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protocolSection identificationModule nctId: NCT06308146, orgStudyIdInfo id: S21-1249496, briefTitle: Effect of Bacillus Subtilis ATCC 122264 Supplementation on Gas Symptoms and Quality of Life in Participants With Functional Bloating, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-21, primaryCompletionDateStruct date: 2022-10-11, completionDateStruct date: 2022-10-11, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Kerry Group P.L.C, class: INDUSTRY, collaborators name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc., descriptionModule briefSummary: A randomized, double blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy of Bacillus subtillis in providing relief and improving quality of life in participants suffering from functional abdominal bloating/distension when administered for a period of 8 weeks., conditionsModule conditions: Functional Bloating, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned in a 1:1 ratio to receive either the probiotic or placebo. Study products (i.e., TP and placebo) will be dispensed by the site as per the randomization scheme at the study visits., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: To minimize bias, the sponsor representatives involved in the study, the investigator, the participants, and any healthcare professionals or site personnel involved in participant management or outcome assessment remained blinded to interventional assignments, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Bacillus subtilis ATCC 122264, interventions name: Placebo, outcomesModule primaryOutcomes measure: Effect on intestinal gas symptoms and quality of life, secondaryOutcomes measure: Effect on intestinal gas symptoms and quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Apex Trials, city: Guelph, state: Ontario, zip: N1G 0B4, country: Canada, geoPoint lat: 43.54594, lon: -80.25599, hasResults: False
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protocolSection identificationModule nctId: NCT06308133, orgStudyIdInfo id: CD34+CE_2023, briefTitle: Biological Variables Affecting CD34+ Peripheral Cells Collection Efficiency, acronym: CD34+CE_2023, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: All procedures performed during the study will comply with current clinical practice, international and national guidelines. Main object of the study is the PBSC apheresis procedure performed by using the continuous mononuclear cells collection (cMNC) system with Spectra Optia (Terumo BCT), specifically the biological and clinical factors affecting the procedure efficiency., conditionsModule conditions: Optimize PBSC Harvest Through Automated Buffy Coat, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 113, type: ACTUAL, armsInterventionsModule interventions name: apheresis procedure, outcomesModule primaryOutcomes measure: measured by statistical correlation, primaryOutcomes measure: Correlation of clinical, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, city: Milan, state: Milano, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-10, uploadDate: 2024-03-06T12:44, filename: Prot_SAP_000.pdf, size: 378344, hasResults: False
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protocolSection identificationModule nctId: NCT06308120, orgStudyIdInfo id: ISI-IONCN-002, briefTitle: A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB, acronym: ARTICULAtE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Intuitive Surgical, class: INDUSTRY, collaborators name: Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd, descriptionModule briefSummary: Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules., conditionsModule conditions: Pulmonary Nodule, Solitary, conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Stratified, randomized controlled trial with parallel group assignment, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: Pathologist reviewing biopsy results will be blinded, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 354, type: ESTIMATED, armsInterventionsModule interventions name: Ion Endoluminal System, interventions name: superDimension Navigation System and Accessories, outcomesModule primaryOutcomes measure: Diagnostic Yield, secondaryOutcomes measure: Sensitivity for malignancy of biopsy obtained samples, secondaryOutcomes measure: Incidence of pneumothorax that requires chest tube placement and/or re-hospitalization or extended hospitalization, secondaryOutcomes measure: Incidence of intraoperative severe airway bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Jiyuan Sun, M.D., role: CONTACT, contacts name: Jiyuan Sun, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Zhongshan Hospital, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Yuanlin Song, M.D., role: CONTACT, contacts name: Yuanlin Song, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital, status: NOT_YET_RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Dan Liu, role: CONTACT, contacts name: Dan Liu, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06308107, orgStudyIdInfo id: IRB00433127, briefTitle: Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2028-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. Thirty patients will receive treatment. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery., conditionsModule conditions: Myocardial Stunning, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: IV Diazoxide, outcomesModule primaryOutcomes measure: Safety as assessed by mean change in blood pressure, primaryOutcomes measure: Safety as assessed by change in blood glucose levels, primaryOutcomes measure: Safety as assessed by incidence of adverse events, secondaryOutcomes measure: Efficacy as assessed by change in ejection fraction, secondaryOutcomes measure: Efficacy as assessed by use of mechanical circulatory support, secondaryOutcomes measure: Efficacy as assessed by change in Vasoactive Inotropic Score (VIS), secondaryOutcomes measure: Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06308094, orgStudyIdInfo id: IRB00429859, briefTitle: 320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. The study will assess if higher ECV levels correlate with increased risks of AF recurrence, hospitalization, and poor cardiac function recovery. Positive findings could make ECV a key factor in deciding AF treatment strategies., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: Two independent blinded trained readers will detect, interpret and quantify interstitial fibrosis using CT images, to ascertain intra- and inter-observer variability. The readers will determine the region of interest (ROI), myocardial and blood pool attenuation values in the pre-contrast and 5 minutes delayed acquisition., enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: CT, outcomesModule primaryOutcomes measure: Recurrence of Atrial Fibrillation, primaryOutcomes measure: Occurrence of ER visits, hospitalizations for cardiovascular causes, secondaryOutcomes measure: Change in Ejection Fraction, secondaryOutcomes measure: Quality of Life as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308081, orgStudyIdInfo id: UPCC 13023, secondaryIdInfos id: 849052, type: OTHER, domain: University of Pennsylvania, briefTitle: Social Media Anti-Vaping Messages to Reduce ENDS Use Among Sexual and Gender Minority Teens, acronym: SMART, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Abramson Cancer Center at Penn Medicine, class: OTHER, collaborators name: University of Florida, descriptionModule briefSummary: The investigators long-term goal is to reduce tobacco use and tobacco-related health disparities among SGM populations. The objective of Project SMART (Social Media Anti-Vaping Messages to Reduce ENDS Use Among Sexual and Gender Minority Teens) is to evaluate the effectiveness of an sexual gender minority (SGM) -tailored social media intervention to prevent vaping initiation among SGM youth ages 13-20 years. The investigators central hypothesis is that SGM-tailored anti-vaping social media messages will be more effective than existing non-tailored messages to prevent vaping initiation among SGM youth. The scientific premise for this work is based on principles of cultural tailoring in health communication for vulnerable populations, the Health Equity Promotion Model, and the Message Impact Framework. The investigators are developing and evaluating a social media intervention because SGM youth have a high rate of social media use and are more likely to go online for health information than non-SGM youth. Social media, moreover, are increasingly used for health promotion to address health disparities and well-being of SGM populations. The investigators will conduct rapid-cycle feedback with stakeholders including SGM organization leaders to provide input on the message design, testing, and intervention implementation to ensure feasibility and acceptability of the intervention., conditionsModule conditions: Vaping, conditions: Adolescent Behavior, conditions: Communication Research, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to 1 of 2 conditions: SGM-tailored anti-vaping messages versus non-tailored messages. Block randomization will achieve balance across the two conditions based on age group, gender identity, sexual orientation, race, ethnicity, and prior use. Both conditions will receive repeated exposure of messages within their assigned condition daily for 4, up to a total of 24 messages over the course of the study. Messages will be delivered using texting to participants mobile phones. We will record participants' self-reported engagement to the messages at the follow-up survey (after measuring the study outcomes). Participants will be asked to complete a baseline survey comprising vaping susceptibility and characteristics, surveys at 1-, 2-, 3-, and 4-weeks follow-up to measure vaping susceptibility., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Tailored, outcomesModule primaryOutcomes measure: Susceptibility to vaping, secondaryOutcomes measure: Vaping initiation, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Pennsylvania, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Elaine Hanby, MA, role: CONTACT, phone: 215-573-5140, email: elaine.hanby@asc.upenn.edu, contacts name: Jenine Pilla, MPH, role: CONTACT, email: Jenine.Pilla@asc.upenn.edu, contacts name: Andy Tan, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06308068, orgStudyIdInfo id: BE24-002, briefTitle: Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-30, primaryCompletionDateStruct date: 2024-08-03, completionDateStruct date: 2024-08-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: International Bio service, class: NETWORK, descriptionModule briefSummary: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions, conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Diacerein 50 mg Capsule, outcomesModule primaryOutcomes measure: Bioequivalence based on Cmax period, primaryOutcomes measure: Bioequivalence based on AUC parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308055, orgStudyIdInfo id: 2022-R01, briefTitle: Abiomed Impella RT-DAQ - Observational Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Abiomed Inc., class: INDUSTRY, descriptionModule briefSummary: Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition, conditionsModule conditions: Cardiogenic Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: Data Acquisition, outcomesModule primaryOutcomes measure: Collection of hemodynamic parameters (Cardiac Output in l/min), primaryOutcomes measure: Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg), primaryOutcomes measure: Collection of hemodynamic parameters (Mixed Venous Saturation in %), primaryOutcomes measure: Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 ), secondaryOutcomes measure: Rate of Patient Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308042, orgStudyIdInfo id: 2024/5558, briefTitle: Remote Evaluation in Patients With Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-06-24, completionDateStruct date: 2024-06-29, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: This study aimed to demonstrate the remote reliability of the 30-second sit-to-stand test in patients with multiple sclerosis., conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: 30 second sit and stand test, outcomesModule primaryOutcomes measure: 30 second sit and stand test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308029, orgStudyIdInfo id: Edge003203, secondaryIdInfos id: T001122N, type: OTHER_GRANT, domain: Research Foundations Flanders, secondaryIdInfos id: s68058, type: OTHER, domain: UZ/KU Leuven ID, briefTitle: Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment, acronym: PECAN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2027-03-20, completionDateStruct date: 2028-03-20, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, collaborators name: Universitaire Ziekenhuizen KU Leuven, collaborators name: University Ghent, collaborators name: KU Leuven, collaborators name: University Hospital, Antwerp, descriptionModule briefSummary: The scientific goals of the project are:1. The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to: * usual care (i.e. superiority of the eHealth self-management support program) and * a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program) on pain-related disability (measured with the Pain Disability Index).2. The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including: * Other dimensions of pain * Health-related quality of life * Physical functioning, including physical activity levels * Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence * Participation in society, including return to work * Healthcare-related costs for the patient and society3. The tertiary scientific objectives of this study are * to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets. * To examine the implementation process, mechanisms of impact and contextual factors., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pragmatic randomized, multi-centric, three-arm controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: eHealth self-management support program, interventions name: Face-to-face rehabilitation program, outcomesModule primaryOutcomes measure: Pain-related disability, secondaryOutcomes measure: Pain related disability, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Severity of neuropathic Pain, secondaryOutcomes measure: Medication use, secondaryOutcomes measure: Pain location, secondaryOutcomes measure: Knowledge of neurophysiology of pain, secondaryOutcomes measure: Physical Activity pattern, secondaryOutcomes measure: Physical functioning, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Sleep disturbance, secondaryOutcomes measure: Pain Beliefs, secondaryOutcomes measure: Pain-related worrying, secondaryOutcomes measure: Vigilance to bodily sensations, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Determinants for physical activity, secondaryOutcomes measure: Participation, secondaryOutcomes measure: Well-being, secondaryOutcomes measure: Social Support, secondaryOutcomes measure: Return to work rate, secondaryOutcomes measure: Medical costs of medical consumption, secondaryOutcomes measure: Indirect costs related to disease outside health care, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Patient Global Impression of Change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universiteit Antwerpen, status: RECRUITING, city: Antwerpen, country: Belgium, contacts name: An De Groef, PhD, role: CONTACT, email: an.degroef@uantwerpen.be, contacts name: Lore Dams, PhD, role: CONTACT, email: lore.dams@uantwerpen.be, geoPoint lat: 51.21989, lon: 4.40346, locations facility: KU Leuven, status: RECRUITING, city: Leuven, country: Belgium, contacts name: Nele Devoogdt, PhD, role: CONTACT, email: nele.devoogdt@kuleuven.be, contacts name: An De Groef, PhD, role: CONTACT, email: an.degroef@kuleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
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protocolSection identificationModule nctId: NCT06308016, orgStudyIdInfo id: 25/IRE/23, briefTitle: Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Regina Elena Cancer Institute, class: OTHER, descriptionModule briefSummary: Multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria., conditionsModule conditions: Laryngeal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Identification of risk factors, secondaryOutcomes measure: Stratify patients, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: "Regina Elena" National Cancer Institute, status: RECRUITING, city: Rome, zip: 00144, country: Italy, contacts name: Raul Pellini, MD, role: CONTACT, phone: ND, email: raul.pellini@ifo.it, contacts name: Francesco Mazzola, Doctor, role: CONTACT, phone: 06 5266 4485, email: francesco.mazzola@ifo.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06308003, orgStudyIdInfo id: PTA CONF, briefTitle: Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-13, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: The study is, in accordance with current legislation, definable as monocentric Prospective Observational.The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.adult patients who will undergo surgery of hip arthroplasty.Patients will undergo:Preoperative T0: clinical visit/medical history, completion of the VAS questionnaire, Blood sampling to assess hemoglobin values Operative T1: hip arthroplasty surgery using one of the surgical approaches routinely used within our Institute T2 - Postoperative at 1 day from T1: VAS questionnaire, evaluation of any Adverse events T3 - Postoperative at 3 days from T1: blood loss based on the values of hemoglobin (Hb), assessment of any adverse events, and VAS questionnaire T4- Post operative at 45 days +/- 10 days from T1: evaluation of any events adverse, follow-up visit., conditionsModule conditions: Hip Arthropathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Anterior hip arthroplasty, outcomesModule primaryOutcomes measure: The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Clinico San Siro, status: RECRUITING, city: Milan, country: Italy, contacts name: Elena Cittera, role: CONTACT, phone: 0283502224, email: elena.cittera@grupposandonato.it, contacts name: Alberto Ventura, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06307990, orgStudyIdInfo id: 05M202, briefTitle: Understanding, Diagnosis and Monitoring of Thyroid Hormone Action Defects, acronym: ADAM-THAD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: ASST Fatebenefratelli Sacco, collaborators name: Federico II University, descriptionModule briefSummary: The goal of this observational study is to learn about the neurological and cardiological phenotype of patients with resistance to thyroid hormone (RTH) syndromes beta and alpha (RTHß and RTHa) due to dominant negative variants in the genes encoding the thyroid hormone receptors alpha (THRA) and beta (THRB).The main question\[s\] it aims to answer are:* Define frequency and improve early diagnosis for RTH syndromes* Developing tools to accelerate diagnosis of RTH syndromes* Development and validation of monitoring toolsParticipants, recruited at neonatal screening or from cohorts of patients with unexplained specific neuro-cognitive or cardiovascular phenotypes will be submitted to biochemical and genetic investigations. In addition pluripotent stem cells will be generated from peripheral blood cells of RTHs patients and studied in vitro to understand the molecular mechanisms underlying neurological and cardiovascular consequences. In vitro and clinical data, will be correlated to identify biomarkers for monitoring treatment., conditionsModule conditions: Resistance, Thyroid Hormone, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: NGS sequencing, interventions name: serological tests, outcomesModule primaryOutcomes measure: to define the frequency and improve early diagnosis for RTH syndromes., primaryOutcomes measure: to demonstrate that zebrafish zygotes are useful for screening of the pathogenicity of new TR mutations, primaryOutcomes measure: Direct differentiation of THRA mutant patients-derived human induced pluripotent stem cells (hiPSCs) to neural progenitors (hiPSc-CNeu) and cardiomyocyte (hiPSC-CMs), primaryOutcomes measure: To identify TH-target genes involved in determining stemness, proliferation potential and differentiation of hiPSC, secondaryOutcomes measure: to define the prevalence of RTH syndromes in specific cohorts of patients with unexplained phenotypes, secondaryOutcomes measure: Generation of a comprehensive RTH database, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milan, zip: 20145, country: Italy, contacts name: Irene Campi, MD, PhD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Department of Endocrine & Metabolic Diseases, San Luca Hospital, status: RECRUITING, city: Milan, country: Italy, contacts name: Luca Persani, Prof, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06307977, orgStudyIdInfo id: R01DA059272, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA059272, briefTitle: Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples, acronym: CHP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Hunter College of City University of New York, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC)., conditionsModule conditions: Substance Use, conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC)., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Couples Health Project, outcomesModule primaryOutcomes measure: Drug use Frequency, primaryOutcomes measure: Urine assay for drug use, primaryOutcomes measure: CAS with casual partners, secondaryOutcomes measure: Bacterial sexually transmitted infections, secondaryOutcomes measure: Binge Drinking, secondaryOutcomes measure: PrEP Uptake, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 34 Years, stdAges: ADULT, contactsLocationsModule locations facility: Wayne State University, city: Detroit, state: Michigan, zip: 48201, country: United States, contacts name: Angulique Outlaw, PHD, role: CONTACT, email: aoutlaw@med.wayne.edu, geoPoint lat: 42.33143, lon: -83.04575, locations facility: Hunter College, city: New York, state: New York, zip: 10018, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22904, country: United States, contacts name: Karen Ingersoll, role: CONTACT, email: kes7a@virginia.edu, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False
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protocolSection identificationModule nctId: NCT06307964, orgStudyIdInfo id: 69HCL23_1137, secondaryIdInfos id: ID-RCB, type: OTHER, domain: 2024-A00480-47, briefTitle: Intra-Hepatic Microbiota in Alcoholic Hepatitis, acronym: HepMAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Alcoholic hepatitis (AH) is a serious complication of alcoholic liver disease (ALD). The histological presentation of AH is characterized by neutrophilic lobular inflammation, macrovesicular steatosis, hepatocyte ballooning and necrosis and the presence of Mallory bodies. In cases of severe HA, defined by a modified Maddrey score of 32 or above, mortality at 1 month is estimated at between 10 and 50%. The only treatment to reduce early mortality is corticosteroid therapy. However, only 60% of patients respond to corticosteroids, and no benefit has been demonstrated on late mortality. Identifying new therapeutic targets is therefore a major challenge in this disease.Numerous pre-clinical studies and human data suggest the involvement of the intestinal microbiota in the pathogenesis of AH. Translocation of viable bacteria and microbial products from the digestive tract to the liver contributes to local and systemic inflammation, hepatocyte death and fibrogenesis. However, the intrahepatic microbial environment has never been characterized in HA.The study hypothesis is that the intrahepatic microbiota is modulated by bacterial translocation and is associated with clinical outcomes.The aim of this study is to determine the composition of the intrahepatic (obtained from transjugular liver biopsy), blood and fecal microbiota in patients with suspected severe AH from a monocentric prospective cohort in the Hepatology Department at Croix-Rousse Hospital (Lyon). Fifty consecutive patients with clinical suspicion of AH and indication for transjugular liver biopsy will be included. About thirty-five patients are expected in the confirmed AH group, and 15 in the group "alcoholic liver disease with no AH", based on data from the literature. The composition of the various microbiota will be determined by sequencing the 16S rRNA gene, and the results will be correlated with clinical data (corticosteroid sensitivity, overall survival, transplant-free survival, MELD score in particular) and histological data.This exploratory study will enable to analyze the intra-hepatic microbiota, and to study its link with intra-hepatic inflammation and the clinical course of patients with AH. The data generated by HepMAH will thus help identify potential new therapeutic targets linked to the gut microbiota, and provide a scientific basis for the development of therapeutic interventions targeting the microbiota in HA., conditionsModule conditions: Cirrhosis, conditions: Alcoholic Liver Disease, conditions: Alcoholic Hepatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Biological sampling, outcomesModule primaryOutcomes measure: Microbiota composition, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307951, orgStudyIdInfo id: JCDC/BHR/24/012, briefTitle: Exploration of Infant and Young Child Feeding Practices and Their Determinants, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-25, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Hirabai Cowasji Jehangir Medical Research Institute, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to assess infant and young child-feeding practices among women living in urban areas and slums in Pune and rural areas around Pune, India, and to investigate the reasons for the adopted infant and young child-feeding practices in Slum-dwelling women aged 18 to 49 years who have an infant/s less than 24 months of age.The main question it aims to answer are:* Are infant and young child-feeding practices among women living in urban areas and slums appropriate?* What the reasons for the adopted infant and young child-feeding practices in Slum-dwelling women Participants will be measured for their height and weight, interviewed for Socio-demographic characteristics, birth history of the infant, infant feeding indicators and will be involved in focused group discussions and in-depth interviews to gain understanding into their adopted appropriate and inappropriate feeding practices., conditionsModule conditions: Infant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 510, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Infant and young child-feeding practices among women living in urban areas and slums in Pune and rural areas around Pune, India will have been assessed, secondaryOutcomes measure: Reasons for the adopted infant and young child-feeding practices will have been investigated, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hirabai Cowasji Jehangir Medical Research Institute, status: RECRUITING, city: Pune, state: Maharashtra, zip: 411001, country: India, contacts name: Anuradha V. Khadilkar, MBBS,MD, role: CONTACT, phone: 9850244305, email: anuradhavkhadilkar@gmail.com, contacts name: Rubina M. Mandlik, Ph.D., role: CONTACT, phone: 9922959588, email: rubymandlik@hotmail.com, geoPoint lat: 18.51957, lon: 73.85535, hasResults: False
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protocolSection identificationModule nctId: NCT06307938, orgStudyIdInfo id: 619020, briefTitle: Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer, acronym: CoLiQ, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Helse Nord-Trøndelag HF, class: OTHER, collaborators name: Norwegian University of Science and Technology, descriptionModule briefSummary: CoLiQ is an observational study designed to evaluate the clinical usefulness of circulating tumor DNA (ctDNA) markers found in blood, as a liquid biopsy for diagnosis, prognosis and follow-up of colorectal cancer. The main questions it aims to answer are: 1) Can a panel of ctDNA markers identify CRC patients among the other patients summoned for colonoscopy? and 2) Does the type, number and level of ctDNA markers vary with the subtype and clinical course of CRC? Participants will be asked to answer a questionnaire and give a blood sample at inclusion. In addition, patients with CRC will be asked to give an extra test tube at their routine treatment and follow-up blood sampling., conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Adenoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: liquid biopsy, outcomesModule primaryOutcomes measure: Colorectal cancer, primaryOutcomes measure: Colorectal adenoma, primaryOutcomes measure: Inflammatory bowel disease, secondaryOutcomes measure: Recurrence, secondaryOutcomes measure: Death, secondaryOutcomes measure: Treatment response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307925, orgStudyIdInfo id: HC010-001, briefTitle: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: HC Biopharma Inc., class: INDUSTRY, descriptionModule briefSummary: This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule interventions name: HC010, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicity, primaryOutcomes measure: Adverse events, primaryOutcomes measure: serious adverse events, primaryOutcomes measure: Maximum Tolerated Dose, primaryOutcomes measure: Recommended Dose for Phase II Clinical Studies, secondaryOutcomes measure: pharmacokinetics:Cmax, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: duration of response, secondaryOutcomes measure: progression-free survival, secondaryOutcomes measure: overall survival, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: pharmacokinetics:AUC0-last, secondaryOutcomes measure: pharmacokinetics:tmax, secondaryOutcomes measure: pharmacokinetics:Vd, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Li Zhang, MD, role: CONTACT, phone: +86 139 0228 2893, email: zhangli@sysucc.org.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06307912, orgStudyIdInfo id: 202301, briefTitle: Physiotherapists' Placebo or Nocebo Communication Regarding VR, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: HAN University of Applied Sciences, class: OTHER, descriptionModule briefSummary: Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered nonpharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in healthy participants.Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in healthy participants.Study design: Web-based randomized controlled trial.Study population: 126 participantsIntervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ)., conditionsModule conditions: Communication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ACTUAL, armsInterventionsModule interventions name: Video placebo communication, interventions name: Video nocebo communication, outcomesModule primaryOutcomes measure: Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ), primaryOutcomes measure: Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ), secondaryOutcomes measure: Change in openness to VR measured using a single question, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HAN University of Applied Sciences, city: Nijmegen, state: Overijssel, zip: 6525EN, country: Netherlands, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False
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protocolSection identificationModule nctId: NCT06307899, orgStudyIdInfo id: E-77082166-302.08.01-639069, briefTitle: Immediate Effects of Different Stretching Methods for Pectoralis Minor Muscle, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-11, primaryCompletionDateStruct date: 2024-07-03, completionDateStruct date: 2024-09-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, descriptionModule briefSummary: The aim of our study is to compare the effects of different stretching methods for the pectoralis minor (PM) muscle on scapula position, PM muscle length and scapular muscle activation in individuals with shoulder protraction. Unilateral corner stretching, manual stretching and proprioceptive neuromuscular facilitation (PNF) stretching methods will be applied randomly, 2 days apart, to volunteer individuals who agree to participate in our study. Three different stretching methods (unilateral corner stretching, manual stretching and PNF stretching) will be applied to individuals randomly, 48 hours apart, and PM length, PM index, scapula upward rotation and EMG values will be recorded by a blind evaluator before and after the stretching application., conditionsModule conditions: Rounded Shoulder Posture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Unilateral Corner Stretch, interventions name: Manual Stretching, interventions name: PNF Stretching, outcomesModule primaryOutcomes measure: Pectoralis Minor Length, primaryOutcomes measure: Pectoralis Minor Length, primaryOutcomes measure: Pectoralis Minor Index, primaryOutcomes measure: Pectoralis Minor Index, primaryOutcomes measure: Scapula Upward Rotation Measurement, primaryOutcomes measure: Scapula Upward Rotation Measurement, primaryOutcomes measure: EMG Analysis, primaryOutcomes measure: EMG Analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gazi University, status: RECRUITING, city: Ankara, state: Çankaya, zip: 06490, country: Turkey, contacts name: Tuğçe Çoban, MSc, role: CONTACT, phone: +905454098540, email: fzttugce@yahoo.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06307886, orgStudyIdInfo id: GaziosmanpasaTREHSs, briefTitle: Comparison of Five-year Survival and Disease-free Survival in Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Gaziosmanpasa Research and Education Hospital, class: OTHER_GOV, descriptionModule briefSummary: Comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without a uterine manipulator, conditionsModule conditions: Endometrial Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulator, interventions name: lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulator, outcomesModule primaryOutcomes measure: five year survival in patients diagnosed with endometrial cancer, primaryOutcomes measure: disease-free survival in patients diagnosed with endometrial cancer, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gaziosmanpasa Training and research hospital, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Süleyman Salman, Professor, role: CONTACT, phone: +905059345470, email: sleymansalman@gmail.com, contacts name: Havva Betül Bacak, Specialist, role: CONTACT, phone: +905333610088, email: hbbacak90@gmail.com, contacts name: Fatma Ketenci Gencer, Associate Professor, role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06307873, orgStudyIdInfo id: GaziosmanpasaTREH., briefTitle: Comparison of the Effects of Sacrospinous Fixation and V-notes Lateral Suspension Operations, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Gaziosmanpasa Research and Education Hospital, class: OTHER_GOV, descriptionModule briefSummary: Comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations on anatomical recovery, effectiveness and quality of life in a training and research hospital gynecology and obstetrics clinic., conditionsModule conditions: Genital Prolapse, Unspecified, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: pre and post operative POP-Q results, interventions name: pre and post operative PİSQ-12 results, outcomesModule primaryOutcomes measure: Pre and post operative assessment of POP-Q measurements, primaryOutcomes measure: Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gaziosmanpasa Training and Research Hospital, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Süleyman Salman, Professor, role: CONTACT, phone: +905059345470, email: sleymansalman@gmail.com, contacts name: Havva Betül Bacak, Specialist, role: CONTACT, phone: +905333610088, email: hbbacak90@gmail.com, contacts name: Fatma Ketenci Gencer, Associate Professor, role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06307860, orgStudyIdInfo id: 15270977512@163.com, briefTitle: Comparison of Different Ablation Surgeries on Left Atrial Reverse Remodeling in Patients With Atrial Fibrillation, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Yun Wan, class: OTHER, descriptionModule briefSummary: The goal of this Ambispective cohort Study is to compare in patients with paroxysmal atrial fibrillation undergo pulse field ablation and radiofrequency ablation, respectively. The main question it aims to answer are:Comparison of the therapeutic effects of pulse field ablation and traditional thermal ablation on patients with paroxysmal atrial fibrillation and postoperative left atrial reverse remodeling.Participants will Perform pulse field ablation or radiofrequency ablation according to different groups, and cooperate to complete outpatient follow-up 6 months after surgery., conditionsModule conditions: Atrial Fibrillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: pulsed field ablation, interventions name: radiofrequency ablation, outcomesModule primaryOutcomes measure: Recurrence rate of atrial arrhythmias, primaryOutcomes measure: Left atrial end diastolic diameter, secondaryOutcomes measure: p wave dispersion, secondaryOutcomes measure: Pulmonary vein stenosis rate, otherOutcomes measure: Postoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ganzhou People's Hospital, status: RECRUITING, city: Ganzhou, state: Jiangxi, zip: 341000, country: China, contacts name: Wan Yun, Bachelor, role: CONTACT, phone: 15270977512, email: 15270977512@163.com, contacts name: Luo Jun, doctor, role: CONTACT, phone: 13970107015, email: luojun1966@163.com, hasResults: False
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protocolSection identificationModule nctId: NCT06307847, orgStudyIdInfo id: SP-HA-003, briefTitle: Pivotal Study to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-14, primaryCompletionDateStruct date: 2022-10-25, completionDateStruct date: 2022-10-25, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Shin Poong Pharmaceutical Co. Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blind, multicenter, non-inferiority, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M001) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis., conditionsModule conditions: Osteoarthritis Thumb, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 223, type: ACTUAL, armsInterventionsModule interventions name: SP5M001 inj, interventions name: Synovian inj, outcomesModule primaryOutcomes measure: Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2), secondaryOutcomes measure: Changes in the following at each visit : Weight Bearing pain(WBP) (Weeks 2, 6, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Rest pain (RP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Night pain (NP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Motion pain (MP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Patient Global Assessment(PGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Investigator Global Assessment (IGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total score and individual score evaluation (Pain, function, stiffness) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Physical assessments at each post-administration visit: Swelling (Weeks 2, 6, 12, 24, and 36), secondaryOutcomes measure: Physical assessments at each post-administration visit: joint-line tenderness on pressure (Weeks 2, 6, 12, 24, and 36), secondaryOutcomes measure: Physical assessments at each post-administration visit: range of motion (Weeks 2, 6, 12, 24, and 36), secondaryOutcomes measure: Proportion of participants who took rescue medication at each post-administration visit and dose of rescue medication (Weeks 2, 6, 12, 24, and 36), secondaryOutcomes measure: Post-administration response rate A. Proportion at which WBP decreases by at least 20 mm or improves by at least 40% from baseline at the time of evaluation (B section-Description), otherOutcomes measure: The incidence rate of Pre-treatment AEs, otherOutcomes measure: The incidence rate of Solicited Local AEs, otherOutcomes measure: The incidence rate of treatment-emergent adverse event (TEAE), otherOutcomes measure: The incidence rate of Serious TEAEs, otherOutcomes measure: The incidence rate of Serious TEAEs leading to Drug withdrawn, otherOutcomes measure: The incidence rate of Serious TEAEs leading to Death, otherOutcomes measure: The incidence rate of abnormal CS at Post-Treatment on Laboratory, otherOutcomes measure: The incidence rate of abnormal CS at Post-Treatment on Electrocardiogram, otherOutcomes measure: The incidence rate of abnormal on Physical Examination, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yeungnam University Medical Center, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Cheonam National University Hwasun Hospital, city: Hwasun, country: Korea, Republic of, geoPoint lat: 35.06125, lon: 126.98746, locations facility: Gachon University Gil Medical Center, city: Incheon, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Jeonbuk National University Hospital, city: Jeonju, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, locations facility: Chungnam National University Hospital, city: Sejong, country: Korea, Republic of, geoPoint lat: 36.59245, lon: 127.29223, locations facility: Seoul National University Bundang Hospital, city: Seongnam-si, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Asan Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Chung-ang University Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kyung Hee University Hospital at Gangdong, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kyunghee University Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Samsung Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Seoul National University Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Soon Chun Hyang University Hospital Seoul, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: The Catholic University of Korea, Seoul St. Mary's Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06307834, orgStudyIdInfo id: 26760, secondaryIdInfos id: 24POST1194772, type: OTHER_GRANT, domain: American Heart Association (AHA), briefTitle: Restoring Grasp Ability in Stroke Survivors Through MI-Based Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: North Carolina State University, class: OTHER, descriptionModule briefSummary: Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. The cause of their disability is changes in their brain's activity patterns of the motor cortex area. Traditional therapy does not directly alter these brain changes, which makes it less effective. As a way to help stroke survivors, people are looking into ways to train the brain directly. A method they found is motor imagery, which involves mental practicing of a task. Studies suggest that this type of training can potentially alter the brain's patterns, which can be seen through EEG. An EEG shows a fixed pattern during movement, called SMR (sensory motor rhythm). Studies have found that people can learn to control this SMR through mental practice of a task. The SMR changes in a similar way during both movement and motor imagery. Therefore, mental practice of hand tasks can lead to improvement in actual hand movements. It has already been shown that stroke survivors can open their hands more easily after receiving SMR training. Along with that, they also have trouble to hold and release objects. SMR training may be able to address these issues by changing brain patterns. But it is not clear yet if SMR training can improve all three stages of grasping (open, close, release), and to what extent it can enhance overall hand function.This study plans to include 20 adults who have experienced a stroke and have ongoing problems with moving their hands. Half of these participants will take part in a training in which they will learn to control their SMR for three distinct hand tasks (open, close, and release). The first session will be followed by eight training sessions. To guide users toward specific changes in EEG activity, we will provide visual feedback in training. As soon as an appropriate EEG change is made, a hand exoskeleton will help them open and close their hand. The other group of 10 patients will have traditional therapy. They will do 9 sessions of hand exercises. During and after the training, we will test both groups to see how well their hand function improved. The result will help us determine which training method is better for stroke survivors., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Neurofeedback - based therapy, interventions name: Standard hand exercise therapy, outcomesModule primaryOutcomes measure: Change of Box & Block test (BBT), primaryOutcomes measure: Change of Action Research Arm Test (ARAT), primaryOutcomes measure: Change of Wolf Motor Function Test (WMFT), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hand Rehabilitation Lab, city: Raleigh, state: North Carolina, zip: 27695, country: United States, contacts name: Rinku Roy, PhD, role: CONTACT, phone: 212-731-4114, email: rroy2@ncsu.edu, contacts name: Derek G Kamper, PhD, role: CONTACT, phone: 9195154411, email: dgkamper@ncsu.edu, geoPoint lat: 35.7721, lon: -78.63861, hasResults: False
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protocolSection identificationModule nctId: NCT06307821, orgStudyIdInfo id: WK2024002, briefTitle: the Role of Probiotic in Protein Metabolism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-06-25, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Wecare Probiotics Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study investigates the functional effects of probiotics on athletes by administering Weizmannella coagulans BC99 for six weeks. It aims to assess the probiotic's influence on skeletal muscle content, athletic performance, and protein digestion and metabolism. This is achieved by monitoring changes in digestive enzymes, amino acids, body composition, and hormone levels. The research seeks to offer a theoretical foundation for optimizing athletes' training and nutrition strategies and suggests the potential of probiotics in enhancing nutrient absorption and utilization, particularly in individuals with compromised digestive capabilities., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Double（Participant,Investigator）, whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, outcomesModule primaryOutcomes measure: Digestibility and absorption of dietary protein, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Henan University of Science and Technology, status: RECRUITING, city: Luoyang, state: Henan, zip: 471000, country: China, contacts name: Ying Wu, Dr., role: CONTACT, phone: +86 18639283502, email: wuying2000@126.com, geoPoint lat: 34.68361, lon: 112.45361, hasResults: False
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protocolSection identificationModule nctId: NCT06307808, orgStudyIdInfo id: Vitamin, briefTitle: Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination, acronym: VITAMIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, collaborators name: National Agency for Research on AIDS and Viral Hepatitis (ANRS), descriptionModule briefSummary: Solid Organ Transplantation (SOT) is made possible by the use of a lifelong immunosuppressive treatment. This treatment limits the response of the immune system, enabling long-term survival of the transplanted organ, but also leading to weaker anti-infectious responses.In this study, we will compare the response to a booster Hepatitis B vaccination (HBV) in SOT patients, either after kidney or liver transplantation. We will also compare the immune response depending on the immunosuppressive treatment.In order to provide a detailed picture of the immune response, we will investigate the usual serological response (anti-HBs antibodies), but also the cellular memory (both T and B) using ELISpot assays and flow-cytometry, over a 6 months period following booster vaccination., conditionsModule conditions: HBV, conditions: Kidney Transplantation, conditions: Liver Transplantation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Tacrolimus, interventions name: Belatacept, outcomesModule primaryOutcomes measure: Titer of anti-HBs ELISA antibody, secondaryOutcomes measure: Number of anti-HBs memory B cells, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Grenoble University Hospital, city: Grenoble, state: Aura, zip: 38043, country: France, contacts name: Pr Thomas Jouve, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.16667, lon: 5.71667, hasResults: False
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protocolSection identificationModule nctId: NCT06307795, orgStudyIdInfo id: ANS014004-I-US-01, briefTitle: A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Avistone Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors., conditionsModule conditions: Locally Advanced or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: ANS014004, outcomesModule primaryOutcomes measure: Incidence of Adverse Events (AEs), primaryOutcomes measure: Incidence of Serious Adverse Events (SAEs), primaryOutcomes measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol, primaryOutcomes measure: Incidence of baseline laboratory finding, ECG and vital signs changes, primaryOutcomes measure: Proportion of patients with radiological response (ORR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Plasma PK concentrations, secondaryOutcomes measure: Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Clearance, secondaryOutcomes measure: Pharmacokinetics of ANS014004: Half-life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sarah Cannon Research Institute, city: Denver, state: Colorado, zip: 80218, country: United States, contacts name: MD, role: CONTACT, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Advent Health, city: Orlando, state: Florida, zip: 32804, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: The University of Texas - MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: NEXT Oncology, Virginia, city: Fairfax, state: Virginia, zip: 22031, country: United States, geoPoint lat: 38.84622, lon: -77.30637, locations facility: Univ. of Washington Medical Center, city: Seattle, state: Washington, zip: 98109-1024, country: United States, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
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protocolSection identificationModule nctId: NCT06307782, orgStudyIdInfo id: 12833, briefTitle: The Effect of Oral Whey Consumption on Insulin Resistance, Cortisol, Crp, Albumin Level and Healing Quality Before Total Hip Arthroplasty, acronym: WHEY THA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-25, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: Purpose: It was planned to determine the effect of oral whey given before total hip arthroplasty (THA) on postoperative insulin resistance, cortisol, CRP((C reactive protein), albumin level and healing quality.Design: It was planned as Randomized Controlled. Method: Research: The study is planned to include individuals aged 50-70, who are planned for THA in the orthopedics and traumatology clinic of a public hospital, who have undergone spinal anesthesia, who have BMI \<40 and ASA (American Society of Anesthesiologists)1,2,3. Individuals with endocrine or renal disorders or allergies to whey will be excluded from the study. It was planned to include at least 60 patients in the study (30 in the intervention group, 30 in the control group). It is planned to use the Patient Introduction Information Form, Physiological Measurements Chart (vital findings (blood pressure, pulse, respiratory SpO2 (pulse oximetry) value), blood glucose, cortisol, CRP and albumin value and insulin resistance) and postoperative recovery quality scale in data collection. The intervention group will be given 600 ml of oral whey 6 hours before the surgery, and the control group will be allowed to drink 600 ml of drinking water 6 hours before the surgery. 3ml of blood will be taken for blood glucose, CRP, cortisol, albumin and insulin resistance values 24 hours before the surgery, just before entering the surgery and 24 hours after the surgery. The first part of the healing quality scale is planned to be evaluated immediately before the surgery, and the second part 24 hours after the surgery.Conclusion: When the literature was scanned, it was seen that the number of studies examining the effect of oral whey on metabolic and endocrine values in orthopedic patients was very limited and academic studies were needed. In this context, examining the effect of whey intake given before THA on the patient's blood glucose, CRP, albumin, cortisol, insulin resistance and healing quality is an original research that will contribute to the field., conditionsModule conditions: Crp, conditions: Insulin Resistance, conditions: Cortisol; Hypersecretion, conditions: Albus; Lichen, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomize control trials, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: randomize clinical study, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: whey protein intake before surgery, interventions name: Water before surgery, outcomesModule primaryOutcomes measure: Rate of C Reactive Protein, primaryOutcomes measure: Rate of insulin resistance, primaryOutcomes measure: Rate of albumen, primaryOutcomes measure: Rate of cortisol, primaryOutcomes measure: Healing Quality, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HÜMEYRA, city: Nevşehir, state: Nevşehi̇r, zip: 50000, country: Turkey, geoPoint lat: 38.625, lon: 34.71222, hasResults: False
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protocolSection identificationModule nctId: NCT06307769, orgStudyIdInfo id: 2024.02.42, briefTitle: Ten-meter Walking Test With Obstacle in Geriatric Individuals., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-05-25, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Balance and fall problems are one of the most common geriatric syndromes in the elderly. Falls are one of the leading factors causing mortality in the elderly. One-third of individuals aged sixty-five and over fall once or more every year. When the causes of death in elderly individuals are examined; Accidents come in fifth place, and 2/3 of these accidents occur due to falls. The frequency of falls increases with age in 22% of individuals between the ages of 65-69. This rate is stated as 31% between the ages of seventy-five and seventy-nine, and 40% between the ages of 80-84.Geriatric individuals may be at risk of falling in different situations, often inside and outside the home. Falls generally occur more frequently in indoor areas such as bathrooms, kitchens and bedrooms. In these areas, falls caused by potentially dangerous factors such as slippery floors, carpet edges, and high thresholds are more common. A frequent fall occurs when jumping over an obstacle. Factors such as poor balance, vision problems or reduced muscle strength when overcoming obstacles can increase the risk of falling in this situation. The ability of geriatric individuals to overcome obstacles during daily activities is an important factor determining quality of life. Climbing stairs or crossing high thresholds is an important part of daily living activities and poses a risk of falling. Therefore, determining the stair height threshold and assessing obstacle crossing skills should be considered effective measures. When the literature is examined, clinicians generally prefer simpler functional tests because assessments involving disabilities take a long time to be administered, involve some equipment, and also require training to perform the assessment. In the literature, there is currently a version of the functional tests that is applied only by adding obstacles to the timed get up and go test. Thanks to this test, the ability of geriatric individuals to overcome obstacles can be evaluated and people can be trained with this test. For this reason, we wanted to determine the suitability of the 10-meter walking test, which is frequently used in geriatric individuals, when applied with the addition of an obstacle., conditionsModule conditions: Geriatric, conditions: Balance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Ten Meter Walk Test, secondaryOutcomes measure: Berg Balance Scale, secondaryOutcomes measure: Functional Reach Test, secondaryOutcomes measure: Timed up and go test, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ataturk University, status: RECRUITING, city: Erzurum, country: Turkey, contacts name: Birol Önal, Dr., role: CONTACT, phone: +904422311233, email: birol.onal@atauni.edu.tr, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
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protocolSection identificationModule nctId: NCT06307756, orgStudyIdInfo id: SayıNo:521, briefTitle: The Effect of Music on Maternal Stress and Milk Amount, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Adiyaman University, class: OTHER, descriptionModule briefSummary: Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. It is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. This stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. Mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; It causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. In order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. Music improves endothelial function by dilating the vessels; It has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. This study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk., conditionsModule conditions: Amount of Breast Milk, conditions: Maternal Anxiety Level, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Music group, outcomesModule primaryOutcomes measure: amount of breast milk measured at the same time every day, secondaryOutcomes measure: State Anxiety Inventory, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sağlık Bilimleri Üniversitesi Gazi Yaşargil Eğitim ve Araştırma Hastanesi, status: RECRUITING, city: Diyarbakır, country: Turkey, contacts name: Özlem Sıdıka Kartal, role: CONTACT, phone: +90 05534452828, email: ozlem.kartal.002.@gmail.com, geoPoint lat: 37.91363, lon: 40.21721, hasResults: False
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protocolSection identificationModule nctId: NCT06307743, orgStudyIdInfo id: RAPID-SAVE, briefTitle: Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke, acronym: RAPID-SAVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-09-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital, class: OTHER, collaborators name: Zhangzhou Municipal Hospital of Fujian Province, collaborators name: Shanghai East Hospital, collaborators name: First People's Hospital of Hangzhou, collaborators name: RenJi Hospital, descriptionModule briefSummary: The objective of this clinical trial is to determine whether rapid local ischemic postconditioning (RL-IPostC) is effective in preventing brain edema and safe in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy. In this trial, researchers will block antegrade cerebral blood flow temporarily by the way of balloon inflation/deflation in AIS patients immediately after revascularization. It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration. Researchers will evaluate the protective role and safety of different duration of balloon inflation/deflation. The optimal postconditioning intervention dose will be determined for further confirmative investigation., conditionsModule conditions: Acute Ischemic Stroke, conditions: Mechanical Thrombectomy, conditions: Ischemic Postconditioning, conditions: Brain Edema, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: rapid local ischemic postconditioning, outcomesModule primaryOutcomes measure: Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events., secondaryOutcomes measure: Rate of participants without clinically meaningful cerebral swelling, secondaryOutcomes measure: Rate of participants with significant increase in infarct volume from baseline or intervention-related serious adverse events., secondaryOutcomes measure: Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours, secondaryOutcomes measure: Change of net water uptake (∆NWU24) at 24 hours, secondaryOutcomes measure: Change of net water uptake (∆NWU72) at 72 hours, secondaryOutcomes measure: Midline shift at 24 hours, secondaryOutcomes measure: Midline shift at 72 hours, secondaryOutcomes measure: Change of NIHSS at 24 hours, secondaryOutcomes measure: Early therapeutic response to treatment, secondaryOutcomes measure: Good outcome at 90 days, secondaryOutcomes measure: Excellent outcome at 90 days, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307730, orgStudyIdInfo id: CHSD_0033_GERIATRIE, briefTitle: Application of the Recommendations of the SPLIF (French Society of Infectious Pathology) in a Geriatric Population on the Duration of Treatment for Bacterial Pneumonia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Saint-Denis, class: OTHER, descriptionModule briefSummary: Pneumopathy is the leading cause of death from infectious disease in the elderly. Prior to 2021, the recommended duration of antibiotic therapy for pneumonia, in adults, was 7 days.Two theses have shown that these recommendations were poorly applied in geriatric services. Indeed, the duration of treatment exceeded 7 days, and less than 30% of antibiotic antibiotic treatments were re-evaluated at 72 hours.In 2021, the SPLIF ( published new recommendations reducing this duration to 5 days in the event of clinical improvement observed on the 3rd day of treatment. These new recommendations are based on studies, in which the average age of participants was 65 years. However, the average age of patients in geriatric short-stay departments is 84.7 years.In addition, the geriatric population is characterized by immunosenescence, pulmonary vulnerability and undernutrition, raising questions about the validity of these recommendations in the geriatric population.The investigators offer a monocentric, retrospective, observational study of the geriatric hospital Casanova to assess the application of SPLIF recommendations in the geriatric population., conditionsModule conditions: Pneumonia, Bacterial, conditions: Pneumopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 35, type: ACTUAL, outcomesModule primaryOutcomes measure: Sex, primaryOutcomes measure: Age, primaryOutcomes measure: Weight, primaryOutcomes measure: Phone Number, primaryOutcomes measure: Origins, primaryOutcomes measure: Autonomy in daily life's score before hospitalisation, primaryOutcomes measure: Charlson's morbidity score, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hopitalier de Saint-Denis, city: Saint-Denis, state: Seine Saint Denis, zip: 93200, country: France, geoPoint lat: 48.93326, lon: 2.36666, hasResults: False
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protocolSection identificationModule nctId: NCT06307717, orgStudyIdInfo id: PLAGH-DA-002, briefTitle: Effects of Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety in Elderly Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-04-01, primaryCompletionDateStruct date: 2021-10-31, completionDateStruct date: 2022-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, collaborators name: Beijing Tsinghua Changgeng Hospital, collaborators name: Peking University First Hospital, collaborators name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, collaborators name: Xiangya Hospital of Central South University, collaborators name: Beijing Anzhen Hospital, collaborators name: Central South University, collaborators name: Peking University People's Hospital, collaborators name: Zhejiang University, collaborators name: Fudan University, collaborators name: Sun Yat-sen University, collaborators name: Wuhan Union Hospital, China, collaborators name: China-Japan Friendship Hospital, collaborators name: The Affiliated Hospital Of Guizhou Medical University, collaborators name: First Affiliated Hospital of Xinjiang Medical University, collaborators name: First Affiliated Hospital of Guangxi Medical University, collaborators name: Taihe Hospital, descriptionModule briefSummary: This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the impact of volatile anaesthetics on the incidence of postoperative depression and anxiety among elderly patients., conditionsModule conditions: Cohort Studies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 8000, type: ACTUAL, armsInterventionsModule interventions name: volatile anaesthetic (sevoflurane, isoflurane, desflurane), outcomesModule primaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA General Hospital, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06307704, orgStudyIdInfo id: LUSPEEPORRPC, briefTitle: Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Nazmy Edward Seif, class: OTHER, descriptionModule briefSummary: There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC).Preventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices.Bedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability.The aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications., conditionsModule conditions: Prostate Cancer, conditions: Urinary Bladder Cancer, conditions: Surgery, conditions: Positive End Expiratory Pressure, conditions: Lung Ultrasound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Lung Ultrasound - guided Stepwise PEEP, interventions name: Standard Ventilation Protocol, outcomesModule primaryOutcomes measure: Post-operative lung consolidation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo University Hospitals, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Mustafa E Mohamed, MD, role: CONTACT, phone: 01140806330, phoneExt: +2, email: mustafaemam931@gmail.com, contacts name: Nazmy S Mikhael, MD, role: CONTACT, phone: 01227400808, phoneExt: +2, email: nazmy.edwar.seif@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06307691, orgStudyIdInfo id: 11423, briefTitle: Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2025-12-20, completionDateStruct date: 2026-12-20, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: For the purpose of the study, patients will be divided into two groups, i.e., Group A and Group B. In Group (A), 14 immediate implants will be placed using traditional drilling technique, while in Group (B), 14 immediate implants will be placed using OD drilling technique Osseodensification is a system for implant osteotomy preparation, it compresses the cancellous bone around the revolving drills. It largely improves low bone volume by physically increasing the interlocking between the bone and the implant surface. The Densah burs enhances bone density while generating the least amount of heat.Traditional oversized drilling is the regular manufacturer recommended technique of drilling. It functions by cutting the bone during osteotomy preparation by sharp fluted drills. The undersizing of the preparation allows the implant to partially compact the bone during insertion.The objective of the current study is to compare between osseodensification drilling protocol versus traditional undersized drilling protocol in immediate implant placement in anterior maxillary region in terms of implant stability., conditionsModule conditions: Implant Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: patients will be randomly selected into either group using computer generated randomization using (www.randomizer.org). The randomized numbers will be allocated to each site in each patient and will be placed in opaque, sealed and sequentially numbered envelopes. patients will be randomly allocated to test and control groups using randomization schedule.Masking/blinding:* Participants will be blinded* Blinding of the operator will be blinded* The outcome assessor will be blinded* The biostatistician will be blinded, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Conventional drilling, interventions name: Osseodensification drilling, outcomesModule primaryOutcomes measure: Implant stability quotient (ISQ), secondaryOutcomes measure: Crestal bone level, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry Cairo University, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Omar M Ibrahim, master, role: CONTACT, phone: 01000953710, phoneExt: 002, email: omar_ibrahim@dentistry.cu.edu.eg, contacts name: Omnia K Tawfik, PhD, role: CONTACT, phone: 01006002618, email: omnia.tawfik@dentistry.cu.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06307678, orgStudyIdInfo id: AtaturkU-DHF-MS-01, briefTitle: Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-07, primaryCompletionDateStruct date: 2023-12-10, completionDateStruct date: 2023-12-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited.The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on the release of RANKL/OPG, TNF-α, PGE-2 and TGF-β1 in root canal treated teeth with periapical lesions., conditionsModule conditions: Periapical; Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: outcome assessments have performed by a investigator who was blinded to groups., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Calcium Hydroxide, interventions name: Calcium Silicate, outcomesModule primaryOutcomes measure: preoperative and postoperative levels of RANKL/OPG ratio, primaryOutcomes measure: preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio, primaryOutcomes measure: preoperative and postoperative levels of TNF alpha ratio, primaryOutcomes measure: preoperative and postoperative levels of TGF beta ratio, secondaryOutcomes measure: dependent variables (sex, age, teeth number, smoking habit), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ataturk University, city: Erzurum, zip: 25240, country: Turkey, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
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protocolSection identificationModule nctId: NCT06307665, orgStudyIdInfo id: D6934C00001, briefTitle: Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma, acronym: ACADIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2027-10-13, completionDateStruct date: 2027-10-13, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Parexel, descriptionModule briefSummary: The purpose of this study is to compare the budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI) administered as needed on severe asthma exacerbations in adolescent participants aged 12 to \< 18 years with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year., conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 440, type: ESTIMATED, armsInterventionsModule interventions name: BDA MDI, interventions name: AS MDI, outcomesModule primaryOutcomes measure: Annualized rate of severe asthma exacerbations (AAER), secondaryOutcomes measure: Time to first (TTF) severe asthma exacerbation, secondaryOutcomes measure: Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma, secondaryOutcomes measure: Number of participants with adverse events (AEs) and severe adverse events (SAEs), secondaryOutcomes measure: Maximum Observed Concentration (Cmax), secondaryOutcomes measure: Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast), secondaryOutcomes measure: Area under plasma concentration-time curve from time 0 to infinity (AUCinf), secondaryOutcomes measure: Time to reach maximum concentration following drug administration (Tmax), secondaryOutcomes measure: Time to reach maximum concentration following drug administration (Tlast), secondaryOutcomes measure: Terminal elimination half-life (t½λz), secondaryOutcomes measure: Terminal elimination rate constant (λz), secondaryOutcomes measure: Apparent total body clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution based on the terminal phase (Vz/F), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Research Site, city: White Marsh, state: Maryland, zip: 21162, country: United States, geoPoint lat: 39.38372, lon: -76.43218, hasResults: False
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protocolSection identificationModule nctId: NCT06307652, orgStudyIdInfo id: D6402C00012, briefTitle: Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function, acronym: BalanceD-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2027-06-11, completionDateStruct date: 2027-06-11, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events., conditionsModule conditions: Heart Failure and Impaired Kidney Function, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4800, type: ESTIMATED, armsInterventionsModule interventions name: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg, interventions name: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg, interventions name: dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin, outcomesModule primaryOutcomes measure: Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation, secondaryOutcomes measure: Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation, secondaryOutcomes measure: Total occurrences (first and recurrent) of HF hospitalisations, secondaryOutcomes measure: Time to CV death, secondaryOutcomes measure: The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation, secondaryOutcomes measure: Time to death from any cause, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Alexander City, state: Alabama, zip: 35010, country: United States, geoPoint lat: 32.94401, lon: -85.95385, locations facility: Research Site, city: Fairhope, state: Alabama, zip: 36532, country: United States, geoPoint lat: 30.52297, lon: -87.90333, locations facility: Research Site, city: Little Rock, state: Arkansas, zip: 72205, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Research Site, city: Los Angeles, state: California, zip: 90089, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Research Site, city: Newport Beach, state: California, zip: 92663, country: United States, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Research Site, city: San Diego, state: California, zip: 92123, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Research Site, city: Santa Ana, state: California, zip: 92704, country: United States, geoPoint lat: 33.74557, lon: -117.86783, locations facility: Research Site, city: Thousand Oaks, state: California, zip: 91360, country: United States, geoPoint lat: 34.17056, lon: -118.83759, locations facility: Research Site, city: Altamonte Springs, state: Florida, zip: 32701, country: United States, geoPoint lat: 28.66111, lon: -81.36562, locations facility: Research Site, city: Clearwater, state: Florida, zip: 33756, country: United States, geoPoint lat: 27.96585, lon: -82.8001, locations facility: Research Site, city: Jacksonville, state: Florida, zip: 32209, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Research Site, city: Miami, state: Florida, zip: 33133, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Research Site, city: Saint Augustine, state: Florida, zip: 32086, country: United States, geoPoint lat: 29.89469, lon: -81.31452, locations facility: Research Site, city: Atlanta, state: Georgia, zip: 30303, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Research Site, city: Tucker, state: Georgia, zip: 30084, country: United States, geoPoint lat: 33.85455, lon: -84.21714, locations facility: Research Site, city: Chicago, state: Illinois, zip: 60637, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Research Site, city: Hazel Crest, state: Illinois, zip: 60429, country: United States, geoPoint lat: 41.5717, lon: -87.69449, locations facility: Research Site, city: Hammond, state: Indiana, zip: 46324, country: United States, geoPoint lat: 41.58337, lon: -87.50004, locations facility: Research Site, city: Munster, state: Indiana, zip: 46321, country: United States, geoPoint lat: 41.56448, lon: -87.51254, locations facility: Research Site, city: Richmond, state: Indiana, zip: 47374, country: United States, geoPoint lat: 39.82894, lon: -84.89024, locations facility: Research Site, city: Wichita, state: Kansas, zip: 67218, country: United States, geoPoint lat: 37.69224, lon: -97.33754, locations facility: Research Site, city: Wichita, state: Kansas, zip: 67226, country: United States, geoPoint lat: 37.69224, lon: -97.33754, locations facility: Research Site, city: Louisville, state: Kentucky, zip: 40202, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Research Site, city: Alexandria, state: Louisiana, zip: 71301, country: United States, geoPoint lat: 31.31129, lon: -92.44514, locations facility: Research Site, city: Shreveport, state: Louisiana, zip: 71105, country: United States, geoPoint lat: 32.52515, lon: -93.75018, locations facility: Research Site, city: Augusta, state: Maine, zip: 04330, country: United States, geoPoint lat: 44.31062, lon: -69.77949, locations facility: Research Site, city: Dearborn, state: Michigan, zip: 48126, country: United States, geoPoint lat: 42.32226, lon: -83.17631, locations facility: Research Site, city: Flint, state: Michigan, zip: 48504, country: United States, geoPoint lat: 43.01253, lon: -83.68746, locations facility: Research Site, city: Saint Paul, state: Minnesota, zip: 55102, country: United States, geoPoint lat: 44.94441, lon: -93.09327, locations facility: Research Site, city: Kansas City, state: Missouri, zip: 64128, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Research Site, city: Lincoln, state: Nebraska, zip: 68506, country: United States, geoPoint lat: 40.8, lon: -96.66696, locations facility: Research Site, city: Somerset, state: New Jersey, zip: 08873, country: United States, geoPoint lat: 40.4976, lon: -74.48849, locations facility: Research Site, city: Bronx, state: New York, zip: 10455, country: United States, geoPoint lat: 40.84985, lon: -73.86641, locations facility: Research Site, city: Buffalo, state: New York, zip: 14215, country: United States, geoPoint lat: 42.88645, lon: -78.87837, locations facility: Research Site, city: Chapel Hill, state: North Carolina, zip: 27517, country: United States, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Research Site, city: Greensboro, state: North Carolina, zip: 27405, country: United States, geoPoint lat: 36.07264, lon: -79.79198, locations facility: Research Site, city: Cincinnati, state: Ohio, zip: 45267, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Research Site, city: Maumee, state: Ohio, zip: 43537, country: United States, geoPoint lat: 41.56283, lon: -83.65382, locations facility: Research Site, city: Abington, state: Pennsylvania, zip: 19001, country: United States, geoPoint lat: 40.12067, lon: -75.11795, locations facility: Research Site, city: Camp Hill, state: Pennsylvania, zip: 17011, country: United States, geoPoint lat: 40.23981, lon: -76.91997, locations facility: Research Site, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, geoPoint lat: 40.28592, lon: -76.65025, locations facility: Research Site, city: Horsham, state: Pennsylvania, zip: 19044, country: United States, geoPoint lat: 40.17844, lon: -75.12851, locations facility: Research Site, city: Providence, state: Rhode Island, zip: 02908, country: United States, geoPoint lat: 41.82399, lon: -71.41283, locations facility: Research Site, city: Rapid City, state: South Dakota, zip: 57701, country: United States, geoPoint lat: 44.08054, lon: -103.23101, locations facility: Research Site, city: Jackson, state: Tennessee, zip: 38301, country: United States, geoPoint lat: 35.61452, lon: -88.81395, locations facility: Research Site, city: Knoxville, state: Tennessee, zip: 37916, country: United States, geoPoint lat: 35.96064, lon: -83.92074, locations facility: Research Site, city: Memphis, state: Tennessee, zip: 38128, country: United States, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Research Site, city: Nashville, state: Tennessee, zip: 37212, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Research Site, city: Tullahoma, state: Tennessee, zip: 37388, country: United States, geoPoint lat: 35.36202, lon: -86.20943, locations facility: Research Site, city: Cypress, state: Texas, zip: 77429, country: United States, geoPoint lat: 29.96911, lon: -95.69717, locations facility: Research Site, city: El Paso, state: Texas, zip: 79905, country: United States, geoPoint lat: 31.75872, lon: -106.48693, locations facility: Research Site, city: Houston, state: Texas, zip: 77025, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Research Site, city: Houston, state: Texas, zip: 77090, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Research Site, city: Katy, state: Texas, zip: 77493, country: United States, geoPoint lat: 29.78579, lon: -95.8244, locations facility: Research Site, city: Odessa, state: Texas, zip: 79761, country: United States, geoPoint lat: 31.84568, lon: -102.36764, locations facility: Research Site, city: Sherman, state: Texas, zip: 75092, country: United States, geoPoint lat: 33.63566, lon: -96.60888, locations facility: Research Site, city: Falls Church, state: Virginia, zip: 22042, country: United States, geoPoint lat: 38.88233, lon: -77.17109, locations facility: Research Site, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: Research Site, city: Buenos Aires, zip: 1425DES, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, city: Buenos Aires, zip: C1056ABJ, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, city: Buenos Aires, zip: C1180AAX, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, city: Buenos Aires, zip: C1430EGF, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, city: Caba, zip: C1425AGC, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, city: Ciudad de Buenos Aires, zip: C1419AHL, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, city: Cordoba, zip: X5006CBI, country: Argentina, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Research Site, city: Corrientes, zip: W3400CDS, country: Argentina, geoPoint lat: -27.4806, lon: -58.8341, locations facility: Research Site, city: Córdoba, zip: X5003DCE, country: Argentina, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Research Site, city: Esperanza, zip: S3080BQU, country: Argentina, geoPoint lat: -31.4488, lon: -60.93173, locations facility: Research Site, city: Florencio Varela, zip: 1888, country: Argentina, geoPoint lat: -34.82722, lon: -58.39556, locations facility: Research Site, city: Ganadero Baigorria, zip: 2152, country: Argentina, locations facility: Research Site, city: Mar del Plata, zip: B7600GNY, country: Argentina, geoPoint lat: -38.00228, lon: -57.55754, locations facility: Research Site, city: Rosario, zip: 2123, country: Argentina, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Research Site, city: San Miguel de Tucuman, zip: 4000, country: Argentina, geoPoint lat: -26.82414, lon: -65.2226, locations facility: Research Site, city: San Miguel de Tucuman, zip: T4000ICL, country: Argentina, geoPoint lat: -26.82414, lon: -65.2226, locations facility: Research Site, city: Santa Fe, zip: S3000FWO, country: Argentina, geoPoint lat: -31.63333, lon: -60.7, locations facility: Research Site, city: Chermside, zip: 4032, country: Australia, geoPoint lat: -27.38472, lon: 153.03062, locations facility: Research Site, city: Geelong, zip: 3220, country: Australia, geoPoint lat: -38.14711, lon: 144.36069, locations facility: Research Site, city: Braunau am Inn, zip: 5280, country: Austria, geoPoint lat: 48.25628, lon: 13.04343, locations facility: Research Site, city: Graz, zip: 8036, country: Austria, geoPoint lat: 47.06667, lon: 15.45, locations facility: Research Site, city: Linz, zip: 4020, country: Austria, geoPoint lat: 48.30639, lon: 14.28611, locations facility: Research Site, city: Saint Stefan/Stainz, zip: 8511, country: Austria, locations facility: Research Site, city: Salzburg, zip: 5020, country: Austria, geoPoint lat: 47.79941, lon: 13.04399, locations facility: Research Site, city: St. Pölten, zip: 3100, country: Austria, geoPoint lat: 48.2, lon: 15.63333, locations facility: Research Site, city: Wien, zip: 1090, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Research Site, city: Wien, zip: 1100, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Research Site, city: Wien, zip: 1160, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Research Site, city: New Westminster, state: British Columbia, zip: V3L 3W4, country: Canada, geoPoint lat: 49.20678, lon: -122.91092, locations facility: Research Site, city: North Vancouver, state: British Columbia, zip: V7M 2H4, country: Canada, geoPoint lat: 49.31636, lon: -123.06934, locations facility: Research Site, city: Vancouver, state: British Columbia, zip: V6Z 1Y6, country: Canada, geoPoint lat: 49.24966, lon: -123.11934, locations facility: Research Site, city: Winnipeg, state: Manitoba, zip: R2H 2A6, country: Canada, geoPoint lat: 49.8844, lon: -97.14704, locations facility: Research Site, city: Sydney, state: Nova Scotia, zip: B1P 1P3, country: Canada, geoPoint lat: 46.13511, lon: -60.1831, locations facility: Research Site, city: Cambridge, state: Ontario, zip: N1R 6V6, country: Canada, geoPoint lat: 43.3601, lon: -80.31269, locations facility: Research Site, city: London, state: Ontario, zip: N6A 5A5, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, locations facility: Research Site, city: Newmarket, state: Ontario, zip: L3Y 2P6, country: Canada, geoPoint lat: 44.05011, lon: -79.46631, locations facility: Research Site, city: North York, state: Ontario, zip: M6B 3H7, country: Canada, geoPoint lat: 43.76681, lon: -79.4163, locations facility: Research Site, city: Oshawa, state: Ontario, zip: L1J 2K1, country: Canada, geoPoint lat: 43.90012, lon: -78.84957, locations facility: Research Site, city: Ottawa, state: Ontario, zip: K1Y 4W7, country: Canada, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Research Site, city: Peterborough, state: Ontario, zip: K9J 0B2, country: Canada, geoPoint lat: 44.30012, lon: -78.31623, locations facility: Research Site, city: Toronto, state: Ontario, zip: M6G 1M2, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Research Site, city: Waterloo, state: Ontario, zip: N2T 0C1, country: Canada, geoPoint lat: 43.4668, lon: -80.51639, locations facility: Research Site, city: Chicoutimi, state: Quebec, zip: G7H 7K9, country: Canada, geoPoint lat: 48.41963, lon: -71.06369, locations facility: Research Site, city: Greenfield Park, state: Quebec, zip: J4V 2H1, country: Canada, geoPoint lat: 45.48649, lon: -73.46223, locations facility: Research Site, city: Montreal, state: Quebec, zip: H3G 1A4, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, city: Montreal, state: Quebec, zip: H4J 1C5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, city: St Jean sur Richelieu, state: Quebec, zip: J3A 1J2, country: Canada, geoPoint lat: 45.30713, lon: -73.26259, locations facility: Research Site, city: Trois-Rivières, state: Quebec, zip: G9A 4P3, country: Canada, geoPoint lat: 46.34515, lon: -72.5477, locations facility: Research Site, city: Antofagasta, country: Chile, geoPoint lat: -23.65236, lon: -70.3954, locations facility: Research Site, city: Santiago, zip: 7500587, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Research Site, city: Santiago, zip: 8330044, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Research Site, city: Temuco, zip: 4781156, country: Chile, geoPoint lat: -38.73965, lon: -72.59842, locations facility: Research Site, city: Temuco, zip: 4810345, country: Chile, geoPoint lat: -38.73965, lon: -72.59842, locations facility: Research Site, city: Valdivia, zip: 5110683, country: Chile, geoPoint lat: -39.81422, lon: -73.24589, locations facility: Research Site, city: Victoria, zip: 4720097, country: Chile, geoPoint lat: -38.23291, lon: -72.33292, locations facility: Research Site, city: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, city: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, city: Changsha, zip: 430033, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, city: Chengdu, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, city: Hangzhou, zip: 310014, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Research Site, city: Lanzhou, zip: 730030, country: China, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Research Site, city: Nanjing, zip: 210029, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Research Site, city: Wuhan, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, city: Xian, zip: 710061, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Research Site, city: Barranquilla, zip: 80007, country: Colombia, geoPoint lat: 10.96854, lon: -74.78132, locations facility: Research Site, city: Bogotá, country: Colombia, geoPoint lat: 4.60971, lon: -74.08175, locations facility: Research Site, city: Cali, zip: 760036, country: Colombia, geoPoint lat: 3.43722, lon: -76.5225, locations facility: Research Site, city: Brno, zip: 60200, country: Czechia, geoPoint lat: 49.19522, lon: 16.60796, locations facility: Research Site, city: Brno, zip: 639 00, country: Czechia, geoPoint lat: 49.19522, lon: 16.60796, locations facility: Research Site, city: Broumov, zip: 55001, country: Czechia, geoPoint lat: 50.58566, lon: 16.33181, locations facility: Research Site, city: Ceska Lipa, zip: 470 77, country: Czechia, geoPoint lat: 50.68551, lon: 14.53764, locations facility: Research Site, city: Jaromer, zip: 551 01, country: Czechia, geoPoint lat: 50.3562, lon: 15.92136, locations facility: Research Site, city: Louny, zip: 440 01, country: Czechia, geoPoint lat: 50.35699, lon: 13.79667, locations facility: Research Site, city: Plzen - Bory, zip: 305 99, country: Czechia, geoPoint lat: 49.74747, lon: 13.37759, locations facility: Research Site, city: Plzen, zip: 31001, country: Czechia, geoPoint lat: 49.74747, lon: 13.37759, locations facility: Research Site, city: Praha 2, zip: 120 00, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Research Site, city: Prerov, zip: 75152, country: Czechia, geoPoint lat: 49.45511, lon: 17.4509, locations facility: Research Site, city: Slany, zip: 274 01, country: Czechia, geoPoint lat: 50.23046, lon: 14.08693, locations facility: Research Site, city: Svitavy, zip: 568 25, country: Czechia, geoPoint lat: 49.75594, lon: 16.46829, locations facility: Research Site, city: Ustí nad Labem, zip: 40011, country: Czechia, geoPoint lat: 50.6607, lon: 14.03227, locations facility: Research Site, city: Zlin, zip: 760 01, country: Czechia, geoPoint lat: 49.22645, lon: 17.67065, locations facility: Research Site, city: Helsinki, zip: 00290, country: Finland, geoPoint lat: 60.16952, lon: 24.93545, locations facility: Research Site, city: Jyväskylä, zip: 40620, country: Finland, geoPoint lat: 62.24147, lon: 25.72088, locations facility: Research Site, city: Tampere, zip: 33520, country: Finland, geoPoint lat: 61.49911, lon: 23.78712, locations facility: Research Site, city: Turku, zip: 20520, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, locations facility: Research Site, city: Beziers, zip: 34500, country: France, geoPoint lat: 43.34122, lon: 3.21402, locations facility: Research Site, city: Bron, zip: 69667, country: France, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Research Site, city: Caen Cedex 9, zip: 14033, country: France, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Research Site, city: Creteil, zip: 94010, country: France, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Research Site, city: Dijon, zip: 21079, country: France, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Research Site, city: La Tronche, zip: 38043, country: France, geoPoint lat: 45.20429, lon: 5.73645, locations facility: Research Site, city: Le Coudray, zip: 28630, country: France, geoPoint lat: 48.42115, lon: 1.50057, locations facility: Research Site, city: Limoges, zip: 87000, country: France, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Research Site, city: Montauban, zip: 82017, country: France, geoPoint lat: 44.01667, lon: 1.35, locations facility: Research Site, city: Montpellier Cedex, zip: 34295, country: France, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Research Site, city: Nantes cedex 1, zip: 44093, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Research Site, city: Orleans, zip: 45100, country: France, geoPoint lat: 47.90289, lon: 1.90389, locations facility: Research Site, city: Paris, zip: 75010, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Research Site, city: Paris, zip: 75015, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Research Site, city: Poitiers, zip: 86021, country: France, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Research Site, city: Reims, zip: 51092, country: France, geoPoint lat: 49.25, lon: 4.03333, locations facility: Research Site, city: Rennes Cedex 9, zip: 35033, country: France, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Research Site, city: Toulon, zip: 83100, country: France, geoPoint lat: 43.12442, lon: 5.92836, locations facility: Research Site, city: Toulouse, zip: 31059, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Research Site, city: TOURS Cedex 9, zip: 37044, country: France, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Research Site, city: Valenciennes, zip: 59300, country: France, geoPoint lat: 50.35, lon: 3.53333, locations facility: Research Site, city: Bad Nauheim, zip: 61231, country: Germany, geoPoint lat: 50.36463, lon: 8.73859, locations facility: Research Site, city: Bechhofen, zip: 66894, country: Germany, geoPoint lat: 49.35, lon: 7.4, locations facility: Research Site, city: Bernau bei Berlin, zip: 16321, country: Germany, geoPoint lat: 52.67982, lon: 13.58708, locations facility: Research Site, city: Chemnitz, zip: 9113, country: Germany, geoPoint lat: 50.8357, lon: 12.92922, locations facility: Research Site, city: Coburg, zip: 96450, country: Germany, geoPoint lat: 50.25937, lon: 10.96384, locations facility: Research Site, city: Dresden, zip: 1307, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Research Site, city: Elsterwerda, zip: 04910, country: Germany, geoPoint lat: 51.46043, lon: 13.52001, locations facility: Research Site, city: Frankfurt, zip: 60590, country: Germany, geoPoint lat: 50.11552, lon: 8.68417, locations facility: Research Site, city: Freiburg, zip: 79106, country: Germany, geoPoint lat: 47.9959, lon: 7.85222, locations facility: Research Site, city: Hagen, zip: 58135, country: Germany, geoPoint lat: 51.36081, lon: 7.47168, locations facility: Research Site, city: Hamburg, zip: 20246, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Research Site, city: Hamburg, zip: 22457, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Research Site, city: Kaiserslautern, zip: 67655, country: Germany, geoPoint lat: 49.443, lon: 7.77161, locations facility: Research Site, city: Köln, zip: 50733, country: Germany, geoPoint lat: 50.93333, lon: 6.95, locations facility: Research Site, city: Langen, zip: 63225, country: Germany, geoPoint lat: 49.98955, lon: 8.66852, locations facility: Research Site, city: Leipzig, zip: 04103, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Research Site, city: Leverkusen, zip: 51375, country: Germany, geoPoint lat: 51.0303, lon: 6.98432, locations facility: Research Site, city: Mainz, zip: 55131, country: Germany, geoPoint lat: 49.98419, lon: 8.2791, locations facility: Research Site, city: Mönchengladbach, zip: 41063, country: Germany, geoPoint lat: 51.18539, lon: 6.44172, locations facility: Research Site, city: Papenburg, zip: 26871, country: Germany, geoPoint lat: 53.07738, lon: 7.40444, locations facility: Research Site, city: Regensburg, zip: 93053, country: Germany, geoPoint lat: 49.01513, lon: 12.10161, locations facility: Research Site, city: Remscheid, zip: 42859, country: Germany, geoPoint lat: 51.17983, lon: 7.1925, locations facility: Research Site, city: Rostock, zip: 18059, country: Germany, geoPoint lat: 54.0887, lon: 12.14049, locations facility: Research Site, city: Völklingen, zip: 66333, country: Germany, geoPoint lat: 49.25162, lon: 6.85873, locations facility: Research Site, city: Wermsdorf, zip: 04779, country: Germany, geoPoint lat: 51.28333, lon: 12.95, locations facility: Research Site, city: Witten, zip: 58455, country: Germany, geoPoint lat: 51.44362, lon: 7.35258, locations facility: Research Site, city: Athens, zip: 11521, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, city: Athens, zip: 11526, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, city: Athens, zip: 11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, city: Athens, zip: 12462, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, city: Athens, zip: 14233, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, city: Athens, zip: 15123, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, city: Dragana, zip: 68100, country: Greece, locations facility: Research Site, city: Heraklio, zip: 71110, country: Greece, locations facility: Research Site, city: Thessaloniki, zip: 54636, country: Greece, geoPoint lat: 40.64361, lon: 22.93086, locations facility: Research Site, city: Thessaloniki, zip: 54642, country: Greece, geoPoint lat: 40.64361, lon: 22.93086, locations facility: Research Site, city: Budapest, zip: 1122, country: Hungary, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Research Site, city: Afula, zip: 1834111, country: Israel, geoPoint lat: 32.60907, lon: 35.2892, locations facility: Research Site, city: Ashkelon, zip: 78278, country: Israel, geoPoint lat: 31.66926, lon: 34.57149, locations facility: Research Site, city: Be'er Ya'akov, zip: 70300, country: Israel, locations facility: Research Site, city: Beer Sheva, zip: 8410101, country: Israel, geoPoint lat: 31.25181, lon: 34.7913, locations facility: Research Site, city: Haifa, zip: 3109601, country: Israel, geoPoint lat: 32.81841, lon: 34.9885, locations facility: Research Site, city: Jerusalem, zip: 00000, country: Israel, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Research Site, city: Kfar-Saba, zip: 4428164, country: Israel, geoPoint lat: 32.175, lon: 34.90694, locations facility: Research Site, city: Nahariya, zip: 22100, country: Israel, geoPoint lat: 33.00892, lon: 35.09814, locations facility: Research Site, city: Petah Tikva, zip: 49372, country: Israel, geoPoint lat: 32.08707, lon: 34.88747, locations facility: Research Site, city: Tiberias, zip: 15208, country: Israel, geoPoint lat: 32.79221, lon: 35.53124, locations facility: Research Site, city: Acquaviva delle Fonti, zip: 70021, country: Italy, geoPoint lat: 40.89704, lon: 16.8433, locations facility: Research Site, city: Bari, zip: 70124, country: Italy, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Research Site, city: Bergamo, zip: 24127, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Research Site, city: Brescia, zip: 25100, country: Italy, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Research Site, city: Catanzaro, zip: 88100, country: Italy, geoPoint lat: 38.88247, lon: 16.60086, locations facility: Research Site, city: Cona, zip: 44124, country: Italy, geoPoint lat: 44.80583, lon: 11.7069, locations facility: Research Site, city: Cortona, zip: 52044, country: Italy, geoPoint lat: 43.27467, lon: 11.98533, locations facility: Research Site, city: Firenze, zip: 50134, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Research Site, city: Milan, zip: 20138, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Research Site, city: Novara, zip: 28100, country: Italy, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Research Site, city: Pavia, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Research Site, city: San Giovanni Rotondo, zip: 71013, country: Italy, geoPoint lat: 41.70643, lon: 15.7277, locations facility: Research Site, city: Fujisawa-shi, zip: 251-8550, country: Japan, geoPoint lat: 35.34926, lon: 139.47666, locations facility: Research Site, city: Fukutsu-shi, zip: 811-3298, country: Japan, geoPoint lat: 33.783, lon: 130.49114, locations facility: Research Site, city: Hakusan-shi, zip: 924-8588, country: Japan, locations facility: Research Site, city: Himeji, zip: 670-8560, country: Japan, geoPoint lat: 34.81667, lon: 134.7, locations facility: Research Site, city: Iwakuni-shi, zip: 740-8510, country: Japan, geoPoint lat: 34.16297, lon: 132.22, locations facility: Research Site, city: Kawaguchi, zip: 333-0842, country: Japan, geoPoint lat: 35.80521, lon: 139.71072, locations facility: Research Site, city: Kobe-shi, zip: 654-0155, country: Japan, geoPoint lat: 34.6913, lon: 135.183, locations facility: Research Site, city: Matsumoto-shi, zip: 390-8621, country: Japan, geoPoint lat: 36.23333, lon: 137.96667, locations facility: Research Site, city: Moriyama-shi, zip: 524-8524, country: Japan, geoPoint lat: 35.06667, lon: 135.98333, locations facility: Research Site, city: Oita-shi, zip: 870-8511, country: Japan, geoPoint lat: 33.23333, lon: 131.6, locations facility: Research Site, city: Osaka-shi, zip: 540-0006, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Research Site, city: Sagamihara-shi, zip: 252-5188, country: Japan, geoPoint lat: 35.54899, lon: 139.26064, locations facility: Research Site, city: Saitama shi, zip: 336 8522, country: Japan, geoPoint lat: 35.90807, lon: 139.65657, locations facility: Research Site, city: Sakai-shi, zip: 599-8247, country: Japan, geoPoint lat: 34.58333, lon: 135.46667, locations facility: Research Site, city: Sakata City, zip: 998-8501, country: Japan, geoPoint lat: 38.91667, lon: 139.855, locations facility: Research Site, city: Toshima-ku, zip: 171-0014, country: Japan, locations facility: Research Site, city: Ueda-shi, zip: 386-8610, country: Japan, geoPoint lat: 36.40265, lon: 138.28161, locations facility: Research Site, city: Uji-shi, zip: 611-0041, country: Japan, geoPoint lat: 34.89044, lon: 135.80325, locations facility: Research Site, city: Uwajima-shi, zip: 798-8510, country: Japan, geoPoint lat: 33.22375, lon: 132.56001, locations facility: Research Site, city: Yokohama-shi, zip: 221-0855, country: Japan, geoPoint lat: 35.43333, lon: 139.65, locations facility: Research Site, city: Busan, zip: 49241, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Research Site, city: Seongnam-si, zip: 13620, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Research Site, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Wonju-si, zip: 26426, country: Korea, Republic of, locations facility: Research Site, city: Kajang, zip: 43000, country: Malaysia, geoPoint lat: 2.99424, lon: 101.78875, locations facility: Research Site, city: Kota Kinabalu, zip: 88300, country: Malaysia, geoPoint lat: 5.9749, lon: 116.0724, locations facility: Research Site, city: Kota Samarahan, zip: 94300, country: Malaysia, locations facility: Research Site, city: Kuala Lumpur, zip: 50400, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, locations facility: Research Site, city: Kuala Terengganu, zip: 20400, country: Malaysia, geoPoint lat: 5.3302, lon: 103.1408, locations facility: Research Site, city: Kuantan, zip: 25200, country: Malaysia, geoPoint lat: 3.8077, lon: 103.326, locations facility: Research Site, city: Sungai Buloh, zip: 47000, country: Malaysia, geoPoint lat: 3.2, lon: 101.58333, locations facility: Research Site, city: Aguascalientes, zip: 20230, country: Mexico, geoPoint lat: 21.88234, lon: -102.28259, locations facility: Research Site, city: Cuauhtémoc, zip: 06700, country: Mexico, geoPoint lat: 19.44506, lon: -99.14612, locations facility: Research Site, city: Culiacán, zip: 80200, country: Mexico, geoPoint lat: 24.79032, lon: -107.38782, locations facility: Research Site, city: Guadalajara, zip: 44670, country: Mexico, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Research Site, city: Mazatlán, zip: 82110, country: Mexico, geoPoint lat: 23.2329, lon: -106.4062, locations facility: Research Site, city: Metepec, zip: 52170, country: Mexico, geoPoint lat: 19.25934, lon: -99.60175, locations facility: Research Site, city: Mexico City, zip: 03310, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Research Site, city: Mexico City, zip: 07300, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Research Site, city: Mexico, zip: 14080, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Research Site, city: Monterey, zip: 64060, country: Mexico, locations facility: Research Site, city: Morelia, zip: 58260, country: Mexico, geoPoint lat: 19.70078, lon: -101.18443, locations facility: Research Site, city: México, zip: 11650, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Research Site, city: Querétaro, zip: 76000, country: Mexico, locations facility: Research Site, city: San Luis Potosí, zip: 78250, country: Mexico, geoPoint lat: 22.14982, lon: -100.97916, locations facility: Research Site, city: Tijuana, zip: 22014, country: Mexico, geoPoint lat: 32.5027, lon: -117.00371, locations facility: Research Site, city: Veracruz, zip: 91910, country: Mexico, geoPoint lat: 19.18095, lon: -96.1429, locations facility: Research Site, city: Xalapa, zip: 91193, country: Mexico, geoPoint lat: 19.53124, lon: -96.91589, locations facility: Research Site, city: Arnhem, zip: 6815 AD, country: Netherlands, geoPoint lat: 51.98, lon: 5.91111, locations facility: Research Site, city: Emmen, zip: 7824 AA, country: Netherlands, geoPoint lat: 52.77917, lon: 6.90694, locations facility: Research Site, city: Goes, zip: 4462 RA, country: Netherlands, geoPoint lat: 51.50417, lon: 3.88889, locations facility: Research Site, city: Groningen, zip: 9728 NT, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Research Site, city: Hardenberg, zip: 7772 SE, country: Netherlands, geoPoint lat: 52.57583, lon: 6.61944, locations facility: Research Site, city: Bellavista, zip: CALLAO 2, country: Peru, geoPoint lat: -7.05614, lon: -76.5911, locations facility: Research Site, city: Lima, zip: 15024, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, city: Lima, zip: 15046, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, city: Lima, zip: 15072, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, city: Lima, zip: 15088, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, city: Lima, zip: 15131, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, city: Lima, zip: L18, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, city: Lima, zip: LIMA 11, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, city: Lima, zip: LIMA 27, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, city: Lima, zip: LIMA 41, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, city: Piura, zip: 20001, country: Peru, geoPoint lat: -5.19449, lon: -80.63282, locations facility: Research Site, city: Angeles City, zip: 2009, country: Philippines, geoPoint lat: 15.15, lon: 120.58333, locations facility: Research Site, city: Davao City, zip: 8000, country: Philippines, geoPoint lat: 7.07306, lon: 125.61278, locations facility: Research Site, city: Davao City, zip: PH-8000, country: Philippines, geoPoint lat: 7.07306, lon: 125.61278, locations facility: Research Site, city: Iloilo City, zip: 5000, country: Philippines, geoPoint lat: 10.69694, lon: 122.56444, locations facility: Research Site, city: Las Pinas City, zip: PH-1704, country: Philippines, locations facility: Research Site, city: Mabalacat, zip: 2023, country: Philippines, geoPoint lat: 15.22303, lon: 120.57117, locations facility: Research Site, city: Manadaluyong City, zip: 1552, country: Philippines, locations facility: Research Site, city: Manila, zip: 1008, country: Philippines, geoPoint lat: 14.6042, lon: 120.9822, locations facility: Research Site, city: Marikina, zip: 1800, country: Philippines, locations facility: Research Site, city: Pasig City, zip: 1605, country: Philippines, geoPoint lat: 14.58691, lon: 121.0614, locations facility: Research Site, city: Quezon City, zip: 1101, country: Philippines, geoPoint lat: 14.6488, lon: 121.0509, locations facility: Research Site, city: Quezon City, zip: 1112, country: Philippines, geoPoint lat: 14.6488, lon: 121.0509, locations facility: Research Site, city: Taguig City, zip: 1634, country: Philippines, locations facility: Research Site, city: West San Juan City, zip: 1502, country: Philippines, locations facility: Research Site, city: Biała Podlaska, zip: 21-500, country: Poland, geoPoint lat: 52.03238, lon: 23.11652, locations facility: Research Site, city: Białystok, zip: 15-481, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: Research Site, city: Bielsko-Biała, zip: 43-316, country: Poland, geoPoint lat: 49.82245, lon: 19.04686, locations facility: Research Site, city: Bydgoszcz, zip: 85-605, country: Poland, geoPoint lat: 53.1235, lon: 18.00762, locations facility: Research Site, city: Bydgoszcz, zip: 85-794, country: Poland, geoPoint lat: 53.1235, lon: 18.00762, locations facility: Research Site, city: Chrzanów, zip: 32-500, country: Poland, geoPoint lat: 50.13546, lon: 19.40203, locations facility: Research Site, city: Gdynia, zip: 81-157, country: Poland, geoPoint lat: 54.51889, lon: 18.53188, locations facility: Research Site, city: Kazimierza Wielka, zip: 28-500, country: Poland, geoPoint lat: 50.26564, lon: 20.49358, locations facility: Research Site, city: Kraków, zip: 30-082, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, city: Kraków, zip: 30-688, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, city: Kraków, zip: 31-513, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, city: Kędzierzyn-Koźle, zip: 47-200, country: Poland, geoPoint lat: 50.34984, lon: 18.22606, locations facility: Research Site, city: Lublin, zip: 20-044, country: Poland, geoPoint lat: 51.25, lon: 22.56667, locations facility: Research Site, city: Lublin, zip: 20-857, country: Poland, geoPoint lat: 51.25, lon: 22.56667, locations facility: Research Site, city: Olsztyn, zip: 10-010, country: Poland, geoPoint lat: 53.77995, lon: 20.49416, locations facility: Research Site, city: Piekary Śląskie, zip: 41-940, country: Poland, geoPoint lat: 50.38017, lon: 18.92653, locations facility: Research Site, city: Poznań, zip: 61- 848, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, locations facility: Research Site, city: Rzeszow, zip: 35-055, country: Poland, geoPoint lat: 50.04132, lon: 21.99901, locations facility: Research Site, city: Rzeszów, zip: 35-205, country: Poland, geoPoint lat: 50.04132, lon: 21.99901, locations facility: Research Site, city: Szczecin, zip: 71-526, country: Poland, geoPoint lat: 53.42894, lon: 14.55302, locations facility: Research Site, city: Tarnów, zip: 33-100, country: Poland, geoPoint lat: 50.01381, lon: 20.98698, locations facility: Research Site, city: Toruń, zip: 87-100, country: Poland, geoPoint lat: 53.01375, lon: 18.59814, locations facility: Research Site, city: Tychy, zip: 43-100, country: Poland, geoPoint lat: 50.13717, lon: 18.96641, locations facility: Research Site, city: Warszawa, zip: 00-416, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Research Site, city: Warszawa, zip: 04-501, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Research Site, city: Zabrze, zip: 41-800, country: Poland, geoPoint lat: 50.32492, lon: 18.78576, locations facility: Research Site, city: Łódź, zip: 90-549, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, city: Łódź, zip: 91-053, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, city: Łódź, zip: 93-513, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, city: Łódź, zip: 94-046, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, city: Bucharest, zip: 014461, country: Romania, geoPoint lat: 44.43225, lon: 26.10626, locations facility: Research Site, city: Bucharest, zip: 040883, country: Romania, geoPoint lat: 44.43225, lon: 26.10626, locations facility: Research Site, city: Bucuresti, zip: 022328, country: Romania, geoPoint lat: 44.42802, lon: 26.09665, locations facility: Research Site, city: Cluj-Napoca, zip: 400437, country: Romania, geoPoint lat: 46.76667, lon: 23.6, locations facility: Research Site, city: Iasi, zip: 700503, country: Romania, geoPoint lat: 47.16667, lon: 27.6, locations facility: Research Site, city: Targu Mures, zip: 540099, country: Romania, geoPoint lat: 46.54245, lon: 24.55747, locations facility: Research Site, city: Targu Mures, zip: 540136, country: Romania, geoPoint lat: 46.54245, lon: 24.55747, locations facility: Research Site, city: Timisoara, zip: 300595, country: Romania, geoPoint lat: 45.75372, lon: 21.22571, locations facility: Research Site, city: Timișoara, zip: 300310, country: Romania, geoPoint lat: 45.75372, lon: 21.22571, locations facility: Research Site, city: Bratislava, zip: 831 01, country: Slovakia, geoPoint lat: 48.14816, lon: 17.10674, locations facility: Research Site, city: Brezno, zip: 977 01, country: Slovakia, geoPoint lat: 48.80431, lon: 19.63631, locations facility: Research Site, city: Kosice, zip: 04022, country: Slovakia, geoPoint lat: 48.71395, lon: 21.25808, locations facility: Research Site, city: Martin, zip: 036 01, country: Slovakia, geoPoint lat: 49.06651, lon: 18.92399, locations facility: Research Site, city: Myjava, zip: 90701, country: Slovakia, geoPoint lat: 48.75876, lon: 17.56866, locations facility: Research Site, city: Nitra, zip: 949 01, country: Slovakia, geoPoint lat: 48.30763, lon: 18.08453, locations facility: Research Site, city: Nove Zamky, zip: 940 01, country: Slovakia, geoPoint lat: 47.98544, lon: 18.16195, locations facility: Research Site, city: Považská Bystrica, zip: 017 01, country: Slovakia, geoPoint lat: 49.12153, lon: 18.42169, locations facility: Research Site, city: Presov, zip: 080 01, country: Slovakia, geoPoint lat: 48.99839, lon: 21.23393, locations facility: Research Site, city: Prešov, zip: 080 01, country: Slovakia, geoPoint lat: 48.99839, lon: 21.23393, locations facility: Research Site, city: Rimavska Sobota, zip: 979 01, country: Slovakia, geoPoint lat: 48.38284, lon: 20.02239, locations facility: Research Site, city: Svidník, zip: 08901, country: Slovakia, geoPoint lat: 49.30819, lon: 21.5703, locations facility: Research Site, city: A Coruña, zip: 15006, country: Spain, geoPoint lat: 43.37135, lon: -8.396, locations facility: Research Site, city: Barcelona, zip: 08025, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Research Site, city: Barcelona, zip: 08035, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Research Site, city: Barcelona, zip: 08036, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Research Site, city: Lugo, zip: 27004, country: Spain, geoPoint lat: 43.00992, lon: -7.55602, locations facility: Research Site, city: Madrid, zip: 28007, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Research Site, city: Madrid, zip: 28027, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Research Site, city: Majadahonda, zip: 28222, country: Spain, geoPoint lat: 40.47353, lon: -3.87182, locations facility: Research Site, city: Sevilla, zip: 41009, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Research Site, city: Sevilla, zip: 41014, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Research Site, city: Alingsås, zip: 441 83, country: Sweden, geoPoint lat: 57.93033, lon: 12.53345, locations facility: Research Site, city: Göteborg, zip: 413 46, country: Sweden, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Research Site, city: Helsingborg, zip: 252 23, country: Sweden, geoPoint lat: 56.04673, lon: 12.69437, locations facility: Research Site, city: Jönköping, zip: 551 85, country: Sweden, geoPoint lat: 57.78145, lon: 14.15618, locations facility: Research Site, city: Karlstad, zip: 651 85, country: Sweden, geoPoint lat: 59.3793, lon: 13.50357, locations facility: Research Site, city: Lund, zip: 22242, country: Sweden, geoPoint lat: 55.70584, lon: 13.19321, locations facility: Research Site, city: Stockholm, zip: 118 83, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Research Site, city: Stockholm, zip: 171 64, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Research Site, city: Uppsala, zip: 75185, country: Sweden, geoPoint lat: 59.85882, lon: 17.63889, locations facility: Research Site, city: Västerås, zip: 723 35, country: Sweden, geoPoint lat: 59.61617, lon: 16.55276, locations facility: Research Site, city: Changhua, zip: 500, country: Taiwan, geoPoint lat: 24.07327, lon: 120.56276, locations facility: Research Site, city: Kaohsiung, zip: 80756, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Research Site, city: Kaohsiung, zip: 81362, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Research Site, city: New Taipei City, zip: 25160, country: Taiwan, geoPoint lat: 25.01111, lon: 121.44583, locations facility: Research Site, city: New Taipei, zip: 220, country: Taiwan, geoPoint lat: 25.01111, lon: 121.44583, locations facility: Research Site, city: New Taipei, zip: 231, country: Taiwan, geoPoint lat: 25.01111, lon: 121.44583, locations facility: Research Site, city: Taichung, zip: 40447, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Research Site, city: Taichung, zip: 433, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Research Site, city: Taipei City, zip: 110, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 0116, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 10002, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 10449, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 11101, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 11217, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: TAIWAN, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taoyuan, zip: 333, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, locations facility: Research Site, city: Yilan, zip: 260, country: Taiwan, geoPoint lat: 24.757, lon: 121.753, locations facility: Research Site, city: Yung Kang City, zip: 71044, country: Taiwan, locations facility: Research Site, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Research Site, city: Bangkok, zip: 10400, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Research Site, city: Chiang Mai, zip: 50200, country: Thailand, geoPoint lat: 18.79038, lon: 98.98468, locations facility: Research Site, city: Hat Yai, zip: 90110, country: Thailand, geoPoint lat: 7.00836, lon: 100.47668, locations facility: Research Site, city: Khon Kaen, zip: 40002, country: Thailand, geoPoint lat: 16.44671, lon: 102.833, locations facility: Research Site, city: Naimuang, zip: 30000, country: Thailand, locations facility: Research Site, city: Pathumthani, zip: 12120, country: Thailand, geoPoint lat: 14.01346, lon: 100.53049, locations facility: Research Site, city: Adana, zip: 01060, country: Turkey, geoPoint lat: 37.00167, lon: 35.32889, locations facility: Research Site, city: Ankara, zip: 06, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Research Site, city: Antalya, zip: 07059, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, locations facility: Research Site, city: Antalya, zip: 07100, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, locations facility: Research Site, city: Dinar, zip: 03400, country: Turkey, geoPoint lat: 38.065, lon: 30.16557, locations facility: Research Site, city: Eskisehir, zip: 26480, country: Turkey, geoPoint lat: 39.77667, lon: 30.52056, locations facility: Research Site, city: Istanbul, zip: 34668, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Research Site, city: Izmir, zip: 35340, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, locations facility: Research Site, city: Kocaeli, zip: 41380, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, locations facility: Research Site, city: Kütahya, zip: 43100, country: Turkey, geoPoint lat: 39.42417, lon: 29.98333, locations facility: Research Site, city: Merkez, zip: 78200, country: Turkey, locations facility: Research Site, city: Mugla, zip: 48000, country: Turkey, geoPoint lat: 37.21807, lon: 28.3665, locations facility: Research Site, city: Sivas, zip: 58140, country: Turkey, geoPoint lat: 39.74833, lon: 37.01611, locations facility: Research Site, city: Airdrie, zip: ML6 0JS, country: United Kingdom, geoPoint lat: 55.86602, lon: -3.98025, locations facility: Research Site, city: Barnet, zip: EN5 3DJ, country: United Kingdom, geoPoint lat: 51.65, lon: -0.2, locations facility: Research Site, city: Cambridge, zip: CB2 0AY, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, locations facility: Research Site, city: Chertsey, zip: KT16 0PZ, country: United Kingdom, geoPoint lat: 51.38812, lon: -0.50782, locations facility: Research Site, city: Clydebank, zip: G81 4DY, country: United Kingdom, geoPoint lat: 55.90137, lon: -4.4057, locations facility: Research Site, city: Exeter, zip: EX2 5DW, country: United Kingdom, geoPoint lat: 50.7236, lon: -3.52751, locations facility: Research Site, city: Harefield, zip: UB9 6JH, country: United Kingdom, geoPoint lat: 51.60333, lon: -0.48546, locations facility: Research Site, city: Hastings, zip: TN37 7RD, country: United Kingdom, geoPoint lat: 50.85519, lon: 0.57292, locations facility: Research Site, city: High Wycombe, zip: HP11 2TT, country: United Kingdom, geoPoint lat: 51.62907, lon: -0.74934, locations facility: Research Site, city: King's Lynn, zip: PE30 4ET, country: United Kingdom, geoPoint lat: 52.75172, lon: 0.39516, locations facility: Research Site, city: Lincoln, zip: LN2 5QY, country: United Kingdom, geoPoint lat: 53.22683, lon: -0.53792, locations facility: Research Site, city: London, zip: EC1A 7BE, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, city: London, zip: SE5 9RS, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, city: Middlesborough, zip: TS4 3BW, country: United Kingdom, geoPoint lat: 54.57623, lon: -1.23483, locations facility: Research Site, city: Portsmouth, zip: PO6 3LY, country: United Kingdom, geoPoint lat: 50.79899, lon: -1.09125, locations facility: Research Site, city: Sheffield, zip: S5 7AU, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, locations facility: Research Site, city: Sunderland, zip: SR4 7TP, country: United Kingdom, geoPoint lat: 54.90465, lon: -1.38222, locations facility: Research Site, city: Wakefield, zip: WF1 4DG, country: United Kingdom, geoPoint lat: 53.68331, lon: -1.49768, locations facility: Research Site, city: Da Nang, zip: 550000, country: Vietnam, geoPoint lat: 16.06778, lon: 108.22083, locations facility: Research Site, city: Hai Phong, zip: 180000, country: Vietnam, geoPoint lat: 20.86481, lon: 106.68345, locations facility: Research Site, city: Hanoi, zip: 100000, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, locations facility: Research Site, city: Ho Chi Minh, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, locations facility: Research Site, city: Hochiminh city, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, hasResults: False
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protocolSection identificationModule nctId: NCT06307639, orgStudyIdInfo id: MYMSwifee, briefTitle: Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: * Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).* Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples., conditionsModule conditions: Male Infertility Due to Azoospermia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE)., outcomesModule primaryOutcomes measure: Know more about the functional role of PGK2 and ACRV1 in the process of spermatogenesis., primaryOutcomes measure: Detect if PGK2 and/or AVRV1 level can used as predictor for spermatogenesis in infertile men with non-obstructive azoospermia undergoing Testicular Sperm Extraction., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06307626, orgStudyIdInfo id: ARGX-113-2309, secondaryIdInfos id: 2023-509198-22-00, type: CTIS, briefTitle: A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: argenx, class: INDUSTRY, descriptionModule briefSummary: This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks., conditionsModule conditions: Thyroid Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Efgartigimod PH20 SC, interventions name: Placebo PH20 SC, outcomesModule primaryOutcomes measure: Percentage of participants who were proptosis responders, secondaryOutcomes measure: Change in proptosis measurement in the study eye from baseline, secondaryOutcomes measure: Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline, secondaryOutcomes measure: Percentage of participants with a resolution of diplopia (responders), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Research, status: RECRUITING, city: Boynton Beach, state: Florida, zip: 33437, country: United States, contacts name: Sirtaz S. Sibia, MD, role: CONTACT, phone: 857-350-4834, email: clinicaltrials@argenx.com, geoPoint lat: 26.52535, lon: -80.06643, hasResults: False
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protocolSection identificationModule nctId: NCT06307613, orgStudyIdInfo id: ARGX-113-2301, secondaryIdInfos id: 2023-509197-35-00, type: CTIS, briefTitle: A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: argenx, class: INDUSTRY, descriptionModule briefSummary: This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks., conditionsModule conditions: Thyroid Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Efgartigimod PH20 SC, interventions name: Placebo PH20 SC, outcomesModule primaryOutcomes measure: Percentage of participants who were proptosis responders, secondaryOutcomes measure: Change in proptosis measurement in the study eye from baseline, secondaryOutcomes measure: Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline, secondaryOutcomes measure: Percentage of participants with a resolution of diplopia (responders), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Clinical Research, status: RECRUITING, city: Coral Springs, state: Florida, zip: 33067, country: United States, contacts name: Shailesh Gupta, MD, role: CONTACT, phone: 857-350-4834, email: clinicaltrials@argenx.com, geoPoint lat: 26.27119, lon: -80.2706, hasResults: False
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protocolSection identificationModule nctId: NCT06307600, orgStudyIdInfo id: BHCT-RD06-03, briefTitle: The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Anhui Provincial Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia., conditionsModule conditions: B Lymphoblastic Leukemia/Lymphoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: RD06-03 cell injection, outcomesModule primaryOutcomes measure: Dose-limiting toxicity, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, city: Hefei, state: Anhui, zip: 230036, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
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protocolSection identificationModule nctId: NCT06307587, orgStudyIdInfo id: 2023/2355, briefTitle: Vastus Intermedius Dry Needling for Knee Stiffness Resulted From Surgically Managed Femoral Fractures With Open Reduction & Internal Fixation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-03-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Al-Razi Hospital, class: OTHER_GOV, descriptionModule briefSummary: Orthopedic traumatic injuries are considered a major health epidemic, challenged by high morbidity, mortality, and socioeconomic burden. The management of traumatic orthopedic injuries is challenging and complex, with high resources utilization. Particularly, the prevalence of femoral fractures in Kuwait is 8.8%, being one of the most prevalent injuries. Open reduction and internal fixation (ORIF) is a common surgical procedure for the management of femoral fractures demonstrating successful outcome for allowing minimally invasive percutaneous plate osteosynthesis, early union of 93% to 100%, and low infection rate of only 0% to 2%. Yet, one of the major complications post ORIF is knee stiffness and reduced function, which brings many inconveniences to patients' daily lives, lead to disability, and could seriously threaten the functional activities of patients. The incidence of knee stiffness requiring surgical intervention is 14.5%. Particularly, the potential loss of knee flexion is 30 to 40 degrees, 13% of the patients failed to reach 90 degrees of knee flexion, and only 48% of patients reached \>120 degrees of flexion. Ultimately, knee stiffness in flexion forms a major issue in distal femoral fractures. Various reasons could explain such complication including intrinsic adhesions, fibrosis and shortening of the vastus intermedius muscle.There are various surgical procedures which could be used to manage knee stiffness. However, there is no consensus regarding the ideal approach and strategy with many postoperative complications including deep sepsis, quadricep tendon rupture, skin dehiscence and infection, delayed wound healing, patella fracture, lateral femoral condyle fracture and extension lag. In contrast, dry needling (DN) is a minimal invasive intervention for the management of musculoskeletal dysfunction, and it could be used to reduce the adhesion and fibrosis between the vastus intermedius and the femoral bone. However, there is limited research investigating the effect of DN on the vastus intermedius muscle after ORIF of the femoral fractures. The effectiveness of DN was explored for the management of various musculoskeletal conditions, and a systematic review addressing DN in the lower quarter concluded that DN is an effective procedure (Morihisa et a,., 2016). In ACL reconstruction, DN for the vastus medialis improved ROM at short-term and improved function at both short and long term. DN has been proposed as a useful addition to the rehabilitation of ACL reconstructed in reducing pain intensity, increasing knee flexion range, and modifying the mechanical properties of the quadriceps muscle during the late-stage of rehabilitation. DN has also altered the passive mechanical properties of the quadriceps muscle where decrement and resistance of the vastus medialis were significantly reduced. It is hypothesized that releasing the adhesions and fibrosis of the vastus intermedius could play an important role in managing knee stiffness post ORIF of the distal femur fractures. Therefore, the aim of this project is to identify the incidence rate and risk factors of knee stiffness resulted from surgically managed femoral fractures with open reduction and internal fixation in Kuwait, and to investigate the effect of DN on the vastus intermedius muscle in improving knee joint range of motion and function after ORIF of the distal femur using single blind randomized controlled trial (RCT)., conditionsModule conditions: Femur Fracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: dry needling, outcomesModule primaryOutcomes measure: knee flexion range of motion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307574, orgStudyIdInfo id: STUDY00002804, briefTitle: bpMedManage: Digital Technology to Support Adherence to Hypertension Medications, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Arizona, class: OTHER, collaborators name: University of Illinois at Urbana-Champaign, descriptionModule briefSummary: The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. There will be two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on an education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes on primary and secondary measures will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention., conditionsModule conditions: Aging, conditions: Mild Cognitive Impairment, conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be screened and randomly assigned to either the bpMedManage-S or bpMedManage-P group, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: All primary and secondary outcome assessments following the intervention, Week 4, are blinded. One of the supplementary outcome measures following the intervention at Week 12, requires the assessor to know the group assignment. This outcome pertains to their experience in the intervention. The follow-up outcome assessments at Week 12 will be administered by an unblinded assessor., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: bpMedManage, outcomesModule primaryOutcomes measure: Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap), primaryOutcomes measure: Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne), secondaryOutcomes measure: Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings, secondaryOutcomes measure: Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale, secondaryOutcomes measure: System Usability measured by the System Usability Scale, otherOutcomes measure: Opinion Interview, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Arizona, status: RECRUITING, city: Tucson, state: Arizona, zip: 85721, country: United States, contacts name: Kathleen Insel, PhD, role: CONTACT, phone: 520-626-6220, email: insel@arizona.edu, geoPoint lat: 32.22174, lon: -110.92648, locations facility: University of Illinois, Urbana-Champaign, status: NOT_YET_RECRUITING, city: Champaign, state: Illinois, zip: 61820, country: United States, contacts name: Raksha Mudar, PhD, role: CONTACT, phone: 217-333-4718, email: raksha@illinois.edu, geoPoint lat: 40.11642, lon: -88.24338, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-21, uploadDate: 2024-02-21T16:53, filename: Prot_000.pdf, size: 560648, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-04, uploadDate: 2024-03-08T14:33, filename: ICF_001.pdf, size: 563829, hasResults: False
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protocolSection identificationModule nctId: NCT06307561, orgStudyIdInfo id: GGurzoglu, briefTitle: The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Acıbadem Atunizade Hospital, class: OTHER, descriptionModule briefSummary: Dystonia is the most common movement disorder in the pediatric population after spasticity. It can affect normal motor development and cause significant motor retardation. The presence of dystonia may affect motor function, pain, and ease of care in CP. Additionally, it can cause serious difficulties in daily living activities and social participation and long-term joint deformity. The increase in the severity of dystonia in CP children with secondary dystonia may affect the quality of life, activity and participation of the children, as well as the caregiver. The importance of caregivers is an undeniable fact, especially in these patient groups. This study aims to investigate the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia., conditionsModule conditions: Secondary Dystonia, conditions: Cerebral Palsy, Mixed, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 20, type: ACTUAL, outcomesModule primaryOutcomes measure: The Barry-Albright Dystonia Scale (BADS), primaryOutcomes measure: The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), primaryOutcomes measure: The Care and Comfort Hypertonicity Questionnaire (CCHQ), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Acıbadem Altunizade Hospital, city: Istanbul, state: Altunizade, zip: 34662, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06307548, orgStudyIdInfo id: I-3670923, secondaryIdInfos id: NCI-2024-01256, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3670923, type: OTHER, domain: Roswell Park Cancer Institute, secondaryIdInfos id: UL1TR001412, type: NIH, link: https://reporter.nih.gov/quickSearch/UL1TR001412, briefTitle: Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, collaborators name: National Center for Advancing Translational Sciences (NCATS), descriptionModule briefSummary: This phase I/II trial studies the side effects and how well fluorescence image guided surgery followed by intraoperative photodynamic therapy for improving local tumor control in patients with colorectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back after a period of improvement (recurrent). Fluorescence image guided surgery uses a drug named aminolevulinic acid hydrochloride. Aminolevulinic acid hydrochloride is a photosensitizing agent, meaning that is activated by light and, is converted to another drug in cancer cells more than in normal cells. The converted drug emits fluorescence red light when activated with low power blue light. It is used to assist the surgeon to see cancer cells and small cancerous tissue that may have been missed during routine surgery. In addition to emitting fluorescence light, the converted drug in the cancer cells and tissue can be activated with red laser light to kill cancer cells. This procedure is called photodynamic therapy (PDT). Performing fluorescence image guided surgery followed by intraoperative photodynamic therapy after the surgical removal of the colorectal tumor before the surgical site will be closed may be effective and improve outcomes in patients with locally advanced or recurrent colorectal cancer., conditionsModule conditions: Locally Advanced Colorectal Carcinoma, conditions: Recurrent Colorectal Carcinoma, conditions: Stage III Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Aminolevulinic Acid, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Fluorescence-Guided Surgery, interventions name: Magnetic Resonance Imaging, interventions name: Photodynamic Therapy, interventions name: Surgical Procedure, outcomesModule primaryOutcomes measure: Accuracy of the fluorescence imaging (Phase I), primaryOutcomes measure: Incidence of adverse events (Phase I), primaryOutcomes measure: Evidence of disease (Phase II), primaryOutcomes measure: Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II), secondaryOutcomes measure: Changes in CEA and ctDNA (Phase I), secondaryOutcomes measure: Rate of recurrence (Phase I), secondaryOutcomes measure: Rate of local recurrence (Phase II), secondaryOutcomes measure: Disease free survival (Phase II), secondaryOutcomes measure: Correlation between disease free survival and changes in levels of CEA (Phase II), secondaryOutcomes measure: Correlation between disease free survival and changes in levels of ctDNA (Phase II), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Anthony S. Dakwar, role: CONTACT, phone: 716-845-5807, email: Anthony.Dakwar@RoswellPark.org, contacts name: Anthony S. Dakwar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
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protocolSection identificationModule nctId: NCT06307535, orgStudyIdInfo id: 23-376, briefTitle: A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2029-03-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule briefSummary: Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires.After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires.Participants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away., conditionsModule conditions: Caregiver Burden, conditions: Caregiver Burnout, conditions: Caregiver Stress Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Meaning-Centered Psychotherapy for Caregivers, interventions name: Supportive Psychotherapy for Caregivers, outcomesModule primaryOutcomes measure: Number of participants with improved primary outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami (Data Collection AND Data Analysis), status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Wendy Lichtenthal, PhD, role: CONTACT, phone: 305-243-8983, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Allison Applebaum, PhD, role: CONTACT, phone: 646-888-0034, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (Limited protocol activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Allison Applebaum, PhD, role: CONTACT, phone: 646-888-0034, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Allison Applebaum, PhD, role: CONTACT, phone: 646-888-0034, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Allison Applebaum, PhD, role: CONTACT, phone: 646-888-0034, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (Consent only), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Allison Applebaum, PhD, role: CONTACT, phone: 646-888-0034, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center, status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Allison Applebaum, PhD, role: CONTACT, phone: 646-888-0034, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites), status: RECRUITING, city: Rockville Centre, state: New York, zip: 11553, country: United States, contacts name: Allison Applebaum, PhD, role: CONTACT, phone: 646-888-0034, geoPoint lat: 40.65871, lon: -73.64124, hasResults: False
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protocolSection identificationModule nctId: NCT06307522, orgStudyIdInfo id: MRG24ALC, briefTitle: MRG-001 in Patients With Alcoholic Hepatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: MedRegen LLC, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis (AH)., conditionsModule conditions: Alcoholic Hepatitis, conditions: Acute Alcoholic Hepatitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: MRG-001, outcomesModule primaryOutcomes measure: Assessment of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Pharmacokinetic Response, secondaryOutcomes measure: Pharmacodynamic Response, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307509, orgStudyIdInfo id: GN23AN097, briefTitle: Adiposity and Immunometabolism in Sepsis, acronym: AIMS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: NHS Greater Glasgow and Clyde, class: OTHER, collaborators name: University of Glasgow, descriptionModule briefSummary: Obesity has been shown to increase adverse outcomes in some critically ill patients e.g. those with COVID-19. For patients with sepsis this association is less clear cut but there is evidence that body fat distribution, resulting from impaired subcutaneous adipose tissue function, is associated with adverse clinical outcomes in critical care. The investigators aim to study subcutaneous adipose tissue function in lean and obese sepsis patients in critical care and compare that to healthy controls.First, the study will investigate differences in adipose tissue function (inflammation and mitochondrial function) related to obesity. Second, the investigators will examine whether lean critically ill patients with sepsis have enhanced adipose tissue inflammation and mitochondrial dysfunction compared to lean controls and whether this is further exacerbated by obesity.Patients will be either undergoing emergency abdominal surgery, or will have been admitted to a critical care unit with a diagnosis of sepsis.The investigators will collect blood and adipose tissue biopsies from the patients, and these will be analysed for markers of inflammation and of mitochondrial function.The aim is to better understand the relationship between obesity, inflammation, mitochondrial dysfunction and sepsis. The investigators hope that this may improve the understanding of the pathophysiology of sepsis and allow more targeted interventions for patients based on differences in their baseline metabolic state., conditionsModule conditions: Obesity, conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Diagnosis of sepsis, outcomesModule primaryOutcomes measure: Difference in adipocyte cytokine secretion between patients with sepsis, and patients without sepsis, and between SAT and VAT samples, secondaryOutcomes measure: Differences in adipocyte size, secondaryOutcomes measure: Differences in mitochondrial morphology, secondaryOutcomes measure: Differences in adipocyte pro-inflammatory gene expression, secondaryOutcomes measure: Differences in adipocyte mitochondrial number, secondaryOutcomes measure: Differences in adipocyte mitochondrial viability, secondaryOutcomes measure: Differences in SVF cytokine secretion, secondaryOutcomes measure: Differences in capacity of pre-adipocytes to differentiate into mature adipocytes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Critical Care Medicine, Queen Elizabeth University Hospital, city: Glasgow, zip: G51 4TF, country: United Kingdom, geoPoint lat: 55.86515, lon: -4.25763, hasResults: False
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protocolSection identificationModule nctId: NCT06307496, orgStudyIdInfo id: Pro00133913, briefTitle: VIDeOS for Smoking Cessation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, collaborators name: Alliance NCORP Research Base Cancer Control Program, descriptionModule briefSummary: The purpose of the current study is to pilot the efficacy, feasibility, and acceptability of an evidence-based smoking cessation intervention adapted for cancer patients and delivered via video. Investigators aim to assess if this intervention is considered acceptable by participants, feasible to implement, and effective at increasing knowledge about smoking cessation before conducting a fully powered clinical trial., conditionsModule conditions: Cancer, conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Smoking cessation intervention, interventions name: Informational intervention, outcomesModule primaryOutcomes measure: Acceptability, primaryOutcomes measure: Feasibility, primaryOutcomes measure: Retention Rates, secondaryOutcomes measure: Changes in knowledge about quitting smoking, secondaryOutcomes measure: Changes in smoking behaviors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307483, orgStudyIdInfo id: 20240108, briefTitle: Dose-effect Relationship of Tai Chi on Health Promotion in Different Age Groups, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-25, primaryCompletionDateStruct date: 2023-11-25, completionDateStruct date: 2023-11-25, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Beijing Sport University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the physical and mental health status of middle-aged and elderly people of different ages and practicing Tai chi for different periods of time, so as to provide a strong theoretical basis and practical guidance for delaying age-related aging and preventing and treating the occurrence and development of chronic diseases., conditionsModule conditions: Sleep Disorder, conditions: Cardiovascular Diseases, conditions: Hypertension, conditions: Cognitive Impairment, conditions: Metabolic Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 499, type: ACTUAL, armsInterventionsModule interventions name: Taichi group, interventions name: Exercise group, outcomesModule primaryOutcomes measure: Pittsburgh Sleep Quality Index, primaryOutcomes measure: Heart rate variability (HRV), primaryOutcomes measure: Flow-mediated dilation (FMD), primaryOutcomes measure: Cardiac Output (CO), primaryOutcomes measure: Intima-Media Thickness (IMT), primaryOutcomes measure: The Berg Balance Scale（BBS）, primaryOutcomes measure: The 30-s Chair Stand Test, primaryOutcomes measure: Lower limb muscle strength test, secondaryOutcomes measure: Body Fat Percentage, secondaryOutcomes measure: Finger-Ring Test, secondaryOutcomes measure: Hand Grip Strength, secondaryOutcomes measure: Upper and Lower Body Flexibility, secondaryOutcomes measure: The SARC-F scale, secondaryOutcomes measure: Shape Trail Test (STT), secondaryOutcomes measure: 1-back Task more-odd shifting Task Stroop Task, secondaryOutcomes measure: Timed Up and Go, secondaryOutcomes measure: Close-eyed stepping in place, secondaryOutcomes measure: Single-leg stance with eyes closed, secondaryOutcomes measure: Ankle-Brachial Index (ABI), secondaryOutcomes measure: Short-Physical Performance Battery (SPPB), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Blood pressure variability (BPV), secondaryOutcomes measure: HUR Labs Balance Software Suite, secondaryOutcomes measure: E/A ratio, secondaryOutcomes measure: Star Excursion Balance Test apparatus（SEBT）, secondaryOutcomes measure: Montreal Cognitive Assessment(MoCA), secondaryOutcomes measure: Brachial-ankle pulse wave velocity (BaPWV), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Sport University, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06307470, orgStudyIdInfo id: 276879, briefTitle: Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Arkansas, class: OTHER, collaborators name: Intimate Pathways Center for Sexual Health, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:1. What is the feasibility of this intervention in an online, private setting?2. What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 8 - 10 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time., conditionsModule conditions: Women's Health: Neoplasm of Breast, conditions: Menopause, Premature, conditions: Body Image, conditions: Sexual Dysfunction, conditions: Cancer, Breast, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience), outcomesModule primaryOutcomes measure: Vulvovaginal Symptoms Questionnaire (VSQ), primaryOutcomes measure: Body Image Scale, primaryOutcomes measure: Female Sexual Functioning Index, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307457, orgStudyIdInfo id: A5481188, briefTitle: A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer. The study will consider participants who:* have advanced or metastatic breast cancer that is spread to other parts of the body.* have HR+/HER2- (hormone receptor positive\* / human epidermal growth factor receptor 2 negative\*\*) breast cancer types. * Hormone receptor positive (HR+): are cells that have a group of proteins that bind to a specific hormone. For example, some breast cancer cells have receptors for the hormones estrogen or progesterone.These cells are hormone receptor positive, and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Knowing if the cancer is hormone receptor positive may help plan treatment.* Human epidermal growth factor receptor 2 negative (HER2-): cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Checking to see if a cancer is HER2 negative may help plan treatment. * have started treatment in the period between January 2017 and December 2021.The study will describe the treatment effect for different patient groups in terms of age and comorbidities. Comorbidity is the condition of having two or more diseases at the same time. The data is collected by the Danish Breast Cancer Group in the period between 2017 to 2023., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 580, type: ESTIMATED, armsInterventionsModule interventions name: Palbociclib in combination with AI, outcomesModule primaryOutcomes measure: Progression-free Survival (PFS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment, primaryOutcomes measure: Overall Survival (OS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment, secondaryOutcomes measure: Age distribution in the full data set of mBC patients receiving palbociclib + AI as first-line treatment, secondaryOutcomes measure: PFS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment, secondaryOutcomes measure: PFS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment, secondaryOutcomes measure: PFS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment, secondaryOutcomes measure: OS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment, secondaryOutcomes measure: OS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment, secondaryOutcomes measure: OS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into Charlson Comorbidity Index (CCI) point score of 0, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 3 or higher (3+), secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 0, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 3 or higher (3+), secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease, secondaryOutcomes measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease, secondaryOutcomes measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen University Hospital, Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06307444, orgStudyIdInfo id: stellate block and ESP block, briefTitle: Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions., conditionsModule conditions: Acute Herpes Zoster Pain Managment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 93, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-Guided Stellate Ganglion Block, interventions name: T2 T3 (High Thorathic) ESP Block, outcomesModule primaryOutcomes measure: reduction of a numeric rating scale (NRS) pain score, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06307431, orgStudyIdInfo id: V940-004, secondaryIdInfos id: 2023-505177-32, type: OTHER, domain: EU CT, briefTitle: A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2028-01-08, completionDateStruct date: 2032-06-08, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, collaborators name: ModernaTX, Inc., descriptionModule briefSummary: The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS., conditionsModule conditions: Renal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 272, type: ESTIMATED, armsInterventionsModule interventions name: V940, interventions name: Pembrolizumab, interventions name: Placebo, outcomesModule primaryOutcomes measure: Disease-Free Survival (DFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Distant Metastasis-free survival (DMFS), secondaryOutcomes measure: Percentage of Participants Who Experience an Adverse Event (AE), secondaryOutcomes measure: Percentage of Participants Who Discontinue Study Treatment Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 0102), status: RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 203-785-5720, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 1502), status: RECRUITING, city: Macquarie University, state: New South Wales, zip: 2109, country: Australia, contacts name: Study Coordinator, role: CONTACT, phone: +61 2 9812 3526, locations facility: CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008), status: RECRUITING, city: Québec, state: Quebec, zip: G1R 2J6, country: Canada, contacts name: Study Coordinator, role: CONTACT, phone: 4185254444, geoPoint lat: 46.81228, lon: -71.21454, locations facility: FALP-UIDO ( Site 1202), status: RECRUITING, city: Santiago, state: Region M. De Santiago, zip: 7500921, country: Chile, contacts name: Study Coordinator, role: CONTACT, phone: 56224457254, geoPoint lat: -33.45694, lon: -70.64827, locations facility: ONCOCENTRO APYS-ACEREY ( Site 1200), status: RECRUITING, city: Viña del Mar, state: Valparaiso, zip: 2520598, country: Chile, contacts name: Study Coordinator, role: CONTACT, phone: +56992369820, geoPoint lat: -33.02457, lon: -71.55183, hasResults: False
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protocolSection identificationModule nctId: NCT06307418, orgStudyIdInfo id: Carer eSupport RCT, briefTitle: Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, collaborators name: The Swedish Research Council, collaborators name: Swedish Cancer Society, collaborators name: Umeå University, collaborators name: Region Örebro County, collaborators name: Sahlgrenska University Hospital, Sweden, collaborators name: University Hospital, Umeå, collaborators name: Uppsala University Hospital, descriptionModule briefSummary: The aim of this randomized controlled trial is to investigate the effects of internet-based support (Carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. The main question\[s\] it aims to answer are:* What are the effects of internet-based support on informal caregivers preparedness for caregiving?* What are the effects of internet-based support on informal caregivers burden and wellbeing?Informal caregivers who are randomized to Carer eSupport will have access to Carer eSupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at:* baseline (before randomization)* 18 weeks (post-intervention) and at* 3 months after the intervention is completed (long term follow-up).Informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing., conditionsModule conditions: Head and Neck Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Informal caregivers of patients with Head and neck cancer will be randomized to internet-based support or to support as usual., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Carer eSupport, outcomesModule primaryOutcomes measure: The self-reported questionnaire Preparedness for caregiving scale, secondaryOutcomes measure: The self-reported questionnaire Caregiver Burden Scale, secondaryOutcomes measure: The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21), secondaryOutcomes measure: The self-reported health-related quality of life questionnaire RAND-36, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Örebro University Hospital, city: Örebro, state: Blekinge Län, zip: 70185, country: Sweden, geoPoint lat: 59.27412, lon: 15.2066, locations facility: Uppsala university hospital, city: Uppsala, state: Uppsala Län, zip: 75105, country: Sweden, geoPoint lat: 59.85882, lon: 17.63889, locations facility: Norrland University Hospital, city: Umeå, state: Västerbottens Län, zip: 90737, country: Sweden, geoPoint lat: 63.82842, lon: 20.25972, locations facility: Sahlgrenska university hospital, city: Göteborg, state: Västra Götaland, zip: 41345, country: Sweden, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False
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protocolSection identificationModule nctId: NCT06307405, orgStudyIdInfo id: WJP2023, briefTitle: The Value of mNGS in Diagnosis of Pulmonary Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-04-20, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Yunfeng Hou, class: OTHER, descriptionModule briefSummary: Retrospective analysis of clinical data from 50 hospital-admitted patients with suspected pulmonary infection (as judged by clinical manifestations and imaging findings) was performed on study participants who had collected two different samples of alveolar lavage fluid (BALF) and sputum and underwent metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively. The positive rate of pathogen detection and the consistency of pathogen detection results of the two detection methods were compared to evaluate the clinical manifestation and role of mNGS in pathogen diagnosis., conditionsModule conditions: Pulmonary Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: next generation sequencing, outcomesModule primaryOutcomes measure: Etiological detection rates of two detection techniques, secondaryOutcomes measure: Consistency of detection results of two detection techniques, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307392, orgStudyIdInfo id: RC22_0393, briefTitle: Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial), acronym: BETA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2027-03-26, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: Emergency intubation is routinely performed in the prehospital setting. Airway management in the prehospital setting has substantial challenges, such as hostile environment or lack of technical support in case of first attempt intubation failure, and inherent risk of complications, such as hypoxemia, aspiration or oesophageal intubation. This risk is higher when several attempts are needed to succeed endotracheal intubation. Thus, a successful first attempt intubation is highly desirable to avoid adverse intubation-related events. Noteworthy, prehospital emergency intubation is associated with a lower rate of first attempt intubation success when compared to emergency intubation in the emergency department (ED). Research is needed to overcome the specific challenges of airway management in the prehospital setting, and to improve the safety and efficiency of prehospital emergency intubation. Literature reports that the use of assistive devices such as bougie may increase the rate of first-attempt intubation success in the ED. To date, no randomized trial has ever studied this device in the prehospital setting. Thus, the aim of the BETA trial is to compare first attempt intubation success facilitated by the bougie versus the endotracheal tube alone in the prehospital setting., conditionsModule conditions: Acute Respiratory Failure Requiring Intubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 710, type: ESTIMATED, armsInterventionsModule interventions name: First intubation attempt with endotracheal tube plus bougie, interventions name: First intubation attempt with endotracheal tube alone, outcomesModule primaryOutcomes measure: Number of first pass success during prehospital emergency intubation, secondaryOutcomes measure: Occurrence of hypoxia, secondaryOutcomes measure: Occurrence of bradycardia, secondaryOutcomes measure: Occurrence of cardiac arrest, secondaryOutcomes measure: Occurrence of death, secondaryOutcomes measure: Occurrence of pulmonary aspirations, secondaryOutcomes measure: Occurrence of severe cardiovascular collapse, secondaryOutcomes measure: Time between blade introduction to the confirmation of a correct tube placement, secondaryOutcomes measure: Change in SpO2 (pulsed oxygen saturation) from the time of induction to lowest SpO2 up to 2 minutes after confirmation of correct tube placement, secondaryOutcomes measure: Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement, secondaryOutcomes measure: Cormack-Lehane grade of glottic view at first intubation attempt, secondaryOutcomes measure: Number of laryngoscopies attempts to achieve correct endotracheal tube placement, secondaryOutcomes measure: Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting, secondaryOutcomes measure: Difficulty perceived by the operator on first intubation attempt, secondaryOutcomes measure: Occurrence of injuries, secondaryOutcomes measure: Occurrence of complications, secondaryOutcomes measure: Change of SpO2/FiO2 ratio (pulsed oxygen saturation / fraction of inspired oxygen) between the time of confirmation of correct tube placement and the minimum ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes University Hospital, status: RECRUITING, city: Nantes, state: Loire Atlantique, zip: 44093, country: France, contacts name: Quentin Le Bastard, MD, role: CONTACT, phone: 0240087839, email: quentin.lebastard@chu-nantes.fr, contacts name: Quentin Le Bastard, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False
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protocolSection identificationModule nctId: NCT06307379, orgStudyIdInfo id: EC 23022, briefTitle: Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures, acronym: BRONCHOPROEM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Vitaz, class: OTHER, descriptionModule briefSummary: 'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare.Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce., conditionsModule conditions: Bronchial Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Procedure-related dyspnea scale (VAS), primaryOutcomes measure: Procedure-related pain scale (VAS), primaryOutcomes measure: Procedure related cough scale (VAS), primaryOutcomes measure: General patient satisfaction, secondaryOutcomes measure: Procedure-related complications:, secondaryOutcomes measure: Sedation-related complications, secondaryOutcomes measure: Diagnostic yield, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VITAZ, status: RECRUITING, city: Sint-Niklaas, country: Belgium, contacts name: Jonas Yserbyt, role: CONTACT, email: jonas.yserbyt@vitaz.be, geoPoint lat: 51.16509, lon: 4.1437, hasResults: False
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protocolSection identificationModule nctId: NCT06307366, orgStudyIdInfo id: ErasmusMC10365, briefTitle: Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research, acronym: PANDAcc, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research., conditionsModule conditions: Mental Illness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: No intervention will be used, outcomesModule primaryOutcomes measure: Themes around the topics (related to perceptions and experiences) explored., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Center, city: Rotterdam, state: Zuid-Holland, zip: 3000CB, country: Netherlands, contacts name: Lisanne AE van Houtum, PhD, role: CONTACT, phone: +31107037005, email: l.vanhoutum@erasmusmc.nl, contacts name: Hilmar H Bijma, MD, PhD, role: CONTACT, phone: +31107036109, email: h.bijma@erasmusmc.nl, contacts name: Hilmar H Bijma, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Neeltje EM van Haren, PhD, role: SUB_INVESTIGATOR, contacts name: Lisanne AE van Houtum, PhD, role: SUB_INVESTIGATOR, contacts name: Eline MP Poels, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
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protocolSection identificationModule nctId: NCT06307353, orgStudyIdInfo id: Soh_Med_23_12_05MS, briefTitle: Trends of Contraception Methods in Urban Medical Center in el_Balyana, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: family planning is avital primary Health care intervention that saves lives of mothers and infants empowers women and support their choices regarding their health public life and additional education .In addition family planning is considered as a short term intervention to limit population growth and manage overpopulation problems.Globally the contraception prevalance rate an indicator for family planning programs continue to face challenges in developing countries., conditionsModule conditions: Contraception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 385, type: ESTIMATED, armsInterventionsModule interventions name: trends of contraception methods, outcomesModule primaryOutcomes measure: number of married women in child bearing period attending the El_Balyana Medical Center using contraception methods ., eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307340, orgStudyIdInfo id: 22-01058, briefTitle: Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors., conditionsModule conditions: Polysubstance Abuse, conditions: Posttraumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: The data analyst is blinded to participant arm., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT), interventions name: Treatment as Usual, outcomesModule primaryOutcomes measure: Proportion of Eligible Participants, primaryOutcomes measure: Proportion of Eligible Participants who Enroll, primaryOutcomes measure: Number of Intervention Sessions Completed, primaryOutcomes measure: Clinician-Rated Feasibility of Intervention Measure (FIM) Score, primaryOutcomes measure: Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score, primaryOutcomes measure: Number of Days of Co-Use of Cocaine and Illicit Opioids, primaryOutcomes measure: Number of Substances Used based on ASI Self-Report, primaryOutcomes measure: Number of Substances Used based on Urine Drug Screen, primaryOutcomes measure: Number of Substances Used based on Chart Abstraction of Toxicology Results, primaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5) Score, primaryOutcomes measure: Negative Mood Regulation Scale Score, primaryOutcomes measure: Inventory of Interpersonal Problems Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Florida State University, city: Tallahassee, state: Florida, zip: 32306, country: United States, contacts name: Tanya Renn, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.43826, lon: -84.28073, locations facility: START Treatment and Recovery Centers, city: Brooklyn, state: New York, zip: 11238, country: United States, contacts name: Ana Ventuneac, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.6501, lon: -73.94958, locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06307327, orgStudyIdInfo id: NFEC-2024-098, briefTitle: Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples., conditionsModule conditions: Head and Neck Cancer, conditions: Radiation-Induced Mucositis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 894, type: ESTIMATED, outcomesModule primaryOutcomes measure: Evaluation consistency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Southern medical university, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Jian Guan, M.D, role: CONTACT, phone: 86+13632102247, email: guanjian5461@163.com, geoPoint lat: 23.11667, lon: 113.25, locations facility: Huizhou Central People's Hospital, status: NOT_YET_RECRUITING, city: Huizhou, state: Guangdong, zip: 516000, country: China, contacts name: Yunming Tian, role: CONTACT, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Jieyang people's hospital, status: NOT_YET_RECRUITING, city: Jieyang, state: Guangdong, zip: 522000, country: China, contacts name: Peibao Lai, role: CONTACT, phone: 86+15975196057, email: boa71@139.com, geoPoint lat: 23.5418, lon: 116.36581, locations facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou, status: NOT_YET_RECRUITING, city: Meizhou, state: Guangdong, zip: 514000, country: China, contacts name: Jianda Sun, role: CONTACT, geoPoint lat: 24.2886, lon: 116.11767, hasResults: False
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protocolSection identificationModule nctId: NCT06307314, orgStudyIdInfo id: NFEC-2024-093, briefTitle: Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Head and Neck Cancer, conditions: Radiotherapy-induced Oral Mucositis, conditions: Biomarker, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Different grades radiotherapy-induced oral mucositis, secondaryOutcomes measure: Start and duration of radiotherapy-induced oral mucositis, secondaryOutcomes measure: Side effects of radiotherapy, secondaryOutcomes measure: Tumor response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang hospital, Southern medical university, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Jian Guan, Ph.D., role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Fujian Provinical Hospital, status: NOT_YET_RECRUITING, city: Fuzhou, country: China, contacts name: Yongmei Dai, role: CONTACT, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Huizhou Central People's Hospital, status: NOT_YET_RECRUITING, city: Huizhou, country: China, contacts name: Yunming Tian, role: CONTACT, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Jieyang People's Hospital, status: NOT_YET_RECRUITING, city: Jieyang, country: China, contacts name: Peibao Lai, role: CONTACT, geoPoint lat: 23.5418, lon: 116.36581, locations facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou, status: NOT_YET_RECRUITING, city: Meizhou, country: China, contacts name: Jianda Sun, role: CONTACT, geoPoint lat: 24.2886, lon: 116.11767, hasResults: False
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protocolSection identificationModule nctId: NCT06307301, orgStudyIdInfo id: PRO00031998, briefTitle: Study in ALS With Abatacept & IL-2, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-10-28, primaryCompletionDateStruct date: 2024-10-17, completionDateStruct date: 2024-10-17, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The Methodist Hospital Research Institute, class: OTHER, descriptionModule briefSummary: In Amyotrophic Lateral Sclerosis (ALS), the reduction of regulatory T-lymphocyte (Treg) numbers and suppressive function correlates with rapid disease progression. The investigator completed a phase 1 study of infusions of expanded autologous Tregs in combination with subcutaneous IL-2 injections in ALS patients, which showed enhancement of Treg numbers and suppressive function in vivo. The enhanced Treg suppressive function correlated strongly with slowing and stabilization of disease progression. Drugs that enhance endogenous Treg numbers and suppressive function may also stabilize disease in ALS. This phase 1 study aims to determine whether the combination therapy of subcutaneous IL-2 and abatacept (Orencia®) is safe and well-tolerated in 6 patients with ALS, and whether the therapy enhances Treg numbers and suppressive function in vivo., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: Abatacept Injection [Orencia] and Proleukin (aldesleukin), outcomesModule primaryOutcomes measure: To evaluate adverse events and laboratory abnormalities to assess the safety and tolerability of abatacept followed by Interleukin 2 (IL-2) administration in ALS patients, secondaryOutcomes measure: Change in Regulatory T cells (Tregs) numbers in the blood from baseline, secondaryOutcomes measure: Change in Regulatory T cells (Tregs) suppressive function in the blood from baseline, secondaryOutcomes measure: Changes in the level of cytokines secreted by PBMCs from baseline, otherOutcomes measure: Changes in Appel Amyotrophic Lateral Sclerosis rating scale ( AALS) slope, otherOutcomes measure: Changes in Amyotrophic Lateral Sclerosis functional rating scale-revised (ALSFRS-R) slope, otherOutcomes measure: Changes in forced vital capacity (FVC) and maximum inspiratory pressure (MIP) scores, otherOutcomes measure: Changes in maximum inspiratory pressure (MIP) scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Houston Methodist Research Institute, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06307288, orgStudyIdInfo id: 20240301-2, briefTitle: Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-10-16, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable mast cell stabilizers in recent years. Tranilast stabilizes mast cells and basophils by acting on their cell membranes and preventing their degranulation. Tranilast has been used in the treatment of various skin disease, such as hypertrophic scars and atopic dermatitis. Minocycline is a first-line treatment for rosacea, and low-dose minocycline treatment (50mg/day) is believed to have anti-inflammatory effects without antibacterial effects, thus minimizing the dysbiosis and bacterial resistance caused by antibiotic use. Therefore, this study aims to investigate the effectiveness and safety of combining mast cell stabilizer tranilast with low-dose minocycline treatment for rosacea, providing new treatment options and insights for rosacea patients., conditionsModule conditions: Rosacea, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: minocycline, interventions name: tranilast, outcomesModule primaryOutcomes measure: lesion counts, primaryOutcomes measure: Clinician's Erythema Assessment score, primaryOutcomes measure: Global Flushing Severity Scale score, primaryOutcomes measure: Global Acne Grading System score, secondaryOutcomes measure: patient satisfaction evaluation, secondaryOutcomes measure: melanin index, secondaryOutcomes measure: erythema index, secondaryOutcomes measure: transepidermal water loss, secondaryOutcomes measure: Dermatology Life Quality Index score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Xi'an Jiaotong Universi, city: Xi'an, state: Shaanxi, zip: 710000, country: China, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
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protocolSection identificationModule nctId: NCT06307275, orgStudyIdInfo id: 5170221, briefTitle: Intermittent Fasting on Body Fat and Quality of Life, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Loma Linda University, class: OTHER, descriptionModule briefSummary: The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Fasting, interventions name: non fasting, outcomesModule primaryOutcomes measure: Body fat percentage, primaryOutcomes measure: Visceral fat, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Loma Linda University, status: RECRUITING, city: Loma Linda, state: California, zip: 92350, country: United States, contacts name: Gurinder Bains, PhD, role: CONTACT, phone: 909-558-4000, phoneExt: 87274, email: gbains@llu.edu, geoPoint lat: 34.04835, lon: -117.26115, hasResults: False
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protocolSection identificationModule nctId: NCT06307262, orgStudyIdInfo id: EuroTR Registry, briefTitle: European Registry of Transcatheter Repair for Tricuspid Regurgitation, acronym: EuroTR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: LMU Klinikum, class: OTHER, descriptionModule briefSummary: To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement., conditionsModule conditions: Tricuspid Regurgitation, conditions: Valvular Heart Disease, conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: T-TEER, outcomesModule primaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Procedural Safety, secondaryOutcomes measure: Heart Failure Biomarker, secondaryOutcomes measure: Dyspnea on exertion, secondaryOutcomes measure: Functional capacity, secondaryOutcomes measure: Right ventricular size, secondaryOutcomes measure: Right ventricular function, secondaryOutcomes measure: Tricuspid regurgitation reduction, secondaryOutcomes measure: Tricuspid valve stenosis, secondaryOutcomes measure: Pulmonary hypertension, secondaryOutcomes measure: Right heart congestion, secondaryOutcomes measure: Hospitalization for heart failure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LMU Klinikum, status: RECRUITING, city: Munich, state: Bavaria, zip: 81377, country: Germany, contacts name: Jörg Hausleiter, Prof. Dr., role: CONTACT, phone: +49 89 4400 72360, email: Joerg.Hausleiter@med.uni-muenchen.de, contacts name: Lukas Stolz, Dr., role: CONTACT, email: Lukas.Stolz@med.uni-muenchen.de, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False
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protocolSection identificationModule nctId: NCT06307249, orgStudyIdInfo id: LU_HH_Cancer_Precision Therapy, briefTitle: Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA, acronym: PTST_PALBEVA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Lebanese University, class: OTHER, collaborators name: Haykel Hospital, descriptionModule briefSummary: Solid tumors pose significant challenges in current therapeutic approaches. Targeted therapy has emerged as a promising avenue, aiming to enhance treatment efficacy while minimizing adverse effects. This clinical trial focuses on an innovative combination of two targeted inhibitors, Palbociclib and Bevacizumab, for their potential synergistic effects in addressing these challenging malignancies. Moreover, this study incorporates a molecular approach by considering Long Non-Coding RNAs (LncRNAs) as biomarkers. Initiating with a focus on colorectal cancer, the study aims to expand its scope to other solid tumors, including lung, breast, ovarian and other cancers. Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, disrupts the cell cycle progression, particularly in cancer cells with specific molecular characteristics. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets angiogenesis-a critical process for tumor growth and metastasis. The rationale behind combining these agents lies in their complementary mechanisms of action, potentially leading to enhanced antitumor effects. LncRNAs have shown promise in predicting treatment response and prognosis in various cancers, providing an additional layer of precision to the treatment strategy. By elucidating the molecular basis through LncRNA analysis, the trial aims to tailor the treatment to the specific molecular profile of each patient, ultimately striving for better outcomes and improved survival rates. This novel combination therapy, coupled with a personalized biomarker-driven approach, represents a cutting-edge strategy in the pursuit of more effective and individualized treatment for solid tumors., conditionsModule conditions: Cancer, conditions: Solid Tumor, conditions: Colorectal Cancer, conditions: Breast Cancer, conditions: Ovarian Cancer, conditions: Lung Cancer, conditions: Targeted Therapy, conditions: Chemotherapy, conditions: Immunotherapy, conditions: Precision Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: SNP, interventions name: Palbociclib 125mg, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: Assessment of Cancer Progression, primaryOutcomes measure: Identification of Potential Biomarkers, primaryOutcomes measure: Evaluation of Treatment Response to Palbociclib and Bevacizumab Combination Therapy, secondaryOutcomes measure: Survival Rates, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Assessment of Immune Checkpoint Expression (e.g., PD-1 and CTLA-4), secondaryOutcomes measure: Measurement of Angiogenic Factors (e.g., VEGF), secondaryOutcomes measure: Measurement of Tumor Proliferation Markers (e.g., Ki67, P16), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haykel Hospital, status: RECRUITING, city: Tripoli, state: North Lebanon, zip: 961, country: Lebanon, contacts name: David Wehbe, MD, role: CONTACT, email: Wehbehdavid@hotmail.com, contacts name: Malak Naboulsi, PharmD, role: CONTACT, email: malak.naboulsi@gmail.com, geoPoint lat: 34.43667, lon: 35.84972, locations facility: Lebanese University, status: RECRUITING, city: Tripoli, state: North Lebanon, zip: 961, country: Lebanon, contacts name: Neham Makdissy, Professor, role: CONTACT, phone: 71210250, phoneExt: +961, email: nehman.makdissy@ul.edu.lb, contacts name: Samar Hamoui, PhD, role: SUB_INVESTIGATOR, contacts name: Fida Ayoubi, PhD, role: SUB_INVESTIGATOR, contacts name: Nouha Ibrahim, PhD, role: SUB_INVESTIGATOR, contacts name: Nadine Ghotme, PhD, role: SUB_INVESTIGATOR, contacts name: Elisa Makdessi, PhD Student, role: SUB_INVESTIGATOR, geoPoint lat: 34.43667, lon: 35.84972, hasResults: False
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protocolSection identificationModule nctId: NCT06307236, orgStudyIdInfo id: E-41997688-050.99-105442, briefTitle: Dysmenorrhea of Emotional Freedom Techniques (EFT) and Its Effect on Perceived Stress Level, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kutahya Health Sciences University, class: OTHER, descriptionModule briefSummary: The aim of the study is to determine the effect of EFT application on the level of dysmenorrhea and stress perception in women with dysmenorrhea. For this purpose, EFT will be applied to women with dysmenorrhea with high stress perception assigned to the experimental and control groups, and their stress perceptions and dysmenorrhea levels will be re-evaluated after the application. Perceived Stress Scale (PSS) and Visual Analog Scale (VAS) will be used in the research., conditionsModule conditions: Dysmenorrhea Primary, conditions: Stress, conditions: Emotional Freedom, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Single Blinded, whoMasked: PARTICIPANT, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Emotional Freedom Techniques, outcomesModule primaryOutcomes measure: EFT application, primaryOutcomes measure: Control, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kütahya Health Science University, city: Kütahya, zip: 43000, country: Turkey, geoPoint lat: 39.42417, lon: 29.98333, hasResults: False
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protocolSection identificationModule nctId: NCT06307223, orgStudyIdInfo id: 20240301, briefTitle: Efficacy and Safety of 30% Supramolecular Salicylic Acid Combined With Supramolecular Active Zinc in the Treatment of Malassezia Folliculitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-07, primaryCompletionDateStruct date: 2023-09-20, completionDateStruct date: 2023-09-20, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: Malassezia folliculitis is a common dermatological disorder. While antifungal agents generally demonstrate efficacy in application, the prevalence of recurrence and drug resistance remains a common occurrence. Supramolecular salicylic acid represents a novel class of superficial chemical peel agents, exhibiting keratolytic, anti-inflammatory, and bacteriostatic properties. Zinc pyrithione has broad spectrum antibacterial, antifungal, and anti-inflammatory effects. In the present study, investigators evaluated the clinical efficacy of topical application of supramolecular salicylic acid in combination with zinc pyrithione for the treatment and prevention of Malassezia folliculitis recurrence. All data are recorded and compared after the end of the experiment. The enrolled patients received daily application of topical supramolecular active zinc anti-dandruff lotion, in conjunction with weekly application of 30% supramolecular salicylic acid, for a duration of 8 weeks. Lesion counts, Malassezia detection, clinical symptom scores, patient satisfaction, and side effects were recorded at each visit till the week 12., conditionsModule conditions: Malassezia Folliculitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ACTUAL, armsInterventionsModule interventions name: 30% supramolecular salicylic acid, interventions name: supramolecular active zinc, outcomesModule primaryOutcomes measure: lesion counts, primaryOutcomes measure: The reduction rate of lesion counts, primaryOutcomes measure: Clinical efficacy, secondaryOutcomes measure: Clinical symptoms scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Xi'an Jiaotong University, city: Xi'an, state: Shaanxi, zip: 710000, country: China, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
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protocolSection identificationModule nctId: NCT06307210, orgStudyIdInfo id: coreset_2020_2022, briefTitle: Is Inpatient Rehabilitation Effective for Very Old Patients?, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-01-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Klinik Valens, class: OTHER, descriptionModule briefSummary: The goal of this retrospective longitudinal observational study is to compare the effects of physical and mental performance as well as quality of life in patients with neurological and musculoskeletal disorders.The main question it aims to answer is: Do very old patients benefit in a similar way from inpatient rehabilitation like younger patients? Data from about 2000 patients will be retrospectively analyzed. Functional Independence Measurement (FIM), Timed Up and Go Test (TUG), EuroQol 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS) were recorded on admission and discharge.Researchers will compare the age group 75 to 84 and 85 to 99 to see if physical and mental performance as well as quality of life will improve., conditionsModule conditions: Activity, Motor, conditions: Elderly Patients, conditions: Musculoskeletal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2270, type: ACTUAL, armsInterventionsModule interventions name: inpatient rehabilitation, outcomesModule primaryOutcomes measure: FIM, primaryOutcomes measure: TUG, primaryOutcomes measure: EQ-5D (Quality of life), primaryOutcomes measure: PROMIS, eligibilityModule sex: ALL, minimumAge: 75 Years, maximumAge: 100 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinik Valens, city: Valens, state: Saint Gallen, zip: CH-7317, country: Switzerland, geoPoint lat: 46.96658, lon: 9.47705, hasResults: False
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protocolSection identificationModule nctId: NCT06307197, orgStudyIdInfo id: INRCA_008_2023, briefTitle: HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia, acronym: HAAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-02, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Istituto Nazionale di Ricovero e Cura per Anziani, class: OTHER, descriptionModule briefSummary: HAAL project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver., conditionsModule conditions: Dementia, conditions: Devices, conditions: Artificial Intelligence, conditions: Older People, conditions: Caregiver Burden, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: HAAL platform, outcomesModule primaryOutcomes measure: Care load of caregivers, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS INRCA Hospital, status: RECRUITING, city: Ancona, country: Italy, contacts name: Elvira Maranesi, role: CONTACT, email: e.maranesi@inrca.it, contacts name: Roberta Bevilacqua, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.5942, lon: 13.50337, hasResults: False
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protocolSection identificationModule nctId: NCT06307184, orgStudyIdInfo id: 2301-LIS-007-AN, briefTitle: Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Instituto Valenciano de Infertilidade de Lisboa, class: NETWORK, collaborators name: Gedeon Richter Ltd., descriptionModule briefSummary: This study will assess the convenience of the natural proliferative phase frozen embryo transfer (NPP-FET) in terms of number of number of appointments needed before cycle scheduling., conditionsModule conditions: Frozen Embryo Transfer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 530, type: ESTIMATED, armsInterventionsModule interventions name: Natural proliferative phase frozen embryo transfer, outcomesModule primaryOutcomes measure: Number of appointments needed before cycle scheduling, secondaryOutcomes measure: Cycle duration until embryo transfer (days), secondaryOutcomes measure: Proportion of patients with low progesterone values on the day of embryo transfer, secondaryOutcomes measure: Human corionic gonadotropin (hCG) positive rate, secondaryOutcomes measure: Miscarriage rate, secondaryOutcomes measure: Ongoing pregnancy rate, secondaryOutcomes measure: Live birth rate, otherOutcomes measure: Serum Relaxin-2 levels, otherOutcomes measure: Serum Luteinizing Hormone (LH) levels, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Instituto Valenciano de Infertilidade, status: RECRUITING, city: Lisboa, country: Portugal, contacts name: Samuel Santos-Ribeiro, MD PhD, role: CONTACT, geoPoint lat: 38.71667, lon: -9.13333, hasResults: False
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protocolSection identificationModule nctId: NCT06307171, orgStudyIdInfo id: 2023-11, briefTitle: Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers, acronym: LeishmARPs, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-22, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples.General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria., conditionsModule conditions: Leishmaniasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: In-house Western blot, specific for Leishmania, outcomesModule primaryOutcomes measure: Biomarkers from Leishmania spp, secondaryOutcomes measure: ARPs in different Leishmania infantum and L. donovani strains, secondaryOutcomes measure: Cross reaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Silvia Longoni, role: CONTACT, phone: +390456013111, email: silvia.longoni@sacrocuore.it, contacts name: Silvia Longoni, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
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protocolSection identificationModule nctId: NCT06307158, orgStudyIdInfo id: CT2024-ZJU-OBS1, briefTitle: Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2020-12-31, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Shulan (Hangzhou) Hospital, descriptionModule briefSummary: The practice of intraoperative blood salvage and autotransfusion (IBSA) during deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) can potentially reduce the need for allogeneic blood transfusion. However, implementing IBSA remains debatable due to concerns about its possible detrimental effects on oncologic recurrence. Hence, a nationwide multi-center study was conducted to investigate further the association between IBSA and post-transplant HCC recurrence, including a stratified subgroup analysis., conditionsModule conditions: Liver Transplant; Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 998, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Postoperative recurrence of liver cancer, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06307145, orgStudyIdInfo id: K-NHIS-HIP, briefTitle: Korea Hip Replacement Surgery Registry, statusModule overallStatus: COMPLETED, startDateStruct date: 2003-01-01, primaryCompletionDateStruct date: 2020-12-31, completionDateStruct date: 2020-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: This cohort study obtained data from the Korean National Health Insurance Service (K-NHIS) database. For the hip replacement registry, we included all adult patients older than 19 who received total or hemiarthroplasty surgery between January 1, 2003, and December 31, 2019. Using this registry, we compared efficacy and safety by type of head or liner., conditionsModule conditions: Hip Replacement Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 124556, type: ACTUAL, outcomesModule primaryOutcomes measure: Cancer, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06307132, orgStudyIdInfo id: SAHoWMU-CR2024-03-106, briefTitle: Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Wenzhou Medical University, class: OTHER, descriptionModule briefSummary: This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time periods after medication, measuring urine drug concentration, calculating urine excretion, analyzing the individualized differences in metabolism and excretion of Aximus capsules under different health states of human components, and providing guidance for clinical precision medication., conditionsModule conditions: Bioequivalence Trial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Aximus capsules（test）, interventions name: Aximus capsules（reference）, outcomesModule primaryOutcomes measure: Excretion volume, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of WMU Phase l Clinical Trial Unit /Center Of Bioequivalence Study, city: Wenzhou, country: China, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False
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protocolSection identificationModule nctId: NCT06307119, orgStudyIdInfo id: 2020-01, briefTitle: Model of Human Occupation-Based Intervention on Premenstrual Syndrome Symptoms, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-02, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: This study was conducted to examine the effect of two different occupational therapy interventions on premenstrual syndrome symptoms in university students. This study was designed according to the CONSORT statement, which provides a standard method for randomised controlled trial (RCT) design. The study was approved by the Local Ethics Committee. Written informed consent was obtained from all participants before the study., conditionsModule conditions: Premenstrual Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 95, type: ACTUAL, armsInterventionsModule interventions name: Occupational Therapy and Relaxation Group, interventions name: Relaxation Group, outcomesModule primaryOutcomes measure: Occupational Self-Assessment, secondaryOutcomes measure: The Model of Human Occupation Screening Tool (MOHOST), otherOutcomes measure: Premenstrual Symptom Screening Tool, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Sciences Turkey, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06307106, orgStudyIdInfo id: #40\14-Jan-2024, briefTitle: Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-14, primaryCompletionDateStruct date: 2024-07-14, completionDateStruct date: 2024-07-14, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve of post operative pain. This is a randomizes comparative prospective clinical trial., conditionsModule conditions: Acute Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: ketorolac and light marcaine, interventions name: light marcaine, interventions name: Corticosteroids injection, interventions name: Diclofenac Sodium Gel, outcomesModule primaryOutcomes measure: age, primaryOutcomes measure: sex, primaryOutcomes measure: number of hemorrhoids, primaryOutcomes measure: degree of hemorroids, primaryOutcomes measure: post operative pain, primaryOutcomes measure: ambulation, primaryOutcomes measure: return to work, primaryOutcomes measure: patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zagazig University Hospitals, city: Zagazig, zip: 44519, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
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protocolSection identificationModule nctId: NCT06307093, orgStudyIdInfo id: CL01860198, briefTitle: Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-12-11, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: R-Pharm, class: INDUSTRY, collaborators name: Data Management 365, collaborators name: Exacte Labs LLC, collaborators name: Federal State Budgetary Institution "NMIC of Hematology" of the Ministry of Health of the Russian Federation, collaborators name: Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor, descriptionModule briefSummary: The goal of this double-blind, randomized study is to establish the equivalence of pharmacokinetic properties, as well as the comparability of safety, immunogenicity and pharmacodynamics of the drug RPH-075 (international nonproprietary name (INN) is pembrolizumab) in comparison with the drug Keytruda® (INN is pembrolizumab) after a single intravenous injection to patients with malignant neoplasms as a first or second line therapy in a monotherapy regimen.The main main tasks are:* To evaluate and compare the pharmacokinetic properties of RPH-075 and Keytruda® after a single intravenous administration of pembrolizumab to patients with malignant neoplasms;* To evaluate the safety profile of the drug RPH-075 in comparison with the drug Keytruda® when used in patients with malignant neoplasms when used as a 1st or 2nd line therapy in a monotherapy regimen.This study will also include a comparative assessment of immunogenicity, pharmacodynamic parameters and a pilot evaluation of RPH-075 efficacy., conditionsModule conditions: Skin Melanoma, conditions: Squamous Non-small-cell Lung Cancer, conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: RPH-075, interventions name: Keytruda®, outcomesModule primaryOutcomes measure: Area under the curve "concentration-time" (AUC(0-504)) of pembrolizumab, primaryOutcomes measure: Incidence of Adverse Reactions (ARs), secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of pembrolizumab, secondaryOutcomes measure: Maximum serum concentration of pembrolizumab at steady state (Сmax ss), secondaryOutcomes measure: Minimal serum concentration of pembrolizumab at steady state (Сmin ss), secondaryOutcomes measure: Area under the curve "concentration-time" of pembrolizumab at steady state (AUCtau ss), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (AEs), secondaryOutcomes measure: Incidence of Immune-mediated adverse reactions (imARs), secondaryOutcomes measure: Incidence of Treatment-Emergent AEs with grade 3 or more, secondaryOutcomes measure: Incidence of Treatment-Emergent ARs with grade 3 or more, secondaryOutcomes measure: Incidence of imARs with grade 3 or more, secondaryOutcomes measure: Incidence of serious adverse events (SAEs), secondaryOutcomes measure: Incidence of serious adverse reactions (SARs), secondaryOutcomes measure: The proportion of patients (%) who required therapy discontinuation due to AR development, secondaryOutcomes measure: The proportion of patients (%) who developed binding antibodies and neutralizing antibodies to pembrolizumab, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: State Budgetary Healthcare Institution of the city of Moscow "Moscow City Oncological Hospital No. 62 of the Department of Health of the City of Moscow", city: Istra, state: Moscow Region, zip: 143423, country: Russian Federation, geoPoint lat: 55.91997, lon: 36.86867, locations facility: "New Clinic" LLC, city: Pyatigorsk, state: Stavropol Territory, zip: 357500, country: Russian Federation, geoPoint lat: 44.04861, lon: 43.05944, locations facility: Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary", city: Barnaul, state: The Altai Republic, zip: 656045, country: Russian Federation, geoPoint lat: 53.36056, lon: 83.76361, locations facility: Autonomous Institution of the Chuvash Republic "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Chuvash Republic, city: Cheboksary, state: The Chuvash Republic, zip: 428020, country: Russian Federation, geoPoint lat: 56.13222, lon: 47.25194, locations facility: State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Bashkortostan, city: Ufa, state: The Republic Of Bashkortostan, zip: 450054, country: Russian Federation, geoPoint lat: 54.74306, lon: 55.96779, locations facility: State Budgetary Healthcare Institution of the Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary", city: Arkhangelsk, zip: 163045, country: Russian Federation, geoPoint lat: 64.5401, lon: 40.5433, locations facility: Regional budgetary healthcare institution "Ivanovo Regional Oncological Dispensary", city: Ivanovo, zip: 153040, country: Russian Federation, geoPoint lat: 56.99719, lon: 40.97139, locations facility: State Budgetary healthcare Institution "Kuzbass Clinical Oncological Dispensary named after M.S. Rappoport", city: Kemerovo, zip: 650036, country: Russian Federation, geoPoint lat: 55.33333, lon: 86.08333, locations facility: State Budgetary Healthcare Institution of the city of Moscow "City Clinical Oncological Hospital No. 1 of the Department of Health of the City of Moscow", city: Moscow, zip: 105005, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow", city: Moscow, zip: 111123, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation, city: Moscow, zip: 115478, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky", city: Moscow, zip: 119435, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), city: Moscow, zip: 119991, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Medsi Group of Companies JSC, city: Moscow, zip: 123056, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: "Research lab" LLC, city: Moscow, zip: 127521, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Healthcare Institution of the Perm Territory "Perm Regional Oncological Dispensary", city: Perm, zip: 614066, country: Russian Federation, geoPoint lat: 58.01046, lon: 56.25017, locations facility: State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital, city: Saint Petersburg, zip: 188300, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Private healthcare institution "Clinical Hospital "Russian Railways-Medicine" of the city of St. Petersburg", city: Saint Petersburg, zip: 195271, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: "Av Medical Group" LLC, city: Saint Petersburg, zip: 196006, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary", city: Saint Petersburg, zip: 197022, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Federal State Budgetary Institution "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation, city: Saint Petersburg, zip: 197758, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: State Budgetary Healthcare Institution "Samara Regional Clinical Oncological Dispensary", city: Samara, zip: 443031, country: Russian Federation, geoPoint lat: 53.20007, lon: 50.15, locations facility: The State Autonomous healthcare Institution of the Tyumen region "Multidisciplinary clinical Medical Center "Medical City", city: Tyumen, zip: 625041, country: Russian Federation, geoPoint lat: 57.15222, lon: 65.52722, hasResults: False
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protocolSection identificationModule nctId: NCT06307080, orgStudyIdInfo id: IIT2023-064, briefTitle: Clinical Study of Multi-mode Thermal Ablation for the Treatment of Pancreatic Cancer With Liver Metastasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-08, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: 1. Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.2. Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.3. Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Multi-mode thermal ablation device, interventions name: Intravenous anti-PD-1 and chemotherapy, outcomesModule primaryOutcomes measure: Safety and efficacy assessment, secondaryOutcomes measure: Survival benefit, otherOutcomes measure: The application of medical-mechanical combination therapy mode, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai General Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200040, country: China, contacts name: Jiang Long, MD, role: CONTACT, phone: +86 18017317460, email: jiang.long@shgh.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06307067, orgStudyIdInfo id: URINDO, briefTitle: Improving Care for Uncomplicated URinary Tract Infection-associated Symptoms in Primary Healthcare Settings in INDOnesia, acronym: URINDO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-11-04, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Saiful Anwar Hospital, collaborators name: Brawijaya University, Malang, Indonesia, collaborators name: Diponegoro University/Diponegoro National Hospital, Semarang, Indonesia, collaborators name: Bali Mandara Hospital, Denpasar, Bali, Indonesia, descriptionModule briefSummary: In the present study, we aim to analyze the impact of the introduction of a urinary dipstick test for patients presenting with uncomplicated UTI-associated symptoms on antibiotic prescription in primary health care in Indonesia. In addition, the knowledge of HCW regarding antibiotics and prudent use of antibiotics in the community setting will be investigated.Specific aims of the study:1. To analyze the quality of antibiotic prescriptions for uncomplicated UTI in the primary health care settings in Indonesia, before introduction of urinary dipstick testing compared to after introduction of urinary dipstick testing.2. To analyze the knowledge level of healthcare workers on uncomplicated UTI and prudent antibiotic use in primary health care settings in Indonesia., conditionsModule conditions: Urinary Tract Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Urine dipstick, outcomesModule primaryOutcomes measure: appropriateness of prescriptions for uncomplicated UTI-associated symptoms in the primary health care settings in Indonesia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Center, city: Rotterdam, state: Zuid-Holland, zip: 3015 GD, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
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protocolSection identificationModule nctId: NCT06307054, orgStudyIdInfo id: SHSY-CAR-NK-AML01, briefTitle: CLL-1 CAR-NK Cells for Relapsed/Refractory AML, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2027-03-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: This study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia., conditionsModule conditions: Relapsed Adult AML, conditions: Refractory AML, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: anti-CLL-1 CAR NK cells, outcomesModule primaryOutcomes measure: AE, primaryOutcomes measure: DLT, secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: PD, secondaryOutcomes measure: Complete response, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Number of participants with treatment-related AEs as assessed by CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai General Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200080, country: China, contacts name: Xianmin Song, MD, role: CONTACT, phone: +86 21 63240090, phoneExt: 3175, email: shongxm@139.com, contacts name: Xianmin Song, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06307041, orgStudyIdInfo id: OSATAGUN, briefTitle: Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-03, primaryCompletionDateStruct date: 2023-07-07, completionDateStruct date: 2023-08-11, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Özlem SARAÇ ATAGÜN, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the effects of 0.2% HA-impregnated dental flosses on the clinical periodontal parameters of patients with gingivitis., conditionsModule conditions: Gingivitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: single-center, single-blinded, split-mouth, randomized clinical trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The investigator who performed the measurements was blinded to which side of patients was the test group, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Dental floss+Gengigel, interventions name: Dental Floss, outcomesModule primaryOutcomes measure: Clinical Periodontal Parameter-Gingival Index (GI), primaryOutcomes measure: Clinical Periodontal Parameter-Papillary Bleeding Index (PBI), primaryOutcomes measure: Clinical Periodontal Parameter-Plaque Index(PI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 47 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi, city: Ankara, zip: 06010, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06307028, orgStudyIdInfo id: Pro2023002116, secondaryIdInfos id: K01DA050496, type: NIH, link: https://reporter.nih.gov/quickSearch/K01DA050496, briefTitle: Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P), acronym: SISTA-P, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rutgers, The State University of New Jersey, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: In this project, the investigators will provide a new HIV prevention training and empowerment sessions to Black women in Washington D.C. who are at high risk for getting HIV. This training is tailored to the experience of Black women and seeks to reduce the high HIV transmission rates in the Black community., conditionsModule conditions: Health Behavior, Risky, conditions: Health Knowledge, Attitudes, Practice, conditions: Health-Related Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: SISTA-P Intervention, outcomesModule primaryOutcomes measure: Feasibility of the Intervention Scale, primaryOutcomes measure: Acceptability of the Intervention Scale, primaryOutcomes measure: Appropriateness of the Intervention Scale, secondaryOutcomes measure: Recruitment, secondaryOutcomes measure: Intervention Fidelity- participant characteristics, secondaryOutcomes measure: Intervention Fidelity, secondaryOutcomes measure: Acceptability of the intervention delivery, secondaryOutcomes measure: Participant Enrollment, secondaryOutcomes measure: Participant Retention, secondaryOutcomes measure: Feasibility of delivering 6 sessions in 6 weeks, secondaryOutcomes measure: Visual confirmation of self-reported PrEP uptake, secondaryOutcomes measure: Post-Intervention Follow-up, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Women's Collective, status: ACTIVE_NOT_RECRUITING, city: Washington, state: District of Columbia, zip: 20002, country: United States, geoPoint lat: 38.89511, lon: -77.03637, locations facility: Rutgers University, status: RECRUITING, city: New Brunswick, state: New Jersey, zip: 08854, country: United States, contacts name: Shawnika Hull, PhD, role: CONTACT, phone: 520-661-3300, email: shawnika.hull@rutgers.edu, contacts name: Shawnika Hull, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.48622, lon: -74.45182, hasResults: False
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protocolSection identificationModule nctId: NCT06307015, orgStudyIdInfo id: 2023/ETH02441, briefTitle: De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE), acronym: DE-RADIATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2031-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Royal North Shore Hospital, class: OTHER, descriptionModule briefSummary: The goal of this prospective clinical trial is to determine if HPV-associated oropharyngeal squamous cell carcinoma that is non-hypoxic on FMISO PET can be successfully treated with a lower dose of radiation therapy.The main questions it aims to answer are:1. What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection?2. What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT?3. What are the acute and late toxicities in patients selected for radiation dose de-escalation?4. What are the quality of life scores in patients selected for radiation dose de-escalation?5. What are the local, regional and distant failure rates of patients selected for radiation dose de-escalation?Patients with cT1-2N1-2b (AJCC 7th edition) oropharyngeal tumours will undergo surgical resection of the primary tumour. Following this, they will be allocated to standard radiation therapy (70Gy with concurrent cisplatin chemotherapy) or de-escalation radiation therapy (30Gy with concurrent cisplatin chemotherapy) based on the results of FMISO PET. Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group. 3-4 months after completion of radiation therapy, all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response.Researchers will assess the pathologic response rate after surgery in the de-escalation group. They will also compare the outcomes (oncological outcomes and quality of life) between the group receiving the standard treatment (70Gy) and the group receiving de-escalated radiation therapy (30Gy)., conditionsModule conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: De-escalation, interventions name: Standard of care, outcomesModule primaryOutcomes measure: Pathologic complete response, secondaryOutcomes measure: Correlation between MRI and FMISO PET assessment of hypoxia, secondaryOutcomes measure: Quality of Life of patients undergoing de-escalation radiation therapy, secondaryOutcomes measure: Quality of Life of patients undergoing de-escalation radiation therapy, secondaryOutcomes measure: Local control, secondaryOutcomes measure: Regional control, secondaryOutcomes measure: Distant metastases, secondaryOutcomes measure: Acute toxicities, secondaryOutcomes measure: Late toxicities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Sydney Cancer Centre, Royal North Shore Hospital, city: Saint Leonards, state: New South Wales, zip: 2065, country: Australia, contacts name: Carol Kwong, role: CONTACT, phone: 9463 1300, email: carolyn.kwong@health.nsw.gov.au, contacts name: Anna Lawless, role: PRINCIPAL_INVESTIGATOR, contacts name: Sarah Bergamin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.82344, lon: 151.19836, hasResults: False
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protocolSection identificationModule nctId: NCT06307002, orgStudyIdInfo id: CAS_EB_2024, briefTitle: Evaluating What's My Method? in Barbados, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Quinnipiac University, class: OTHER, collaborators name: Barbados Family Planning Association, descriptionModule briefSummary: The purpose of this study is to measure the impact of the What's My Method game on participants' sense of agency, education, and empowerment around contraceptive decision-making. Patients receiving standard of care contraceptive counseling will be compared to those who play the game in addition to counseling., conditionsModule conditions: Contraception Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a 2 arm randomized controlled trial comparing standard of care (SOC) counseling alone to What's My Method? (WMM) gameplay in addition to SOC., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Playing a contraception education videogame, outcomesModule primaryOutcomes measure: Contraceptive Self-Efficacy (CSE) score, secondaryOutcomes measure: Method Adoption, secondaryOutcomes measure: Qualitative feedback on game intervention, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 48 Years, stdAges: ADULT, contactsLocationsModule locations facility: Barbados Family Planning Association, status: RECRUITING, city: Bridgetown, state: Saint Michaels, zip: BB11085, country: Barbados, contacts name: Anderson Langdon, MA, role: CONTACT, phone: 2462336750, email: anderson@bfpaonline.com, contacts name: Tiffany Jordan, MD, role: CONTACT, phone: 2468324827, email: tiffany@bfpaonline.com, contacts name: Tiffany Jordan, MD, role: SUB_INVESTIGATOR, geoPoint lat: 13.10731, lon: -59.62021, hasResults: False
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protocolSection identificationModule nctId: NCT06306989, orgStudyIdInfo id: Zhengzhou University, briefTitle: Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cao Weijie, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to get a series of clinical data related to the prevention of CMV infection after allo-HSCT with letemovir. The main question it aims to answer are:* Efficacy and safety of letemovir for the prevention of CMV infection after allo-HSCT.* Optimal initiation of letemovir to prevent CMV infection. Participants will be categorized into high-risk and intermediate-risk groups based on risk factors for CMV infection.Initiate letemovir prophylaxis on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients.(240 mg, qd in patients with concomitant cyclosporine; 480 mg, qd in patients with concomitant tacrolimus) to +100 days. For patients with comorbid GVHD who require intensive immunosuppression, consider extending the regimen to +200 days.Treatments they will be given and use bullets., conditionsModule conditions: Letemovir for the Prevention of CMV Infection After Allo-HSCT, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Letermovir, outcomesModule primaryOutcomes measure: Prevalence of CMV viremia and CMV disease within 100 days after allogeneic hematopoietic stem cell transplantation., secondaryOutcomes measure: +30-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +30-day relapse rate; +30-day aGVHD incidence., secondaryOutcomes measure: +100-day overall survival, non-relapse mortality; + 100-day relapse rate; + 100-day aGVHD incidence., secondaryOutcomes measure: +180-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +180-day relapse rate; +180-day aGVHD incidence., eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cao, Weijie, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450000, country: China, contacts name: Weijie W Cao, doctor of medicine, role: CONTACT, phone: +8618937390269, email: 2549509184@qq.com, contacts name: Mengyang M Zhu, Postgraduate medical students, role: CONTACT, phone: +8615093360671, phoneExt: 0371-66913114, email: Caoweijie2003@126.com, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
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protocolSection identificationModule nctId: NCT06306976, orgStudyIdInfo id: 2066031, briefTitle: Shear-Wave Elastography, acronym: ELASTOGRAPHY, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Prisma Health-Upstate, class: OTHER, descriptionModule briefSummary: Prospective cohort study of patients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR.Study groups: Study groups are selected across a range of morphology and based on factors known or suspected to affect the ability to achieve fascial closure.Control groups: The study plans to enlist 5 volunteers with no incisional hernia or prior laparotomy to establish internal baseline SWE values and interrater reliability. The study will also plan to recruit 5 patients undergoing primary laparotomy in order to correlate SWE findings with closure tension., conditionsModule conditions: Ventral Incisional Hernia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Specific Aim 1:Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology.Specific Aim 2:Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure.Specific Aim 3:Correlate SWE-determined elasticity of abdominal wall to intraoperative assessment of tension required to achieve fascial closure., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Elective Midline Laparotomy, interventions name: Imaging: Ultrasound, interventions name: Tensiometry, outcomesModule primaryOutcomes measure: Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1), primaryOutcomes measure: Correlate Elastography measurements with MFR (Specific Aim 2), primaryOutcomes measure: Correlate SWE Assessment to Tensiometer (Specific Aim 3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prisma Health, city: Greenville, state: South Carolina, zip: 29615, country: United States, geoPoint lat: 34.85262, lon: -82.39401, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-06-01, uploadDate: 2024-03-11T16:32, filename: Prot_000.pdf, size: 301771, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2023-07-12, uploadDate: 2024-03-11T16:33, filename: SAP_001.pdf, size: 170975, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-12, uploadDate: 2024-03-11T16:33, filename: ICF_002.pdf, size: 179351, hasResults: False
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protocolSection identificationModule nctId: NCT06306963, orgStudyIdInfo id: 23-004669, briefTitle: Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias, acronym: GAVE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning., conditionsModule conditions: Gastric Antral Vascular Ectasia, conditions: Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Gastric Emptying, outcomesModule primaryOutcomes measure: Abridged Bowel Disease Questionnaire, primaryOutcomes measure: Nepean Dyspepsia Index, primaryOutcomes measure: Leuven Postprandial Distress Scale, secondaryOutcomes measure: Gastric Emptying Half Time (T 1/2) of Solids, secondaryOutcomes measure: Gastric Emptying Half Time (T 1/2) of liquids, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Taylor N Hines, role: CONTACT, phone: 507-538-9959, email: hines.taylor@mayo.edu, contacts name: Anjali Rajagopal, MBBS, role: CONTACT, phone: 507-266-8779, email: Rajagopal.Anjali@mayo.edu, contacts name: Xiao Jing Wang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06306950, orgStudyIdInfo id: PMK-00098, briefTitle: Prioritization of Cerebral Deoxygenation in Severe Traumatic Brain Injury and Mortality Benefit., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-01, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Phramongkutklao College of Medicine and Hospital, class: OTHER, descriptionModule briefSummary: Severe traumatic brain injury with a decrease in cerebral oximetry is associated with multiple impaired systemic microcirculations, more morbidities, and a higher mortality rate. When using the brain as an index organ, interventions to improve brain oxygen delivery may have systemic benefits for these patients., conditionsModule conditions: Cerebral Hypoxia, conditions: Severe Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In a prospective study, 80 patients were randomized to either application of near-infrared reflectance spectroscopy (NIRS) monitoring with active display or attempt to make an intervention to keep regional cortical cerebral oxygen saturation (rSO2) ≥ 55% by increased cardiac output, mean arterial pressure, and adjusting the ventilator to hypoventilation (PaCO2 40-45 mmHg) (exclude in radiographic brain herniation) (intervention, n = 40), compared with usual care (n = 40). Clinical outcomes were assessed by a blind observer. Data collection comprised of patients' demographic data, intervention process, and outcomes of treatment assessed by modified Rankin scale (mRS) followed up at 1 year., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Upon arrival in the emergency department, the randomization envelope was opened, and patients were assigned into either active treatment (intervention) or usual care (control) groups with cerebral oximetry monitoring using NIRS bilaterally (Root; Prime Medical Corporation, MASIMO, USA)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Near infrared spectroscopy neuromonitor to prevent cerebral desaturation, outcomesModule primaryOutcomes measure: modified Rankin scale (mRS) followed up at 1 year, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Phramongkutklao College of Medicine and Hospital, city: Bangkok, zip: 10400, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
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protocolSection identificationModule nctId: NCT06306937, orgStudyIdInfo id: A24020822, briefTitle: Serum Levels of Vitamin D and IL8 in Patients With Periodontitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2023-09-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: We evaluated vitamin D and IL8 levels in the serum of patients with periodontitis as well as the healthy controls to correlate their levels with the degree of periodontitis., conditionsModule conditions: Periodontal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 98, type: ACTUAL, armsInterventionsModule interventions name: Evalution of serum levels of vitamin D and IL8, outcomesModule primaryOutcomes measure: Serum Levels of 25(OH)vitamin D, primaryOutcomes measure: Serum Levels of IL8, secondaryOutcomes measure: Plaque Index (Pl), secondaryOutcomes measure: Clinical Attachment Loss (CAL), secondaryOutcomes measure: Probing Pocket Depth (PPD), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mansoura University, Faculty of Dentistry, city: Mansoura, state: Dakahlia, zip: 35516, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06306924, orgStudyIdInfo id: LCCC2303, briefTitle: UNC Metastatic Cancer Radiation Therapy Registry, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-21, primaryCompletionDateStruct date: 2033-05, completionDateStruct date: 2033-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this registry is to collect clinical data from participants attending UNC Hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. The goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. The relevant clinical data will be linked to patient-reported outcomes (PROs) thus allowing for a unique and robust dataset. Ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes., conditionsModule conditions: Cancer, conditions: Metastatic Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Radiation therapy, outcomesModule primaryOutcomes measure: Clinical Data, secondaryOutcomes measure: Patient reported outcomes (PRO), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Shivani Sud, MS, role: CONTACT, phone: 919-918-5924, email: sshivani.sud@unchealth.unc.edu, contacts name: Shivani Sud, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
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protocolSection identificationModule nctId: NCT06306911, orgStudyIdInfo id: BB-BAM, briefTitle: Bioavailability of Aronia Melanocarpa, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, collaborators name: BioActor, descriptionModule briefSummary: The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified., conditionsModule conditions: Bioavailability, conditions: Kinetics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Aronia Melanocarpa extract, outcomesModule primaryOutcomes measure: Aronia metabolites in blood, primaryOutcomes measure: Aronia metabolites in urine, secondaryOutcomes measure: Aronia metabolites in feces, secondaryOutcomes measure: length - baseline characteristics, secondaryOutcomes measure: weight - baseline characteristics, secondaryOutcomes measure: blood pressure (systolic and diastolic) - baseline characteristics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University, status: RECRUITING, city: Maastricht, country: Netherlands, contacts name: Sanne Ahles, Msc, role: CONTACT, email: s.ahles@maastrichtuniversity.nl, contacts name: Jogchum Plat, Prof, role: CONTACT, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False
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protocolSection identificationModule nctId: NCT06306898, orgStudyIdInfo id: IAV-2024-01, briefTitle: Intra-Arrest-Ventilation in Human Cadavers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Gerrit Jansen, class: OTHER, collaborators name: Ruhr University of Bochum, collaborators name: Bielefeld University, descriptionModule briefSummary: The study investigates the influence of non-synchronized bag-device-ventilation and intermittent positive pressure ventilation (IPPV), as recommended in the current resuscitation guidelines of the European Resuscitation Concil (tidal Volume (Vt) = 5-6 mL/kg body weight, respiratory rate = 10 min-1) and Chest Compression Synchronized Ventilation (pInsp = 40 mbar; respiratory rate = chest compression rate) with regard to achieving a sufficient tidal volume and the tightness of various supraglottic airway devices (laryngeal mask, i-Gel-laryngeal mask, laryngeal tube) and endotracheal intubation., conditionsModule conditions: Cardiac Arrest, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized crossover design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Endotracheal Intubation, interventions name: Laryngeal tube, interventions name: Laryngeal mask, interventions name: I-Gel-Laryngeal Mask, outcomesModule primaryOutcomes measure: Expiratory Volume with different Airway Devices in IPPV, primaryOutcomes measure: Ventilation Pressure with different Airway devices in CCSV, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06306885, orgStudyIdInfo id: CLF23/03, briefTitle: Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.Fifty-one patients with hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform an AOMI-training before sleeping or in the morning respectively, while Control group will be asked to observe landscape video-clips. Participants will be assessed for manual dexterity, hand range of motion, hand disability and quality of life at baseline before and after the training and at 1 month after the training end., conditionsModule conditions: Hand Injuries, conditions: Action Observation, conditions: Motor Imagery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: Action observation plus motor imagery followed by sleep, interventions name: Action observation plus motor imagery, interventions name: Control, outcomesModule primaryOutcomes measure: Changes in Purdue Pegboard Test, secondaryOutcomes measure: Changes in kinematic indexes during Nine Hole Peg Test, secondaryOutcomes measure: Changes in Visual Analogue Scale, secondaryOutcomes measure: Changes in Quick-DASH, secondaryOutcomes measure: Changes in EQ5D, secondaryOutcomes measure: Changes in Total Active Motion, secondaryOutcomes measure: Hand-grip strength, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06306872, orgStudyIdInfo id: ABSK-011-102, briefTitle: A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Abbisko Therapeutics Co, Ltd, class: INDUSTRY, descriptionModule briefSummary: The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose, conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will be randomly assigned 1:1 to arms A (Sequence A) or arms B (Sequence B) to receive a single dose of ABSK-011 orally in two separate doses, spaced at least 4 days apart. Among them, subjects in sequence A will be given ABSK-011 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) and ABSK-011 200 mg (100 mg capsule \*2) on an empty stomach in the morning of the first day of cycle 1 (C1D1) and the first day of cycle 2 (C2D1), respectively. Subjects in sequence B will be given ABSK-011 new formulation 200 mg (100 mg capsule \*2) and ABSK-011 old formulation 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) on an empty stomach in the morning of Cycle 1 day (C1D1) and cycle 2 day (C2D1), respectively., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 73, type: ESTIMATED, armsInterventionsModule interventions name: Sequence A ABSK-011, interventions name: Sequence B ABSK-011, outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: AUC, primaryOutcomes measure: tmax, secondaryOutcomes measure: AEs, secondaryOutcomes measure: SAEs SAEs, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: Vz/F, secondaryOutcomes measure: CL/F CL/F, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Jiangnan University, status: RECRUITING, city: Wuxi, state: Jiangsu, zip: 214062, country: China, contacts name: Yiqing Zhao, role: CONTACT, phone: 13358100007, email: 13358100007@126.com, geoPoint lat: 31.56887, lon: 120.28857, hasResults: False
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protocolSection identificationModule nctId: NCT06306859, orgStudyIdInfo id: SIKIDI 2024, briefTitle: Development of Health Monitoring System on Patient's Well Being in Dialysis Context, acronym: SIKIDI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Universitas Muhammadiyah Yogyakarta, class: OTHER, collaborators name: Ministry of Education Culture, Research and Technology, descriptionModule briefSummary: One of the goals in the Sustainable Development Goals (SDGs) is the availability of a healthy and prosperous life for all ages. This goal mentions health priorities i.e. non-communicable diseases. Chronic kidney failure (CRF) is one of the non-communicable diseases that is the main cause of death and disability both in the world and in Indonesia. The prevalence of CRF in Indonesia is 0.5% with 83.2% of patients being of productive age and the highest number of CRF patients in North Kalimantan, Southeast Sulawesi, DKI Jakarta and Yogyakarta. Monitoring and evaluation of patients with CRF is currently mostly carried out conventionally not using health technology that is integrated with hospital information systems. This study aims to design and provide a health information system for patients with CRF, hereinafter referred to as SIKIDI, which integrates mobile-health applications used independently by patients with existing information systems in hospitals., conditionsModule conditions: Quality of Life, conditions: Self Efficacy, conditions: Chronic Kidney Diseases, conditions: M-health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention group will be given access to m-health to monitor and education provision for about four weeks, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The sample will be divided based on the schedule of hemodialysis. Intervention group will be chosen from Monday-Thursday., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Using m-health for monitoring and education provision, interventions name: Standard care, outcomesModule primaryOutcomes measure: Quality of Life that will be measured using KDQOL before and after intervention, secondaryOutcomes measure: Self-efficacy that will be measured using CKD SE before and after, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RS PKU Muhammadiyah Bantul, city: Bantul, state: Yogy, zip: 55183, country: Indonesia, contacts name: Indra Prasetyantori, Master, role: CONTACT, geoPoint lat: -7.88806, lon: 110.32889, hasResults: False
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