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protocolSection identificationModule nctId: NCT06348459, orgStudyIdInfo id: 18/010-E, briefTitle: Registry of Catheter Intervention in Pulmonary Embolism, acronym: RiTEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-09-18, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Hospital San Carlos, Madrid, class: OTHER, collaborators name: Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología, descriptionModule briefSummary: Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism., conditionsModule conditions: Pulmonary Embolism, conditions: Pulmonary Embolism Acute Massive, conditions: Pulmonary Embolism Acute, conditions: Pulmonary Embolism and Thrombosis, conditions: Pulmonary Thromboembolisms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: All cause-death, secondaryOutcomes measure: all cause-death, secondaryOutcomes measure: all cause-death, secondaryOutcomes measure: all cause-death, secondaryOutcomes measure: procedural success, secondaryOutcomes measure: in-hospital complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clinico San Carlos, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Pablo Salinas, MD, PhD, role: CONTACT, phone: +34913303000, email: salinas.pablo@gmail.com, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06348446, orgStudyIdInfo id: FY20-2963, briefTitle: Tacrolimus Exposure in Kidney Transplantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, collaborators name: Astellas Pharma Inc, descriptionModule briefSummary: Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation., conditionsModule conditions: Kidney Transplant Rejection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 12000, type: ESTIMATED, outcomesModule primaryOutcomes measure: relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes, secondaryOutcomes measure: relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome, secondaryOutcomes measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection, secondaryOutcomes measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event, secondaryOutcomes measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asan medical center, Seoul, Korea, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Young Hoon Kim, MD, role: CONTACT, phone: 82-10-2705-6998, email: kyh-001@hanmail.net, geoPoint lat: 37.566, lon: 126.9784, locations facility: Samsung medical center, Seoul, Korea, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Jae Berm Park, MD, role: CONTACT, phone: 82-10-8971-1953, email: jbparkmd@gmail.com, geoPoint lat: 37.566, lon: 126.9784, locations facility: Seoul St. Mary's hospital, Seoul, Korea, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Sun Cheol Park, MD, role: CONTACT, phone: 82-10-6310-2847, email: sun60278@catholic.ac.kr, geoPoint lat: 37.566, lon: 126.9784, locations facility: Severance hospital, Seoul, Korea, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: kyuha Hur, MD, role: CONTACT, phone: 82-10-2043-9947, email: KHHUH@yuhs.ac, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06348433, orgStudyIdInfo id: QL000003, briefTitle: Efficacy Evaluation and Mechanism Study of Ketogenic Diet on Autism Spectrum Disorder in Children, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, which is characterized by social interaction and communication defects, rigid repetitive behaviors, and often accompanied by speech development retardation. According to the report released by the Morbidity and Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC), according to the statistical data analysis in 2020, one out of every 36 8-year-old children (2.76%) was confirmed to have autism spectrum disorder (ASD). This ratio is higher than that published in December 2021, when the prevalence rate of 8-year-old children was 1/44 (2.3%) according to the statistics in 2018. Although ASD has a high incidence, there is still a lack of effective treatment measures for autism at present. Drug treatment can only partially alleviate some related symptoms, such as irritability and aggressiveness. Other interventions mainly focus on behavioral and educational interventions, which have limited help to patients. The high cost also leads to a huge burden on families and health care systems. Therefore, finding targeted treatment measures and treatment mechanisms for ASD as soon as possible has become an urgent problem for us to solve.Faced with limited treatment options, as many as a third of parents try various dietary pattern interventions to help their autistic children. In recent years, ketogenic diet, as a diet mode with extremely low carbohydrate, high fat, proper amount of protein and other nutrients, has attracted wide attention. In this mode, increased lipolysis puts the body in a ketosis state, thus ensuring energy supply.Although ketogenic diet (KD) has been proved to be effective in reducing the core symptoms in autistic patients and mouse models, the specific mechanism of KD in autism spectrum disorder (ASD) is still not completely clear.This study aims to evaluate the efficacy of ketogenic diet in improving core symptoms, sleep disorders and gastrointestinal symptoms of ASD children, explore the changes of excitation/inhibition (dorsolateral prefrontal cortex) in prefrontal cortex of ASD children before and after ketogenic diet intervention, and try to reveal the mechanism of ketogenic diet in treating ASD., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Ketogenic diet, outcomesModule primaryOutcomes measure: Autism Behavior Checklist（ABC）, primaryOutcomes measure: Childhood Autism Rating Scale(CARS), secondaryOutcomes measure: Gastrointestinal Symptom Scale（GSRS), secondaryOutcomes measure: Children's Sleep Habits Questionnaire（CSHQ), otherOutcomes measure: MRS, eligibilityModule sex: ALL, minimumAge: 18 Months, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Yu Wang, city: Jinan, state: Shandong, zip: 274400, country: China, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06348420, orgStudyIdInfo id: 2023-QILU-LU 03, briefTitle: Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment, acronym: ARMV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2027-04-20, completionDateStruct date: 2027-08-13, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, collaborators name: Shandong University, descriptionModule briefSummary: The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs)., conditionsModule conditions: Gastroesophageal Reflux Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: anti-reflux mucosal valvuloplasty (ARMV), outcomesModule primaryOutcomes measure: The total score of the GERD-HRQL questionnaire, secondaryOutcomes measure: Number of Participants with PPI usage, secondaryOutcomes measure: Appearance of the mucosal flap, secondaryOutcomes measure: Presence of reflux esophagitis, secondaryOutcomes measure: Safety evaluation indicators, secondaryOutcomes measure: Total score of GERD GerdQ questionnaire, secondaryOutcomes measure: DeMeester score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06348407, orgStudyIdInfo id: 2024-BA-001, briefTitle: A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE), acronym: ESSENCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.Previous studies have reported that nearly 90% of patients with severe asthma were cases of allergic asthma, in which Immunoglobulin E (IgE) plays a critical role.Omalizumab was approved as an anti-IgE humanized monoclonal antibody for the treatment of patients with poorly controlled moderate-to-severe asthma, and was the first targeted drug used in the field of asthma treatment.The drug was launched in mainland China in August 2017.whereas,the clinical application experience, effects, and relevant data in the domestic population still lacking.The aim of this study was to observe the efficacy and safety of omalizumab, and to investigate whether baseline clinical characteristics and biomarkers can predicted response and adherence to treatment., conditionsModule conditions: Moderate to Severe Allergic Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: IgE monoclonal antibody, outcomesModule primaryOutcomes measure: Change in Asthma Control Test (ACT), primaryOutcomes measure: Global Evaluation of Treatment Effectiveness (GETE), secondaryOutcomes measure: Forced Expiratory Volume in 1 second（FEV1), secondaryOutcomes measure: FEV1/predicted%., secondaryOutcomes measure: Forced Vital Capacity （FVC）, secondaryOutcomes measure: FEV1/FVC., secondaryOutcomes measure: Number of Acute Exacerbations（AE）, secondaryOutcomes measure: Oral glucocorticoid dosage, secondaryOutcomes measure: Good adherence, secondaryOutcomes measure: Poor adherence, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Linfu zhou, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Xuejun Zhang, Master, role: CONTACT, phone: 86+13704726254, email: zxj1301@163.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06348394, orgStudyIdInfo id: 023-318, briefTitle: Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion, acronym: ICETEE, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-14, primaryCompletionDateStruct date: 2025-12-14, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Baylor Research Institute, class: OTHER, descriptionModule briefSummary: This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach., conditionsModule conditions: Left Atrial Appendage Closure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized, parallel controlled, open-label, single center study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 444, type: ESTIMATED, armsInterventionsModule interventions name: Intracardiac Echocardiography, outcomesModule primaryOutcomes measure: Procedural success following implantation of the left atrial appendage occlusion (LAAO) device., secondaryOutcomes measure: Periprocedural complications, secondaryOutcomes measure: Procedural characteristics, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Periprocedural complications, secondaryOutcomes measure: Periprocedural complications, secondaryOutcomes measure: Procedural characteristics, secondaryOutcomes measure: Procedural characteristics, secondaryOutcomes measure: Procedural characteristics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baylor Scott and White Heart Hospital, city: Plano, state: Texas, zip: 75093, country: United States, geoPoint lat: 33.01984, lon: -96.69889, hasResults: False
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protocolSection identificationModule nctId: NCT06348381, orgStudyIdInfo id: IS24030, briefTitle: Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Shanghai Chest Hospital, class: OTHER, descriptionModule briefSummary: Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury., conditionsModule conditions: Esophageal Neoplasm, conditions: Anastomotic Leak, conditions: Recurrent Laryngeal Nerve Injuries, conditions: Anastomotic Stenosis, conditions: Endoscopic Evaluation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: anastomotic leak, primaryOutcomes measure: anastomotic stenosis, primaryOutcomes measure: laryngeal nerve injury, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, Shanghai Jiao Tong University, status: RECRUITING, city: Shanghai, zip: SH 21, country: China, contacts name: Zhigang Li, Doctor, role: CONTACT, phone: 86-18930619260, email: zhigang.li@shchest.org, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06348368, orgStudyIdInfo id: Soh-Med-23-01-29, briefTitle: Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study, conditionsModule conditions: Corneal Ectasia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 4000, type: ACTUAL, armsInterventionsModule interventions name: Pentacam and autorefractometry, outcomesModule primaryOutcomes measure: Values anterior and posterior corneal elevation values by pentacam., eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Elshimaa A.Mateen, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06348355, orgStudyIdInfo id: D5084C00016, secondaryIdInfos id: 2023-508334-34-00, type: OTHER, domain: EMA-CTIS, briefTitle: A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure brain exposure of \[11C\]savolitinib in healthy volunteers.This study will determine brain exposure of \[11C\]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when the BBB is intact. The study design allows up to 3 site visits. Two PET examinations will be performed for each healthy volunteer. The first PET examination will use IV administration of \[11C\]savolitinib. The second PET examination using \[11C\]savolitinib will occur after a single oral dose of 300 mg of savolitinib. PET image analysis will include kinetic compartment modelling using arterial input function, and will generate a set of brain exposure parameters (eg, maximum %ID, maximum \[11C\]savolitinib concentration in brain, partition coefficients between brain and plasma)., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: [11C]savolitinib, interventions name: Savolitinib, outcomesModule primaryOutcomes measure: Percentage of injected radioactivity entering the brain (%ID) as %IDmax_brain, secondaryOutcomes measure: The following endpoint: Cmax_brain SUV, secondaryOutcomes measure: The following endpoint: Tmax brain, secondaryOutcomes measure: The following endpoint: AUCbrain 0-90, secondaryOutcomes measure: The following endpoint: AUCplasma 0-90, secondaryOutcomes measure: The following endpoint: Kp, secondaryOutcomes measure: The following endpoint: Kp,uu, secondaryOutcomes measure: The following endpoint: VT, secondaryOutcomes measure: The following endpoint: Cmax_brain SUV, secondaryOutcomes measure: The following endpoint: Tmax brain, secondaryOutcomes measure: The following endpoints: AUCbrain 0-90, secondaryOutcomes measure: The following endpoints: AUCplasma 0-90, secondaryOutcomes measure: The following endpoints: Kp, secondaryOutcomes measure: The following endpoints: Kp,uu, secondaryOutcomes measure: The following endpoints: VT, otherOutcomes measure: Number of participants with safety findings, AEs, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Solna, zip: 171 64, country: Sweden, geoPoint lat: 59.36004, lon: 18.00086, hasResults: False
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protocolSection identificationModule nctId: NCT06348342, orgStudyIdInfo id: TÜTF-GOBAEK 2023/24, briefTitle: Pelvic Floor Muscle Exercises and Core Exercises in Menopausal Women, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-10-15, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Trakya University, class: OTHER, descriptionModule briefSummary: The prospective and four-arm randomized controlled study was conducted on n = 136 (34 = control, 34 = kegel, 34 = core, 34 = kegel+ core group) menopausal women at Trakya University Health Research and Application Center Urology Polyclinic between Oct 2023 and June 2024. In the first interview, the researcher will apply an information form to all four groups, asking about personal information, habits, bladder irritants and fluid intake-related features, obstetric, gynecological and systemic disease-related features, and stress urinary incontinence-related features. This form will only be filled at the beginning. In addition, the \"Pelvic Floor Distress Scale (PFDI)\" and \"Pelvic Floor Impact Questionnaire (PFIQ)\" will be applied and will be repeated by the executive researcher at the 1st, 2nd and 3rd controls. It will be terminated at the 3rd follow-up. Descriptive statistics, Pearson, Spearman\'s correlation, and regression analyzes will be used in the analysis of research data., conditionsModule conditions: Menopause, conditions: Stress Urinary Incontinence, conditions: Kegel Exercises, conditions: Core Strength, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Before starting the research, four groups of mothers will be randomly formed. As a randomization method, mothers who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumbergenerator.aspx)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic Floor Muscle Exercise, interventions name: Core Exercise, outcomesModule primaryOutcomes measure: Pelvic floor evaluated using the Pelvic Floor Distress Inventory (PFDI - Pelvic Floor Distress Inventionary), primaryOutcomes measure: Pelvic floor impact evaluated using the Pelvic Floor Impact Questionnaire (PFIQ Pelvic Floor Impact Questionnaire), secondaryOutcomes measure: Urinary incontinence evaluated using the Stress Test, secondaryOutcomes measure: Urinary incontinence evaluated using the Uroflowmetry, secondaryOutcomes measure: Urinary incontinence evaluated using the Pelvic Floor Muscle Strength Measurement, secondaryOutcomes measure: Urinary incontinence evaluated using the Digital Palpation, eligibilityModule sex: FEMALE, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bartın University, city: Bartin, zip: 78100, country: Turkey, geoPoint lat: 41.63583, lon: 32.3375, hasResults: False
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protocolSection identificationModule nctId: NCT06348329, orgStudyIdInfo id: TÜTF-GOBAEK 2023/41, briefTitle: Pregnant Women Participating in Birth Preparation Training With Their Spouses on the Parenting Role, Attitudes of Their Spouses Towards Participating in the Birth, and Birth Self-Efficacy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-29, primaryCompletionDateStruct date: 2023-10-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Trakya University, class: OTHER, descriptionModule briefSummary: In this prospective, randomized controlled study, it was aimed to examine the effect of pregnant women participating in birth preparation training together with their partners on the parenting role, spouses' attitudes towards participation in birth, and birth self-efficacy.The study was shared via the web on social media (Facebook, Instagram, Twitter, Telegram) forum pages between 25.09.2023-25.03.2025, and n=158 pregnant women who met the inclusion criteria and volunteered to participate in the study (79= education without spouse participation, 79= spouse Participatory education) will be conducted randomly in two groups: case and control.Before starting the research, two groups will be randomly formed among pregnant women. As a randomization method, pregnant women who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx)., conditionsModule conditions: Birth Order, conditions: Parenting, conditions: Self Efficacy, conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule interventions name: Birth Preparation Training, outcomesModule primaryOutcomes measure: Parenting behavior evaluated using the Postpartum Parenting Behavior Scale, primaryOutcomes measure: Parenting self-efficacy in labor evaluated using the Self-Efficacy in Labor Scale, primaryOutcomes measure: Spouse support evaluated using the Spouse Support Scale, primaryOutcomes measure: Father candidates towards participating in the birth evaluated using the Attitude Scale for Father Candidates Towards Participating in the Birth, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Trakya University, status: RECRUITING, city: Edirne, zip: 22030, country: Turkey, contacts name: Burcu Küçükkaya, role: CONTACT, phone: 05422931357, email: burcukucukkaya1992@gmail.com, geoPoint lat: 41.67719, lon: 26.55597, hasResults: False
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protocolSection identificationModule nctId: NCT06348316, orgStudyIdInfo id: TÜTF-GOBAEK 2023/45, briefTitle: Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-30, primaryCompletionDateStruct date: 2024-04-02, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Trakya University, class: OTHER, descriptionModule briefSummary: Aim: In this prospective, randomized controlled study, it was aimed to examine the effects of early half-swaddle and kangaroo care practices in term babies on maternal sleep quality and postpartum depression.Design: The prospective, randomized controlled study, conditionsModule conditions: Mothers, conditions: Postpartum Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: Half swaddle, interventions name: Kangaroo care, outcomesModule primaryOutcomes measure: Mother sleep quality evaluated using the Pittsburgh Sleep Quality Index (PSQI), primaryOutcomes measure: Postpartum depression evaluated using the Edinburgh Postnatal Depression Scale (EPDS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Trakya University, status: RECRUITING, city: Edirne, zip: 22030, country: Turkey, contacts name: Burcu Küçükkaya, role: CONTACT, phone: 05422931357, email: burcukucukkaya1992@gmail.com, geoPoint lat: 41.67719, lon: 26.55597, hasResults: False
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protocolSection identificationModule nctId: NCT06348303, orgStudyIdInfo id: PMMD-01, briefTitle: Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Primus Pharmaceuticals, class: INDUSTRY, collaborators name: ClinOhio Research Services, LLC, descriptionModule briefSummary: Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Each participant will be enrolled to two (2), single dose, study treatment arms in a crossover design. The treatments will occur consecutively with seven (7) days separating days of dosing., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Single mask of participants. Participants will be prevented from knowing product dose., whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Metaxalone m640 mg oral tablet, interventions name: Metaxalone 800 mg oral tablet, outcomesModule primaryOutcomes measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test)., primaryOutcomes measure: Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path, primaryOutcomes measure: Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path, secondaryOutcomes measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale, secondaryOutcomes measure: Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds, secondaryOutcomes measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes, secondaryOutcomes measure: The number of product related adverse events experienced by participants from Visit 2 through Visit 4, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: ClinOhio Research Institute, status: RECRUITING, city: Columbus, state: Ohio, zip: 43213, country: United States, contacts name: J Sanders, role: CONTACT, phone: 614-683-4900, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
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protocolSection identificationModule nctId: NCT06348290, orgStudyIdInfo id: JY-JM1899-105, briefTitle: Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Jemincare, class: INDUSTRY, descriptionModule briefSummary: This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort., conditionsModule conditions: Solid Tumor, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: JMKX001899, interventions name: Itraconazole, interventions name: Midazolam, interventions name: Rifampin, interventions name: dextromethorphan, interventions name: Rosuvastatin, interventions name: digoxin, outcomesModule primaryOutcomes measure: maximum concentrations (Cmax ) for plasma, primaryOutcomes measure: area under the curve from time 0 to infinity(AUC0-inf) for plasma, primaryOutcomes measure: area under the curve from time 0 to the last time point (AUC0-t) for plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348277, orgStudyIdInfo id: 121119, briefTitle: Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-02, primaryCompletionDateStruct date: 2020-04-07, completionDateStruct date: 2020-06-17, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Lawrence University, class: OTHER, descriptionModule briefSummary: The investigators examined whether brief, app-based interventions were helpful in alleviating mental health symptoms during the transition to college. In particular, the investigators were interested in whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone., conditionsModule conditions: Depression, Anxiety, conditions: Self-Injurious Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: Mindfulness plus mood monitoring, interventions name: Mood monitoring, outcomesModule primaryOutcomes measure: Depressive Symptoms, primaryOutcomes measure: Anxiety Symptoms, primaryOutcomes measure: Urges to Self-injure, primaryOutcomes measure: Rumination, primaryOutcomes measure: Worry, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Anxiety Symptoms, secondaryOutcomes measure: Anxiety Symptoms, secondaryOutcomes measure: Urges to self-injure, secondaryOutcomes measure: Urges to self-injure, secondaryOutcomes measure: Rumination, secondaryOutcomes measure: Rumination, secondaryOutcomes measure: Worry, secondaryOutcomes measure: Worry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lawrence University, city: Appleton, state: Wisconsin, zip: 54911, country: United States, geoPoint lat: 44.26193, lon: -88.41538, hasResults: False
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protocolSection identificationModule nctId: NCT06348264, orgStudyIdInfo id: SDC-1, briefTitle: Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2029-03-30, completionDateStruct date: 2031-03-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, collaborators name: Jiangsu Hengrui Pharmaceutical Co., Ltd., collaborators name: Beijing Biote Pharmaceutical Co.,Ltd, descriptionModule briefSummary: The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC).The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years., conditionsModule conditions: Salivary Gland Neoplasm Duct, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: Rezvilutamide, interventions name: Leuprolide Acetate, outcomesModule primaryOutcomes measure: 3-year disease-free survival (DFS), secondaryOutcomes measure: 3-year overall survival (OS), secondaryOutcomes measure: 3-year disease-specific survival (DSS), secondaryOutcomes measure: 3-year distant-metastatic free survival (DMFS), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: 5-year disease-free survival (DFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University First Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100034, country: China, contacts name: Xueying Ren, MD, role: CONTACT, phone: +86 10 83572408, email: xy_ren1031@126.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University School and Hospital of Stomatology, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Xiaofeng Shan, MD, role: CONTACT, phone: +86 10 82195390, email: kqsxf@263.net, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06348251, orgStudyIdInfo id: STU00219612, briefTitle: FoodSteps for Binge Eating & Food Insecurity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity., conditionsModule conditions: Binge Eating, conditions: Type 2 Diabetes, conditions: Food Insecurity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: FoodSteps, outcomesModule primaryOutcomes measure: Recruitment and retention rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern University Feinberg School of Medicine, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Andrea K Graham, PhD, role: CONTACT, phone: 312-503-5266, email: andrea.graham@northwestern.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06348238, orgStudyIdInfo id: 2074997, briefTitle: Strategies to Improve Well-Being and Diabetes Management, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Elizabeth Scharnetzki, class: OTHER, collaborators name: MaineHealth Institute for Research, descriptionModule briefSummary: This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are:* Will self-affirmation reduce feelings of stigmatization?* Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors.* Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it.After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Self-Affirmation, outcomesModule primaryOutcomes measure: Social Identity Threat Concerns (SITC) Scale, primaryOutcomes measure: Two-Factor Weight Bias Internalization Scale, primaryOutcomes measure: Diabetes Stigma Assessment Scale, primaryOutcomes measure: The Revised Diabetes Self-Management Questionnaire, primaryOutcomes measure: Confidence in Diabetes Self-Care Scale, primaryOutcomes measure: Blood glucose, secondaryOutcomes measure: Hemoglobin A1C, secondaryOutcomes measure: Patient-reported age, secondaryOutcomes measure: Patient Gender, secondaryOutcomes measure: Patient Race, secondaryOutcomes measure: Patient ethnicity, secondaryOutcomes measure: Patient's highest level of education completed, secondaryOutcomes measure: Household income, secondaryOutcomes measure: Zip code, secondaryOutcomes measure: Years since diagnosis, secondaryOutcomes measure: Diabetes Management Plan, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Continuous glucose monitor use, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: History of weight-based victimization (moderator/covariate), secondaryOutcomes measure: Problem Areas in Diabetes Questionnaire (moderator/covariate), secondaryOutcomes measure: Generalized Anxiety Disorder 7-item (moderator/covariate), secondaryOutcomes measure: Patient Health Questionnaire (PHQ-9) (moderator/covariate), secondaryOutcomes measure: Stigma Consciousness Questionnaire (moderator/covariate), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research, city: Westbrook, state: Maine, zip: 04092, country: United States, contacts name: Elizabeth Scharnetzki, role: CONTACT, phone: 805-340-9716, email: elizabeth.scharnetzki@mainehealth.org, geoPoint lat: 43.67703, lon: -70.37116, hasResults: False
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protocolSection identificationModule nctId: NCT06348225, orgStudyIdInfo id: FY24-10, briefTitle: Post-exercise Hot Water Immersion to Improve Overnight Blood Pressure, acronym: ExHT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Providence College, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test whether putting your legs in a hot bath after exercise improves blood pressure in people with higher blood pressure.. The main questions it aims to answer are:* Whether exercise alone, hot water leg bath alone, or both treatments together cause blood pressure to be lower during sleep.* If there are any changes in heart rhythm or blood vessel health after exercise, hot water leg bath, or the two treatments together that relate to changes in blood pressure.Participants will complete four different trials:* 30 minutes of walking with a 45-minute lukewarm leg bath after* 30 minutes of walking with a 45-minute hot leg bath after* 45 minutes of a hot leg bath with no exercise* A day with no exercise or leg bath Researchers will look at their heart rhythm, blood vessels, and blood pressure after each of these trials to see if there are differences, and if exercise and heat together can improve heart health more than exercise or heat alone., conditionsModule conditions: Elevated Blood Pressure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A repeated-measures design will be used with all participants completing the three acute interventions (exercise, heat, or exercise + heat) as well as a control day., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: It is not possible to mask the participant to treatments (exercise/no exercise, water temperature, etc) or the PI who is monitoring them during treatment. However, all data (hourly blood pressure, heart rate variability, and flow-mediated dilation) will be analyzed by an individual blinded to the trial/intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Exercise or heat treatment, outcomesModule primaryOutcomes measure: Ambulatory blood pressure, primaryOutcomes measure: Heart Rate Variability, primaryOutcomes measure: Flow-mediated dilation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-28, uploadDate: 2024-03-28T10:14, filename: Prot_SAP_000.pdf, size: 198276, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-28, uploadDate: 2024-03-28T10:15, filename: ICF_001.pdf, size: 162356, hasResults: False
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protocolSection identificationModule nctId: NCT06348212, orgStudyIdInfo id: 2022-11-008C, briefTitle: Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID, acronym: COVID-19, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Taipei Veterans General Hospital, Taiwan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to test whether the intervention of probiotics supplement can improve symptoms of long covid syndrome.Participants will be given probiotics or placebo capsules for two month. Symptom questionnaires, cognitive function, eeg and fecal sample are recorded/collected before and after the supplement.Researchers will compare the probiotic group and the placebo to see if probiotic supplement really make differences., conditionsModule conditions: Long COVID, conditions: Brain Fog, conditions: Cognitive Change, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Randomization were performed by the provider of probiotic and placebo. The participant will never know their group. The study Investigator and Outcome assessor will not know the groups of participants until they finish recruiting and data processing., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Lactobacillus paracasei PS23, interventions name: microcrystalline cellulose, outcomesModule primaryOutcomes measure: Long covid related symptoms, primaryOutcomes measure: Hospital Anxiety and Depression Scale, primaryOutcomes measure: The Pittsburgh sleep quality index, primaryOutcomes measure: Fatigue Severity Scale, primaryOutcomes measure: GI symptoms, primaryOutcomes measure: Cognitive function-Digit symbol substitution test, primaryOutcomes measure: Cognitive function-The Montreal Cognitive Assessment(MoCA), primaryOutcomes measure: Cognitive function-Color Trails making Test, primaryOutcomes measure: Cognitive function-Cogstate Brief Battery (CBB), primaryOutcomes measure: EEG, primaryOutcomes measure: Gut microbiota, primaryOutcomes measure: Fecal metabolite, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348199, orgStudyIdInfo id: SB27-3004, briefTitle: A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Samsung Bioepis Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:• How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda., conditionsModule conditions: Non-small Cell Lung Cancer Stage IV, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 616, type: ESTIMATED, armsInterventionsModule interventions name: SB27, interventions name: Keytruda, outcomesModule primaryOutcomes measure: Objective response rate (ORR) at Week 24, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SB Investigative Site, status: RECRUITING, city: Batumi, country: Georgia, geoPoint lat: 41.64228, lon: 41.63392, locations facility: SB Investigative Site, status: RECRUITING, city: Tbilisi, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: SB Investigative Site, status: RECRUITING, city: Jaipur, country: India, geoPoint lat: 26.91962, lon: 75.78781, locations facility: SB Investigative Site, status: RECRUITING, city: Surat, country: India, geoPoint lat: 21.19594, lon: 72.83023, locations facility: SB Investigative Site, status: RECRUITING, city: Cluj-Napoca, country: Romania, geoPoint lat: 46.76667, lon: 23.6, locations facility: SB Investigative Site, status: RECRUITING, city: Craiova, country: Romania, geoPoint lat: 44.31667, lon: 23.8, locations facility: SB Investigative Site, status: RECRUITING, city: Sibiu, country: Romania, geoPoint lat: 45.8, lon: 24.15, locations facility: SB Investigative Site, status: RECRUITING, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06348186, orgStudyIdInfo id: Fascial Tissue Response, briefTitle: Fascial Tissue Response To Manual Therapy: Implications In Long Covid Rehabilitation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of the State of Santa Catarina, class: OTHER, collaborators name: Larissa Sinhorim, descriptionModule briefSummary: According to the World Health Organization (WHO), as of mid-September 2022, more than 21 million Brazilians have recovered from COVID-19. However, post-infection symptoms continue to appear months after the end of the acute infection, a syndrome called long COVID. Therefore, the aim of this study is to investigate the responses of fascia-focused manual therapy in participants with long COVID., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Guidebook, interventions name: Guidebook and Myofascial Reorganization® (RMF)., outcomesModule primaryOutcomes measure: Functioning and disability, primaryOutcomes measure: Biomechanical and tissue viscoelastic properties, secondaryOutcomes measure: Work capacity, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Upper limb dysfunctions, secondaryOutcomes measure: Balance, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Santa Catarina State University, status: RECRUITING, city: Florianópolis, state: Santa Catarina, zip: 88.035-001, country: Brazil, contacts name: Larissa Sinhorim, role: CONTACT, geoPoint lat: -27.59667, lon: -48.54917, hasResults: False
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protocolSection identificationModule nctId: NCT06348173, orgStudyIdInfo id: 2021-2190, briefTitle: Response and Remission to Treatment With Anti-IL5/IL5R Antagonists, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Université de Montréal, class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: The aim of this retrospective observational study is to compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials.This study will be performed using the charts of the patients., conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 109, type: ACTUAL, armsInterventionsModule interventions name: Mepolizumab, outcomesModule primaryOutcomes measure: Response to IL5/IL5R antagonists one year after cohort entry among subjects fulfilling and not fulfilling the original RCT inclusion criteria, primaryOutcomes measure: Remission rate with IL5/IL5R antagonists one year after cohort entry in subjects fulfilling and not fulfilling the original RCT inclusion criteria, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital du Sacré-Coeur de Montréal, city: Montréal, state: Quebec, zip: H4J 1C5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06348160, orgStudyIdInfo id: STUDY20230187, briefTitle: iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Julia Blanchette, class: OTHER, collaborators name: The Leona M. and Harry B. Helmsley Charitable Trust, descriptionModule briefSummary: This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom., conditionsModule conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: iHERO Toolkit Resource, outcomesModule primaryOutcomes measure: Change in financial stress as measured by the Personal Financial Well-Being Scale© (PFW) Scale (PFW), primaryOutcomes measure: Change in health insurance literacy as measured by The Health Insurance Literacy Measure (HILM) Measure (HILM), primaryOutcomes measure: Change in diabetes-specific quality of life as measured by The Type 1 Diabetes and Life Young Adult (T1DAL- Young Adult) for ages 18-25 or The Type 1 Diabetes and Life (T1DAL- Adult) for Ages 26-30., primaryOutcomes measure: Change in transition navigation readiness as measured by the The Readiness for Emerging Adults with Diabetes Diagnosed in Youth (READDY) Navigation Subscale, primaryOutcomes measure: Change in HbA1c levels as measured by self-collect capillary HbA1c, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Children's Hospital Los Angeles, city: Los Angeles, state: California, zip: 90027, country: United States, contacts name: Jaquelin Flores Garcia, MPH, role: CONTACT, contacts name: Jennifer Raymond, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: University of Florida Diabetes Institute, city: Gainesville, state: Florida, zip: 32610, country: United States, contacts name: Michael Haller, MD, role: CONTACT, contacts name: Michael Haller, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.65163, lon: -82.32483, locations facility: University Hospitals, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Dionne Williams, PhD, role: CONTACT, phone: 216-238-6100, email: dionne.williams@uhhospitals.org, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Steven Willi, MD, role: CONTACT, contacts name: Steven Willi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06348147, orgStudyIdInfo id: LCCC2323, briefTitle: Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing., conditionsModule conditions: Newly Diagnosed Multiple Myeloma, conditions: Multiple Myeloma, conditions: Autologous Stem Cell Transplantation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Daratumumab, interventions name: Lenalidomide, interventions name: Bortezomib, interventions name: Dexamethasone, outcomesModule primaryOutcomes measure: The rate of achievement of bone marrow minimal residual disease (MRD) negativity, secondaryOutcomes measure: Progression Free Survival (PFS ), secondaryOutcomes measure: Stringent complete response (sCR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Therapeutic discontinuation, secondaryOutcomes measure: Time to first response, secondaryOutcomes measure: Time to best response, secondaryOutcomes measure: Maximum depth of response (from PR to CR, including sCR), secondaryOutcomes measure: Overall response rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UNC Lineberger Comprehensive Cancer Center, city: Chapel Hill, state: North Carolina, zip: 27516, country: United States, contacts name: Ralph L Dessieu, role: CONTACT, email: ralph-lyne_dessieu@med.unc.edu, contacts name: Samuel M Rubinstein, MD, MSCI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
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protocolSection identificationModule nctId: NCT06348134, orgStudyIdInfo id: IRB23-0502, briefTitle: Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2034-07-01, completionDateStruct date: 2036-07-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery., conditionsModule conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, conditions: HER2-positive Breast Cancer, conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Trastuzumab emtansine, interventions name: Pertuzumab Injection, interventions name: Docetaxel, interventions name: Tamoxifen, interventions name: Letrozole, interventions name: Goserelin, outcomesModule primaryOutcomes measure: Pathological Complete Response, secondaryOutcomes measure: Reported Adverse Events and clinical/medical records of participants, secondaryOutcomes measure: Percentage of participants who are suitable for breast-conserving surgery, secondaryOutcomes measure: Event-free survival duration reported among participants, secondaryOutcomes measure: Quality of life reported among study participants, secondaryOutcomes measure: Genetic and epigenetic factors associated with breast cancer in Nigeria, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago, city: Chicago, state: Illinois, zip: 60615, country: United States, contacts name: Olufunmilayo Olufunmilayo, role: CONTACT, phone: 773-702-1632, email: folopade@medicine.bsd.uchicago.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06348121, orgStudyIdInfo id: WK2024003, briefTitle: Impact of Probiotics on Children With ADHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-07, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Wecare Probiotics Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To evaluate the efficacy and safety of probiotic product WecProB as food supplements for the treatment of clinical symptoms in children with ADHD, in comparison with placebo., conditionsModule conditions: Attention Deficit Hyperactivity Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, outcomesModule primaryOutcomes measure: Clinical symptoms of ADHD, eligibilityModule sex: MALE, minimumAge: 6 Years, maximumAge: 14 Years, stdAges: CHILD, hasResults: False
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protocolSection identificationModule nctId: NCT06348108, orgStudyIdInfo id: 232514, secondaryIdInfos id: NCI-2024-01992, type: REGISTRY, domain: NCI Clinical Trials Reporting Program, briefTitle: Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Thomas Martin, MD, class: OTHER, collaborators name: Bristol-Myers Squibb, collaborators name: Janssen Research & Development, LLC, descriptionModule briefSummary: This phase I trial tests the safety, side effects, and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma (RRMM) who are triple class refractory and have been exposed to B-cell maturation antibody (BCMA) targeted therapy. These patients currently have limited treatment options and poor survival. Talquetamab is approved for use by the Food and Drug Administration (FDA) to treat RRMM when given alone. Talquetamab can bring T-cells to the myeloma cell, resulting in myeloma cell death. Iberdomide is an investigational drug. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. Dexamethasone is a corticosteroid, is similar to a natural hormone produced by the adrenal glands. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain types of cancer including myeloma. Giving talquetamab in combination with iberdomide and dexamethasone may be safe, tolerable and effective in treating patients with RRMM, conditionsModule conditions: Multiple Myeloma, conditions: Refractory Multiple Myeloma, conditions: Relapsed Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Talquetamab, interventions name: Iberdomide, interventions name: Dexamethasone, interventions name: Bone Marrow Biopsy, outcomesModule primaryOutcomes measure: Proportion of participants reporting treatment-emergent adverse events (AEs) (Dose Escalation Cohorts), primaryOutcomes measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Escalation Cohorts), primaryOutcomes measure: Recommended phase 2 dose (RP2D) (Dose Escalation Cohorts), primaryOutcomes measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Expansion Cohort), primaryOutcomes measure: Objective response rate (ORR) (Dose Expansion Cohort), secondaryOutcomes measure: Objective response rate (ORR) (Dose Escalation Cohorts), secondaryOutcomes measure: Number of participants achieving VGPR or CR and MRD (negative (-)) response, secondaryOutcomes measure: Proportion of participants with treatment-related adverse events, secondaryOutcomes measure: Changes in scores on the European Organization for Research and Treatment of Cancer - Quality of Life questionnaire (EORTC-QLQ-C30) over time, secondaryOutcomes measure: Changes in scores on the EORTC QLQ- Multiple Myeloma Questionnaire (EORTC-QLQ-M20) over time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Calfornia, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Kenya Gomez, role: CONTACT, email: Kenya.Gomez@ucsf.edu, contacts role: CONTACT, phone: 877-827-3222, email: cancertrials@ucsf.edu, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False
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protocolSection identificationModule nctId: NCT06348095, orgStudyIdInfo id: WK2024004, briefTitle: Effect of Probiotics on Viral Pneumonia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-07, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Wecare Probiotics Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with viral pneumonia, in comparison with placebo., conditionsModule conditions: Viral Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: Respiratory syncytial virus (RSV) viral load, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 3 Years, stdAges: CHILD, hasResults: False
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protocolSection identificationModule nctId: NCT06348082, orgStudyIdInfo id: 2000036068, secondaryIdInfos id: 1R18HS029812-01, type: AHRQ, link: https://reporter.nih.gov/quickSearch/1R18HS029812-01, briefTitle: Project Women's Insomnia Sleep Health Equity Study (WISHES), acronym: Project WISHES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-09, primaryCompletionDateStruct date: 2028-07, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: Department of Health and Human Services, descriptionModule briefSummary: The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women., conditionsModule conditions: Insomnia, conditions: Sleep Health, conditions: Cardiometabolic Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Hybrid Type 1 effectiveness/implementation study using a pragmatic randomized controlled trial (RCT) with MBTI and a waitlist control. Participants will be randomly assigned by a computer-generated sequence to either the MBTI or waitlist control in a 1:1 ratio using permuted blocks stratified by age (2 strata: ≤50 or postmenopausal age \>51) with random block sizes of 2 or 4 to reduce predictability., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 340, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness-based therapy for insomnia (MBTI), outcomesModule primaryOutcomes measure: Change in Insomnia Severity, primaryOutcomes measure: Change in Perceived Stress, primaryOutcomes measure: Acceptability of Intervention (AIM), primaryOutcomes measure: Feasibility of Intervention (FIM), primaryOutcomes measure: Treatment Fidelity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yale School of Nursing Biobehavioral Lab, city: West Haven, state: Connecticut, zip: 06516, country: United States, geoPoint lat: 41.27065, lon: -72.94705, hasResults: False
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protocolSection identificationModule nctId: NCT06348069, orgStudyIdInfo id: 2022-11-15783, briefTitle: Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe, acronym: TOPAZ, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-03-11, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of California, Berkeley, class: OTHER, collaborators name: Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe), collaborators name: University of California, San Francisco, collaborators name: Liverpool School of Tropical Medicine, descriptionModule briefSummary: Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr. Euphemia Sibanda, Reader (Associate Professor) of Global Health and Epidemiology at Liverpool School of Tropical Medicine, UK and Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe) and Dr. Sandra McCoy, Professor of Epidemiology and Biostatistics at the University of California, Berkeley. The goal of the proposed study is to optimize, refine and pilot a pharmacy-based PrEP intervention for female sex workers (FSW) in Zimbabwe. Despite efforts to reach the most impacted and vulnerable populations with PrEP, retention rates, particularly among FSW in Africa, are very low. Relatively high levels of uptake indicate that FSW are interested in PrEP and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. Pharmacy-based PrEP has the potential to address known barriers to PrEP retention among FSW such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of PrEP., conditionsModule conditions: Adherence, Medication, conditions: HIV Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Groups (sites/clusters) are randomized to either the intervention (pharmacy-based PrEP refills plus gift card incentives) or the control (standard of care) and are followed and compared over time., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Pharmacy-based PrEP refill and gift voucher, interventions name: Control (Standard of care), outcomesModule primaryOutcomes measure: PrEP retention at 6 months, otherOutcomes measure: PrEP retention at 6 months among FSW who are 18-24 years of age, otherOutcomes measure: : PrEP retention at 6 months among participants who have remained active in sex work, otherOutcomes measure: FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies, otherOutcomes measure: HIV tests, otherOutcomes measure: HIV care referrals, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CESHHAR Zimbabwe, status: RECRUITING, city: Harare, zip: 0000, country: Zimbabwe, contacts name: Oppah Kuguyo, role: CONTACT, email: oppah.kuguyo@ceshhar.co.zw, geoPoint lat: -17.82772, lon: 31.05337, hasResults: False
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protocolSection identificationModule nctId: NCT06348056, orgStudyIdInfo id: 2022-07-15499, briefTitle: A Comparison of the Metabolic Effects of Zinc-Amino Acid (ZnAA) Versus Zinc Gluconate, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of California, Berkeley, class: OTHER, descriptionModule briefSummary: Food consumption affects zinc metabolism within the body. Lowe and colleagues demonstrated that zinc is directed out of plasma and into tissues, such as into the liver, postprandially . It is likely that zinc absorbed with a meal is directed to the liver via the portal circulation whereas that zinc taken in the fasted state is more readily directed to peripheral blood plasma. Zinc taken with food is more likely to be bound to components of the food matrix and, therefore, it is not absorbed as efficiently by Zip4 ionic zinc transporters in the upper gastrointestinal tract. Some of the zinc in the food matrix may, however, be co-absorbed with amino acids over the whole length of the small intestine . Co-absorption of zinc with amino acids may explain the greater effects of zinc taken with food on omega-6 fatty acid desaturation . The investigators propose that this effect may be maximized by providing supplemental zinc complexed with amino acids. Since the zinc amino acid complex likely mimics the absorption and retention of zinc bound to protein in food, the investigators further propose that zinc, bound to amino acids taken in the fasted state will be directed into the cellular compartments more efficiently than zinc associated with gluconate.The primary aim in this study is to determine whether providing a zinc amino acid complex has a greater effect on indices of essential fatty acid desaturation compared with zinc gluconate when the zinc complexes are taken in the fasting state.The investigators hypothesize that taking a zinc amino acid (Zn-AA) complex in a fasted state daily for two weeks has a greater effect on the Fatty Acid Desaturase 1 (FADS1) activity compared with zinc gluconate. Also, if the uptake of ionic zinc gluconate into cellular compartments is reduced in comparison to Zn-AA because the zinc gluconate is retained in the plasma, two weeks of a daily zinc gluconate will have a greater effect on fasting plasma zinc concentrations compared to a Zn- AA complex., conditionsModule conditions: Response of Fatty Acid Desaturation to Zinc Intake, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will take the first zinc supplement for two weeks, followed by a two-week washout period, and then take the second zinc supplement for two weeks. The order of whether the first supplement is the zinc amino acid complex, or zinc gluconate, will be randomized., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: The two zinc supplements will have the same appearance, and will be in coded bottles, such that the participant, care provider, investigator, and outcomes assessor may be kept unaware of the order of the supplements for each participant until the data analysis is complete., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 30 mg Zn Amino Acid daily for 13 days, interventions name: 30 mg Zn Gluconate daily for 13 days, outcomesModule primaryOutcomes measure: FADS1 activity index, secondaryOutcomes measure: Fasted plasma zinc concentration, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California, Berkeley, status: RECRUITING, city: Berkeley, state: California, zip: 94720, country: United States, contacts name: Yasaman Massih, MPH, role: CONTACT, phone: 415-279-2171, email: ynmassih@berkeley.edu, geoPoint lat: 37.87159, lon: -122.27275, hasResults: False
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protocolSection identificationModule nctId: NCT06348043, orgStudyIdInfo id: SU_PumpKIN, secondaryIdInfos id: 1UG3HL163311-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG3HL163311-01A1, briefTitle: Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial, acronym: PumpKIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: University of Texas, collaborators name: Carelon Research, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, conditions: Pediatric HD, Stage IV, conditions: LVAD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Jarvik 2015 LVAD, outcomesModule primaryOutcomes measure: Survival to heart transplant, recovery or 180 days of support in the absence of severe stroke., primaryOutcomes measure: Freedom from symptomatic stroke, secondaryOutcomes measure: Incidence rate of all protocol-defined SAE's through 180 days of support definitely or probably related to the device, secondaryOutcomes measure: Distribution of Pediatric Stroke Outcomes Measures, secondaryOutcomes measure: The KOSCHI score, secondaryOutcomes measure: Overall survival on Jarvik 2015 support to 180 days, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348030, orgStudyIdInfo id: 17401, briefTitle: Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: St. Joseph's Healthcare Hamilton, class: OTHER, descriptionModule briefSummary: Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels \<7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Medtronic Signia Stapler, interventions name: Vessel Sealer Extend Energy Device and SureForm Stapler, outcomesModule primaryOutcomes measure: Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection, secondaryOutcomes measure: Operating Room Time, secondaryOutcomes measure: Length of Stay in Hospital, secondaryOutcomes measure: Duration of Chest Tube, secondaryOutcomes measure: Intraoperative Complications and Adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Joseph's Healthcare Hamilton, city: Hamilton, state: Ontario, zip: L8N 4A6, country: Canada, contacts name: Yogita S Patel, BSc, role: CONTACT, phone: 905-522-1155, phoneExt: 35096, email: patelys@mcmaster.ca, contacts name: Waël C Hanna, MDCM, MBA, FRCSC, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, hasResults: False
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protocolSection identificationModule nctId: NCT06348017, orgStudyIdInfo id: Yozgat City Hospital, briefTitle: Frequency of Neuropathic Pain in Patients With Plantar Fasciitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-19, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Yozgat City Hospital, class: OTHER, descriptionModule briefSummary: Study Design This prospective cross-sectional study was undertaken between November 2023 and March 2024. Written and verbal informed consent was obtained from all patients. The study protocol was approved by University Human Research Ethics Committee (AEŞH-EK 1-2023-612).Patients While 106 patients who applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months, received foot radiography and were diagnosed with PF were included in the study as a patient group; 100 patients who did not have foot pain and had musculoskeletal pain for at least 6 months were included in the study as a control group, between November 2023 and March 2024. All the participants were aged 18 to 65 years. Patients with a history of diabetes, hypothyroidism and CKD, a history of malignancy, with vasculitis, neurological diseases that may cause neuropathic pain, lumbar discopathy, those with a previous history of fracture or surgery in the heel area, received injections or ESWT treatment due to heel pain in the last 3 months, rheumatic diseases that may affect pain such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, and severe circulatory disorders on the side with pain, were excluded from the study. The study was commenced after obtaining the approval of the local ethics committee and informed consent of the participants.All patients' personal information (age, gender, occupation, education information), general health information (smoking and alcohol use information, known chronic disease history, body mass index), severity of heel pain and when it started were recorded. While the Foot Function Index (FFI) scale, which evaluates the functionality of the foot, was applied to the patient group; the Visual Analog Scale (VAS), which evaluates pain intensity, the Pain-DETECT scale, which evaluates neuropathic pain, and the Central Sensitization Scale (CSI), which evaluates central sensitization, were applied to the patient and control groups. The details of the implementation of the instruments are as follows:, conditionsModule conditions: Chronic Plantar Fasciitis, conditions: Control Group, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 206, type: ACTUAL, outcomesModule primaryOutcomes measure: Pain-DETECT, primaryOutcomes measure: Foot Function Index, primaryOutcomes measure: Central Sensitization Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yozgat City Hospital, city: Yozgat, zip: 66100, country: Turkey, geoPoint lat: 39.82, lon: 34.80444, hasResults: False
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protocolSection identificationModule nctId: NCT06348004, orgStudyIdInfo id: 2024IIT-0125, briefTitle: The Association Between Albumin Administration and Short-term Rebleeding Risk in Cirrhosis Patients With Acute Variceal Hemorrhage and Stable Hemodynamics, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: The impact of albumin administration in cirrhotics with acute variceal hemorrhage (AVH) is controversial. We aim to investigate the short-term rebleeding risk associated with albumin administration in a retrospective study of hospitalized cirrhotics with AVH with stable hemodynamics. This retrospective analysis includes clinical data of cirrhosis patients with acute variceal bleeding admitted to our hospital from January 2021 to October 2023. Propensity score matching will be performed to account for potential confounders associated with albumin use for outcome analysis. According to the outcome, patients will be divided into rebleeding group and non-rebleeding group. To investigate the impact of albumin infusion on the rebleeding risk in the propensity-matched cohort, patients will be divided into albumin user group and albumin non-user group. The primary outcome is the rebleeding risk within 30 days after discharge., conditionsModule conditions: Cirrhosis, conditions: Acute Variceal Haemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The rebleeding risk within 30 days after discharge., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital, Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06347991, orgStudyIdInfo id: Pro00140155, briefTitle: Alberta Chiropractic SelfBack Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, collaborators name: Chiropractic Association of Alberta, descriptionModule briefSummary: Recurrent and persistent low back pain (LBP) is a massive problem in Canada that causes a substantial pain, disability, cost, and even premature death.The good news is that treatments for recurrent and persistent LBP are available. Many guidelines now recommend education and exercise as the best intervention for chronic LBP. Unfortunately, education and exercise programs are not publicly funded in Canada-only Canadians with extended health benefits can access these programs.As a result, the 50% of Canadians who do not have extended health benefits often seek care for LBP from their publicly funded physicians. Physicians, in turn, have little choice but to reach for what they have available, including opioids, x-rays and referrals to specialists. Not only are these interventions unhelpful for chronic LBP, they are often harmful, sometimes deadly, and disproportionately affect lower socio-economic status households.A possible solution to this problem exists in a validated app (SelfBack) that provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of treatment plans to individuals is achieved by using case-based reasoning (CBR) methodology which is a branch of artificial intelligence.This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through their chiropractors.The results of this study will help us understand the barriers and facilitators of distributing and using the app through Alberta Chiropractors. This information will be used to apply for funding for a larger study to understand the effectiveness of the app as an intervention for persistent and recurrent LBP., conditionsModule conditions: Chronic Low-back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: SelfBack, outcomesModule primaryOutcomes measure: The percentage of patients who utilize the SelfBack app, secondaryOutcomes measure: The percentage of clinicians who utilize the SelfBack app, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06347978, orgStudyIdInfo id: 24-41296, briefTitle: Personalized DBS for OCD Guided by Stereoencephalography Mapping, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Andrew Moses Lee, MD, PhD, class: OTHER, descriptionModule briefSummary: This is a double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment., conditionsModule conditions: Obsessive-Compulsive Disorder, conditions: OCD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Deep Brain Stimulation, outcomesModule primaryOutcomes measure: Primary Feasibility Endpoint #1 - Stimulation Target That Acutely Improves OCD Symptoms, primaryOutcomes measure: Primary Feasibility Endpoint #2 - Identifying an electrophysiological biomarker of OCD, primaryOutcomes measure: Primary Feasibility Endpoint #3 - Acute Symptomatic Improvement, primaryOutcomes measure: Primary Feasibility Endpoint #4 - Completion of Stages 1 and 2, primaryOutcomes measure: Primary Safety Endpoint - Serious Adverse Events, primaryOutcomes measure: Primary Efficacy Endpoint - Treatment Response, secondaryOutcomes measure: Secondary Efficacy Endpoint #1 - Improvement in YBOCS scores from Baseline, secondaryOutcomes measure: Secondary Efficacy Endpoint #2 - Improvement in OCD Symptoms from Baseline, secondaryOutcomes measure: Secondary Efficacy Endpoint #3 - Improvement in Depression Symptoms from Baseline, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False
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protocolSection identificationModule nctId: NCT06347965, orgStudyIdInfo id: IIT20220541B-R1, briefTitle: Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Xin Wang, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to verify the effectiveness and safety of the low load blood flow restriction training program. The intervention effect, tolerance and compliance of low load blood flow restriction training and progressive resistance training on lung cancer patients complicated with sarcopenia during chemotherapy will be compared, in order to provide new ideas for improving or reversing sarcopenia.The main questions it aims to answer are:Can low load blood flow restriction training improve sarcopenia in chemotherapy induced lung cancer patients? Which training method is more effective and tolerable between low load blood flow restriction training and progressive resistance training?Participants will be randomly divided into 3 groups：1. Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.2. Low load blood flow restriction group (LL-BFRT): The researchers will provide participants with a low load blood flow restriction training program constructed by our research group.3. Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training., conditionsModule conditions: Sarcopenia, conditions: Lung Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ACTUAL, armsInterventionsModule interventions name: Low load blood flow restriction training, interventions name: Progressive resistance training group, outcomesModule primaryOutcomes measure: Grip strength, primaryOutcomes measure: Appendicular Skeletal Muscle Index (ASMI), primaryOutcomes measure: Step speed, secondaryOutcomes measure: Body mass index (BMI), secondaryOutcomes measure: Quality of life for lung cancer patients, secondaryOutcomes measure: Exercise compliance, secondaryOutcomes measure: Exercise safety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital, Zhejiang University School of Medicine, city: HangZhou, state: Zhejiang, zip: 310020, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06347952, orgStudyIdInfo id: SE1188, briefTitle: Mapping Arterial Perforators Within the Breast During Mammoplasty, acronym: Map-total, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-27, primaryCompletionDateStruct date: 2024-01-25, completionDateStruct date: 2024-01-29, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Royal Marsden NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result.In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery.We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery.A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps).We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply.In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Use of Acoustic and color imaging doppler during surgery for breast cancer, outcomesModule primaryOutcomes measure: Full-thickness (complete or partial) necrosis of nipple-areolar complex, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Marsden - Surrey, city: Sutton, state: England, zip: SM2 5PT, country: United Kingdom, geoPoint lat: 51.35, lon: -0.2, hasResults: False
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protocolSection identificationModule nctId: NCT06347939, orgStudyIdInfo id: 2023-06638-01, briefTitle: Mediastinal EBUS Cryobiopsy Study In Sweden, acronym: MECRIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Region Skane, class: OTHER, descriptionModule briefSummary: This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis).Follow up four weeks after the procedure to assess the risk for postoperative complications., conditionsModule conditions: Mediastinal Lymphadenopathy, conditions: Lung Cancer, conditions: Sarcoidosis, conditions: Lymphoma, conditions: Tuberculosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Mediastinal lymph nodes cryobiopsies, outcomesModule primaryOutcomes measure: Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis., secondaryOutcomes measure: Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Respiratory medicine and allergy department, Skåne University Hospital, status: RECRUITING, city: Lund, country: Sweden, contacts name: Hamid Akbarshahi, MD, PhD, role: CONTACT, phone: 004646171000, email: hamid.akbarshahi@med.lu.se, geoPoint lat: 55.70584, lon: 13.19321, locations facility: Norrlands universitetssjukhus, status: RECRUITING, city: Umeå, country: Sweden, contacts name: Annelie Behndig, MD, PhD, role: CONTACT, phone: 0907850000, email: annelie.behndig@umu.se, geoPoint lat: 63.82842, lon: 20.25972, hasResults: False
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protocolSection identificationModule nctId: NCT06347926, orgStudyIdInfo id: PROICM 2023-11 EVA, briefTitle: Evaluation of the Effect of Photobiomodulation on Sexual Quality of Life in Women With Breast Cancer, acronym: EVABIOSEIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Institut du Cancer de Montpellier - Val d'Aurelle, class: OTHER, descriptionModule briefSummary: The treatment of breast cancer as well as the disease are responsible for genito-urinary symptoms that can persist over time and impair quality of life. Given the improved prognosis of breast cancer, more and more patients are confronted with specific post-cancer issues, and the care has become a major health challenge.Sexual health is a crucial component of well-being and overall quality of life. Vaginal dryness and dyspareunia are symptoms frequently found in patients treated for breast cancer, with chemotherapy and hormone therapy as risk factors. However, the treatment of sexual disorders remains underdeveloped in France.Vaginal dryness is part of a broader syndrome known as genitourinary syndrome of menopause (GSM), or vulvovaginal atrophy, which may combine vulvovaginal (dryness, irritation, burning), sexual (dyspareunia) and urinary (infections, pollakiuria, urgency) symptoms secondary to hypoestrogenemia, exacerbated by breast cancer treatments. Since hormonal treatments are contraindicated, the first-line treatment for GSM in patients treated for breast cancer is the application of non-hormonal trophic treatments (regular vaginal moisturizers, lubricants during intercourse). However, these treatments are often insufficient to provide effective relief. There is therefore growing interest in the development of second-line treatments for GSM : intra-vaginal hyaluronic acid injections, laser, photobiomodulation (PBM), etc. PBM using Light Emitting Diodes (LED) has been proposed as an alternative treatment for genitourinary syndrome of the menopause. The tissues are exposed to light sources in the visible spectrum, inducing non-thermal, non-cytotoxic biological effects that improve vaginal tissue trophicity. A study is planned to evaluate the use of photobiomodulation in 2nd-line treatment of GSM (after 1st-line treatment with vaginal moisturizers) and on the quality of sexual life of patients treated for breast cancer at any stage of treatment., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Treatment by photobiomodulation, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Photobiomodulation, outcomesModule primaryOutcomes measure: Sexual satisfaction score on one dimension of the SHQ-22 questionnaire, secondaryOutcomes measure: Sexual quality of life scores obtained on all dimensions of the SHQ-22 questionnaire, secondaryOutcomes measure: Patient Global Impression of Improvement (PGI-I) score, secondaryOutcomes measure: Determination of the Vaginal Health Index clinical score, secondaryOutcomes measure: Determination of symptoms of vulvovaginal atrophy by a visual numerical scale, secondaryOutcomes measure: Determination of adverse events by using Common Terminology Criteria for Adverse Events (CTCAE) scale of the National Cancer Institute., secondaryOutcomes measure: Number of patients taking other treatments for treating sexual troubles, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Cancer in Montpellier, city: Montpellier, state: Hérault, zip: 34298, country: France, contacts name: Angélique Bobrie, MD, role: CONTACT, phone: 467618576, phoneExt: +33, email: angelique.bobrie@icm.unicancer.fr, contacts name: Angélique Bobrie, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False
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protocolSection identificationModule nctId: NCT06347913, orgStudyIdInfo id: Soh-Med-24-03-09MS, briefTitle: Umblical Artery Systolic \Diastolic Ratio and Amniotic Fluid Index in Prediction of Fetal Outcome in Term Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Antepartum fetal surveillance is the cornerstone of management in pregnancy. \[1\] It is done primarily to reduce the incidence of adverse fetal outcomes. It minimizes morbidity by optimizing the timing of delivery. Fetus at risk of chronic hypoxia is identified and unnecessary interventions are avoided. However, fetal surveillance acts as a diagnostic modality to detect the influence of maternal, placental, and fetal factors on the fetus. The timely detection of morbid changes in the fetal status followed by adequate interventions to avoid death or disability is one of the most important objectives of prenatal care. \[2\] Tests now commonly done for antepartum fetal surveillance are nonstress test (NST), amniotic fluid index (AFI), biophysical profile, Doppler study of umbilical artery (UA), and middle cerebral artery (MCA).\[3 6\] However, AFI and UA Doppler velocimetry both form an essential part of the antenatal surveillance in the assessment of fetal well being. UA Doppler is a powerful tool that allows the obstetrician to follow a sequence of fetal hemodynamic events that happen in response to placental insufficiency. \[7\] However, several studies have reported higher sensitivities and specificities for UA Doppler ratio for prediction of fetal prognosis. \[3 6\] Amniotic fluid is the product of complex and dynamic fetal and placental physiologic processes. Disruption of the fine balance may result in overproduction or underproduction of fluid. Liquor adequacy often reflects the fetal status. Oligohydramnios is associated with increased perinatal loss. Furthermore, other studies indicate that UA velocimetry is a predictor of adverse outcomes in pregnancies complicated by oligohydramnios. \[8,9\] Thus, arterial Doppler velocimetry measurement may be useful in predicting adverse pregnancy outcomes adjunct to other antenatal surveillance tests, especially the AFI. Therefore, the present study will be done to evaluate the comparative assessment of UA ratio and AFI in predicting adverse perinatal outcomes., conditionsModule conditions: Umblical Artery Doppler in Term Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 213, type: ESTIMATED, armsInterventionsModule interventions name: ultrasound, outcomesModule primaryOutcomes measure: Umbilical Artery Systolic/Diastolic Ratio, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sohag university Hospital, city: Sohag, country: Egypt, contacts name: Magdy M Amin, professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06347900, orgStudyIdInfo id: Soh-Med-23-09-7PD, briefTitle: Corneal Topographic Changes in Different Grades of OSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Corneal topographic parameters in different degrees of obstructive sleep apnea, conditionsModule conditions: Corneal Ectasia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pentacam (corneal topographic changes detection), Polysymnography, outcomesModule primaryOutcomes measure: Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ophthalmology department, Sohag University, status: RECRUITING, city: Sohag, zip: 82511, country: Egypt, contacts name: Elshimaa A.Mateen, role: CONTACT, phone: 0201282223427, email: elshimaa.moussa@yahoo.com, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06347887, orgStudyIdInfo id: SGI-PCR-01, briefTitle: Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-31, primaryCompletionDateStruct date: 2024-01-16, completionDateStruct date: 2024-01-16, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Singlera Genomics Inc., class: INDUSTRY, descriptionModule briefSummary: The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence., conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1965, type: ACTUAL, armsInterventionsModule interventions name: ColonAiQ test and Colonoscopy, outcomesModule primaryOutcomes measure: Sensitivity for colorectal cancer with ColonAiQ test, primaryOutcomes measure: Specificity for colorectal cancer with ColonAiQ test, secondaryOutcomes measure: PPV for colorectal cancer with ColonAiQ test, secondaryOutcomes measure: NPV for colorectal cancer with ColonAiQ test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Affiliated Hospital of Xuzhou Medical University, city: Xuzhou, state: Jiangsu, zip: 221000, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: The First Affiliated Hospital of Shandong First Medical University, city: Jinan, state: Shandong, zip: 250000, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shanxi Provincial People's Hospital, city: Taiyuan, state: Shanxi, zip: 030012, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Xi'an Daxing Hospital, city: Xi'an, state: Shanxi, zip: 710000, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Xi'an Gaoxin Hospital, city: Xi'an, state: Shanxi, zip: 710000, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Zhejiang provincial people's hospital, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06347874, orgStudyIdInfo id: ANES-2024-32820, briefTitle: Cryo Rib Fracture Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter., conditionsModule conditions: Rib Fractures, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The individual doing the outcome assessments will be blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Cryoablation, interventions name: ESP Catheter, outcomesModule primaryOutcomes measure: Maximum pain score on POD (Post Operative Day) 7, primaryOutcomes measure: Opioid Use, primaryOutcomes measure: Functional Pain Scores, primaryOutcomes measure: Number of Patients using opioids at POD 30, primaryOutcomes measure: Length of hospital stay, primaryOutcomes measure: Number of patients returned home by POD 30, primaryOutcomes measure: time to first ambulation, primaryOutcomes measure: number of patients admitted to ICU, primaryOutcomes measure: number of patients that required mechanical ventilation, primaryOutcomes measure: Pulmonary Function Testing., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347861, orgStudyIdInfo id: C4891003, briefTitle: A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-06-16, completionDateStruct date: 2024-07-05, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, collaborators name: Arvinas Estrogen Receptor, Inc., descriptionModule briefSummary: The purpose of the study is to look at how various tablets of a study medicine called vepdegestrant are processed in the body. This will be studied in healthy adult participants after food.This study looks at how the medicine is changed and removed from the body after a participant takes it.This study is seeking for participant who:* are healthy males, and healthy females who do not have the possibility to have children.* are 18 years of age or older.* weigh more than 45 Kilograms (99 pounds).The study consists of 3 treatments. Each participant will be assigned by chance to receive the 3 treatments in a certain sequence. This will be done over 3 study periods. Each treatment consists of a single amount of vepdegestrant taken by mouth in each study period. There will be a washout period between each study periods. The washout period is the time allowed for the medicine to get washed out from the body. How the medicine was processed will be calculated following each dose in each period. The total study duration is about 13 weeks., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: single dose of vepdegestrant as tablet formulation (Treatment A), interventions name: single dose of vepdegestrant as tablet formulation (Treatment B), interventions name: single dose of vepdegestrant as tablet formulation (Treatment C), outcomesModule primaryOutcomes measure: Maximum observed concentration (Cmax) for vepdegestrant, primaryOutcomes measure: Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for vepdegestrant, secondaryOutcomes measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants With Clinical Laboratory Abnormalities, secondaryOutcomes measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, secondaryOutcomes measure: Number of Participants With Electrocardiogram (ECG) Abnormalities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prism Research LLC dba Nucleus Network, status: RECRUITING, city: Saint Paul, state: Minnesota, zip: 55114, country: United States, geoPoint lat: 44.94441, lon: -93.09327, hasResults: False
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protocolSection identificationModule nctId: NCT06347848, orgStudyIdInfo id: IstanbulUCKA, briefTitle: The Effect of Psychoeducation Focused on Reducing Internalized Stigma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: In the fight against stigma, the focus should be on the education of individuals diagnosed with mental illness. Psychoeducation has an important place in the treatment and rehabilitation of mental health problems. Psychoeducation is necessary for early recognition of signs and symptoms of diseases, ensuring compliance with treatment, improving coping skills, as well as combating stigma, preventing internalized stigma, and counteracting social stigma. If individuals with mental disorders have adequate knowledge about the causes of stigma, they may be less prone to internalized stigma., conditionsModule conditions: Schizophrenia, conditions: Treatment Adherence, conditions: Stigma, Social, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two parallel groups randomized control study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Psychoeducation Focused on Reducing Internalized Stigma, outcomesModule primaryOutcomes measure: Internalized Stigma of Mental Illness Scale, primaryOutcomes measure: Medication Adherence Reporting Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University - Cerrahpasa (IUC), city: Istanbul, state: Şişli, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06347835, orgStudyIdInfo id: Gut-Intervention-SAR-2024, briefTitle: Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Currently, there is a lack of definition criteria for sarcopenia based on biomarkers. The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. Therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: symbiotic, interventions name: whey protein, interventions name: symbiotic placebo, interventions name: whey protein placebo, outcomesModule primaryOutcomes measure: Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks, primaryOutcomes measure: Change from Baseline of grip strength at 12 weeks, secondaryOutcomes measure: Change from Baseline of Short Physical Performance Battery score at 12 weeks, secondaryOutcomes measure: Change from Baseline of gait speed at 12 weeks, secondaryOutcomes measure: Change from Baseline of gut microbiota composition at 12 weeks, secondaryOutcomes measure: Change from Baseline of inflammation status at 12 weeks, secondaryOutcomes measure: Change from Baseline of microbiota-derived metabolites at 12 weeks, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Kang Yu, MD, role: CONTACT, phone: +86 010-69155550, email: yuk1997@sina.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06347822, orgStudyIdInfo id: 23-011276, briefTitle: Increasing Access to Evidence-Based Care in Integrated Behavioral Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future., conditionsModule conditions: Psychotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Therapy Session, outcomesModule primaryOutcomes measure: Satisfaction with IBH therapy, primaryOutcomes measure: Satisfaction with Action Plan, primaryOutcomes measure: Change in readiness for change scores, primaryOutcomes measure: Change in PHQ-9 scores, primaryOutcomes measure: Change in GAD-7 scores, secondaryOutcomes measure: Change in Valuing Questionnaire (Values Progress subscale), secondaryOutcomes measure: Change in Valuing Questionnaire (Values Obstruction subscale), secondaryOutcomes measure: Change in CompACT scores (Valued Action), secondaryOutcomes measure: Change in CompACT scores (Openness to Experience), secondaryOutcomes measure: Change in CompACT scores (Behavioral Awareness), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06347809, orgStudyIdInfo id: 18-006343, secondaryIdInfos id: NCI-2024-01225, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 18-006343, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2018-11-07, primaryCompletionDateStruct date: 2029-02-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study explores the potential use of DNA markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests., conditionsModule conditions: Prostate Adenocarcinoma, conditions: Prostate Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP), secondaryOutcomes measure: Accuracy of CAP detection, secondaryOutcomes measure: Comparison of sample volumes, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06347796, orgStudyIdInfo id: 23-0160, secondaryIdInfos id: 1UG3NS128397-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG3NS128397-01A1, briefTitle: Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study, acronym: CHESS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2029-09, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: The University of Texas Medical Branch, Galveston, class: OTHER, collaborators name: National Institute of Neurological Disorders and Stroke (NINDS), descriptionModule briefSummary: The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are:* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?* What is the safety of MMAE and conventional open surgery in these patients?Participants will be asked to:* Share their medical history and undergo physical examinations* Have blood drawn* Have CT scans of the head* Answer questionnaires* Undergo MMAE or conventional open surgery* Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety., conditionsModule conditions: Chronic Subdural Hematoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 520, type: ESTIMATED, armsInterventionsModule interventions name: Conventional Surgery, interventions name: Middle Meningeal Artery Embolization (MMAE), outcomesModule primaryOutcomes measure: Need for Rescue Surgery or Death, secondaryOutcomes measure: Safety of MMAE and Conventional Open Surgery, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Texas Medical Branch, city: Galveston, state: Texas, zip: 77555, country: United States, contacts name: Study Manager, role: CONTACT, phone: 262-470-4293, email: jlspahn@utmb.edu, contacts name: Peter Kan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.30135, lon: -94.7977, hasResults: False
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protocolSection identificationModule nctId: NCT06347783, orgStudyIdInfo id: STUDY00026893, briefTitle: Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Oregon Health and Science University, class: OTHER, descriptionModule briefSummary: The purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. We are hoping to also explore the relationship between insulin pumps, sleep, and overnight blood sugar control. Your information will not be stored and used for future research.The goal of this observational study is learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. The main questions it aims to answer are:Do insulin pumps improve sleep, worsen sleep or have no effect at all? What is the relationship between insulin pumps, sleep, and overnight blood sugar control?Participants will be asked to:* Complete questionnaires regarding demographic data and diabetes history.* Complete surveys regarding sleep quality before and after starting an insulin pump.* Wear a FitBit during sleep for 2 weeks and fill out daily sleep diaries over a 2 week period prior to starting an insulin pump.After 1-2 months after initiation of an insulin pump, participants will be asked again to:* Complete surveys regarding sleep quality* Wear a FitBit during sleep for 2 weeks* Fill out daily sleep diaries over the same 2 week period., conditionsModule conditions: Type1diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Insulin pump, outcomesModule primaryOutcomes measure: Sleep duration, primaryOutcomes measure: Sleep efficiency, secondaryOutcomes measure: Sleep Disturbance Scale for Children, secondaryOutcomes measure: Promis Short Form 8a, otherOutcomes measure: Time in range, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Oregon Health and Science University, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Rachel L Palting, DO, role: CONTACT, phone: 503-494-1966, email: palting@ohsu.edu, contacts name: Ines Guttman-Bauman, MD, role: CONTACT, phone: 503-494-8509, email: Guttman@ohsu.edu, contacts name: Rachel L Palting, DO, role: PRINCIPAL_INVESTIGATOR, contacts name: Ines Guttman-Bauman, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
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protocolSection identificationModule nctId: NCT06347770, orgStudyIdInfo id: ThirdSunYat-senECII202329903, briefTitle: Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Third Affiliated Hospital, Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effect of probiotics 7 days before cesarean section (CS) on postoperative recovery and the change of gut microbiota in pregnant women. Samples were obtained from a total of 80 pregnant individuals, divided into control group and probiotics group. Anal exhaust time and first defecating time were set as the primary outcome of recovery of CS. 16S rRNA amplicon sequencing of the V4 region was analyzed to evaluate the composition of them., conditionsModule conditions: Microbiota, conditions: Postoperative Recovery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic Blend Oral Tablet, outcomesModule primaryOutcomes measure: analysis of postoperative recovery, primaryOutcomes measure: 16S rRNA amplicon sequencing of the V4 region, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhe Li, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Yiwen Zhang, MD, role: CONTACT, phone: +86-18145701061, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06347757, orgStudyIdInfo id: NorthernJiangsuhospital1, briefTitle: A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Northern Jiangsu People's Hospital, class: OTHER, descriptionModule briefSummary: The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial., conditionsModule conditions: Anti-Reflux Alimentary Reconstruction, conditions: Laparoscopic Proximal Gastrectomy, conditions: Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy, outcomesModule primaryOutcomes measure: Incidence of reflux esophagitis, secondaryOutcomes measure: Incidence of anastomotic leakage, secondaryOutcomes measure: Incidence of anastomotic stenosis, secondaryOutcomes measure: Operative time, secondaryOutcomes measure: Intra-operative blood loss, secondaryOutcomes measure: Overall survival, and disease-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiajie Zhou, city: Yangzhou, country: China, geoPoint lat: 32.39722, lon: 119.43583, hasResults: False
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protocolSection identificationModule nctId: NCT06347744, orgStudyIdInfo id: RADX-P-2401, briefTitle: Radicle Rest 24: A Study of Health and Wellness Products on Sleep and Related Health Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Radicle Science, class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sleep and related health outcomes., conditionsModule conditions: Sleep, conditions: Sleep Disturbance, conditions: Sleep Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be stratified based on gender at birth then randomized to one of the study arms., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Participants will be stratified based on gender at birth then randomized to one of the study arms, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: Radicle Rest Placebo Control Form 1, interventions name: Radicle Rest Active Study Product 1.1 Usage, interventions name: Radicle Rest Placebo Control Form 2, interventions name: Radicle Rest Active Study Product 2.1 Usage, outcomesModule primaryOutcomes measure: Change in sleep, secondaryOutcomes measure: Change in feelings of anxiety, secondaryOutcomes measure: Change in fatigue, secondaryOutcomes measure: Change in mood (emotional distress-depression), secondaryOutcomes measure: Minimal clinically important difference (MCID) in sleep, secondaryOutcomes measure: Minimal clinically important difference (MCID) in feelings of anxiety, secondaryOutcomes measure: Minimal clinically important difference (MCID) in fatigue, secondaryOutcomes measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radicle Science, Inc, city: Del Mar, state: California, zip: 92014, country: United States, geoPoint lat: 32.95949, lon: -117.26531, hasResults: False
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protocolSection identificationModule nctId: NCT06347731, orgStudyIdInfo id: VAR-2024-01, briefTitle: Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Varian, a Siemens Healthineers Company, class: INDUSTRY, descriptionModule briefSummary: This study is a clinical trial of prospective, single-center, single-arm objective performance criteria. This trial will be conducted with a total of 47 participants enrolled. All participants will be treated with radiation therapy using the medical device of Varian ProBeam360° Proton Therapy System (ProBeam360°), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration., conditionsModule conditions: Tumor, Solid, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: prospective, open-label, non-randomized, single-arm objective performance criteria, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 47, type: ESTIMATED, armsInterventionsModule interventions name: Proton Radiation Therapy, outcomesModule primaryOutcomes measure: Effectiveness measure: tumor disease control rate reaches the objective performance criteria (80%), primaryOutcomes measure: Safety measure: Incidence of CTCAE grade 3 toxic reaction is acceptable (lower than 5%), primaryOutcomes measure: Safety measure: Incidence of CTCAE grade 4 and 5 toxic reaction is acceptable (0%), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347718, orgStudyIdInfo id: CASTLE, secondaryIdInfos id: 2022-001366-35, type: EUDRACT_NUMBER, secondaryIdInfos id: DRKS00032279, type: REGISTRY, domain: Deutsches Register Klinischer Studien (DRKS), briefTitle: CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease, acronym: CASTLE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-17, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Erlangen-Nürnberg Medical School, class: OTHER, descriptionModule briefSummary: The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells., conditionsModule conditions: Systemic Lupus Erythematosus, conditions: Systemic Sclerosis, conditions: Dermatomyositis, conditions: Polymyositis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Phase 1:Evaluating the safety of CAR-T-Cells in systemic autoimmune diseases with 8 patientsPhase 2:Evaluating the efficiency of CAR-T-Cells in systemic autoimmune diseases with 16 patients, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: anti-CD19 CAR T cell therapy, outcomesModule primaryOutcomes measure: To assess the safety of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc and DM/PM)., secondaryOutcomes measure: Clinical efficacy SSc, secondaryOutcomes measure: Clinical efficacy SLE, secondaryOutcomes measure: Clinical efficacy DM, secondaryOutcomes measure: Cellular response, secondaryOutcomes measure: Serological response, secondaryOutcomes measure: Success of IMP process, secondaryOutcomes measure: Physicians Global Assessment to measure quality of life, secondaryOutcomes measure: Patient's Global Assessment to measure quality of life, secondaryOutcomes measure: Health Assessment Questionnaire, secondaryOutcomes measure: Functional Assessment of Chronic Illness Therapy, secondaryOutcomes measure: SLE-specific disease activity over time per subject, secondaryOutcomes measure: SSc-specific disease activity over time per subject, secondaryOutcomes measure: DM/PM-specific disease activity over time per subject, secondaryOutcomes measure: SLE-specific disease activity over time per subject, secondaryOutcomes measure: DM/PM-specific disease activity over time per subject, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinikum Erlangen, status: RECRUITING, city: Erlangen, state: Bavaria, zip: 91054, country: Germany, contacts name: Georg Schett, Prof. Dr., role: CONTACT, contacts name: Daniela Bohr, Dr., role: CONTACT, geoPoint lat: 49.59099, lon: 11.00783, hasResults: False
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protocolSection identificationModule nctId: NCT06347705, orgStudyIdInfo id: 23-252, briefTitle: A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2029-03-28, completionDateStruct date: 2029-03-28, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: 2141-V11 Antibody, outcomesModule primaryOutcomes measure: Number of participants with a complete response or minimal residual disease., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Matthew Dallos, MD, role: CONTACT, phone: 646-888-4716, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (Limited protocol activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Matthew Dallos, MD, role: CONTACT, phone: 646-888-4716, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Matthew Dallos, MD, role: CONTACT, phone: 646-888-4716, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Matthew Dallos, MD, role: CONTACT, phone: 646-888-4716, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Matthew Dallos, MD, role: CONTACT, phone: 646-888-4716, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All protocol activites), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Matthew Dallos, MD, role: CONTACT, phone: 646-888-4716, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites), status: RECRUITING, city: Rockville Centre, state: New York, zip: 11553, country: United States, contacts name: Matthew Dallos, MD, role: CONTACT, phone: 646-888-4716, geoPoint lat: 40.65871, lon: -73.64124, hasResults: False
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protocolSection identificationModule nctId: NCT06347692, orgStudyIdInfo id: SCBR-240/2024, briefTitle: Effect of Antigravity Treadmill in Knee Osteoarthritis (AGTreadmill), acronym: AGTreadmill, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-07, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2025-04-20, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Prince Sattam Bin Abdulaziz University, class: OTHER, descriptionModule briefSummary: To date, the anti-gravity treadmill, as a representative method of lower body positive pressure treadmills, has been rarely reported for knee osteoarthritis rehabilitation.Purpose: This study aims to evaluate the effect of antigravity treadmill training on pain, gait characteristics, and function in patients with knee osteoarthritis., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study included 40 patients with knee osteoarthritis who were randomly assigned to one of two groups: the antigravity treadmill group (n=20) or the control group (n=20). For 12 weeks, the antigravity treadmill group received training on the Alter G treadmill (75% weight-bearing, 30 minutes per session, three times per week) combined with traditional physical therapy. During the same period, the control group received only traditional physical therapy. The Visual Analogue Scale, Walkway System, and the Western Ontario and McMaster Universities Arthritis Index were used to assess pain, spatiotemporal gait parameters, and patient function, respectively. All outcome measures were obtained pretreatment, post-treatment, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Patients were randomly assigned to either the antigravity treadmill group (n = 20) or the control group (n = 20 ) using an online randomization website (www.randomization.com). The control group received a conventional physical therapy program. The therapists responsible for measuring and assessing the outcomes remained blinded to the group assignments., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: antigravity treadmill, interventions name: physical therapy exercise program, outcomesModule primaryOutcomes measure: Assessment of patient pain, primaryOutcomes measure: Evaluation of gait parameters (step length), primaryOutcomes measure: Evaluation of gait parameters (step time), primaryOutcomes measure: Evaluation of gait parameters (velocity), primaryOutcomes measure: Evaluation of patient function, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06347679, orgStudyIdInfo id: WCHSIRB-CT-2024-160, briefTitle: Effects of Aromatherapy on Anxiety and Pain During Dental Treatments in Adults: a Randomized Controlled Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sichuan University, class: OTHER, descriptionModule briefSummary: Dental anxiety is a common problem in dental care. The aim of this protocol is to evaluate the effect of orange and tea essential oil for the control of anxiety and pain in adults during dental treatments., conditionsModule conditions: Dental Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Aroma diffuser with single-note sweet orange essential oil, interventions name: Aroma diffuser with single-note tea tree essential oil, interventions name: Aroma diffuser with water, outcomesModule primaryOutcomes measure: Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS), primaryOutcomes measure: Pain scale - Visual Analog Scale (VAS), secondaryOutcomes measure: Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S), secondaryOutcomes measure: Vital sign 1 - systolic blood pressure (SBP), secondaryOutcomes measure: Vital sign 2 - diastolic blood pressure (DBP), secondaryOutcomes measure: Vital sign 3 - heart rate (HR）, secondaryOutcomes measure: Vital sign 4 - oxygen saturation (SpO2）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347666, orgStudyIdInfo id: 23082905, briefTitle: Coaching in Early Development Project, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-12, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Rush University Medical Center, class: OTHER, descriptionModule briefSummary: Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. The purpose of this project is to evaluate an evidence-based model of caregiver coaching for CEH that screen positive for developmental delay. We will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff., conditionsModule conditions: Developmental Delay, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: One group will receive the caregiver coaching intervention., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Caregiver coaching, outcomesModule primaryOutcomes measure: Parenting Sense of Competence Scale, primaryOutcomes measure: Parenting Stress Scale, secondaryOutcomes measure: Mullen Scales of Early Learning, secondaryOutcomes measure: Maternal Behavior Responsivity Scale, eligibilityModule sex: ALL, minimumAge: 12 Months, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Rush University Medical Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Lauren Little, role: CONTACT, phone: 312-942-1759, email: lauren_little@rush.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06347653, orgStudyIdInfo id: 2023KT127, briefTitle: Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2030-01-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients., conditionsModule conditions: Nodal T-follicular Helper Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: linperlisib combined with CHOP regimen, outcomesModule primaryOutcomes measure: progression-free survival, secondaryOutcomes measure: ORR, secondaryOutcomes measure: CR rate, secondaryOutcomes measure: Success rate of stem cell collection, secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: time to next anti-lymphoma treatment, secondaryOutcomes measure: adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bejing Cancer Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: PING WEI LIU, master, role: CONTACT, phone: 0086-13522796323, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06347640, orgStudyIdInfo id: KingAbdullahUH2, briefTitle: Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth Using Platelet-rich Fibrin, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: King Abdullah University Hospital, class: OTHER, collaborators name: Jordan University of Science and Technology, descriptionModule briefSummary: Regenerative endodontic procedures are intended to replace damaged tooth structures, including dentine and root structures, in addition to cells of the pulp-dentine complex. This treatment modality have been tested on immature necrotic teeth because they are anticipated to have a greater chance of pulp tissue regeneration.However, it has been recently suggested for treating fully formed mature necrotic permanent teeth with closed apices since the conventional root canal treatment yielded many drawbacks.A number of studies have evaluated the regeneration outcomes of using blood clot as a scaffold. However, there are limited studies in the literature on using other scaffolds such as platelet-rich fibrin (PRF).This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth. Fifty patients with necrotic mature teeth with periapical lesions will be invited to participate in this study. Teeth will be treated using calcium hydroxide as intracanal medicament then using PRF (n=25) and blood clot (n=25) as scaffold. All teeth will be sealed coronally using NeoMTA Plus™. Treated teeth will be assessed clinically and radiographically using 2D periapical radiographs. The reported clinical and radiographic outcomes will be compared using SPSS., conditionsModule conditions: Pulp Revascularization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: induced bleeding, interventions name: plasma rich fibrin, outcomesModule primaryOutcomes measure: Complete healing, secondaryOutcomes measure: regain the pulp sensibility, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Jordan University of Science and Technology, status: RECRUITING, city: Irbid, zip: POBOX 3030, country: Jordan, contacts name: Lama A Awawdeh, role: CONTACT, phone: 0795412954, email: lawawdeh@hotmail.com, geoPoint lat: 32.55556, lon: 35.85, hasResults: False
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protocolSection identificationModule nctId: NCT06347627, orgStudyIdInfo id: UW23139, briefTitle: Communicating Human Papillomavirus Vaccine With Japanese Parents and Caregivers With Daughters Aged 12-18, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-22, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: London School of Hygiene and Tropical Medicine, collaborators name: Nagasaki University, descriptionModule briefSummary: This study aims to comprehensively assess confidence in and acceptance of human papillomavirus (HPV) vaccines among Japanese parents and caregivers with daughters aged 12-18 and their decision-making process., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule interventions name: Group 1 (I x S x S x F), interventions name: Group 2 (O x S x S x F), interventions name: Group 3 (I x E x S x F), interventions name: Group 4 (O x E x S x F), interventions name: Group 5 (I x S x S x M), interventions name: Group 6 (O x S x S x M), interventions name: Group 7 (I x E x S x M), interventions name: Group 8 (O x E x S x M), interventions name: Group 9 (I x S x D x F), interventions name: Group 10 (O x S x D x F), interventions name: Group 11 (I x E x D x F), interventions name: Group 12 (O x E x D x F), interventions name: Group 13 (I x S x D x M), interventions name: Group 14 (O x S x D x M), interventions name: Group 15 (I x E x D x M), interventions name: Group 16 (O x E x D x M), outcomesModule primaryOutcomes measure: Willingness to receive HPV vaccines for daughters, secondaryOutcomes measure: Confidence in HPV vaccine safety, eligibilityModule sex: FEMALE, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: London School of Hygiene and Tropical Medicine, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06347614, orgStudyIdInfo id: 2021-FXY-042, briefTitle: Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study, acronym: Two-step RP, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. The main questions it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?, conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Two-step Radical Prostatectomy, outcomesModule primaryOutcomes measure: Biochemical Recurrence-free Survival, secondaryOutcomes measure: Surgical time, secondaryOutcomes measure: Estimated blood loss, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: Continence ContinenceContinence Continence Continence Continence Continence Continence Continence Continence, secondaryOutcomes measure: Lower urinary tract symptoms, secondaryOutcomes measure: Erectile function, secondaryOutcomes measure: Positive surgical margin rate, secondaryOutcomes measure: Complication, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510060, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06347601, orgStudyIdInfo id: 2024-03-011AC, briefTitle: Survey on Sexual and Gender in the Healthcare in Taiwan, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-20, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Taipei Veterans General Hospital, Taiwan, class: OTHER_GOV, descriptionModule briefSummary: This study addresses the pervasive issue of sexual harassment within Taiwanese society, particularly within the medical field, where comprehensive research is lacking. The research objective is to explore patterns of sexual harassment and gender discrimination experiences among physicians and medical students in Taiwan, while also investigating potential associations with professional burnout and mental health. Employing a convergent mixed-methods design, the study combines quantitative surveys and qualitative in-depth interviews. While lacking a control group and utilizing non-blinding methods without random assignment, the study aims to recruit 1000 participants aged 18 or older, considering both valid responses and potential dropouts. Additionally, interviews will be conducted with 30 individuals who have experienced sexual harassment or are interested in gender issues. The research methods will assess sexual harassment experiences, professional burnout, and depressive symptoms as primary outcomes or indicators., conditionsModule conditions: Sexual Harassment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Without Intervention, outcomesModule primaryOutcomes measure: Center for Epidemiologic Studies Depression Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei Veterans General Hospital, status: RECRUITING, city: Taipei, zip: 100, country: Taiwan, contacts name: Jheng-Min Yu, M.D., role: CONTACT, phone: 0933238592, email: TaipeiDU2017@gmail.com, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06347588, orgStudyIdInfo id: OBI&ICI, briefTitle: Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Policlinico San Matteo di Pavia, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study., conditionsModule conditions: Occult Hepatitis B Infection in Cancer Patients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA, outcomesModule primaryOutcomes measure: To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV, secondaryOutcomes measure: Evaluation of the incidence of reactivation in patients during immunotherapy, secondaryOutcomes measure: Evaluation of the association between HBV-specific T-cell response and HBV reactivation, secondaryOutcomes measure: Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor characteristics (histology and stage) and type and line of treatment (immunotherapy, combined treatment with chemotherapy + immunotherapy)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs San Matteo Pavia, city: Pavia, state: PV, zip: 27100, country: Italy, contacts name: Alessandra Ferrari, role: CONTACT, phone: 0382.503689, email: alessandra.ferrari@smatteo.pv.it, contacts name: ANGIOLETTA LASAGNA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06347575, orgStudyIdInfo id: APHP230522, briefTitle: Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function on Spinal Cord Injured Patients, acronym: CAVERSTIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, collaborators name: Comphya SA, descriptionModule briefSummary: The main objective of the study is to assess the safety and tolerability of cavernous nerve electrical stimulation in patients with spinal cord injured (SCI) by assessing and measuring complications.As the secondary objectives, despite the limited cohort size, this long-term study aims to obtain preliminary data on efficacy of cavernous nerve stimulation to improve erectile function for sexual intercourse, as well as to assess patient's satisfaction using:* Objective assessment of the erectile response upon CaverSTIM activation with the RigiScan device.* Subjective assessment of the erectile function with validated questionnaires: 1. A 6-item self-report instrument assessing male erectile function (Erectile Function domain of the International Index of Erectile Function, IIEF-EF); 2. A log-diary five item questionnaire completed after each sexual attempt (Sexual Encounter Profile, SEP); 3. A self-reporting measure that scores erection hardness on a 4-point scale (Erection Hardness Score, EHS); 4. The Global Assessment Question (GAQ).In addition, the study aims to refine the method of implantation (step-by-step delineation of all technical approaches for device implantation, including duration of surgical procedure, blood loss, methods to access the periprostatic region, tissue dissection, device placement and fixation) prior to planning for larger scale clinical investigation., conditionsModule conditions: Spinal Cord Injuries, conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Implantation of the caverStim device, outcomesModule primaryOutcomes measure: Safety evaluation, primaryOutcomes measure: Pain assessement, primaryOutcomes measure: Complications related to implantation surgery, secondaryOutcomes measure: Evaluation of IIEF-EF, secondaryOutcomes measure: Evaluation of EHS, secondaryOutcomes measure: Evaluation of SEP, secondaryOutcomes measure: Evaluation of GAQ, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of neurology-urology-andrology, Raymond Poincaré hospital - APHP, city: Garches, zip: 92380, country: France, geoPoint lat: 48.84226, lon: 2.18232, locations facility: Department of Urology, La pitié Salpêtrière Hospital - APHP, city: Paris, zip: 75013, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06347562, orgStudyIdInfo id: 934, briefTitle: Optical Genome Mapping for the Diagnosis of Neurodevelopmental Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-15, primaryCompletionDateStruct date: 2025-06-14, completionDateStruct date: 2025-06-14, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: to evaluate the ability of the Optical genome Mapping (OGM) approach to detect simple and complex constitutional chromosomal aberrations of clinical relevance, which had previously been identified with standard diagnostic approaches (karyotyping, FISH, CNV-microarray) in the context of neurodevelopmental disorders (NDDs) with/wo congenital anomalies (CA), conditionsModule conditions: Neurodevelopmental Disorder (Diagnosis), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Optical Genome Mapping, outcomesModule primaryOutcomes measure: Diagnostic concordance rate, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Scientific Institute E. Medea, status: RECRUITING, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, contacts name: Clara Bonaglia, PhD, role: CONTACT, phone: 031877913, phoneExt: +39, email: clara.bonaglia@lanostrafamiglia.it, geoPoint lat: 45.80075, lon: 9.29, hasResults: False
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protocolSection identificationModule nctId: NCT06347549, orgStudyIdInfo id: HE-SF2024/09, briefTitle: The Impact of Diaphragmatic Breathing Instructions and Inspiratory Pressures on Diaphragm Contraction in Healthy Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-04-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Hong Kong Metropolitan University, class: OTHER, descriptionModule briefSummary: This is a cross-sectional obsessional study.This study aims (1) to investigate the relationship between sternocleidomastoid muscle recruitment and diaphragm thickness fraction during increasing inspiratory resistance in healthy adults; (2) to compare diaphragmatic and sternocleidomastoid muscle recruitment patterns with and without a standard diaphragmatic breathing instruction with increasing inspiratory resistance in healthy adults.Participants will be asked to breathe through a pressure threshold inspiratory loading device under different inspiratory resistances with and without a standard diaphragmatic breathing instruction. sternocleidomastoid muscle activity will be measured with surface electromyography, and diaphragm thickness will be assessed with ultrasonography., conditionsModule conditions: Diaphragm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Various intensities of inspiratory muscle training, outcomesModule primaryOutcomes measure: Diaphragmatic thickening fraction, secondaryOutcomes measure: Muscle activation of the sternocleidomastoid muscle, secondaryOutcomes measure: Perceived Exertion Borg scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-25, uploadDate: 2024-03-28T00:38, filename: Prot_SAP_000.pdf, size: 185477, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-25, uploadDate: 2024-03-28T00:39, filename: ICF_001.pdf, size: 204027, hasResults: False
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protocolSection identificationModule nctId: NCT06347536, orgStudyIdInfo id: IRAS331831, secondaryIdInfos id: NIHR156698, type: OTHER_GRANT, domain: NIHR HTA, briefTitle: Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease, acronym: RAPID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Guy's and St Thomas' NHS Foundation Trust, class: OTHER, collaborators name: King's College London, collaborators name: University College, London, collaborators name: Imperial College London, collaborators name: University of Cambridge, collaborators name: University of Southampton, collaborators name: University of Nottingham, collaborators name: University of Leicester, collaborators name: Frimley Health NHS Foundation Trust, collaborators name: Newcastle University, collaborators name: University of Bristol, collaborators name: Asthma and Lung UK, descriptionModule briefSummary: Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality.Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed.A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum., conditionsModule conditions: COPD, conditions: COPD Exacerbation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1400, type: ESTIMATED, armsInterventionsModule interventions name: Supported rescue pack, outcomesModule primaryOutcomes measure: Time to first all-cause readmission within 90 days of discharge, secondaryOutcomes measure: Time to and frequency of COPD-related readmissions at 30 and 90 days, secondaryOutcomes measure: Days alive and out of hospital at day 90, secondaryOutcomes measure: Time to and frequency of all COPD exacerbations at days 30 and 90, secondaryOutcomes measure: Cumulative systemic oral corticosteroids use over 90 days, secondaryOutcomes measure: Cumulative systemic antibiotic use over 90 days, secondaryOutcomes measure: Health care contacts at baseline, days 90 and 180, and 1 year, secondaryOutcomes measure: All cause readmission at 30 days, secondaryOutcomes measure: All cause-, cardiovascular- and COPD- related mortality at day 90 and over 12 months, secondaryOutcomes measure: EQ-5D-5L Health questionnaire (quality of life) at days 90 and 180, and 1 year, secondaryOutcomes measure: Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at days 90 and 180 and 1 year, secondaryOutcomes measure: Qualitative interviews to examine and describe usual care, secondaryOutcomes measure: Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm, secondaryOutcomes measure: Serious adverse events, secondaryOutcomes measure: Antimicrobial resistance, secondaryOutcomes measure: Quality of life COPD assessment Test (CAT) score at days 90, 180 and 1 year, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Birminham NHS Foundation Trust, city: Birmingham, country: United Kingdom, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Blackpool Teaching Hospitals, city: Blackpool, country: United Kingdom, geoPoint lat: 53.81667, lon: -3.05, locations facility: Bradford Teaching Hospitals NHS Foundation Trust, city: Bradford, country: United Kingdom, geoPoint lat: 53.79391, lon: -1.75206, locations facility: University Hospitals Sussex NHS Foundation Trust, city: Brighton, country: United Kingdom, geoPoint lat: 50.82838, lon: -0.13947, locations facility: North Bristol University Trust, city: Bristol, country: United Kingdom, geoPoint lat: 51.45523, lon: -2.59665, locations facility: County Durham and Darlington NHS Foundation Trust, city: Durham, country: United Kingdom, geoPoint lat: 54.77676, lon: -1.57566, locations facility: East Suffolk and North Essex Foundation Trust, city: Ipswich, country: United Kingdom, geoPoint lat: 52.05917, lon: 1.15545, locations facility: University Hospitals of Morecambe Bay NHS Foundation Trust, city: Lancaster, country: United Kingdom, geoPoint lat: 54.04649, lon: -2.79988, locations facility: University Hospitals of Leicester NHS Trust, city: Leicester, country: United Kingdom, geoPoint lat: 52.6386, lon: -1.13169, locations facility: Cardiff and Vale University Health Board, city: Llandough, country: United Kingdom, geoPoint lat: 51.44556, lon: -3.44722, locations facility: Guy's and St Thomas' NHS Foundation Trust, city: London, country: United Kingdom, contacts name: Mona Bafadhel, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial College Healthcare NHS Trust, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Free London NHS Foundation Trust, city: London, country: United Kingdom, contacts name: John Hurst, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Maidstone and Tunbridge Wells NHS Trust, city: Maidstone, country: United Kingdom, geoPoint lat: 51.26667, lon: 0.51667, locations facility: South Tees NHS Foundation Trust, city: Middlesbrough, country: United Kingdom, geoPoint lat: 54.57623, lon: -1.23483, locations facility: Milton Keynes University Hospital NHS Foundation Trust, city: Milton Keynes, country: United Kingdom, geoPoint lat: 52.04172, lon: -0.75583, locations facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust, city: Newcastle Upon Tyne, country: United Kingdom, geoPoint lat: 54.97328, lon: -1.61396, locations facility: Northumbria Healthcare NHS Foundation Trust, city: North Shields, country: United Kingdom, geoPoint lat: 55.01646, lon: -1.44925, locations facility: Nottingham University Hospitals Trust, city: Nottingham, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, locations facility: Oxford University Hospitals NHS Foundation Trust, city: Oxford, country: United Kingdom, geoPoint lat: 51.75222, lon: -1.25596, locations facility: Salisbury NHS Foundation Trust, city: Salisbury, country: United Kingdom, geoPoint lat: 51.06931, lon: -1.79569, locations facility: University Hospital Southampton NHS Foundation Trust, city: Shirley, country: United Kingdom, geoPoint lat: 52.41074, lon: -1.81952, locations facility: Frimley Health NHS Foundation Trust, city: Slough, country: United Kingdom, geoPoint lat: 51.50949, lon: -0.59541, locations facility: South Tyneside and Sunderland NHS Trust, city: South Shields, country: United Kingdom, geoPoint lat: 54.99859, lon: -1.4323, locations facility: Stockport NHS Foundation Trust, city: Stockport, country: United Kingdom, geoPoint lat: 53.40979, lon: -2.15761, locations facility: North Tees and Hartlepool NHS Foundation Trust, city: Stockton-on-Tees, country: United Kingdom, geoPoint lat: 54.56848, lon: -1.3187, locations facility: Sherwood Forest Hospitals NHS Foundation Trust, city: Sutton In Ashfield, country: United Kingdom, geoPoint lat: 53.12542, lon: -1.26135, locations facility: Somerset Foundation Trust, city: Taunton, country: United Kingdom, geoPoint lat: 51.01494, lon: -3.10293, locations facility: Somerset Foundation Trust, city: Yeovil, country: United Kingdom, geoPoint lat: 50.94159, lon: -2.63211, hasResults: False
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protocolSection identificationModule nctId: NCT06347523, orgStudyIdInfo id: FirstShantou, briefTitle: VR-Based Preoperative Rehabilitation Program for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Shantou University Medical College, class: OTHER, descriptionModule briefSummary: Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. They will be randomly divided into two groups: an experimental group and a control group., conditionsModule conditions: Anterior Cruciate Ligament (ACL) Reconstruction, conditions: Preoperative Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: The VR-based preoperative rehabilitation program;, interventions name: standard nursing care,, outcomesModule primaryOutcomes measure: knee joint range of motion, primaryOutcomes measure: Lysholm knee function score, secondaryOutcomes measure: SAS self-rating anxiety scale scale, secondaryOutcomes measure: SDS self-rating depression scale scale, secondaryOutcomes measure: Visual Analog Scale pain score, secondaryOutcomes measure: Barthel Index for basic activities of daily living, secondaryOutcomes measure: time to first ambulation post-surgery, otherOutcomes measure: postoperative complications, otherOutcomes measure: nursing satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: "The First Affiliated Hospital of Shantou University Medical College, status: RECRUITING, city: Shantou, state: Guangdong, zip: 515000, country: China, contacts name: Zeshan Chen, role: CONTACT, phone: +8613592896271, geoPoint lat: 23.36814, lon: 116.71479, hasResults: False
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protocolSection identificationModule nctId: NCT06347510, orgStudyIdInfo id: E-25403353-050.99-174660, briefTitle: The Level of sST2 in Pediatric Heart Failure, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-16, primaryCompletionDateStruct date: 2024-02-16, completionDateStruct date: 2024-02-16, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Eskisehir Osmangazi University, class: OTHER, descriptionModule briefSummary: Introduction: Suppression of tumorigenicity 2 (ST2) is a receptor member belongs to the Interleukin-1 (IL-1) family. The ligand and soluble versions are its two isoforms. The interleukin-33-ST2 ligand complexs development provides protection against heart fibrosis and hypertrophy. Investigations on heart failure in adults has demonstrated that it does not change by age, body mass index (BMI), creatinine, hemoglobin, and albumin levels, in contrast to NT pro brain natriuretric peptit. In adult heart failure patients, it has been demonstrated to be an independent predictor of mortality and cardiovascular events. The most recent guideline recommends using it as class 2b in the diagnosis of adult heart failure. Studies on ST2 in children are rare. The purpose of this study is to assess the prognostic value of ST2 for cardiovascular events in young individuals suffering from heart failure.Method: The study included pediatric patients (0-18 years old) with congenital heart disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment. Height, weight, gender, saturation, heart failure classification (Ross or New York heart Assosiation), medications taken, the electrocardiogram, echocardiography, Pro BNP, and sST2 values of the patients, as well as any hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery during follow-up Data on arrhythmia and death were gathered during a 1-year follow-up. The SPSS software application was used to carry out the statistical analysis., conditionsModule conditions: Congenital Heart Disease, conditions: Congestive Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 59, type: ACTUAL, armsInterventionsModule interventions name: Suppression of tumorigenicity 2 (ST2), outcomesModule primaryOutcomes measure: Soluble suppression of tumorigenicity levels with or without major cardiovascular event, primaryOutcomes measure: Pro BNP levels, primaryOutcomes measure: Major cardiovascular event ( such as hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery), eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Eskisehir Osmangazi University, city: Eskisehir, state: Odunpazarı, zip: 26040, country: Turkey, geoPoint lat: 39.77667, lon: 30.52056, hasResults: False
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protocolSection identificationModule nctId: NCT06347497, orgStudyIdInfo id: 000001230988, briefTitle: Zonisamide Versus Topiramate in Migraine, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-02, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: Investigators aim to compare the effect of zonisamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency, conditionsModule conditions: Migraine, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We will assess The number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either zonisamide and acetaminophen or topiramate and acetaminophen from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included zonisamide and acetaminophen, and Drug B included topiramate and acetaminophen. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Zonisamide 50 MG, interventions name: Topiramate 50 MG, outcomesModule primaryOutcomes measure: The change in migraine days per 28 days, secondaryOutcomes measure: The total number of migraine days after three months of treatment, secondaryOutcomes measure: The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency., secondaryOutcomes measure: HIT-6 score absolute reduction in each group after three months of treatment, secondaryOutcomes measure: The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months., eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Kafr Elsheikh University Hospital, status: RECRUITING, city: Kafr Ash Shaykh, zip: 33511, country: Egypt, contacts name: mohamed G. Zeinhom, MD, role: CONTACT, phone: 2001009606828, email: mohamed_gomaa@med.kfs.edu.eg, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
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protocolSection identificationModule nctId: NCT06347484, orgStudyIdInfo id: IRB00411716, briefTitle: Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT), acronym: CONNECT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: Morgan State University, collaborators name: American Heart Association, descriptionModule briefSummary: The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning community that provides tailored education on cardiovascular (CV) health and research participation; connects community members to CV-related research; and disseminates CV-related study findings. The overreaching goal of CONNECT is to improve participation of underrepresented communities in CV research, including as women, Black adults, and Latino adults, through increasing participants' clinical trial awareness, trust in biomedical research, and willingness to participate in clinical trials. CONNECT will use digital and community-engaged approaches to identify and recruit 1000 adults with cardiovascular disease or a cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will receive tailored educational information on CV health and research participation via text message. Participants will also have the opportunity to be matched to ongoing CV research studies based on basic demographic information and areas of interest. The educational information will be sent to participants for 12 months. The investigators hypothesize that CONNECT will increase participants' clinical trial awareness, trust, and willingness to participate in clinical trials and that the proportion of Black and Latin adults and women enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for recruitment., conditionsModule conditions: Cardiovascular Diseases, conditions: Hypertension, conditions: Diabetes Type 2, conditions: Stroke, conditions: Recruitment, conditions: Overweight and Obesity, conditions: Hyperlipidemias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Formal Toned Educational Messages, interventions name: Understanding Toned Educational Messages, interventions name: Casual Toned Educational Messages, outcomesModule primaryOutcomes measure: Participant accrual, secondaryOutcomes measure: Participant accrual in partnering cardiovascular research studies, secondaryOutcomes measure: Trust in Biomedical Research using the Perceptions of Research Trustworthiness Scale (PoRT), secondaryOutcomes measure: Clinical trials awareness and knowledge will be assessed using items adapted from the Health Information National Trends Survey (HINTS), secondaryOutcomes measure: Willingness to participate in research will be measured by asking participants one related question, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347471, orgStudyIdInfo id: SBS-2023-477, briefTitle: The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy, acronym: SPARTAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Infectious Diseases Research Collaboration, Uganda, class: OTHER, collaborators name: London School of Hygiene and Tropical Medicine, collaborators name: Radboud University Medical Center, descriptionModule briefSummary: A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and are treated with conventional artemisinin-combination therapies (ACT) as part of standard clinical care. From this population, we will select P. falciparum gametocyte carriers.Before, during and after ACT treatment, the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy, molecular methods, parasite culture and mosquito feeding assays. Parasite clearance will be determined in the first days (d0-3) after treatment.The study population will consist of passively recruited patients with uncomplicated P. falciparum malaria who are microscopy positive for gametocytes. Participants will be treated with conventional therapies for uncomplicated malaria without randomization: artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA-PPQ). All doses are supervised. Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment.Gametocyte carriage and gametocyte commitment/production will be determined for resistant and wild type infections before, during and after treatment. In addition, venous blood will be collected at three timepoints to assess transmission to mosquitoes before (d0), during (d2) and after treatment (d7). The total duration of participation will be 7 days, the primary endpoint will be the reduction in mosquito infection rates at d2 (artemether-lumefantrine) or d7 (dihydroartemisinin-piperaquine) compared to pre-treatment., conditionsModule conditions: Falciparum; Malaria, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Artemether-lumefantrine, interventions name: Dihydroartemisinin-Piperaquine, outcomesModule primaryOutcomes measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline., secondaryOutcomes measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline, secondaryOutcomes measure: Mean oocyst intensity (in all/all infected mosquitoes), secondaryOutcomes measure: Male and female gametocyte sex ratio (proportion male), secondaryOutcomes measure: Gametocyte circulation time, secondaryOutcomes measure: Gametocyte area under the curve, secondaryOutcomes measure: Asexual parasite prevalence, secondaryOutcomes measure: Asexual parasite density, secondaryOutcomes measure: Total parasite prevalence, secondaryOutcomes measure: Total parasite density, secondaryOutcomes measure: The density of ΔPfK13 vs wild type genotypes, secondaryOutcomes measure: The density of ΔPfK13 vs wild type genotypes in oocysts and sporozoites in mosquitoes that become infected before and after initiation of treatment, eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr. Ambrosoli Memorial Hospital, city: Kalongo, state: Agago District, country: Uganda, contacts name: Maurice Akao, MBChB, role: CONTACT, locations facility: Patongo Health Facility IV, city: Patongo, state: Agago District, country: Uganda, contacts name: MD, role: CONTACT, geoPoint lat: 2.74472, lon: 33.32417, hasResults: False
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protocolSection identificationModule nctId: NCT06347458, orgStudyIdInfo id: BG-CA-23-001, briefTitle: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Guangzhou Bio-gene Technology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a single-arm, single-dose dose-escalation and dose-expansion study., conditionsModule conditions: Leukemia, conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: BG1805, outcomesModule primaryOutcomes measure: 1.Dose Limited Toxicity Rate, primaryOutcomes measure: 2.Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: 3.Concentration of CAR-T cells after Infusion (PK), secondaryOutcomes measure: 4.overall response rate, ORR, secondaryOutcomes measure: 5.Concentration of Cytokine after Infusion (PD), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347445, orgStudyIdInfo id: GSM012024, briefTitle: Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus-2 (TEMD-2 Study), acronym: TEMD-2, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2023-01-30, completionDateStruct date: 2023-01-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Gulhane School of Medicine, class: OTHER, descriptionModule briefSummary: This study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey., conditionsModule conditions: Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 5707, type: ACTUAL, armsInterventionsModule interventions name: There is no intervention., outcomesModule primaryOutcomes measure: Glycemia control status of Turkish adult patients with diabetes mellitus, primaryOutcomes measure: Blood pressure control status of Turkish adult patients with diabetes mellitus, primaryOutcomes measure: Lipid control status of Turkish adult patients with diabetes mellitus., primaryOutcomes measure: Weight control status of Turkish adult patients with diabetes mellitus., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gulhane School of Medicine Department of Endocrinology and Metabolism, city: Ankara, zip: 06010, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06347432, orgStudyIdInfo id: 24-119-H, briefTitle: Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Grand Valley State University, class: OTHER, descriptionModule briefSummary: For children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Power wheelchair skills training using the IndieTrainer system, outcomesModule primaryOutcomes measure: Change in understanding how to use a power wheelchair, primaryOutcomes measure: Change in power wheelchair skill performance, secondaryOutcomes measure: Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance, secondaryOutcomes measure: Change in children's perceptions of changes in their performance of power wheelchair skill performance, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Grand Valley State University, city: Grand Rapids, state: Michigan, zip: 49503, country: United States, geoPoint lat: 42.96336, lon: -85.66809, hasResults: False
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protocolSection identificationModule nctId: NCT06347419, orgStudyIdInfo id: Iayas8, briefTitle: Body Awareness and Spinal Stability in Scoliosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, descriptionModule briefSummary: Thirty volunteer patients diagnosed with scoliosis by a specialist physician at Gazi University Hospital Orthopedics and Traumatology Department and subsequently referred to Gazi University Physiotherapy and Rehabilitation Department for exercise training will be included in the study. The lumbar Pressure Measurement Test with Stabilizer and Rotation Stability Tests will be utilized to evaluate the spinal stability of the patients. Body awareness will be assessed using the Body Awareness Survey, comprising 18 questions. All assessments will be conducted at the Orthopedic Rehabilitation Clinic within the relevant department.The results obtained from this study will elucidate the relationship between body awareness and spinal stability in individuals with scoliosis., conditionsModule conditions: Scoliosis Idiopathic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Physiotherapy evaluation, outcomesModule primaryOutcomes measure: Spinal stability, primaryOutcomes measure: Rotary Stability, primaryOutcomes measure: Body Awareness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gazi University Hospital, city: Ankara, zip: 06500, country: Turkey, contacts name: İnci H Ayas, role: CONTACT, phone: 0 312 216 26 21, email: inciayass@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06347406, orgStudyIdInfo id: FSKesihatan, briefTitle: Effects of Combined Physiotherapy Management and Education, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Fakulti Sains Kesihatan, class: OTHER, descriptionModule briefSummary: This observational study aims to determine the effects of combined physiotherapy programs and education in patellofemoral pain syndrome. The main questions it aims to answer are:* Are there any effects of combined physiotherapy program among individuals with PFPS on: i) Pain ii) Muscle functions (strength, muscle bulk, flexibility) iii) Knee muscle functional performance (anteromedial lunge, step-down, bilateral squat, and balance and reach) iv) Kinesiophobia v) Quality of life Participants will be* Measure for the anthropometrics data including body weight, height, and BMI.* Answer the Numerical Pain Rating scale* Abswe Malay version of KOOS-PF and TAMPA scale.* Once they finished with the questionnaire, the participants will be stationed into station 1 (HDD), station 2 (Realtime Ultrasound) and station 3 (Dartfish Motion Analysis) Treatment they will receive* Blood flow restrictions cuff with physiotherapy exercises* Patient education Researcher will compare Blood flow exercises combined with physiotherapy exercises and education (Group A) with Physiotherapy exercises (Group B) to see if there is an effect on i) Pain ii) Muscle Functions (strength, muscle bulk, flexibility iii) Functional performance (anteromedial lunge, step-down, bilateral squat, balance, and reach) iv) Kinesiophobia v) Quality of life, conditionsModule conditions: Patellofemoral Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Blood flow restriction combined with physiotherapy and education, outcomesModule primaryOutcomes measure: Numerical Pain Rating, primaryOutcomes measure: The Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF), primaryOutcomes measure: Tampa Scale, primaryOutcomes measure: Hand held dynamometer (HDD), primaryOutcomes measure: Knee Muscle performance Test with Dartfish software, primaryOutcomes measure: Real time ultrasounds, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fakulti Sains Kesihatan, status: RECRUITING, city: Shah Alam, state: Selangor Darul Ehsan, zip: 42300, country: Malaysia, contacts name: Zarina Zahari, role: CONTACT, phone: 0132094170, email: zarinazahari@uitm.edu.my, contacts name: Nurul Atiqah Mohamed Mosbi, role: CONTACT, phone: 603-3258 4300, email: atiqahmosbi@uitm.edu.my, geoPoint lat: 3.08507, lon: 101.53281, hasResults: False
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protocolSection identificationModule nctId: NCT06347393, orgStudyIdInfo id: 6425, briefTitle: Transgender and Gender Diverse Individuals Screening for Breast Cancer, acronym: GENESIS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, collaborators name: Istituto Europeo di Oncologia, collaborators name: Luigi Sacco University Hospital, collaborators name: Fatebenefratelli Hospital, collaborators name: Ospedale Policlinico San Martino, collaborators name: Università degli studi di Messina, Messina, collaborators name: IRCCS Azienda Ospedaliero-Universitaria di Bologna, collaborators name: Arcispedale Santa Maria Nuova-IRCCS, collaborators name: Federico II University, collaborators name: Azienda Ospedaliero-Universitaria Careggi, descriptionModule briefSummary: The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer in transgender and gender-diverse population., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule interventions name: Mammography and Breast Ultrasound, outcomesModule primaryOutcomes measure: Incidence of Breast Cancer, secondaryOutcomes measure: The adherence rate to the screening, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347380, orgStudyIdInfo id: CIP011, briefTitle: Usability Study of the FemPulse System, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: FemPulse Corporation, class: INDUSTRY, descriptionModule briefSummary: The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable., conditionsModule conditions: Overactive Bladder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: FemPulse System, outcomesModule primaryOutcomes measure: Patient Satisfaction, eligibilityModule sex: FEMALE, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347367, orgStudyIdInfo id: EU-FTR-GK-01, briefTitle: Short-term Effect of Exercise and Self-manual Approaches to Bloating - Distention, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-04-17, completionDateStruct date: 2024-04-19, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: Abdominal bloating and distension (ABD) are the most commonly gastrointestinal symptoms reported by patients with various functional gut disorders such as functional dyspepsia, irritable bowel syndrome and it is frequently associated with constipation. The pathophysiology of ABD is complex, often multifactorial and poorly understood. The reseach was hypothesised that short-term self-manual approaches and exercise for core muscles would have a positive effect on the symptoms of ABD., conditionsModule conditions: Gastrointestinal System Disease, conditions: Functional Bloating, conditions: Distension; Bowel, conditions: Gastrointestinal Motility Disorder, conditions: Pelvic Floor Dyssynergia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be assigned to Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) and Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Triple (Participant, Investigator and Outcomes Assessor), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles), interventions name: Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles), outcomesModule primaryOutcomes measure: Abdominal bloating and distention (ABD) Perception of sensations, secondaryOutcomes measure: Superficial Electromyography (EMG), otherOutcomes measure: Gastrointestinal Symptom Rating Scale (GSRS), otherOutcomes measure: High-resolution anorectal manometry (HRAM), otherOutcomes measure: Balloon Expulsion Test (BET), otherOutcomes measure: Colon Transit Time (CTT), otherOutcomes measure: Ultrasonography (USG), otherOutcomes measure: Digital dynamometer, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ege University Faculty of Medicine, Department of Gastroenterology, status: RECRUITING, city: İzmir, state: Bornova, zip: 35100, country: Turkey, contacts name: Gülruh KARABAĞLI, role: CONTACT, phone: +90 5326612245, email: gulruhazad@gmail.com, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06347354, orgStudyIdInfo id: CRO-2024-15, briefTitle: Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Breast Cancer and Metastatic Lymph Nodes, acronym: FLUO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Centro di Riferimento Oncologico - Aviano, class: OTHER, descriptionModule briefSummary: In the case of a pre-operative diagnosis of ductal carcinoma in situ (DCIS), sentinel lymph node biopsy is generally not indicated whereas it is considered standard clinical practice for patients with clinical stage I-II infiltrating breast cancer who have clinically negative axillary lymph nodes or clinically suspicious lymph nodes with negative needle aspiration findings. It is not uncommon that, in patients with ductal carcinoma in situ at preoperative diagnosis, there may be an upgrade on definitive histological examination due to the identification of foci of infiltration (about one-fifth of cases), requiring axillary lymph node biopsy in a second surgery. Prospective studies have shown that the sentinel lymph node identification rate after recent breast-conserving surgery is suboptimal. With regard to the false negative rate (FNR), several studies demonstrated that it could be associated with different techniques used for lymph node identification. Lymph node biopsy by Indocyanine green (ICG) is capable of identifying the sentinel lymph node, however, there are no data in literature on the permanence of ICG in the lymph node system. The knowledge of this data would allow the application of this method, already considered safe for the identification of the sentinel lymph node at the time of breast surgery, also in those situations in which the sentinel lymph node biopsy is postponed due to the upgrade of definitive histological diagnosis from carcinoma in situ to infiltrating/micro-infiltrating carcinoma.The main objective of this trial is to evaluate the permanence of fluorescence at the level of axillary lymph nodes 3 weeks after subcutaneous injection in patients who are candidates to radical axillary surgery. Marking the sentinel lymph node before breast surgery in cases of DCIS with risk factors could reduce the false negative rate, allowing to increase the accuracy of the procedure in identifying the lymph node potentially involved by metastatic infiltration. In addition, the identification of the sentinel lymph node in patients who are candidates to radical axillary surgery, could increase the sensitivity of the surgery in staging axillary disease and could make the lymph node exeresis more targeted, reducing the morbidity of the surgery resulting in a better outcome for the patient., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Indocyanine green, outcomesModule primaryOutcomes measure: Permanence of fluorescence at the level of axillary lymph nodes at 2-3 weeks after subcutaneous injection of Indocyanine Green (2.5 mg), in patients who will undergo radical axillary surgery, secondaryOutcomes measure: Identification of the total number of fluorescent lymph nodes, secondaryOutcomes measure: Differences in the qualitative assessment (intensity) of fluorescence between the removed lymph nodes: lymph nodes will be divided into group A "intense fluorescence" and group B "mild fluorescence", secondaryOutcomes measure: Association between histological positivity for metastases in sentinel and non-sentinel lymph nodes, secondaryOutcomes measure: Association between the patient's demographic/clinical variables and the presence or absence of fluorescent lymph nodes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS, city: Aviano, state: Pordenone, zip: 33081, country: Italy, contacts name: Stefano Fracon, MD, role: CONTACT, phone: 0434659317, email: stefano.fracon@cro.it, contacts name: Samuele Massarut, MD, role: CONTACT, email: smassarut@cro.it, contacts name: Stefano Fracon, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.07056, lon: 12.59472, hasResults: False
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protocolSection identificationModule nctId: NCT06347341, orgStudyIdInfo id: 2019-A02014-53, briefTitle: GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity, acronym: GLUTN, statusModule overallStatus: TERMINATED, startDateStruct date: 2021-10-27, primaryCompletionDateStruct date: 2023-03-24, completionDateStruct date: 2023-03-24, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Clermont-Ferrand, class: OTHER, collaborators name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, collaborators name: UCA (UFR de Médecine et UFR Pharmacie), descriptionModule briefSummary: For 25 years, non-celiac gluten sensitivity (NCGS) has been the subject of very prolific and confusing scientific literature. This clinical entity is defined by the appearance of digestive and extradigestive symptoms in the hours/days following the consumption of foods containing gluten, in the absence of celiac disease (CD) and wheat allergy (WA). The physiopathological mechanisms, neither allergic or autoimmune, remain poorly defined and no The main objective of the study was to demonstrate the role of gluten in triggering digestive symptoms and extradigestive products from the NCGS. The secondary objectives were to identify the pathophysiological mechanisms and diagnostic marker(s).usable diagnostic marker in the clinic has not yet been identified., conditionsModule conditions: The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Prospective, crossover, randomized, double-blind clinical study comparing a gluten-containing diet to a gluten-free diet., primaryPurpose: DIAGNOSTIC, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Clinical study comparing a gluten-containing diet to a gluten-free diet, outcomesModule primaryOutcomes measure: The main objective of the study is to confirm the role of gluten in triggering the digestive and extradigestive symptoms of NCGS., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Estaing, city: Clermont-Ferrand, zip: 63100, country: France, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False
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protocolSection identificationModule nctId: NCT06347328, orgStudyIdInfo id: 23-AOI-01, briefTitle: The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain, acronym: InCHO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: Lumbar facet joints have been implicated in chronic low back pain in over 45% of patients with isolated chronic common low back pain.Low back pain is the most common form of spinal pain, more chronic and severe than cancer pain. The annual prevalence of chronic low back pain ranges from 15% to 45% (one-off prevalence, 30%; lifetime prevalence, 54-80%). Because of this extremely high incidence, doctors from a wide range of specialities perform interventional techniques in a variety of settings.Facet joints have long been recognised as a source of back pain. In 1911, Goldthwait first recognised their role as a potential source of back pain. In 1933, Ghormley introduced the term "facet syndrome", defining lumbosacral pain with or without radicular pain. Badgley later suggested that facet joints could be a primary source of pain independently of spinal nerve compression. They demonstrated the role of posterior facet joints (PFJs) in a large number of patients with low back pain whose symptoms were not caused by a herniated disc. The underlying physiological concept of the PJF was introduced by Hirsch et al in 1963. They demonstrated that injecting a hypertonic saline solution into the region of the facet joints caused pain.The management of chronic low back pain due to zygapophyseal involvement (lumbar facet joints) consists primarily of conservative treatment. This is based on analgesics, anti-inflammatory drugs, physiotherapy and weight loss, where appropriate. Other non-surgical options may be proposed, including glucocorticoid injections into the facet joints. Glucocorticoid injections, which act by reducing inflammation, are commonly used in routine care to treat spinal pain. This pain may be due to a variety of pathologies, including discogenic or facet-related, or mixed, ligamentous or muscular, linked to a regional or global disorder of spinal statics. They are commonly used as a standard treatment for chronic spinal pain.Traditionally, in routine clinical practice, if there is significant paravertebral contracture and the clinical signs point to posterior joint involvement, a glucocorticoid injection is given in the doctor's surgery at the time of consultation, using anatomical landmarks to guide needle placement. However, few studies have demonstrated the efficacy of anatomical marking for infiltration of posterior joints, notably Cohen et al. Sui's systematic review of the use of this technique.With the advent of new imaging modalities such as ultrasound, more and more practitioners are turning to image-guided injections. To date, only the fluoroscopy-guided technique is considered reliable for facet joint infiltration.In order to improve the clinical efficacy of the various interventional therapeutic solutions, some authors have supported the use of ultrasound guidance. Several studies have been published comparing ultrasound-guided infiltration and infiltration using anatomical location in the shoulder region, the iliopsoas and in epicondilitis. While ultrasound guidance in areas such as the iliopsoas or the shoulder seems useful, it has not yet been proven that guidance is advantageous in spinal areas, such as the facet joints.To our knowledge, no randomised, methodologically sound study has yet been carried out to compare the benefit of ultrasound-guided infiltration versus infiltration with anatomical location.The aim of our study is to show that ultrasound-guided zygoapophyseal infiltration is superior to anatomically-guided infiltration in terms of pain assessment., conditionsModule conditions: Chronic Low-back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: echo-guided infiltration, interventions name: non-echo-guided infiltration, outcomesModule primaryOutcomes measure: Change of pain progression, secondaryOutcomes measure: measure function state by EIFEL questionnaire, secondaryOutcomes measure: measure function state by ODI questionnaire, secondaryOutcomes measure: pain evaluation by VAS scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de NICE, city: Nice, state: CHU De Nice, zip: 06000, country: France, contacts name: STEPHANIE FERRERO, MD, role: CONTACT, phone: +33492035477, email: ferrero.s@chu-nice.fr, contacts name: CHRISTIAN ROUX, Pr, role: CONTACT, email: roux.c2@chu-nice.fr, contacts name: STEPHANIE FERRERO, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: CHRISTIAN ROUX, Pr, role: SUB_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Ch Cannes, city: Cannes, country: France, contacts name: JOHANNA AZYLAY, MD, role: CONTACT, email: J.AZULAY@ch-cannes.fr, geoPoint lat: 43.55135, lon: 7.01275, hasResults: False
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protocolSection identificationModule nctId: NCT06347315, orgStudyIdInfo id: 2302.CLI, briefTitle: Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2027-12-15, completionDateStruct date: 2027-12-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Société des Produits Nestlé (SPN), class: INDUSTRY, descriptionModule briefSummary: Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI), conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: parallel and pivotal, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: Randomized, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 380, type: ESTIMATED, armsInterventionsModule interventions name: BrainXpert, interventions name: Placebo, outcomesModule primaryOutcomes measure: Preclinical Alzheimer's Cognitive Composite (PACC) score, secondaryOutcomes measure: Preclinical Alzheimer's Cognitive Composite (PACC) (components effects), secondaryOutcomes measure: Montreal Cognitive Assessment (MoCA) score, secondaryOutcomes measure: Preclinical Alzheimer's Cognitive Composite (PACC) accelerated decline, secondaryOutcomes measure: Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory IIb Delayed Recall Score accelerated decline, secondaryOutcomes measure: Mini-Mental State Examination (MMSE) score accelerated decline, secondaryOutcomes measure: Emergent Adverse Events (Safety and tolerability), eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347302, orgStudyIdInfo id: EID 2023, briefTitle: Study of Vitreoretinal Molecular Changes During Rhegmatogenous Retinal Detachment, acronym: LIPIDRET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Dijon, class: OTHER, descriptionModule briefSummary: Retinal detachment is a condition with an estimated incidence of between 9.5 and 18.2 cases per 100,000 individuals.It is an ophthalmological emergency that threatens visual acuity and requires surgery. However, despite satisfactory post-operative anatomical results, vitreoretinal proliferation and photoreceptor death can still have a negative impact on visual prognosis. These complications are still not fully understood.A previous study carried out by the Eye, Nutrition and Cell Signalling team at the CSGA, comparing mouse models of retinal detachment with healthy control retinas, revealed an increase in pro-inflammatory cytokines and a change in retinal lipid abundance in detached retinas.However, these results have yet to be confirmed in humans. Our main hypothesis is that the vitreous content of omega-3 PUFAs and proteins is altered during the onset of retinal detachment, since it reflects both intraocular inflammation and photoreceptor apoptosis.We therefore wish to demonstrate that the protein and PUFA contents of the vitreous humour are different between eyes with retinal detachment and eyes not affected by retinal detachment after macular surgery (epiretinal membrane or macular hole). We would like to show that the vitreous PUFA content is lower in the macular surgery group due to the absence of photoreceptor apoptosis and the absence of dehiscence causing communication between the subretinal space (photoreceptors whose membranes are very rich in PUFAs) and the vitreous space. We also hope to identify changes in the protein composition of vitreous fluid in patients with retinal detachment, with overexpression of proteins involved in inflammation pathways.In addition, we hypothesise that retinal omega-3 PUFA content is a factor influencing retino-vitreal proliferation and functional and anatomical recovery from retinal detachment. To this end, we will study the correlation between retinal PUFA-3 content and the clinical presentation and postoperative course of retinal detachment.Finally, with the aim of identifying a serum marker for the prognostic evaluation of retinal detachment, we will use as a candidate a biomarker of retinal omega-3 PUFA content that we have developed in an Age-Related Macular Degeneration (AMD) model. We will analyse the correlation between this biomarker and levels of omega-3 PUFAs measured directly in the retina.To do this, we will analyse intraoperative samples of vitreous humour, sub-retinal fluid and retinal fluid from patients undergoing vitrectomy for retinal detachment in the Ophthalmology Department of the Dijon University Hospital. A group of control patients will consist of patients operated on by vitrectomy for macular surgery (epiretinal membrane or macular hole) for whom a vitreous humour sample will also be taken.Clinical information on the characteristics of the retinal detachment will be collected. During the consultation, the patient will be questioned about any history of dyslipidaemia and any current treatment, including the use of lipid-enriched food supplements. Post-operative follow-up with prospective collection of clinical and paraclinical data on anatomical and functional evolution will be carried out up to 6 months after the occurrence of retinal detachment.A blood sample will be taken to establish a lipid profile in all patients. We will thus gain a better understanding of the changes in lipid and protein content in the vitreous humour, sub-retinal fluid and retina, and the demonstration of a link between the initial presentation and the postoperative anatomical and functional evolution of retinal detachment. This will provide a better understanding of the lipid-dependent mechanisms linked to inflammation and photoreceptor degeneration during retinal detachment, and will ultimately make it possible to develop new therapeutic strategies to improve visual prognosis., conditionsModule conditions: Rhegmatogenous Retinal Detachments, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Blood sampling, interventions name: vitreous sampling, interventions name: Sub-retinal fluid sampling, interventions name: Retinal tissue sampling, outcomesModule primaryOutcomes measure: Molecular content of fatty acids and proteins in the vitreous humour of eyes operated on for retinal detachment and eyes operated on for macular surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Dijon Bourgogne, city: Dijon, zip: 21000, country: France, contacts name: Petra EID, role: CONTACT, phone: 0380295173, phoneExt: +33, email: petra.eid@chu-dijon.fr, geoPoint lat: 47.31667, lon: 5.01667, hasResults: False
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protocolSection identificationModule nctId: NCT06347289, orgStudyIdInfo id: CHSD_0024_REA, briefTitle: Refusal of Organ Donation: a Study of Psychological, Anthropological and Cultural Factors, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2024-03-29, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Saint-Denis, class: OTHER, collaborators name: Agence de La Biomédecine, descriptionModule briefSummary: The Hospital of Saint Denis (HSD) has been involved for several years in the dynamics of organ donation. In spite of the evolution of the practices of coordination of the collection of samples, the rate of refusal of organ donation is increasing in our hospital, contrary to the rest of France.Based on hypotheses derived from psychological and anthropological perspectives, this survey will provide first-hand information on the personal, family and cultural issues related to organ donation. It will be a question of identifying and locating individual and collective representations concerning death, its definition, and the associated symbols and rites. Based on the collection of these representations, we will be able to propose hypotheses of a psychological, social and anthropological nature on resistance to organ donation., conditionsModule conditions: Psychology, conditions: Anthropology, conditions: Refusal, Organ Donation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ACTUAL, outcomesModule primaryOutcomes measure: Demographic information, primaryOutcomes measure: Demographic information, primaryOutcomes measure: Demographic information, primaryOutcomes measure: Demographic information, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hopitalier de Saint-Denis, city: Saint-Denis, state: Seine Saint Denis, zip: 93200, country: France, geoPoint lat: 48.93326, lon: 2.36666, hasResults: False
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protocolSection identificationModule nctId: NCT06347276, orgStudyIdInfo id: 2023-RW320-08, briefTitle: Cerebral Microembolization Associated With PFO Closure, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: China National Center for Cardiovascular Diseases, class: OTHER_GOV, descriptionModule briefSummary: This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO., conditionsModule conditions: Thrombosis Cardiac, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: PFO occluder; ASD occluder, outcomesModule primaryOutcomes measure: De novo cerebral microembolization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chaowu Yan, status: RECRUITING, city: Beijing, state: Beijing, zip: 100037, country: China, contacts name: Chaowu Yan, PhD and MD, role: CONTACT, phone: +861088398408, email: chaowuyan@163.com, contacts name: Chaowu Yan, PhD and MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06347263, orgStudyIdInfo id: PER 332, briefTitle: Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis., conditionsModule conditions: Isolated Intrabony Periodontal Defects in Patients With Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Blinding of the operator and patient is not applicable.- Outcome assessor (primary and secondary outcomes) \& biostatistician will be blinded, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Entire papilla preservation technique, outcomesModule primaryOutcomes measure: Clinical attachment level (CAL) gain change from baseline to 12 months, secondaryOutcomes measure: Linear bone fill change from baseline to 12 months, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of dentistry, Cairo University, status: RECRUITING, city: Cairo, zip: 3753450, country: Egypt, contacts name: Nesma M Shemias, Ass Lecturer, role: CONTACT, email: nesma.shemais@dentistry.cu.edu.eg, contacts name: Manal M Hosny, Professor, role: CONTACT, email: manal.hosny@dentistry.cu.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06347250, orgStudyIdInfo id: SGB-Bulbar Palsy, briefTitle: A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-05-02, completionDateStruct date: 2023-05-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Babujinaya Cela, class: OTHER_GOV, descriptionModule briefSummary: This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function., conditionsModule conditions: Bulbar Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 122, type: ACTUAL, armsInterventionsModule interventions name: Nerve Block, interventions name: Lidocaine Hydrochloride, interventions name: routine therapy, interventions name: placebo block, outcomesModule primaryOutcomes measure: The Functional Oral Intake Scale, secondaryOutcomes measure: Yale Pharyngeal Residue Severity Rating Scale, secondaryOutcomes measure: penetration-aspiration scale, secondaryOutcomes measure: Video fluoroscopic swallowing study, secondaryOutcomes measure: The Swallowing Quality of Life Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ZhenD No.1 Hos., city: Zhenzhou, country: China, geoPoint lat: 32.28034, lon: 119.16999, hasResults: False
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protocolSection identificationModule nctId: NCT06347237, orgStudyIdInfo id: NL84429.078.23, briefTitle: PsA Digital Phenotyping and Inflammation Drivers Study, acronym: PDPID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Jolanda Luime, class: OTHER, collaborators name: University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, collaborators name: Aristotle University of Thessaloniki - Hipokrateion Hospital Thessaloniki, collaborators name: Portuguese Society of Rheumatology - The Rheumatic Diseases Portuguese Registry (Reuma.pt), descriptionModule briefSummary: The goal of this observational study is to develop and internally validate a machine learning model for detecting flare using a digital biomarker and a machine learning model for predicting flare, in patients with psoriatic arthritis. The main questions it aims to answer are:* In patients with psoriatic arthritis, is a digital biomarker capable of detecting a flare as compared to clinical defined flare by the rheumatologist?* In patients with psoriatic arthritis, what factors trigger a psoriatic arthritis flare ?Participants will be requested to:* Install app on their phone* Use a smartwatch* Complete questionnaires* Collect biological material, conditionsModule conditions: Psoriatic Arthritis, conditions: Flare Up, Symptom, conditions: Psoriatic Arthritis Aggravated, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: Absence of flare in patients, secondaryOutcomes measure: Minimal disease Activity (MDA), secondaryOutcomes measure: Psoriatic Arthritis Disease Activity Score (PASDAS), secondaryOutcomes measure: Disease Activity Psoriatic Arthritis (DAPSA), secondaryOutcomes measure: Psoriatic Arthritis Impact of Disease (PsAID), secondaryOutcomes measure: Morning stiffness, otherOutcomes measure: Keystroke dynamics, otherOutcomes measure: Screen time, otherOutcomes measure: Accelerometer data, otherOutcomes measure: Gyroscope sensor data, otherOutcomes measure: Steps count, otherOutcomes measure: Physical activity intensity and categories, otherOutcomes measure: Motion, otherOutcomes measure: Distance, otherOutcomes measure: Pulse Ox, otherOutcomes measure: Respiration, otherOutcomes measure: Body battery, otherOutcomes measure: Stress (digital), otherOutcomes measure: Heart rate, otherOutcomes measure: Beat-to-beat intervals, otherOutcomes measure: Sleeping time, otherOutcomes measure: Sleeping type, otherOutcomes measure: Hand and feet photos, otherOutcomes measure: Hand and body movements videos, otherOutcomes measure: Medical history, otherOutcomes measure: Joint count, otherOutcomes measure: Enthesitis, otherOutcomes measure: Body surface area, otherOutcomes measure: Weight, otherOutcomes measure: Height, otherOutcomes measure: Abdominal circumference, otherOutcomes measure: ClASsification criteria for Psoriatic ARthritis (CASPAR) score, otherOutcomes measure: Demographics, otherOutcomes measure: VAS Pain, otherOutcomes measure: HAQ questionnaire, otherOutcomes measure: VAS patient global, otherOutcomes measure: PSAID questionnaire, otherOutcomes measure: SF-36 questionnaire, otherOutcomes measure: EQ5d questionnaire, otherOutcomes measure: Work Productivity and Activity Impairment (WPAI) questionnaire, otherOutcomes measure: Health care questionnaire, otherOutcomes measure: Patient Health Questionnaire (PHQ9) questionnaire, otherOutcomes measure: Perceived Stress Scale (PSS), otherOutcomes measure: Global Rating of Change (GRoC) Scale, otherOutcomes measure: Life events questionnaire, otherOutcomes measure: Digital literacy questionnaire, otherOutcomes measure: Inflammatory blood marker, otherOutcomes measure: Genetic variants, otherOutcomes measure: Gut microbiome, otherOutcomes measure: Stress (cortisol levels), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06347224, orgStudyIdInfo id: BCFC-BCS-VIRTUAL2024, briefTitle: Both Column Fixation Corridor in Pelvic Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, class: OTHER_GOV, descriptionModule briefSummary: The concepts of the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. This study aims to evaluate the feasibility and potential advantages of this novel screw fixation technique, thereby filling the existing gap in knowledge and establishing standards for its application., conditionsModule conditions: Acetabular Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 400, type: ACTUAL, armsInterventionsModule interventions name: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models., outcomesModule primaryOutcomes measure: Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06347211, orgStudyIdInfo id: Attikon Hospital, briefTitle: "Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2026-01-10, completionDateStruct date: 2026-01-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Attikon Hospital, class: OTHER, descriptionModule briefSummary: The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension., conditionsModule conditions: Hypotension During Surgery, conditions: Prevention of Hypotension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithm, outcomesModule primaryOutcomes measure: TWA hypotension (measured with Acumen IQ sensor), secondaryOutcomes measure: Incidence of hypotension, secondaryOutcomes measure: Time spent in hypotension, secondaryOutcomes measure: Treatment choice (drugs/fluids), secondaryOutcomes measure: Diagnostic guidance protocol deviations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Attikon Hospital, status: RECRUITING, city: Athens, zip: 12462, country: Greece, contacts name: Orestis Milionis, role: CONTACT, phone: +306948333359, email: Orestismilionis@gmail.com, contacts name: Orestis Milionis, role: PRINCIPAL_INVESTIGATOR, contacts name: Tatiana Sidiropoulou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.97945, lon: 23.71622, hasResults: False
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protocolSection identificationModule nctId: NCT06347198, orgStudyIdInfo id: 20230807-02, briefTitle: Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, collaborators name: Huazhong University of Science and Technology, descriptionModule briefSummary: This is a single-center exploratory clinical study to explore the efficacy and safety of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer., conditionsModule conditions: Metastatic Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Fruquintinib, interventions name: Sintilimab, interventions name: Inulin, outcomesModule primaryOutcomes measure: Intestinal microbiota diversity, abundance and taxonomic information, primaryOutcomes measure: adverse events, secondaryOutcomes measure: Objective remission rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of remission (DOR), secondaryOutcomes measure: Concentration of various serum metabolites, secondaryOutcomes measure: Concentration of various plasma Cytokine Changes, secondaryOutcomes measure: Frequency of peripheral blood lymphocyte, otherOutcomes measure: Correlation between dietary fiber intake and progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Min Jin, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Min Jin, role: CONTACT, phone: 18807108606, email: minjin86@126.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06347185, orgStudyIdInfo id: EORTC-2236-HNCG-QLG, briefTitle: Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study, acronym: SupCare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: European Organisation for Research and Treatment of Cancer - EORTC, class: NETWORK, descriptionModule briefSummary: This is a late phase II, prospective, multicenter randomized study, to assess the value of early palliative care integrated with the standard oncologic care in patients with Recurrent Metastatic (RM) Head and Neck Cancer (HNC) proposed to first line palliative systemic treatment.The study randomizes patients in a 1:1 fashion to standard oncologic care, in which the palliative care is requested as needed (reactive approach) or to early palliative care integrated with the standard oncologic care (proactive approach).Standard of Care: the oncologist will be the main referral of the patient, deciding the therapeutic approach, the assessments requested, in terms of type of exams and timing and the need of possible further support from other expertise. The oncologist will base the choices also upon the results of the Liverpool Head and Neck Patient Concern Inventory (PCI-H\&N) and the patient's preferences. At the end of the first oncological visit, the physician will be asked to predict the survival of the patient.Integrated approach: Besides the Oncology visit, patient will have the palliative care expert visit and follow up. The oncologist will define the therapeutic approach and the assessments requested, in terms of type of exams and timing. The palliative care clinician and the oncologist will judge the burden of symptoms and together they will propose the suggested interventions to relief the symptoms, with a particular attention to a validated instrument (the PCI-H\&N) and patient priority questionnaire's results.Stratification Factors* Institution* Performance Status (PS) (0 vs 1-2)* Presence of any caregiver at home* Type of treatment (Immunotherapy alone vs any other combination)Study duration: the total study duration is estimated at 36 months, with a total accrual time estimated to be 24 months from first patient in (FPI) and with an additional follow-up period of 12 months.End of study occurs when all patients have completed their end of study visit and the study is mature for all analyses defined in the protocol and the database has been cleaned and frozen for these analyses., conditionsModule conditions: Head and Neck Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Early palliative care, integrated with the standard oncologic care (proactive approach), interventions name: Palliative care requested as needed, integrated with the standard oncologic care (reactive approach), outcomesModule primaryOutcomes measure: Change from baseline in emotional functioning and pain scores according to Item List (IL) 250 questionnaire at 15 weeks., secondaryOutcomes measure: Change from baseline in emotional functioning and pain scores according to Item List 250 (IL250) questionnaire at 6 weeks, 24 weeks and 52 weeks., secondaryOutcomes measure: Change from baseline in the selected Health Related Quality of Life (HRQoL) scales from the Item List 250 (IL250) questionnaire at 6 weeks, 15 weeks, 24 weeks and 52 weeks, secondaryOutcomes measure: Number of unplanned visits to emergency room or specialist visits, secondaryOutcomes measure: Hospitalization due to treatment toxicities or tumour signs/symptoms, as evaluated by number of admissions and duration, secondaryOutcomes measure: Identification of the rate of patients starting a new systemic treatment in the last three months of life, secondaryOutcomes measure: Rate of patients receiving systemic treatment in the last month of life, secondaryOutcomes measure: Rate of patients with a tracheostomy performed in the last 3 months of life, secondaryOutcomes measure: Rate of patients with gastrostomy performed in the last 3 months of life, secondaryOutcomes measure: Caregiver/family members' satisfaction (FAMcare questionnaire) at 15 weeks, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Prediction error of survival (defined as the difference between actual survival (AS) of patients and clinician prediction of survival (CPS)), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347172, orgStudyIdInfo id: 2024p000278, secondaryIdInfos id: U54AG063546, type: NIH, link: https://reporter.nih.gov/quickSearch/U54AG063546, briefTitle: Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Brown University, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified., conditionsModule conditions: Alzheimer Disease, conditions: Mild Cognitive Impairment, conditions: Dementia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Nudge Intervention, outcomesModule primaryOutcomes measure: Composite of the percentage of eligible PCPs or their PLWD/care partners who view or click on information, secondaryOutcomes measure: Number of nudges that fire as intended: Fidelity, secondaryOutcomes measure: Discontinuation or prescribed reduction in medication, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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