data
stringlengths 358
232k
|
|---|
protocolSection identificationModule nctId: NCT06286033, orgStudyIdInfo id: AG181-C-001, briefTitle: A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Agios Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: AG-181, interventions name: Placebo, outcomesModule primaryOutcomes measure: SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug, primaryOutcomes measure: MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug, primaryOutcomes measure: Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181, primaryOutcomes measure: Food Effect: Area Under the Concentration-time Curves (AUCs) of AG-181, primaryOutcomes measure: Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181, primaryOutcomes measure: Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181, primaryOutcomes measure: Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181, primaryOutcomes measure: Food Effect: Apparent Oral Clearance (CL/F) of AG-181, primaryOutcomes measure: Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181, secondaryOutcomes measure: SAD: Maximum Observed Plasma Concentration (Cmax) of AG-181, secondaryOutcomes measure: SAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181, secondaryOutcomes measure: SAD: Terminal Elimination Rate Constant (Kel) of AG-181, secondaryOutcomes measure: SAD: Terminal Elimination Half-Life (t1/2) of AG-181, secondaryOutcomes measure: SAD: Area Under the Concentration-time Curves (AUCs) of AG-181, secondaryOutcomes measure: SAD: Apparent Oral Clearance (CL/F) of AG-181, secondaryOutcomes measure: SAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181, secondaryOutcomes measure: SAD: Renal Clearance (CLR) of AG-181, secondaryOutcomes measure: SAD: Total Percent of AG-181 Dose Excreted Unchanged in Urine (Fet%), secondaryOutcomes measure: SAD: Percent of AG-181 Dose Excreted Unchanged in Urine Between Time 1 and Time 2 (Fet1-t2%), secondaryOutcomes measure: SAD: Cumulative Amount of AG-181 Drug Excreted in Urine (Ae0-t), secondaryOutcomes measure: SAD: Amount of AG-181 Drug Excreted in Urine Between Time 1 and Time 2 (Aet1-t2), secondaryOutcomes measure: MAD: Maximum Observed Plasma Concentration (Cmax) of AG-181, secondaryOutcomes measure: MAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181, secondaryOutcomes measure: MAD: Terminal Elimination Rate Constant (Kel) of AG-181, secondaryOutcomes measure: MAD: Terminal Elimination Half-Life (t1/2) of AG-181, secondaryOutcomes measure: MAD: Area Under the Concentration-time Curve (AUC) of AG-181, secondaryOutcomes measure: MAD: Apparent Oral Clearance (CL/F) of AG-181, secondaryOutcomes measure: MAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181, secondaryOutcomes measure: MAD: Time to Maximum Observed Plasma Concentration at Steady State (Cmax_ss) of AG-181, secondaryOutcomes measure: MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181, secondaryOutcomes measure: MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181, secondaryOutcomes measure: Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ICON 1255 East 3900 South, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84124, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False |
protocolSection identificationModule nctId: NCT06286020, orgStudyIdInfo id: VR-Zhenqiu, briefTitle: Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy., conditionsModule conditions: Wallenberg Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality Therapy, interventions name: Conventional dysphagia treatment, outcomesModule primaryOutcomes measure: standardized swallowing assessment, secondaryOutcomes measure: Murray secretion scale, secondaryOutcomes measure: Rosenbek penetration-aspiration scale, secondaryOutcomes measure: swallowing-quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinzhu Rehabilitation Hospital, status: RECRUITING, city: Xinzhu, country: Taiwan, contacts name: Haim Liu, role: CONTACT, geoPoint lat: 22.46205, lon: 120.47335, hasResults: False |
protocolSection identificationModule nctId: NCT06286007, orgStudyIdInfo id: PRIPASCO-2023, briefTitle: Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control, acronym: PRIPASCO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-21, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Hospital Clinico Universitario de Santiago, class: OTHER, collaborators name: Translational Research In Airway Diseases Group (TRIAD), collaborators name: CIBER of Respiratory Diseases CIBERES, collaborators name: Complexo Hospitalario Universitario de A Coruña, collaborators name: Hospital de Galdakao, collaborators name: Hospital Universitario Doctor Peset, collaborators name: Hospital San Pedro de Alcantara, collaborators name: Hospital Universitario Marqués de Valdecilla, collaborators name: Hospital Universitario Vall d´Hebron, collaborators name: Universitat Autonoma de Barcelona, collaborators name: Universidade de Santiago de Compostela, collaborators name: Consortium for Biomedical Research in Epidemiology and Public Health, collaborators name: Hospital Universitario Virgen del Rocio, collaborators name: Hospital de La Princesa, collaborators name: University Hospital Virgen de las Nieves, collaborators name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, collaborators name: Germans Trias i Pujol Hospital, collaborators name: Hospital Universitario de Navarra, collaborators name: Hospital Universitario de Jerez de la Frontera, collaborators name: Hospital El Bierzo, collaborators name: Hospital Clinico Universitario San Cecilio, collaborators name: Hospital Universitario Donostia, collaborators name: Hospital Universitario Central de Asturias, collaborators name: Hospital Universitario de la Ribera, collaborators name: Hospital Costa del Sol, collaborators name: Hospital General Universitario Dr. Balmis, collaborators name: Hospital de Sagunto, collaborators name: Hospital Lluis Alcanyís de Xàtiva, collaborators name: Hospital Universitario Lucus Augusti, collaborators name: Hospital del Mar, collaborators name: Hospital Clínico Universitario Virgen de la Arrixaca, collaborators name: Hospital Clinic of Barcelona, descriptionModule briefSummary: The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI).A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up, conditionsModule conditions: Asthma, conditions: Pertussis, conditions: RSV Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 784, type: ESTIMATED, armsInterventionsModule interventions name: PCR, outcomesModule primaryOutcomes measure: Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,, secondaryOutcomes measure: To describe the seroprevalence of Bordetella pertussis in adult patients with asthma, secondaryOutcomes measure: To describe the seroprevalence of RSV in adult patients with asthma, secondaryOutcomes measure: To evaluate the severity and control of the asthma caused by either BP or RSV infection, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínico Universitario de Santiago de Compostela, status: RECRUITING, city: Santiago De Compostela, state: A Coruña, zip: 15706, country: Spain, contacts name: Francisco Javier González Barcala, Ph.D., role: CONTACT, email: [email protected], geoPoint lat: 42.88052, lon: -8.54569, hasResults: False |
protocolSection identificationModule nctId: NCT06285994, orgStudyIdInfo id: SRB2024016, briefTitle: Complications of High Frequency Jet Ventilation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Erasme University Hospital, class: OTHER, descriptionModule briefSummary: High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as:* Hypoxia: SpO2 \< 90% for 1 min* Severe hypoxia: SpO2 \< 85% for 1 min* Hemodynamic instability, defined as Arterial pressure \< 90/60* Cardiac arrhythmia* Laryngospasm or bronchospasm* Barotrauma or volutrauma* Need for ICU admissionA model predicting the risk for developing any complication will be developped using 2 mathematical methods:* a multivariate analysis* a data mining approachFor both approaches, the following variables will be included in the model:* Age* Gender* Weight* Height* BMI* Smoking* Alcohol consumption* Consumption of Other drugs* ASA class* Obstructive pulmonary disease* Restrictive lung disease* COPD status (1, 2, 3, 4)* Interstitial lung disease* Lung tumor * Trachea location * Carina location * Bronchial location* Pulmonary or tracheal stenosis* Presence of stridor* Severe stenosis (\< 6 mm)* Baseline SpO2 (pre-intervention)* Pre-intervention oxygen requirement Procedure* Duration (min)* Stent placement* Dilation* Laser treatment* Length of hospital stay Lung function tests* FEV1 (forced expiratory volume)* VC (Vital Capacity)* FEV1/VC (Tiffeneau ratio)* CPT (total lung capacity)* DLCO (carbon monoxide diffusion), conditionsModule conditions: High-Frequency Jet Ventilation, conditions: Bronchoscopy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: High frequency jet ventilation, outcomesModule primaryOutcomes measure: Occurence of complications, secondaryOutcomes measure: Prediction model of complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Universitaire de Bruxelles - Hôpital erasme, status: RECRUITING, city: Brussels, zip: 1070, country: Belgium, contacts name: Denis Schmartz, MD, role: CONTACT, phone: +3225553919, email: [email protected], geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06285981, orgStudyIdInfo id: OCI_2206, briefTitle: Retrospective Study Chimaera Long Nail in Adult Patient, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Orthofix s.r.l., class: INDUSTRY, descriptionModule briefSummary: The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice., conditionsModule conditions: Pertrochanteric Fracture of Femur, conditions: Intertrochanteric Fracture of Femur, conditions: Subtrochanteric Fracture of Femur, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Chimaera Long Nail, outcomesModule primaryOutcomes measure: percent of patients in wich bone union has been achieved, secondaryOutcomes measure: percent of patients that required a reoperation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AORN Sant'Anna e San Sebastiano, status: NOT_YET_RECRUITING, city: Caserta, state: CE, zip: 81100, country: Italy, contacts name: Gaetano Bruno, role: CONTACT, phone: 0823 232111, geoPoint lat: 41.07262, lon: 14.33231, locations facility: Craeggi Hospital, status: RECRUITING, city: Florence, state: FI, zip: 50134, country: Italy, contacts name: Roberto Civinini, role: CONTACT, phone: 055 794 111, geoPoint lat: 43.77925, lon: 11.24626, hasResults: False |
protocolSection identificationModule nctId: NCT06285968, orgStudyIdInfo id: AAAU8937, secondaryIdInfos id: P50MD017341, type: NIH, link: https://reporter.nih.gov/quickSearch/P50MD017341, briefTitle: The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Columbia University, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The purpose of this randomized controlled trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in Hispanic/Latina/o/x adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention., conditionsModule conditions: Blood Pressure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Multidimensional Sleep Health Promotion Intervention, outcomesModule primaryOutcomes measure: Change in office systolic blood pressure, secondaryOutcomes measure: Change in office systolic blood pressure (sustained effect at 24 weeks), secondaryOutcomes measure: Change in office diastolic blood pressure, secondaryOutcomes measure: Change in out-of-office blood pressure, secondaryOutcomes measure: Change in fasting glucose, secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in diet quality, secondaryOutcomes measure: Change in sleep health, secondaryOutcomes measure: Acceptability of Implementation, secondaryOutcomes measure: Feasibility of Implementation, secondaryOutcomes measure: Appropriateness of Implementation, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Columbia University Irving Medical Center, Mailman School of Public Health, status: RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts name: Nour Makarem, PhD, role: CONTACT, email: [email protected], geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06285955, orgStudyIdInfo id: 307-reinforced teeth, briefTitle: Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Beijing 302 Hospital, class: OTHER, descriptionModule briefSummary: Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate., conditionsModule conditions: Pilot Study, conditions: Clips, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, outcomesModule primaryOutcomes measure: Clinical success rate, secondaryOutcomes measure: Technical success rate, secondaryOutcomes measure: Delayed bleeding rate, secondaryOutcomes measure: Delayed perforation rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The fifth Medical Center of Chinese PLA General Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100071, country: China, contacts name: Jindong Chu, MD, role: CONTACT, phone: +8615811201126, email: [email protected], contacts name: Shuqian Hu, role: CONTACT, phone: +8618526504112, email: [email protected], contacts name: Yan Liu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06285942, orgStudyIdInfo id: 277.535, secondaryIdInfos id: CE366/2023, type: REGISTRY, domain: CET AOU Maggiore della Carità di Novara, briefTitle: EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation, acronym: ORIGAMI II, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH.Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation.The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months., conditionsModule conditions: Atrial Fibrillation, conditions: Fragility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: An interim-analysis will be performed on the primary endpoint when at least 50% of patients will have been randomized and completed the 6 months follow-up. The interim-analysis will be performed by an independent statistician, blinded for the treatment allocation. The statistician will report to the independent data and safety monitoring board, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: Edoxaban, interventions name: No Edoxaban, outcomesModule primaryOutcomes measure: Difference in Anti-Clot treatment scale (ACTS) questionnaire results among the two groups assessed at 6 and 12 months., secondaryOutcomes measure: Number of cardio-embolic events at 6 and12 months, secondaryOutcomes measure: Number of bleeding events, secondaryOutcomes measure: Assessment of drugs efficacy by measuring the anti-factor Xa activity, secondaryOutcomes measure: Assessment of drugs efficacy by measuring the thrombin generation, secondaryOutcomes measure: Assess the quality of life, secondaryOutcomes measure: Cost-effectiveness analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Policlinico San Martino, status: RECRUITING, city: Genova, zip: 16132, country: Italy, contacts name: Pietro Ameri, Prof, role: CONTACT, phone: +39 010 3538975, email: [email protected], geoPoint lat: 44.40478, lon: 8.94438, locations facility: AOU Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Domenico D'Amario, Prof, role: CONTACT, phone: 0039 0321 3733141, email: [email protected], geoPoint lat: 45.44694, lon: 8.62118, locations facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: Cristiano Spada, Prof, role: CONTACT, phone: 06 30151, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06285929, orgStudyIdInfo id: 2013209-1, briefTitle: ACS Community Access to Resources Education and Support, acronym: ACS CARES, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: American Cancer Society, Inc., class: OTHER, collaborators name: University of Alabama at Birmingham, descriptionModule briefSummary: The goal of this study is to evaluate the pilot phase of ACS Cares to identify key implementation outcomes and assess effectiveness of the program to improve distress, enhance communication, and reduce missed appointments and healthcare utilization., conditionsModule conditions: Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: ACS CARES Student Navigation, outcomesModule primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers, primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: Information Needs, primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: Distress needs, primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program, primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs, primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication, primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge, primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: Patient activation, primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity, primaryOutcomes measure: Measure the impact of ACS CARES on patient-reported outcomes: Quality of life, primaryOutcomes measure: Context, Training, and Process Measures: Service Penetrance and Process Measures: Service Penetrance, secondaryOutcomes measure: Sociodemographic differences between ACS CARES supported and non-ACS CAREs supported patients, secondaryOutcomes measure: Impact of ACS CARES on treatment adherence and healthcare, secondaryOutcomes measure: Context, Training, and Process Measures: Volunteer Satisfaction, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA Health, city: Los Angeles, state: California, zip: 90024, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: American Cancer Society, city: Kennesaw, state: Georgia, zip: 30144, country: United States, geoPoint lat: 34.02343, lon: -84.61549, locations facility: University of Iowa Health Care, city: Iowa City, state: Iowa, zip: 52242, country: United States, geoPoint lat: 41.66113, lon: -91.53017, locations facility: Medical University Hospital Authority, Hollings Cancer Center, city: Charleston, state: South Carolina, zip: 29492, country: United States, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False |
protocolSection identificationModule nctId: NCT06285916, orgStudyIdInfo id: NORA520-PT-US-1a, briefTitle: A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression, acronym: NuMom, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Gerbera Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:* How well NORA520 is tolerated and what side effects it may cause* If NORA520 reduces depressive symptoms in subjects with severe PPD* The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken* In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days., conditionsModule conditions: Depression, Postpartum, conditions: Postpartum Depression, conditions: Post-partum Depression, conditions: Postnatal Depression, conditions: Post-Natal Depression, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: NORA520 Dose 1, interventions name: NORA520 Dose 2, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence, severity, and causality of AEs, SAEs, and AESIs, primaryOutcomes measure: Change from baseline in HAM-D17 total score compared to placebo, secondaryOutcomes measure: Change from baseline in HAM-D17 total score, secondaryOutcomes measure: HAM-D17 response, secondaryOutcomes measure: HAM-D17 remission, secondaryOutcomes measure: Change from baseline in HAM-D17 subscale and individual item scores, secondaryOutcomes measure: Change from baseline in Clinical Global Impression - Severity (CGI-S) score, secondaryOutcomes measure: Clinical Global Impression - Improvement (CGI-I) scale positive response, secondaryOutcomes measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, secondaryOutcomes measure: Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score, secondaryOutcomes measure: Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score, secondaryOutcomes measure: Number of patients who start any new antidepressant or anti-anxiety medication, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gerbera site, city: Canoga Park, state: California, zip: 91304, country: United States, geoPoint lat: 34.20112, lon: -118.59814, locations facility: Gerbera sites, city: Miami Gardens, state: Florida, zip: 33014, country: United States, geoPoint lat: 25.94298, lon: -80.24452, locations facility: Gerbera site, city: Orlando, state: Florida, zip: 32807, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Gerbera site, city: Saint Petersburg, state: Florida, zip: 33607, country: United States, geoPoint lat: 27.77086, lon: -82.67927, locations facility: Gerbera site, city: League City, state: Texas, zip: 77573, country: United States, geoPoint lat: 29.50745, lon: -95.09493, locations facility: Gerbera site, city: Richardson, state: Texas, zip: 75080, country: United States, geoPoint lat: 32.94818, lon: -96.72972, hasResults: False |
protocolSection identificationModule nctId: NCT06285903, orgStudyIdInfo id: AUAREC20220002-11, briefTitle: Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing, acronym: RCT, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-02, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone sur-rounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain, conditionsModule conditions: Bone Density, Low, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to de-termine implant stability by recording the values of implant stability quotient (ISQ) im-mediately after implant placement and after 3 months. CBCT was performed before, af-ter 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 months and after 12 months via CBCT., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: internal sinus lift surgery, outcomesModule primaryOutcomes measure: Implant stability using the Osstell device by percentage, secondaryOutcomes measure: Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm, otherOutcomes measure: Bone Densityby mm, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alazhar university ,Assuit branch ,Egypt, city: Assiut, state: Assuit, zip: 0000, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06285890, orgStudyIdInfo id: 2023-1016, secondaryIdInfos id: NCI-2024-01733, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: HiberCell, Inc., descriptionModule briefSummary: To find a recommended dose of HC-7366 that can be given in combination with azacitidine and venetoclax to patients with AML. The safety and effects of this drug combination will also be studied., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: HC-7366, interventions name: Azacitidine, interventions name: Venetoclax, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Abhishek Maiti, MD, role: CONTACT, phone: 346-725-0901, email: [email protected], contacts name: Abhishek Maiti, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06285877, orgStudyIdInfo id: 291120234382023, briefTitle: Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-02, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Universidad Rey Juan Carlos, class: OTHER, descriptionModule briefSummary: Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. The aim is to improve postural control in both seated and standing positions and to maintain and improve cognitive capacity.Material and methods: one group (experimental group) will receive a total of 8 one-hour sessions or 16 half-hour sessions, depending on their individual needs, for 8 weeks using the Nintendo Switch. The other group (control group) will continue to receive their conventional scheduled therapy.Measures: Abilhand, MEC-Lobo, FIST, Fugl-Meyer, Berg Balance Scale and CSQ-8., conditionsModule conditions: Occupational Therapy, conditions: Acquired Brain Injury, conditions: Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Control Group (CG), which received their usual sessions of conventional therapy sessions, and an Experimental Group (EG), which received therapy with Nintendo Switch plus their conventional therapy sessions., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Conventional therapy sessions, interventions name: Conventional therapy sessions plus Nintendo Switch, outcomesModule primaryOutcomes measure: Abilhand, primaryOutcomes measure: MEC-Lobo, primaryOutcomes measure: Function in Sitting Test (FIST), primaryOutcomes measure: Fugl-Meyer, primaryOutcomes measure: Berg Balance Scale (BBS), secondaryOutcomes measure: Client Satisfaction Questionnaire (CSQ-8), eligibilityModule sex: ALL, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad Rey Juan Carlos, status: RECRUITING, city: Móstoles, state: Madrid, zip: 28933, country: Spain, contacts name: Isabel Quirosa Galan, MsC, role: CONTACT, phone: +34655551210, email: [email protected], geoPoint lat: 40.32234, lon: -3.86496, hasResults: False |
protocolSection identificationModule nctId: NCT06285864, orgStudyIdInfo id: 122/2023, briefTitle: Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Iscte-University Institute of Lisbon, class: OTHER, collaborators name: Foundation for Science and Technology (FCT), collaborators name: University of Évora, descriptionModule briefSummary: The ability to be connected and act according to bodily information is fundamental in chronic pain adjustment. This study aims to test the feasibility of an intervention designed to improve interoceptive sensibility, i.e., the ability to sense, interpret, and regulate bodily sensations in chronic musculoskeletal pain patients., conditionsModule conditions: Musculoskeletal Pain, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be unaware of their assigned treatment., whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Interoception-based intervention, outcomesModule primaryOutcomes measure: Feasibility - Sessions' acceptability, primaryOutcomes measure: Feasibility - Program acceptability, appropriateness, and feasibility, primaryOutcomes measure: Feasibility - Recruitment, retention, and attendance rates, primaryOutcomes measure: Feasibility - safety/unexpected events, primaryOutcomes measure: Feasibility - Treatment Fidelity Check, secondaryOutcomes measure: Interoceptive sensibility, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Emotion regulation, secondaryOutcomes measure: Pain-related self-efficacy, secondaryOutcomes measure: Pain catastrophizing, secondaryOutcomes measure: Activity patterns, secondaryOutcomes measure: Affective distress (depression and anxiety), secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Physical function and Vitality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Iscte - University Institute of Lisbon, status: RECRUITING, city: Lisbon, zip: 1649-026, country: Portugal, contacts name: Inês Oliveira, MSc, role: CONTACT, phone: +351217903000, email: [email protected], contacts name: Sónia Bernardes, PhD, role: CONTACT, phone: +351217903000, email: [email protected], contacts name: Inês Oliveira, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.71667, lon: -9.13333, locations facility: University of Évora, status: RECRUITING, city: Évora, zip: 7004-516, country: Portugal, contacts name: Inês Oliveira, MSc, role: CONTACT, phone: +351266740800, email: [email protected], contacts name: Sónia Bernardes, PhD, role: CONTACT, phone: +351217903000, email: [email protected], contacts name: Inês Oliveira, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.56667, lon: -7.9, hasResults: False |
protocolSection identificationModule nctId: NCT06285851, orgStudyIdInfo id: 23-0825, briefTitle: A Novel Iron Supplement for Athletes: Phase I, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2023-12-12, completionDateStruct date: 2023-12-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Lallemand Bio-Ingredients, descriptionModule briefSummary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance., conditionsModule conditions: Constipation, conditions: Diarrhea, conditions: Cramp, Abdominal, conditions: Bleeding Gastric, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: FeSC, outcomesModule primaryOutcomes measure: GI Symptoms, primaryOutcomes measure: Gastrointestinal symptoms, secondaryOutcomes measure: Supplement Tolerability and Preferences Questionnaire, secondaryOutcomes measure: Recovery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Calgary, city: Calgary, state: Alberta, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False |
protocolSection identificationModule nctId: NCT06285838, orgStudyIdInfo id: 2020/2706, briefTitle: Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-07-17, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-01-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Singapore Health Services, class: OTHER, descriptionModule briefSummary: Swift and decisive actions on the part of healthcare and hospital authorities are required to effectively contain the current COVID-19 pandemic. These measures firstly allow personnel and facilities leeway to provide surge capabilities to meet anticipated increased demands on the healthcare service. In addition, by deferring none urgent hospital visits, admissions and investigations, such measures support social distancing and aid attempts to control disease transmission. Deferring perceived non-urgent patient services may however lead to unintended delayed diagnoses and exacerbation of current patient conditions and lead to increased emergency admissions and surgeries.A policy decision was made that essential surgical services pertaining to cancer and urgent cardiovascular surgery were allowed but that surgeons had the option to postpone what is assessed to be less urgent cases. Increasingly patients also postpone their surgeries or visits because of anxieties over the developing situation. Elective surgical services at the Outram Campus were thus significantly reduced from January 2020 as part of the measures to contain the COVID-19 outbreak.The surgical philosophy during this period was that a judicious policy that allowed surgeons to proceed with surgery deemed critical but to postpone those deemed less so will at the system level, avoid poor outcomes for patients who required surgery and yet successfully re-allocate resources required to address the unfolding pandemic., conditionsModule conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 11000, type: ACTUAL, outcomesModule primaryOutcomes measure: Impact of measures taken to contain COVID-19 on hospital surgical care services and clinical outcomes, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Singapore Health Services Pte ltd, city: Singapore, zip: 169856, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
protocolSection identificationModule nctId: NCT06285825, orgStudyIdInfo id: 2023-0864, secondaryIdInfos id: NCI-2024-01736, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2026-08-22, completionDateStruct date: 2028-08-22, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Sobi, Inc., descriptionModule briefSummary: To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART., conditionsModule conditions: Cytopenia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Emapalumab, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Paolo Strati, MD, role: CONTACT, phone: 713-745-1776, email: [email protected], contacts name: Paolo Strati, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06285812, orgStudyIdInfo id: 000003, briefTitle: Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children, acronym: OTO-MATIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-10, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: PhotoniCare, Inc., class: INDUSTRY, collaborators name: TTi Health Research & Economics, descriptionModule briefSummary: A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs., conditionsModule conditions: Otitis Media Acute, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: OtoSight Middle Ear Scope, outcomesModule primaryOutcomes measure: Change the clinician rate of antibiotic prescriptions, primaryOutcomes measure: Change the number of antibiotic rounds per patient, primaryOutcomes measure: Change costs associated with management of pediatric patients presenting with ear-related pain, secondaryOutcomes measure: Change in unnecessary antibiotic prescriptions, secondaryOutcomes measure: Change in prescription adherence, secondaryOutcomes measure: Change in antibiotic prescription rate when fluid not present, secondaryOutcomes measure: Improve patient outcomes, secondaryOutcomes measure: Change medical resource utilization, secondaryOutcomes measure: Change unnecessary medical intervention, secondaryOutcomes measure: Impact clinician confidence, secondaryOutcomes measure: Impact caregiver satisfaction, secondaryOutcomes measure: Change in Health-related Quality of Life (HQoL), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's National Hospital, status: NOT_YET_RECRUITING, city: Washington, state: District of Columbia, zip: 20010, country: United States, contacts name: Bobbe Thomas, role: CONTACT, geoPoint lat: 38.89511, lon: -77.03637, locations facility: Trillim Health, status: RECRUITING, city: Rochester, state: New York, zip: 14620, country: United States, contacts name: Shealynn Hilliard, role: CONTACT, geoPoint lat: 43.15478, lon: -77.61556, locations facility: Cyn3rgy Research, status: RECRUITING, city: Gresham, state: Oregon, zip: 97030, country: United States, contacts name: Allie Calaman, role: CONTACT, geoPoint lat: 45.49818, lon: -122.43148, locations facility: Carolina ENT, status: RECRUITING, city: Orangeburg, state: South Carolina, zip: 29118, country: United States, contacts name: Simone Ansley, role: CONTACT, geoPoint lat: 33.49182, lon: -80.85565, hasResults: False |
protocolSection identificationModule nctId: NCT06285799, orgStudyIdInfo id: IHAT_ID_2024, briefTitle: Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Nemysis Ltd, class: INDUSTRY, collaborators name: RDC Clinical Pty Ltd, descriptionModule briefSummary: This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks., conditionsModule conditions: Iron-deficiency, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Low Dose IHAT, interventions name: High Dose IHAT, interventions name: Carob Flour, outcomesModule primaryOutcomes measure: Percentage of women recovering from iron deficiency at week 12, secondaryOutcomes measure: Time to reach normalisation of ferritin levels, secondaryOutcomes measure: Change in iron status, secondaryOutcomes measure: Change in fatigue, secondaryOutcomes measure: Incidence and prevalence of gastrointestinal side effects, secondaryOutcomes measure: Iron deficiency symptoms, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RDC Clinical Pty Ltd, status: RECRUITING, city: Brisbane, state: Queensland, zip: 4006, country: Australia, contacts name: Amanda Rao, PhD, role: CONTACT, phone: +61 414 488 559, email: [email protected], contacts name: David Briskey, PhD, role: CONTACT, phone: +61 421 784 077, email: [email protected], contacts name: Amanda Rao, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False |
protocolSection identificationModule nctId: NCT06285786, orgStudyIdInfo id: REB 2023-109, briefTitle: Patient Handling Techniques and New Technology for Health Care Workers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of New Brunswick, class: OTHER, descriptionModule briefSummary: Patient handling is a major risk-factor for the development of musculoskeletal injuries in healthcare providers. To have a significant impact on injury reduction related to patient handling will require the incorporation of technology. This project is to investigate a piece of technology that has been designed to facilitate in-bed patient handling: The Vendlet.The purpose of this research project is to assess the ability of the Vendlet system outfitted on a Span-America Medical Systems (SAMS) bed to reduce the physical load on healthcare providers performing patient handling tasks. This evidence-based outcomes will be used to support the mitigation of the Vendlet from the European market into the Canadian market. The SAMS bed is currently available in North America and has several adjustable features to support patient transfer activities.The project will provide a biomechanical comparison of commonly used patient handling techniques performed using a SAMS bed outfitted with and without a Vendlet patient transfer device. This Vendlet technology has the potential to significantly reduce the musculoskeletal and joint strain of healthcare providers while handling patients., conditionsModule conditions: Work-related Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: One single group of participants will be performing the same patient handling tasks:1. During session 1 (Pre-Intervention) participants will not receive any instruction on how to perform the patient handling techniques on both beds.2. During session 2 (Post-Intervention) participants will be asked to perform the patient handling techniques as seen during the intervention on both beds., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Participants will be masked of the proper technique/training during the pre-intervention session (with and without the use of technology). Specifically, on how to manually move the patient in both beds., enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ergonomic Training on Patient Handling Techniques, outcomesModule primaryOutcomes measure: Neuromuscular Activity - Average muscle activation, primaryOutcomes measure: Neuromuscular Activity - Peak muscle activation, primaryOutcomes measure: Motion Capture: To assess postural changes in patient handling technique., primaryOutcomes measure: Motion Capture: To assess cumulative load forces, primaryOutcomes measure: Motion Capture: To assess joint angles, primaryOutcomes measure: Foot Pressure Distribution: Peak pressure will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique., primaryOutcomes measure: Foot Pressure Distribution: Contact area will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique., primaryOutcomes measure: Bed Pressure Distribution: Average pressure distribution will be outcome measures to assess the safe placement of the patient., primaryOutcomes measure: Bed Pressure Distribution: Peak pressure distribution will be outcome measures to assess the safe placement of the patient., secondaryOutcomes measure: Self Reported Questionnaires, secondaryOutcomes measure: Exit Survey, secondaryOutcomes measure: Rating of Perceived Exertion (RPE), eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Universite de Moncton, status: RECRUITING, city: Moncton, state: New Brunswick, zip: E1A 3E9, country: Canada, contacts name: Dre. Michelle Cardoso, PhD, Doctorate, role: CONTACT, phone: 506-470-3979, email: [email protected], geoPoint lat: 46.09454, lon: -64.7965, hasResults: False |
protocolSection identificationModule nctId: NCT06285773, orgStudyIdInfo id: Medipol Hospital 36, briefTitle: Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-10-20, completionDateStruct date: 2024-11-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy., conditionsModule conditions: Cardiac Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for open heart surgery (coronary artery bypass) with median sternotomy will be included in the study. Patients will be randomly divided into two groups (Group PR = PIFPB + RIFPB group, Group C = Control group) including 30 patients each, before entering the operating room., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Outcomes Assessor and participant were blinded to the study, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: RIFPB block, interventions name: Postoperative analgesia management, interventions name: PIFPB block, outcomesModule primaryOutcomes measure: Global recovery scoring system / Quality of Recovery 15 questionairre, secondaryOutcomes measure: Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable"), secondaryOutcomes measure: The use of rescue analgesia, secondaryOutcomes measure: The use of rescue analgesia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Medipol University Hospital, status: RECRUITING, city: Istanbul, state: Bagcilar, zip: 34070, country: Turkey, contacts name: Bahadir Ciftci, MD, role: CONTACT, phone: +905325034428, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06285760, orgStudyIdInfo id: 135/23, briefTitle: Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY), acronym: SANDI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Puerta de Hierro University Hospital, class: OTHER, collaborators name: Hospital Clinic of Barcelona, collaborators name: Hospital Central de la Defensa Gómez Ulla, collaborators name: Hospital Vall d'Hebron, collaborators name: Hospital Universitario Ramon y Cajal, collaborators name: University Hospital of Girona Dr.Josep Trueta, collaborators name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, descriptionModule briefSummary: The goal of this observational study is to assess the natriuretic effect of intravenous acetazolamide in patients admitted with heart failure and persistent congestion despite treatment with intravenous furosemide and sodium-glucose cotransporter type 2 (iSGLT2) inhibitors.The main question it aims to answer is whether there is a difference in natriuresis 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2)., conditionsModule conditions: Heart Failure, conditions: Persistent Congestion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Standarized diuretic therapy, outcomesModule primaryOutcomes measure: Change in natriuresis 48 hours after acetazolamide, secondaryOutcomes measure: Increase in diuresis 48 hours after acetazolamide administration, secondaryOutcomes measure: Weight difference 48 hours after acetazolamide administration, secondaryOutcomes measure: Difference in congestion score 48 hours after acetazolamide administration., secondaryOutcomes measure: Difference in ultrasound measurements 48 hours after acetazolamide administration., otherOutcomes measure: Changes in renal function 48 hours after acetazolamide administration., otherOutcomes measure: Ionic (potassium (mmol/L) changes, otherOutcomes measure: chloride (mmol/L) changes 48 hours after acetazolamide administration, otherOutcomes measure: bicarbonate (mmol/L) changes 48 hours after acetazolamide administration, otherOutcomes measure: Changes in blood pressure 48 hours after administration of acetazolamide, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Julia González González, city: Madrid, zip: 28222, country: Spain, contacts name: Julia González González, role: CONTACT, phone: 0034617453693, email: [email protected], geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06285747, orgStudyIdInfo id: 23-004117, secondaryIdInfos id: NCI-2024-01191, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-004117, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-28, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function., conditionsModule conditions: Breast Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Chest wall lymphedema, primaryOutcomes measure: Quality of life - Limb Lymphoedema Quality of Life (LymQOL), primaryOutcomes measure: Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH), eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Kayla A. Van Der Weerd, PT, DPT, role: CONTACT, phone: 507-266-8721, email: [email protected], contacts name: Kayla A. Van Der Weerd, PT, DPT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06285734, orgStudyIdInfo id: KYLL-202312-049, briefTitle: Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Distention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-01-07, completionDateStruct date: 2025-01-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Shandong University, class: OTHER, collaborators name: Qilu Hospital of Shandong University (Qingdao), collaborators name: Jinan Central Hospital, collaborators name: Zaozhuang Municipal Hospital, collaborators name: Binzhou Medical University, collaborators name: Weihai Municipal Hospital, collaborators name: Central Hospital of Zibo, collaborators name: Weifang People's Hospital, collaborators name: Qilu hospital of Shandong University Dezhou hospital, collaborators name: Qihe Xian Renmin Hospital, descriptionModule briefSummary: Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention., conditionsModule conditions: Abdominal Distention, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 402, type: ESTIMATED, armsInterventionsModule interventions name: Breath test, outcomesModule primaryOutcomes measure: Positive rate of SIBO in patients with abdominal distension, secondaryOutcomes measure: Positive rate of abnormal OCTT in patients with abdominal distension, secondaryOutcomes measure: Correlation between clinical features of patients with abdominal distension and SIBO, secondaryOutcomes measure: Correlation between clinical features of patients with abdominal distension and OCTT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06285721, orgStudyIdInfo id: DELTES, briefTitle: Delirium Treatment With Transcranial Electrical Stimulation, acronym: DELTES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: A.J.C. Slooter, class: OTHER, collaborators name: Radboud University Medical Center, collaborators name: HagaZiekenhuis, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with postoperative delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial.To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment.Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months postoperative., conditionsModule conditions: Delirium, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 159, type: ESTIMATED, armsInterventionsModule interventions name: transcranial alternating current stimulation (tACS), interventions name: Sham transcranial alternating current stimulation (tACS), outcomesModule primaryOutcomes measure: Relative delta power, secondaryOutcomes measure: Duration of delirium, secondaryOutcomes measure: Severity of delirium, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Cognitive status three months post delirium, secondaryOutcomes measure: Subjective sensations during treatment, secondaryOutcomes measure: Average peak frequency, secondaryOutcomes measure: Phase Lag Index, secondaryOutcomes measure: Corrected Amplitude Envelope Correlation (AECc), secondaryOutcomes measure: Relative power, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboudumc, city: Nijmegen, state: Gelderland, zip: 6525 GA, country: Netherlands, contacts name: Indira Tendolkar, MD, PhD, role: CONTACT, geoPoint lat: 51.8425, lon: 5.85278, locations facility: HagaZiekenhuis, city: Den Haag, state: Zuid-Holland, zip: 2545 AA, country: Netherlands, contacts name: Thomas H Ottens, MD, PhD, role: CONTACT, geoPoint lat: 52.07667, lon: 4.29861, hasResults: False |
protocolSection identificationModule nctId: NCT06285708, orgStudyIdInfo id: 2023B0193, briefTitle: Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD., conditionsModule conditions: PTSD, conditions: Suicidal Ideation, conditions: Suicide, Attempted, conditions: Trauma, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Prolonged exposure, outcomesModule primaryOutcomes measure: Beck Scale for Suicidal Ideation (SSI), primaryOutcomes measure: Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R), primaryOutcomes measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5), secondaryOutcomes measure: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure, secondaryOutcomes measure: Interpersonal Needs Questionnaire (INQ) - Abbreviated, secondaryOutcomes measure: Beck Hopelessness Scale (BHS) - Abbreviated, secondaryOutcomes measure: Brief Suicide Cognitions Scale (SCS), secondaryOutcomes measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF), secondaryOutcomes measure: Monetary Choice Questionnaire (MCQ), secondaryOutcomes measure: Behavioral Inhibition Scale (BIS), secondaryOutcomes measure: Behavioral Activation Scale (BAS), secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Jaryd Hiser, role: CONTACT, phone: 614-814-0163, email: [email protected], contacts name: Justin Baker, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False |
protocolSection identificationModule nctId: NCT06285695, orgStudyIdInfo id: ILS241-I001, briefTitle: Clareon Toric Study (T2-T9), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Alcon Research, class: INDUSTRY, descriptionModule briefSummary: The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs)., conditionsModule conditions: Aphakia, conditions: Corneal Astigmatism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Clareon Toric IOL, interventions name: Cataract surgery, outcomesModule primaryOutcomes measure: Mean monocular best corrected distance visual acuity (BCDVA), secondaryOutcomes measure: Mean monocular absolute residual refractive cylinder, secondaryOutcomes measure: Mean absolute IOL rotation from previous visit, secondaryOutcomes measure: Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gimbel Eye Centre, status: RECRUITING, city: Calgary, state: Alberta, zip: T3B 0M3, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Uptown Eye Specialists, status: RECRUITING, city: Concord, state: Ontario, zip: L4K 2Z5, country: Canada, geoPoint lat: 43.80011, lon: -79.48291, locations facility: Prism Eye Institute, status: RECRUITING, city: Oakville, state: Ontario, zip: L6H 0J8, country: Canada, geoPoint lat: 43.45011, lon: -79.68292, locations facility: Laurentians Eye Institute, status: RECRUITING, city: Boisbriand, state: Quebec, zip: J7H 0E8, country: Canada, geoPoint lat: 45.61678, lon: -73.83249, locations facility: Bellevue, status: RECRUITING, city: Montréal, state: Quebec, zip: H1V 1G5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: McGill University, status: RECRUITING, city: Montréal, state: Quebec, zip: R7A 3N2, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06285682, orgStudyIdInfo id: ETH2324-2826, briefTitle: Bioavailability of Hydroxytyrosol in Healthy Adult Humans, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-03, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Anglia Ruskin University, class: OTHER, collaborators name: Fattoria La Vialla, collaborators name: Instituto Kurz, descriptionModule briefSummary: Brief summary: There is current scientific interest in hydroxytyrosol due to its anti-inflammatory and antioxidant properties, efficient protection of vascular tissue and ability to neutralise free radicals via hydrogen donation. Recognised as the potent polyphenol within a commercially available olive-fruit water (OliPhenolia®), data from this research will determine the dose of OliPhenolia® required for the optimum absorption and metabolism of hydroxytyrosol. The primary aim of this research is to identify the dose of hydroxytyrosol (0.5, 1.0 or 1.5 mg∙kg-1) within OliPhenolia® that demonstrates the greatest area under the plasma concentration curve for hydroxytyrosol over a four-hour period. A secondary aim is to assess maximum concentration (CMAX) and time to maximum concentration (TMAX) of total hydroxytyrosol and secondary metabolites (Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein) following consumption of 3 randomised doses of OliPhenolia® on separate occasions with healthy adult volunteers., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants are randomly assigned a dose of olive-derived hydroxytyrosol in a double-blind manner. Following a ≥3 day wash out participants then cross-over to an alternate dose. This process is then repeated for the third and final dose., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Volume of nutritional supplement is provided in a double-blinded manner. Both participants and research testers will be masked from knowing the specifics of the volume allocation., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: OliPhenolia®), outcomesModule primaryOutcomes measure: Hydroxytyrosol bioavailability, primaryOutcomes measure: Bioavailability of hydroxytyrosol metabolites., secondaryOutcomes measure: Hydroxytyrosol CMax, secondaryOutcomes measure: Hydroxytyrosol TMAX, secondaryOutcomes measure: CMAX of hydroxytyrosol secondary metabolites, secondaryOutcomes measure: TMAX of hydroxytyrosol secondary metabolites, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University, city: Cambridge, zip: CB5 8DZ, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, hasResults: False |
protocolSection identificationModule nctId: NCT06285669, orgStudyIdInfo id: KA18/35, briefTitle: Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2020-06-30, completionDateStruct date: 2020-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV. It is hypothesized that the application of kinesio taping to the chest area of preterm infants may improve respiratory functions and oxygenation at the alveolar level, leading to decreased work of breathing, reduced respiratory rate, and improved neonatal stability by promoting respiratory mechanics and enhancing chest expansion., conditionsModule conditions: Preterm, conditions: Premature, conditions: Infant, Newborn, Diseases, conditions: Respiratory Distress Syndrome, conditions: Neonatal Respiratory Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Kinesio-Taping Application, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: kinesiotaping application, outcomesModule primaryOutcomes measure: Level of pH, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 4 Months, stdAges: CHILD, contactsLocationsModule locations facility: Nilay Çömük Balci, city: Samsun, state: Atakum, zip: 55139, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False |
protocolSection identificationModule nctId: NCT06285656, orgStudyIdInfo id: ASH-KG, briefTitle: Femoral Blood Gas and Prediction of Postoperative Bleeding, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: Postoperative bleeding is still an important concern after major abdominal surgery. Postoperative bleeding is the most important determinant of morbidity and death. It results in longer hospital stays, the necessity for extra radiological tests, interventional radiology treatments, and the possibility of reoperation. Early detection of postoperative bleeding reduces morbidity and mortality with appropriate intervention.Simultaneous arterial and venous blood gas measurements can be used to quickly identify the degree of bleeding and the need for replacement in serious trauma patients brought to the emergency room.Lactate levels, venous oxygen saturation, and the differential in partial pressure of carbon dioxide between arterial and venous blood can all be used to indicate the requirement for replacement, as demonstrated in several studies. The purpose of this study is to evaluate lactate levels, venous oxygen saturation, and arterial-venous partial pressure of carbon dioxide difference in blood gas analysis in order to assess the severity of bleeding in patients undergoing major abdominal surgery as early as possible and perform replacement as soon as possible., conditionsModule conditions: Postoperative Hemorrhage, conditions: Blood Transfusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Eritrocyte replacement, secondaryOutcomes measure: Postoperative Hemmorhagea, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06285643, orgStudyIdInfo id: ASK-PD5-CS201, briefTitle: A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD), acronym: REGENERATE-PD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-11-30, completionDateStruct date: 2027-11-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Asklepios Biopharmaceutical, Inc., class: INDUSTRY, collaborators name: Bayer, descriptionModule briefSummary: The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 87, type: ESTIMATED, armsInterventionsModule interventions name: AAV2-GDNF Gene therapy, interventions name: Control Surgery, outcomesModule primaryOutcomes measure: Motor symptoms-MDS-UPDRS parts 2 and 3, primaryOutcomes measure: PD Motor Diary Non-Motor symptoms-MDS-UPDRS part1, primaryOutcomes measure: PDQ39 Levodopa Equivalent Daily Dose, secondaryOutcomes measure: Change from baseline in the MDS-UPDRS parts 2 and 3, and the PD Motor Diary, secondaryOutcomes measure: Change from baseline in the MDS-UPDRS part 1 and PDQ-39, secondaryOutcomes measure: Change in Levodopa equivalent daily dose, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06285630, orgStudyIdInfo id: Alba101, secondaryIdInfos id: 2023-05299-01, type: OTHER, domain: Ethix, briefTitle: The Development and Health of the Intestinal Flora During the First Year of Life, acronym: PREVENT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Alba Health AB, class: INDUSTRY, collaborators name: Universiteit Antwerpen, collaborators name: Uppsala University, collaborators name: Copenhagen Studies on Asthma in Childhood, descriptionModule briefSummary: In this research study (PREVENT 1), Alba Health, in collaboration with academic institutions (Uppsala University, COPSAC and University of Antwerp) is investigating the association between the developing gut microbiota (collection of microbes present in the human gut) in the first year of life and lifestyle, wellbeing and health in a Swedish population. The study is the first of its kind in a Swedish population to collect and associate microbiome composition to an extensive family history and health questionnaire, stool colour and crying type, building on learnings from previous studies performed in other countries, such as the HELMI and COPSAC studies (HELMI - Finnish Health and Early Life Microbiota cohort from the University of Helsinki in Finland; COPSAC - Copenhagen Prospective Studies on Asthma in Childhood in Denmark).The PREVENT 1 study is an observational research study led by Alba Health involving 300 families in Sweden with children between 0 and 12 months of age at the time of the study's start. After providing informed consent, the participating families will be asked to provide three stool samples from their child (the sample collection is not invasive and does not cause discomfort) and will be asked to answer questionnaires on lifestyle, well-being and family health. The participating families will not be asked to change their lifestyle beyond sample and data collection.From the collected stool samples, we will extract microbial DNA and subject this to deep metagenomic sequence analysis. The study will only analyze microbial DNA, any human related material will be discarded. The stool samples will be destroyed within one month of sequencing (maximum 3 months from collection). The data will be stored according to GDPR and Swedish law, with informed consent in Sweden and with appropriate security measures. All research will be carried out in Sweden., conditionsModule conditions: Healthy, conditions: Microbial Colonization, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Observational, no intervation will be made, outcomesModule primaryOutcomes measure: Microbiome composition of infants in variable age ranges, secondaryOutcomes measure: Is the composition associated with and gastrointestinal issues, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Alba Health AB, city: Stockholm, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False |
protocolSection identificationModule nctId: NCT06285617, orgStudyIdInfo id: 2022GDRC016, briefTitle: Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis, acronym: SAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Xinqiao Hospital of Chongqing, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the efficacy and safety of short-term versus 6-week prednisone in the treatment of moderate-to-severe subacute thyroiditis. The main questions it aims to answer are: Does the short-term medication regimen reduce glucocorticoid side effects while achieving similar efficacy as the guideline treatment group? Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/day prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy in the control group., conditionsModule conditions: Subacute Thyroiditis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prednisone, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: 1-week predisone+1-week celecoxib, interventions name: 6-weeks predisone, outcomesModule primaryOutcomes measure: The difference in efficacy between the two groups at the completion., secondaryOutcomes measure: Thyroid function, secondaryOutcomes measure: Total cholesterol (TC), secondaryOutcomes measure: Triglycerides (TG), secondaryOutcomes measure: Systolic blood pressure (SBP), secondaryOutcomes measure: Diastolic blood pressure (DBP), secondaryOutcomes measure: Parathyroid hormone (PTH), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06285604, orgStudyIdInfo id: IRB-20230398-R, briefTitle: Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Women's Hospital School Of Medicine Zhejiang University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are:* Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy.* To provide objective basis for clinical rational use of blood in the selection of blood products.Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators., conditionsModule conditions: Neonatal Anemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Blood transfusion, outcomesModule primaryOutcomes measure: Clinical efficacy of different red blood cell products transfusion in anemic neonates, primaryOutcomes measure: The changes of inflammatory response before and after transfusion in anemic neonates, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: Women's Hospital School of Medicine Zhejiang University, city: Hangzhou, state: Zhejiang, zip: 310006, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06285591, orgStudyIdInfo id: 2023-1801, briefTitle: Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus Reuteri is a natural flora of the human body that can be found in the gastrointestinal tract, skin, etc. Among them, Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry, and are common Lactobacillus strains marketed for the production of oral probiotics, which are commonly used in infant formulas, among others. In oral inflammatory diseases, it has been reported in the literature that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce gingival and periodontal inflammation, mainly through the mechanisms of modulating the host inflammatory response and displacing pathogenic bacteria. In terms of safety, oral Lactobacillus Reuteri has good stability, very low pathogenic potential, and is not toxic to humans. Therefore, this study is a placebo-controlled, multi-center, open, randomized controlled clinical study to evaluate the efficacy of Lactobacillus Reuteri for the prevention of radioactive oral mucosal reactions in intensity-modulated radiotherapy for head and neck tumors, including nasopharyngeal carcinoma., conditionsModule conditions: Oral Mucositis (Ulcerative) Due to Radiation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Lactobacillus Reuteri Tablets, interventions name: Placebo-containing tablets, interventions name: Radiotherapy, outcomesModule primaryOutcomes measure: The incidence of Severe Oral mucositis (WHO grade ≥3), primaryOutcomes measure: The time to onset of Severe Oral mucositis (WHO grade ≥3), primaryOutcomes measure: The duration of Severe Oral mucositis (WHO grade ≥3), secondaryOutcomes measure: Taste function, secondaryOutcomes measure: Xerostomia summated xerostomia inventory (SXI), secondaryOutcomes measure: Functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Oral activities scores, secondaryOutcomes measure: Mouth and throat soreness (MTS) scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Xingchen Peng, PhD, role: CONTACT, phone: +86 18980606753, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06285578, orgStudyIdInfo id: MOST 107-2410-H-277-003, briefTitle: Effects of Probiotic and HIIT in Obese Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-10-01, primaryCompletionDateStruct date: 2019-01-31, completionDateStruct date: 2019-03-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Taipei, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate whether there are the additive effects when implementing both high-intensity interval training (HIIT) and probiotics simultaneously on improving cardiorespiratory endurance and metabolism in middle-aged women., conditionsModule conditions: Cardiorespiratory Fitness, conditions: Metabolism, conditions: Anthropometry, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: Probiotics supplementation, interventions name: HIIT training, interventions name: Placebo supplementation, outcomesModule primaryOutcomes measure: Height, primaryOutcomes measure: Body weight, primaryOutcomes measure: Body mass index (BMI), primaryOutcomes measure: Body fat percentage, primaryOutcomes measure: Waist circumference, primaryOutcomes measure: Hip circumference, primaryOutcomes measure: Maximum oxygen uptake (VO2max), primaryOutcomes measure: Time to exhaustion (TTE), primaryOutcomes measure: Running economy (RE), primaryOutcomes measure: Fasting blood glucose (FBG), primaryOutcomes measure: Total cholesterol (TC), primaryOutcomes measure: Triglyceride (TG), primaryOutcomes measure: High-density lipoprotein cholesterol (HDL-C), primaryOutcomes measure: Low-density lipoprotein cholesterol (LDL-C), secondaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Bone mineral density (BMD), secondaryOutcomes measure: Caloric intake, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Taipei, city: Taipei, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06285565, orgStudyIdInfo id: CE390/2023, briefTitle: A Nurse-led Coaching Programme With Telemonitoring in Heart Failure, acronym: INTERCOACH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Alberto Dal Molin, class: OTHER, collaborators name: Azienda Ospedaliero Universitaria Maggiore della Carita, descriptionModule briefSummary: The goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. The main questions it aims to answer are:* Are implementation strategies effective in facilitating participant fidelity?* What factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence?* Are the methods and tools established the most appropriate to ensure the completeness of the data collection?Participants will follow a combined intervention consisting of:1. pre-discharge educational meeting;2. telephone nurse-led coaching sessions;3. home telemonitoring of vital signs.In the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities, conditionsModule conditions: Heart Failure, conditions: Telemonitoring, conditions: Hospitalizations, conditions: Feasibility, conditions: Mentoring, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A parallel, open-label randomized controlled feasibility study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The assessors will collect clinical outcomes by telephone and will be blinded to the group assignment, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Nurse-led telephone coaching intervention with home telemonitoring of vital signs, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Adherence to the coaching intervention, primaryOutcomes measure: Adherence to telemonitoring program, primaryOutcomes measure: Completeness of data collection, secondaryOutcomes measure: 90- and 180-day all-cause hospital readmissions, secondaryOutcomes measure: 90- and 180-day heart failure-related hospital readmissions, secondaryOutcomes measure: 90- and 180-day Emergency Departments visits, secondaryOutcomes measure: 90- and 180-day General Practioner visits, secondaryOutcomes measure: 90- and 180-day oupatient visits, secondaryOutcomes measure: Self-care capacity (Self-Care of Heart Failure Index ), secondaryOutcomes measure: Self Care - Self-Efficacy Scale, secondaryOutcomes measure: Quality of life (SF-12 scale), secondaryOutcomes measure: Anxiety (Hamilton Anxiety Scale ), secondaryOutcomes measure: Depression (Geriatric Depression Scale), secondaryOutcomes measure: Heart Failure Somatic Perception Scale v.3 (HFSPS), secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Università del Piemonte Orientale Amedeo Avogadro, city: Novara, zip: 28100, country: Italy, contacts name: Alberto Dal Molin, Prof, role: CONTACT, phone: +390321660607, email: [email protected], contacts name: INES BASSO, role: CONTACT, phone: +393927599727, email: [email protected], geoPoint lat: 45.44694, lon: 8.62118, hasResults: False |
protocolSection identificationModule nctId: NCT06285552, orgStudyIdInfo id: 4792/0842, briefTitle: Evaluation of the Comprehensive Family Support Program (PAIF), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, collaborators name: Gobierno de Cantabria, collaborators name: Loyola University, collaborators name: University of Jaen, descriptionModule briefSummary: The goal of this study is to evaluate the effectiveness of positive parenting programs targeted to parents of toddlers, children and adolescents carried out in Cantabria (Spain).We will collect information from the participants before the intervention, in the last session of the program and some months after, to verify if there have been some changes in the family dynamics of these parents, and if these changes continue after some time. Besides, we will compare these results with information from other families that are not taking part in the program. The main caregivers of the participating families and the practitioners in charge of the intervention will provide the information for the study.We expect that families participating in the programs will improve their parenting competencies and their family dynamics, and that these change will stay after the program., conditionsModule conditions: Parenting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants will be assigned to the manualized program according to the inclusion criteria. The comparison group will be composed of families in areas where the intervention is not available but with similar sociodemographic characteristics., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Positive parenting PAIF program, outcomesModule primaryOutcomes measure: Perception of the parental role, primaryOutcomes measure: Parenting practices (Authoritative parenting style: Warmth and Support, Reasoning/Induction, Democratic Participation), primaryOutcomes measure: Parenting practices (Overreactivity and Laxness), secondaryOutcomes measure: Satisfaction with the intervention, secondaryOutcomes measure: Children adjustment, secondaryOutcomes measure: Social support, secondaryOutcomes measure: Satisfaction with Family Life, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Consejería de Inclusión Social, Juventud, Familias E Igualdad, status: RECRUITING, city: Santander, state: Cantabria, zip: 39004, country: Spain, contacts name: JOSÉ ANGEL RODRÍGUEZ, role: CONTACT, phone: 942 207 756, email: [email protected], geoPoint lat: 43.46472, lon: -3.80444, hasResults: False |
protocolSection identificationModule nctId: NCT06285539, orgStudyIdInfo id: 2022-502968-20, briefTitle: Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases, acronym: DRIMID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: Alfasigma S.p.A., collaborators name: ReumaNederland, collaborators name: Autoimmune Research and Collaboration Hub, descriptionModule briefSummary: Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations. Patients with Behçet's disease (BD), idiopathic inflammatory myopathy (IIM, also known as myositis) and IgG4-related disease (IgG4-RD) are treated with high-dosed glucocorticoids, methotrexate, azathioprine and mycophenolate mofetil, mostly for long periods of time with attendant risks of long-term toxicity, including infections. Therefore, there is an urgent need for new, more specific anti-inflammatory therapies such as targeted synthetic and biological disease-modifying antirheumatic drugs. Due to the role of type 1 interferon in both BD, IIM and IgG4-RD, JAK-STAT inhibition may be a promising treatment strategy in these conditions, because JAK1 is critical for the signal transduction of pro-inflammatory cytokine receptors. Previous research showed that JAK1 inhibition reduces activation of type 1 interferon-regulated proteins and key chemokines that control tissue inflammation., conditionsModule conditions: Behcet's Disease, conditions: Idiopathic Inflammatory Myopathies, conditions: IgG4-related Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A 26-week multicenter, open-label, uncontrolled, non-randomized, non-blinded proof-of-concept, two-stage phase 2 study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Filgotinib, outcomesModule primaryOutcomes measure: EQ-5D-5L, primaryOutcomes measure: Disease activity in Behcet's patients, primaryOutcomes measure: Disease activity in myositis patients, primaryOutcomes measure: Disease activity in IgG4-RD patients, secondaryOutcomes measure: Corticosteroid toxicity, secondaryOutcomes measure: Corticosteroid dosage, secondaryOutcomes measure: VAS score of pain, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, city: Amsterdam, country: Netherlands, contacts name: Joost Raaphorst, Dr., role: CONTACT, email: [email protected], contacts name: Joost Raaphorst, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Sander W Tas, Prof. dr., role: SUB_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Hagaziekenhuis, city: Den Haag, country: Netherlands, contacts name: Robbert J Goekoop, MD, role: CONTACT, email: [email protected], contacts name: Robbert J Goekoop, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Zuyderland Medical Center, city: Heerlen, country: Netherlands, contacts name: Cesar Magro Checa, Dr, role: CONTACT, email: [email protected], contacts name: Cesar Magro Checa, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.88365, lon: 5.98154, locations facility: Radboud university medical center, city: Nijmegen, country: Netherlands, contacts name: Rogier Thurlings, Dr, role: CONTACT, email: [email protected], contacts name: Rogier Thurlings, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Erasmus MC, city: Rotterdam, country: Netherlands, contacts name: Jan van Laar, Dr., role: CONTACT, email: [email protected], contacts name: Jan van Laar, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, locations facility: University Medical Center, city: Utrecht, country: Netherlands, contacts name: Anne Karien Marijnissen, Dr., role: CONTACT, email: [email protected], contacts name: Jaap M. van Laar, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Bettina C. Geertsema-Hoeve, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False |
protocolSection identificationModule nctId: NCT06285526, orgStudyIdInfo id: 2023/0046/OB, secondaryIdInfos id: 2023-A00350-45, type: REGISTRY, domain: French Minister, briefTitle: Glycocalyx Monitoring in Major Abdominal Surgery, acronym: GLYCOCHIP, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-05, primaryCompletionDateStruct date: 2024-07-05, completionDateStruct date: 2025-01-05, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters., conditionsModule conditions: Major Abdominal Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy, interventions name: Cephalic DuodenoPancreatectomy, outcomesModule primaryOutcomes measure: Glycocalyx thickness, secondaryOutcomes measure: Glycocalyx thickness and a biological marker of tissue hypoperfusion, secondaryOutcomes measure: Glycocalyx thickness and a biological marker of tissue hypoxia, secondaryOutcomes measure: Blood cell velocity and macrocirculatory function, secondaryOutcomes measure: Perfused capillary density and macrocirculatory function, secondaryOutcomes measure: Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rouen University Hospital, status: RECRUITING, city: Rouen, zip: 76000, country: France, contacts name: DEMAILLY Zoé, MD, role: CONTACT, phone: 02 32 88 24 40, phoneExt: +33, email: [email protected], contacts name: Thomas CLAVIER, MD, role: CONTACT, phone: 02 32 88 82 92, phoneExt: +33, email: [email protected], geoPoint lat: 49.44313, lon: 1.09932, hasResults: False |
protocolSection identificationModule nctId: NCT06285513, orgStudyIdInfo id: 2021/387/OB, secondaryIdInfos id: 2023-A00503-42, type: REGISTRY, domain: Frecnh Ministry, briefTitle: Cardiovascular Metabolic Remodeling in Shock, acronym: METASHOCK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved., conditionsModule conditions: Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac ultrasound, outcomesModule primaryOutcomes measure: Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Rouen, city: Rouen, country: France, contacts name: Grégoire JOLLY, MD, role: CONTACT, geoPoint lat: 49.44313, lon: 1.09932, hasResults: False |
protocolSection identificationModule nctId: NCT06285500, orgStudyIdInfo id: UNIQUE, secondaryIdInfos id: 23-5095, type: OTHER, domain: University Health Network, briefTitle: Umbrella Study for Single Patient Treatments in Oncology, acronym: UNIQUE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments., conditionsModule conditions: Advanced Cancer, conditions: Rare Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Patient-specific treatments, outcomesModule primaryOutcomes measure: Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy, secondaryOutcomes measure: Overall survival rate, secondaryOutcomes measure: Progression-free survival rate, secondaryOutcomes measure: Number of participants with adverse events as assessed by CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, Princess Margaret Cancer Centre, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, contacts name: Amit Oza, Dr., role: CONTACT, phone: 416 946 4450, email: [email protected], geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06285487, orgStudyIdInfo id: 23-1600, briefTitle: Depression in Youth Onset Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes., conditionsModule conditions: Type 2 Diabetes, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Group Program, outcomesModule primaryOutcomes measure: Acceptability of IPT-T2D, primaryOutcomes measure: Depression Changes, primaryOutcomes measure: Changes in Glycemic Control, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False |
protocolSection identificationModule nctId: NCT06285474, orgStudyIdInfo id: 22-001323, briefTitle: Investigating LIFUP in Anhedonic Depression, acronym: ILIAD, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-10-27, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, collaborators name: Wellcome Trust, descriptionModule briefSummary: This study will observe changes in brain imaging, behavior, and symptom measures following intervention with low intensity focused ultrasound pulsation (LIFUP) targeting reward circuitry in individuals who are depressed and anhedonic., conditionsModule conditions: Depression, conditions: Anhedonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Low Intensity Focused Ultrasound Pulsation (LIFUP), outcomesModule primaryOutcomes measure: Change in Patient health questionnaire-14 self report measure (PHQ-14) from baseline, primaryOutcomes measure: Change in Positive valence systems scale-21 self report measure (PVSS-21) from baseline, primaryOutcomes measure: Changes in MRI images from Pre-scan to week 5, primaryOutcomes measure: Change in Ecological momentary assessment (EMA) from W0/Baseline, secondaryOutcomes measure: Changes in digital behavioral phenotype sleep measurement, secondaryOutcomes measure: Changes in digital behavioral phenotype physical activity measurement, secondaryOutcomes measure: Changes in heart rate, secondaryOutcomes measure: Changes in heart rate variability, secondaryOutcomes measure: Changes in respiratory rate, secondaryOutcomes measure: changes in World Health Organization (WHO) -5 Wellbeing index score from W0/Baseline to end of study, secondaryOutcomes measure: changes in Pittsburgh Sleep Quality Index (PSQI) score from W0/Baseline to end of study, otherOutcomes measure: changes in Quick Inventory of Depressive Symptoms (QIDS-SR15) score from W0/Baseline to end of study, otherOutcomes measure: changes in Patient Health Questionnaire (PHQ-9) score from day 2 to week 2, otherOutcomes measure: changes in Brief Irritability Test (BITe) score from W0/Baseline to end of study, otherOutcomes measure: changes in Generalized Anxiety Disorder (GAD-7) score from W0/Baseline to end of study, otherOutcomes measure: Changes in Snaith Hamilton Pleasure Scale (SHAPS) score from W0/Baseline to end of study, otherOutcomes measure: Changes in Suicidal Ideation measure from Pre-scan to end of study, otherOutcomes measure: changes in Apathy Motivation Index (AMI) score from W0/Baseline to end of study, otherOutcomes measure: changes in Eudaimonic Well-Being Questionnaire (EWBQ) score from W0/Baseline to end of study, otherOutcomes measure: Changes in Work and Social Adjustment Scale (WSAS) score from W0/Baseline to end of study, otherOutcomes measure: Changes in Ruminative Response Scale (RRS) - brooding subscale score from W0/Baseline to end of study, otherOutcomes measure: changes in Trauma History Questionnaire (THQ) score from W0/Baseline to end of study, otherOutcomes measure: changes in Routines Survey from W0/Baseline to end of study, otherOutcomes measure: changes in USDA Housing and Food Insecurity score from W0/Baseline to end of study, otherOutcomes measure: changes in Holmes-Rahe Life Stress Survey score from W0/Baseline to end of study, otherOutcomes measure: Changes in emotion recognition accuracy scores from Pre-scan to end of study, otherOutcomes measure: Changes in emotion recognition response times from Pre-scan to end of study, otherOutcomes measure: Changes in continuous concentration accuracy scores from Pre-scan to end of study, otherOutcomes measure: Changes in continuous concentration response times from Pre-scan to end of study, otherOutcomes measure: Changes in continuous concentration error scores from Pre-scan to end of study, otherOutcomes measure: Changes in Apple Gathering task behavior from Pre-scan to end of study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California Los Angeles, city: Los Angeles, state: California, zip: 90095-1563, country: United States, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06285461, orgStudyIdInfo id: T2566/2023, briefTitle: Food Intake, Endocrine Factors and Brown Fat, acronym: FoodBAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Turku University Hospital, class: OTHER_GOV, collaborators name: University of Turku, descriptionModule briefSummary: This study will investigate how the acute intake of foods with high and low hedonic reward differentially affects brown adipose tissue and the interplay between gut peptides, brown fat, and the brain (gut-BAT-brain axis)., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This will be a crossover study in which participants undergo two postprandial test days with meals with high- or low-hedonic reward and two weeks of washout between interventions., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Non-palatable meal, interventions name: Palatable meal, outcomesModule primaryOutcomes measure: Brown adipose tissue metabolism, primaryOutcomes measure: Changes in gut peptides, primaryOutcomes measure: Differences in μ-opioid receptors in the human brain, secondaryOutcomes measure: Energy expenditure/Meal-induced thermogenesis, secondaryOutcomes measure: Visual Analogue scale (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Turku PET Centre, status: RECRUITING, city: Turku, zip: 20520, country: Finland, contacts name: Kirsi A Virtanen, role: CONTACT, phone: +358407626564, email: [email protected], geoPoint lat: 60.45148, lon: 22.26869, hasResults: False |
protocolSection identificationModule nctId: NCT06285448, orgStudyIdInfo id: A24-028, briefTitle: Feasibility of Lecanemab Registry and Clinical Outcome Measures, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: HealthPartners Institute, class: OTHER, descriptionModule briefSummary: Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners., conditionsModule conditions: Alzheimer Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Lecanemab, outcomesModule primaryOutcomes measure: Feasibility of enrollment, primaryOutcomes measure: Feasibility of completing visits, primaryOutcomes measure: Qualitative experience at 3 months, primaryOutcomes measure: Qualitative experience at 12 months, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HealthPartners Neuroscience Center, city: Saint Paul, state: Minnesota, zip: 55130, country: United States, geoPoint lat: 44.94441, lon: -93.09327, hasResults: False |
protocolSection identificationModule nctId: NCT06285435, orgStudyIdInfo id: coagulation activation in PV, briefTitle: Coagulation Activation in Patients With Pemphigus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Aim of work:1. To evaluate the plasma markers of coagulation activation: prothrombin F1+2 and d-dimer levels in pemphigus patients with active disease and compare them with age and sex-matched controls.2. To evaluate the correlation of these markers with disease severity score by using Pemphigus Disease Area Index (PDAI) and with disease activity by measurement of anti-desmoglein 1 and 3 antibody titers., conditionsModule conditions: Pemphigus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: prothrombin fragment 1+2, outcomesModule primaryOutcomes measure: Comparison of coagulation activation markers in pemphigus patients with controls, secondaryOutcomes measure: Correlation of markers with disease severity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06285422, orgStudyIdInfo id: SC262-101, briefTitle: Study Evaluating SC262 in Subjects With r/r B-cell Malignancies (VIVID), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sana Biotechnology, class: INDUSTRY, descriptionModule briefSummary: SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers., conditionsModule conditions: Non Hodgkin's Lymphoma, conditions: Large B-cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: SC262, outcomesModule primaryOutcomes measure: Evaluate safety and tolerability of SC262, secondaryOutcomes measure: Evaluate preliminary anti-tumor activity of SC262, secondaryOutcomes measure: Evaluate cellular kinetics and persistence of SC262, secondaryOutcomes measure: Evaluate cellular kinetics and persistence of SC262, secondaryOutcomes measure: Evaluate cellular kinetics and persistence of SC262, secondaryOutcomes measure: Evaluate host immunogenicity to SC262, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06285409, orgStudyIdInfo id: 24-02, briefTitle: Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, class: OTHER, descriptionModule briefSummary: This study will investigate the effects of drugs called "uterotonics" that help with the contraction of the uterus after a baby is born. This uterine contraction is very important to stop the bleeding after delivery. An uncontracted uterine state is called "uterine atony", which can lead to an excessive amount of post-delivery bleeding. Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding. In some cases, carbetocin is not enough to contract the uterus, and ongoing bleeding continues. When that happens, there are other uterotonic medications that can be used. In this study, we aim to find which uterotonic drug, amongst those available (oxytocin, carbetocin, ergometrine or carboprost), is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered.This study will be done by using a very small sample of uterine tissue, taken from the incision site, following delivery by cesarean section. The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs. The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further., conditionsModule conditions: Postpartum Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Carbetocin, interventions name: Oxytocin, interventions name: Carbetocin, interventions name: Oxytocin, interventions name: Ergonovine, interventions name: Carboprost, outcomesModule primaryOutcomes measure: Motility index, secondaryOutcomes measure: Amplitude of contraction, secondaryOutcomes measure: Frequency of contraction, secondaryOutcomes measure: Integrated area under response curve (AUC), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G1X5, country: Canada, contacts name: Mrinalini Balki, MD, role: CONTACT, phone: 416-586-4800, phoneExt: 5270, email: [email protected], contacts name: Wafa Bellan, MD, role: SUB_INVESTIGATOR, contacts name: Ronald George, MD, role: SUB_INVESTIGATOR, contacts name: Joseph Park, BSc, role: SUB_INVESTIGATOR, contacts name: Anuradha Baishnob, BSc, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06285396, orgStudyIdInfo id: 24-01, briefTitle: Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes.Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH.It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory., conditionsModule conditions: Postpartum Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Ephedrine, interventions name: Phenylephrine, interventions name: Norepinephrine, interventions name: Oxytocin, outcomesModule primaryOutcomes measure: Motility index, secondaryOutcomes measure: Amplitude of contraction, secondaryOutcomes measure: Frequency of contraction, secondaryOutcomes measure: Integrated area under response curve (AUC), eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G1X5, country: Canada, contacts name: Mrinalini Balki, MD, role: CONTACT, phone: 416-586-4800, phoneExt: 5270, email: [email protected], contacts name: Caroline Carruthers, role: SUB_INVESTIGATOR, contacts name: Joseph Park, BSc, role: SUB_INVESTIGATOR, contacts name: Cynthia Maxwell, MD, role: SUB_INVESTIGATOR, contacts name: Anuradha Baishnob, BSc, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06285383, orgStudyIdInfo id: Kar.neck, briefTitle: The Effects of Music on Neck Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: KTO Karatay University, class: OTHER, descriptionModule briefSummary: The effects of passive music listening on pain, anxiety and quality of life in patients with chronic neck pain in addition to physical therapy will be examined., conditionsModule conditions: Pain, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Music listening, interventions name: classic physical therapy, outcomesModule primaryOutcomes measure: Beck anxiety inventory, primaryOutcomes measure: Visual Analogue Scale, primaryOutcomes measure: Short form-36, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mustafa Savaş Torlak, status: RECRUITING, city: Karatay, state: Eyalet/Yerleşke, zip: 42000, country: Turkey, contacts name: Mustafa S Torlak, role: CONTACT, phone: +905373660138, email: [email protected], geoPoint lat: 37.86726, lon: 32.52863, hasResults: False |
protocolSection identificationModule nctId: NCT06285370, orgStudyIdInfo id: 0761-CN001, secondaryIdInfos id: CTR20230672, type: OTHER, domain: National Medical Products Administration, briefTitle: A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-29, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Kyowa Kirin China Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate the efficacy and safety of mogamulizumab (KW-0761) in chinese subjects with mycosis fungoides or sézary syndrome previously treated with systemic therapy, conditionsModule conditions: Cutaneous T-Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an open-label, multicenter, single arm study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: No Masking, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Mogamulizumab, outcomesModule primaryOutcomes measure: Overall Response Rate, secondaryOutcomes measure: Skin disease response rate;, secondaryOutcomes measure: Lymth nodes response rate, secondaryOutcomes measure: Visceral metastases response rate;, secondaryOutcomes measure: Blood disease response rate;, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Time to response (TTR), secondaryOutcomes measure: Response rate of lymph node evaluated by Lugano 2014., secondaryOutcomes measure: Response rate of viscera evaluated by Lugano 2014 criteria., otherOutcomes measure: To evaluate pharmacokinetics (plasma mogamulizumab concentration) of mogamulizumab., otherOutcomes measure: To evaluate immunogenicity (anti-mogamulizumab antibody) of mogamulizumab., otherOutcomes measure: To evaluate the effects of skin disease on health-related Quality of Life (HRQoL) -Skindex 29., otherOutcomes measure: The incidence and frequency of treatment-related adverse events (TEAEs) and drug-related TEAEs as assessed by CTCAE v5.0., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Sciences, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Yuankai Shi, role: CONTACT, phone: 13701251865, email: [email protected], contacts name: Yuankai Shi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University First Hospital, Department of Dermatology and Venereology, status: RECRUITING, city: Beijing, state: Beijing, zip: 100034, country: China, contacts name: Ping Tu, role: CONTACT, phone: 13021262219, email: [email protected], contacts name: Ping Tu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Sun Yat-sen University Cancer Center, Department of Medical Oncology, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Huiqiang Huang, role: CONTACT, phone: 13808885154, email: [email protected], contacts name: Huiqiang Huang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: The 2nd Affiliated Hospital of Harbin Medical University, status: NOT_YET_RECRUITING, city: Harbin, state: Heilongjiang, zip: 150001, country: China, contacts name: Yuzhen Li, role: CONTACT, phone: 13936367628, email: [email protected], contacts name: Yuzhen Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.75, lon: 126.65, locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, country: China, contacts name: Liling Zhang, role: CONTACT, phone: 15871725926, email: [email protected], contacts name: Liling Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Cancer Hospital, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410031, country: China, contacts name: Hui Zhou, role: CONTACT, phone: 13975879796, email: [email protected], contacts name: Hui Zhou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The Affiliated Hospital of Inner Mongolia Medical University, status: NOT_YET_RECRUITING, city: Hohhot, state: Inner Mongolia, zip: 010000, country: China, contacts name: Da Gao, role: CONTACT, phone: 13947130473, email: [email protected], contacts name: Da Gao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.81056, lon: 111.65222, locations facility: The First Hospital of China Medical University, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110002, country: China, contacts name: Xinghua Gao, role: CONTACT, phone: 13940152467, email: [email protected], contacts name: Xinghua Gao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Zhongshan Hospital Fudan University, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Peng Liu, role: CONTACT, phone: 1581725926, email: [email protected], contacts name: Peng Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital, Sichuan University, status: NOT_YET_RECRUITING, city: Chengdu, state: Sichuan, zip: 610044, country: China, contacts name: Lin Wang, role: CONTACT, phone: 18980601701, email: [email protected], contacts name: Lin Wang, role: PRINCIPAL_INVESTIGATOR, contacts name: Liqun Zou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, locations facility: ZheJiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310005, country: China, contacts name: Haiyan Yang, role: CONTACT, phone: 18960860662, email: [email protected], contacts name: Haiyan Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: First Affiliated Hospital of Zhengzhou University, status: NOT_YET_RECRUITING, city: Henan, state: Zhengzhou, zip: 450052, country: China, contacts name: Xinhua Wang, role: CONTACT, phone: 15036115299, email: [email protected], contacts name: Xinhua Wang, role: PRINCIPAL_INVESTIGATOR, hasResults: False |
protocolSection identificationModule nctId: NCT06285357, orgStudyIdInfo id: EPISTOP_22, briefTitle: The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Lo.Li.Pharma s.r.l, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (EGCG), vitamin B12 and folic acid in the treatment of infections with papilloma virus of the cervix., conditionsModule conditions: HPV Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: EGCG + folic acid + B12, outcomesModule primaryOutcomes measure: HPV DNA test negativity, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero-Universitaria di Modena, status: RECRUITING, city: Modena, zip: 41124, country: Italy, contacts name: Giovanni Grandi, role: CONTACT, geoPoint lat: 44.64783, lon: 10.92539, hasResults: False |
protocolSection identificationModule nctId: NCT06285344, orgStudyIdInfo id: kilis_3, briefTitle: Impact of Workload and Fatigue on Sleep in OR Nurses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Kilis 7 Aralik University, class: OTHER, collaborators name: Hasan Kalyoncu University, descriptionModule briefSummary: This study aims to explore the impact of individual workload and fatigue levels on the sleep quality of operating room (OR) nurses, highlighting a critical aspect of healthcare professionals' well-being that directly affects patient safety and care quality. Operating room nurses face unique challenges due to the high-stress, fast-paced environment of surgical settings, which can lead to increased stress levels, emotional challenges, and a higher incidence of fatigue compared to other nursing specialties. Factors contributing to this fatigue include the demanding nature of surgical procedures, the need for constant vigilance, and the irregular hours associated with shift work, all of which can impair sleep quality.The literature review suggests that while the relationship between workload, fatigue, and sleep quality has been extensively studied in general nursing populations, there is a lack of specific focus on operating room nurses. These professionals work under distinct conditions that may exacerbate the effects of workload and fatigue on sleep quality, yet comprehensive studies targeting this group are limited. Understanding the nuances of how workload and fatigue specifically impact the sleep quality of OR nurses is crucial for developing targeted interventions aimed at improving their health and job performance, thereby enhancing patient care and safety.This cross-sectional and correlational study seeks to fill the gap in the literature by examining the specific effects of workload and fatigue on sleep perception among OR nurses. By identifying these relationships, the study aims to contribute valuable insights into strategies for mitigating fatigue and improving sleep among this critical group of healthcare workers, with the ultimate goal of ensuring both nurse well-being and patient safety., conditionsModule conditions: Shift Work, conditions: Sleep Perception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 250, type: ESTIMATED, outcomesModule primaryOutcomes measure: Demographic Information Form, primaryOutcomes measure: Individual Workload Perception Scale (IWPS), primaryOutcomes measure: Chalder Fatigue Scale (CFS), primaryOutcomes measure: Richard-Campbell Sleep Questionnaire (RCSQ), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Islam Elagöz, city: Kilis, zip: 79100, country: Turkey, geoPoint lat: 36.71611, lon: 37.115, hasResults: False |
protocolSection identificationModule nctId: NCT06285331, orgStudyIdInfo id: 2023ZDSYLL483-P01, briefTitle: the Impact of Manual or Mechanical Ways to Perform PLR on the Accuracy of Evaluation of Fluid Responsiveness, acronym: PLR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-06, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Southeast University, China, class: OTHER, descriptionModule briefSummary: Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness., conditionsModule conditions: Circulatory Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Automatic Bed, interventions name: Manual, outcomesModule primaryOutcomes measure: Accuracy of fluid responsiveness evaluation, secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongda Hospital Southeast University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Jingyuan Xu, M.D., role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06285318, orgStudyIdInfo id: 64007957MMY4004, briefTitle: A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials, acronym: REALiTEC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-18, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2026-01-28, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Janssen-Cilag Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to describe the use of teclistamab in the treatment of patients with RRMM outside of clinical trials., conditionsModule conditions: Relapsed/Refractory Multiple Myeloma (RRMM), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: teclistamab, outcomesModule primaryOutcomes measure: Describe Baseline Characteristics of Patients with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab Outside of Clinical Trials, secondaryOutcomes measure: Describe the Use of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials, secondaryOutcomes measure: Describe the Safety Management of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials, secondaryOutcomes measure: Describe the Clinical Outcomes of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Odense University Hospital, status: RECRUITING, city: Odense, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Sygehus Lillebælt, Vejle, status: RECRUITING, city: Vejle, zip: 7100, country: Denmark, geoPoint lat: 55.70927, lon: 9.5357, locations facility: Hopital Albert Calmette - CHU Lille, status: RECRUITING, city: Lille cedex, zip: 59037, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Institut Paoli Calmettes, status: RECRUITING, city: Marseille, zip: 13009, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Hopital Saint Louis, status: RECRUITING, city: Paris, zip: 75475, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Institut Universitaire du Cancer Toulouse Oncopole, status: RECRUITING, city: Toulouse Cedex 9, zip: 31100, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii, status: RECRUITING, city: Wurzburg, zip: 97080, country: Germany, geoPoint lat: 49.79391, lon: 9.95121, locations facility: Sheba Medical Center, status: RECRUITING, city: Ramat Gan, zip: 52621, country: Israel, geoPoint lat: 32.08227, lon: 34.81065, locations facility: Tel Aviv Sourasky Medical Center, status: RECRUITING, city: Tel Aviv Yafo, zip: 6423906, country: Israel, geoPoint lat: 32.08088, lon: 34.78057, locations facility: Policlinico Sant'Orsola Malpighi, status: RECRUITING, city: Bologna, zip: 40138, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Policlinico di Milano, status: RECRUITING, city: Milano, zip: 20121, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Presidio Ospedaliero Santo Spirito in Sassia, status: RECRUITING, city: Roma, zip: 65124, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Hosp. Univ. de La Paz, status: RECRUITING, city: Madrid, zip: 28046, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hosp. Costa Del Sol, status: RECRUITING, city: Malaga, zip: 29603, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Länssjukhuset Ryhov, status: RECRUITING, city: Jonkoping, zip: 551 85, country: Sweden, geoPoint lat: 57.78145, lon: 14.15618, hasResults: False |
protocolSection identificationModule nctId: NCT06285305, orgStudyIdInfo id: kilis_2, briefTitle: Surgical ICU Nurses' Attitudes on End-of-Life Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Kilis 7 Aralik University, class: OTHER, collaborators name: Hasan Kalyoncu University, descriptionModule briefSummary: This study aims to explore the attitudes and behaviors of nurses working in surgical intensive care units (ICUs) towards end-of-life care, alongside identifying the barriers they face in providing such care. Despite the universal need for end-of-life care, with an estimated 56.8 million people requiring it annually, only a fraction receive adequate services. The concept of a "good death" has evolved, now emphasizing patient and family wishes, and aligning with clinical, cultural, and ethical standards. In the U.S., a significant portion of deaths occur in hospitals, often involving surgical interventions in the final stages of life. Nurses in ICUs play a crucial role in delivering end-of-life care, making their attitudes and behaviors pivotal to the quality of care provided. Previous studies have indicated a positive correlation between nurses' attitudes towards end-of-life care and their ethical conduct in care delivery. However, research specifically focusing on surgical ICU nurses and the challenges they encounter in end-of-life care is limited. This study seeks to fill that gap, enhancing understanding of the factors that influence end-of-life care in surgical ICUs and potentially guiding improvements in care practices and policy., conditionsModule conditions: PATİENT CARE, conditions: Intensive Care Unit, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, outcomesModule primaryOutcomes measure: Descriptive Information Form, primaryOutcomes measure: Attitudes and Behaviors Towards End-of-Life Care Scale for Intensive Care Nurses, primaryOutcomes measure: Barriers to End-of-Life Care in Surgical Intensive Care Form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Islam, city: Kilis, zip: 79100, country: Turkey, geoPoint lat: 36.71611, lon: 37.115, hasResults: False |
protocolSection identificationModule nctId: NCT06285292, orgStudyIdInfo id: RC24_0097, briefTitle: Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence., acronym: PRIME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, collaborators name: FIZIMED Company, descriptionModule briefSummary: Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation., conditionsModule conditions: Urinary Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: EMY, outcomesModule primaryOutcomes measure: Urinary symptoms using the ICIQ-UI SF questionnaire, secondaryOutcomes measure: Quality of life using the I-QoL questionnaire, secondaryOutcomes measure: Urinary symptoms using the ICIQ-UI SF questionnaire, secondaryOutcomes measure: Cost-utility ratio using the EQ-5D questionnaire, secondaryOutcomes measure: Qualitative component, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06285279, orgStudyIdInfo id: NJCT-2401, briefTitle: FKC288 in Participants With Autoimmune Kidney Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Nanjing University School of Medicine, class: OTHER, descriptionModule briefSummary: This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\^6 cells/kg, 1.0×10\^6 cells/kg, 3.0×10\^6 cells/kg, and an alternative dose of 0.1×10\^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases)., conditionsModule conditions: Lupus Nephritis, conditions: ANCA-associated Vasculitis, conditions: Membranous Nephropathy - PLA2R Induced, conditions: IgG4-Related Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: FKC288, outcomesModule primaryOutcomes measure: The proportion of subjects with dose-limiting toxicity, primaryOutcomes measure: The proportion of subjects with adverse events, secondaryOutcomes measure: Proportion of subjects achieving renal response, secondaryOutcomes measure: Duration of response (DoR) of all subjects, secondaryOutcomes measure: Progression-free survival (PFS) of all subjects, secondaryOutcomes measure: Overall survival (OS) of all subjects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinling Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210016, country: China, contacts name: Xianghua Huang, MD, role: CONTACT, phone: 13770648824, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06285266, orgStudyIdInfo id: kilis_1, briefTitle: Nursing Students' Perceptions and Participation in Surgical Clinical Learning, acronym: NSPSCP_CL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Kilis 7 Aralik University, class: OTHER, collaborators name: Hasan Kalyoncu University, descriptionModule briefSummary: This cross-sectional study investigates the perceptions of nursing students regarding the clinical learning environment (CLE) in surgical services and their participation in clinical practices. Surgical services present a complex, dynamic, and intense learning environment crucial for the development of nursing students' professional competencies. The study explores the challenges nursing students face in these settings, including limited opportunities for participation in intraoperative processes and intensive care units, and the impact of these challenges on their learning outcomes and professional development.Previous research has highlighted various factors that can either facilitate or hinder nursing students' ability to engage effectively in clinical practices, such as the learning atmosphere, support from nurse educators, peer support, and effective communication. However, there is a noted gap in understanding the specific difficulties encountered in surgical services, the adequacy of students' clinical skills and knowledge, and their ability to apply theoretical knowledge in practice.By examining nursing students' experiences, this study aims to shed light on the suitability and quality of CLEs in surgical services, contributing valuable insights for optimizing clinical learning and enhancing nursing education programs. The hypotheses tested whether nursing students' perceptions of CLEs in surgical services and their participation in clinical practices are influenced by their descriptive characteristics.Keywords: Nursing Student, Surgical Services, Clinical Practice, Clinical Learning Environment, conditionsModule conditions: Clinical Practice, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Descriptive Characteristics Form, primaryOutcomes measure: Clinical Learning Environment Scale (CLES):, primaryOutcomes measure: Clinical Practice Participation Determination Form:, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06285253, orgStudyIdInfo id: MIRO-01-001, briefTitle: miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Miromatrix Medical Inc., class: INDUSTRY, descriptionModule briefSummary: The clinical trail will assess the safety of miroliverELAP for the treatment of acute liver failure without underlying chronic liver disease. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver., conditionsModule conditions: Acute Liver Failure, conditions: Acute Liver Injury, Drug Induced, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm, open label, safety study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: miroliverELAP treatment, outcomesModule primaryOutcomes measure: Survival, primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: 21-day survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California San Francisco Medical Center, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Bilal Hameed, MD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Emory University School of Medicine, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Northwestern Memorial Hospital, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Justin Boike, MD, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: University of Michigan Medical School, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Lena Napolitano, MD, role: CONTACT, geoPoint lat: 42.27756, lon: -83.74088, locations facility: University of Minnesota Medical School, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, contacts name: Thomas Leventhal, MD, role: CONTACT, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55902, country: United States, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Mount Sinai Recanati/Miller Transplantation Institute, city: New York, state: New York, zip: 10029, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Cleveland Clinic Foundation, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Intermountain Healthcare, city: Salt Lake City, state: Utah, zip: 84103, country: United States, contacts name: Richard Gilroy, MD, role: CONTACT, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Virginia Commonwealth University Medical Center, city: Richmond, state: Virginia, zip: 23970, country: United States, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False |
protocolSection identificationModule nctId: NCT06285240, orgStudyIdInfo id: 1167-007, briefTitle: Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-07-25, completionDateStruct date: 2024-07-25, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to assess the safety and efficacy of MK-1167 administered to participants with Alzheimer's Disease (AD) receiving stable Donepezil treatment., conditionsModule conditions: Alzheimer's Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: MK-1167, interventions name: Donepezil, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants experiencing an Adverse Event (AE), primaryOutcomes measure: Number of participants discontinuing study treatment due to an AE, secondaryOutcomes measure: Area Under the Plasma Concentration-Time Curve from Dosing to 24 Hours Postdose (AUC0-24) of MK-1167, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of MK-1167, secondaryOutcomes measure: Plasma Concentration at 24 hours postdose (C24), secondaryOutcomes measure: Time to Reach Maximum Plasma Concentration (Tmax) of MK-1167, secondaryOutcomes measure: Apparent Terminal Half-Life (t½) of MK-1167, secondaryOutcomes measure: Oral Clearance (CL/F) of MK-1167 from Plasma, secondaryOutcomes measure: Apparent Volume of Distribution (Vz/F) of MK-1167, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity Clinical Research, Hallandale Beach ( Site 0001), status: RECRUITING, city: Hallandale Beach, state: Florida, zip: 33009, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 954-455-5757, geoPoint lat: 25.9812, lon: -80.14838, locations facility: CenExel iResearch, LLC ( Site 0003), status: RECRUITING, city: Decatur, state: Georgia, zip: 30030, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 404-537-1281, geoPoint lat: 33.77483, lon: -84.29631, locations facility: CenExel iResearch, LLC ( Site 0004), status: RECRUITING, city: Savannah, state: Georgia, zip: 31405, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 912-744-0800, geoPoint lat: 32.08354, lon: -81.09983, hasResults: False |
protocolSection identificationModule nctId: NCT06285227, orgStudyIdInfo id: CM313-100001, briefTitle: Study of CM313 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Keymed Biosciences Co.Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: CM313 injection, outcomesModule primaryOutcomes measure: Adverse event, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06285214, orgStudyIdInfo id: OAG1050, briefTitle: Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-26, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Imbrium Therapeutics, class: INDUSTRY, collaborators name: Purdue Pharma LP, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo., conditionsModule conditions: Interstitial Cystitis/Bladder Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: V117957, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline for bladder pain/discomfort scores over last 12 hours (morning and evening)., secondaryOutcomes measure: Change from baseline in mean number of micturitions per 12 hours (morning and evening), secondaryOutcomes measure: Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS), secondaryOutcomes measure: Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS), secondaryOutcomes measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI), secondaryOutcomes measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI), secondaryOutcomes measure: Change from baseline in Subject Global Response Assessment (SGRA), secondaryOutcomes measure: Change from baseline in Symptom Impact Sleep Questionnaire (SISQ), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Urology Centers of Alabama, PC, status: RECRUITING, city: Homewood, state: Alabama, zip: 35209, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 33.47177, lon: -86.80082, locations facility: Urological Associates of Southern Arizona, status: RECRUITING, city: Tucson, state: Arizona, zip: 85715, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Applied Research Center of Arkansas, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72212, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Investigational Site, status: RECRUITING, city: Escondido, state: California, zip: 92025, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 33.11921, lon: -117.08642, locations facility: Urology Group of Southern California, status: RECRUITING, city: Los Angeles, state: California, zip: 90017, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Hope Clinical Research, LLC, status: RECRUITING, city: Los Angeles, state: California, zip: 91303, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Tri Valley Urology Medical Group, status: RECRUITING, city: Murrieta, state: California, zip: 92562, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 33.55391, lon: -117.21392, locations facility: Accel Research Sites, status: RECRUITING, city: DeLand, state: Florida, zip: 32720, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 29.02832, lon: -81.30312, locations facility: Accel Research Site - Neurostudies, status: RECRUITING, city: Decatur, state: Georgia, zip: 30033, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 33.77483, lon: -84.29631, locations facility: Providea Health Partners LLC, status: RECRUITING, city: Evergreen Park, state: Illinois, zip: 60805, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 41.72059, lon: -87.70172, locations facility: Otrimed Clinical Research, status: TERMINATED, city: Edgewood, state: Kentucky, zip: 41017, country: United States, geoPoint lat: 39.01867, lon: -84.58189, locations facility: Southern Clinical Research Associates, status: RECRUITING, city: Metairie, state: Louisiana, zip: 70001, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Boston Clinical Trials, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02131, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Bay State Clinical Trials, Inc., status: RECRUITING, city: Watertown, state: Massachusetts, zip: 02472, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 42.37093, lon: -71.18283, locations facility: Revive Research Institute, Inc, status: RECRUITING, city: Dearborn Heights, state: Michigan, zip: 48127, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 42.33698, lon: -83.27326, locations facility: CentraCare - Urology Clinic, status: TERMINATED, city: Sartell, state: Minnesota, zip: 56377, country: United States, geoPoint lat: 45.62163, lon: -94.20694, locations facility: Adult & Pediatric Urology P.C., status: RECRUITING, city: Omaha, state: Nebraska, zip: 68114, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Great Lakes Physician, PC, status: WITHDRAWN, city: Cheektowaga, state: New York, zip: 14225, country: United States, geoPoint lat: 42.90339, lon: -78.75475, locations facility: AccuMed Research Associates, status: RECRUITING, city: Garden City, state: New York, zip: 11530, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 40.72677, lon: -73.6343, locations facility: Manhattan Medical Research Practice, status: TERMINATED, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Unified Women's Clinical Research-Lyndhurst Clinical Research, status: RECRUITING, city: Winston-Salem, state: North Carolina, zip: 27103, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 36.09986, lon: -80.24422, locations facility: The Lindner Research Center at The Christ Hospital, status: WITHDRAWN, city: Cincinnati, state: Ohio, zip: 45219, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: MidLantic Urology, status: TERMINATED, city: Bala-Cynwyd, state: Pennsylvania, zip: 19004, country: United States, geoPoint lat: 40.00761, lon: -75.23407, locations facility: Antria, Inc., status: WITHDRAWN, city: Indiana, state: Pennsylvania, zip: 15701, country: United States, geoPoint lat: 40.62146, lon: -79.15253, locations facility: Epic Clinical Research, status: RECRUITING, city: Lewisville, state: Texas, zip: 75057, country: United States, contacts name: Central Contact, role: CONTACT, geoPoint lat: 33.04623, lon: -96.99417, locations facility: Urology of Virginia, PLLC, status: WITHDRAWN, city: Virginia Beach, state: Virginia, zip: 23462, country: United States, geoPoint lat: 36.85293, lon: -75.97799, hasResults: False |
protocolSection identificationModule nctId: NCT06285201, orgStudyIdInfo id: TJ202001BE104, briefTitle: Study of Felzartamab in Healthy Adult Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: TJ Biopharma Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design), conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: T, interventions name: R, outcomesModule primaryOutcomes measure: Primary PK Endpoint, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Hospital of Jilin University, status: RECRUITING, city: Jilin, state: Changchun, country: China, contacts name: Xiaojiao Li, Doctor, role: CONTACT, phone: +8613514314089, email: [email protected], geoPoint lat: 43.85083, lon: 126.56028, hasResults: False |
protocolSection identificationModule nctId: NCT06285188, orgStudyIdInfo id: APHP221174, secondaryIdInfos id: 2023-A01398-37, type: REGISTRY, domain: ID-RCB, briefTitle: Immunomonitoring of Mold Invasive Infections, acronym: IMMUNOFIL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Mold invasive infections are associated with an important mortality despite optimization of the antifungal treatment. In a few case reports, immune checkpoints inhibitors, initially developed for neoplastic diseases, have shown a potential beneficial effect in such devastating infections by restoring an efficient immune response. The investigators propose a longitudinal monitoring of the adaptative immune response, notably immune checkpoint expression on T cells, during mold invasive infections to help identify the patients who could benefit from the adjunction of immunotherapy and the optimal timing of such strategy., conditionsModule conditions: Invasive Fungal Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Immune checkpoint expression on T cells, secondaryOutcomes measure: Aspergillus/Mucorales FLUOROSPOT, secondaryOutcomes measure: T cell proliferation, secondaryOutcomes measure: Immune checkpoint expression on monocytes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Necker Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Alexandra SERRIS, MD, role: CONTACT, phone: +33 6 68 80 24 92, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06285175, orgStudyIdInfo id: APP-22-04497, briefTitle: REINVENT: A Brain and Muscle Computer Interface for Stroke, acronym: REINVENT, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, descriptionModule briefSummary: Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (\>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Tele-REINVENT, outcomesModule primaryOutcomes measure: Fugl Meyer Assessment - Upper Extremity, primaryOutcomes measure: Maximum EMG activity, primaryOutcomes measure: Corticomuscular coherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Southern California, city: Los Angeles, state: California, zip: 90033, country: United States, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06285162, orgStudyIdInfo id: 69HCL23_1372, secondaryIdInfos id: 2024-A00294-43, type: OTHER, domain: ID-RCB, briefTitle: Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy, acronym: UFANI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed., conditionsModule conditions: Critically Ill, conditions: Renal Replacement Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Percentage of changes in ANI., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel, city: Bron, zip: 69500, country: France, contacts name: Martin RUSTE, MD, role: CONTACT, phone: +33472118956, phoneExt: +33, email: [email protected], contacts name: Martin RUSTE, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Matthias JACQUET-LAGREZE, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, hasResults: False |
protocolSection identificationModule nctId: NCT06285149, orgStudyIdInfo id: AKLD-22, briefTitle: Tace With Icaritin in First-line Treatment of Middle and Advanced HCC in Child Grade B Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus, TACE+Icaritin may potentially optimize treatment strategies for patients with poor liver function reserve., conditionsModule conditions: HCC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Icaritin, outcomesModule primaryOutcomes measure: ORR, primaryOutcomes measure: PFS, secondaryOutcomes measure: Overall survival，OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06285136, orgStudyIdInfo id: SHEN-PJ-KE-2024-15, briefTitle: Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Kunming Medical University, class: OTHER, collaborators name: Institute of hematology hospital,Chinese Academy of Medical Sciences, collaborators name: Handan Central Hospital, collaborators name: Taian City Central Hospital, collaborators name: Tianjin People's Hospital, collaborators name: Guizhou Provincial People's Hospital, collaborators name: Central South University, collaborators name: Western Theater General Hospital, collaborators name: First Affiliated Hospital of Guangxi Medical University, collaborators name: Chengdu Jingdongfang Hospital, descriptionModule briefSummary: This study proposes to conduct a prospective, multicenter, single-arm study to explore the efficacy and safety of venetoclax in combination with high-dose decitabine (DEC3-VEN) in new diagnosed adult patients with AML, and to provide evidence for the optimal selection of clinical treatment regimens, which is planned to be conducted in 10 research centers across the country., conditionsModule conditions: Acute Myeloid Leukemia, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: DEC3-VEN, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Kunming Medical University., city: Kunming, state: Yunnan, country: China, geoPoint lat: 25.03889, lon: 102.71833, hasResults: False |
protocolSection identificationModule nctId: NCT06285123, orgStudyIdInfo id: HUM00248235 and HUM00248331, secondaryIdInfos id: 1U01FD007803-01, type: FDA, link: https://reporter.nih.gov/quickSearch/1U01FD007803-01, briefTitle: Implementing the COMFORT Guidelines for Postpartum Pain Management, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: Food and Drug Administration (FDA), descriptionModule briefSummary: A new national clinical practice guideline (CPG) for pain management after childbirth aims to mitigate peripartum opioid-related risks without compromising or exacerbating existing inequities in pain management in the United States. Standard dissemination approaches are often insufficient to change clinical practice-more active implementation efforts are generally required. Replicating Effective Programs (REP) is a theory-driven implementation intervention that is publicly available and highly scalable, but REP alone may be insufficient for effectively embedding the CPG across all maternity sites. For sites needing more support, REP can be augmented with facilitation (e.g., individualized consultation with site champions to overcome local barriers to CPG adoption, "Enhanced-REP" \[E-REP\]). Because E-REP is more expensive and difficult to scale than REP, it is essential to identify those settings where REP alone is effective versus those where REP may need augmentation, but this has not been evaluated in maternity contexts. Our objective is to determine the effect of a new postpartum pain management CPG, as implemented by REP and E-REP, on postpartum opioid prescribing (primary outcome: rate and amount of opioid prescribed within three days of childbirth), overall, by hospital, and among key subgroups.This is a non-responder randomized trial within the Obstetrics Initiative (OBI), a perinatal collaborative quality initiative funded by Blue Cross Blue Shield of Michigan that includes 68 member hospitals serving more than 120,000 postpartum people over an approximately 15-month study time period. Hospitals not initially responding to REP (defined by performance below the top 15th percentile of all OBI hospitals for a) inpatient order for opioid-sparing postpartum pain management, \[e.g., scheduled acetaminophen and ibuprofen\], or b) amount of opioid prescribed at discharge, or c) provision of non-medication pain management interventions) will be allocated, via block randomization, to either continue REP vs. augment REP with facilitation (E-REP).The primary analysis will evaluate the rate of postpartum opioid-sparing prescribing metrics at the time of discharge (primary outcome) and opioid prescription refills and high-risk prescribing (secondary outcomes) before and after CPG implementation with REP, using interrupted time series analyses. Inequities in outcomes by patient, procedure, prescriber, and hospital factors will be evaluated. Exploratory analyses will examine temporal trends in patient-reported outcomes. The effects of continued REP vs. E-REP among non-responder sites will also be examined. Finally, implementation outcomes will be characterized using clinician and patient surveys and qualitative methods., conditionsModule conditions: Postpartum Pain, conditions: Opioid Stewardship, conditions: Maternity Care, conditions: Obstetric Care, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: REP, interventions name: Facillitation, outcomesModule primaryOutcomes measure: Postpartum opioid prescribing - Rate, primaryOutcomes measure: Postpartum opioid prescribing - Amount, secondaryOutcomes measure: Refill opioid prescribing, secondaryOutcomes measure: High-risk opioid prescribing, otherOutcomes measure: Patient-reported outcomes, otherOutcomes measure: Implementation outcomes - reach, otherOutcomes measure: Implementation outcomes - adoption, otherOutcomes measure: Implementation outcomes - feasibility, otherOutcomes measure: Implementation outcomes - acceptability, otherOutcomes measure: Implementation outcomes - appropriateness, otherOutcomes measure: Implementation outcomes - fidelity, otherOutcomes measure: Implementation outcomes - potential mechanisms of implementation, otherOutcomes measure: Implementation outcomes - costs of delivering implementation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False |
protocolSection identificationModule nctId: NCT06285110, orgStudyIdInfo id: DTG Resist, briefTitle: HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen, acronym: DTG-Resist, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-13, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Bern, class: OTHER, collaborators name: University of Zurich, collaborators name: ETH Zurich, collaborators name: University of KwaZulu, collaborators name: University of Bristol, descriptionModule briefSummary: This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of \>1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure.To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS)., conditionsModule conditions: Hiv, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Type of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen., primaryOutcomes measure: Prevalence of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen., primaryOutcomes measure: Time to virologic failure, primaryOutcomes measure: Number of INSTI DRMs per patient, primaryOutcomes measure: DTG drug resistance, primaryOutcomes measure: Phenotypic resistance levels of novel DRMs, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro Medico Huesped, status: RECRUITING, city: Buenos Aires, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Instituto Nacional de Infectiologia Evandro Chagas - Fiocruz, status: RECRUITING, city: Rio De Janeiro, country: Brazil, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Hopital de Jour du Centre Hospitalier Universitaire (CHU Souro Sanou), status: RECRUITING, city: Bobo-Dioulasso, country: Burkina Faso, geoPoint lat: 11.17715, lon: -4.2979, locations facility: National Centre for HIV/AIDS, Dermatology and STDs (NCHADS), status: RECRUITING, city: Phnom Penh, country: Cambodia, geoPoint lat: 11.56245, lon: 104.91601, locations facility: Regional Hospital Limbe, status: RECRUITING, city: Limbe, country: Cameroon, geoPoint lat: 4.02356, lon: 9.20608, locations facility: Hospital Jamot, status: RECRUITING, city: Yaounde, country: Cameroon, geoPoint lat: 3.86667, lon: 11.51667, locations facility: Centre de Traitement Ambulatoire, status: RECRUITING, city: Brazzaville, country: Congo, geoPoint lat: -4.26613, lon: 15.28318, locations facility: Centre de Traitement Ambulatoire, status: RECRUITING, city: Pointe Noire, country: Congo, geoPoint lat: -4.77609, lon: 11.86352, locations facility: ACONDA Centre de Prise en Charge et de Formation (CePReF), status: RECRUITING, city: Abidjan, country: Côte D'Ivoire, geoPoint lat: 5.30966, lon: -4.01266, locations facility: Centre médical de suivi des donneurs de sang, CNTS, status: RECRUITING, city: Abidjan, country: Côte D'Ivoire, geoPoint lat: 5.30966, lon: -4.01266, locations facility: Moi University, AMPATH, status: RECRUITING, city: Eldoret, country: Kenya, geoPoint lat: 0.52036, lon: 35.26993, locations facility: Lighthouse clinic, status: RECRUITING, city: Lilongwe, country: Malawi, geoPoint lat: -13.96692, lon: 33.78725, locations facility: Martin Preuss Centre, status: RECRUITING, city: Lilongwe, country: Malawi, geoPoint lat: -13.96692, lon: 33.78725, locations facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, status: RECRUITING, city: Mexico City, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Research for Development, Einstein-Rwanda Research and Capacity Building Program, status: RECRUITING, city: Kigali, country: Rwanda, geoPoint lat: -1.94995, lon: 30.05885, locations facility: National Institute for Medical Research (NIMR), status: RECRUITING, city: Kisesa, country: Tanzania, geoPoint lat: -3.08333, lon: 34.15, locations facility: HIV-NAT/Thai Red Cross AIDS Research Center (TRCARC), status: RECRUITING, city: Bangkok, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Ramathibodi Hospital, Mahidol University, status: RECRUITING, city: Bangkok, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Masaka Regional Referral Hospital / AHF Uganda Cares, status: RECRUITING, city: Masaka, country: Uganda, geoPoint lat: -0.33379, lon: 31.73409, locations facility: Mbarara University of Science and Technology / Mbarara ISS Clinic (MUST), status: RECRUITING, city: Mbarara, country: Uganda, geoPoint lat: -0.60467, lon: 30.64851, locations facility: Centre for Infectious Disease Research Zambia (CIDRZ), status: RECRUITING, city: Lusaka, country: Zambia, geoPoint lat: -15.40669, lon: 28.28713, locations facility: Newlands Clinic, status: RECRUITING, city: Harare, country: Zimbabwe, geoPoint lat: -17.82772, lon: 31.05337, hasResults: False |
protocolSection identificationModule nctId: NCT06285097, orgStudyIdInfo id: C5391001, briefTitle: A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors., conditionsModule conditions: Neoplasms, conditions: Non-small-cell Lung Cancer, conditions: Melanoma, conditions: Squamous Cell Carcinoma of the Head and Neck, conditions: Renal Cell Carcinoma, conditions: Urothelial Carcinoma, conditions: Colorectal Carcinoma, conditions: Ovarian Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: PF-07820435, interventions name: Sasanlimab, outcomesModule primaryOutcomes measure: Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B), primaryOutcomes measure: Number of patients with adverse events (AEs), primaryOutcomes measure: Number of patients with clinically significant lab abnormalities, primaryOutcomes measure: Objective response rate (ORR) in Part 2 Expansion, secondaryOutcomes measure: Objective response rate (ORR) in dose escalation (Part 1A and Part 1B), secondaryOutcomes measure: Duration of tumor response, secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Cmax (maximum concentration) of PF-07820435 and its active metabolite, secondaryOutcomes measure: Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite, secondaryOutcomes measure: AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite, secondaryOutcomes measure: Cmin (minimum concentration) of PF-07820435 and its active metabolite after multiple dosing only, secondaryOutcomes measure: Change from baseline of immune markers within biopsied tumor tissue, secondaryOutcomes measure: Pre-dose trough concentrations of sasanlimab (Part 1B and Part 2), secondaryOutcomes measure: Incidence and titers of ADA and NAb against sasanlimab (Part 1B and Part 2), secondaryOutcomes measure: Cmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2, secondaryOutcomes measure: Tmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2, secondaryOutcomes measure: AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Corewell Health (reference non-engagement letter), status: NOT_YET_RECRUITING, city: Grand Rapids, state: Michigan, zip: 49503, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: START Midwest, status: NOT_YET_RECRUITING, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: National Cancer Center Hospital East, status: NOT_YET_RECRUITING, city: Kashiwa, state: Chiba, zip: 277-8577, country: Japan, geoPoint lat: 35.86224, lon: 139.97732, locations facility: The Cancer Institute Hospital of JFCR, status: NOT_YET_RECRUITING, city: Koto, state: Tokyo, zip: 135-8550, country: Japan, geoPoint lat: 35.66667, lon: 139.81718, locations facility: Hospital Oncologico Dr. Isaac Gonzalez-Martinez, status: RECRUITING, city: Rio Piedras, zip: 00935, country: Puerto Rico, geoPoint lat: 18.39745, lon: -66.04989, locations facility: Pan American Center for Oncology Trials, LLC, status: RECRUITING, city: Rio Piedras, zip: 00935, country: Puerto Rico, geoPoint lat: 18.39745, lon: -66.04989, hasResults: False |
protocolSection identificationModule nctId: NCT06285084, orgStudyIdInfo id: VALETUDO Trial (L4195), briefTitle: Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility, acronym: VALETUDO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2025-11-02, completionDateStruct date: 2027-02-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: The goal of this observationl study is to evaluate the possibility of building a Deep Learning (DL) model capable of analyzing electrocardiographic traces of athletes and providing information in the form of a probability stratification of cardiovascular disease.Researchers will enroll a training cohort of 455 participants, evaluated following standard clinical practice for eligibility in competitive sports. The response of the clinical evaluation and ECG traces will be recorded to build a DL model.Researchers will subsequently enroll a validation cohort of 76 participants. ECG traces will be analyzed to evaluate the accuracy of the model to discriminate participants cleared for sports eligibility versus participants who need further medical tests, conditionsModule conditions: Sports Cardiology, conditions: Preventive Cardiology, conditions: Electrocardiogram, conditions: Artificial Intelligence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 531, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: DL model accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ospedale Galeazzi-Sant'Ambrogio, status: RECRUITING, city: Milano, state: Lombardy, zip: 20157, country: Italy, contacts name: davide marchetti, MD, role: CONTACT, phone: +390283506734, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06285071, orgStudyIdInfo id: NN7415-7557, secondaryIdInfos id: U1111-1274-4740, type: OTHER, domain: World Health Organization (WHO), briefTitle: Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2030-04-30, completionDateStruct date: 2030-04-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years., conditionsModule conditions: Haemophilia A, conditions: Haemophilia B, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Concizumab, outcomesModule primaryOutcomes measure: Number of adverse reaction (AR), secondaryOutcomes measure: Number of serious adverse reaction (SAR), secondaryOutcomes measure: Number of serious adverse event (SAE), secondaryOutcomes measure: Number of thromboembolic adverse event (AE), secondaryOutcomes measure: Number of shock/anaphylaxis AE, secondaryOutcomes measure: Number of treated spontaneous and traumatic bleeding episodes, secondaryOutcomes measure: Number of treated spontaneous and traumatic target joint bleeding episodes, secondaryOutcomes measure: Number of all treatment requiring bleeding episode, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novo Nordisk Investigational Site, city: Toshima, state: Tokyo, country: Japan, hasResults: False |
protocolSection identificationModule nctId: NCT06285058, orgStudyIdInfo id: LUNAI, briefTitle: Deep Learning Model Predicts Pathological Complete Response of Lung Cancer Following Neoadjuvant Immunochemotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: This study presents the development and validation of an artificial intelligence (AI) prediction system that utilizes pre-neoadjuvant immunotherapy plain scans and enhanced multimodal CT scans to extract deep learning features. The aim is to predict the occurrence of pathological complete response in non-small cell lung cancer patients undergoing neoadjuvant immunochemotherapyy., conditionsModule conditions: Deep Learning Model, conditions: Pathological Complete Response, conditions: Non-small Cell Lung Cancer, conditions: Neoadjuvant Chemoimmunotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: No interventions, outcomesModule primaryOutcomes measure: the accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of predicting model, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06285045, orgStudyIdInfo id: 2060302-1703-05, briefTitle: Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-10-01, primaryCompletionDateStruct date: 2019-08-31, completionDateStruct date: 2019-08-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of Roujin Formula in the treatment of fibromyalgia syndrome(FMS)patients with blood deficiency and liver depression through a randomized,single-blind,placebo-parallel controlled exploratory clinical trial study,and to provide reliable clinical evidence for the treatment of fibromyalgia syndrome with Roujin Formula. 48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data., conditionsModule conditions: Fibromyalgia Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Roujin Formula, outcomesModule primaryOutcomes measure: The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline, primaryOutcomes measure: The change of the Visual Analogue Scale (VAS) for pain from baseline, secondaryOutcomes measure: The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline, secondaryOutcomes measure: The change of the Beck depression inventory(BDI) from baseline, secondaryOutcomes measure: The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Juan Jiao, city: Beijing, state: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06285032, orgStudyIdInfo id: STUDY00017244, secondaryIdInfos id: R34DA058325, type: NIH, link: https://reporter.nih.gov/quickSearch/R34DA058325, briefTitle: Decreasing Loneliness to Optimize Pain Care, acronym: DLoop, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse., conditionsModule conditions: Loneliness, conditions: Opioid Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavior Therapy (CBT), interventions name: Social Navigation Group, interventions name: Controlled Group, outcomesModule primaryOutcomes measure: Opioid Misuse, secondaryOutcomes measure: Determine Functional Outcome, otherOutcomes measure: Loneliness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Washington, city: Seattle, state: Washington, zip: 98105, country: United States, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06285019, orgStudyIdInfo id: GWK-2023-004, briefTitle: Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: TOMOX-HAIC, interventions name: Sintilimab, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: objective response rate (ORR), secondaryOutcomes measure: disease control rate (DCR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Time to progression (TTP), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: adverse event (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200062, country: China, contacts name: Lu Wang, M.D., role: CONTACT, phone: +86-18121299357, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06285006, orgStudyIdInfo id: MScAZASTPED025/23/202/12/2021, briefTitle: Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis., conditionsModule conditions: Nocturnal Enuresis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Desmopressin, outcomesModule primaryOutcomes measure: The number of episodes per week after desmopressin treatment, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Alazhar university, status: RECRUITING, city: Assiut, zip: 11884, country: Egypt, contacts name: Omnia Nassar, Dr, role: CONTACT, phone: 01010112054, email: [email protected], contacts name: Hosny Elmasry, Prof, role: CONTACT, phone: 01010112054, email: [email protected], geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06284993, orgStudyIdInfo id: 2023-214-KY, briefTitle: Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences, class: OTHER, descriptionModule briefSummary: Plantar fasciitis (PF) is one of the most common causes of heel pain, typically characterized by a sharp pain in the plantar aponeurosis, specifically near the insertion site close to the medial process of the calcaneal tuberosity. It has been reported that 1 in 10 people are expected to be affected by PF in their lifetime. A comprehensive internet-panel survey conducted among the adult United States population revealed the population-based prevalence of self-reported PF with pain in the last month was 0.85 percent. Approximately 1 million patients are diagnosed with this disease each year in the United States. PF was believed to be an acute inflammatory disease, but patient samples show it is actually a chronic degenerative process caused by various factors such as repetitive stresses, vascular and metabolic disorders, excess free radicals, high temperatures, genetic factors, and conditions like rheumatoid arthritis and spondyloarthropathies. PF may be associated with impaired health-related quality of life, including reduced life functioning, poor perceived health status and social isolation. Additionally, a recent study indicates that the annual cost associated with PF is $284 million.The first-line treatments recommended by guidelines for PF encompass physical therapy (including manual therapy, stretching, and others), pharmacological therapy (involving corticosteroids or platelet-rich plasma), and surgical treatment. However, the definite effects of physical therapy still require confirmation. Pharmacological treatments, such as local corticosteroid injections, exhibit a short maintenance period. Some studies indicate that the relief provided by corticosteroid injections lasts up to one month, yet its efficacy diminishes after 6 months. Surgical treatment is generally advised 6 to 12 months after unsuccessful conservative treatment, albeit with the drawback of higher costs, post-surgery recovery time, and patient apprehension.Acupuncture is one of the most common complementary alternative therapy for the treatment of pain-related diseases such as musculoskeletal muscle, and recent guidelines recommend dry needling as a treatment for relief of plantar fasciitis, with a level of evidence of B. Dry acupuncture is different from acupuncture in terms of theoretical basis, therapeutic apparatus, technical operation and scope of indications, however, the American Alliance for Professional Acupuncture Safety also believes that dry needling falls under the umbrella of acupuncture, but under a different name. In addition, there are systematic evaluations that suggest acupuncture can be a safe and effective treatment for PF, and most of the trials in the systematic evaluations used 4-week treatment courses. Our prior study demonstrated that a 4-week intervention of both electroacupuncture and manual acupuncture resulted in improved pain outcomes among patients with PF.The frequency of acupuncture stands as a crucial factor influencing its efficacy. A study revealed that needling trials with negative results had a significantly lower frequency compared to those yielding positive results. Furthermore, several studies indicate that acupuncture once a week can be help in conditions such as simple obesity, functional dyspepsia, and overactive bladder in women. There is no universally accepted standard of frequency of treatment for many conditions, including PF. In China, patients with chronic diseases usually receive 3-5 acupuncture treatments per week. However, in most previous trials, individuals with chronic diseases received 1-2 needling sessions per week. An increase in the frequency of acupuncture means an increase in the pain, time, and financial investment associated with the acupuncture process. Therefore, it is critical to optimize the frequency of acupuncture to ensure the effectiveness and feasibility of the treatment while avoiding increasing the burden on the patient. Accordingly, we designed the current trial to compare the effects of different acupuncture sessions (1 session per week versus 3 sessions per week) in a randomized controlled trial (RCT) of chronic PF. The hypothesis is that 1 session per week compared with 3 sessions per week of electroacupuncture treatment over a total of 4 weeks of treatment will provide a similar effect on pain relief in chronic PF., conditionsModule conditions: Plantar Fasciitis, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: electroacupuncture(more frequent), interventions name: electroacupuncture(less frequent), outcomesModule primaryOutcomes measure: The response rate, secondaryOutcomes measure: The response rate, secondaryOutcomes measure: Change from baseline in the VAS score for worst pain intensity during the first steps in the morning, secondaryOutcomes measure: Change from baseline in the VAS score for mean pain intensity during the day, secondaryOutcomes measure: Change from baseline in the duration of heel pain during the day, secondaryOutcomes measure: Change from baseline in heel pressure pain threshold (PPT), secondaryOutcomes measure: Change from baseline in ankle range of motion (AROM), secondaryOutcomes measure: Change from baseline in Foot and Ankle Ability Measure (FAAM) total score and subscale scores, secondaryOutcomes measure: Participant global assessment of improvement, otherOutcomes measure: Participants' expectation towards acupuncture, otherOutcomes measure: Safety assessment, otherOutcomes measure: Adherence assessment, otherOutcomes measure: Number of cases and number of times painkillers and other treatments, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Jiaxiang Shi, role: CONTACT, phone: +8618396129770, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06284980, orgStudyIdInfo id: 2369, briefTitle: Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study, acronym: TITANIUM, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-01-24, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Gestational trophoblast diseases are characterized by abnormal proliferation of trophoblastic tissue, which can occur consequent to any pregnancy event. Pre-malignant forms (partial hydatiform mola and complete mola) and malignant forms are distinguished, the latter also known as gestational trophoblast neoplasms (invasive hydatiform mola, choriocarcinoma, placental site trophoblastic tumor, and epithelioid trophoblastic tumor).These are neoplasms associated with good prognosis, amenable to conservative treatment and highly sensitive to chemotherapy.The identification of ultrasonographic and echofluximetric features typical of malignant forms as well as the identification of ultrasonographic parameters predictive of chemoresistance to single-drug treatments could help improve their management., conditionsModule conditions: Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination, conditions: To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients, conditions: To Identify Ultrasound Predictors of Resistance to First-line Single Drug Chemotherapy in Low-risk GTN Patients, conditions: To Investigate if Machine Learning (ML) Algorithms (Radiomics, Deep Neural Networks (DNN), and Other Machine Learning Algorithms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: typical features of Gestational Trophoblastic Neoplasia, secondaryOutcomes measure: differences at the baseline US scan between low-risk and high-risk patients, otherOutcomes measure: changes characteristics of Gestational Trophoblastic Neoplasia during treatment, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, status: RECRUITING, city: Rome, zip: 00168, country: Italy, contacts name: Floriana Mascilini, role: CONTACT, phone: 0630156399, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06284967, orgStudyIdInfo id: Vitamin D In Spondylolysis, briefTitle: Association Of Serum Vitamin D Level With Isthmic Spondylolysis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare vitamin D level between young adults with isthmic spondylolysis and a matched healthy control group., conditionsModule conditions: Spondylolysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 184, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Mean serum vitamin D in both groups., secondaryOutcomes measure: Mean serum calcium level, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06284954, orgStudyIdInfo id: ARGX-117-2301, secondaryIdInfos id: 2023-508337-14, type: OTHER, domain: CTIS number, briefTitle: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis, acronym: empacific, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2025-07-18, completionDateStruct date: 2028-01-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: argenx, class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM)., conditionsModule conditions: Dermatomyositis, conditions: Myositis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Empasiprubart IV, interventions name: Placebo IV, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (AEs), primaryOutcomes measure: Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE), secondaryOutcomes measure: Mean TIS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06284941, orgStudyIdInfo id: KY 2023-001-001, briefTitle: A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-06-20, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Wang wanxia, class: OTHER, descriptionModule briefSummary: Total hip arthroplasty is currently the most effective method for treating hip joint lesions and improving quality of life, but postoperative severe pain is not conducive to rapid recovery of patients. In recent years, the widespread application of ultrasound has achieved good clinical results in iliac fascia block for postoperative analgesia in THA. However, the use of high-dose local anesthetics can increase the risk of local anesthetic poisoning, and the single block analgesia time is generally less than 24 hours. Methylene blue, as a long-acting analgesic drug, can block the pain transmission of nerve fibers for a long time, achieving analgesic effects without damaging neurons. This study used ultrasound-guided ropivacaine combined with methylene blue to perform iliac fascia block on patients undergoing total hip replacement, with the aim of prolonging pain relief time, reducing complications, and promoting postoperative recovery on the basis of traditional methods., conditionsModule conditions: Femoral Neck Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Ropivacaine combined with methylene blue for iliac fascia block, outcomesModule primaryOutcomes measure: Neutrophil lymphocyte ratio, primaryOutcomes measure: visual analogue scale（VAS）, primaryOutcomes measure: Procalcitonin, primaryOutcomes measure: Hypersensitive C-reactive protein, secondaryOutcomes measure: Mean arterial pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Duration of surgery, secondaryOutcomes measure: Number of postoperative salvage analgesia, secondaryOutcomes measure: Walking distance for the first time getting out of bed, secondaryOutcomes measure: The number of activities of getting out of bed 48 hours after surgery, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine, city: Taizhou, state: Jiang Su, zip: 225500, country: China, geoPoint lat: 32.49069, lon: 119.90812, hasResults: False |
protocolSection identificationModule nctId: NCT06284928, orgStudyIdInfo id: 20240104-01, briefTitle: Gut Microbiota and New Hypertension, acronym: MIPHYP-CROSS, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-12-01, primaryCompletionDateStruct date: 2020-06-01, completionDateStruct date: 2020-12-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Xinjiang Medical University, class: OTHER, descriptionModule briefSummary: This study aims to explore the gut microbiota patterns in patients newly diagnosed with hypertension, comparing them to those in non-hypertensive individuals. Utilizing cross-sectional analysis, it seeks to identify specific microbial profiles associated with hypertension, which could provide insights into the disease's pathogenesis and potential new avenues for treatment. The research focuses on analyzing fecal samples collected from both groups, using advanced genomic techniques to assess the diversity and abundance of gut bacteria. This investigation could contribute significantly to our understanding of the role gut microbiota plays in cardiovascular health and disease., conditionsModule conditions: Hypertension, conditions: Gut Microbiota, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Gut Microbiota Analysis, outcomesModule primaryOutcomes measure: Change in Gut Microbiota Composition, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Xinjiang Medical University, city: Ürümqi, state: Xinjiang, zip: 630000, country: China, geoPoint lat: 43.80096, lon: 87.60046, hasResults: False |
protocolSection identificationModule nctId: NCT06284915, orgStudyIdInfo id: MEQ00089, secondaryIdInfos id: MEQ00089, type: OTHER, domain: Sanofi Identifier, secondaryIdInfos id: 2023-508177-85, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1280-6981, type: REGISTRY, domain: ICTRP, briefTitle: Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-03-10, completionDateStruct date: 2025-03-11, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sanofi Pasteur, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants., conditionsModule conditions: Meningococcal Immunisation, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: The study will be performed in a modified double-blind fashion:* Investigators and study staff who conduct the safety assessment, and the participants parent/ legally acceptable representative will not know which study intervention is administered* Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 840, type: ESTIMATED, armsInterventionsModule interventions name: MenACYW conjugate vaccine, interventions name: MenACYW conjugate vaccine, outcomesModule primaryOutcomes measure: Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, Y and W, secondaryOutcomes measure: hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W, secondaryOutcomes measure: hSBA antibody titers against meningococcal serogroups A, C, W, and Y, secondaryOutcomes measure: hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W, secondaryOutcomes measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA, secondaryOutcomes measure: hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse, secondaryOutcomes measure: Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y, secondaryOutcomes measure: rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W, secondaryOutcomes measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA, secondaryOutcomes measure: rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse, secondaryOutcomes measure: Number of participants with immediate adverse events (AEs), secondaryOutcomes measure: Number of participants with solicited injection site reactions or systemic reactions, secondaryOutcomes measure: Number of participants with unsolicited AEs, secondaryOutcomes measure: Number of participants with serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 14 Months, stdAges: CHILD, contactsLocationsModule locations facility: Investigational Site Number: 2030001, status: RECRUITING, city: Ceske Budejovice, country: Czechia, geoPoint lat: 48.97447, lon: 14.47434, locations facility: Investigational Site Number: 2030005, status: RECRUITING, city: Prague, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Investigational Site Number: 2080004, status: RECRUITING, city: Aarhus, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Investigational Site Number: 2460006, status: RECRUITING, city: Jaarvenpa, country: Finland, locations facility: Investigational Site Number: 2460007, status: RECRUITING, city: Oulu, country: Finland, geoPoint lat: 65.01236, lon: 25.46816, locations facility: Investigational Site Number: 2460004, status: RECRUITING, city: Tampere, country: Finland, geoPoint lat: 61.49911, lon: 23.78712, locations facility: Investigational Site Number: 2460012, status: RECRUITING, city: Turku, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, locations facility: Investigational Site Number: 2760007, status: RECRUITING, city: Erfurt, country: Germany, geoPoint lat: 50.9787, lon: 11.03283, locations facility: Investigational Site Number: 2760001, status: RECRUITING, city: Moenchengladbach, country: Germany, geoPoint lat: 51.18539, lon: 6.44172, locations facility: Investigational Site Number: 2760005, status: RECRUITING, city: Schoenau Am Koenigssee, country: Germany, locations facility: Investigational Site Number: 6160017, status: RECRUITING, city: Bydgoszcz, country: Poland, geoPoint lat: 53.1235, lon: 18.00762, locations facility: Investigational Site Number: 6160015, status: RECRUITING, city: Krakow, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Investigational Site Number: 6160021, status: RECRUITING, city: Krakow, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Investigational Site Number: 6160016, status: RECRUITING, city: Leczna, country: Poland, geoPoint lat: 51.30121, lon: 22.88135, locations facility: Investigational Site Number: 6160012, status: RECRUITING, city: Lubon, country: Poland, geoPoint lat: 52.34705, lon: 16.89267, locations facility: Investigational Site Number: 6160007, status: RECRUITING, city: Torun, country: Poland, geoPoint lat: 53.01375, lon: 18.59814, locations facility: Investigational Site Number: 6160014, status: RECRUITING, city: Trzebnica, country: Poland, geoPoint lat: 51.31076, lon: 17.06331, locations facility: Investigational Site Number: 6160010, status: RECRUITING, city: Wroclav, country: Poland, locations facility: Investigational Site Number: 6420005, status: RECRUITING, city: Calarasi, country: Romania, geoPoint lat: 44.2051, lon: 27.31356, hasResults: False |
protocolSection identificationModule nctId: NCT06284902, orgStudyIdInfo id: BDR17987, briefTitle: Bioavailability Study of Fexofenadine HCl New Formulation Tablet, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-05-08, completionDateStruct date: 2024-05-23, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Opella Healthcare Group SAS, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to assess the relative bioavailability of a new galenic form of fexofenadine HCl new formulation tablet (test drug) taken with or without water compared to fexofenadine HCl film-coated tablets (reference form) taken with water under fasting conditions., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Fexofenadine HCl Coated tablet, interventions name: Fexofenadine HCl New Formulation Tablet, outcomesModule primaryOutcomes measure: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine, primaryOutcomes measure: Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) of Fexofenadine, primaryOutcomes measure: Maximal Observed Concentration (Cmax) of Fexofenadine, secondaryOutcomes measure: Time When the Maximal Concentration is Observed (Tmax) of Fexofenadine, secondaryOutcomes measure: Time of Observation Prior to the First Observation with a Measurable (non-zero) Concentration (Tlag) of Fexofenadine, secondaryOutcomes measure: Terminal Half-life Associated with the Terminal Slope (T1/2z) of Fexofenadine, secondaryOutcomes measure: Terminal Elimination Rate Constant (Kel) of Fexofenadine, secondaryOutcomes measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Syneos Health Clinic inc., status: RECRUITING, city: Quebec, zip: G1P 0A2, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False |
protocolSection identificationModule nctId: NCT06284889, orgStudyIdInfo id: DepActive, briefTitle: Behavioral Activation for the Treatment of Depression in Older Adults, acronym: DepActive, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, collaborators name: Västmanland County Council, Sweden, collaborators name: Sormland County Council, Sweden, collaborators name: Uppsala County Council, Sweden, descriptionModule briefSummary: Depression affects between 5-15% of adults ≥ 65 years in Sweden. Depression in older adults reduces functional ability and quality of life, and increases the risk for morbidity, loneliness, and suicide. Psychological treatment is recommended as a first-line treatment for depression, which about 3% of older adults with depression in Sweden report receiving. One effective psychological treatment is behavioral activation, which reduces depressive symptoms by increasing enjoyable, meaningful and important activities, for example exercise and social activities. The research group conducted a pilot study of telephone based behavioral activation for isolated older adults with depression during the COVID-19 pandemic. The intervention consisted of four telephone calls, and the results showed a significant decrease in depressive symptoms, with maintained effects for six months.250 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving treatment as usual at their respective primary care center. Participants will be asked to fill in questionnaires before, after treatment. Questionnaires will also be sent 3- and 6 months after treatment to follow up on the results. Patients will be asked to wear an accelerometer for 5-7 days to record their activity level at baseline, post-intervention and after 3-months. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled multi-center trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Behavioural activation, interventions name: Treatment as usual (TAU), outcomesModule primaryOutcomes measure: Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S, secondaryOutcomes measure: Change from baseline in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI, secondaryOutcomes measure: Change from baseline in Physical Activity level, secondaryOutcomes measure: Change from baseline in anxiety symptoms using the Geriatric Anxiety Scale - 10 item (GAS-10) is a self-rating scale designed to capture anxiety specifically in older adults, with items reflecting affective-, cognitive- and somatic anxiety symptoms., secondaryOutcomes measure: Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS, secondaryOutcomes measure: Change from baseline in self rated quality of life using the EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L, secondaryOutcomes measure: Changes from baseline in Self Efficacy measured with the New General Self-Efficacy Scale, S-GSE., secondaryOutcomes measure: Changes from baseline in loneliness measured with the UCLA Loneliness Scale version 3, UCLA-LS-3., secondaryOutcomes measure: Diagnostic accuracy, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Uppsala university, city: Uppsala, state: Uppland, zip: 753 10, country: Sweden, contacts name: Mattias Damberg, MD, role: CONTACT, phone: +46739480910, email: [email protected], geoPoint lat: 59.85882, lon: 17.63889, hasResults: False |
protocolSection identificationModule nctId: NCT06284876, orgStudyIdInfo id: IY-NTNS03, briefTitle: Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-30, primaryCompletionDateStruct date: 2026-08-30, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Il-Yang Pharm. Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24, conditionsModule conditions: Peptic Ulcer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 416, type: ESTIMATED, armsInterventionsModule interventions name: Ilaprazole, interventions name: Lansoprazole, interventions name: Ilaprazole Placebo, interventions name: Lansoprazole Placebo, outcomesModule primaryOutcomes measure: Ilaprazole, Lansoprazole peptic ulcer, secondaryOutcomes measure: Ilaprazole, Lansoprazole peptic ulcer, secondaryOutcomes measure: Ilaprazole, Lansoprazole GI bleeding, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chung Ang University Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06284863, orgStudyIdInfo id: 04-2023-200315, briefTitle: Impact Of Nutritional Education Program In Hemodialysis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program, conditionsModule conditions: Hemodialysis Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Natritional Education Program In Hemodialysis Patients, outcomesModule primaryOutcomes measure: The percentage patients responded to nutritional education program on hemodialysis patients., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06284850, orgStudyIdInfo id: Christina Trakatelli, briefTitle: Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-30, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Aristotle University Of Thessaloniki, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors., conditionsModule conditions: Hematocrit Change, conditions: Cardiovascular Prevention, conditions: Empagliflozin, conditions: SGLT2-Inhibitors, conditions: Tissue Oxygenation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Empagliflozin10Mg Tab, outcomesModule primaryOutcomes measure: Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml), secondaryOutcomes measure: Mean change in Hct (%), secondaryOutcomes measure: Hb (mg/dl), secondaryOutcomes measure: RBC (x1000000/μl), secondaryOutcomes measure: MCV (fl),, secondaryOutcomes measure: HbA1c (%, mmol/mol),, secondaryOutcomes measure: erythropoietin (mU/ml), secondaryOutcomes measure: eGFR (ml/min/1.73m2),, secondaryOutcomes measure: Urine Albumin to Creatinine Ratio (mg/g), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Papageorgiou General Hospital, status: RECRUITING, city: Thessaloniki, state: Central Macedonia, zip: 56403, country: Greece, contacts name: KONSTANTINOS KITSIOS, MD,MSc,PhD, role: CONTACT, phone: +306977295744, email: [email protected], geoPoint lat: 40.64361, lon: 22.93086, hasResults: False |
protocolSection identificationModule nctId: NCT06284837, orgStudyIdInfo id: HREC/99382/Alfred-2023, briefTitle: Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?, acronym: SAFER-TAVI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: The Alfred, class: OTHER, collaborators name: Epworth Healthcare, collaborators name: Cabrini Health, descriptionModule briefSummary: Transcatheter aortic valve implantation (TAVI) is a well known safe treatment for severe aortic stenosis. To perform TAVI safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. While the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of TAVI. The two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. Accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral TAVI, to assess if radial access is superior to femoral access as a secondary access site., conditionsModule conditions: Valve Stenoses, Aortic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 560, type: ESTIMATED, armsInterventionsModule interventions name: Access site, outcomesModule primaryOutcomes measure: All bleeding and vascular complications, secondaryOutcomes measure: All bleeding, secondaryOutcomes measure: All vascular complications, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Major adverse cardiovascular events, secondaryOutcomes measure: Length of stay post-procedure, secondaryOutcomes measure: Overall procedure duration, secondaryOutcomes measure: Radiation dose, secondaryOutcomes measure: Conversion rate to alternative vascular access site, secondaryOutcomes measure: Tertiary site utilised to treat vascular complication, secondaryOutcomes measure: Failure to perform angiogram of primary access site at completion of TAVI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alfred Health, status: RECRUITING, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Jennifer Zhou, MBBS, BMedSc, role: CONTACT, email: [email protected], contacts name: Antony Walton, MBBS, role: PRINCIPAL_INVESTIGATOR, contacts name: Dion Stub, MBBS, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, locations facility: Epworth Healthcare, status: NOT_YET_RECRUITING, city: Melbourne, state: Victoria, zip: 3121, country: Australia, contacts name: Jennifer Zhou, MBBS, BMedSc, role: CONTACT, email: [email protected], contacts name: Antony Walton, MBBS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, locations facility: Cabrini Health, status: NOT_YET_RECRUITING, city: Melbourne, state: Victoria, zip: 3144, country: Australia, contacts name: Jennifer Zhou, MBBS, BMedSc, role: CONTACT, email: [email protected], contacts name: Dion Stub, MBBS, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, hasResults: False |
protocolSection identificationModule nctId: NCT06284824, orgStudyIdInfo id: DPS-JMP-2022-040, briefTitle: Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Southeast Orthopedic Specialists, class: NETWORK, collaborators name: DePuy Orthopaedics, collaborators name: Stryker Orthopaedics, descriptionModule briefSummary: The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:* Will the patient reported outcomes differ between the two groups?* Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken., conditionsModule conditions: Knee Osteoarthritis, conditions: Knee Arthritis, conditions: Knee Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Stryker Triathlon with MAKO Robotic-Arm, interventions name: DePuy Attune with VELYS Robotic-Assistance, outcomesModule primaryOutcomes measure: KSS, primaryOutcomes measure: KSS, primaryOutcomes measure: KSS, primaryOutcomes measure: KSS, primaryOutcomes measure: KOOS JR, primaryOutcomes measure: KOOS JR, primaryOutcomes measure: KOOS JR, primaryOutcomes measure: KOOS JR, primaryOutcomes measure: FJS-12 Knee, primaryOutcomes measure: FJS-12 Knee, primaryOutcomes measure: FJS-12 Knee, secondaryOutcomes measure: Operative step time, otherOutcomes measure: Bone resected, otherOutcomes measure: Costs for surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06284811, orgStudyIdInfo id: 050.06.04/155, briefTitle: Massage and Percussion Therapy on Muscle and Performance Parameters, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-31, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, collaborators name: Istanbul Aydın University, collaborators name: Biruni University, descriptionModule briefSummary: DOMS, muscle viscoelastic properties, quadriceps strength and vertical jump performance will be evaluated in physically active individuals before the exercise and after the exercise and intervention which is either Swedish massage or Percussion therapy, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Exercise program focusing on quadriceps, outcomesModule primaryOutcomes measure: Muscle tone/tension(Hz), primaryOutcomes measure: Muscle dynamic stiffness (N/m), primaryOutcomes measure: Muscle elasticity (log), primaryOutcomes measure: DOMS, primaryOutcomes measure: Vertical Jump Performance, primaryOutcomes measure: Quadriceps isometric strength, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Acibadem University, status: RECRUITING, city: Istanbul, state: Ataşehir, zip: 34752, country: Turkey, contacts name: Özge Haklı, Research Assisstant, role: CONTACT, phone: +902165004221, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06284798, orgStudyIdInfo id: NN9650-5027, secondaryIdInfos id: 2023-506134-79, type: OTHER, domain: European Medical Agency (EMA), secondaryIdInfos id: U1111-1291-7535, type: OTHER, domain: World Health Organization (WHO), briefTitle: A Research Study of a New Medicine (NNC0650-0013) in Healthy Men, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-30, primaryCompletionDateStruct date: 2025-03-22, completionDateStruct date: 2025-03-22, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: NNC0650-0013 A, interventions name: Placebo, outcomesModule primaryOutcomes measure: S.C. Cohort: Number of treatment emergent adverse events (TEAEs), secondaryOutcomes measure: S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose, secondaryOutcomes measure: S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose, secondaryOutcomes measure: S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose, secondaryOutcomes measure: S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose, secondaryOutcomes measure: S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose, secondaryOutcomes measure: S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose, secondaryOutcomes measure: I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose, secondaryOutcomes measure: I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose, secondaryOutcomes measure: I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose, secondaryOutcomes measure: S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Profil Institut für Stoffwechselforschung GmbH, status: RECRUITING, city: Neuss, zip: 41460, country: Germany, geoPoint lat: 51.19807, lon: 6.68504, hasResults: False |
protocolSection identificationModule nctId: NCT06284785, orgStudyIdInfo id: 2023.0121, briefTitle: The Effects of Bariatric Surgery on Kidney Oxygenation in Obese Adults With Type 2 Diabetes and Hyperfiltration, acronym: ECSTASY, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, collaborators name: Dutch Kidney Foundation, collaborators name: Dutch Diabetes Research Foundation, descriptionModule briefSummary: In this study the investigators will examine the effects of VAT reduction by bariatric surgery on kidney hypoxia and compare kidney oxygenation before- and after surgery in both sexes using BOLD-MRI and measures of kidney hemodynamic function. Furthermore, the investigators will assess whether kidney oxygenation is reduced in obese T2D men and women versus various controls as described below. This will determine whether kidney hypoxia can be appointed as a modifiable pathogenic factor in early DKD and non-surgical interventions targeting kidney hypoxia can be designed to slow DKD progression., conditionsModule conditions: Kidney Hypoxia, conditions: Diabetes Mellitus, Type 2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Bariatric surgery, outcomesModule primaryOutcomes measure: Difference in kidney oxygenation before and after bariatric surgery, secondaryOutcomes measure: Difference in kidney oxygenation between men and women, secondaryOutcomes measure: Difference in kidney oxygenation between obese, hyperfiltering men and women with T2D versus non-diabetic lean controls, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: VU University Medical Center, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1081HV, country: Netherlands, contacts name: Daniel H van Raalte, MD, role: CONTACT, phone: +31 204442974, email: [email protected], contacts name: Daniel H van Raalte, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06284772, orgStudyIdInfo id: 4457/2023, briefTitle: FINRISK 2002 Re-examination, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-06-25, completionDateStruct date: 2024-06-25, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Turku, class: OTHER, collaborators name: Finnish Institute for Health and Welfare, descriptionModule briefSummary: The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of CMD. To achieve this goal, repeat stool samples will be collected of \~2300 Finnish individuals who gave stool samples in the year 2002. In addition, \~300 individuals will undergo a in-depth health examination in 2024., conditionsModule conditions: Cardiometabolic Syndrome, conditions: Cardiovascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2300, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire and fecal sampling, interventions name: Health examination, outcomesModule primaryOutcomes measure: Gut microbiome change between 2002-2024, secondaryOutcomes measure: Correlates of gut microbiome change between 2002-2024, eligibilityModule sex: ALL, minimumAge: 47 Years, maximumAge: 96 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Turku, city: Turku, zip: 20100, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False |
protocolSection identificationModule nctId: NCT06284759, orgStudyIdInfo id: E-77082166-302.08.01-380534, briefTitle: The Effect of Tele-Nursing Application on Self-Care Ability and Daily Living Activities in Fracture Surgery Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2024-03-28, completionDateStruct date: 2024-03-28, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, collaborators name: Lokman Hekim Üniversitesi, collaborators name: Ankara City Hospital Bilkent, descriptionModule briefSummary: This study aims to determine the effect of tele-nursing application based on Orem's Self-care Theory on self-care agency and daily living activities in trauma-related lower extremity fracture surgery patients., conditionsModule conditions: Lower Extremity Fracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: In the study, the statistician was blinded using the blind technique., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: post-discharge telenursing intervention, outcomesModule primaryOutcomes measure: Self Care, Assessed using the Self-Care Agency scale., primaryOutcomes measure: Activities of daily living, Assessed using the Katz index of independence in activities of daily living (ADL) scale., primaryOutcomes measure: Instrumental activities of daily living, Assessed using the The Lawton instrumental activities of daily living scale., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lokman Hekim University, city: Ankara, zip: 06510, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06284746, orgStudyIdInfo id: 301Qiaoz, briefTitle: Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Lin Chen, class: OTHER, descriptionModule briefSummary: This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research., conditionsModule conditions: Locally Advanced Gastric Carcinoma, conditions: HER2 Negative, conditions: Efficacy, conditions: Safety, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Tirolizumab+SOX/XELOX, interventions name: SOX/XELOX, outcomesModule primaryOutcomes measure: Pathological complete response (pCR), primaryOutcomes measure: Objective Response Rate（ORR）, secondaryOutcomes measure: Disease-free survival（DFS）, secondaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Major Pathologic Response（MPR）, secondaryOutcomes measure: The incidence of adverse events during treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General Surgery Institute, China PLA General Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, contacts name: Yunhe Gao, Ph.D., role: CONTACT, phone: 86-010-66937164, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.