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protocolSection identificationModule nctId: NCT06386172, orgStudyIdInfo id: 2023-03537-01, secondaryIdInfos id: FoUI-986028, type: OTHER_GRANT, domain: ALF Medicin, Region Stockholm, briefTitle: Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm, acronym: ALMA-CKD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-09, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Danderyd Hospital, collaborators name: Region Stockholm, descriptionModule briefSummary: One in 10 adults in Region Stockholm have chronic kidney disease (CKD), which dramatically increases healthcare costs and the risk of medication errors or adverse health outcomes, including cardiovascular disease and death. Identification and early management of these patients is done in primary care settings. However, most adults with CKD in our region are under detected, undiagnosed and undertreated, with low rates of referral to nephrology-specialist care.This is a pragmatic cluster randomized controlled trial (RCT) involving 66 primary healthcare centers in Region Stockholm, and testing the effect of an electronic clinical decision support (CDS) triggering system to assist general practitioners through the guideline-recommended processes of CKD care.The centers, providing healthcare to approximately 780.000 citizens, will be randomized 50:50 to this CDS trigger (vs basic advice) for 18 months. Study outcomes will consider the improvement in the indicators of CKD care.As a pragmatic trial there is no active recruitment or active data collection. The trial is embedded into the ongoing Stockholm CREAtinine Measurements (SCREAM) project, a database collection of healthcare use for the complete population of Stockholm. Using this real-world healthcare data collection, the investigators will be able to measure with precision the impact of our CDS trigger and its potential to improve clinical care., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The primary healthcare network system of the region of Stockholm coordinates 66 public primary healthcare centers. Collectively, these centers offer care to an estimated population of 780.000. Since November 2022, a new platform for CDS (clinical decision support) triggers called ALMA has been implemented in these centers. ALMA is connected to patient records and uses CDS triggers to identify medical problems, issue alerts and propose solutions.Using the ALMA platform, this project has the following objectives:Objective 1: to develop a CDS trigger connected with the electronic healthcare records specific to the processes of screening, diagnosis, and nephrologist referral of patients with CKD, including individualized CKD management optimization, in primary care.Objective 2: to evaluate the effectiveness of this CDS trigger (versus current basic advice) through a 2-arm pragmatic cluster RCT., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 780000, type: ESTIMATED, armsInterventionsModule interventions name: Clinical decision support trigger, outcomesModule primaryOutcomes measure: Number of participants screened for creatinine and albuminuria, primaryOutcomes measure: Number of screened participants with retesting for creatinine and albuminuria, secondaryOutcomes measure: Number of participants with laboratory-determined CKD receiving a clinical diagnosis, secondaryOutcomes measure: Number of participants receiving CKD-modifying agents, secondaryOutcomes measure: Number of participants referred to nephrologist care, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, status: RECRUITING, city: Stockholm, country: Sweden, contacts name: Juan J Carrero, Prof, role: CONTACT, phone: 0046739636948, email: [email protected], geoPoint lat: 59.33258, lon: 18.0649, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-04-01, uploadDate: 2024-04-23T02:35, filename: SAP_000.pdf, size: 292236, hasResults: False |
protocolSection identificationModule nctId: NCT06386159, orgStudyIdInfo id: 2023-1178, briefTitle: Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application., conditionsModule conditions: Post-extubation Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: Electrical vagus nerve stimulation, outcomesModule primaryOutcomes measure: functional oral intake scale（FOIS）, primaryOutcomes measure: standardized Swallowing Assessment（SSA）, secondaryOutcomes measure: Rate of total oral feeding after the intervention, secondaryOutcomes measure: Duration of Enteral Nutrition Tube Indwelling, secondaryOutcomes measure: Rate of Re-intubation after Endotracheal Intubation, secondaryOutcomes measure: Incidence of aspiration within one week after extubation, secondaryOutcomes measure: The incidence of aspiration pneumonia within one week after extubation, secondaryOutcomes measure: Inflammation-related indicators: serum C-reactive protein (CRP), secondaryOutcomes measure: Inflammation-related indicators: serum interleukin-6 (IL-6), secondaryOutcomes measure: Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh), secondaryOutcomes measure: Inflammation-related indicators: high mobility group box-1 protein (HMGB1), secondaryOutcomes measure: Days of ICU hospitalization, secondaryOutcomes measure: Total days of hospitalization, secondaryOutcomes measure: In-hospital survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Feng Xiuqin, status: RECRUITING, city: Hangzhou, zip: 310000, country: China, contacts name: Feng Feng, Xiuqin, role: CONTACT, phone: 13757119151, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06386146, orgStudyIdInfo id: JAB-30355-1001, briefTitle: JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Jacobio Pharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation., conditionsModule conditions: Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: JAB-30355, interventions name: JAB-30355, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT), primaryOutcomes measure: Number of participants with adverse events, secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Time to reach the observed maximum (peak) concentration (Tmax), secondaryOutcomes measure: Terminal half-life (t1/2), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DOR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06386133, orgStudyIdInfo id: MS Boost, briefTitle: Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care, acronym: MSBoost, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ad scientiam, class: OTHER, collaborators name: Assistance Publique - Hôpitaux de Paris, descriptionModule briefSummary: The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS).The secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution.Patients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program.Healthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a "big picture" of the patient's condition over time., conditionsModule conditions: Multiple Sclerosis, conditions: Fatigue Syndrome, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Boost group: Use of MSCopilot Boost and wear of an actimeter during the whole study participation duration.Control group: Standard practice and wear of an actimeter during the whole study participation duration., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 208, type: ESTIMATED, armsInterventionsModule interventions name: MS Boost, interventions name: Standard of care, outcomesModule primaryOutcomes measure: To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis, secondaryOutcomes measure: To evaluate the impact of fatigue in both groups., secondaryOutcomes measure: To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term), secondaryOutcomes measure: To compare the fatigue impact between the two groups., secondaryOutcomes measure: To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home., secondaryOutcomes measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home., secondaryOutcomes measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home., secondaryOutcomes measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home., secondaryOutcomes measure: To assess the number of adverse events of using MSCopilot Boost., secondaryOutcomes measure: To compare the effect of MSCopilot Boost on walking compared to standard practice: -Assessed by the functional standard test performed at the hospital -Assessed at home, secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue impact., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on anxiety and depression., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Depression., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Walking., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Dexterity., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Cognition., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on the Low-contrast Vision., secondaryOutcomes measure: To compare the effect of MSCopilot Boost on quality of life compared to standard practice., secondaryOutcomes measure: To compare the effect of MSCopilot Boost on the mean overall physical activity compared to standard practice., secondaryOutcomes measure: To evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost., secondaryOutcomes measure: To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals., secondaryOutcomes measure: To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals., secondaryOutcomes measure: To assess user compliance with MSCopilot Boost throughout the follow-up period., otherOutcomes measure: To evaluate the link between MSCopilot Boost use compliance and fatigue improvement., otherOutcomes measure: To assess the relationship between self-reported and objectively measured physical activity., otherOutcomes measure: To explore the factors that might influence the effect of MSCopilot Boost on fatigue and its impact., otherOutcomes measure: To assess the changes in sleep patterns and areas of life impacted by fatigue, as measured with MSCopilot Boost at home., otherOutcomes measure: To assess the evolution of overall physical activity reported by patients., otherOutcomes measure: To explore the correlation between overall physical activity and the change in : -Fatigue impact -Fatigue, otherOutcomes measure: Calculation of cost-effectiveness in reducing fatigue at 1, 3, 6 and 9 months using MSCopilot Boost as an intervention, compared to standard care., otherOutcomes measure: To assess the impact of MSCopilot Boost on work-related factors (duration without working, absenteeism from work, return-to-work time, presenteeism) at 3, 6 and 9 months, compared to baseline (Day 0), in both groups., otherOutcomes measure: To evaluate behavioral changes in terms of physical activity and energy management., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06386120, orgStudyIdInfo id: 2024-z033, briefTitle: Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is:Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care., conditionsModule conditions: Lung Contusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: PEEP setting strategy, outcomesModule primaryOutcomes measure: ventilation blood flow ratio, secondaryOutcomes measure: oxygenation index, secondaryOutcomes measure: 28-day mortality, secondaryOutcomes measure: Mechanical ventilation-free from day 1 to 28, secondaryOutcomes measure: Length of ICU stay, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: The rate of successful weaning, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06386107, orgStudyIdInfo id: 23PH188, secondaryIdInfos id: 2023-A02175-40, type: OTHER, domain: ANSM, briefTitle: Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis, acronym: CATforCAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, collaborators name: Diagnostica Stago, collaborators name: LEO Pharma, collaborators name: Ligue contre le cancer, France, descriptionModule briefSummary: Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment., conditionsModule conditions: Cancer, conditions: Pulmonary Embolism, conditions: Thrombosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective cohort of consecutive patients initiating full-dose anticoagulant therapy for an episode of CAT, followed up until the 6th month of treatment to assess the risk of clinically relevant adjunctive bleeding events and any other adverse event during anticoagulant therapy (recurrence of CAT, death).TGT measurement is fully automated and calibrated with quality control., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 212, type: ESTIMATED, armsInterventionsModule interventions name: Thrombin Generation Assay (TGA), outcomesModule primaryOutcomes measure: The measurement of the area under the curve ( endogenious thrombin potential) nMxmin, primaryOutcomes measure: the measurement of the lag time unit = seconds, primaryOutcomes measure: the measurement of the peak height unit = nm, primaryOutcomes measure: the measurement of the time to peak unit = seconds, secondaryOutcomes measure: Effect of adding TGT results on the performance of bleeding risk prediction scores, secondaryOutcomes measure: Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT, secondaryOutcomes measure: Occurrence of an event of interest under treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Clermont-Ferrand, city: Clermont-Ferrand, zip: 63003, country: France, contacts name: Jeannot SCHMIDT, MD PHD, role: CONTACT, contacts name: Jeannot SCHMIDT, MD PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Aurélien LEBRETON, MD PHD, role: SUB_INVESTIGATOR, contacts name: Fares MOUSTAFA, MD PHD, role: SUB_INVESTIGATOR, contacts name: Nicolas DUBLANCHET, MD, role: SUB_INVESTIGATOR, contacts name: Dorian TEISSANDIER, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU de Grenoble, city: Grenoble, zip: 38043, country: France, contacts name: Gilles PERNOD, MD PHD, role: CONTACT, phone: 04 76 76 57 17, phoneExt: +33, email: [email protected], contacts name: Gilles PERNOD, MD PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Raphaël MARLU, MD PHD, role: SUB_INVESTIGATOR, geoPoint lat: 45.16667, lon: 5.71667, locations facility: HCL, city: Lyon, country: France, contacts name: Yesim DARGAUD, MD PHD, role: CONTACT, contacts name: Judith CATELLA, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Claire GRANGE, MD, role: SUB_INVESTIGATOR, contacts name: Yesim DARGAUD, MD PHD, role: SUB_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Chu St-Etienne, city: Saint-Étienne, zip: 42055, country: France, contacts name: Géraldine POENOU, MD PHD, role: CONTACT, email: [email protected], contacts name: Laurent BERTOLETTI, MD PHD, role: SUB_INVESTIGATOR, contacts name: Xavier DELAVENNE, MD PHD, role: SUB_INVESTIGATOR, contacts name: Coline LEGENDRE, MD, role: SUB_INVESTIGATOR, contacts name: Pauline NOYEL, MD, role: SUB_INVESTIGATOR, contacts name: Brigitte TARDY, MD PHD, role: SUB_INVESTIGATOR, contacts name: Géraldine POENOU, MD PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False |
protocolSection identificationModule nctId: NCT06386094, orgStudyIdInfo id: INT/IEC/2023/SPL-902, briefTitle: Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-15, primaryCompletionDateStruct date: 2025-08-15, completionDateStruct date: 2025-11-15, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Post Graduate Institute of Medical Education and Research, Chandigarh, class: OTHER, descriptionModule briefSummary: Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS), septic shock., heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality., conditionsModule conditions: NAFLD, conditions: Cardiac Disease, conditions: Fatty Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Echocardiographic assessment, outcomesModule primaryOutcomes measure: To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease, secondaryOutcomes measure: Presence of myocardial abnormalities in CCM dysfunction, secondaryOutcomes measure: Presence of perfusion abnormalities in CCM dysfunction, secondaryOutcomes measure: All cause mortality in NAFLD, secondaryOutcomes measure: Cardiac event related mortality in NAFLD, secondaryOutcomes measure: To determine the severity of cardiac dysfunction in patients with non-alcoholic fatty liver disease, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr. Madhumita Premkumar, status: RECRUITING, city: Chandigarh, zip: 160012, country: India, contacts name: Dr. Madhumita Premkumar, MD, role: CONTACT, phone: +9101722754777, email: [email protected], geoPoint lat: 30.73629, lon: 76.7884, hasResults: False |
protocolSection identificationModule nctId: NCT06386081, orgStudyIdInfo id: AC18/00031, briefTitle: Dietary Intervention in Food Allergy, acronym: AC18/00031, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2023-01-31, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, class: OTHER, descriptionModule briefSummary: The goal of this randomized double-blind placebo-controlled clinical study is to determine whether the dietary intervention with pectins leads to food immunomodulation in non-specific lipid transfer proteins (nsLTP) allergic patients. The main question it aims to answer is if the microbiome is a target of intervention against food allergy through the use of prebiotics such as pectins.Participants will be enrolled to receive a two-month dietary intervention with either two different pectins (citrus or apple pectin) or placebo. Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge (DBPCFC). Microbiome, proteomic and metabolomic studies will also be performed in blood and stool samples., conditionsModule conditions: Food Allergy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Treatment will be blinded to the participants and research team., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 51, type: ACTUAL, armsInterventionsModule interventions name: Citrus pectin with low DE, interventions name: Apple pectin with high DE, interventions name: Placebo, outcomesModule primaryOutcomes measure: Clinical efficacy of pectin dietary intervention in nsLTP allergic patients, secondaryOutcomes measure: Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention, secondaryOutcomes measure: Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention, secondaryOutcomes measure: Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention, secondaryOutcomes measure: Changes in Pru p 3-specific basophil activation induced by pectin intervention, secondaryOutcomes measure: Changes induced in the taxonomic diversity of gut microbiota, secondaryOutcomes measure: Changes in feaces metabolome induced by pectin dietary intervention, secondaryOutcomes measure: Changes in serum metabolome induced by the pectin dietary intervention, secondaryOutcomes measure: Epigenomic changes induced by the pectin dietary intervention, secondaryOutcomes measure: Pectin safety profile, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Regional Universitario de Málaga, city: Malaga, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, hasResults: False |
protocolSection identificationModule nctId: NCT06386068, orgStudyIdInfo id: 2110041, briefTitle: Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Persistent Whiplash Associated Disorders., acronym: VALIANT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program for individuals with persistent whiplash. The main question it aims to answer are:* What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash?* What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program?Participants will undergo a replicated multiple baselines single-case experimental design (SCED). Twelve participants who meet specific eligibility criteria will be block-randomized to a 1, 2, or 3-week baseline phase, serving as their own controls. The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions, focusing on psychological and physical rehabilitation. Participants will be required to attend these sessions as part of the treatment protocol. Data collection includes daily online self-reports and comprehensive measurements at pre-treatment, post-treatment, and a three-month follow-up., conditionsModule conditions: Whiplash Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Values-based Cognitive Behavioral Therapy (V-CBT), outcomesModule primaryOutcomes measure: Value-based living, primaryOutcomes measure: Pain interference, primaryOutcomes measure: Value-based living, primaryOutcomes measure: Pain interference, secondaryOutcomes measure: Pain catastrophizing, secondaryOutcomes measure: Positive affect, secondaryOutcomes measure: Negative affect, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Pain-related acceptance, secondaryOutcomes measure: Pain-related self-efficacy, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Neck Disability, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Pain-related acceptance, secondaryOutcomes measure: Pain-related self-efficacy, secondaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Self-perceived improvement, secondaryOutcomes measure: Satisfaction with treatment, secondaryOutcomes measure: Pain Disability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Specialized Hospital for Polio and Accident Victims, status: RECRUITING, city: Rødovre, state: Capital Region Of Denmark, zip: 2610, country: Denmark, contacts name: Anders O Aaby, PhD, role: CONTACT, email: [email protected], geoPoint lat: 55.68062, lon: 12.45373, hasResults: False |
protocolSection identificationModule nctId: NCT06386055, orgStudyIdInfo id: STUDY00007545, briefTitle: Air Pollution and Physical Activity: A Randomized Controlled Trial, acronym: PARC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: State University of New York at Buffalo, class: OTHER, descriptionModule briefSummary: This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study., conditionsModule conditions: Physical Inactivity, conditions: Pollution; Exposure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Active exercise, outcomesModule primaryOutcomes measure: blood pressure, secondaryOutcomes measure: Self-report questionnaire, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University at Buffalo, city: Buffalo, state: New York, zip: 14214, country: United States, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False |
protocolSection identificationModule nctId: NCT06386042, orgStudyIdInfo id: MEC-2022-0252, briefTitle: Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry, acronym: TITRATE-HF, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-06-05, primaryCompletionDateStruct date: 2029-02-14, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Netherlands Heart Institute, descriptionModule briefSummary: SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice.Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF).Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given).Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project.Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate.Data: aggregated dataIntervention: none / noMain study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up.Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 4289, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, observational study, outcomesModule primaryOutcomes measure: Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Hospital admission due to heart failure related event and/or urgent visit with necessity of furosemide iv., secondaryOutcomes measure: Hospital admission due to non heart failure related event, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus MC, city: Rotterdam, state: Zuid-Holland, zip: 3015CE, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False |
protocolSection identificationModule nctId: NCT06386029, orgStudyIdInfo id: STUDY24010191, briefTitle: The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, descriptionModule briefSummary: The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are:1. Is the Power Down feasible for caregivers to do each night?2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?, conditionsModule conditions: Autism, conditions: Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot, non-blinded intervention trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Power Down bedtime manipulation, outcomesModule primaryOutcomes measure: Recruitment rates of participants through the trial, primaryOutcomes measure: Retention rates of participants through the trial, primaryOutcomes measure: Caregiver reported acceptability, secondaryOutcomes measure: Treatment adherence, secondaryOutcomes measure: Data collection rates- Questionnaires, secondaryOutcomes measure: Data collection rates- Daily diaries, secondaryOutcomes measure: Data collection rates- Wearing the actigraphy watch, secondaryOutcomes measure: Credibility/Expectancy Questionnaire, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Amy G Hartman, PhD, role: CONTACT, phone: 614-989-6303, email: [email protected], geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06386016, orgStudyIdInfo id: Stethoscope study, briefTitle: Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Xiao-dong Zhuang, class: OTHER, descriptionModule briefSummary: The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention., conditionsModule conditions: Valvular Heart Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: artificial intelligence-based stethoscope, outcomesModule primaryOutcomes measure: valvular heart disease, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital, Sun Yat-Sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Xiaodong Zhuang, PhD, role: CONTACT, phone: +86 13760755035, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06386003, orgStudyIdInfo id: 23-230, briefTitle: Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Unity Health Toronto, class: OTHER, collaborators name: Toronto Metropolitan University, collaborators name: University of Ottawa, descriptionModule briefSummary: This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD)., conditionsModule conditions: Post Traumatic Stress Disorder, conditions: PTSD, conditions: Chronic PTSD, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, outcomesModule primaryOutcomes measure: Feasibility and tolerability, secondaryOutcomes measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score, secondaryOutcomes measure: Posttraumatic stress disorder Checklist-5 (PCL-5), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Generalized Anxiety Disorder Scale, 7-item (GAD-7), secondaryOutcomes measure: Dissociative Experiences Scale II (DES-II), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: World Health Organization Well-Being Index, 5-item (WHO-5), secondaryOutcomes measure: Quality of relationships inventory (QRI), secondaryOutcomes measure: Inventory of psychosocial functioning (IPF), secondaryOutcomes measure: Posttraumatic Maladaptive Beliefs Scale (PMBS), secondaryOutcomes measure: Brief Experiential Avoidance Questionnaire (BEAQ), secondaryOutcomes measure: 24-items Multidimensional Psychological Flexibility Inventory (MPFI-24), secondaryOutcomes measure: Working Alliance Inventory- Short Form (WAI-SF), secondaryOutcomes measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF), secondaryOutcomes measure: Self-Compassion Scale-Short Form (SCS-SF), secondaryOutcomes measure: Psychological Insight Questionnaire (PIQ), secondaryOutcomes measure: Emotional Breakthrough Inventory (EBI), secondaryOutcomes measure: Altered States of Consciousness Rating Scale (ASC), secondaryOutcomes measure: Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ), otherOutcomes measure: Effect on digital physiological passive data collected through the use of a wearable device, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Michael's Hospital, Unity Health Toronto, city: Toronto, state: Ontario, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06385990, orgStudyIdInfo id: 2024ks01, briefTitle: Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-03-29, completionDateStruct date: 2027-03-29, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hunan Cancer Hospital, class: OTHER, descriptionModule briefSummary: This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles., conditionsModule conditions: Triple Negative Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: UTD1, outcomesModule primaryOutcomes measure: 2-year disease-free survival (DFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease Free Survival (DFS), secondaryOutcomes measure: Invasive Disease free survival (iDFS), secondaryOutcomes measure: Distant Disease-free Survival (DDFS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Quchang Ouyang, status: RECRUITING, city: Changsha, state: Hunan, zip: 410083, country: China, contacts name: Quchang Ouyang, role: CONTACT, phone: 8673189762161, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, hasResults: False |
protocolSection identificationModule nctId: NCT06385977, orgStudyIdInfo id: ShaanxiPPH, briefTitle: Risk Factors for Chronic Prostatitis Patients in Northwest China, statusModule overallStatus: RECRUITING, startDateStruct date: 2016-01, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Shaanxi Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. The main questions it aims to answer are:* Is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome* Is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome.Participants will:* Independently receive a survey questionnaire on lifestyle, medication, and sexual habits.* Symptomatic individuals will undergo additional prostate fluid examination for diagnosis.Researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups., conditionsModule conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: lifestyle, interventions name: sexual habits, interventions name: medication, outcomesModule primaryOutcomes measure: Odds Ratio, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shaanxi Provincial People's Hospital, status: RECRUITING, city: Xi'an, state: Shaanxi, zip: 710061, country: China, contacts name: Qian Deng, Doctor, role: CONTACT, phone: 86-029-85251331, phoneExt: 2079, email: [email protected], geoPoint lat: 34.25833, lon: 108.92861, hasResults: False |
protocolSection identificationModule nctId: NCT06385964, orgStudyIdInfo id: SHR-4597-101, briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Guangdong Hengrui Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this randomized, double-blind, single/multiple ascending dose, placebo-controlled Phase I clinical trial was to evaluate the safety and tolerability of SHR-4597 in healthy subjects and asthmatic patients. The study consists of two parts: Part 1 involves single ascending inhalation dose in healthy subjects; Part 2 involves multiple ascending inhalation dose in asthmatic patients, further divided into Part 2A: multiple ascending inhalation dose in mild to moderate asthmatic patients, and Part 2B: multiple ascending inhalation dose in moderate to severe asthmatic patients. Subsequent lung pharmacokinetic studies of SHR-4597 inhalation will be conducted based on patients' PKPD data., conditionsModule conditions: Healthy Subjects, conditions: Asthmatic Patients, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: SHR-4597, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of inhalant adverse events after 4 days of single inhalation of SHR4597 in healthy subjects, primaryOutcomes measure: Incidence and severity of inhalant adverse events after 16 days of multiple inhalation of SHR4597 in asthmatic patients,, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385951, orgStudyIdInfo id: ONZ-2023-0323, briefTitle: Spatial Navigation for the Early Detection of Alzheimer's Disease., acronym: ALLO-task, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-10-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, descriptionModule briefSummary: Alzheimer's Disease (AD) is the most common form of dementia and may contribute to 60-70 % of all cases. An early, accurate diagnosis of AD will become increasingly important with disease-modifying therapies. Different types of fluid and neuroimaging biomarkers are available for the early detection of AD. However, implementation of routine use of these biomarkers in clinical settings is held back due to the risk of overdiagnosis, increased cost and invasiveness of the assessment method. Therefore, novel biomarkers are needed beyond the amyloid and tau pathologies for the early diagnosis of AD. Neuropsychological paper and pencil tests can detect AD and discriminate between different clinical stages. Since medial temporal lobe structures, including the hippocampus and entorhinal cortex (EC), are involved in spatial navigation and degenerate in the earliest stages of AD, spatial navigation can be considered as an early cognitive biomarker of the disease. Nonetheless, the measurement of spatial navigation needs further improvement since the current paper and pencil tests lack ecological validity. Therefore, the test environment should be set up in immersive Virtual Reality (iVR). Dr. Andrea Castegnaro (Space and Memory Lab of University College of London) developed the Allocentric Spatial Update Task (ALLO task), which is an iVR task measuring egocentric and allocentric spatial abilities.Therefore, the main objective of this study is to evaluate whether allocentric and egocentric spatial navigation, measured by the ALLO iVR task can be considered a cognitive biomarker for the early detection of AD. In addition, the investigators want to report on the neuronal correlates of both spatial navigation strategies.Through the Department of Neurology of the University Hospital of Ghent, which has a large cognitive disorders clinic, patients with mild cognitive impairment and mild Alzheimer's dementia will be recruited. Participants will undergo standard clinical assessment, including a neuropsychological examination, Magnetic Resonance Imaging, a 18F-fluorodeoxyglucose PET and a Lumbar Puncture. In addition, participants will also be asked to undergo Tau PET imaging, Amyloid PET imaging and complete the ALLO iVR task. Healthy controls will also be recruited and have to undergo the same investigations, except for the amyloid PET and lumbar puncture., conditionsModule conditions: Mild Cognitive Impairment, conditions: Alzheimer Disease, conditions: Healthy Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Procedure for patients, interventions name: Procedure for healthy controls, outcomesModule primaryOutcomes measure: Spatial navigation abilities, secondaryOutcomes measure: Medial Temporal Lobe atrophy, secondaryOutcomes measure: Amount and spreading of amyloid in the brain, secondaryOutcomes measure: Amount and spreading of tau in the brain, secondaryOutcomes measure: Decreases in cerebral glucose metabolism in the brain, secondaryOutcomes measure: Cognitive functioning, secondaryOutcomes measure: amyloidB1-42 / 40 ratio, total tau and phosphorylated tau, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Gent, status: RECRUITING, city: Ghent, state: East-Flanders, zip: 9000, country: Belgium, contacts name: Tineke Van Vrekhem, role: CONTACT, phone: 093326483, email: [email protected], geoPoint lat: 51.05, lon: 3.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06385938, orgStudyIdInfo id: 23-012048, briefTitle: Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The goal of this study is to find out if the use of ultrasound pictures of bones can spot changes in the growth areas of children with rickets, a condition that affects how bones harden. Researchers want to see if these ultrasound pictures can help tell the difference between children who have rickets and those who don't., conditionsModule conditions: Rickets, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound with quantitative vibro-acoustic assessment, outcomesModule primaryOutcomes measure: Relationship of quantitative vibro-acoustic ultrasound and rickets severity score, secondaryOutcomes measure: Relationship of ultrasound images with radiographic evidence of rickets, secondaryOutcomes measure: Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects, secondaryOutcomes measure: Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets, eligibilityModule sex: ALL, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mayo Clinic Minnesota, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Mary A Johnson, role: CONTACT, phone: 507-422-6823, email: [email protected], contacts name: Tom D. Thacher, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06385925, orgStudyIdInfo id: TSN1611-2023-101, briefTitle: A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-10-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Tyligand Bioscience (Shanghai) Limited, class: INDUSTRY, descriptionModule briefSummary: The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part., conditionsModule conditions: Malignant Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: TSN1611, outcomesModule primaryOutcomes measure: Dose limiting toxicities (DLTs) in phase 1 part, primaryOutcomes measure: Objective response rate (ORR) in phase 2 part, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC), secondaryOutcomes measure: Maximum blood concentrations (Cmax), secondaryOutcomes measure: Time to maximum blood concentration (Tmax), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Time to response (TTR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Siqing Fu, MD, PhD, role: CONTACT, geoPoint lat: 29.76328, lon: -95.36327, locations facility: NEXT Oncology, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: David Sommerhalder, MD, PhD, role: CONTACT, geoPoint lat: 29.42412, lon: -98.49363, locations facility: NEXT Virginia, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Alexander Spira, MD, PhD, role: CONTACT, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False |
protocolSection identificationModule nctId: NCT06385912, orgStudyIdInfo id: 2024-TJ-SLIDS, briefTitle: Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2006-07-01, primaryCompletionDateStruct date: 2021-02-10, completionDateStruct date: 2021-02-10, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, descriptionModule briefSummary: The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is:Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy?The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question., conditionsModule conditions: Ovarian Cancer, conditions: Postoperative Complications, conditions: Neoadjuvant Therapy, conditions: Lymph Node Excision, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1090, type: ACTUAL, armsInterventionsModule interventions name: lymphadenectomy, outcomesModule primaryOutcomes measure: Progression free survival (PFS), primaryOutcomes measure: Overall survival (OS), eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06385899, orgStudyIdInfo id: : Poorly controlled T2DM-12, briefTitle: Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-01, primaryCompletionDateStruct date: 2023-01-01, completionDateStruct date: 2023-03-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Goztepe Prof Dr Suleyman Yalcın City Hospital, class: OTHER, descriptionModule briefSummary: In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. It is aimed to determine the characteristics of patients with type 2 diabetes (HbA1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months., conditionsModule conditions: Type 2 Diabetes, conditions: Poor Glycemic Control, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 266, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Changes in HbA1c levels after 12 months treatment, primaryOutcomes measure: percentage of patients who reached the HbA1c target of equal to or below 7%, secondaryOutcomes measure: The effect of education on the HbA1c changes, secondaryOutcomes measure: The effect of depression on the HbA1c changes, secondaryOutcomes measure: The effect of the level of physical activity on the HbA1c changes, secondaryOutcomes measure: The effect of weight loss on the HbA1c changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06385886, orgStudyIdInfo id: 1R01HL158807-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01HL158807-01A1, briefTitle: Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease, acronym: RECIPE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-08, primaryCompletionDateStruct date: 2027-10, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: RTI International, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life?, conditionsModule conditions: Sickle Cell Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Linkage Coordinator, outcomesModule primaryOutcomes measure: Identification of unaffiliated patients, primaryOutcomes measure: Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist, secondaryOutcomes measure: Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama, Birmingham (UAB), status: RECRUITING, city: Birmingham, state: Alabama, zip: 35233, country: United States, contacts name: Julie Kanter, MD, role: CONTACT, phone: 205-934-0435, email: [email protected], geoPoint lat: 33.52066, lon: -86.80249, locations facility: University of California, San Francisco (UCSF), status: RECRUITING, city: Oakland, state: California, zip: 94609, country: United States, contacts name: Marsha Treadwell, PhD, role: CONTACT, phone: 510-428-3356, email: [email protected], geoPoint lat: 37.80437, lon: -122.2708, locations facility: Augusta University, status: RECRUITING, city: Augusta, state: Georgia, zip: 30901, country: United States, contacts name: Robert Gibson, PhD, role: CONTACT, phone: 706-721-1005, email: [email protected], geoPoint lat: 33.47097, lon: -81.97484, locations facility: University of Illinois, status: RECRUITING, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Lewis Hsu, MD, PhD, role: CONTACT, phone: 312-355-5019, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06385873, orgStudyIdInfo id: 2024-SR-233, briefTitle: RC48 Combined With Adebrelimab and Apatinib and S-1 of the Neoadjuvant Therapy of Locally Advanced Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression., conditionsModule conditions: Gastric Cancer/Gastroesophageal Junction Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: RC48, interventions name: Adebrelimab, interventions name: Apatinib, interventions name: S-1, outcomesModule primaryOutcomes measure: Pathological Complete Response Rate (pCR), secondaryOutcomes measure: Major Pathological Response rate (MPR), secondaryOutcomes measure: R0 Resection rate, secondaryOutcomes measure: Disease-Free Survival (DFS）, secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385860, orgStudyIdInfo id: GTMGS0423, briefTitle: Prediction Model for Early Biliary Stasis After Bariatric Surgery, acronym: PM-EBS-BS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery, conditionsModule conditions: Obesity, conditions: Diabetes, conditions: Gallstones, conditions: Biliary Stasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: early biliary stasis, primaryOutcomes measure: prediction model, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385847, orgStudyIdInfo id: GOMIMP, briefTitle: To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xiamen University, class: OTHER, descriptionModule briefSummary: The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer, conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Prospective, randomized, open-label, cross-over phase II trial, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Zoladex, interventions name: LY01005, outcomesModule primaryOutcomes measure: Patient preference, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Xiamen University, status: RECRUITING, city: Xiamen, state: Fujian, zip: 361003, country: China, contacts name: Xuegang Wang, doctor, role: CONTACT, phone: 15960263909, email: [email protected], geoPoint lat: 24.47979, lon: 118.08187, hasResults: False |
protocolSection identificationModule nctId: NCT06385834, orgStudyIdInfo id: LY2014-041-A, briefTitle: The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2028-07-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: The aim of the study was to intervene in the Aerobic exercise time of patients with STEMI and to explore the optimal exercise time for STEMI patients, conditionsModule conditions: ST-segment Elevation Myocardial Infarction (STEMI), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was divided into three groups: morning intervention group (8:00-9:00AM), evening intervention group (16:00-17:00AM) and control group, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: In this study, outcome measurement personnel and intervention personnel were separated during the whole process of the experiment, outcome measurement personnel did not know the grouping status, intervention personnel and rehabilitation therapists did not participate in the outcome measurement work., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 201, type: ESTIMATED, armsInterventionsModule interventions name: Morning aerobic exercise, interventions name: Evening aerobic exercise, outcomesModule primaryOutcomes measure: left ventricle ejection fraction, secondaryOutcomes measure: Oxygen consumption, secondaryOutcomes measure: Endothelial Function, secondaryOutcomes measure: Skeletal muscle and fat mass, secondaryOutcomes measure: Cardiac structure, secondaryOutcomes measure: One year major Adverse Cardiovascular Events, secondaryOutcomes measure: VE/VCO2-SLOPE, secondaryOutcomes measure: Flow-mediated dilation, secondaryOutcomes measure: glucose, secondaryOutcomes measure: Blood lipid, secondaryOutcomes measure: N-terminal pro-BNP, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385821, orgStudyIdInfo id: GriQv-ch-III-22, briefTitle: A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-21, primaryCompletionDateStruct date: 2023-06-15, completionDateStruct date: 2023-10-09, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: NPO Petrovax, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination"., conditionsModule conditions: Influenza, conditions: Influenza A, conditions: Influenza, Human, conditions: Influenza Type B, conditions: Flu, conditions: Influenza A H3N2, conditions: Influenza A H1N1, conditions: Influenza Epidemic, conditions: Flu, Human, conditions: Acute Respiratory Infection, conditions: Vaccine Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 824, type: ACTUAL, armsInterventionsModule interventions name: Grippol Quadrivalent, interventions name: Grippol Plus, outcomesModule primaryOutcomes measure: To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines, secondaryOutcomes measure: Geometric mean antibody titers, secondaryOutcomes measure: Proportion of those vaccinated with seroconversion and geometric mean titer, secondaryOutcomes measure: Multiplicity of the increase in the geometric mean titer, secondaryOutcomes measure: Seroprotection, secondaryOutcomes measure: Incidence of influenza and acute respiratory infections (ARI), secondaryOutcomes measure: The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications, secondaryOutcomes measure: To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus, secondaryOutcomes measure: Frequency and nature of SAEs, secondaryOutcomes measure: Frequency and nature of medically attended AEs, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: State Autonomous Healthcare Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11", city: Ekaterinburg, zip: 620028, country: Russian Federation, geoPoint lat: 56.8519, lon: 60.6122, locations facility: Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V. Petrovsky", city: Moscow, zip: 119435, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Healthcare Institution "Children's City Clinical Hospital No.9 named after G.N. Speransky of Moscow Healthcare Department", city: Moscow, zip: 123317, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Health Institution of the Perm Territory "City Children's Clinical Polyclinic No. 5, city: Perm, zip: 614066, country: Russian Federation, geoPoint lat: 58.01046, lon: 56.25017, locations facility: Limited Liability Company "Clinic USI 4D", city: Pyatigorsk, zip: 357502, country: Russian Federation, geoPoint lat: 44.04861, lon: 43.05944, locations facility: Limited Liability Company Medical technology, city: Saint Petersburg, zip: 192148, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District", city: Saint Petersburg, zip: 193312, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Limited Liability Company " Energiia Zdoroviya", city: Saint Petersburg, zip: 194156, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Limited Liability Company PiterClinica, city: Saint Petersburg, zip: 196158, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases under the Federal Medical Biological Agency, city: Saint Petersburg, zip: 197022, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution City Polyclinic No.106 Children's Polyclinic Department No. 37, city: Saint Petersburg, zip: 198328, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: State Budgetary Healthcare Institution of the Samara region "Samara Regional Children's Clinical Hospital named after N.N. Ivanova", city: Samara, zip: 443079, country: Russian Federation, geoPoint lat: 53.20007, lon: 50.15, locations facility: Limited Liability Company Center DNK-issledovaniy, city: Saratov, zip: 410005, country: Russian Federation, geoPoint lat: 51.54056, lon: 46.00861, locations facility: Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" of the Ministry of Healthcare of the Russian Federation, city: Tyumen, zip: 625023, country: Russian Federation, geoPoint lat: 57.15222, lon: 65.52722, hasResults: False |
protocolSection identificationModule nctId: NCT06385808, orgStudyIdInfo id: XJTU1AF-CRF-2023-XK014, briefTitle: Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients., conditionsModule conditions: Relapse Leukemia, conditions: Refractory Acute Myeloid Leukemia, conditions: Conditioning, conditions: Hematopoietic Stem Cell Transplantation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. The one-year recurrence-free survival after transplantation of these patients and the safty of the MTBF regimen will be studied., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: MTBF regimen, outcomesModule primaryOutcomes measure: Recurrence rate, secondaryOutcomes measure: Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0), secondaryOutcomes measure: Neutrophil recovery time, secondaryOutcomes measure: Platelet recovery time, secondaryOutcomes measure: OS, secondaryOutcomes measure: PFS, otherOutcomes measure: aGVHD, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385795, orgStudyIdInfo id: NOE-PMM-201, briefTitle: A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Noema Pharma AG, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women., conditionsModule conditions: Menopause Syndrome, conditions: Menopause, conditions: Hot Flashes, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: NOE-115, outcomesModule primaryOutcomes measure: Withdrawals Due to Adverse Events While on NOE-115 for Any Reason, secondaryOutcomes measure: Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs), secondaryOutcomes measure: Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4, secondaryOutcomes measure: Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4, secondaryOutcomes measure: Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385782, orgStudyIdInfo id: 20dz1207200, briefTitle: Exploring HRV in Antarctic Overwintering Members of Asia, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-01, primaryCompletionDateStruct date: 2022-04-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ya-Wei Xu, class: OTHER, descriptionModule briefSummary: Extreme changes in the Antarctic environment can cause emotional and autonomic dysfunction. In this study, volunteers from the Antarctica stations in China provided scale scores and heart rate variability (HRV) data, which were used to assess the autonomic nervous system. Enroll twenty-two members from Zhongshan Station and the Great Wall Station who are overwintering. Using the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire-9 (PHQ-9) scale, and the SF-36 quality of life scale to evaluate the individual's general physical and mental health. Analyze HRV and other associated parameters., conditionsModule conditions: Heart Rate Variability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Antarctic environment, outcomesModule primaryOutcomes measure: changes in HRV, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Tenth People's Hospital, city: Shanghai, state: Shanghai, zip: 200079, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06385769, orgStudyIdInfo id: PamukkaleU.ftr-NYıldız-3, briefTitle: Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.The main questions aimed to be answered are:What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week)., conditionsModule conditions: Urinary Bladder, Overactive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous tibial nerve stimulation (TTNS), interventions name: Sham Transcutaneous tibial nerve stimulation (TTNS), outcomesModule primaryOutcomes measure: Decreased frequency of increased voiding, secondaryOutcomes measure: Frequency of voiding, secondaryOutcomes measure: The Quality of Life, secondaryOutcomes measure: Barthel Index for Activities of Daily Living (ADL), secondaryOutcomes measure: The Overactive Bladder Symptom Score (OABSS), secondaryOutcomes measure: Treatment Satisfaction Level, secondaryOutcomes measure: Cystometric value, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University, city: Denizli, country: Turkey, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False |
protocolSection identificationModule nctId: NCT06385756, orgStudyIdInfo id: TJ-IRB202403020, briefTitle: Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, descriptionModule briefSummary: At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.The main questions it aims to answer are:* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.Participants will:* Induction of anesthesia with the experimental drug or placebo；* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded., conditionsModule conditions: Amobarbital Sodium, conditions: Hemodynamics Instability, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Amobarbital, interventions name: Propofol, outcomesModule primaryOutcomes measure: Mean arterial pressure (MAP) during Induction of anesthesia, secondaryOutcomes measure: MAP at different time points, secondaryOutcomes measure: Incidence of postoperative nausea and vomiting (ponv), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06385743, orgStudyIdInfo id: yeditepe15, briefTitle: The Effectiveness of Neuromuscular Training-Based Exercise Program, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-17, primaryCompletionDateStruct date: 2024-07-14, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Yeditepe University, class: OTHER, descriptionModule briefSummary: This randomised controlled study aimed to investigate the effectiveness of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain.The main hypothesis is;H0: There is no difference between the "Thrower's Ten" exercise program and the neuromuscular training-based exercise program applied to overhead athletes with shoulder pain, on pain, function, risk factors specific to shoulder injuries, and performance.H1: The effects of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain are superior to the effects of "Thrower's Ten" exercise program, conditionsModule conditions: Pain, Shoulder, conditions: Sports Physical Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Neuromuscular Training-based Exercise Program, interventions name: ''Thrower's Ten'' Exercise Program, outcomesModule primaryOutcomes measure: Pain Assessment, primaryOutcomes measure: Disabilities of the Arm, Shoulder and Hand (DASH), secondaryOutcomes measure: Tampa Kinesiophobia Scale, secondaryOutcomes measure: Hylyght Injury Prevention and Return to the Sports Screening Program (, secondaryOutcomes measure: Y Balance Test- Upper Quarter, secondaryOutcomes measure: Closed Kinetic Chain Extremity Stability Test, secondaryOutcomes measure: Single Arm Seated Shot Put Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yeditepe University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06385730, orgStudyIdInfo id: SCE2401, briefTitle: Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS), acronym: BLESS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Chest Hospital, class: OTHER, descriptionModule briefSummary: The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC)., conditionsModule conditions: Esophageal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: neoadjuvant anti-PD-1, interventions name: neoadjuvant anti-PD-1 with LDRT, outcomesModule primaryOutcomes measure: MPR rate, secondaryOutcomes measure: pCR rate, secondaryOutcomes measure: Adverse events and treatment-related adverse events, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Objective Response rate, secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Correlation between potential biomarkers and tumor response, eligibilityModule sex: ALL, minimumAge: 76 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, city: Shanghai, state: Shanghai, zip: 200030, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06385717, orgStudyIdInfo id: ZhejiangU, briefTitle: Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer, acronym: ESCORT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2029-01-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection., conditionsModule conditions: Esophagus Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: chemo-radiation, outcomesModule primaryOutcomes measure: Incidence of toxic events, secondaryOutcomes measure: 3-year overall survival, secondaryOutcomes measure: 3-year local-regional recurrence free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Jing Xu, MD, role: CONTACT, phone: 0086-0571-87783521, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Second Affiliated Hospital of Zhejiang University, School of Medicine, status: NOT_YET_RECRUITING, city: Hangzhou, country: China, contacts name: Jing Xu, role: CONTACT, phone: 0086-0571-87783521, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06385704, orgStudyIdInfo id: DMRIBFGM0420, briefTitle: Research on Changes in Intestinal Barrier Function and Gut Microbiome in Patients With Type 2 Diabetes After Duodenal Mucosal Resurfacing (DMR), acronym: DMR-IBF-GM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Wang Siqi, class: OTHER, collaborators name: China-Japan Friendship Hospital, descriptionModule briefSummary: The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiomic analysis and High Performance Liquid Chromatography（HPLC）, combined with changes in clinical data., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: DMR Procedure, outcomesModule primaryOutcomes measure: Microbiome Analysis, primaryOutcomes measure: High Performance Liquid Chromatography, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385691, orgStudyIdInfo id: ET22-145, briefTitle: Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer., acronym: MyDIET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Centre Leon Berard, class: OTHER, descriptionModule briefSummary: This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer., conditionsModule conditions: Gastric Cancer, conditions: Oesogastric Junction Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a prospective, single-center, single-arm Phase II study., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: myDIET software tool, outcomesModule primaryOutcomes measure: Proportion of patients starting adjuvant chemotherapy within 2 months, secondaryOutcomes measure: Adherence to the tool, secondaryOutcomes measure: Number of supportive care and emergency consultations initiated by the caregiver, secondaryOutcomes measure: Proportion of patients with malnutrition, secondaryOutcomes measure: Evolution of body composition in L3 section (volumes), secondaryOutcomes measure: Evolution of body composition in L3 section (indexes), secondaryOutcomes measure: Evolution of resting energy expenditure, secondaryOutcomes measure: Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day, secondaryOutcomes measure: Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry, secondaryOutcomes measure: Weight changes, secondaryOutcomes measure: Brachial circumference changes, secondaryOutcomes measure: Triceps skin fold changes, secondaryOutcomes measure: Initiation time for post-operative chemotherapy, secondaryOutcomes measure: Proportion of patient with incomplete scheme of pre operative chemotherapy, secondaryOutcomes measure: Proportion of patient with incomplete scheme of post operative chemotherapy, secondaryOutcomes measure: Proportion of patients with severe post operative complication, secondaryOutcomes measure: Tolerance to perioperative chemotherapy, secondaryOutcomes measure: Changes in food intake, secondaryOutcomes measure: Changes in SEFI (Easy Food Intake Score), secondaryOutcomes measure: Measurement of quality of life, secondaryOutcomes measure: Average lengh of hospital stay, secondaryOutcomes measure: Recurrence free survival (RFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Adherence to the physical activity program, secondaryOutcomes measure: Physical activity levels, secondaryOutcomes measure: Assessment of muscular function by the 6-min walk test, secondaryOutcomes measure: Assessment of muscular function by muscular strength, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Léon Berard, city: Lyon, zip: 69008, country: France, contacts name: Pamela Funk-Debleds, MD, role: CONTACT, phone: 0469856020, phoneExt: +33, email: [email protected], contacts name: Clélia Coutzac, MD, role: CONTACT, phone: 0469856020, phoneExt: +33, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, hasResults: False |
protocolSection identificationModule nctId: NCT06385678, orgStudyIdInfo id: HRS-4642-201, briefTitle: A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation., conditionsModule conditions: Advanced KRAS G12D Mutant Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: HRS-4642, interventions name: Adebrelimab, interventions name: SHR-A1921, interventions name: Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection, outcomesModule primaryOutcomes measure: Phase IB: Safety endpoints: adverse events (AEs)., primaryOutcomes measure: Phase IB： Maximum tolerated dose (MTD), primaryOutcomes measure: Phase IB：Recommended phase 2 dose (RP2D), primaryOutcomes measure: Phase II: Overall response rate (ORR)., secondaryOutcomes measure: Efficacy endpoints: Overall response rate (ORR)., secondaryOutcomes measure: Efficacy endpoints: Duration of response (DoR)., secondaryOutcomes measure: Efficacy endpoints: Disease control rate (DCR)., secondaryOutcomes measure: Efficacy endpoints: Progression free survival (PFS)., secondaryOutcomes measure: Efficacy endpoints: overall survival (OS)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai East Hospital, city: Shanghai, state: Shanghai, zip: 200120, country: China, contacts name: Caicun Zhou, Doctor, role: CONTACT, phone: 13301825532, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06385665, orgStudyIdInfo id: Xin Peng, briefTitle: The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-04-22, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Xin Peng, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:1. Patients with advanced breast cancer need family companionship2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 304, type: ESTIMATED, armsInterventionsModule interventions name: Graded companionship, outcomesModule primaryOutcomes measure: Change from Baseline meatal state on GAD-7 at Week 48., primaryOutcomes measure: Change from Baseline physical state on kps at Week 48., eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, zip: 430022, country: China, contacts name: Peng Xin, postgraduate, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06385652, orgStudyIdInfo id: PekingUFH-MM-NB381, briefTitle: PET Imaging Study of 68Ga-NB381 in Multiple Myeloma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, descriptionModule briefSummary: Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.Addressing the limitations in specificity and sensitivity of traditional PET imaging agents, this project is dedicated to developing a new type of nanobody PET/CT imaging probe, 68Ga-NB381, which possesses high affinity and targets CD38. This probe, which is an intellectual property of our institution, aims to enhance the accuracy and specificity of early MM diagnosis. In terms of clinical evaluation, the project will implement a comprehensive assessment process including case selection, collection of baseline information, high-precision imaging, expert-level image interpretation, and follow-up studies, comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381. This lays the groundwork for the clinical translation of this radiopharmaceutical in China. Furthermore, the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab, a drug also targeting CD38. This makes the project of significant academic value and clinical importance, thus promoting the development of personalized treatment strategies., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: In this sequential assignment clinical trial, we aim to evaluate and compare the diagnostic performance of two PET imaging agents, 68Ga-NB381 and 18F-FDG, in patients diagnosed with multiple myeloma (MM). The study will enroll MM patients who meet the inclusion criteria and are scheduled for routine diagnostic imaging.Each participant will undergo PET imaging with 18F-FDG first, followed by a second PET scan using 68Ga-NB381 (or reversed). To minimize potential interference between the two imaging sessions and ensure patient safety, a minimum interval of one day will be maintained between the two scans, with all imaging completed within one week. This sequential imaging approach allows for direct comparison of the imaging agents in the same patient, thus controlling for inter-patient variability and providing a more accurate assessment of the relative merits of each imaging agent in the same metabolic and pathological condition., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: All PET/CT images are jointly interpreted by at least two imaging and nuclear medicine physicians, each with several years of diagnostic experience and at least at the attending physician level. They compare and record the number of lesions detected and the SUVs (Standard Uptake Values) for both 18F-FDG and 68Ga-NB381 PET/CT scans. After consultation, they provide a unified diagnostic opinion., enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-NB381, outcomesModule primaryOutcomes measure: Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University First Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Ronghui Yu, Master, role: CONTACT, phone: +8613466379791, email: [email protected], contacts name: Lei Kang, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: TIANYAO Wang, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Yongkang Qiu, Master, role: SUB_INVESTIGATOR, contacts name: Zhenghao Tong, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06385639, orgStudyIdInfo id: WK2024005, briefTitle: Efficacy and Safety of Probiotic Products for Digestive Health, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-05-25, completionDateStruct date: 2024-06-25, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Wecare Probiotics Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota., conditionsModule conditions: Healthy Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, outcomesModule primaryOutcomes measure: Intestinal health, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: [email protected], status: RECRUITING, city: Jakarta, state: Pusat, zip: 10430, country: Indonesia, contacts name: Danang A. Yunaidi, MD, role: CONTACT, phone: 217515932, phoneExt: +62, email: [email protected], geoPoint lat: -6.21462, lon: 106.84513, hasResults: False |
protocolSection identificationModule nctId: NCT06385626, orgStudyIdInfo id: UREC: 23_15-Raspberry Leaf Tea, briefTitle: The Effects of Raspberry Leaf Tea on Blood Glucose Control, acronym: RLT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-18, primaryCompletionDateStruct date: 2024-12-23, completionDateStruct date: 2024-12-23, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Reading, class: OTHER, descriptionModule briefSummary: The aim of the present clinical trial is to assess how raspberry leaf polyphenols impact on postprandial glucose and insulin levels in healthy individuals consuming sucrose.The questions the project will address:* Do raspberry leaf polyphenols lower sucrose-induced increases in plasma glucose in humans?* Do these polyphenols mediate these effects by inhibiting digestion of sucrose or the absorption of glucose. 20 healthy adults will be recruited between the ages of 18-65 years who are non-smokers and not taking certain types of medication (e.g., drugs from a GP for high blood pressure, high blood fats, inflammatory conditions, and depression) or dietary supplements (e.g., cholesterol-lowering spreads, fish oil, probiotics, prebiotics, and natural laxatives), antibiotics in the last three months or if they used any drugs or supplements that could affect their blood glucose or lipid metabolism. No abnormal results for liver function tests, renal function tests, and lipid profile tests. If they have food allergies or consume more than 14 units of alcohol per week (i.e., to help they calculate a alcohol intake, one standard glass of wine (175 ml) or one pint of regular lager is equivalent to just over two units of alcohol), frequently travel for work or are participating in another intervention study, they will not be able to participate. Women who are pregnant or lactating or planning a pregnancy in the next six months will also not be able to take part, not use herbal medicines for at least the previous three months, not be on a weight loss program six months before screening, not involved in clinical trials six months before the screening, and not having severe cardiac, hepatic, or renal function impairment. Not Sufferers of chronic illnesses, not Individuals with food allergies, not people with coeliac disease.They will be asked to attend a four-study visit after an eight-hour overnight fast. Volunteers will be asked to consume 50 g of carbohydrate powder (sucrose and glucose) with or without 10 g of raspberry leaf tea, which will be dissolved in 300 mL of warm water during four visits (every month). Blood samples will be taken at intervals for a period of two hours after the consumption of raspberry leaf or control. Blood glucose and insulin levels will be tested 15 minutes before, at 15,30,60,90, and 120 minutes after carbohydrate intake., conditionsModule conditions: Type II Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Volunteers will be asked to consume 50 g of carbohydrate powder (sucrose and glucose) with or without 10 g of raspberry leaf tea, which will be dissolved in 300 mL of warm water during four visits (every month)., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Raspberry leaf tea, outcomesModule primaryOutcomes measure: Blood Glucose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hugh Sinclair Unit of Human Nutrition, University of Reading, status: RECRUITING, city: Reading, state: Berkshire, zip: RG6 5SG, country: United Kingdom, geoPoint lat: 51.45625, lon: -0.97113, hasResults: False |
protocolSection identificationModule nctId: NCT06385613, orgStudyIdInfo id: TDK-2024-13377, briefTitle: The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-04-22, completionDateStruct date: 2025-08-22, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Stomas are most commonly used in the gastrointestinal tract as ileostomy or colostomy. Although colorectal cancers are the most important factor causing intestinal stoma opening, intestinal ostomies are also used in cases such as congenital anomalies, obstructive or inflammatory bowel diseases, traumas requiring surgery, large defects caused by colorectal injuries as well as sigmoid colon volvulus and ischemic colitis. In stoma surgery performed to increase the duration and quality of life of individuals, the patient's compliance with the stoma and awareness of possible complications are important. Conditions such as peristomal skin problems, noisy bowel movements, stool leakage and pain make it difficult to adapt to the stoma.In addition, despite all the advances in stoma care products and surgical techniques, individuals are faced with stoma complications. Therefore, individuals with stoma should be closely monitored for complications. Inappropriately selected stoma site or bag/adapter system, lack of knowledge and skills related to stoma care can be listed among the possible causes of complications. Complications such as edema, bleeding, ischemia and mucocutaneous separation may develop in the first days after stoma surgery. In studies evaluating patients in terms of stoma compliance and complications in the literature, it has been observed that mobile-based trainings given to patients increase their stoma compliance and reduce the incidence of complications. With the mobile-based training planned to be used in the study, it is thought to contribute to the ability of individuals to perform stoma care independently. With the decrease in peristomal skin lesions and stoma complications, it is predicted that the quality of life of patients with stoma will increase, self-care competence will be formed, and health expenditures and therefore national health expenditures will decrease. It is thought that this mobile training application will not only provide support to patients with stoma but also guide healthcare professionals. It will also contribute to closing the shortage of stoma and wound care nurses in hospitals., conditionsModule conditions: Intestinal Stoma Site Hemorrhage, conditions: Intestinal Stoma Leakage, conditions: Life Style, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Groups will be divided into control and intervention. People in the group will be randomly assigned in a simple randomized manner., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Individuals assigned to controls and interventions will not know which group they are in., whoMasked: PARTICIPANT, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Mobile-based stoma care education group, outcomesModule primaryOutcomes measure: Adaptation of Quality Life Scale, primaryOutcomes measure: Ostomy Self-Care Index, primaryOutcomes measure: Pittman Ostomy Complication Severity Index, primaryOutcomes measure: Peristomal Skin Tool, primaryOutcomes measure: Ostomy Adjustment Inventory-23, primaryOutcomes measure: Computer System Usability Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ataturk University Faculty of Nursing, city: Erzurum, country: Turkey, contacts name: Nilgün Söylemez, PhD Student, role: CONTACT, phone: +905439790424, email: [email protected], geoPoint lat: 39.90861, lon: 41.27694, hasResults: False |
protocolSection identificationModule nctId: NCT06385600, orgStudyIdInfo id: severe preeclampsia, briefTitle: Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2026-01-20, completionDateStruct date: 2026-03-20, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. At this time, there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another. However, certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy. The choice of therapy depends on the acuity and severity of hypertension, conditionsModule conditions: Severe Pre-eclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Labetalol, interventions name: Phentolamine, outcomesModule primaryOutcomes measure: the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring., secondaryOutcomes measure: The effect of labetalol and phentolamine on blood pressure of the patients, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06385587, orgStudyIdInfo id: ADH-OL-Study-01-23, briefTitle: Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients, acronym: SYMTECH01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2024-12-29, completionDateStruct date: 2025-09-27, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Aptar Digital Health, class: INDUSTRY, descriptionModule briefSummary: The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleena™, designed to assist head and neck cancer patients undergoing chemoradiation in managing common and distressing symptoms in real-time, as well as to assess the satisfaction and usability of the related HCP web portal. Additional secondary usage and clinical endpoints that would be used to assess intervention efficacy in future trials will be collected., conditionsModule conditions: Head and Neck Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Oleena, outcomesModule primaryOutcomes measure: Users' satisfaction, secondaryOutcomes measure: Feasibility of the technology enabled symptom management solution, secondaryOutcomes measure: Usability of the technology enabled symptom management solution, secondaryOutcomes measure: Appropriateness of the recommendations, secondaryOutcomes measure: Semi-structured exit interviews, otherOutcomes measure: Symptom burden will be measured using the NIH PRO-CTCAE measurement system, which includes validated scales for individual toxicities, otherOutcomes measure: Quality of life will be measured using the previously validated FACT-G scale, otherOutcomes measure: Treatment adherence, otherOutcomes measure: Health-economic outcome, otherOutcomes measure: Complaints, alleged deficiencies or malfunctions of the device reported, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385574, orgStudyIdInfo id: 2023-088, briefTitle: Technological Based Rehabilitation on Individuals With Rheumatic Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, descriptionModule briefSummary: Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life., conditionsModule conditions: Rheumatic Diseases, conditions: Hand Rheumatism, conditions: Virtual Reality Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are three groups in the study. First group is leap motion interventional group, second group is hand exercises group and the third group is waiting list., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator and outcome assessors do not know which patient is in which group., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality therapy, outcomesModule primaryOutcomes measure: Hand grip strength measurement, primaryOutcomes measure: Jebsen Hand Function Test (JHFT), primaryOutcomes measure: Nine Hole Peg Test (NHPT), primaryOutcomes measure: Duruoz Hand Index (DHI), primaryOutcomes measure: Michigan Hand Outcome questionnaire (MHQ), secondaryOutcomes measure: Disease Activity Score 28 (DAS 28), secondaryOutcomes measure: Hand fine grip strength measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sebahat Yaprak Cetin, status: RECRUITING, city: Antalya, state: Konyaaltı, zip: 07100, country: Turkey, contacts name: Sebahat Yaprak Cetin, PhD, role: CONTACT, email: [email protected], geoPoint lat: 36.90812, lon: 30.69556, hasResults: False |
protocolSection identificationModule nctId: NCT06385561, orgStudyIdInfo id: Tramadol_OIBD, secondaryIdInfos id: 2022-500108-23-00, type: CTIS, briefTitle: The Influence of Tramadol on Opioid-induced Bowel Dysfunction, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-11, primaryCompletionDateStruct date: 2023-05-15, completionDateStruct date: 2023-05-15, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Asbjørn Mohr Drewes, class: OTHER, descriptionModule briefSummary: Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers., conditionsModule conditions: Opioid-Induced Bowel Dysfunction, conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Tramadol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Total gastrointestinal transit time, primaryOutcomes measure: Colorectal transit time, secondaryOutcomes measure: Constipation symptoms, secondaryOutcomes measure: Bowel movement frequency, secondaryOutcomes measure: Stool consistency, secondaryOutcomes measure: Gastrointestinal symptoms, secondaryOutcomes measure: Opioid-induced constipation, secondaryOutcomes measure: Diagnostic evaluation of opioid-induced constipation, secondaryOutcomes measure: Colonic motility patterns, secondaryOutcomes measure: Opiate withdrawal symptoms, secondaryOutcomes measure: Colon volume, secondaryOutcomes measure: Colonic water content, secondaryOutcomes measure: Gastric half emptying time, secondaryOutcomes measure: Gastric contraction assessment, secondaryOutcomes measure: Gastric contraction assessment, secondaryOutcomes measure: Small bowel motility assessment, secondaryOutcomes measure: Small bowel water content, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aalborg University Hospital, city: Aalborg, zip: 9000, country: Denmark, geoPoint lat: 57.048, lon: 9.9187, hasResults: False |
protocolSection identificationModule nctId: NCT06385548, orgStudyIdInfo id: VHIO21001, briefTitle: Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer, acronym: LiDer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Vall d'Hebron Institute of Oncology, class: OTHER, descriptionModule briefSummary: Background:Endometrial cancer is a prevalent gynecological malignancy, with a significant number of cases diagnosed at an advanced stage or recurring following initial treatment. Platinum-based chemotherapy represents a standard treatment option for these patients; however, disease progression often occurs, highlighting the need for novel therapeutic approaches. Lurbinectedin, a synthetic analog of marine alkaloid-derived compounds, and dostarlimab, a monoclonal antibody targeting PD-1, have demonstrated promising antitumor activity in various malignancies. This phase I-II clinical trial seeks to evaluate the safety, tolerability, and efficacy of combining lurbinectedin and dostarlimab in patients with advanced or recurrent endometrial cancer who have experienced disease progression following platinum-based chemotherapy.Primary Objectives:To determine the maximum tolerated dose (MTD) and recommended dose for further investigation of lurbinectedin and dostarlimab in combination therapy for advanced or recurrent endometrial cancer.To assess the antitumor activity of lurbinectedin and dostarlimab combination therapy, measured by objective response rate (ORR), in patients with advanced or recurrent endometrial cancer.Secondary Objectives:To evaluate the safety and tolerability of lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer.To characterize the pharmacokinetic profile of lurbinectedin and dostarlimab when administered in combination therapy.To explore pharmacogenomic biomarkers predictive of response and/or resistance to lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer.To assess progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and overall survival (OS) in patients receiving lurbinectedin and dostarlimab combination therapy for advanced or recurrent endometrial cancer.To investigate the impact of lurbinectedin and dostarlimab combination therapy on quality of life and symptom control in patients with advanced or recurrent endometrial cancer., conditionsModule conditions: Endometrial Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Lurbinectedin, interventions name: Dostarlimab, outcomesModule primaryOutcomes measure: Maximum Tolerated Dose (MTD) and Recommended Dose (RD) Determination, primaryOutcomes measure: Evaluation of Lurbinectedin and Dostarlimab Combination Therapy in Advanced/Recurrent Cervical Cancer Patients, secondaryOutcomes measure: Safety Evaluation of Lurbinectedin in combination with Dostarlimab, secondaryOutcomes measure: Evaluate the progression-free survival (PFS), secondaryOutcomes measure: Pharmacokinetic (PK) and Pharmacogenomic Evaluation, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Evaluate the Duration of Response (DOR), secondaryOutcomes measure: Evaluate the Clinical Benefit Rate (CBR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385535, orgStudyIdInfo id: IRB_00171031, briefTitle: Clinical Characteristics and Temporal Properties of Individual Tics in Persistent Tic Disorder, acronym: PTD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: The goal of this clinical study is to learn more about the timing of tics (sudden, fast movements and sounds that people do and make without meaning to) in people who have multiple tics that have been going on for more than one year. The main questions it aims to answer are:1. See whether a tic's timing is related to other characteristics of the tic, like how long it has been happening and how well the person can control/stop that tic2. See whether the timing of a tic can tell us how well the person can control/stop that tic3. See whether tic treatment changes the timing of tics, and if the timing of a tic has anything to do with how well treatment will work to stop itParticipants will meet with a study researcher to learn more about the study, ask questions, and decide whether or not they would like to be involved. If they decide to do the study, they will meet with the researcher 6 times:1. During the first visit, the study researcher will ask questions about the participant's life, tics, and other psychological symptoms. The researcher will watch the participant's tics for 10 minutes. The participant will do a computer task where they follow instructions to tic or not tic.2. During the second visit, the study researcher will treat one of the participant's tics.3. During the third visit, the study researcher will treat another one of the participant's tics.4. During the fourth visit, the study researcher will treat another one of the participant's tics.5. During the fifth visit, the study researcher will treat another one of the participant's tics.6. During the sixth visit, the study researcher will ask questions about the participant's tics and other psychological symptoms. The participant will do a computer task where they follow instructions to tic or not tic., conditionsModule conditions: Tics, conditions: Tic Disorders, conditions: Vocal Tic, conditions: Motor Tic, conditions: Tourette Syndrome, conditions: Tourette Syndrome in Children, conditions: Tourette Syndrome in Adolescence, conditions: Tics/Tremor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Clinical trial with a single arm (i.e., participants are not assigned to groups)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: The Principal Investigator and Outcomes Assessors will be blinded to the fractal properties of participants' tics until all study procedures have been completed., enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Habit Reversal Training (HRT), outcomesModule primaryOutcomes measure: Estimates of baseline individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies, primaryOutcomes measure: Voluntary tic suppression success at baseline, primaryOutcomes measure: Total tic severity at baseline as measured by the Yale Global Tic Severity Scale (YGTSS), primaryOutcomes measure: Total and individual tic severity at baseline as measured by the Parent Tic Questionnaire (PTQ), primaryOutcomes measure: Changes in voluntary individual and total tic suppression success pre- and post-intervention, primaryOutcomes measure: Changes in individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies pre- and post-intervention, primaryOutcomes measure: Changes in individual and total tic severity pre- and post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) and Parent Tic Questionnaire (PTQ), secondaryOutcomes measure: Individual and total premonitory urge severity at baseline as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS), secondaryOutcomes measure: Individual and total premonitory urge severity post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS), secondaryOutcomes measure: Changes in individual and total premonitory urge severity pre- and post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS), secondaryOutcomes measure: Total tic severity post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS), secondaryOutcomes measure: Individual and total tic severity post-intervention as measured by the Parent Tic Questionnaire (PTQ), secondaryOutcomes measure: Voluntary tic suppression success post-intervention, secondaryOutcomes measure: Estimates of individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies post-intervention, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Utah, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Kirsten Bootes, MS, role: CONTACT, phone: 801-585-7114, email: [email protected], contacts name: Kirsten Bootes, MS, role: CONTACT, email: [email protected], geoPoint lat: 40.76078, lon: -111.89105, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-11, uploadDate: 2024-01-30T18:49, filename: ICF_000.pdf, size: 244576, hasResults: False |
protocolSection identificationModule nctId: NCT06385522, orgStudyIdInfo id: BITR2101-C-01, briefTitle: A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Boston Immune Technologies and Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year., conditionsModule conditions: NHL, conditions: Cutaneous T Cell Lymphoma, conditions: Peripheral T-cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: BITR2101, outcomesModule primaryOutcomes measure: to assess the safety and tolerability of BITR2101 administered intravenously every 3 weeks in order to determine the MTD, if any, and to inform the RDE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06385509, orgStudyIdInfo id: TOL-CLAR-20024, briefTitle: A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Tolmar Inc., class: INDUSTRY, collaborators name: ICON plc, descriptionModule briefSummary: TOL-CLAR-20024 is a Phase 4, multi-center, open-label safety study evaluating the potential effect of JATENZO on adrenal function in hypogonadal men treated with JATENZO for 12 months., conditionsModule conditions: Hypogonadism, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Jatenzo, outcomesModule primaryOutcomes measure: CST Test, secondaryOutcomes measure: Adrenal Insufficiency, otherOutcomes measure: Estrogen changes, otherOutcomes measure: Follicle Stimulating Hormone (FSH) changes., otherOutcomes measure: Luteinizing hormone (LH) changes, otherOutcomes measure: Sperm analysis, otherOutcomes measure: Sperm analysis, otherOutcomes measure: Sperm analysis, otherOutcomes measure: Testis volume analysis, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385496, orgStudyIdInfo id: NCI-2024-01145, secondaryIdInfos id: NCI-2024-01145, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAY131-L, secondaryIdInfos id: EAY131-L, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: EAY131-L, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With mTOR Genetic Changes (MATCH - Subprotocol L), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2017-03-12, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II MATCH treatment trial tests how well MLN0128 (TAK-228) works in treating patients with cancer that has certain genetic changes called mTOR mutations. MLN0128 (TAK-228) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth., conditionsModule conditions: Advanced Lymphoma, conditions: Advanced Malignant Solid Neoplasm, conditions: Refractory Lymphoma, conditions: Refractory Malignant Solid Neoplasm, conditions: Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Magnetic Resonance Imaging, interventions name: Sapanisertib, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: 6-month progression free survival (PFS), secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ECOG-ACRIN Cancer Research Group, city: Philadelphia, state: Pennsylvania, zip: 19103, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06385483, orgStudyIdInfo id: NCI-2024-01125, secondaryIdInfos id: NCI-2024-01125, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAY131-A, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: EAY131-A, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2015-08-11, primaryCompletionDateStruct date: 2024-12-06, completionDateStruct date: 2024-12-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II MATCH treatment trial tests how well afatinib works in treating patients with cancer that has certain genetic changes. Afatinib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the EGFR gene. It works by blocking the action of mutated EGFR that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells., conditionsModule conditions: Advanced Lymphoma, conditions: Advanced Malignant Solid Neoplasm, conditions: Refractory Lymphoma, conditions: Refractory Malignant Solid Neoplasm, conditions: Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Afatinib, interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Echocardiography, interventions name: Magnetic Resonance Imaging, interventions name: Radionuclide Imaging, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: 6-month progression free survival (PFS), secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ECOG-ACRIN Cancer Research Group, city: Philadelphia, state: Pennsylvania, zip: 19103, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06385470, orgStudyIdInfo id: HSEARS20231112001, briefTitle: Treatment of Cantonese Speakers With Childhood Apraxia of Speech, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, collaborators name: University of Vermont, collaborators name: The University of Hong Kong, descriptionModule briefSummary: The proposed study aims to investigate the efficacy of the Dynamic Temporal and Tactile Cueing treatment in Cantonese-English bilingual speakers with childhood apraxia of speech., conditionsModule conditions: Childhood Apraxia of Speech, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ESTIMATED, armsInterventionsModule interventions name: Dynamic Temporal and Tactile Cueing treatment, outcomesModule primaryOutcomes measure: Phonemes accuracy, primaryOutcomes measure: Stress accuracy, primaryOutcomes measure: Tone accuracy, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, status: RECRUITING, city: Kowloon, country: Hong Kong, contacts name: Min Ney Wong, PhD, role: CONTACT, phone: +852 2766 7268, email: [email protected], geoPoint lat: 22.31667, lon: 114.18333, hasResults: False |
protocolSection identificationModule nctId: NCT06385457, orgStudyIdInfo id: 24-2933, briefTitle: The Effects of Mindhelper on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, collaborators name: TrygFonden, Denmark, collaborators name: Danske Regioner, collaborators name: Jascha Fonden, collaborators name: Centre for Digital Psychiatry, Mental Health Services in the Region of Southern Denmark, descriptionModule briefSummary: In this study the investigators will evaluate the effectiveness of Mindhelper.dk, which is the most comprehensive online youth mental health promotion service in Denmark.A minimum of 9,426 young people aged 15 to 25 will be recruited through social media and invited to participate in the study. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group. The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization.The investigators expect a small, positive effect on participants well-being and psychological functioning in intervention groups as compared to the control group., conditionsModule conditions: Mental Health Issue, conditions: Well-Being, conditions: Adolescents, conditions: Young Adults, conditions: Online Intervention, conditions: Internet-Based Intervention, conditions: Randomized Controlled Trial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study.Young people will be recruited through social medias. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group.The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: The participants are partly masked. The control group will be masked; however, the intervention group will not be masked.There is no care provider nor outcome assessor as all measures are self-reported and collected through online questionnaires.Analyses of data and interpretation of results will be done masked., whoMasked: INVESTIGATOR, enrollmentInfo count: 9426, type: ESTIMATED, armsInterventionsModule interventions name: Mindhelper- A national youth mental health promotion website, outcomesModule primaryOutcomes measure: General well-being measure by "The Well-Being Index WHO-5" (WHO5), secondaryOutcomes measure: Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS)., secondaryOutcomes measure: Intentions to help-seeking, otherOutcomes measure: Body Appreciation measured by the "2-items Short forms of the Body Appreciation Scale-2" (2-item BAS-2SF)., eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: National Institute of Public Health (NIPH), University of Southern Denmark, city: Copenhagen, state: Copenhagen K, zip: 1455, country: Denmark, contacts name: Sofie H Hoffmann, role: CONTACT, phone: 65 50 77 34, phoneExt: +45, email: [email protected], contacts name: Lau C Thygesen, role: CONTACT, phone: 65 50 77 71, phoneExt: +45, email: [email protected], geoPoint lat: 55.67594, lon: 12.56553, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-04-22, uploadDate: 2024-04-22T08:21, filename: SAP_000.pdf, size: 353976, hasResults: False |
protocolSection identificationModule nctId: NCT06385444, orgStudyIdInfo id: 2024-HS-020, briefTitle: IVF Failure and Pregnancy Loss on Couples' Psychological Stress, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Jilin University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about The purpose of this study was to compare the psychological differences between couples after IVF transplant failure and IVF pregnancy loss, including the differences in anxiety, depression, stress and post-traumatic stress between women and their spouses. The main question it aims to answer is:What are the psychological effects of IVF implantation failure and IVF pregnancy loss on women and the psychological differences between couples? Participants already taking IVF as part of their regular medical care will answer online survey questions about their joint pain for 1 years., conditionsModule conditions: Fertilization in Vitro, conditions: Pregnancy Loss, conditions: Psychological Stress, conditions: Post-traumatic Stress, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: As the number of failed IVF implants increases, does it increase the difference in anxiety and depression between couples?, primaryOutcomes measure: As the number of failed IVF implants increases, does it increase the difference in fertility stress between couples?, primaryOutcomes measure: Does pregnancy loss after IVF transplantation have a differential effect on anxiety and depression between couples?, primaryOutcomes measure: Does pregnancy loss after IVF transplantation have a differential effect on post-traumatic stress responses between couples?, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: the first hospital of Jilin University, city: Chang chun, state: Jilin, zip: 130000, country: China, contacts name: Qi Xi, doctorate, role: CONTACT, phone: 15804303801, email: [email protected], geoPoint lat: 42.74694, lon: 126.24667, hasResults: False |
protocolSection identificationModule nctId: NCT06385431, orgStudyIdInfo id: Charm, briefTitle: Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks, acronym: Charm, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-28, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Cardiovascular and metabolic diseases refer to a large category of cardiovascular diseases accompanied by a series of metabolic disorders (including dyslipidemia, obesity, abnormal glucose tolerance, diabetes, hypertension, thyroid dysfunction, etc.), which is the primary cause of death and disease burden of Chinese residents.The number of deaths from atherosclerotic cardiovascular disease (ASCVD) in China is about 2.4 million, accounting for 61% of the total cardiovascular deaths, accounting for more than 40% of the all-cause deaths. In Chinese patients with coronary heart disease, 52.9% are complicated with diabetes.Despite the 1.1 million coronary stents implanted in China, there has been no reduction in cardiovascular mortality, which highlights the importance of threshold advancement and the management of metabolic risk factors.In recent years, the new concept of cardiovascular and metabolic diseases has been actively promoted at home and abroad, and the focus of prevention and treatment strategy of cardiovascular and metabolic diseases has been called for.The project proposed the concept of co-treatment of metabolic diseases based on disorders of blood pressure regulation, disorders of glucose metabolism and disorders of lipid metabolism. Subjects eligible for cardiovascular and metabolic diseases were screened, their past medical records were registered, education and diagnosis and treatment management were conducted., conditionsModule conditions: Metabolic Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 8000, type: ESTIMATED, armsInterventionsModule interventions name: observational study, outcomesModule primaryOutcomes measure: incidence rate of cardiovascular and metabolic diseases, primaryOutcomes measure: treatment rate of cardiovascular and metabolic diseases, primaryOutcomes measure: control rate of cardiovascular and metabolic diseases., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385418, orgStudyIdInfo id: WST-CRC-202404, briefTitle: Fluorouracil Treatment Via Colon for Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2029-05-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The Second Hospital of Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Colonic local administration of fluorouracil with enhanced adhesion, outcomesModule primaryOutcomes measure: Objective response rate (according to RECIST1.1, investigator assessment), secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Disease control rate (according to RECIST1.1, investigator assessment), secondaryOutcomes measure: Drop period to ensure operation resection, secondaryOutcomes measure: Converted resection rate, secondaryOutcomes measure: Actual R0 resection rate, secondaryOutcomes measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, contacts name: Faming Zhang, MD, PhD, role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06385405, orgStudyIdInfo id: 2024y0423, briefTitle: Electroencephalography-based Precise Repetitive Transcranial Magnetic Stimulation Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Mental Health Center, class: OTHER, collaborators name: National Natural Science Foundation of China, collaborators name: Shanghai Municipal Science and Technology Commission, collaborators name: Shanghai Jiao Tong University School of Medicine, descriptionModule briefSummary: This study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental Health Center (SMHC), an authoritative institution in the field of mental health. We will eventually facilitate optimization of physical therapy for major depressive disorder (MDD)., conditionsModule conditions: Major Depressive Disorder (MDD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To test the hypothesis that repetitive transcranial magnetic stimulation based on individualized EEG modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), patients were tested in a parallel controlled trial.During the treatment period, patients will be randomly grouped into the precision group, which will be treated with rTMS based on personalized modulation of EEG data, and the conventional group, which will be treated with TMS at a frequency of 10 Hz to stimulate the left dorsolateral prefrontal cortex (DLPFC)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment, interventions name: 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC), outcomesModule primaryOutcomes measure: the effective rate, secondaryOutcomes measure: complete remission rate, secondaryOutcomes measure: alpha band spectral connectivity in electroencephalogram (EEG) parameters, secondaryOutcomes measure: Evaluation of therapeutic effect, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Mental Health Center, city: Shanghai, state: Shanghai, zip: 200030, country: China, contacts name: TianHong Zhang, Doctor, role: CONTACT, phone: 13127577024, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06385392, orgStudyIdInfo id: A23-354, briefTitle: Continuous Wearable Monitor for the Detection and Release of Freezing of Gait., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: HealthPartners Institute, class: OTHER, descriptionModule briefSummary: The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Haptic module and insole device, outcomesModule primaryOutcomes measure: To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial., eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Struthers Parkinson's Center, city: Golden Valley, state: Minnesota, zip: 55427, country: United States, contacts name: Research Coordinator, role: CONTACT, phone: 651-495-6363, email: [email protected], geoPoint lat: 45.00969, lon: -93.34912, locations facility: HealthPartners Neuroscience Center, city: Saint Paul, state: Minnesota, zip: 55130, country: United States, contacts name: Clinical Trial Coordinator, role: CONTACT, phone: 651-495-6363, email: [email protected], geoPoint lat: 44.94441, lon: -93.09327, hasResults: False |
protocolSection identificationModule nctId: NCT06385379, orgStudyIdInfo id: WQ21-2301, briefTitle: Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hangzhou Endonom Medtech Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study), conditionsModule conditions: Aortic Arch Aneurysm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system, outcomesModule primaryOutcomes measure: Rate of all-cause mortality and major stroke within 12 months after surgery, secondaryOutcomes measure: Rate of immediate technical success following surgery, secondaryOutcomes measure: Rate of aortic aneurysm progression under control, secondaryOutcomes measure: Incidence of Type I or Type III endoleak, secondaryOutcomes measure: Incidence of aortic covered stent graft displacement, secondaryOutcomes measure: Postoperative branch vessel patency rate, secondaryOutcomes measure: Rate of conversion to thoracotomy or secondary intervention, secondaryOutcomes measure: Rate of major adverse events, secondaryOutcomes measure: Rate of aortic aneurysm-related mortality, secondaryOutcomes measure: Incidence of severe adverse events, secondaryOutcomes measure: Incidence of device-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Anzhen Hospital, Capital Medical University, status: RECRUITING, city: Beijing, country: China, contacts name: Zhong Chen, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chinese PLA Gencral Hosptial, status: RECRUITING, city: Beijing, country: China, contacts name: Wei Guo, role: CONTACT, phone: 13910758706, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First Hospital of Jilin University, status: RECRUITING, city: Changchun, country: China, contacts name: Yongsheng Gao, role: CONTACT, geoPoint lat: 43.88, lon: 125.32278, locations facility: Xiangya Hospital of Central South University, status: RECRUITING, city: Changsha, country: China, contacts name: Wei Wang, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: West China Hospital of Sichuan University, status: RECRUITING, city: Chengdu, country: China, contacts name: Jia Hu, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Guangdong Provincial Hospital of Traditional Chinese Medicine, status: RECRUITING, city: Guangzhou, country: China, contacts name: Xiaoping Fan, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital ,Sun Yat-sen University, status: RECRUITING, city: Guangzhou, country: China, contacts name: Guangqi Chang, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, country: China, contacts name: Baodong Xie, role: CONTACT, geoPoint lat: 45.75, lon: 126.65, locations facility: Shandong Provincial Hospital, status: RECRUITING, city: Jinan, country: China, contacts name: Xuejun Wu, role: CONTACT, geoPoint lat: 36.66833, lon: 116.99722, locations facility: The First People's Hospital of Yunnan Province, status: RECRUITING, city: Kunming, country: China, contacts name: Kunmei Gong, role: CONTACT, geoPoint lat: 25.03889, lon: 102.71833, locations facility: The Second Affiliated Hospital Of Nanchang University, status: RECRUITING, city: Nanchang, country: China, contacts name: Weimin Zhou, role: CONTACT, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Nanjing First Hospital, status: RECRUITING, city: Nanjing, country: China, contacts name: Xin Chen, role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, country: China, contacts name: Yongfeng Shao, role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital Of Qingdao University, status: RECRUITING, city: Qingdao, country: China, contacts name: Mingjin Guo, role: CONTACT, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Dan Zhu, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Zhongshan Hospital, Fudan University, status: RECRUITING, city: Shanghai, country: China, contacts name: Weiguo Fu, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The First Affiliated Hospital of China Medical University, status: RECRUITING, city: Shenyang, country: China, contacts name: Shijie Xin, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Xiamen Cardiovascular Hospital, status: RECRUITING, city: Xiamen, country: China, contacts name: Xijie Wu, role: CONTACT, geoPoint lat: 24.47979, lon: 118.08187, locations facility: The First Affiliated Hospital of PLA Air Force Military Medical University, status: RECRUITING, city: Xian, country: China, contacts name: Jian Zuo, role: CONTACT, geoPoint lat: 34.25833, lon: 108.92861, locations facility: First Affiliated Hospital of Zhengzhou University, status: RECRUITING, city: Zhengzhou, country: China, contacts name: Zhen Li, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False |
protocolSection identificationModule nctId: NCT06385366, orgStudyIdInfo id: GS_NP1, briefTitle: Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-05-06, completionDateStruct date: 2025-06-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Gene Solutions, class: INDUSTRY, collaborators name: Medical Genetics Institute (MGI), descriptionModule briefSummary: This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam., conditionsModule conditions: Pregnant With Complication, conditions: Preeclampsia, conditions: Preterm Birth, conditions: Gestational Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1105, type: ESTIMATED, outcomesModule primaryOutcomes measure: Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation), primaryOutcomes measure: Characteristics of pregnant women at recruitment, primaryOutcomes measure: Define the significant differences between cases and controls, primaryOutcomes measure: The development of learning machine models, primaryOutcomes measure: Evaluation of the developed models, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385353, orgStudyIdInfo id: 2022-CHITS-003, secondaryIdInfos id: 2023-A02652-43, type: OTHER, domain: ID-RCB number, briefTitle: DVT Burden and the Risk of Post-thrombotic Syndrome, acronym: DVT-Burden, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, class: OTHER, collaborators name: Assistance Publique Hopitaux De Marseille, collaborators name: F-CRIN INNOVTE Research Network, descriptionModule briefSummary: Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity.Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS.The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT.This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months., conditionsModule conditions: Postthrombotic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome, outcomesModule primaryOutcomes measure: Presence of moderate to severe Post-thrombotic Syndrome (PTS), primaryOutcomes measure: Thrombosis burden, secondaryOutcomes measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline, secondaryOutcomes measure: Thrombosis burden adjusted to other prognostic factors at baseline, secondaryOutcomes measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up, secondaryOutcomes measure: Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up, secondaryOutcomes measure: Time to complete resolution of the thrombus as a function of thrombosis burden at baseline, secondaryOutcomes measure: Presence of moderate to severe PTS at baseline and at follow-up visits, secondaryOutcomes measure: Thrombosis burden at baseline and at follow-up visits, otherOutcomes measure: Disease specific health related quality of life, otherOutcomes measure: General health related quality of life, otherOutcomes measure: Coagulation and fibrinolysis markers, otherOutcomes measure: Fibrinolytic and pro-coagulant activities of microvesicles/microparticles, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Carcassonne, city: Carcassonne, state: Aude, zip: 11010, country: France, contacts name: Géraldine PAOLI-CAZANAVE, role: CONTACT, email: [email protected], geoPoint lat: 43.21667, lon: 2.35, locations facility: Cabinet libéral, city: Martigues, state: Bouches-du-Rhône, zip: 13500, country: France, contacts name: Damien DIAS, role: CONTACT, email: [email protected], geoPoint lat: 43.40735, lon: 5.05526, locations facility: Cabinet libéral, city: Ajaccio, state: Corse-du-sud, zip: 20090, country: France, contacts name: Jean-François SECONDI, role: CONTACT, email: [email protected], geoPoint lat: 41.91888, lon: 8.73811, locations facility: Cabinet libéral, city: Ajaccio, state: Corse-du-sud, zip: 20090, country: France, contacts name: Céline DE MARI, role: CONTACT, email: [email protected], geoPoint lat: 41.91888, lon: 8.73811, locations facility: Centre Hospitalier Universitaire de Brest, city: Brest, state: Finistère, zip: 29069, country: France, contacts name: Benjamin ESPINASSE, role: CONTACT, email: [email protected], geoPoint lat: 48.3903, lon: -4.48628, locations facility: Clinique Rive Gauche, city: Toulouse, state: Haut-Garonne, zip: 31076, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Hospices Civils de Lyon, Hôpital Edouard Herriot, city: Lyon, state: Rhône, zip: 69003, country: France, contacts name: Judith CATELLA, role: CONTACT, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, locations facility: Centre Hospitalier Universitaire Amiens Picardie, city: Amiens, state: Somme, zip: 830054, country: France, contacts name: Simon SOUDET, role: CONTACT, email: [email protected], geoPoint lat: 49.9, lon: 2.3, locations facility: Centre Hospitalier de Fréjus/Saint-Raphaël, city: Fréjus, state: Var, zip: 83600, country: France, contacts name: Hatem BOUGHIDA, role: CONTACT, email: [email protected], geoPoint lat: 43.43286, lon: 6.73524, locations facility: Polyclinique Les Fleurs, city: Ollioules, state: Var, zip: 83190, country: France, contacts name: Anaïs CORNE, role: CONTACT, email: [email protected], geoPoint lat: 43.13517, lon: 5.848, locations facility: Centre cardio-vasculaire Esterel, city: Saint-Raphaël, state: Var, zip: 83700, country: France, geoPoint lat: 43.42332, lon: 6.7735, locations facility: Cabinet libéral, city: Sanary-sur-Mer, state: Var, zip: 83110, country: France, contacts name: Colin RICHARD, role: CONTACT, email: [email protected], geoPoint lat: 43.11783, lon: 5.80007, locations facility: Cabinet libéral, city: Six-Fours-les-Plages, state: Var, zip: 83140, country: France, contacts name: Sophia BENSEDRINE, role: CONTACT, email: [email protected], geoPoint lat: 43.1, lon: 5.85, locations facility: Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer, city: Toulon, state: Var, zip: 830054, country: France, contacts name: Jean-Noël POGGI, role: CONTACT, email: [email protected], geoPoint lat: 43.12442, lon: 5.92836, locations facility: Centre Hospitalier d'Avignon, city: Avignon, state: Vaucluse, zip: 84000, country: France, contacts name: Olivier GRAS, role: CONTACT, email: [email protected], geoPoint lat: 43.94834, lon: 4.80892, hasResults: False |
protocolSection identificationModule nctId: NCT06385340, orgStudyIdInfo id: CentroDerm_LRP22003, briefTitle: Investigation of the Effect of Lipikar Baume AP+M, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: CentroDerm GmbH, class: NETWORK, descriptionModule briefSummary: Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms.It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.A total of 20 subjects will be enrolled.The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application))., conditionsModule conditions: Actinic Keratoses, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Lipikar Baume AP+M, outcomesModule primaryOutcomes measure: Skin hydration measured by Corneometrie, primaryOutcomes measure: Transepidermal water loss measured by Tewameter®, primaryOutcomes measure: Aktinic keratosis area and severity index (AKASI), primaryOutcomes measure: S. aureus colonization and S. epidermidis colonization (application area), primaryOutcomes measure: Subjects's skin aspect, secondaryOutcomes measure: Absolute lesion count by application site, secondaryOutcomes measure: Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site, secondaryOutcomes measure: Number of new lesions on application area over the study period by application site, secondaryOutcomes measure: Symptom severity score: percentage across individual scores at each visit by application site, secondaryOutcomes measure: modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9), secondaryOutcomes measure: Compliance (percentage of subjects using topical agents at all intended days, 90% of days or 75% of days), secondaryOutcomes measure: Pictures at all time points, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385327, orgStudyIdInfo id: ABI-5366-101, briefTitle: A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Assembly Biosciences, class: INDUSTRY, descriptionModule briefSummary: This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A., conditionsModule conditions: Recurrent Genital Herpes Simplex Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: ABI-5366, interventions name: ABI-5366 Placebo, outcomesModule primaryOutcomes measure: Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results, primaryOutcomes measure: Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366, primaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of ABI-5366, primaryOutcomes measure: Time to Cmax (Tmax) of ABI-5366, primaryOutcomes measure: Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366, primaryOutcomes measure: Apparent Systemic Clearance (CL/F) of ABI-5366, primaryOutcomes measure: Apparent Volume of Distribution (Vz/F) of ABI-5366, primaryOutcomes measure: Dose normalized AUCs and Cmax of ABI-5366, secondaryOutcomes measure: SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments, secondaryOutcomes measure: MAD Cohorts: If applicable, comparison of plasma PK profiles and parameters with and without loading doses, secondaryOutcomes measure: MAD Cohorts: Difference in viral shedding rate (number of anogenital swabs positive for HSV-2 DNA/total number of swabs) across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in mean and median HSV-2 DNA copies/mL for swab samples positive for HSV-2 DNA across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in the proportion of swab samples with HSV-2 DNA >4 log10 copies/mL across treatments (number of swabbing samples with HSV-2 DNA >4 log10 copies/mL / total number of swabs obtained), secondaryOutcomes measure: MAD Cohorts: Difference in number of shedding episodes during the swabbing period across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in duration of shedding episodes during the swabbing period across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in subclinical shedding rate (number of swabs positive for HSV-2 DNA in the absence of lesions/total number of swabs in the absence of lesions) across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in lesion rate during the swabbing period across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in lesion duration during the swabbing period across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in recurrence rate (number of reappearances of lesions during the swabbing period/total days assessed) across treatments, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: New Zealand Clinical Research, city: Auckland, country: New Zealand, contacts name: Study Principal Investigator, role: CONTACT, geoPoint lat: -36.84853, lon: 174.76349, hasResults: False |
protocolSection identificationModule nctId: NCT06385314, orgStudyIdInfo id: Degirmenci1499, briefTitle: A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-05, primaryCompletionDateStruct date: 2023-11-25, completionDateStruct date: 2023-12-29, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effect of the clinical removal of fixed partial dentures (FPDs) on oral health-related quality of life (OHRQoL) and the anxiety values of individuals and to determine the risk factors of high anxiety levels. 300 participants were included in this study. Six different reasons for the clinical removal of FPDs (oral examination, denture renewal, root canal treatment, tooth extraction, periodontal treatment, and composite filling restoration) were defined. Questions pertaining to the United Kingdom Oral Health-Related Quality-of-Life Measure (OHQoL-UK), the Modified Dental Anxiety Scale (MDAS), and the Spielberger State-Trait Anxiety Inventory - State (STAI-S) and Trait (STAI-T) were answered., conditionsModule conditions: Dental Anxiety, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: Collecting data with oral health related quality of life, dental anxiety and state anxiety, outcomesModule primaryOutcomes measure: United Kingdom Oral Health-Related Quality-of-Life Measure, primaryOutcomes measure: Modified Dental Anxiety Scale, primaryOutcomes measure: Spielberger State Anxiety Inventory, primaryOutcomes measure: Spielberger Trait Anxiety Inventory, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kubra Degirmenci, city: Bolu, country: Turkey, geoPoint lat: 40.73583, lon: 31.60611, hasResults: False |
protocolSection identificationModule nctId: NCT06385301, orgStudyIdInfo id: Lung_disease_6MWD_SOT, briefTitle: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise., conditionsModule conditions: Lung Disease Chronic, conditions: Lung Diseases, Interstitial, conditions: Lung Diseases, Obstructive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Each participant is its own control, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: 6-minute walk distance (6MWD) test on ambient air, interventions name: 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal), outcomesModule primaryOutcomes measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air, secondaryOutcomes measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zürich, city: Zurich, zip: 8091, country: Switzerland, contacts name: Silvia Ulrich, Prof. Dr., role: CONTACT, phone: 0041 44 255 22 20, email: [email protected], contacts name: Mona Lichtblau, Dr., role: CONTACT, phone: +41442552220, email: [email protected], contacts name: Silvia Ulrich, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False |
protocolSection identificationModule nctId: NCT06385288, orgStudyIdInfo id: 268/2021BO2, briefTitle: Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-21, primaryCompletionDateStruct date: 2026-07-21, completionDateStruct date: 2031-07-21, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: "Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcoma" is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging., conditionsModule conditions: Soft Tissue Sarcoma Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: Open Label, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Blood and tissue collection for immunological studies, advanced imaging., interventions name: neoadjuvant Therapy, outcomesModule primaryOutcomes measure: Description of the cellular immune status via flow-cytometrie from collected blood samples, primaryOutcomes measure: Description of the cellular immune status on tissue samples ussing komplex immunohistochemie, primaryOutcomes measure: Measurement of the cellular free DNA from collected blood samples, primaryOutcomes measure: Measurement of HMGB1 from collected blood samples, primaryOutcomes measure: Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Tuebingen, status: RECRUITING, city: Tübingen, state: Baden-Württemberg, zip: 72076, country: Germany, contacts name: Vlatko Potkrajcic, MD, role: CONTACT, phone: +49 7071 29, phoneExt: 82165, email: [email protected], contacts name: Cihan Gani, MD, role: CONTACT, phone: +49 7071 29, phoneExt: 82165, email: [email protected], geoPoint lat: 48.52266, lon: 9.05222, hasResults: False |
protocolSection identificationModule nctId: NCT06385275, orgStudyIdInfo id: H-44897, briefTitle: The Role of Vitamin K on Knee Osteoarthritis Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Boston University, class: OTHER, collaborators name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), descriptionModule briefSummary: The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 360µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known,The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures., conditionsModule conditions: Osteo Arthritis Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A stratified permuted block randomization will be used to assign 55 participants in a 1:1:1:1 ratio to each intervention arm. A random allocation sequence will be generated by computer in blocks of 4 or 8, stratified by sex and race., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Use of a placebo from Johnson Compounding Pharmacy (Waltham, MA) of similar appearance and taste to the vitamin K supplements will allow for masking of participants, the study PI, and other study team members to the treatment allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin K1 500 µg, interventions name: K1 1000 µg, interventions name: Vitamin K2 (MK-7) 360 µg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in uncarboxylated matrix Gla protein (ucMGP) levels, primaryOutcomes measure: Change in phylloquinone levels, primaryOutcomes measure: Sufficient phylloquinone levels, primaryOutcomes measure: Change in menaquinone-7 (MK-7) levels, secondaryOutcomes measure: Study adherence, secondaryOutcomes measure: Participant acceptability of intervention, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Boston Medical Center, Rheumatology Clinic, city: Boston, state: Massachusetts, zip: 02118, country: United States, contacts name: Jean Liew, MD MS, role: CONTACT, phone: 617-358-9655, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06385262, orgStudyIdInfo id: Pro00114645, briefTitle: TOP 2301: Neoadjuvant Chemo for NSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: In this open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) will receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery.Eligible patients will be randomized with equal allocation to two treatment groups. Permuted block randomization algorithm will be used for treatment assignment with stratification factors: stage (1B, 2A, 2B, 3A), and performance status (0 vs. 1).The study hypothesis is that the addition of alirocumab to neoadjuvant chemoimmunotherapy will make tumor cells more immunogenic to cytotoxic T cells, resulting in an increase in complete pathologic responses in surgically resected tumor., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Alirocumab, interventions name: Cemiplimab, interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab., secondaryOutcomes measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by objective response rate (ORR), secondaryOutcomes measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by disease-free survival (DFS), secondaryOutcomes measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by overall survival (OS), secondaryOutcomes measure: Determine the safety of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC), secondaryOutcomes measure: Determine the tolerability of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385249, orgStudyIdInfo id: NAV-0012, briefTitle: An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Wellspect HealthCare, class: INDUSTRY, descriptionModule briefSummary: The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents., conditionsModule conditions: Bowel Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Navina Mini, outcomesModule primaryOutcomes measure: Overall patient satisfaction, secondaryOutcomes measure: Incomplete bowel emptying, secondaryOutcomes measure: Episodes of fecal incontinence, secondaryOutcomes measure: Level of independence, secondaryOutcomes measure: Perception of handling of the device, secondaryOutcomes measure: Safety outcome, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset, status: RECRUITING, city: Linköping, country: Sweden, contacts name: Peter Wide, role: CONTACT, phone: +46101031341, email: [email protected], contacts name: Jenny Axelsson, role: CONTACT, phone: +46101032432, email: [email protected], geoPoint lat: 58.41086, lon: 15.62157, hasResults: False |
protocolSection identificationModule nctId: NCT06385236, orgStudyIdInfo id: 804913, secondaryIdInfos id: R01HL161362, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL161362, briefTitle: Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping, acronym: EPIPHANY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, collaborators name: Mayo Clinic, collaborators name: Yale University, collaborators name: University of Arizona, collaborators name: Harvard University, collaborators name: Brigham and Women's Hospital, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples.By evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment., conditionsModule conditions: Moderate to Severe Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study is significant in determining molecular disease endotypes in a large group of moderate to severe asthmatics. By evaluating within-person genomic level changes and response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Dupilumab, interventions name: Benralizumab, outcomesModule primaryOutcomes measure: Predicting asthma outcomes and therapeutic responses, primaryOutcomes measure: Responses to the biologic therapies at the single cell level, primaryOutcomes measure: Unique asthma subgroups clinical and molecular endotype approaches, secondaryOutcomes measure: Asthma Control Questionnaire (ACQ), secondaryOutcomes measure: CompEx events, secondaryOutcomes measure: Asthma Quality of Life Questionnaire (AQLQ), secondaryOutcomes measure: Forced expiratory volume in 1 second (FEV1), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, status: RECRUITING, city: Scottsdale, state: Arizona, zip: 85259, country: United States, contacts name: Karalyn Folmes, Ph.D., role: CONTACT, phone: 480-301-4298, email: [email protected], contacts name: Gene R Bleecker, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Deborah A Meyers, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: University of California, San Diego, status: RECRUITING, city: La Jolla, state: California, zip: 92093, country: United States, contacts name: Asthma Research Team, role: CONTACT, phone: 619-431-0995, email: [email protected], contacts name: Kelan Tantisira, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Praveen Akuthota, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: Yale University, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06520, country: United States, contacts name: Katherine Spaulding, role: CONTACT, phone: 203-737-5572, email: [email protected], contacts name: Geoffrey L Chupp, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, hasResults: False |
protocolSection identificationModule nctId: NCT06385223, orgStudyIdInfo id: DSRB 2023/00680, briefTitle: A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Institute of Mental Health, Singapore, class: OTHER, collaborators name: National University of Singapore, descriptionModule briefSummary: The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Beam F3 targeted accelerated iTBS, interventions name: Individualized connectome-guided accelerated iTBS, outcomesModule primaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale, secondaryOutcomes measure: Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report), secondaryOutcomes measure: Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: EQ-5D (EuroQol), secondaryOutcomes measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF), otherOutcomes measure: TMS induced changes in resting-fMRI functional connectivity, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385210, orgStudyIdInfo id: 22SM7855, briefTitle: Barriers to Routine Surgical Video Recording, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-24, completionDateStruct date: 2024-04-24, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: In order to improve the implementation of routine surgical video recording, the researchers want to understand what the challenges associated with the uptake of this technology are. The aim of this study is to explore the barriers faced by key stakeholders including the surgical care team, information governance, and patients within the field of surgical video reporting. The data from this qualitative study will allow the researchers to understand better the challenges associated with uptake of surgical video recording. This will allow the researchers to develop strategies to overcome these challenges and subsequently improve uptake of surgical video recording which will promote safer and more transparent surgery., conditionsModule conditions: Minimally Invasive Surgery, conditions: Laparoscopic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: Semi structured interviews, outcomesModule primaryOutcomes measure: Stakeholder perceived barriers to surgical video recording, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery and Cancer, city: London, zip: W2 1NY, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06385197, orgStudyIdInfo id: 170886-HMO-CTIL, briefTitle: Improving the Effect of Multiple Sclerosis Drugs by Chronobiology, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-08, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-06-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, descriptionModule briefSummary: A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows., primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: App randomizing dosing regimen, outcomesModule primaryOutcomes measure: safety assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hadassah Medical Center, city: Jerusalem, country: Israel, geoPoint lat: 31.76904, lon: 35.21633, hasResults: False |
protocolSection identificationModule nctId: NCT06385184, orgStudyIdInfo id: NCR234859, briefTitle: Social & QoL Behaviors in Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Gregory Wallace, class: OTHER, descriptionModule briefSummary: Adults with Parkinson's Disease experience an array of challenges and changes in daily living, behaviors, and functioning throughout the progression of their condition. The investigators want to learn more about the effects of Parkinson's Disease on individuals' social behavior and quality of life (QoL) compared to people of the same age without Parkinson's Disease., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Subjective Quality of Life, primaryOutcomes measure: Social Behavior, primaryOutcomes measure: Activities of Daily Living, primaryOutcomes measure: Mental Health, primaryOutcomes measure: Cognition, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The George Washington University, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20052, country: United States, contacts name: Gregory Wallace, PhD, role: CONTACT, phone: 202-994-8285, email: [email protected], geoPoint lat: 38.89511, lon: -77.03637, hasResults: False |
protocolSection identificationModule nctId: NCT06385171, orgStudyIdInfo id: FFA-BTX-1, briefTitle: Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-08-01, completionDateStruct date: 2027-01-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Global Aesthetics LLC, class: OTHER, descriptionModule briefSummary: A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable., conditionsModule conditions: Wrinkle, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Botulinum toxin type A, outcomesModule primaryOutcomes measure: Change in facial wrinkles and Lines, primaryOutcomes measure: Facial Appearance, primaryOutcomes measure: Assessment of Wrinkle Severity, secondaryOutcomes measure: Assessment of Skin Reaction, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Global Aesthetics LLC, city: Cisco, state: Texas, zip: 76437, country: United States, geoPoint lat: 32.38819, lon: -98.97923, locations facility: Global Aesthetics LLC, city: Lubbock, state: Texas, zip: 79413, country: United States, contacts name: Otis Scroggins, BS, CNA, role: CONTACT, phone: 806-370-7428, email: [email protected], geoPoint lat: 33.57786, lon: -101.85517, hasResults: False |
protocolSection identificationModule nctId: NCT06385158, orgStudyIdInfo id: GenSci074-101, briefTitle: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Changchun GeneScience Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population, conditionsModule conditions: Vasomotor System; Labile, conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: GS1-144 tablet, outcomesModule primaryOutcomes measure: Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), primaryOutcomes measure: Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)., primaryOutcomes measure: Part 3: Number of Participants With TEAEs and SAEs, secondaryOutcomes measure: Part1,Part2 and Part3 AUC0-t- Area Under the Drug Concentration-time Curve From Time 0 to the Last Sample Collection Time t for GS1-144, secondaryOutcomes measure: Part 1, Part2 and Part 3: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144, secondaryOutcomes measure: Part 1, Part2 and Part 3: Cmax- Maximum Observed Plasma Concentration for GS1-144, secondaryOutcomes measure: Part 1 Part2 and Part 3: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144, secondaryOutcomes measure: Part 1 Part2 and Part 3:: T1/2- Terminal Half-life for GS1-144, secondaryOutcomes measure: Part 1 Part2 and Part 3: CL/F- Apparent Clearance for GS1-144, secondaryOutcomes measure: Part 1 Part2 and Part 3: Vd/F- Apparent Volume of Distribution for GS1-144, secondaryOutcomes measure: Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144, secondaryOutcomes measure: Part 3: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144, secondaryOutcomes measure: Part 3: Tmax,ss- Time of Cmax at Steady State for GS1-144, secondaryOutcomes measure: Part 3: Cavg,ss- Average Concentration at Steady State for GS1-144, secondaryOutcomes measure: Part 3: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144, secondaryOutcomes measure: Part 3: CLss/F- CL for Bioavailability at Steady State for GS1-144, secondaryOutcomes measure: Part 3: T1/2,ss- Terminal Half-life at Steady State for GS1-144, secondaryOutcomes measure: Part 3: Accumulation Ratio for GS1-144, secondaryOutcomes measure: Part 1: Baseline and placebo-adjusted changes in ∆∆QTc and other ECG parameters after oral administration of GF1-144 in healthy subjects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huashan Hospital, Fudan University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200040, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06385145, orgStudyIdInfo id: GenSci004-107, briefTitle: A Bioavailability Study of Two Different PEG-rhGH Preparations., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2024-07-13, completionDateStruct date: 2024-12-26, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Changchun GeneScience Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations., conditionsModule conditions: Pediatric Growth Hormone Deficiency (PGHD), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: PEG-rhGH with new preparation (T), interventions name: PEG-rhGH with present preparation (R), outcomesModule primaryOutcomes measure: Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation, primaryOutcomes measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation, primaryOutcomes measure: Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0-last)) of PEG-rhGH with present and new preparation, primaryOutcomes measure: Safety and tolerability (Number of participants with treatment-related adverse events), secondaryOutcomes measure: Peak Plasma Concentration (Cmax) of Insulin-like growth factor-1 (IGF-1) with present and new preparation, secondaryOutcomes measure: Area under the concentration-time curve from time zero to time infinity (AUC0-inf) of Insulin-like growth factor-1 (IGF-1) with present and new preparation, secondaryOutcomes measure: Anti-drug antibody (Number of Participants with positive ADA), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chengdu Xinhua Hospital, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Xiaolan Yong, Doctor, role: CONTACT, phone: +862860212136, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06385132, orgStudyIdInfo id: 6447, briefTitle: Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer, acronym: APPOINT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Approximately 30% of cancer patients may experience psychopathological disorders. The most common psychopathological disorders in cancer patients are mood disorders, anxiety, depression, adjustment disorders, and suicidal ideation. Among depressive disorders, mixed depression, with the simultaneous presence of symptoms of both depressive and manic polarity, is associated to higher levels of chronicity, functional impairment and suicidality. These disorders can also be worsened by loneliness and demoralization.Patients with head and neck cancer (H\&N-C) and Glioblastoma multiforme (GBM) have high psychological and sometimes psychiatric comorbidity probably due to the severity, poor prognosis of these cancers and harsh treatment toxicities.The most important protective factor for psychopathology is psychological resilience, which is "the capacity of a person to protect themselves and their mental health when facing life adversities," such as a GBM or H\&N-C diagnosis. Resilience is influenced by the affective temperament, which refers to basic personality traits related to behavioral and emotional reactivity to environmental stimuli. It is believed to be biologically determined and relatively stable throughout life.To date, the literature does not clarify the role of resilience and temperament in mediating the psychological profile of cancer patients. Furthermore, extensive profiling of the psychological and psychiatric profile of these patients at such a critical and pivotal moment in their journey is currently lacking in the literature.Aim of this study is to evaluate global psychological and psychiatric profile of patients affected by GBM and H\&N-C and the eventual fluctuation over time during RT course. Conducting an early and accurate screening for potential psychopathological issues will give the opportunity to avoid factors that could: worsen patient compliance, lead to suicidal risk, and increase hospitalizations.The results obtained will be utilized for planning precocious psychological or psychiatric take-in-charge aimed at promoting psychological well-being of H\&N-C and GBM patients., conditionsModule conditions: Glioblastoma, conditions: Head and Neck Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 207, type: ESTIMATED, armsInterventionsModule interventions name: Psychological Tests' administration, outcomesModule primaryOutcomes measure: Distress Thermometer, secondaryOutcomes measure: Brief Psychiatric Rating Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Roma, zip: 00168, country: Italy, contacts name: LOREDANA DINAPOLI, role: CONTACT, phone: +390630154428, email: [email protected], contacts name: Loredana Dinapoli, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06385119, orgStudyIdInfo id: F8394-101, briefTitle: A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-11-25, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Fore Biotherapeutics, class: INDUSTRY, descriptionModule briefSummary: The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine:* The effect of food on the single dose PK of plixorafenib administered with cobicistat.* The effect of cobicistat administration on the single dose PK of plixorafenib.* The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Plixorafenib, interventions name: Cobicistat, outcomesModule primaryOutcomes measure: Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)., primaryOutcomes measure: AUC from time 0 extrapolated to infinity (AUC0-inf)., primaryOutcomes measure: Maximum observed plasma concentration (Cmax)., primaryOutcomes measure: Time to maximum observed plasma concentration (Tmax)., primaryOutcomes measure: Terminal elimination rate constant (Kel)., primaryOutcomes measure: Terminal phase half-life (t1/2)., primaryOutcomes measure: Apparent oral clearance (CL/F)., primaryOutcomes measure: Apparent volume of distribution (Vd/F)., primaryOutcomes measure: Terminal rate constant calculated from the terminal slope of the log-linear regression of concentration with time (z)., secondaryOutcomes measure: Cumulative amount of plixorafenib excreted in urine, calculated as the sum of the product of urine concentration and urine volume (Ae)., secondaryOutcomes measure: Percent of dose excreted in urine in 48 hours calculated as 100*Ae/Dose., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: PPD - Austin Research Unit, city: Austin, state: Texas, zip: 78744, country: United States, contacts name: Kristie Miller, MD, role: CONTACT, phone: 877-362-2608, geoPoint lat: 30.26715, lon: -97.74306, hasResults: False |
protocolSection identificationModule nctId: NCT06385106, orgStudyIdInfo id: rTMS in AD, briefTitle: Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Zhejiang University, class: OTHER, descriptionModule briefSummary: Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in Alzheimer's disease (AD), but studies on the improvement of sleep disorders in AD are limited. The aim of this study was to evaluate the effects of rTMS on sleep and cognition in patients with mild-to-moderate Alzheimer's disease (AD)., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Real repetitive transcranial magnetic stimulation, interventions name: Sham repetitive transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: Cognitive funtion, primaryOutcomes measure: Sleep parameters, secondaryOutcomes measure: glymphatic system, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385093, orgStudyIdInfo id: EDR-IIS-003, briefTitle: A Study on the Prevention and Treatment of GIOP With Eldecalcitol, acronym: ELEGANT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Chinese SLE Treatment And Research Group, class: OTHER, collaborators name: Beijing Life oasis public service center, descriptionModule briefSummary: The study will be a multi-center, randomized, open label, parallel trial conducted in rheumatoid arthritis patients treated with glucocorticoids. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 314 eligible patients will be enrolled. The enrolled patients will be randomly assigned to either Eldecalcitol group or Alfacalcidol group in a 1:1 ratio and followed up for 12 months. On-site follow up visits will be conducted at Month 6 and 12 after enrollment. The study is designed to evaluate the efficacy and safety of Eldecalcitol in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients., conditionsModule conditions: Rheumatoid Arthritis, conditions: Osteoporosis, conditions: Osteopenia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 314, type: ESTIMATED, armsInterventionsModule interventions name: Eldecalcitol capsules, interventions name: Alfacalcidol tablets, interventions name: Calcium carbonate tablets, outcomesModule primaryOutcomes measure: Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD), secondaryOutcomes measure: Percent change from baseline to month 6 in lumbar spine (L1-4) BMD, secondaryOutcomes measure: Percent change from baseline in total hip BMD, secondaryOutcomes measure: Percent change from baseline in femoral neck BMD, secondaryOutcomes measure: Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS), secondaryOutcomes measure: Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP), secondaryOutcomes measure: Percent change from baseline in Type 1 Collagen C-telopeptide (CTX), secondaryOutcomes measure: Percentage of patients diagnosed with osteoporosis at month 12, secondaryOutcomes measure: Incidence of new vertebral fracture, secondaryOutcomes measure: Change from baseline in Quality of Life assessed using EQ-5D-5L, secondaryOutcomes measure: Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI), secondaryOutcomes measure: Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score, secondaryOutcomes measure: Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT), secondaryOutcomes measure: Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT), secondaryOutcomes measure: Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Ying Jiang, MD, role: CONTACT, phone: +86-13391701765, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Aerospace Central Hospital, city: Beijing, state: Beijing, country: China, contacts name: Jian Liu, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Luhe hospital, Capital Medical University, city: Beijing, state: Beijing, country: China, contacts name: Baoyu Zhang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Shijingshan Hospital, city: Beijing, state: Beijing, country: China, contacts name: Lian'na Xu, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Shijitan Hospital, city: Beijing, state: Beijing, country: China, contacts name: Yuhua Wang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Shunyi hospital, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, state: Beijing, country: China, contacts name: Yi Zhao, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06385080, orgStudyIdInfo id: 61186372HNC2002, briefTitle: A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer, acronym: OrigAMI-4, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-07-17, completionDateStruct date: 2026-07-17, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Janssen Research & Development, LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel., conditionsModule conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 117, type: ESTIMATED, armsInterventionsModule interventions name: Amivantamab, interventions name: Pembrolizumab, interventions name: Paclitaxel, outcomesModule primaryOutcomes measure: Cohorts 1, 2, and 3B: Objective Response Rate, primaryOutcomes measure: Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT), primaryOutcomes measure: Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity, secondaryOutcomes measure: Cohorts 1, 2, and 3B: Duration of Response (DoR), secondaryOutcomes measure: Cohorts 1, 2, and 3B: Clinical Benefit Rate (CBR), secondaryOutcomes measure: Cohorts 1, 2, and 3B: Progression-free Survival (PFS), secondaryOutcomes measure: Cohorts 1, 2, and 3B: Overall Survival (OS), secondaryOutcomes measure: Cohorts 1, 2, and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity, secondaryOutcomes measure: Cohort 1: Maximum Observed Serum Concentration (Cmax) of Amivantamab, secondaryOutcomes measure: Cohort 1: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab, secondaryOutcomes measure: Cohort 1: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab, secondaryOutcomes measure: Cohort 1: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab, secondaryOutcomes measure: Cohort 1: Trough Serum Concentration (Ctrough) of Amivantamab, secondaryOutcomes measure: Cohort 1: Accumulation Ratio (R) of Amivantamab, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False |
protocolSection identificationModule nctId: NCT06385067, orgStudyIdInfo id: JW-PM-DCB-2024, briefTitle: Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: JW Medical Systems Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Biolimus Coated Coronary Artery Balloon Dilation Catheter, outcomesModule primaryOutcomes measure: Target lesion failure rate (TLF), secondaryOutcomes measure: Interventional success rate, secondaryOutcomes measure: Device-related cardiovascular clinical composite endpoint, secondaryOutcomes measure: Patient-related cardiovascular clinical composite endpoint, secondaryOutcomes measure: Major adverse cardiac events (MACEs), secondaryOutcomes measure: Incidence of thrombotic events as defined by ARC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06385054, orgStudyIdInfo id: L-027, secondaryIdInfos id: 2023-A02612-43, type: REGISTRY, domain: ID-RCB, secondaryIdInfos id: PEC23063, type: OTHER, domain: Biofortis, briefTitle: Effect of Probiotics on Infantile Colic Symptoms, acronym: EPIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Lallemand Health Solutions, class: INDUSTRY, collaborators name: BioFortis, descriptionModule briefSummary: The aim of this clinical trial is to assess the impact of a probiotic formulation on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention., conditionsModule conditions: Infantile Colic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in daily crying duration, secondaryOutcomes measure: Change in crying patterns, secondaryOutcomes measure: Change in sleep duration, secondaryOutcomes measure: Change in maternal quality of life, secondaryOutcomes measure: Change in bowel habits, secondaryOutcomes measure: Change in gut microbiota composition, secondaryOutcomes measure: Probiotic strain recovery, otherOutcomes measure: Safety and tolerability of the intervention, otherOutcomes measure: Change in fecal immune markers and proteins, eligibilityModule sex: ALL, maximumAge: 8 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Centre Hospitalier de Boulogne-sur-Mer, city: Boulogne-sur-Mer, zip: 62200, country: France, contacts name: Mohamad Hage, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.71667, lon: 1.61667, locations facility: Cabinet privé Dr Regimbart-Trubuil Christine, city: Bécon-les-Granits, zip: 49370, country: France, contacts name: Christine Regimbart-Trubuil, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.50134, lon: -0.8, locations facility: CHU Caen Normandie, city: Caen, zip: 14033, country: France, contacts name: Edouard Lacotte, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.18585, lon: -0.35912, locations facility: CHU Grenoble Alpes, city: La Tronche, zip: 38700, country: France, contacts name: Ellen Katranji, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.20429, lon: 5.73645, locations facility: Hôpital Saint Vincent de Paul, city: Lille, zip: 59000, country: France, contacts name: Pr. Nicholas Kalach, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Centre Hospitalier de Montauban, city: Montauban, zip: 82000, country: France, contacts name: Sabine Charpentier, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.01667, lon: 1.35, locations facility: CHU de NANTES, city: Nantes, zip: 44000, country: France, contacts name: Hugues Piloquet, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Biofortis, Unité d'investigation Clinique, city: Paris, zip: 75012, country: France, contacts name: Stéphanie Cavigoli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Biofortis, Unité d'investigation Clinique, city: Saint-Herblain, zip: 44800, country: France, contacts name: Isabelle Metreau, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21765, lon: -1.64841, locations facility: Centre Hospitalier du val d'Ariège, city: Saint-Jean-de-Verges, zip: 09000, country: France, contacts name: Lucas Percheron, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.01371, lon: 1.61076, hasResults: False |
protocolSection identificationModule nctId: NCT06385041, orgStudyIdInfo id: BE-2-83, briefTitle: Cardiac Rehabilitation and Frailty Physical Training Program in Elderly Patients After Open Heart Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-12, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Vitalija Stonkuvienė, class: OTHER, descriptionModule briefSummary: The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation., conditionsModule conditions: Frailty Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Intervention group 1, interventions name: Intervention group 2, outcomesModule primaryOutcomes measure: Collecting data from the medical history, primaryOutcomes measure: Frailty level by Edmonton frail scale score, primaryOutcomes measure: Fear of Falling by Falls Efficacy Scale International; FES-I)., primaryOutcomes measure: Quality of life by EuroQoL FiveDimensionsEQ-5D-5L., primaryOutcomes measure: Motivation by Multidimensional Health Locus of Control scale, primaryOutcomes measure: Change from baseline functional capacity by six minutes walking test (6MWT), primaryOutcomes measure: Change from baseline physical performance by Short Physical Performance Battery (SPPB), primaryOutcomes measure: Change from baseline muscular strength by one repetition maximum test (1RM), primaryOutcomes measure: Change from baseline grip strength by hydraulic hand dinanometer, primaryOutcomes measure: Change from baseline balance parameters by Biodex Balance System SD, primaryOutcomes measure: Change from baseline stance and gait parameters by Zebris Medical GmbH, secondaryOutcomes measure: Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt), secondaryOutcomes measure: Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva, status: RECRUITING, city: Kaunas, country: Lithuania, contacts name: Vitalija Stonkuvienė, role: CONTACT, geoPoint lat: 54.90272, lon: 23.90961, hasResults: False |
protocolSection identificationModule nctId: NCT06385028, orgStudyIdInfo id: 20230213_PIANISSIMO, briefTitle: Physical Activity Promotion in Osteoarthritis Patients, acronym: PIANISSIMO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Luxembourg Institute of Health, class: OTHER_GOV, collaborators name: Œuvre Nationale de Secours Grande Duchesse Charlotte, descriptionModule briefSummary: The main purpose of this project is to promote physical activity in patients with osteoarthritis. More specifically, this study aims to test the acceptability of an app to promote physical activity in the target population, and consequently the feasibility of such an approach.A mobile phone application - namely PIANISSIMO - will be developed specifically for this project. It aims to spread knowledge on the benefits of physical activity and collect data on how this knowledge can induce behavior changes toward a more physically active lifestyle.The intervention is delivered via the app, which will send daily notifications on physical activity and sedentary behavior, and ask the participants to set their weekly goal (i.e., daily steps). The app will also collect daily steps count and ask the participant to fill in questionnaire on pain once a week., conditionsModule conditions: Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: pilot feasibility study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity promotion, outcomesModule primaryOutcomes measure: Weekly number of connections to the application over time, primaryOutcomes measure: Response rate to the weekly questionnaires over time, secondaryOutcomes measure: Evolution of physical activity metrics, secondaryOutcomes measure: influence of pain on physical activity practice, secondaryOutcomes measure: influence of physical activity on pain report, otherOutcomes measure: long-term evolution of daily steps, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Luxembourg Institute of Health, city: Strassen, zip: 1445, country: Luxembourg, geoPoint lat: 49.62056, lon: 6.07333, hasResults: False |
protocolSection identificationModule nctId: NCT06385015, orgStudyIdInfo id: IRB#23-001257, briefTitle: T-UP: Engaging Vulnerable Students in Diabetes Prevention, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, collaborators name: American Diabetes Association, descriptionModule briefSummary: The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity.The specific aims are to: 1) Evaluate the efficacy of adolescents and young adults (AYA)-tailored version of the University of California Diabetes Prevention Program (UC DPP) for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months); and, 2) Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP.The investigators will randomize participants to the AYA-tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the AYA-tailored DPP in the following academic year. Participants will be organized into groups within their DPP cohort based on their student status and/or place of residence. The intervention will include 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a lifestyle coach. At the end of each session, intervention participants will receive an email/text with a unique link to a brief REDCap survey to ascertain acceptability of the session. Control group will receive access to materials about study habits, alcohol use, and financial literacy. Control group will receive materials via e-mail for participants to review on their own time and will receive acceptability surveys. A research assistant (RA) will meet with control participants via Zoom to explain the materials. Participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire via REDCap and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: PreDiabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Tailored DPP Intervention, outcomesModule primaryOutcomes measure: Change in weight (pounds, lbs) between baseline and 9-month follow-up, primaryOutcomes measure: Change in self-reported quality of life (Centers for Disease Control and Prevention Health-Related Quality of Life-14 item (CDC HRQOL-14)) between baseline and 9-month follow-up, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of California, Los Angeles, city: Los Angeles, state: California, zip: 90095, country: United States, geoPoint lat: 34.05223, lon: -118.24368, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-09-22, uploadDate: 2024-01-23T16:50, filename: ICF_000.pdf, size: 203319, hasResults: False |
protocolSection identificationModule nctId: NCT06385002, orgStudyIdInfo id: 2024-0158, briefTitle: Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Pusan National University Yangsan Hospital, class: OTHER, descriptionModule briefSummary: Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone., conditionsModule conditions: Gynecological Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Remimazolam, outcomesModule primaryOutcomes measure: time to emergence, primaryOutcomes measure: time to tracheal extubation, secondaryOutcomes measure: usage of vasopressors, secondaryOutcomes measure: severity of cough, secondaryOutcomes measure: time to discharge from the recovery room, secondaryOutcomes measure: postoperative pain scores, secondaryOutcomes measure: scores for postoperative nausea and vomiting, eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06384989, orgStudyIdInfo id: MinnesotaHealthSolutions_LL, briefTitle: Safety-Enhancing Motor Vehicle Child Safety Seat, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Minnesota HealthSolutions, class: INDUSTRY, descriptionModule briefSummary: This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design., conditionsModule conditions: Motor Vehicle Injury, conditions: Safety Issues, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Child restraint system with load leg feature, outcomesModule primaryOutcomes measure: Correct use of load leg, primaryOutcomes measure: Load leg error types, secondaryOutcomes measure: Other installation errors, secondaryOutcomes measure: Opinion on load leg design and instructions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Julie Mansfield, PhD, role: CONTACT, phone: 614-366-2101, email: [email protected], geoPoint lat: 39.96118, lon: -82.99879, hasResults: False |
protocolSection identificationModule nctId: NCT06384976, orgStudyIdInfo id: KYV101-007, briefTitle: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Kyverna Therapeutics, class: INDUSTRY, descriptionModule briefSummary: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis, conditionsModule conditions: Multiple Sclerosis, Primary Progressive, conditions: Multiple Sclerosis, Secondary Progressive, conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: KYV-101, interventions name: Standard lymphodepletion regimen, interventions name: Anti-CD20 mAB, outcomesModule primaryOutcomes measure: To evaluate efficacy of KYV-101, secondaryOutcomes measure: To characterize the safety and tolerability of KYV-101, secondaryOutcomes measure: To characterize the safety and tolerability of KYV-101, secondaryOutcomes measure: To characterize the safety and tolerability of KYV-101, secondaryOutcomes measure: To evaluate efficacy of KYV-101, secondaryOutcomes measure: To characterize the pharmacokinetics (PK), secondaryOutcomes measure: To characterize the pharmacokinetics (PK), secondaryOutcomes measure: To characterize the Pharmacodynamics (PD), secondaryOutcomes measure: To characterize the Pharmacodynamics (PD), secondaryOutcomes measure: To evaluate the immunogenicity (humoral response) of KYV-101, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06384963, orgStudyIdInfo id: Cer22/02, briefTitle: Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF, acronym: RSA-PACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ceryx Medical Australia, class: INDUSTRY, collaborators name: Avania, descriptionModule briefSummary: The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out.The main questions the trial aims to answer are:* Is the new type of pacemaker safe?* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)?Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Atrial pacing with respiratory sinus arrhythmia (RSA) variability, interventions name: Monotonic right atrial overdrive pacing, outcomesModule primaryOutcomes measure: Number of arrhythmia episodes per patient during pacing, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Waikato Hospital, city: Hamilton, zip: 3240, country: New Zealand, contacts name: Martin Stiles, MB ChB, role: CONTACT, phone: +64 07 957 6080, email: [email protected], contacts name: Kelly Henderson, BSc, role: CONTACT, phone: +64 0272564243, phoneExt: 25015, email: [email protected], geoPoint lat: -37.78333, lon: 175.28333, hasResults: False |
protocolSection identificationModule nctId: NCT06384950, orgStudyIdInfo id: 2023-11-005A, briefTitle: Evaluating the Role of ChatGPT in Educating Patients With Early-stage Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-11-29, completionDateStruct date: 2025-03-21, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Taipei Veterans General Hospital, Taiwan, class: OTHER_GOV, descriptionModule briefSummary: Liver cancer is a leading cause of cancer-related deaths in Taiwan, with its onset linked to factors like chronic liver conditions, cirrhosis, and genetic predispositions. According to the "Barcelona Clinic Liver Cancer (BCLC)" classification, early-stage liver cancer is demarcated by stages 0 to A. Upon such diagnosis, both patients and their families often have numerous questions and concerns, ranging from treatment choices to long-term outcomes. The research proposes a GPT-3.5-based chatbot to assist these patients by providing timely, personalized information, aiming to enrich their understanding of the disease and improve communication between patients and health professionals.The research methodology employs a Randomized Controlled Trial (RCT) design, dividing participants into a control cohort receiving standard patient education routine and an experimental cohort receiving both the AI chatbot and traditional education routine. The comparative analysis of these cohorts will determine the effectiveness of the AI intervention in improving patients' health literacy and satisfaction., conditionsModule conditions: Carcinoma, Hepatocellular, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To compare the educational effectiveness of a chatbot integrated with health education information to traditional health education methods. This comparison encompassed aspects such as the patient's health literacy and clinical satisfaction. Based on the findings, recommendations and improvements would be proposed to promote the application and development of large language models in the medical field., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: The research uses a Randomized Controlled Trial (RCT) methodology, dividing patients into a control group undergoing the conventional patient education routine, and an experimental group that leverages both the chatbot and traditional education. By comparing selected outcomes between the two groups, the experiment's effectiveness will be determined., whoMasked: PARTICIPANT, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: ChatGPT, interventions name: patient education with traditional methods., outcomesModule primaryOutcomes measure: Health literacy score of patients, primaryOutcomes measure: Satisfaction score with medical care, secondaryOutcomes measure: Degree of patient anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei Veterans General Hospital, status: RECRUITING, city: Taipei, state: Beitou District, zip: 11217, country: Taiwan, contacts name: Chun-Ying Wu, role: CONTACT, phone: +886-28712121, phoneExt: 4190, email: [email protected], contacts name: HSIAO-PING CHEN, role: CONTACT, phone: +886-28712121, phoneExt: 4190, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06384937, orgStudyIdInfo id: GCA-PRO-2022-001-01, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False |
protocolSection identificationModule nctId: NCT06384924, orgStudyIdInfo id: SBU-RAMAN-SKINCANCER, briefTitle: Raman Spectroscopy and Skin Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Renee Cattell, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:-Can Raman Spectroscopy help figure out how far a tumor spreads?This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin., conditionsModule conditions: Skin Cancer, conditions: Basal Cell Carcinoma, conditions: Squamous Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Raman Spectroscopy handheld probe (EmVision, FL, USA), interventions name: Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA), outcomesModule primaryOutcomes measure: Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin., secondaryOutcomes measure: Compare the size of clinically defined margin and Raman-defined margin, secondaryOutcomes measure: Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stony Brook Hospital, city: Stony Brook, state: New York, zip: 11794, country: United States, contacts name: Renee Cattell, PhD, role: CONTACT, email: [email protected], contacts name: Renee Cattell, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.92565, lon: -73.14094, hasResults: False |
protocolSection identificationModule nctId: NCT06384911, orgStudyIdInfo id: STUDY00004543, briefTitle: InvesT1D: Promoting Adolescent Investment in Diabetes Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: Harvard Pilgrim Health Care, descriptionModule briefSummary: The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels and person-reported outcomes between groups., conditionsModule conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Financial Incentives Program, outcomesModule primaryOutcomes measure: Time In Range, secondaryOutcomes measure: Time Above Range, secondaryOutcomes measure: Time Below Range, secondaryOutcomes measure: Hemoglobin A1c (HbA1c), secondaryOutcomes measure: Diabetes Distress, secondaryOutcomes measure: Diabetes Family Conflict, secondaryOutcomes measure: Adolescent Quality of Life, secondaryOutcomes measure: Caregiver Quality of Life, secondaryOutcomes measure: Diabetic Ketoacidosis, secondaryOutcomes measure: Severe Hypoglycemia, secondaryOutcomes measure: Insulin Adminstration, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06384898, orgStudyIdInfo id: STUDY00002259, secondaryIdInfos id: UH3AT012413, type: OTHER_GRANT, domain: National Center for Complementary and Integrative Health, briefTitle: Remote Tai Chi for Knee Osteoarthritis, acronym: TAICHIKNEE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Tufts Medical Center, class: OTHER, collaborators name: Boston Medical Center, collaborators name: University of California, Los Angeles, collaborators name: The Cleveland Clinic, collaborators name: National Center for Complementary and Integrative Health (NCCIH), descriptionModule briefSummary: The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:* Does remote Tai Chi improve the extent to which pain interferes with physical, mental, and social activities (PROMIS-Pain Interference at 3 months, primary outcome), as well as knee pain and function (WOMAC subscales) and analgesic use (secondary outcomes)* Does remote tai chi decreases healthcare utilization?Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is an individually randomized group-treatment (IRGT) trial. Individuals randomly allocated to remote Tai Chi receive the intervention with other participants through an instructor., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Remote Tai Chi, outcomesModule primaryOutcomes measure: PROMIS Pain Interference score, primaryOutcomes measure: PROMIS Pain Interference score, primaryOutcomes measure: PROMIS Pain Interference score, secondaryOutcomes measure: WOMAC total score, secondaryOutcomes measure: WOMAC total score, secondaryOutcomes measure: WOMAC total score, secondaryOutcomes measure: SF-12 PCS score, secondaryOutcomes measure: SF-12 PCS score, secondaryOutcomes measure: SF-12 PCS score, secondaryOutcomes measure: Number of knee joint injections, otherOutcomes measure: WOMAC Pain Score, otherOutcomes measure: WOMAC Pain Score, otherOutcomes measure: WOMAC Pain Score, otherOutcomes measure: WOMAC Pain Score on nominated activity chosen at baseline, otherOutcomes measure: WOMAC Pain Score on nominated activity chosen at baseline, otherOutcomes measure: WOMAC Pain Score on nominated activity chosen at baseline, otherOutcomes measure: WOMAC function score, otherOutcomes measure: WOMAC function score, otherOutcomes measure: WOMAC function score, otherOutcomes measure: WOMAC stiffness score, otherOutcomes measure: WOMAC stiffness score, otherOutcomes measure: WOMAC stiffness score, otherOutcomes measure: Patient's global assessment score, otherOutcomes measure: Patient's global assessment score, otherOutcomes measure: Patient's global assessment score, otherOutcomes measure: PROMIS sleep disturbance OA Knee- Short Form 6a, otherOutcomes measure: PROMIS sleep disturbance OA Knee- Short Form 6a, otherOutcomes measure: PROMIS sleep disturbance OA Knee- Short Form 6a, otherOutcomes measure: Beck Depression Inventory-II score, otherOutcomes measure: Beck Depression Inventory-II score, otherOutcomes measure: Beck Depression Inventory-II score, otherOutcomes measure: SF-12 MCS score, otherOutcomes measure: SF-12 MCS score, otherOutcomes measure: SF-12 MCS score, otherOutcomes measure: Receipt of knee surgery, otherOutcomes measure: OMERACT/OARSI responder, otherOutcomes measure: OMERACT/OARSI responder, otherOutcomes measure: OMERACT/OARSI responder, otherOutcomes measure: Pain medication use, otherOutcomes measure: Pain medication use, otherOutcomes measure: Pain medication use, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tufts Medical Center, city: Boston, state: Massachusetts, zip: 02111, country: United States, contacts name: Sherwood Alexis, MHA, MBA, role: CONTACT, phone: 617-636-5405, email: [email protected], contacts name: Chenchen Wang, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Tim McAlindon, MD, role: SUB_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06384885, orgStudyIdInfo id: 2024-079, briefTitle: Ultrasound Investigation Into Swimming Induced Pulmonary Edema in Open Water Swimming Athletes, acronym: SIPE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Rocky Vista University, LLC, class: OTHER, descriptionModule briefSummary: Swimming-induced pulmonary edema (SIPE) is a potentially life-threatening condition that can affect swimmers of all abilities. The pathophysiology is not well understood and early identification strategies are not established. Handheld ultrasound is a validated tool for the identification of pulmonary edema and is not well-studied in this population. Understanding the incidence of signs of pulmonary edema and its usefulness as a sign of early pulmonary edema would be beneficial This study evaluates triathletes and open water swimmers at endurance events. A validated protocol for lung ultrasound is used to identify the signs of pulmonary edema. The findings will be analyzed for differences in experience level, type of athlete, gender, age, and environmental factors. The findings may then be used in the future to aid in the early identification and treatment of athletes and military personnel in similar situations to decrease morbidity and mortality., conditionsModule conditions: Swimming Induced Pulmonary Edema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Lung ultrasound, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rocky Vista University, status: RECRUITING, city: Parker, state: Colorado, zip: 80012, country: United States, contacts name: Kathryn A Vidlock, MD, role: CONTACT, phone: 651-226-1642, email: [email protected], contacts name: Brady Patterson, role: PRINCIPAL_INVESTIGATOR, contacts name: Harrison Steins, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.5186, lon: -104.76136, hasResults: False |
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