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protocolSection identificationModule nctId: NCT06293846, orgStudyIdInfo id: IRB-300012108, secondaryIdInfos id: IRB Designation, type: OTHER, domain: UAB, briefTitle: BeFit Toolbox Collaboration: Building Empowerment Through Fitness, acronym: BEFIT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population., conditionsModule conditions: Low-Income Population, conditions: Women's Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: What I Learned at Home, outcomesModule primaryOutcomes measure: Barriers to Physical Activity Self-Report, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35233, country: United States, contacts name: Kimberly McCall, PhD, role: CONTACT, phone: 205-934-3378, email: [email protected], contacts name: Keith Mcgregor, PhD, role: CONTACT, phone: 3523598084, phoneExt: Mcgregor, email: [email protected], contacts name: Keith Mcgregor, role: SUB_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False |
protocolSection identificationModule nctId: NCT06293833, orgStudyIdInfo id: 003315, briefTitle: Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan, acronym: ZORALCS, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, collaborators name: Universiteit Antwerpen, collaborators name: Belgian Cancer Registry, descriptionModule briefSummary: The goal of this clinical trial is to implement lung cancer screening in a targeted high-risk population of heavy (ex-)smokers in Flanders (Belgium). This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation., conditionsModule conditions: Lung Cancer, Nonsmall Cell, conditions: Lung Cancer, conditions: Smoking Cessation, conditions: Lung Cancer, Small Cell, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Low-dose CT scan, interventions name: Smoking Cessation, outcomesModule primaryOutcomes measure: Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA, secondaryOutcomes measure: Responders, secondaryOutcomes measure: Number of true and false positive nodules, secondaryOutcomes measure: Impact of smoking cessation intervention, secondaryOutcomes measure: Success of smoking cessation intervention, secondaryOutcomes measure: Evaluation of shared decision making tool, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZA, city: Edegem, state: Antwerp, zip: 2650, country: Belgium, geoPoint lat: 51.15662, lon: 4.44504, hasResults: False |
protocolSection identificationModule nctId: NCT06293820, orgStudyIdInfo id: TL-925-304, briefTitle: A Study Of TL-925 For The Treatment of AC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Telios Pharma, Inc., class: INDUSTRY, descriptionModule briefSummary: In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis., conditionsModule conditions: Allergic Conjunctivitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The sponsor, investigators, and study staff will be masked throughout the study. The study site will have the capacity to unmask in case of emergency.Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject, and the database has been locked., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: TL-925, interventions name: Placebo, outcomesModule primaryOutcomes measure: Ocular Itching, primaryOutcomes measure: Conjunctival Redness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Andover Eye Associates, status: RECRUITING, city: Andover, state: Massachusetts, zip: 01810, country: United States, geoPoint lat: 42.65843, lon: -71.137, hasResults: False |
protocolSection identificationModule nctId: NCT06293807, orgStudyIdInfo id: 20220162HU, briefTitle: Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-06, primaryCompletionDateStruct date: 2023-04-16, completionDateStruct date: 2023-04-16, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center at San Antonio, class: OTHER, descriptionModule briefSummary: Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal., conditionsModule conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized, placebo-controlled, parallel design study., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Both the surgeon and patient will be blinded as to the intervention provided by covering identifying marks of the anesthetic carpules to be administered. Randomization will be assured by random selection of a slip of paper drawn from a sealed envelope assigning the patient to one of three groups., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Xylocaine 2 % with 1:100,000 epinephrine, interventions name: Bupivicaine 0.5% with 1:200,000 epinephrine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in pain using Visual Analog Scale (VAS), primaryOutcomes measure: Number of Ibuprofen administered, primaryOutcomes measure: Number of Tylenol administered, secondaryOutcomes measure: Arch Response, secondaryOutcomes measure: Number of teeth, secondaryOutcomes measure: Type of procedure, secondaryOutcomes measure: Gender of patient, secondaryOutcomes measure: Age of patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center at San Antonio, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False |
protocolSection identificationModule nctId: NCT06293794, orgStudyIdInfo id: 22-0991, briefTitle: Decision Support for Heart Failure Prescribing, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: Clinical decision support (CDS) tools can 'nudge' clinicians to make the best decisions easy. Although required by "meaningful use" regulations, more than 40% of CDS lead to no change and the remaining lead to improvements that are modest at best. This is because CDS tools often ignore contextual factors and present irrelevant information. Although many tools have undergone patient-specific optimization, 'traditional CDS' are rarely clinician-specific. For example, a traditional CDS tool for beta blockers and heart failure with reduced ejection fraction (HFrEF) addresses common prescribing misconceptions by stating asthma is not a contraindication and providing a safe threshold for blood pressure. For clinicians without these misconceptions, these statements are irrelevant and distract from key information. A 'personalized CDS' would evaluate clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions. The objective of this research is to create personalized clinician-specific CDS that overcome shortcomings of traditional CDS. The central hypothesis is a personalized CDS that minimizes irrelevant information will lead to a higher rate of prescribing guideline-directed management and therapy (GDMT) for HFrEF compared to a traditional CDS., conditionsModule conditions: Decision Support Systems, Clinical, conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Compare traditional and personalized CDS in a pragmatic randomized controlled trial at one health system., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1075, type: ESTIMATED, armsInterventionsModule interventions name: Personalized Clinical Decision Support (CDS), interventions name: Traditional Clinical Decision Support (CDS), outcomesModule primaryOutcomes measure: Number of CDS alerts resulting in the prescription of a recommended medication, secondaryOutcomes measure: Number of patients the CDS alerted for, secondaryOutcomes measure: Number of alerts that were not outright dismissed, secondaryOutcomes measure: Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293781, orgStudyIdInfo id: GachonU, briefTitle: Application of the Web-based Acceptance and Commitment Therapy for Depression, acronym: ACTION, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-19, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Gachon University, class: OTHER, descriptionModule briefSummary: PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY, conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Web-based ACT, interventions name: Treatment as usual, outcomesModule primaryOutcomes measure: Acceptance and Action Questionnaire-II, secondaryOutcomes measure: Cognitive Fusion Questionnaire, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kyoung-Sae Na, status: RECRUITING, city: Incheon, state: Please Incheon, zip: 21565, country: Korea, Republic of, contacts name: Kyoung-Sae Na, MD, PhD, role: CONTACT, phone: 82324689932, email: [email protected], geoPoint lat: 37.45646, lon: 126.70515, hasResults: False |
protocolSection identificationModule nctId: NCT06293768, orgStudyIdInfo id: FADOI.05.2018, briefTitle: Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T), acronym: GreenLineH-T, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-09-23, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Fadoi Foundation, Italy, class: OTHER, descriptionModule briefSummary: Monocentric prospective controlled randomized in open-label study. The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control), aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring., conditionsModule conditions: Hospitalization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control). 50 of the patients undergoing continuous monitoring come from the group A and 100 from group B, same ratio in the control group.Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 208, type: ACTUAL, armsInterventionsModule interventions name: continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients), outcomesModule primaryOutcomes measure: difference in the incidence of major complications at 30 days, secondaryOutcomes measure: number of acute patients who in seven days reach the criteria to be discharged or ransferred to the subacute ward, secondaryOutcomes measure: Difference in the incidence of major complications at the end of the telemonitoring phase, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale di Albano - Polo H2, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06293755, orgStudyIdInfo id: COA022/66, briefTitle: Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-03-05, completionDateStruct date: 2024-06-25, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Dhurakij Pundit University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores., conditionsModule conditions: Enlarged Pores, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Microneedle patch, interventions name: Intradermal injection, outcomesModule primaryOutcomes measure: Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dhurakij Pundit University, city: Lak Si, state: Bangkok, country: Thailand, geoPoint lat: 13.88724, lon: 100.5792, hasResults: False |
protocolSection identificationModule nctId: NCT06293742, orgStudyIdInfo id: EC0007, briefTitle: ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2024-04-19, completionDateStruct date: 2024-04-19, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Eccogene, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants., conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: ECC5004, interventions name: Midazolam, interventions name: Rosuvastatin, interventions name: Digoxin, interventions name: Atorvastatin, outcomesModule primaryOutcomes measure: Atorvastatin PK parameters: AUC(0-tlast), primaryOutcomes measure: Atorvastatin PK parameters: AUC(0-inf), primaryOutcomes measure: Atorvastatin PK parameters: Cmax, primaryOutcomes measure: Rosuvastatin PK parameters: AUC(0-tlast), primaryOutcomes measure: Rosuvastatin PK parameters: AUC(0-inf), primaryOutcomes measure: Rosuvastatin PK parameters: Cmax, primaryOutcomes measure: Digoxin PK parameters: AUC(0-tlast), primaryOutcomes measure: Digoxin PK parameters: AUC(0-inf), primaryOutcomes measure: Digoxin PK parameters: Cmax, primaryOutcomes measure: Midazolam PK parameters: AUC(0-tlast), primaryOutcomes measure: Midazolam PK parameters: AUC(0-inf), primaryOutcomes measure: Midazolam PK parameters: Cmax, secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG), secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Digoxin safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: Digoxin safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: Digoxin safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: Digoxin safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Midazolam safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: Midazolam safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: Midazolam safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: Midazolam safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: ECC5004 PK parameters: AUC (0-τ), secondaryOutcomes measure: ECC5004 PK parameters: AUC(0-24), secondaryOutcomes measure: ECC5004 PK parameters: tmax, secondaryOutcomes measure: ECC5004 PK parameters: t1/2, secondaryOutcomes measure: ECC5004 PK parameters: CL/F, secondaryOutcomes measure: ECC5004 PK parameters: Ctau, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eccogene Investigational Site, status: RECRUITING, city: Anaheim, state: California, zip: 92801, country: United States, contacts name: Eccogene, role: CONTACT, geoPoint lat: 33.83529, lon: -117.9145, hasResults: False |
protocolSection identificationModule nctId: NCT06293729, orgStudyIdInfo id: NGGT006-P-2302, briefTitle: Safety and Efficacy Study of NGGT006 in Refractory Hypercholesterolemia Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Suzhou Municipal Hospital, class: OTHER, descriptionModule briefSummary: This is an early phase 1, open-label, single-center, dose-escalation pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in patients with refractory Hypercholesterolemia diagnosed by gene testing for familial hypercholesterolemia. NGGT006 uses adeno-associated virus (AAV) as a vector, carrying a liver specific promoter and codon optimized human LDLR gene, driving the expression of LDLR protein with normal function and promoting the clearance of low-density lipoprotein cholesterol (LDL-C)., conditionsModule conditions: Refractory Hypercholesterolemia, conditions: Familial Hypercholesterolemia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: NGGT006, outcomesModule primaryOutcomes measure: Incidence of treatment-related adverse events (AE) and serious adverse events (SAE), primaryOutcomes measure: Absolute change and percent change in LDL-C, secondaryOutcomes measure: Absolute change and percent change in non-high density lipoprotein cholesterol, secondaryOutcomes measure: Absolute change and percent change in apolipoprotein B, secondaryOutcomes measure: Absolute change and percent change in total cholesterol, secondaryOutcomes measure: Absolute change and percent change in HDL-C, secondaryOutcomes measure: Absolute change and percent change in triglycerides, secondaryOutcomes measure: Absolute change and percent change in very low-density lipoprotein cholesterol, secondaryOutcomes measure: Absolute change and percent change in lipoprotein(a), secondaryOutcomes measure: Absolute change and percent change in apolipoprotein A-I, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293716, orgStudyIdInfo id: CVL237-A2001, briefTitle: CVL237 Tablets for APDS/PASLI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-12-29, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Convalife (Shanghai) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study was designed to evaluate the efficacy and safety of CVL237 tablets in patients with APDS/PASLI (activated phosphoinositol 3-kinase δ syndrome /p110 delta-activated mutation leading to senescent T cells, lymphadenopathy, and immune deficiency)., conditionsModule conditions: PI3K and P110delta Hyperactivation Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: CVL237 tablets for APDS/PASLI (Activated phosphoinositol 3-kinase delta syndrome /p110 delta-activated Mutation leading to senescent T cells, lymphadenopathy, and immune deficiency), primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Part II is a randomized, double-blind, placebo-controlled study of approximately 30 patients with APDS/PASLI. On day 1, patients were randomly assigned to the trial and placebo groups in a 2:1 ratio to take an oral CVL237 tablet or a placebo CVL237 simulant once daily. Efficacy and safety were evaluated on days 29, 57, and 85. The efficacy of CVL237 tablets in reducing lymphadyopathy will be investigated as measured by changes in the sum of diameter products (SPD) of target lesions selected from MRI or CT imaging according to the Lugano 2014 method, as well as changes in the percentage of naive B cells to total B cells, relative to baseline. The CVL237 tablets will also be evaluated for safety, PK, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: CVL237 tablets, interventions name: CVL237 placebo tablets, outcomesModule primaryOutcomes measure: part 1 : Incidence of Treatment-Emergent Adverse Events, primaryOutcomes measure: part 2:After 84 days of treatment, changes in the sum of diameter product (SPD) of log10 conversion in target lesions and changes in the percentage of naive B cells to total B cells from baseline were observed, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: AUC, secondaryOutcomes measure: Tmax, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Public Health Clinical Center, city: Shanghai, state: Shanghai, zip: 201508, country: China, contacts name: Yun Ling, ph.D, role: CONTACT, phone: 18121157875, email: [email protected], contacts name: Ying Lv, role: CONTACT, phone: 18916099680, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06293703, orgStudyIdInfo id: 23-1228, briefTitle: Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study), acronym: CLIMB II, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-12, primaryCompletionDateStruct date: 2025-12-11, completionDateStruct date: 2030-12-11, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Salvador Navarrete, class: OTHER, descriptionModule briefSummary: The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics., conditionsModule conditions: Morbid Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will be a prospective, randomized controlled trial with a 1:1 recruitment allocation ratio coordinated at the Cleveland Clinic Foundation (CCF), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 262, type: ESTIMATED, armsInterventionsModule interventions name: Surgery, outcomesModule primaryOutcomes measure: To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients, secondaryOutcomes measure: To compare rates of DM resolution between aRYGB Vs sRYGB by DM subgroup analysis, secondaryOutcomes measure: To investigate postoperative efficacy rates of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity, secondaryOutcomes measure: To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Salvador Navarrete, MD, role: CONTACT, phone: 216-219-9211, email: [email protected], geoPoint lat: 41.4995, lon: -81.69541, hasResults: False |
protocolSection identificationModule nctId: NCT06293690, orgStudyIdInfo id: L23-407, briefTitle: Toripalimab Combined With SBRT for NSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Shanghai Pulmonary Hospital, Shanghai, China, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the efficacy and safety of Toripalimab injection (js001) combined with SBRT radiotherapy and neoadjuvant therapy with or without chemotherapy for operable or potentially operable stage IIa to IIIb NSCLC, conditionsModule conditions: Non-small Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Toripalimab, interventions name: Toripalimab, outcomesModule primaryOutcomes measure: Major pathological remission rate, secondaryOutcomes measure: Complete pathological remission rate, secondaryOutcomes measure: disease-free survival（DFS）, secondaryOutcomes measure: overall survival, otherOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Pulmonary Hospital, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Deping Zhao, role: CONTACT, phone: 0086-20-65115006, email: [email protected], contacts name: Deping Zhao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06293677, orgStudyIdInfo id: 2023-01013, briefTitle: Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance, acronym: DAR-ARC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Vaudois, class: OTHER, collaborators name: Unisanté Centre universitaire de médecine générale et santé publique, collaborators name: FORCE Fondation Recherche sur le Cancer de l'Enfant, descriptionModule briefSummary: This clinical trial focuses on children with cancer who face infections after receiving chemotherapy. Chemotherapy affects the bone marrow, leading to a decrease in the production of certain white blood cells, particularly those that defend against bacterial infections (neutrophils). One significant concern is febrile neutropenia, where children experience a fever during a period of low white blood cell count. This condition often results from bacterial infections, necessitating prompt wide-spectrum antibiotic treatment. However, some children eliminate antibiotics in the urine too quickly during febrile neutropenia. Their kidneys function more than they normally do (renal hyperfiltration). This can lead to insufficient exposure to antibiotics to control the infection. The current standard antibiotic regimens do not account for this variable elimination rate. In this study we focus on two antibiotics used in this context: piperacillin-tazobactam and meropenem.The main questions this study aims to answer are, in these children:* Would higher doses of antibiotics result in better blood levels of antibiotics?* Would they have more sides effects with higher antibiotics dosages?* Would they recover more quickly with higher antibiotic doses? All patients will undergo a blood test upon hospital arrival, including an assessment of renal function. If renal function is normal or diminished, the patient will receive the standard antibiotic dose. Children with increased renal function will be randomly assigned to two groups during each episode of febrile neutropenia. One group will receive standard antibiotic dosages, while the other will receive higher doses to compensate for renal hyperfiltration. Throughout the study, antibiotic levels in the blood will be monitored for all patients. This monitoring will determine if target concentrations can be achieved more quickly with experimental dosages and will allow doctors to readjust the doses if needed., conditionsModule conditions: Febrile Neutropenia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Our study is an open-label, re-randomized controlled trial in multi-episodes settings. So the care team, researchers and patients will be informed of the allocation group. Patients will be able to participate in each episode of febrile neutropenia. At each inclusion the patient may be in a different group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem, interventions name: Standard dosages of piperacillin-tazobactam or meropenem, outcomesModule primaryOutcomes measure: Achievement of antibiotic concentration targets in the intervention group (1i) vs control groupe (1c), secondaryOutcomes measure: Achievement of antibiotic concentration targets in control group 2, secondaryOutcomes measure: Fever duration, secondaryOutcomes measure: Side effects of antibiotic therapy, secondaryOutcomes measure: Number of dosage adjustments required to achieve the target concentration, secondaryOutcomes measure: Difference between eGFR measured by creatinine-based Schwartz formula and other eGFR calculation formulas, eligibilityModule sex: ALL, minimumAge: 61 Days, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Centre Hospitelier Universitaire Vaudois (CHUV), city: Lausanne, state: Vaud, zip: 1011, country: Switzerland, contacts name: Margherita Plebani, role: CONTACT, phone: +41795563598, email: [email protected], contacts name: Pierre-Alex Crisinel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.516, lon: 6.63282, hasResults: False |
protocolSection identificationModule nctId: NCT06293664, orgStudyIdInfo id: RAHM-2023-006, briefTitle: Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes, acronym: α-MSH & T2DM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-04-04, completionDateStruct date: 2024-04-04, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Dasman Diabetes Institute, class: OTHER, descriptionModule briefSummary: Alpha-melanocyte stimulatory hormone (α-MSH) is a melanocyte-stimulating hormone produced by the hypothalamus and released from the pituitary gland. It acts as an agonist to the melanocortin 5 receptor (MC5R) in human skeletal muscle, playing a role in glucose uptake and disposal. This study aims to investigate whether α-MSH can enhance glucose tolerance in patients with Type 2 Diabetes Mellitus (T2DM)., conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The research involves a double-blinded, randomized, placebo-controlled crossover study to assess the therapeutic potential of α-MSH infusion in T2DM patients., primaryPurpose: SCREENING, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 13, type: ESTIMATED, armsInterventionsModule interventions name: α-MSH infusion, interventions name: Placebo solutions, outcomesModule primaryOutcomes measure: Difference in the total or incremental area under the curve of glucose and insulin concentration at an OGTT during saline vs. α-MSH infusion, secondaryOutcomes measure: Difference in the total or incremental area under the curve of the concentration of metabolites (C-peptide, Glucagon, Gut hormones, α-MSH) during OGTT with saline or α-MSH infusion., otherOutcomes measure: Difference in energy intake measured by an ad libitum meal test at the saline vs. α-MSH infusion, otherOutcomes measure: Adverse events (including flushing), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dasman Diabetes Institute, status: RECRUITING, city: Kuwait City, country: Kuwait, contacts name: Ebaa Al Ozairi, MD, role: CONTACT, contacts name: Dalal Alsaeed, PhD, role: CONTACT, contacts name: Carel Roux, MD, role: SUB_INVESTIGATOR, geoPoint lat: 29.36972, lon: 47.97833, hasResults: False |
protocolSection identificationModule nctId: NCT06293651, orgStudyIdInfo id: DA4505_AMST_I/IIa, briefTitle: Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2030-04, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Dong-A ST Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors., conditionsModule conditions: Locally Advanced or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: DA-4505, interventions name: DA-4505 + Pembrolizumab, outcomesModule primaryOutcomes measure: Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria, primaryOutcomes measure: PK parameters for DA-4505 (Peak Plasma Concentration (Cmax)), primaryOutcomes measure: PK parameters for DA-4505 (Area Under the Curve (AUC)), primaryOutcomes measure: PK parameters for DA-4505 (half-life (t1/2)), primaryOutcomes measure: Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06293638, orgStudyIdInfo id: 23-1125, briefTitle: Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor, acronym: TRaNCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to collect electrophysiological data related to functional brain network changes in patients undergoing deep brain stimulation for the treatment of essential tremor. Participants will be asked to remain seated with their head inside of a Magnetoencephalography (MEG) recording system as resting-state and task-related data are acquired. Spontaneous electrophysiological activity will be recorded in both the eyes open and eyes closed conditions with the participant seated comfortably. These recordings will be repeated in the DBS OFF and DBS ON states, with the ON state involving specific settings identified as optimal, sub-optimal, or ineffective at achieving tremor control. They will also be repeated following the optional administration non-DBS tremor mitigation techniques, which may include one or more of 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation., conditionsModule conditions: Essential Tremor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Alcohol, interventions name: Alprazolam, interventions name: Cold Therapy, interventions name: Peripheral Nerve Stimulation, outcomesModule primaryOutcomes measure: CTCM Coherence, primaryOutcomes measure: Power of oscillatory activity across the CTCM network in response to tremor interventions, secondaryOutcomes measure: Essential tremor severity: Tremor Research Group Essential Tremor Rating Scale (TETRAS), secondaryOutcomes measure: Essential tremor severity: Grip force, secondaryOutcomes measure: Essential tremor severity: Limb acceleration, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Jeff Negrey, MA, role: CONTACT, phone: 216-636-5504, email: [email protected], contacts name: James Liao, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ken baker, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False |
protocolSection identificationModule nctId: NCT06293625, orgStudyIdInfo id: LEPAGE PHRCK 2022-2, briefTitle: Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced But Resecable Colon Cancer in the Elderly of 70 Years Old or More, acronym: FOxTROT2France, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2032-03, completionDateStruct date: 2032-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Dijon, class: OTHER, descriptionModule briefSummary: Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp).Almost all of these patients undergo surgery, but many do not receive AC due to frailty (following surgery). This particularly affects patients over 70, who represent the majority of patients diagnosed with CC.FOxTROT 2, a trial to test the role of NAC in older patients., conditionsModule conditions: Colon Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Folfox, interventions name: Surgery, outcomesModule primaryOutcomes measure: DFS (disease Free Survival), eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Dijon Bourgogne, city: Dijon, zip: 21000, country: France, contacts name: Côme LEPAGE, role: CONTACT, email: [email protected], geoPoint lat: 47.31667, lon: 5.01667, hasResults: False |
protocolSection identificationModule nctId: NCT06293612, orgStudyIdInfo id: 22/449-3651, secondaryIdInfos id: 2022-I2M-C&T-B-077, type: OTHER_GRANT, domain: CAMS Innovation Fund for Medical Sciences (CIFMS), secondaryIdInfos id: 7244398, type: OTHER_GRANT, domain: Youth program of Beijing Natural Science Foundation, secondaryIdInfos id: Beijing Hope Run Special Fund, type: OTHER_GRANT, domain: LC2021A12, briefTitle: Constructing a Multimodal Imaging System to Predict the Risk of Heterochronous Metastasis of Rectal Cancer, acronym: MIS-MRC, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2018-12-31, completionDateStruct date: 2022-11-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to construct a multimodal intelligent model to predict the risk of heterochronous metastasis of rectal cancer, which is helpful for individualized diagnosis and treatment and follow-up planning. The main questions it aims to answer are:* what are the independent risk factors of distant metastasis (DM) in locally advanced rectal cancer (LARC)* What is the influence weight of the above factors on the heterochronous metastasis of LARC, and how to build a risk-prediction modelThis study will not affect or interfere with the routine medical diagnosis and treatment of participants, and will not increase the cost and risk of participants. Participant's information is protected and identified by a unique code., conditionsModule conditions: Locally Advanced Rectal Cancer, conditions: Distant Metastasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 302, type: ACTUAL, armsInterventionsModule interventions name: No intervention was administrated to the two cohorts., outcomesModule primaryOutcomes measure: Heterochronous distant metastasis, secondaryOutcomes measure: Distant metastasis-free survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, city: Beijing, zip: 100021, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06293599, orgStudyIdInfo id: P.T.REC/012/003131, briefTitle: Effect of Scapular Stabilization Exercises Versus Virtual Reality Exercises in Basketball Players With Scapular Dyskinesia, acronym: SD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: this study will be conducted to compare virtual reality and scapular stabilizing exercise among basketball player with scapular dyskinesia on scapular muscle performance, rounded shoulder, pain intensity, disability and hand grip strength, conditionsModule conditions: Scapular Dyskinesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: scapular stabilization and virtual reality exercise, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: opaque sealed envelope, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: scapular stabilization exercises, interventions name: virtual reality exercises, interventions name: regular routine exercises, outcomesModule primaryOutcomes measure: agonist antagonist ratio, secondaryOutcomes measure: Hand grip strength, secondaryOutcomes measure: rounded shoulder posture, secondaryOutcomes measure: pain intensity level, secondaryOutcomes measure: The disabilities of the arm, shoulder and hand, secondaryOutcomes measure: peak force, secondaryOutcomes measure: total work, secondaryOutcomes measure: work fatigue, secondaryOutcomes measure: average power, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 25 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06293586, orgStudyIdInfo id: MD-11-2022, briefTitle: Comparison Between Peribulbar And Sub-tenon Blocks on Oculocardiac Reflex (OCR) During Pediatric Strabismus Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare between peribulbar block and subtenon block as an adjunct to general anesthesia in children undergoing strabismus surgery on oculocardiac reflex (OCR), post-operative analgesia and postoperative vomiting. Both techniques will be compared to intra-operative intravenous (IV) paracetamol combined with general anesthesia as a sole anesthetic technique., conditionsModule conditions: Anesthesia, Local, conditions: Ophthalmopathy, conditions: Strabismus, conditions: Pediatric ALL, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: peribulbar block, interventions name: sub-tenon block, interventions name: Paracetamol, outcomesModule primaryOutcomes measure: The incidence of intraoperative oculocardiac reflex (OCR), secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: heart rate, otherOutcomes measure: Post-operative pain using the MOPS, otherOutcomes measure: Post-operative analgesia requirements, otherOutcomes measure: The incidence of POV using numeric scoring, otherOutcomes measure: Complications resulting from orbital regional anesthesia were recorded, otherOutcomes measure: Total intraoperative atropine requirements, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cairo University faculty of medicine, status: RECRUITING, city: Cairo, zip: 11559, country: Egypt, contacts name: Essam Nossair, Masters degree, role: CONTACT, phone: 0201002014809, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06293573, orgStudyIdInfo id: 012/005031, briefTitle: Whole- Body Vibration Among Egyptian Elderly With Sarcopenia, acronym: WBV, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-11-29, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: To investigate and compare between the effectiveness of whole body vibration and aerobic training exercises in management of sarcopenia, muscle mass, physical performance and muscle strength in elderly., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants will be assigned randomly into three groups of equal number (study group A, study group B, and group C) the randomization will be performed by computerized randomization. Assessors will be blinded to the groups of the subjects., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Whole-body vibration, interventions name: aerobic exercises, interventions name: resistance exercises, outcomesModule primaryOutcomes measure: Muscle Mass, primaryOutcomes measure: muscle strength, primaryOutcomes measure: timed Up and Go Test (TUG), primaryOutcomes measure: Gait Speed test, primaryOutcomes measure: 400 m Walking Test, primaryOutcomes measure: Six minute walk test (6MWT), eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, city: Dokki, state: Giza, zip: 12612, country: Egypt, geoPoint lat: 30.03823, lon: 31.2113, hasResults: False |
protocolSection identificationModule nctId: NCT06293560, orgStudyIdInfo id: H-49046, secondaryIdInfos id: 5U01EY032403-03, type: NIH, link: https://reporter.nih.gov/quickSearch/5U01EY032403-03, briefTitle: Microphthalmia, Anophthalmia, and Coloboma Genetic Epidemiology in Children, acronym: MAGIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-25, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Baylor College of Medicine, class: OTHER, collaborators name: National Eye Institute (NEI), collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: The investigators are inviting families to take part in a research study that will help us better understand the physical characteristics associated with children who have Microphthalmia, Anophthalmia, and Coloboma (MAC) and how changes in their DNA sequence, called genetic mutations, play a role in the risk of developing MAC, conditionsModule conditions: Microphthalmia, conditions: Coloboma, conditions: Anophthalmia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Stage 1, primaryOutcomes measure: Stage 2, primaryOutcomes measure: Stage 3, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baylor College of Medicine, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: EpiCenter, role: CONTACT, phone: 713-798-2920, email: [email protected], contacts name: Philip Lupo, PhD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06293547, orgStudyIdInfo id: DIS-2022-295, briefTitle: Clinical Effectiveness and Parental Acceptance of Silver Diamine Fluoride in Preschool Children: A Non-randomized Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-10, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cumhuriyet University, class: OTHER, descriptionModule briefSummary: Silver diamine fluoride (SDF) is a topical fluoride agent that has emerged in recent years and has a strong potential to arrest dentinal caries in early childhood caries. SDF has been developed as an effective non-invasive treatment method, especially in the non-cooperative preschool group, with its advantages such as easy application, low cost, and limited technical difficulties. The aims of this study were as follow: (a) to evaluate the efficacy of 38% GDF in arresting active dental caries lesions and reducing or preventing associated dental pain and infections in at-risk young children; and (b) how SDF treatment is perceived and acceptable by parents. The null hypothesis of the study was that 38% SDF treatment will be effective in arresting active dental caries lesions and reducing the incidence of pain and infection in young children, and is well-accepted by parents. The study group of this clinical research will consist of pediatric patients and their parents who were selected by easily accessible case sampling method and applied to Sivas Cumhuriyet University Faculty of Dentistry Pediatric Dentistry clinic. The working group will consist of a total of 48 children and their parents who meet the inclusion criteria. Parents will also be briefed on the GDF, follow-up instructions, oral hygiene instructions, and dietary education. After a baseline examination including radiographs taken during a standard dental examination, 38% GDF will be applied to carious lesions detected in primary teeth. Carious lesions will be treated with 38% SDF application once or twice. Children will be reassessed at 3-week, 3-month and 6-month follow-up sessions to assess color and structural changes in carious lesions (soft/hard). Parents will be asked to answer a questionnaire including questions about pain or infection symptoms and their views on SDF treatment., conditionsModule conditions: Silver Diamine Fluoride, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study group of this non-randomized, prospective, single-arm clinical research consisted of pediatric patients and their parents who presented to the Department of Pediatric Dentistry, Faculty of Dentistry, Cumhuriyet University, selected using convenient sampling method. For determining the sample size in this study, assuming a 5% alpha error, 80% power, and a cessation rate (35.7%) from a previous study, it was calculated that at least 40 participants should be included. Considering potential patient loss/follow-up, the study group was increased by 20%, resulting in a final decision to include 48 children and their parents in the study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Silver Diamine Fluoride, outcomesModule primaryOutcomes measure: Clinical Assessment of Arrested Caries Lesions, secondaryOutcomes measure: Parental acceptance of SDF treatment, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sivas Cumhuriyet University, city: Sivas, state: Merkez, country: Turkey, geoPoint lat: 39.74833, lon: 37.01611, hasResults: False |
protocolSection identificationModule nctId: NCT06293534, orgStudyIdInfo id: PsychThyroid, briefTitle: Thyroid Dysfunction in Patients With Major Psychiatric Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital, conditionsModule conditions: Thyroid Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 173, type: ESTIMATED, armsInterventionsModule interventions name: TSH,T3,T4, outcomesModule primaryOutcomes measure: the level of thyroid hormones among psychiatric patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293521, orgStudyIdInfo id: 06091995, briefTitle: Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-16, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits, conditionsModule conditions: Deep Caries, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Pulpotomy, interventions name: Partial Pulpectomy, outcomesModule primaryOutcomes measure: Radiographic assessment, secondaryOutcomes measure: Clinical effectiveness, secondaryOutcomes measure: Child cooperation, secondaryOutcomes measure: Time elapsed till final restoration performed, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cairo University, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06293508, orgStudyIdInfo id: NMRR ID-22-02616-I2I, briefTitle: mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public, acronym: mBLISS-B, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Clinical Research Centre, Malaysia, class: OTHER, collaborators name: Ministry of Health, Malaysia, collaborators name: National University of Malaysia, collaborators name: Institute for Health Behavioral Research, Malaysia, descriptionModule briefSummary: Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy and potentially effective at motivating breast cancer screening among the public. Such studies are scarce in the South East Asian region, particularly in Malaysia, which is the prime motivation for the current study,Based on this promising prospect, we designed a randomized controlled trial to study the effects of applying persuasive health communication materials to initiate behavior change among a group of Malaysian women. Materials are delivered in the form of a health communication program over a social messaging application to promote breast cancer screening practices, which is either a clinical breast examination, or a mammogram. We hypothesize that Malaysian women who are exposed to such materials that are designed based on behavior science and behavior change principles will be nudged and hence more likely to attend breast cancer screening compared to a control group., conditionsModule conditions: Breast Neoplasm Female, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1180, type: ESTIMATED, armsInterventionsModule interventions name: Standard Health Communication Intervention, interventions name: Behavioural Change Health Communication Intervention, outcomesModule primaryOutcomes measure: Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram)., secondaryOutcomes measure: Health literacy level, secondaryOutcomes measure: Perception based on domains in Health Belief Model, secondaryOutcomes measure: Perceived acceptance and usefulness of health communication program, secondaryOutcomes measure: Reasons behind participants not participating in breast cancer screening., eligibilityModule sex: FEMALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Clinical Research, National Institutes of Health, Malaysia, city: Shah Alam, state: Selangor, zip: 40170, country: Malaysia, contacts name: Nicholas Yee Liang Hing, MSc, role: CONTACT, email: [email protected], geoPoint lat: 3.08507, lon: 101.53281, hasResults: False |
protocolSection identificationModule nctId: NCT06293495, orgStudyIdInfo id: CUT-OUT, briefTitle: Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Puerta de Hierro University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out).Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate., conditionsModule conditions: Proximal Femoral Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, prospective trial with a CE-marked medical devices, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Gamma 3 Nail (Stryker), interventions name: Chimaera Nail (Orthofix), outcomesModule primaryOutcomes measure: Incidence of cut-out., secondaryOutcomes measure: Functional Ambulatory Categories (FAC), secondaryOutcomes measure: Tip-apex distance, secondaryOutcomes measure: Parker index, secondaryOutcomes measure: Baumgaertner reduction quality criteria, secondaryOutcomes measure: Number of Surgical complications (Intraoperative), secondaryOutcomes measure: Number of Surgical complications (post-operative), eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Puerta de Hierro Majadahonda, city: Majadahonda, state: Madrid, zip: 28222, country: Spain, geoPoint lat: 40.47353, lon: -3.87182, hasResults: False |
protocolSection identificationModule nctId: NCT06293482, orgStudyIdInfo id: CAM5850, briefTitle: Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population, acronym: ACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cochlear, class: INDUSTRY, collaborators name: NAMSA, collaborators name: LWB Consulting, descriptionModule briefSummary: This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits., conditionsModule conditions: Hearing Loss, Sensorineural, conditions: Hearing Loss, Bilateral, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cochlear™ Nucleus® System, outcomesModule primaryOutcomes measure: Number of device and procedure-related adverse events and serious adverse events, primaryOutcomes measure: Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted, primaryOutcomes measure: Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition, secondaryOutcomes measure: Number of device and procedure related adverse events and serious adverse events, secondaryOutcomes measure: Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline, secondaryOutcomes measure: Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement, secondaryOutcomes measure: Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted, secondaryOutcomes measure: Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition, secondaryOutcomes measure: Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition, secondaryOutcomes measure: Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barrow Neurological Institute, city: Phoenix, state: Arizona, zip: 85013, country: United States, contacts name: Shawn Stevens, role: CONTACT, email: [email protected], geoPoint lat: 33.44838, lon: -112.07404, locations facility: University of Miami, city: Coral Gables, state: Florida, zip: 33146, country: United States, contacts name: Meredith Holcomb, role: CONTACT, email: [email protected], geoPoint lat: 25.72149, lon: -80.26838, locations facility: Midwest Ear Institute, city: Kansas City, state: Missouri, zip: 64111, country: United States, contacts name: Sarah Zlomke, role: CONTACT, email: [email protected], geoPoint lat: 39.09973, lon: -94.57857, locations facility: New York University, city: New York, state: New York, zip: 10016, country: United States, contacts name: William Shapiro, role: CONTACT, email: [email protected], geoPoint lat: 40.71427, lon: -74.00597, locations facility: Cleveland Clinic, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Sarah Sydlowski, role: CONTACT, email: [email protected], geoPoint lat: 41.4995, lon: -81.69541, locations facility: University of Pennsylvania Hospitals, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Tiffany Hwa, role: CONTACT, email: [email protected], geoPoint lat: 39.95233, lon: -75.16379, locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23219, country: United States, contacts name: Daniel Coelho, role: CONTACT, email: [email protected], geoPoint lat: 37.55376, lon: -77.46026, locations facility: Virginia Mason, city: Seattle, state: Washington, zip: 98101, country: United States, contacts name: Daniel Zeitler, role: CONTACT, email: [email protected], geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06293469, orgStudyIdInfo id: IRB00434587, briefTitle: Accelerated Flap Coverage in Severe Lower Extremity Trauma, acronym: FLAP ATTACK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-05, completionDateStruct date: 2029-11, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: McMaster University, collaborators name: University of Maryland, Baltimore, collaborators name: Orthopaedic Trauma Association, collaborators name: Foundation of Orthopedic Trauma, descriptionModule briefSummary: The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility)., conditionsModule conditions: Open Tibia Fracture, conditions: Open Dislocation of Ankle, conditions: Extremity Fracture Lower, conditions: Extremity Injuries Lower, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 356, type: ESTIMATED, armsInterventionsModule interventions name: Accelerated Flap Coverage Surgery, interventions name: Standard of Care Flap Timing, outcomesModule primaryOutcomes measure: Clinical status, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Amputation, secondaryOutcomes measure: Unplanned re-operation, secondaryOutcomes measure: Number of days in hospital, secondaryOutcomes measure: Quality of life as assessed by the Limb-Q, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293456, orgStudyIdInfo id: 23-360, briefTitle: Study of Poetic Dignity Therapy for Sexual and Gender Minority Patients at End of Life, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to find out if dignity therapy is practical and works well for sexual and gender (SGM) patients in hospice care. SGM includes, but is not limited to, people who identify as lesbian, gay, bisexual, transgender, and/or queer/questioning (LGBTQ+). Dignity therapy is a type of psychotherapy where the clinician asks the patient questions to allow the patient to express their individual life story and ultimately be able to create a legacy document of their experiences that can be shared with their loved ones., conditionsModule conditions: End of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Dignity Therapy, outcomesModule primaryOutcomes measure: the number of patients who complete the intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering Cancer Center, city: New York, state: New York, zip: 10065, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06293443, orgStudyIdInfo id: IMU-OP-TT-01, briefTitle: Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests., conditionsModule conditions: Amputation, conditions: Amputation; Traumatic, Leg, Lower, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: participants underwent functional testing at clinical centers, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Lower extremity unilateral amputee, outcomesModule primaryOutcomes measure: Amputee Mobility Scale, secondaryOutcomes measure: One Leg Standing Test, secondaryOutcomes measure: Houghton Scale, secondaryOutcomes measure: 8-Shape Walking Test, secondaryOutcomes measure: joint range of motion, secondaryOutcomes measure: proprioception, secondaryOutcomes measure: l test, secondaryOutcomes measure: 10 Meter Walking Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Medıpol University, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Medipol University, role: CONTACT, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06293430, orgStudyIdInfo id: P002, briefTitle: Registry on Luma Vision's VERAFEYE System (ENLIgHT), acronym: ENLIgHT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: LUMA Vision Ltd., class: INDUSTRY, descriptionModule briefSummary: The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.Results from this study will be used to guide development of the VERAFEYE System., conditionsModule conditions: Atrial Fibrillation, conditions: Left Atrial Appendage Closure, conditions: Atrial Arrhythmia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: VERAFEYE System, outcomesModule primaryOutcomes measure: Clinical Success of procedure, primaryOutcomes measure: Procedural Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293417, orgStudyIdInfo id: HT-EF-01, briefTitle: To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM, acronym: ENSEMBLE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Korea University Anam Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:* major adverse cardiovascular events within 48 months of the trial duration* microvascular events within 48 months of the trial duration, conditionsModule conditions: T2DM (Type 2 Diabetes Mellitus), conditions: Dyslipidemias, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3958, type: ESTIMATED, armsInterventionsModule interventions name: Statin and Ezefeno, interventions name: Statin doubling, outcomesModule primaryOutcomes measure: major adverse cardiovascular events and diabetic microvascular events for 48 months, secondaryOutcomes measure: proportion of patients achieving Non-HDL-C less than 100mg/dL, secondaryOutcomes measure: proportion of patients achieving LDL less than 70mg/dL, secondaryOutcomes measure: change in Non-HDL-C at 48month from baseline, secondaryOutcomes measure: change in LDL at 48month from baseline, secondaryOutcomes measure: change in HDL-C at 48month from baseline, secondaryOutcomes measure: change in TG at 48month from baseline, secondaryOutcomes measure: change in LDL-C/HDL-C ratio at 48month from baseline, secondaryOutcomes measure: change in TC/HDL-C ratio at 48month from baseline, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Korea University Anam Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06293404, orgStudyIdInfo id: column flexion, secondaryIdInfos id: AnkaraCHBilkent, type: OTHER, domain: AnkaraCHBilkent, briefTitle: The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: The effect of two different positions on spinal anesthesia in hip fracture surgery, conditionsModule conditions: Hip Fractures, conditions: Spinal Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacain, outcomesModule primaryOutcomes measure: Hemodynamic change, primaryOutcomes measure: Hemodynamic change, primaryOutcomes measure: Hemodynamic change, primaryOutcomes measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position., primaryOutcomes measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position., primaryOutcomes measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position., secondaryOutcomes measure: To compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of bupivacaine 7.5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral lower, otherOutcomes measure: To compare the efficacy of bupivacaine 7.5 mg/ml in the duration of sensory block at dermatome T10 level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293391, orgStudyIdInfo id: 2022-11/2097, briefTitle: The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-03-01, completionDateStruct date: 2024-02-05, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Esophageal Doppler Monitoring (Deltex CardioQ Esophageal Doppler Monitor, ODM) is used to manage patients' fluid therapy by non-invasively measuring continuous cardiac output with an esophageal probe. The aim of this study was to compare the effects of patient position changes on cardiac indices and vital signs in patients who underwent major abdominal cancer surgery with laparoscopic and open surgery using ODM., conditionsModule conditions: Abdominal Cancer, conditions: Blood Pressure, conditions: Cardiac Indices, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: cardiac indices in supine and trendelenburg position, outcomesModule primaryOutcomes measure: Cardiac Output, primaryOutcomes measure: Stroke Volume, primaryOutcomes measure: Flow time corrected, primaryOutcomes measure: Peak Velocity, primaryOutcomes measure: Stroke Distance, primaryOutcomes measure: Mean arterial pressure, primaryOutcomes measure: Pulse, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital, city: Ankara, zip: 06200, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06293378, orgStudyIdInfo id: Pengmingli, briefTitle: Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2028-10-10, completionDateStruct date: 2028-11-10, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Chongqing Medical University, class: OTHER, descriptionModule briefSummary: This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, changes in fecal flora and metabolites before and after the use of sulfasalazine were observed., conditionsModule conditions: Cirrhosis, Liver, conditions: Fibrosis, Liver, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Sulfasalazine enteric-coated tablets, outcomesModule primaryOutcomes measure: Serum alkaline phosphatase (ALP), primaryOutcomes measure: Serum γ-glutamyl transpeptidase (GGT), primaryOutcomes measure: Serum bilirubin, primaryOutcomes measure: Serum bile acids, primaryOutcomes measure: Serum aspartate aminotransferase(AST), primaryOutcomes measure: Serum alanine aminotransferase (ALT), secondaryOutcomes measure: Hepatic fibrosis and the improvement of microbial metabolites, otherOutcomes measure: Changes in immune cells, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chongqing Medical University, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400000, country: China, contacts name: Mingli Peng, Doctor, role: CONTACT, phone: +8613512362906, email: [email protected], contacts name: Yinghua Lan, Doctor, role: CONTACT, phone: +8613796050629, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Chongqing, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400000, country: China, contacts name: Mingli Peng, Doctor, role: CONTACT, phone: 13512362906, email: [email protected], contacts name: Yinghua Lan, Doctor, role: CONTACT, phone: +8613796050629, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False |
protocolSection identificationModule nctId: NCT06293365, orgStudyIdInfo id: CVAY736A2202, secondaryIdInfos id: 2023-508996-35, type: EUDRACT_NUMBER, briefTitle: Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-26, primaryCompletionDateStruct date: 2025-07-29, completionDateStruct date: 2029-02-08, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS., conditionsModule conditions: Sjögrens Disease, conditions: Systemic Lupus Erythematosus, conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: VAY736 1ml PFS, interventions name: VAY736 2 ml PFS, interventions name: VAY736 2ml AI, outcomesModule primaryOutcomes measure: Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab, primaryOutcomes measure: Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab, primaryOutcomes measure: Cohort 2 (optional): Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab, primaryOutcomes measure: Cohort 2 (optional): Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab, secondaryOutcomes measure: Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab, secondaryOutcomes measure: Cohort 2 (optional): Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab, secondaryOutcomes measure: Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab, secondaryOutcomes measure: Cohort 2 (optional): Concentration at the end of a dosing interval (Ctrough) for ianalumab, secondaryOutcomes measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Anti-ianalumab antibodies (ADA), secondaryOutcomes measure: Incidence of ADA positive participants, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293352, orgStudyIdInfo id: STU00220012, briefTitle: Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in.There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in.We know that both the one- and two-stage revision work equally well to heal the infection, but we don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction., conditionsModule conditions: Prosthetic-joint Infection, conditions: Knee Infection, conditions: Arthroplasty Complications, conditions: Joint Infection, conditions: Arthroplasty, Replacement, Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 153, type: ESTIMATED, armsInterventionsModule interventions name: All-cement articulating spacer, interventions name: Durable, real-component articulating spacer, interventions name: Rigid Spacer, outcomesModule primaryOutcomes measure: 24 month Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: 6 week Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: 6 week 10-item PROMIS Global Health survey (PROMIS-10), secondaryOutcomes measure: 6 month Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: 6 month 10-item PROMIS Global Health survey (PROMIS-10), secondaryOutcomes measure: 12 month Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: 12 month 10-item PROMIS Global Health survey (PROMIS-10), secondaryOutcomes measure: 24 month 10-item PROMIS Global Health survey (PROMIS-10), otherOutcomes measure: Revision/reoperation for infection (defined by positive culture by MSIS criteria), otherOutcomes measure: revision for aseptic failure (defined by negative culture by MSIS criteria), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern Medicine, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Orthopaedic Surgery Research, role: CONTACT, phone: 312-695-0332, email: [email protected], contacts name: Adam I Edelstein, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kevin D Hardt, MD, role: SUB_INVESTIGATOR, contacts name: Linda I Suleiman, MD, role: SUB_INVESTIGATOR, contacts name: David W Manning, MD, role: SUB_INVESTIGATOR, contacts name: William C Thomas, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06293339, orgStudyIdInfo id: CoGA-Re, briefTitle: Durability of Protection After Single Immunisation With GA2 Sporozoites (CoGA-Rechallenge), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, descriptionModule briefSummary: This study will assess the durability of protection of a single immunisation with the Genetically Attenuated Parasite 2 (GA2) against controlled human malaria infection by rechallenging previously immunised and protected participants from the CoGA study (NCT05468606), conditionsModule conditions: Malaria,Falciparum, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: CHMI with 3D7 malaria, outcomesModule primaryOutcomes measure: Protective efficacy, primaryOutcomes measure: Time to parasitaemia, secondaryOutcomes measure: Humoral immune responses after homologous CHMI rechallenge, secondaryOutcomes measure: Cellular immune responses after homologous CHMI rechallenge, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293326, orgStudyIdInfo id: 22553, briefTitle: A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2024-06-06, completionDateStruct date: 2024-06-06, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time. Heartburn is the burning sensation or pain in the chest which occurs when stomach acid rises up in the food pipe (esophagus).Calcium carbonate tablets are used to treat heartburn, indigestion, and related digestive problems. Calcium carbonate works by neutralizing the excess acid in the stomach. The study treatment is a new bi-layer calcium carbonate tablet that has two layers. One layer quickly releases calcium carbonate aimed to provide quick relief (called immediate release) while the other layer releases calcium carbonate slowly to make the relief last longer (called sustained release).In this study, bi-layer calcium carbonate tablets will be given to healthy men for the first time. This study will provide information on how the new bi-layer tablet works inside the body.The main purpose of this study is to learn about how the new bi-layer calcium carbonate tablet changes the average acidity levels (measured using pH) compared to the standard calcium carbonate tablet during the night-time.For this, researchers will measure the acidity levels in the upper part of the stomach at regular intervals during the night-time.The participants will be randomly (by chance) assigned to one of two treatment groups:Participants in the first group will take the treatments at night.Participants in the second group will take the treatments during the day.All participants in both groups will take 2 bi-layer tablets and 2 standard tablets after a meal with a gap of 6 to 8 days between treatments. However, in each group, half the participants will receive the bi-layer tablets first while the other half will receive the standard tablets first.Each participant will be in the study for around 52 days with up to 4 visits to the study site. This includes:1. visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study2. visits for treatment with a gap of 6-8 days between each treatment, and1 visit 7 to 14 days after the treatment ends during which the doctors will monitor the participants' health.During the study, the doctors and their study team will:check participants' overall health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)take images of the stomach at different times after taking the treatmentmeasure acidity level (pH) using a device called pH probe that is inserted into the upper part of the stomachask the participants questions about how easy it is to take the study treatmentask the participants what adverse events they are having.An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think it is related to the study treatment, or not.As this study is conducted in healthy men who will not gain any benefit from this treatment, access to the study treatment after the study is not planned., conditionsModule conditions: Heartburn, conditions: Indigestion, conditions: Stomach Acid Related Symptoms, conditions: Nocturnal Stomach Acid Related Symptoms, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: bi-layer calcium carbonate tablet (BAY1180654), interventions name: Immediate release calcium carbonate tablet (BAY1180654), outcomesModule primaryOutcomes measure: Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus., secondaryOutcomes measure: Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus., secondaryOutcomes measure: Percentage of total time gastric pH is above pH 3.5 from time of dosing until 8h post-dose during night-time comparing the bi-layer tablet and standard comparator, secondaryOutcomes measure: Percentage of total time gastric pH is above pH 3.5 from time of dosing until 6h post-dose during daytime comparing the bi-layer tablet and standard comparator., secondaryOutcomes measure: Change in mean gastric pH, secondaryOutcomes measure: Gastrointestinal tract location using scintigraphic images., secondaryOutcomes measure: Initial radiolabel release time, using scintigraphic images, secondaryOutcomes measure: Disintegration rate (t50%) of each formulation will be determined quantitatively via analysis of scintigraphic images., secondaryOutcomes measure: Complete radiolabel release time, using scintigraphic images, secondaryOutcomes measure: Gastric emptying kinetics of the dispersed radiolabeled material (t50% and t90%) of each formulation will be determined quantitatively via analysis of the scintigraphic images., secondaryOutcomes measure: Participant questionnaire, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: BDD Pharma Bio-imaging Unit, status: RECRUITING, city: Glasgow, zip: G4 0SF, country: United Kingdom, geoPoint lat: 55.86515, lon: -4.25763, hasResults: False |
protocolSection identificationModule nctId: NCT06293313, orgStudyIdInfo id: Inonu-SBF-SO-03, briefTitle: The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-04-28, completionDateStruct date: 2024-08-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test., conditionsModule conditions: Dysmenorrhea, conditions: Anxiety, conditions: Anxiety Disorders and Symptoms, conditions: Pain, Menstrual, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A total of two groups, a control group and a experimental group wo mindfulness group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The determination of which university would be included in the control and experimental groups in the research was made through a randomization method. The selection was done blindly by an independent academician unrelated to the research. As a result of the randomization, the control group and the experimental groups., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness training, interventions name: Will not be given any application, outcomesModule primaryOutcomes measure: VAS Pain Scale, secondaryOutcomes measure: State and Trait Anxiety Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bartin University, status: RECRUITING, city: Bartın, zip: 74001, country: Turkey, contacts name: Simge Öztürk, Ph.D, role: CONTACT, phone: 05398751788, email: [email protected], geoPoint lat: 41.63583, lon: 32.3375, hasResults: False |
protocolSection identificationModule nctId: NCT06293300, orgStudyIdInfo id: 20231056, secondaryIdInfos id: HT94252310608, type: OTHER_GRANT, domain: Department of Defense Awarding Office: U.S. Army Medical Research Acquisition Activity (USAMRAA), briefTitle: Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2026-08-30, completionDateStruct date: 2026-08-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Miami, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: BoNT A, outcomesModule primaryOutcomes measure: Change in photophobia measured by Numerical Rating Scale, primaryOutcomes measure: Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA), secondaryOutcomes measure: Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8), secondaryOutcomes measure: Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye)., secondaryOutcomes measure: Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25), secondaryOutcomes measure: Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS), secondaryOutcomes measure: Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6, secondaryOutcomes measure: Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5), secondaryOutcomes measure: Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI), secondaryOutcomes measure: Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST), secondaryOutcomes measure: Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Mariela Aguilar, PhD, role: CONTACT, phone: 305-326-6069, email: [email protected], contacts name: Anat Galor, MD/MSPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False |
protocolSection identificationModule nctId: NCT06293287, orgStudyIdInfo id: DJ-2023-02, briefTitle: Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Zhongshan Hospital (Xiamen), Fudan University, class: OTHER, descriptionModule briefSummary: The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure, conditionsModule conditions: Radial Artery Occlusion, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Subcutaneous enoxaparin sodium, interventions name: Placebo, outcomesModule primaryOutcomes measure: RAO rate after 24 hours and 21days, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital, Fudan University (Xiamen Branch), status: RECRUITING, city: Xiamen, state: Fujian, zip: 361015, country: China, contacts name: BoHeng Zhang, PHD, role: CONTACT, phone: 0592-3501990, email: [email protected], geoPoint lat: 24.47979, lon: 118.08187, hasResults: False |
protocolSection identificationModule nctId: NCT06293274, orgStudyIdInfo id: sdilek5, briefTitle: The Importance of Discharge Education for Mommy Blues, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Kocaeli University, class: OTHER, descriptionModule briefSummary: The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province.The sample size of the study was calculated using the G\*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G\*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up., conditionsModule conditions: Postpartum Sadness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Discharge training, outcomesModule primaryOutcomes measure: Motherhood Sadness Scale, primaryOutcomes measure: Edinburgh Postnatal Depression Scale - EPDS, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kocaeli University, status: RECRUITING, city: Kocaeli, zip: 41380, country: Turkey, contacts name: Sena Dilek Aksoy, Ph.D., role: CONTACT, phone: +902623034739, email: [email protected], contacts name: Resmiye Ozdilek, Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.62497, lon: 27.51145, hasResults: False |
protocolSection identificationModule nctId: NCT06293261, orgStudyIdInfo id: YMC043, briefTitle: Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-06-27, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Yuhan Corporation, class: INDUSTRY, descriptionModule briefSummary: This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia, conditionsModule conditions: Hypertension, conditions: Hypercholesterolemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 5047, type: ACTUAL, armsInterventionsModule interventions name: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg, outcomesModule primaryOutcomes measure: Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events), secondaryOutcomes measure: Change from baseline to 6/12 months in SBP and DBP, secondaryOutcomes measure: Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C), secondaryOutcomes measure: Change from baseline to 6/12 months in hs-CRP, secondaryOutcomes measure: Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose), secondaryOutcomes measure: Change from baseline to 6/12 months in Diabetes indicator ( HbA1c), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hallym University Sacred Heart Hospital, city: Anyang-si, country: Korea, Republic of, geoPoint lat: 37.3925, lon: 126.92694, locations facility: Dong-A University Hospital, city: Busan, zip: 49201, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Changwon Fatima Hospital, city: Changwon, country: Korea, Republic of, geoPoint lat: 35.22806, lon: 128.68111, locations facility: Gyeongsang National University Changwon Hospital, city: Changwon, country: Korea, Republic of, geoPoint lat: 35.22806, lon: 128.68111, locations facility: Soon Chun Hyang University Hospital Cheonan, city: Chungbuk, country: Korea, Republic of, geoPoint lat: 35.55292, lon: 127.49042, locations facility: Dankook University Hospital, city: Chungnam, country: Korea, Republic of, geoPoint lat: 36.27333, lon: 128.02522, locations facility: Daegu Catholic University Medical Center, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Keimyung University Dongsan Medical Center, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Yeungnam University Medical Center, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Daejeon Eulji Medical Center Eulji University, city: Daejeon, country: Korea, Republic of, geoPoint lat: 36.32139, lon: 127.41972, locations facility: Myungji Hospital, city: Goyang-si, country: Korea, Republic of, geoPoint lat: 37.65639, lon: 126.835, locations facility: Chonnam National University Hospital, city: Gwangju, country: Korea, Republic of, geoPoint lat: 35.15472, lon: 126.91556, locations facility: Chosun University Hospital, city: Gwangju, country: Korea, Republic of, geoPoint lat: 35.15472, lon: 126.91556, locations facility: Bundang Jesaeng General Hospital, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Cha University Bundang Medical Center, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Hallym University Dongtan Sacred Heart Hospital, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Korea University Ansan Hospital, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: National Health Insurance Service Ilsan Hospital, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Samsung Changwon Hospital, city: Gyeongsang, country: Korea, Republic of, geoPoint lat: 35.3164, lon: 126.93455, locations facility: Wonkwang University Hospital, city: Iksan, country: Korea, Republic of, geoPoint lat: 35.94389, lon: 126.95444, locations facility: Dongguk University Ilsan Hospital, city: Ilsan, country: Korea, Republic of, geoPoint lat: 35.5, lon: 129.43333, locations facility: Inje University Ilsan Paik Hospital, city: Ilsan, country: Korea, Republic of, geoPoint lat: 35.5, lon: 129.43333, locations facility: Inha University Hospital, city: Incheon, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Kwandong University International St.Mary'S Hospital, city: Incheon, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Kwangju Veterance Hospital, city: Kwangju, country: Korea, Republic of, geoPoint lat: 36.9122, lon: 127.1279, locations facility: Pusan National University Hospital, city: Pusan, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Pusan National University Yangsan Hospital, city: Pusan, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Gangnam Severance Hospital, city: Seoul, zip: 06273, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Ewha Womans University Mokdong Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Ewha Womans University Seoul Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Hallym University Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kangdong Sacred Heart Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Korea University Anam Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Korea University Guro Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kyung Hee University Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: National Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Samsung Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Ulsan University, city: Ulsan, country: Korea, Republic of, geoPoint lat: 35.53722, lon: 129.31667, locations facility: Wonju Severance Christian Hospital, city: Wŏnju, country: Korea, Republic of, geoPoint lat: 37.35139, lon: 127.94528, hasResults: False |
protocolSection identificationModule nctId: NCT06293248, orgStudyIdInfo id: 77979112, briefTitle: Music Application in Patients Undergoing Percutaneous Coronary Intervention, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-07-10, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kocaeli University, class: OTHER, descriptionModule briefSummary: This study was planned to examine the effect of music application on recovery in patients undergoing coronary angiography (CAG) and to obtain the opinions of patients and nurses about music.This study was conducted to examine the effect of music application on recovery in patients undergoing CAG and to obtain the opinions of patients and nurses about music.The study was planned as a pre-test, post-test design, single-center, randomized controlled experimental study. The study is planned to be conducted in the CAG unit of a university hospital between July 2023 and December 2023, the study sample will be composed of a total of 210 individuals, 105 in each group (music applied group before and after the procedure = 105, control group = 105) To collect data in the study, the "Patient Information Form", Vital Signs Evaluation Form", "Numerical Rating Scale", State-Trait Anxiety Inventory, "Perianesthesia Comfort Scale" and "Patient Satisfaction Survey on Nursing Care Quality" were used., conditionsModule conditions: Healthy, conditions: Nurse's Role, conditions: Patient Satisfaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Single (Participant), whoMasked: PARTICIPANT, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: musical application, outcomesModule primaryOutcomes measure: Means of subjective pain scores, primaryOutcomes measure: Means of body temperature (0C), primaryOutcomes measure: Means of systolic blood pressure (mmHg), primaryOutcomes measure: Means of diastolic blood pressure (mmHg), primaryOutcomes measure: Means of heart rate (/minutes), primaryOutcomes measure: Means of respiratory rate (/minutes), primaryOutcomes measure: Means of oxygen saturation (%), primaryOutcomes measure: Means of subjective anxiety scores, primaryOutcomes measure: Means of Perianesthesia Comfort Scale Scores, primaryOutcomes measure: Means of Patient Satisfaction Survey on Nursing Care Quality Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kocaeli University Hospital, city: Kocaeli, state: Umuttepe Campus, İzmit, zip: 41380, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, hasResults: False |
protocolSection identificationModule nctId: NCT06293235, orgStudyIdInfo id: 2024/2120, briefTitle: Towards Optimal Fertility, Fathering and Fatherhood studY, acronym: TOFFFY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: KK Women's and Children's Hospital, class: OTHER_GOV, descriptionModule briefSummary: This case-control study involving fertile and subfertile couples aims to identify male factors related to pregnancy likelihood, create a fertility index measure combining male and female factors to predict pregnancy likelihood, and examine how male factors relate to the semen physical and biological characteristics., conditionsModule conditions: Reproductive Issues, conditions: Fertility Issues, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 960, type: ESTIMATED, armsInterventionsModule interventions name: Lifestyle and metabolic indicators, outcomesModule primaryOutcomes measure: Pregnancy rate, secondaryOutcomes measure: Fertility index, secondaryOutcomes measure: Oxidative stress, secondaryOutcomes measure: Semen volume, secondaryOutcomes measure: Sperm concentration, secondaryOutcomes measure: Sperm total motility, secondaryOutcomes measure: Sperm progressive motility, secondaryOutcomes measure: Total progressive motile sperm count, secondaryOutcomes measure: Single strand sperm DNA fragmentation, secondaryOutcomes measure: Double strand sperm DNA fragmentation, secondaryOutcomes measure: mRNA level, secondaryOutcomes measure: sncRNA level, secondaryOutcomes measure: DNA methylation, otherOutcomes measure: Sperm morphology, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293222, orgStudyIdInfo id: SCD Support, briefTitle: Patient and Public Involvement and Engagement in Research With Children and Young People With Sickle Cell Disorder and Their Families, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-21, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: Sickle Cell Society, descriptionModule briefSummary: Aim: To co-produce resources for inclusive and equitable Patient and Public Involvement and Engagement in research on life-limiting conditions, with children and young people with sickle cell disorder and their families.Methods: Workshops with a) members of a patient advocacy organisation (Sickle Cell Society n=5) b): i) Children and young people (10-18 years) with sickle cell disorder (n=15) and ii) their siblings (10-18 years, n=10) and iii) their parents (n=15), c) Researchers form the Cicely Saunders Institute Outputs: Resources that enable children and young people with sickle cell disorder and their families to engage in research, conditionsModule conditions: Sickle Cell Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Workshops with participants to develop resources that enable children and young people with sickle cell disorder and their families to engage in research, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King's College London, city: London, zip: SE5 9RS, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06293209, orgStudyIdInfo id: Sunpasitthiprasong Hospital, secondaryIdInfos id: Sunpasitthiprasong Hospital, type: OTHER, domain: Sunpasitthiprasong Hospital, briefTitle: Effect of Cool Spray and Cold Packs in Reducing Preoperative Edema and Pain in Ankle Fractures in Ubonratchathani, acronym: 3-armRCT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-05-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Thai Traditional Medical Knowledge Fund, class: OTHER_GOV, descriptionModule briefSummary: The use of evaporative coolants in the management of acute musculoskeletal injury has received increasing attention recently. However, its efficacy compared with conventional cryotherapy in treating injured human subjects remains unclear.The purpose of this study is to compare the efficacy of evaporative coolants with that of ice packs in the preoperative management of edema and pain in patients with an ankle fracture, conditionsModule conditions: Ankle Fractures, conditions: Swelling, conditions: Cryotherapy Effect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: PopulationThe sample group comprises 30 patients admitted for treatment in the male orthopedic surgery department, female orthopedic surgery department, and accident orthopedic surgery department at Sunpasitthiprasong Hospital, Ubon Ratchathani from August 2023 to January 2024. ., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: 3M cold pack, interventions name: Perskindol cold spray, interventions name: Placebo, outcomesModule primaryOutcomes measure: swelling, secondaryOutcomes measure: pain score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Orthopedics, Sunpasitthiprasong hospital, Ubonratchathani, Thailand., city: Multiple Locations, state: Ubonrachathani, zip: 34000, country: Thailand, hasResults: False |
protocolSection identificationModule nctId: NCT06293196, orgStudyIdInfo id: 20231107, briefTitle: Effects of Acupoint Massage Around Eyes on Ocular Biological Indexes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Zhongnan Hospital, class: OTHER, descriptionModule briefSummary: This study aims to investigate whether the acupoint eye exercise could impact the biological parameters of the eye., conditionsModule conditions: Investigating the Effects of Periocular Acupressure on Ocular Biological Indicators, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: acupressure, outcomesModule primaryOutcomes measure: Changes in blood flow to the eye, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongnan Hospital of Wuhan University, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Min Ke, doctor of medicine, role: CONTACT, phone: 18672395959, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06293183, orgStudyIdInfo id: EGE-HEM-STO-01, briefTitle: The Effect of Artificial Intelligence Supported Mobile Learning on Nutrition/Hydration Control and Individual Management, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: The adherence to recommended nutrition and fluid restrictions is crucial for the success of hemodialysis treatment. However, approximately 80% of patients receiving HD treatment are non-compliant with fluid restriction, leading to various complications. Cardiovascular complications are among the most common complications associated with this issue. When reviewing national and international literature on the subject, it is observed that in order to improve treatment adherence in HD patients, written materials are often used in addition to individual or group education sessions, focusing mainly on assessing patients\' quality of life and self-efficacy. However, a mobile-supported learning method that enables patients to manage their nutrition and fluid control individually is not commonly utilized.This research aims to investigate the impact of an artificial intelligence-supported mobile application developed for HD patients on the control of nutrition/fluid intake and individual management., conditionsModule conditions: Cronich Kidney Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Mobile app, outcomesModule primaryOutcomes measure: Fluid intake compliance, secondaryOutcomes measure: Change of individual management, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06293170, orgStudyIdInfo id: 2024-DETECTIVENEUROLOGYUKD0001, briefTitle: Automated Screening for Clinically Ascertained Loss of Cerebral Functions, acronym: DETECT-IVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Technische Universität Dresden, class: OTHER, descriptionModule briefSummary: Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF.Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support.Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trialStudy population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge.Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination.Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization.Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT., conditionsModule conditions: Irreversible Loss of Brain Function (ILBF), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4800, type: ESTIMATED, armsInterventionsModule interventions name: DETECT, interventions name: Conventional care, outcomesModule primaryOutcomes measure: Number of patients with diagnosis of ILBF, secondaryOutcomes measure: Number of patients who undergo deceased organ donation, secondaryOutcomes measure: Number of patients in whom diagnosis of ILBF was missed, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, city: Dresden, zip: 01307, country: Germany, contacts name: Kristian Barlinn, MD, role: CONTACT, phone: +49 (0)351 458 3565, email: [email protected], geoPoint lat: 51.05089, lon: 13.73832, hasResults: False |
protocolSection identificationModule nctId: NCT06293157, orgStudyIdInfo id: 2023/ABM/01/00013, briefTitle: Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2033-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Copernicus Memorial Hospital, class: OTHER, collaborators name: Medical Research Agency, Poland, descriptionModule briefSummary: Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants.Study plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants.Study population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment.Assumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible., conditionsModule conditions: Metastatic Spinal Cord Compression, conditions: Metastasis Spine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 226, type: ESTIMATED, armsInterventionsModule interventions name: Transpedicular spinal stabilization - carbon fibers-based implants, interventions name: Transpedicular spinal stabilization - titanium implants, interventions name: Stereotactic body radiotherapy, outcomesModule primaryOutcomes measure: The assessment of time to local recurrence after treatment with SBRT., primaryOutcomes measure: The assessment of frequency of local recurrence after treatment with SBRT., secondaryOutcomes measure: DICE convergence factor evaluation between groups of patients., secondaryOutcomes measure: The subjective difficulty of planning radiotherapy treatment., secondaryOutcomes measure: The frequency of radiation complications assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC)., secondaryOutcomes measure: Failure rate of stabilizing systems., secondaryOutcomes measure: Pain assessment on the VAS scale between groups., secondaryOutcomes measure: Frequency of postoperative infections., secondaryOutcomes measure: Differences in dosimetric parameter Dmin PTV/CTV., secondaryOutcomes measure: Differences in dosimetric parameter D95., secondaryOutcomes measure: Differences in dosimetric parameter D98., secondaryOutcomes measure: Differences in dosimetric parameter D100., secondaryOutcomes measure: Differences in dosimetric parameter conformity index (CI) / homogeneity index (HI))., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copernicus Memorial Hospital in Lodz, status: RECRUITING, city: Łódź, state: Łódzkie, zip: 93-513, country: Poland, contacts name: Krystkiewicz, role: CONTACT, geoPoint lat: 51.75, lon: 19.46667, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-05-16, uploadDate: 2024-02-25T03:37, filename: ICF_000.pdf, size: 249036, hasResults: False |
protocolSection identificationModule nctId: NCT06293144, orgStudyIdInfo id: yuewei20231129, briefTitle: the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-29, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Second Hospital of Shanxi Medical University, class: OTHER, descriptionModule briefSummary: Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the 95% effective dose of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia using a biased coin design up-and-down sequential method(BCD-UDM), conditionsModule conditions: Sedation, conditions: ED95, conditions: Knee Arthroplasty, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Ciprofol, outcomesModule primaryOutcomes measure: Modified Alertness Sedation Score (MOAA/S), primaryOutcomes measure: Bispectral index (BIS), secondaryOutcomes measure: systolic blood pressure （SBP）, secondaryOutcomes measure: diastolic blood pressure（DBP）, secondaryOutcomes measure: heart rate (HR), secondaryOutcomes measure: pulse oxygen saturation（SpO2）, otherOutcomes measure: Occurrence of Sedation-related adverse events, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Hospital of Shanxi Medical University, status: RECRUITING, city: Taiyuan, state: Shanxi, zip: 030001, country: China, contacts name: Zheng Guo, M.B.,Ph.D., role: CONTACT, phone: +863513365790, email: [email protected], geoPoint lat: 37.86944, lon: 112.56028, hasResults: False |
protocolSection identificationModule nctId: NCT06293131, orgStudyIdInfo id: yuewei20230705, briefTitle: Median Effective Dose of Ciprofol-Assisted Sedation for Elderly Patients Undergoing Knee Arthroplasty, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-29, primaryCompletionDateStruct date: 2023-09-28, completionDateStruct date: 2023-09-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Second Hospital of Shanxi Medical University, class: OTHER, descriptionModule briefSummary: Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the median effective dose(ED50) of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia, conditionsModule conditions: Sedation, conditions: ED50, conditions: Knee Arthroplasty, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Ciprofol, outcomesModule primaryOutcomes measure: Modified Alertness Sedation Score (MOAA/S), primaryOutcomes measure: Bispectral index (BIS), secondaryOutcomes measure: systolic blood pressure （SBP）, secondaryOutcomes measure: diastolic blood pressure（DBP）, secondaryOutcomes measure: heart rate (HR), secondaryOutcomes measure: pulse oxygen saturation（SpO2）, otherOutcomes measure: Occurrence of Sedation-related adverse events, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Hospital of Shanxi Medical University, city: Taiyuan, state: Shanxi, zip: 030001, country: China, geoPoint lat: 37.86944, lon: 112.56028, hasResults: False |
protocolSection identificationModule nctId: NCT06293118, orgStudyIdInfo id: 71055423.3.0000.0071, briefTitle: The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2028-01-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Hospital Israelita Albert Einstein, class: OTHER, descriptionModule briefSummary: Ischemic conditioning (IC) is a promising therapy that can mimic the physiological effects of physical exercise. IC consists of using a cuff to measure blood pressure and calibrate 200 mmHg on the upper or lower limb. Thus, at alternating intervals of 5 minutes, ischemia or reperfusion occurs, depending on whether the cuff is inflated or deflated. IC induces changes in spinal cord excitability for the last reflex reactions of recruited motoneurons with improved balance control in healthy young people and improved learning in the elderly. The objective of the present study is to evaluate the chronic effect of IC on the motor function and cognitive performance of patients with Parkinson's disease. Furthermore, the investigators will evaluate secondary outcomes such as mobility, quality of life, and immunological responses., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1. Ischemic conditioning group2. control group (Sham), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients were unaware of the allocation., whoMasked: PARTICIPANT, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Ischemic conditioning group, interventions name: Sham group, outcomesModule primaryOutcomes measure: Motor function, primaryOutcomes measure: Cognitive performance, secondaryOutcomes measure: PDQ-39, secondaryOutcomes measure: Timed up and go (TUG), secondaryOutcomes measure: Assessment of cellular and soluble immune response, secondaryOutcomes measure: Quantifications of systemic soluble mediators, secondaryOutcomes measure: PBMC acquisition and flow cytometry, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293105, orgStudyIdInfo id: MR/T040688/1, briefTitle: Social Responses to Stigma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: Groundswell, collaborators name: Lambeth Service Users Council, collaborators name: Museum of Homelessness, collaborators name: Inclusive Insight, descriptionModule briefSummary: The Social Responses to Stigma study will explore experiences of stigma and discrimination amongst people who are homeless in south London, and then seek to understand how this stigma is created, mediated or mitigated within health, social, housing and legal care and support systems and social contexts.The methodology is an ethnographic case study of the south London care and support system and its social context. The study will use a range of methods for data collection: interviews with people who are homeless, delivery stakeholders, and policy makers; a survey of peoples' experiences; observation within selected care sites; and gathering of documentary sources.The study will be implemented through two parallel studies. The first, with KCL-REMAS approval, will operate in non-NHS sites. The second, with NHS-IRAS approval, will operate in NHS sites. The protocols are aligned with adaptations for each type of site.A linked method to develop theory is cross-case comparison between South London and Vancouver, Canada, through secondary data analysis to linked studies ongoing there. The study will be ongoing from 2022 until January 2025. The project is funded in two phases, with potential to extend the study by a further three years, to January 2028.The results of the study will inform the design of a novel intervention strategy to address the social dimensions of stigma. Subject to additional funding applications, the intervention strategy will be piloted and evaluated from 2025 onwards. The study results will be disseminated through scientific publications, public reports and a range of public and policy engagement activities., conditionsModule conditions: Stigma, Social, conditions: Drug Use, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Qualitative interview, participant observation, outcomesModule primaryOutcomes measure: Experiences of stigma and discrimination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: to Be Determined, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06293092, orgStudyIdInfo id: P.T.REC/012/004008, briefTitle: Effect of Intradialytic Exercises in Chronic Kidney Disease Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-30, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease., conditionsModule conditions: Chronic Kidney Disease stage3, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: control group receive medical treatment only ,first study group receive medical treatment and intradialytic aerobic exercise, second study group receive medical treatment and intradialytic resistive exercise, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: leg pedaling cycling device, interventions name: sand bags, interventions name: hemodialysis sessions, outcomesModule primaryOutcomes measure: Concentration of immunoglobulin g, primaryOutcomes measure: Total leukocyte count, primaryOutcomes measure: lymphocyte count, primaryOutcomes measure: neutrophil count, primaryOutcomes measure: Concentration of HbA1c, secondaryOutcomes measure: hemoglobin concentration, secondaryOutcomes measure: thrombocytes count, secondaryOutcomes measure: diastolic blood pressure, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: six minute walk test, secondaryOutcomes measure: (KDQOL-SFTM) questionnaire, eligibilityModule sex: MALE, minimumAge: 50 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fayoum hospital, city: Fayoum, country: Egypt, geoPoint lat: 29.30995, lon: 30.8418, hasResults: False |
protocolSection identificationModule nctId: NCT06293079, orgStudyIdInfo id: BiruniUnive, secondaryIdInfos id: Researcher, type: OTHER, domain: Biruni University, briefTitle: The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs in Patients With Multiple Sclerosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2024-02-12, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, descriptionModule briefSummary: The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Program, outcomesModule primaryOutcomes measure: Gait Speed, primaryOutcomes measure: Functional Capacity, secondaryOutcomes measure: EMG muscle activation, secondaryOutcomes measure: EMG muscle activation, secondaryOutcomes measure: Modified Fatigue Impact Scale, otherOutcomes measure: Global Rating of Change Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Biruni University, status: RECRUITING, city: İstanbul, country: Turkey, contacts name: Güzin Kaya Aytutuldu, role: CONTACT, phone: 05366265884, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06293066, orgStudyIdInfo id: KCH23-257, briefTitle: Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: King's College Hospital NHS Trust, class: OTHER, descriptionModule briefSummary: Primary Objective:To assess whether there is a higher incidence of uninformative ultrasound in black vs white women, conditionsModule conditions: Postmenopausal Bleeding, conditions: Endometrial Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 330, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: To assess whether there is a higher incidence of uninformative ultrasound in black vs white women, eligibilityModule sex: FEMALE, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Suite 8, King's College Hospital, city: London, zip: SE5 9RS, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06293053, orgStudyIdInfo id: PKM17836, secondaryIdInfos id: U1111-1287-7255, type: REGISTRY, domain: ICTRP, briefTitle: A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2027-10-28, completionDateStruct date: 2027-11-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.The study consists of 3 periods:* Screening period: 2 to 4 weeks.* Treatment period: 24 weeks.* Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).The total number of planned study visits for each participant will be 6., conditionsModule conditions: Prurigo Nodularis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Dupilumab, outcomesModule primaryOutcomes measure: Concentration of dupilumab in serum, secondaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs), secondaryOutcomes measure: Incidence of anti-drug antibodies (ADA) to dupilumab over time, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293040, orgStudyIdInfo id: IRB00434441, secondaryIdInfos id: R01DA052295, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA052295, briefTitle: Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states)., conditionsModule conditions: Cannabis Intoxication, conditions: Alcohol Intoxication, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: All participants will complete all dose conditions (study arms) in a randomized order, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Double-blind (Participant, Outcomes Assessor), placebo controlled, and double-dummy, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Cannabis, interventions name: Alcohol, interventions name: Placebo Cannabis, interventions name: Placebo Alcohol, outcomesModule primaryOutcomes measure: DRUID application global impairment score, primaryOutcomes measure: Correct Trials on Paced Auditory Serial Addition Task (PASAT), primaryOutcomes measure: Correct Trials on the Digit Symbol Substitution Task (DSST), primaryOutcomes measure: Cumulative score on Field Sobriety Tests, primaryOutcomes measure: Drug Effect Questionnaire (DEQ) - Feel Drug Effect, primaryOutcomes measure: Drug Effect Questionnaire (DEQ) - Feel High, primaryOutcomes measure: Drug Effect Questionnaire (DEQ) - Confidence to Drive, primaryOutcomes measure: Drug Effect Questionnaire (DEQ) - Willingness to Drive, primaryOutcomes measure: Biphasic alcohol effects scale (BAES) - Sedative Score, primaryOutcomes measure: Biphasic alcohol effects scale (BAES) - Stimulant Score, primaryOutcomes measure: Subjective high assessment scale (SHAS), primaryOutcomes measure: Driving performance as assessed by standard deviation of lateral position (SDLP), primaryOutcomes measure: Driving performance as assessed by composite drive score, secondaryOutcomes measure: Driving performance as assessed by standard deviation of speed (SDSP), secondaryOutcomes measure: Driving performance (mean speed), secondaryOutcomes measure: Driving performance (number of speed exceedances), secondaryOutcomes measure: Driving performance (number of accidents), secondaryOutcomes measure: Driving performance (total rule violations), secondaryOutcomes measure: Driving performance (distance to lead vehicles), secondaryOutcomes measure: Attempted Trials on the Digit Symbol Substitution Task (DSST), secondaryOutcomes measure: Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST), secondaryOutcomes measure: Reaction time on Paced Auditory Serial Addition Task, secondaryOutcomes measure: Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test, secondaryOutcomes measure: Field Sobriety Test - Score on Walk and Turn test, secondaryOutcomes measure: Field Sobriety Test - Score on One Leg Stand, secondaryOutcomes measure: Field Sobriety Test - Score on Modified Romberg Balance, secondaryOutcomes measure: Drug Effect Questionnaire - Like Drug Effect, secondaryOutcomes measure: Drug Effect Questionnaire - Want more, secondaryOutcomes measure: Drug Effect Questionnaire - Dislike Drug Effect, secondaryOutcomes measure: Pharmacokinetics - CMax for THC and THC metabolites, secondaryOutcomes measure: Pharmacokinetics - AUC for THC and THC metabolites, secondaryOutcomes measure: Pharmacokinetics - Breath Alcohol Concentration (BAC), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Behavioral Pharmacology Research Unit, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: Madyson Slutzky, role: CONTACT, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, hasResults: False |
protocolSection identificationModule nctId: NCT06293027, orgStudyIdInfo id: IMAGINER FXS, briefTitle: Optical Imaging as a Tool for Monitoring Brain Function in Fragile X Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, descriptionModule briefSummary: The objective of this project is to explore the potential of functional near- infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Fragile X Syndrome (FXS) that is still without cure. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With clinical trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. The investigators seek to address this gap by assessing the prognostic reliability of both resting and task- evoked fNIRS. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with FXS; 2. to collect pilot data on individuals with FXS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls., conditionsModule conditions: Fragile X Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Resting-state functional connectivity, primaryOutcomes measure: Amplitude of sensory-evoked hemodynamic responses, secondaryOutcomes measure: Correlation between neurophysiology endpoints and the response on neuropsychological scale., eligibilityModule sex: MALE, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione Stella Maris, status: RECRUITING, city: Marina di Pisa-Tirrenia-Calambrone, state: Toscana, zip: 56128, country: Italy, contacts name: Roberta Battini, MD, role: CONTACT, phone: +39 050886282, email: [email protected], contacts name: Laura Baroncelli, PhD, role: CONTACT, phone: +39 050886233, email: [email protected], contacts name: Elena Scaffei, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.62719, lon: 10.29204, hasResults: False |
protocolSection identificationModule nctId: NCT06293014, orgStudyIdInfo id: QLMA-CRC-IIT-001, briefTitle: TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2025-10-15, completionDateStruct date: 2026-11-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: TAS-102+bevacizumab, interventions name: Standard chemotherapy+bevacizumab, outcomesModule primaryOutcomes measure: Time to treatment failure (TTF), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: European Quality of Life Five Dimensions Five Level Scale Questionnaire (EQ-5D-5L), secondaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university, status: RECRUITING, city: ZhengZhou, state: Henan, zip: 450008, country: China, contacts name: Ying Liu, MD, role: CONTACT, phone: +86-13783604602, email: [email protected], geoPoint lat: 34.75778, lon: 113.64861, hasResults: False |
protocolSection identificationModule nctId: NCT06293001, orgStudyIdInfo id: SBA 23/349, briefTitle: Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the ADAP Shoulder Scale, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2024-04-26, completionDateStruct date: 2024-04-26, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: Shoulder pain is a common musculoskeletal problem that increases disability and decreases quality of life in addition to socio-economic impact. Chronic pain is defined as pain lasting longer than three months. Chronic pain is a multidimensional and complex experience. According to this model, chronic pain is a multidimensional and complex experience. This experience may be accompanied by different pain beliefs, pain avoidance behaviours, pain-related fear of movement, anxiety and depression. Many conditions involving the shoulder complex including traumatic and non-traumatic pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive capsulitis, shoulder instabilities may lead to pain-related fear of movement.Until now, pain-related fear and avoidance behaviours in patients with shoulder pain have been evaluated with the Tampa Kinesiophobia Scale, Pain Avoidance Beliefs Scale and Fear of Pain Scale. However, only patients with low back pain were included in the development of these scales. There was no scale developed specifically for shoulder pain. To fill this gap in the literature, Ansanello et al. developed the "Avoidance Daily Activities Photo Scale for Patients With Shoulder Pain (ADAP)" scale to evaluate pain avoidance behaviours in individuals with shoulder pain. Cross-cultural adaptation, validity and reliability of the Turkish version of the ADAP scale has not been studied.The aim of our study was to perform cross-cultural adaptation, validity and reliability of the Turkish version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale)., conditionsModule conditions: Questionnaire, conditions: Shoulder Pain, conditions: Validity, conditions: Reliability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Elif Turgut, status: RECRUITING, city: Ankara, zip: 06300, country: Turkey, contacts name: Elif Turgut, Assoc. Prof., role: CONTACT, phone: +90 (544) 264 56 00, email: [email protected], contacts name: Pınar KUYULU HAKSAL, Master, role: SUB_INVESTIGATOR, contacts name: Kübra CAYLAN GURSES, Master, role: SUB_INVESTIGATOR, contacts name: Birgül DINGIRDAN, Master, role: SUB_INVESTIGATOR, contacts name: Büşra PAKOZ, Master, role: SUB_INVESTIGATOR, contacts name: Irem DUZGUN, Proffessor, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06292988, orgStudyIdInfo id: MYELO, briefTitle: Predictive Factors for Medullary Thyroid Cancer Aggressiveness, acronym: MYELO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Aristotle University Of Thessaloniki, class: OTHER, descriptionModule briefSummary: This study is a retrospective study trying to find the predictive factors for medullary thyroid aggressiveness in terms of tumor metastasis and patients' survival., conditionsModule conditions: Medullary Thyroid Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Total Thyroidectomy, outcomesModule primaryOutcomes measure: Central lymph node metastasis, primaryOutcomes measure: Lateral lymph node metastasis, primaryOutcomes measure: Distant metastasis, secondaryOutcomes measure: Nuclear atypia as histological predictor of aggressiveness, secondaryOutcomes measure: Amyloid as histological predictor of aggressiveness, secondaryOutcomes measure: Immunohistochemistry as histological predictor of aggressiveness, secondaryOutcomes measure: Desmoplasia as histological predictor of aggressiveness, secondaryOutcomes measure: CEA as Biochemical predictor of aggressiveness, secondaryOutcomes measure: Calcitonin as Biochemical predictor of aggressiveness, secondaryOutcomes measure: White blood cell as Biochemical predictor of aggressiveness, secondaryOutcomes measure: Platelet count as Biochemical predictor of aggressiveness, secondaryOutcomes measure: CEA drop as Biochemical cure marker, secondaryOutcomes measure: Calcitonin drop as Biochemical cure marker, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oregon Health & Science University, Oregon, city: Oregon City, state: Oregon, zip: 97239, country: United States, contacts name: James Lim, role: CONTACT, email: [email protected], geoPoint lat: 45.35734, lon: -122.60676, locations facility: Department of Surgery, Saint John of God Hospital, Salzburg, Austria, city: Salzburg, country: Austria, contacts name: Michael De Cilia, role: CONTACT, email: [email protected], geoPoint lat: 47.79941, lon: 13.04399, locations facility: Saint Luc, University Clouvain, Belgium, city: Bruxelles, country: Belgium, contacts name: Antoine Buemi, Prof, role: CONTACT, email: [email protected], geoPoint lat: 50.85045, lon: 4.34878, locations facility: Head and Neck Surgery Department, Hospital Ana Nery, Santa Cruz do Sul, Brazil, city: Santa Cruz Do Sul, country: Brazil, contacts name: Fabio Muradas Girardi, role: CONTACT, email: [email protected], geoPoint lat: -29.7175, lon: -52.42583, locations facility: University Clinic of Surgery, University Hospital "Lozenec", city: Sofia, country: Bulgaria, contacts name: Rumen Pandev, role: CONTACT, email: [email protected], geoPoint lat: 42.69751, lon: 23.32415, locations facility: Chinese University of Hong Kong, city: Hong Kong, country: China, contacts name: Shirley Liu, role: CONTACT, email: [email protected], geoPoint lat: 22.39407, lon: 114.13737, locations facility: Head and Neck Department Oncologos del Occidente, Universidad de Caldas, Manizales, Colombia, city: Manizales, country: Colombia, contacts name: Andres Chalas, role: CONTACT, email: [email protected], geoPoint lat: 5.06889, lon: -75.51738, locations facility: the University Hospital Center Sestre milosrdnice, Zagreb, Croatia, Department of Otorhinolaryngology and Head and Neck Surgery, city: Zagreb, country: Croatia, contacts name: Andro Kosec, Prof, role: CONTACT, email: [email protected], geoPoint lat: 45.81444, lon: 15.97798, locations facility: Head and Neck Surgery, Brest University Hospital, Brest, France, city: Brest, country: France, contacts name: 27. Jean-Christophe Leclere, role: CONTACT, email: [email protected], geoPoint lat: 48.3903, lon: -4.48628, locations facility: The University Hospital of Poitiers, France, city: Poitiers, country: France, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Thyroid Surgery Clinic IKE, Athens, Greece, city: Athens, country: Greece, contacts name: Stavros Karakozis, role: CONTACT, email: [email protected], contacts name: Lampros Karakozis, role: SUB_INVESTIGATOR, geoPoint lat: 37.97945, lon: 23.71622, locations facility: ENT Department University Hospital of Larissa, city: Larissa, country: Greece, contacts name: Jiannis Hajiioannou, role: CONTACT, email: [email protected], geoPoint lat: 39.63689, lon: 22.41761, locations facility: Department of Surgery, General University Hospital of Patras, city: Patra, country: Greece, contacts name: Franko Mulita, role: CONTACT, email: [email protected], geoPoint lat: 38.24444, lon: 21.73444, locations facility: Aristotle University of Thessaloniki, city: Thessaloníki, country: Greece, geoPoint lat: 40.64361, lon: 22.93086, locations facility: Gennimatas General Hospital, city: Thessaloníki, country: Greece, contacts name: Ioannis Koutelidakis, role: CONTACT, email: [email protected], contacts name: Nikolaos Voloudakis, role: SUB_INVESTIGATOR, geoPoint lat: 40.64361, lon: 22.93086, locations facility: Department of ENT-Head and Neck Surgery, All India Institute of Medical Sciences, Bhubaneswar, city: Bhubaneswar, country: India, contacts name: Kumar Parida Pradipta, role: CONTACT, email: [email protected], geoPoint lat: 20.27241, lon: 85.83385, locations facility: KMCH and KMCH Comprehensive Cancer Center, city: Coimbatore, country: India, contacts name: Manoj Dhiwakar, role: CONTACT, email: [email protected], geoPoint lat: 11.00555, lon: 76.96612, locations facility: Department of Endocrine and Breast Surgery at Sanjay Gandhi Post Graduate Institute of Medical Sciences, city: Madurai, country: India, contacts name: Sabaretnam Mayilvaganan, role: CONTACT, email: [email protected], geoPoint lat: 9.91769, lon: 78.11898, locations facility: Department of Surgery, Maulana Azad Medical College & Lok Nayak Hospital, city: New Delhi, country: India, contacts name: Lovenish Bains, role: CONTACT, email: [email protected], geoPoint lat: 28.63576, lon: 77.22445, locations facility: Endocrine and Metabolic Surgery, Bhargav Endocrine Hospital, Vijayawada, India, city: Vijayawada, country: India, contacts name: Ramakanth Bhargav Panchangam, role: CONTACT, email: [email protected], geoPoint lat: 16.50745, lon: 80.6466, locations facility: University of Sulaimani | UNIVSUL ,Department of Surgery, Kurdistan, city: Erbil, country: Iraq, contacts name: Fahmi Hussein, role: CONTACT, email: [email protected], geoPoint lat: 36.19257, lon: 44.01062, locations facility: ASL VCO - San Biagio Hospital - Domodossola (VB) - Italy, city: Domodossola, country: Italy, contacts name: Luigi Oragano, role: CONTACT, email: [email protected], geoPoint lat: 46.1165, lon: 8.29313, locations facility: Dipartimento di Scienze Chirurgiche (DISC), University of Genoa, Italy, city: Genoa, country: Italy, contacts name: Michele Minuto, role: CONTACT, email: [email protected], geoPoint lat: 44.40478, lon: 8.94438, locations facility: Asst Santi Paolo e Carlo - Ospedale Polo Universitario San Paolo, Milan, Italy, city: Milan, country: Italy, contacts name: Loredana De Pasquale, role: CONTACT, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, locations facility: UOC Chirurgia Endocrina e Metabolica, Fondazione Policlinico Universitario A Gemelli IRCCS, city: Roma, country: Italy, contacts name: Marco Raffaelli, role: CONTACT, email: [email protected], contacts name: Francesco Pennestri, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Department of Medical and Surgical Sciences, University of Trieste, Cattinara Teaching Hospital, Trieste, Italy, city: Trieste, country: Italy, contacts name: Chiara Dobrinja, role: CONTACT, email: [email protected], geoPoint lat: 45.64953, lon: 13.77679, locations facility: Department of Surgery and Oncology, Endocrine Surgery Unit, Verona University Hospital, city: Verona, country: Italy, contacts name: Giacomo DiFilippo, role: CONTACT, email: [email protected], geoPoint lat: 45.4299, lon: 10.98444, locations facility: Hashemite University of Zarqa, city: Zarqa, country: Jordan, contacts name: Sohail Bakkar, Prof, role: CONTACT, email: [email protected], geoPoint lat: 32.07275, lon: 36.08796, locations facility: Hepatobiliairy and endocrine surgery, Ibn Sina Hospital, Medical School of Medecine Rabat, Mohamed Vth University of Rabat Morocco, city: Marrakech, country: Morocco, contacts name: Omar El Malki Hadj, Prof, role: CONTACT, email: [email protected], geoPoint lat: 31.63416, lon: -7.99994, locations facility: Division of General, Endocrine and Transplant Surgery, Medical University of Gdańsk, city: Gdańsk, country: Poland, contacts name: Andrzej Hellman, Prof, role: CONTACT, email: [email protected], geoPoint lat: 54.35205, lon: 18.64637, locations facility: Surgical Oncology Clinic, Institute for Oncology and Radiology of Serbia, Medical School, University of Belgrade, city: Belgrad, country: Serbia, contacts name: Nada Santrac, role: CONTACT, email: [email protected], geoPoint lat: 44.80401, lon: 20.46513, locations facility: Comenius University in Bratislava, Department of Paediatric Surgery, National Institute of Children's Diseases, city: Bratislava, country: Slovakia, contacts name: Petra Zahradníková, Prof, role: CONTACT, email: [email protected], geoPoint lat: 48.14816, lon: 17.10674, locations facility: Department of oncological surgery, St. Elisabeth cancer Institute, city: Bratislava, country: Slovakia, contacts name: Robert Kralik, role: CONTACT, email: [email protected], geoPoint lat: 48.14816, lon: 17.10674, locations facility: Hospital Clinic (Barcelona, Spain), city: Barcelona, country: Spain, contacts name: Aida Orois, role: CONTACT, email: [email protected], contacts name: Òscar Vidal Perez, role: SUB_INVESTIGATOR, contacts name: Marti Manyalich, role: SUB_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Universitaria de Cordoba, city: Córdoba, country: Spain, contacts name: Constanza Ramacciotti, role: CONTACT, email: [email protected], geoPoint lat: 37.89155, lon: -4.77275, locations facility: Hospital Regional de Málaga, city: Málaga, country: Spain, contacts name: Viyey Kishore Doulatram, role: CONTACT, email: [email protected], contacts name: Marta Iturregui Guevara, role: SUB_INVESTIGATOR, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Department of General and Digestive Surgery, Division of Endocrine Surgery, Complexo Hospitalario Universitario de Vigo, Vigo, Spain, city: Vigo, country: Spain, contacts name: Angel Rivo Vazaquez, role: CONTACT, email: [email protected], geoPoint lat: 42.23282, lon: -8.72264, locations facility: Bern University Hospital, city: Bern, country: Switzerland, contacts name: Reto Kaderli, Prof, role: CONTACT, email: [email protected], contacts name: Nesti Cedric, role: SUB_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, locations facility: Geneva University Hospital, city: Geneva, country: Switzerland, geoPoint lat: 46.20222, lon: 6.14569, locations facility: Division of Endocrinology and Metabolism Department of Medicine Faculty of Medicine Ramathibodi Hospital Mahidol University Bangkok, Thailand, city: Bangkok, country: Thailand, contacts name: Sriphrapradang Chutintorn, role: CONTACT, email: [email protected], geoPoint lat: 13.75398, lon: 100.50144, locations facility: Ankara University Faculty of Medicine, Department of Endocrine Surgery, city: Ankara, country: Turkey, contacts name: Volkan Cenc, role: CONTACT, email: [email protected], geoPoint lat: 39.91987, lon: 32.85427, locations facility: Acibadem MAA University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Cerrahpasa medical faculty endocrine surgery department, city: Istanbul, country: Turkey, contacts name: Selen Soylu, role: CONTACT, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, locations facility: Department of Endocrin Pathology Unit, University of Health Sciences, Faculty of Medicine, Bakırköy Dr Sadi Konuk Training and Research Hospital, Istanbul, Turkey, city: Istanbul, country: Turkey, contacts name: Altinay Serdar, role: CONTACT, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, locations facility: Endocrine surgeon-consultant, International medical center "CITIDOCTOR", city: Kyiv, country: Ukraine, contacts name: Sergii Cherenko, role: CONTACT, email: [email protected], geoPoint lat: 50.45466, lon: 30.5238, locations facility: Department of Radiology, Thien Hanh Hospital, Buon Ma Thuot, Vietnam, city: Việt Trì, country: Vietnam, contacts name: Hoang Van Trung, role: CONTACT, email: [email protected], geoPoint lat: 21.32274, lon: 105.40198, hasResults: False |
protocolSection identificationModule nctId: NCT06292975, orgStudyIdInfo id: RS210 - 326709, briefTitle: Exercise for Improving Radiotherapy Efficacy in Rectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Hull, class: OTHER, collaborators name: Hull University Teaching Hospitals NHS Trust, descriptionModule briefSummary: This is a single arm feasibility study of exercise for improving short- course neoadjuvant radiotherapy efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patient's will be provided with a 7 weeks course of structured aerobic exercises and resistance training in the periods before, during and after their radiotherapy treatment. The patients will be followed up for 6 months post short course neoadjuvant radiotherapy, with a total of 3 assessment periods., conditionsModule conditions: Locally Advanced Rectal Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Feasibility study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Supervised Vigorous intensity aerobic interval exercise, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Attendance rate, primaryOutcomes measure: withdrawal rate, secondaryOutcomes measure: Serum Carcinoembryonic antigen levels, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Physical activity levels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06292962, orgStudyIdInfo id: SH-34988389, briefTitle: Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain, acronym: VNSDPN, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Saima Abass Tahammal, class: OTHER, collaborators name: Al Ain University, descriptionModule briefSummary: The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes., conditionsModule conditions: Diabetes Mellitus, conditions: Diabetic Neuropathies, conditions: Type2diabetes, conditions: Neuropathic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: a randomized, double-blinded, sham-controlled, parallel group clinical trial, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 165, type: ACTUAL, armsInterventionsModule interventions name: non-invasive transcutaneous vagal nerve stimulation (tVNS), interventions name: Sham device, outcomesModule primaryOutcomes measure: Neuropathic pain scores, secondaryOutcomes measure: Quality of life score, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shifa Hospital, city: Lahore, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
protocolSection identificationModule nctId: NCT06292949, orgStudyIdInfo id: TJ-IRB20230956, briefTitle: Clinical Study of Resistant Starch in Improving Constipation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-09-25, completionDateStruct date: 2024-09-25, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Huaping Xie, class: OTHER, descriptionModule briefSummary: Constipation is one of the most common gastrointestinal (GI) disorders in clinical practice, with approximately 11-20% of adults worldwide suffering from constipation. Clinically, the frequency of defecation is reduced, or the defecation is laborious, obstructed, difficult, and the stool is dry and difficult to solve, which is called constipation. Clinically, constipation is difficult to treat and over-reliance on laxatives often leads to water and electrolyte imbalance, gastrointestinal dysfunction, melanosis of the colon, relaxation of anal sphincter and other problems, and even leads to colorectal cancer, diabetes, anorexia nervosa and other complications in some cases. Therefore, it is very important to find a safe and effective laxative drug or diet to improve and relieve constipation symptoms. The health promotion effect of resistant starch is mainly due to the short-chain fat and gas produced by microbial fermentation in the colon, and its role in preventing colorectal cancer and some diet-related chronic diseases is stronger than dietary fiber, and it can effectively overcome the adverse odor, rough texture, poor quality and other drawbacks of food fortified with dietary fiber. Ruminococcus bromii is a specific microorganism that degrades resistant starch. The starch decomposing enzyme of R. bromii has a unique tissue structure and forms a multi-enzyme complex. Through the adhesion protein and dockerin module, it is attached to the cell surface through the scaffold protein in the cellulose body. Big data analysis showed that the relative abundance of R. bromii in healthy people was significantly higher than that in patients with constipation. Therefore, the purpose of this clinical trial is to supplement resistant starch to patients with constipation: (1) Observe whether the symptoms of patients with constipation have improved; (2) Analyze the changes of intestinal microorganisms in patients with constipation; and (3) Verify whether the relative abundance of R. bromii is increased and analyze the correlation between the relative abundance of R. bromii in intestine and the improvement of constipation symptoms in patients with constipation., conditionsModule conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Resistant starch, outcomesModule primaryOutcomes measure: Changes in constipation symptoms, primaryOutcomes measure: Changes in the diversity of intestinal flora, primaryOutcomes measure: Changes in the relative abundance of species of intestinal flora, primaryOutcomes measure: Changes in the number of intestinal flora, primaryOutcomes measure: Changes in the metabolic function of intestinal flora, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: ping h Xie, role: CONTACT, phone: 86+13437187007, email: [email protected], contacts name: qiang Ding, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-09-21, uploadDate: 2024-02-29T21:24, filename: Prot_SAP_000.pdf, size: 358565, hasResults: False |
protocolSection identificationModule nctId: NCT06292936, orgStudyIdInfo id: 30692, briefTitle: RemI for Post-Bariatric Surgery Weight Regain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Temple University, class: OTHER, collaborators name: Rush University, descriptionModule briefSummary: The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100).The main research aims are:1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control.2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups.3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior., conditionsModule conditions: Obesity, conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance-Based Behavioral Intervention, outcomesModule primaryOutcomes measure: Weight, secondaryOutcomes measure: Caloric Intake, secondaryOutcomes measure: Eating Behavior - Cognitive Constraint, secondaryOutcomes measure: Eating Behavior - Disinhibition, secondaryOutcomes measure: Eating Behavior - Hunger, secondaryOutcomes measure: Physical Activity, secondaryOutcomes measure: Weight-Related Medical Comorbidities - Number of participants with hypertension, secondaryOutcomes measure: Weight-Related Medical Comorbidities - Number of participants with diabetes, secondaryOutcomes measure: Weight-Related Medical Comorbidities - Number of participants with hypercholesterolemia, secondaryOutcomes measure: Weight-Related Medical Comorbidities - Number of participants with hyperlipidemia, otherOutcomes measure: Mechanisms of Action (Exploratory) - Acceptance of food-related internal experiences, otherOutcomes measure: Mechanisms of Action (Exploratory) - Mindfulness, otherOutcomes measure: Mechanisms of Action (Exploratory) - Defusion, otherOutcomes measure: Mechanisms of Action (Exploratory) - Values clarity, otherOutcomes measure: Mechanisms of Action (Exploratory) - Depressive symptoms, otherOutcomes measure: Mechanisms of Action (Exploratory) - Anxiety, otherOutcomes measure: Mechanisms of Action (Exploratory) - Internal states, otherOutcomes measure: Mechanisms of Action (Exploratory) - Maladaptive eating behaviors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rush University, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Lauren Bradley, PhD, role: CONTACT, phone: 312-942-2714, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, locations facility: Temple University, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: David B Sarwer, PhD, role: CONTACT, phone: 215-707-8632, email: [email protected], contacts name: Sarah R Fischbach, MPH, role: CONTACT, phone: 215-707-8633, email: [email protected], geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06292923, orgStudyIdInfo id: TILS-021, briefTitle: A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Tiziana Life Sciences LTD, class: INDUSTRY, descriptionModule briefSummary: Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases.The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS).The primary objectives that this study aims to answer are:1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment., conditionsModule conditions: Secondary Progressive Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The treating physician, study staff, and patients will be blinded to treatment. The research pharmacy at each site will have the treatment code assignments., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Foralumab, interventions name: Placebo, outcomesModule primaryOutcomes measure: The number of patients with adverse event (AE) reports., primaryOutcomes measure: Changes in the Total Nasal Symptom Score (TNSS)., primaryOutcomes measure: Change from baseline for [18F]PBR06-positron emission tomography (PET) scans for microglial activation after 12 weeks (3 months) of study treatment., secondaryOutcomes measure: Changes in the Expanded Disability Status Scale (EDSS)., secondaryOutcomes measure: Changes in the Multiple Sclerosis Functional Composite-4 (MSFC-4)., secondaryOutcomes measure: Changes in the Modified Fatigue Impact Scale (MFIS)., otherOutcomes measure: Changes in the mean number of gadolinium-enhancing lesions per T1-weighted MRI scan, as measured by 3T MRI., otherOutcomes measure: Changes in percent brain volume change by 3T MRI analysis pipeline between the Screening Visit (Baseline) and after 3 months of treatment, as measured by 3T MRI., otherOutcomes measure: Paramagnetic rim lesions by quantitative susceptibility mapping sequences on MRI, as measured by 3T MRI (if center is able)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Niveditha Gopalakrishnan, role: CONTACT, phone: 617-732-5588, email: [email protected], contacts name: Tanuja Chitnis, M.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06292910, orgStudyIdInfo id: REC 64-299-1-1, briefTitle: Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery, acronym: VACO2, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-08, primaryCompletionDateStruct date: 2023-12-21, completionDateStruct date: 2023-12-26, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research, conditionsModule conditions: Congenital Heart Disease, conditions: Perioperative/Postoperative Complications, conditions: Lactate Blood Increase, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 136, type: ACTUAL, armsInterventionsModule interventions name: arterial and central venous blood gas analysis, lactate, outcomesModule primaryOutcomes measure: number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation, secondaryOutcomes measure: ventilator days, secondaryOutcomes measure: inotrope days, secondaryOutcomes measure: length of stay in ICU, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Prince of Songkla University, city: Hat Yai, state: Songkhla, zip: 90110, country: Thailand, geoPoint lat: 7.00836, lon: 100.47668, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-05, uploadDate: 2024-02-09T09:23, filename: Prot_SAP_000.pdf, size: 745529, hasResults: False |
protocolSection identificationModule nctId: NCT06292897, orgStudyIdInfo id: 3312, briefTitle: Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression, acronym: OBESITA'&PCa, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-20, primaryCompletionDateStruct date: 2026-09-15, completionDateStruct date: 2027-01-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, collaborators name: National Research Council, descriptionModule briefSummary: Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI \> 27.5) and non-severely overweight/normoweight (BMI \< 27.5) patients affected by prostate carcinoma.ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients.iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways., conditionsModule conditions: Prostate Cancer, conditions: Prostate Adenocarcinoma, conditions: Prostate Neoplasm, conditions: Prostatic Neoplasm, conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: observational study, outcomesModule primaryOutcomes measure: Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, status: RECRUITING, city: Milan, country: Italy, contacts name: giancarlo albo, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06292884, orgStudyIdInfo id: IMAGINER CREATINE, briefTitle: Optical Imaging as a Tool for Monitoring Brain Function in Creatine Deficiency Syndromes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-06, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, descriptionModule briefSummary: The objective of this project is to explore the potential of functional near-infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Creatine Deficiency Syndromes (CDS), a group of rare neurodevelopmental disorders. Among these disorders, effective treatments are lacking for two. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With gene therapy trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. This project seeks to address this gap by assessing the prognostic reliability of both resting and task-evoked fNIRS. Arousal of participants will be also assessed through the measure of spontaneous heart rate (HR) fluctuations. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with CDS; 2. to collect pilot data on individuals with CDS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls., conditionsModule conditions: Creatine Deficiency, X-linked, conditions: Creatine Deficiency Syndrome Due to Gamt Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Resting-state functional connectivity, primaryOutcomes measure: Amplitude of sensory-evoked hemodynamic responses, secondaryOutcomes measure: Correlation between neurophysiology endpoints and the response on neuropsychological scale., eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione Stella Maris, status: RECRUITING, city: Pisa, zip: 56128, country: Italy, contacts name: Roberta Battini, MD, role: CONTACT, phone: +39 050886282, email: [email protected], contacts name: Laura Baroncelli, PhD, role: CONTACT, phone: +39 050886233, email: [email protected], contacts name: Elena Scaffei, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False |
protocolSection identificationModule nctId: NCT06292871, orgStudyIdInfo id: 2023/2712, briefTitle: The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: KK Women's and Children's Hospital, class: OTHER_GOV, collaborators name: Singapore Institute of Technology, descriptionModule briefSummary: To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically,i. To measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform.ii. To measure the feasibility of using the social media platform to provide GDM support through participants' engagement levels and feedback questionnaire.iii. To measure the efficacy of using the social media platform to manage emotional responses in women with GDM.iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM., conditionsModule conditions: Gestational Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will employ a randomized controlled trial design, with GDM patients from KKH randomly assigned to either the intervention or control group. Randomization will be conducted via the electronic randomization list., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Additional GDM management through social media, interventions name: Usual care, outcomesModule primaryOutcomes measure: Acceptance levels, primaryOutcomes measure: Satisfaction levels, secondaryOutcomes measure: Engagement levels, secondaryOutcomes measure: Appropriateness levels, secondaryOutcomes measure: Feasibility levels, secondaryOutcomes measure: Emotional wellbeing, secondaryOutcomes measure: Blood glucose levels, secondaryOutcomes measure: Proportion of participants with optimal blood glucose control, otherOutcomes measure: Confidence levels, otherOutcomes measure: Meal skipping, otherOutcomes measure: Proportion of participants with cigarette smoking, otherOutcomes measure: Proportion of participants with alcohol intake, otherOutcomes measure: Gestational weight gain rate, otherOutcomes measure: Proportion of participants with inappropriate weight gain, otherOutcomes measure: Motivational levels, otherOutcomes measure: Proportion of participants with induced labour, otherOutcomes measure: Proportion of participants with caesarean delivery, otherOutcomes measure: Birth weight, otherOutcomes measure: Birth length, otherOutcomes measure: Head circumference, otherOutcomes measure: Birth size-for-gestational age, otherOutcomes measure: Gestational length at birth, otherOutcomes measure: Proportion of participants with preterm delivery, otherOutcomes measure: Neonatal apgar score, otherOutcomes measure: Proportion of participants delivering healthy live birth, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06292858, orgStudyIdInfo id: IMB071703-101, briefTitle: Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-24, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Beijng Immunoah Pharma Tech Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors, conditionsModule conditions: Recurrent or Metastatic, Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 93, type: ESTIMATED, armsInterventionsModule interventions name: IMB071703 injection, outcomesModule primaryOutcomes measure: Incidence of adverse events/serious adverse event related with IMB071703 injection, primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of IMB071703 injection, secondaryOutcomes measure: Maximum measured plasma concentration (Cmax) of IMB071703 injection., secondaryOutcomes measure: Time to maximum plasma concentration (Tmax) of IMB071703 injection., secondaryOutcomes measure: Half-life (T1/2) of IMB071703 injection., secondaryOutcomes measure: Immunogenicity profile of IMB071703 injection., secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Oncology, Shanghai East Hospital, Tongji University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200120, country: China, contacts name: Ye Guo, Doctor, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06292845, orgStudyIdInfo id: 11272, briefTitle: Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents, acronym: SprayDye, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: This is a proof-of-principle study, that uses freshly resected human solid tumor specimens to assess the performance of topically applied fluorescent imaging agents for the detection of tumor tissue and close / tumor-positive resection margins ex vivo. Surgery will be performed in conformity with hospital protocol. The study will not interfere with the standard clinical care., conditionsModule conditions: Solid Tumor, Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Topical application of a fluorescent imaging agent, outcomesModule primaryOutcomes measure: Tumor-to-background ratio (TBR) of the fluorescence signal on the resection specimen surface and on 3-5 mm thick tissue slices., secondaryOutcomes measure: Imaging agent fluorescence signal intensity on close / tumor-positive resection planes compared with (wide) tumor-negative resection planes, as confirmed by histopathology, secondaryOutcomes measure: Difference in tumor-to-background ratio (TBR) between different imaging time windows, secondaryOutcomes measure: The concordance between the presence of tumor cells and fluorescence signal, secondaryOutcomes measure: Depth of the fluorescence signal on 4-μm tissue slides, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus University Medical Center, city: Rotterdam, state: Zuid-Holland, zip: 3015 GD, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False |
protocolSection identificationModule nctId: NCT06292832, orgStudyIdInfo id: MSR/AZAST/AIP029/22/222/8/2023, briefTitle: Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-09-10, completionDateStruct date: 2024-09-10, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS., conditionsModule conditions: Cesarean Section Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-guided pain block, interventions name: Ultrasound Machine, outcomesModule primaryOutcomes measure: postoperative time to rescue analgesia requirement, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Al-Azhar University, city: Assiut, country: Egypt, contacts name: Warda Ali, role: CONTACT, phone: 010300020456, email: [email protected], geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06292819, orgStudyIdInfo id: CMUH112-REC2-214, briefTitle: Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, descriptionModule briefSummary: The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events., conditionsModule conditions: Photobiomodulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Bright light, interventions name: Near-infrared light, interventions name: Bright light+ near-infrared light, outcomesModule primaryOutcomes measure: Actigraphy-derived sleep indicators, primaryOutcomes measure: Dim-light melatonin onset, primaryOutcomes measure: Sleep quality, primaryOutcomes measure: Emotional state, secondaryOutcomes measure: Daytime sleepiness, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06292806, orgStudyIdInfo id: 001-2024, briefTitle: Inhibin B/AFC Ratio for Ovarian Response, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Insemine Humen Reproduction Centre, class: NETWORK, descriptionModule briefSummary: Ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (IVF). Anti-müllerian hormone (AMH), inhibin B, and antral follicle count (AFC) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. Ovarian responsiveness can also be assessed through the Follicular Output Rate (FORT), which evaluates the proportion of follicles that developed during stimulation by the ratio of PFC (preovulatory follicle count) to AFC. FORT highlights that some follicles do not respond to the FSH; therefore, this project proposes an endocrinological approach to this issue by relating AFC to inhibin B and AMH ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. The inhibin B/AFC and AMH/AFC ratios correlated with FORT and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness.A prospective cohort study will be conducted with patients of the Insemine Center for Human Reproduction. Antral follicle count and AMH measurement will be performed before IVF cycle initiation, and inhibin B measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. The primary outcomes will be the Follicular Output Rate (FORT) and the number of oocytes retrieved. Secondary outcomes include the number of metaphase II oocytes, oocyte quality, fertilization rate and embryo quality., conditionsModule conditions: IVF, conditions: Infertility, Female, conditions: Ovulation Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: FSH-R, outcomesModule primaryOutcomes measure: serum Inhibin B levels, primaryOutcomes measure: serum Anti Mullerian Hormone levels, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06292793, orgStudyIdInfo id: STUDY00004696, briefTitle: Cyclical Sighing for Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2024-02-26, completionDateStruct date: 2024-02-26, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Florida State University, class: OTHER, descriptionModule briefSummary: This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 81, type: ACTUAL, armsInterventionsModule interventions name: Pain Coping Information, interventions name: Cyclical Sighing, outcomesModule primaryOutcomes measure: Change in Pain Unpleasantness Numeric Rating Scale, secondaryOutcomes measure: Change in Pain Intensity Numeric Rating Scale, secondaryOutcomes measure: Change in Anxiety Numeric Rating Scale, secondaryOutcomes measure: Change in Depression Numeric Rating Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tallahassee Orthopedic Clinic (TOC), city: Tallahassee, state: Florida, zip: 32308, country: United States, geoPoint lat: 30.43826, lon: -84.28073, hasResults: False |
protocolSection identificationModule nctId: NCT06292780, orgStudyIdInfo id: R5458-ONC-2274, secondaryIdInfos id: 2023-507809-34-00, type: OTHER, domain: EUCT Number, briefTitle: A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis), acronym: LINKER-AL2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2028-08-26, completionDateStruct date: 2035-02-26, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching an experimental drug called linvoseltamab ("study drug").This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.The study consists of 2 phases (Phase 1 and Phase 2):* In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2.* In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis.The study is looking at several other research questions, including:* How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long* How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long* What the right dosing regimen is for linvoseltamab* What side effects may happen from taking linvoseltamab* How much linvoseltamab is in your blood at different times* Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects), conditionsModule conditions: Relapsed/Refractory Systemic Light Chain Amyloidosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Note: Participants enrolled in Phase 2 will be randomized 1:1, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Linvoseltamab, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicity (DLTs), primaryOutcomes measure: Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC), secondaryOutcomes measure: Achievement of hematologic CR, as determined by the IRC, secondaryOutcomes measure: Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC, secondaryOutcomes measure: Achievement of overall hematologic response (PR or better), as determined by the IRC, secondaryOutcomes measure: Time to initial hematologic response, secondaryOutcomes measure: Time to best hematologic response, secondaryOutcomes measure: Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC, secondaryOutcomes measure: Hematologic progression-free survival (PFS), secondaryOutcomes measure: Incidence of death, secondaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Severity of TEAEs, secondaryOutcomes measure: Incidence of serious adverse events (SAEs), secondaryOutcomes measure: Severity of SAEs, secondaryOutcomes measure: Incidence of adverse events of special interest (AESIs), secondaryOutcomes measure: Severity of AESIs, secondaryOutcomes measure: Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2, secondaryOutcomes measure: Incidence of TEAEs in dose regimen 1 vs 2, secondaryOutcomes measure: Severity of TEAEs in dose regimen 1 vs 2, secondaryOutcomes measure: Incidence of SAEs in dose regimen 1 vs 2, secondaryOutcomes measure: Severity of SAEs in dose regimen 1 vs 2, secondaryOutcomes measure: Incidence of AESIs in dose regimen 1 vs 2, secondaryOutcomes measure: Severity of AESIs in dose regimen 1 vs 2, secondaryOutcomes measure: Time from treatment initiation to hematologic disease progression as determined by the IRC, secondaryOutcomes measure: Time from treatment initiation to cardiac deterioration, as determined by the IRC, secondaryOutcomes measure: Time from treatment initiation to kidney deterioration as determined by the IRC, secondaryOutcomes measure: Time from treatment initiation to death as determined by the IRC, secondaryOutcomes measure: Time from initiation of treatment to date of death from any cause, secondaryOutcomes measure: Achievement of renal response in participants with renal involvement at baseline, as determined by IRC, secondaryOutcomes measure: Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC, secondaryOutcomes measure: Time to first renal response in participants with renal involvement at baseline, secondaryOutcomes measure: Time to first cardiac response in participants with cardiac involvement at baseline, secondaryOutcomes measure: Linvoseltamab concentration in serum over time, secondaryOutcomes measure: Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time, secondaryOutcomes measure: Titers of ADAs to linvoseltamab over time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06292767, orgStudyIdInfo id: 2023/462, briefTitle: Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-04-25, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications., conditionsModule conditions: Postoperative Pulmonary Atelectasis, conditions: Pneumothorax, conditions: Pneumonia, conditions: Ards, conditions: Respiratory Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: mechanical power calculation, outcomesModule primaryOutcomes measure: mechanical power, secondaryOutcomes measure: mechanical power, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06292754, orgStudyIdInfo id: 2023.211, briefTitle: Rotator Cuff Repair With Magnesium Pin, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes., conditionsModule conditions: Arthroscopic Rotator Cuff Repair, 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: 40, type: ESTIMATED, armsInterventionsModule interventions name: magnesium pin in additional to the suture anchor, interventions name: routine suture anchor, outcomesModule primaryOutcomes measure: Imaging Examinations, primaryOutcomes measure: Cofield classification, primaryOutcomes measure: Sugaya Score, primaryOutcomes measure: Goutallier Classification, secondaryOutcomes measure: Height measurement, secondaryOutcomes measure: Weight measurement, secondaryOutcomes measure: BMI measurement, secondaryOutcomes measure: Shoulder flexibility (range of motion), secondaryOutcomes measure: Shoulder muscle strength, secondaryOutcomes measure: Western Ontario Rotator Cuff (WORC) Index Western Ontario Rotator Cuff (WORC) Index Index, secondaryOutcomes measure: Constant-Murley Score, secondaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: C-reactive protein measurement, secondaryOutcomes measure: Calcium (Ca) measurement, secondaryOutcomes measure: Magnesium (Mg) measurement, secondaryOutcomes measure: Phosphorous (P) measurement, secondaryOutcomes measure: Creatinine (Cr) measurement, secondaryOutcomes measure: Urea measurement, secondaryOutcomes measure: Alanine transaminase (ALT) measurement, secondaryOutcomes measure: Aspartate aminotransferase (AST) measurement, secondaryOutcomes measure: Total protein (TP) measurement, secondaryOutcomes measure: Albumin (ALB) measurement, secondaryOutcomes measure: Globulin (GLB) measurement, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Chinese University of Hong Kong, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06292741, orgStudyIdInfo id: 4956, briefTitle: Autonomic Involvement in Patient With Cognitive Decline, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-11, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline, conditionsModule conditions: Dementia, Mild, conditions: Dementia of Alzheimer Type, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Sudoscan, outcomesModule primaryOutcomes measure: evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia, secondaryOutcomes measure: correlation between the extent of autonomic involvement and the severity of cognitive decline, secondaryOutcomes measure: evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction., eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS, status: RECRUITING, city: Roma, state: Lazio, zip: 00168, country: Italy, contacts name: Camillo Marra, MD, role: CONTACT, phone: 0630154333, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06292728, orgStudyIdInfo id: ENDOPLY1, briefTitle: ENDOPLY System in Humans: a Pilot Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: ENDOPLY, class: OTHER, collaborators name: Just 4 Device s.r.o., descriptionModule briefSummary: Prospective, non-randomized study aimed at defining the initial pattern of gastric plication with the ENDOPLY System, and assess feasibility, ergonomics and safety of the device Prospective, single-centre, open label, consecutive enrolment, conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: ENDOPLY System, outcomesModule primaryOutcomes measure: Time of duration of the ENDOPLY System study procedure, primaryOutcomes measure: Number of ligatures placed by ENDOPLY System study procedure, primaryOutcomes measure: Gastric perforation events, primaryOutcomes measure: Gastrointestinal bleeding events, primaryOutcomes measure: Initial weight-loss, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Institut klinické a experimentální medicíny (IKEM), Klinika hepatogastroenterologie, city: Prague, zip: 14021, country: Czechia, contacts name: Evžen Machytka, MD, Ph.D., role: CONTACT, email: [email protected], contacts name: Evžen Machytka, MD, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False |
protocolSection identificationModule nctId: NCT06292715, orgStudyIdInfo id: Microwave Ablation01, briefTitle: Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism., conditionsModule conditions: Secondary Hypersplenism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: microwave ablation of the spleen, interventions name: Splenic artery balloon implantation, outcomesModule primaryOutcomes measure: Portal venous pressure, primaryOutcomes measure: Hepatic artery blood flow velocity, primaryOutcomes measure: Routine blood test, primaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Cancer Institute & Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300060, country: China, contacts name: Huikai Li, role: CONTACT, phone: +862223340123, phoneExt: 3091, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06292702, orgStudyIdInfo id: Modified Burch Colposuspension, briefTitle: Reducing Early Urinary Disorders After Stress Incontinence Surgery: The Role of Vaginal Wall Tension., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-10-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Damascus University, class: OTHER, descriptionModule briefSummary: The progress in surgical procedures for treating female stress urinary incontinence has led to the development of tension-free techniques such as the trans-obturator tape (TOT). Nonetheless, concerns regarding complications associated with the use of artificial mesh have sparked renewed interest in traditional retropubic suspension techniques (Burch). This study introduces a modified technique that creates lateral tension for the anterior vaginal wall before the conventional suspending to the Cooper ligament, limiting the tension on the urethra and reducing the risk of postoperative urinary voiding dysfunction with the same success rates. This technique offers the advantages of a tension-free procedure while still providing the benefits of retropubic suspension. Moreover, this modified technique eliminates the need for artificial mesh, reducing the risk of associated complications. This promising alternative offers effective support for the urethra and reduces postoperative emptying disorders. However, further research and studies are necessary to validate the long-term efficacy and safety of this modified technique., conditionsModule conditions: Stress Urinary Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: Traditional Burch colposuspension, interventions name: Modified Burch colposuspension, outcomesModule primaryOutcomes measure: Subjective voiding dysfunction after surgery, first evaluation, primaryOutcomes measure: Urinary peak flow rate after surgery, first evaluation, primaryOutcomes measure: Residual urine after surgery, first evaluation, primaryOutcomes measure: Urinary retention after surgery, first evaluation, primaryOutcomes measure: Subjective voiding dysfunction after surgery, second evaluation, primaryOutcomes measure: Urinary peak flow rate after surgery, second evaluation, primaryOutcomes measure: Residual urine after surgery, second evaluation, primaryOutcomes measure: Urinary retention after surgery, second evaluation, primaryOutcomes measure: Subjective voiding dysfunction after surgery, third evaluation, primaryOutcomes measure: Urinary peak flow rate after surgery, third evaluation, primaryOutcomes measure: Residual urine after surgery, third evaluation, primaryOutcomes measure: Urinary retention after surgery, third evaluation, secondaryOutcomes measure: Subjective recovery from urinary incontinence, first evaluation, secondaryOutcomes measure: Objective recovery from urinary incontinence, first evaluation, secondaryOutcomes measure: Subjective recovery from urinary incontinence, second evaluation, secondaryOutcomes measure: Objective recovery from urinary incontinence, second evaluation, secondaryOutcomes measure: Subjective recovery from urinary incontinence, third evaluation, secondaryOutcomes measure: Objective recovery from urinary incontinence, third evaluation, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Damascus university, city: Damascus, country: Syrian Arab Republic, geoPoint lat: 33.5102, lon: 36.29128, hasResults: False |
protocolSection identificationModule nctId: NCT06292689, orgStudyIdInfo id: IRB-2024-5(IIT), briefTitle: A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2026-03-22, completionDateStruct date: 2027-03-22, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, collaborators name: Akeso, collaborators name: Innovent Biologics, Inc., descriptionModule briefSummary: To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment., conditionsModule conditions: Vulvar and Vaginal 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: Cardunolizumab, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Adverse events (AEs), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, city: Hangzhou, state: Zhejiang, zip: 310005, country: China, contacts name: Hanmei Lou, MD., role: CONTACT, phone: +8619817462599, email: [email protected], contacts name: Hanmei Lou, MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06292676, orgStudyIdInfo id: ObGynEASC004, briefTitle: Emergency Home Delivery. Learning Skills for Medical Doctors and Nurses. Kirkpatrick Levels of Learning, acronym: ERdeliv, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: G. d'Annunzio University, class: OTHER, descriptionModule briefSummary: Mannequin training for emergency home delivery on medical doctors and nurses, conditionsModule conditions: Home Birth Delivery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: skills retained for home birth delivery in emergency, outcomesModule primaryOutcomes measure: Kirkpatrick levels improvement, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Claudio Celentano, status: RECRUITING, city: Pescara, state: Italia, zip: 65100, country: Italy, contacts name: Claudio Celentano, MD, role: CONTACT, phone: 3285577305, email: [email protected], geoPoint lat: 42.4584, lon: 14.20283, hasResults: False |
protocolSection identificationModule nctId: NCT06292663, orgStudyIdInfo id: EMN-2023-08767, briefTitle: Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety?, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Zealand University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test and learn about Virtual Reality (VR) providing preoperative information to patients undergoing elective TKA surgery in spinal anesthesia. The main question(s) aim(s) to answer if:* Can preoperative information through a VR headset lower the patients preoperative anxiety?* Can VR information make the patients more ready for surgery. Painscore will also be collected.Participants will be randomized into two groups. One that will have preoperative information through VR versus standard information.If there is a comparison group: Researchers will compare enrolled TKA patients to see if VR have an impact on anxiety, readiness and pain, conditionsModule conditions: Anxiety, conditions: Surgery, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The subjects are being randomized to one of two groups., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The primary investigator will stay blinded in this study and an assistant to the investigator is screening and including the patients and collecting data., whoMasked: INVESTIGATOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality, outcomesModule primaryOutcomes measure: Preoperative anxiety, secondaryOutcomes measure: Cumulative sedative consumption, secondaryOutcomes measure: Opioid consumption, secondaryOutcomes measure: Patient preoperatively expectations, secondaryOutcomes measure: Patient preoperatively readiness, secondaryOutcomes measure: Adverse events, otherOutcomes measure: Level of pain, otherOutcomes measure: The need for information, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zealand University Hospital, status: RECRUITING, city: Køge, state: Zealand, zip: 4600, country: Denmark, contacts name: Karsten Lomholt Lassen, CRNA, role: CONTACT, phone: 26131350, email: [email protected], contacts name: Nanna Wagner Christiansen, B.Eng, role: CONTACT, phone: 40306799, email: [email protected], contacts name: Karsten Lomholt Lassen, Ph.D Student, CRNA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.45802, lon: 12.18214, hasResults: False |
protocolSection identificationModule nctId: NCT06292650, orgStudyIdInfo id: ZM-02, briefTitle: Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients, acronym: ZM-02, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2027-12-25, completionDateStruct date: 2028-12-25, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Zhongmou Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This trial is meant to evaluate the safety and efficacy of ZM-02 in Retinitis pigmentosa (RP) patients. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye., conditionsModule conditions: Retinitis Pigmentosa, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: ZM-02-L, interventions name: ZM-02-H, interventions name: ZM-02-S, outcomesModule primaryOutcomes measure: Incidence of adverse events and serious adverse events, primaryOutcomes measure: Changes in intraocular pressure (IOP) in Subjects, secondaryOutcomes measure: Change of FST outcome, secondaryOutcomes measure: Change of MLMT level, secondaryOutcomes measure: Change of Quality of Life, otherOutcomes measure: Change in best corrected visual acuity (BCVA), otherOutcomes measure: Change in visual field (VF), otherOutcomes measure: Change in Fundus Autofluorescence (FAF), otherOutcomes measure: Change in central foveal thickness (CFT) using Optical Coherence Tomography (OCT), otherOutcomes measure: Change in central macular thickness (CMT) using Optical Coherence Tomography (OCT), otherOutcomes measure: Changes in the fundus using fundus color photography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tongren Hospital of Capital Medical University, city: Beijing, state: Beijing, country: China, contacts name: Pei Cao, role: CONTACT, phone: +86 18707134160, email: [email protected], contacts name: Yin Shen, role: CONTACT, contacts name: Wenbin Wei, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Laichun Lu, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06292637, orgStudyIdInfo id: 2020-1484, secondaryIdInfos id: A545000, type: OTHER, domain: UW Madison, secondaryIdInfos id: NUR/FACULTY AFFAIRS/ADMIN, type: OTHER, domain: UW Madison, secondaryIdInfos id: Protocol Version 4/4/2024, type: OTHER, domain: UW Madison, secondaryIdInfos id: 1R01HS029477-01, type: AHRQ, link: https://reporter.nih.gov/quickSearch/1R01HS029477-01, briefTitle: Cognitive Behavioral and Faith Fellowship to Improve Thy Health, acronym: CB-FAITH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: Agency for Healthcare Research and Quality (AHRQ), descriptionModule briefSummary: Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized stepped wedge design (R-SWD), a type of cluster randomized controlled trial, will be used to randomize a cluster (church groups with a group of 10 participants), not individual subjects.At the start of a R-SWD, all clusters begin as control groups. At certain time points during the course of the trial, some of the clusters are randomly selected to be switched to the CB-FAITH treatment, with all clusters eventually crossing over to receive the treatment. The sample will be comprised of 12 groups, each with 10 individuals (N=120)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH), outcomesModule primaryOutcomes measure: Patient Health Questionnaire, primaryOutcomes measure: Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR), secondaryOutcomes measure: Multidimensional Measure of Religious Involvement (MMRI) score, secondaryOutcomes measure: Client Satisfaction Inventory (CSI) score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Baptist Church, city: Madison, state: Wisconsin, zip: 53711-3800, country: United States, contacts name: Anthony Wade, role: CONTACT, phone: 608-278-1430, email: [email protected], contacts name: Anthony Wade, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, locations facility: The Board of Regents of the UW System, city: Madison, state: Wisconsin, zip: 53715-1218, country: United States, contacts name: Earlise Ward, PhD, role: CONTACT, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False |
protocolSection identificationModule nctId: NCT06292624, orgStudyIdInfo id: HSEARS20230417002, briefTitle: Effectiveness of Intermittent Vacuum Therapy Combined With Aerobic Exercise in Individuals With Diabetes Mellitus, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, collaborators name: Yan Chai Hospital Social Services, descriptionModule briefSummary: Consequences of the compromised vascular system in diabetes mellitus (DM) are among the most devastating complications. Reduction in blood flow and oxygen uptake of skeletal muscle leads to muscle fatigue and impaired skeletal muscle post-exercise adaptation. Recent studies showed that intermittent vacuum therapy (IVT) augments the blood flow of the foot in people with DM. This pilot study investigates the effects of combined IVT and aerobic exercise in improving lower limb muscle oxygenation and distal circulation in individuals with DM. Positive results of the study shed light on strategy that enhances the effectiveness of aerobic exercise in people with DM., conditionsModule conditions: Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Clinical trials with a single arm, receiving IVT combined with cycling exercise, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: Intermittent vacuum therapy (Weyergans High Care® Medial, Germany), interventions name: Cycling exercise, outcomesModule primaryOutcomes measure: Muscle oxygenation, primaryOutcomes measure: Muscle oxygenation, secondaryOutcomes measure: Surface Electromyography, secondaryOutcomes measure: Surface Electromyography, secondaryOutcomes measure: Foot Sensation, secondaryOutcomes measure: Foot Sensation, secondaryOutcomes measure: Functional muscle strength, secondaryOutcomes measure: Functional muscle strength, secondaryOutcomes measure: Functional mobility, secondaryOutcomes measure: Functional mobility, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06292611, orgStudyIdInfo id: ST-23-U35, briefTitle: Two Week Cumulative Extrinsic Stain Removal of a Battery-powered Toothbrush and a Manual Toothbrush, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2023-12-12, completionDateStruct date: 2024-01-25, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Church & Dwight Company, Inc., class: INDUSTRY, descriptionModule briefSummary: To evaluate and compare the extrinsic stain removal efficacy of a battery-powered toothbrush and a manual toothbrush following two weeks of brushing., conditionsModule conditions: Dental Devices, Home Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 102, type: ACTUAL, armsInterventionsModule interventions name: Battery operated toothbrush, interventions name: Manual toothbrush, outcomesModule primaryOutcomes measure: Extrinsic Stain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Salus Research, Inc., city: Fort Wayne, state: Indiana, zip: 46825, country: United States, geoPoint lat: 41.1306, lon: -85.12886, hasResults: False |
protocolSection identificationModule nctId: NCT06292598, orgStudyIdInfo id: AOI2022/2023/CDR-01, briefTitle: Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Versus a Control Population, acronym: NARCOBIOTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: Narcolepsy type 1 (NT1) is a rare disease characterized by severe drowsiness, cataplexy, hypnagogic hallucinations, sleep paralysis, poor night sleep, and often obesity. NT1 is caused by irreversible loss of orexin (ORX)/hypocretin neurons in the lateral hypothalamus with decreased ORX levels in the cerebrospinal fluid (CSF). Although the underlying process leading to this destruction remains unclear; an autoimmune origin is suspected.The study authors recently compared the bacterial communities of the fecal microbiota of NT1 patients and control subjects. Initial results demonstrated a difference in overall bacterial community structure in NT1 compared to controls, as assessed by beta diversity, even after adjusting for body mass index (BMI). The Shannon biodiversity index was also correlated with the duration of NT1 disease. However, no association was found between the structure of the microbial community and the clinical characteristics of NT1 patients.In 2022, a second study from the SOMNOBANK cohort on a larger population confirmed these results, showing dysbiosis between NT1 patients and the control population. The altered intestinal microbial diversity supports the important role of the environment in the development and pathogenesis of NT1. Other studies have established a link between dysbiosis, intestinal permeability and inflammation in other neuroimmune pathologies. Currently, no study has focused on these phenomena of bacterial translocation, intestinal permeability and immune activation linked to the microbiota in type 1 narcolepsy patients.The study hypothesis is that NT1 patients with dysbiosis in their intestinal microbiota also present a bacterial translocation with an intestinal origin, leading to a systemic inflammatory syndrome favoring an autoimmune damage destroying hypocretin neurons in the hypothalamus. The study authors suspect that microbial elements (DNA) involved in the autoimmune process could be detected in the CSF. This bacterial translocation could vary over time depending on: i) the progression of the disease and its management; ii) changing dysbiosis and: iii) the increase in intestinal permeability and inflammation., conditionsModule conditions: Narcolepsy Type 1, conditions: Bacterial Translocation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample, interventions name: Stool sample, interventions name: CSF sample, outcomesModule primaryOutcomes measure: Plasma bacterial translocation profiles between groups, secondaryOutcomes measure: Plasma bacterial translocation profiles in NT1 patients, secondaryOutcomes measure: Taxonomic characteristics of DNA in the CSF of NT1 patients according to narcolepsy severity, secondaryOutcomes measure: Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation, secondaryOutcomes measure: Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation, secondaryOutcomes measure: Beta diversity of the intestinal microbiota between groups, secondaryOutcomes measure: Beta diversity of the intestinal microbiota in NT1 patients, secondaryOutcomes measure: Alpha diversity of the intestinal microbiota between groups, secondaryOutcomes measure: Alpha diversity of the intestinal microbiota in NT1 patients, secondaryOutcomes measure: Composition of the intestinal microbiota between groups, secondaryOutcomes measure: Composition of the intestinal microbiota between groups, secondaryOutcomes measure: Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile between groups, secondaryOutcomes measure: Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile in NT1 patients, secondaryOutcomes measure: Plasma LPS-binding Protein (LBP) profile between groups, secondaryOutcomes measure: Plasma LPS-binding Protein (LBP) profile in NT1 patients, secondaryOutcomes measure: Plasma Soluble CD14 profile between groups, secondaryOutcomes measure: Plasma Soluble CD14 profile in NT1 patients, secondaryOutcomes measure: Age of onset of symptoms in NT1 patients, secondaryOutcomes measure: Duration of disease progression in NT1 patients, secondaryOutcomes measure: Severity of sleep-related symptoms in NT1 patients, secondaryOutcomes measure: Severity of narcolepsy symptoms in NT1 patients, secondaryOutcomes measure: Description of comorbidities in NT1 patients, secondaryOutcomes measure: Sleep onset latency in NT1 patients, secondaryOutcomes measure: Number of rapid eye movement sleep episodes in NT1 patients, secondaryOutcomes measure: Orexin levels in CSF in NT1 patients, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nîmes University Hospital, city: Nîmes, state: Gard, zip: 30029, country: France, contacts name: Anissa MEGZARI, role: CONTACT, phone: +33 4 66 68 42 36, email: [email protected], contacts name: Catherine DUNYACH-REMY, role: PRINCIPAL_INVESTIGATOR, contacts name: Jean-Philippe LAVIGNE, role: SUB_INVESTIGATOR, contacts name: Béatrix ABRIL, role: SUB_INVESTIGATOR, geoPoint lat: 43.83333, lon: 4.35, locations facility: Centre Hospitalier Universitaire de Montpellier, city: Montpellier, country: France, contacts name: Yves DAUVILLIERS, role: CONTACT, email: [email protected], contacts name: Yves DAUVILLIERS, role: PRINCIPAL_INVESTIGATOR, contacts name: Lucie BARATEAU, role: SUB_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False |
protocolSection identificationModule nctId: NCT06292585, orgStudyIdInfo id: AEDH-MT, briefTitle: Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, descriptionModule briefSummary: A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study., conditionsModule conditions: EpiDural Hematoma, conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: MMA embolization plus medical therapy, interventions name: Medical therapy alone, outcomesModule primaryOutcomes measure: The proportion of patients who die within 72 hours after injury or progress to require craniotomy due to epidural hematoma., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai hospital, city: Shanghai, state: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06292572, orgStudyIdInfo id: 2024PI029, briefTitle: Clinical Characteristics and Surgical Outcomes of the Fellow Eye in Bilateral Retinal Detachments, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: To assess the clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments, conditionsModule conditions: Retinal Detachment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Retinal Detachment Surgery, outcomesModule primaryOutcomes measure: Rate of surgical success, secondaryOutcomes measure: Visual Acuity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU de Nancy, city: Vandoeuvre les nancy, state: Meurthe-et-Moselle, zip: 54511, country: France, geoPoint lat: 48.65, lon: 6.18333, hasResults: False |
protocolSection identificationModule nctId: NCT06292559, orgStudyIdInfo id: STN or GPi in Meige Syndrom, briefTitle: A Comparison Between STN-DBS and GPi-DBS in Meige Syndrome Evaluated by Flexible Electrodes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-30, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are both accepted targets for this treatment. Researchers designed this study to compare the 12-month outcomes for patients who undergo bilateral stimulation of the GPi or STN., conditionsModule conditions: Meige Syndrome, 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: 100, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral STN deep brain stimulation, interventions name: Bilateral GPi deep brain stimulation, outcomesModule primaryOutcomes measure: Change in motor function, secondaryOutcomes measure: health-related quality of life, secondaryOutcomes measure: sleep quality status, secondaryOutcomes measure: Mental syndrome, secondaryOutcomes measure: Mental syndrome, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chao Zhang, status: RECRUITING, city: Jinan, state: Sichuan, zip: 250100, country: China, contacts name: chao zhang, role: CONTACT, phone: +8613969007232, email: [email protected], geoPoint lat: 36.66833, lon: 116.99722, hasResults: False |
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