage 1 SOC - Behavioral: Stage 2 HERS - Behavioral: Stage 3 HERS Label: Stage 1 SoC + Stage 2 and 3 HERS Type: EXPERIMENTAL #### Arm Group 4 Description: Start with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Intervention Names: - Behavioral: Stage 1 SOC - Behavioral: Stage 2 HERS - Behavioral: Stage 3 HERS - Behavioral: Stage 4 HERS Label: Stage 1 SoC + Stage 2, 3, and 4 HERS Type: EXPERIMENTAL #### Arm Group 5 Description: Start with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Intervention Names: - Behavioral: Stage 1 SOC - Behavioral: Stage 2 HERS - Behavioral: Stage 3 HERS - Behavioral: Stage 4 HERS+HC Label: Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC Type: EXPERIMENTAL #### Arm Group 6 Description: Start with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. Intervention Names: - Behavioral: Stage 1 HERS - Behavioral: Stage 3 HERS Label: Stage 1 and 3 HERS Type: EXPERIMENTAL #### Arm Group 7 Description: Start with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Intervention Names: - Behavioral: Stage 1 HERS - Behavioral: Stage 3 HERS - Behavioral: Stage 4 HERS Label: Stage 1, 3, and 4 HERS Type: EXPERIMENTAL #### Arm Group 8 Description: Start with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Intervention Names: - Behavioral: Stage 1 HERS - Behavioral: Stage 3 HERS - Behavioral: Stage 4 HERS+HC Label: Stage 1 and 3 HERS + Stage 4 HERS+HC Type: EXPERIMENTAL #### Arm Group 9 Description: Start with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. Intervention Names: - Behavioral: Stage 1 HERS - Behavioral: Stage 2 HERS - Behavioral: Stage 3 HERS Label: Stage 1, 2, and 3 HERS Type: EXPERIMENTAL #### Arm Group 10 Description: Start with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Intervention Names: - Behavioral: Stage 1 HERS - Behavioral: Stage 2 HERS - Behavioral: Stage 3 HERS - Behavioral: Stage 4 HERS Label: Stage 1, 2, 3, and 4 HERS Type: EXPERIMENTAL #### Arm Group 11 Description: Start with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Intervention Names: - Behavioral: Stage 1 HERS - Behavioral: Stage 2 HERS - Behavioral: Stage 3 HERS - Behavioral: Stage 4 HERS+HC Label: Stage, 2, and 3 HERS + Stage 4 HERS+HC Type: EXPERIMENTAL #### Arm Group 12 Description: Start with Stage 1 HERS intervention, patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS+HC intervention. Continue with Stage 3 HERS+HC intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. Intervention Names: - Behavioral: Stage 1 HERS - Behavioral: Stage 2 HERS+HC - Behavioral: Stage 3 HERS+HC Label: Stage 1 HERS + Stage 2 and 3 HERS+HC Type: EXPERIMENTAL #### Arm Group 13 Description: Start with Stage 1 HERS intervention, patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS+HC intervention. Continue with Stage 3 HERS+HC intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Intervention Names: - Behavioral: Stage 1 HERS - Behavioral: Stage 2 HERS+HC - Behavioral: Stage 3 HERS+HC - Behavioral: Stage 4 HERS+HC Label: Stage 1 HERS + Stage 2, 3, and 4 HERS+HC Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Stage 1 SoC + Stage 2 and 3 HERS - Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC - Stage 1 SoC + Stage 2, 3, and 4 HERS - Stage 1 and 3 SoC - Stage 1 and 3 SoC + Stage 4 HERS Description: Participants will receive high Standard Care, consisting of a telephone call approximately one month before the appointment to confirm the appointment date for the baseline colposcopy appointment, followed by a notification letter including scheduled appointment date and clinic contact information should the clinic be unable to reach the patient by telephone. Name: Stage 1 SOC Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - Stage 1 HERS + Stage 2 and 3 HERS+HC - Stage 1 HERS + Stage 2, 3, and 4 HERS+HC - Stage 1 and 3 HERS - Stage 1 and 3 HERS + Stage 4 HERS+HC - Stage 1, 2, 3, and 4 HERS - Stage 1, 2, and 3 HERS - Stage 1, 3, and 4 HERS - Stage, 2, and 3 HERS + Stage 4 HERS+HC Description: Participants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment. Name: Stage 1 HERS Type: BEHAVIORAL #### Intervention 3 Arm Group Labels: - Stage 1 SoC + Stage 2 and 3 HERS - Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC - Stage 1 SoC + Stage 2, 3, and 4 HERS - Stage 1, 2, 3, and 4 HERS - Stage 1, 2, and 3 HERS - Stage, 2, and 3 HERS + Stage 4 HERS+HC Description: Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages. Name: Stage 2 HERS Type: BEHAVIORAL #### Intervention 4 Arm Group Labels: - Stage 1 HERS + Stage 2 and 3 HERS+HC - Stage 1 HERS + Stage 2, 3, and 4 HERS+HC Description: Participants will receive another barriers assessment and another round of text message barriers counseling as well as health coaching (HC) after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less. Name: Stage 2 HERS+HC Type: BEHAVIORAL #### Intervention 5 Arm Group Labels: - Stage 1 and 3 SoC - Stage 1 and 3 SoC + Stage 4 HERS Description: Participants will receive a telephone call before their 12-month follow-up appointments to remind participants about their upcoming appointment and schedule/reschedule if needed. Name: Stage 3 SOC Type: BEHAVIORAL #### Intervention 6 Arm Group Labels: - Stage 1 SoC + Stage 2 and 3 HERS - Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC - Stage 1 SoC + Stage 2, 3, and 4 HERS - Stage 1 and 3 HERS - Stage 1 and 3 HERS + Stage 4 HERS+HC - Stage 1, 2, 3, and 4 HERS - Stage 1, 2, and 3 HERS - Stage 1, 3, and 4 HERS - Stage, 2, and 3 HERS + Stage 4 HERS+HC Description: Participants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment. Name: Stage 3 HERS Type: BEHAVIORAL #### Intervention 7 Arm Group Labels: - Stage 1 HERS + Stage 2 and 3 HERS+HC - Stage 1 HERS + Stage 2, 3, and 4 HERS+HC Description: Participants will receive text message barriers counseling as well as HC after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less. Name: Stage 3 HERS+HC Type: BEHAVIORAL #### Intervention 8 Arm Group Labels: - Stage 1 SoC + Stage 2, 3, and 4 HERS - Stage 1 and 3 SoC + Stage 4 HERS - Stage 1, 2, 3, and 4 HERS - Stage 1, 3, and 4 HERS Description: Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages. Name: Stage 4 HERS Type: BEHAVIORAL #### Intervention 9 Arm Group Labels: - Stage 1 HERS + Stage 2, 3, and 4 HERS+HC - Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC - Stage 1 and 3 HERS + Stage 4 HERS+HC - Stage, 2, and 3 HERS + Stage 4 HERS+HC Description: Participants will receive another barriers assessment and another round of text message barriers counseling as well as HC. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less. Name: Stage 4 HERS+HC Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Patient attendance or non-attendance at baseline colposcopy appointment assessed via appointment attendance history in electronic medical records Measure: Attendance at baseline colposcopy appointment Time Frame: Up to 3 months post-baseline #### Secondary Outcomes Description: Patient attendance or non-attendance at 12-month follow-up appointment assessed via appointment attendance history in electronic medical records Measure: Attendance at 12-month follow-up appointment Time Frame: Up to 15 months post-baseline ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * 18 to 90 years of age (screening is still recommended for some women over 65-depending on screening and medical history and proceeds until age 90 in the study's clinic recruitment sites), * referral for colposcopic evaluation at the clinic sites, * able to communicate with ease in English, * have a cell phone with texting ability, and * competent to give consent. Exclusion Criteria: * are pregnant at the time of recruitment, * display current evidence or have a history of positive invasive carcinoma of the cervix, or * require follow-up but not a colposcopy. Healthy Volunteers: True Maximum Age: 90 Years Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: suzanne.miller@fccc.edu Name: Suzanne M Miller, PhD Phone: 215-728-4069 Role: CONTACT Contact 2: Email: erin.tagai@fccc.edu Name: Erin K Tagai, PhD, MPH Phone: 215-728-5621 Role: CONTACT #### Locations Location 1: City: New Brunswick Contacts: *Contact 1:* - Email: hudsonsh@rutgers.edu - Name: Shawna Hudson, PhD - Phone: 848-932-0215 - Role: CONTACT Country: United States Facility: Rutgers, The State University of New Jersey State: New Jersey Zip: 08901 Location 2: City: Philadelphia Country: United States Facility: Thomas Jefferson University State: Pennsylvania Zip: 19107 Location 3: City: Philadelphia Country: United States Facility: Fox Chase Cancer Center State: Pennsylvania Zip: 19111 #### Overall Officials Official 1: Affiliation: Fox Chase Cancer Center Name: Suzanne M Miller, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Access Criteria: Contact the study PI to request data or supporting information. Description: Data sharing is essential to increase reproducibility and transparency of research and the translation of research findings into practice, leading to improved health outcomes. Data generated from the proposed study will be shared with the research community through presentations at scientific meetings and publications in peer-reviewed journals. Further, data will be available to qualified researchers after the main findings are published in a peer-reviewed journal. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers. Info Types: - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE IPD Sharing: YES Time Frame: Study data will be available after publication of the main study outcomes. ## 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 - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000007239 - Term: Infections - ID: D000015229 - Term: Sexually Transmitted Diseases, Viral - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000003141 - Term: Communicable Diseases - ID: D000004266 - Term: DNA Virus Infections - ID: D000014412 - Term: Tumor Virus Infections - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M13131 - Name: Papilloma - Relevance: HIGH - As Found: Papilloma - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: HIGH - As Found: Viral Infection - ID: M23687 - Name: Papillomavirus Infections - Relevance: HIGH - As Found: Papilloma Viral Infection - 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 - ID: M20451 - Name: Neoplasms, Squamous Cell - 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: M15558 - Name: Sexually Transmitted Diseases - Relevance: LOW - As Found: Unknown - ID: M17933 - Name: Sexually Transmitted Diseases, Viral - 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: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014777 - Term: Virus Diseases - ID: D000030361 - Term: Papillomavirus Infections - ID: D000002583 - Term: Uterine Cervical Neoplasms - ID: D000010212 - Term: Papilloma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416137 Brief Title: Dementia in Migrants Living in Italy: Promoting a Diversity-sensitive Clinical Approach and Provision of Care Official Title: Dementia in Migrants Living in Italy: Promoting a Diversity-sensitive Clinical Approach and Provision of Care #### Organization Study ID Info ID: GR-2021-12372081 #### Organization Class: OTHER Full Name: Istituto Superiore di Sanità ### Status Module #### Completion Date Date: 2025-06-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-06-30 Type: ESTIMATED #### Start Date Date: 2024-06-30 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-08 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Istituto Superiore di Sanità #### Responsible Party Investigator Affiliation: Istituto Superiore di Sanità Investigator Full Name: Marco Canevelli Investigator Title: Principal Investigator Type: PRINCIPAL_INVESTIGATOR ### Description Module Brief Summary: The number of older migrants with cognitive impairment and dementia living in Italy and attending national healthcare services is rapidly increasing. There is a need to develop diversity-sensitive policies and practices to include migrants and people with different cultural values in the public health response to dementia. Detailed Description: Based on the gaps and barriers identified by the ImmiDem study (GR-2016-02364975), the present project aims to: i) Describe the clinical and sociodemographic characteristics of migrants with cognitive disorders living in Italy, their health outcomes, and their access to healthcare resources; ii) develop and disseminate screening and assessment tools allowing the cross-cultural cognitive examination of individuals with a migration background; iii) raise awareness about dementia among culturally diverse people and train healthcare professionals in how to provide culturally competent care and support for migrants with cognitive disorders. ### Conditions Module Conditions: - Dementia - Alzheimer Disease Keywords: - dementia - migrants - cross-cultural ### Design Module #### Design Info Observational Model: CASE_CONTROL Time Perspective: CROSS_SECTIONAL #### Enrollment Info Count: 3000 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: A group of 1,500 migrants with cognitive impairment will be enrolled at CCDDs. Intervention Names: - Diagnostic Test: Neuropsychological tests Label: Migrants #### Arm Group 2 Description: A group of 1,500 natives with cognitive impairment will be enrolled at CCDDs. Intervention Names: - Diagnostic Test: Neuropsychological tests Label: Natives ### Interventions #### Intervention 1 Arm Group Labels: - Migrants - Natives Description: Participants will be assessed with neuropsychological tests and will be collected information about their lifestyle, clinical history and sociodemographic status. Special attention will be paid to the presence of modifiable risk factors for dementia (i.e., low education, hearing impairment, traumatic brain injury, excessive alcohol consumption, obesity, smoking, hypertension, depression, physical inactivity, diabetes, and social isolation). Name: Neuropsychological tests Type: DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes Description: Global cognitive functioning will be assessed through the Rowland Universal Dementia Assessment Scale (RUDAS). This is a short cognitive screening instrument designed to minimise the effects of cultural learning and language diversity on the assessment of baseline cognitive performance. The score ranges from 0 to 30. Higher scores indicate better cognitive functioning. Measure: Global cognitive functioning Time Frame: Baseline #### Secondary Outcomes Description: Frailty will be assessed by computing a Frailty Index (FI) focusing on the clinical history of the patient and collecting diverse deficits. Patients with a higher number of deficits will be considered frailer. Measure: Frailty Time Frame: Baseline Description: Special attention will be paid to the presence of modifiable risk factors for dementia (i.e., low education, hearing impairment, traumatic brain injury, excessive alcohol consumption, obesity, smoking, hypertension, depression, physical inactivity, diabetes, and social isolation). They will be collected and analyzed through a specific questionnaire. Measure: Risk factors Time Frame: Baseline ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Migrant (person who was not born in Italy) attending an Italian CCDD; * Presence of a cognitive impairment. Exclusion Criteria: * A person without any cognitive impairment. Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT Study Population: All migrants consecutively referred to CCDDs due to cognitive disturbances in one year will be considered. The following definition of migrants will be consistently adopted in the project: any person living in Italy but born abroad, regardless of the legal status, the reason for migration, and the length of the stay (source: International Organization for Migration). ### Contacts Locations Module #### Central Contacts Contact 1: Email: marco.canevelli@iss.it Name: Marco Canevelli Phone: +393393415890 Role: CONTACT ### IPD Sharing Statement Module Description: A workshop will be organized at the end of the project for disseminating the study results to major stakeholders (e.g., healthcare professionals, representatives of migrant communities, local authorities). Info Types: - STUDY_PROTOCOL - SAP IPD Sharing: YES Time Frame: After 36 months by the beginning of the study ### References Module #### See Also Links Label: The website created during the first part of this project. URL: http://www.immidem.it/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000024801 - Term: Tauopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M6904 - Name: Dementia - Relevance: HIGH - As Found: Dementia - ID: M3885 - Name: Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M23002 - Name: Tauopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000544 - Term: Alzheimer Disease - ID: D000003704 - Term: Dementia ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416124 Acronym: ANTHROLYMPMX Brief Title: Anthropometric Characteristics of Elite and Olympic Mexican Track and Field Athletes Official Title: Anthropometric Characteristics of Elite and Olympic Mexican Track and Field Athletes #### Organization Study ID Info ID: IICDEM-ID-001-2013 #### Organization Class: OTHER Full Name: Iberoamerican Institute of Sports Science and Human Movement ### Status Module #### Completion Date Date: 2013-07-07 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: COMPLETED #### Primary Completion Date Date: 2013-07-07 Type: ACTUAL #### Start Date Date: 2013-07-05 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-07 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: University of Guadalajara #### Lead Sponsor Class: OTHER Name: Iberoamerican Institute of Sports Science and Human Movement #### Responsible Party Investigator Affiliation: Iberoamerican Institute of Sports Science and Human Movement Investigator Full Name: Cesar Octavio Ramos Garcia, PhD 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: Sport specialization requires an understanding of morphological variability to optimize performance. However, the current literature lacks a detailed analysis of the anthropometric profile of track and field athletes, especially in Latin America. Additionally, the five-way fractionation method of body mass has been under-documented. These gaps highlight the need for more research to maximize the potential of athletes, particularly in emerging countries like Mexico. This study aims to determine the anthropometric characteristics of elite and Olympic Mexican track and field athletes. A descriptive cross-sectional study will be conducted. Forty-three anthropometric variables will be assessed to characterize the athlete´s physical composition using the standards of the International Society for the Advancement of Kinanthropometry (ISAK). Those variables will be used to describe the anthropometric profile (Heath and Carter somatotype, body composition through five-way fractionation method, muscle bone index, muscular adipose index, sum of skinfold thicknesses, and proportionality through Ross \& Wilson Phantom strategy. Correspondences of those variables will also be established among different tests and specialties: sprint, middle-distance, long-distance, endurance, combined events, jumps, and throws. This study aims to provide the opportunity to generate reliable references for high-performance Mexican athletes. ### Conditions Module Conditions: - Athletes Keywords: - Athletes - Kinanthropometry - Body composition - Somatotype - High performance - Track and Field ### Design Module #### Design Info Observational Model: CASE_ONLY Time Perspective: CROSS_SECTIONAL #### Enrollment Info Count: 74 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: All 74 athletes competing in track and field events during the XXIV Central American and Caribbean Athletics Championship will be considered Intervention Names: - Diagnostic Test: Anthropometric assessment Label: Elite and Olympic Mexican track and field athletes ### Interventions #### Intervention 1 Arm Group Labels: - Elite and Olympic Mexican track and field athletes Description: A total of 43 anthropometric variables (complete profile) will be assessed following the guidelines of the International Society for the Advancement of Kinanthropometry. All measurements will be taken on the right side of the body. The full anthropometric profile will be undertaken in duplicate to establish retest reliability. If the difference between duplicate measures exceeds 5% for skinfolds or 1% for all other variables, a third measurement will be taken, but only after the full profile has been completed in duplicate. The mean of duplicate or median of triplicate anthropometric measurements will be used for all subsequent analysis. The intra-evaluator technical error of measurement (TEM) was calculated according to the 1996 protocol of Pederson and Gore. Name: Anthropometric assessment Type: DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes Description: Body composition assessment through anthropometric five-way fractionation method of Ross and Kerr Measure: Anthropometric body composition profile Time Frame: One day #### Secondary Outcomes Description: A cuantitative method to assess body shape obtained from diferent anthropometric measurements Measure: Heath and Carter somatotype Time Frame: One day Description: A total of 43 measurements will be obtained using the standards of the methodology of the International Society for the Advancement of Kinanthropometry (ISAK) Measure: Anthropometric profile Time Frame: One day Description: Ratio between muscle mass and bone mass in Kg Measure: Muscle Bone Ratio Time Frame: One day Description: Ratio between muscle mass and adipose mass in Kg Measure: Muscular Adipose Ratio Time Frame: One day Description: Sum of 6 different skinfold thicknesses Measure: Sum of skinfold thicknesses Time Frame: One day Description: Correction of girth value by sustracting the skinfold thickness value Measure: Corrected girths Time Frame: One day Description: Ross phantom strategy for the analisys of body proportions Measure: Proportionality Time Frame: One day ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Elite and Olympic Mexican track and field athletes * Female and male, * All national teams * Actively competing in national and/or international competitions Exclusion Criteria: * Injured or not classified athletes * Not informed consent signed Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT Study Population: Elite and Olympic Mexican track and field athletes from different national teams and actively competing in national and international competitions ### Contacts Locations Module #### Locations Location 1: City: Zapopan Country: Mexico Facility: Iberoamerican Institute of Sports Science and Human Movement State: Jalisco Zip: 45128 #### Overall Officials Official 1: Affiliation: Institute of Sports Medicine (IMD), Cuba Name: Wiliam Carvajal-Veitía, PhD Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: University of Almeria (UAL), Spain Name: Fernando Alacid-Carceles, PhD Role: PRINCIPAL_INVESTIGATOR Official 3: Affiliation: Andres Bello University (UNAB), Chile Name: Rodrigo Yáñez-Sepúlveda, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: Because the participants were informed that data management would be protected only by the principal investigators. IPD Sharing: NO ### References Module #### References Citation: Bernal-Orozco MF, Posada-Falomir M, Quinonez-Gastelum CM, Plascencia-Aguilera LP, Arana-Nuno JR, Badillo-Camacho N, Marquez-Sandoval F, Holway FE, Vizmanos-Lamotte B. Anthropometric and Body Composition Profile of Young Professional Soccer Players. J Strength Cond Res. 2020 Jul;34(7):1911-1923. doi: 10.1519/JSC.0000000000003416. PMID: 32058363 Citation: Carvajal W, Rios A, Echevarria I, Martinez M, Minoso J, Rodriguez D. Body type and performance of elite cuban baseball players. MEDICC Rev. 2009 Apr;11(2):15-20. doi: 10.37757/MR2009V11.N2.6. PMID: 21483313 Citation: Dengel DR, Keller KA, Stanforth PR, Oliver JM, Carbuhn A, Bosch TA. Body Composition and Bone Mineral Density of Division 1 Collegiate Track and Field Athletes, a Consortium of College Athlete Research (C-CAR) Study. J Clin Densitom. 2020 Apr-Jun;23(2):303-313. doi: 10.1016/j.jocd.2019.07.008. Epub 2019 Jul 12. PMID: 31399322 Citation: Mangine GT, Mangine GT, Eggerth A, Gough J, Stratton MT, Feito Y, VanDusseldorp TA. Endocrine and Body Composition Changes Across a Competitive Season in Collegiate Speed-Power Track and Field Athletes. J Strength Cond Res. 2021 Aug 1;35(8):2067-2074. doi: 10.1519/JSC.0000000000004069. PMID: 34100783 Citation: Bonato M, Bizzozero S, Filipas L, LA Torre A. The influence of anthropometric parameters in track and field curve sprint. J Sports Med Phys Fitness. 2023 Dec;63(12):1254-1261. doi: 10.23736/S0022-4707.23.15056-0. Epub 2023 Aug 3. PMID: 37535342 Citation: Withers RT, Craig NP, Ball CT, Norton KI, Whittingham NO. The Drinkwater-Ross anthropometric fractionation of body mass: comparison with measured body mass and densitometrically estimated fat and fat-free masses. J Sports Sci. 1991 Autumn;9(3):299-311. doi: 10.1080/02640419108729891. PMID: 1960800 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416111 Brief Title: Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation Official Title: Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation With Near-infrared Spectroscopy #### Organization Study ID Info ID: Tissue Oxygen Saturation #### Organization Class: OTHER Full Name: Ankara City Hospital Bilkent ### Status Module #### Completion Date Date: 2024-12-15 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-11-15 Type: ESTIMATED #### Start Date Date: 2024-05-22 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-26 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Ankara City Hospital Bilkent #### Responsible Party Investigator Affiliation: Ankara City Hospital Bilkent Investigator Full Name: Hija Yazıcıoğlu Investigator Title: Prof.MD Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: In arteriovenous fistula surgery, the effect of infraclavicular brachial plexus block and local anesthesia on tissue oxygenation and the effect of primary patency of the AV fistula is intended to research. Detailed Description: It is planned to include patients who are ASA III and between the ages of 18-80 who will undergo arteriovenous fistula surgery in the research population.In our study, patients who come to the operating room for arteriovenous fistula operation will be randomly divided into two groups.Patients who undergo simple randomization with coin toss method will be assigned to one of two groups: group Local infiltrative anesthesia (Local) and group infraclavicular brachial plexus block with 0.25% bupivacaine (Block). Local infiltrative anesthesia will be applied with 15 ml 2% prilocaine for group Local patients.For Group Block patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.Before the start of surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded . ### Conditions Module Conditions: - Renal Disease, Chronic Keywords: - arteriovenous fistula operation - Infraclavicular nerve block - Near-infrared spectroscopy (NIRS) - local anesthesia ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER Intervention Model Description: NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded ##### Masking Info Masking: NONE Primary Purpose: OTHER #### Enrollment Info Count: 60 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Local infiltrative anesthesia will be applied with 15 ml 2% prilocaine for group Local patients.Before surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded . Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery. Intervention Names: - Device: NIRS - Behavioral: Surgeon and patient satisfaction Label: group Local Type: OTHER #### Arm Group 2 Description: For Group Block patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.The effect of the peripheral nerve block will be evaluated with 10-minute intervals until regional anesthesia is achieved.Sensory block will be evaluated with the "Pinprick Test" and motor block with the "Modified Bromage Scale".Failed block or the patients who experience pain at any time during the operation will be excluded. Before surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded . Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery. Intervention Names: - Device: NIRS - Behavioral: Surgeon and patient satisfaction - Other: Pinprick Test - Other: Modified Bromage Scale Label: group Block Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - group Block - group Local Description: Before surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded . Name: NIRS Type: DEVICE #### Intervention 2 Arm Group Labels: - group Block - group Local Description: Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery. Name: Surgeon and patient satisfaction Type: BEHAVIORAL #### Intervention 3 Arm Group Labels: - group Block Description: Sensory block of group B patients will be evaluated with the "Pinprick Test" . Name: Pinprick Test Type: OTHER #### Intervention 4 Arm Group Labels: - group Block Description: motor block of Group B patients will be evaluated with the "Modified Bromage Scale". Name: Modified Bromage Scale Type: OTHER ### Outcomes Module #### Other Outcomes Description: Assessment of motor blockade uses 4 point Modified Bromage Score. 0.Normal motor function with full extension and flexion of elbow, wrist, and fingers 1. Decreased motor strengths with ability to full flexion elbow and move fingers but inability to raise arm 2. More decreased motor strengths with inability to move elbow and ability to move fingers 3. Complete motor block with inability to move elbow, wrist, and fingers. In this study ,motor block of Group B patients will be evaluated with the "Modified Bromage Scale". Measure: Modified Bromage Scale Time Frame: evaluation of the satisfactory block before the surgery Description: Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery. Measure: Surgeon and patient satisfaction Time Frame: at the end of the operation. #### Primary Outcomes Description: Near Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation.In this study ,peripheral oxygenation will be measured with a NIRS device at group Local infiltrative anesthesia and group Infraclavicular brachial plexus block. Before surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded . Measure: Near-infrared spectroscopy (NIRS) Time Frame: beginning and every 5 minutes till the end of surgery #### Secondary Outcomes Description: With the pinprick test, the practitioner gently touches the skin with the pin and asks the patient whether it feels sharp or blunt .Test begins distally and then move proximally (aiming to test each dermatome and each main nerve).In this study ,sensory block of group B patients will be evaluated with the Pinprick Test. Measure: Pinprick test Time Frame: evaluation of the satisfactory block before the surgery ### Eligibility Module Eligibility Criteria: Inclusion Criteria: - It is planned to include patients who are ASA III and between the ages of 18-80 undergoing arteriovenous fistula operation in the research population. There will be no gender difference. Exclusion Criteria: * disabled patients, children, patients with difficult communicating Pinprick test and Modified Bromage Scale showing the success of peripheral nerve block , which depends on subjective evaluation and the cooperation of the patient.The verbal tests mentioned above may not be appropriate for disabled patients, children, patients with difficult communicating in operating room conditions Maximum Age: 80 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: drmerveatay44@gmail.com Name: Merve Atay Phone: 05375277009 Role: CONTACT Contact 2: Email: hija001@hotmail.com Name: Hija Yazıcıoğlu Phone: 05326086960 Role: CONTACT #### Locations Location 1: City: Ankara Contacts: *Contact 1:* - Email: drmerveatay44@gmail.com - Name: Merve atay - Phone: 5375277009 - Role: CONTACT Country: Turkey Facility: Ankara Bilkent City Hospital State: Çankaya Zip: 06800 #### Overall Officials Official 1: Affiliation: Ankara Bilkent City Hospital Name: Hija Yazıcıoğlu Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001165 - Term: Arteriovenous Malformations - ID: D000054079 - Term: Vascular Malformations - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000016157 - Term: Vascular Fistula - ID: D000014652 - Term: Vascular Diseases - ID: D000000013 - Term: Congenital Abnormalities - ID: D000051437 - Term: Renal Insufficiency ### 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: BC14 - Name: Heart and Blood Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M8532 - Name: Fistula - Relevance: HIGH - As Found: Fistula - ID: M4472 - Name: Arteriovenous Fistula - Relevance: HIGH - As Found: Arteriovenous Fistula - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Renal Disease, Chronic - 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: M22519 - Name: Pathological Conditions, Anatomical - 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: M4473 - Name: Arteriovenous Malformations - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M27558 - Name: Vascular Malformations - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown - ID: M18619 - Name: Vascular Fistula - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000001164 - Term: Arteriovenous Fistula - ID: D000005402 - Term: Fistula ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M14191 - Name: Prilocaine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416098 Brief Title: [Trial of device that is not approved or cleared by the U.S. FDA] Official Title: [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info ID: BH-A-05 #### Organization Full Name: [Redacted] ### Status Module Delayed Posting: True #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: WITHHELD #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Name: [Redacted] #### Responsible Party Old Name Title: [Redacted] Old Organization: [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416085 Brief Title: Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer Official Title: Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer: A Phase II Open-Label Trial #### Organization Study ID Info ID: PEARL #### Organization Class: OTHER Full Name: University Health Network, Toronto #### Secondary ID Infos Domain: University Health Network ID: 21-5781 Type: OTHER ### Status Module #### Completion Date Date: 2026-06-15 Type: ESTIMATED #### Last Update Post Date Date: 2024-05-28 Type: ACTUAL Last Update Submit Date: 2024-05-24 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-01-15 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-01-14 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University Health Network, Toronto #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Oversight Has DMC: True ### Description Module Brief Summary: The PEARL Pilot is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Detailed Description: Individuals with advanced cancer often experience high levels of distress due to physical suffering, difficult treatment decisions, social isolation, and fear of death. While there are many treatment options for the management of physical symptoms associated with cancer, there are relatively few standard treatment approaches to help patients deal with psychological and existential suffering. Over the past decade, research has shown that psychotherapies incorporating existential, attachment and relational approaches can address the specific needs and challenges of the advanced cancer population and thus help to reduce distress. Simultaneously, recent research has shown that psilocybin-assisted psychotherapy, in which, an individual ingests the psychoactive drug within the carefully monitored therapeutic setting, can reduce end-of-life distress and greatly benefit those with advanced disease. The multidisciplinary team has combined these two evidence-based approaches into what the team calls Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. PEARL therapy combines elements from psilocybin-assisted psychotherapy, including preparatory therapy sessions, a high-dose drug session, and integration sessions, with important elements from manualized individual psychotherapies designed for patients with advanced cancer. This study will assess the feasibility, acceptability, and safety of PEARL therapy among patients with advanced cancer. This study will yield important information about the feasibility of this type of therapy and contribute to the growing research around the efficacy of psychedelic-assisted therapies. This type of therapy has the potential to improve quality of life among those with advanced disease and careful research is needed to build upon previous findings to outline the necessary components of therapy and guide public policy, legislation, and clinical guidelines. ### Conditions Module Conditions: - Advanced Cancer - Stage IV Solid Tumor Cancer - Stage IV Sarcoma of Bone - Stage IV Lymphoma - Stage IV Melanoma - Endocrine Cancer Keywords: - Advanced Cancer ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 15 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: Psilocybin Label: Psilocybin Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Psilocybin Description: Single high-dose (25mg) capsule of psilocybin taken orally in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy Name: Psilocybin Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Used to assess feasibility of PEARL therapy. Measure: Recruitment feasibility as assessed by the number of patients who consent/number of patients who meet eligibility criteria. Time Frame: 24 months Description: Used to assess feasibility of PEARL therapy. Measure: Retention feasibility as assessed by the number of patients completing primary endpoint measures/number of patients consented. Time Frame: 24 months Description: Used to assess feasibility of PEARL therapy. Measure: Adherence feasibility as assessed by the number of patients completing all PEARL sessions/number of patients consented. Time Frame: 24 months Description: Participants will be interviewed regarding their experiences with PEARL, including acceptability and perceived positive and negative effects of the intervention, with a semi-structured interview guide. Measure: Acceptability of PEARL therapy from the perspective of advanced cancer patients obtained through qualitative interviews. Time Frame: 24 months Description: Safety will be assessed throughout the trial. Adverse events (AEs) attributed to psilocybin will be monitored for and recorded after the psilocybin session. This study will use CTCAE v5.0 to assess AEs. Serious adverse events (SAEs) will be tracked until study completion and will be defined as any adverse drug experience that: results in death; that is life-threatening (i.e. any AE that places the participant, in the view of the investigators, at immediate risk of death from the reaction as it occurs); requires hospital admission; results in persistent or significant disability (i.e. a substantial disruption of a person's ability to conduct normal life functions); or may jeopardize the participant or necessitate medical intervention to prevent one of the aforementioned criteria. Measure: Safety of PEARL therapy Time Frame: 24 months #### Secondary Outcomes Description: The Death and Dying Distress Scale (DADDS) is a 15-item self-report measure designed for populations facing imminent death and addresses fears about the dying process, and about lost opportunities and self-perceived burden placed on others as a result of impending mortality. Total score range is 0 to 75. Higher scores indicate greater death-related distress. Measure: Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Death anxiety in advanced cancer patients as assessed with the DADDS Time Frame: 24 months Description: The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report scale measuring depressive symptoms. Total score range is 0 to 27. Higher scores indicate greater severity of depression. Measure: Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Depressive symptoms as assessed with the PHQ-9 Time Frame: 24 months Description: The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report scale used to screen for and measure anxiety symptoms. Total score range is 0 to 21. Higher scores indicate higher levels of anxiety. Measure: Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Anxiety symptoms as assessed with the GAD-7 Time Frame: 24 months Description: The Demoralization Symptoms (DS) is a 24-item self-report measure that assesses loss of meaning and purpose, disheartenment, and helplessness. Total score range is 0 to 96. Higher scores indicate higher levels of demoralization. Measure: Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Loss of meaning and purpose, disheartenment and helplessness as assessed with the DS Time Frame: 24 months Description: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp) is a 12-item scale designed to measure important aspects of spirituality including sense of meaning in one's life, harmony, peacefulness and a sense of comfort and strength from one's faith. Total score range is 0 to 48. Higher scores indicate higher spiritual well-being. Measure: Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Overall measure of spiritual well-being, meaning/peace and faith as assessed with the FACIT-Sp Time Frame: 24 months Description: The Quality of Life at the End of Life-Cancer (QUAL-EC) is a 17-item measure that includes subscales which assess symptom impact, preparation for end of life (i.e., the extent to which the family is prepared and financial plans have been made), relationship with healthcare providers (i.e., the extent to which patients feel informed and are able to participate in decisions about their care) and sense of life completion (i.e., being able to share important things and feel connected to others). For Symptom Control, score range is 3 to 15, with higher scores reflecting greater symptom control; for the Relationship with Healthcare Provider, score range is 5 to 25, with higher scores reflecting a better relationship with healthcare providers; for the Preparation for End-of-Life, score range is 4 to 20, with higher scores reflecting greater preparation for end-of-life; and the for Life Completion, score range is 5 to 25, with higher scores reflecting a greater sense of life completion. Measure: Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Broad quality of life construct in patients facing end of life as assessed with the QUAL-EC Time Frame: 24 months Description: The Schedule of Attitudes Toward Hastened Death (SAHD) is a 20-item self-report measure of desire for death in the medically ill. Total score range is 0 to 20. Higher scores indicate greater desire for death. Measure: Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Desire for death in the medically ill as assessed with the SAHD Time Frame: 24 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. \>18 years of age; 2. Ability to speak and read English (patient to provide written informed consent and participate in PEARL intervention, as determined by study personnel); 3. No cognitive impairment indicated in medical record or by attending oncologist or palliative care physician; 4. Confirmed diagnosis of stage IV solid tumour cancers, sarcoma, endocrine, melanoma cancers, or stage 4 lymphoma with expected survival of greater than 6 months as determined by their oncologist or palliative care physician; 5. At least mild depressive symptoms, defined as \>8 on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke et la., 2001); 6. Interest in and ability to participate in and complete the PEARL intervention and protocol as outlined; 7. Normal hepatic functioning as determined by prior medical history or/and screening bloodwork (INR\<1.5, Aspartate aminotransferase/Alanine Aminotransferase (AST/ALT) \< 2x upper limit of normal, normal range bilirubin, platelets \> 150) 8. Normal renal functioning as determined by prior medical history or/and screening bloodwork (eGFR\>45) 9. Participants who are sexually active and could become pregnant must be using effective birth control (per their physician), prior to study entry, during study participation, and for the duration of the study. Participants who are sexually active and could inseminate a partner must agree to use effective birth control after psilocybin administration until the end of study. For participants of child-bearing potential, a negative serum pregnancy test result is required at screening. A urine pregnancy test will be administered on the morning of psilocybin administration for applicable participants. Participants cannot be pregnant or nursing through the duration of the study; 10. If using prescribed medications or other substances, participants must agree to refrain from taking them if instructed by study investigators. These include: * not using any non-prescription medication, nutritional supplement, or herbal supplement except when approved by the treatment team (exceptions will be evaluated by the Investigator and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals), * not using nicotine for at least 2 hours before psilocybin administration, and not again until approximately 7 hours after psilocybin administration, * consuming approximately the same amount of caffeine-containing beverages (e.g., coffee, tea) that they consume on a usual morning before arriving at the treatment centre for the psilocybin session day, * not taking any as needed medications on the mornings of psilocybin sessions (with the exception of daily and as needed opioid pain medication), * refraining from using any psychoactive drugs, including alcoholic beverages, within 24 hours of the psilocybin administration. 11. Participants must have someone drive them after the session to where they are staying (home, hotel or another location), because psilocybin may affect their alertness and concentration on the evening of the dosing session. Exclusion Criteria: 1. Cancer of the brain or metastasis to the brain; 2. Symptoms consistent with delirium, psychosis, or other symptoms judged to be incompatible with establishment of rapport or safe exposure to psilocybin; 3. A history of past intolerability of psilocybin or other psychedelics; 4. Past/present psychiatric diagnoses including bipolar disorder, psychotic disorders, active substance use disorders or suicidality (as distinguished from desire for hastened death or readiness for death, per the discretion of the study team); 5. If participant is under 30 years of age and has first degree relative with a primary psychotic disorder; 6. Severe hypertension (defined as systolic blood pressure \>140/or diastolic pressure \>90) based on two readings on the same day. If the second reading remains over 140/90 patient can be brought in for another reading on a different day. Patients can be re-screened for participation once blood pressure is adequately controlled; 7. Known paraneoplastic syndrome or "ectopic" hormone production by the primary tumor if incompatible with psilocybin, determined in consultation with the study palliative care physician. Patients could be enrolled if it is determined that the patient's condition is compatible with psilocybin administration. 8. Cardiovascular conditions including uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation without rate control), transient ischemic attack in the last six months, stroke, peripheral or pulmonary vascular disease (no active claudication); 9. Uncontrolled epilepsy or history of seizures in past 6 months; 10. Participants with diabetes who are unable to skip a meal (lunch), or whose diabetes requires administration of medication more than twice daily, or who have had symptomatic hypoglycemia within the prior 30 days 11. GI bleed in last 6 months; 12. Use of other agents that would be inappropriate to take with psilocybin in the judgement of the investigator. These agents may include psychoactive prescription medications (e.g., benzodiazepines, lithium, Selective serotonin reuptake inhibitors), medications having a primary pharmacological effect on serotonin-2a (5-HT2A) receptors (e.g., olanzapine), or medications that are monoamine oxidase (MAO) inhibitors, any potent metabolic inducers (e.g. rifamycin, rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, taxol, dexamethasone, St John's wort) or inhibitors (e.g. HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin). Of note, in suitable patients, these medications may be paused or tapered between study enrolment and prior to the start of the intervention when it is deemed safe to do so. A safe and appropriate tapering regimen will then be developed based on the particular medication, on a case-by-case basis. If taking an MAO inhibitor, the psilocybin session will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose. Patients prescribed opioids will be allowed to take their usual dose regimen for analgesia, including the use of as needed analgesic medications on psilocybin session days. Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: UHNPPRG@uhn.ca Name: Sarah Hales, MD Phone: 416-340-4800 Phone Ext: 8051# Role: CONTACT #### Locations Location 1: City: Toronto Contacts: *Contact 1:* - Name: Sarah Hales, MD - Role: CONTACT *Contact 2:* - Name: Sarah Hales, MD - Role: PRINCIPAL_INVESTIGATOR *Contact 3:* - Name: Emma Hapke, MD - Role: PRINCIPAL_INVESTIGATOR *Contact 4:* - Name: Daniel Rosenbaum, MD - Role: PRINCIPAL_INVESTIGATOR Country: Canada Facility: Princess Margaret Cancer Centre State: Ontario Zip: M5G 2M9 #### Overall Officials Official 1: Affiliation: University Health Network, Toronto Name: Sarah Hales, MD Role: PRINCIPAL_INVESTIGATOR ### References Module #### References Citation: Albers G, Echteld MA, de Vet HC, Onwuteaka-Philipsen BD, van der Linden MH, Deliens L. Evaluation of quality-of-life measures for use in palliative care: a systematic review. Palliat Med. 2010 Jan;24(1):17-37. doi: 10.1177/0269216309346593. Epub 2009 Oct 20. PMID: 19843620 Citation: Breitbart W, Rosenfeld B, Gibson C, Pessin H, Poppito S, Nelson C, Tomarken A, Timm AK, Berg A, Jacobson C, Sorger B, Abbey J, Olden M. Meaning-centered group psychotherapy for patients with advanced cancer: a pilot randomized controlled trial. Psychooncology. 2010 Jan;19(1):21-8. doi: 10.1002/pon.1556. PMID: 19274623 Citation: Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513. PMID: 27909165 Citation: Grossman CH, Brooker J, Michael N, Kissane D. Death anxiety interventions in patients with advanced cancer: A systematic review. Palliat Med. 2018 Jan;32(1):172-184. doi: 10.1177/0269216317722123. Epub 2017 Aug 8. PMID: 28786328 Citation: Kissane DW, Wein S, Love A, Lee XQ, Kee PL, Clarke DM. The Demoralization Scale: a report of its development and preliminary validation. J Palliat Care. 2004 Winter;20(4):269-76. PMID: 15690829 Citation: Krause S, Rydall A, Hales S, Rodin G, Lo C. Initial validation of the Death and Dying Distress Scale for the assessment of death anxiety in patients with advanced cancer. J Pain Symptom Manage. 2015 Jan;49(1):126-34. doi: 10.1016/j.jpainsymman.2014.04.012. Epub 2014 May 28. PMID: 24878066 Citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. PMID: 11556941 Citation: Lo C, Hales S, Zimmermann C, Gagliese L, Rydall A, Rodin G. Measuring death-related anxiety in advanced cancer: preliminary psychometrics of the Death and Dying Distress Scale. J Pediatr Hematol Oncol. 2011 Oct;33 Suppl 2:S140-5. doi: 10.1097/MPH.0b013e318230e1fd. PMID: 21952572 Citation: Morita T, Murata H, Kishi E, Miyashita M, Yamaguchi T, Uchitomi Y; Japanese Spiritual Care Task Force. Meaninglessness in terminally ill cancer patients: a randomized controlled study. J Pain Symptom Manage. 2009 Apr;37(4):649-58. doi: 10.1016/j.jpainsymman.2008.04.017. Epub 2008 Oct 1. PMID: 18834700 Citation: Rodin G, Lo C, Mikulincer M, Donner A, Gagliese L, Zimmermann C. Pathways to distress: the multiple determinants of depression, hopelessness, and the desire for hastened death in metastatic cancer patients. Soc Sci Med. 2009 Feb;68(3):562-9. doi: 10.1016/j.socscimed.2008.10.037. Epub 2008 Dec 7. PMID: 19059687 Citation: Rodin G, Lo C, Rydall A, Shnall J, Malfitano C, Chiu A, Panday T, Watt S, An E, Nissim R, Li M, Zimmermann C, Hales S. Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer. J Clin Oncol. 2018 Aug 10;36(23):2422-2432. doi: 10.1200/JCO.2017.77.1097. Epub 2018 Jun 29. PMID: 29958037 Citation: Rosenfeld B, Breitbart W, Galietta M, Kaim M, Funesti-Esch J, Pessin H, Nelson CJ, Brescia R. The schedule of attitudes toward hastened death: Measuring desire for death in terminally ill cancer patients. Cancer. 2000 Jun 15;88(12):2868-75. doi: 10.1002/1097-0142(20000615)88:123.0.co;2-k. PMID: 10870074 Citation: Smith KA, Harvath TA, Goy ER, Ganzini L. Predictors of pursuit of physician-assisted death. J Pain Symptom Manage. 2015 Mar;49(3):555-61. doi: 10.1016/j.jpainsymman.2014.06.010. Epub 2014 Aug 10. PMID: 25116913 Citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PMID: 16717171 Citation: Steinhauser KE, Clipp EC, Bosworth HB, McNeilly M, Christakis NA, Voils CI, Tulsky JA. Measuring quality of life at the end of life: validation of the QUAL-E. Palliat Support Care. 2004 Mar;2(1):3-14. doi: 10.1017/s1478951504040027. PMID: 16594230 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15327 - Name: Sarcoma - Relevance: LOW - As Found: Unknown - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M11528 - Name: Melanoma - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: HIGH - As Found: Endocrine Cancer - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms ### Intervention Browse Module - Ancestors - ID: D000006213 - Term: Hallucinogens - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M14419 - Name: Psilocybin - Relevance: HIGH - As Found: Cover - ID: M9305 - Name: Hallucinogens - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011562 - Term: Psilocybin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416072 Acronym: APEX Brief Title: Alzheimer's Plasma Extension Official Title: Alzheimer's Plasma Extension #### Organization Study ID Info ID: ATRI-013 #### Organization Class: OTHER Full Name: University of Southern California #### Secondary ID Infos ID: 5R01AG054029 Link: https://reporter.nih.gov/quickSearch/5R01AG054029 Type: NIH ### Status Module #### Completion Date Date: 2028-06 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-28 Type: ACTUAL Last Update Submit Date: 2024-05-24 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2028-06 Type: ESTIMATED #### Start Date Date: 2023-09-21 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2023-02-21 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: NIH Name: National Institute on Aging (NIA) Class: UNKNOWN Name: Alzheimer's Clinical Trials Consortium (ACTC) Class: OTHER Name: Alzheimer's Therapeutic Research Institute #### Lead Sponsor Class: OTHER Name: University of Southern California #### Responsible Party Investigator Affiliation: University of Southern California Investigator Full Name: Paul S. Aisen 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 APEX study is a multicenter, observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years. Approximately 1000 participants will be enrolled across three groups: * Group A: Approximately 500 participants who are discordant on screening (plasma positive / Positron Emission Tomography (PET) negative), * Group B: Approximately 250 participants who are concordant on screening (plasma negative / PET negative), and * Group C: Approximately 250 participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in Alzheimer's disease (AD) clinical trials. Primary Objectives: * Collect longitudinal cognitive and functional assessments and blood-based biomarker data * Evaluate, characterize, and compare the longitudinal cognitive and functional data between the three groups of participants * Compare longitudinal change across race and ethnicity, sex, and Apolipoprotein E (ApoE) status Exploratory Objectives: • Collect baseline amyloid PET on participants without prior amyloid PET data (Group C) ### Conditions Module Conditions: - Preclinical Alzheimer's Disease - Early Preclinical Alzheimer's Disease ### Design Module #### Bio Spec Description: blood, plasma Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 1000 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Approximately 500 participants who screen failed from the AHEAD study that were plasma positive / PET negative Label: Group A #### Arm Group 2 Description: Approximately 250 participants who screen failed from the AHEAD study that were plasma negative / PET negative Label: Group B #### Arm Group 3 Description: Approximately 250 participants who screen failed prior to PET imaging will undergo amyloid PET imaging with NAV4694 injection. Intervention Names: - Radiation: NAV4694 Label: Group C ### Interventions #### Intervention 1 Arm Group Labels: - Group C Description: Amyloid PET imaging with NAV4694 injection Name: NAV4694 Other Names: - [18F]NAV4694 Type: RADIATION ### Outcomes Module #### Other Outcomes Measure: Collection of baseline amyloid PET on participants without prior amyloid PET data Time Frame: Baseline #### Primary Outcomes Measure: Rate of change from Baseline to Month 48 on plasma beta-amyloid (Aβ) 40 or 42 ratio Time Frame: Baseline, Month 12, Month 24, Month 36 and Month 48 Description: Assess longitudinal changes from initial visit in plasma phosphorylated tau (ptau) 217 ratio using a proteomics assay Measure: Rate of change from Baseline to Month 48 on plasma phosphorylated tau (ptau) 217 Time Frame: Baseline, Month 12, Month 24, Month 36 and Month 48 #### Secondary Outcomes Description: PACC5:Free/cued selective reminding test:number of words recalled without cuing/with cuing(0\[worst\]-96\[best recall\]);Delayed Paragraph Recall test: recall of 1 short story(25 bits information),immediately after reading and again after delay of 30 minutes (0\[worst\]-25\[best recall\]);Digit-symbol substitution test: Participant uses a key to fill in blank squares as fast as possible in 90 seconds(0\[none\]-91\[best performance\]);Mini Mental State Score:to evaluate orientation, memory, attention, concentration, naming, repetition, comprehension and ability to create sentence, to copy 2 overlapping pentagons, scored as number of correctly completed items(0\[worse\]-30\[perfect performance\]);Category fluency task: participants generate words in 60 second belonging to a semantic category(total score:number of appropriate words generated per task, higher values indicate better performance). Measure: Rate of Change from Baseline to Month 48 as measured by the Preclinical Alzheimer Cognitive Composite 5(PACC5) Time Frame: Baseline, Month 12, Month 24, Month 36 and Month 48 Description: CFI assessment to assess the participant's perceived ability to perform high-level functional tasks in daily life and sense of overall cognitive functional ability. Study participants (18 questions) and their study partners (15 questions) independently rate the participant's abilities. Total score combines participant and study partner scores, with higher scores indicating greater impairment. For participants, 0 = minimum;18 = maximum. For study partners, 0 = minimum; 15 = maximum. The CFI may be self-administered or completed as an interview conducted by clinical site personnel in-person or, if necessary, over the phone. Measure: Rate of Change from Baseline to Month 48 as measured Cognitive Function Index (CFI) Time Frame: Baseline, Month 12, Month 24, Month 36 and Month 48 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Documentation of the participant's informed consent to study procedures and for the use of protected health information (HIPAA Authorization, if applicable). Informed consent processes and documentation must adhere to state laws/local requirements, including consent provided by the participant's legally authorized representative (LAR), responsible next of kin, surrogate consent with assent, etc. 2. Previously consented to participate in A3-45 screening. 3. Has A3-45 screening plasma biomarker results required for determining eligibility to participate in the A3-45 trial. 4. If an amyloid PET scan was conducted in A3-45, the scan was determined to be below the 20 centiloid cutpoint required for eligibility into the treatment arms of the A3 or A45 trial. 5. As assessed by the site PI, participant is likely to be able to comply with the protocol, including completion of all required procedures for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy in English or Spanish sufficient for compliance with required testing procedures. Exclusion Criteria: 1. Current treatment with an FDA approved medication for Alzheimer's disease, including prior or current treatment with a prohibited medication. 2. Enrollment in another investigational study, or intake of investigational drug, within 30 days prior to screening, or five half-lives of the investigational drug, whichever is longer, unless it can be documented that the participant was in the placebo treatment arm. Participants enrolled in other observational studies may be permitted with Medical Monitor review and approval. 3. Screen failed from A3-45 due to not meeting basic inclusion criterion (i.e., age requirement; current diagnosis of AD dementia). Healthy Volunteers: True Maximum Age: 80 Years Minimum Age: 55 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: This study will enroll approximately 1000 participants who screen failed from the AHEAD study without evidence of elevated or intermediate amyloid by plasma biomarker or by amyloid PET scan at screening. Participants will have consented to participate in the AHEAD study and previously met demographic, cognitive and clinical criteria, however, had screening plasma biomarker and/or PET scan results that fell below the ABeta threshold levels required for randomization into the treatment arms for the AHEAD study. ### Contacts Locations Module #### Locations Location 1: City: Birmingham Country: United States Facility: University of Alabama, Birmingham State: Alabama Zip: 35233 Location 2: City: Phoenix Country: United States Facility: Banner Alzheimer's Institute State: Arizona Zip: 85006 Location 3: City: Sun City Country: United States Facility: Banner Sun Health Research Institute State: Arizona Zip: 85351 Location 4: City: Irvine Country: United States Facility: University of California, Irvine State: California Zip: 92697 Location 5: City: Palo Alto Country: United States Facility: Stanford University State: California Zip: 94304 Location 6: City: San Diego Country: United States Facility: Sharp Neurocognitive Research Center State: California Zip: 92123 Location 7: City: Walnut Creek Country: United States Facility: University of California, Davis State: California Zip: 94598 Location 8: City: New Haven Country: United States Facility: Yale University School of Medicine State: Connecticut Zip: 06510 Location 9: City: Washington Country: United States Facility: Georgetown University State: District of Columbia Zip: 20007 Location 10: City: Washington Country: United States Facility: Howard University State: District of Columbia Zip: 20060 Location 11: City: Delray Beach Country: United States Facility: Brain Matters Research State: Florida Zip: 33445 Location 12: City: Jacksonville Country: United States Facility: Mayo Clinic, Jacksonville State: Florida Zip: 32224 Location 13: City: Maitland Country: United States Facility: K2 Medical Research, LLC State: Florida Zip: 32751 Location 14: City: Miami Beach Country: United States Facility: Wien Center for Clinical Research State: Florida Zip: 33140 Location 15: City: Miami Country: United States Facility: Gonzalez MD & Aswad MD Health Services State: Florida Zip: 33135 Location 16: City: Tampa Country: United States Facility: University of South Florida - Health Byrd Alzheimer Institute State: Florida Zip: 33613 Location 17: City: Winter Park Country: United States Facility: Charter Research State: Florida Zip: 32792 Location 18: City: Atlanta Country: United States Facility: Emory University State: Georgia Zip: 30322 Location 19: City: Chicago Country: United States Facility: Northwestern University State: Illinois Zip: 60611 Location 20: City: Chicago Country: United States Facility: Rush University Medical Center State: Illinois Zip: 60612 Location 21: City: Indianapolis Country: United States Facility: Indiana University State: Indiana Zip: 46202 Location 22: City: Fairway Country: United States Facility: University of Kansas State: Kansas Zip: 66205 Location 23: City: Lexington Country: United States Facility: University of Kentucky State: Kentucky Zip: 40504 Location 24: City: Boston Country: United States Facility: Boston University State: Massachusetts Zip: 02215 Location 25: City: Boston Country: United States Facility: Brigham and Women's Hospital State: Massachusetts Zip: 21155 Location 26: City: Plymouth Country: United States Facility: Headlands Eastern MA LLC State: Massachusetts Zip: 02360 Location 27: City: Ann Arbor Country: United States Facility: University of Michigan, Ann Arbor State: Michigan Zip: 48105 Location 28: City: Rochester Country: United States Facility: Mayo Clinic, Rochester State: Minnesota Zip: 55905 Location 29: City: Saint Louis Country: United States Facility: Washington University, St. Louis State: Missouri Zip: 63108 Location 30: City: Las Vegas Country: United States Facility: Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas State: Nevada Zip: 89101 Location 31: City: New York Country: United States Facility: Mount Sinai School of Medicine State: New York Zip: 10029 Location 32: City: New York Country: United States Facility: Columbia University State: New York Zip: 10032 Location 33: City: Rochester Country: United States Facility: University of Rochester Medical Center State: New York Zip: 14620 Location 34: City: Winston-Salem Country: United States Facility: Wake Forest University Health Sciences State: North Carolina Zip: 27157 Location 35: City: Beachwood Country: United States Facility: Case Western Reserve University State: Ohio Zip: 44122 Location 36: City: Columbus Country: United States Facility: Ohio State University State: Ohio Zip: 43210 Location 37: City: Tulsa Country: United States Facility: Central States Research State: Oklahoma Zip: 74136 Location 38: City: Philadelphia Country: United States Facility: University of Pennsylvania State: Pennsylvania Zip: 19104 Location 39: City: Providence Country: United States Facility: Butler Hospital Memory and Aging Program State: Rhode Island Zip: 02906 Location 40: City: Charleston Country: United States Facility: Ralph H. Johnson VA Health Care System State: South Carolina Zip: 29401 Location 41: City: Nashville Country: United States Facility: Vanderbilt University Medical Center Center for Cognitive Medicine State: Tennessee Zip: 37212 Location 42: City: Dallas Country: United States Facility: University of Texas, Southwestern MC at Dallas State: Texas Zip: 75390 Location 43: City: Houston Country: United States Facility: Baylor College of Medicine State: Texas Zip: 77030 Location 44: City: Houston Country: United States Facility: Houston Methodist Neurological Institute State: Texas Zip: 77030 Location 45: City: San Antonio Country: United States Facility: University of Texas Health Science Center at San Antonio State: Texas Zip: 78229 Location 46: City: Norfolk Country: United States Facility: Eastern Virginia Medical School State: Virginia Zip: 23510 Location 47: City: Richmond Country: United States Facility: National Clinical Research Inc. State: Virginia Zip: 23294 Location 48: City: Seattle Country: United States Facility: University of Washington, Memory and Brain Wellness Center State: Washington Zip: 98195 Location 49: City: Madison Country: United States Facility: University of Wisconsin State: Wisconsin Zip: 53792 #### Overall Officials Official 1: Affiliation: University of Southern California (USC) Alzheimer's Therapeutic Research Institute (ATRI) Name: Paul Aisen, MD Role: STUDY_DIRECTOR Official 2: Affiliation: Brigham and Women's Hospital and Massachusetts General Hospital Name: Reisa Sperling, MD Role: STUDY_DIRECTOR ### References Module #### See Also Links Label: Alzheimer's Clinical Trials Consortium URL: https://www.actcinfo.org/ Label: Alzheimer's Therapeutic Research Institute URL: https://atri.usc.edu/ Label: APEX Study Home Page URL: https://www.actcinfo.org/alzheimers-plasma-extension-apex-study/ ## 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3885 - Name: Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease - 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: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416059 Brief Title: A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking Official Title: A Mobile-Delivered Personalized Feedback Intervention for Black Individuals Who Engage in Hazardous Drinking #### Organization Study ID Info ID: STUDY00004389 #### Organization Class: OTHER Full Name: University of Houston #### Secondary ID Infos ID: R41AA031398 Link: https://reporter.nih.gov/quickSearch/R41AA031398 Type: NIH ### Status Module #### Completion Date Date: 2024-08-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-05-31 Type: ESTIMATED #### Start Date Date: 2024-05-09 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: NIH Name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) #### Lead Sponsor Class: OTHER Name: University of Houston #### Responsible Party Investigator Affiliation: University of Houston Investigator Full Name: Michael J. Zvolensky, Ph.D. Investigator Title: Distinguished 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 purpose of this study is to develop and examine a culturally adapted, brief, integrated mobile health application for the Android and iOS platform, optimized to deliver a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Black hazardous drinkers with clinical anxiety. Detailed Description: Investigators will develop a culturally adapted, brief, single-session PFI delivered via a mobile health application for the Android and iOS platform through an iterative approach using expert input and semi-structured interview sessions. Next, Black hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Black hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate the feasibility, acceptability, and initial effects. Initial screening will be conducted via Zoom; baseline and post-treatment data will be collected via Zoom and 1-week, 1-month, and 3-months follow-up data will be collected remotely. ### Conditions Module Conditions: - Alcohol Abuse - Anxiety Keywords: - African American - Black - Personalized Feedback Intervention ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 50 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants complete a 45 minute intervention at baseline and will have access to intervention material for up to 3-months after the baseline appointment via the mobile health application. Intervention Names: - Behavioral: Mobile Application Label: Mobile Application Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Mobile Application Description: The mobile application is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety, Name: Mobile Application Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: The Alcohol Use Disorders Identification Test will be used to assess drinking quantity, craving, and related consequences to alcohol use. The 10 items are rated with various Likert-type scales. The measure produces a total score by adding all of the items of the measure with higher scores indicating greater problems with alcohol (possible range 0 to 40). A higher score indicates a worse outcome. Measure: Alcohol Use Disorders Identification Test Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion Description: The 5-item Overall Anxiety Severity and Impairment Scale will be used to assess anxiety symptom severity and impairment. Each of the items is rated on a Likert-type scale ranging from 0 to 4. Items are summed to produce a total score (possible range 0 to 20). A higher score indicates a worse outcome. Measure: Overall Anxiety Severity and Impairment Scale Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion #### Secondary Outcomes Description: The 1-item Motivation to Reduce Alcohol Consumption Scale will be used to measure current motivation/intention to reduce alcohol. Participants will be asked to select the statement that best describes their motivation/intention to reduce drinking (e.g., "I really want to cut down on drinking alcohol and intend to in the next month"). Higher scores on this measure indicate greater motivation/intention to reduce alcohol consumption (possible range (0-7). Measure: Motivation to Reduce Alcohol Consumption Scale Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion Description: The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking. For the current study, the 28-item questionnaire will be used as a measure of expectancies of drinking to reduce/cope with anxiety. The measure utilizes a 5-point Likert scale ranging from 1 (almost never/never) to 5 (almost always/always). Scores are averaged with higher scores indicating greater expectancies of drinking to reduce/cope with anxiety (possible range 1 to 5). Measure: Modified Drinking Motives Questionnaire-Revised Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion Description: The 7-item Alcohol Attitudes Scale will be utilized to measure maladaptive attitudes for drinking (e.g., "Drinking alcohol is good"). Items are rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). Scores will be averaged to create a composite score (possible range 1 to 7). Higher scores indicate greater maladaptive attitudes for drinking. Measure: Alcohol Attitudes Scale Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Being 21 years of age or older * Self-identifying as Black or African American * Meeting criteria for current hazardous drinking pattern * Meeting criteria for clinical anxiety * Being able to provide written, informed consent * Owning a smartphone. Exclusion Criteria: * Current participation in alcohol or other substance abuse treatment * Engaged in psychotherapy for anxiety or depression * Concurrent use of medication for anxiety or depression * Being pregnant by self-report * Residence outside of the United States confirmed via survey geolocation * Inability to provide a valid United States-issued driver's license or identification card to verify identity. Minimum Age: 21 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: byredmond@cougarnet.uh.edu Name: Brooke Y Redmond, Ph.D. Phone: 713-743-8056 Role: CONTACT Contact 2: Email: mjzvolen@central.uh.edu Name: Michael J Zvolensky, Ph.D. Phone: 713-743-8595 Role: CONTACT #### Locations Location 1: City: Houston Contacts: *Contact 1:* - Email: mssuffis@cougarnet.uh.edu - Name: Maxwell S Suffis, M.A. - Phone: 206-795-8350 - Role: CONTACT *Contact 2:* - Name: Michael J Zvolensky, Ph.D. - Role: PRINCIPAL_INVESTIGATOR *Contact 3:* - Name: Richard A Brown, Ph.D. - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity State: Texas Status: RECRUITING Zip: 77204 #### Overall Officials Official 1: Affiliation: University of Houston Name: Michael Zvolensky, Ph.D. Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: There are currently no plans to make individual participant data (IPD) available to other researchers. IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019973 - Term: Alcohol-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC25 - Name: Substance Related Disorders ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M3783 - Name: Alcoholism - Relevance: HIGH - As Found: Alcohol Abuse - ID: M21842 - Name: Alcohol-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000437 - Term: Alcoholism ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416046 Brief Title: Efficacy of Photobiomodulation in the Treatment and Relief of Pain in Recurrent Aphthous Stomatitis Official Title: Efficacy of Photobiomodulation in the Treatment and Relief of Pain in Recurrent Aphthous Stomatitis: a Randomized, Triple-blind, Controlled Clinical Trial #### Organization Study ID Info ID: PMB and RAS #### Organization Class: OTHER Full Name: Federal University of Rio Grande do Sul ### Status Module #### Completion Date Date: 2025-12-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-10-30 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-08 Study First Submit QC Date: 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Federal University of Rio Grande do Sul #### Responsible Party Investigator Affiliation: Federal University of Rio Grande do Sul Investigator Full Name: Manoela Domingues Martins Investigator Title: Principal Professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: True Oversight Has DMC: True ### Description Module Brief Summary: Photobiomodulation (PBM) is a therapy that stimulates repair, pain relief, and reduces inflammation. The aim of this study is to evaluate the effectiveness of a new PBM protocol in the treatment and pain relief of RAS lesions. Detailed Description: Recurrent aphthous stomatitis (RAS) is the most common chronic ulcerative inflammatory disorder of the oral cavity, affecting approximately 20% of the general population, with no gender predilection. Its etiopathogenesis remains undefined, although factors such as local trauma and syndromes like Behcet's syndrome are implicated in predisposition. RAS manifests in three distinct clinical presentations, with the smallest being the most common, accounting for 80% of cases. Minor RAS present as round or oval ulcers, smaller than 1 cm, covered by a grayish-white pseudomembrane, commonly occurring on non-keratinized mucosa such as lips, buccal mucosa, and floor of the mouth. Photobiomodulation (PBM) is a therapy that stimulates repair, pain relief, and reduces inflammation. The aim of this study is to evaluate the effectiveness of a new PBM protocol in the treatment and pain relief of RAS lesions. The study is a randomized, triple-blind, placebo-controlled clinical trial to be conducted at the Hospital de Clinicas de Porto Alegre (HCPA) in Rio Grande do Sul, from March 2023 to December 2025. Thirty-four patients of both genders will be selected and randomly allocated into three groups: 17 patients in the PBM treatment group with 4.5J and 17 patients in the control group. Inclusion criteria are patients over 18 years old with at least one painful ulcer in the mouth. If the patient has more than one ulcer, all will be treated. Exclusion criteria include patients who have undergone previous treatment for RAS, patients with asymptomatic ulcers, and patients with any systemic condition related to RAS - for example, Behçet's Syndrome, Periodic Fever Syndrome, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis, HIV infection. The study outcome is lesion healing, and the independent variables analyzed in the study will be: pain, lesion size, and difficulty in eating, drinking, and brushing teeth due to the presence of RAS. These variables will be collected through questionnaires administered during all patient visits. Analyses will be performed using PASW 18.0 software. Initially, data distribution will be assessed using Shapiro-Wilk and Kolmogorov-Smirnov tests. If the data show normal distribution (p\>0.05), the t-test will be used. If the distribution is non-normal (p\<0.05), the Wilcoxon test will be employed. The significance level (p-value) will be set at 5%. ### Conditions Module Conditions: - Photobiomodulation - Stomatitis, Aphthous ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Participants will be allocated and randomized into 2 groups: Group I: PBM (n=17) photobiomodulation intra oral high potency laser (4.5J) and Group II: control (n=17). ##### Masking Info Masking: TRIPLE Masking Description: The participant, examiner and outcomes assessor will not know which group has been allocated (triple-blind). Another person (the applicator) will carry out the randomization and know which group the patient belongs to. Who Masked: - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 34 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: A gallium-aluminum arsenide diode laser (Gemini® manufactured by Azena Medical, LLC, distributed by Ultradent Products, Inc.) with double wavelength 810 + 980 nm. The equipment will be programmed with 0,3W of power. The application of PBM will be carried out for at least 03 alternate days within 01 week by a trained professional. Patients who still have an ulcerated lesion on the 7th day will be assessed every 2 days until complete healing. During each irradiation, the applicator and patients will wear specific protective goggles and the instruments will be disinfected with an antiseptic solution (Chlorhexidine 2%). Points of application: Equidistant points (0.5cm) along the length of the lesion and in contact with the lesion. Intervention Names: - Device: Gemini laser Label: Intraoral photobiomodulation (PBM) Type: EXPERIMENTAL #### Arm Group 2 Description: The application of placebo will be carried out for at least 03 alternate days within 01 week (3x within 07 days) by a trained professional. Patients who still have an ulcerated lesion on the 7th day will be assessed every 2 days until complete healing. The device will not be activated and the applicator and patients will wear specific protective goggles and the instruments will be disinfected with antiseptic solution (Chlorhexidine 2%). Intervention Names: - Other: Placebo Label: Placebo Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Intraoral photobiomodulation (PBM) Description: Photobiomodulation (810 + 980 nm, 15s/point, 11.8J/cm²) to evaluate healing and pain relief in recurrent aphthous stomatitis. A 0.7mm intraoral tip will be used - spot 0.38cm2 on the extent of the lesion. Name: Gemini laser Type: DEVICE #### Intervention 2 Arm Group Labels: - Placebo Description: Examination and follow-up until the lesion heals spontaneously. The laser will not be activated. Name: Placebo Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Pain will be assessed at all appointments using the Visual Analog Scale (VAS), which will be represented by a 10 cm straight line, where 0 corresponds to the best situation and 10 to the worst situation. The research subjects will be instructed by the evaluator to mark a point on the 10 cm line. Measure: Pain assessment Time Frame: 1 week Description: Ulcer size will be assessed at every appointment using the tip of a millimeter-sized periodontal probe. Measure: Assessment of ulcer size Time Frame: 1 week Description: The functional assessment will be carried out at all appointments, evaluating the patient's subjective experience of difficulty in eating, drinking and brushing their teeth due to the presence of RAS. The answers will be scored from 0 (no difficulty) to 4 (a lot of difficulty) according to the questionnaire given to the patients Measure: Functional assessment Time Frame: 1 week #### Secondary Outcomes Description: The time of all the sessions carried out will be timed with the aid of a stopwatch, starting at the beginning of the device's activation until its deactivation. The time in seconds will be recorded on the daily evaluation form. Measure: Time measurement Time Frame: 1 week Description: Saliva samples will be collected from participants at two clinical assessment points. Patients must abstain from eating or drinking for 30 minutes prior. Saliva is collected unstimulated, with patients seated, eyes open, head slightly tilted down, and refraining from speaking, swallowing, or mouth opening for 5 minutes. Samples are collected in sterile Falcon tubes, immediately placed on ice, and stored at -80°C for later inflammatory marker analysis. Samples are stored in HCPA's Biobank per regulations and analyzed at CPE, then discarded post-analysis. Measure: Saliva collection Time Frame: 1 week ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients over the age of 18 * Patients presenting at least one painful mouth ulcer (minor ulcer), located on the tongue, jugal mucosa or labial mucosa, starting on the same day or the day before. Exclusion Criteria: * Patients who have already undergone other treatment for RAS; * Patients with asymptomatic ulcers; * Patient must not be undergoing or have undergone any treatment for RAS; * Patients with any systemic condition related to RAS - e.g. Behcet's Syndrome, Periodic Fever Syndrome, Pharyngitis and Cervical Adenitis, HIV infection. Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: manomartins@gmail.com Name: Manoela Martins, PhD Phone: 555133085011 Role: CONTACT Contact 2: Email: lili.wolfb@hotmail.com Name: Liliana Braun Phone: 5551996664438 Role: CONTACT #### Overall Officials Official 1: Affiliation: Federal University of Rio Grande do Sul Name: Manoela Martins, PhD Role: STUDY_DIRECTOR ### IPD Sharing Statement Module Access Criteria: If formally requested and referenced by the interested researcher Description: All collected IPD Info Types: - STUDY_PROTOCOL - SAP - ICF - CSR IPD Sharing: YES Time Frame: After publication of the outcomes, for one year ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M16070 - Name: Stomatitis - Relevance: HIGH - As Found: Stomatitis - ID: M16071 - Name: Stomatitis, Aphthous - Relevance: HIGH - As Found: Stomatitis, Aphthous - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: T455 - Name: Aphthous Stomatitis - Relevance: HIGH - As Found: Aphthous Stomatitis ### Condition Browse Module - Meshes - ID: D000013280 - Term: Stomatitis - ID: D000013281 - Term: Stomatitis, Aphthous ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M5953 - Name: Chlorhexidine - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M344731 - Name: Chlorhexidine gluconate - Relevance: LOW - As Found: Unknown - ID: M4215 - Name: Anti-Infective Agents, Local - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416033 Brief Title: Serum Irisin Level In Leprosy Patients Official Title: Serum Irisin Level In Leprosy Patients #### Organization Study ID Info ID: Irisin Level In Leprosy #### Organization Class: OTHER Full Name: Aswan University ### Status Module #### Completion Date Date: 2024-07-15 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-07-01 Type: ESTIMATED #### Start Date Date: 2024-01-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Aswan University #### Responsible Party Investigator Affiliation: Aswan University Investigator Full Name: Esraa Nagy Zaki Faheem Investigator Title: Resident at Dermatology, Venereology and Andrology Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: * Measurement of plasma irisin level in leprosy patients. * Correlation of plasma irisin level between leprosy patients and healthy controls. * Correlation of plasma irisin level in different leprosy types. Detailed Description: Leprosy is a chronic granulomatous infectious disease which infects mainly superficial peripheral nerves, mucosa of upper respiratory tract, testicles, bones, and eyes. It's an intracellular infection caused by the acid-fast bacillus, Mycobacterium leprae. Both age and sex are important risk factors for leprosy infection, adolescents aged between 10 and 19 years and adults aged more than 30 years are more liable to leprosy, and the possibility of leprosy infection of adult males is twice as much as adult females. Leprosy evolution involves complex host immune mechanisms that influence the clinical presentation of the disease . the spectral pathology of leprosy can be diagnosed by using two coexisting classification systems. The WHO classification system which is based on the number of lesions and Ridley and Jopling classification system which is based on the histopathology . The WHO classification system includes individuals with more than five lesions which are classified as multibacillary (MB) patients, and individuals with less than five lesions which are classified as paucibacillary (PB) patients .While Ridley and Jopling classification system includes tuberculoid leprosy (TT), lepromatous leprosy (LL) and borderline phenotypes: {borderline tuberculoid (BT), mid-borderline (BB), and borderline lepromatous (BL). Tuberculoid leprosy (TT) is characterized by the presence of one to three cutaneous lesions, called plaques. These lesions are circular or oval, erythematous/hypopigmented, hairless, scaly, dry and anesthetic. On the other hand, lepromatous leprosy (LL) is characterized by extensive and multiple bilateral lesions, which may include macules, papules, nodules, and plaques . The majority of patients, however, present with the borderline phenotypes. In these phenotypes, the bacterial load correlates with the histological features, borderline tuberculoid (BT) being more closely related to tuberculoid leprosy( TT) patients while borderline lepromatous (BL) to lepromatous leprosy (LL) patients. The borderline states are immunologically unstable and susceptible to the occurrence of leprosy reactions. In 1991 the World Health Assembly decided to 'eliminate leprosy as a public health problem' by the year 2000. Elimination was defined as decreasing the disease prevalence globally to less than 1 case per 10,000 populations. In 2000 the World Health Organization (WHO) announced that elimination was reached globally. Irisin is a protein formed of 112 amino acids. It was discovered in 2012 at Harvard University. And named after an ancient Goddess called Iris, who served as a messenger among the Gods in Greek mythology. Irisin has been linked to many metabolic diseases, including obesity, lipid metabolism ,cardiovascular disease (CVD), type 2 diabetes mellitus (T2DM) ,polycystic ovary syndrome (PCOS) ,Nonalcoholic fatty liver disease (NAFLD) and metabolic bone diseases . ### Conditions Module Conditions: - Leprosy Keywords: - Leprosy - Irisin - tuberculoid leprosy - lepromatous leprosy ### Design Module #### Design Info Observational Model: CASE_CONTROL Time Perspective: PROSPECTIVE #### Enrollment Info Count: 58 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: About 29 patients newly affected with Leprosy and The plasma irisin level of the participants will be measured by enzyme-linked immunosorbent assay (ELISA). Intervention Names: - Procedure: Serum Irisin Label: Group A :(Leprosy Group) #### Arm Group 2 Description: About 29 apparently healthy individuals and The plasma irisin level of the participants will be measured by enzyme-linked immunosorbent assay (ELISA). Intervention Names: - Procedure: Serum Irisin Label: Group B:(Control Group) ### Interventions #### Intervention 1 Arm Group Labels: - Group A :(Leprosy Group) - Group B:(Control Group) Description: Measurement of plasma irisin level in leprosy patients. Name: Serum Irisin Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: comparing the plasma irisin levels in leprosy patients with healthy Participants Measure: measurement of Serum Irisin Time Frame: 24 hours ### Eligibility Module Eligibility Criteria: Inclusion Criteria: - New cases of leprosy patients. Exclusion Criteria: * Old cases with leprosy. * Patients with cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). * Patients with polycystic ovary syndrome (PCOS), Nonalcoholic fatty liver disease (NAFLD) and metabolic bone diseases. Healthy Volunteers: True Maximum Age: 80 Years Minimum Age: 15 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT Study Population: Study will include patients with leprosy and healthy controls attending in the outpatient clinic of Dermatology, Venereology and Andrology, Aswan University Hospital, Aswan University. ### Contacts Locations Module #### Central Contacts Contact 1: Email: dresraanagy@yahoo.com Name: Esraa Nagi Faheem, Resident Phone: +201147915086 Role: CONTACT Contact 2: Email: moustafa.eltaib@aswu.edu.eg Name: Moustafa Adam EL Taieb, professor Phone: +201092991101 Role: CONTACT #### Locations Location 1: City: Aswan Contacts: *Contact 1:* - Email: ali_mohamed@aswu.edu.eg - Name: Ali Mohamed Younis, Lecturer - Phone: +201015500195 - Role: CONTACT *Contact 2:* - Email: mahmoud.ahmed@med.aswu.edu.eg - Name: Mahmoud Ahmed Ali, Lecturer - Phone: +201002364902 - Role: CONTACT Country: Egypt Facility: Aswan University Hospital Status: RECRUITING #### Overall Officials Official 1: Affiliation: Department of Dermatology, Venereology and Andrology Faculty of Medicine, Aswan University Name: Moustafa El Taieb, Professor Role: STUDY_CHAIR ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009165 - Term: Mycobacterium Infections, Nontuberculous - 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 ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10930 - Name: Leprosy - Relevance: HIGH - As Found: Leprosy - ID: M18110 - Name: Leprosy, Lepromatous - 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: M12119 - Name: Mycobacterium Infections - Relevance: LOW - As Found: Unknown - ID: M12120 - Name: Mycobacterium Infections, Nontuberculous - 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: T2664 - Name: Hansen's Disease - Relevance: HIGH - As Found: Leprosy ### Condition Browse Module - Meshes - ID: D000007918 - Term: Leprosy ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416020 Brief Title: Integrating MOUD in African American Community Settings (Better Together) Official Title: Integrating MOUD in African American Community Settings (Better Together) #### Organization Study ID Info ID: NIDA CTN Protocol 0144 #### Organization Class: OTHER Full Name: Howard University #### Secondary ID Infos ID: UG1DA013720 Link: https://reporter.nih.gov/quickSearch/UG1DA013720 Type: NIH ### Status Module #### Completion Date Date: 2027-11-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2027-05-31 Type: ESTIMATED #### Start Date Date: 2024-09-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-19 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: University of Illinois at Chicago Class: OTHER Name: University of Miami Class: NIH Name: National Institute on Drug Abuse (NIDA) Class: INDUSTRY Name: The Emmes Company, LLC #### Lead Sponsor Class: OTHER Name: Howard University #### Responsible Party Investigator Affiliation: Howard University Investigator Full Name: Richard Schottenfeld Investigator Title: Professor and Chair, Department of Psychiatry Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: A multisite effectiveness-implementation study will be conducted in three sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment of Black persons with OUD. The investigators hypothesize that treatment with the Better Together Integrated Collaborative Community MOUD care model (BT-MOUD) will result in better retention in treatment than standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) through 24 weeks following randomization. BT-MOUD provides MOUD with buprenorphine in nonmedical community-based settings via telemedicine from a hub buprenorphine clinic combined with Recovery Guiding, a manual guided coaching developed for this approach, provided onsite in the community organization. Detailed Description: This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, and Miami-Dade County will evaluate: 1) the effectiveness of providing MOUD with buprenorphine onsite (via telemedicine from a hub buprenorphine clinic) combined with Recovery Guiding in nonmedical community-based settings (the Better Together Integrated Collaborative Community MOUD care model - BT-MOUD) compared to standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) and 2) BT-MOUD implementation barriers and facilitators. In the BT-MOUD intervention, community sites serve as "spokes" for telemedicine provision of MOUD by buprenorphine providers based in a "hub" buprenorphine clinic. A trained and supervised Recovery Guide with roots or connections with the community provides manual-guided Recovery Guiding on-site in the community site. Recovery Guiding includes psychoeducation (about OUD and effective buprenorphine MOUD) and behavioral counseling to promote engagement in MOUD with buprenorphine, retention in care, medication adherence, and behavioral change supportive of recovery. In HC-MOUD Only, participants will receive MOUD with buprenorphine and other available services in the hub buprenorphine clinic only. A Peer Outreach Specialist (POS) will assist with outreach and recruitment of all participants across conditions and with maintaining high rates of follow-up in research assessments. This study will test the hypothesis that BT-MOUD is more effective than HC-MOUD Only in retaining Black persons with OUD in MOUD with buprenorphine through six months post-randomization. ### Conditions Module Conditions: - Opioid Use Disorder Keywords: - MOUD - African American - OUD - Buprenorphine ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: A multisite hybrid Type 1 effectiveness-implementation randomized clinical trial ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 330 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will receive MOUD with buprenorphine prescribed by providers based at participating hub clinics. MOUD treatment with buprenorphine will follow standard guidelines for induction and maintenance using a sublingual buprenorphine formulation. Hub clinic buprenorphine providers and participants may shift to long acting injection buprenorphine formulations after initial induction with sublingual buprenorphine. If telemedicine prescribing of MOUD with buprenorphine is part of the usual standard of care at the clinic, participants assigned to HC-MOUD Only may be prescribed buprenorphine via telemedicine, following the clinic's usual guidelines. Participants may not receive telemedicine services at the community spokes or Recovery Guiding, which are available only to participants assigned to BTMOUD. All study participants, however, may have access to any services that are routinely provided as part of the MOUD with buprenorphine treatment-as-usual care in the hub clinic. Intervention Names: - Behavioral: HC-MOUD Only Label: Hub Clinic MOUD with buprenorphine only (HC-MOUD Only) Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: Better Together Medications for Opioid Use Disorder (BT-MOUD) includes HC-MOUD plus access to telemedicine provision of MOUD with buprenorphine at a nonmedical community organization spoke, plus manual-guided Recovery Guiding provided onsite at the spoke, and plus any other services available at the community organization spoke. Recovery Guiding is a manualized, highly structured, stepwise intervention that uses educational and behavioral tools to provide pragmatic guidance for patients beginning buprenorphine treatment and to address the key recovery misconceptions and dysfunctional behaviors that frequently interfere with recovery efforts of patients initiating medication for opioid use disorder (MOUD) treatment. Intervention Names: - Behavioral: BT-MOUD with Buprenorphine Label: Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Hub Clinic MOUD with buprenorphine only (HC-MOUD Only) Description: MOUD with buprenorphine provided in a hub buprenorphine clinic Name: HC-MOUD Only Other Names: - Hub Clinic MOUD with Buprenorphine Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures Description: MOUD with buprenorphine provided by a hub buprenorphine provider either in the hub clinic or via telemedicine at a community hub; Recovery Guiding provided to participants Name: BT-MOUD with Buprenorphine Other Names: - Better Together MOUD with Buprenorphine Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Duration of continuous participation in the hub clinic provided buprenorphine treatment Measure: Buprenorphine MOUD Treatment Retention Time Frame: 0-168 days #### Secondary Outcomes Description: Number of days self-reported adherence to MOUD with buprenorphine assessed using timeline follow back (TLFB) Adherence to buprenorphine during the 168-day study period Measure: Self-reported adherence to MOUD with buprenorphine Time Frame: 0-168 days Description: Number of days self-reported days of nonmedical opioid use, stimulant use, benzodiazepine use during the 168 study period Measure: Self-reported nonmedical opioid use Time Frame: 0-168 days Description: Number of days self-reported other drug use Measure: Self-reported nonmedical other drug use Time Frame: 0-168 days Description: Number of opioid-negative urine toxicology tests, ranging from 0 to 6. Measure: Urine Toxicology Time Frame: Months 1,2 3,4,5,6 Description: Assess quality of life using the Health-related Quality of Life Health Related Quality of Life -4: Scores range from 1-5 for Q1, assessing overall health-related quality of life, and from 0-30 for Q2, Q3, and Q4 assessing physical health (Q2), mental health (Q3), and interference from health or mental health problems (Q4); higher scores indicate worse outcomes. Measure: Health-related quality of life (HRQOL) Time Frame: Months 1,2 3,4,5,6 Description: Assess depressive symptoms using Patient Health Questionnaire Depression Scale-8 (PHQ-8). Scores range from 0 to 24. Higher scores are indicators of greater depression severity. Measure: Patient Health Questionnaire Depression Scale Time Frame: Months 1,2,3,4,5,6 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Be 16 years of age or older, as documented by self-report and verified by staff at the hub buprenorphine clinic. 2. Self-identify race as Black (or African American, African, or Afro-Caribbean) (self report) 3. Meets the Diagnostic Statistical Manual (DSM) -5 diagnostic criteria for current moderate or severe OUD, based on clinical evaluation by a hub clinic buprenorphine provider and documented in the hub clinic medical record. 4. Be seeking, interested in receiving, and suitable for MOUD with buprenorphine, based on clinical evaluation by a hub clinic buprenorphine provider and documented in the hub clinic medical record. 5. Have not received MOUD in the 30 days prior to enrolling in MOUD in the hub buprenorphine clinic (based on Prescription Drug Monitoring Program \[PDMP\] and self-report) 6. Willing and able to provide informed consent, and when applicable, signed assent (consent process) 7. Speak English well enough to be able to comprehend the study procedures and complete the assessments. Exclusion Criteria: 1. Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent/assent. 2. Have a psychiatric, cognitive, or medical condition which would make participation inappropriate or contraindicated, as assessed by the hub buprenorphine clinic provider. 3. Plan to move out of the area or do not anticipate being able to remain in the study for 6 months. 4. Are unable or unwilling to provide reliable locator information. 5. Are currently in jail, prison, or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities. 6. They have previously enrolled in Clinical Trials Network (CTN) Protocol-0144 or are currently enrolled in another clinical trial for treatment of OUD. Minimum Age: 16 Years Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: richard.schottenfeld@howard.edu Name: Richard S Schottenfeld, MD Phone: 202-865-6615 Role: CONTACT Contact 2: Email: nkarnik@uic.edu Name: Niranjan Karnik, MD, PhD Phone: 312-273-0185 Role: CONTACT #### Locations Location 1: City: Washington Contacts: *Contact 1:* - Email: richard.schottenfeld@howard.edu - Name: Richard S Schottenfeld, MD - Phone: 202-865-6615 - Role: CONTACT *Contact 2:* - Email: d_m_scott@howard.edu - Name: Denise M Scott, PhD - Phone: 202-806-5264 - Phone Ext: Scott - Role: CONTACT *Contact 3:* - Name: Richard S Schottenfeld, MD - Role: PRINCIPAL_INVESTIGATOR *Contact 4:* - Name: Denise M Scott, PhD - Role: SUB_INVESTIGATOR Country: United States Facility: Howard University State: District of Columbia Zip: 20059 Location 2: City: Miami Contacts: *Contact 1:* - Email: jSzapoz@med.miami.edu - Name: Jose Szapocznik, PhD - Role: CONTACT *Contact 2:* - Email: bxl@med.miami.edu - Name: Bijan Lochart-Rodriquez, MBA - Phone: 636-387-8154 - Role: CONTACT *Contact 3:* - Name: Jose Szapocznik, PhD - Role: PRINCIPAL_INVESTIGATOR *Contact 4:* - Name: Viviana Horigian, MD,MHA - Role: SUB_INVESTIGATOR Country: United States Facility: University of Florida State: Florida Zip: 33136 Location 3: City: Chicago Contacts: *Contact 1:* - Name: Niranjan Karnik, MD, PhD - Phone: 312-273-0185 - Role: CONTACT *Contact 2:* - Email: jkfoko@uic.edu - Name: Konadu Fokuo, PhD - Phone: 312-413-8357 - Role: CONTACT *Contact 3:* - Name: Niranjan Karnik, MD, PhD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: University of Illinois- Chicago State: Illinois Zip: 60608 #### Overall Officials Official 1: Affiliation: Howard University Name: Richard S Schottenfeld, MD Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: University of Miami Name: Jose Szapocznik, PhD Role: PRINCIPAL_INVESTIGATOR Official 3: Affiliation: University of Illinois- Chicago Name: Niranjan Karnik, MD, PhD Role: PRINCIPAL_INVESTIGATOR Official 4: Affiliation: Howard University Name: Denise M. Scott, PhD Role: STUDY_DIRECTOR ### IPD Sharing Statement Module Access Criteria: Access to the scientific data generated from CTN-0144 will be controlled via a registration agreement for data use on the NIDA Data Share Website. Description: This study will comply with the NIH Policy for Data Management and Sharing (Notice Number: NOT-OD-21-013) (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) and for Helping to End Addiction Long-Term (HEAL) funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal initiative/research/heal public-access-data-sharing-policy)\]. For more details on data sharing please visit https://datashare.nida.nih.gov/. Info Types: - STUDY_PROTOCOL - SAP - ICF - CSR IPD Sharing: YES Time Frame: Datasets for Clinical Trials Network Protocol -144 (CTN-0144) will be available when either (1) the primary outcome paper has been accepted for publication, (2) the data has been locked for more than 18 months, or (3) the grant concludes; whichever comes first. The datasets will remain accessible via NIDA Data Share contingent on NIDA's continued support of the archive. To date, NIDA Data Share has not deleted any deposited data. URL: https://datashare.nida.nih.gov/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000079524 - Term: Narcotic-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12244 - Name: Opioid-Related Disorders - Relevance: HIGH - As Found: Opioid Use Disorder - ID: M2057 - Name: Narcotic-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009293 - Term: Opioid-Related Disorders ### Intervention Browse Module - Ancestors - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000009292 - Term: Narcotic Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: NarcAntag - Name: Narcotic Antagonists - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5317 - Name: Buprenorphine - Relevance: HIGH - As Found: Class - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M12243 - Name: Narcotic Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002047 - Term: Buprenorphine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06416007 Brief Title: Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors Official Title: A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors #### Organization Study ID Info ID: UCCC-RT-23-01 #### Organization Class: OTHER Full Name: University of Cincinnati ### Status Module #### Completion Date Date: 2027-06-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2027-01-01 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-06 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University of Cincinnati #### Responsible Party Investigator Affiliation: University of Cincinnati Investigator Full Name: Andrew Frankart Investigator Title: Principal 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 research study is to determine if lattice radiation therapy (LRT) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy. Detailed Description: This will be a single-institution, single-arm Phase II trial with an anticipated total of 37 patients enrolled. Treatment will consist of 5 fractions of lattice radiation therapy delivered every other day. The primary endpoints will include the efficacy of lattice therapy as evaluated by ORR (CR or PR per RECIST criteria) at 60 days (2 months) post-treatment and safety. Toxicity will be evaluated at day 5 (+/- 2 days), day 15 (+/- 5 days), day 30 (+/- 5 days), and day 60 (+/- 7 days) post-completion of lattice therapy. This study will also include a translational analysis of the impact of lattice therapy on systemic immune responses. ### Conditions Module Conditions: - Cancer - Metastatic Cancer - Locally Advanced - Locally Advanced Solid Tumor - Locally Advanced Carcinoma Keywords: - Radiation - Radiotherapy - Bulky - Spatial fractionation - Lattice therapy - Palliative - Palliation ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 37 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Lattice radiation therapy (LRT) : 5 fractions Intervention Names: - Radiation: Lattice therapy (LRT) Label: Lattice radiation therapy (LRT) Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Lattice radiation therapy (LRT) Description: 5 Fractions LRT Name: Lattice therapy (LRT) Type: RADIATION ### Outcomes Module #### Other Outcomes Description: Blood will be collected pre-treatment, after the last lattice fraction, and at 5 days post-lattice therapy for analysis via flow cytometry. Differences in immune anti-tumor responses be assessed between timepoints/tumor types. Increased immune anti-tumor responses after therapy compared to baseline are anticipated. Measure: Impact of Lattice Therapy on Systemic Immune Anti-tumor Responses via analysis of peripheral blood samples. Time Frame: Up to 5 days post-treatment #### Primary Outcomes Description: To evaluate the efficacy of lattice therapy in patients with bulky tumors, as measured by objective response rate (ORR) at 60 days post-treatment. Measure: Overall Response Rate Time Frame: 60 days post treatment Description: To characterize the safety profile and adverse events (AEs) of lattice therapy. Measure: Adverse Events Time Frame: Up to 60 days post-treatment #### Secondary Outcomes Description: To assess overall survival (OS) following lattice therapy. Overall survival will be assessed via review of medical and vital records. Measure: Overall Survival Time Frame: 12 months post treatment Description: To determine patient-reported quality of life outcomes after lattice therapy via the Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) tool as a measure of global quality of life. This is measured on 5 point Likert-type scale ranging from 0-4. Higher scores reflect better QOL. Measure: Patient-reported Quality of Life Time Frame: 60 days post treatment ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Solid tumor malignancy with a clinical indication for radiation * Patients must have measurable disease * Target lesion(s) which are amenable to lattice therapy plan * When applicable, target lesion for radiation amenable to immobilization during delivery of radiotherapy * Age ≥18 years. * ECOG Performance status ≤2 * Life expectancy greater than 3 months * Women of child-bearing potential and men must agree to avoid conception via abstinence (ideal) or a method of birth control (e.g., hormonal or barrier method of birth control) prior to study entry and for at least 30 days after completion of lattice therapy administration. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients receiving cytotoxic chemotherapy or known radiosensitizing agents within 5 days before or after lattice therapy. * Patients with hematologic malignancies including lymphoma and leukemia as well as primary or metastatic central nervous system (CNS) malignancies. * Patients with a history of conditions which predispose them to increased radiation toxicity * Patients with known contraindications to radiation therapy * Patients with uncontrolled intercurrent illness * Pregnant women Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: cancer@uchealth.com Name: UCCC Clinical Trials Office Phone: 513-584-7698 Role: CONTACT Contact 2: Name: Andrew Frankart, MD Role: CONTACT #### Locations Location 1: City: Cincinnati Contacts: *Contact 1:* - Name: Andrew Frankart, MD - Role: CONTACT Country: United States Facility: University of Cincinnati Medical Center State: Ohio Zip: 45219 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009385 - Term: Neoplastic Processes - ID: D000009369 - Term: Neoplasms - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastatic Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009362 - Term: Neoplasm Metastasis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415994 Brief Title: Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder Official Title: Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder #### Organization Study ID Info ID: RADY-IIR-19751 #### Organization Class: OTHER Full Name: Indiana University #### Secondary ID Infos ID: R01DA059321 Link: https://reporter.nih.gov/quickSearch/R01DA059321 Type: NIH ### Status Module #### Completion Date Date: 2029-12-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2028-12-01 Type: ESTIMATED #### Start Date Date: 2024-02-13 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-03-04 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: NIH Name: National Institute on Drug Abuse (NIDA) #### Lead Sponsor Class: OTHER Name: Indiana University #### Responsible Party Investigator Affiliation: Indiana University Investigator Full Name: Rupa Radhakrishnan Investigator Title: Associate Professor of Radiology & Imaging Sciences Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are: * Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment. * To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment. In this study participants will: * Receive two placental-fetal MRIs, one during second trimester and one in third trimester. * Answer surveys relating to their medical and social history. * Have blood drawn during pregnancy and delivery. * Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment. ### Conditions Module Conditions: - Opioid Use Disorder - Substance-Related Disorders - Pregnancy Related - Narcotic-Related Disorders - Buprenorphine Dependence - Methadone Dependence Keywords: - Pregnant with Opioid Use Disorder - Opioid Use Disorder - Subutex - Buprenorphine - Pregnant taking buprenorphine/subutex ### Design Module #### Bio Spec Description: Blood samples will be collected at MRI visits for substances, DNA, RNA and epigenetic analysis. Placental sample: A sample of the placenta will be collected during delivery for analysis DNA, RNA and epigenetic analysis. Retention: SAMPLES_WITH_DNA #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 250 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: 150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment Intervention Names: - Drug: Buprenorphine or Methadone Treatment - Diagnostic Test: Fetal and Placental MRI - Behavioral: Child Developmental Assessment - Behavioral: Questionnaires - Other: Blood and Placental Samples Label: Pregnant Mothers with Opioid Use Disorder #### Arm Group 2 Description: 100 pregnant mother who to not have a history of opioid use disorder Intervention Names: - Diagnostic Test: Fetal and Placental MRI - Behavioral: Child Developmental Assessment - Behavioral: Questionnaires - Other: Blood and Placental Samples Label: Pregnant Mothers ### Interventions #### Intervention 1 Arm Group Labels: - Pregnant Mothers with Opioid Use Disorder Description: Pregnant mothers must be taking Buprenorphine or Methadone Name: Buprenorphine or Methadone Treatment Type: DRUG #### Intervention 2 Arm Group Labels: - Pregnant Mothers - Pregnant Mothers with Opioid Use Disorder Description: Two MRIs : * Second Trimester * Third Trimester Name: Fetal and Placental MRI Type: DIAGNOSTIC_TEST #### Intervention 3 Arm Group Labels: - Pregnant Mothers - Pregnant Mothers with Opioid Use Disorder Description: At 1 year of life child will receive a developmental assessment Name: Child Developmental Assessment Type: BEHAVIORAL #### Intervention 4 Arm Group Labels: - Pregnant Mothers - Pregnant Mothers with Opioid Use Disorder Description: Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development Name: Questionnaires Type: BEHAVIORAL #### Intervention 5 Arm Group Labels: - Pregnant Mothers - Pregnant Mothers with Opioid Use Disorder Description: At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers. At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis. Name: Blood and Placental Samples Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls Measure: Alterations in fetal brain volume Time Frame: Between 20 weeks gestation and delivery Description: Comparing differences in placenta signal using MRI between the POE group and controls Measure: Differences in placenta signal Time Frame: Between 20 weeks gestation and delivery #### Secondary Outcomes Description: Compare placental DNA methylation in POE group and control group Measure: Placental epigenetic changes related to POE Time Frame: Between 20 weeks gestation and delivery Description: Compare concentrations of blood proteins in POE group vs controls Measure: Placental dysfunction biomarkers related to POE Time Frame: Between 20 weeks gestation and delivery Description: Measuring NOWs severity in the POE group using eat sleep console scores Measure: Neonatal Opioid Withdrawal Syndrome (NOWS) severity Time Frame: After birth through one year of life Description: Measuring NOWs severity in the POE group using length of hospital stay Measure: Length of Hospital Stay Time Frame: After birth through one year of life Description: Comparing neurodevelopment of POE group and controls using the ages and stages questionnaire at multiple time points in baby's first year of life. This questionnaire assesses infants developmental level. Scores can identify whether child is below cutoff and needs professional intervention, close to cutoff and requires more developmental support and learning, or above cutoff and on track. Measure: Ages and Stages Questionnaire Scores during infancy Time Frame: After birth through one year of life Description: Comparing neurodevelopment of POE group and controls using the Bayley's 4 assessment at one year of age. This assessment is administered by professionals to identify development delays in children. Measure: Neurocognitive and behavioral development assessment (Bayley-4) at one year of age Time Frame: After birth through one year of life ### Eligibility Module Eligibility Criteria: Pregnant women with opioid use disorder Inclusion Criteria: * Age \>18 years * Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program * Singleton Pregnancy * Planned delivery at Indiana University or University of Pittsburgh study sites Exclusion Criteria: * Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures * Known or suspected major fetal/ neonatal congenital abnormalities * HIV or AIDS Infants with prenatal opioid exposure: Inclusion: 1. Prenatal buprenorphine or methadone exposure 2. Born to mother enrolled in Opioid Use Disorder arm of study Exclusion: Major congenital anomalies or genetic syndromes affecting neurodevelopment Control Pregnant Women: Inclusion: 1. Women \>18 Years of age 2. Healthy singleton pregnancy 3. Planned delivery at Indiana University or University of Pittsburgh study sites Exclusion: 1. Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures 2. HIV or AIDS 3. Known or suspected major fetal congenital abnormalities 4. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes. Control infants: Inclusion: Born to control pregnant mother enrolled in study Exclusion: Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment. Healthy Volunteers: True Maximum Age: 100 Years Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT Study Population: Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine or methadone for opioid use disorder. ### Contacts Locations Module #### Locations Location 1: City: Indianapolis Country: United States Facility: Riley Hospital for Children State: Indiana Zip: 46202 Location 2: City: Pittsburgh Country: United States Facility: University of Pittsburg State: Pennsylvania Zip: 15260 ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M21837 - Name: Substance-Related Disorders - Relevance: HIGH - As Found: Substance-Related Disorders - ID: M2057 - Name: Narcotic-Related Disorders - Relevance: HIGH - As Found: Narcotic-Related Disorders - ID: M12244 - Name: Opioid-Related Disorders - Relevance: HIGH - As Found: Opioid Use Disorder - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009293 - Term: Opioid-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000079524 - Term: Narcotic-Related Disorders ### Intervention Browse Module - Ancestors - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000009292 - Term: Narcotic Antagonists - ID: D000000996 - Term: Antitussive Agents - ID: D000019141 - Term: Respiratory System Agents ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: NarcAntag - Name: Narcotic Antagonists - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnTuAg - Name: Antitussive Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: AnObAg - Name: Anti-Obesity Agents - Abbrev: VaCoAg - Name: Vasoconstrictor Agents ### Intervention Browse Module - Browse Leaves - ID: M5317 - Name: Buprenorphine - Relevance: HIGH - As Found: Class - ID: M11671 - Name: Methadone - Relevance: HIGH - As Found: Before surgery - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M12243 - Name: Narcotic Antagonists - Relevance: LOW - As Found: Unknown - ID: M13570 - Name: Phenylpropanolamine - Relevance: LOW - As Found: Unknown - ID: M9238 - Name: Guaifenesin - Relevance: LOW - As Found: Unknown - ID: M186319 - Name: Chlorpheniramine, phenylpropanolamine drug combination - Relevance: LOW - As Found: Unknown - ID: M4312 - Name: Antitussive Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002047 - Term: Buprenorphine - ID: D000008691 - Term: Methadone ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415981 Brief Title: Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea Official Title: Single Center Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea #### Organization Study ID Info ID: IM-003 #### Organization Class: INDUSTRY Full Name: Invicta Medical Inc. ### Status Module #### Completion Date Date: 2024-07 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2024-06 Type: ESTIMATED #### Start Date Date: 2022-12-21 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-07 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: University College London Hospitals #### Lead Sponsor Class: INDUSTRY Name: Invicta Medical Inc. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: True Oversight Has DMC: True ### Description Module Brief Summary: This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays. ### Conditions Module Conditions: - Sleep Apnea - Sleep Apnea, Obstructive - Sleep Disorder - Sleep Apnea Syndromes Keywords: - Sleep Apnea ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: BASIC_SCIENCE #### Enrollment Info Count: 7 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation Label: Hypoglossal nerve and/or Ansa Cervicalis stimulation Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Hypoglossal nerve and/or Ansa Cervicalis stimulation Description: Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis Name: Hypoglossal nerve and/or Ansa Cervicalis stimulation Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Assessment of patients with changes in acute cross-sectional area airway opening measured in cm2 under nasoendoscopy when stimulating two neural targets (the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures. Measure: Incidence of participants with changes in cross-sectional area airway opening during target stimulation Time Frame: Day 0 Description: Assessment of acute changes in airflow when stimulating the HGN in combination with the AC during a flow limited event (hypopnea or apnea). Measure: Assessment of changes in airflow outcomes Time Frame: Day 0 #### Secondary Outcomes Description: To evaluate and report all observed participant adverse events observed during study. Measure: Number of participant adverse events observed during the study Time Frame: Day 30 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Age above 18 years not under guardianship, under curatorship or under judicial protection. * Body Mass Index (BMI) \< 35 kg/m2. * Subject suffers from OSA (15 \< AHI \< 80) documented by a sleep study performed during the past 36 months. * Subject must be eligible for a diagnostic or surgical procedure. * Written informed consent obtained from the patient prior to performing any study specific procedure. * Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial. Exclusion Criteria: * Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned * Significant comorbidities that contraindicate surgery or general anesthesia * Significant tongue weakness * Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator. * Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems: * Airway cancer surgery or radiation, * Mandible or maxilla surgery in the previous 3 years (not counting dental treatments), * Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery), * Prior hypoglossal nerve stimulation device implantation. * Currently pregnant, or breastfeeding during the study period Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: London Country: United Kingdom Facility: University College London Hospital Zip: NWI 2PG ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012818 - Term: Signs and Symptoms, Respiratory - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000001523 - Term: Mental Disorders ### 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: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M4361 - Name: Apnea - Relevance: HIGH - As Found: Apnea - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: HIGH - As Found: Sleep Apnea, Obstructive - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Disorders - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - 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: D000001049 - Term: Apnea - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000020181 - Term: Sleep Apnea, Obstructive - ID: D000012893 - Term: Sleep Wake Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415968 Acronym: HEMATO-WAST Brief Title: Prevalence and Characteristics of Intimate Partner Violence Against Individuals Seeking Hematological Consultations Official Title: Prevalence and Characteristics of Intimate Partner Violence Against Individuals Seeking Hematological Consultations #### Organization Study ID Info ID: NIMAO/2023-2/JCG-01 #### Organization Class: OTHER Full Name: Centre Hospitalier Universitaire de Nīmes ### Status Module #### Completion Date Date: 2025-06 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-13 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-06 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-13 Study First Submit QC Date: 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Centre Hospitalier Universitaire de Nīmes #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Intimate violence against individuals, which is particularly marked among women, is one of the most widespread human rights violations in the world. The Women Abuse Screening Tool (WAST) self-questionnaire is a screening tool validated in French. Our preliminary data describing the association between intimate violence against women and the first attack of unexplained venous thromboembolic disease, show a significant frequency of positive responses to the WAST among women attending a biological hematology consultation at the CHU de Nîmes, for reasons of hemostasis disorders (8% out of the first 200 cases). The study authors wish to establish the prevalence of this situation among patients presenting to the CHU de Nîmes for hematological exploration and management. They hypothesize that the prevalence of violence against individuals seen in Hematology consultations is higher among individuals with hemostasis pathologies (hemorrhagic and thrombotic pathologies) than those with cellular pathologies, and higher among women than men. ### Conditions Module Conditions: - Intimate Partner Violence - Deep Vein Thrombosis (DVT)/Thrombophlebitis - Pulmonary Embolism and Thrombosis ### Design Module #### Design Info Observational Model: ECOLOGIC_OR_COMMUNITY Time Perspective: PROSPECTIVE #### Enrollment Info Count: 3240 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Label: Patients presenting at a biological hematology consultation ### Outcomes Module #### Primary Outcomes Description: Percentage of patients with a Women Abuse Screening Tool (WAST) score ≥ 5 consulting in the hemostasis pathology versus cellular hematological pathology department. The WAST is an 8-item questionnaire with a score ranging from 0 to 16 (worst violence), with a cut-off of 5 for presence of violence Measure: Prevalence of patients experiencing Intimate Partner Violence according to consulting department Time Frame: Day 0 #### Secondary Outcomes Description: WAST score ≥ 5 consulting in the hemostasis pathology versus cellular hematological pathology department in women versus men Measure: Prevalence of Intimate Partner Violence in men versus women according to consulting department Time Frame: Day 0 Description: WAST questionnaire total score in women versus men, for hemostasis disease versus cellular hematological disease versus hemorrhagic symptomatology versus thrombotic symptomatology Measure: Prevalence of Intimate Partner Violence according to patient disease status and gender Time Frame: Day 0 Description: Score for individual items of WAST questionnaire in women versus men, for hemostasis disease versus cellular hematological disease versus hemorrhagic symptomatology versus thrombotic symptomatology Measure: WAST questionnaire score according to patient disease status and gender Time Frame: Day 0 Description: WAST questionnaire total score according to: Number of years together, Violence at home growing up, Marital status (divorced or separated), Children living at home, Working status, Finances (personal income, financial difficulties), Living status (together vs separate, size of dwelling, neighbors nearby), Health status of living partner, Health status of patient Measure: Association between the major risk factors for Intimate Partner Violence and WAST score. Time Frame: Day 0 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Currently in a relationship or has been in one in the last 12 months, regardless of the length of the relationship * Willing to complete the anonymous WAST self-questionnaire * able to read and understand French * Outpatient consultant at Nîmes University Hospital in one of the following departments: * Biological hematology consultation * Clinical hematology consultation * Vascular medicine consultation Exclusion Criteria: * Individuals under court protection, guardianship or curatorship * Individuals unable to read and understand French * Individuals who have already completed the WAST questionnaire during the study period * Individuals unable to get away from their partner during the consultation to complete the questionnaire in isolation Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Outpatients attending consultations at the CHU de Nîmes for hematological diseases. ### Contacts Locations Module #### Central Contacts Contact 1: Email: jean.christophe.gris@chu-nimes.fr Name: Jean-Christophe Gris Phone: 04.66.68.32.11 Role: CONTACT #### Locations Location 1: City: Nîmes Contacts: *Contact 1:* - Email: drc@chu-nimes.fr - Name: Anissa Megzari - Phone: 0466684236 - Role: CONTACT Country: France Facility: CHUNimes #### Overall Officials Official 1: Affiliation: CHU de Nimes Name: Jean-Christophe Gris Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010689 - Term: Phlebitis - ID: D000016491 - Term: Peripheral Vascular Diseases - ID: D000014657 - Term: Vasculitis ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M16686 - Name: Thrombosis - Relevance: HIGH - As Found: Thrombosis - ID: M14509 - Name: Pulmonary Embolism - Relevance: HIGH - As Found: Pulmonary Embolism - ID: M7784 - Name: Embolism - Relevance: HIGH - As Found: Embolism - ID: M22071 - Name: Venous Thrombosis - Relevance: HIGH - As Found: Deep Vein Thrombosis - ID: M19128 - Name: Embolism and Thrombosis - Relevance: HIGH - As Found: Embolism and Thrombosis - ID: M16683 - Name: Thrombophlebitis - Relevance: HIGH - As Found: Thrombophlebitis - ID: M17400 - Name: Vascular Diseases - 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: M13594 - Name: Phlebitis - Relevance: LOW - As Found: Unknown - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: LOW - As Found: Unknown - ID: M18894 - Name: Peripheral Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M17405 - Name: Vasculitis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011655 - Term: Pulmonary Embolism - ID: D000013927 - Term: Thrombosis - ID: D000004617 - Term: Embolism - ID: D000020246 - Term: Venous Thrombosis - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000013924 - Term: Thrombophlebitis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415955 Acronym: AMPUTEEFACT Brief Title: Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation: Official Title: Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation: Biomechanical, Physiological, Psychological. #### Organization Study ID Info ID: LOCAL/2024/EP-01 #### Organization Class: OTHER Full Name: Centre Hospitalier Universitaire de Nīmes #### Secondary ID Infos Domain: IRB CHU de Nîmes ID: IRB 24.03.08 Type: OTHER ### Status Module #### Completion Date Date: 2024-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-13 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-12 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-13 Study First Submit QC Date: 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Centre Hospitalier Universitaire de Nīmes #### 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 experience of amputation leads to a deterioration in quality of life, with undeniable somatic and functional repercussions. The result is a reduction in general mobility, increased metabolic energy requirements and a feeling of discomfort and pain. The rehabilitation objectives focus on improving, or at least maintaining, the range of movement of the lower limbs, strengthening the overall muscles, ensuring that the equipment is correctly adapted, re-training for physical exertion and working on balance and walking. The rehabilitation objectives focus on social inclusion with the equipment, to optimise the return home and promote social and professional reintegration, and therapeutic education. Factors influencing the postoperative resumption of walking in amputees have been identified as key elements in the success of rehabilitation management. These include maintaining joint range of motion before fitting any equipment, combating postoperative loss of muscle mass, managing cardiorespiratory deconditioning and, finally, resuming walking with the aid of equipment, taking account of fluctuating balance. The literature shows that a change in the centre of gravity and postural instability, particularly when changing stance, are responsible for a greater risk of falls in lower-limb amputees. This asymmetry of gait, which is the cause of a greater risk of secondary joint degeneration, is found in both transtibial and transfemoral amputees. This alteration in balance has a direct influence on walking ability, and therefore calls for significant proprioceptive management in the rehabilitation programme. Gait analysis in lower-limb amputees therefore seems essential, both for the purposes of evaluating and monitoring rehabilitation treatment, and for prosthetic selection and adjustment. Three-dimensional assessment of walking in amputees, coupled with force platforms, is the test of choice for providing kinematic, kinetic and spatiotemporal data (motion capture). ### Conditions Module Conditions: - Lower Limb Amputation ### Design Module #### Design Info Observational Model: COHORT Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 200 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, at any level (trans-femoral or trans-tibial) and hospitalised in the locomotor rehabilitation department of the Nîmes University Hospital. Intervention Names: - Other: None, pure observationnal study Label: Lower Limb Amputation ### Interventions #### Intervention 1 Arm Group Labels: - Lower Limb Amputation Description: None, pure observationnal study Name: None, pure observationnal study Type: OTHER ### Outcomes Module #### Primary Outcomes Description: To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the level of amputation. VO2 consumption is measured using a VO2 master calorimetric mask, which analyses gas exchange for 3 minutes. To quantify the cost of the task, VO2 consumption over the 3rd minute is used, normalised in relation to VO2 consumption at rest. Measure: VO2 consumption as a function of amputation level Time Frame: Before and during performance of a standardised motor task Description: Quantify the cost (Vo2 consumption in mL/kg/min) of a task as a function of gait asymmetry compared with VO2 consumption at rest. Measure: VO2 consumption as a function of gait asymmetry Time Frame: Before and during performance of a standardised motor task Description: To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the prosthetic equipment compared with the consumption of VO2 at rest. Measure: Consumption of VO2 as a function of prosthetic equipment Time Frame: Before and during performance of a standardised motor task Description: To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the walking condition compared with the consumption of VO2 at rest. Measure: Consumption of VO2 as a function of walking condition. Time Frame: Before and during performance of a standardised motor task ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Amputees in PRM hospitalisation at the CHU Nîmes RRL service University Rehabilitation Hospital in Le Grau du Roi. * All aetiologies: vascular, traumatic and septic. * Appropriate vascular equipment validated by PRM doctor. * Able to walk for 5 minutes on a treadmill. * Patient affiliated to or benefiting from a health insurance scheme. * Adult patient (\>18 years) and under 80 years of age. Exclusion Criteria: * Patients with uncorrected or untreated visual disorders. * Patients with major cognitive impairment (MOCA\>23). * Patients with vestibular disorders. * Patient with uncontrolled epilepsy. * Patient with an unhealed amputation stump. * Weight \> 135kg or \< 20kg * Patients with a FAC of 1 (i.e. patients requiring the firm and continuous assistance of another person to carry their weight and maintain their balance) or less. * Inability to properly adjust the sling to the corresponding body part due to: * Body shape * Colostomy bags * Skin lesions that cannot be adequately protected. * Any other reason that prevents the harness from being adjusted correctly and painlessly. Maximum Age: 80 Years Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, whatever the level (trans-femoral or trans-tibial) and hospitalised in the locomotor rehabilitation department. Patients who were not autonomous enough to walk and required a third person (human aid) were not included. ### Contacts Locations Module #### Central Contacts Contact 1: Email: eric.pantera@chu-nimes.fr Name: Eric PANTERA Phone: +(33)4.66.68.25.36 Role: CONTACT #### Overall Officials Official 1: Affiliation: Centre Hospitalier Universitaire de Nīmes Name: Anissa MEGZARI Role: STUDY_DIRECTOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415942 Acronym: MOMS Brief Title: Assessing the Maternal Outcome Monitoring Systems Official Title: Single Arm Clinical Trial of a Novel Smartphone-based Somatic and Psychological Symptom Monitoring and Decision Support Tool for African American and Spanish Speaking Patients in the Near Postpartum Period #### Organization Study ID Info ID: AAAU9647 #### Organization Class: OTHER Full Name: Columbia University #### Secondary ID Infos ID: 5R00MD015781-04 Link: https://reporter.nih.gov/quickSearch/5R00MD015781-04 Type: NIH ### Status Module #### Completion Date Date: 2026-01-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-31 Type: ESTIMATED Last Update Submit Date: 2024-05-30 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-12-31 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-13 Study First Submit QC Date: 2024-05-13 ### Sponsor Collaborators Module #### Collaborators Class: NIH Name: National Institute on Minority Health and Health Disparities (NIMHD) #### Lead Sponsor Class: OTHER Name: Columbia University #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including African-Americans and Spanish-speaking Latinas. Our proposal aims to improve a patient's ability to detect warning signs of pregnancy related death and seek medical care. Detailed Description: Pregnancy-related death (PRD) rates have risen 120-200% in the United States in the past two decades, and experts estimate that 40-60% of these cases are preventable. Improvement initiatives are predominantly hospital-based and rely on perinatal people recognizing their own symptoms and seeking care without ample support or education. We hypothesize that we can improve patients' self-efficacy and decision-making about when to seek care by helping them to self-monitor symptoms and by providing decision support. We propose to develop a mHealth-based, patient-reported outcome (PRO) and decision-support system to help mothers determine when to seek care for warning signs of PRD. Our project focuses on diverse populations facing postpartum disparities, particularly African- American and Spanish-speaking Latina women. This protocol involves a single-arm pilot trial assessing the feasibility and preliminary effectiveness of MOMS/MAMA for improving knowledge and patient activation among postpartum patients. ### Conditions Module Conditions: - Maternal Death - Maternal Complication of Pregnancy Keywords: - pregnancy related death - patient reported outcomes - mHealth - patient activation ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: OTHER #### Enrollment Info Count: 80 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants in this condition will receive the MOMS symptom monitoring and decision support intervention. This is a single arm trial. Intervention Names: - Other: Maternal Outcome Monitoring and Support system Label: MOMS intervention Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - MOMS intervention Description: The Maternal Outcome Monitoring and Support system is a mobile health application that allows participants to choose symptoms they may be having that are warning signs of pregnancy related death. They then receive decision support about when they should seek medical care (call their provider or go to an emergency room). Name: Maternal Outcome Monitoring and Support system Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Change in patient activation measured using the validated Patient Activation Measure (PAM) Measure: Patient activation Time Frame: Baseline to 6 weeks postpartum #### Secondary Outcomes Description: Change in knowledge of warning signs for pregnancy related death Measure: Knowledge of pregnancy related death warning signs Time Frame: Baseline to 6 weeks postpartum ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Greater than 28 weeks pregnant * Receiving healthcare in the United States * Age 18 years or older * \[Identify as Black or African American race AND able to speak and read English, AND preferred language of English\] OR \[Identify as Hispanic/Latino Ethnicity AND Spanish able to speak and read Spanish AND preferred language of Spanish\] * Planned delivery at the following NewYork-Presbyterian hospitals: Children's Hospital of New York, Allen Hospital, Weill Cornell Medical Center, Lower Manhattan Hospital Exclusion Criteria: * Severe cognitive impairment * Major psychiatric illness * Concomitant terminal illness that would preclude participation. Healthy Volunteers: True Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: nb3115@cumc.columbia.edu Name: Natalie Benda Phone: 917-426-3069 Role: CONTACT #### Locations Location 1: City: New York Contacts: *Contact 1:* - Email: nb3115@cumc.columbia.edu - Name: Natalie Benda - Role: CONTACT *Contact 2:* - Name: Natalie Benda, PhD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: NewYork-Presbyterian Columbia University Irving Medical Center State: New York Zip: 10032 Location 2: City: New York Contacts: *Contact 1:* - Email: ncb4001@med.cornell.edu - Name: Natalie Benda - Role: CONTACT *Contact 2:* - Email: rbk9001@med.cornell.edu - Name: Robin Kalish - Role: CONTACT Country: United States Facility: NewYork-Prebyterian/Weill Cornell Medical Center State: New York Zip: 10065 ### IPD Sharing Statement Module Description: Data will be shared in the aggregate. There is no plan to make IDP available to other researchers. IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003643 - Term: Death - ID: D000010335 - Term: Pathologic Processes - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000063129 - Term: Parental Death ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M14127 - Name: Pregnancy Complications - Relevance: HIGH - As Found: Complication of Pregnancy - ID: M6845 - Name: Death - Relevance: LOW - As Found: Unknown - ID: M30058 - Name: Maternal Death - Relevance: HIGH - As Found: Maternal Death - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M30057 - Name: Parental Death - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000063130 - Term: Maternal Death - ID: D000011248 - Term: Pregnancy Complications ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415929 Brief Title: Etude rétrospective Monocentrique MATRIX Official Title: Single-center Retrospective Study Evaluating the Characteristics, Quality of Life and Satisfaction of Patients Undergoing Nail Resection With Dermal Matrix and Skin Graft Reconstruction at Nice University Hospital. #### Organization Study ID Info ID: 24Chirplast04 #### Organization Class: OTHER Full Name: Centre Hospitalier Universitaire de Nice ### Status Module #### Completion Date Date: 2024-04-15 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-13 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-04-15 Type: ACTUAL #### Start Date Date: 2024-03-20 Type: ACTUAL Status Verified Date: 2024-03 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-13 Study First Submit QC Date: 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Centre Hospitalier Universitaire de Nice #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: "Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy. Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus. Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy. Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus. " ### Conditions Module Conditions: - Melanoma ### Design Module #### Design Info Observational Model: CASE_ONLY Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 15 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patient with history of complete exeresis of the nail apparatus, with dermal matrix repair and total skin grafting Label: Patient with history ### Outcomes Module #### Primary Outcomes Description: Quality of life evaluation- questionnaire Measure: Quality of life evaluation Time Frame: 3 months too 36 months after the surgery ### Eligibility Module Eligibility Criteria: Inclusion Criteria: - Adult patients who have undergone complete nail removal for malignancy - Reconstructed with INTEGRA dermal matrix and total skin graft. Exclusion Criteria: -Minor patients -Patients who have undergone complete removal of the nail apparatus for malignancy but have been reconstructed in another way (flap, isolated skin graft) Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Hopital de soins tertiaires- Hopital Pasteur 2-Nice ### Contacts Locations Module #### Locations Location 1: City: Nice Country: France Facility: CHU NiICE State: Alpes Maritimes Zip: 0600 #### Overall Officials Official 1: Affiliation: Centre Hospitalier Universitaire de Nice Name: Elise Elise Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018326 - Term: Nevi and Melanomas - ID: D000012878 - Term: Skin Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11528 - Name: Melanoma - Relevance: HIGH - As Found: Melanoma - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12448 - Name: Nevus, Pigmented - Relevance: LOW - As Found: Unknown - ID: M12446 - Name: Nevus - Relevance: LOW - As Found: Unknown - ID: M20470 - Name: Nevi and Melanomas - Relevance: LOW - As Found: Unknown - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - 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 ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415916 Acronym: FLUID-REACT Brief Title: Ultrasound and Clinical Approach for the Dynamic Assessment of Fluid Tolerance in the Intensive Care Unit Official Title: Ultrasound and Clinical Approach for the Dynamic Assessment of Fluid Tolerance in the Intensive Care Unit : FLUID-REACT Study #### Organization Study ID Info ID: GUINOT 2024 #### Organization Class: OTHER Full Name: Centre Hospitalier Universitaire Dijon ### Status Module #### Completion Date Date: 2026-06 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-13 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-06 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-13 Study First Submit QC Date: 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Centre Hospitalier Universitaire Dijon #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: A major cause of admission to intensive care is acute circulatory failure resulting from organ hypoperfusion due to factors such as hypotension and myocardial dysfunction. The standard treatment, including volume expansion and vasopressor/inotropic agents, often leads to water and sodium overload, increasing the risk of morbidity and mortality in the ICU. The combination of this overload and myocardial dysfunction lead to venous congestion, particularly affecting the lungs, kidneys and gastrointestinal system. Effective fluid management is therefore crucial to maintain a balance between adequate tissue perfusion and prevention of fluid overload. Fluid tolerance, defined as a patient's ability to tolerate additional volumes of solutes without adverse effects, is assessed retrospectively by clinical signs (capillary refill time, oedema, hepatojugular reflux, etc.) and ultrasound scores (VExUS score, LUS score, etc.). However, these indicators do not fully reflect the complexity of venous congestion in patients with various conditions. Assessing fluid tolerance remains a challenge in clinical practice. It requires a personalised approach and the use of dynamic tests such as passive leg raising to predict response to vascular filling. Despite their common use, there are no studies evaluating the ability of changes in congestion markers during passive leg raising to predict fluid tolerance. In conclusion, the main hypothesis is that changes in ultrasound congestion parameters (VExUS score, LUS score and others) during passive leg raising could predict a patient's subsequent tolerance to volume expander. ### Conditions Module Conditions: - Volume Expander ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 100 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients admitted to intensive care who require volume expander Intervention Names: - Procedure: Cardiac ultrasound - Procedure: Lung ultrasound Label: patient ### Interventions #### Intervention 1 Arm Group Labels: - patient Description: Performed 5 times between 0 and 120 minutes Name: Cardiac ultrasound Type: PROCEDURE #### Intervention 2 Arm Group Labels: - patient Description: Performed 5 times between 0 and 120 minutes Name: Lung ultrasound Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: The VExUS score is calculated from ultrasound-doppler measurements of the inferior vena cava (IVC), suprahepatic venous flow (S wave, D wave), portal flow (continuous, pulsatile \>30%, pulsatile \>50%), renal venous flow (continuous, pulsatile biphasic, pulsatile monophasic). It is graded from 0 to 3 Measure: the variation in the VExUs score during passive leg raising Time Frame: Through study completion, on average of 2 hours ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Adult patient * Patient who has provided non-opposition (or health proxy or a close relative if unable to receive the information) * Patient admitted to intensive care and requiring volume expander Exclusion Criteria: * Person subject to a legal protection measure (curatorship, guardianship) * Person subject to a legal protection measure * Pregnant, parturient or breast-feeding women * Poor echogenicity assessed by the operator * Chronic AC/FA * Mechanical cardiac assistance Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Eligible patients will be identified by the investigator on admission to the intensive care unit. ### Contacts Locations Module #### Central Contacts Contact 1: Email: pierregregoire.guinot@chu-dijon.fr Name: Pierre-Grégoire GUINOT Phone: 0380281554 Phone Ext: +33 Role: CONTACT #### Locations Location 1: City: Dijon Contacts: *Contact 1:* - Email: pierregregoire.guinot@chu-dijon.fr - Name: Pierre-Grégoire GUINOT - Phone: 0380281554 - Phone Ext: +33 - Role: CONTACT Country: France Facility: Chu Dijon Bourgogne Zip: 21000 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415903 Brief Title: A Clinical Trial of TQB3117 Tablets in Patients With Advanced Malignant Cancer Official Title: A Phase I Study to Evaluate the Safety and Tolerance of TQB3117 Tablets in Patients With Advanced Malignant Cancer #### Organization Study ID Info ID: TQB3117-I-01 #### Organization Class: INDUSTRY Full Name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date Date: 2026-08 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-06 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-01 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-13 Study First Submit QC Date: 2024-05-14 ### 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: The study is divided into two phases: dose escalation and dose extension. The dosing regimens include a single-dose study and a multiple-dose study. It adopts a single-center, open-label, non-randomized, single-arm clinical trial design, where patients with advanced malignant cancer are selected to orally take TQB3117 tablets. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TQB3117 tablets in patients. ### Conditions Module Conditions: - Advanced Malignant Cancer ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 59 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: TQB3117 tables is administered as a single dose or multiple dose, ranging from 20 to 180 mg once daily. Oral administration on fast condition, with each cycle lasting 21 days. Intervention Names: - Drug: TQB3117 tablets Label: TQB3117 tablets Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - TQB3117 tablets Description: TQB3117 is a protein inhibitor. Name: TQB3117 tablets Type: DRUG ### Outcomes Module #### Primary Outcomes Description: DLT refers to occurrence of drug-related adverse events within the first treatment cycle after subjects receive single-dose or multiple-dose treatment, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria. Measure: Dose Limiting Toxicity (DLT) Time Frame: At the end of Cycle 1 (each cycle is 21 days) Description: MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. Measure: Maximum tolerated dose (MTD) Time Frame: At the end of Cycle 1 (each cycle is 21 days) Description: DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3117 tablets in adult patients with advanced malignant cancer. Measure: Recommended Phase II Dose (RP2D) Time Frame: Baseline up to 24 months #### Secondary Outcomes Description: The occurrence of all adverse events (AE). Measure: Adverse events (AE) Time Frame: 30 days after the last administration Description: The occurrence of all serious adverse events (SAE). Measure: Serious adverse events (SAE) Time Frame: 30 days after the last administration Description: To characterize the pharmacokinetics of TQB3117 by assessment of time to reach maximum plasma concentration after single and multiple dosing. Measure: Time to reach maximum plasma concentration (Tmax) Time Frame: Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21of cycle1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Description: The maximum observed plasma concentration of study drug. Measure: Peak concentration (Cmax) Time Frame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21 of cycle 1: at 0.5,1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Description: Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. Measure: Half-life (t1/2) Time Frame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Description: To characterize the pharmacokinetics of TQB3117 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity. Measure: Area under the concentration-time curve (AUC [0-infinity] Time Frame: Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose, Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Description: To characterize the pharmacokinetics of TQB3117 by assessment of area under the plasma concentration time curve from the first dose to a certain time point. Measure: Area under the concentration-time curve (AUC [0-t] Time Frame: Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Description: Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Measure: Apparent clearance (CL/F) Time Frame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Description: Apparent volume of distribution of the TQB3117 in plasma. Measure: Apparent volume of distribution (Vd/F) Time Frame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Description: The percentage of complete response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. Measure: Objective Response Rate (ORR) Time Frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; * Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria; * The main organs function well; * Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug. Exclusion Criteria: * There were other malignant tumors in 3 years; * Has multiple factors affecting oral medication; * Unalleviated toxicity ≥ grade 1 above CTCAE v5.0 due to any previous therapy, excluding hair loss; * Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period; * Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; * Have a history of psychotropic drug abuse and can not quit or have mental disorders; * Subjects with any severe and / or uncontrolled disease included: active hepatitis, have a history of immunodeficiency; * Has known symptomatic central nervous system metastases and/or cancerous meningitis; * Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one month after receiving the investigational drug for the first time; * Has participated in other clinical trials within 4 weeks before first dose; * According to the judgement of the investigators, there are other factors that may lead to the termination 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: sdyujinming@126.com Name: Jinming Yu, Doctor Phone: 13806406293 Role: CONTACT Contact 2: Email: 13370582181@163.com Name: Yuping Sun, Doctor Phone: 0531-67627156 Role: CONTACT #### Locations Location 1: City: Jinan Contacts: *Contact 1:* - Email: sdyujinming@126.com - Name: Jinming Yu, Doctor - Phone: 13806406293 - Role: CONTACT Country: China Facility: The First Affiliated Hospital of Shandong First Medical University State: Shandong Zip: 250117 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415890 Brief Title: Effect of 4-7-8 Breathıng Technıque on Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholesectectomy Official Title: The Effect of Usıng The 4-7-8 Breathıng Technıque on Postoperatıve Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholecystectomy #### Organization Study ID Info ID: HMKU-SERBEST-001 #### Organization Class: OTHER Full Name: Mustafa Kemal University ### Status Module #### Completion Date Date: 2025-07-15 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-04-15 Type: ESTIMATED #### Start Date Date: 2024-07-15 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-05 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Mersin University #### Lead Sponsor Class: OTHER Name: Mustafa Kemal University #### Responsible Party Investigator Affiliation: Mustafa Kemal University Investigator Full Name: Ayse Nur Serbest Baz Investigator Title: Lecturer Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This study was planned as a randomized controlled clinical trial to determine the effect of 4-7-8 breathing technique on shoulder pain and pulmonary function tests after laporoscopic cholecystectomy. A sample of 96 patients will be randomly assigned to the study and control groups. The study group will be administered the 4-7-8 breathing technique after LK, while the control group will be given routine care of the ward. Shoulder pain and pulmonary function tests will be measured in the first 24 hours and at discharge. The data obtained will be analyzed by appropriate statistical methods. Detailed Description: Laporoscopic cholecystectomy (LC) is the most commonly used method for the treatment of cholecystitis, one of the most common diseases of the digestive system. In addition to its advantages such as low risk of complications and usually requiring less than 24 hours of hospitalization, shoulder pain develops in approximately 35-80% of patients after LC. After LK, patients' lungs may be affected due to factors such as intraoperative general anesthesia, mechanical ventilation support, carbon dioxide (CO2) pneumoperitoneum administration, anesthetic drugs and patient positioning, and patients experience shoulder pain, especially with CO2 pneumoperitoneum administration. In patients undergoing LK, shoulder pain felt throughout the thorax causes spasm and restriction of movement in the muscles assisting respiration and an increase in intercostal tone. This leads to a decrease in the amount of air filling the lungs, accumulation of secretions, pneumonia, decreased functional residual volume and increased risk of atelectasis. For this reason, it is necessary to evaluate the respiratory system in patients undergoing LK as in all surgical interventions and to monitor pulmonary functions (FVC, FEV1, FEV1/FCV) to evaluate the deterioration in lung functions and to control pain with pharmacologic and non-pharmacologic methods. One of the respiratory exercises that nurses can apply independently in the removal of CO₂, improvement of respiratory functions and pain control after surgery is the 4-7-8 breathing technique. This technique has been proven to have positive contributions in pain control, and its easy application, reliability and non-invasiveness make its use widespread. This study was planned as a randomized controlled clinical trial to determine the effect of 4-7-8 breathing technique on shoulder pain and pulmonary function tests after LK. A sample of 96 patients will be randomly assigned to the study and control groups. The study group will be administered the 4-7-8 breathing technique after LK, while the control group will be given routine care of the ward. Shoulder pain and pulmonary function tests will be measured in the first 24 hours and at discharge. The data obtained will be analyzed by appropriate statistical methods. ### Conditions Module Conditions: - Laparoscopic Cholecystectomy - Breathing Exercise - Pulmonary Function Test - Shoulder Pain - Surgical Nursing - 4-7-8 Breathing Technique ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: The study was planned as a prospective, two-arm randomized controlled clinical trial. ##### Masking Info Masking: DOUBLE Masking Description: The information that the patients included in the research sample were assigned to groups A and B according to the randomization table will be kept by the consultant, the researcher will fill out the "Informed Consent Form" for all patients when he/she goes to the patient for the application, and then the consultant will share the information about which group the patient is in with the researcher. When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups and the data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will be blinded to group assignment. Who Masked: - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 98 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: In addition to the routine treatment and care practices of the clinic, the patients included in the study group will be taught the 4-7-8 breathing technique by the researcher and applied after surgery. They will be provided to complete one set (4 breaths) by practicing the 4-7-8 breathing technique first with the researcher and then alone. The training will last approximately 15 minutes for each patient. Patients will be asked to start the first breathing exercise at the 4th hour after coming to the clinic after laparoscopic cholecystectomy and perform one set (4 breaths) every two hours. Intervention Names: - Other: 4-7-8 Breathing Technique Label: Breathing Exercise Group Type: EXPERIMENTAL #### Arm Group 2 Description: Patients in the control group will receive routine treatment and care after laparoscopic cholecystectomy. In the clinic, patients are not trained on postoperative breathing exercises and the use of triflow is recommended. However, there is no planned training for the use of this tool and the patients' use of the tool is not monitored. Label: Control Group Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Breathing Exercise Group Description: The 4-7-8 breathing technique to be applied to the patients in the experimental group; the patient will be asked to sit or lie in a comfortable position with his/her hands on his/her lap, press the tip of his/her tongue on the tissue protrusion behind the upper front teeth and hold it there during the breathing cycle, breathe in through the nose for four counts, hold the breath for seven counts and then slowly exhale through the mouth for eight counts and complete a set. Within one set of practice, this cycle repeats four times. Name: 4-7-8 Breathing Technique Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Visual Analog Scale (VAS):The VAS used in this study is a one-dimensional pain scale commonly used in adult populations. The VAS is a continuous scale consisting of a horizontal or vertical line 10 centimeters (100 mm) long. Pain intensity is determined by statements ranging from "no pain" at one end of the scale to "excruciating pain" at the other end. The participant is asked to place a line perpendicular to the VAS line at the point representing pain intensity. Pain scoring is determined by measuring the distance (mm) on the 10-centimeter line using a ruler and is defined by providing a score range between 0-100 mm (No pain=0-4 mm, mild pain=5-44 mm, moderate pain=45-74 mm and severe pain=75-100 mm). In this study, the vertical form of the VAS will be used to evaluate shoulder pain in patients after surgical intervention based on the information that the vertical form of the VAS gives more accurate results than the horizontal form Translated with DeepL.com (free version) Measure: Shoulder Pain Time Frame: Second postoperative day Description: Pulmonary Function Test: Pulmonary function values will be evaluated with a portable . FVC (%), FEV1 (%) and FEV1/FVC (%) parameters will be used in the evaluationpulmonary function test device. Measure: Pulmonary Function Test Time Frame: Second postoperative day ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Undergoing elective laparoscopic cholecystectomy, * Admitted to the clinic at least 2 hours before the surgical procedure, * Open to communication and cooperation, * Written and verbal permission to participate in the study was obtained, * Conscious, oriented and cooperative, * No cognitive and mental problems, * Speaks and understands Turkish, * American Society of Anesthesiologists (ASA) classification scores of I and II, * Hospitalized at least one night after surgical intervention, * Patients aged 18 years and older will be included in the study. Exclusion Criteria: * Undergoing emergency laparoscopic cholecystectomy, * Open cholecystectomy, * Not admitted to the clinic at least 2 hours before the surgical procedure, * Not open to communication and cooperation, * Written and verbal permission to participate in the research could not be obtained, * Unconscious, disoriented and uncooperative, * Cognitively and mentally impaired, * Speaking Turkish but not understanding it, * Discharged on the same day after surgical intervention, * ASA score III and above, * Patients aged 18 years and younger will not be included in the study. Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: aysenurserbest@hotmail.com Name: Ayşe Nur SERBEST BAZ Phone: 03262213317 Role: CONTACT Contact 2: Email: gulaltun@mersin.edu.tr Name: Gülay ALTUN UĞRAŞ Phone: 03243610001 Role: CONTACT #### Overall Officials Official 1: Affiliation: Mersin University Name: Gülay ALTUN UĞRAŞ Role: STUDY_DIRECTOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Hosseinzadeh F, Nasiri E, Behroozi T. Investigating the effects of drainage by hemovac drain on shoulder pain after female laparoscopic surgery and comparison with deep breathing technique: a randomized clinical trial study. Surg Endosc. 2020 Dec;34(12):5439-5446. doi: 10.1007/s00464-019-07339-z. Epub 2020 Jan 13. PMID: 31932939 Citation: Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8. PMID: 36480101 Citation: Chinagudi, S., Badami, S., Herur, A., Patil, S., Gv, S., & Ankad, R. (2014). Immediate effect of short duration of slow deep breath-ing on heart rate variability in healthy adults. National Journal of Physiology, Pharmacy and Pharmacology, 4(3), 233- 235. Citation: Vierra J, Boonla O, Prasertsri P. Effects of sleep deprivation and 4-7-8 breathing control on heart rate variability, blood pressure, blood glucose, and endothelial function in healthy young adults. Physiol Rep. 2022 Jul;10(13):e15389. doi: 10.14814/phy2.15389. PMID: 35822447 Citation: Toleska M, Dimitrovski A, Shosholcheva M, Kartalov A, Kuzmanovska B, Dimitrovska NT. Pain and Multimodal Analgesia in Laparoscopic Cholecystectomy. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2022 Jul 13;43(2):41-49. doi: 10.2478/prilozi-2022-0017. PMID: 35843915 Citation: Lee J, Hur MH. The Effects of Aroma Essential Oil Inhalation on Stress, Pain, and Sleep Quality in Laparoscopic Cholecystectomy Patients: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2022 Feb;16(1):1-8. doi: 10.1016/j.anr.2021.11.002. Epub 2021 Dec 24. PMID: 34954406 Citation: Russo MA, Santarelli DM, O'Rourke D. The physiological effects of slow breathing in the healthy human. Breathe (Sheff). 2017 Dec;13(4):298-309. doi: 10.1183/20734735.009817. PMID: 29209423 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000018771 - Term: Arthralgia - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M27137 - Name: Respiratory Aspiration - Relevance: HIGH - As Found: Breathing - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M21907 - Name: Shoulder Pain - Relevance: HIGH - As Found: Shoulder Pain - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M20833 - Name: Arthralgia - 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: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020069 - Term: Shoulder Pain - ID: D000053120 - Term: Respiratory Aspiration ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415877 Acronym: Episiotomy Brief Title: The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training Official Title: The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training #### Organization Study ID Info ID: 1111111 #### Organization Class: OTHER Full Name: Osmaniye Korkut Ata University ### Status Module #### Completion Date Date: 2024-06-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-06-20 Type: ESTIMATED #### Start Date Date: 2024-05-30 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-09 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Emine Yıldırım #### Responsible Party Investigator Affiliation: Osmaniye Korkut Ata University Investigator Full Name: Emine Yıldırım Investigator Title: Assistant Professor Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: It was planned as a randomized controlled study to determine the effect of the modified simulation model on self-efficacy, anxiety and academic motivation in episiotomy training. It will be held online with students from the midwifery department of Osmaniye Korkut Ata University. ### Conditions Module Conditions: - Episiotomy - Anxiety - Simulation Keywords: - episiotomy - anxiety - simulation ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: BASIC_SCIENCE #### Enrollment Info Count: 90 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: beef tongue stitched Intervention Names: - Other: Episio Training Label: placebo Type: PLACEBO_COMPARATOR #### Arm Group 2 Description: episio model Intervention Names: - Other: Episio Training Label: sham comparator Type: SHAM_COMPARATOR #### Arm Group 3 Description: modified tripe coated veal Intervention Names: - Other: Episio Training Label: experimental group Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - experimental group - placebo - sham comparator Description: episio repair training Name: Episio Training Type: OTHER ### Outcomes Module #### Primary Outcomes Description: questionnaire Measure: self-efficacy Time Frame: 1 week #### Secondary Outcomes Description: questionnaire Measure: academic motivation Time Frame: 1 week ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Midwifery student * volunteers Exclusion Criteria: * involuntary Healthy Volunteers: True Sex: FEMALE Standard Ages: - CHILD - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415864 Brief Title: Oral Cladribine B-cell Study Official Title: Oral Cladribine B-cell Study #### Organization Study ID Info ID: 262436 #### Organization Class: OTHER Full Name: Queen Mary University of London ### Status Module #### Completion Date Date: 2024-01-31 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-01-31 Type: ACTUAL #### Start Date Date: 2019-07-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-03 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Queen Mary University of London #### 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 study the impact of cladribine on peripheral and intrathecal B-cell, plasma cells, T cells and Tregs Detailed Description: Primary: To quantify the temporal changes of memory B cells (CD19+/CD27+/IgD-/+), plasmablasts (CD19-/CD138+/CD38+) and T cells (CD4/CD45RA-/+, CCR7-/+, CD8+/CD45RA-/+/CCR7-/+), Tregs (CD4/CD8)/CD25+/CD127-/Fox3 P+) in the peripheral venous blood of pwMS with RRMS over 96w of treatment with oral cladribine. These will be compared to the populations of non-memory or class-switched B cells (immature/transitional B cells CD10+/CD38+/CD19+, immature regulatory B cells CD10+/CD38+/CD19+/CD24+/IL-10+, mature B cells CD10-/CD38+/CD19+). Secondary: 1. To study the effects of oral cladribine on: 1. CSF OCBs and free immunoglobulin kappa and lambda light chain levels (FLC). 2. CSF markers of inflammation, in particular CXCL-13 and urine markers of inflammation (neopterin). 3. CSF markers of neuroaxonal damage, in particular free neurofilament light chains. 4. On the peripheral repertoire B-cells (immunoglobulin) and T-cells (T cell receptor) and plasma cells (soluble receptors). 2. To compare CSF OCB positivity and CSF light chain levels with a contemporary control group of alemtuzumab treated pwMS (historical data). Tertiary: 1. To compare B and T cell repertoire with a contemporary control group of alemtuzumab treated pwMS (historical data). 2. To evaluate the effect of changes in the immune cell profile on clinical measures of disability, MRI activity and PROMS. ### Conditions Module Conditions: - Multiple Sclerosis Keywords: - MS ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 10 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight Label: Cladribine (Mavenclad, Merck Serono Ltd) ### Outcomes Module #### Other Outcomes Description: To compare B and T cell repertoire with a contemporary control group of alemtuzumab treated pwMS (historical data Measure: Compare the data of T and B cells from the CladB study versus Alemtuzumab Time Frame: 2 years #### Primary Outcomes Description: The temporal changes of memory B cells (CD19+/CD27+/IgD-/+), plasmablasts (CD19-/CD138+/CD38+) T cells (CD4/CD45RA-/+, CCR7-/+, CD8+/CD45RA-/+/CCR7-/+) and Tregs (CD4/CD8)/CD25+/CD127-/Fox3 P+), will be performed in the peripheral venous blood of pwMS with RRMS over 96w of treatment with oral cladribine, using Flow Cytometry. These populations of cells will be compared to the populations of non-memory or class-switched B cells (immature/transitional B cells CD10+/CD38+/CD19+, immature regulatory B cells CD10+/CD38+/CD19+/CD24+/IL-10+, mature B cells CD10-/CD38+/CD19+). Measure: To study B cells subsets changes Time Frame: 2 years #### Secondary Outcomes Description: To study the effects of oral cladribine on CSF OCBs and FLC between baseline, 48kws and 96 wks Measure: Changes in OCBs and free immunoglobulin kappa and lambda light chain levels (FLC) Time Frame: 2 years Description: To study the effects of oral cladribine on CSF markers of inflammation, in particular CXCL-13 and neopterin between baseline, 48kws and 96 wks Measure: Measure of CXCL-13 and urine markers of inflammation (neopterin) Time Frame: 2 years Description: To study the effects of oral cladribine on CSF NFL between baseline, 48kws and 96 wks Measure: Measure of Neurofilament light chain (NFL) Time Frame: 2 years Description: o study the effects of oral cladribine on CSF sCD138 between baseline, 48kws and 96 wks Measure: Measure of soluble CD138 Time Frame: 2 years Description: o study the effects of oral cladribine on CSF cytokines and chemokines between baseline, 48kws and 96 wks Measure: Measure of cytokines and chemokines Time Frame: 2 years ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients with MS who are being treated with oral cladribine at Barts Health NHS Trust will be approached to participate in this study. * Patients must be willing and able to undergo lumbar punctures * Patients who are OCB positive in their CSF (previous diagnostic lumbar puncture) Exclusion Criteria: * Ineligible for oral cladribine under NHS England prescribing guidelines and those participating in MAGNIFY-MS study (cladribine tablets in active MS) * Unsuitable to have a lumbar puncture, for example spinal deformity, tethered cord syndrome or the use of aspirin or anticoagulants, and those unable to comply with study requirements, including frequency of visits and lumbar punctures. * Presence of comorbidities in which the administration of cladribine is contraindicated. * Abnormal baseline investigations (WBC\<3 x 10\9/l, lymphocytes \<1.0 x 10\9/l, neutrophil count \<1.5 x 10\9/l, platelet count \<100 x 10\9, haemoglobin \<110g/l, LFT\>/3x upper limit of normal of site reference ranges, potassium \<2.8mmol/l or \>5.5mmol/l, sodium \<125 mmol/l, creatinine \>130 umol/l) Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT Study Population: Relapsing-remitting MS ### Contacts Locations Module #### Locations Location 1: City: London Country: United Kingdom Facility: Barts Health NHS Trust ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: LOW - As Found: Unknown - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19625 - Name: Cladribine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415851 Brief Title: Chemotherapy Plus Bevacizumab and Anti-PD-1 Followed by Induction Therapy of Chemotherapy Plus Bevacizumab Official Title: Efficacy and Safety of Chemotherapy Plus Bevacizumab and Anti-PD-1 Followed by Induction Therapy of Chemotherapy Plus Bevacizumab as First-line Therapy in MSS Unresectable Metastatic Colorectal Cancer: a Prospective, Single-center, Single-arm Trial #### Organization Study ID Info ID: SRRS-CAPTUR #### Organization Class: OTHER Full Name: Sir Run Run Shaw Hospital ### Status Module #### Completion Date Date: 2026-05-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-05-30 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-03 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Zhangfa Song #### Responsible Party Investigator Affiliation: Sir Run Run Shaw Hospital Investigator Full Name: Zhangfa Song Investigator Title: Professor Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Is US Export: False Oversight Has DMC: True ### Description Module Brief Summary: Fluorouracil and oxaliplatin-based combined with molecular targeted drugs are still the main treatment strategies for patients with advanced metastatic colorectal cancer (mCRC). Multiple studies have confirmed that anti-PD-1 combined chemotherapy regimens can bring better survival benefits to patients with advanced mCRC. Slulimab is a humanized IgG4 monoclonal antibody with clear anti-tumor efficacy and easy management of adverse reactions. Therefore, the main purpose of this study is to explore the effectiveness of chemotherapy and bevacizumab induction therapy combined with PD-1 monoclonal antibody in the first-line treatment of MSS-type initial unresectable mCRC. Detailed Description: Colorectal Cancer (CRC) is a common malignant tumor. Its incidence ranks third and second among men and women respectively, and its mortality rate ranks third. Data from the World Health Organization's International Agency for Research on Cancer (IARC) in 2020 show that more than 930,000 patients died due to CRC. Since 2000, the incidence and mortality of colorectal cancer have been steadily increasing in China. The National Cancer Center of China (NCC) reported that there were approximately 408,000 new cases of CRC in China in 2016, and approximately 196,000 deaths. Most of the patients are in the mid-to-late stage when diagnosed, and about 35% of them are in the advanced stage. They have no chance of radical surgery and can only receive palliative care. In the early days when leucovorin (LV) and 5-fluorouracil (5-FU) were used as the main treatment options for patients with metastatic colorectal cancer (mCRC), the efficacy was poor, and the median overall survival (OS) of patients was only for 8-12 months. Since the introduction of effective cytotoxic drugs such as irinotecan and oxaliplatin in 2000, the combination regimens FOLFOX (5-FU/LV + oxaliplatin) and FOLFIRI (5-FU/LV + irinotecan) have become first-line systemic Standard protocol in treatment. The use of biologics targeting key pathways in the development and progression of mCRC, such as epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF)-related pathways, further extends the survival of mCRC patients. In the latest version of CSCO colorectal cancer diagnosis and treatment guidelines, the main recommended first-line treatments are FOLFOX/FOLFIRI±bevacizumab or cetuximab (both RAS and BRAF are wild-type), FOLFOX/FOLFIRI±bevacizumab (RAS or BRAF mutant). PD-1 plays an important role in suppressing immune responses and promoting immune tolerance by inhibiting the activity of T cells, allowing cancer cells to evade immune surveillance. Cells in the tumor microenvironment often express PD-1 and PD-L1. Consistent with the inducible expression of PD-L1 by tumor cells, activated CD8+ effector T cells often express PD-1, indicating that tumor cells are resistant to adaptive immune responses. PD-L1 has been found to be expressed in many types of cancer, including melanoma, lung cancer, urothelial cancer, and hepatocellular carcinoma. Its expression can also be induced by various factors such as radiation, which helps cancer cells evade immune regulation. Blocking the PD-1/PD-L1 interaction has been shown to treat a variety of cancers. Clinical studies have proven that anti-PD-1 and anti-PD-L1 monoclonal antibodies can induce long-lasting anti-tumor activity against a variety of tumors. Anti-PD-1 monoclonal antibodies have been approved for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, entities with high microsatellite instability or mismatch repair deficiency and colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma (HCC), Merkel cell carcinoma (MCC), renal cell carcinoma, endometrial cancer, bladder cancer, primary mediastinal large B-cell lymphoma ( PMBCL) and classic Hodgkin lymphoma. A large number of clinical studies of anti-PD-1 antibodies are currently underway, some as monotherapy and some in combination with multiple drugs. This study is an open-label, single-arm, phase II clinical trial. The study inclusion criteria are patients with unresectable mCRC aged 18-75 years old and histologically confirmed by multidisciplinary treatment (MDT). The patients have RAS gene mutations and are confirmed to be MSS. state. All patients received treatment with sintilimab combined with CapeOx and bevacizumab. After the disease achieved complete response (CR)/partial response (PR)/stable disease (SD), maintenance treatment was performed. The main purpose of the study Endpoints include objective response rate (ORR) as assessed by RECIST v1.1 and adverse events as assessed by CTCAE v5.0. The secondary endpoint is progression-free survival (PFS). This study mainly aims to explore the effectiveness of chemotherapy and bevacizumab induction therapy combined with PD-1 monoclonal antibody in the first-line treatment of MSS-type initial unresectable metastatic colorectal cancer. The second is its safety and tolerability. ### Conditions Module Conditions: - Metastatic Colorectal Cancer - MSS ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 36 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Induction therapy: mFOLFOX6 regimen + bevacizumab. mFOLFOX6 regimen: Oxaliplatin 85 mg/m2 ; LV 400 mg/m2; 5-FU 400 mg/m2, Intravenous bolus injection, day 1, then maintain 1200mg/(m2∙d) × 2d continuous intravenous infusion (total volume 2400mg/m2, infusion 46-48h), q2w; Bevacizumab: 5mg/kg; lasting 2 cycles. Combination therapy: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody. mFOLFOX6 regimen: Oxaliplatin 85 mg/m2 intravenously infused for 90-120 minutes on day 1; LV 400 mg/m2 intravenous infusion for 2 hours, combined with oxaliplatin injection time on day 1; 5-FU 400 mg/m2, Intravenous bolus injection, day 1, then maintain 1200mg/(m2∙d) × 2d continuous intravenous infusion (total volume 2400mg/m2, infusion 46-48h), q2w; bevacizumab: 5mg/kg, intravenously Infusion, day 1, q2w; Slulimab: 200 mg, intravenous infusion, day 1, q2w. Every 2 weeks is a cycle. Intervention Names: - Drug: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody Label: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody Description: This study is a single-arm intervention study. All subjects in this study will be treated with this study protocol, that is, after mFOLFOX6 protocol and bevacizumab induction therapy, combined with slulimumab treatment. Name: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody Type: DRUG ### Outcomes Module #### Primary Outcomes Description: The time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Measure: progression free survival(PFS) Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months #### Secondary Outcomes Description: It refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time Measure: objective response rate(ORR) Time Frame: through study completion, an average of 1 year Description: Refers to the proportion of patients with best overall assessment of complete response, partial response, or stable disease. Measure: disease control rate(DCR) Time Frame: through study completion, an average of 1 year Description: Overall survival (os) is defined as the date from randomization to death from any cause. Measure: overall survival(OS) Time Frame: 5 years Description: Vital signs, laboratory indicators, adverse events (AEs) and serious adverse events (SAEs), drug-related AEs and SAEs, and AEs specific to this type of drug (such as hypertension, proteinuria, etc.); according to NCI-CTCAE V5. 0 standard judgment. Measure: Adverse events Time Frame: through study completion, an average of 1 year ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. The patient volunteered to participate in the study, signed the informed consent form, and had good compliance. 2. Age: 18-75 years old (including 18 years old and 75 years old). 3. Body weight of 40kg. 4. Metastatic colorectal cancer confirmed by histology and / or cytology and initially unresectable. 5. MSS type or pMMR. 6. Patients are required to have at least one measurable lesion (RECIST 1.1). 7. ECOG physical strength status: 0-1 point. 8. Expected survival of 12 weeks. 9. Blood test (no transfusion within 14 days, no correction with granulocyte colony stimulating factor or other hematopoietic stimulating factor within 7 days before the laboratory test) 1. Absolute neutrophil value of 1.5109/ L, platelet 1010109/ L, hemoglobin concentration of 9 g/dL); 2. Liver function test (bilirubin 1.5 ULN; aspartate aminase and glutamate aminase 2.5 ULN, AST and ALT 5 ULN); 3. Renal function (serum creatinine 1.5 ULN or creatinine clearance (CCr) 60 mL/min); 4. Coagulation (international normalized ratio (INR) 1.5 ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) 1.5 ULN); 5. Thyroid function, upper limit of normal (TSH); if abnormal, FT3 and FT4 levels should be examined, normal FT3 and FT4 levels can be included. 10. Women of childbearing age must have a negative serum pregnancy test within 14 days before treatment and be willing to use medically approved effective contraception (e. g., IU, contraceptives or condoms) during 3 months after the study and the last study drug; surgical sterilization for male subjects with a woman of childbearing age, or effective contraception is recommended during the study and 3 months after the last study dose. Exclusion Criteria: 1. Have received the following treatments within the first 4 weeks of treatment: tumor radiotherapy, surgery, chemotherapy, immune or molecular targeted therapy, and other clinical study drugs. 2. Active autoimmune diseases requiring systemic treatment (i. e., corticosteroids or immunosuppressive agents) have occurred in the past 2 years. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment. 3. Diagnosis with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first treatment. A physiological dose of corticosteroids may be approved after consultation with the investigator. 4. Previous small molecule targeted drug therapy, such as fuquintinib, etc. 5. Previous treatment with an oxaliplatin-based chemotherapy regimen. 6. Symptomatic brain or meningeal metastases. 7. Metastatic colorectal cancer with either MSI-H or dMMR. 8. Severe infection (e. g. intravenous infusion of antibiotics, antifungals or antiviral drugs), or unexplained fever\> 38.5℃ during screening / first dose. 9. Hypertension that is not well controlled with antihypertensive medication (systolic 140 mmHg or diastolic 90 mmHg). 10. Significant clinical bleeding symptoms or significant bleeding tendency (bleeding\> 30 mL, hematemesis, black feces, stool within 3 months), hemoptysis (\> 5 mL of fresh blood within 4 weeks); or venous / venous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; or long-term anticoagulation with Chinese standard or heparin, or long-term antiplatelet therapy (aspirin 300 mg / day or clopidogrel 75 mg / day). 11. During screening, the tumor was found to invade large vascular structures, such as pulmonary artery, superior vena cava vein or inferior vena cava vein, which was judged to be at risk of large bleeding by the investigators. 12. Active heart disease, including myocardial infarction, severe / unstable angina, within 6 months before treatment. Echocardiography showed a left ventricular ejection fraction of \<50%, and the arrhythmia was poorly controlled. 13. Other malignancies within or during the previous 5 years (except for cured skin basal cell carcinoma and carcinoma of the cervix in situ). 14. Known allergy to the study drug or any of its excipients. 15. Active or uncontrolled serious infection; A)known human immunodeficiency virus (HIV) infection; B) known history of clinically significant liver disease, including: viral hepatitis \[known hepatitis B virus (HBV) carriers must exclude active HBV infection, namely HBV DNA positive (\> 1104 copies / mL or\> 2000 IU / mL); known hepatitis C virus infection (HCV) and HCV RNA positive (\> 1103 copies / mL)\], or other hepatitis, cirrhosis; 16. Any other disease, clinically significant metabolic abnormalities abnormal physical examination or laboratory abnormalities, according to the investigator, there is reason to suspect a disease or state is not suitable for the study drug (such as seizures and need treatment), or will affect the interpretation of the results, or make the patient in a high risk situation. 17. Routine urine indicates urine protein 2 +, and 24-hour urine protein quantification\> 1.0g. Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Hanzhou Country: China Facility: Sir Run Run Shao hospital State: Zhejiang Zip: 310012 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### 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: D000007155 - Term: Immunologic Factors ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: HIGH - As Found: Given - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: HIGH - As Found: Chemotherapy - ID: M246 - Name: Bevacizumab - Relevance: HIGH - As Found: Non- - ID: M8600 - Name: Fluorouracil - Relevance: LOW - As Found: Unknown - ID: M1674 - Name: Oxaliplatin - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - 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: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068258 - Term: Bevacizumab - ID: D000000906 - Term: Antibodies - ID: D000000911 - Term: Antibodies, Monoclonal ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415838 Acronym: DePrevent Brief Title: Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context Official Title: Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context: A Randomized Controlled Trial #### Organization Study ID Info ID: DePrevent #### Organization Class: OTHER Full Name: Sormland County Council, Sweden ### Status Module #### Completion Date Date: 2026-08 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-08 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-07 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Eskilstuna municipality #### Lead Sponsor Class: OTHER Name: Sormland County Council, Sweden #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The goal of this randomized clinical trial is to investigate if a brief psychological treatment called Behavioral Activation (BA) works to prevent and treat depression in older adults in a municipal context in Sweden. It will also learn about the patients' and therapists' experiences of the BA-treatment. The main questions it aims to answer are if the BA-treatment has an effect on the short and long term on: * Depressive symptoms * Anxiety symptoms * Self-rated activation * Functional ability * Loneliness * Self efficacy * Mental wellbeing * Quality of life * Need for community care services All participants will continue their care as usual (CAU), and half of the participants will be randomized to receive a five-session BA-treatment spread over two months as an add-on to CAU. All participants will answer a questionnaire in the beginning of the study, after two months, and after 3-, 6- and 12 months. Detailed Description: One third of the Swedish population aged 70 years and above report depressive symptoms, and between 5 - 15% have a major depressive disorder. Depression in older adults reduces quality of life and functional ability, and is associated with an increased risk for morbidity and mortality. Psychological treatment is considered a first-line treatment for depression, but is currently only offered to about 3% of older adults with depression in Sweden. A majority of older adults suffering from depression in Sweden are likely not to be identified and diagnosed, and thereby not treated for their depression. Furthermore, many older adults receive municipal care, and psychological treatment is currently not available in this context. The goal of this randomized clinical trial is to investigate if a brief psychological treatment called Behavioral Activation (BA) works to prevent and treat depression in older adults in a municipal context in Sweden. It will also learn about the patients' and therapists' experiences of the BA-treatment. The therapists in the trial are social workers working in Eskilstuna municipality in Sweden. All participants will continue their care as usual (CAU), and half of the participants will be randomized to receive a five-session BA-treatment spread over two months as an add-on to CAU. The BA-treatment will be delivered in the participants' home. All participants will answer a questionnaire in the beginning of the study, after two months, and after 3-, 6- and 12 months. The main questions that the trial aims to answer are if the BA-treatment has an effect on the short and long term on: * Depressive symptoms * Anxiety symptoms * Self-rated activation * Functional ability * Loneliness * Self efficacy * Mental wellbeing * Quality of life * Need for community care services ### Conditions Module Conditions: - Depression - Depressive Symptoms Keywords: - Behavioral activation - Behavior therapy - Psychological treatment - Older adults - Geriatric ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 160 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Five-session Brief Behavioral Activation intervention. Sessions 1 - 4 are completed once a week, and session 5 is a booster-session completed four weeks after session 4. Intervention Names: - Behavioral: Brief Behavioral Activation - Other: Care as Usual Label: Brief Behavioral Activation plus Care as Usual Type: EXPERIMENTAL #### Arm Group 2 Description: Care as usual as provided by primary care and/or municipal care. Intervention Names: - Other: Care as Usual Label: Care as Usual Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Brief Behavioral Activation plus Care as Usual Description: A five-session brief behavioral activation treatment delivered face-to-face in the participants' home. Session outline: Session 1: Psychoeducation about depression; treatment rationale for Behavioral Activation (BA); rationale and instructions for activity log Session 2: Discussion of life goals and values; planning of activities aligned with life goals and values for coming week Session 3: Troubleshooting any problems carrying out activities; planning activities aligned with life goals and values for coming week. Session 4: Troubleshooting any problems carrying out activities; planning activities aligned with life goals and values for the coming week; instructing the participant to independently continue to plan activities for the coming month. Session 5: Troubleshooting any problems carrying out activities; reviewing treatment; stressing the importance of continuing to engage in activities aligned with life goals and values; creating a maintenance plan. Name: Brief Behavioral Activation Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - Brief Behavioral Activation plus Care as Usual - Care as Usual Description: Care as Usual provided by primary care and/or municipal care. Name: Care as Usual Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Depressive symptoms will be measured with the Montgomery-Åsberg Depression Rating Self-rating Scale (MADRS-S). The MADRS-S is a nine-item questionnaire designed to measure depression severity during the past two weeks. The total score ranges from 0-54, with higher scores indicating higher depression severity. Measure: Montgomery-Åsberg Depression Rating Scale, MADRS-S Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group #### Secondary Outcomes Description: Depressive symptoms and depression diagnoses will also be measured using the Geriatric Depression Rating Scale 15-item short form (GDS-15), a 15-item questionnaire used to identify depression in older individuals with scores ranging from 0-15, with higher scores indicating higher depression severity. Measure: Geriatric Depression Scale 15, GDS-15 Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group Description: Anxiety symptoms will be measured with the Geriatric Anxiety Scale - 10 item version (GAS-10), with a score ranging from 0 - 30, with higher scores indicating higher levels of anxiety. Measure: Geriatric Anxiety Scale 10, GAS-10 Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group Description: Functional impairment will be assessed with the WHO Disability Assessment Schedule 12-item (WHODAS-12), a self-rating scale with 12 items ranging from 0 - 48, with higher scores indicating more functional impairment. Measure: WHO disability assessment schedule 12-item, WHODAS-12 Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group Description: Self-rated avoidance and activation will be measured using the Behavioral Activation for Depression Scale - Short Form (BADS-SF), a 9-item scale with scores ranging from 0 - 54, with higher scores indicating a higher degree of activation and lower degree of avoidance. Measure: Behavioral activation for depression scale - short form, BADS-SF Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group Description: Subjective feelings of loneliness and social isolation will be measured using the UCLA Loneliness Scale version 3 (UCLA-LS 3), a 20-item scale with scores ranging from 20 - 80 points, with higher scores indicating higher loneliness. Measure: UCLA Loneliness Scale version 3, UCLA-LS 3 Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group Description: New General Self-Efficacy Scale (S-GSE) is an 10-item measure with scores ranging between 10 - 40 points, that assesses how much people believe they can achieve their goals, despite difficulties. Higher scores indicate higher levels of self-efficacy. Measure: The New General Self-Efficacy Scale, S-GSE Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group Description: Health related quality of life and estimation of quality-adjusted life years (QALY) for health economic evaluations will be measured using the EuroQol-5 Dimensions-5 Level Scale (EQ-5D-5L), a 5-item scale ranging between 1 - 5 per item, measuring health status with regards to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The Eq-5D-5L also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, with higher scores indicating better overall health. Measure: EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group Description: Self-rated mental wellbeing will be measured with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS), a 7-item scale with scores ranging from 7 - 35, with higher scores indicating higher positive mental wellbeing. Measure: Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWBS Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group Description: Need for municipal care service will be measured by recording types of services and number of hours granted by the municipality for each participant. Measure: Need for municipal care service Time Frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * 65 years or older * 5 points or above on the Geriatric Depression Scale 15, GDS-15 * Fluent in written and spoken Swedish * Consents to participate in the trial Exclusion Criteria: * Not able to use the patient materials due to visual impairment * Not able to communicate with therapist due to hearing impairment * Diagnosis of major neurocognitive disorder * Below 25 points on the Mini Mental State Examination, MMSE * Elevated suicide risk * Current substance- or alcohol use disorder * Previous or current psychotic disorder * Previous or current bipolar disorder * Ongoing psychological treatment/pscyhotherapy Minimum Age: 65 Years Sex: ALL Standard Ages: - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: johnny.pellas@pubcare.uu.se Name: Johnny Pellas, PhD Phone: +46702319795 Role: CONTACT Contact 2: Email: marina.arkkukangas@fou.sormland.se Name: Marina Arkkukangas, PhD Role: CONTACT #### Overall Officials Official 1: Affiliation: Research and Development Sormland Name: Johnny Pellas, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Info Types: - STUDY_PROTOCOL - SAP IPD Sharing: YES Time Frame: Study protocol and statistical analysis plan to be shared/published before data collection has ended. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415825 Acronym: PMQRPDP Brief Title: Preliminary Muscle Contraction in the Rehabilitation and Prevention of Degenerative Pain in the Locomotor System Official Title: Preliminary Muscle Contraction in the Rehabilitation and Prevention of Degenerative Pain in the Spine, Hip, Knee, Ankle, Shoulder, Elbow, and Ankle Joints, as Well as After Hip and Knee Arthroplasty #### Organization Study ID Info ID: 757/29012024 #### Organization Class: OTHER Full Name: Medical University of Sofia ### Status Module #### Completion Date Date: 2026-05-14 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-05-14 Type: ESTIMATED #### Start Date Date: 2024-05-14 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-03-29 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Medical University of Sofia #### Responsible Party Investigator Affiliation: Medical University of Sofia Investigator Full Name: Assen Aleksiev Investigator Title: Head of Physical Medicine and Rehabilitation Department Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: RESEARCH OBJECTIVE: To investigate the effect of muscle preliminary contraction in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. HYPOTHESIS: Muscle preliminary contraction has a significant short-term and long-term effect in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. RESEARCH METHODS: At least 216 patients with degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty, will be studied. They will be randomized into pairwise sub-groups. All will receive standard advice. The maneuver sub¬groups will receive additional advice - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area. The following follow-up parameters will be used: visual analogue pain scale, manual muscle testing, goniometry, centimeter, and preliminary contraction success rate. Their follow-up will be threefold - at the beginning, after 1, and after 6 months. For statistical processing, multiple analysis of variance (MANOVA), with post hoc Bonferroni multiple tests, and Pearson correlation analysis, with post hoc regression analysis, will be used. CONCLUSION: The positive results will allow the preliminary muscle contraction to be used as a universal tool in the rehabilitation, prevention, and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty (international contribution). This maneuver is very short (seconds), easy (everybody can perform it), does not require the allocation of time, space, and resources (including financial ones), and is instantly incorporated into everyday life. Detailed Description: RESEARCH OBJECTIVE: To investigate the effect of muscle preliminary contraction in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. SCIENTIFIC IDEA: Muscle latency (M1, M2, triggered response, proprioceptive visual/vestibular responses, and M3) leads to chronic damage. During the first 50-200 milliseconds of the movement, there is no internal muscular protective counterforce against external loads on discs, joints, ligaments, insertions, etc. inert structures (including arthroplastic ones), happening thousands of times a day. This leads to repetitive cumulative microtrauma with damage to the "pneumatic hammer" principle, as well as faster wear in arthroplasties. Precontraction of muscles eliminates latency and stabilizes inert (and arthroplastic) structures. WORKING HYPOTHESIS: Muscle preliminary contraction has a significant short-term and long-term effect in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. RESEARCH METHODS: At least 216 patients with degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty, will be studied. They will be randomized into pairwise sub-groups. All will receive standard advice. The maneuver sub¬groups will receive additional advice - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area. The following follow-up parameters will be used: visual analogue pain scale, manual muscle testing, goniometry, centimeter, and preliminary contraction success rate. Their follow-up will be threefold - at the beginning, after 1, and after 6 months. For statistical processing, multiple analysis of variance (MANOVA), with post hoc Bonferroni multiple tests, and Pearson correlation analysis, with post hoc regression analysis, will be used. CONCLUSION: The positive results will allow the preliminary muscle contraction to be used as a universal tool in the rehabilitation, prevention, and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty (international contribution). This maneuver is very short (seconds), easy (everybody can perform it), does not require the allocation of time, space, and resources (including financial ones), and is instantly incorporated into everyday life. ### Conditions Module Conditions: - Pain, Back - Pain, Neck - Pain, Hip Burning - Pain, Shoulder - Arthropathy of Knee - Arthropathy of Hip - Pain Syndrome Keywords: - degenerative pain - spine - hip - knee - ankle - shoulder - elbow - hip and knee arthroplasty ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Both groups will receive standard advice. The maneuver group will receive additional advice - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area. ##### Masking Info Masking: SINGLE Masking Description: Participants will not know which group they will be in. Who Masked: - PARTICIPANT Primary Purpose: TREATMENT #### Enrollment Info Count: 216 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: The patients will receive standard advice and an additional one - preliminary contraction of the muscles in the corresponding kinesiology segment. Intervention Names: - Behavioral: Standard advice and Preliminary muscle contraction - Behavioral: Standard advice Label: With pre-contr. Type: EXPERIMENTAL #### Arm Group 2 Description: The patients will receive standard advice. Intervention Names: - Behavioral: Standard advice Label: Without pre-contr. Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - With pre-contr. Description: The maneuver groups will receive standard advice and an additional one - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area. Name: Standard advice and Preliminary muscle contraction Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - With pre-contr. - Without pre-contr. Description: Standard advice includes avoiding heavy physical activity, sudden and unexpected loads, repetitive and prolonged overloads, and long periods of hypomobility. Name: Standard advice Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: To assess the intensity of pain on a visual analog scale, a 10 centimeters segment is drawn on a piece of paper. The patient notes the intensity of pain on this line between the left end of the line (0=no pain) and the right end (10=maximum pain intensity). The result is registered in centimeters - from 0 to 10 centimeters. Measure: Visual analogue pain scale Time Frame: At baseline, at 1 month, and at 6 months. #### Secondary Outcomes Description: Success rate refers to how often patients remember to perform preliminary muscle contraction. For example, if this maneuver is skipped every second movement (standing, sitting, bending, standing, lifting, etc.), the success rate is 50%, every third - 77%, every fourth - 85%, and so on. Measure: Preliminary muscle contraction success rate Time Frame: At baseline, at 1 month, and at 6 months. Description: Muscle strength is verified against the examiner's manual resistance and grading on a 0 to 5 scale accordingly: 0 - No movement; 1 - Flicker of movement; 2 - Through full range actively with gravity counterbalanced; 3 - Through full range actively against gravity; 4 -Through full range actively against some resistance; 5 - Through full range actively against strong resistance. For statistical comparability and prognostic value, this scale will be transformed into percentages of the norm: 0=0%; 1=14.29%; 2=35.72%; 3=57.14%; 4=78.57%; 5=100%. Measure: Manual muscle testing Time Frame: At baseline, at 1 month, and at 6 months. Description: Each specific joint has a range of motion that is expressed in degrees measured by goniometer. For statistical comparability and prognostic value, the angular degrees will be transformed into percentages of the norm from 0 to 100%. Measure: Range of motion Time Frame: At baseline, at 1 month, and at 6 months. Description: Centimeter measurements of circumferences of kinetic segments for verification of muscle hypotrophy - in centimeters. Measure: Centimeter measurements Time Frame: At baseline, at 1 month, and at 6 months. Description: Thomayer's test is performed from a standing position with maximum flexion of the torso, bending the body forward and down with relaxed arms to the floor. The distance from the tip of the extended fingers to the floor is measured in centimeters. Inability to reach the floor with fingers is considered limited ROM (centimeters with a negative sign), when touching the floor with fingers - normal ROM (0 centimeters), and when touching the floor with palms - hypermobility (centimeters with a positive sign). Measure: Thomayer's test Time Frame: At baseline, at 1 month, and at 6 months. Description: Schober's test is performed from a standing position. A 15 cm descending segment from the processus spinosus of L1 (in the caudal direction) is measured and the two points are marked. Maximum flexion of the torso is performed by bending the body forward and downward. From the final flexion position, the distance between the two marked points is measured. The increase in the distance between the two points is recorded. The reference values are from 2.5 to 5 cm., i.e. under 2.5 cm. is considered hypomobility, and over 5 cm. - hypermobility. Measure: Schober's test Time Frame: At baseline, at 1 month, and at 6 months. Description: Ott's test is performed from a standing position. A 30 cm descending segment from the processus spinosus of C7 is measured (in the caudal direction) and the two points are marked. Maximum flexion of the torso is performed by bending the body forward and downward. From the final flexion position, the distance between the two marked points is measured. The increase in the distance between the two points is registered. Reference values are from 2.5 to 5 cm., i.e. under 2.5 cm. is considered hypomobility, and over 5 cm. - hypermobility. Measure: Ott's test Time Frame: At baseline, at 1 month, and at 6 months. ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * age over 18 years; * legal capacity; * patients with recurrent degenerative pain (at least two relapses in the last 12 months), in various joints (vertebral, hip, knee, ankle, shoulder, elbow, and knee), in an exacerbation stage (started up to 2 weeks before recruitment), occurring with periodic exacerbations and remissions (relapse duration of more than 24 hours, preceded and separated by remission of at least 1 month); * with excitatory (painful) symptoms (but without ablated ones - without paresis, paralysis, and pelvic-reservoir damage); * as well as after hip and knee arthroplasty. Exclusion Criteria: * age under 18, * incapacity; * neurological symptoms have disappeared (paresis, paralysis, and pelvic-reservoir disorders), * macro-injuries (fractures, dislocations, distortions), * structural anomalies, severe osteoporosis, infectious diseases, febrility, malignant diseases, specific inflammatory and autoimmune diseases (such as rheumatoid arthritis, ankylosing spondylarthritis, etc.), mental diseases, increased tendency to bleed (hemophilia, etc.), as well as cardiovascular vascular, respiratory, liver, kidney and metabolic damage with marked failure. Maximum Age: 90 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: assen_aleksiev@doctor.com Name: Assen R Aleksiev, MD, PhD, DMS Phone: +359899401615 Role: CONTACT Contact 2: Email: natanasova@mu-sofia.bg Name: Natali Dimitrova-Atanasova Phone: +359 2 9152150 Role: CONTACT #### Overall Officials Official 1: Affiliation: Head Department of Physical Medicne and Rehabilitation, Medical University of Sofia Name: Assen R Aleksiev Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Access Criteria: The data will become available upon request from the principal investigator. Description: All global statistical data except personal information from the patients. Info Types: - STUDY_PROTOCOL - SAP - ICF IPD Sharing: YES Time Frame: The data will become available from 11.05.2025 to 11.05.2026. ### References Module #### References Citation: Aleksiev AR. Ten-year follow-up of strengthening versus flexibility exercises with or without abdominal bracing in recurrent low back pain. Spine (Phila Pa 1976). 2014 Jun 1;39(13):997-1003. doi: 10.1097/BRS.0000000000000338. PMID: 24732860 Citation: Magnusson ML, Aleksiev A, Wilder DG, Pope MH, Spratt K, Lee SH, Goel VK, Weinstein JN. European Spine Society--the AcroMed Prize for Spinal Research 1995. Unexpected load and asymmetric posture as etiologic factors in low back pain. Eur Spine J. 1996;5(1):23-35. doi: 10.1007/BF00307824. PMID: 8689414 Citation: Wilder DG, Aleksiev AR, Magnusson ML, Pope MH, Spratt KF, Goel VK. Muscular response to sudden load. A tool to evaluate fatigue and rehabilitation. Spine (Phila Pa 1976). 1996 Nov 15;21(22):2628-39. doi: 10.1097/00007632-199611150-00013. PMID: 9045348 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000018771 - Term: Arthralgia ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M10621 - Name: Joint Diseases - Relevance: HIGH - As Found: Arthropathy - ID: M5326 - Name: Burns - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M21907 - Name: Shoulder Pain - Relevance: HIGH - As Found: Pain, Shoulder - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Pain, Back - ID: M21485 - Name: Neck Pain - Relevance: HIGH - As Found: Pain, Neck - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M20833 - Name: Arthralgia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007592 - Term: Joint Diseases - ID: D000020069 - Term: Shoulder Pain - ID: D000001416 - Term: Back Pain - ID: D000019547 - Term: Neck Pain ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415812 Acronym: ESTP Brief Title: Evolutionary Systems Therapy for Personality Pathology Official Title: Evolutionary Systems Therapy for Early Onset of Personality Pathology: A Pilot Study on the Effectiveness and Feasibility With Adolescents and Young Adults #### Organization Study ID Info ID: 0124 #### Organization Class: OTHER Full Name: Tages Onlus ### Status Module #### Completion Date Date: 2024-09 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-08 Type: ESTIMATED #### Start Date Date: 2023-10-02 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Tages Onlus #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: Evolutionary Systems Therapy is a new form of therapy that has been previously tested in a randomized controlled trial and in a few cases of patients diagnosed with Cluster A personality disorders. The objective of the present study is to investigate the feasibility and preliminary efficacy of Evolutionary Systems Therapy in all forms of personality disorders. The study includes three project actions: (i) a case series on adolescents with personality disorders; (ii) a case series on young adults with personality disorders; (iii) an ecological momentary assessment study to confirm the conceptualization model on all the patients. Detailed Description: To explore the feasibility and preliminary efficacy of Evolutionary Systems Therapy, the present study includes three actions. In the first action investigators enroll 6 adolescents (16-19 years) with personality disorders, in the second 15 young adults (20-25 years) with personality disorders. All participants receive 6 months of psychotherapy. The two subsamples of patients (adolescents and young adults) are assessed based on the conceptualization model of Evolutionary Systems Therapy which envisages three macro-organizations of personality (consistently with dimensional and hierarchical models such as Hierarchical Taxonomy of Psychopathology): internalizing, externalizing, schizotypal. Investigators plan to recruit patients until the size of the sub-samples is reached (15 young adults divided into 3 groups of 5 patients, each for each of the three interpersonal patterns; 6 adolescents divided into 3 groups of 2 patients, each for each of the three patterns interpersonal). In the third action, an ecological momentary assessment study will investigate the consistency over time between the conceptualization model and the experiences of the young adult patients enrolled: investigators will explore whether the hypothesized conceptualization will be confirmed by collected data on the patients' interpersonal styles. ### Conditions Module Conditions: - Personality Disorders Keywords: - compassion - metacognition - personality disorder - personality pathology - evolutionary psychopathology ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP Intervention Model Description: Two individual parallel groups will be recruited: adolescent patients and young adult patients. Both groups will receive a 6-month Evolutionary Systems Therapy treatment. Both groups will access a longitudinal evaluation of the effectiveness of the treatment. All the participants will access a more extensive ecological momentary assessment to evaluate the progress of specific psychopathological mechanisms that are the targets of the treatment. Consistent with the conceptualization model of Evolutionary Systems Therapy and with the scientific literature on dimensional and hierarchical models of psychopathology, this conceptualization will be shared with the patient based on three macro-functionings: externalizing patterns, internalizing patterns, schizotypal patterns. ##### Masking Info Masking: NONE Masking Description: All data will be collected in a blinded manner by an assessor other than the therapists. Subsequently, the data will be anonymized and analyzed by a researcher from an institution different from the one in which the study takes place. Primary Purpose: TREATMENT #### Enrollment Info Count: 21 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: All the participants receive as active treatment a form of psychotherapy for personality disorders (Evolutionary Systems Therapy). The treatment last 6 months (24 weekly sessions, each lasting 50-60 minutes). Intervention Names: - Behavioral: Evolutionary Systems Therapy Label: Psychotherapy Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Psychotherapy Description: Evolutionary Systems Therapy is an individual form of psychotherapy (talk therapy) that has been previously tested trough a randomized controlled trial and a few cases series, confirming its feasibility and safety. Name: Evolutionary Systems Therapy Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: At least 75% rate of change in personality pathology over time as defined by a downward trend in mean of total score of Personality Inventory for DSM-5 Brief Form) Measure: Rate of individual change in personality pathology over time Time Frame: 9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy. Description: Group change in personality pathology over time as defined by statistically significant change of sample mean of total score of Personality Inventory for DSM-5 Brief Form) Measure: Group change in personality pathology over time Time Frame: 9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy. Description: At least 70% rate of completion, adherence, therapeutic alliance and adverse events Measure: Feasibility of the intervention Time Frame: 6 measurements: at the end of each of the six months of therapy #### Secondary Outcomes Description: Comparison between efficacy of intervention between three interpersonal patterns (internalizing, antagonistic, schizotypal) as being the target of the intervention. The comparison is aimed to show no statistically significant difference between the three patterns in terms of pre-post change in personality pathology as measured by Personality Inventory for DSM-5 Brief Form Measure: Differential effect of the intervention between interpersonal patterns Time Frame: 9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy. Description: Comparison between efficacy of intervention between three interpersonal patterns (internalizing, antagonistic, schizotypal) as being the target of the intervention. The comparison is aimed to show no statistically significant difference between the three patterns in terms of pre-post change in personality pathology as measured by Personality Inventory for DSM-5 Brief Form. Measure: Specific effect of the intervention between interpersonal patterns Time Frame: 40 measurements: 20 measurements in the month before surgery (2 measurements per day for the 10 days before the start of therapy) and 20 measurements in the month after surgery (2 measurements per day for the 10 days after the end of therapy) Description: At least 70% rate of remission from diagnosis of personality pathology Measure: Remission from diagnosis Time Frame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Being diagnosed with personality pathology in accordance with Structured Clinical Interview for DSM-5 - Alternative Model of Personality Disorders Module I * Being capable of read and sign the inform consent form Exclusion Criteria: * Being diagnosed with schizophrenia spectrum disorders and other psychosis * Being diagnosed with bipolar disorders * Being diagnosed with autism spectrum disorder * Being diagnosed with intellectual disability * Being under any psychopharmacological or psychosocial treatment Maximum Age: 25 Years Minimum Age: 16 Years Sex: ALL Standard Ages: - CHILD - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: alessia.saini@tagesonlus.org Name: Alessia Saini Phone: +39 055679037 Role: CONTACT #### Locations Location 1: City: Firenze Contacts: *Contact 1:* - Email: alessia.saini@tagesonlus.org - Name: Alessia Saini - Phone: +39 055 679037 - Role: CONTACT *Contact 2:* - Name: Simone Cheli, PhD - Role: PRINCIPAL_INVESTIGATOR *Contact 3:* - Name: Gil Goldzweig, PhD - Role: SUB_INVESTIGATOR *Contact 4:* - Name: Martin Bruene, MD - Role: SUB_INVESTIGATOR *Contact 5:* - Name: Veronica Cavalletti, PsyD - Role: SUB_INVESTIGATOR Country: Italy Facility: Centro di Psicologia e Psicoterapia Tages Onlus - Firenze State: FI Status: RECRUITING Zip: 50137 #### Overall Officials Official 1: Affiliation: Tages Onlus Name: Simone Cheli, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Access Criteria: Open Access Description: All the data collected as well as the study documents will be available on the Open Science Foundation no later than September 2024 Info Types: - STUDY_PROTOCOL - SAP - ICF IPD Sharing: YES Time Frame: May 2024 URL: https://osf.io/urjdz/ ### References Module #### References Citation: Cheli, S., Chiarello, F., & Cavalletti, V. (2023). A psychotherapy oriented by compassion and metacognition for schizoid personality disorder: A two cases series. Journal of Contemporary Psychotherapy: On the Cutting Edge of Modern Developments in Psychotherapy, 53(1), 61-70. https://doi.org/10.1007/s10879-022-09566-3 Citation: Cheli, S., Cavalletti, V. An Evolutionarily Oriented Therapy for Autistic Adolescents with Extraordinary Skills: A Two-Case Series. J Contemp Psychother 53, 297-304 (2023). https://doi.org/10.1007/s10879-023-09586-7 Citation: Cheli, S., & Brüne, M. (In press). When do personality traits become pathological? An epistemological and evolutionary view. To appear in Konrad Banicki and Peter Zachar (Eds.), Novel Conceptual Approaches to Personality Disorders for Psychologists and Philosophers. Cambridge University Press. Citation: Cheli S, Cavalletti V, Lysaker PH, Dimaggio G, Petrocchi N, Chiarello F, Enzo C, Velicogna F, Mancini F, Goldzweig G. A pilot randomized controlled trial comparing a novel compassion and metacognition approach for schizotypal personality disorder with a combination of cognitive therapy and psychopharmacological treatment. BMC Psychiatry. 2023 Feb 20;23(1):113. doi: 10.1186/s12888-023-04610-5. PMID: 36803673 Citation: Cheli S, Goldzweig G, Chiarello F, Cavalletti V. Evolutionary systems therapy for paranoid personality disorder: A seven cases series. Bull Menninger Clin. 2024 Winter;88(1):61-80. doi: 10.1521/bumc.2024.88.1.61. PMID: 38527104 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13462 - Name: Personality Disorders - Relevance: HIGH - As Found: Personality Disorder - 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: D000010554 - Term: Personality Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415799 Brief Title: OM2 Abbreviated Sensor Verification Official Title: Verification of Investigational Pulse Oximetry Devices With the Abbreviated Sensor Line in Adult Volunteers #### Organization Study ID Info ID: MDT23027OM2AB #### Organization Class: INDUSTRY Full Name: Medtronic - MITG ### Status Module #### Completion Date Date: 2024-02-22 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-02-22 Type: ACTUAL #### Start Date Date: 2024-02-11 Type: ACTUAL Status Verified Date: 2024-04 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-19 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Medtronic - MITG #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Is US Export: True Oversight Has DMC: False ### Description Module Brief Summary: The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations. Detailed Description: To verify the SpO2 and pulse rate accuracy in comparison to reference-standard blood measurements. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects. ### Conditions Module Conditions: - Hypoxia ### Design Module #### Design Info Observational Model: CASE_ONLY Time Perspective: PROSPECTIVE #### Enrollment Info Count: 28 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Label: Healthy Volunteers ### Outcomes Module #### Primary Outcomes Description: Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for the investigational Pulse Oximetry PCBA system, SpO2 across the saturation range of 70-100%: SpO2 Max-A ±2% (ARMS) OxySoft-N ±2% (ARMS) Max-Fast ±2% (ARMS) FlexMax ±2.5%(ARMS) DS-100A ±3% (ARMS) D-YS ±3% (ARMS) Measure: Verification of Saturation Accuracy Time Frame: 2.5 hours Description: Pulse rate in a diverse subject population over a specified saturation range. The acceptance criteria for pulse rate from 20-250 BPM over a specified saturation range of 70-100%: Pulse Rate Max-A ≤3% BPM (ARMS) OxySoft-N ≤3% BPM (ARMS) Max-Fast ≤3% BPM (ARMS) FlexMax ≤3% BPM (ARMS) DS-100A ≤3% BPM (ARMS) D-YS ≤3% BPM (ARMS) Measure: Verification of Pulse Rate Time Frame: 2.5 hours ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Male or female subjects 18 to 50 years of age 2. Subject is willing and able to comply with study procedures and duration 3. Subject is willing to sign an informed consent 4. Subject weighs \>40kg 5. Subject is a non-smoker or has not smoked within 2 days prior to the study 6. Cleared same day health assessment form and health screening 7. Successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow. Exclusion Criteria: 1. Subject is considered as being morbidly obese (defined as BMI \>39.5) 2. Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized) 3. Females of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study 4. Subjects with COHb levels \>3% as assessed by CO-Oximetry during the procedure 5. tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure 6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure 7. Subjects with known respiratory conditions such as: 1. uncontrolled / severe asthma 2. flu or influenza type infection 3. pneumonia / bronchitis 4. shortness of breath / respiratory distress 5. unresolved respiratory or lung surgery 6. emphysema, COPD, lung disease 7. recent COVID (last 2 months) 8. Subjects with known heart or cardiovascular conditions such as: 1. hypertension: systolic \>140mmHg, or Diastolic \>90mmHg on 3 consecutive readings 2. have had cardiovascular surgery 3. chest pain (angina) 4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen) 5. previous heart attack 6. blocked artery 7. unexplained shortness of breath 8. congestive heart failure (CHF) 9. history of stroke 10. transient ischemic attack 11. carotid artery disease 12. myocardial ischemia 13. myocardial infarction 14. cardiomyopathy 15. implantable active medical device such as pacemaker or automatic defibrillator 9. Self-reported health conditions as identified in the Health Assessment Form 1. diabetes 2. uncontrolled thyroid disease 3. kidney disease / chronic renal impairment 4. history of seizures (except childhood febrile seizures) 5. epilepsy 6. history of unexplained syncope 7. recent history of frequent migraine headaches 8. recent symptomatic head injury, within the last 2 months 9. cancer requiring chemotherapy, radiation, or current treatment 10. subjects with known clotting disorders 11. history of bleeding disorders or personal history of prolonged bleeding from injury 12. history of blood clots 13. hemophilia 14. sickle cell trait or disease 15. current use of blood thinner: prescription or daily use of aspirin 16. subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors 17. participants with severe allergy to iodine (only applicable if iodine is used) 18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin 19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right) 20. history of clinically significant complications from previous arterial cannulation 21. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits 22. other known health condition, upon disclosure in Health Assessment form Healthy Volunteers: True Maximum Age: 50 Years Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT Study Population: Healthy Male or Female volunteers age 18 to 50 years, weighing greater than 40kgs. Volunteers must be non-smokers or not smoked within 2 days prior to the study. Cleared a same day health assessment form and health screen to ensure none of the exclusion criteria was met. With a successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow. ### Contacts Locations Module #### Locations Location 1: City: Louisville Country: United States Facility: Element State: Colorado Zip: 80027 #### Overall Officials Official 1: Affiliation: Element Labs Name: Monica Rabanal Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4185 - Name: Hypoxia - Relevance: HIGH - As Found: Hypoxia - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000860 - Term: Hypoxia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415786 Brief Title: OM2 Motion Verification Study Official Title: Verification of Investigational Pulse Oximetry Devices During Motion and Non-Motion Conditions in Adult Volunteers #### Organization Study ID Info ID: MDT23026OM2VMT #### Organization Class: INDUSTRY Full Name: Medtronic - MITG ### Status Module #### Completion Date Date: 2024-03-27 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-03-27 Type: ACTUAL #### Start Date Date: 2024-03-07 Type: ACTUAL Status Verified Date: 2024-04 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-24 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Medtronic - MITG #### 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 verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations. Detailed Description: To verify the SpO2 and pulse rate accuracy in comparison to reference-standard blood measurements during motion and non-motion conditions. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects. ### Conditions Module Conditions: - Hypoxia ### Design Module #### Design Info Observational Model: CASE_ONLY Time Perspective: PROSPECTIVE #### Enrollment Info Count: 30 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Label: Healthy Volunteers ### Outcomes Module #### Primary Outcomes Description: Saturation accuracy in a diverse subject population over a specified saturation range during motion and non-motion conditions. The acceptance criteria for the Nellcor™ Pro 7 Pulse Oximetry PCBA are as follows: The acceptance criteria for SpO2 during motion and non-motion conditions across the saturation range of 70-100%: Motion: SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS) Non-Motion: SpO2 SC-A ±2 % (ARMS) Measure: Verification of saturation accuracy during motion and non-motion conditions Time Frame: 2.5 hours Description: The acceptance criteria for pulse rate during motion and non-motion conditions from 20-250 BPM over a specified saturation range of 70-100%: Motion: Pulse Rate Max-A ≤5% BPM (ARMS) Max-N ≤5% BPM (ARMS) OxySoft-N ≤5% BPM (ARMS) Non-Motion: Pulse Rate SC-A ≤3% BPM (ARMS) Measure: Verification of Pulse Rate during motion and non-motion conditions Time Frame: 2.5 hours ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Male or female subjects 18 to 50 years of age 2. Subject is willing and able to comply with study procedures and duration 3. Subject is willing to sign an informed consent 4. Subject weighs \>40kg 5. Subject is a non-smoker or has not smoked within 2 days prior to the study 6. Cleared same day health assessment form and health screening 7. Successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow. Exclusion Criteria: 1. Subject is considered as being morbidly obese (defined as BMI \>39.5) 2. Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized) 3. Females of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study 4. Subjects with COHb levels \>3% as assessed by CO-Oximetry during the procedure 5. tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure 6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure 7. Subjects with known respiratory conditions such as: 1. uncontrolled / severe asthma 2. flu or influenza type infection 3. pneumonia / bronchitis 4. shortness of breath / respiratory distress 5. unresolved respiratory or lung surgery 6. emphysema, COPD, lung disease 7. recent COVID (last 2 months) 8. Subjects with known heart or cardiovascular conditions such as: 1. hypertension: systolic \>140mmHg, or Diastolic \>90mmHg on 3 consecutive readings 2. have had cardiovascular surgery 3. chest pain (angina) 4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen) 5. previous heart attack 6. blocked artery 7. unexplained shortness of breath 8. congestive heart failure (CHF) 9. history of stroke 10. transient ischemic attack 11. carotid artery disease 12. myocardial ischemia 13. myocardial infarction 14. cardiomyopathy 15. implantable active medical device such as pacemaker or automatic defibrillator 9. Self-reported health conditions as identified in the Health Assessment Form 1. diabetes 2. uncontrolled thyroid disease 3. kidney disease / chronic renal impairment 4. history of seizures (except childhood febrile seizures) 5. epilepsy 6. history of unexplained syncope 7. recent history of frequent migraine headaches 8. recent symptomatic head injury, within the last 2 months 9. cancer requiring chemotherapy, radiation, or current treatment 10. subjects with known clotting disorders 11. history of bleeding disorders or personal history of prolonged bleeding from injury 12. history of blood clots 13. hemophilia 14. sickle cell trait or disease 15. current use of blood thinner: prescription or daily use of aspirin 16. subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors 17. participants with severe allergy to iodine (only applicable if iodine is used) 18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin 19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right) 20. history of clinically significant complications from previous arterial cannulation 21. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits 22. other known health condition, upon disclosure in Health Assessment form Healthy Volunteers: True Maximum Age: 50 Years Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT Study Population: Healthy Male or Female volunteers age 18 to 50 years, weighing greater than 40kgs. Volunteers must be non-smokers or not smoked within 2 days prior to the study. Cleared a same day health assessment form and health screen to ensure none of the exclusion criteria was met. With a successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow. ### Contacts Locations Module #### Locations Location 1: City: Louisville Country: United States Facility: Element State: Colorado Zip: 80027 #### Overall Officials Official 1: Affiliation: Element Labs Name: Monica Rabanal Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4185 - Name: Hypoxia - Relevance: HIGH - As Found: Hypoxia - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000860 - Term: Hypoxia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415773 Brief Title: Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled (Dapagliflozin), Parallel Group Efficacy and Safety Study of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone #### Organization Study ID Info ID: HTD1801.PCT109 #### Organization Class: INDUSTRY Full Name: HighTide Biopharma Pty Ltd ### Status Module #### Completion Date Date: 2025-09 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-07 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-04 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Shenzhen HighTide Biopharmaceutical Ltd. #### Lead Sponsor Class: INDUSTRY Name: HighTide Biopharma Pty 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: The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone. Detailed Description: This Phase 3 randomized, double-blind, active-controlled, parallel-group study will evaluate the efficacy and safety of HTD1801 compared to dapagliflozin after 24 weeks of treatment. All patients will remain on a stable dose of metformin throughout the study. To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 1:1 to receive HTD1801 1000 mg BID or dapagliflozin 10 mg QD. ### Conditions Module Conditions: - T2DM (Type 2 Diabetes Mellitus) ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - INVESTIGATOR Primary Purpose: TREATMENT #### Enrollment Info Count: 418 Type: ESTIMATED Phases: - PHASE3 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Administered orally twice daily (BID) Intervention Names: - Drug: HTD1801 Label: HTD1801 Type: EXPERIMENTAL #### Arm Group 2 Description: Administered orally once daily (QD) Intervention Names: - Drug: Dapagliflozin Label: Dapagliflozin Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - HTD1801 Description: HTD1801 1000 mg BID administered orally BID as four capsules Name: HTD1801 Other Names: - Berberine Ursodeoxycholate Type: DRUG #### Intervention 2 Arm Group Labels: - Dapagliflozin Description: Dapagliflozin 10 mg tablet administered orally QD Name: Dapagliflozin Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Mean change in HbA1c from baseline to Week 24 Measure: Primary Endpoint: Mean change in HbA1c Time Frame: 24 Weeks #### Secondary Outcomes Description: Mean change in fasting plasma glucose from baseline to Week 24 Measure: Mean Change in Fasting Plasma Glucose Time Frame: 24 Weeks Description: Mean change in 2-hour postprandial glucose from baseline to Week 24 Measure: Mean Change in 2-Hour Postprandial Glucose Time Frame: 24 Weeks Description: Proportion of patients achieving HbA1c \<7.0% after 24 weeks of treatment Measure: Proportion of Patients Achieving HbA1c <7.0% Time Frame: 24 Weeks Description: Proportion of patients achieving HbA1c \<6.5% after 24 weeks of treatment Measure: Proportion of Patients Achieving HbA1c <6.5% Time Frame: 24 Weeks Description: Mean change in homeostatic model assessment for insulin resistance (HOMA-IR) from baseline to Week 24 Measure: Mean Change in Insulin Sensitivity (HOMA-IR) Time Frame: 24 Weeks Description: Mean change in LDL-C from baseline to Week 24 Measure: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C) Time Frame: 24 Weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Have been diagnosed with type 2 diabetes * Have received a stable dose of metformin monotherapy for at least 8 weeks prior to screening * If used any glucose-lowering drugs other than metformin within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening * Have HbA1c ≥7.5% to ≤11.0% (screening) and HbA1c ≥7.0% to ≤10.5% (pre-randomization) * Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization) * Have a body mass index ≥19.0 kg/m\^2 and ≤35.0 kg/m\^2 Exclusion Criteria: * Have type 1 diabetes * Have had any acute diabetic complications within 12 months prior to screening * Have had any Grade 3 hypoglycemic event within 12 months prior to screening * Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot * Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 12 weeks prior to screening * Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening * Have used any hypoglycemic drug other than metformin during the 4-week run-in period prior to randomization * Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization * Have a history of refractory or recurrent urinary tract infections or genital infections Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: huangyi@hightidetx.com Name: Yi Huang Phone: 86 13512789816 Role: CONTACT #### Locations Location 1: City: Beijing Country: China Facility: Beijing Pinggu Hospital Status: RECRUITING Location 2: City: Beijing Country: China Facility: Peking University People's Hospital Status: RECRUITING Location 3: City: Binzhou Country: China Facility: Binzhou Medical University Hospital Status: RECRUITING Location 4: City: Changchun Country: China Facility: Jilin Province FAW General Hospital Status: RECRUITING Location 5: City: Changchun Country: China Facility: The Second Norman Bethune Hospital of Jilin University Status: RECRUITING Location 6: City: Changde Country: China Facility: The First People's Hospital of Changde City Status: RECRUITING Location 7: City: Changsha Country: China Facility: The First Hospital of Changsha Status: RECRUITING Location 8: City: Changsha Country: China Facility: The Fourth Hospital of Changsha Status: RECRUITING Location 9: City: Changsha Country: China Facility: The Second Xiangya Hospital of Central South University Status: RECRUITING Location 10: City: Changsha Country: China Facility: The Third Xiangya Hospital of Central South University Status: RECRUITING Location 11: City: Chongqing Country: China Facility: Bishan Hospital of Chongqing Status: RECRUITING Location 12: City: Deyang Country: China Facility: Deyang People's Hospital Status: RECRUITING Location 13: City: Handan Country: China Facility: Handan First Hospital Status: RECRUITING Location 14: City: Harbin Country: China Facility: The Fourth Affiliated Hospital of Harbin Medical University Status: RECRUITING Location 15: City: Huai'an Country: China Facility: Huai'an Second People's Hospital Status: RECRUITING Location 16: City: Huanggang Country: China Facility: Huanggang Central Hospital Status: RECRUITING Location 17: City: Huangshi Country: China Facility: Huangshi Central Hospital Status: RECRUITING Location 18: City: Huizhou Country: China Facility: Huizhou Municipal Central Hospital Status: RECRUITING Location 19: City: Huzhou Country: China Facility: Huzhou Central Hospital Status: RECRUITING Location 20: City: Jincheng Country: China Facility: Jincheng General Hospital Status: RECRUITING Location 21: City: Langfang Country: China Facility: Hebei Petro China Center Hospital Status: RECRUITING Location 22: City: Lianyungang Country: China Facility: The Second People's Hospital of Lianyungang Status: RECRUITING Location 23: City: Liaocheng Country: China Facility: Liaocheng People's Hospital Status: RECRUITING Location 24: City: Luoyang Country: China Facility: Luoyang Third People's Hospital Status: RECRUITING Location 25: City: Luoyang Country: China Facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua) Status: RECRUITING Location 26: City: Luoyang Country: China Facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan) Status: RECRUITING Location 27: City: Nanchang Country: China Facility: The First Affiliated Hospital of Nanchang University Status: RECRUITING Location 28: City: Nanchang Country: China Facility: The Second Affiliated Hospital of Nanchang University Status: RECRUITING Location 29: City: Nanjing Country: China Facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School Status: RECRUITING Location 30: City: Nanjing Country: China Facility: The Second Affiliated Hospital of Nanjing Medical University Status: RECRUITING Location 31: City: Nantong Country: China Facility: Affiliated Hospital of Nantong University Status: RECRUITING Location 32: City: Nanyang Country: China Facility: The First Affiliated Hospital of Nanyang Medical College Status: RECRUITING Location 33: City: Panjin Country: China Facility: Panjin Liaohe Oilfield Gem Flower Hospital Status: RECRUITING Location 34: City: Pingxiang Country: China Facility: Pingxiang People's Hospital Status: RECRUITING Location 35: City: Qiqihar Country: China Facility: The First Hospital of Qiqihar Status: RECRUITING Location 36: City: Sanmenxia Country: China Facility: Sanmenxia Central Hospital Status: RECRUITING Location 37: City: Shanghai Country: China Facility: Huadong Hospital Status: RECRUITING Location 38: City: Shanghai Country: China Facility: Shanghai Sixth People's Hospital Status: RECRUITING Location 39: City: Shenyang Country: China Facility: Shengjing Hospital of China Medical University Status: RECRUITING Location 40: City: Shenyang Country: China Facility: The People's Hospital of Liaoning Province Status: RECRUITING Location 41: City: Wuhan Country: China Facility: Wuhan Third Hospital Status: RECRUITING Location 42: City: Xi'an Country: China Facility: The First Affiliated Hospital of Xi'an Jiaotong Univerity Status: RECRUITING Location 43: City: Xi'an Country: China Facility: The Second Affiliated Hospital of Xi'an Jiaotong University Status: RECRUITING Location 44: City: Xiangtan Country: China Facility: The First People's Hospital of Xiangtan City Status: RECRUITING Location 45: City: Xiangtan Country: China Facility: Xiangtan Central Hospital Status: RECRUITING Location 46: City: Xianyang Country: China Facility: Xianyang Hospital of Yan'an University Status: RECRUITING Location 47: City: Xuzhou Country: China Facility: Xuzhou Cancer Hospital Status: RECRUITING Location 48: City: Yibin Country: China Facility: The Second People's Hospital of Yibin Status: RECRUITING Location 49: City: Yiyang Country: China Facility: Yiyang Central Hospital Status: RECRUITING Location 50: City: Yueyang Country: China Facility: Yueyang People's Hospital Status: RECRUITING Location 51: City: Zaozhuang Country: China Facility: Shandong Healthcare Group Zaozhuang Central Hospital Status: RECRUITING Location 52: City: Zhengzhou Country: China Facility: The Second Affiliated Hospital of Zhengzhou Status: RECRUITING Location 53: City: Zhenjiang Country: China Facility: Affiliated Hospital of Jiangsu University Status: RECRUITING Location 54: City: Zhumadian Country: China Facility: Zhumadian Central Hospital Status: RECRUITING #### Overall Officials Official 1: Affiliation: Shenzhen HighTide Biopharmaceutical Ltd. Name: Kui Liu, MD 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 ### 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: 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 ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M348449 - Name: Dapagliflozin - Relevance: HIGH - As Found: COPD - ID: M11667 - Name: Metformin - Relevance: LOW - As Found: Unknown - ID: M17329 - Name: Ursodeoxycholic Acid - Relevance: LOW - As Found: Unknown - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000529054 - Term: Dapagliflozin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415760 Brief Title: Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients Official Title: Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients #### Organization Study ID Info ID: HEMCS-047 #### Organization Class: INDUSTRY Full Name: HemoSonics LLC ### Status Module #### Completion Date Date: 2024-10-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2024-09-30 Type: ESTIMATED #### Start Date Date: 2024-05-07 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: HemoSonics LLC #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: True Oversight Has DMC: False ### Description Module Brief Summary: This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy Detailed Description: During pregnancy, there is a progressive shift of hemostasis toward a hypercoagulable state that is protective against postpartum hemorrhage. To assess the clinical utility of the Quantra System in high-risk OB patients during delivery, it is important to understand how the normal physiological changes of pregnancy impact Quantra results. This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy. ### Conditions Module Conditions: - Obstetric Hemostasis - Coagulation Keywords: - Quantra - Viscoelastic testing - Coagulation ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 150 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Adult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy. Intervention Names: - Diagnostic Test: Quantra System Label: Obstetric Patients ### Interventions #### Intervention 1 Arm Group Labels: - Obstetric Patients Description: Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care Name: Quantra System Other Names: - QStat Cartridge Type: DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes Description: Reference range intervals for CSL for pregnant women in third trimester Measure: Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter Time Frame: Baseline, determined from a single blood draw Description: Reference range intervals for FCS for pregnant women in third trimester Measure: Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter Time Frame: Baseline, determined from a single blood draw Description: Reference range intervals for PCS for pregnant women in third trimester Measure: Reference range intervals for measurement of Platelet Contribution (PCS) parameter Time Frame: Baseline, determined from a single blood draw Description: Reference range intervals for CS for pregnant women in third trimester Measure: Reference range intervals for measurement of Clot Stiffness (CS) parameter Time Frame: Baseline, determined from a single blood draw Description: Reference range intervals for CT for pregnant women in third trimester Measure: Reference range intervals for measurement of Clot Time (CT) parameter Time Frame: Baseline, determined from a single blood draw ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Subject is female, age 18 to 45 years old. * Subject is pregnant with a single fetus and duration of pregnancy is \>28weeks * Subject is willing to participate and has provided informed consent. Exclusion Criteria: * Subject has a history of a coagulation disorder (including excessive bleeding, thrombosis, VWD, or any factor deficiencies). * Subject has taken medications known to alter coagulation during pregnancy including heparin, warfarin/Coumadin®, antiplatelet drugs including Plavix® or aspirin at a dose greater than 81 mg/day, Xarelto® or Eliquis®, or other anticoagulants. * Subject has experienced one or more complications during pregnancy such as gestational diabetes, high blood pressure, pre-eclampsia or eclampsia, hypovolemia or pre-term labor. * Subject had a blood transfusion during pregnancy. * Subject has a history of smoking/vaping during pregnancy Gender Based: True Gender Description: Pregnant women Healthy Volunteers: True Maximum Age: 45 Years Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: FEMALE Standard Ages: - ADULT Study Population: Adult pregnant women 18 years of age or older in their third trimester of pregnancy with no prenatal risk factors and an uncomplicated pregnancy. ### Contacts Locations Module #### Locations Location 1: City: Raleigh Country: United States Facility: Unified Womens Clinical Research State: North Carolina Zip: 27612 Location 2: City: Winston-Salem Country: United States Facility: Unified Womens Clinical Research State: North Carolina Zip: 27103 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415747 Brief Title: Early Pain Finding in Infants With Brachial Plexus Birth Injury Official Title: Early Pain Finding in Infants With Brachial Plexus Birth Injury #### Organization Study ID Info ID: GO 23/12 #### Organization Class: OTHER Full Name: Hacettepe University ### Status Module #### Completion Date Date: 2023-06-01 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-16 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-06-01 Type: ACTUAL #### Start Date Date: 2021-01-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Hacettepe University #### Responsible Party Investigator Affiliation: Hacettepe University Investigator Full Name: Kıvanç Delioğlu Investigator Title: Assistant Professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: In Brachail Plexus Birth Palsy (BPBI), fractures, glenohumeral joint dislocation, torticollis and plagiocephaly, facial nerve palsy, phrenic nerve palsy, obesity, speech delay, integumentary system problems, and central nervous system disorders are common comorbidities. Clinical assessments such as observation, palpation, and radiologic imaging are commonly used to identify early period comorbidities after delivery .Since fractures or joint deformities may occur in the affected upper extremity due to high-energy trauma at birth, pain assessment in the early postnatal period is recommended and several objective assessment methods have been proposed. Due to the difficulty of pain assessment in early childhood, the assessment is mostly performed by palpation. Pain is suspected if the baby grimaces with light palpation of the neck and upper shoulder area. Although some hospitals have adopted objective assessment of pain and objective assessment is recommended, the level of pain in early childhood has not been investigated. Therefore, the aim of our study was to determine the level of pain in BPBI in early childhood and to examine the relationship between pain and motor function. In addition, the second aim of the study is to determine the cut-off value of the pain level that may be a sign of fracture in patients with BPBI, in order to suspect a fracture in the shoulder region and request additional examinations. The diagnosis of BPBI, determination of Narakas classification and evaluation of comorbidities were performed by a senior orthopedic surgeon. After the initial doctor's examination, patients are routinely referred to the physiotherapy clinic for a physiotherapy evaluation.In the assessment, active joint movement and pain assessments of children were used, and all of these assessments were performed by a hand and pediatric physiotherapist. ### Conditions Module Conditions: - Brachial Plexus Palsy ### Design Module #### Design Info Observational Model: OTHER Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 59 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: It was determined that 76 babies with BPBI and their families applied to our hospital for their first medical check or examination. Inclusion criteria: a diagnosis of BPBI, initial evaluation and not having started treatment before, being in the age range of 15-90 days old, and consent to participate in the study. Exclusion criteria: Children with BPBI who are older than 90 days or younger than 15 days and have started regular physical therapy or home program before applying to our hospital. In addition, causes of pseudo-paralysis that are diseases that may show symptoms similar to BPBI were excluded. Seventeen children who were excluded because they did not meet the inclusion criteria. Hence, 59 children with BPBI were included in the study. Intervention Names: - Other: Observational pain and motor function assessments, and also comorbidities assessments with x-ray. Label: Brachial Plexus Birth Injury ### Interventions #### Intervention 1 Arm Group Labels: - Brachial Plexus Birth Injury Description: There was no intervention in our study, only observational and quantitative clinical evaluations. Name: Observational pain and motor function assessments, and also comorbidities assessments with x-ray. Type: OTHER ### Outcomes Module #### Primary Outcomes Description: In BPBI, fractures, glenohumeral joint dislocation, torticollis and plagiocephaly, facial nerve palsy, phrenic nerve palsy, obesity, speech delay, integumentary system problems, and central nervous system disorders are common comorbidities. In our university hospital, humerus or scapula fracture, glenohumeral joint dislocation, torticollis and plagiocephaly, facial nerve palsy, phrenic nerve palsy, Horner's syndrome, and central nervous system disorders are checked with clinical examinations and X-ray to record as a comorbidities and additional problems. Measure: Comorbidities Time Frame: Baseline, initial examination of children with BPBI who applied for medical follow-up. Description: The AMS is a standardized assessment of 15 active joint movements on the affected side using an eight-point scale. The 15 movements were assessed by the AMS include. For each movement, the range of 0-4 points is evaluated in gravity eliminated position, while the range of 5-7 represents movement against gravity. The AMS-Total score is the sum of the scores of all 15 movements and represents the total function of the affected upper extremity, therefore the score can range from 0 to 105 points, with 0 being poor and 105 being the best score. Measure: Active Movement Scale - Motor Function Assessment Time Frame: Baseline, initial examination of children with BPBI who applied for medical follow-up. Description: The FLACC Pain Scale is an observational behavioral scale developed by Merkel et al. in 1997. It provides a simple and consistent method for the assessment of pain in early childhood, especially in the age group when the child cannot verbally express his pain. It is used to evaluate procedural and postoperative pain in children older than 1 month. The FLACC scale is used to assess pain at rest, during a medical procedure or during various environmental stimuli. It scores 5 behaviors of the infant, including facial expression, leg movements, activities, crying and consolability, between 0 and 2 points. The scale produces a total pain score between 0 and 10 points. Measure: Flacc Pain Scale Time Frame: Baseline, initial examination of children with BPBI who applied for medical follow-up. ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Having diagnosis of Brachial Plexus Birth Injury (BPBI), * Being initial evaluation and not having started treatment before, * Being in the age range of 15-90 days old, * Consent to participate in the study. Exclusion Criteria: * Children with BPBI who are older than 90 days or younger than 15 days, * Starting regular physical therapy or home program before applying to our hospital, * Pseudo-paralysis that are diseases that may show symptoms similar to BPBI (clavicle or humerus fracture only, pseudo-paralysis not BPBI injury, glenohumeral joint septic arthritis, arthrogryposis multiplex congenita (AMC), cerebral palsy, spinal cord ischemic injury, spinal cord congenital aplasia, spinal tumor, congenital radial palsy). Maximum Age: 90 Days Minimum Age: 15 Days Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD Study Population: -In retrospective data collection, it was determined that 76 babies with BPBI and their families applied to our hospital for their first medical check or examination. Inclusion criteria were as follows: a diagnosis of BPBI, initial evaluation and not having started treatment before, being in the age range of 15-90 days old, and consent to participate in the study. Exclusion criteria: Children with BPBI who are older than 90 days or younger than 15 days and have started regular physical therapy or home program before applying to our hospital. Seventeen children who were excluded because they did not meet the inclusion criteria (4 had started physiotherapy or a home program, 1 had humerus fracture without BPBI, 1 had congenital radial palsy, 2 had AMC, 1 had spinal tumor, 8 were older than 90 days). Hence, 59 children with BPBI were included in the study. ### Contacts Locations Module #### Locations Location 1: City: Ankara Country: Turkey Facility: Hacettepe University, Faculty of Physical Therapy Rehabilitation State: Altındağ Zip: 06230 #### Overall Officials Official 1: Affiliation: Hacettepe University Name: Kıvanç Delioğlu, Assist Prof Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: Hacettepe University Name: Akin Uzumcugil, Assoc Prof Role: STUDY_CHAIR Official 3: Affiliation: Hacettepe University Name: Ebru Ozturk, PhD Role: STUDY_CHAIR Official 4: Affiliation: Hacettepe University Name: Mintaze Kerem, Professor Role: STUDY_CHAIR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M5002 - Name: Birth Injuries - Relevance: HIGH - As Found: Birth Injuries - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001720 - Term: Birth Injuries ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415734 Brief Title: Effect of Repetitive Transcranial Magnetic Stimulation on Neurological Recovery in Patients With Ischaemic Stroke Official Title: Repeated Transcranial Magnetic Stimulation (rTMS) Promotes Neural Function Recovery in Patients With Ischemic Stroke by Affecting Local Cerebral Blood Flow and Brain Network #### Organization Study ID Info ID: 202405n #### Organization Class: OTHER Full Name: The First Affiliated Hospital with Nanjing Medical University ### Status Module #### Completion Date Date: 2024-08-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-07-15 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: The First Affiliated Hospital with Nanjing Medical University #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: The goal of this clinical trial is to learn if transcranial magnetic stimulation(rTMS) can improve neurological rehabilitation in patients with acute ischemic stroke. The main questions it aims to answer are: Can rTMS Promote Recovery of Limb Impairment in Patients with Acute Ischemia? Can rTMS Cause Changes in the Functional Connections of Brain Networks in Patients? Researchers will compare rTMS therapy to non-stimulation therapy to see if rTMS is effective in promoting neurological recovery from ischemic stroke. Participants will: Receive rTMS or sham stimulation with LF-rTMS on the contralateral M1 of the brain lesion for 20 minutes, 1200 pulses, 120% RMT, and a treatment period of 5 days； Be evaluated on a scale before and after treatment ### Conditions Module Conditions: - Stroke Ischemic Keywords: - rTMS - stroke Ischemic ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: TREATMENT #### Enrollment Info Count: 40 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Subjects were treated with transcranial magnetic stimulation with the addition of a figure-of-eight coil on top of conventional western medicine treatment, and the treatment modalities were all LF-rTMS 20 min, 1200 pulses, 120% RMT in M1 contralateral to the brain lesion, with a treatment cycle of 5 days. And subjects will be assessed on the relevant scales on Day 1 and Day 5 of treatment and will be tested using a near infrared functional brain imaging device before, during and after treatment on that day. Intervention Names: - Device: rTMS Label: rTMS Type: EXPERIMENTAL #### Arm Group 2 Description: Patients received only conventional Western medications. And subjects will be assessed on the relevant scales on Day 1 and Day 5 of treatment and will be tested using a near infrared functional brain imaging device before, during and after treatment on that day. Label: control Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - rTMS Description: LF-rTMS of M1 contralateral to the brain lesion for 20 min, 1200 pulses, 120% RMT, treatment cycle of 5 days Name: rTMS Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: scale assessment score Measure: Improvement in patient motor function Time Frame: Before patient treatment and 5 days after patient treatment #### Secondary Outcomes Description: data from near-infrared functional brain imaging acquisitions Measure: Altered functional connectivity of brain networks in patients Time Frame: Patient before and after treatment on the first and fifth day of treatment and during rTMS treatment ### Eligibility Module Eligibility Criteria: Inclusion Criteria:1. The age range is 18\~75 years old 2. Meet the diagnostic criteria of China Acute Ischaemic Stroke Diagnosis and Treatment Guidelines 2018 and confirmed by head CT or MRI scanning 3. Acute stage of the disease \<14 days and stable condition 4. Stroke patients with only unilateral limb involvement (without bilateral cerebrovascular lesions) 5. Patients with upper limb muscle strength ≥ grade 3, able to perform fNIRS tasks with the patient. 6. Subjects were right-handed 7. Participants give their informed consent and sign an informed consent form - Exclusion Criteria:1. Those who have metal implants or any electronic devices in their body 2. Those with previous epilepsy or mental abnormality. 3. Combined with serious heart, liver, lung and other important organ failure 4. Those who have brain haemorrhage or bleeding tendency. 5. Deteriorating condition, new cerebral infarction or secondary cerebral haemorrhage. 6. Patients with history of craniocerebral trauma and craniocerebral surgery. 7. Those with severe cognitive and communication disorders who are unable to cooperate - Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: zhaoluwang@njmu.edu.cn Name: Zhaolu Wang Phone: +86 18100613663 Role: CONTACT #### Locations Location 1: City: Nanjing Contacts: *Contact 1:* - Email: zhaoluwang@njmu.edu.cn - Phone: 18100613663 - Role: CONTACT Country: China Facility: Jiangsu Provincial People's Hospital State: Jiangsu Zip: 210029 ### IPD Sharing Statement Module Info Types: - STUDY_PROTOCOL - SAP - ICF IPD Sharing: YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M2400 - Name: Ischemic Stroke - Relevance: HIGH - As Found: Stroke Ischemic - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemic - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke - ID: D000083242 - Term: Ischemic Stroke - ID: D000007511 - Term: Ischemia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415721 Brief Title: Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder Official Title: Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder #### Organization Study ID Info ID: PADNEW_0003 #### Organization Class: FED Full Name: VA Palo Alto Health Care System ### Status Module #### Completion Date Date: 2026-01-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-09 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-01-01 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-09 Study First Submit QC Date: 2024-05-09 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: Stanford University Class: NIH Name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) #### Lead Sponsor Class: FED Name: VA Palo Alto Health Care System #### Responsible Party Investigator Affiliation: VA Palo Alto Health Care System Investigator Full Name: Daniel McCalley Investigator Title: Postdoctoral Fellow Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: False Oversight Has DMC: True ### Description Module Brief Summary: Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States, constituting a humanitarian crisis with substantial financial burden on society and medical facilities. While several pharmacological interventions exist, 60% of individuals who seek these treatments relapse to alcohol within 6 months. These high relapse rates are due in part to elevated brain response to alcohol cues in the environment. This study seeks to evaluate the efficacy of one session of functional Magnetic Resonance Imaging (fMRI) guided transcranial magnetic stimulation (TMS) as a strategy to reduce brain reactivity to alcohol cues. Detailed Description: At least 60% of those with AUD will experience a major relapse period within 6 months of treatment, irrespective of the intervention (psychosocial and/or pharmacological) employed. Consequently, the high prevalence of AUD and relapse following treatment in Veterans is associated with substantial resource allocation and costs for the VA Health Care System. Current pharmacological and psychosocial interventions demonstrate only a moderate level of efficacy, which is reflected in the high rate of relapse in AUD. Transcanial Magnetic Stimulation (TMS) is a neurostimulation method that is at the forefront of innovative, non-invasive, and safe treatments for AUD, and other psychiatric disorders. To reduce the high rate of relapse in Veterans with AUD, it is necessary for interventions to more effectively address the associated neurobiological dysfunction. Non-invasive neuromodulation techniques are showing promise toward the aim of modifying specific and selective neural targets related to AUD and relapse. To date, TMS has been primarily delivered to the dorsolateral and medial prefrontal cortices as these regions are, on average, highly reactive to alcohol cues. On an individual basis, however, peak brain response to alcohol cues can vary substantially in spatial location within the brain. Retrospective analyses of TMS-AUD clinical trails has demonstrated that when TMS is delivered to an individual's peak brain response to alcohol cues, the likelihood of remaining abstinent is increased by a factor of 5.6 (relative to sham TMS treatment). This study aims to deliver one session of TMS to a cortical target which displays peak functional connectivity to the ventral striatum, a key brain region mediating reward and alcohol cue reactivity. The ultimate goal of this study evaluate change in brain reactivity to alcohol cues following active and sham TMS. ### Conditions Module Conditions: - Alcohol Use Disorder - Alcohol Abuse - Alcoholism - Drinking Behavior - Drinking Problem Keywords: - Transcranial Magnetic Stimulation - Veterans - Neuroimaging - Relapse ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: QUADRUPLE Who Masked: - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 40 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Device: Active Transcranial Magnetic Simulation Label: Active fMRI-guided TMS Type: EXPERIMENTAL #### Arm Group 2 Intervention Names: - Device: Sham Label: Sham fMRI-guided TMS Type: SHAM_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Active fMRI-guided TMS Description: 1 session of active continuous theta burst stimulation (3600 pulses, 110% RMT) will be delivered to the cortical region demonstrating maximal functional connectivity with the striatum during alcohol cue presentation. TMS will be delivered using the Magventure MagPro X100. Name: Active Transcranial Magnetic Simulation Other Names: - MagVenture MagPro X100 - Continuous Theta Burst Stimulation Type: DEVICE #### Intervention 2 Arm Group Labels: - Sham fMRI-guided TMS Description: 1 session of sham continuous theta burst stimulation (3600 pulses, 110% RMT) will be delivered to the cortical region demonstrating maximal functional connectivity with the striatum during alcohol cue presentation. The MagVenture MagPro x100 is capable of administering a sham stimulation. The reverse side of the TMS coil is plated with a magnetic shield such that electromagnetic energy cannot stimulate the brain. The device offers compatibility with Transcutaneous Electrical Nerve Stimulation devices such that titrated electrical pulses can be delivered to the scalp location to mimic the sensation of a TMS pulse without stimulating the brain. Name: Sham Other Names: - MagVenture MagPro X100 Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: The effect of real versus sham fMRI-guided TMS on alcohol cue reactivity will be assessed by comparing brain reactivity to images of alcohol ('alcohol cues') shown during the fMRI scan. Change in blood-oxygen level dependent signal magnitude will be measured within the striatum, a key brain region involved in cue-reactivity. Measure: Change in blood-oxygen level dependent signal as a measure of change in alcohol cue reactivity Time Frame: Baseline (pre-TMS) and Day 2 (post-TMS) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Between age 25 and 75. * Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms). * Able to attend scheduled clinic visits * Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments. * If on a medication regimen, that regimen will be stable for the duration of the study; * Fluency in English. Exclusion Criteria: * Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected in the head and body within 30 cm of the treatment coil. * General medical condition, disease or neurological disorder that interferes with the assessments or participation. * Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk. * Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen. * Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder. • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study. * Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols. • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness). * Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold * unstable chronic illness. * Current or lifetime history of bipolar disorder or psychosis. * Participation in another concurrent intervention based clinical trial. Maximum Age: 75 Years Minimum Age: 25 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Palo Alto Country: United States Facility: VA Palo Alto Health Care System State: California Zip: 94304 #### Overall Officials Official 1: Affiliation: Palo Alto VA Health Care System Name: Daniel McCalley, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Access Criteria: Researchers who provide a methodologically sound proposal. Description: Any data, specimens, forms, reports and other records that leave the site will be identified only by a participant ID number to maintain confidentiality. The ID Number will have no relationship to any aspect of identifiable private information. Therefore, the data associated with each participant will be completely de-identified and there will be no mechanism by which users can re-identify participant data with the subject code. Info Types: - STUDY_PROTOCOL - SAP - ICF IPD Sharing: YES Time Frame: Three to twelve months after publication ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019973 - Term: Alcohol-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3783 - Name: Alcoholism - Relevance: HIGH - As Found: Alcohol Use Disorder - ID: M3774 - Name: Alcohol Drinking - Relevance: HIGH - As Found: Alcohol Use - ID: M7502 - Name: Drinking Behavior - Relevance: HIGH - As Found: Drinking Behavior - ID: M21842 - Name: Alcohol-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000437 - Term: Alcoholism - ID: D000000428 - Term: Alcohol Drinking - ID: D000004327 - Term: Drinking Behavior ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415708 Brief Title: Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma Official Title: Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma: an Open-label, Multicenter Study #### Organization Study ID Info ID: BDHBcell2023 #### Organization Class: OTHER Full Name: Institute of Hematology & Blood Diseases Hospital, China ### Status Module #### Completion Date Date: 2026-06-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-11-30 Type: ESTIMATED #### Start Date Date: 2023-11-30 Type: ACTUAL Status Verified Date: 2024-01 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-03-04 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Institute of Hematology & Blood Diseases Hospital, China #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: This is a prospective, single-center, single-arm clinical study to evaluate the efficacy and safety of maintenance therapy with obinutuzumab for 2 years in patients ≥ 18 years of age with newly diagnosed mature B-cell lymphoma (including follicular lymphoma\[FL\], marginal zone cell lymphoma\[MZL\] , waldenström macroglobulinemia\[WM\], hairy-cell leukemia variant\[HCL-v\]) who achieved ≥ PR after 6 cycles of obinutuzumab in combination with bendamustine. Detailed Description: This study will explore whether induction therapy with obinutuzumab in combination with bendamustine followed by maintenance therapy with obinutuzumab in treatment-naïve patients with mature B-cell lymphoma will improve the prognosis of patients with this type of indolent mature B-cell lymphoma and the efficacy and safety of this regimen in different lymphoma subtypes. ### Conditions Module Conditions: - B Cell Lymphoma Keywords: - Obinutuzumab - Bendamustine ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 134 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: Obinutuzumab Combined With Bendamustine Label: Obinutuzumab Combined With Bendamustine Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Obinutuzumab Combined With Bendamustine Description: The treatment is divided into two phases: induction therapy and maintenance therapy Induction therapy: 6 cycles of obinutuzumab (1000 mg, IV) on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-6 (28 days/cycle). Bendamustine (90 mg/m2, IV) on Days 1 and 2 of Cycles 1-6. Maintenance therapy: Patients who achieved at least a partial response after 6 months of induction therapy were eligible to enter the maintenance phase, during which obinutuzumab (1000 mg, IV) was administered every 2 months for 2 years. Name: Obinutuzumab Combined With Bendamustine Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Disease response evaluation after 6 cycles will be used to determine the overall remission rate Measure: Overall Remission Rate(ORR) Time Frame: 24 weeks #### Secondary Outcomes Description: Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date. Measure: Progression Free Survival Time Frame: up to 4.5 years Description: Event-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause. Measure: Event-Free Survival Time Frame: up to 4.5 years Description: Disease response evaluation after 6 cycles will be used to determine the overall remission rate Measure: Complete Response Rate Time Frame: 24 weeks Description: Overall survival will be measured from the date of inclusion to the date of death from any cause. Alive patients will be censored at their last date known to be alive Measure: Overall survival Time Frame: up to 4.5 years ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Patients voluntarily participate in this study, sign informed consent and comply with the study trial protocol 2. Age ≥ 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 4. FL (grade 1 - 3a), MZL, WM, HCL-v with histological documentation of CD20 positivity 5. Systemic therapy as assessed by the investigator based on tumor size and/or GELF criteria 6. Histological confirmation of MZL. For splenic marginal zone lymphoma (SMZL) for which splenic histological specimens cannot be obtained, it is required to meet the minimum diagnostic criteria for SMZL and rule out any other type of small B-cell lymphoma, that is, it is required to confirm the diagnosis of MZL. If the patient had gastric extranodal MZL with symptoms: H. pylori-negative primary lesion or re-lesion after local therapy (i.e., surgery or radiation therapy), the investigator judged whether treatment was required, and if H. pylori-positive, stable disease, progression, or recurrence after antibiotic treatment, the investigator judged whether treatment was required 7. Waldenström macroglobulinemia,lymphoplasmacytic lymphoma,WM/LPL(WM/LPL): meets the diagnostic criteria for WM/LPL and is indicated for treatment (meets at least one of the following conditions): symptomatic hyperviscosity; symptomatic peripheral neuropathy; amyloidosis; cold agglutinin disease; cryoglobulinemia; disease-related cytopenias (Hb \< 100 g/L, PLT \< 100 × 109/L); giant lymph nodes; those with systemic symptoms: persistent for two weeks/recurrent fever (above 38℃) and not caused by infection, or night sweats and/or weight loss \> 10% within 6 months; rapid disease progression, such as lymph node enlargement of more than 50% within 2 months, and/or absolute doubling time of peripheral blood lymphocytes \< 6 months, and/or rapid decrease in hemoglobin or platelets due to non-autoimmune causes 8. HCL-v: Meet the WHO diagnostic criteria (4th Edition, 2016), and treatment is indicated 9. At least one two-dimensional measurable lymph node lesion (maximum diameter \> 1.5 cm by CT scan or MRI), or at least one two-dimensional measurable extranodal lesion (maximum diameter \> 1.0 cm by CT scan or MRI) 10. Life expectancy ≥ 3 months 11. Adequate blood function (except for abnormalities considered by the investigator to be due to the underlying disease of lymphoma), defined as follows: hemoglobin ≥ 7 g/dL absolute neutrophil count ≥ 1.0 × 10\^9/L platelet count ≥ 50 × 10\^9/L 12. Normal laboratory values: creatinine clearance ≥ 30 mL/min AST or ALT ≤ 2.5 x upper limit of normal (ULN) Serum bilirubin ≤ 2 x ULN (≤ 3 x ULN for patients with Gilbert's syndrome) measured or estimated according to institutional standard methods 13. For men who are not surgically sterile: Agree to use barrier contraception during treatment and for at least 3 months after the last dose of otuzumab or bendamustine or as required by guidelines established by the institution, whichever is longer. In addition, male patients must agree to have their partner use an alternative method of contraception (e.g., oral contraceptive, intrauterine device, barrier method, or spermicide) 14. For women who are not surgically sterilized: agree to use two appropriate methods of contraception, such as oral contraceptives, intrauterine devices, or barrier methods, with spermicide for at least 28 days before starting study drug, during treatment, and for at least 12 months after the last dose of otuzumab or bendamustine, or for the time required by the guidelines established by the study institution (whichever is longer) Exclusion Criteria: 1. Mature B-cell lymphoma previously treated with chemotherapy, immunotherapy, or radiation therapy 2. Evidence of aggressive NHL transformation 3. Known hypersensitivity to any study drug 4. Known sensitive to murine products 5. Central nervous system or meningeal involvement by lymphoma 6. Contraindications to the investigational drug included in the study treatment regimen 7. Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology) 8. Hepatitis C positive (hepatitis C virus \[HCV\] antibody serology) 9. HIV or Human T-Lymphocytic Leukemia Virus 1 (HTLV1) positive 10. Evidence of any serious, uncontrolled co-morbidities that could affect compliance with the study protocol or interpretation of results, including but not limited to significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina), or significant pulmonary disease (including history of obstructive pulmonary disease or bronchospasm); 11. Infection caused by known active bacteria, viruses, fungi, or other microorganisms (except fungal infection of the nail bed), or any major infection requiring intravenous antibiotics or hospitalization (completion of the entire course of antibiotics, except for neoplastic fever) within 4 weeks prior to enrollment 12. Previous history of malignancy other than lymphoma, unless the subject has a disease-free survival of ≥ 5 years 13. Pregnant or lactating women. 14. Participated in other clinical trials using drug interventions during the trial or within 28 days prior to Cycle 1 Corticosteroids within 4 weeks of enrollment, unless administered at a dose equivalent to ≤ 30 mg/day prednisone (within 4 weeks) 16. Past history of progressive multifocal leukoencephalopathy (PML) Vaccination with live vaccines within 28 days prior to start of treatment 18. History of solid organ transplantation 19. Presence of any serious disease or abnormality in the clinical laboratory test results that, in the opinion of the investigator, could make the patient unable to safely participate in and complete this study, or affect protocol compliance or interpretation of results Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: yishuhua@ihcams.ac.cn Name: Shuhua Yi, Dr Phone: 86-22-23909106 Role: CONTACT Contact 2: Email: qiulg@ihcams.ac.cn Name: Lugui Qiu, Dr Phone: 86-22-23909172 Role: CONTACT #### Locations Location 1: City: Tianjin Contacts: *Contact 1:* - Name: Yuting Yan - Role: CONTACT Country: China Facility: Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences State: Tianjin Status: RECRUITING Zip: 300020 #### Overall Officials Official 1: Affiliation: Institute of Hematology & Blood Diseases Hospital, Chinese Name: Shuhua Yi, Dr Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000008228 - Term: Lymphoma, Non-Hodgkin ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M18828 - Name: Lymphoma, B-Cell - Relevance: HIGH - As Found: B-cell Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T640 - Name: B-cell Lymphoma - Relevance: HIGH - As Found: B-cell Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000016393 - Term: Lymphoma, B-Cell ### Intervention Browse Module - Ancestors - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000074322 - Term: Antineoplastic Agents, Immunological ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M288906 - Name: Obinutuzumab - Relevance: HIGH - As Found: Contraction - ID: M430 - Name: Bendamustine Hydrochloride - Relevance: HIGH - As Found: Dressing - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069461 - Term: Bendamustine Hydrochloride - ID: C000543332 - Term: Obinutuzumab ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415695 Brief Title: Evaluating the Feasibility of a Dietary Weight Loss Program to Overcome Obesity and Its Comorbidity Among Arab Populations Official Title: Evaluating the Feasibility of a Dietary Weight Loss Program to Overcome Obesity and Its Comorbidity Among Arab Populations: Pilot Study #### Organization Study ID Info ID: IRB23-0344 #### Organization Class: OTHER Full Name: University of Illinois at Urbana-Champaign ### Status Module #### Completion Date Date: 2024-10-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-13 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: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-23 Study First Submit QC Date: 2024-05-13 ### Sponsor Collaborators Module #### Collaborators Class: OTHER_GOV Name: King Abdullah Medical City #### Lead Sponsor Class: OTHER Name: Asma Yahya #### Responsible Party Investigator Affiliation: University of Illinois at Urbana-Champaign Investigator Full Name: Asma Yahya Investigator Title: Doctoral Student - Main Investigator Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This study aims to develop and test a culturally tailored online weight loss program for the Saudi population. Building upon the success of a previous program in the United States, the research team will adapt educational materials and conduct a pilot study to assess the feasibility and initial outcomes of the program among Arab participants. The study seeks to answer questions about the program's acceptability, effectiveness, and scalability, with the ultimate goal of combating obesity and its related health issues in Saudi Arabia. Detailed Description: This research project aims to help Saudi individuals lose weight in a way that suits their culture. Obesity is a significant problem and can lead to serious health issues like diabetes and heart problems. Even though Saudi Arabia has attempted to help individuals lose weight before, previous efforts haven't been successful enough. Therefore, the investigators aim to develop a new weight loss program that is better suited to Saudi individuals. First, educational materials will be created in Arabic to teach individuals how to eat better and live healthier. Then, collaboration will be undertaken with individuals in Saudi Arabia to ensure the program fits their needs. Afterward, the program will be tested with a small group of individuals to evaluate its effectiveness and acceptability. Approximately 20 individuals will be invited to join the program at King Abdullah Medical City. They will participate in ten online sessions, where they will learn about healthy eating and lifestyle improvements. Additionally, they will regularly weigh themselves. Data will be collected before and after the program to assess its impact on weight loss and overall well-being. By the end of the project, the investigators hope to have developed an effective program that assists Saudi individuals in losing weight and maintaining good health. ### Conditions Module Conditions: - Overweight and Obesity Keywords: - Online weight loss program - Feasibility assessment - Dietary education - Sustainable weight loss - Pilot study ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP Intervention Model Description: The interventional study model for this research involves implementing a single-group, pre-post design to assess the effectiveness of a three-month weight loss intervention among participants with a body mass index (BMI) over 25 kg/m². Participants will engage in ten weekly online sessions covering topics related to dietary and lifestyle improvements. The intervention will be delivered through educational materials specifically tailored for the Saudi population and accessed via an online platform. Participants will also receive a Wi-Fi-enabled scale for self-monitoring of their weight loss progress throughout the intervention period. Data collection will include surveys, dietary assessments, physical measurements, and lifestyle habit assessments at baseline and three months. ##### Masking Info Masking: NONE Primary Purpose: OTHER #### Enrollment Info Count: 20 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Ten 40-minute education sessions appropriate to Saudi people will be developed and will cover essential topics for enhancing diet, lifestyle, and health. Each session comprises four modules, including activities and homework reviewed by a dietitian. Based on the EMPOWER weight loss program developed by the Nakamura lab for the US population, adjustments will be made to align with Saudi preferences, including food choices and cooking methods. Participants will access these materials online. Intervention Names: - Behavioral: Education sessions Label: A single-group, pre-post design to evaluate a three-month weight loss intervention in adult. Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - A single-group, pre-post design to evaluate a three-month weight loss intervention in adult. Description: Ten 40-minute education sessions appropriate to Saudi people will be developed and will cover essential topics for enhancing diet, lifestyle, and health. Each session comprises four modules, including activities and homework reviewed by a dietitian. Based on the EMPOWER weight loss program developed by the Nakamura lab for the US population, adjustments will be made to align with Saudi preferences, including food choices and cooking methods. Participants will access these materials online. Name: Education sessions Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Participants' views on the program's feasibility and acceptability will be gauged through structured surveys or interviews at the intervention's end. We'll employ two surveys: Feasibility Survey: this survey developed based on a previous study, examines various aspects like personal gain, program content, and engagement. Participants rate questions on a 1-5 scale and provide open-ended feedback. Feedback Survey: Participants will rate enjoyment, likelihood of recommendation, perceived benefits, and willingness to pay for services on a 1-5 scale. Open-ended questions will capture additional feedback. Measure: Program feasibility and acceptability Time Frame: 3 months #### Secondary Outcomes Description: Change in body weight from baseline to three months. Measure: Weight Loss Time Frame: 3 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Adults within the age range of 18 to 75 years old * Individuals with a BMI greater than 25 kg/m² * Proficient in the Arabic language * Not currently pregnant or breastfeeding * Not using glucagon-like peptide -1 (GLP-1) or any weight loss medications * Have not undergone bariatric surgery * Possess Wi-Fi connectivity at their residence * Own a smartphone * Willing to provide consent for participation in 10 educational sessions spanning three months. Exclusion Criteria: * Individuals not meeting the inclusion criteria. 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: yahya2@illinois.edu Name: Asma M Yahya, Master Phone: 2177224045 Role: CONTACT Contact 2: Email: asmaa.m.shathli@hotmail.com Name: Asma Yahya Phone: 2177224045 Role: CONTACT #### Locations Location 1: City: Makkah Contacts: *Contact 1:* - Email: irb@kamc.med.sa - Name: Dr. Osama Shams - Phone: 012 5549999 - Role: CONTACT *Contact 2:* - Name: Midad Ali, PhD - Role: PRINCIPAL_INVESTIGATOR Country: Saudi Arabia Facility: King Abdullah Medical City (KAMC) Zip: 22555 ### IPD Sharing Statement Module Description: IPD won't be shared due to privacy and confidentiality concerns. IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight - ID: D000001836 - Term: Body Weight Changes ### 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: HIGH - As Found: Overweight - ID: M18102 - Name: Weight Loss - Relevance: HIGH - As Found: Weight Loss - ID: M5114 - Name: Body Weight - 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: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000015431 - Term: Weight Loss ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415682 Brief Title: The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD Official Title: The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD #### Organization Study ID Info ID: 2024-SR-290 #### Organization Class: OTHER Full Name: The First Affiliated Hospital with Nanjing Medical University ### Status Module #### Completion Date Date: 2024-12-06 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-28 Type: ACTUAL Last Update Submit Date: 2024-05-23 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-12-06 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-05 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: The First Affiliated Hospital with Nanjing Medical University #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This study is a double-blinded randomized study examining the efficacy of the double-site (M1+SMA) repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) will improve FOG and gait symptoms in patients with Parkinson's disease. Detailed Description: Patients in the double-site group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the single-site group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the sham group underwent 10 sessions of sham rTMS on bilateral primary motor cortex of the lower leg. Assessments of FOG severity, gait, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention. ### Conditions Module Conditions: - Parkinson Disease Keywords: - Parkinson's disease - gait symptoms - freezing of gait - TMS - neural mechanism ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 53 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA. Intervention Names: - Device: SMA+M1 Transcranial Magnetic Stimulation Label: double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA Type: EXPERIMENTAL #### Arm Group 2 Description: Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg. Intervention Names: - Device: M1 Transcranial Magnetic Stimulation Label: single-site high frequency rTMS over the bilateral M1 of the lower leg Type: ACTIVE_COMPARATOR #### Arm Group 3 Description: Patients in the Sham Comparator group underwent ten sessions of double sham rTMS on the bilateral M1 of the lower leg. Intervention Names: - Device: Sham Transcranial Magnetic Stimulation Label: sham magnetic stimulation on the bilateral M1 of the lower leg Type: SHAM_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA Description: The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). For SMA stimulation, a 5s burst of 10Hz rTMS was repeated 20 times (1000 pulse, 20 minutes' duration). Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex (M1) of the lower leg and supplementary motor area (SMA). Name: SMA+M1 Transcranial Magnetic Stimulation Type: DEVICE #### Intervention 2 Arm Group Labels: - single-site high frequency rTMS over the bilateral M1 of the lower leg Description: The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg. Name: M1 Transcranial Magnetic Stimulation Type: DEVICE #### Intervention 3 Arm Group Labels: - sham magnetic stimulation on the bilateral M1 of the lower leg Description: Patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on M1 of the lower leg. Name: Sham Transcranial Magnetic Stimulation Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: The Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the FOGQ are 0 and 24. A higher score means a worse outcome. The differences in FOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment. Measure: Changes of Freezing of Gait severity Time Frame: Assessed at baseline, one day post intervention, one month post intervention #### Secondary Outcomes Description: The New Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the NFOGQ are 0 and 28. A higher score means a worse outcome. The differences in NFOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment. Measure: Freezing of Gait severity assessment Time Frame: Assessed at baseline, one day post intervention, one month post intervention Description: The measure mainly reflects the overall severity of Parkinson's disease motor symptoms and non-motor symptoms. The minimum value is 0 and the maximum value is 132. A higher score means a worse outcome. The score will be compared to the baseline. The differences in MDS-UPDRS III part scores before and after treatment can be used to evaluate the effect of TMS treatment. Measure: Changes of Movement Disorder Society Unified Parkinson's disease rating scale part III (MDS-UPDRS-III) Time Frame: Assessed at baseline, one day post intervention, one month post intervention Description: Gait speed (m/s) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. The differences in gait speed before and after treatment can be used to evaluate the effect of TMS treatment. Measure: Changes of Gait speed Time Frame: Assessed at baseline, one day post intervention, one month post intervention Description: Stride length (cm) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. The differences in stride length before and after treatment can be used to evaluate the effect of TMS treatment. Measure: Changes of Stride length Time Frame: Assessed at baseline, one day post intervention, one month post intervention Description: Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF) are conducted by TMS devices to assess the cortical excitation and inhibition. SICI was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with 2ms, 3ms, 4ms interstimulus interval between conditioning and test stimuli. ICF was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with 10, 12, 15 ms interstimulus interval between conditioning and test stimuli. For SICF, a subthreshold first stimulus (S1) intensity was set at 1 mV and a subsequent suprathreshold second stimulus (S2) intensity was set at RMT. Interstimulus intervals were 1.0 to 5.0 milliseconds with increments of 0.5 millisecond.The differences in SICI, ICF and SICF before and after treatment can be used to evaluate the effect of TMS treatment. Measure: Changes in Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF) Time Frame: Assessed at baseline, one day post intervention Description: The functional connectivity in the brain cortex will be recorded by functional MRI. The differences in brain regions' functional connectivity before and after treatment can be used to evaluate the effect of TMS treatment. Measure: Changes in functional connectivity in the brain cortex Time Frame: Assessed at baseline, one day post intervention Description: Studying the brain structure among groups. The differences in brain microstructure before and after treatment can be used to evaluate the effect of TMS treatment. Measure: Changes in brain structure Time Frame: Assessed at baseline, one day post intervention ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. aged between 40-80 years; 2. diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society clinical diagnostic criteria; 3. patients were stable on dopaminergic treatment for at least 3 months; 4. Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1; 5. Patients experienced FOG during an interview. Exclusion Criteria: 1. comorbidities of major neurologic diseases other than PD; 2. suffer from musculoskeletal disorders that could have interfered with their ability to walk; 3. presence of contraindications for transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI); 4. marked tremor interfered with TMS detection; 5. previously receiving any kinds of TMS interventions; 6. severe cognitive impairment making cooperation impossible \[Mini Mental State Examination (MMSE) \< 24\]; 7. were unable to walk independently during the OFF state. Healthy Volunteers: True Maximum Age: 80 Years Minimum Age: 40 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: kezhong_zhang1969@126.com Name: Kezhong Zhang Phone: 13770840575 Role: CONTACT #### Overall Officials Official 1: Affiliation: The First Affiliated Hospital with Nanjing Medical University Name: Kezhong Zhang Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415669 Brief Title: A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma Official Title: A Study of Paclitaxel (Albumin-bound) Combined With Apatinib and Adebrelimab in the Treatment of Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma Following Previous Immunotherapy Progression #### Organization Study ID Info ID: 23-OBU-FJ-GC-II-013 #### Organization Class: OTHER Full Name: The First Affiliated Hospital of Xiamen University ### Status Module #### Completion Date Date: 2027-05-19 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-29 Type: ACTUAL Last Update Submit Date: 2024-05-26 Overall Status: RECRUITING #### Primary Completion Date Date: 2026-05-19 Type: ESTIMATED #### Start Date Date: 2024-05-19 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-27 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: The First Affiliated Hospital of Xiamen University #### Responsible Party Investigator Affiliation: The First Affiliated Hospital of Xiamen University Investigator Full Name: Mingquan Cai Investigator Title: Director of medical oncology Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound) in combination with apatinib mesylate and adebrelimab in the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the progression of previous immunotherapy. ### Conditions Module Conditions: - Gastric/Gastroesophageal Junction Adenocarcinoma Keywords: - paclitaxel - apatinib - adebrelimab - adenocarcinoma of the gastroesophageal junction - gastric carcinoma ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 30 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Paclitaxel for injection (albumin-bound) in combination with Apatinib mesylate and adebrelimab Intervention Names: - Drug: Paclitaxel for injection (albumin-bound) - Drug: Adebrelimab - Drug: Apatinib mesylate Label: Single arm Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Single arm Description: 100 mg/m2, day 1, day 8, every 21 days for a cycle. Name: Paclitaxel for injection (albumin-bound) Type: DRUG #### Intervention 2 Arm Group Labels: - Single arm Description: 20mg/kg or 1200mg, the first day, every 21 days as a cycle. Name: Adebrelimab Other Names: - SHR-1316 Type: DRUG #### Intervention 3 Arm Group Labels: - Single arm Description: 250mg once a day for 5 consecutive days and discontinue for 2 days Name: Apatinib mesylate Type: DRUG ### Outcomes Module #### Other Outcomes Description: ORR corresponding to PD-L1 negative expression, positive expression (TPS≥1%), low expression (\<10%), high expression (TPS\>50%) Measure: Explore potential biomarkers in tumor tissue Time Frame: 1 years #### Primary Outcomes Description: Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria. Measure: Objective response rate（ORR） Time Frame: 1 years #### Secondary Outcomes Description: Refers to the proportion of all subjects with the best overall response (BOR) according to RECIST1.1 criteria as complete remission (CR), partial remission (PR) and stable disease (SD). Measure: Disease control rate（DCR） Time Frame: 1 years Description: PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by RECIST1.1 criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first. Measure: Progression-free survival (PFS) Time Frame: 1 years Description: It refers to the time between the first evaluation of a tumor as CR or PR and the second evaluation as Progressive Disease (PD) or death from any cause. Measure: Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Time Frame: 1 years Description: Defined as the time from the date of the first dose to the death of the subject from any cause. Measure: Overall survival（OS） Time Frame: 2 years Description: Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0） Measure: Occurence of AE and SAE Time Frame: 2 years Description: Quality of life scale for cancer patients(The EORTC's QLQ-C30 (V3.0)) is a core scale for all cancer patients with 30 entries.Items 29 and 30 are divided into seven grades, ranging from 1 to 7 according to their answer choices; Other items are rated on a four-point scale,with a straightforward scale of 1 to 4.Except for items 29 and 30, they are all reverse entries (the larger the value, the worse the quality of life).The score for each field is obtained by adding and dividing the scores for the items included in each field by the number of items included (RS).The standard component of the computing function area also changes direction. Specifically, it is calculated according to the following formula (where R is the score range of each field or item).Functional area: SS=\[1-(RS-1)/R\]\100 Symptom domain and general health status domain :SS=\[(RS-1)/R\]\100 Measure: Appraisal of life quality Time Frame: 1 years ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * 1) Age: 18 \~ 75 years old, male and female; * 2) ECOG score: 0 or 1; * 3) Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology; * 4) Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment lines does not exceed 2 lines; The best curative effect of frontline containing PD-1/PD-L1 was CR, PR or SD; * 5) According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy can also be selected as target lesions if progression is confirmed); * 6) The major organs function normally and meet the following criteria * a. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109 /L; * b. Platelets ≥100×109 /L in the past 14 days without blood transfusion; * c. Hemoglobin \>90g/L in the last 14 days without blood transfusion or use of erythropoietin; * d. Total bilirubin ≤1.5× upper limit of normal (ULN); * e. aspartate aminotransferase (AST), alanine aminotransferase (ALT) in ≤2.5×ULN (ALT or AST ≤5×ULN for patients with liver metastasis); * f. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml/min; * g. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; * h. The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included); * 7) Expected survival ≥3 months; * 8) Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period; * 9) Sign informed consent. Exclusion Criteria: * 1) Patients who have previously received paclitaxel chemotherapy; Patients with neoadjuvant or adjuvant treatment with taxoid drugs and disease progression more than 6 months after the last chemotherapy were excluded; * 2) HER2-positive patients; * 3) Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment; * 4) Patients with severe liver and kidney insufficiency or heart insufficiency; * 5) have multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction); * 6) Patients with brain metastases accompanied by symptoms or symptom control for less than 3 months; * 7) Patients who are known to be allergic to any investigational drug or drug excipient; * 8) Pregnant or lactating female patients; * 9) Patients who underwent major surgical procedures (craniotomy, thoracotomy, or laparotomy) or had unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to initial dosing, except for patients ≥2 weeks after surgery and patients with old fractures that the investigator determined could be treated with the study drug; * 10) Patients with moderate to severe ascites accompanied by clinical symptoms requiring repeated drainage; Patients with uncontrolled or clinical symptoms of pleural effusion or pericardial effusion; * 11) Patients with clinically significant electrolyte disorders; * 12) People with acute or chronic active hepatitis B or hepatitis C: hepatitis B virus (HBV) DNA \> 2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA \> 103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive patients; * 13) Patients with central nervous system metastasis, but with no clinical symptoms or accompanied by clinical symptoms after treatment, disease control and stable time ≥4 weeks can be enrolled; To meet the need for measurable lesions outside the central nervous system, hormone therapy should be discontinued 14 days before the first study of medication * 14) Any life-threatening bleeding event within the previous 3 months, including patients requiring transfusion therapy, surgery or local therapy, and ongoing medication; * 15) Patients with a history of arteriovenous thromboembolism events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism within the past 6 months. The exception is implantable intravenous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, which is stable after conventional anticoagulant therapy. Allow patients to prophylactically use small doses of low molecular weight heparin (e.g., enoxaparin 40 mg/ day); * 16) Uncontrolled hypertension, systolic blood pressure \> 160 MMHG or diastolic blood pressure \> 100mmHg after optimal medical treatment, hypertensive crisis or hypertensive encephalopathy history; * 17) Symptomatic congestive heart failure (New York Heart Association Grade II-IV). Symptomatic or poorly controlled arrhythmia. Patients with a history of congenital long QT syndrome or a QTc \> 500ms (calculated using the Fridericia method) corrected at screening; * 18) For patients who received radiation therapy more than 4 weeks before the first treatment, all of the following conditions must be met to be enrolled: there is no current toxic reaction related to radiation therapy, no need to take glucocorticoids, and radiation pneumonia, radiation hepatitis, and radiation enteritis are excluded; * 19) Patients with previous or current pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severe impairment of lung function; * 20) Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection; * 21) Patients with unhealed wounds, fractures, gastric and duodenal ulcers, persistent positive stool occultiblood, ulcerative colitis, or other conditions that researchers have determined may cause gastrointestinal bleeding or perforation; * 22) All adverse events during the screening period have not returned to baseline or ≤ Grade 1 (NCI-CTCAE V5.0) (except for alopecia, or peripheral sensory neuropathy, which can be grade 2); * 23) Patients with severe infections that are active or poorly controlled clinically. Patients with severe infections in the 4 weeks prior to initial dosing, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; * 24) Use of immunosuppressive drugs within 4 weeks prior to initial administration, excluding nasal, inhaled, or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10mg/ day of prednisone or equivalent doses of other corticosteroids); To allow temporary use of glucocorticoids for the treatment of breathing difficulties in diseases such as asthma and chronic obstructive pulmonary disease; * 25) Patients who received live attenuated vaccine within 4 weeks prior to initial administration or who planned to receive live attenuated vaccine during the study period; * 26) Patients who received major surgical treatment or significant traumatic injury 4 weeks prior to initial dosing * 27) Patients who received traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose; * 28) Patients with a history of gastrointestinal perforation or abscess within 6 months prior to enrollment; * 29) Received treatment in other clinical trials within 4 weeks prior to initial dosing; * 30) Patients whose urine routine indicated urinary protein ≥2+, or 24-hour urinary protein quantity \>1.0g; * 31) The presence of any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis); Patients with asthma requiring medical intervention with bronchodilators were not included); However, the following patients were admitted: vitiligo, psoriasis, alopecia, well-controlled type I diabetes without systemic therapy, hypothyroidism with normal thyroid function treated by replacement therapy; * 32) Other acute or chronic medical conditions, psychiatric disorders, or abnormalities in laboratory test values that may contribute to these results: increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and, in the investigator's judgment, classify patients as ineligible to participate in the study; * 33) Other situations deemed unsuitable for inclusion by the researcher. Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: mingquan035@163.com Name: Mingquan Cai Phone: 13696908231 Role: CONTACT #### Locations Location 1: City: Fuzhou Contacts: *Contact 1:* - Email: mingquan035@163.com - Name: Mingquan Cai - Phone: 13696908231 - Role: CONTACT Country: China Facility: The First Affiliated Hospital of Xiamen University State: Fujian Status: RECRUITING #### Overall Officials Official 1: Affiliation: The First Affiliated Hospital of Xiamen University Name: Mingquan Cai Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: Xiamen Hongai Hospital Name: Xia Lv Role: PRINCIPAL_INVESTIGATOR Official 3: Affiliation: Xiamen Hongai Hospital Name: Jun Qiu Role: PRINCIPAL_INVESTIGATOR Official 4: Affiliation: Zhongshan Hospital Affiliated to Xiamen University Name: Huita Wu Role: PRINCIPAL_INVESTIGATOR Official 5: Affiliation: Zhongshan Hospital (Xiamen), Fudan University Name: Xiuping Zhang Role: PRINCIPAL_INVESTIGATOR Official 6: Affiliation: Xiamen Changgeng Hospital Name: Xiaojian Yin Role: PRINCIPAL_INVESTIGATOR Official 7: Affiliation: Quanzhou First Hospital Name: Jinfeng Zhu Role: PRINCIPAL_INVESTIGATOR Official 8: Affiliation: The Second Affiliated Hospital of Fujian Medical University Name: Wen Chen Role: PRINCIPAL_INVESTIGATOR Official 9: Affiliation: Zhangzhou Hospital Name: Yijun Wang Role: PRINCIPAL_INVESTIGATOR Official 10: Affiliation: The 73rd Army Hospital Name: Guoqin Qiu Role: PRINCIPAL_INVESTIGATOR Official 11: Affiliation: West China Xiamen Hospital of Sichuan University Name: Yongmei Liu Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## 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: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - 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: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Gastroesophageal Junction Adenocarcinoma - 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: 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: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000230 - Term: Adenocarcinoma - ID: D000004938 - Term: Esophageal 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: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M288166 - Name: Apatinib - Relevance: HIGH - As Found: Myopia - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - 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: D000017239 - Term: Paclitaxel - ID: C000553458 - Term: Apatinib ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415656 Brief Title: VitalTraq for the Detection of CRS Official Title: Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy #### Organization Study ID Info ID: Pro00115012 #### Organization Class: OTHER Full Name: Duke University ### Status Module #### Completion Date Date: 2025-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-06-30 Type: ESTIMATED #### Start Date Date: 2024-10 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-07 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Blue Spark Technologies #### Lead Sponsor Class: OTHER Name: Duke University #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Is US Export: False Oversight Has DMC: False ### Description Module Brief Summary: The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia. ### Conditions Module Conditions: - Hematologic Malignancy ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: DIAGNOSTIC #### Enrollment Info Count: 32 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program. Intervention Names: - Device: TempTraq - Device: VitalTraq Label: Patients with hematologic malignancies Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Patients with hematologic malignancies Description: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature. Name: TempTraq Type: DEVICE #### Intervention 2 Arm Group Labels: - Patients with hematologic malignancies Description: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure. Name: VitalTraq Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers. Measure: TempTraq's ability to measure axillary temperature in the intended use population. Time Frame: Day 14 #### Secondary Outcomes Description: The times to first detection of fever, if applicable, will be measured for each patient using temperature data derived from the TempTraq device and standard-of-care oral thermometers. The mean time to first fever (i.e., temperature \> 38 degrees Celsius), will be calculated and described for both the TempTraq device and standard-of-care oral thermometers. Measure: Lead time by which fevers can be detected using TempTraq compared to SOC interval oral thermometer measurements. Time Frame: Day 14 Description: Determined by use of an equivalence test to test the hypothesis that there is no difference in the systolic and diastolic measurements using VitalTraq compared to SOC interval vitals measurements. The smallest tolerable differences in systolic and diastolic blood pressure are set to be 20 mmHg and 10 mmHg, respectively. Measure: VitalTraq's ability to measure blood pressure in the intended use population. Time Frame: Day 14 Description: Determined by use of an equivalence test to test the hypothesis that there is no difference in the heart rate measurements using VitalTraq compared to SOC interval oral thermometer measurements. The smallest tolerable difference is set to be 10 beats per minute. Measure: VitalTraq's ability to measure heart rate in the intended use population. Time Frame: Day 14 Description: The mean scores on individual questions in a post-intervention survey featuring 7-point Likert scale responses, where 1=strongly agree and 7=strongly disagree, will be calculated and described. A lower score indicates lower burden. Measure: Patient's perspective on the burden of using TempTraq and VitalTraq. Time Frame: Day 28 Description: The times to first detection of grade 2 or higher CRS, if applicable, will be measured for each patient using vitals data derived from the TempTraq and VitalTraq devices, as well as via standard-of-care vitals measurements. The mean time to first detection of grade 2 or higher CRS will be calculated and described for both the investigational devices and standard-of-care monitoring. Measure: Lead time by which TempTraq and VitalTraq can detect grade 2 or higher Cytokine Release Syndrome (CRS) as compared to the standard of care. Time Frame: Day 14 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (CAR) T-cell therapy or bispecific T-cell engagers (BiTE), as follows: * Axicabtagene ciloleucel * Lisocabtagene maraleucel * Brexucabtagene autoleucel * Idecabtagene vicleucel * Ciltacabtagene autoleucel * Tisagenlecleucel * Blinatumomab * Mosunetuzumab * Talquetamab * Elranatamab * Teclistamab * Glofitamab 2. Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening. 3. Able to read and understand English 4. Willing and able to provide informed consent to the study Exclusion Criteria: 1. Receiving a non-FDA approved CAR-T or BiTE product 2. Receiving Epcoritamab Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: lauren9494@gmail.com Name: Lauren Hill Phone: 7045774113 Role: CONTACT Contact 2: Email: chenyu.lin@duke.edu Name: Chenyu Lin, MD Phone: +1 919 684 8964 Role: CONTACT #### Overall Officials Official 1: Affiliation: Duke University Name: Chenyu Lin, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M21314 - Name: Hematologic Neoplasms - Relevance: HIGH - As Found: Hematologic Malignancies - ID: M2157 - Name: Cytokine Release Syndrome - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019337 - Term: Hematologic Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415643 Brief Title: The Use of Islet Organoids in the Treatment of Pancreatic Surgery-related Diabetes Official Title: The Use of Islet Organoids in the Treatment of Pancreatic Surgery-related Diabetes #### Organization Study ID Info ID: YD-ZE-001 #### Organization Class: OTHER Full Name: Zhejiang University ### Status Module #### Completion Date Date: 2026-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-12-31 Type: ESTIMATED #### Start Date Date: 2024-05-10 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-09 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Newislet Biotechnology (Shanghai) Ltd. #### Lead Sponsor Class: OTHER Name: Zhejiang University #### Responsible Party Investigator Affiliation: Zhejiang University Investigator Full Name: Sheng Yan Investigator Title: Professor, MD 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 clinical trial is to verify the safety and effectiveness of autologous islet organoids transplantation after in vitro expansion for the treatment of pancreatogenic diabetes. Detailed Description: The purpose of this clinical trial is to verify the safety and effectiveness of autologous islet transplantation after in vitro expansion in the forms of functional islet organoids, for the treatment of pancreatogenic diabetes in patients who have undergone pancreatic resection through a single-center single-arm study We aim to establish the entire operational process of isolating expanding and transplanting islets from the pancreas removed from the patient and managing postoperative care We hope to accumulate clinical experience in treating pancreatogenic diabetes with transplanted autologous islet cell clusters expanded in vitro establish standard and regulated medical operations and gather materials for future applications of this treatment method in clinical practice. ### Conditions Module Conditions: - T3c Diabetes ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 5 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: transplantation group Intervention Names: - Other: Islet organoids transplantation Label: Transplantation group Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Transplantation group Description: autologous transplantation of ex vivo expanded islet organoids. Name: Islet organoids transplantation Type: OTHER ### Outcomes Module #### Primary Outcomes Description: C-peptide detection assay Measure: C-peptide secretion Time Frame: before transplantation and 1 year after transplantation #### Secondary Outcomes Description: HbA1c detection assay Measure: HbA1c level Time Frame: before transplantation and 1 year after transplantation Description: Glucose measurement Measure: MAGE Time Frame: 12 weeks and 52 weeks post transplantation Description: recorded events of severe hypoglycemia Measure: Ryan Hypoglycemia event Time Frame: baseline and 52 weeks post transplantation Description: comparison of Insulin usage Measure: Insulin usage Time Frame: 12 weeks and 52 weeks post transplantation ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Voluntarily sign the informed consent form and adhere to the trial treatment plan and visit schedule. 2. When signing the informed consent form, the age should be between 18-70 years old, with no gender restrictions. 3. Good overall health condition: no damage to important organs such as heart, lungs, liver, kidneys, no serious or uncontrolled infections, and no history of severe mental disorders. 4. Meets the diagnosis of pancreatic tumor, chronic pancreatitis (diffuse pancreatic duct stones, refractory pain, associated with high risk of pancreatic cancer), pancreatic trauma, postoperative pancreatic fistula with class C, pancreatic cystic fibrosis, has indications for total or subtotal pancreatectomy, and no chronic organ failure. 5. Clinical examinations must meet the following criteria: Normal glycated hemoglobin (HbA1c) measurement. 6. Normal alanine aminotransferase (ALT) measurement, or abnormal but clinically insignificant 7. negative for Hepatitis A virus antibody (HAV antibody), Hepatitis B virus surface antigen (HBsAg) and e antigen, Hepatitis C virus antibody (HCV antibody), Human Immunodeficiency Virus antibody (HIV-1 and HIV-2 antibody), Syphilis antibody, Epstein-Barr virus antibody (EBV antibody), Cytomegalovirus (CMV-DNA), B19 virus nucleic acid, Human T-lymphotropic virus antibody. 8. Male participants who are sexually active and have not undergone surgical sterilization or whose partners are capable of childbearing, agree to take effective contraceptive measures for the entire trial period and at least 6 months after the end of the study, and not to donate sperm. Female participants capable of childbearing agree to take effective contraceptive measures for the entire study period and at least 6 months after the end of the study. 9. Post-pancreatic surgery blood sugar increase, meeting the diagnostic criteria for diabetes (World Health Organization 2019 edition). 10. C-peptide level \<0.3 ng/mL 120 minutes after mixed meal stimulation before pancreatic islet transplantation. Exclusion Criteria: 1. The investigator considers the following diseases to be clinically significant: a history of diabetes, or preoperative hyperglycemia, meeting the diagnosis of diabetes. 2. Undergone previous pancreatic or islet transplantation 3. Uncontrolled hypertension, such as systolic blood pressure (SBP) \>160 mmHg and/or diastolic blood pressure (DBP) \>100 mmHg after treatment with a stable dose (at least 4 weeks) of antihypertensive drugs. 4. Fatty hepatitis, portal vein thrombosis, portal hypertension, anterolateral pancreatic jejunostomy, or visceral hyperalgesia.Impaired liver and kidney function at screening (reference to the normal range of laboratory tests in the research center): aspartate aminotransferase (AST) \>3 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \>3 times ULN, total bilirubin level (TBL) \>2 times ULN (excluding Gilbert's syndrome). Creatinine clearance \<45 mL/min (calculated by Cockcroft-Gault formula) 5. Women in pregnancy, less than 6 months after miscarriage, less than 1 year after delivery and lactation. 6. History of infectious diseases including but not limited to hepatitis A, hepatitis B, hepatitis C, HIV and syphilis 7. Presence of known hemoglobin-related diseases, anemia (moderate to severe) or other known hemoglobin diseases that interfere with HbA1c measurement (such as sickle cell disease). Presence of massive albuminuria (urinary protein excretion rate \>300 mg/g) or past medical history. 8. Presence of severe heart disease or cardiovascular disease within 6 months before screening, including: stroke, decompensated heart failure (NYHA class III or IV), myocardial infarction, unstable angina, those who have undergone coronary artery bypass grafting. 9. History of coagulation disorders or need for long-term anticoagulation treatment (such as warfarin) (low-dose aspirin treatment is allowed) or INR\>1.5 10. Treatment (local, intra-articular, intraocular, or inhaled formulations) for any other factors or diseases, other than the above reasons, that the researcher deems unsuitable for participation in this clinical study. Maximum Age: 70 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: xima@zju.edu.cn Name: Xi Ma, MD Phone: 86-18768117002 Role: CONTACT Contact 2: Email: qing.yu@newislet.com Name: Qing Cissy Yu, PhD Phone: 86-13916205952 Role: CONTACT #### Locations Location 1: City: Hangzhou Contacts: *Contact 1:* - Email: xima@zju.edu.cn - Name: Xi Ma, MD - Phone: 86-18768117002 - Role: CONTACT *Contact 2:* - Name: Sheng Yan, PhD,MD - Role: PRINCIPAL_INVESTIGATOR Country: China Facility: Zhejiang University Second Affiliated Hospital State: Zhejiang Status: RECRUITING #### Overall Officials Official 1: Affiliation: Zhejiang University Second Affiliated Hospital Name: Sheng Yan, PhD, MD Role: PRINCIPAL_INVESTIGATOR ### 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 - 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: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415630 Acronym: ADreintubate Brief Title: Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection Official Title: Multiple Automated Machine-learning Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection #### Organization Study ID Info ID: WHUH-AADreintu #### Organization Class: OTHER Full Name: Wuhan Union Hospital, China ### Status Module #### Completion Date Date: 2023-12-31 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-09 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-10-31 Type: ACTUAL #### Start Date Date: 2018-01-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-09 Study First Submit QC Date: 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Wuhan Union Hospital, China #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Reintubation is an adverse postoperative complication in patients with Type A aortic dissection (AAD) that correlates to poor outcomes. This study aims to analyze the risk factors associated with reintubation and to create a fully automated score model to predict the incidence of reintubation. A total of 861 patients diagnosed with AAD and undergoing surgical procedures in a single institution between January 2018 and October 2023 were selected in wuhan Union Hospital. Preoperative and postoperative informmation was used for seeking risk factors and build prediction model for postoperative reintubation. Finally, 5 risk factors wasidentified and a nomogram was established for predicting postoperative reintubation in patients with AAD. ### Conditions Module Conditions: - Nomogram - Prediction Model - Type A Aortic Dissection - Postoperative Reintubation ### Design Module #### Design Info Observational Model: COHORT Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 861 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: To determine potential predictive factors, the training group was subjected to LASSO regression analysis, which effectively eliminated several irrelevant or multicollinearity independent variables to reduce high-dimensional data.Seven models were initially constructed in the training group: multivariable logistics regression (MLR), decision-tree modeling, random forest, XGBoost, Support Vector Machines, k-nearest neighbors, and LightGBM. Intervention Names: - Procedure: Type A aortic dissection surgery Label: training group #### Arm Group 2 Description: Testing group was used to examine the performance of the seven prediction models, including discrimination and calibration performance. Finally, the model with best discrimination and calibration performance was used to construct nomogram for predicting reintubation. Intervention Names: - Procedure: Type A aortic dissection surgery Label: testing group ### Interventions #### Intervention 1 Arm Group Labels: - testing group - training group Description: Patients with type A aortic dissection undergone surgery. Name: Type A aortic dissection surgery Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: reintubation incidence in patients with type A aortic dissection undergoing surgery Measure: postoperative reintubation Time Frame: 3 month ### Eligibility Module Eligibility Criteria: Inclusion Criteria: (1) patients diagnosed with AAD admitted for open surgery; (2) aged 18 years or older. Exclusion Criteria: (1) patients deceased during or within 24 hours after surgery; (2) patients with preoperative intubation. Maximum Age: 90 Years Minimum Age: 19 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: A total of 892 patients with AAD who underwent open surgery at Wuhan Union Hospital between January 2018 and October 2023 were enrolled using a convenient sampling method. ### Contacts Locations Module #### Locations Location 1: City: Wuhan Country: China Facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology State: Hubei Zip: 430022 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000094665 - Term: Dissection, Blood Vessel - ID: D000000783 - Term: Aneurysm - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000094683 - Term: Acute Aortic Syndrome - ID: D000001018 - Term: Aortic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4114 - Name: Aortic Dissection - Relevance: HIGH - As Found: Aortic Dissection - ID: M3081 - Name: Dissection, Blood Vessel - Relevance: LOW - As Found: Unknown - ID: M4113 - Name: Aneurysm - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M3085 - Name: Acute Aortic Syndrome - Relevance: LOW - As Found: Unknown - ID: M4334 - Name: Aortic Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000784 - Term: Aortic Dissection ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415617 Brief Title: Home-based Psychoeducation for Older Adults With Frailty: A Feasibility Trial Official Title: Effects of A Home-based Psychoeducation Programme on Subjective Well-being for Older Adults With Frailty in the Community: A Feasibility Trial #### Organization Study ID Info ID: 2023.585.p #### Organization Class: OTHER Full Name: Chinese University of Hong Kong ### Status Module #### Completion Date Date: 2024-04-09 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-04-09 Type: ACTUAL #### Start Date Date: 2023-11-24 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: TAO An #### Responsible Party Investigator Affiliation: Chinese University of Hong Kong Investigator Full Name: TAO An Investigator Title: Mr Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: This study aims to test the feasibility and acceptability of home-based psychoeducation in older adults with frailty in the community. The main questions it aims to answer are 1. Are the proposed eligibility criteria for participants and the study process in recruiting and retaining the participants appropriate? 2. Is home-based psychoeducation feasible and acceptable for older adults with frailty in the community? Participants will receive 12 weekly online group-based sessions at their homes. The content for the experimental group and control group is different: * Intervention group: psychoeducation * Control group: physical health education Participants will receive two home visits for data collection. An individual interview will be conducted with participants in the experimental group to explore their experiences. ### Conditions Module Conditions: - Frailty - Well-Being, Psychological Keywords: - Subjective well-being - frailty - psychoeducation ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - OUTCOMES_ASSESSOR Primary Purpose: HEALTH_SERVICES_RESEARCH #### Enrollment Info Count: 24 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will receive 60-minute weekly online group-based psychoeducation sessions for 12 weeks. Intervention Names: - Other: Psychoeducation Label: Experimental group Type: EXPERIMENTAL #### Arm Group 2 Description: Participants will receive 60-minute weekly online group-based physical health sessions for 12 weeks. Intervention Names: - Other: Attention control Label: Control group Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Experimental group Description: The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving" . The participants will be engaged in psychoeducation through group discussion, individualised goal setting and reflective exercises. Name: Psychoeducation Type: OTHER #### Intervention 2 Arm Group Labels: - Control group Description: The content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management. Name: Attention control Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The feasibility of the study will be measured in terms of participation rate, self-reported intervention adherence, and attrition rate. Measure: Participation rate, self-reported intervention adherence, and attrition rate. Time Frame: 12 weeks post-allocation Description: A 5-item satisfaction survey will be conducted by the end of the intervention for participants to rate the intervention in terms of appropriates of the session content, length of each session, overall intervention duration and delivery mode, from 1 (very dissatisfied) to 5 (very satisfied). Measure: Acceptability Time Frame: 12 weeks post-allocation #### Secondary Outcomes Description: FRAIL scale Measure: Frailty level Time Frame: 12 weeks post-allocation Description: The Senior Fitness Test: It covers four dimensions, including muscle endurance, balance, flexibility, and tolerance measured by 30-sec arm-curl test, 30-sec chair-stand test, back-scratch test, chair sit-and-reach test, 8-foot up-and-go test, two-min step test. Measure: Physical functioning Time Frame: 12 weeks post-allocation Description: Katz Index of Independence in Activities of Daily Living Measure: Activities of daily living Time Frame: 12 weeks post-allocation Description: Lawton Instrumental Activities of Daily Living Scale Measure: Instrumental activities of daily living Time Frame: 12 weeks post-allocation Description: The Chinese 5-item World Health Organization Well-Being Index Measure: Subjective well-being Time Frame: 12 weeks post-allocation Description: 4-item Geriatric Depression scale Measure: Depressive symptoms Time Frame: 12 weeks post-allocation Description: 10-item Duke Social Support Index Measure: Social support Time Frame: 12 weeks post-allocation Description: EuroQol 5-Dimension 5-Level Measure: Quality of life Time Frame: 12 weeks post-allocation ### Eligibility Module Eligibility Criteria: Inclusion Criteria: (1) aged 65 years or over; (2) meeting frailty criteria by FRAIL scale (score 3 or above) ; (3) mentally competent screened by The Abbreviated Mental Test (AMT≥6) ; (4) able to speak and understand Cantonese; (5) living at home; (6) having experience using a smartphone (e.g.: sending messages, watching videos) Exclusion Criteria: (1) have a visual or hearing problem or a language barrier that may affect their communication or understanding; (2) being unfit for home-based exercise, as defined by having one point or above at either the 25-item Home Falls and Accidents self-reported screening tool (HOME-FAST), which is a comprehensive tool for identify home hazards for fall (3) are currently practising exercise for at least 150 minutes per week in previous four weeks; (4) are receiving active psychiatric or antidepressant treatment or joining other physical exercises or rehabilitation programmes Minimum Age: 65 Years Sex: ALL Standard Ages: - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Shatin Country: Hong Kong Facility: The Nethersole School of Nursing, The Chinese University of Hong Kong State: New Territories ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M1175 - Name: Frailty - Relevance: HIGH - As Found: Frailty ### Condition Browse Module - Meshes - ID: D000073496 - Term: Frailty ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415604 Brief Title: Home-based Psychoeducation for Older Adults With Frailty: A Randomised Controlled Trial Official Title: Effects of a Home-based Psychoeducation on Subjective Well-being for Older Adults With Frailty in the Community: A Randomised Controlled Trial #### Organization Study ID Info ID: 2023.585.M #### Organization Class: OTHER Full Name: Chinese University of Hong Kong ### Status Module #### Completion Date Date: 2025-01-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-01-01 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: TAO An #### Responsible Party Investigator Affiliation: Chinese University of Hong Kong Investigator Full Name: TAO An Investigator Title: Mr Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: This study aims to examine the effectiveness of a 12-week home-based telerehabilitation programme on improving subjective well-being among community-dwelling older people with frailty. The main question it aims to answer is - Could home-based psychoeducation significantly enhance subjective well-being in older adults with frailty in the community? Participants will receive 12 weekly online group-based sessions at their homes. The content for the experimental group and control group is different: * Intervention group: psychoeducation * Control group: physical health education Participants will receive three home visits for data collection. Some of participants in experimental group will receive interview for process evaluation. ### Conditions Module Conditions: - Frailty - Well-Being, Psychological Keywords: - Subjective well-being - frailty - psychoeducation ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - OUTCOMES_ASSESSOR Primary Purpose: HEALTH_SERVICES_RESEARCH #### Enrollment Info Count: 138 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will receive 60-minute weekly online group-based psychoeducation sessions for 12 weeks. Intervention Names: - Other: Psychoeducation Label: Experimental group Type: EXPERIMENTAL #### Arm Group 2 Description: Participants will receive 60-minute weekly online group-based physical health sessions for 12 weeks. Intervention Names: - Other: Attention control Label: Control group Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Experimental group Description: The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving". Name: Psychoeducation Type: OTHER #### Intervention 2 Arm Group Labels: - Control group Description: The content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management. Name: Attention control Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The Chinese 5-item World Health Organization Well-Being Index Measure: Subjective well-being Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation #### Secondary Outcomes Description: FRAIL scale Measure: Frailty level Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation Description: The Senior Fitness Test: It covers four dimensions, including muscle endurance, balance, flexibility, and tolerance measured by 30-sec arm-curl test, 30-sec chair-stand test, back-scratch test, chair sit-and-reach test, 8-foot up-and-go test, two-min step test Measure: Physical functioning Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation Description: Katz Index of Independence in Activities of Daily Living Measure: Activities of daily living Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation Description: Lawton Instrumental Activities of Daily Living Scale Measure: Instrumental activities of daily living Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation Description: 4-item Geriatric Depression scale Measure: Depressive symptoms Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation Description: 10-item Duke Social Support Index Measure: Social support Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation Description: EuroQol 5-Dimension 5-Level Measure: Quality of life Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation ### Eligibility Module Eligibility Criteria: Inclusion Criteria: (1) Aged 65 or older; (2) Identified as frail by the FRAIL scale (score ≥3); (3) Mentally competent as determined by the Abbreviated Mental Test (AMT ≥6); (4) Able to speak and understand Cantonese; (5) Living at home; (6) Experienced in using a smartphone (e.g., sending messages, watching videos). Exclusion Criteria: (1) Have visual or hearing impairments or language barriers that may impact communication or understanding; (2) Unfit for home-based exercise, as indicated by a score of 1 or higher on the 25-item HOME-FAST, a tool for identifying home fall hazards; (3) Currently engaging in exercise for at least 150 minutes per week over the past four weeks; (4) Undergoing active psychiatric or antidepressant treatment or participating in other physical exercise or rehabilitation programs. Minimum Age: 65 Years Sex: ALL Standard Ages: - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: andersontao@link.cuhk.edu.hk Name: An TAO Phone: (852) 39439929 Role: CONTACT #### Locations Location 1: City: Shatin Contacts: *Contact 1:* - Email: andersontao@link.cuhk.edu.hk - Name: An TAO - Phone: (+852) 39439929 - Role: CONTACT Country: Hong Kong Facility: The Nethersole School of Nursing, The Chinese University of Hong Kong State: New Territories Status: RECRUITING ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M1175 - Name: Frailty - Relevance: HIGH - As Found: Frailty ### Condition Browse Module - Meshes - ID: D000073496 - Term: Frailty ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415591 Brief Title: Auricular Neuromodulation in Veterans With Fibromyalgia Official Title: Auricular Neuromodulation in Veterans With Fibromyalgia: A Randomized, Sham-Controlled Study #### Organization Study ID Info ID: F5050-R #### Organization Class: FED Full Name: VA Office of Research and Development #### Secondary ID Infos Domain: VA RR&D ID: I01RX005050 Type: OTHER_GRANT ### Status Module #### Completion Date Date: 2028-10-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-22 Type: ACTUAL Last Update Submit Date: 2024-05-21 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2028-09-01 Type: ESTIMATED #### Start Date Date: 2024-10-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-08 Study First Submit QC Date: 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor Class: FED Name: VA Office of Research and Development #### 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: PENFS (percutaneous electrical nerve field stimulation) is an FDA-approved acupuncture-like therapy applied to the external ear targeting several cranial nerve branches including the auricular branch of the vagus nerve to improve pain, physical function, and reduce symptoms of opioid withdrawal. PENFS has been previously shown to provide improvements in fibromyalgia, a difficult to treat chronic pain syndrome, which correlate with changes observed using a special kind of MRI called resting state functional connectivity MRI (rs-fcMRI) that evaluates brain activity at rest. The goals of this study are to rigorously test the initial promising results of PENFS in a much larger group of Veterans suffering from fibromyalgia and to identify potential mechanisms of PENFS effects. Further developing non-pharmacologic therapies for pain can help to improve quality of life and function for those suffering from fibromyalgia and decrease reliance on opioids and other drugs that have numerous side effects for individuals suffering from chronic pain. Detailed Description: BACKGROUND: In the setting of the opioid epidemic, it is crucial to develop and assess non-pharmacologic treatments for pain and understand underlying mechanisms. In the present investigation, the investigators assess a novel non-pharmacologic approach to chronic pain treatment in Veterans suffering from fibromyalgia (a notoriously difficult to treat pain syndrome that affects 5-10 million Americans and disproportionately affects those returning from the Gulf War), utilizing brain imaging as a biomarker and heart rate variability (HRV) to assess a vagal mechanism. Preliminary results from prior VA-funded feasibility study reveal a trend towards improved pain and function with a FDA-approved, non-pharmacologic therapy - auricular percutaneous electrical nerve field stimulation (PENFS) - over standard therapy control for Veterans suffering from fibromyalgia, correlating to altered network connectivity on rs-fcMRI (resting state functional connectivity MRI). PENFS-related improvements continued through 12 weeks following the completion of treatment and correlated to changes in cross-network connectivity, which differed between groups. Based on the preliminary data, the investigators now intend to rigorously assess the treatment effects of PENFS in a large, double-blind, randomized, sham-controlled study. OBJECTIVE: The proposed Merit, a randomized, sham-controlled trial of auricular PENFS, evaluates the clinical utility of PENFS for fibromyalgia as compared to sham placebo control, acute and longitudinal PENFS-related neural changes visualized on rs-fcMRI and effects of PENFS on HRV as a potential vagal mechanism of pain relief. HYPOTHESIS: True PENFS results in non-placebo-related short-and long-term pain and physical function improvements that can be correlated with altered connectivity and HRV. METHODS: For Aim 1, 240 total participants meeting 2016 diagnostic criteria for fibromyalgia (male and female, age 18-60 years old) will be randomized to either true (n=120) or sham (n=120) auricular PENFS. Neuroimaging data, self-reported pain, and physical function will be assessed at baseline and at 1- and 12- weeks post-treatment to evaluate neural correlates of PENFS-related treatment. Participants who meet study criteria will be randomized to either true or sham PENFS (series of 4, weekly) treatments and assessed for rsfcMRI and functional changes at 1- and 12-weeks post-treatment. Baseline and follow-up rs-fcMRI will be utilized to identify biomarkers of fibromyalgia and PENFS treatment effects for Aim 2 in a subset of 62 participants from Aim 1 who qualify for MRI procedures. Cardiopulmonary data will be simultaneously collected during rs-fcMRI and utilized for the exploratory Aim 3 to evaluate potential PENFS effects on HRV as an outcome measure for vagal effects. In the initial phase preliminary analytical validation will be accomplished in the first 30 participants following IRB approval, hiring and training of staff, and establishment of an image processing pipeline. If initial milestones are met, the rigorous, double-blind, sham-controlled study in a larger group of Veterans will continue. Veterans who are initially assigned to sham placebo PENFS and are not identified as placebo-responders will be offered the opportunity to test the true PENFS device. This study addresses the critical need to clinically evaluate non-pharmacologic therapies for chronic pain. ### Conditions Module Conditions: - Fibromyalgia Keywords: - Pain - Fibromyalgia - Magnetic Resonance Imaging - Veterans - Percutaneous Electrical Nerve Field Stimulation - Vagus Nerve ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Participants will be randomized 1:1 to either true or sham PENFS using the auricular device (series of 4, weekly placement with ongoing 5 day (M-F) stimulation - manufacturer recommended) treatments, then assessed for changes in pain and function at 12 and 24 weeks post-treatment. The 12-week time point is chosen to evaluate longer-term neural changes as an indicator of neural plasticity, given the continued improvements seen in the investigators' PENFS group based on preliminary data. The 24- week timepoint is chosen to evaluate longer term (6 months) pain outcomes related to PENFS. ##### Masking Info Masking: QUADRUPLE Masking Description: Double-blind, sham placebo controlled. Randomization will be performed by a research coordinator, who will assign each participant a study number and keep a record of whether they are receiving true or sham PENFS, thus maintaining blinding of the participant, the study physicians, the research assistant, and the data analysis team including the P.I. (A.W.) until completion of the follow-up period and data analyses can be performed. Who Masked: - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 240 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Percutaneous electrical nerve stimulation applied to the ear x 4 over a 4 week period. The device is placed over the area of the ear and worn home continuously for a 5-day period, during which time it stimulates at a pre-set on/off duty cycle. At each in-person visit, the device is replaced until the device has been placed 4 times. The stimulation delivered is below the threshold of sensory perception. Intervention Names: - Device: Percutaneous electrical nerve field stimulation Label: True PENFS Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: A device is placed at the same points for the same amount of time and at the same intervals as the true device. This device will not deliver electrical stimulation. Intervention Names: - Device: Percutaneous electrical nerve field stimulation Label: Sham PENFS Type: SHAM_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Sham PENFS - True PENFS Description: FDA-approved acupuncture-like therapy applied to the external ear targeting several cranial nerve branches including the auricular branch of the vagus nerve to improve pain, physical function, and reduce symptoms of opioid withdrawal. Name: Percutaneous electrical nerve field stimulation Other Names: - PENFS Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: The investigators will assess whether pain and functional improvements occur with the application of PENFS. Clinical pain, as measured by the Defense Veterans Pain Rating Scale (DVPRS), will be our primary outcome. This measure is rated on a scale of 0 to 10, with 0 being "no pain" and 10 being "as bad as it could be, nothing else matters". Assessments will be administered at baseline, immediately pre- and post-treatment (the device is replaced every 5 days for a total of 4 device applications), 12 weeks post-treatment, and 24 weeks post-treatment. Measure: Improvements in Clinical Pain (DVPRS) Time Frame: Through study completion, an average of 1 year Description: The investigators will assess whether pain and functional improvements occur with the application of PENFS. Changes in clinical pain will also be assessed for this outcomes via self-reported analgesic consumption. This measure is not rated on a scale - it is self-reported use. Assessments will be administered at baseline, immediately pre- and post-treatment (the device is replaced every 5 days for a total of 4 device applications), 12 weeks post-treatment, and 24 weeks post-treatment. Measure: Improvements in Clinical Pain (Self-reported analgesic consumption) Time Frame: Through study completion, an average of 1 year #### Secondary Outcomes Description: Resting state functional connectivity magnetic resonance imaging (rs-fcMRI) will be performed at baseline and 12 weeks post-treatment to assess changes in cross-network connectivity with the default mode network (DMN) and sensorimotor network (SMN) as well as connectivity within the salience network (SN). Measure: rs-fcMRI as a biomarker of treatment response Time Frame: Baseline, 12 weeks post-treatment Description: Heart rate variability (HRV) will be assessed at the MRI scans at baseline and 12 weeks post-treatment with an MR-compatible pulse oximeter to evaluate the effects of PENFS on parasympathetic tone. Measure: PENFS effects on parasympathetic tone as measured by heart rate variability (HRV) Time Frame: Baseline, 12 weeks post-treatment Description: Fibromyalgia severity will be assessed via the Fibromyalgia Impact Questionnaire (FIQ-R). Each question is rated on a scale of 1 to 10 with 1 being the least impact/severity and 10 being the most impact/severity. Assessments will be administered at baseline, immediate post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment. Measure: Changes in Fibromyalgia Severity (FIQ-R) Time Frame: Through study completion, an average of 1 year Description: Functional improvements will be assessed using the arm curl test. Assessments will be administered at baseline, immediate post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment. Measure: Functional Improvements (Arm curls) Time Frame: Through study completion, an average of 1 year Description: Fibromyalgia severity will be assessed via the Polysymptomatic Distress Scale (PSD). This measure ranges from scores of 0 to 31, with 0 being the least severe and 31 being the most severe. Assessments will be administered at baseline, immediate post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment. Measure: Changes in Fibromyalgia Severity (PSD) Time Frame: Through study completion, an average of 1 year Description: Functional improvements will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) measures ("physical function," "anxiety," "depression," "fatigue," "sleep disturbance," "social function," "pain interference," "global health"). PROMIS measures are rated on a scale of 1 to 5 with 1 being the least intense ("Never") and 5 being the most intense ("Always"). There are a few questions (i.e. PROMIS "global health" measure, item 07r) rated on different scales, such as from 1 to 10, with 1 being the least intense and 10 being the most intense. Assessments will be administered at baseline, immediate post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment. Measure: Functional Improvements (PROMIS change) Time Frame: Through study completion, an average of 1 year Description: Functional improvements will be assessed using the 30-s chair stand. Assessments will be administered at baseline, immediate post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment. Measure: Functional Improvements (30-s chair stand) Time Frame: Through study completion, an average of 1 year ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Age 20-60 years old (limit set to minimize brain structural changes due to aging). * Diagnosis of fibromyalgia by the American College of Rheumatology 2016 criteria.71 * Right-handedness, to provide consistency in brain structure and function. * Pain score of 4 or greater on DVPRS53 in the 3 months prior to enrollment. * Intact skin in area of PENFS treatment * For those who elect to participate in the MRI portion, the ability to safely tolerate MRI Exclusion Criteria: Exclusion criteria include: * pregnancy * history of seizures or neurologic conditions that alter the brain * claustrophobia * MRI-incompatible implants, or other conditions incompatible with MRI (only for those who elect to perform MRI) * history of uncontrolled psychiatric illness * autoimmune disease that leads to pain * skin conditions that can increase risk of infection at PENFS site Maximum Age: 60 Years Minimum Age: 20 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: Anna.Woodbury@va.gov Name: Anna Woodbury, MD Phone: (404) 321-6111 Phone Ext: 6939 Role: CONTACT Contact 2: Email: anna.ree@va.gov Name: Anna M Ree, BA Phone: (404) 321-6111 Phone Ext: 202561 Role: CONTACT #### Locations Location 1: City: Decatur Contacts: *Contact 1:* - Email: Anna.Woodbury@va.gov - Name: Anna Woodbury, MD - Phone: 404-321-6111 - Phone Ext: 6939 - Role: CONTACT *Contact 2:* - Name: Anna Woodbury, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Atlanta VA Medical and Rehab Center, Decatur, GA State: Georgia Zip: 30033-4004 #### Overall Officials Official 1: Affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA Name: Anna Woodbury, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### See Also Links Label: Woodbury PAIN Lab Page URL: https://www.woodburypainlab.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8486 - Name: Fibromyalgia - Relevance: HIGH - As Found: Fibromyalgia - ID: M12161 - Name: Myofascial Pain Syndromes - Relevance: HIGH - As Found: Fibromyalgia - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005356 - Term: Fibromyalgia - ID: D000009209 - Term: Myofascial Pain Syndromes ### 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 ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415578 Brief Title: Effectiveness of Ergonomics Training and Exercise in Esports Players Official Title: Effectiveness of Ergonomics Training and Exercise in Esports Players #### Organization Study ID Info ID: Uskudar9 #### Organization Class: OTHER Full Name: Uskudar University ### Status Module #### Completion Date Date: 2024-07-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-07-20 Type: ESTIMATED #### Start Date Date: 2024-05-15 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-09 Study First Submit QC Date: 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Uskudar University #### Responsible Party Investigator Affiliation: Uskudar University Investigator Full Name: Dr. Öğr. Üyesi Ömer Şevgin Investigator Title: Asst. Prof. Dr. 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 investigate the effectiveness of ergonomics training and exercise in e-sports players. Detailed Description: After detailed information about the study is given to the individuals to be included in the study, individuals who voluntarily agree to participate in the study will sign an informed consent form. Participants will be divided into 2 groups consisting of equal numbers of individuals. The groups were called control group and exercise group. All participants will be given ergonomics training. In addition to the exercise group, exercise training will be given for 8 weeks, 3 days a week and 45 minutes a day. Sociodemographic information form, Arm, Shoulder and Hand Problems Questionnaire (DASH), Neck Disability Questionnaire (NDI), Rapid Upper Extremity Assessment (RULA) and Pittsburgh Sleep Quality Index (PSQI) will be used as evaluation scales. Evaluations will be made at the beginning and end of the study. will be done once. ### Conditions Module Conditions: - Musculoskeletal Diseases - Musculoskeletal Pain ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 50 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Only ergonomics training will be given Intervention Names: - Other: ergonomics training Label: control Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: Exercise training will be provided along with ergonomics training. Intervention Names: - Other: ergonomics training - Other: Exercises Label: exercise Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - control - exercise Description: In this training; What is ergonomics, the importance of ergonomics, the purpose of ergonomics, risk factors for musculoskeletal disorders that can be seen in e-sports players, ergonomic arrangements that can be made in the working environment and methods of protection from musculoskeletal injuries, posture disorders and various ergonomic arrangements that can be made for posture disorders and chair selection, screen selection. selection and rest breaks were included. Participants will be trained twice in total, on the first day of the study and at the end of the 4th week. The training will be carried out interactively, supported by videos and visuals. Training will be done individually and will last approximately 2 hours. Name: ergonomics training Type: OTHER #### Intervention 2 Arm Group Labels: - exercise Description: The exercise training program will be implemented for 8 weeks, 3 days a week, lasting an average of 45 minutes. All participants will be given information about the exercises before the exercise training. The exercise protocol was designed as 3 parts: warm-up, exercise and cool-down. Stretching exercises, mobility and strength exercises will be applied. A rest period of 30-45 seconds was given between sets and 2-3 minutes between exercises. Participants will be given dynamic and static stretching, nerve stretching, postural strength and functional exercises for the upper extremity. Relevant movements will be modified according to the exercise capacity of the participants. Exercise content will also include median, ulnar and radial nerve stretching, neck and thoracic mobility exercises, and functional strength exercises for the shoulder, arm, hand and wrist. Exercise tracking will be checked regularly through online conversations. Name: Exercises Type: OTHER ### Outcomes Module #### Primary Outcomes Description: This index evaluates sleep quality and disturbance over the past month. It contains a total of 24 questions. 19 of these questions are answered by the person's self-assessment, and 5 of them are answered by the roommate who shares the same room with the person. The 5 questions answered by the person's roommate are not included when calculating the score. In scoring, the lowest (0) and the highest (21) points are obtained. A score of 4 and above indicates poor sleep quality. Measure: Pittsburgh Sleep Quality Index Time Frame: 8 weeks Description: It is an ergonomics risk assessment method that quickly analyzes the employee's upper extremity from an ergonomic perspective. It evaluates upper extremity movements in 14 separate steps. 8 of these steps are scored for arm and hand position, and 6 for neck and trunk position, according to the table. The minimum Rapid Upper Limb Assessment Score = 1, and the maximum Rapid Upper Limb Assessment Score = 7. A high score means high risk. Measure: Rapid Upper Limb Assessment Time Frame: 8 weeks Description: It was developed to evaluate functional status and symptoms by focusing on physical function in upper extremity injuries. According to the results of the survey; a result from 0-100 is obtained from each part; 0-no apology 100-maximum apology. Measure: Disabilities of the Arm, Shoulder and Hand Questionnaire Time Frame: 8 weeks Description: There are 10 parameters in the Neck disability index, each with 6 answer choices. These; The severity of neck pain is personal care, lifting loads, reading, headache, concentration, business life, driving, sleep and leisure activities. It is scored between 0 (no pain or functional limitation) and 5 (maximum pain and maximum limitation). The subjects were asked to choose the most appropriate option for themselves from each parameter. At the end of the survey, the total score was determined by adding up the scores of the selected options. In the Neck disability index, 35 points and above were defined as complete apology, 25 to 34 points as severe apology, 15 to 24 points as moderate apology, 5 to 14 points as mild apology, and 0 to 4 points as no apology. Measure: Neck disability index Time Frame: 8 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * those who signed the voluntary consent form * Having actively participated in E-sports organizations and tournaments within 16 months * not having a chronic disease that will affect the musculoskeletal system * Not having any health problems that prevent him from exercising and not having had a surgical operation in the last 6 months. Exclusion Criteria: * Players under 18 years of age * have a chronic disease that affects the musculoskeletal system * Having had a surgical operation in the last 6 months that would prevent him from being interested in e-sports games Healthy Volunteers: True Maximum Age: 30 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: omer.sevgin@uskudar.edu.tr Name: ŞEVGİN Phone: +905069787535 Role: CONTACT #### Locations Location 1: City: Istanbul Contacts: *Contact 1:* - Name: Ömer ŞEVGİN - Role: CONTACT Country: Turkey Facility: Uskudar Üniversity Status: RECRUITING #### Overall Officials Official 1: Affiliation: Uskudar University Name: Atakan GÜRGAN Role: STUDY_CHAIR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Monteiro Pereira A, Costa JA, Verhagen E, Figueiredo P, Brito J. Associations Between Esports Participation and Health: A Scoping Review. Sports Med. 2022 Sep;52(9):2039-2060. doi: 10.1007/s40279-022-01684-1. Epub 2022 Apr 29. PMID: 35486374 Citation: Ketelhut S, Martin-Niedecken AL, Zimmermann P, Nigg CR. Physical Activity and Health Promotion in Esports and Gaming-Discussing Unique Opportunities for an Unprecedented Cultural Phenomenon. Front Sports Act Living. 2021 Sep 16;3:693700. doi: 10.3389/fspor.2021.693700. eCollection 2021. PMID: 34604743 Citation: DiFrancisco-Donoghue J, Balentine J, Schmidt G, Zwibel H. Managing the health of the eSport athlete: an integrated health management model. BMJ Open Sport Exerc Med. 2019 Jan 10;5(1):e000467. doi: 10.1136/bmjsem-2018-000467. eCollection 2019. PMID: 30792883 Citation: Seffah KD, Salib K, Dardari L, Taha M, Dahat P, Toriola S, Satnarine T, Zohara Z, Adelekun A, Ahmed A, Gutlapalli SD, Patel D, Khan S. Health Benefits of Esports: A Systematic Review Comparing the Cardiovascular and Mental Health Impacts of Esports. Cureus. 2023 Jun 20;15(6):e40705. doi: 10.7759/cureus.40705. eCollection 2023 Jun. PMID: 37485153 Citation: Eltayeb SM, Staal JB, Hassan AA, Awad SS, de Bie RA. Complaints of the arm, neck and shoulder among computer office workers in Sudan: a prevalence study with validation of an Arabic risk factors questionnaire. Environ Health. 2008 Jun 27;7:33. doi: 10.1186/1476-069X-7-33. PMID: 18588691 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M29444 - Name: Musculoskeletal Pain - Relevance: HIGH - As Found: Musculoskeletal Pain - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: HIGH - As Found: Musculoskeletal Diseases - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059352 - Term: Musculoskeletal Pain - ID: D000009140 - Term: Musculoskeletal Diseases ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415565 Brief Title: Investigation of the Effectiveness of Thoracic Mobilization Exercise in Fibromyalgia Patients Official Title: Investigation of the Effectiveness of Thoracic Mobilization Exercise in Fibromyalgia Patients #### Organization Study ID Info ID: Uskudar11 #### Organization Class: OTHER Full Name: Uskudar University ### Status Module #### Completion Date Date: 2024-07-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-07-20 Type: ESTIMATED #### Start Date Date: 2024-05-15 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-09 Study First Submit QC Date: 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Uskudar University #### Responsible Party Investigator Affiliation: Uskudar University Investigator Full Name: Dr. Öğr. Üyesi Ömer Şevgin Investigator Title: Asst. Prof. Dr. 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 investigate the effects of mobilization exercises applied to the thoracic region on pain, anxiety, depression, disease impact questionnaire, sympathetic and parasympathetic activity in patients diagnosed with fibromyalgia. Detailed Description: The patients included in the study were randomly divided into two as Thoracic Mobilization Group and Control Group and will be included in the treatment programs after the initial evaluations. Patients in both groups will receive a treatment of 11 sessions in total, 5 sessions per week. Participants will be evaluated twice before and after treatment with the Fibromyalgia impact questionnaire, Beck anxiety and Beck depression questionnaires. In addition, the E-motion Faros device will be used to measure heart rate variability. Measurements of heart rate variables will be made before and after the first day of treatment, before and after the 11th session, and on the 45th day. ### Conditions Module Conditions: - Fibromyalgia ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 40 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Conventional physiotherapy practices will be performed. Intervention Names: - Other: conventional physiotherapy Label: control Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: In addition to conventional physiotherapy applications, thoracic mobilization applications will be performed. Intervention Names: - Other: conventional physiotherapy - Other: thoracic mobilization methods Label: mobilization Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - control - mobilization Description: Methods applied as conventional physiotherapy methods are: hotpack, Transcutaneous electrical nerve stimulation and ultrasound. Name: conventional physiotherapy Type: OTHER #### Intervention 2 Arm Group Labels: - mobilization Description: Methods applied as conventional physiotherapy methods: hotpack, Transcutaneous electrical nerve stimulation and ultrasound applications will be applied. Also within the scope of thoracic mobilization: thoracic region extension stretching in the kneeling position, thoracic flexion in the crawling position, halo exercise, thoracic rotation exercises in the crawling position, thoracic rotation in the side lying position. , quadruped extension and rotation exercises will be applied. Patients will be informed that these exercises can also be done as home exercises and they will be asked to practice for 8 weeks. Name: thoracic mobilization methods Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The Beck Depression Scale is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The 21 questions in the Beck Depression Scale reflect the symptoms, attitudes and intensity of depression; Items receive a score between zero and three. The total score ranges from 0 to 63. Scores from 0 to 9 indicate no or minimal depression; Scores from 10 to 18 indicate mild to moderate depression; Scores from 19 to 29 indicate moderate to severe depression, and scores from 30 to 63 indicate severe depression. Measure: Beck Depression Scale Time Frame: 8 weeks Description: The Beck Anxiety Scale is a self-report questionnaire that measures 21 common somatic and cognitive symptoms of anxiety. Beck Anxiety Scale has 21 questions, each question scored between 0 and 3. The total score to be obtained from the scale varies between 0-63. Beck Anxiety Scale scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63). Measure: Beck Anxiety Scale Time Frame: 8 weeks Description: The Fibromyalgia Impact Questionnaire is an assessment tool developed to measure the condition, progress and outcomes of fibromyalgia patients. It is designed to measure the health status components believed to be most affected in fibromyalgia. Fibromyalgia Impact Questionnaire consists of 10 items. The maximum possible score for each of the 10 items is 10. Therefore the maximum possible score is 100. The average fibromyalgia patient's score is around 50, with severely affected patients often scoring above 70. Measure: Fibromyalgia Impact Survey Time Frame: 8 weeks Description: The E-motion Faros device will be used to measure heart rate variability. E-motion Faros is a 3-electrode device that measures heart rate changes. Two of the electrodes in the device are placed under the patient's right and left clavicle, and the other one is placed just above the lowest left rib. Electrocardiogram measurement takes an average of 5 minutes. Measure: Heart rate Time Frame: 8 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Being diagnosed with fibromyalgia by a specialist physician according to the 2013 American Association of Rheumatology diagnostic criteria * Being between the ages of 18-45 Exclusion Criteria: * Those with neurological deficit * During menopause and postmenstrual period * Diagnosed with diabetes * Those with neuropathic disease * Those with chronic inflammation * Have immunodeficiency * Those with cardiac disease * Patients who are pregnant Healthy Volunteers: True Maximum Age: 45 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: omer.sevgin@uskudar.edu.tr Name: Ömer ŞEVGİN Phone: +905069787535 Role: CONTACT #### Locations Location 1: City: Istanbul Contacts: *Contact 1:* - Name: Ömer ŞEVGİN - Role: CONTACT Country: Turkey Facility: Uskudar Üniversity Status: RECRUITING #### Overall Officials Official 1: Affiliation: Uskudar University Name: Cansu ÇİFTÇİ Role: STUDY_CHAIR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Larsson A, Palstam A, Lofgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia--a randomized controlled trial. Arthritis Res Ther. 2015 Jun 18;17(1):161. doi: 10.1186/s13075-015-0679-1. PMID: 26084281 Citation: Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat. 2010 Feb 25;18:3. doi: 10.1186/1746-1340-18-3. PMID: 20184717 Citation: Hoogvliet P, Randsdorp MS, Dingemanse R, Koes BW, Huisstede BM. Does effectiveness of exercise therapy and mobilisation techniques offer guidance for the treatment of lateral and medial epicondylitis? A systematic review. Br J Sports Med. 2013 Nov;47(17):1112-9. doi: 10.1136/bjsports-2012-091990. Epub 2013 May 24. PMID: 23709519 Citation: Assumpcao A, Matsutani LA, Yuan SL, Santo AS, Sauer J, Mango P, Marques AP. Muscle stretching exercises and resistance training in fibromyalgia: which is better? A three-arm randomized controlled trial. Eur J Phys Rehabil Med. 2018 Oct;54(5):663-670. doi: 10.23736/S1973-9087.17.04876-6. Epub 2017 Nov 29. PMID: 29185675 Citation: Reis MS, Durigan JL, Arena R, Rossi BR, Mendes RG, Borghi-Silva A. Effects of posteroanterior thoracic mobilization on heart rate variability and pain in women with fibromyalgia. Rehabil Res Pract. 2014;2014:898763. doi: 10.1155/2014/898763. Epub 2014 May 29. PMID: 24991436 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M8486 - Name: Fibromyalgia - Relevance: HIGH - As Found: Fibromyalgia - ID: M12161 - Name: Myofascial Pain Syndromes - Relevance: HIGH - As Found: Fibromyalgia - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005356 - Term: Fibromyalgia - ID: D000009209 - Term: Myofascial Pain Syndromes ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415552 Brief Title: Implementation of Online Mindfulness-Based Stress Reduction Tailored for People With Multiple Sclerosis Official Title: Implementation of Online Mindfulness-Based Stress Reduction Tailored for People With Multiple Sclerosis #### Organization Study ID Info ID: Mindfulness for PwMS #### Organization Class: OTHER Full Name: Unity Health Toronto ### Status Module #### Completion Date Date: 2027-05-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-09 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-12-31 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-08 Study First Submit QC Date: 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Robert Simpson #### Responsible Party Investigator Affiliation: Unity Health Toronto Investigator Full Name: Robert Simpson Investigator Title: Investigator Type: SPONSOR_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This project aims to implement and investigate a mindfulness-based stress reduction (MBSR) in people with multiple sclerosis (PwMS). The main objective is to implement MBSR intervention for PwMS in a major tertiary care clinic for PwMS. We will iteratively refine the intervention as required based on stakeholder feedback and any other emergent contextual findings. Participants will be asked to take part in an 8-week MBSR course and report changes in anxiety, depression, quality of life, emotional regulation, self-compassion, mindfulness, and health services use. ### Conditions Module Conditions: - Multiple Sclerosis Keywords: - Mindfulness ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: HEALTH_SERVICES_RESEARCH #### Enrollment Info Count: 120 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: 8-week Mindfulness-Based Stress Reduction course Intervention Names: - Behavioral: Mindfulness-Based Stress Reduction Label: Mindfulness-Based Stress Reduction Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - Mindfulness-Based Stress Reduction Description: Eight iterations of the MBSR course will be delivered, over a total period of 24 months. Each iteration will take place over 8 weeks. Courses would consist of 8 weekly sessions, led by certified mindfulness instructors. Sessions will include core meditation practices, psychoeducation, and home practices. Name: Mindfulness-Based Stress Reduction Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: The investigators will measure the number of participants eligible for and recruited to the study. Measure: Recruitment Time Frame: 24 months Description: The investigators will measure the percentage of participants who complete outcome data. Measure: Retention Time Frame: 24 months Description: The investigators will measure the number of participants who completed the mindfulness-based stress reduction course. Measure: Adherence Time Frame: 24 months Description: The investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention. Measure: Follow-up rates Time Frame: 24 months #### Secondary Outcomes Description: Measured using the Multiple Sclerosis Impact Scale. Items on the scale have a Likert scale from 1-5, with a range of 0-100 total and higher scores indicating greater disability. Measure: Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29) Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the EQ-5D-5L. The total score ranges from 1-100, with higher values indicating better perceived health. Measure: Quality of Life using the EuroQol (EQ-5D-5L) Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms. Measure: Anxiety Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms. Measure: Depression Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Client Services Receipt Inventory. This instrument is used to collect information on the use of health services. Measure: Health services use Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Difficulties in Emotion Regulation Scale - Short Form. Answers are assessed using a 5-point Likert scale. Higher values indicate greater difficulties in emotion regulation. Measure: Emotion regulation Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Self-Compassion Scale - Short Form. The total score ranges from a 1-5 Likert scale, with higher scores representing high self-compassion. Measure: Self-compassion Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Five-facet Mindfulness Questionnaire. Answers are assessed using a 5-point Likert scale. Higher scores in each facet indicate higher levels of mindfulness. Measure: Mindfulness Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Group Climate Questionnaire-Engage Scale. Each item response is measured on a Likert scale from 0-6, with total subscale scores reflecting the average of responses. Higher scores indicate higher group engagement. Measure: Climate Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Working Alliance Inventory. Each item is measured on a 7-point Likert scale, with a range of 36-252 total. Higher scores indicates stronger alliance. Measure: Therapeutic alliance Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Insomnia Severity Index. The total score ranges from 0-28, with higher scores indicating worse insomnia. Measure: Sleep Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Pain Effects Scale. The total score ranges from 6-30, with higher scores indicating greater impact of pain on behavior and mood. Measure: Pain Effects Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Modified Fatigue Impact Scale. The total score ranges from 0-84, with higher scores indicating a greater impact of fatigue. Measure: Fatigue Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up Description: Measured using the Symbol Digits Modalities Test. The total score ranges from 0-110, with higher scores indicating better cognitive functioning. Measure: Cognitive function Time Frame: Measured at baseline, 8-week follow-up, and 3-month follow-up ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Age \>18 years \</= 60 years 2. Diagnosis of MS or related condition (Clinically Isolated Syndrome, Neuromyelitis Optica Spectrum Disorder, Chronic Inflammatory Demyelinating Neuropathy) 3. Able to understand spoken and written English 4. Willing to take part in an MBSR course Exclusion Criteria: 1. Cognitive impairment (\<26 on the Montreal Cognitive Assessment) 2. Severe active mental health impairment (psychosis, suicidality) 3. Medical instability (terminal/life threatening inter-current illness) Maximum Age: 60 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: Robert.Simpson@unityhealth.to Name: Robert Simpson Phone: 416-360-4000 Phone Ext: 40047 Role: CONTACT ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415539 Brief Title: The Effect of Exercise Practices on Hyperactivity Levels in Children With Autism Spectrum Disorder Official Title: The Effect of Vestibular and Proprioceptive Exercise Practices on Hyperactivity Levels in Children With Autism Spectrum Disorder #### Organization Study ID Info ID: Uskudar10 #### Organization Class: OTHER Full Name: Uskudar University ### Status Module #### Completion Date Date: 2024-07-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-16 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-07-20 Type: ESTIMATED #### Start Date Date: 2024-05-15 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-09 Study First Submit QC Date: 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Uskudar University #### Responsible Party Investigator Affiliation: Uskudar University Investigator Full Name: Dr. Öğr. Üyesi Ömer Şevgin Investigator Title: Asst. Prof. Dr. 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 effect of vestibular and proprioceptive exercise practices on the hyperactivity level in children with autism spectrum disorder. Detailed Description: The families of all children participating in the study will be informed and their written consent will be obtained. Vestibular and proprioceptive evaluation, hyperactivity evaluation and nystagmus evaluation will be applied to each child participating in the study twice, before and after treatment. Children will be divided into two groups: an exercise group and a control group, consisting of equal numbers of patients. A classical physical therapy program will be applied to both groups. In addition to the exercise group, a treatment program including vestibular and proprioceptive exercise training will be applied. The training program for both groups will be held in 40-minute sessions, 2 days a week for 8 weeks. ### Conditions Module Conditions: - Autism Spectrum Disorder - Autism ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 24 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Classic physical therapy program will be applied Intervention Names: - Other: classical physical therapy program Label: control Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: In addition to the classical physical therapy program, a treatment program including vestibular and proprioceptive exercise training will be applied. Intervention Names: - Other: classical physical therapy program - Other: exercises Label: exercise Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - control - exercise Description: Children in the control group, where classical physiotherapy and rehabilitation methods are applied, will continue their individual training programs with a physiotherapist for 40 minutes, 2 days a week, for 8 weeks. Name: classical physical therapy program Type: OTHER #### Intervention 2 Arm Group Labels: - exercise Description: Children in this group will be given vestibular and proprioceptive exercise training in addition to the classical physiotherapy program. Skateboard, swing, hammock, bowl, ball, sensory pads, ball pool, slide, climbing bar, trampoline and balance board will be used as materials in vestibular and proprioceptive exercise training. In addition, at the end of the training sessions, parents will be informed about the application of exercise training to daily activities. Name: exercises Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The most common diagnostic assessment for vestibular function includes use of the postrotary nystagmus test17 and clinical observation. The postrotary nystagmus test is used to identify whether a child has a vestibular disability During the test, the subject is seated on a rotation disk, with his or her head fixed in a 30-degree angle forward, to ensure that the semicircular canals are horizontal.19 Next, the subject is rotated for ten clockwise or counterclockwise rotations, at 2 seconds per rotation. The subject is asked to gaze forward with both eyes, and the examiner observes the degree of nystagmus produced by the rotations. Measure: Postrotary Nystagmus Assessment Test Time Frame: 8 weeks Description: Sensory Profile is a report-based questionnaire that is applied to measure the sensory processing abilities of children between the ages of 3-10 and to reveal the effects of the sensory processing process on the functional performance of children in their daily lives, and can determine children's sensory performances in detail. The survey can be applied to children with different types and degrees of disability. Mother, father or caregiver; That is, the evaluation is carried out by the people who are primarily responsible for the child's care by rating the 33 items in the survey according to their frequency. Items are scored as "always = 1, often = 2, sometimes = 3, rarely = 4, never = 5". Raw score totals for each section and factor in the survey. Higher scores indicate a higher frequency of specific sensory responses. Measure: Sensory Profile Test Time Frame: 8 weeks Description: Both parent and teacher assessment scales have two components: symptom assessment and impairment in performance. The symptom assessment component screens for symptoms relevant to inattentive and hyperactive ADHD subtypes. To meet criteria for ADHD diagnoses, one must have 6 positive responses to either the core 9 inattentive symptoms or core 9 hyperactive symptoms, or both. A positive response is either a score of 2 or 3 ("often" to "very often"). The final 8 questions of both versions ask the respondent to rate the child's performance in school and his or her interactions with others on a 1-5 scale, with 1-2 meaning "above average", 3 meaning "average", and 4-5 meaning "problematic". To meet the criteria for ADHD, there must be at least one score for the performance set that is a 5, or two scores that are at least 4, as these scores indicate impairment in performance. Measure: Vanderbilt Assessment Scale Time Frame: 8 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * children whose voluntary consent form is signed by their parents * Children ages 6 to 10 * not using supplements * not having undergone any surgical operation Exclusion Criteria: * children who have any obstacle to exercise * They were determined as children who could not cooperate in the study. Healthy Volunteers: True Maximum Age: 10 Years Minimum Age: 6 Years Sex: ALL Standard Ages: - CHILD ### Contacts Locations Module #### Central Contacts Contact 1: Email: omer.sevgin@uskudar.edu.tr Name: Ömer ŞEVGİN Phone: +905069787535 Role: CONTACT #### Locations Location 1: City: Istanbul Contacts: *Contact 1:* - Name: Ömer ŞEVGİN - Role: CONTACT Country: Turkey Facility: Uskudar University Status: RECRUITING #### Overall Officials Official 1: Affiliation: Uskudar University Name: Evren ERİK Role: STUDY_CHAIR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Tse CYA, Lee HP, Chan KSK, Edgar VB, Wilkinson-Smith A, Lai WHE. Examining the impact of physical activity on sleep quality and executive functions in children with autism spectrum disorder: A randomized controlled trial. Autism. 2019 Oct;23(7):1699-1710. doi: 10.1177/1362361318823910. Epub 2019 Jan 20. PMID: 30663324 Citation: Xiao N, Shinwari K, Kiselev S, Huang X, Li B, Qi J. Effects of Equine-Assisted Activities and Therapies for Individuals with Autism Spectrum Disorder: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 1;20(3):2630. doi: 10.3390/ijerph20032630. PMID: 36767996 Citation: Kashefimehr B, Kayihan H, Huri M. The Effect of Sensory Integration Therapy on Occupational Performance in Children With Autism. OTJR (Thorofare N J). 2018 Apr;38(2):75-83. doi: 10.1177/1539449217743456. Epub 2017 Dec 27. PMID: 29281930 Citation: Padmanabha H, Singhi P, Sahu JK, Malhi P. Home-based Sensory Interventions in Children with Autism Spectrum Disorder: A Randomized Controlled Trial. Indian J Pediatr. 2019 Jan;86(1):18-25. doi: 10.1007/s12098-018-2747-4. Epub 2018 Jul 25. PMID: 30043192 Citation: Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2. PMID: 30078460 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M9999 - Name: Hyperkinesis - Relevance: LOW - As Found: Unknown - ID: M4623 - Name: Autistic Disorder - Relevance: HIGH - As Found: Autism - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001321 - Term: Autistic Disorder - ID: D000067877 - Term: Autism Spectrum Disorder - ID: D000002659 - Term: Child Development Disorders, Pervasive ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415526 Brief Title: OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction Official Title: Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction #### Organization Study ID Info ID: 202400581B0 #### Organization Class: OTHER Full Name: Chang Gung Memorial Hospital ### Status Module #### Completion Date Date: 2024-05-10 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-05-10 Type: ACTUAL #### Start Date Date: 2024-05-03 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Chang Gung Memorial Hospital #### Responsible Party Investigator Affiliation: Chang Gung Memorial Hospital Investigator Full Name: Jung-Ju Huang Investigator Title: Associate Professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: Current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. Breast reconstruction with free deep inferior epigastric artery perforator (DIEP) flap was considered the gold standard, however, the donor site morbidity remains an endless concern. Here we applied robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA). A retrospective chart review identified 14 patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction. The patient demographics and mastectomy and flap characteristics were reviewed. ### Conditions Module Conditions: - Breast Cancer - Mastectomy; Lymphedema ### Design Module #### Design Info Observational Model: CASE_ONLY Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 14 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction Intervention Names: - Procedure: OPERA Label: OPERA group ### Interventions #### Intervention 1 Arm Group Labels: - OPERA group Description: Robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction Name: OPERA Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: The length of incision on anterior rectus sheath Measure: ARS incision Time Frame: Intra-operative Description: The time it took to dissect pedicles with robotic arms Measure: Robotic time Time Frame: Intra-operative Description: The weight of the flap harvested Measure: Flap size Time Frame: Intra-operative ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients with ASA (American Society of Anesthesiologist) classification 1-2 * Breast skin should be free from cancer involvement, with adequate tumor to skin distance, and the largest preoperative tumor size no more than 5 cm * The lesion should be located in any of the 4 quadrants away from the nipple, at least 1 cm distance between the lesion and the nipple Exclusion Criteria: * Patients with previous pelvis surgeries (except C-section) Maximum Age: 80 Years Minimum Age: 20 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT Study Population: Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction ### Contacts Locations Module #### Locations Location 1: City: Taoyuan Country: Taiwan Facility: Chang Gung Memorial Hospital Zip: 33305 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008206 - Term: Lymphatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M11206 - Name: Lymphedema - Relevance: HIGH - As Found: Lymphedema - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008209 - Term: Lymphedema ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415513 Brief Title: The Effect of (ASMR) Videos on Sleep Quality and Stress Levels on Nursing Students Official Title: The Effect of Autonomous Sensory Meridian Response (ASMR) Videos on Sleep Quality and Stress Levels of Nursing Students Before First Clinical Practice #### Organization Study ID Info ID: 23.02.2024/420449 #### Organization Class: OTHER Full Name: Zonguldak Bulent Ecevit University ### Status Module #### Completion Date Date: 2024-05-05 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-04-29 Type: ACTUAL #### Start Date Date: 2024-04-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Zonguldak Bulent Ecevit University #### Responsible Party Investigator Affiliation: Zonguldak Bulent Ecevit University Investigator Full Name: Ayşe Kabuk Investigator Title: Asst. Prof. Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This study was planned to evaluate the effect of Autonomous Sensory Meridian Response (ASMR) videos on sleep quality and stress levels of nursing students before clinical practice. Detailed Description: Autonomous Sensory Meridian Response (ASMR) is a physiological phenomenon that describes a tingling sensation caused by specific visual and auditory triggers, usually starting on the scalp and travelling down the body. These trigger stimuli are often socially intimate in nature and often involve repetition of movements and/or sounds. According to studies conducted among university students, it is generally stated that university students have poor sleep quality and sleep inadequately. Negative impact on students' sleep quality is a factor that causes them to experience stress. Nursing students are faced with an important source of stress due to the various situations they encounter in the education and practice processes. Although clinical education offers rich opportunities to gain hands-on experience, it is reported that the clinical component of nursing education provides the highest source of stress for nursing students. This study was planned to evaluate the effect of Autonomous Sensory Meridian Response (ASMR) videos on sleep quality and stress levels of nursing students before clinical practice. ### Conditions Module Conditions: - Students - Nursing Keywords: - Autonomous Sensory Meridian Response - anxiety - sleep ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: intervention group: Autonomous Sensory Meridian Response; control group: no intervention ##### Masking Info Masking: NONE Primary Purpose: HEALTH_SERVICES_RESEARCH #### Enrollment Info Count: 87 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: For 7 days, they were asked to watch ASMR videos for 20-30 minutes every evening at 22:00 before going to bed. The videos were downloaded to the student's computer or phone in advance, the student was asked to switch his/her phone to airplane mode to block the stimuli during the viewing, to watch these videos with headphones, to reduce the sounds in the room as much as possible, to lie on his/her bed and to wear comfortable clothes. Intervention Names: - Other: ASMR Label: intervention Type: EXPERIMENTAL #### Arm Group 2 Description: no intervention Label: control Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - intervention Description: We used 7 ASMR videos published on the most watched ASMR channel on the YouTube platform, in which applications such as hair combing, brushing, massaging the head are applied sequentially and repeatedly, and there is no speech. Name: ASMR Type: OTHER ### Outcomes Module #### Primary Outcomes Description: PUKI was accepted in determining sleep quality, and in 1989 and its validity and reliability were determined (Cronbach's alpha=0.80). In our country, the validity and reliability study was carried out by Ağargün et al. (16) and the Cronbach alpha value of the scale was found to be 0.80. The scale is a four-point Likert type and contains a total of 24 questions; subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6) and daytime dysfunction (component 3) 7) consists of 7 components. The sum of the seven component scores gives the total PUKI score. The response of each is scored between 0-3 according to symptom frequency. The total score has a value between 0-21. Measure: sleep quality Time Frame: In the study, The sleep quality of the students in the intervention group was measured before the interventions and on the 8th day after the 7-day interventions. Sleep quality of the students in the control group was measured on day 1 and day 8. Description: State - Trait Anxiety Inventory-STAI. It was developed by Spielberger et al. (1970). The scale consists of two parts: the State Anxiety Inventory and Trait Anxiety Inventory. The State Anxiety Inventory determines how the individual feels at a certain moment and under certain conditions, and the Trait Anxiety Inventory determines how the individual feels regardless of the situation and conditions. Each scale contains two types of statements with 20 items. In the state anxiety scale, the responses were evaluated with a 4-point scale (never, a little, a lot, completely). In the trait anxiety scale, the answers of the participants were measured with a 4-point scale (never, sometimes, very often, almost always). The total score value obtained from both scales varies between 20 and 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety. Measure: anxiety Time Frame: In the study, The anxiety of the students in the intervention group was measured before the interventions and on the 8th day after the 7-day interventions. Anxiety of the students in the control group was measured on day 1 and day 8. ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Over 18 years, * illiterate, * volunteer to participate in the study * First-year nursing students who have not done clinical practice before Exclusion Criteria: * have done clinical practice before Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Zonguldak Country: Turkey Facility: Ayşe Kabuk State: Kozlu/Zonguldak Zip: 67100 ### IPD Sharing Statement Module Description: ı want to share my research protocol after six months. IPD Sharing: NO ### References Module #### References Citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PMID: 2748771 Citation: Stinson C, Curl ED, Hale G, Knight S, Pipkins C, Hall I, White K, Thompson N, Wright C. Mindfulness Meditation and Anxiety in Nursing Students. Nurs Educ Perspect. 2020 Jul/Aug;41(4):244-245. doi: 10.1097/01.NEP.0000000000000635. PMID: 32168090 Citation: Smejka T, Wiggs L. The effects of Autonomous Sensory Meridian Response (ASMR) videos on arousal and mood in adults with and without depression and insomnia. J Affect Disord. 2022 Mar 15;301:60-67. doi: 10.1016/j.jad.2021.12.015. Epub 2021 Dec 13. PMID: 34915083 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415500 Brief Title: A Study on the Safety and Preliminary Efficacy of NK042 in the Treatment of Malignant Ascites Official Title: A Single Center, Open, Single Arm Clinical Study on the Safety and Preliminary Efficacy of NK042 in the Treatment of Malignant Ascites #### Organization Study ID Info ID: NK042-IIT-MA #### Organization Class: OTHER_GOV Full Name: Anhui Provincial Hospital ### Status Module #### Completion Date Date: 2026-12-06 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-12-06 Type: ESTIMATED #### Start Date Date: 2024-05-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-07 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER_GOV Name: Anhui Provincial 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: The purpose of this study is to assess the safety and efficacy of NK042 for treatment of malignant ascites. Detailed Description: This is a phase 1 ,open-label , Single Arm,dose escalation study to evaluate the safety, tolerability, PK, PD and preliminary efficacy of NK042 in patients with treatment of malignant ascites caused by Gynecologic Cancer.About 3-9 subjects are planned to be enrolled, Subjects will receive intraperitoneal infusion of NK042 once a week (D0、D7、D14)for 2 cycles, with 3 times during each cycle and a total of 6 infusions. The occurrence of DLTs will be observed from the first intraperitoneal infusion of NK042 to 28 days after infusion. ### Conditions Module Conditions: - Gynecologic Cancer Keywords: - malignant ascites ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 9 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: NK042 Label: NK042 Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - NK042 Description: NK042 intraperitoneal infusion on Days 0,7 and 14. Name: NK042 Other Names: - NKR-NK Type: DRUG ### Outcomes Module #### Primary Outcomes Description: The occurrence of DLTs will be observed from the first intraperitoneal infusion of NK042 to 28 days after infusion. Measure: Maximum Tolerated Dose (MTD) and Dose-limiting Toxicity (DLT) Time Frame: 28 Days #### Secondary Outcomes Description: Five-point method to measure ascites volume(base on CT). Measure: ascites volume Time Frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months). Description: The time to the next puncture/drainage Measure: Time to next therapeutic puncture，TTpu Time Frame: From the time of first dosing (Day 1) to the next puncture/drainage (up to 6 months) Description: The time to the next puncture/drainage or death Measure: Puncture-free survival, PuFS Time Frame: From the time of of first dosing (Day 1) to the next puncture/drainage or death (up to 6 months) Description: The time to disease progression assessed by the imaging evaluation or toxicity or death Measure: Progression-free Survival, PFS Time Frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance or death (up to 6 months). Description: The time to death Measure: Overall survival, OS Time Frame: From the time of first dosing (Day 1) until death (up to 6 months). ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Patients have the ability to know and sign informed consent; 2. Age 18-70 years old; any sex; 3. Histologically or pathologically confirmed Gynecologic Cancer,including but are not limited to patients with malignant ascites caused by advanced malignant tumors such as ovarian cancer and endometrial cancer; 4. The volume of ascites ≥1L based on CT or more than the same amount of abdominal fluid (definition: abdominal fluid ≥4.5cm detected by B ultrasound in lying position, accompanied by clinical symptoms such as abdominal distension and discomfort); 5. Ascites should be treated by puncture; 6. Expected survival time ≥ 12 weeks; 7. the Eastern Cooperative Oncology Group (ECOG) scored 0-2 points; 8. Appropriate organ and bone marrow function,Laboratory test results must meet the following criteria(unless otherwise specified, the test results of the research center shall prevail)： (1)blood routine examination: White blood cell count \> 3×10\^9/L; Absolute neutrophil Count (ANC)≥1.5×10\^9/L; Haemoglobin \> 90 g/L; lymphocyte count ≥ 0.7×10\^9/L; Platelet count ≥ 75×10\^9/L. (2)renal function: Serum creatinine and/or urea \< 1.5×ULN; serum total bilirubin (TBIL) ≤ 1.5 × Upper limit of normal value (ULN)(bilirubin ≤ 3×ULN for patients with Gilbert's syndrome; (3)liver function: ALT and AST ≤ 2.5 × ULN(≤ 5×ULN for patients with complication of liver metastases); 9. Fertility capable subjects (male and female) must agree to use reliable;contraceptive methods (hormone or barrier methods or abstinence) during the trial and at least 1 year after the last dose; Female subjects of reproductive age must have a negative blood or urine pregnancy test within 14 days before enrollment; 10. For previous anti-malignant ascites therapy (except systemic chemotherapy to control the primary tumor), the washout period is set to 2 weeks or 5 half-lives after the end of the last dose, whichever is shorter; 11. The subjects were able to communicate well with the researchers, and understand and comply with the requirements of this trial. Exclusion Criteria: 1. Currently, or within 30 days prior to enrollment, participating in a clinical trial of another drug or biologic therapy, or having received comparable cellular therapy; 2. Patients undergoing treatment for intraperitoneal malignant ascites, including therapeutic paracentesis; 3. Systemic or other treatments that have a significant impact on the evaluation of efficacy are determined according to the study; 4. Patients with extensive liver metastases Patients with extensive liver metastases (tumor volume occupying approximately \>70% of total liver volume); 5. Occurrence of complete intestinal obstruction within 30 days before the first dose, or diagnosis of incomplete intestinal obstruction deemed unsuitable for participation in the trial based on symptoms and signs as determined by the investigator; 6. Laboratory results indicating bacterial peritonitis (neutrophil count \> 250 / µl ascites); 7. Serum albumin ≤ 30 g/L; 8. Meet any of the following criteria related to cardiac function: 1) Various clinical significant arrhythmia or conduction abnormalities that require clinical intervention; 2) Congenital QT interval prolongation syndrome or men with QTc\>450 msec and women with QTc\>470 msec (QTc is calculated using Fridericia's correction formula), or taking drugs that may cause QT interval prolongation or torsade de pointe arrhythmia; 3) Various clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina pectoris, coronary artery bypass surgery or peripheral artery bypass grafting surgery, and cerebrovascular events (referring to thromboembolic or hemorrhagic cerebrovascular events, excluding cerebrovascular events caused by anemia caused by underlying disease ) within the first 6 months of enrollment, congestive heart failure with a New York Heart Association (NYHA, Attachment 8) rating of 3 or higher, or a left ventricular ejection fraction (LVEF) of\<50%; 9. Subjects with chronic or relapsed severe autoimmune or immune-mediated disease requiring high-dose steroid or other immunosuppressive therapy; 10. The presence of central nervous system (CNS) metastases is known; 11. Subjects with active systemic infections requiring treatment, including, but not limited to, subjects with active tuberculosis, subjects with Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) positivity and peripheral blood HBV DNA titers greater than the upper limit of detection, subjects who are RNA positive for Hepatitis C (HCV), subjects who are seropositive for Human Immunodeficiency Virus (HIV), subjects who are seropositive for Helicobacter syphilis, etc.; and Subjects who are seropositive for Hepatitis C (HCV); 12. Subjects who have previously undergone liver transplantation, organ allograft transplantation, or renal replacement therapy; 13. Active lung disease, including but not limited to interstitial lung disease or pneumonia (except for local interstitial pneumonia induced by radiotherapy), pulmonary fibrosis, etc; 14. Meet any of the following criteria, 1) history of abuse of psychotropic substances and unable to abstain or with mental disorders, 2) have a serious concomitant disease that endangers the safety of the patient or affects the completion of the trial judged by the researcher; 15. Women during pregnancy or lactation; 16. Hypersensitivity to albumin, DMSO; 17. Co-existing HBV and HCV and two or more viral infections; 18. The researcher judge the patient with factors that may affect the results of the study or interfere the participation in the entire study process, including but not limited to previous or existing physical conditions, treatment or laboratory abnormalities, etc; Or putting the patient in a high-risk situation. Maximum Age: 70 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: caddiezy@ustc.edu.cn Name: Ying Zhou, MD Phone: +8613865901025 Role: CONTACT #### Locations Location 1: City: Hefei Contacts: *Contact 1:* - Email: caddiezy@ustc.edu.cn - Name: Ying Zhou, MD - Phone: +8613865901025 - Role: CONTACT Country: China Facility: Anhui Provincal Hospital State: Anhui Zip: 230001 #### Overall Officials Official 1: Affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital) Name: Ying Zhou, MD Role: STUDY_CHAIR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4509 - Name: Ascites - Relevance: HIGH - As Found: Ascites ### Condition Browse Module - Meshes - ID: D000001201 - Term: Ascites ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415487 Brief Title: ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) Official Title: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) #### Organization Study ID Info ID: ACE2016-001 #### Organization Class: INDUSTRY Full Name: Acepodia Biotech, Inc. ### Status Module #### Completion Date Date: 2027-03-25 Type: ESTIMATED #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-12-18 Type: ESTIMATED #### Start Date Date: 2024-05-31 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-30 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Acepodia Biotech, Inc. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True ### Description Module Brief Summary: ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). ### Conditions Module Conditions: - Locally Advanced Solid Tumor - Metastatic Solid Tumor ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: SEQUENTIAL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 30 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016. Intervention Names: - Drug: Cyclophosphamide - Drug: Fludarabine - Drug: ACE2016 Label: ACE2016 ONLY: 1 DOSE Type: EXPERIMENTAL #### Arm Group 2 Description: ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016. Intervention Names: - Drug: Cyclophosphamide - Drug: Fludarabine - Drug: ACE2016 Label: ACE2016 ONLY: 3 DOSES Type: EXPERIMENTAL #### Arm Group 3 Description: ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab. Intervention Names: - Drug: Cyclophosphamide - Drug: Fludarabine - Drug: ACE2016 - Drug: Pembrolizumab Label: ACE2016 AND PEMBROLIZUMAB: 3 DOSES Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - ACE2016 AND PEMBROLIZUMAB: 3 DOSES - ACE2016 ONLY: 1 DOSE - ACE2016 ONLY: 3 DOSES Description: Lymphodepleting agent Name: Cyclophosphamide Type: DRUG #### Intervention 2 Arm Group Labels: - ACE2016 AND PEMBROLIZUMAB: 3 DOSES - ACE2016 ONLY: 1 DOSE - ACE2016 ONLY: 3 DOSES Description: Lymphodepleting agent Name: Fludarabine Type: DRUG #### Intervention 3 Arm Group Labels: - ACE2016 AND PEMBROLIZUMAB: 3 DOSES - ACE2016 ONLY: 1 DOSE - ACE2016 ONLY: 3 DOSES Description: Allogeneic gamma delta T (gdT) cell therapy Name: ACE2016 Type: DRUG #### Intervention 4 Arm Group Labels: - ACE2016 AND PEMBROLIZUMAB: 3 DOSES Description: Immune checkpoint anti-PD-1 antibody Name: Pembrolizumab Type: DRUG ### Outcomes Module #### Other Outcomes Description: Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets. Measure: Pharmacodynamics of ACE2016 Time Frame: 1 year Description: Optional biopsy to examine gdT cell infiltration Measure: gdT infiltration in tumor mass Time Frame: 1 year #### Primary Outcomes Measure: Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort Time Frame: 1 year Description: Number of subject with change from baseline clinical significant lab findings by cohort (descriptive) Measure: Change from baseline in clinical laboratory tests results Time Frame: 1 year Description: Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive) Measure: Change from baseline in vital signs results Time Frame: 1 year Measure: Recommended Dose (RD) Time Frame: 1 year #### Secondary Outcomes Description: Half-life of ACE2016 Measure: Persistence of ACE2016 before and after administration Time Frame: 1 year Description: Titration of anti-ACE2016 antibodies after administration Measure: Measure of anti-ACE2016 antibodies after administration Time Frame: 1 year Description: Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1 Measure: Objective Response Rate (ORR) Time Frame: 1 year Description: Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1 Measure: Disease Control Rate (DCR) Time Frame: 1 year Description: Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death. Measure: Duration Of Response (DOR) Time Frame: 1 year Description: Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death Measure: Progression Free Survival (PFS) Time Frame: 1 year ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy) * At least one measurable lesion as defined by RECIST v1.1 criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Adequate hematologic and renal, hepatic and cardiac function * Oxygen saturation via pulse oximeter ≥92% at rest on room air Exclusion Criteria: * Prior treatment with a genetically modified cell therapy product targeting EGFR * History of allogeneic transplantation * Subjects with active CNS metastases * History or presence of clinically relevant Central Nervous System (CNS) disorder (e.g. epilepsy) * Clinically significant active infection * Human Immunodeficiency Virus (HIV) infection, active hepatitis B infection, or hepatitis C infection. * History of malignancies with the exception of certain treated malignancies with no evidence of disease. * Primary immunodeficiency disorder * Pregnant or lactating female * Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: clinical@acepodiabio.com Name: Stephanie Chien Phone: +1 415 366 7822 Role: CONTACT #### Locations Location 1: City: Denver Contacts: *Contact 1:* - Name: James Vick - Role: CONTACT *Contact 2:* - Name: Jason Henry, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: SCRI Denver Drug Development Unit State: Colorado Zip: 80218 Location 2: City: Nashville Contacts: *Contact 1:* - Name: Emily Lay Petcu - Role: CONTACT *Contact 2:* - Name: Meredith Pelster, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Sarah Cannon Research Institute (SCRI) Oncology Partners State: Tennessee Zip: 37203 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Ancestors - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019653 - Term: Myeloablative Agonists - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000082082 - Term: Immune Checkpoint Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M283230 - Name: Fludarabine - Relevance: HIGH - As Found: Combined - ID: M225513 - Name: Fludarabine phosphate - Relevance: LOW - As Found: Unknown - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Blind - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M11900 - Name: Mitogens - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: 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: D000003520 - Term: Cyclophosphamide - ID: C000582435 - Term: Pembrolizumab - ID: C000024352 - Term: Fludarabine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415474 Acronym: REAPHEN Brief Title: Evolution of the Lymphocyte Phenotype in Patients With Infection in Intensive Care Unit Official Title: Evolution of the Lymphocyte Phenotype in Patients With Infection in Intensive Care Unit #### Organization Study ID Info ID: 29BRC23.0109 #### Organization Class: OTHER Full Name: University Hospital, Brest ### Status Module #### Completion Date Date: 2026-07-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-07-01 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-26 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University Hospital, Brest #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Patients admitted for polytrauma, severe neurological injury, post-operative monitoring or sepsis/septic shock present with significant inflammation, leading to immunoparalysis, which is responsible for infection, particularly prolonged infection. A study of their lymphocyte phenotype over time could help explore the phenomenon of immunoparalysis. ### Conditions Module Conditions: - Patients Undergoing Esophagectomy - Patients With Severe Polytrauma - Patients With Severe Neurological Lesion - Patients With Abdominal Infection ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP Intervention Model Description: For all patients, lymphocyte phenotyping will be performed on biological samples taken on D0, D7 and the day of discharge. In case of infection, phenotyping will also be performed on the day of infection diagnosis and on the day corresponding to half the duration of antibiotic therapy. For phenotyping, only 1.5 mL (0.5 mL per analysis) will be used (if no infection). In case of infection, an additional 1mL will be collected (0.5mL on the day of inclusion diagnosis and 0.5 mL on the day corresponding to half the duration of antibiotic therapy). Blood is collected during sampling, which takes place several times a day as part of the standard management of these patients. ##### Masking Info Masking: NONE Primary Purpose: BASIC_SCIENCE #### Enrollment Info Count: 80 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: There is only one arm in the study. All patients (i.e. our 4 target populations) will undergo the same phenotyping procedure. Intervention Names: - Procedure: Lymphocyte Phenotyping Procedure Label: Phenotyping arm Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - Phenotyping arm Description: For all patients, lymphocyte phenotyping will be performed on biological samples taken on D0, D7 and the day of discharge. In case of infection, phenotyping will also be performed on the day of infection diagnosis and on the day corresponding to half the duration of antibiotic therapy. For phenotyping, only 1.5 mL will be used. In case of infection, an additional 1mL will be collected (0.5mL on the day of inclusion diagnosis and 0.5 mL on the day corresponding to half the duration of antibiotic therapy). Blood is collected during sampling, which takes place several times a day as part of the standard management of these patients. It is important to note that phenotyping is not routinely performed as part of routine care. An additional tube is therefore taken specifically for this analysis, but this is done without the need for an additional puncture. Name: Lymphocyte Phenotyping Procedure Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: - Numbers of various lymphocytes (LT, LB, NK and their subclasses) at D0 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes numbers variation Time Frame: Day 0 Description: - Numbers of various lymphocytes (LT, LB, NK and their subclasses) at D7 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes numbers variation Time Frame: Day 7 Description: - Numbers of various lymphocytes (LT, LB, NK and their subclasses) at discharge according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes numbers variation Time Frame: Immediately upon prescribed discharge date Description: - Numbers of various lymphocytes (LT, LB, NK and their subclasses) at diagnosis of infection according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes numbers variation Time Frame: Immediately after diagnosis of infection Description: - Numbers of various lymphocytes (LT, LB, NK and their subclasses) at half duration of infection's treatment according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes numbers variation Time Frame: At the midpoint of the prescribed antibiotic course Description: - Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at D0 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes percentages variation Time Frame: Day 0 Description: - Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at D7 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes percentages variation Time Frame: Day 7 Description: - Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at discharge according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes percentages variation Time Frame: Immediately upon prescribed discharge date Description: - Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at day of diagnosis according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes percentages variation Time Frame: Immediately after diagnosis of infection Description: - Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at half duration of infection's treatment according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury) Measure: Lymphocytes percentages variation Time Frame: At the midpoint of the prescribed antibiotic course #### Secondary Outcomes Description: Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at D0 Measure: Lymphocytes percentages variation in case of infection Time Frame: Day 0 Description: Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection Measure: Lymphocytes percentages variation in case of infection Time Frame: At the onset of symptoms of infection Description: Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at resolution of infection Measure: Lymphocytes percentages variation in case of infection Time Frame: Immediately following resolution of infection Description: Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at D0 Measure: Lymphocytes numbers variation in case of infection Time Frame: Day 0 Description: Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection Measure: Lymphocytes numbers variation in case of infection Time Frame: Immediately after diagnosis of infection Description: Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at resolution of infection Measure: Lymphocytes numbers variation in case of infection Time Frame: Immediately following resolution of infection ### Eligibility Module Eligibility Criteria: Inclusion criteria: * Postoperative esophagectomy surveillance within the last 24 hours. * Patients with intra-abdominal infection * Neurological patients with intubation planned for more than 24 hours (subarachnoid hemorrhage with coma, severe head trauma, ischemic or hemorrhagic stroke with coma). * Polytrauma with intubation planned for more than 24 hours * Patient aged 18 and over * Patient with social security coverage Non-inclusion criteria : * Hereditary immune deficiency HIV-AIDS * Malignant hemopathies * Immunosuppressive treatment other than corticosteroid therapy or chemotherapy * Patient under legal protection * Pregnant or breast-feeding women Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries ### 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: M29465 - Name: Intraabdominal Infections - Relevance: HIGH - As Found: Abdominal Infections - ID: M12061 - Name: Multiple Trauma - Relevance: HIGH - As Found: Polytrauma - ID: M17685 - Name: Wounds and Injuries - 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: D000059413 - Term: Intraabdominal Infections - ID: D000009104 - Term: Multiple Trauma ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415461 Acronym: SIJ Brief Title: Open Label Dose Ranging Study Assessing the Safety of Cord Blood Product in Sacroiliac Joint Syndrome (SIJ) Official Title: A Phase 1, Open Label Dose-Ranging Study to Assess the Safety, Tolerability, Preliminary Efficacy, and Dose Effect of CFL001 Cord Blood Product in Patients With Symptomatic Sacroiliac Joint Syndrome #### Organization Study ID Info ID: IRB202300181 #### Organization Class: OTHER Full Name: University of Florida ### Status Module #### Completion Date Date: 2025-12-30 Type: ESTIMATED #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-13 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-06-30 Type: ESTIMATED #### Start Date Date: 2024-05-10 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2023-05-26 Study First Submit QC Date: 2024-05-13 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Cord for Life, Inc. #### Lead Sponsor Class: OTHER Name: University of Florida #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Oversight Has DMC: True ### Description Module Brief Summary: This is a Phase 1 trial. The overall objective is to evaluate the safety and potential efficacy effect of specific type of umbilical cord blood product (CFL001), which, other than specific modifications in manufacturing to render it compatible with cGMP, is essentially similar to that reported in real-world experience. Detailed Description: The Phase 1 trial will enroll three subjects into an initial group receiving a low dose of CFL001. Provided that these subjects tolerate this dose well, will proceed to enroll three subjects into a group receiving a middle dose of CFL001. Provided that these subjects tolerate this dose well, will proceed to enroll three subjects into a group receiving the highest dose of CFL001. All subjects will have Symptomatic Sacroiliac Joint (SIJ) syndrome, with clinical average pain score in the month prior to enrollment ≥50 and ≤90 on a 100-point scale. ### Conditions Module Conditions: - Sacroiliac; Backache - Pain, Back Keywords: - pain - sacroiliac joint syndrome ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Masking Description: This is an open-label study with nine subjects, who will all receive an intra-articular injection of the CFL test agent, at either of three dose levels (30 x 106 TNC, 60 x 106 TNC, and 90 x 106 TNC). The administration will be performed under ultrasound image guidance. The first three subjects will receive the 30 x 106 TNC dose; provided that the adverse event profile is acceptable, the next three subjects will receive the 60 x 106 TNC dose; provided that the adverse event profile remains acceptable, the next three subjects will receive the 90 x 106 TNC dose. Primary Purpose: TREATMENT #### Enrollment Info Count: 9 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: The first three subjects will receive the 30 x 106 TNC dose. Intervention Names: - Biological: PremierMaxCB®-Platinum (CFL001); Label: Arm 1: Low dose Type: EXPERIMENTAL #### Arm Group 2 Description: The next three subjects will receive the 60 x 106 TNC dose. Intervention Names: - Biological: PremierMaxCB®-Platinum (CFL001); Label: Arm 2: Medium Dose Type: EXPERIMENTAL #### Arm Group 3 Description: The next three subjects will receive the 90 x 106 TNC dose. Intervention Names: - Biological: PremierMaxCB®-Platinum (CFL001); Label: Arm 3: High Dose Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Arm 1: Low dose - Arm 2: Medium Dose - Arm 3: High Dose Description: Stem Cell: Human cell, tissue, and cellular or tissue-based product (HCT/P) manufactured from umbilical cord blood Name: PremierMaxCB®-Platinum (CFL001); Type: BIOLOGICAL ### Outcomes Module #### Primary Outcomes Description: All Adverse events (types and frequencies) will be collected for all patients. Protocol defined study endpoints will also be collected on all patients. Study endpoints include: • Stopping criteria as defined in protocol section 6.11.2.8 Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 and assessment of protocol defined study endpoints Time Frame: 7, 30, 90, and 180 days post dose Description: Vital Sign Measurements (changes from baseline) Blood Pressure -systolic and diastolic (mm Hg) Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 and assessment of protocol defined study endpoints Time Frame: 7, 30, 90, and 180 days post dose #### Secondary Outcomes Description: Changes from baseline in overall activity obtained by actigraphy Measure: CFL001 Efficacy Time Frame: 7, 30, 90, and 180 days post dose Description: Changes from baseline in patient reported outcomes with respect to SIJ and lower back pain measured the using the Visual Analog Scale Measure: CFL001 Efficacy Time Frame: 7, 30, 90, and 180 days post dose Description: Changes from baseline in Quality of Life Measured by PROMISE 29 Measure: CFL001 Efficacy Time Frame: 7, 30, 90, 180 days post dose ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Age ≥ 18 years and ≤ 90 years. 2. Diagnosis of SIJ syndrome based on clinical findings, including the Fortin, FABER and compression sign. 3. Severity of SIJ syndrome with a baseline ODI score ≥ 30% and an SI joint pain score of ≥ 50 and ≤ 90 on the VAS 100 mm scale. 4. Individuals with either unilateral or bilateral SIJ arthritis can be candidates for enrollment; if both joints are deemed appropriate for administration of the test agent by all other inclusion criteria, then the SIJ which the participants reports as more painful will be treated, or if both are equally painful then we will use a random generator approach ("flip a coin") to determine which joint will be treated. 5. ≥75% decrease in pain within 2 days after image-guided injection of only local anesthetic (with no steroid) into the SIJ within 3 months prior to screening. OR Established SIJ condition based on decrease in pain after image-guided injection of local anesthetic and steroid into the SIJ 3 months prior to screening. 6. Body mass index \< 40 kg/m2. 7. Ability to comply with the requirements of the study. 8. Ability to understand and provide written informed consent. 9. All participants of reproductive age/capacity to confirm use of adequate contraception during the study period. 10. All participants should have tried and failed conservative therapies such as medications (acetaminophen and/or NSAIDs or Tramadol); daily home exercise or home stretching, including hip-girdle and core exercise, with the target of 20 minutes; and guided physical therapy at a facility once weekly for six weeks, if logistically practical. Failure of the above conservative therapeutic approaches is defined as persistent pain after three months despite attempting the above. Exclusion Criteria: 1. Prior radiation to the SIJ. 2. Use of any pain medication or therapy less than 15 days prior to test product administration that has not or will not have had a stable dosage, frequency, or intensity for at least 3 months prior to test agent administration. Use of scheduled pain medication other than acetaminophen for conditions unrelated to SIJ syndrome that has not had a stable dosage for at least 3 months prior to test agent administration. Unwillingness to consider avoiding the use of pain medication for at least 24 hours prior to each follow up evaluation. 3. Intra-articular treatment with corticosteroids or systemic steroid use within 3 months prior to screening. 4. Intra-articular treatment with regenerative medicines (e.g., plasma, stem cell, placental products) at any point prior to screening. 5. Participated in another clinical trial within the last 6 months. 6. An absolute value vital sign outside the following ranges: Systolic blood pressure \>170 or \<100, pulse rate of \>100 or \<50 bpm, and respiratory rate \>22. Reasonable delay (i.e., one hour) may be provided at investigator's discretion to evaluate for return to acceptable parameters in the event that the subject had been subjected to a stressful circumstance prior to arrival in clinic. 7. Intra-articular treatment with hyaluronic acid within 6 months prior to screening. 8. Surgical intervention on the index SIJ \< 12 months, or arthroscopy \< 3 months prior to screening. 9. Non-ambulatory status. 10. Past or current diagnosis of fibromyalgia or inflammatory arthritis, gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, active infection of the SIJ or at the site of injection, pes anserine bursitis, neurogenic or vascular claudication, or uncontrolled diabetes mellitus (HbA1C \>8%). 11. Past or current diagnosis of concurrent diseases, including uncontrolled arrhythmias, Class 3 or 4 congestive heart failure, active hepatitis B or C, liver enzymes ≥ 2 times ULN if there is also elevation of bilirubin, hypercoagulable state, eGFR \<45 mL/min by CKD-EPI, and untreated malignancy or malignancy diagnosed within 6 months. 12. Poorly controlled condition anticipated to have a likelihood of steroid requirement during the course of the trial that could potentially confound the outcomes. 13. Past or current diagnosis of cancer, or at a high risk of recurrence. 14. Diagnosis of secondary arthritis due to traumatic injury in the index SIJ within 2 years of screening. 15. SIJ effusion in the index SIJ at screening that requires drainage for diagnostic purposes or symptomatic relief. 16. Clinically significant, ongoing illness or medical condition, that in the opinion of the investigator constitutes a safety risk for participation in the study or that could interfere with achieving the study objectives, conduct or evaluation. 17. Females who are pregnant or lactating. 18. Regular use of anticoagulants (daily use of aspirin \< 325 mg is acceptable). 19. Active alcohol or substance abuse or any other reason that makes it unlikely that the subject will comply with study procedures. 20. Positive results on the urine drug screen for a banned substance or substance for which a subject does not have a valid prescription, using standard screen at clinical site. 21. Subjects with a psychiatric illness or condition, which, in the opinion of the investigation, would interfere with the conduct of the study or the interpretation of study results. Subjects with stable anxiety and depression defined as being on stable doses of antidepressant and anxiety drugs for the last 6 months and for which no dose changes are expected during the study can be included. 22. Clinically significant medical, surgical, psychiatric, or laboratory abnormality that, in the judgment of the investigator, is likely to adversely affect the subject's risk-benefit or interfere with study compliance or assessment of safety or efficacy. 23. Known allergy to local anesthetics or components of the study drug, including DMSO. 24. Known allergy to radiographic contrast. 25. Subjects with autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV). 26. Severe back pain due to other causes (e.g., lumbar disk degeneration, spinal stenosis), that in the opinion of the clinical investigator will render assessment of the SIJ pain difficult or ambiguous. 27. History of recent (\<1 year) major trauma to the pelvis. 28. Metabolic bone disease (either induced or idiopathic). 29. Involvement in litigation. 30. Receiving disability payments or worker's compensation for back or SI joint pain. Maximum Age: 90 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: leach@ufl.edu Name: Dana D Leach, DNP Phone: 352-273-8933 Role: CONTACT Contact 2: Email: handbem@ufl.edu Name: Eileen M Handberg, PhD Phone: 352-273-8944 Role: CONTACT #### Locations Location 1: City: Gainesville Contacts: *Contact 1:* - Email: agunnett@anest.ufl.edu - Name: Amy Gunnett, RN, BSN - Phone: 352-273-8911 - Role: CONTACT Country: United States Facility: University of Florida Pain Clinic State: Florida Status: RECRUITING Zip: 32610 #### Overall Officials Official 1: Affiliation: University of Florida Name: Rene Przkora, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Pauza, K. (2008). Educational Guidelines for Interventional Spinal Procedures. https://www.aapmr.org/practice/guidelines/Documents/edguidelines.pdf. Accessed June 5 2015. 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Clin Exp Rheumatol. 2002 Jan-Feb;20(1):52-4. PMID: 11892709 Citation: Luukkainen R, Nissila M, Asikainen E, Sanila M, Lehtinen K, Alanaatu A, Kautiainen H. Periarticular corticosteroid treatment of the sacroiliac joint in patients with seronegative spondylarthropathy. Clin Exp Rheumatol. 1999 Jan-Feb;17(1):88-90. PMID: 10084038 Citation: Fortin JD, Tolchin RB. Sacroiliac arthrograms and post-arthrography computerized tomography. Pain Physician. 2003 Jul;6(3):287-90. 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PMID: 23615883 Citation: Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJ, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA; ASIPP-IPM. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):699-802. PMID: 19644537 Citation: American Society of Anesthesiologists Task Force on Chronic Pain Management; American Society of Regional Anesthesia and Pain Medicine. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010 Apr;112(4):810-33. doi: 10.1097/ALN.0b013e3181c43103. No abstract available. PMID: 20124882 Citation: Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c. PMID: 18648237 Citation: Patel N, Gross A, Brown L, Gekht G. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2. PMID: 22299761 Citation: Buchowski JM, Kebaish KM, Sinkov V, Cohen DB, Sieber AN, Kostuik JP. Functional and radiographic outcome of sacroiliac arthrodesis for the disorders of the sacroiliac joint. Spine J. 2005 Sep-Oct;5(5):520-8; discussion 529. doi: 10.1016/j.spinee.2005.02.022. PMID: 16153580 Citation: Rudolf L. Sacroiliac Joint Arthrodesis-MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. Open Orthop J. 2012;6:495-502. doi: 10.2174/1874325001206010495. Epub 2012 Nov 30. PMID: 23284593 Citation: Cummings J Jr, Capobianco RA. Minimally invasive sacroiliac joint fusion: one-year outcomes in 18 patients. Ann Surg Innov Res. 2013 Sep 16;7(1):12. doi: 10.1186/1750-1164-7-12. PMID: 24040944 Citation: Sachs D, Capobianco R. Minimally invasive sacroiliac joint fusion: one-year outcomes in 40 patients. Adv Orthop. 2013;2013:536128. doi: 10.1155/2013/536128. Epub 2013 Aug 13. PMID: 23997957 Citation: Gaetani P, Miotti D, Risso A, Bettaglio R, Bongetta D, Custodi V, Silvani V. Percutaneous arthrodesis of sacro-iliac joint: a pilot study. J Neurosurg Sci. 2013 Dec;57(4):297-301. PMID: 24091432 Citation: Duhon BS, Cher DJ, Wine KD, Lockstadt H, Kovalsky D, Soo CL. Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study. Med Devices (Auckl). 2013 Dec 13;6:219-29. doi: 10.2147/MDER.S55197. eCollection 2013. PMID: 24363562 Citation: Di Matteo B, Vandenbulcke F, Vitale ND, Iacono F, Ashmore K, Marcacci M, Kon E. Minimally Manipulated Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Systematic Review of Clinical Evidence. Stem Cells Int. 2019 Aug 14;2019:1735242. doi: 10.1155/2019/1735242. eCollection 2019. PMID: 31485234 Citation: Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19. PMID: 32551947 Citation: Malemud CJ. Anticytokine therapy for osteoarthritis: evidence to date. Drugs Aging. 2010 Feb 1;27(2):95-115. doi: 10.2165/11319950-000000000-00000. PMID: 20104937 Citation: Wang F, Liu J, Chen X, Zheng X, Qu N, Zhang B, Xia C. IL-1beta receptor antagonist (IL-1Ra) combined with autophagy inducer (TAT-Beclin1) is an effective alternative for attenuating extracellular matrix degradation in rat and human osteoarthritis chondrocytes. Arthritis Res Ther. 2019 Jul 10;21(1):171. doi: 10.1186/s13075-019-1952-5. PMID: 31291980 Citation: O'Shaughnessey K, Matuska A, Hoeppner J, Farr J, Klaassen M, Kaeding C, Lattermann C, King W, Woodell-May J. Autologous protein solution prepared from the blood of osteoarthritic patients contains an enhanced profile of anti-inflammatory cytokines and anabolic growth factors. J Orthop Res. 2014 Oct;32(10):1349-55. doi: 10.1002/jor.22671. Epub 2014 Jul 1. PMID: 24981198 Citation: Angadi DS, Macdonald H, Atwal N. Autologous cell-free serum preparations in the management of knee osteoarthritis: what is the current clinical evidence? Knee Surg Relat Res. 2020 Mar 23;32(1):16. doi: 10.1186/s43019-020-00036-5. PMID: 32660628 Citation: King W, van der Weegen W, Van Drumpt R, Soons H, Toler K, Woodell-May J. White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution. J Exp Orthop. 2016 Dec;3(1):9. doi: 10.1186/s40634-016-0043-7. Epub 2016 Feb 9. PMID: 26915009 Citation: Lee MW, Jang IK, Yoo KH, Sung KW, Koo HH. Stem and progenitor cells in human umbilical cord blood. Int J Hematol. 2010 Jul;92(1):45-51. doi: 10.1007/s12185-010-0619-4. Epub 2010 Jun 25. PMID: 20577840 Citation: Zhang H, Tao Y, Ren S, Liu H, Zhou H, Hu J, Tang Y, Zhang B, Chen H. Isolation and characterization of human umbilical cord-derived endothelial colony-forming cells. Exp Ther Med. 2017 Nov;14(5):4160-4166. doi: 10.3892/etm.2017.5035. Epub 2017 Aug 25. PMID: 29067104 Citation: Hu Y, Rao SS, Wang ZX, Cao J, Tan YJ, Luo J, Li HM, Zhang WS, Chen CY, Xie H. Exosomes from human umbilical cord blood accelerate cutaneous wound healing through miR-21-3p-mediated promotion of angiogenesis and fibroblast function. Theranostics. 2018 Jan 1;8(1):169-184. doi: 10.7150/thno.21234. eCollection 2018. PMID: 29290800 Citation: Rehman J, Li J, Orschell CM, March KL. Peripheral blood "endothelial progenitor cells" are derived from monocyte/macrophages and secrete angiogenic growth factors. Circulation. 2003 Mar 4;107(8):1164-9. doi: 10.1161/01.cir.0000058702.69484.a0. PMID: 12615796 Citation: Caplan AI. Mesenchymal Stem Cells: Time to Change the Name! Stem Cells Transl Med. 2017 Jun;6(6):1445-1451. doi: 10.1002/sctm.17-0051. Epub 2017 Apr 28. PMID: 28452204 Citation: Gupta A, El-Amin SF 3rd, Levy HJ, Sze-Tu R, Ibim SE, Maffulli N. Umbilical cord-derived Wharton's jelly for regenerative medicine applications. J Orthop Surg Res. 2020 Feb 13;15(1):49. doi: 10.1186/s13018-020-1553-7. PMID: 32054483 Citation: Fortin JD, Falco FJ. The Fortin finger test: an indicator of sacroiliac pain. Am J Orthop (Belle Mead NJ). 1997 Jul;26(7):477-80. PMID: 9247654 Citation: Szadek KM, van der Wurff P, van Tulder MW, Zuurmond WW, Perez RS. Diagnostic validity of criteria for sacroiliac joint pain: a systematic review. J Pain. 2009 Apr;10(4):354-68. doi: 10.1016/j.jpain.2008.09.014. Epub 2008 Dec 19. PMID: 19101212 #### See Also Links Label: Overview URL: http://emedicine.medscape.com/article/1930582 Label: Flexion Therapeutics, Inc. (2021, February 18). Flexion therapeutics to Advance Investigational gene Therapy FX201 into high Dose cohort of Phase 1 clinical trial in knee OSTEOARTHRITIS and Expand low and Mid dose treatment groups. Retrieved May 19, 2 URL: https://www.globenewswire.com/news-release/2021/02/18/2177939/0/en/Flexion-Therapeutics-to-Advance-Investigational-Gene-Therapy-FX201-into-High-Dose-Cohort-of-Phase-1-Clinical-Trial-in-Knee-Osteoarthritis-and-Expand-Low-and-Mid-Dose-Treatment-Grou.html ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Pain, Back - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001416 - Term: Back Pain ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415448 Brief Title: Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema Official Title: Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema (HAE) #### Organization Study ID Info ID: ISIS 721744-E01 #### Organization Class: INDUSTRY Full Name: Ionis Pharmaceuticals, Inc. ### Status Module #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: AVAILABLE Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Ionis Pharmaceuticals, Inc. #### Responsible Party Type: SPONSOR ### Description Module Brief Summary: The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial. Detailed Description: The Expanded Access Program (EAP) is intended to provide pre-approval access to donidalorsen for eligible patients with HAE who complete the ISIS 721744-CS3 clinical trial. ### Conditions Module Conditions: - Hereditary Angioedema Keywords: - HAE - IONIS PKK-LRx - Donidalorsen - ISIS 721744 ### Design Module #### Expanded Access Types Intermediate: True Study Type: EXPANDED_ACCESS ### Arms Interventions Module ### Interventions #### Intervention 1 Description: Donidalorsen administered once monthly or every other month by subcutaneous (SC) injections in the abdomen, thigh, or upper arm. Name: Donidalorsen Other Names: - IONIS PKK-LRx - ISIS 721744 Type: DRUG ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients in the ISIS 721744-CS3 (Open-Label Extension \[OLE\] Study) who have completed 205 weeks of treatment. * Female patients of childbearing potential, and male patients with partners of childbearing potential must be willing to use acceptable contraception, or refrain from sexual activity. Exclusion Criteria: * Any patient who is pregnant or plans to become pregnant. * Any patient who was withdrawn from the ISIS 721744-CS3 OLE study due to a serious adverse event (SAE) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of treatment. Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: MedInfo@ionisph.com Name: Ionis Pharmaceuticals Medical Information Phone: 1-833-644-6647 (833-MI-IONIS) Role: CONTACT ### References Module #### See Also Links Label: Related Info URL: https://www.ionispharma.com/patients/expanded-access-policy/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014581 - Term: Urticaria - ID: D000017445 - Term: Skin Diseases, Vascular - ID: D000012871 - Term: Skin Diseases - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases - ID: D000081208 - Term: Hereditary Complement Deficiency Diseases - ID: D000081207 - Term: Primary Immunodeficiency Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000007153 - Term: Immunologic Deficiency Syndromes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4127 - Name: Angioedema - Relevance: HIGH - As Found: Angioedema - ID: M27584 - Name: Angioedemas, Hereditary - Relevance: HIGH - As Found: Hereditary Angioedema - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M17330 - Name: Urticaria - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19714 - Name: Skin Diseases, Vascular - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M2286 - Name: Hereditary Complement Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: LOW - As Found: Unknown - ID: M2285 - Name: Primary Immunodeficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: T2734 - Name: Hereditary Angioedema - Relevance: HIGH - As Found: Hereditary Angioedema ### Condition Browse Module - Meshes - ID: D000000799 - Term: Angioedema - ID: D000054179 - Term: Angioedemas, Hereditary ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415435 Brief Title: Sylfirm X Radiofrequency Microneedling for the Treatment of Melasma Official Title: A Multi-Center, Open-Label, Prospective Study of the Sylfirm X Device for the Treatment of Melasma #### Organization Study ID Info ID: VIOL-MEL-2022 #### Organization Class: INDUSTRY Full Name: Benev Company, Inc. ### Status Module #### Completion Date Date: 2024-10-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-07-01 Type: ESTIMATED #### Start Date Date: 2023-05-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-30 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Benev Company, Inc. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: False ### Description Module Brief Summary: Microneedling radiofrequency technology has been shown in clinical studies to improve skin quality, tone, pigment, and to treat various skin conditions related to aging. The purpose of this study is to evaluate efficacy and safety of Sylfrim X device for the treatment of melasma. ### Conditions Module Conditions: - Melasma ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: SINGLE Who Masked: - INVESTIGATOR Primary Purpose: TREATMENT #### Enrollment Info Count: 90 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Device: Radiofrequency Microneedling Label: Sylfirm X Treatment with Sunscreen Type: EXPERIMENTAL #### Arm Group 2 Label: No Treatment, Sunscreen Only Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Sylfirm X Treatment with Sunscreen Description: Sylfirm X radiofrequency microneedling device Name: Radiofrequency Microneedling Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Success criteria: 80% accuracy in identifying the baseline photo from post-treatment photos. Measure: Percentage of photos accurately identified as post-treatment photo vs. baseline by a blind investigator from 0-100% Time Frame: 28 days #### Secondary Outcomes Description: The Modified Melasma Area and Severity Index scale will be utilized to grade melasma severity. Success criteria: improvement by 1 point, ie. at least 1 point lower than baseline. Measure: Change in Modified Melasma Area and Severity Index (mMASI) scale measured by investigator (range 0-24), a lower score indicating clearer skin. Time Frame: 28 days Description: MELQoL is a questionnaire on a scale of 0 to 7 on how the patients feel about skin appearance, skin condition, embarrassment about skin condition, etc. Measure: Percentage of subjects with an increase in satisfaction level assessed from Melasma Quality of Life questionnaire (MELQoL) after treatment compared to baseline Time Frame: 28 days Description: Success criteria: On a scale of -1 (skin got worse) to 3 (skin very much improved), incidence of subject improvement was statistically significant. Measure: Statistical improvement of investigator Global Aesthetic Improvement Scale (GAIS) Time Frame: 28 days ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Subject must be able to read, understand and sign informed consent form. 2. Healthy females, 19 and older 3. Fitzpatrick I-VI 4. Has melasma 5. Willing to have RF microneedling treatment and able to adhere to treatments, follow up schedule, and post-treatment instructions 6. Willing to have limited sun exposure and use sunscreen on treatment area everyday for duration of study 7. Willing to have photographs taken of treatment area and agree to use of photographs 8. Willing to refrain from using topical corticosteroids, or retinoids 9. Agree to undergo procedure in treatment area during study 10. Females: not pregnant, or lactating and is either post-menopausal, surgically sterilized, or using birth control at least 1 month prior to enrollment 11. Willing to wear sunscreen and apply once daily in morning and every 2 hours Exclusion Criteria: 1. Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study. 2. Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser/light procedures, and those used for general aesthetic correction, neuromodulators, facial peel, lightening creams, or facial surgery. 3. Any fillers within 3 months prior to enrollment or during the study. 4. Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity. 5. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion). 6. . Pregnant and/or breastfeeding or planning to become pregnant. 7. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication. 8. Any use of any medication that is known to increase sensitivity to light or hypersensitivity to light exposure according to the Investigator's discretion. 9. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising. 10. If you have a history of squamous cell carcinoma or melanoma in the treatment area, this includes basal cell carcinoma unless: basal cell carcinoma was treated or excised with no evidence of reoccurrence within the past 6 months prior to screening. Squamous cell carcinoma in situ, which has been treated or excised without evidence or reoccurrence within the past 6 months prior to screening. 11. . History of epidermal or dermal disorders (particularly if involving collagen or micro vascularity), including collagen vascular disease or vasculitis disorders. 12. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment. 13. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. Sponsor: VIOL Version 1, 25APR2022 Protocol: VIOL-MEL-2022 Page 18 of 47 14. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen. 15. Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study. 16. Excessive facial hair in the area to be treated (beards, sideburns, and/or mustache,) that would interfere with diagnosis, assessment, and treatment. 17. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements. 18. To reduce potential effects of hormonal changes in melasma, a 6-month washout period is required for female subjects who have recently stopped or started contraceptive use, have recently delivered an infant, or have stopped breastfeeding. Healthy Volunteers: True Maximum Age: 70 Years Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: jamie@benev.com Name: Jamie Solorsa Phone: 9494572222 Phone Ext: 206 Role: CONTACT #### Locations Location 1: City: La Jolla Contacts: *Contact 1:* - Email: biggers.joy@scrippshealth.org - Name: Joy Biggers - Phone: 858-554-5273 - Role: CONTACT *Contact 2:* - Name: Victor Ross, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Scripps Health State: California Status: RECRUITING Zip: 92037 Location 2: City: Charlotte Contacts: *Contact 1:* - Email: raziaL@carolinaskin.com - Name: Razia Ludin - Phone: 704-973-3687 - Role: CONTACT *Contact 2:* - Name: Gilly Munavalli, MD - Role: PRINCIPAL_INVESTIGATOR Country: United States Facility: Dermatology, Laser & Vein Specialists of the Carolinas, PLLC State: North Carolina Status: RECRUITING Zip: 28207 Location 3: City: Houston Country: United States Facility: Refresh Dermatology State: Texas Status: COMPLETED Zip: 77081 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017495 - Term: Hyperpigmentation - ID: D000010859 - Term: Pigmentation Disorders - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11531 - Name: Melanosis - Relevance: HIGH - As Found: Melasma - ID: M19760 - Name: Hyperpigmentation - Relevance: LOW - As Found: Unknown - ID: M13754 - Name: Pigmentation Disorders - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008548 - Term: Melanosis ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16255 - Name: Sunscreening Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415422 Acronym: PAPAYE Brief Title: Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma Official Title: Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma #### Organization Study ID Info ID: 29BRC22.0226 #### Organization Class: OTHER Full Name: University Hospital, Brest ### Status Module #### Completion Date Date: 2026-08-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-02-01 Type: ESTIMATED #### Start Date Date: 2024-08-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-03 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: University Hospital, Brest #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The brain is encased in three membranes: the pia mater, arachnoid, and dura mater. A subdural hematoma is often a post-traumatic accumulation of blood between the dura mater and the brain, occurring when a trauma tears a small vein on the brain. As the hematoma expands, it compresses the brain, potentially leading to severe neurological symptoms that may require urgent surgical removal. Patients on antiplatelet therapy are at increased risk of larger subdural hematomas and higher morbidity. The reversibility of antiplatelet effects and the potential benefits of platelet transfusions to halt hematoma expansion or prevent significant re-bleeding during surgical management are still debated. The French Society of Anesthesia and Intensive Care (SFAR) recommends delaying neurosurgical interventions by 5 days if clinically tolerable, with platelet transfusions provided for urgent surgeries within this period. However, prolonged cessation of antithrombotic treatments increases the risk of perioperative thrombotic events. Literature also notes individual variability in the effectiveness of antiplatelet treatments. European guidelines suggest using platelet function analysis devices alongside standard laboratory coagulation monitoring in trauma patients suspected of platelet dysfunction (Level 2C). The 2019 SFAR guidelines for the emergency management of patients on antiplatelets do not recommend these devices outside of cardiovascular surgery due to a lack of studies. Detailed Description: The brain is encased in three membranes: the pia mater, arachnoid, and dura mater. A subdural hematoma is often a post-traumatic accumulation of blood between the dura mater and the brain, occurring when a trauma tears a small vein on the brain. As the hematoma expands, it compresses the brain, potentially leading to severe neurological symptoms that may require urgent surgical removal. Patients on antiplatelet therapy are at increased risk of larger subdural hematomas and higher morbidity. The reversibility of antiplatelet effects and the potential benefits of platelet transfusions to halt hematoma expansion or prevent significant re-bleeding during surgical management are still debated. The French Society of Anesthesia and Intensive Care (SFAR) recommends delaying neurosurgical interventions by 5 days if clinically tolerable, with platelet transfusions provided for urgent surgeries within this period. However, prolonged cessation of antithrombotic treatments increases the risk of perioperative thrombotic events. Literature also notes individual variability in the effectiveness of antiplatelet treatments. European guidelines suggest using platelet function analysis devices alongside standard laboratory coagulation monitoring in trauma patients suspected of platelet dysfunction (Level 2C). The 2019 SFAR guidelines for the emergency management of patients on antiplatelets do not recommend these devices outside of cardiovascular surgery due to a lack of studies. ### Conditions Module Conditions: - Hematoma, Subdural ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: PREVENTION #### Enrollment Info Count: 40 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: The management of patients included in this study is not altered from the standard recommended care. The only exception is the daily blood draw into a dry tube for decentralized analysis using VeriFyNow until the normalization of platelet function, which is not part of routine care. Intervention Names: - Biological: Biological samples Label: Daily Sampling in Platelet Function Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - Daily Sampling in Platelet Function Description: Biological samples are taken from the patient's catheter inserted upon admission (the usual access route for patients): A daily sample is collected into a dry tube for off-site analysis by VeriFyNow until platelet function normalizes (for example, if platelet function normalizes on Day 2, no further VeriFyNow analysis will be conducted on subsequent days). Name: Biological samples Type: BIOLOGICAL ### Outcomes Module #### Primary Outcomes Description: Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug Measure: Evaluation of Platelet Function Progression Time Frame: Day 0 Description: Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug Measure: Evaluation of Platelet Function Progression Time Frame: Day 1 Description: Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug Measure: Evaluation of Platelet Function Progression Time Frame: Day 2 Description: Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function (defined by the time elapsed between the last intake of antiplatelet drugs and the normalization of platelet function measured by VeriFyNow), and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug An analysis of the kinetics of recovery of platelet function in patients on aspirin managed for a subdural hematoma will be conducted to assess this criterion. Measure: Evaluation of Platelet Function Progression Time Frame: Day 3 Description: Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug Measure: Evaluation of Platelet Function Progression Time Frame: Day 4 Description: Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug Measure: Evaluation of Platelet Function Progression Time Frame: Day 5 #### Secondary Outcomes Description: Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow. Measure: Comparison of platelet function measurement between calculation and VerifyNow Time Frame: Day 0 Description: Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow. Measure: Comparison of platelet function measurement between calculation and VerifyNow Time Frame: Day 1 Description: Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow. Measure: Comparison of platelet function measurement between calculation and VerifyNow Time Frame: Day 2 Description: Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow. Measure: Comparison of platelet function measurement between calculation and VerifyNow Time Frame: Day 3 Description: Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow. Measure: Comparison of platelet function measurement between calculation and VerifyNow Time Frame: Day 4 Description: Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow. Measure: Comparison of platelet function measurement between calculation and VerifyNow Time Frame: Day 5 Description: Description and comparison of the actual surgical management time and the time to achieve functional platelets calculated by the theoretical formula based on the initial platelet count of the patient and a 10% daily platelet turnover rate. Measure: Comparison of the actual surgical management time with the theoretical formula-based time Time Frame: Immediately after intervention Description: Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time Measure: Evaluation of Incidence of Platelet Transfusion Time Frame: Day 0 Description: Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time Measure: Evaluation of Incidence of Platelet Transfusion Time Frame: Day 1 Description: Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time Measure: Evaluation of Incidence of Platelet Transfusion Time Frame: Day 2 Description: Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time Measure: Evaluation of Incidence of Platelet Transfusion Time Frame: Day 3 Description: Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time Measure: Evaluation of Incidence of Platelet Transfusion Time Frame: Day 4 Description: Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time Measure: Evaluation of Incidence of Platelet Transfusion Time Frame: Day 5 Description: Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management. Measure: Comparison of the total duration of antiplatelet cessation Time Frame: Day 0 Description: Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management. Measure: Comparison of the total duration of antiplatelet cessation Time Frame: Day 1 Description: Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management. Measure: Comparison of the total duration of antiplatelet cessation Time Frame: Day 2 Description: Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management. Measure: Comparison of the total duration of antiplatelet cessation Time Frame: Day 3 Description: Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management. Measure: Comparison of the total duration of antiplatelet cessation Time Frame: Day 4 Description: Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management. Measure: Comparison of the total duration of antiplatelet cessation Time Frame: Day 5 Description: Evaluation of the number of cardiovascular complications occurring within 6 months (acute coronary syndrome, ischemic stroke, thrombophlebitis, or pulmonary embolism) Measure: Evaluation of cardiovascular complications Time Frame: Month 3 Description: Evaluation of the number of cardiovascular complications occurring within 6 months (acute coronary syndrome, ischemic stroke, thrombophlebitis, or pulmonary embolism) Measure: Evaluation of cardiovascular complications Time Frame: Month 6 Description: Evaluation of the mRs (modified Rankin Scale) score at discharge from the neurosurgery department, and at 3 and 6 months. Measure: Evaluation of the mRs score Time Frame: Immediately after discharge Description: Evaluation of the mRs (modified Rankin Scale) score at discharge from the neurosurgery department, and at 3 and 6 months. Measure: Evaluation of the mRs score Time Frame: Month 3 Description: Evaluation of the mRs (modified Rankin Scale) score at discharge from the neurosurgery department, and at 3 and 6 months. Measure: Evaluation of the mRs score Time Frame: Month 6 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: Patient \>18 years old Patient managed for a subdural hematoma in neurosurgery or intensive care under Acetylsalicylic Acid (aspirin) regardless of the dose. No objection from the patient Exclusion Criteria: Patient under effective anticoagulation or on antiplatelet therapy other than acetylsalicylic acid (combination of two antiplatelets) Pregnant or breastfeeding woman Refusal to participate Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: anais.caillard@chu-brest.fr Name: Anaïs CAILLARD Phone: +33 Role: CONTACT ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006470 - Term: Hemorrhage - ID: D000010335 - Term: Pathologic Processes - ID: D000020198 - Term: Intracranial Hemorrhage, Traumatic - 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: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - 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: BC14 - Name: Heart and Blood Diseases - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M9493 - Name: Hematoma - Relevance: HIGH - As Found: Hematoma - ID: M9495 - Name: Hematoma, Subdural - Relevance: HIGH - As Found: Hematoma, Subdural - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M22113 - Name: Intracranial Hemorrhages - Relevance: LOW - As Found: Unknown - ID: M22025 - Name: Intracranial Hemorrhage, Traumatic - 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: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006408 - Term: Hematoma, Subdural - ID: D000006406 - Term: Hematoma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415409 Acronym: REHYDR8 Brief Title: Rehydration Efficiency With Different Sports Drinks Official Title: Rehydration After Exercise With High-electrolyte Sport Drink #### Organization Study ID Info ID: FP00034719 #### Organization Class: OTHER Full Name: Arizona State University ### Status Module #### Completion Date Date: 2024-01-12 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-01-05 Type: ACTUAL #### Start Date Date: 2023-05-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2023-08-23 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Arizona State University #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: It is well established that post-exercise rehydration with a carbohydrate-electrolyte solution is better when compared to plain water. However, most of the commercially available drinks today are high in carbohydrates and sodium with low potassium without other active ingredients. The aim of the present study is to examine the impact of a higher electrolyte sports drink compared with traditional sports drinks and water on the time course and extent of rehydration after exercise-induced dehydration Detailed Description: Dehydration: Based on our previous work, dehydration will be accomplished on the morning of testing via mild exercise and heat exposure to elicit a body weight loss of -2%. The subjects will perform four bouts of 25-min low-intensity exercise and 5 min rest (alternating cycling \& walking) or till they reach -2% of body weight dehydration. Rehydration: Following a 20 min rest in thermo-comfortable environment a dehydrated baseline blood sample will be taken, and subject will start the rehydration protocol. The volunteers will consume one of the four drinks below in a cross over balance mode. During the first hour four equal doses will be consumed in15-min intervals at a total volume of 150% of their body weight loss. Trials/Drinks (block randomization will be used to assign individual participants to each specific trial/drink using their ID number): * Water * GoodSport® * Gatorade® * BodyArmor® Measurements: All measurements will be performed at one of the test rooms at our lab facility that boarders the room where participants can relax and wait out the end of the study day. When certain measurements need to be performed they simply move from one room to the next. Duration of taking blood and urine samples will take not more than 30-90 seconds each, bioelectrical impedance will take a bit more time to ensure the body is in a stable rested state as a result measurement will be taken in 10 minutes, finally perceptual data will take 30-60 seconds to be reported. To allow to perform all measurements study days will take up to 7 hours. Therefore, there will be a separate space available that allows for self-study or watching TV that includes a chair and table to work on and a couch to relax. Blood samples (8 per trial, maximal 12 minutes): A total of eight 10 mL blood samples will be collected on the euhydrated baseline, dehydrated baseline and at 30, 60, 90, 120, 180, and 240 min of the rehydration period. All samples will be analyzed for glucose, osmolality, total plasma protein, hematocrit, hemoglobin (for plasma volume changes), sodium, potassium, and chloride. Urine samples (6 per trial, maximal 9 minutes): Urine samples will be collected using \~900 mL cups at euhydrated baseline, dehydrated baseline and cumulative totals will be collected at 60, 120, 180, and 240 min of the rehydration period. All samples will be analyzed for urine osmolality, specific gravity, volume, sodium, and potassium. Perceptual Data (6 per trial, maximal 9 minutes): Thirst, stomach fullness, and taste, assessed via a visual analog scale ### Conditions Module Conditions: - Dehydration ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER Intervention Model Description: Randomized Cross over design. ##### Masking Info Masking: SINGLE Masking Description: Unidentified bottles. Who Masked: - PARTICIPANT Primary Purpose: OTHER #### Enrollment Info Count: 12 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: rehydration with Plain water Intervention Names: - Other: Water Label: Water Type: PLACEBO_COMPARATOR #### Arm Group 2 Description: rehydration with Gatorade drink Intervention Names: - Other: Gatorade Label: Gatorade Type: ACTIVE_COMPARATOR #### Arm Group 3 Description: Rehydration with Body Armor Drink Intervention Names: - Other: BodyArmor Label: BodyArmor Type: ACTIVE_COMPARATOR #### Arm Group 4 Description: Rehydration with Good Sport drink Intervention Names: - Other: GoodSport Label: GoodSport Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Water Description: Plain water Name: Water Type: OTHER #### Intervention 2 Arm Group Labels: - Gatorade Description: Sport Drink Gatorade Name: Gatorade Type: OTHER #### Intervention 3 Arm Group Labels: - BodyArmor Description: Sport Drink BodyArmor Name: BodyArmor Type: OTHER #### Intervention 4 Arm Group Labels: - GoodSport Description: Sport Drink GoodSport Name: GoodSport Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Net fluid balance based on body weight changes during the 4 h of the rehydration period Measure: Net Fluid Balance Time Frame: 3 hours of rehydration Description: Net fluid balance based on body weight changes during the 4 h of the rehydration period Measure: Net Fluid Balance Time Frame: 4 hours of rehydration Description: cumulative Urine output during the rehydration period Measure: Urine volume Time Frame: 3 hours of rehydration Description: Urine osmotic excretion during rehydration Measure: Urine osmotic excretion Time Frame: 3 hours of rehydration Description: Urine osmotic excretion during rehydration Measure: Urine osmotic excretion Time Frame: 4 hours of rehydration #### Secondary Outcomes Description: Assessed via a Visual Analog scale during rehydration Measure: Stomach fullness Time Frame: 3 hours of rehydration Description: Assessed via a Visual Analog scale during rehydration. Scale is from 0-125mm with higher number indicating greater perception Measure: Stomach fullness Time Frame: 4 hours of rehydration Description: Assessed via a Visual Analog scale during rehydration. Scale is from 0-125mm with higher number indicating greater perception Measure: Thirst Time Frame: 3 hours of rehydration Description: Assessed via a Visual Analog scale during rehydration. Scale is from 0-125mm with higher number indicating greater perception Measure: Thirst Time Frame: 4 hours of rehydration ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Training \> 2x per week * Age 18-55 y * stable weight for the last 2 months (\<5 lbs. fluctuation) Exclusion Criteria: * night shifting work * thyroid medication * bariatric surgery * cardiovascular disease * renal disease * hepatic disease * Participating in another study at the same time * Bodyweight \<110 lbs. Healthy Volunteers: True Maximum Age: 55 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Locations Location 1: City: Phoenix Country: United States Facility: Interdisciplinary Science and Technology Building 8 State: Arizona Zip: 85004 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014883 - Term: Water-Electrolyte Imbalance - ID: D000008659 - Term: Metabolic Diseases - ID: D000010335 - Term: Pathologic Processes ### 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: M6883 - Name: Dehydration - Relevance: HIGH - As Found: Dehydration - ID: M17624 - Name: Water-Electrolyte Imbalance - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003681 - Term: Dehydration ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415396 Brief Title: Effects of Extracorporeal Shock Wave Therapy (ESWT) and Low Intensity Laser Therapy (LLLT) Added to Complete Decongestive Therapy (CDT) on Extremity Volume, Pain Intensity, Functional Status and Quality of Life in Patients With Postmastectomy Stage 2 Lymphedema Official Title: Effects of Extracorporeal Shock Wave Therapy (ESWT) and Low Intensity Laser Therapy (LLLT) Added to Complete Decongestive Therapy (CDT) on Extremity Volume, Pain Intensity, Functional Status and Quality of Life in Patients With Postmastectomy Stage 2 Lymphedema #### Organization Study ID Info ID: 10025145 #### Organization Class: OTHER Full Name: Ankara City Hospital Bilkent ### Status Module #### Completion Date Date: 2023-06-25 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-06-20 Type: ACTUAL #### Start Date Date: 2021-12-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Ankara City Hospital Bilkent #### Responsible Party Investigator Affiliation: Ankara City Hospital Bilkent Investigator Full Name: Bilge Büşra Ceylan Investigator Title: Medical Doctor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This study aimed to comparatively investigate the effects of ESWT and LLLT added to conventional CDT (which is the standard treatment for breast cancer-related lymphedema) on patients' limb volume, pain intensity, functional status and quality of life. Detailed Description: after being informed study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility recruitments will get treatment into three groups in conventional complet decongestive therapy (CDT) program, electrocorporeal shock wave therapy (ESWT) combined with CDT program and low level laser therapy (LLLT) combined with CDT program ### Conditions Module Conditions: - Lymphedema, Breast Cancer Keywords: - Lymphedema - ESWT - LLLT ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 66 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: 22 breast cancer related lymphedema patients will received complete decongestive therapy Intervention Names: - Other: Complete Decongestive Therapy Label: Complete Decongestive Therapy Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: 22 breast cancer related lymphedema patients will received ESWT added complete decongestive therapy Intervention Names: - Other: Complete Decongestive Therapy - Device: ESWT Label: Complete Decongestive Therapy and ESWT Type: ACTIVE_COMPARATOR #### Arm Group 3 Description: 22 breast cancer related lymphedema patients will received LLLT added complete decongestive therapy Intervention Names: - Other: Complete Decongestive Therapy - Device: LLLT Label: Complete Decongestive Therapy and LLLT Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Complete Decongestive Therapy - Complete Decongestive Therapy and ESWT - Complete Decongestive Therapy and LLLT Description: conventional CDT program consisting of MLD, compression bandage, skin care and lymphedema exercises, for a total of 15 sessions, five days a week for three weeks. Name: Complete Decongestive Therapy Type: OTHER #### Intervention 2 Arm Group Labels: - Complete Decongestive Therapy and ESWT Description: ESWT was applied to the second group for a total of 5 sessions, 2 sessions in the first two weeks and 1 session in the last week. . Name: ESWT Type: DEVICE #### Intervention 3 Arm Group Labels: - Complete Decongestive Therapy and LLLT Description: In the third group, LLLT was applied for a total of 9 sessions, 3 sessions per week, in addition to conventional CDT. Name: LLLT Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Upper limb Volume measured by perometer Measure: Extremity volumes Time Frame: Baseline, after three weeks #### Secondary Outcomes Description: quality of life questionnaire that is spesific for upper limb lymphedema Measure: Lymphedema Quality of Life-arm (LYMQOL-arm ) Time Frame: Baseline, after three weeks Description: questionnaire that shows functional status Measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire Time Frame: Baseline, after three weeks Description: a straight line with one end meaning no pain and the other end meaning the worst pain imaginable Measure: Visual Anologue Scale -Pain (VAS) Time Frame: Baseline, after three weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Female patients with unilateral lymphedema after breast cancer-related surgery Patients whose chemotherapy and radiotherapy protocols have been completed Patients with stage 2 lymphedema according to ISL staging Exclusion Criteria: * Patients with arm edema before breast cancer * Patients with ongoing chemotherapy and radiotherapy Those with metastatic breast cancer Patients with acute infection Patients with BMI \>35 Patients with pregnancy Patients who have previously received KDT Patients with active cancer Patients with recurrence or metastasis of breast cancer on follow-up imaging Those with decompensated heart failure Those with kidney failure Patients with liver failure Patients with a history of deep vein thrombosis in the last 3 months Those who are allergic to the dressing materials to be applied Patients with active infection or open wound on their extremities Those with cognitive impairment Patients with sensory deficits Immobilized patients Gender Based: True Gender Description: we received female patients who had postmastectomy lymphedema Maximum Age: 65 Years Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Ankara Country: Turkey Facility: Ankara bilkent City Hospiatal Physical Therapy and Rehabilitation Hospital State: Çankaya Zip: 06800 #### Overall Officials Official 1: Affiliation: Ankara Bilkent City Hospital Name: BilgeBüşra Ceylan, Medical Doctor Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Lee JH, Kim SB, Lee KW, Ha WW. Long-Term Effects of Extracorporeal Shock Wave Therapy on Breast Cancer-Related Lymphedema. J Clin Med. 2022 Nov 15;11(22):6747. doi: 10.3390/jcm11226747. PMID: 36431224 Citation: Baxter GD, Liu L, Petrich S, Gisselman AS, Chapple C, Anders JJ, Tumilty S. Low level laser therapy (Photobiomodulation therapy) for breast cancer-related lymphedema: a systematic review. BMC Cancer. 2017 Dec 7;17(1):833. doi: 10.1186/s12885-017-3852-x. PMID: 29216916 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008206 - Term: Lymphatic Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: LOW - As Found: Unknown - ID: M11206 - Name: Lymphedema - Relevance: HIGH - As Found: Lymphedema - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: HIGH - As Found: Pain Intensity - ID: M1071 - Name: Breast Cancer Lymphedema - Relevance: HIGH - As Found: Lymphedema, Breast Cancer - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000008209 - Term: Lymphedema - ID: D000072656 - Term: Breast Cancer Lymphedema - ID: D000010146 - Term: Pain ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415383 Brief Title: The Effects of Vitamin B6 Supplementation on Pain Thresholds and Tolerance Official Title: Testing the Effects of High-dose Vitamin B6 Supplements on Pain Thresholds and Tolerance in Healthy Adults #### Organization Study ID Info ID: UREC24/13 #### Organization Class: OTHER Full Name: University of Reading ### Status Module #### Completion Date Date: 2025-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-23 Type: ACTUAL Last Update Submit Date: 2024-05-21 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-12 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: INNOPURE #### Lead Sponsor Class: OTHER Name: University of Reading #### Responsible Party Investigator Affiliation: University of Reading Investigator Full Name: David Field Investigator Title: Associate professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: This clinical trial aims to explore the effect of Vitamin B6 supplementation on pain thresholds and tolerance in healthy adults using thermal and electrical stimulation. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 increases pain thresholds and tolerance. Detailed Description: The main questions it aims to answer are: * How does vitamin B6 affect pain thresholds and tolerance following a single 100mg dose? * How does vitamin B6 affect pain thresholds following daily supplementation for up to a month? * Does vitamin B6 supplementation affect measures related to the experience of pain, such as state anxiety, sleep, diet, and mood at different time points ### Conditions Module Conditions: - Pain Keywords: - Vitamin B6 - GABA - Excitation-Inhibition balance ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: DOUBLE Who Masked: - PARTICIPANT - INVESTIGATOR Primary Purpose: TREATMENT #### Enrollment Info Count: 20 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will consume one high-dose Vitamin B6 100 mg tablet orally once daily for one month. Vitamin B6 will be provided as Pyridoxal-5'-Phosphate (PLP). Intervention Names: - Drug: Vitamin B6 100 MG Label: Vitamin-B6 Type: EXPERIMENTAL #### Arm Group 2 Description: Participants will consume a Placebo tablet matching the appearance of the Vitamin B6 tablets in the Experimental arm orally once daily for one month. Intervention Names: - Other: Placebo Label: Placebo Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Vitamin-B6 Description: Vitamin B6 in for the form of pyridoxal phosphate (PLP) Name: Vitamin B6 100 MG Type: DRUG #### Intervention 2 Arm Group Labels: - Placebo Description: Placebo tablet containing microcrystalline cellulose Name: Placebo Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Sensory threshold will be measured using thermal stimulation (heat stimulation). The starting temperature of the applied probe will be adjusted to the individual's skin temperature and then slowly increased (0.5 deg C/s) until the participant feels a slight warm sensation. For safety, the temperature will never exceed 50 deg C. The procedure will be repeated three times. The average change in temperature (in degree Celsius) needed for participants to perceive a warm sensation will be used as outcome measure. Low values will therefore indicate a high sensitivity to warmth, whereas high values will indicate a low warmth sensitivity. Measure: Thermal sensory threshold Time Frame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention Description: Pain threshold will be measured using thermal stimulation (heat stimulation). The starting temperature of the applied probe will be adjusted to the individual's skin temperature and then slowly increased (1 deg C/s) until the participant feels a slight pain/burning sensation. For safety, the temperature will never exceed 50 deg C. The procedure will be repeated three times. The average change in temperature (in degree Celsius) needed for participants to perceive a slight pain/burning sensation will be used as outcome measure. Low values will therefore indicate high pain sensitivity, whereas high values will indicate low pain sensitivity. Measure: Thermal pain threshold Time Frame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention Description: Pain sensitivity will be measured using electrical stimulation. Starting at an initial intensity of 0.3 mA, the intensity of each subsequently applied electrical stimulus will be increased in steps of 0.3 mA each, with a maximum intensity of 10 mA. The procedure will be continued until the participant perceives the applied shock as moderately painful (equivalent to a pain rating of 5 out of 10 or higher). The procedure will be repeated three times. The average intensity (in mA) needed for participants to perceive a moderate pain sensation will be used as outcome measure. Low values will therefore indicate a high sensitivity to electrical stimulation, whereas high values will indicate a low pain sensitivity in response to electrical stimulation. Measure: Electrical pain sensitivity Time Frame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention Description: Pain tolerance will be measured using thermal stimulation (heat stimulation). The starting temperature of the applied probe will be adjusted to the individual's skin temperature and then slowly increased (1 deg C/s) until the participant feels that they can't tolerate the heat anymore. For safety, the temperature will never exceed 50 deg C. The procedure will be repeated three times. The average change in temperature (in degree Celsius) needed for participants to reach their pain tolerance will be used as outcome measure. Low values will therefore indicate low pain tolerance, whereas high values will indicate high pain tolerance. Measure: Thermal pain tolerance Time Frame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention Description: Pain tolerance will be measured by recording the number of seconds the participant is willing to keep their hand immersed in a 5 degree celsius cold bath, up to a maximum of 120 sec. Measure: Cold immersion pain tolerance Time Frame: This will be done at baseline, 3-5 days, 11-13, and 28-35 days after the start of the intervention Description: Pain sensitisation will be measured using a wind-up paradigm (temporal summation) with thermal stimulation (heat simulation). The thermal probe will start at 32 deg C and increase in temperature (100 deg C/s) to 49 deg C. After a duration of 800 ms, the temperature will return to baseline. Participants will be asked for a pain rating on a scale form 0 (not painful) to 10 (extremely painful). Subsequently, a series of 10 heat stimuli (identical to the once above, ISI 400 ms) will be applied. Participants will be asked to rate the most intense pain that they felt across the series, using the same 0-10 rating scale. The difference in pain ratings in response to the series and to the single stimulus will be used as the outcome measure. Higher (positive) ratings will indicate a stronger sensitisation to repeated painful stimuli. In contrast, negative values will indicate habituation to repeated painful stimuli. Measure: Pain wind-up Time Frame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention #### Secondary Outcomes Description: State anxiety will be measured using the State-Trait Anxiety Inventory (STAI), which produces a minimum score of 20 and a maximum score of 80, where higher scores indicate greater anxiety. Measure: State anxiety Time Frame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention Description: State positive and negative affect will be measured using the The Positive And Negative Affect Schedule Now (PANAS-N) (PANAS-N; adapted from Watson et al., 1988). Measure: Positive and negative affect Time Frame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention Description: Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which results in a score ranging between 0 and 21, where higher scores indicate worse sleep quality. Measure: Sleep quality Time Frame: This will be done at baseline, 3-5 days, 11-13, and 28-35 days after the start of the intervention Description: Dietary intake will be measured using the Mediterranean Diet Adherence Screener(MEDAS), which produces a score ranging between 0 and 14, where higher scores indicate greater adherence to the Mediterranean diet. Measure: Dietary intake Time Frame: This will be measured at baseline during their first visit only ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Over the age of 18 years * Fluent speaker of English language Exclusion Criteria: * Under 18 years * Presence or history of chronic pain * Presence of neuropathic/nerve pain * Raynaud's syndrome * Using any vitamin supplementations that contain Vitamin B6 at more than the RDA, or combinations of B vitamins. * On any medication that is GABA agonistic * Any use of analgesic/anti-inflammatory medication up to 48 hours prior to any of the testing sessions. * Any heart conditions * Newly acquired tattoos on the pain stimulation site Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: d.t.field@reading.ac.uk Name: David T Field, PhD Phone: +441183785004 Role: CONTACT Contact 2: Email: a.cameron@pgr.reading.ac.uk Name: Alex JA Cameron, MSc Role: CONTACT #### Locations Location 1: City: Reading Contacts: *Contact 1:* - Email: d.t.field@reading.ac.uk - Name: David T Field, PhD - Phone: +441183785004 - Role: CONTACT Country: United Kingdom Facility: University of Reading State: Berkshire Status: RECRUITING Zip: RG6 6AL ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Spielberger, C. D., Gonzalez-Reigosa, F., Martinez-Urrutia, A., Natalicio, L. F., & Natalicio, D. S. (1971). The state-trait anxiety inventory. Revista Interamericana de Psicologia/Interamerican journal of psychology, 5(3 & 4). Citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. PMID: 3397865 Citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PMID: 2748771 Citation: Martinez-Gonzalez MA, Garcia-Arellano A, Toledo E, Salas-Salvado J, Buil-Cosiales P, Corella D, Covas MI, Schroder H, Aros F, Gomez-Gracia E, Fiol M, Ruiz-Gutierrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Munoz MA, Warnberg J, Ros E, Estruch R; PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134. doi: 10.1371/journal.pone.0043134. Epub 2012 Aug 14. PMID: 22905215 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014803 - Term: Vitamin B Complex ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M23026 - Name: Vitamin B 6 - Relevance: HIGH - As Found: Brentuximab - ID: M14583 - Name: Pyridoxal - Relevance: HIGH - As Found: Brentuximab - ID: M14589 - Name: Pyridoxine - Relevance: HIGH - As Found: Brentuximab - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M14585 - Name: Pyridoxal Phosphate - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T474 - Name: Vitamin B6 - Relevance: HIGH - As Found: Brentuximab - ID: T459 - Name: Pyridoxal - Relevance: HIGH - As Found: Brentuximab - ID: T461 - Name: Pyridoxine - Relevance: HIGH - As Found: Brentuximab - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000025101 - Term: Vitamin B 6 - ID: D000011730 - Term: Pyridoxal - ID: D000011736 - Term: Pyridoxine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415370 Brief Title: Food and Friends: Healthy Meals Delivered to You Official Title: Examining the Relationship Between Home-Delivered Healthy Meals to Seniors and Social Connectedness: A Mixed Methods Study #### Organization Study ID Info ID: 24-0190 #### Organization Class: OTHER Full Name: University of North Carolina, Chapel Hill ### Status Module #### Completion Date Date: 2024-09 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-09 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Humana Foundation #### Lead Sponsor Class: OTHER Name: University of North Carolina, Chapel Hill #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The goal of this clinical trial is to learn if home delivered healthy meals (HDHM) with or without (intervention vs. control) social interaction can impact mental health and food security in adults aged 65 and older who live alone and have trouble accessing food. The main questions it aims to answer are: Does HDHM with or without social interaction change the quality of participant food intake? Does HDHM with or without social interaction change the loneliness that participants may experience? Does HDHM with or without social interaction change the depression that participants may experience? Researchers will compare a group that receives HDHM only to a group that receives HDHM and social interaction to see if there is a difference between the two groups in their experienced loneliness and depression, and the quality of food that they eat. Participants will receive 12 weeks' worth of HDHM delivered to their home. Half of the participants will receive weekly phone calls from volunteer student "companions) Participants will also be asked to complete questionnaires over the phone at three timepoints (baseline, 6 weeks, and 12 weeks) during the study. Some participants may also be asked to give their opinions on the program via a telephone conversation. Detailed Description: This study is a randomized control trial (RCT) to measure the impact of a combined social interaction and culturally tailored home delivered healthy meals (HDHM) intervention on participants' mental health and food insecurity compared to those in the control group receiving HDHM alone. In addition, the study aims to test the feasibility of including structured, consistent social interactions as part of HDHM. This study will include a sample size of 60 participants. Participants in the study will be randomized to a HDHM only group (control), or HDHM with social interactions group (intervention). All participants will receive HDHM (a frozen meal product based on the Mediterranean Diet adapted for United States Southeastern taste preferences) for 12 weeks. The study team will collect data from participants at baseline, 6 weeks, and 12 weeks via a telephone-administered survey. A subgroup of 10 participants (5 from the intervention, 5 from the control group) will participate in informant interviews to assess feasibility. ### Conditions Module Conditions: - Mental Health Issue - Food Insecurity Keywords: - Food Insecurity - Mental Health - Seniors ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 60 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Home delivered healthy meals are delivered in-person, including a "friendly visit" with the participant if the participant desires. Student companions will also contact participants at least one time weekly for telephone reassurance and to provide resource referrals. Intervention Names: - Behavioral: Home Delivered Healthy Meals Plus Social Interactions Label: HDHM and Social Interaction (Intervention) Type: EXPERIMENTAL #### Arm Group 2 Description: Home delivered healthy meals are delivered directly to the participant or dropped off at the participant's home in a cooler at their front door if they are not available. Any interaction will be limited. Label: HDHM Only (Control) Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - HDHM and Social Interaction (Intervention) Description: In-person delivery of HDHM with "friendly visits" and also Student Companion calls at least one time weekly. "Friendly visits" last approximately 5-10 minutes and include brief "wellness check" questions such as, "How are you doing today?" "Did you try \[HDHM recipe\] yesterday- how did it taste? Any suggestions for future flavors?" "What are some of the things you plan to do in the next few days?" "Is there anything else you want to share with me?" Student Companions call participants at least one time weekly to provide telephone reassurance- i.e., checking on the participant's well-being. These calls may also include referrals to appropriate resources such as NCCARE 360 (statewide network that connects individuals with complex health and social needs, to community resources and service) Facilitators of the "Friendly Visits" and Student Companion calls will use an online system to facilitate the sharing of information that would benefit the participants. Name: Home Delivered Healthy Meals Plus Social Interactions Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: Food security status will be assessed using the United States Adult Food Security Survey Module- a 10-item measure that assesses a person's ability to access food. Questions include topics such as having enough food in the house, running out of food due to lack of money, skipping meals, and reducing portion sizes. Scoring range is from 0-10. A higher score represents a lower food security status. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Adult Food Security Score Time Frame: Baseline up to week 12 Description: Food security status will be assessed using the United States Adult Food Security Survey Module- a 10-item measure that assesses a person's ability to access food. Questions include topics such as having enough food in the house, running out of food due to lack of money, skipping meals, and reducing portion sizes. Scoring range is from 0-10. A higher score represents a lower food security status. Assessed at baseline, week 6, and week 12. Measure: Median Change of Adult Food Security Score Time Frame: Baseline up to week 12 Description: Total cups of fruit eaten per day will be assessed using question 1 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of fruit do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of fruit consumed. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Fruit Eaten Per Day Time Frame: Baseline up to week 12 Description: Total cups of fruit eaten per day will be assessed using question 1 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of fruit do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of fruit consumed. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Fruit Eaten Per Day Time Frame: Baseline up to week 12 Description: Total cups of vegetables eaten per day will be assessed using question 2 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of vegetables do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of vegetables consumed. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Vegetables Eaten Per Day Time Frame: Baseline up to week 12 Description: Total cups of vegetables eaten per day will be assessed using question 2 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of vegetables do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of vegetables consumed. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Vegetables Eaten Per Day Time Frame: Baseline up to week 12 Description: Frequency of water consumed per day will be assessed using question 3 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink water (count tap, bottled, or sparkling water)?"). Scoring range is from 0-4. A higher score represents a greater frequency of water consumption. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Water Consumed Per Day Time Frame: Baseline up to week 12 Description: Frequency of water consumed per day will be assessed using question 3 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink water (count tap, bottled, or sparkling water)?"). Scoring range is from 0-4. A higher score represents a greater frequency of water consumption. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Water Consumed Per Day Time Frame: Baseline up to week 12 Description: Frequency of soda consumed per day will be assessed using question 4 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink regular (not diet) soda?"). Scoring range is from 0-4. A higher score represents a greater frequency of soda consumption. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Soda Consumed Per Day Time Frame: Baseline up to week 12 Description: Frequency of soda consumed per day will be assessed using question 4 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink regular (not diet) soda?"). Scoring range is from 0-4. A higher score represents a greater frequency of soda consumption. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Soda Consumed Per Day Time Frame: Baseline up to week 12 Description: Usage of 1% milk, skim milk, and/or low-fat yogurt per day will be assessed using question 5 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use 1% milk, skim milk, and/or low-fat yogurt?"). Scoring range is from 0-4. A higher score represents a greater usage of 1% milk, skim milk, and/or low-fat yogurt. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Usage of 1% Milk, Skim Milk, and/or Low-fat Yogurt Per Day Time Frame: Baseline up to week 12 Description: Usage of 1% milk, skim milk, and/or low-fat yogurt per day will be assessed using question 5 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use 1% milk, skim milk, and/or low-fat yogurt?"). Scoring range is from 0-4. A higher score represents a greater usage of 1% milk, skim milk, and/or low-fat yogurt. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Usage of 1% Milk, Skim Milk, and/or Low-fat Yogurt Per Day Time Frame: Baseline up to week 12 Description: Frequency of consumption of greater than 1 kind of fruit per day will be assessed using question 6 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you eat more than one kind of fruit each day (apple, peach, berries, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one fruit per day. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Fruit Per Day Time Frame: Baseline up to week 12 Description: Frequency of consumption of greater than 1 kind of fruit per day will be assessed using question 6 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you eat more than one kind of fruit each day (apple, peach, berries, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one fruit per day. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Fruit Per Day Time Frame: Baseline up to week 12 Description: Frequency of consumption of greater than 1 kind of vegetable per day will be assessed using question 7 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat more than one kind of vegetable each day (carrots, corn, green beans, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one vegetable per day. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Vegetable Per Day Time Frame: Baseline up to week 12 Description: Frequency of consumption of greater than 1 kind of vegetable per day will be assessed using question 7 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat more than one kind of vegetable each day (carrots, corn, green beans, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one vegetable per day. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Vegetable Per Day (Baseline to Week 6) Time Frame: Baseline up to week 12 Description: How often someone considers healthy food choices when deciding what to eat will be assessed using question 8 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("When deciding what to eat, how often do you think about healthy food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency considering healthy food choices when deciding what to eat. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Healthy Food Option Consideration Time Frame: Baseline up to week 12 Description: How often someone considers healthy food choices when deciding what to eat will be assessed using question 8 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("When deciding what to eat, how often do you think about healthy food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency considering healthy food choices when deciding what to eat. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Healthy Food Option Consideration Time Frame: Baseline up to week 12 Description: How often someone uses a "Nutrition Facts" label to when making food choices will be assessed using question 9 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use the "Nutrition Facts" on the food label to make food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the "Nutrition Facts" when making food choices. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Usage of "Nutrition Facts" Label Time Frame: Baseline up to week 12 Description: How often someone uses a "Nutrition Facts" label to when making food choices will be assessed using question 9 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use the "Nutrition Facts" on the food label to make food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the "Nutrition Facts" when making food choices. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Usage of "Nutrition Facts" Label Time Frame: Baseline up to week 12 Description: How often someone uses a food label to select food with less salt or sodium will be assessed using question 10 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less salt or sodium?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less salt or sodium. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Consideration of Food Label (Salt/Sodium) Time Frame: Baseline up to week 12 Description: How often someone uses a food label to select food with less salt or sodium will be assessed using question 10 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less salt or sodium?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less salt or sodium. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Consideration of Food Label (Salt/Sodium) Time Frame: Baseline up to week 12 Description: How often someone uses a food label to select food with less or no added sugar will be assessed using question 11 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less or no added sugar?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less or no added sugar. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Consideration of Food Label (Sugar) Time Frame: Baseline up to week 12 Description: How often someone uses a food label to select food with less or no added sugar will be assessed using question 11 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less or no added sugar?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less or no added sugar. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Consideration of Food Label (Sugar) Time Frame: Baseline up to week 12 Description: How often someone uses a food label to select food with less saturated fat will be assessed using question 12 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less saturated fat?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less saturated fat. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Consideration of Food Label (Fat) Time Frame: Baseline up to week 12 Description: How often someone uses a food label to select food with less saturated fat will be assessed using question 12 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less saturated fat?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less saturated fat. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Consideration of Food Label (Fat) Time Frame: Baseline up to week 12 Description: How often someone consumes whole grain instead of white or enriched flour ones will be assessed using question 13 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat whole grains (whole wheat bread, whole wheat tortillas, brown rice, oatmeal, etc.) in place of white or enriched flour ones?"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming whole grains instead of white or enriched flour ones. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Whole Grain Consumption Time Frame: Baseline up to week 12 Description: How often someone consumes whole grain instead of white or enriched flour ones will be assessed using question 13 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat whole grains (whole wheat bread, whole wheat tortillas, brown rice, oatmeal, etc.) in place of white or enriched flour ones?"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming whole grains instead of white or enriched flour ones. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Whole Grain Consumption Time Frame: Baseline up to week 12 Description: How often someone prepares meals at home will be assessed using question 14 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you prepare meals at home?"). Scoring range is from 0-4. A higher score represents a greater frequency of preparing meals at home. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Meal Preparation Time Frame: Baseline up to week 12 Description: How often someone prepares meals at home will be assessed using question 14 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you prepare meals at home?"). Scoring range is from 0-4. A higher score represents a greater frequency of preparing meals at home. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Meal Preparation Time Frame: Baseline up to week 12 Description: How often someone includes strength training when they exercise will be assessed using question 19 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you include strength training when you exercise?"). Scoring range is from 0-4. A higher score represents a greater frequency of strength training. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Strength Training Time Frame: Baseline up to week 12 Description: How often someone includes strength training when they exercise will be assessed using question 19 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you include strength training when you exercise?"). Scoring range is from 0-4. A higher score represents a greater frequency of strength training. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Strength Training Time Frame: Baseline up to week 12 Description: Participants' amount of physical activity will be assessed using question 20 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How much physical activity (exercise) do you do in a day?"). Scoring is categorical, with the following answer choices: 0-20 minutes; 21-30 minutes; 31-40 minutes; 41-60 minutes; more than 60 minutes. A higher score represents a greater amount of physical activity. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Food Frequency Assessment- Physical Activity Time Frame: Baseline up to week 12 Description: Participants' amount of physical activity will be assessed using question 20 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How much physical activity (exercise) do you do in a day?"). Scoring is categorical, with the following answer choices: 0-20 minutes; 21-30 minutes; 31-40 minutes; 41-60 minutes; more than 60 minutes. A higher score represents a greater amount of physical activity. Assessed at baseline, week 6, and week 12. Measure: Median Change in Food Frequency Assessment- Physical Activity Time Frame: Baseline up to week 12 Description: Distinct social determinant of health risks will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experience (PRAPARE) assessment- a 21-item measure that assesses a participant's various social determinant of health risk responses. Questions include topics such as housing status, work situations, level of education, and others. Scoring range is from 0-22, with a higher score representing a higher amount of risks present. Assessed at baseline, week 6, and week 12. Measure: Mean Change of PRAPARE Score Time Frame: Baseline up to week 12 Description: Distinct social determinant of health risks will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experience (PRAPARE) assessment- a 21-item measure that assesses a participant's various social determinant of health risk responses. Questions include topics such as housing status, work situations, level of education, and others. Scoring range is from 0-22, with a higher score representing a higher amount of risks present. Assessed at baseline, week 6, and week 12. Measure: Median Change of PRAPARE Score Time Frame: Baseline up to week 12 Description: Depressive symptoms will be assessed using the Patient Health Questionnaire-8, an 8-item measure that assesses the number of days a person has experienced various symptoms of depression over the past two weeks. Questions include assessing how often a participant has had little to no interest in doing things, how often they feel down, depressed, irritable, or hopeless, etc. Scoring range is from 0-24. A higher score means greater depressive symptoms. Assessed at baseline, week 6, and week 12. Measure: Mean Change in Patient Health Questionaire-8 Time Frame: Baseline up to week 12 Description: Depressive symptoms will be assessed using the Patient Health Questionnaire-8, an 8-item measure that assesses the number of days a person has experienced various symptoms of depression over the past two weeks. Questions include assessing how often a participant has had little to no interest in doing things, how often they feel down, depressed, irritable, or hopeless, etc. Scoring range is from 0-24. A higher score means greater depressive symptoms. Assessed at baseline, week 6, and week 12. Measure: Median Change in Patient Health Questionaire-8 Time Frame: Baseline up to week 12 Description: Loneliness will be assessed using the University of California- Los Angeles Loneliness Scale Short Form, a 6 item measure that assesses how often participants feel left out or not connected to other people. Scoring range is from 3-9. A higher score means greater loneliness. Assessed at baseline, week 6, and week 12. Measure: Mean Change in sum of University of California- Los Angeles Loneliness Scale Short form Time Frame: Baseline up to week 12 Description: Loneliness will be assessed using the University of California- Los Angeles Loneliness Scale Short Form, a 6 item measure that assesses how often participants feel left out or not connected to other people. Scoring range is from 3-9. A higher score means greater loneliness. Assessed at baseline, week 6, and week 12. Measure: Median Change in sum of University of California- Los Angeles Loneliness Scale Short form Time Frame: Baseline up to week 12 Description: Program feasibility will be assessed using the number of successful HDHM deliveries made to participants during the study. This is defined as the delivery driver being able to deliver the HDHM to the participant's residence. A higher number of successful deliveries indicate greater feasibility. Measure: Number of successful HDHM Deliveries made to participants in control group Time Frame: Baseline up to week 12 Description: Program feasibility will be assessed using the number of successful HDHM deliveries including "friendly visits" made to intervention participant's homes during the study. This is defined as the delivery driver being able to deliver the HDHM to the participant's residence and complete a brief social interaction. A higher number of successful deliveries indicates greater feasibility of the program. Measure: Number of successful HDHM Deliveries and Social Interactions made to participants in intervention group Time Frame: Baseline up to week 12 Description: Program feasibility will be assessed using the number of meals consumed by participants per week. A higher number of meals consumed indicates greater feasibility of the program. Measure: Number of HDHM meals consumed by participants weekly Time Frame: Baseline up to week 12 Description: Program feasibility will be assessed using the duration of Student Companion calls that take place during the study for participants in the intervention group. Duration will be assessed in minutes per week. A higher number of minutes indicates greater feasibility of the program. Measure: Duration of Student Companion Calls Time Frame: Baseline up to week 12 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * 65 and older * Live alone * Screen positive for food insecurity or have a medical professional concerned about their food security * Diagnosed with at least 1 diet-related chronic illness * Be a Medicaid/Medicare dual beneficiary * Speak English * Have a microwave Exclusion Criteria: * Diagnosis of dementia/Alzheimer's * Presence of illness or allergies that would preclude consuming HDHM Minimum Age: 65 Years Sex: ALL Standard Ages: - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: lhaynes6@email.unc.edu Name: Lindsey Haynes-Maslow, PhD, MHA Phone: 910-612-3299 Role: CONTACT #### Overall Officials Official 1: Affiliation: University of North Carolina, Chapel Hill Name: Lindsey Haynes-Maslow, PhD, MHA Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC. Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. IPD Sharing: YES Time Frame: beginning 9 and continuing for 36 months following publication ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415357 Brief Title: Zambia Healthy Choices Project for Emerging Adults Living With HIV Official Title: Adapting mHealth Interventions to Improve Self-management of HIV and Substance Use Among Emerging Adults in Zambia #### Organization Study ID Info ID: STUDY00001496 #### Organization Class: OTHER Full Name: University of Massachusetts, Worcester #### Secondary ID Infos ID: 1R34DA059935 Link: https://reporter.nih.gov/quickSearch/1R34DA059935 Type: NIH ### Status Module #### Completion Date Date: 2026-07-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: RECRUITING #### Primary Completion Date Date: 2026-01-31 Type: ESTIMATED #### Start Date Date: 2024-04-20 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: NIH Name: National Institute on Drug Abuse (NIDA) Class: OTHER Name: University of Zambia #### Lead Sponsor Class: OTHER Name: University of Massachusetts, Worcester #### Responsible Party Investigator Affiliation: University of Massachusetts, Worcester Investigator Full Name: Bo Wang Investigator Title: Professor Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: This project will develop and implement a multi-component intervention using mobile health technology to improve HIV self-management and reduce substance use. Specifically, the investigators will adapt Healthy Choices (HC) to develop mobile HC (mHC) and develop Motivational text messaging (MTM) for Zambian emerging adults living with HIV. ### Conditions Module Conditions: - Pre-Exposure Prophylaxis Keywords: - Pre-Exposure Prophylaxis (PrEP) - HIV Prevention - mHealth ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: FACTORIAL ##### Masking Info Masking: NONE Primary Purpose: PREVENTION #### Enrollment Info Count: 100 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants in this arm will receive standard ART counseling, followed by two mHealth interventions (mHC and MTM) to improve PrEP uptake and adherence. Intervention Names: - Behavioral: Mobile Healthy Choices (mHC) - Behavioral: Motivational Text Messaging (MTM) - Behavioral: Standard ART Counseling Label: Standard ART counseling, mHC, and MTM Type: EXPERIMENTAL #### Arm Group 2 Description: Participants in this arm will receive standard ART counseling, followed by one mHealth intervention (mHC) to improve PrEP uptake and adherence. Intervention Names: - Behavioral: Mobile Healthy Choices (mHC) - Behavioral: Standard ART Counseling Label: Standard ART counseling and mHC Type: EXPERIMENTAL #### Arm Group 3 Description: Participants in this arm will receive standard ART counseling, followed by one mHealth intervention (MTM) to improve PrEP uptake and adherence. Intervention Names: - Behavioral: Motivational Text Messaging (MTM) - Behavioral: Standard ART Counseling Label: Standard ART counseling and MTM Type: EXPERIMENTAL #### Arm Group 4 Description: Participants in this arm will receive standard ART counseling. Intervention Names: - Behavioral: Standard ART Counseling Label: Standard ART counseling Type: ACTIVE_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Standard ART counseling and mHC - Standard ART counseling, mHC, and MTM Description: mHC is a four-session computer-delivered intervention based on the Information-Motivation-Behavioral (IMB) model and socioecological model (SEM). Using motivational interviewing, it tailors content to participants' responses. Sessions 1 and 2 focus on HIV self-management and alcohol reduction, gauging importance, confidence, and goals. Strengths, barriers, resources, and strategies are explored. Sessions 3 and 4 review goals, reinforce importance, confidence, and motivation, and strategize behavior maintenance. Over two months, participants engage in goal-oriented sessions, promoting sustained behavior change. Name: Mobile Healthy Choices (mHC) Type: BEHAVIORAL #### Intervention 2 Arm Group Labels: - Standard ART counseling and MTM - Standard ART counseling, mHC, and MTM Description: Text messages with motivational statements will be sent to participants based on their readiness to change, as assessed during mHC session 1. The statements promoting HIV self-management and alcohol use reduction will be derived from an MTM library written by Zambian young people living with HIV. MTM will be delivered to participants daily for two months and weekly for an additional four months at a time that a participant prefers. Name: Motivational Text Messaging (MTM) Type: BEHAVIORAL #### Intervention 3 Arm Group Labels: - Standard ART counseling - Standard ART counseling and MTM - Standard ART counseling and mHC - Standard ART counseling, mHC, and MTM Description: All participants will receive one-on-one, face-to-face in clinic. Standard ART counseling includes the management and treatment of HIV, reproductive health, substance abuse, and mental health. They will also be counseled about treatment adherence and side-effect management. Name: Standard ART Counseling Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: SUS is a 10-item, 5-point Likert scale for subjective assessment of usability. Each item ranges from 1 to 5. Depending on the item, the score is calculated by subtracting either one from the user response or the user response from 5. Then, the score for each item will be summed and multiplied by 2.5 for the total score. The overall SUS scores range from 0 to 100. A score of \> 50 indicates that the technology-based interventions are acceptable. Measure: Intervention Acceptability: System Usability Score (SUS) Time Frame: Month 3 Description: SUS is a 10-item, 5-point Likert scale for subjective assessment of usability. Each item ranges from 1 to 5. Depending on the item, the score is calculated by subtracting either one from the user response or the user response from 5. Then, the score for each item will be summed and multiplied by 2.5 for the total score. The overall SUS scores range from 0 to 100. A score of \> 50 indicates that the technology-based interventions are acceptable. Measure: Intervention Acceptability: System Usability Score (SUS) Time Frame: Month 6 Description: CSQ-8 is an 8-item, 4-point Likert scale measuring the construct of global intervention satisfaction. The total possible composite score ranges from 8 to 32, with higher scores indicating greater acceptability. Measure: Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8) Time Frame: Month 3 Description: CSQ-8 is an 8-item, 4-point Likert scale measuring the construct of global intervention satisfaction. The total possible composite score ranges from 8 to 32, with higher scores indicating greater acceptability. Measure: Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8) Time Frame: Month 6 Description: Participants will be invited to share their experiences with mHC and MTM, including feedback on acceptability, ease of use, suggestions for improvement, and impact on ART adherence and alcohol use reduction. Measure: Intervention Acceptability: Exit Interview Time Frame: Month 3 Description: Intervention feasibility will be assessed based on participant retention at Month 6. The retention rate can range from 70 to 90%, with a retention rate of over 85% deemed the minimum criterion for feasibility. Measure: Intervention Feasibility: Participant Retention Time Frame: Baseline to Month 6 Description: Intervention feasibility will be evaluated by the total number of responses to MTM. Measure: Intervention Feasibility: Number of Responses to MTM Time Frame: Baseline to Month 6 Description: Intervention feasibility will be evaluated by the number of completed intervention sessions. Measure: Intervention Feasibility: Number of mHC Sessions Completed Time Frame: Baseline to Month 6 Description: ART adherence will be assessed through the Young Adult Adherence Interview via computer-assisted self-interview (CASI) survey, which contains a visual analog scale (VAS) ranging from 0 to 100. Higher percentages on the VAS indicate greater adherence to ART. Measure: ART Adherence: Visual Analog Scale Time Frame: Baseline, Month 3, and Month 6 Description: ART adherence will be evaluated through self-reported adherence over the past four weeks via a CASI survey. Participants will rate their adherence on a scale ranging from 0 to 100%, with higher percentages indicating better adherence to ART. Measure: ART Adherence: Self-Reported Adherence Time Frame: Baseline, Month 3, and Month 6 Description: ART adherence will be evaluated by examining the HIV viral load in DBS. Maintaining a viral load of less than 200 copies/ml will indicate adherence to ART. Measure: ART Adherence: Dried Blood Spot (DBS) Testing Time Frame: Baseline, Month 3, and Month 6 Description: Alcohol use will be assessed using the TLFB interview. Using a calendar, participants will be asked to provide estimates of their daily drinking over the last 30 days, as well as the max number of drinks in a one-week period, the number of heavy drinking days, the number of standard drinks in 30 days, and binge drinking. Measure: Alcohol Use: The Timeline Followback (TLFB) Interview Time Frame: Baseline, Month 3, and Month 6 #### Secondary Outcomes Description: HIV transmission risk awareness will be evaluated through an 18-item HIV Knowledge Questionnaire. Total possible composite scores range from 0 to 18, with higher scores indicating a higher level of HIV knowledge. Measure: Information: HIV Knowledge Time Frame: Baseline, Month 3, and Month 6 Description: ART knowledge will be evaluated through a 21-item HIV Treatment Knowledge Questionnaire. Total possible composite scores range from 0 to 21, with higher scores indicating a higher level of ART knowledge. Measure: Information: ART Knowledge Time Frame: Baseline, Month 3, and Month 6 Description: Intentions to improve HIV self-management and alcohol consumption behaviors will be evaluated using the 5-item Rollnick's Readiness Ruler. Each item ranges from 0 to 10, with higher scores indicating a greater readiness for change. Measure: Motivation: Rollnick's Readiness Ruler Time Frame: Baseline, Month 3, and Month 6 Description: Attitudes toward risk behaviors will be assessed using the 32-item Decisional Balance for Problem Behavior scale. This 5-point Likert scale evaluates the perceived pros and cons of engaging in risk behaviors Measure: Motivation: Decisional Balance for Problem Behavior Time Frame: Baseline, Month 3, and Month 6 Description: Behavioral skills in HIV self-management will be assessed using a 5-item adapted version of the Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. This 5-point Likert scale measures confidence levels (score range: 5-25), with higher scores indicating greater confidence in HIV self-management tasks. Measure: Behavioral Skills: Self-Efficacy Time Frame: Baseline, Month 3, and Month 6 Description: Syphilis testing will employ a treponemal test with rapid plasma reagin (RPR), while gonorrhea and chlamydia testing will utilize pooled urine, oropharyngeal, and rectal swabs. Measure: STI Diagnosis: Number of participants who are diagnosed with syphilis, gonorrhea, or chlamydia Time Frame: Baseline and Month 6 Description: Sexual risk will be assessed using TLFB interview via CASI, capturing sexual behavior over the past 30 days, such as condom usage and the number of sexual partners. Measure: Sexual Risk Time Frame: Baseline, Month 3, and Month 6 Description: Drug use will be assessed with ASSIST, which is a questionnaire to identify substance use health risks and disorders, with each item scored from 0 to 12. The total score ranges up to 24, with higher scores indicating greater risk based on current substance use patterns. Measure: Drug Use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Time Frame: Baseline, Month 3, and Month 6 Description: Alcohol use will be assessed by using AUDIT-C to identify individuals with hazardous drinking habits or alcohol use disorders. Each item scores from 0 to 4, with 0 indicating no alcohol consumption. The total score maxes out at 12, with higher scores suggesting greater risks of harm. Measure: Drug Use: Alcohol Use Disorder Identification Text (AUDIT-C) Time Frame: Baseline, Month 3, and Month 6 Description: Mental health will be evaluated with BSI-18. This 18-item questionnaire utilizes a 5-point Likert scale to gauge psychological distress. Scores range up to 72, with higher scores indicating a higher level of psychological distress. Measure: Mental health: Brief Symptom Inventory (BSI-18) Time Frame: Baseline, Month 3, and Month 6 Description: Social support will be evaluated using the Social Provision Scale. This 5-point Likert scale, 13-item survey assesses the availability of social support, such as emotional, information, and instrumental support, as well as companionship and social isolation. Scores range up to 65, with higher scores indicating more extensive availability of social support. Measure: Social support: Social Provision Scale Time Frame: Baseline, Month 3, and Month 6 Description: HIV-related stigma will be evaluated using the 10-item Berger's Stigma Scale. This scale, based on a 4-point Likert scale, assesses the stigma perceived by people living with HIV. The score can range from 10 to 40, with a higher score indicating greater perceived stigma associated with HIV. Measure: HIV stigma: Shortened Version of Berger's Stigma Scale Time Frame: Baseline, Month 3, and Month 6 ### Eligibility Module Eligibility Criteria: Zambian emerging adults living with HIV Inclusion Criteria: * Aged between 18 and 24 years * Report visual analogue scale showing \<80% medication adherence in the last month AND problematic/risky alcohol use in the last month * Speak English, Nyanja, or Bemba Exclusion Criteria: * Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent * currently enrolled in another HIV intervention study Healthy Volunteers: True Maximum Age: 24 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: josephmumbazulu@gmail.com Name: Joseph Zulu, PhD Phone: +260771514511 Role: CONTACT Contact 2: Email: deogwoon.kim13@umassmed.edu Name: Deogwoon Kim, PhD Role: CONTACT #### Locations Location 1: City: Lusaka Contacts: *Contact 1:* - Email: josephmumbazulu@gmail.com - Name: Joseph Zulu, PhD - Phone: +260771514511 - Role: CONTACT *Contact 2:* - Name: Joseph Zulu, PhD - Role: PRINCIPAL_INVESTIGATOR Country: Zambia Facility: University of Zambia Status: RECRUITING #### Overall Officials Official 1: Affiliation: University of Massachusetts, Worcester Name: Bo Wang, PhD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Access Criteria: Anyone who wises to access the data. Description: All IPD collected during the trial, after deidentification. Info Types: - STUDY_PROTOCOL - SAP - ICF - CSR IPD Sharing: YES Time Frame: Immediately following publication. No end date. ### References Module #### References Citation: Chenneville T, Machacek M, St John Walsh A, Emmanuel P, Rodriguez C. Medication Adherence in 13- to 24-Year-Old Youth Living With HIV. J Assoc Nurses AIDS Care. 2017 May-Jun;28(3):383-394. doi: 10.1016/j.jana.2016.11.002. Epub 2016 Nov 11. PMID: 27931753 Citation: Nabukeera-Barungi N, Elyanu P, Asire B, Katureebe C, Lukabwe I, Namusoke E, Musinguzi J, Atuyambe L, Tumwesigye N. Adherence to antiretroviral therapy and retention in care for adolescents living with HIV from 10 districts in Uganda. BMC Infect Dis. 2015 Nov 14;15:520. doi: 10.1186/s12879-015-1265-5. PMID: 26573923 Citation: St Clair-Sullivan N, Mwamba C, Whetham J, Bolton Moore C, Darking M, Vera J. Barriers to HIV care and adherence for young people living with HIV in Zambia and mHealth. Mhealth. 2019 Sep 30;5:45. doi: 10.21037/mhealth.2019.09.02. eCollection 2019. PMID: 31620472 Citation: Williams EC, Hahn JA, Saitz R, Bryant K, Lira MC, Samet JH. Alcohol Use and Human Immunodeficiency Virus (HIV) Infection: Current Knowledge, Implications, and Future Directions. Alcohol Clin Exp Res. 2016 Oct;40(10):2056-2072. doi: 10.1111/acer.13204. Epub 2016 Sep 22. PMID: 27696523 Citation: Denison JA, Packer C, Stalter RM, Banda H, Mercer S, Nyambe N, Katayamoyo P, Mwansa JK, McCarraher DR. Factors Related to Incomplete Adherence to Antiretroviral Therapy among Adolescents Attending Three HIV Clinics in the Copperbelt, Zambia. AIDS Behav. 2018 Mar;22(3):996-1005. doi: 10.1007/s10461-017-1944-x. PMID: 29103190 Citation: Tarantino N, Lowery A, Brown LK. Adherence to HIV Care and Associated Health Functioning among Youth Living with HIV in Sub-Saharan Africa. AIDS Rev. 2020 Jul 8;22(2):93-102. doi: 10.24875/AIDSRev.20000101. PMID: 32180589 Citation: Scott-Sheldon LA, Carey KB, Cunningham K, Johnson BT, Carey MP; MASH Research Team. Alcohol Use Predicts Sexual Decision-Making: A Systematic Review and Meta-Analysis of the Experimental Literature. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S19-39. doi: 10.1007/s10461-015-1108-9. PMID: 26080689 Citation: Hendershot CS, Stoner SA, Pantalone DW, Simoni JM. Alcohol use and antiretroviral adherence: review and meta-analysis. J Acquir Immune Defic Syndr. 2009 Oct 1;52(2):180-202. doi: 10.1097/QAI.0b013e3181b18b6e. PMID: 19668086 Citation: Mulawa MI, LeGrand S, Hightow-Weidman LB. eHealth to Enhance Treatment Adherence Among Youth Living with HIV. Curr HIV/AIDS Rep. 2018 Aug;15(4):336-349. doi: 10.1007/s11904-018-0407-y. PMID: 29959649 Citation: Doyle AM, Bandason T, Dauya E, McHugh G, Grundy C, Dringus S, Dziva Chikwari C, Ferrand RA. Mobile Phone Access and Implications for Digital Health Interventions Among Adolescents and Young Adults in Zimbabwe: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2021 Jan 13;9(1):e21244. doi: 10.2196/21244. PMID: 33439136 Citation: Ramsey SE, Ames EG, Uber J, Habib S, Clark S, Waldrop D. A Preliminary Test of an mHealth Facilitated Health Coaching Intervention to Improve Medication Adherence among Persons Living with HIV. AIDS Behav. 2021 Nov;25(11):3782-3797. doi: 10.1007/s10461-021-03342-5. Epub 2021 Jun 12. PMID: 34117965 Citation: Cooper V, Clatworthy J, Whetham J, Consortium E. mHealth Interventions To Support Self-Management In HIV: A Systematic Review. Open AIDS J. 2017 Nov 21;11:119-132. doi: 10.2174/1874613601711010119. eCollection 2017. PMID: 29290888 Citation: Hutton A, Prichard I, Whitehead D, Thomas S, Rubin M, Sloand E, Powell TW, Frisch K, Newman P, Goodwin Veenema T. mHealth Interventions to Reduce Alcohol Use in Young People: A Systematic Review of the Literature. Compr Child Adolesc Nurs. 2020 Sep;43(3):171-202. doi: 10.1080/24694193.2019.1616008. Epub 2019 Jun 13. PMID: 31192698 Citation: Garofalo R, Kuhns LM, Hotton A, Johnson A, Muldoon A, Rice D. A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults. AIDS Behav. 2016 May;20(5):1049-59. doi: 10.1007/s10461-015-1192-x. PMID: 26362167 Citation: Suffoletto B, Chung T, Muench F, Monti P, Clark DB. A Text Message Intervention with Adaptive Goal Support to Reduce Alcohol Consumption Among Non-Treatment-Seeking Young Adults: Non-Randomized Clinical Trial with Voluntary Length of Enrollment. JMIR Mhealth Uhealth. 2018 Feb 16;6(2):e35. doi: 10.2196/mhealth.8530. PMID: 29453191 Citation: Horvath KJ, Smolenski D, Amico KR. An empirical test of the information-motivation-behavioral skills model of ART adherence in a sample of HIV-positive persons primarily in out-of-HIV-care settings. AIDS Care. 2014 Feb;26(2):142-51. doi: 10.1080/09540121.2013.802283. Epub 2013 Jun 3. PMID: 23724908 Citation: Amico KR, Barta W, Konkle-Parker DJ, Fisher JD, Cornman DH, Shuper PA, Fisher WA. The information-motivation-behavioral skills model of ART adherence in a Deep South HIV+ clinic sample. AIDS Behav. 2009 Feb;13(1):66-75. doi: 10.1007/s10461-007-9311-y. Epub 2007 Sep 18. PMID: 17876697 Citation: Naar-King S, Outlaw AY, Sarr M, Parsons JT, Belzer M, Macdonell K, Tanney M, Ondersma SJ; Adolescent Medicine Network for HIV/AIDS Interventions. Motivational Enhancement System for Adherence (MESA): pilot randomized trial of a brief computer-delivered prevention intervention for youth initiating antiretroviral treatment. J Pediatr Psychol. 2013 Jul;38(6):638-48. doi: 10.1093/jpepsy/jss132. Epub 2013 Jan 28. PMID: 23359664 Citation: Murphy DA, Chen X, Naar-King S, Parsons JT; Adolescent Trials Network. Alcohol and marijuana use outcomes in the Healthy Choices motivational interviewing intervention for HIV-positive youth. AIDS Patient Care STDS. 2012 Feb;26(2):95-100. doi: 10.1089/apc.2011.0157. Epub 2011 Dec 22. PMID: 22191456 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415344 Brief Title: Long-term Extension of GTX-102 in Angelman Syndrome Official Title: A Long-term Extension Trial Investigating the Safety and Efficacy of GTX-102 in Patients With Angelman Syndrome #### Organization Study ID Info ID: GTX-102-CL302 #### Organization Class: INDUSTRY Full Name: Ultragenyx Pharmaceutical Inc #### Secondary ID Infos ID: 2024-510917-14-00 Type: CTIS ### Status Module #### Completion Date Date: 2029-02 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2029-02 Type: ESTIMATED #### Start Date Date: 2024-08 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Ultragenyx Pharmaceutical Inc #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Oversight Has DMC: True ### Description Module Brief Summary: The primary objective of the study is to evaluate the long-term safety profile of GTX-102 in participants with Angelman Syndrome (AS) Detailed Description: This is a Phase 3 long term extension (LTE) study to evaluate the safety and efficacy of GTX-102 in participants with AS. Participants may remain in the study until GTX-102 is approved and/or becomes available in their geographical region or the sponsor stops the study. ### Conditions Module Conditions: - Angelman Syndrome ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 75 Type: ESTIMATED Phases: - PHASE3 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Participants will receive GTX-102 via intrathecal lumbar puncture (IT LP) on a intrapatient flexible dosing schedule. Intervention Names: - Drug: GTX-102 Label: GTX-102 Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - GTX-102 Description: Antisense Oligonucleotide Name: GTX-102 Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: Frequency, Severity, and Relationship to Investigational Drug of Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Time Frame: 5 Years #### Secondary Outcomes Measure: Change from LTE Month 0 and Pretreatment in the Bayley-4 Raw Score Time Frame: Month 0, 5 Years ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Signed informed consent from parent(s) or legal guardian(s). * Prior participation in a clinical trial with GTX-102; the timing for the roll-over into this study from a prior GTX-102 study is based on the Investigator and Ultragenyx Medical Monitor's approval. * From the time of informed consent through the end of the study and for at least 6 months after the final dose of GTX-102, females of childbearing potential who are sexually active must use highly effective contraception or abstinence. Males are able to participate if they agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the study and for at least 3 months after the final dose of GTX-102. Exclusion Criteria: * Known hypersensitivity to GTX-102 or its excipients that, in the judgment of the Investigator, places the subject at increased risk for adverse effects. * Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: trialrecruitment@ultragenyx.com Name: Patients Contact: Trial Recruitment Phone: 1-888-756-8657 Role: CONTACT Contact 2: Email: medinfo@ultragenyx.com Name: HCPs Contact: Medical Information Phone: 1-888-756-8657 Role: CONTACT #### Locations Location 1: City: Los Angeles Country: United States Facility: University of California, Los Angeles (UCLA) State: California Zip: 90095 Location 2: City: San Diego Country: United States Facility: University of California, San Diego - Rady Children's Hospital State: California Zip: 92123 Location 3: City: Atlanta Country: United States Facility: Rare Disease Research, LLC State: Georgia Zip: 30329 Location 4: City: Chicago Country: United States Facility: Rush University Medical Center State: Illinois Zip: 60612 Location 5: City: Boston Country: United States Facility: Boston Children's Hospital State: Massachusetts Zip: 02115 Location 6: City: New York Country: United States Facility: Weill Cornell Medicine State: New York Zip: 10021 Location 7: City: South Brisbane Country: Australia Facility: Queensland Children's Hospital State: Queensland Zip: 4101 Location 8: City: Heidelberg Country: Australia Facility: Austin Health State: Victoria Zip: 3084 Location 9: City: Melbourne Country: Australia Facility: The Royal Children's Hospital State: Victoria Zip: 3052 Location 10: City: Calgary Country: Canada Facility: MAGIC Clinic Ltd State: Alberta Zip: T2E 7Z4 Location 11: City: Vancouver Country: Canada Facility: British Columbia Children's Hospital State: British Columbia Zip: V6H 3V4 Location 12: City: London Country: Canada Facility: Childrens Hospital London Health Sciences Centre State: Ontario Zip: N6A 5W9 Location 13: City: Ottawa Country: Canada Facility: Childrens Hospital of Eastern Ontario State: Ontario Zip: K1H 8L1 Location 14: City: Montreal Country: Canada Facility: The Research Institute of the McGill University Health Centre State: Quebec Zip: H3G 1A4 Location 15: City: Marseille Country: France Facility: AP-HM - Hopital de la Timone Zip: 13385 Location 16: City: Paris Country: France Facility: AP-HP Hopital Necker-Enfants Malades Zip: 75015 Location 17: City: Hamburg Country: Germany Facility: Universitaetsklinikum Hamburg-Eppendorf Zip: 20246 Location 18: City: Leipzig Country: Germany Facility: Universitaetsklinikum Leipzig Zip: 04103 Location 19: City: Tel HaShomer Country: Israel Facility: Sheba Medical Center Zip: 5265601 Location 20: City: Majadahonda Country: Spain Facility: Hospital Universitario Puerta de Hierro Zip: 28222 Location 21: City: Sabadell Country: Spain Facility: Corporacio Sanitaria Parc Tauli - Hospital de Sabadell Zip: 08208 Location 22: City: Cambridge Country: United Kingdom Facility: University of Cambridge Zip: CB2 0QQ Location 23: City: London Country: United Kingdom Facility: Great Ormond Street Hospital for Children Zip: WC1N 3JH Location 24: City: Oxford Country: United Kingdom Facility: Oxford University Hospitals NHS Foundation Trust Zip: OX3 9DU #### Overall Officials Official 1: Affiliation: Ultragenyx Pharmaceuticals Inc. Name: Medical Director Role: STUDY_DIRECTOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000009069 - Term: Movement Disorders - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000000015 - Term: Abnormalities, Multiple - ID: D000000013 - Term: Congenital Abnormalities - ID: D000025063 - Term: Chromosome Disorders - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000096803 - Term: Imprinting Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: 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: M19508 - Name: Angelman Syndrome - Relevance: HIGH - As Found: Angelman Syndrome - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M14 - Name: Abnormalities, Multiple - Relevance: LOW - As Found: Unknown - ID: M23023 - Name: Chromosome Disorders - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T389 - Name: Angelman Syndrome - Relevance: HIGH - As Found: Angelman Syndrome ### Condition Browse Module - Meshes - ID: D000017204 - Term: Angelman Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415331 Brief Title: Effectiveness of Conventional Therapy Plus Pulsed-Radiofrequency for Herniated Nucleus Pulposus Official Title: Comparison of The Effectiveness Between Conventional Therapy and Conventional Therapy Plus Pulsed-Radiofrequency in Herniated Nucleus Pulposus Patients at Dr. Saiful Anwar Hospital, Malang #### Organization Study ID Info ID: RSSA-00124 #### Organization Class: OTHER Full Name: Dr. Syaiful Anwar Hospital, Malang ### Status Module #### Completion Date Date: 2023-09-16 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-07-14 Type: ACTUAL #### Start Date Date: 2023-02-02 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Dr. Syaiful Anwar Hospital, Malang #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: The purpose of this research was to study whether the additional application of a certain medical intervention making use of radiofrequencies (pulsed-radiofrequency) would reduce pain in patients with herniated disk. Detailed Description: Pain is an uncomfortable sensory and emotional experience that can affect quality of life. Low back pain (LBP) is one of the most common causes of pain, with herniated nucleus pulposus (HNP) being a common etiology. Pulsed radiofrequency (PRF) is a relatively novel technique that has shown promising results in many applications, including spinal pain conditions. This quasi-experimental study aimed to compare pain levels between patients who underwent conventional therapy (CT) alone and CT plus PRF as management in patients with HNP. Pain severity was measured in the numeric rating scale before and 1 month after treatment. ### Conditions Module Conditions: - Herniated Nucleus Pulposus - Pain ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 60 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Subjects in this arm received interventions which were conventional, including opioid and non-opioid analgesics, adjuvant analgesics, muscle relaxants, and physiotherapy. Intervention Names: - Other: Conventional therapy Label: Conventional therapy Type: ACTIVE_COMPARATOR #### Arm Group 2 Description: Subjects in this arm received pulsed radiofrequency in addition to the same conventional therapy as the other arm. Intervention Names: - Procedure: Pulsed radiofrequency - Other: Conventional therapy Label: Conventional therapy + pulsed radiofrequency Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Conventional therapy + pulsed radiofrequency Description: Individualized dose of pulsed radiofrequency is given for 6 minutes. Name: Pulsed radiofrequency Type: PROCEDURE #### Intervention 2 Arm Group Labels: - Conventional therapy - Conventional therapy + pulsed radiofrequency Description: Conventional therapy for HNP consisting of: * Acetaminophen * NSAID: Etoricoxib, celecoxib, meloxicam, diclofenac, ibuprofen * Muscle relaxant: eperisone, diazepam * Opioid: codein, tramadol * Adjuvant analgesics: Amitriptyline, pregabalin, gabapentin * Physiotherapy: Short wave diathermy, ultrasound diathermy, transcutaneous electrical nerve stimulation, and exercise Name: Conventional therapy Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Pain severity measured with the numeric rating scale (NRS). The numeric rating scale measures pain on a scale of 0-10 with 0 representing "no pain" and 10 representing "the worst pain possible". Measure: Pain severity Time Frame: 1 month after treatment ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Having an established diagnosis of HNP * Complaint present for at least the pas 3 months * Experiencing pain intensity of 4 or greater on the numeric rating scale * Capable of giving informed consent Exclusion Criteria: * Pregnant patients * Presence of infection at the site of pulsed radiofrequency * HNP with red flags. Maximum Age: 80 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Malang Country: Indonesia Facility: Dr. Saiful Anwar Hospital State: East Java Zip: 65112 #### Overall Officials Official 1: Affiliation: Faculty of Medicine, Universitas Brawijaya, Malang, Indonesia Name: Hana H Fachir, M.D. Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: AnEm - Name: Antiemetics - Abbrev: MuRelCen - Name: Muscle Relaxants, Central - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: AnTuAg - Name: Antitussive Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M2340 - Name: Acetaminophen - Relevance: LOW - As Found: Unknown - ID: M10102 - Name: Ibuprofen - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M476 - Name: Pregabalin - Relevance: LOW - As Found: Unknown - ID: M3977 - Name: Amitriptyline - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M1869 - Name: Etoricoxib - Relevance: LOW - As Found: Unknown - ID: M16901 - Name: Tramadol - Relevance: LOW - As Found: Unknown - ID: M7197 - Name: Diclofenac - Relevance: LOW - As Found: Unknown - ID: M277 - Name: Celecoxib - Relevance: LOW - As Found: Unknown - ID: M1694 - Name: Gabapentin - Relevance: LOW - As Found: Unknown - ID: M1713 - Name: Meloxicam - Relevance: LOW - As Found: Unknown - ID: M7167 - Name: Diazepam - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M6290 - Name: Codeine - Relevance: LOW - As Found: Unknown - ID: M208150 - Name: Eperisone - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415318 Brief Title: TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer Official Title: A Single-center, Single-arm Clinical Study of TIP(Paclitaxel + Ifosfamide + Cisplatin) Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer #### Organization Study ID Info ID: B2024-043-01 #### Organization Class: OTHER Full Name: Sun Yat-sen University ### Status Module #### Completion Date Date: 2027-12-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2027-06-01 Type: ESTIMATED #### Start Date Date: 2024-06-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Sun Yat-sen University #### Responsible Party Investigator Affiliation: Sun Yat-sen University Investigator Full Name: ZHOU FANGJIAN Investigator Title: Director Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: Primary Objective: To evaluate the efficacy and safety of TIP (paclitaxel + ifosfamide + cisplatin) combined with Toripalimab as a neoadjuvant treatment in locally advanced penile cancer Detailed Description: Penile cancer is a rare malignant tumor, which often occurs in the inner plate of the prepuce and glans. Squamous cell carcinoma is the most common pathological type. Lymph node metastasis is a crucial factor that leads to poor prognosis of penile cancer. The 5-year OS of penile cancer patients without lymph node metastasis is 90%. Still, it goes down sharply in patients with inguinal lymph node metastasis and pelvic lymph node metastasis, which is 50% and 0%, respectively. Using neoadjuvant chemotherapy to treat patients with locally advanced penile cancer (T4, any N stage, or any T stage, N3) may improve their prognosis. TIP (Paclitaxel + Ifosfamide + Cisplatin) regimen is the first-line neoadjuvant treatment recommended by NCCN guidelines. PD-1 is an immune checkpoint molecule on the surface of T cells. In recent years, immune checkpoint inhibitors targeting PD-1 have shown good efficacy in a variety of tumors. Some phase II / III clinical trials have shown that PD-1 inhibitors can improve the prognosis of patients with lung squamous cell carcinoma, head and neck squamous cell carcinoma, and cervical cancer. Previous studies have found that PD-L1 is highly expressed in 40% - 60% of penile cancer, suggesting that penile cancer patients may benefit from immunotherapy. The management of penile cancer with lymph node metastasis is difficult, especially for the N2-3 stage. This phase II study aims to explore an effective combination therapy for locally advanced penile cancer. 25 patients need to be enrolled.TIP \& toripalimab will be administered every 21 days until surgery, evidence of disease progression, or onset of unacceptable toxicity. ### Conditions Module Conditions: - Penile Cancer ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 25 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Drug: Toripalimab 240mg, ivgtt, d1 Drug: Paclitaxel 175 mg/m2, ivgtt, d1 Drug: Cisplatin 25mg/m2·d, ivgtt, d1-3 Drug: Ifosfamide 1.2g/m2·d, ivgtt, d1-3 Intervention Names: - Drug: Paclitaxel + Ifosfamide + Cisplatin & Toripalimab Label: Experimental: Neoadjuvant Therapy TIP (Paclitaxel + Ifosfamide + Cisplatin) & Toripalimab Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Experimental: Neoadjuvant Therapy TIP (Paclitaxel + Ifosfamide + Cisplatin) & Toripalimab Description: Paclitaxel + Ifosfamide + Cisplatin \& Toripalimab Name: Paclitaxel + Ifosfamide + Cisplatin & Toripalimab Type: DRUG ### Outcomes Module #### Primary Outcomes Description: Objective Response Rate (ORR) based on RECIST 1.1 criteria. Measure: ORR Time Frame: 6 weeks #### Secondary Outcomes Description: Percentage of Participants With Pathologically Complete Response Measure: pCR Time Frame: 12 weeks Description: Event-free survival, EFS Measure: EFS Time Frame: 2 months Description: Overall Survival Measure: OS Time Frame: 6 months Description: Number of participants with treatment-related adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Measure: Adverse events Time Frame: 2 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Squamous cell carcinoma confirmed by histology or cytology; 2. Clinical Stage is Locally advanced penile cancer (T4, any N stage; or any T stage, N3); 3. No prior chemotherapy for newly diagnosed or relapsed patients or the time from the last chemotherapy to relapse should be longer than 12 months; 4. There is at least one measurable lesion according to the solid tumor efficacy evaluation standard RECIST1.1; 5. the Eastern Cooperative Oncology Group (ECOG) scored 0-2; 6. Blood marrow function: Hemoglobin(Hb) \>/= 80g/L; White blood cell count \>/= 3.0x10\^9/L; Neutrophil count \>/= 1.5x10\^9/L; Platelet count \>/ = 100x10\^9/L; 7. Liver function: AST, ALT, ALP \</= 2.5 ULN; Total bilirubin \</= 1.5 ULN; 8. Estimated survival \>/= 12 months; 9. No prior serious disease history of a systemic organ; 10. The participant understands this study procedure and signs the informed consent. Exclusion Criteria: 1. Peripheral neuropathy degree \>/=2 (affecting patient's function); 2. Previously received any other experimental drug treatment within 4 weeks before enrollment; 3. Patients with other cancer at present, or have other malignant tumor histories within the past 5 years. Except for (1) Cured skin non-malignant melanoma; (2) Curable tumor, including low-risk prostate cancer (T1a, Gleason score\<6, PSA\<0.5ng/ml), superficial bladder cancer and so on; (3) Other solid tumors have received radical treatment, and no recurrence or metastasis has been found at least 5 years; 4. Other serious or poorly controlled concomitant diseases, including but not limited to (1) Severe or acute attack disease history of cardiovascular, liver, respiratory, kidney, blood, endocrine or neuropsychiatric system within 6 months; (2) Active infection history and needed antibiotic treatment within 2 weeks before enrollment; (3) Congestive heart failure (grade III-IV); (4) Unstable angina pectoris or myocardial infarction history within 6 months Maximum Age: 75 Years Minimum Age: 18 Years Sex: MALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: hanhui@sysucc.org.cn Name: Hui Han Phone: 13002018798 Phone Ext: +86 Role: CONTACT Contact 2: Email: xueting1@sysucc.org.cn Name: Ting Xue Phone: 18243057370 Phone Ext: +86 Role: CONTACT ## 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: D000010409 - Term: Penile 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13323 - Name: Penile Neoplasms - Relevance: HIGH - As Found: Penile Cancer - 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: M13320 - Name: Penile Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T4483 - Name: Penile Cancer - Relevance: HIGH - As Found: Penile Cancer ### Condition Browse Module - Meshes - ID: D000010412 - Term: Penile 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: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M10117 - Name: Ifosfamide - Relevance: HIGH - As Found: Rich - ID: M230811 - Name: Isophosphamide mustard - 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: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000007069 - Term: Ifosfamide ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415305 Brief Title: A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne Official Title: The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne #### Organization Study ID Info ID: WINSCO - 2023 #### Organization Class: INDUSTRY Full Name: Sun Pharmaceutical Industries Limited ### Status Module #### Completion Date Date: 2024-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2024-12 Type: ESTIMATED #### Start Date Date: 2023-09-01 Type: ACTUAL Status Verified Date: 2024-02 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Sun Pharmaceutical Industries Limited #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Is US Export: False Oversight Has DMC: False ### Description Module Brief Summary: Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation. Data is limited for skin of color patients in Phase III registration trials. Data is limited because there a few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data. ### Conditions Module Conditions: - Acne Vulgaris ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 10 Type: ESTIMATED Phases: - PHASE4 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: Winlevi (clascoterone) 1% cream Label: Winlevi (clascoterone) 1% cream Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Winlevi (clascoterone) 1% cream Description: Dosed twice daily (BID) Name: Winlevi (clascoterone) 1% cream Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16. Time Frame: Week 16 #### Secondary Outcomes Measure: Percent of total lesion reduction at week 16 compared to baseline Time Frame: Week 16 Measure: Percent of inflammatory lesion reduction at week 16 compared to baseline Time Frame: Week 16 Measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline Time Frame: Week 16 Description: The score in the scale ranges from 0-4. Lower score represents absence of erythema and higher score represents severe condition. Measure: Tolerability measures of erythema based on 5-point severity scale Time Frame: Week 52 Description: The score in the scale ranges from 0-4. Lower score represents absence of dryness and higher score represents severe condition. Measure: Tolerability measures of dryness based on 5-point severity scale Time Frame: Week 52 Description: The score in the scale ranges from 0-4. Score 0 represents absence of peeling and Score 4 represents 'Extensive peeling'. Measure: Tolerability measures of peeling based on 5-point severity scale Time Frame: Week 52 Description: The score in the scale ranges from 0-4. Score 0 represents absence of Oiliness and Score 4 represents severe condition. Measure: Assessment of skin oiliness based on 5-point severity scale Time Frame: Week 52 Description: The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. Measure: Tolerability measures of pruritus based on 6-point severity scale Time Frame: Week 52 Description: The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. Measure: Tolerability measures of burning/stinging based on 6-point severity scale Time Frame: Week 52 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: i. Outpatient, male or female subjects of any race (Fitzpatrick skin types IV, V, VI), and at least 12 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study: A female is considered of childbearing potential unless she is: * postmenopausal for at least 12 months prior to study drug administration; * without a uterus and/or both ovaries; or * has been surgically sterile for at least 6 months prior to study drug administration. Reliable methods of contraception are: * hormonal methods or intrauterine device in use \> 90 days prior to study drug administration; * barrier methods plus spermicide in use at least 14 days prior to study drug administration; or * vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice) \[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.\] ii. Facial acne IGA score of 3 or 4. iii. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian. Exclusion Criteria: i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control. ii. Allergy or sensitivity to any component of the test medications (Section 5.2). iii. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I). iv. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study. v. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse. vii. History of poor cooperation, non-compliance with medical treatment, or unreliability. viii. Exposure to an investigational drug study within 30 days of the Baseline Visit. Minimum Age: 12 Years Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Louisville Country: United States Facility: Skin Sciences, PLLC State: Kentucky Zip: 40217 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017486 - Term: Acneiform Eruptions - ID: D000012871 - Term: Skin Diseases - ID: D000012625 - Term: Sebaceous Gland Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3512 - Name: Acne Vulgaris - Relevance: HIGH - As Found: Acne Vulgaris - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M19751 - Name: Acneiform Eruptions - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15439 - Name: Sebaceous Gland Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000152 - Term: Acne Vulgaris ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415292 Brief Title: A Study to Evaluate the Impact of Clacoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients Official Title: A Clinical Study to Assess the Barrier Impact of Winlevi #### Organization Study ID Info ID: DCS-94-23 #### Organization Class: INDUSTRY Full Name: Sun Pharmaceutical Industries Limited ### Status Module #### Completion Date Date: 2023-12-16 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-12-16 Type: ACTUAL #### Start Date Date: 2023-11-27 Type: ACTUAL Status Verified Date: 2024-02 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Sun Pharmaceutical Industries Limited #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Is US Export: False Oversight Has DMC: False ### Description Module Brief Summary: Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance. Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications, however, dryness is an unwanted side effect. A new acne medication, 1% clascoterone, has been placed in a novel vehicle for excellent drug delivery in combination with excellent barrier properties. The barrier properties of 1% clascoterone have never been demonstrated. This study is aimed at better understanding the positive barrier effects of 1% clascoterone. ### Conditions Module Conditions: - Acne Vulgaris ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 50 Type: ACTUAL Phases: - PHASE4 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: Winlevi (clascoterone) 1% cream Label: Winlevi (clascoterone) 1% treated Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Winlevi (clascoterone) 1% treated Description: Split face. Blinded study treatment product to be applied to the randomized half face Name: Winlevi (clascoterone) 1% cream Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: The primary endpoint is the change in corneometry reading between the two sides of the face treated with Winlevi versus no treatment. Time Frame: Week 2 #### Secondary Outcomes Measure: The secondary endpoint is the change in TEWL reading between the two sides of the face treated with Winlevi versus no treatment Time Frame: Week 2 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Subjects who self identify as having sensitive acne prone skin. 2. Female or male subjects 18+ years of age. 3. Subjects with Fitzpatrick skin types I-VI. 4. Subject agrees not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, powder) or skin care products during the study. 5. Subjects must be willing to use only a cleanser and sunscreen on the entire face and no other skin care products. 6. Subjects must be willing to use the Winlevi study product to designated half face. No other topical acne treatment products on the entire face for the 2 week duration of the study. 7. Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects." 8. Subject is dependable and able to follow directions and is willing to comply with the schedule of visits. 9. Subject is in generally good physical and mental health. Exclusion Criteria: 1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the conditions associated with sensitive skin. 2. Subjects who are not willing to use only the assigned study product and nothing else one randomized half face, except for cleanser and sunscreen that must remain unchanged during the study. Moisturizers or topical acne treatment products should not be used during the 2 week study period on either side of the face. 3. Subjects who do not agree to refrain from direct sun exposure during the study duration. 4. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. 5. Subjects, who are pregnant, breast feeding, or planning a pregnancy. 6. Subjects with clinically significant unstable medical disorders. 7. Subjects who are unwilling or unable to comply with the requirements of the protocol. 8. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. 9. Subjects who are currently participating in any other clinical study. 10. Subjects with any planned surgeries and/or invasive medical procedures during the course of the study. 11. Subjects who currently or frequently use high doses of anti-inflammatory drugs for a defined medication condition. Aspirin use should not exceed 2 tablets (650 mg) per day. 12. Subjects currently receiving any anticancer, immunosuppressive treatments/ medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by the initial paperwork. 13. Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara) and/or radiation as determined by study documentation. Healthy Volunteers: True Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: High Point Country: United States Facility: Dermatology Consulting Services, PLLC State: North Carolina Zip: 27262 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017486 - Term: Acneiform Eruptions - ID: D000012871 - Term: Skin Diseases - ID: D000012625 - Term: Sebaceous Gland Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3512 - Name: Acne Vulgaris - Relevance: HIGH - As Found: Acne Vulgaris - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M19751 - Name: Acneiform Eruptions - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15439 - Name: Sebaceous Gland Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000152 - Term: Acne Vulgaris ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415279 Brief Title: A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients Official Title: Clinical Evaluation of the Sebum Reduction Induced by Clascoterone Cream 1% #### Organization Study ID Info ID: DCS-67-22 #### Organization Class: INDUSTRY Full Name: Sun Pharmaceutical Industries Limited ### Status Module #### Completion Date Date: 2025-04 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: ACTIVE_NOT_RECRUITING #### Primary Completion Date Date: 2025-02 Type: ESTIMATED #### Start Date Date: 2024-02-29 Type: ACTUAL Status Verified Date: 2024-02 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Sun Pharmaceutical Industries Limited #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: True Is US Export: False Oversight Has DMC: False ### Description Module Brief Summary: The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c. acnes. If no sebum is present, there is no nutritional source for the c. acnes, the bacteria die, and acne resolves. A newly FDA approved acne medication consisting of clascoterone cream 1% is believed to effectively treat acne due to a decrease in sebum production. This mechanism of action has been postulated based on efficacy observed in the phase III trials that lead to its approval. This research aims to demonstrate the effect of clascoterone cream 1% in sebum reduction. ### Conditions Module Conditions: - Acne Vulgaris ### Design Module #### Design Info Allocation: NA Intervention Model: SINGLE_GROUP ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 40 Type: ESTIMATED Phases: - PHASE4 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: Winlevi (clascoterone) 1% cream Label: Winlevi (clascoterone) 1% cream Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Winlevi (clascoterone) 1% cream Description: Twice daily (BID) dosing Name: Winlevi (clascoterone) 1% cream Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: The primary efficacy endpoint is the reduction in causal sebum measurements from the forehead obtained with a sebumeter during the study. Time Frame: Weeks 16 #### Secondary Outcomes Measure: The secondary efficacy endpoint is the changes in the facial microbiome induced by 8, 12, and 52 weeks of clascoterone 1% cream application. Time Frame: Weeks 52 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Males and females 12+ years of age. 2. Subjects with mild to moderate acne. 3. Subjects must possess 10-100 total non-inflammatory lesions (open comedones and closed comedones), 10-50 total inflammatory lesions, no cysts, and up to 2 nodules (if deemed appropriate by the PI) on the face. 4. Subjects with all Fitzpatrick skin types I-VI. 5. Subjects who agree to use only the study products for acne treatment. No other medicated cleansers or moisturizers or acne treatments of any kind are allowed. 6. Subjects agree not to introduce any new colored cosmetics or skin care products while participating in the study (lipsticks, eye shadows, facial foundations, blush, powder, cleansers, moisturizers). 7. Subjects agree to arrive at all visits with a clean face, having washed his/her face and removed all facial and eye makeup products within 2 hours to 4 hours prior to the visit and is not to use/apply any topical facial product(s) until the visit is completed. 8. No known medical conditions that, in the investigator's opinion, may interfere with study participation. 9. Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide) and abstinence. 10. Subjects are dependable and able to follow directions and willing to comply with the schedule of visits. 11. Subjects in generally good physical and mental health. 12. Able to read, write, speak, and understand English 13. Individual (and/or his/her legally acceptable representative, as applicable) has signed the Consent for Photograph Release and ICD (and/or Assent Document, as applicable) including Health Insurance Portability and Accountability Act (HIPAA) disclosure. 14. Subject must avoid sun exposure, or use sunscreen if sun exposure is unavoidable. 15. Subject must avoid professional or facial spa procedures during the study. Exclusion Criteria: 1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the study condition of acne. 2. Subjects who are not willing to use the assigned study product to their face as instructed. 3. Subjects who have acne nodules/cysts representative of severe acne. 4. Subjects who are currently using, planning to use during the study or has used any of the following in the specified time range (based on subject report): * 1 month prior to Visit 1: Prescription (oral or topically applied on the face) antibiotics, inhaled steroids (except those prescribed for allergies), or hormones (pre- or post-menopausal hormone-replacement therapy; insulin, etc.), or other medications that could make skin more sensitive or have an effect on the skin, as determined by the PI or designee. Oral contraceptives are acceptable. * 1 month prior to Visit 1: Prescription medication for acne (e.g. doxycycline, minocycline, clindamycin, sulfamethoxazole and trimethoprim \[Bactrim\], tetracycline, erythromycin, azithromycin, or Vibramycin®) * 1 month prior to Visit 1: Topical prescription retinoids (e.g. Retin-A®, Retin-A Micro®, Renova®, Adapalene, Tazarotene, Avita®, Tazorac®, Avage®, Differin®), azelaic acid, benzoyl peroxide, dapsone, sodium sulfacetamide, Epiduo®, or other similar prescription drug on the face * 6 months prior to Visit 1: Accutane or other oral retinoid * 2 weeks prior to Visit 1: Any of the following on the face: * Light therapy * OTC topical medications/products (including antiacne or antibacterial agents, topical anti-inflammatories, topical retinoids, etc.). Sunscreens (SPF) are acceptable. 5. Females who are pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion. (Subject must document her response in either the source documentation or informed consent/assent forms). 6. Subject has a surgery and/or invasive medical procedure planned during the study. 7. Subject has observable suntan, scars, nevi, tattoo, excessive hair (including beard, mustache, or goatee), or other dermal conditions on the face that that could interfere with study evaluations or confound study results, as determined by the PI or designee. 8. Subject is taking medications that would mask an adverse event (AE) or influence the study results, including: * Immunosuppressive drugs and steroidal and/or non-steroidal anti-inflammatory drugs within 3 months before Visit 1 and during the study. * Regular use of antihistamines within 1 month before Visit 1 and during the study. 9. Subject has a history of or a concurrent health condition/situation, which in the opinion of the PI, if medically qualified, or Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study. 10. Subject is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor. 11. Subjects with clinically significant unstable medical disorders. 12. Subjects who are unwilling or unable to comply with the requirements of the protocol. 13. Subjects with any known allergies or sensitivities to the study acne products. 14. Subjects who are currently under the care of a dermatologist for acne. 15. Subjects who are currently experiencing an acne flare. 16. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. 17. Subjects having started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to the study entry or who plan on starting, stopping or changing doses of HRT or hormones for birth control during the study. Minimum Age: 12 Years Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: High Point Country: United States Facility: Dermatology Consulting Services, PLLC State: North Carolina Zip: 27262 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017486 - Term: Acneiform Eruptions - ID: D000012871 - Term: Skin Diseases - ID: D000012625 - Term: Sebaceous Gland Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3512 - Name: Acne Vulgaris - Relevance: HIGH - As Found: Acne Vulgaris - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M19751 - Name: Acneiform Eruptions - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15439 - Name: Sebaceous Gland Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000152 - Term: Acne Vulgaris ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415266 Acronym: VENUS Brief Title: Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request Official Title: Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request #### Organization Study ID Info ID: PROICM 2023-07 VEN #### Organization Class: OTHER Full Name: Institut du Cancer de Montpellier - Val d'Aurelle #### Secondary ID Infos Domain: IDRCB ID: 2023-A02474-41 Type: OTHER ### Status Module #### Completion Date Date: 2028-05 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-22 Type: ACTUAL Last Update Submit Date: 2024-05-21 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2027-05 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-17 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Institut du Cancer de Montpellier - Val d'Aurelle #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. The aim is to improve the quality of sexual life of these patients. Detailed Description: Breast cancer and its treatment are responsible for symptoms that can persist over time and affect quality of life. Given the improved prognosis for breast cancer, more and more patients are faced with the specific problems of the post-cancer period, and caring for them has become a major health issue. Sexual health is a crucial component of well-being and overall quality of life. The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. For that, quality of life questionnaires will be completed by patients at inclusion and every 6 months for 2 years. ### Conditions Module Conditions: - Breast Cancer Keywords: - quality of sexual life ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: NONE Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 264 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Repeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified. Intervention Names: - Other: Quality of life questionnaire (QLQ) - Other: Satisfaction survey - Other: Assessment of patient needs in the field of oncosexology Label: Patients receiving oncoSexology supportive care on proactive Type: EXPERIMENTAL #### Arm Group 2 Description: One-off distribution of a flyer to the patient containing both general information on sexual health and contact telephone numbers and e-mail addresses for oncosexology help Intervention Names: - Other: Quality of life questionnaire (QLQ) - Other: Satisfaction survey Label: Patients receiving oncoSexology supportive care on request Type: OTHER ### Interventions #### Intervention 1 Arm Group Labels: - Patients receiving oncoSexology supportive care on proactive - Patients receiving oncoSexology supportive care on request Description: Quality of life questionnaire : EORTC QLQ-C30, EORTC QLQ-Breast cancer module (BR) 23, EORTC SHQ-C22 et HADS at inclusion, visit 1 (6 months +/-1 month before the inclusion), visit 2 (12 months +/-1 month before the inclusion), visit 3 (18 months +/-1 month before the inclusion) and visit 4 (24 months +/-1 month before the inclusion). Name: Quality of life questionnaire (QLQ) Type: OTHER #### Intervention 2 Arm Group Labels: - Patients receiving oncoSexology supportive care on proactive - Patients receiving oncoSexology supportive care on request Description: The satisfaction score will be collected using a visual analog scale from 0 to 10 and the satisfaction questionnaire will also be completed at visit 4 (24 months +/- 1 month before the inclusion). Name: Satisfaction survey Type: OTHER #### Intervention 3 Arm Group Labels: - Patients receiving oncoSexology supportive care on proactive Description: Assessment of patient needs in the field of oncosexology during a face-to-face or virtual interview at inclusion and every 6 months for 2 years. If a need is identified, an oncosexology consultation will be organised. Following this, a personalised care plan may be proposed. Name: Assessment of patient needs in the field of oncosexology Type: OTHER ### Outcomes Module #### Primary Outcomes Description: EORTC Sexual Health Questionnaire (SHQ)-C22 specific questionnaire sexual satisfaction scale score. Questionnaire comprising 2 multi-item scales assessing sexual satisfaction and dyspareunia; as well as 11 single items (including: importance of sexual activity, libido, incontinence, fatigue, impact of treatment on sexual life, communication with professionals, partner); as well as 4 items related to gender: 2 specific items for women (body image, vaginal dryness); 2 specific items for men (body image, confidence in maintaining an erection). The score ranges from 0 to 100. A high scale score represents a higher response level. Measure: Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm Time Frame: at 12 months after the inclusion #### Secondary Outcomes Description: Scores obtained on the EORTC SHQ-C22 questionnaire scales. Questionnaire comprising 2 multi-item scales assessing sexual satisfaction and dyspareunia; as well as 11 single items (including: importance of sexual activity, libido, incontinence, fatigue, impact of treatment on sexual life, communication with professionals, partner); as well as 4 items related to gender: 2 specific items for women (body image, vaginal dryness); 2 specific items for men (body image, confidence in maintaining an erection). The score ranges from 0 to 100. A high scale score represents a higher response level. Measure: Description of evolution in sexual quality of life Time Frame: at inclusion, 6,12,18, and 24 months before inclusion Description: Scores obtained on the scales of the EORTC QLQ-C30. Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Measure: Description of evolution in quality of life - QLQ-C30 Time Frame: at inclusion, 6,12,18, and 24 months before inclusion Description: Scores obtained on the scales of the QLQ-BR23 This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms. Measure: Description of evolution in quality of life - QLQ-Breast (BR)cancer module 23 questionnaires. Time Frame: at inclusion, 6,12,18, and 24 months before inclusion Description: Coefficients obtained with a model adapted for longitudinal quality of life data scores as a function of covariates potentially associated with sexual and global quality of life. Measure: Search for associations between comorbidities and risk factors Time Frame: at inclusion, 6,12,18, and 24 months before inclusion Description: Anxiety and depression (psychological distress variables) will be assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. Measure: Search for associations between comorbidities and risk factors -questionnaire Time Frame: at inclusion, 6,12,18, and 24 months before inclusion Description: Percentage of adherence in the interventional arm Measure: Assessment of adherence to the programme in the interventional arm Time Frame: at inclusion Description: Satisfaction score measured on a visual analogue scale ranging from 1 to 10 (10 indicating high satisfaction) Measure: Oncosexology programme satisfaction Time Frame: at 24 months before inclusion ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Woman or man at least 18 years old * Diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor * Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously * Patient with sufficient command of the French language to be able to answer the questionnaires * Patient having given informed, written and express consent. * Affiliation to the French Social Security System * Willingness and ability to comply with scheduled visits, treatment plan and other study procedures Exclusion Criteria: * Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments) * Metastatic disease * Patient under guardianship, curatorship or safeguard of justice Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: DRCI-icm105@icm.unicancer.fr Name: Aurore MOUSSION Phone: 04 67 61 31 02 Phone Ext: +33 Role: CONTACT Contact 2: Email: DRCI-icm105@icm.unicancer.fr Name: Emmanuelle TEXIER Phone: 04 67 61 31 02 Phone Ext: +33 Role: CONTACT #### Locations Location 1: City: Saint-Herblain Contacts: *Contact 1:* - Email: aliette.dezellus@ico.unicancer.fr - Name: Aliette DEZELLUS, Dr - Phone: 02 40 67 99 00 - Phone Ext: +33 - Role: CONTACT Country: France Facility: Institut de Cancérologie de l'Ouest State: Saint Herblain Zip: 44805 Location 2: City: Vandœuvre-lès-Nancy Contacts: *Contact 1:* - Email: c.brunaud@nancy.unicancer.fr - Name: Claire CHARRA-BRUNAUD, Dr - Phone: 03 83 59 86 10 - Phone Ext: +33 - Role: CONTACT Country: France Facility: Institut de Cancérologie de Lorraine State: Vandoeuvre LES Nancy Zip: 54519 Location 3: City: Lyon Contacts: *Contact 1:* - Email: philippe.toussaint@lyon.unicancer.fr - Name: Philippe TOUSSAINT, Dr - Phone: 04 78 78 28 40 - Phone Ext: +33 - Role: CONTACT Country: France Facility: Centre Léon Bérard Zip: 69008 Location 4: City: Montpellier Contacts: *Contact 1:* - Email: Veronique.Dhondt@icm.unicancer.fr - Name: Véronique D'HONDT, Dr - Phone: 04 67 61 25 07 - Phone Ext: +33 - Role: CONTACT *Contact 2:* - Email: Angelique.Bobrie@icm.unicancer.fr - Name: Angélique BOBRIE, Dr - Phone: 04 67 61 85 76 - Phone Ext: +33 - Role: CONTACT Country: France Facility: ICM Val d'Aurelle Zip: 34298 Location 5: City: Nice Contacts: *Contact 1:* - Email: anne.creisson@nice.unicancer.fr - Name: Anne CREISSON, Dr - Phone: 04 92 03 16 43 - Phone Ext: +33 - Role: CONTACT Country: France Facility: Centre Antoine Lacassagne Zip: 06189 Location 6: City: Nîmes Contacts: *Contact 1:* - Email: frederic.fiteni@chu-nimes.fr - Name: Frédéric FITENI, Dr - Phone: 04 66 68 33 01 - Phone Ext: +33 - Role: CONTACT Country: France Facility: CHU de Nîmes Zip: 30029 Location 7: City: Paris Contacts: *Contact 1:* - Email: silene.delorme@curie.fr - Name: Silène DELORME - Role: CONTACT Country: France Facility: Institut Curie Zip: 75005 Location 8: City: Toulouse Contacts: *Contact 1:* - Email: jouve.eva@iuct-oncopole.fr - Name: Eva JOUVE, Dr - Phone: 05 31 15 60 16 - Phone Ext: +33 - Role: CONTACT Country: France Facility: IUCT - Oncopole Zip: 31100 Location 9: City: Villejuif Contacts: *Contact 1:* - Email: Marion.AUPOMEROL@gustaveroussy.fr - Name: Marion AUPOMEROL, Dr - Role: CONTACT Country: France Facility: Institut Gustave Roussy Zip: 94800 #### Overall Officials Official 1: Affiliation: Institut du Cancer de Montpellier (ICM) Name: Véronique D'HONDT, Dr Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients. IPD Sharing: NO ### References Module #### References Citation: Carter J, Lacchetti C, Andersen BL, Barton DL, Bolte S, Damast S, Diefenbach MA, DuHamel K, Florendo J, Ganz PA, Goldfarb S, Hallmeyer S, Kushner DM, Rowland JH. Interventions to Address Sexual Problems in People With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Adaptation of Cancer Care Ontario Guideline. J Clin Oncol. 2018 Feb 10;36(5):492-511. doi: 10.1200/JCO.2017.75.8995. Epub 2017 Dec 11. PMID: 29227723 Citation: Bobrie A, Jarlier M, Moussion A, Jacot W, D'Hondt V. Sexual quality of life assessment in young women with breast cancer during adjuvant endocrine therapy and patient-reported supportive measures. Support Care Cancer. 2022 Apr;30(4):3633-3641. doi: 10.1007/s00520-022-06810-3. Epub 2022 Jan 14. PMID: 35028721 Citation: Del Pup L, Villa P, Amar ID, Bottoni C, Scambia G. Approach to sexual dysfunction in women with cancer. Int J Gynecol Cancer. 2019 Mar;29(3):630-634. doi: 10.1136/ijgc-2018-000096. Epub 2019 Feb 13. PMID: 30765487 Citation: Dizon DS. Quality of life after breast cancer: survivorship and sexuality. Breast J. 2009 Sep-Oct;15(5):500-4. doi: 10.1111/j.1524-4741.2009.00766.x. Epub 2009 Jul 14. PMID: 19614908 Citation: Seguin L, Touzani R, Bouhnik AD, Charif AB, Marino P, Bendiane MK, Goncalves A, Gravis G, Mancini J. Deterioration of Sexual Health in Cancer Survivors Five Years after Diagnosis: Data from the French National Prospective VICAN Survey. Cancers (Basel). 2020 Nov 20;12(11):3453. doi: 10.3390/cancers12113453. PMID: 33233583 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415253 Brief Title: Comparison of ARISCAT Score and Post-operative Pulmonary Complication Rate in Percutaneous Nephrolithotomy Official Title: Comparison of ARISCAT Score and Post-operative Pulmonary Complication Rate in Percutaneous Nephrolithotomy Cases: The Effect of Prone Position and Endoscopic Intervention #### Organization Study ID Info ID: MAIEAH630003 #### Organization Class: OTHER Full Name: Sanliurfa Mehmet Akif Inan Education and Research Hospital ### Status Module #### Completion Date Date: 2024-05-01 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-05-01 Type: ACTUAL #### Start Date Date: 2023-08-31 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Sanliurfa Mehmet Akif Inan Education and Research Hospital #### Responsible Party Investigator Affiliation: Sanliurfa Mehmet Akif Inan Education and Research Hospital Investigator Full Name: ahmet kaya 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: Postoperative pulmonary complications are relatively common in all age groups and are closely related to increased costs, morbidity and mortality in the postoperative period. In recent years, various risk indices have been developed for preoperative evaluation to predict postoperative pulmonary complications, such as the American Society of Anaesthesiologists Physical Status Classification (ASA), the Assessment of Respiratory Risk in Surgical Patients in Catalonia (ARISCAT). The ARISCAT score has demonstrated promising results in identifying patients at higher risk for pulmonary complications. The ARISCAT risk index is derived from multiple variables, including age, oxygen saturation, previous respiratory tract infections, anaemia, abdominal or thoracic surgery, operative time, and emergency surgery. The ARISCAT risk index is used to predict respiratory failure, bronchospasm, respiratory tract infections, atelectasis, pneumothorax, pleural effusion, and aspiration pneumonia. Percutaneous nephrolithotomy (PNL) is a type of operation performed endoscopically in a prone position in cases of kidney stones that cannot be broken by extracorporeal shockwave lithotripsy (ESWL) and/or cannot be removed by ureterocystoscopy. The prone position is one of the positions that limits lung capacity and respiratory function. The objective of this study was to assess the relationship between the ARISCAT score in patients undergoing PNL and the occurrence of pulmonary complications in the postoperative period. ### Conditions Module Conditions: - Postoperative Complications - Nephrolithotomy, Percutaneous ### Design Module #### Design Info Observational Model: CASE_CONTROL Time Perspective: PROSPECTIVE #### Enrollment Info Count: 50 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Label: Patients who had undergone Percutaneous Nephrolithotomy ### Outcomes Module #### Primary Outcomes Description: rate of pulmonary complication such as respiratory failure, bronchospasm, atelectasis, pneumothorax, pleural effusion, or aspiration pneumonia. Measure: rate of pulmonary complication Time Frame: The postoperative period in the first 24 hours Description: rate of pneumonia (bacterial or virutic) Measure: rate of lung infection Time Frame: The postoperative period in the first 72 hours ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * American Society of Anesthesiologists (ASA) I-III patients * Patients who undergone of Percutaneous Nephrolithotomy procedure Exclusion Criteria: * Patients with any liver and/or kidney failure * Obese patients (body mass index (BMI) 30 and above) * Trauma patients * Cancer patients * American Society of Anesthesiologists (ASA) IV patients * Cardiac arrhythmia, implanted pacemakers * A history of chronic pain Maximum Age: 80 Years Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: The study included 50 ASA I-III patients aged between 18 and 80 years who were about to undergo percutaneous nephrolithotomy. ### Contacts Locations Module #### Locations Location 1: City: Şanlıurfa Country: Turkey Facility: University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital Zip: 63050 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14065 - Name: Postoperative Complications - Relevance: HIGH - As Found: Postoperative Complications ### Condition Browse Module - Meshes - ID: D000011183 - Term: Postoperative Complications ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415240 Brief Title: Effect of Facilitated Tucking and Gentle Human Touch on Procedural Pain Among Neonates Official Title: Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit #### Organization Study ID Info ID: STMU #### Organization Class: OTHER Full Name: Shifa Tameer-e-Millat University ### Status Module #### Completion Date Date: 2024-11-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-09-30 Type: ESTIMATED #### Start Date Date: 2024-05-20 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Shifa Tameer-e-Millat University #### Responsible Party Investigator Affiliation: Shifa International Hospital Investigator Full Name: Nazma Hamid Investigator Title: Assistant Clinical Nurse Manager Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: This is a Randomized Control Trial intended to investigate the effect of two non-pharmacological interventions on procedural pain among neonates. Detailed Description: The Study Design is a Randomized Control Trial, intended to investigate the effect of facilitated tucking and gentle human touch on procedural pain among neonates (age 28 days). Neonatal Infant Pain Scale will be used for pain scoring, data will be collected by recording demographic variables for all neonates and then capturing a video recording for pain scoring by an independent research assistant. ### Conditions Module Conditions: - Non Pharmacological Pain Management Keywords: - Non Pharmacological Pain Management - Neonates - Procedural Pain ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: Randomized Control Trial ##### Masking Info Masking: DOUBLE Masking Description: As participants are neonates, they are not able to judge any intervention. Data is being collected by an independent data collector and pain scoring is also planned to be done by an independent Research Assistant. So, an investigator is masked. Who Masked: - PARTICIPANT - INVESTIGATOR Primary Purpose: TREATMENT #### Enrollment Info Count: 159 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: A non pharmacological intervention to be implemented during arterial prick. Intervention Names: - Other: Facilitated Tucking Label: Facilitated Tucking Type: EXPERIMENTAL #### Arm Group 2 Description: A non pharmacological intervention to be implemented during arterial prick. Intervention Names: - Other: Gentle Human Touch Label: Gentle Human Touch Type: EXPERIMENTAL #### Arm Group 3 Description: Usual Care Label: Usual Care Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Facilitated Tucking Description: Facilitated Tucking is a position to be adopted for pain relief in neonates. Name: Facilitated Tucking Type: OTHER #### Intervention 2 Arm Group Labels: - Gentle Human Touch Description: while gentle human touch is caressing on head for pain relief. Name: Gentle Human Touch Type: OTHER ### Outcomes Module #### Primary Outcomes Description: scoring of pain based on a scale used in neonates both for term and pre term babies.( Minimum Pain Score 0, Maximum 7, Higher number indicates the worse outcome Measure: Neonatal Infant Pain Scale Time Frame: Before,During Arterial Prick and after three minutes ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Both term and preterm neonates. 2. APGAR scores of a minimum of 6 at one minute and 8 at 5 minutes 3. Admitted to the Neonatal Intensive Care Unit 4. Undergoing arterial prick for the first time. Exclusion Criteria: 1. Documented birth asphyxia 2. Congenital anomalies 3. Neurological diagnosis, 4. ventilated with paralysis 5. Extremely premature newborns (Gestational age \< 28 weeks) Maximum Age: 28 Days Minimum Age: 1 Day Sex: ALL Standard Ages: - CHILD ### Contacts Locations Module #### Central Contacts Contact 1: Email: nazmahamid07@gmail.com Name: Nazma Hamid, MSN Phone: 03421547629 Role: CONTACT #### Locations Location 1: City: Islamabad Contacts: *Contact 1:* - Email: nazmahamid07@gmail.com - Name: Nazma Hamid, MSN - Phone: 03421547629 - Role: CONTACT Country: Pakistan Facility: Shifa Tameer E Millat University Zip: 44000 #### Overall Officials Official 1: Affiliation: Shifa Tameer E Millat Univesrity Name: Nazma Hamid, MSN Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: Not intended IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M1219 - Name: Pain, Procedural - Relevance: HIGH - As Found: Procedural Pain - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000073818 - Term: Pain, Procedural ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415227 Acronym: ViVA Brief Title: The Impact of Vericiguat on Microvascular Function in Patients With Documented Vasospastic Angina Pectoris Official Title: Vericiguat in Vasospastic Angina #### Organization Study ID Info ID: EU CT 2022-502998-42-00 #### Organization Class: OTHER Full Name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Status Module #### Completion Date Date: 2026-06-01 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-06-01 Type: ESTIMATED #### Start Date Date: 2024-07-01 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-04-25 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: Bayer #### Lead Sponsor Class: OTHER Name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) #### Responsible Party Investigator Affiliation: Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC) Investigator Full Name: Jan J. Piek, MD, PhD Investigator Title: Prof. dr. Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: Vasospastic angina is increasingly recognized as an important contributor to anginal symptoms in patients with non-obstructive coronary artery disease (ANOCA). Endothelial dysfunction and smooth muscle cell dysfunction are considered elementary in the development of vasospastic angina. As one of many functions, the vascular endothelium regulates local vascular tone, mainly through the vasodilatory effect of endothelium-derived nitric oxide (NO). Vericiguat is a soluble guanylate cyclase (sGC) stimulator and thereby acts directly on the NO signalling pathway from the endothelium towards the vascular smooth muscle cells. As such, Vericiguat potentially has an beneficial therapeutic effect in patients with vasospastic angina.The VIVA study aims to demonstrate the effect of Vericiguat on endothelial function and microvascular vasodilator responses, as well as its tolerability and safety in patients with vasospastic angina as the pathophysiological substrate of ANOCA. ### Conditions Module Conditions: - Vasospastic Angina ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER ##### Masking Info Masking: QUADRUPLE Who Masked: - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 55 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Treatment with Vericiguat will be uptitrated every two weeks to the highest tolerated dose, with a target maintenance dose of maximum 10 mg once daily. After a washout period of 2 weeks, matching placebo will be started and is uptitrated every two weeks to maintain double blinding. Intervention Names: - Drug: Vericiguat Label: Vericiguat (2.5 mg, 5 mg and 10 mg) first; placebo second Type: EXPERIMENTAL #### Arm Group 2 Description: Matching placebo is uptitrated every two weeks to maintain double blinding. After a washout period of 2 weeks, treatment with Vericiguat will be started and is uptitrated every two weeks to the highest tolerated dose, with a target maintenance dose of maximum 10 mg once daily. Intervention Names: - Drug: Vericiguat Label: Placebo first; Vericiguat (2.5 mg, 5 mg and 10 mg) second Type: PLACEBO_COMPARATOR ### Interventions #### Intervention 1 Arm Group Labels: - Placebo first; Vericiguat (2.5 mg, 5 mg and 10 mg) second - Vericiguat (2.5 mg, 5 mg and 10 mg) first; placebo second Description: The target dose of vericiguat is 10 milligrams once daily, which will be started at 2.5mg once daily and uptitrated every two weeks to reach the target dose. Dose modification will depend on mean sitting systolic blood pressure and the absence of symptoms indicative of hypotension. The intention of the protocol is to reach and maintain the target study drug dose after completion of uptitration. If the dose is temporarily interrupted, then resumption of study drug treatment and continued uptitration will be considered at any subsequent visit when the investigator feels it is medically appropriate. Vericiguat will be taken orally once daily at about the same time. Name: Vericiguat Other Names: - Verquvo Type: DRUG ### Outcomes Module #### Other Outcomes Description: Relationship between vericiguat plasma concentrations and change in microvascular function from baseline to 10-week placebo and 10-week vericiguat treatment (in case an overall clinical benefit has been demonstrated). Measure: Relationship between vericiguat plasma concentrations and change in microvascular function Time Frame: 10-week and 22-week follow-up #### Primary Outcomes Description: Difference in area under the curve for cutaneous microvascular conductance in APU/s during acetylcholine iontophoresis after 10-week placebo- versus 10-week vericiguat treatment periods Measure: Microvascular function assessed with LASCA : Area under the curve for cutaneous microvascular conductance during acetylcholine iontophoresis Time Frame: 10-week and 22-week follow-up #### Secondary Outcomes Description: Difference in peak cutaneous microvascular conductance in APU/mmHg during acetylcholine iontophoresis after 10-week placebo- versus 10-week vericiguat treatment periods Measure: Microvascular function assessed with LASCA : Peak cutaneous microvascular conductance during acetylcholine iontophoresis Time Frame: 10-week and 22-week follow-up Description: Difference in the absolute and relative change in cutaneous microvascular conductance from baseline conditions to peak conductance during acetylcholine iontophoresis in APU/mmHg after 10-week placebo- versus 10-week vericiguat treatment. Measure: Microvascular function assessed with LASCA : Absolute and relative change in cutaneous microvascular conductance (peak-baseline) during acetylcholine iontophoresis. Time Frame: 10-week and 22-week follow-up Description: Difference in vasodilator function assessed with EndoPAT after 10-week placebo versus 10-week vericiguat treatment expressed by the Reactive hyperemia index (RHI), calculated as the index of signal amplitude pre-to-post occlusion in the occluded arm, divided by the same ratio in the control arm. Measure: Vasodilator function assessed with EndoPAT. Time Frame: 10-week and 22-week follow-up Description: Difference in cutaneous microvascular conductance in APU/mmHg during SNP or insulin iontophoresis after 10-week placebo- versus 10-week vericiguat treatment periods Measure: Microvascular function assessed with LASCA on placebo versus vericiguat treatment using SNP and insulin. Time Frame: 10-week and 22-week follow-up Description: Difference in the area under the curve for cutaneous microvascular conductance in APU/s during SNP or insulin iontophoresis after 10-week placebo- versus 10-week vericiguat treatment periods Measure: Microvascular function assessed with LASCA on placebo versus vericiguat treatment using SNP and insulin. Time Frame: 10-week and 22-week follow-up Description: Difference in peak cutaneous microvascular conductance in APU/mmHg after 10-week placebo versus 10-week vericiguat treatment stratified by the vericiguat dose reached during the treatment phase (5 or 10mg). Measure: Microvascular function assessed with LASCA stratified by the vericiguat dose reached during the treatment Time Frame: 10-week and 22-week follow-up Description: Difference in area under the curve for cutaneous microvascular conductance in APU/s after 10-week placebo versus 10-week vericiguat treatment stratified by the vericiguat dose reached during the treatment phase (5 or 10mg). Measure: Microvascular function assessed with LASCA stratified by the vericiguat dose reached during the treatment Time Frame: 10-week and 22-week follow-up Description: Difference in absolute and relative changes in cutaneous microvascular conductance in APU/mmHg after 10-week placebo versus 10-week vericiguat treatment stratified by the vericiguat dose reached during the treatment phase (5 or 10mg). Measure: Microvascular function assessed with LASCA stratified by the vericiguat dose reached during the treatment Time Frame: 10-week and 22-week follow-up Description: Difference in reactive hyperemia index (RHI) after 10-week placebo versus 10-week vericiguat treatment stratified by the vericiguat dose reached during the treatment phase (5 or 10mg). RHI is calculated as the index of signal amplitude pre-to-post occlusion in the occluded arm, divided by the same ratio in the control arm. Measure: Vasodilator function assessed with EndoPAT stratified by the vericiguat dose reached during the treatment Time Frame: 10-week and 22-week follow-up Description: Difference in peak cutaneous microvascular conductance in APU/mmHg after 10-week placebo versus 10-week vericiguat treatment stratified by epicardial or microvascular vasospasm endotype. Measure: Microvascular function assessed with LASCA stratified by epicardial or microvascular vasospasm endotype. Time Frame: 10-week and 22-week follow-up Description: Difference in area under the curve for cutaneous microvascular conductance in APU/s after 10-week placebo versus 10-week vericiguat treatment stratified by epicardial or microvascular vasospasm endotype. Measure: Microvascular function assessed with LASCA stratified by epicardial or microvascular vasospasm endotype. Time Frame: 10-week and 22-week follow-up Description: Difference in absolute and relative changes in cutaneous microvascular conductance in APU/mmHg after 10-week placebo versus 10-week vericiguat treatment stratified by epicardial or microvascular vasospasm endotype. Measure: Microvascular function assessed with LASCA stratified by epicardial or microvascular vasospasm endotype. Time Frame: 10-week and 22-week follow-up Description: Difference in reactive hyperemia index (RHI) after 10-week placebo versus 10-week vericiguat treatment stratified by epicardial or microvascular vasospasm endotype. RHI is calculated as the index of signal amplitude pre-to-post occlusion in the occluded arm, divided by the same ratio in the control arm. Measure: Vasodilator function assessed with EndoPAT stratified by epicardial or microvascular vasospasm endotype. Time Frame: 10-week and 22-week follow-up Description: Difference in quality of life measured by the Seattle Angina Questionnaire (SAQ) Summary Score after 10-week placebo versus 10-week vericiguat treatment periods. The SAQ summary score ranges from 0 to 100 with higher scores indicating less angina, fewer functional limitations, and better quality of life. Measure: Quality of life between vericiguat treatment and placebo Time Frame: 10-week and 22-week follow-up Description: Difference in quality of life measured by the Rose Dyspnea Score after 10-week placebo versus 10-week vericiguat treatment periods. The Rose Dyspnea Scale is a four-item questionnaire that assesses a patients' dyspnea level with common activities. One point is assigned to each activity associated with dyspnea. Scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea. Measure: Quality of life between vericiguat treatment and placebo Time Frame: 10-week and 22-week follow-up Description: Difference in quality of life measured by EQ-5D-5L (EuroQol - 5 dimensions - 5 levels. A self-assessed, health-related, quality of life questionnaire) scores after 10-week placebo versus 10-week vericiguat treatment periods. The five severity levels in the EQ-5D-5L are 'no problems', 'slight problems', 'moderate problems', 'severe problems' and 'unable to/extreme problems'. Measure: Quality of life between vericiguat treatment and placebo Time Frame: 10-week and 22-week follow-up Description: Difference in quality of life measured by the EQ visual analogue scale (EQ-VAS) scores after 10-week placebo versus 10-week vericiguat treatment periods. The EQ VAS component contains a scaled vertical line ranging from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine') where respondents rate their overall health status. Measure: Quality of life between vericiguat treatment and placebo Time Frame: 10-week and 22-week follow-up Description: Difference in quality of life measured by iPCQ (iMTA (Institute for Medical Technology Assessment) Productivity Cost Questionnaire) index score after 10-week placebo versus 10-week vericiguat treatment periods. The scoring of the iPCQ questionnaire involves three modules assessing productivity losses due to absenteeism (1), presenteeism (2), and productivity losses associated with unpaid work (3). Scores are calculated in costs with a higher score indicating higher productivity loss. Measure: Quality of life between vericiguat treatment and placebo Time Frame: 10-week and 22-week follow-up Description: Difference in quality of life measured by iMCQ (iMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire) index score after 10-week placebo versus 10-week vericiguat treatment periods. The scoring of the iMCQ questionnaire involves calculating medical consumption by assessing respondents' answers to relevant questions, which inquire about various forms of care and the frequency of their utilization. A higher score indicates higher health care consumption. Measure: Quality of life between vericiguat treatment and placebo Time Frame: 10-week and 22-week follow-up Description: Difference in the change in quality of life measured by the Seattle Angina Questionnaire (SAQ) Summary Score from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods. The SAQ summary score ranges from 0 to 100 with higher scores indicating less angina, fewer functional limitations, and better quality of life. Measure: Quality of life between baseline and end of treatment Time Frame: 10-week and 22-week follow-up Description: Difference in the change of quality of life measured by the Rose Dyspnea Score from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods. The Rose Dyspnea Scale is a four-item questionnaire that assesses a patients' dyspnea level with common activities. One point is assigned to each activity associated with dyspnea. Scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea. Measure: Quality of life between baseline and end of treatment Time Frame: 10-week and 22-week follow-up Description: Difference in the change of quality of life measured by the EQ-5D-5L (EuroQol - 5 dimensions - 5 levels. A self-assessed, health-related, quality of life questionnaire) scores from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods.The five severity levels in the EQ-5D-5L are 'no problems', 'slight problems', 'moderate problems', 'severe problems' and 'unable to/extreme problems'. Measure: Quality of life between baseline and end of treatment Time Frame: 10-week and 22-week follow-up Description: Difference in the change of quality of life measured by the EQ visual analogue scale (EQ-VAS) scores from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods.The EQ VAS component contains a scaled vertical line ranging from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine') where respondents rate their overall health status. Measure: Quality of life between baseline and end of treatment Time Frame: 10-week and 22-week follow-up Description: Difference in the change of quality of life measured by the iPCQ (iMTA (Institute for Medical Technology Assessment) Productivity Cost Questionnaire) index score from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods. The scoring of the iPCQ questionnaire involves three modules assessing productivity losses due to absenteeism (1), presenteeism (2), and productivity losses associated with unpaid work (3). Scores are calculated in costs with a higher score indicating higher productivity loss. Measure: Quality of life between baseline and end of treatment Time Frame: 10-week and 22-week follow-up Description: Difference in the change of quality of life measured by the iMCQ (iMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire) index score from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods. The scoring of the iMCQ questionnaire involves calculating medical consumption by assessing respondents' answers to relevant questions, which inquire about various forms of care and the frequency of their utilization. A higher score indicates higher health care consumption. Measure: Quality of life between baseline and end of treatment Time Frame: 10-week and 22-week follow-up Description: Angina burden calculated by the frequency of angina attacks for placebo versus vericiguat treatment periods Measure: Angina burden Time Frame: 10-week and 22-week follow-up Description: The occurrence of major adverse cardiac events (hospitalization for angina, spontaneous myocardial infarction, unplanned revascularization, death) during the study period. Measure: The occurrence of major adverse cardiac events Time Frame: 24 weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Age \>18 years * Recurrent angina symptoms provoked by exercise and/or repeated attacks of angina at rest at least once weekly despite current medical treatment. * Absence of (co-existing) flow-limiting coronary artery stenosis (as defined by any coronary artery diameter reduction \>50%, or fractional flow reserve≤0.80, or instantaneous wave-free ratio/resting full cycle ratio ≤0.89). * Unambiguous epicardial and/or microvascular coronary vasospasm according to the COVADIS criteria, documented by invasive acetylcholine provocation testing. * A female participant is eligible to participate if at least one of the following conditions applies: Women with a confirmed post-menopausal state (defined as amenorrhea for at least 12 months without an alternative medical cause); or premenopausal women with documented hysterectomy, documented bilateral salpingectomy or documented bilateral oophorectomy; or for women of childbearing potential: Negative highly sensitive urine or serum pregnancy test within 24 hours the first dose of study intervention and practicing a highly effective birth control method (failure rate of less than 1%) during the study intervention period / and for at least one month after the last dose of study intervention: progestogen-only subdermal contraceptive implant, intrauterine system (progestin releasing intrauterine device), non-hormonal intrauterine device, bilateral tubal occlusion, azoospermic partner (vasectomized or secondary to medical cause) or heterosexual abstinence. Exclusion Criteria: * Impaired left ventricular function (LVEF\<50%) * Significant valvular pathology * Contraindication for treatment with sublingual nitrates as background medication only, at the discretion of the treating cardiologist. * Contraindications for treatment with vericiguat: resting systolic blood pressure\<100mmHg, severe renal impairment (estimated glomerular filtration rate \<15ml/min), severe hepatic impairment. * Known hypersensitivity to the active substance or to any of the excipients (Microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium laurilsulfate). * Concomitant use of other soluble guanylate cyclase (sGC) stimulators, such as riociguat. * Concomitant use PDE5 inhibitors, such as sildenafil. * Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. * Patients who are pregnant or nursing and those who plan pregnancy in the period up to 1 month after the study; * Patients with a limited life expectancy less than one year; * Patients unable to provide written informed consent, or are otherwise not suitable for inclusion according to the investigator Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### IPD Sharing Statement Module IPD Sharing: UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002637 - Term: Chest Pain - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000000789 - Term: Angina, Unstable ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4117 - Name: Angina Pectoris - Relevance: HIGH - As Found: Angina - ID: M4118 - Name: Angina Pectoris, Variant - Relevance: HIGH - As Found: Vasospastic Angina - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M5882 - Name: Chest Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M4119 - Name: Angina, Unstable - Relevance: LOW - As Found: Unknown - ID: T4716 - Name: Prinzmetal's Variant Angina - Relevance: HIGH - As Found: Vasospastic Angina ### Condition Browse Module - Meshes - ID: D000000787 - Term: Angina Pectoris - ID: D000000788 - Term: Angina Pectoris, Variant ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415214 Brief Title: Efficacy and Safety of HRS-7535 Tablets in Adults With Type 2 Diabetic Kidney Disease Official Title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetic Kidney Disease #### Organization Study ID Info ID: HRS-7535-203 #### Organization Class: INDUSTRY Full Name: Shandong Suncadia Medicine Co., Ltd. ### Status Module #### Completion Date Date: 2025-09 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-23 Type: ACTUAL Last Update Submit Date: 2024-05-22 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-08 Type: ESTIMATED #### Start Date Date: 2024-06 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Shandong Suncadia Medicine Co., Ltd. #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: The study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed Phase II clinical study. The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetic kidney disease. ### Conditions Module Conditions: - Type 2 Diabetic Kidney Disease ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL ##### Masking Info Masking: QUADRUPLE Who Masked: - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR Primary Purpose: TREATMENT #### Enrollment Info Count: 186 Type: ESTIMATED Phases: - PHASE2 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: Placebo Label: Group A，Subjects will receive Placebo administered orally Type: PLACEBO_COMPARATOR #### Arm Group 2 Intervention Names: - Drug: HRS-7535 Label: Group B，Subjects will receive HRS-7535 administered orally Type: EXPERIMENTAL #### Arm Group 3 Intervention Names: - Drug: HRS-7535 Label: Group C，Subjects will receive escalated HRS-7535 administered orally Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - Group A，Subjects will receive Placebo administered orally Description: Placebo Name: Placebo Type: DRUG #### Intervention 2 Arm Group Labels: - Group B，Subjects will receive HRS-7535 administered orally - Group C，Subjects will receive escalated HRS-7535 administered orally Description: HRS-7535 Name: HRS-7535 Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: Ratio of UACR at week 16 to UACR at baseline Time Frame: at Week 16 #### Secondary Outcomes Measure: 24 hour urine analysis results at Week 16 Time Frame: at Week 16 Measure: Proportion of subjects with a 30% decrease in UACR from baseline at Week 16 Time Frame: at Week 16 Measure: Change from baseline in eGFR at Week 16 Time Frame: at Week 16 Measure: Change from baseline in HbA1c at Week 16 Time Frame: at Week 16 Measure: Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16 Time Frame: at Week 16 Measure: Change from baseline in FPG at Week 16 Time Frame: at Week 16 Measure: Change from baseline in insulin at Week 16 Time Frame: at Week 16 Measure: Change from baseline in c-peptide at Week 16 Time Frame: at Week 16 Measure: Change from baseline in body weight at Week 16 Time Frame: at Week 16 Measure: Proportion of subjects receiving glycemic rescue medicine at Week 16 Time Frame: at Week 16 Measure: A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16 Time Frame: at Week 16 ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Male or female subjects, 18-75 years of age at the time of signing informed consent; 2. Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2; 3. Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2; 4. Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators; 5. UACR ≥300 and \<3000 mg/g; 6. HbA1c ≥6.5% and ≤10.0%; 7. ACEI/ARB was used for ≥3 months and ACEI/ARB was stabilized at either the maximum recommended dose (reference to the drug label) or the maximum tolerated dose within 4 weeks; 8. Use hypoglycemic drugs for ≥3 months (the dosage of SGLT2i remains stable if used); 9. Able and willing to provide a written informed consent; Exclusion Criteria: 1. Have type 1 diabetes mellitus or specific type of diabetes; 2. Acute kidney injury or dialysis treatment within 6 months; 3. Kidney transplantation is planned during the trial; 4. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 5. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix; 6. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 7. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method; Maximum Age: 75 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: liang.peng.lp1@hengrui.com Name: Liang Peng Phone: 0518-82342973 Role: CONTACT Contact 2: Email: tingyu.dong@hengrui.com Name: Tingyu Dong Phone: 0518-82342973 Role: CONTACT ### 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: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M7123 - Name: Diabetic Nephropathies - Relevance: HIGH - As Found: Diabetic Kidney Disease - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: 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 ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000003928 - Term: Diabetic Nephropathies ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415201 Brief Title: Interactive AI-based Mental Health Service for the Patients With Cancer Official Title: Scenario-based Clinical Interview Data Construction and User Experience Evaluation #### Organization Study ID Info ID: HI23C0315 #### Organization Class: OTHER Full Name: Seoul National University Hospital ### Status Module #### Completion Date Date: 2027-12-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2025-12-31 Type: ESTIMATED #### Start Date Date: 2024-03-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Dongguk University Medical Center Class: OTHER Name: Eulji University Hospital #### Lead Sponsor Class: OTHER Name: Seoul National University Hospital #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False ### Description Module Brief Summary: The aims of this study are developments of mental health care services for cancer patients based on interactive artificial intelligence. To do these things, survey of unmet medical needs and data collection of clinical interviews will be done, and newly developed assessment and intervention scenarios will be simulated to cancer patients group. Detailed Description: A total of 20 people will be recruited from 3 institutions to investigate unmet medical needs. Based on the needs, we will develop scenarios to assess, classify, explain and conduct supportive interviews. We plan to develop a stress self-management scenario that helps manage lifestyle habits and provides meditation-based cognitive therapy. For moderate to severe distress, we plan to develop scenarios to link medical care and manage suicide risk. We plan to conduct interviews with a total of 300 people to collect clinical interview data for scenario development. ### Conditions Module Conditions: - Cancer Keywords: - mental health - distress - interactive artificial intelligence - virtual human ### Design Module #### Design Info Observational Model: OTHER Time Perspective: CROSS_SECTIONAL #### Enrollment Info Count: 360 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: 20 people Label: Survey of unmet medical needs #### Arm Group 2 Description: 40 people Intervention Names: - Other: Interactive Artificial Intelligence Label: User experience evaluation #### Arm Group 3 Description: 300 people Label: Clinical interview data collection ### Interventions #### Intervention 1 Arm Group Labels: - User experience evaluation Description: scenario based AI to assess, classify, explain and conduct supportive interviews Name: Interactive Artificial Intelligence Type: OTHER ### Outcomes Module #### Primary Outcomes Description: Distress Thermometer Measure: Distress Time Frame: baseline Description: WHOQOL Measure: Quality of life measurement Time Frame: baseline Description: PSS-10 (Perceived Stress Scale) Measure: Stress Time Frame: baseline Description: K-RES (Korean version of Rosenberg Self-Esteem Scale) Measure: Self-esteem Time Frame: baseline Description: Acceptance of Disability Scale Measure: Acceptance of Disability Time Frame: baseline Description: PBPI (Pain belief \& Perception inventory) Measure: Pain measurement Time Frame: baseline Description: ISI (Insomnia Severity Index) Measure: Insomnia Time Frame: baseline Description: PSQI (Pittsburgh Sleep Quality Index) Measure: Quality of sleep Time Frame: baseline Description: FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy) Measure: Fatigue Time Frame: baseline Description: HADS (Hospital anxiety and depression scale) Measure: Anxiety & Depression Time Frame: baseline Description: MINI-Plus (Mini-international Neuropsychiatric interview) Measure: Suicidality Time Frame: baseline Description: FOP-SF (Fear of Disease Progression Short Form) Measure: Fear of Disease Progression Time Frame: baseline Description: MOS Social support Survey Measure: Social Support Time Frame: baseline ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Patients diagnosed with malignant tumor and undergoing treatment, or patients undergoing follow-up after completing curative treatment Exclusion Criteria: * Patients unable to consent to research or be interviewed due to cognitive decline Minimum Age: 19 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Adult cancer patients without severe cognitive decline ### Contacts Locations Module #### Central Contacts Contact 1: Email: total3562@naver.com Name: Sunhyung Lee, M.D. Phone: 82-2-2072-3767 Role: CONTACT Contact 2: Name: Bong-jin Hahm, M.D., Ph.D. Role: CONTACT #### Locations Location 1: City: Seoul Contacts: *Contact 1:* - Email: total3562@naver.com - Name: Sunhyung Lee, M.D. - Phone: 82-2-2072-3767 - Role: CONTACT Country: Korea, Republic of Facility: Seoul National University Hospital Status: RECRUITING Zip: 16801 #### Overall Officials Official 1: Affiliation: Seoul National University Hospital Name: Bong-jin Hahm, M.D., Ph.D. Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415188 Brief Title: The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction Official Title: The Effect of Therapeutic Play on Pre-Treatment Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction #### Organization Study ID Info ID: SelcukUni2544 #### Organization Class: OTHER Full Name: Selcuk University ### Status Module #### Completion Date Date: 2024-05-10 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: COMPLETED #### Primary Completion Date Date: 2024-04-15 Type: ACTUAL #### Start Date Date: 2023-05-15 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Selcuk University #### Responsible Party Investigator Affiliation: Selcuk University Investigator Full Name: Sibel Küçükoğlu Investigator Title: Prof Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated. Detailed Description: Therapeutic play is defined as activities structured in accordance with children's age and development, or as a set of interventions to improve the well-being of children in the hospital environment. This method reduces the stress of illness or hospitalization, uses play as a means of self-expression and supports the development of positive coping mechanisms in pediatric patients. In the literature, it is seen that therapeutic play methods such as listening to music, drawing, reading stories, puppets, dolls, virtual reality tools, cartoon applications, watching videos and playing video games are used to reduce the child's pain and anxiety about invasive procedures. Studies conducted to reduce the interactions between children in the same environment during their treatment and care are quite limited. No study has been found to examine the effect of methods that jointly block/reduce vision and hearing during treatment and care on anxiety, fear and pain in children treated together in pediatric clinics. ### Conditions Module Conditions: - Child Behavior - Pain, Acute - Anxiety and Fear Keywords: - Pain - anxiety - children - nursing - therapeutic play ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: This study was conducted on children aged 3-6 years. The study was completed with a total of 40 children and parent pairs in the experimental and control groups. Simple randomization method was used in the study. The randomization table for which group the children would be in was made by an independent statistician. Letters A and B were used to represent the experimental and control groups. Which letter represented which group was determined by lottery. While therapeutic play intervention was applied in the experimental group, routine intervention was applied in the control group. ##### Masking Info Masking: SINGLE Who Masked: - PARTICIPANT Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 40 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Children in the experimental group received a therapeutic video game intervention in addition to the pre-treatment routine. Intervention Names: - Behavioral: Video game with headset Label: Therapeutic play group Type: EXPERIMENTAL #### Arm Group 2 Description: Children in the control group underwent routine clinical practice. No other intervention was performed. Label: Control Group Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Therapeutic play group Description: Half an hour before the first treatment in the morning, the screens around the patients' beds were closed by the researcher. The child was asked to choose one of the introduced games and the game he/she chose from the tablet was turned on. Children were asked to wear headphones for sound isolation and the sound was adjusted at the appropriate decibel setting. Half an hour before the treatment, children were allowed to play the video game until the treatment without any different warning. Physiologic Parameter Assessment Form, Child Anxiety and Fear Scale, Child Pain Scale were filled by the researcher 1 minute before and 1 minute after the procedure. Finally, Parental Satisfaction Scale was completed at the end of the intervention. Name: Video game with headset Type: BEHAVIORAL ### Outcomes Module #### Primary Outcomes Description: A descriptive characteristics information form for parents and children was prepared by the researchers in line with the literature and the data of both the experimental and control groups were collected before the intervention. Measure: Descriptive Characteristics Information Form Time Frame: First measurement: 30 minute before treatment Description: The descriptive characteristics form was based on a literature review by the investigator. Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured 1 minute before treatment administration. Measure: Physiological Parameter Monitoring Form Time Frame: First measurement: 1 minute before treatment Description: Children's State Anxiety and Children's Fear Scale was developed by McMurtry et al. in 2011. The scale was designed to measure the fear levels of children aged 4-10 years. The scale was translated into Turkish by Gerçeker et al. in 2018 and the validity-reliability coefficient was found to be 0.89. The scale score is formed by scoring five drawn facial expressions (0=no fear to 4=severe fear) shown visually to the child. Anxiety and fear scores of the child were scored one minute before the treatment. Measure: Children's State Anxiety and Children's Fear Scale Time Frame: First measurement: 1 minute before treatment Description: Visual Analog Scale (VAS) was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by scoring with facial expressions. It is used in children who have the ability to communicate and are conscious. The scale has 6 faces that are scored between 0 and 5. In scoring, the child chooses the face that best expresses him/her and "0" indicates no pain, "1" indicates a little pain, "2" indicates a little more pain, "3" indicates more pain, "4" indicates quite a lot of pain and "5" indicates the most severe pain level. One minute before the treatment, the child's pain is scored by VAS. Measure: Visual Analog Scale Time Frame: First measurement: 1 minute before treatment Description: The PedsQL Health Care Satisfaction Scale was developed by J.W. Varni in 1999. Turkish adaptation of the scale was conducted by Ulus and Kublay in 2012. The scale consists of 25 items with 6 subheadings: emotional support, information, general satisfaction, communication, family involvement and technical skills. The scale is on a five-point scale and each item is rated on a scale of 0 to 4 and is evaluated as "Never satisfied (0)", "Sometimes satisfied (1)", "Most of the time satisfied (2)", "Almost always satisfied (3)" and "Always satisfied (4)". A high score indicates an increase in parental satisfaction. Measure: PedsQL Health Care Satisfaction Scale Time Frame: First measurement: After treatment #### Secondary Outcomes Description: Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured one minute after treatment administration. Measure: Physiological Parameter Monitoring Form Time Frame: Second measurement: 1 minute after treatment Description: 1 minute after the treatment, the child's anxiety and fear score was scored again. Measure: Children's State Anxiety and Children's Fear Scale Time Frame: Second measurement: 1 minute after treatment Description: One minute after the treatment, the child's pain score was scored again Measure: Visual Analog Scale Time Frame: Second measurement: 1 minute after treatment ### Eligibility Module Eligibility Criteria: For the Child; Inclusion Criteria: * Being in the 3-6 age group, * At least one day of inpatient treatment in the pediatric clinics of Selçuk Medical Faculty Hospital * At least one invasive intervention in the treatment plan * To be able to understand and speak Turkish * Staying in a room with at least two beds Exclusion Criteria: * Having a neurological disorder * Not having a parent as a companion * Receiving oral treatment only * Hearing and vision problems * Single bed capacity room or isolated room For the Parent Inclusion Criteria: * Staying with their child as a constant companion * To be able to understand and speak Turkish * Accepting to participate in the study The exclusion criteria: * Not staying with your child all the time Maximum Age: 6 Years Minimum Age: 3 Years Sex: ALL Standard Ages: - CHILD ### Contacts Locations Module #### Locations Location 1: City: Konya Country: Turkey Facility: Selcuk University #### Overall Officials Official 1: Affiliation: Selcuk University Name: Sibel Kucukoglu, Prof Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module Description: It will be shared after the article is published. IPD Sharing: NO ### References Module #### References Citation: Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1. PMID: 29728296 Citation: Silva SGTD, Santos MA, Floriano CMF, Damiao EBC, Campos FV, Rossato LM. Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. Rev Bras Enferm. 2017 Nov-Dec;70(6):1244-1249. doi: 10.1590/0034-7167-2016-0353. English, Portuguese. PMID: 29160486 Citation: Roberts JG, Prys-Roberts C, Foex P, Clarke TN, Bennett M. Proceedings: A comparison of the effects of practolol and propranolol on the response to haemorrhage in anaesthetized dogs after myocardial infarction. Br J Anaesth. 1973 Dec;45(12):1230. doi: 10.1093/bja/45.12.1230. No abstract available. PMID: 4787017 Citation: Kose S, Arikan D. The Effects of Cartoon Assisted Endoscopy Preparation Package on Children's Fear and Anxiety Levels and Parental Satisfaction in Turkey. J Pediatr Nurs. 2020 Jul-Aug;53:e72-e79. doi: 10.1016/j.pedn.2020.02.010. Epub 2020 Mar 13. PMID: 32173165 Citation: Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666. PMID: 30362982 Citation: Masmoudi A, el-Fetouaki J, Weltin D, Belhadj O, Mandel P. Association of mitochondrial ADP-ribosyl transferase activity with the DNA-protein complex. Biochem Mol Biol Int. 1993 Jan;29(1):77-83. PMID: 8387848 Citation: Burns-Nader S, Joe L, Pinion K. Computer tablet distraction reduces pain and anxiety in pediatric burn patients undergoing hydrotherapy: A randomized trial. Burns. 2017 Sep;43(6):1203-1211. doi: 10.1016/j.burns.2017.02.015. Epub 2017 Mar 18. PMID: 28318748 ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415175 Acronym: PROADAP Brief Title: Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain Official Title: Prospective, Observational, Longitudinal Study in Paediatric Patients With AD, Treated With Dupilumab in Spain #### Organization Study ID Info ID: OBS18427 #### Organization Class: INDUSTRY Full Name: Sanofi #### Secondary ID Infos Domain: ICTRP ID: U1111-1306-7579 Type: REGISTRY ### Status Module #### Completion Date Date: 2027-09-30 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2026-09-30 Type: ESTIMATED #### Start Date Date: 2024-05-31 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: Regeneron Pharmaceuticals #### Lead Sponsor Class: INDUSTRY Name: Sanofi #### Responsible Party Type: SPONSOR ### Oversight Module Oversight Has DMC: False ### Description Module Brief Summary: This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied. ### Conditions Module Conditions: - Atopic Dermatitis Keywords: - Pediatric ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 150 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: The information will be collected during consultation as part of the patient's usual follow-up. Intervention Names: - Drug: Dupilumab Label: Dupilumab ### Interventions #### Intervention 1 Arm Group Labels: - Dupilumab Description: This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice. Name: Dupilumab Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age Time Frame: At baseline Measure: Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender Time Frame: At baseline Measure: Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI) Time Frame: At baseline Description: Including course of AD, recent AD treatment history, family history. Measure: Medical history characteristics of pediatric patients initiating treatment with dupilumab for Severe AD Time Frame: At baseline Description: Selected atopic comorbidities over time will be reported. Measure: Medical history of atopic comorbidities Time Frame: At baseline Measure: Medical history of non-atopic diseases Time Frame: At baseline #### Secondary Outcomes Measure: Description of real-world treatment patterns: Dupilumab dosage Time Frame: From baseline up to 24 months Measure: Description of real-world treatment patterns: Dupilumab frequency of administration Time Frame: From baseline up to 24 months Description: Reason for discontinuation will be reported if applicable. Measure: Description of real-world treatment patterns: Dupilumab reason for discontinuation Time Frame: From baseline up to 24 months Description: In case of receiving other treatments for AD, topical or systemic. Measure: Description of real-world treatment patterns (other treatments): Other type of treatment Time Frame: From baseline up to 24 months Description: In case of receiving other treatments for AD, topical or systemic. Measure: Description of real-world treatment patterns (other treatments): Name of treatment Time Frame: From baseline up to 24 months Description: In case of receiving other treatments for AD, topical or systemic. Measure: Description of real-world treatment patterns (other treatments): Duration of treatment Time Frame: From baseline up to 24 months Description: In case of receiving other treatments for AD, topical or systemic. Reason for discontinuation will be reported if applicable. Measure: Description of real-world treatment patterns (other treatments): Reason for discontinuation (if applicable) Time Frame: From baseline up to 24 months Description: The Children's Dermatology Life Quality Index (cDLQI) it is a 10-item questionnaire that assesses six different aspects that may affect quality of life, including symptoms and feelings, daily activities, leisure, work and school performance, personal relationships, and treatment. Each of the 10 questions is scored from 0 (not at all) to 3 (very much) and the overall cDLQI is calculated by summing the score of each question, resulting in a total score between 0-30. The higher the score, the more quality of life is impaired. Measure: Participant-caregiver assessment: Change from baseline in the Children's Dermatology Life Quality Index score Time Frame: From baseline up to 24 months Description: The Infant Dermatology Quality of Life Index (iDLQI) contains 10 questions and a response scale divided into four boxes. Each box gives a point between 0 and 3. The lower number is understood as the most positive for the participant. The index is filled out by a parent to a participating child between the ages of 0 to 5 years. Points from each question are added together and the end-sum represents the score. The sum score can be between 0 and 30. The higher the score the worse the assumed quality of life. Measure: Participant-caregiver assessment: Change from baseline in the Infant's Dermatology Life Quality Index score Time Frame: From baseline up to 24 months Description: The DFI is a 10-item disease specific questionnaire assessing the impact of having a child with AD on family Quality of Life (QoL). The DFI questions are scored ranging from 0 to 3, and the total DFI score ranges from 0 to 30. The time frame of reference is the past week, and a higher DFI score indicates greater impairment in family QoL as affected by AD. Measure: Participant-caregiver assessment: Change from baseline in the Dermatitis Family Impact (DFI) questionnaire Time Frame: From baseline up to 24 months Description: WI-NRS is a validated measure of itch severity. Patients will be asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate more severity. Measure: Participant-caregiver assessment: Change from baseline in the patient's Worst Itch Numerical Rating Scale (WI-NRS) Time Frame: From baseline up to 24 months Description: The WSI-NRS is a single-item caregiver-reported. The caregivers describe their child "scratch" or "itch" in the AD-affected area by using numeric response options (0: no scratching/itching to 10: worst scratching/itching). Higher scores indicate more severity. Measure: Caregiver assessment: Change from baseline in the patient's Worst Itch Scale Numerical Rating Scale (WSI-NRS) Time Frame: From baseline up to 24 months Description: The EASI is calculated by summing 4 separate scores of the (1) head/neck, (2) upper extremities, (3) trunk, and (4) lower extremities. For each of the 4 anatomical regions, the score formula is SxAxM \["S" is the congregate score from the severity of 4 signs: erythema, oedema/papulation, excoriation, and lichenification graded on a discrete scale from 0 to 3, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe, giving S a maximum of 12. "A" represents the area to which AD affects the body, yielding a maximum of 6 points: 0 = 0%, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. "M" is a multiplier, which is 0.1, 0.2, 0.3, and 0.4, respectively, for the region affected in those ≥8 years and 0.2, 0.2, 0.3, and 0.3, respectively, for those \<8 years. The final EASI score is calculated based on the sum of the scores from the 4 anatomical regions. A higher score means higher AD severity. Scores range from 0 (no disease) to 72 (maximal disease severity). Measure: Physician assessment: Change from baseline in the eczema severity using the Eczema Area and Severity Index (EASI) Time Frame: From baseline up to 24 months Description: BSA affected by AD disease will be assessed for each major section of the body (head, neck, anterior trunk, back, upper limbs, lower limbs, and genitals). It will be reported as a percentage of all major body sections combined. Measure: Physician assessment: Percent change from beseline in the Body Surface Area (BSA) (%) affected by AD Time Frame: From baseline up to 24 months Description: The IGA is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). Measure: Physician assessment: Change in Proportion of patients with Validated Investigator's Global Assessment (IGA) Time Frame: From baseline up to 24 months Description: Biomarker analysis will be performed, if available, in routine clinical practice and at routine visits Measure: Physician assessment: Change from baseline in Biomarkers Time Frame: From baseline up to 24 months Description: The number of events and the percentage of patients who had at least one event will be described. Measure: Number of Adverse Events (AE) / Serious Adverse Events (SAE) / Adverse Event of Special Interest (AESI) Time Frame: From date of signed ICF, up to 24 months Description: Health care resource utilization may include hospitalizations (including length of stay), outpatient visits, urgent care or emergency room visits. Measure: Health Care Resource Utilization (HCRU) Questionnaire Time Frame: From baseline up to 24 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Male or female aged 6 months to 11 years old at baseline. * Patients with severe Atopic dermatitis (AD) according to the investigator's assessment. * Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records). * Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age. Exclusion Criteria: * Patients who are participating in an interventional clinical trial that modifies patient care. Maximum Age: 11 Years Minimum Age: 6 Months Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - CHILD Study Population: Patients aged 6 months to 11 years old at baseline and initiating Dupilumab for their Severe Atopic dermatitis (AD) in Spain. ### Contacts Locations Module #### Central Contacts Contact 1: Email: Contact-us@sanofi.com Name: Trial Transparency email recommended (Toll free for US & Canada) Phone: 800-633-1610 Phone Ext: option 6 Role: CONTACT #### Overall Officials Official 1: Affiliation: Sanofi Name: Clinical Sciences & Operations Role: STUDY_DIRECTOR ### IPD Sharing Statement Module Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org IPD Sharing: YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases - ID: D000012873 - Term: Skin Diseases, Genetic - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000017443 - Term: Skin Diseases, Eczematous - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M7071 - Name: Dermatitis, Atopic - Relevance: HIGH - As Found: Atopic Dermatitis - ID: M7655 - Name: Eczema - Relevance: HIGH - As Found: Atopic Dermatitis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15676 - Name: Skin Diseases, Genetic - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M19712 - Name: Skin Diseases, Eczematous - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003876 - Term: Dermatitis, Atopic - ID: D000003872 - Term: Dermatitis - ID: D000004485 - Term: Eczema ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415162 Brief Title: Evaluation of the Effects of Using Cooling Pillowcases, on the Symptoms of Hot Flushes, Sleep and Life Quality Official Title: Evaluation of the Effects of Education on Side Effects Management and the Use of Cooling Pillowcases on Hot Flash Complaints, Sleep and Quality of Life in Women With Breast Cancer Receiving Hormone Therapy #### Organization Study ID Info ID: SaglikBilimleriUBTURKMEN0001 #### Organization Class: OTHER Full Name: Saglik Bilimleri Universitesi ### Status Module #### Completion Date Date: 2024-07-31 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: RECRUITING #### Primary Completion Date Date: 2024-07-31 Type: ESTIMATED #### Start Date Date: 2023-12-19 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Saglik Bilimleri Universitesi #### Responsible Party Investigator Affiliation: Saglik Bilimleri Universitesi Investigator Full Name: Başak Türkmen Investigator Title: Phd Student Internal Medicine Nursing 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 was planned to evaluate the effect of education on the management of side effects and the use of cooling pillowcase on hot flush complaints, sleep and quality of life in women with breast cancer receiving hormone therapy. Detailed Description: It is planned to apply pre-test evaluations in the 1st week and post-test evaluations in the 9th week to the intervention (training) group consisting of women with breast cancer who agree to participate in the study. A total of 3 follow-ups will be performed on the patients in the intervention (education) group in weeks 3 and 7 by telephone interview method and in week 5 by face-to-face interview method using the Patient Follow-up Form. In addition, in order to evaluate the effectiveness of the education given to the patients in the intervention (education) group, the Practices for Coping with the Side Effects of Hormone Therapy Form will be completed in the 5th and 9th weeks. The control group consisting of women with breast cancer who agreed to participate in the study will be administered pre-test evaluations at week 1 and post-test evaluations at week 9. The patients in the control group will not be subjected to any intervention by the researcher, their routine treatment and care will continue, and they will be followed up only once in the 5th week by phone call. ### Conditions Module Conditions: - Breast Cancer Keywords: - Hormone therapy - Breast cancer - Cooling pillowcase - Hot flashes - Quality of life ### Design Module #### Design Info Allocation: NON_RANDOMIZED Intervention Model: PARALLEL Intervention Model Description: The intervention group will fill in the 'Patient Information Form, Menopause Specific Hot Flash Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' in the 1st week and will be given training on treatment side effects, training booklet and 'Hot Flash Diary' to record their hot flashes. The use of cooling pillowcase will be explained. In the 5th week, 'Practices for Coping with the Side Effects of Hormone Therapy Form' will be filled out to evaluate the training and the training will be repeated. In the 3rd and 7th weeks, 'Patient Follow-up Form' will be filled by telephone, and in the 5th week face to face. In the 9th week, 'Menopause Specific Hot Flush Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' and 'Practices Form for Coping with Side Effects of Hormone Therapy' will be completed to evaluate the training given in the 5th week. The routine care and treatment of the control group will be continued. ##### Masking Info Masking: NONE Primary Purpose: SUPPORTIVE_CARE #### Enrollment Info Count: 64 Type: ESTIMATED Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: The intervention group will be given 'Patient Information Form, Menopause Specific Hot Flash Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' to be filled in the 1st week, training on treatment side effects, training booklet and 'Hot Flash Diary' to record the hot flashes they experience. A cooling pillowcase will be given and its use will be explained. In the 5th week, 'Practices for Coping with the Side Effects of Hormone Therapy Form' will be filled out to evaluate the training given and the training will be repeated. A total of 3 follow-ups will be carried out by using the 'Patient Follow-up Form' by telephone in the 3rd and 7th weeks and face-to-face interview in the 5th week. In the 9th week, 'Menopause Specific Hot Flush Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' and 'Practices for Coping with Side Effects of Hormone Therapy Form' will be completed to evaluate the effectiveness of the retraining given in the 5th week. Intervention Names: - Other: Cooling Pillowcases Label: Cooling Pillowcases Type: EXPERIMENTAL #### Arm Group 2 Description: No intervention will be given to the patients in the control group. Label: Control Group Type: NO_INTERVENTION ### Interventions #### Intervention 1 Arm Group Labels: - Cooling Pillowcases Description: No intervention will be given to the patients in the control group. Name: Cooling Pillowcases Other Names: - Control group Type: OTHER ### Outcomes Module #### Primary Outcomes Description: All items in the scale are evaluated between '0' and '10' points. The highest score that can be obtained from the scale is '100' and the lowest score is '0'. The higher the score obtained from the scale, the higher the woman's level of being affected by hot flushes. Measure: Menopausal Hot Flush Scale Time Frame: nine weeks #### Secondary Outcomes Description: The scale consists of 7 sub-dimensions. Each of the questions including the sub-dimension is scored between 0-3. The total score of the seven sub-dimensions varies between 0-21 and gives the total score of The Pittsburgh Sleep Quality Index. A total score above 5 indicates poor sleep quality. Measure: The Pittsburgh Sleep Quality Index Time Frame: nine weeks Description: The responses in the scale are organised in a 5-point Likert scale where '0' means not at all, '1' means very little, '2' means a little, '3' means quite a lot and '4' means very much. Some of the statements in the scale are reversed, and while calculating the total score of the scale, the reversed statements are subtracted from four and the other statements are directly added to the scoring. The total score that can be obtained from the scale varies between 0-148. A higher total score indicates a better quality of life. Measure: Functional Assessment Of Cancer Therapy-Breast (FACT-B) Time Frame: nine weeks ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * 18 years of age or older, * Estrogen and progesterone receptor positive, stage 1, 2, 3 or 4 primary breast cancer, * Receiving hormone therapy (goserelin acetate subcutaneously every 4 weeks), * Pre/Perimenopausal period, * No sensory and emotional barriers to communication, * Understands Turkish, can read and write, * Patients who voluntarily agreed to participate in the study. Exclusion Criteria: * Receiving treatment for anxiety and/or depression, * Receiving gabapentin treatment for neuropathic pain, * Active viral or bacterial infection, * Patients with a history of sleep disorders diagnosed before hormone therapy. Minimum Age: 18 Years Sex: FEMALE Standard Ages: - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: basak.turkmen4234@gmail.com Name: Basak Turkmen, Msc. Phone: +905377217410 Role: CONTACT Contact 2: Email: semihaakin@sbu.edu.tr Name: Semiha Akin Eroglu, Prof. Phone: +902167779317 Role: CONTACT #### Locations Location 1: City: Istanbul Contacts: *Contact 1:* - Name: Basak Turkmen - Role: CONTACT *Contact 2:* - Name: Semiha Akin Eroglu - Role: CONTACT Country: Turkey Facility: University of Health Science Status: RECRUITING #### Overall Officials Official 1: Affiliation: University of Health science Name: Basak Turkmen, Msc. Role: PRINCIPAL_INVESTIGATOR Official 2: Affiliation: University of Health science Name: Semiha Akin Eroglu, Prof. Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M8610 - Name: Flushing - Relevance: LOW - As Found: Unknown - ID: M21519 - Name: Hot Flashes - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415149 Acronym: HPSD Brief Title: High-Power, Short-Duration Ablation in Treatment of Patients With Atrial Fibrillation Official Title: High-Power, Short-Duration Ablation in Treatment of Patients With Atrial Fibrillation #### Organization Study ID Info ID: 27711 #### Organization Class: OTHER Full Name: People's Friendship University of Russia ### Status Module #### Completion Date Date: 2024-03-01 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-30 Type: ACTUAL Last Update Submit Date: 2024-05-28 Overall Status: COMPLETED #### Primary Completion Date Date: 2023-02-01 Type: ACTUAL #### Start Date Date: 2022-02-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Collaborators Class: OTHER Name: City Clinical Hospital No.1 named after N.I. Pirogov #### Lead Sponsor Class: OTHER Name: People's Friendship University of Russia #### Responsible Party Investigator Affiliation: People's Friendship University of Russia Investigator Full Name: afsoon fayez Investigator Title: Dr. Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Atrial fibrillation (AF) stands as the most common type of cardiac arrhythmia. The frequency of AF in the overall population is 1-2%, with the incidence rate increasing with age from 0.5% in the 40-50 years old to 5-15% in those aged 80. \[According to current recommendations for catheter ablation (CA) in patients with AF, the isolation of the pulmonary veins (PV) is a pivotal aspect of treating this arrhythmia. Despite recent advancements, 20-45% of patients experience recurrences after PV isolation. According to the study by Wasmer K. et al., it was demonstrated that most patients with recurrent AF after PVI showed at least one reconnected vein during redo procedures. The primary cause of recurrences is the restoration of conduction, attributed to endurable isolation (non-transmural, intermittent RF). Numerous approaches have been presented to enhance the outcomes of surgical treatment for AF, such as the CLOSE protocol and Ablation Index (AI) . CLOSE protocol represents an approach aimed at isolating the PV ostia through precise continuous (distance between points ≤ 6 mm) radiofrequency intervention, achieving target ablation index values of ≥ 400au for the posterior wall and ≥ 500au for the anterior wall. The Ablation Index is a marker of quality lesion formation, providing a visual representation of the lesion based on the integration of power, contact force, and time parameters, which is displayed on the CARTO® 3 system (Biosense Webster). Throughout radiofrequency ablation, electromagnetic energy undergoes conversion into thermal energy, leading to tissue damage and temperature elevation. The temperature elevation process encompasses two stages: resistive heating, impacting surface tissues (1-2mm), and conductive heating, which facilitates the transfer of heat from surface tissues to underlying tissues. In the presence of good catheter-endocardium contact (25%), only 9% of the power is effectively delivered to the endocardium. For instance, at a power level of 30 watts and optimal contact (25%) with the endocardium, merely 2.7 watts are transferred to the endocardial tissue. When applying 30 watts of power for 30 seconds, a total energy delivery of 900 joules occurs, with only 90 joules being imparted to the endocardium. Similarly, at 50 watts for 10 seconds, only 45 joules of energy are transmitted to the endocardium. When operating at 10 watts, the catheter temperature elevates by 13°C. Consequently, at 30 watts, the temperature reaches 39°C, and at 50 watts, it rises to 65°C. The formation of an irreversible lesion necessitates a temperature exceeding 50°C. During standard radiofrequency ablation (RFA) procedures with power settings ranging from 20 to 45 watts and a duration of 20 to 60 seconds, the formation of ablation points predominantly occurs during the conductive heating phase. High power short duration ablation (HPSD) is an approach that reduces the conductive heating phase while increasing the resistive heating phase. This results in an expanded area of lesion, facilitating the formation of transmural lesions in the atrial myocardium with irreversible tissue damage and reduced risk to surrounding structures, such as thermal injury to the esophagus. The strategy of HPSD ablation was developed to overcome limitations of the traditional approach. However, much remains unknown regarding the safety and effectiveness of this approach. Additionally, the question for the optimal interventional treatment method for atrial fibrillation (AF) and the selection of the optimal RF energy for pulmonary vein isolation still require confirmation. This forms the basis for our research objective. Detailed Description: The research was a multi-center retrospective blind randomized controlled trial between 2021 and 2023. A comprehensive sample of 185 participants was enrolled in the study and categorized into 2 cohorts, each of which was further subdivided into two subgroups. Patients were enrolled in the study after providing informed consent. In the first group (n=95), PVI was performed with power of 50 watts in Ia subgroup (n=55) AI was 400-450 arbitrary units (au) for the posterior wall and 500-550 au for the anterior wall, in Ib (n=40) AI was 400-450 au for the posterior wall and 450-500 au for the anterior wall. In the second group (n=90), PVI was performed at a power of 45 watts, in IIa (n=50) with target AI of 400-450 au for the posterior wall and 500-550 au for the anterior wall in IIb (n=40) AI of 400-450 au for the posterior wall and 450-500 au for the anterior wall. Assessment of conduction block was performed 20 minutes after RFA using a twenty-pole diagnostic electrode (Lasso, Biosense Webster, USA). ### Conditions Module Conditions: - Atrial Fibrillation - Paroxysmal Atrial Fibrillation - Persistent Atrial Fibrillation Keywords: - high-power, short-duration - catheter ablation ### 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: 185 Type: ACTUAL Phases: - NA Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Description: Group 1 (n=95): pulmonary vein isolation for treatment of atrial fibrillation was performed with power of 50 watts in Ia subgroup (n=55) AI (ablation index) was 400-450 arbitrary units (au) for the posterior wall and 500-550 au for the anterior wall, in Ib (n=40) AI was 400-450 au for the posterior wall and 450-500 au for the anterior wall. Intervention Names: - Procedure: High power short duration ablation with 50 W Label: High power short duration ablation with 50 W Type: EXPERIMENTAL #### Arm Group 2 Description: Group 2 (n=90): Pulmonary vein islolation was performed at a power of 45 watts, in IIa subgroup (n=50) with target AI of 400-450 au for the posterior wall and 500-550 au for the anterior wall in IIb (n=40) AI of 400-450 au for the posterior wall and 450-500 au for the anterior wall. Intervention Names: - Procedure: High power short duration ablation with 45 W Label: High power short duration ablation with 45 W Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - High power short duration ablation with 50 W Description: Group 1 (n=95): pulmonary vein isolation for treatment of atrial fibrillation was performed with power of 50 watts in Ia subgroup (n=55) AI (ablation index) was 400-450 arbitrary units (au) for the posterior wall and 500-550 au for the anterior wall, in Ib (n=40) AI was 400-450 au for the posterior wall and 450-500 au for the anterior wall. Name: High power short duration ablation with 50 W Type: PROCEDURE #### Intervention 2 Arm Group Labels: - High power short duration ablation with 45 W Description: Group 2 (n=90): Pulmonary vein islolation was performed at a power of 45 watts, in IIa subgroup (n=50) with target AI of 400-450 au for the posterior wall and 500-550 au for the anterior wall in IIb (n=40) AI of 400-450 au for the posterior wall and 450-500 au for the anterior wall. Name: High power short duration ablation with 45 W Type: PROCEDURE ### Outcomes Module #### Primary Outcomes Description: 1-Radiofrequency (RF) ablation duration from start of first pulmonary vein isolation to end of 2-the last lesion. 3-Total Procedure duration. 4-First pass PVI. 5-Interoperative complications. 6-Total RF energy delivery. 7-Number of RF lesions required for PVI. 8-Freedom from Atrial Fibrillation. Measure: Interoperative outcomes Time Frame: During ablation Description: 1. The proportion of patients maintaining Freedom from Atrial Fibrillation. 2. Overall Complication rate. Measure: Blinded period Time Frame: 1- 3 months after ablation #### Secondary Outcomes Description: 1. The proportion of patients maintaining Freedom from Atrial Fibrillation. 2. The proportion of patients with PV reconnection seen at repeat EP study. Measure: Long-term outcomes Time Frame: 6 -12 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: Symptomatic atrial fibrillation (AF) or resistance to at least one antiarrhythmic drug from the first or third group of antiarrhythmic drugs. Exclusion Criteria: 1. Left atrial thrombosis 2. significant coronary artery disease requiring revascularization 3. valvular heart disease requiring surgical correction 4. acute infectious diseases 5. severe heart failure (NYHA class IV) or left ventricular ejection fraction (LVEF) \<35%, 6. history of stroke within the past 3 months. Sex: ALL Standard Ages: - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations Location 1: City: Moscow Country: Russian Federation Facility: People's friendship university of Russia Zip: 117198 ### IPD Sharing Statement Module IPD Sharing: YES ### References Module #### References Citation: Fayez A. , Safonov N. V., Steklov A. S., Faybushevich A. G., Baranovich V. Y. HIGH POWER SHORT DURATION ABLATION USING ABLATION INDEX (AI) IN PATIENTS WITH ATRIAL FIBRILATION // Современная наука: актуальные проблемы теории и практики. Серия: Естественные и Технические Науки. -2023. -№02. -С. 244-250 DOI 10.37882/2223-2966.2023.02.37 #### See Also Links Label: Related Info URL: http://www.nauteh-journal.ru/index.php/3/2023/%E2%84%9602/6eeb3f6b-3db1-4629-a415-ba018dbd9cbf?lang=en_EN ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001281 - Term: Atrial Fibrillation ### Intervention Browse Module - Ancestors - ID: D000000316 - Term: Adrenergic alpha-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000013566 - Term: Sympathomimetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000014663 - Term: Nasal Decongestants - ID: D000014662 - Term: Vasoconstrictor Agents - ID: D000019141 - Term: Respiratory System Agents ### Intervention Browse Module - Browse Branches - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSSti - Name: Central Nervous System Stimulants ### Intervention Browse Module - Browse Leaves - ID: M13031 - Name: Oxymetazoline - Relevance: HIGH - As Found: Formula - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3668 - Name: Adrenergic alpha-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M16345 - Name: Sympathomimetics - Relevance: LOW - As Found: Unknown - ID: M7966 - Name: Ephedrine - Relevance: LOW - As Found: Unknown - ID: M27586 - Name: Pseudoephedrine - Relevance: LOW - As Found: Unknown - ID: M17410 - Name: Nasal Decongestants - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000010109 - Term: Oxymetazoline ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415136 Brief Title: Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating Official Title: Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating #### Organization Study ID Info ID: SeaSpine-001 #### Organization Class: NETWORK Full Name: Research Source ### Status Module #### Completion Date Date: 2027-05 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2025-05 Type: ESTIMATED #### Start Date Date: 2023-05-05 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: NETWORK Name: Research Source #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: False Oversight Has DMC: False ### Description Module Brief Summary: The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine. Detailed Description: This is a retrospective, prospective, post-market, observational, single-center, single surgeon study evaluating the use of the SeaSpine Shoreline device. Patients will be identified by the Investigator as needing, or already received the device during a cervical fusion surgery and meeting all the inclusion and none of the exclusion criteria. ### Conditions Module Conditions: - Degenerative Disc Disease - Disc Herniation ### Design Module #### Design Info Observational Model: COHORT Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 40 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: All enrolled patients will receive the SeaSpine Shoreline device. Intervention Names: - Device: SeaSpine Shoreline Label: SeaSpine Shoreline ### Interventions #### Intervention 1 Arm Group Labels: - SeaSpine Shoreline Description: The SeaSpine Shoreline device is a minimally invasive cervical plate/cage system. Name: SeaSpine Shoreline Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Motion, bridging on radiograph, and bridging bone on CT scan Measure: Cervical fusion assessed via CT scan Time Frame: 12 months post surgery Description: Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome. Measure: Clinical outcome via neck visual analog scale (VAS) Time Frame: 12 months post surgery Description: Standard of care patient reported neck disability index (NDI) will be used to evaluate patient pain and quality of life. On a vertical scale of 0 to 5 with a score of 0 meaning neck pain (if any) does not interfere with life activities and 5 meaning neck pain strongly interferes with life activities. A low score means a better clinical outcome. A high score means a worse clinical outcome. Measure: Clinical outcome via neck disability index (NDI) Time Frame: 12 months post surgery Description: Standard of care patient reported dysphagia score will be used to evaluate patient inability or difficulty swallowing. On a scale of 0 to 4 with a score of 0 meaning no difficulty and 4 meaning severe problem. A low score means a better clinical outcome. A high score means a worse clinical outcome. Measure: Clinical outcome via Dysphagia score Time Frame: 12 months post surgery ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Appropriate patient, as determined by the Investigator, scheduled for an elective cervical spine fusion to treat adjacent level cervical disc herniation or degeneration resulting in cervical radiculopathy or myelopathy 2. At least 18 years of age 3. Failure of nonoperative care 4. Previous anterior cervical plating 5. Psychosocially, mentally and physically able to comply with this protocol including adhering to follow-up schedule and study requirements Exclusion Criteria: 1. Pregnancy or anticipated to become pregnant during the course of the study 2. No previous cervical spine surgery 3. Non-instrumented cervical fusion 4. Cervical fusion with separate plate fixation 5. Unwilling or unable to sign consent 6. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol 7. Currently a prisoner Healthy Volunteers: True Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the SeaSpine Shoreline device during the surgical procedure. If the surgeon decides intra-operatively not to utilize the SeaSpine Shoreline device, the patient will be considered a screen failure. ### Contacts Locations Module #### Locations Location 1: City: Southfield Country: United States Facility: Michigan Orthopaedic Surgeons State: Michigan Zip: 48033 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006547 - Term: Hernia - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M9625 - Name: Hernia - Relevance: LOW - As Found: Unknown - ID: M10439 - Name: Intervertebral Disc Displacement - Relevance: HIGH - As Found: Disc Herniation - ID: M28405 - Name: Intervertebral Disc Degeneration - Relevance: HIGH - As Found: Degenerative Disc Disease - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007405 - Term: Intervertebral Disc Displacement - ID: D000055959 - Term: Intervertebral Disc Degeneration ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415123 Brief Title: Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft Official Title: A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF) #### Organization Study ID Info ID: CT-003 #### Organization Class: NETWORK Full Name: Research Source ### Status Module #### Completion Date Date: 2027-05 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2026-05 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-09 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: NETWORK Name: Research Source #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: False Oversight Has DMC: False ### Description Module Brief Summary: The purpose of this study is to demonstrate the performance of MagnetOs Flex Matrix in patients with leg pain and/or back pain. Detailed Description: This is a prospective, randomized, multi-center study that intends to demonstrate the performance of MagnetOs Flex Matrix compared to Cellular Allograft in patients with leg pain and/or back pain requiring up to four-level instrumented PLF surgery. ### Conditions Module Conditions: - Degenerative Disc Disease ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 30 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 Description: MagnetOsTM Flex Matrix is a resorbable and osteoconductive bone graft for the repair of bony defects. Name: MagnetOs Flex Matrix Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: The percentage of the posterolateral sides with bridging bone for the MagnetOs Flex Matrix and control treatments using CT-scans and determined by evidence of bridging trabeculae or continuous bony connection between superior and inferior transverse processes. Measure: Posterolateral side fusion Time Frame: 12 months post surgery #### Secondary Outcomes Description: Posterolateral lumbar/thoraco-lumbar fusion at Month 6 post-surgery assessed by CT-scans Measure: Posterolateral lumbar/thoraco-lumbar fusion Time Frame: 6 months post surgery Description: Standard of care patient reported Oswestry Low Back Pain Disability Questionnaire (ODI) will be used to evaluate patient pain. On a scale of 0 to 6 with a score of 0 being no pain and a score of 5 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome. Measure: Clinical outcome via Oswestry Low Back Pain Disability Questionnaire (ODI) Time Frame: 12 months post-surgery Description: Number of patients with revisions, re-operations, removals, supplemental fixations, and any other procedure that adjust or in any way remove part of the original implant configuration with or without replacement of the components within 12 months post-surgery. A low score (numbers of revisions, reoperations, etc.) means better safety outcome. A high score (numbers of revisions, reoperations, etc.) means a worse safety outcome. Measure: Secondary Surgical Interventions (SSI's) Time Frame: 12 months post-surgery Description: Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome. Measure: Clinical outcome via neck visual analog scale (VAS) Time Frame: 12 months post-surgery ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent. 2. Male or female patient ≥ 18 years old. 3. Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1). 4. Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment. Exclusion Criteria: 1. Requires greater than four-level fusion or expected to need secondary intervention within one year following surgery. 2. Had prior PLF fusion or attempted PLF fusion at the involved levels. 3. Had previous decompression at the involved levels. 4. Women who are or intend to become pregnant within the next 12 months. 5. To treat conditions in which general bone grafting is not advisable. 6. In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible). 7. In case of significant vascular impairment proximal to the graft site. 8. In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing. 9. In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis). 10. When intraoperative soft tissue coverage is not planned or possible. 11. Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space. 12. Receiving treatment with medication interfering with calcium metabolism. 13. Has leg pain, and/or back pain related to benign or malignant tumor. 14. Has history or presence of active malignancy. 15. Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements. 16. Is involved in active litigation relating to his/her spinal condition. 17. Has participated in an investigational study within 30 days prior to surgery for study devices Healthy Volunteers: True Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Patient with leg pain and/or back pain requiring treatment with up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (PLF) and who meet the following inclusion criteria and none of the exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the MagnetOs Flex Matrix during the surgical procedure. If the surgeon decides intra-operatively not to utilize the MagnetOs Flex Matrix, the patient will be considered a screen failure. ### Contacts Locations Module #### Locations Location 1: City: Southfield Country: United States Facility: Michigan Orthopaedic Surgeons State: Michigan Zip: 48033 ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M28405 - Name: Intervertebral Disc Degeneration - Relevance: HIGH - As Found: Degenerative Disc Disease - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055959 - Term: Intervertebral Disc Degeneration ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415110 Brief Title: A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion Official Title: A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion #### Organization Study ID Info ID: Allosync Expand #### Organization Class: NETWORK Full Name: Research Source ### Status Module #### Completion Date Date: 2027-05 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2026-05 Type: ESTIMATED #### Start Date Date: 2024-05 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: NETWORK Name: Research Source #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is US Export: False Oversight Has DMC: False ### Description Module Brief Summary: The purpose of this study is to assess the radiographic and clinical outcomes of spinal fusion following use of Allosync Expand and autograft bone graft. Detailed Description: This is a single site, prospective study with patients selected as study subjects from the Investigator's standard patient population who fulfill the Inclusion/Exclusion Criteria and agree to participate in the study. The study surgery is standard of care, with patients identified as requiring surgery prior to enrollment. The study surgery is lumbar posterior fixation with supplemental posterolateral fusion at from 1 to 3 levels. One side of the posterolateral fusion will be Allosync Expand (utilizing the BMA Angel kit to hydrate) and the other side to autograft bone (control). ### Conditions Module Conditions: - Spondylolisthesis, Grade 1 ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 40 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: All enrolled patients will received Allosync Expand at 1-3 contiguous levels (L1-S1). Intervention Names: - Device: Allosync Expand Label: Allosync Expand ### Interventions #### Intervention 1 Arm Group Labels: - Allosync Expand Description: Allosync Expand is used in lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1) Name: Allosync Expand Other Names: - Acceell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Connexus) Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Lumbar fusion rate assessed via CT at 12 months post surgery Measure: Lumbar fusion rate assessed via CT Time Frame: 12 months post surgery #### Secondary Outcomes Description: Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome. Measure: Clinical outcome via neck visual analog scale (VAS) Time Frame: 12 months post surgery Description: Standard of care patient reported Overall Quality of Life (EQ-5D) EuroQol Research Foundation will be used to evaluate patient quality of life. On a scale of 3 levels: no problems, some problems, and extreme problems. With a score of "no problems" being no interference in quality of life and a score of "extreme problems" being a high interference in quality of life. "No problems" responses means a better clinical outcome. "Extreme problems" responses mean a worse clinical outcome. Measure: Clinical outcome via Overall Quality of Life (EQ-5D) EuroQol Research Foundation Time Frame: 12 months post surgery Description: Standard of care patient reported PROMIS short form - Physical Evaluation will be used to evaluate patient physical function. On a scale of 5 levels: without any difficulty, with a little difficulty, with some difficulty, with much difficulty, and unable to do. With a score of "without any difficulty" being no interference in physical function and a score of "unable to do" being high interference in physical function. "Without any difficulty" means a better clinical outcome. "Unable to do" means a worse clinical outcome. Measure: Clinical outcome via PROMIS short form - Physical Evaluation Time Frame: 12 months post surgery ### Eligibility Module Eligibility Criteria: Inclusion Criteria: 1. At least 22years of age at the time of consent 2. Subject must have a documented diagnosis of spondylolisthesis up to Grade I. and have confirmed back and/or radicular pain with associated spinal stenosis as documented by conditions such as: 1. Instability as defined by \>3mm translation or \>5 degree angulation 2. Osteophyte formation of facet joints or vertebral endplates 3. Subject presents with one or more of the following: 1. Radiculopathy 2. Sensory deficit 3. Motor weakness 4. Reflex changes 4. Subject requires lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1). 5. The number of levels decompressed must equal the number of levels fused. 6. Subject must have been unresponsive to conservative care for at least 3 months prior to fusion surgery. 7. Subject must be willing and able to sign an informed consent document. 8. Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen. Exclusion Criteria: 1. Subject has had prior lumbar spine fusion surgery at any level. 2. Subject has greater than grade 1 spondylolisthesis of the lumbar spine. 3. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis 4. Subject has an active local or systemic infection. 5. Subject is a prisoner 6. Patient has any condition (including malignancy), that in the opinion of the Investigator, would prohibit the patient from complying with and/or completing the protocol Minimum Age: 22 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the Allosync Expand during the surgical procedure. If the surgeon decides intra-operatively not to utilize Allosync Expand, the patient will be considered a screen failure. ### Contacts Locations Module #### Locations Location 1: City: Southfield Country: United States Facility: Michigan Orthopaedic Surgeons State: Michigan Zip: 48033 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013169 - Term: Spondylolysis - ID: D000055009 - Term: Spondylosis - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15963 - Name: Spondylolisthesis - Relevance: HIGH - As Found: Spondylolisthesis - ID: M15964 - Name: Spondylolysis - Relevance: LOW - As Found: Unknown - ID: M27993 - Name: Spondylosis - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013168 - Term: Spondylolisthesis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415097 Brief Title: Benefits of Smart Pens in Type 1 Diabetes Official Title: Benefits of Smart Pens in People With Type 1 Diabetes: a Real-word Retrospective Study. #### Organization Study ID Info ID: SMART PENS_RW #### Organization Class: OTHER Full Name: Fundación para la Investigación del Hospital Clínico de Valencia ### Status Module #### Completion Date Date: 2024-12 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-14 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-12 Type: ESTIMATED #### Start Date Date: 2024-07 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-01-23 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor Class: OTHER Name: Fundación para la Investigación del Hospital Clínico de Valencia #### Responsible Party Investigator Affiliation: Fundación para la Investigación del Hospital Clínico de Valencia Investigator Full Name: Francisco Javier Ampudia Blasco 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 address persistent challenges in achieving recommended control goals for patients with type 1 diabetes through innovative interventions. Specifically, the research focuses on assessing the effectiveness of smart insulin pens combined with glucose monitoring devices as a promising treatment option for individuals on multiple daily insulin injections. The study will analyze electronic health records from adults (≥ 18 years) attending the Diabetes Unit of the University Clinical Hospital of Valencia. Participants who are or have used smart insulin pens will be compared with a control group matched for age, sex, duration of diabetes, and HbA1c value at baseline (1:1). Data will be collected on participant characteristics, smart pen usage, glycemic control parameters, and daily insulin doses. The study also aims to identify adverse events associated with the use of smart pens. Ethical considerations include ensuring the anonymity of participant data, and the study is designed to comply with European (EU) data protection regulations. The retrospective nature ensures no interference with physicians' prescription habits. Detailed Description: Rationale: Despite ongoing advancements in type 1 diabetes management, a significant number of patients continue to struggle in attaining recommended control goals, posing an elevated risk of complications and a diminished quality of life. Hence, there is a need for innovative interventions that genuinely improve diabetes management and associated clinical outcomes. Smart insulin pens, coupled with glucose monitoring devices, emerge as a promising treatment option for individuals on multiple daily insulin injections who may not be suitable candidates for continuous subcutaneous insulin infusion (CSII) therapy. These easy-to-use devices offer significant advantages, such as automated tracking of administered insulin doses along with information other relevant diabetes-related data, facilitating treatment optimization, and helping overcome barriers to achieve better glucose control where both patients and healthcare professionals can implement treatment plans with agility, adopting a more proactive and personalized approach to diabetes care. While certain recent studies have shown positive outcomes in glycemic control and quality of life linked to the utilization of these devices, there is still a gap in understanding their impact under real-life conditions. Hence, conducting clinical studies within the framework of routine clinical practice becomes imperative to thoroughly assess their application and effects on individuals with type 1 diabetes undergoing multiple daily insulin injections. The purpose of this study is to provide real-world evidence on the effectiveness of smart pens in enhancing glycemic control and identify specific patient subgroups for targeted interventions. Hypothesis: Our hypothesis suggests that the use of smart pens in patients with type 1 diabetes receiving multiple daily insulin doses and utilizing glucose monitoring devices is associated with improved glycemic control. It is expected that the use of these devices is linked to a significant increase in time in range, a reduction in time below the target range, and a decrease in glucose variability during the usage period, compared to a control group. Primary objectives: * To describe the clinical characteristics of individuals with type 1 diabetes using smart pens for multiple daily insulin doses in the Valencia Clínico-Malvarrosa Health Department, comparing it with a control group. * To evaluate changes in glycemic control parameters (HbA1c and continuous glucose monitoring parameters) as well as the incidence of adverse events with the use of smart pens in patients with type 1 diabetes, comparing it with a control group in real-life conditions. Sample size: The sample will include all adults (≥ 18 years) with type 1 diabetes who attend or have attended the Diabetes Unit of the University Clinical Hospital of Valencia, using or having used smart insulin pens, along with a control group matched for age, sex, diabetes duration, and HbA1c value at the study's outset (1:1). Data and study procedure: Data for this study will be sourced from the electronic health records of adults (≥ 18 years) with type 1 diabetes who attend or have attended the Diabetes Unit of the University Clinical Hospital of Valencia. The medical records of all participants using or having used smart insulin pens and glucose monitoring devices, as well as a control group (1:1), will be reviewed. Retrospective data will be collected on participant characteristics, the type of smart insulin pen used, and individual changes in glycemic control (HbA1c and glucose monitoring device parameters), as well as daily insulin doses, starting from the date of smart pen prescription. Additionally, all adverse events occurring during the use of smart pens will be documented, specifying their type and frequency for each individual. All data will be compiled in an anonymous Microsoft Excel database, which will be deleted upon completion of the study. Anonymization will be performed by an individual external to the clinical research team. Ethical aspects: The study database will not contain any information allowing the individual identification of study participants. The data will be used exclusively for the purposes described in this project. The information will be considered confidential and will be stored and processed in accordance with EU Regulation 2016/679 of the European Parliament and the Council of April 27, 2016, regarding personal data and the free movement of this data, as per Organic Law 3/2018 of December. Although there are objectives related to medication use, being a retrospective study makes it impossible to alter the prescription habits of any physician in the unit under study. ### Conditions Module Conditions: - Type 1 Diabetes ### Design Module #### Design Info Observational Model: CASE_CONTROL Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 100 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Individuals with type 1 diabetes receiving multiple daily doses of insulin (MDI), utilizing glucose monitoring devices, and using or having used insulin smart pens. Intervention Names: - Device: Insulin Smart Pen Label: Type 1 Diabetes MDI Smart Pen Users #### Arm Group 2 Description: Patients with type 1 diabetes receiving multiple daily doses of insulin (MDI) and using glucose monitoring devices. Label: Type 1 Diabetes MDI Smart Pen Non-Users ### Interventions #### Intervention 1 Arm Group Labels: - Type 1 Diabetes MDI Smart Pen Users Description: Retrospective analysis of electronic health records for individuals with type 1 diabetes receiving multiple daily doses of insulin, combined with glucose monitoring devices and who have used or are currently using insulin smart pens. Name: Insulin Smart Pen Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: Type of smart pen prescribed (smart pen prescription) Measure: Type of smart pen prescribed Time Frame: up to 24 months Description: Type of basal insulin prescribed (basal insulin prescription) Measure: Type of basal insulin prescribed Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Daily dose of basal insulin (UI/kg) Measure: Daily dose of basal insulin Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Number of basal insulin injections per day Measure: Number of basal insulin injections Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Omission of basal insulin doses (Yes/No) Measure: Omission of basal insulin Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Type of insulin prescribed for prandial use (prandial insulin prescription) Measure: Type of prandial insulin prescribed Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Daily dose of prandial insulin (UI/kg) Measure: Daily dose of prandial insulin Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Number of prandial insulin injections per day Measure: Number of prandial insulin injections Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Omission of prandial insulin doses (Yes/No) Measure: Omission of prandial insulin Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Total daily insulin dose (UI/kg) Measure: Total daily insulin dose Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Number of total insulin injections per day Measure: Number of total insulin injections Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Self-monitoring of capillary blood glucose (SMBG) (Y/N) Measure: Self-monitoring of capillary glucose Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Glucose monitoring in real-time or intermittently scanned (Yes/No) Measure: Glucose monitoring device Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Percentage of time using the glucose monitoring device Measure: Time using the glucose monitoring device Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: HbA1c concentration: at month -3, 0, 3, 6, 12, 18, and 24. Measure: HbA1c concentration Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Time in Range (%TIR): at month -3, 0, 3, 6, 12, 18, and 24. Measure: Time in Range (%TIR) Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Time Below Range (%TbR): at month -3, 0, 3, 6, 12, 18, and 24. Measure: Time Below Range (%TbR) Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Time Above Range (%TaR): at month -3, 0, 3, 6, 12, 18, and 24. Measure: Time Above Range (%TaR) Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Mean glucose (mg/dL): at month -3, 0, 3, 6, 12, 18, and 24. Measure: Mean glucose (mg/dL) Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Coefficient of variation of continuous glucose sensor values (CV): at month -3, 0, 3, 6, 12, 18, and 24. Measure: Coefficient of variation of continuous glucose sensor values (CV) Time Frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Type of adverse event from the initiation of the prescription of smart insulin pens (if any adverse event occurred): severe hypoglycemia, DKA (Diabetic Ketoacidosis), ketosis, other Measure: Type of adverse event from the initiation of the prescription of smart insulin pens. Time Frame: up to 24 months (from the time of the first prescription and throughout the study follow-up) Description: Number of months post smart pen prescription when the adverse event occurred (nº). Measure: Months post smart pen prescription when the adverse event occurred. Time Frame: up to 24 months (from the time of the first prescription and throughout the study follow-up) Description: Adherence to data transfer in the mobile application when using the smart pen: at month 6, 12, 18, 24 Measure: Adherence to smart insulin pen usage based on the number of days with data uploads Time Frame: up to 24 months (from the time of the first prescription and throughout the study follow-up) Description: Persistence in the use of smart insulin pens after prescription: at month 6, 12, 18, 24 Persistence defined as the percentage of patients continuing treatment since the first smart pen prescription until discontinuation. Measure: Smart pen persistence Time Frame: up to 24 months (from the time of the first prescription and throughout the study follow-up) Description: Exclusive use of smart insulin pens or mixed use with disposable pens (Yes/No) Measure: Exclusive use of smart pen Time Frame: up to 24 months (from the time of the first prescription and throughout the study follow-up) Description: Duration of diabetes at the time of the first smart pen prescription (years) Measure: Duration of diabetes Time Frame: up to 12 months Description: Diabetic ketoacidosis (DKA) in the year prior to the initiation of the smart pen (Yes/No) Measure: Diabetic ketoacidosis Time Frame: up to 12 months Description: Severe hypoglycemia in the year prior to the initiation of the smart pen (Yes/No) Measure: Severe hypoglycemia Time Frame: up to 12 months Description: BMI (kg/m2): at month -3, 0, 6, 12, 18, 24 Measure: BMI Time Frame: From three months before the initiation of the first prescription and up to 24 months (throughout the study follow-up) Description: Age at the time of the first smart pen prescription (years) Measure: Age Time Frame: up to 12 months ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Individuals aged 18 or above * Individuals diagnosed with type 1 diabetes * Individuals receiving multiple daily doses of insulin * Individuals using a glucose monitoring device * Individuals who use or have used smart insulin pens since their introduction to the market Exclusion Criteria: * Individuals with other types of diabetes * Individuals utilizing continuous subcutaneous insulin infusion devices * Individuals using automatic insulin delivery systems Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Population aged 18 years and older registered in the Population Information System of the Valencian Community (SIP), with an assigned doctor and belonging to the Valencia Clínico - Malvarrosa health department (approximately 320,000 citizens). ### Contacts Locations Module #### Central Contacts Contact 1: Email: ana.palanca@gmail.com Name: Ana Palanca, MD, MPH, PhD Phone: 96 197 35 17 Role: CONTACT Contact 2: Email: ampudia_fra@gva.es Name: F. Javier Ampudia-Blasco, MD, PhD Phone: 961 97 35 00 Role: CONTACT #### Locations Location 1: City: Valencia Country: Spain Facility: INCLIVA Zip: 46010 #### Overall Officials Official 1: Affiliation: HCUV-INCLIVA Name: F. Javier Ampudia-Blasco, MD, PhD Role: PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415084 Acronym: PHyperEG1 Brief Title: Prevalence of Hyperemesis Gravidarum Official Title: Hyperemesis Gravidarum Prevalence : A Repeated Cross-sectional Population Based Study #### Organization Study ID Info ID: RNI 2024 VENDITTELLI #### Organization Class: OTHER Full Name: University Hospital, Clermont-Ferrand ### Status Module #### Completion Date Date: 2026-04 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2025-10 Type: ESTIMATED #### Start Date Date: 2024-07 Type: ESTIMATED Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-07 Study First Submit QC Date: 2024-05-14 ### Sponsor Collaborators Module #### Collaborators Class: INDUSTRY Name: Effik Class: OTHER Name: Université d'Auvergne Class: UNKNOWN Name: AUDIPOG #### Lead Sponsor Class: OTHER Name: University Hospital, Clermont-Ferrand #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: Nausea and vomiting during pregnancy represent one of the most common symptoms of pregnancy, affecting 35 to 91% of women. Most often, the symptoms are mild, without impairment of quality of life and disappear at the end of the first trimester. More severe forms constitute hyperemesis gravidarum (HG) (hyperemesis gravidarum). In approximately 35% of women, nausea and vomiting during pregnancy are disabling, alter daily life and professional activity and negatively affect family relationships. For 0.3 to 3.6% of pregnancies, this vomiting is uncontrollable and constitutes the main cause of hospitalization in the first trimester of pregnancy. Faced with the incomprehension and lack of knowledge of their illness, both in society and in the medical community, patient associations have been created in France to gain recognition for HG and raise awareness among caregivers and women about this illness and its consequences. Vomiting repeatedly for weeks, losing weight sometimes significantly, being weakened, no longer able to cope with daily life, family life and work, is what some women can experience while they are pregnant and that society tells them : "pregnancy is not an illness". Although HG is common, its real prevalence is unknown, particularly in France, because there have been few studies involving small samples. A population study is desirable because it is likely that the prevalence of these pregnancy aches differs depending on the country. This subject is important because vomiting during pregnancy has an impact on women's quality of life and their desire to become pregnant again. The main objective of this observation study is to evaluate the prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum), in the general population, in the first trimester of pregnancy. The secondary objectives are: * to assess the prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum), in the second and third trimesters of pregnancy, * to assess the prevalence of uncomplicated pregnancy-related nausea and/or vomiting in the three trimesters of pregnancy, * to evaluate the prevalence of hyperemesis gravidarum (with or without hospitalization) in the three trimesters of pregnancy, * to evaluate the prevalence of hyperemesis gravidarum requiring hospitalization in the three trimesters of pregnancy, * to evaluate the distribution of nausea and/or vomiting (mild, moderate and severe) according to the modified-PUQE score, in the three trimesters of pregnancy, * to evaluate the predictive factors for the occurrence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) in the first trimester of pregnancy, * to assess health-related quality of life in the event of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum), in the three trimesters of pregnancy, * and to compare health-related quality of life between women with pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) and those without, in the first trimester of pregnancy. Detailed Description: Study design: A repeated population based cross sectional survey. A woman can withdraw from the study early for the following reasons: * the woman's decision, * a major protocol deviation, * and loss to follow-up (a subject lost to follow-up is a participant who did not answer to all the surveys) The study may be stopped temporarily or permanently for the following reasons: * Recruitment too low or nonexistent, * Decision of the sponsor and of the investigator-coordinator. Methods of recruitment : The inclusion of women will take place after one of the 1st trimester ultrasounds. They will have to complete, from their home, an online self-questionnaire including, among other things, the modified-PUQE score assessing the severity of nausea and vomiting during the first trimester of pregnancy. Women who have had an early ultrasound, before 10 weeks of amenorrhea (WA), will be re-interviewed at the start of the 2nd trimester via an online questionnaire. Subsequently, women who responded in the 1st trimester and who present with hyperemesis gravidarum or uncomplicated pregnancy-related nausea and/or vomiting will be questioned, again, about the existence of nausea and vomiting just after the deadline for the 2nd trimester ultrasounds (between 20 WA+0 day and 25 WA+0 day) and 3rd trimester (between 30 WA+0 day and 35 WA+0 day), via an online self-questionnaire. ### Conditions Module Conditions: - Nausea and Vomiting Keywords: - Nausea vomiting - Pregnancy - Disease prevalence - Hyperemesis gravidarum ### Design Module #### Design Info Observational Model: OTHER Time Perspective: OTHER #### Enrollment Info Count: 604 Type: ESTIMATED Study Type: OBSERVATIONAL ### Outcomes Module #### Primary Outcomes Description: Prevalence of uncomplicated nausea and/or vomiting or with hyperemesis gravidarum. Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss \< 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6. Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. Measure: Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) Time Frame: First trimester of pregnancy (up to 13 weeks of gestation) #### Secondary Outcomes Description: Prevalence of uncomplicated nausea and/or vomiting or with hyperemesis gravidarum. Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss \< 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6. Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. Measure: Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) Time Frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation) Description: Prevalence of uncomplicated nausea and/or vomiting or with hyperemesis gravidarum. Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss \< 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6. Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. Measure: Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) Time Frame: Third trimester of pregnancy (>= 28 weeks of gestation) Description: Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss \< 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6. Measure: Prevalence of uncomplicated pregnancy-related nausea and vomiting Time Frame: First trimester of pregnancy (up to 13 weeks of gestation) Description: Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss \< 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6. Measure: Prevalence of uncomplicated pregnancy-related nausea and vomiting Time Frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation) Description: Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss \< 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6. Measure: Prevalence of uncomplicated pregnancy-related nausea and vomiting Time Frame: Third trimester of pregnancy (>= 28 weeks of gestation) Description: Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. Measure: Prevalence of hyperemesis gravidarum, with or without hospitalization Time Frame: First trimester of pregnancy (up to 13 weeks of gestation) Description: Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. Measure: Prevalence of hyperemesis gravidarum, with or without hospitalization Time Frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation) Description: Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. Measure: Prevalence of hyperemesis gravidarum, with or without hospitalization Time Frame: Third trimester of pregnancy (>= 28 weeks of gestation) Description: Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. The women are hospitalized. Measure: Prevalence of hyperemesis gravidarum with hospitalization Time Frame: First trimester of pregnancy (up to 13 weeks of gestation) Description: Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. The women are hospitalized. Measure: Prevalence of hyperemesis gravidarum with hospitalization Time Frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation) Description: Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. The women are hospitalized. Measure: Prevalence of hyperemesis gravidarum with hospitalization Time Frame: Third trimester of pregnancy (>= 28 weeks of gestation) Description: Distribution of nausea and vomiting according to the modified-PUQE score: mild (modified-PUQE score ≤ 6), moderate (modified-PUQE score ≥ 7 and ≤ 12) and severe (modified-PUQE score ≥ 13) vomiting. Measure: Distribution of mild, moderate and severe nausea and vomiting Time Frame: First trimester of pregnancy (up to 13 weeks of gestation) Description: Distribution of nausea and vomiting according to the modified-PUQE score: mild (modified-PUQE score ≤ 6), moderate (modified-PUQE score ≥ 7 and ≤ 12) and severe (modified-PUQE score ≥ 13) vomiting. Measure: Distribution of the modified-PUQE score Time Frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation) Description: Distribution of nausea and vomiting according to the modified-PUQE score: mild (modified-PUQE score ≤ 6), moderate (modified-PUQE score ≥ 7 and ≤ 12) and severe (modified-PUQE score ≥ 13) vomiting. Measure: Distribution of mild, moderate and severe nausea and vomiting Time Frame: Third trimester of pregnancy (>= 28 weeks of gestation) Description: The NVP-QOL questionnaire measures health-related quality of life in the last week and contains 30 items covering 4 general domains: physical symptoms and/or aggravating factors (9 items), fatigue (4 items), emotions (7 items), and limitations (10 iteùs). Each item is measured using a 7-point Likert scale from 1 ("none of the time") to 7 ("all the time"). A total score is obtained by summing the scores of each of the 30 items (with reversed score for item 20), and ranges between 30 (corresponding to good QOL) and 210 (corresponding to poor QOL). Measure: Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire Time Frame: First trimester of pregnancy (up to 13 weeks of gestation) Description: The NVP-QOL questionnaire measures health-related quality of life in the last week and contains 30 items covering 4 general domains: physical symptoms and/or aggravating factors (9 items), fatigue (4 items), emotions (7 items), and limitations (10 iteùs). Each item is measured using a 7-point Likert scale from 1 ("none of the time") to 7 ("all the time"). A total score is obtained by summing the scores of each of the 30 items (with reversed score for item 20), and ranges between 30 (corresponding to good quality of life) and 210 (corresponding to poor quality of life). Measure: Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire Time Frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation) Description: The NVP-QOL questionnaire measures health-related quality of life in the last week and contains 30 items covering 4 general domains: physical symptoms and/or aggravating factors (9 items), fatigue (4 items), emotions (7 items), and limitations (10 iteùs). Each item is measured using a 7-point Likert scale from 1 ("none of the time") to 7 ("all the time"). A total score is obtained by summing the scores of each of the 30 items (with reversed score for item 20), and ranges between 30 (corresponding to good quality of life) and 210 (corresponding to poor quality of life). Measure: Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire Time Frame: Third trimester of pregnancy (>= 28 weeks of gestation) Description: The SF-12 questionnaire measures generic health-related quality of life in the last week and includes a subset of 12 items from the commonly used SF-36 questionnaire. Information from all 12 items is used to calculate a physical component score (PCS) representing the physical health domain and a mental component score (MCS) representing the mental health domain. PCS and MCS range from 0 to 100, with higher scores indicating better quality of life. Measure: Self-administered "Short-Form 12" (SF-12) questionnaire Time Frame: First trimester of pregnancy (up to 13 weeks of gestation) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Women having a monitored pregnancy in Auvergne, * Major, * Speaking French, * Socially insured, * Having given their agreement to participate in the study. Exclusion Criteria: * Women refusing to participate in the study, * Not speaking French, * Major incapacitated persons. Gender Based: True Gender Description: Only pregnant women are included in this study. Healthy Volunteers: True Maximum Age: 50 Years Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: FEMALE Standard Ages: - ADULT Study Population: Women will be recruited for the study during their first-trimester ultrasound. They will be informed of the study by the sonographer, who will give them the link to access the first online study questionnaire. This questionnaire will enable tthe collect of the women's consent to particpate to the study, after online verification of eligibility criteria. ### Contacts Locations Module #### Central Contacts Contact 1: Email: promo_interne_drci@chu-clermontferrand.fr Name: Lise Laclautre Phone: 334.73.754.963 Role: CONTACT #### Overall Officials Official 1: Affiliation: University Hospital, Clermont-Ferrand Name: Françoise Vendittelli Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ### References Module #### References Citation: Gadsby R, Barnie-Adshead AM, Jagger C. A prospective study of nausea and vomiting during pregnancy. Br J Gen Pract. 1993 Jun;43(371):245-8. Erratum In: Br J Gen Pract 1993 Aug;43(373):325. PMID: 8373648 Citation: Einarson TR, Piwko C, Koren G. Quantifying the global rates of nausea and vomiting of pregnancy: a meta analysis. J Popul Ther Clin Pharmacol. 2013;20(2):e171-83. Epub 2013 Jul 13. PMID: 23863575 Citation: Attard CL, Kohli MA, Coleman S, Bradley C, Hux M, Atanackovic G, Torrance GW. The burden of illness of severe nausea and vomiting of pregnancy in the United States. Am J Obstet Gynecol. 2002 May;186(5 Suppl Understanding):S220-7. doi: 10.1067/mob.2002.122605. PMID: 12011890 Citation: Mazzotta P, Stewart D, Atanackovic G, Koren G, Magee LA. Psychosocial morbidity among women with nausea and vomiting of pregnancy: prevalence and association with anti-emetic therapy. J Psychosom Obstet Gynaecol. 2000 Sep;21(3):129-36. doi: 10.3109/01674820009075620. PMID: 11076334 Citation: Eliakim R, Abulafia O, Sherer DM. Hyperemesis gravidarum: a current review. Am J Perinatol. 2000;17(4):207-18. doi: 10.1055/s-2000-9424. PMID: 11041443 Citation: Heitmann K, Nordeng H, Havnen GC, Solheimsnes A, Holst L. The burden of nausea and vomiting during pregnancy: severe impacts on quality of life, daily life functioning and willingness to become pregnant again - results from a cross-sectional study. BMC Pregnancy Childbirth. 2017 Feb 28;17(1):75. doi: 10.1186/s12884-017-1249-0. PMID: 28241811 Citation: Lacasse A, Rey E, Ferreira E, Morin C, Berard A. Validity of a modified Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) scoring index to assess severity of nausea and vomiting of pregnancy. Am J Obstet Gynecol. 2008 Jan;198(1):71.e1-7. doi: 10.1016/j.ajog.2007.05.051. PMID: 18166311 Citation: Lacasse A, Berard A. Validation of the nausea and vomiting of pregnancy specific health related quality of life questionnaire. Health Qual Life Outcomes. 2008 May 9;6:32. doi: 10.1186/1477-7525-6-32. PMID: 18471301 Citation: Dochez V, Dimet J, David-Gruselle A, Le Thuaut A, Ducarme G. Validation of specific questionnaires to assess nausea and vomiting of pregnancy in a French population. Int J Gynaecol Obstet. 2016 Sep;134(3):294-8. doi: 10.1016/j.ijgo.2016.01.023. Epub 2016 May 19. PMID: 27262942 Citation: Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7. PMID: 9817135 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000048968 - Term: Morning Sickness - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12273 - Name: Nausea - Relevance: HIGH - As Found: Nausea - ID: M17582 - Name: Vomiting - Relevance: HIGH - As Found: Vomiting - ID: M9990 - Name: Hyperemesis Gravidarum - Relevance: HIGH - As Found: Hyperemesis Gravidarum - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M26009 - Name: Morning Sickness - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006939 - Term: Hyperemesis Gravidarum - ID: D000009325 - Term: Nausea - ID: D000014839 - Term: Vomiting ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415071 Brief Title: Hypertension Longitudinal Data Platform in Tianjin Official Title: Hypertension Longitudinal Data Platform Linked Electronic Health Records and Public Health Follow-up Database (HYLERP) in Tianjin, China #### Organization Study ID Info ID: HYLERP #### Organization Class: OTHER Full Name: West China Hospital ### Status Module #### Completion Date Date: 2021-12-31 Type: ACTUAL #### Expanded Access Info #### Last Update Post Date Date: 2024-05-17 Type: ACTUAL Last Update Submit Date: 2024-05-15 Overall Status: COMPLETED #### Primary Completion Date Date: 2021-12-31 Type: ACTUAL #### Start Date Date: 2015-01-01 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-08 Study First Submit QC Date: 2024-05-13 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: Tianjin Health Care Big Data Ltd. Class: UNKNOWN Name: Tianjin Health Commission #### Lead Sponsor Class: OTHER Name: West China Hospital #### Responsible Party Investigator Affiliation: West China Hospital Investigator Full Name: Sun Xin Investigator Title: Professor and director of Chinese Evidence-based Medicine Center Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: True ### Description Module Brief Summary: Hypertension is one of the leading causes of death globally, and ranks among the top four risk factors for mortality and DALYs in China. However, large-scale population based longitudinal research data source for hypertension is lacking in China. Thus, we aimed to establish the first and most extensive hypertension database in China using healthcare data from the Tianjin city. This hypertension longitudinal data platformlinked electronic medical records (EMR) system 35 stores healthcare data of 1.17 million hypertension patients, from 43 tertiary hospitals and 39 secondary hospitals, along with a public health follow-up management system. Data on demographics, diagnosis, drug prescription, laboratory test, physical examination, and cost information were collected, the median follow-up time was 4.3 \[ interquartile range (IQR): 2.7-5.8\] years, and the median number of outpatient visits was 32 (IQR: 15-64) per patient. This database can address research needs including, drug utilization pattern analysis, policy implementation evaluation, digital medical device development, and other real world evidence studies. These researches would provide robust evidence to assist improving patient health outcomes and healthcare system decision-making. ### Conditions Module Conditions: - Hypertension Keywords: - Longitudinal data platform - Electronic health records - Public health follow-up database ### Design Module #### Design Info Observational Model: COHORT Time Perspective: RETROSPECTIVE #### Enrollment Info Count: 1172280 Type: ACTUAL Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Other: No intervention Label: Patients diagnosed with hypertension ### Interventions #### Intervention 1 Arm Group Labels: - Patients diagnosed with hypertension Description: Exposures of interest would be clearly defined according to a specific research question and identified from the database Name: No intervention Type: OTHER ### Outcomes Module #### Primary Outcomes Description: The first occurence of stroke, acute myocardial infarcation and heart failure after index diagnosis. Cardiovasuclar events were determned from the first ICD-10 diagnosis code recorded in the database. Measure: Incidence rate of major adverse cardiovascular events Time Frame: From index diagnosis to the end of study date (Dec 31, 2021) Description: Counts of a composite adervese events after diagnosis including cardiac arrhythmia, gout, hyperkalaemia, hypocalaemia, hypotension, angioedema, fall, syncope, acute kidney injury and fracture. All ICD-10 diagnosis codes of adervese events among patients incurred after the index diagnosis were included to calculated the prevalence of adervese events. Measure: Prevalence of composite adervese events Time Frame: From index diagnosis to the end of study date (Dec 31, 2021) Description: The mortality records on patients were linked to the national mortality register information system, all-cause mortality and cardiovascular mortality were idenitified through death reaseon recoded in the mortality information system. Measure: Mortality rate Time Frame: From index diagnosis to the end of study date (Dec 31, 2021) Description: (1) Prescribing rate of different antihypertensive drug classes; (2) Substiution of generic drugs; (3) Number of drug therapy; (4) Different combination therapies; (4) Index prescription patterns and prevalent prescription patterns. Measure: Prescription patterns of antihypertensive medications Time Frame: From index prescrition to the end of study date (Dec 31, 2021) Description: Medical expenditures per outpatient visit or inpatient admission would be calculated including total expenditures, drug expenditures and non-drug related expenditures for patients undergoing treatment of hypertension, dyslipidemia, diabetes and chronic ischemic heart diesease. All medical expenditures statistcis were based on the cost information recorded in the electronic medical records database. Measure: Medical expenditures Time Frame: through study completion, an average of 7 year (from Jan 2015 to Dec 31, 2021) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Hypertension first diagnosed between January 1, 2015 and December 31, 2021 * Aged 18 years or older Exclusion Criteria: * None Minimum Age: 18 Years Sampling Method: NON_PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Our study population consisted of 1,172,280 patients aged 18 years or older with hypertension diagnosed between January 1, 2015 and December 31, 2021 in database. Hypertension was defined as having at least two outpatient diagnoses or one hospital discharge diagnosis of hypertension. ### Contacts Locations Module #### Locations Location 1: City: Chengdu Country: China Facility: The West China Hospital of Sichuan university State: Sichuan Zip: 610041 #### Overall Officials Official 1: Affiliation: West China Second University Hospital Name: Xin Sun, Phd Role: STUDY_DIRECTOR ### IPD Sharing Statement Module Description: According to the policy of Tianjin Health Commission, research institutions could apply for data access by submitting a formal study protocol, subjetced to approved by the Tianjin Health Care Big Data Ltd. and the Chinese Evidence -based Medicine Center. Ethical review and research registration are mandatory for all studies. IPD Sharing: YES ## 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: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415058 Brief Title: Study to Investigate Blood Samples Drawn With the HemoIV System Official Title: A Prospective, Nonrandomized Controlled Clinical Investigation of Blood Samples Drawn With the HEMOIV System During Continuous IV Flow #### Organization Study ID Info ID: HemoIV #### Organization Class: OTHER Full Name: Vanderbilt University Medical Center ### Status Module #### Completion Date Date: 2025-06 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-13 Overall Status: ENROLLING_BY_INVITATION #### Primary Completion Date Date: 2024-11 Type: ESTIMATED #### Start Date Date: 2024-04-29 Type: ACTUAL Status Verified Date: 2024-05 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-01 Study First Submit QC Date: 2024-05-13 ### Sponsor Collaborators Module #### Collaborators Class: UNKNOWN Name: MedTG LLC #### Lead Sponsor Class: OTHER Name: Vanderbilt University Medical Center #### Responsible Party Investigator Affiliation: Vanderbilt University Medical Center Investigator Full Name: Brian Bales Investigator Title: Associate Professor, Emergency Medicine Type: PRINCIPAL_INVESTIGATOR ### Oversight Module Is FDA Regulated Device: True Is FDA Regulated Drug: False Is Unapproved Device: True Is US Export: True Oversight Has DMC: False ### Description Module Brief Summary: The goal of this study is to compare blood drawn using a device called HemoIV to standard-of-care blood drawn from a vein in the arm or from an IV catheter. The HemoIV is a device that is attached to an IV line. This device allows for blood to be drawn while a patient is receiving IV fluids. The main questions it aims to answer are: * Will the HemoIV device allow blood to be drawn without having to stop IV fluids? * Will the HemoIV device provide the same laboratory results as blood draws done by current standard practice? Participants will: * Receive standard medical procedures and/or treatment; * Have a HemoIV device inserted into their IV line in one arm; * Have an blood drawn twice from the HemoIV and from an IV line or needle stick from a vein in the other arm. The second blood draw will be done about 8-22 hours after the first blood draw; * Have the device removed after the second blood draw; * Receive a phone call about 8 days later to see how you are doing. Detailed Description: The HemoIV investigational device allows for continuous administration of intravenous fluids for blood draw sampling without exposing patients to additional needle sticks, stoppage of intravenous therapy, and potential exposure to bacteria that are inherent risks when performing blood draws using traditional phlebotomy methods. The purpose of this study is to demonstrate the safety and effectiveness of the HemoIV system. Participants serve as their own control to compare blood measurement parameters. Blood measurements extracted from the participant will be used to compare the control blood sample(s) to the HemoIV blood sample(s). The contralateral arm to the placement of the HemoIV will be the control arm of the study. It is hypothesized that the HemoIV will provide blood samples within the equivalency margin, compared to standard practice (Venipuncture or Peripheral IV Catheter). The main objectives are: * To quantitatively measure and compare blood samples drawn with the HemoIV system during continuous intravenous infusion to blood samples from the contralateral arm to demonstrate safety and efficacy of the HemoIV system * To quantitatively measure and compare the potential advantages of HemoIV to Venipuncture or Peripheral IV Catheter blood draws Participant population will consist of adult patients admitted to the hospital for a medical condition in the emergency department, inpatient, or observation units and are requiring blood draws as well as intravenous fluids. Participants will: * Receive standard of care intravenous therapy via HemoIV inserted through an established peripheral IV catheter * Have blood samples obtained twice over a 24 hour period from the HemoIV and from an IV line or standard venipuncture from the contralateral arm * The second blood sampling will occur approximately 8-22 hours after the first blood sampling * The HemoIV device will be removed one hour after the second blood sampling occurs * Participants will be called 8 days later to assess for adverse events Quality control (QC) procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be generated. Any missing data or data anomalies will be communicated to the site(s) for clarification/resolution. ### Conditions Module Conditions: - Measurement of Blood Parameter Equivalency ### Design Module #### Design Info Observational Model: COHORT Time Perspective: PROSPECTIVE #### Enrollment Info Count: 106 Type: ESTIMATED Study Type: OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 Description: Measurement of protocol specified blood parameters drawn from the HemoIV system Intervention Names: - Device: HemoIV Label: HemoIV Blood Sampling #### Arm Group 2 Description: Measurement of protocol specified blood parameters drawn from the contralateral control arm Label: Control Blood Sampling ### Interventions #### Intervention 1 Arm Group Labels: - HemoIV Blood Sampling Description: A sterile, single use device. It is a non-patient stick blood collection device that attaches to a peripheral IV catheter (PIV catheter) and allows for blood sample collection to occur during continuous IV infusion therapy. The control blood sampling will occur via standard of care blood draws either through peripheral IV catheter or standard venipuncture. Name: HemoIV Type: DEVICE ### Outcomes Module #### Primary Outcomes Description: White Blood Cell Count (WBC) Min: 3.9 to Max:10.7 (10 to the power of 3/uL) Measure: Measurement of Whole Blood Count (WBC) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Red Blood Cell Count (RBC) Min: 4.0 to Max: 6.0 (10 to the power of 6/uL) Measure: Measurement of Red Blood Count (RBC) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Hemoglobin (HGB) Min: 11.8 to Max: 18.1 g/dl Measure: Measurement of Hemoglobin (HGB) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Hematocrit (HCT) Min: 36% to Max: 49% Measure: Measurement of Hematocrit (HCT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Platelets (PLT) Min: 135 to Max: 371 (10 to the power of 3/uL) Measure: Measurement of Platelets (PLT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Albumin (ALB) Min: 3.2 to Max: 5.2 g/dL Measure: Measurement of Albumin (ALB) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Alkaline Phosphatase (AKP) Min: 40 to Max: 164 u/L Measure: Measurement of Alkaline Phosphatase (AKP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Total Bilirubin (T BILI) Min: 0.1 to Max: 1.2 mg/dL Measure: Measurement of Total Bilirubin (T BILI) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Bicarbonate (CO2) Min: 17 to Max: 31 mmol/L Measure: Measurement of Bicarbonate (CO2) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Blood Urea Nitrogen (BUN) Min: 7 to Max: 26 mg/dL Measure: Measurement of Blood Urea Nitrogen (BUN) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Calcium (CA) Min: 8.4 to Max: 10.5 mg/dL Measure: Measurement of Calcium (CA) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Chloride (CL) Min: 98 to Max: 107 mmol/L Measure: Measurement of Chloride (CL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Creatinine (Cr) Min: 0.57 to Max: 1.25 mg/dL Measure: Measurement of Creatinine (Cr) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Glucose (Glu) Min: 70 to Max: 99 mg/dL Measure: Measurement of Glucose (Glu) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Potassium (K) Min: 3.3 to Max: 4.8 mmol/L Measure: Measurement of Potassium (K) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Total Protein (TP) Min: 6.0 to Max: 8.3 g/dL Measure: Measurement of Total Protein (TP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Aspartate Aminotransferase (AST) Min: 5 to Max: 35 u/L Measure: Measurement of Aspartate Aminotransferase (AST) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Alanine Transaminase (ALT) Min: 0 to Max: 55 u/L Measure: Measurement of Alanine Transaminase (ALT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Sodium (NA) Min: 136 to Max: 145 mmol/L Measure: Measurement of Sodium (NA) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Lactate Dehydrogenase (LDH) Min: 125 to Max: 250 u/L Measure: Measurement of Lactate Dehydrogenase (LDH) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: International normalized ratio (INR)/ Prothrombin Time (PT) Min: 11.7 to Max: 14.5 seconds Measure: Measurement of International normalized ratio (INR)/ Prothrombin Time (PT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Partial Thromboplastin Time (PTT) Min: 23.5 to Max: 35.5 seconds Measure: Measurement of Partial Thromboplastin Time (PTT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Fibrinogen Min: 220 to Max: 415 mg/dL Measure: Measurement of Fibrinogen parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Total Cholesterol (CHOL) Min: 0 to Max: 199 mg/dL Measure: Measurement of Total Cholesterol (CHOL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Triglycerides (TRIG) Min: 0 to Max: 149 mg/dL Measure: Measurement of Triglycerides (TRIG) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: High Density Lipoprotein (HDL) Min: 0 to Max: 100 mg/dL Measure: Measurement of High Density Lipoprotein (HDL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Low Density Lipoprotein (LDL) Min: 0 to Max: 300 mg/dL Measure: Measurement of Low Density Lipoprotein (LDL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Troponin I Min: 0.00 to Max: 0.03 ng/mL Measure: Measurement of Troponin I parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Natriuretic Peptides (BNP) Min: 10 to Max: 100 pg/mL Measure: Measurement of Natriuretic Peptides (BNP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: C-Reactive Protein (CRP) Min: 0 to Max: 5 mg/dL Measure: Measurement of C-Reactive Protein (CRP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Erythrocyte Sedimentation Rate (ESR) Min: 1 to Max: 37 mm/hr Measure: Measurement of Erythrocyte Sedimentation Rate (ESR) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) Description: Human chorionic gonadotropin (HCG) Min: 0 to Max: 5 mIU/mL Measure: Measurement of Human chorionic gonadotropin (HCG) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. Time Frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion) #### Secondary Outcomes Description: Wong-Baker Faces Pain Rating Scale is a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst." Measure: Wong-Baker Faces Pain Rating Scale. Time Frame: Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion) Description: Study staff will rate the insertion of the device using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy Measure: Study staff usability evaluation of the insertion of HemoIV device. Time Frame: Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion) Description: Study staff will rate the blood sample collection from the HemoIV device using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy Measure: Study staff usability evaluation of blood sample collection from the HemoIV device. Time Frame: Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion) Description: Study staff will rate the easy of the IV solution infusion with the HemoIV using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy Measure: Study staff usability evaluation of the ease of the IV solution infusion with the HemoIV device. Time Frame: Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion) Description: Study staff will rate the easy of the clearing of the blood channel with the HemoIV using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy Measure: Study staff usability evaluation of the easy of the clearing of the blood channel with the HemoIV device Time Frame: Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion) Description: Study staff will rate the easy of withdrawal of the HemoIV using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy Measure: Study staff usability evaluation of the easy of withdrawal of the HemoIV device Time Frame: Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion) ### Eligibility Module Eligibility Criteria: Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 and older * Willing to adhere to the HemoIV intervention regimen * Patient scheduled for a hospital procedure for medical condition requiring peripheral intravenous catheter placement, intravenous therapy, and blood draw * Patients to receive intravenous therapy including: Normal Saline, Lactate Ringer, or 5% Dextrose in Water. * Patient with peripheral intravenous catheter access vein size \> 2 mm in diameter or per investigator discretion able to accept an 18G Peripheral Intravenous Catheter. * Patient must be able to have a peripheral IV catheter in one arm and can have standard venipuncture blood draws from contralateral arm. * Patient must be able to have an 18G Peripheral Intravenous Catheter inserted for use with the study device up to 1.88" in length. Exclusion Criteria: * Do not speak/understand English * Patients who have a prior history of mastectomy * Concurrent participation/treatment with another investigational drug or other intervention study. * Patient with signs and symptoms of thrombophlebitis at the IV site at the time of study enrollment * Patients receiving chemotherapy, or who have leukemia for example who have fragile formed cellular element * Patients which are hemodynamically unstable * Patients requiring blood transfusion via the 18G peripheral IV catheter used with HemoIV * Patients who are unable to have a peripheral IV catheter on one upper extremity while having the other upper extremity available for blood tests (e.g. subjects must have two arms, not have an AV graft or fistula anticipating dialysis in the near future, etc.) * Subjects who are not able to have an IV infusion rate adjusted in the HemoIV to between 10-250 mL/hr during blood draws via HemoIV * Patient with morbid obesity, (BMI \> 40) Healthy Volunteers: True Minimum Age: 18 Years Sampling Method: PROBABILITY_SAMPLE Sex: ALL Standard Ages: - ADULT - OLDER_ADULT Study Population: Patient population will be enrolled from those admitted in the hospital (emergency department, inpatient, and observation setting) for a medical condition that require peripheral intravenous catheter fluids and blood draws up to a 24 hour period. Patients receiving Normal Saline, Lactate Ringer, or 5% Dextrose in Water will be enrolled. ### Contacts Locations Module #### Locations Location 1: City: Nashville Country: United States Facility: Vanderbilt University Medical Center State: Tennessee Zip: 37232 #### Overall Officials Official 1: Affiliation: Vanderbilt University Medical Center Name: Sean Collins, MD, MSCi Role: STUDY_DIRECTOR Official 2: Affiliation: Vanderbilt University Medical Center Name: Brian Bales, MD Role: PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module IPD Sharing: NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module NCT ID: NCT06415045 Brief Title: A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food Official Title: The Effect of Food on the Pharmacokinetics of BI 1015550 (Formulation C2) Following Single Oral Dose Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design) #### Organization Study ID Info ID: 1305-0039 #### Organization Class: INDUSTRY Full Name: Boehringer Ingelheim #### Secondary ID Infos Domain: CTIS ID: 2023-509889-38-00 Type: REGISTRY Domain: WHO International Clinical Trials Registry Platform (ICTRP) ID: U1111-1301-0891 Type: OTHER ### Status Module #### Completion Date Date: 2024-07-24 Type: ESTIMATED #### Expanded Access Info #### Last Update Post Date Date: 2024-05-16 Type: ACTUAL Last Update Submit Date: 2024-05-10 Overall Status: NOT_YET_RECRUITING #### Primary Completion Date Date: 2024-07-24 Type: ESTIMATED #### Start Date Date: 2024-05-28 Type: ESTIMATED Status Verified Date: 2024-04 #### Study First Post Date Date: 2024-05-16 Type: ACTUAL Study First Submit Date: 2024-05-10 Study First Submit QC Date: 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor Class: INDUSTRY Name: Boehringer Ingelheim #### Responsible Party Type: SPONSOR ### Oversight Module Is FDA Regulated Device: False Is FDA Regulated Drug: False Oversight Has DMC: False ### Description Module Brief Summary: The main objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2. ### Conditions Module Conditions: - Healthy ### Design Module #### Design Info Allocation: RANDOMIZED Intervention Model: CROSSOVER ##### Masking Info Masking: NONE Primary Purpose: TREATMENT #### Enrollment Info Count: 18 Type: ESTIMATED Phases: - PHASE1 Study Type: INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 Intervention Names: - Drug: BI 1015550 Label: BI 1015550 without food, then BI 1015550 with food Type: EXPERIMENTAL #### Arm Group 2 Intervention Names: - Drug: BI 1015550 Label: BI 1015550 with food, then BI 1015550 without food Type: EXPERIMENTAL ### Interventions #### Intervention 1 Arm Group Labels: - BI 1015550 with food, then BI 1015550 without food - BI 1015550 without food, then BI 1015550 with food Description: BI 1015550 Name: BI 1015550 Other Names: - Nerandomilast Type: DRUG ### Outcomes Module #### Primary Outcomes Measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz ) Time Frame: Up to day 7 Measure: Maximum measured concentration of the analyte in plasma (Cmax) Time Frame: Up to day 7 #### Secondary Outcomes Measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) Time Frame: Up to day 7 ### Eligibility Module Eligibility Criteria: Inclusion Criteria : * Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 50 years (inclusive) * Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive) * Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Female subject who meets the criteria defined in the protocol for a highly effective contraception from at least 30 days before the first administration of trial medication until 7 days after last administration Exclusion Criteria : * Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 betas per minute (bpm) at screening * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) at screening * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator * Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to depression and suicidal behavior * History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply. Healthy Volunteers: True Maximum Age: 50 Years Minimum Age: 18 Years Sex: ALL Standard Ages: - ADULT ### Contacts Locations Module #### Central Contacts Contact 1: Email: clintriage.rdg@boehringer-ingelheim.com Name: Boehringer Ingelheim Phone: 1-800-243-0127 Role: CONTACT ### IPD Sharing Statement Module Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency IPD Sharing: NO ### References Module #### See Also Links Label: Related Info URL: http://www.mystudywindow.com ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31