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protocolSection identificationModule nctId: NCT06371872, orgStudyIdInfo id: 2024-A00173-44, briefTitle: French Cohort of Patients With Rotator Cuff Lesions, acronym: PRO-CUFF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2035-12, completionDateStruct date: 2035-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: GCS Ramsay Santé pour l'Enseignement et la Recherche, class: OTHER, descriptionModule briefSummary: The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment., conditionsModule conditions: Rotator Cuff Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 519, type: ESTIMATED, armsInterventionsModule interventions name: total transfixing injury to the rotator cuff, outcomesModule primaryOutcomes measure: Shoulder Pain and Disability Index, primaryOutcomes measure: European quality of life scale - EQ5D, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique Maussins-Nollet, city: Paris, zip: 75019, country: France, contacts name: Geoffroy NOURISSAT, MD, role: CONTACT, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06371859, orgStudyIdInfo id: 3-3031-2915/1, briefTitle: Human-AI Collaborative Intelligence for Improving Fetal Flow Management, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Slagelse Hospital, collaborators name: Technical University of Denmark, descriptionModule briefSummary: This randomized controlled study evaluates the effectiveness of explainable AI (XAI) in improving clinicians' interpretation of Doppler ultrasound images (UA and MCA) in obstetrics. It involves 92 clinicians, randomized into intervention and control groups. The intervention group receives XAI feedback, aiming to enhance accuracy in ultrasound interpretation and medical decision-making.Objectives:1. To develop an interpretable model for commonly used Doppler flows, specifically the Pulsatility Index (PI) of the umbilical artery (UA) and middle cerebral artery (MCA), with the aim to provide quality feedback on Doppler spectrum images and suggest potential gate placements.2. To test the effects of providing Explainable AI (XAI)-feedback for clinicians compared with no feedback on their accuracy in ultrasound interpretation and management., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, maskingDescription: Sealed envelopes will be used and opened at the time of inclusion of each participant. Each participant will be randomized to either AI support or no support. The allocation of participants will be performed by (XYZ) who does not have access to the randomization order., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: "XAI feedback on MCA/UA Doppler spectral curves and gate placement suggestions", outcomesModule primaryOutcomes measure: Responses will be reviewed independently by two fetal medicine sonographers, and in case of disagreement between the two experts, a consensus will be reached., secondaryOutcomes measure: Accuracy of flow image management among competence groups, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, status: RECRUITING, city: Copenhagen, state: Capital Region Of Denmark, zip: 2100, country: Denmark, contacts name: Zahra Bashir, MD, role: CONTACT, contacts name: Zahra Bashir, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Slagelse Hospital, status: RECRUITING, city: Slagelse, state: Region Zealand, zip: 4200, country: Denmark, contacts name: Zahra Bashir, MD, role: CONTACT, contacts name: Zahra Bashir, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.40276, lon: 11.35459, hasResults: False |
protocolSection identificationModule nctId: NCT06371846, orgStudyIdInfo id: 2023 /10850/I, briefTitle: Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-14, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Parc de Salut Mar, class: OTHER, descriptionModule briefSummary: Introduction and objectives: Left bundle branch area pacing (LBBAP), is a novel modality of physiologic pacing that requires an adequate assessment of the endocardium as well as the body-surface electrocardiographic signals for a successful pacing-lead implantation. The objective of the study consist of assessing if LBBAP criteria, specifically septal and left bundle branch pacing (LBBP) criteria, can be satisfactory measured using the signals resulting from different cardiac pacing analyzers (PSAs) by comparing them to the 'conventional' signals obtained from multichannel polygraph systems (MPSs) during the implantation procedure.Methods: Comparative observational, prospective, multicenter study between the signals obtained by PSA vs MPS of consecutive patients who underwent a LBBAP strategy as first intention., conditionsModule conditions: Conduction Disorder, conditions: Pacemaker DDD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Selected signals from Pacing System Analyzers, outcomesModule primaryOutcomes measure: Similarity of signals between multichannel recording system and Pacing System Analyzers, secondaryOutcomes measure: Security, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jesus Jiménez López, status: RECRUITING, city: Barcelona, state: Cataluña, zip: 08005, country: Spain, contacts name: Jesus Jiménez López, role: CONTACT, phone: 680714927, email: [email protected], geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06371833, orgStudyIdInfo id: S-52, briefTitle: PRIMA EU Retrospective & Prospective, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Limacorporate S.p.a, class: INDUSTRY, collaborators name: Iqvia Pty Ltd, descriptionModule briefSummary: This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications., conditionsModule conditions: Arthroplasty, conditions: Replacement, conditions: Shoulder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Shoulder Arthroplasy with PRIMA humeral stem, outcomesModule primaryOutcomes measure: Changes of Costant Murley Score (CS), secondaryOutcomes measure: Changes in the American Shoudler and Elbow Surgeons (ASES) score, secondaryOutcomes measure: Changes in Range of Motion measures, secondaryOutcomes measure: Radiographic stability of the humeral component, secondaryOutcomes measure: Survival rate (Kaplan-Meier estimate), secondaryOutcomes measure: Incidence, type and severity of Adverse Events and Adverse Device Effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371820, orgStudyIdInfo id: 2014/1287-31/4, briefTitle: ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden), acronym: ESPRESSO, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 1965-01-01, primaryCompletionDateStruct date: 2043-05-17, completionDateStruct date: 2043-05-17, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: The ESPRESSO study is a collection of data from all computerised gastrointestinal histopathology reports in Sweden. This allows us to study risk factors for gastrointestinal disease, as well as the prognosis of gastrointestinal disease.A review of the study has been published here:https://pubmed.ncbi.nlm.nih.gov/30679926/, conditionsModule conditions: Gastrointestinal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 13000000, type: ACTUAL, armsInterventionsModule interventions name: ESPRESSO [The study has no intervention], outcomesModule primaryOutcomes measure: Incident Mortality [especially rates], secondaryOutcomes measure: Incident Cancer, secondaryOutcomes measure: Incident Cardiovascular disease, secondaryOutcomes measure: Incident Neurological disease, secondaryOutcomes measure: Incident Autoimmune diseases, otherOutcomes measure: Please note that the recorded outcomes above are examples. Other outcomes may also be studied., eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 110 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371807, orgStudyIdInfo id: EU CTR n.º 2023-507008-30-00, briefTitle: Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab, acronym: KEYPARTNER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Fundacao Champalimaud, class: OTHER, descriptionModule briefSummary: Phase II, randomized, Active-controlled open label trial for treatment of high risk, HR-/HER2- (triple negative) breast cancer, with two sequences of neoadjuvant chemotherapy on a background of pembrolizumab, conditionsModule conditions: Early Breast Cancer, conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab injection, outcomesModule primaryOutcomes measure: Detect immunologic activation signal and the immunologically defined most suitable patient population for the synergistic interaction between pembrolizumab and chemotherapy backbone, primaryOutcomes measure: Rate of pCR, primaryOutcomes measure: Primary translational endpoint, secondaryOutcomes measure: Changes in the immunogenic phenotype, secondaryOutcomes measure: Incidence of treatment relatred Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fundaçao Champalimaud, Avenida Brasilia,, city: Lisbon, zip: 1400-038, country: Portugal, contacts name: Ines Sousa, MSc, role: CONTACT, phone: +351 210480048, email: [email protected], contacts name: Fatima Cardoso, MD, role: CONTACT, phone: +351 210480048, email: [email protected], geoPoint lat: 38.71667, lon: -9.13333, locations facility: Centro Hospitalar Universitário Lisboa Norte E.P.E, city: Lisbon, zip: 1649-028, country: Portugal, geoPoint lat: 38.71667, lon: -9.13333, locations facility: Instituto Português de Oncologia Francisco Gentil, E.P.E, city: Oporto, zip: 4200-072, country: Portugal, contacts name: Joana Maia, role: CONTACT, phone: 22 508 40 00, phoneExt: 2040, email: [email protected], contacts name: Miguel Abreu, MD, role: CONTACT, phone: 22 508 40 00, phoneExt: 2040, email: [email protected], geoPoint lat: 41.14961, lon: -8.61099, hasResults: False |
protocolSection identificationModule nctId: NCT06371794, orgStudyIdInfo id: ID 5460, briefTitle: EXploring novEl Molecular Determinants of DRAvet Syndrome Phenotype Heterogeneity, acronym: EXEDRA, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-07-06, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, collaborators name: IRCCS San Raffaele, descriptionModule briefSummary: Dravet syndrome is characterized as a developmental encephalopathy resulting from mutations of SCN1A, the gene encoding the alpha subunit of the voltage-gated sodium channel Nav1.1. The syndrome typically presents with drug-resistant epilepsy and varying degrees of cognitive disorders. Current treatment efficacy may be hindered by insufficient knowledge of undiscovered molecular determinants of the disease and its heterogeneous nature. Utilizing induced pluripotent stem cells (iPSCs) derived from skin biopsies, accessibility to patients' brain neurons has enabled successful modeling of various genetic neurological diseases. Neurons and brain organoids will be obtained from Dravet syndrome patients exhibiting diverse phenotypic severities, encompassing behavioral and developmental delays, to discern the molecular determinants of phenotypic diversity. Specifically, emphasis will be placed on investigating cellular and molecular mechanisms linking altered neuronal excitability with synaptic dysfunction.The study will focus on exploring the expression of newly identified modifiers potentially associated with neuronal excitability and synaptic function in iPSC-derived human neurons. This aims to establish correlations between the severity of epileptic and cognitive phenotypes and the altered expression of these proteins, whose functions are not fully understood.In the mid to long term, efforts will be directed towards overcoming the limitations of conventional therapeutic approaches for Dravet syndrome. This will involve attempting to reverse the observed morphological and functional alterations in Dravet syndrome neurons using viral vectors to promote overexpression/downregulation of identified modifiers correlated with disease severity. The anticipated outcomes of this project are expected to unveil novel molecular mechanisms underlying the pathophysiology of this severe neurogenetic disease, characterized by varying degrees of cognitive impairment. Moreover, these findings may pave the way for the discovery of innovative therapeutic strategies., conditionsModule conditions: Dravet Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The ethics committee of the foundation FPG considers the study interventional since patients will undergo skin biopsy procedures ( around 4 mm), primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: skin punch biopsy, outcomesModule primaryOutcomes measure: TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS, secondaryOutcomes measure: TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS, otherOutcomes measure: TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS, otherOutcomes measure: TO CLASSIFY THE BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS, otherOutcomes measure: TO CLASSIFY THE BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS, otherOutcomes measure: TO CLASSIFY THE EPILEPTIC PHENOTYPE SEVERITY OF DS PATIENTS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Roma, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06371781, orgStudyIdInfo id: Cumhuriyetobgyn, secondaryIdInfos id: 1919B012108892, type: OTHER_GRANT, domain: TUBITAK, briefTitle: Examination of the Relationship Between Weight Gain During Pregnancy and Sfrp-5, Netrin-4 and Resistin Concentrations, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2022-07-01, completionDateStruct date: 2023-07-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Cumhuriyet University, class: OTHER, collaborators name: Scientific and Technological Research Council of Turkey (TUBITAK), descriptionModule briefSummary: Researchers thought that the molecules Sfrp-5, Resistin and Netrin-4, which will be examine, they may have a significant effect on weight gain during pregnancy. Based on these foundations, researchers expect changes in the levels of these molecules in women who gain excessive weight during pregnancy. In this study, researchers aimed to examine the moderator relationship between the molecules will be examine and weight gain in women who gained weight above the normal limits determined during pregnancy. For this reason, 44 participant who gained excessive weight during pregnancy and 46 pregnant participant who gained normal weight were included in the study. The levels of Netrin-4, Sfrp-5 and Resistin molecules in the blood serum of the individuals in the study group were measured with a Commercial Elisa kit., conditionsModule conditions: Excessive Weight Gain During Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pregnant women who were given birth at Cumhuriyet University Faculty of Medicine Hospital Gynecology and Obstetrics Clinic between July 1, 2021 and July 1, 2022 and whose pregnancy follow-ups were performed in our hospital will be included in our prospectively designed study. Researchers will divide the study into two main groups. The first group will consist of pregnant women with above-normal weight gain during pregnancy, and the other group will consist of pregnant women with normal weight gain during pregnancy. It is estimated that 46 control and 44 pregnant women with overweight will be reached during this period. In the study, first a form containing demographic data such as age, education, height and weight will be filled out., primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Serum Netrin-4, Resistin and Sfrp-5 level measurement, outcomesModule primaryOutcomes measure: Obtaining blood serum for measurement of serum Sfrp-5, Netrin-4 and Resistin, secondaryOutcomes measure: Calculating BMI (kg/m^2) from height (m) and weight (kg) measurement values for diagnosis., eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sivas Cumhuriyet University, city: Sivas, state: Centre, zip: 58140, country: Turkey, geoPoint lat: 39.74833, lon: 37.01611, hasResults: False |
protocolSection identificationModule nctId: NCT06371768, orgStudyIdInfo id: Pro00115400, briefTitle: Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors, acronym: AYA STEPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04-01, primaryCompletionDateStruct date: 2029-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care., conditionsModule conditions: Cancer, conditions: Breast Cancer, conditions: Colorectal Cancer, conditions: Sarcoma, conditions: Lymphoma, conditions: Testicular Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: AYA Educational Information, interventions name: AYA STEPS, outcomesModule primaryOutcomes measure: Pain severity and interference as measured by Brief Pain Inventory, primaryOutcomes measure: Fatigue as measured by PROMIS Fatigue Scale, primaryOutcomes measure: Emotional distress as measured by PROMIS Depression Short Form, primaryOutcomes measure: Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference, primaryOutcomes measure: Emotional distress as measured by PROMIS Anxiety Short Form, primaryOutcomes measure: Health care engagement as measured by Patient Participation Questionnaire, primaryOutcomes measure: Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscale, secondaryOutcomes measure: Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale, secondaryOutcomes measure: Patient activation as measured by Patient Activation Measure (PAM), otherOutcomes measure: Health care utilization: Chart Review, otherOutcomes measure: Area Deprivation Index (ADI), otherOutcomes measure: Health-care utilization: Self-report, otherOutcomes measure: Health literacy as measured by Medical Term Recognition Test (METER), otherOutcomes measure: Participant experiences of discrimination as measured by Everyday Discrimination Scale-Short Form, otherOutcomes measure: Participant evaluation of study mobile application as measured by User Version of the Mobile Application Rating Scale (uMARs), otherOutcomes measure: Satisfaction with Treatment and Interventionist as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R), otherOutcomes measure: Web-based Portal Use as measured by total time using portal in minutes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 39 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06371755, orgStudyIdInfo id: ULTRADXA, briefTitle: Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry (REMS) vs Dual X-ray Absorptiometry (DXA), statusModule overallStatus: RECRUITING, startDateStruct date: 2019-11-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Paola Pisani, class: INDUSTRY, collaborators name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, descriptionModule briefSummary: Bone Density Evaluation by means of the Ultrasound Technology Named Radiofrequency Echographic Multi Spectrometry (REMS) in Comparison With DXA Technique.Clinical Center involved in the study:IRCCS Orthopedic institute Galeazzi - Sant'Ambrogio The clinical study will evaluate the intra- and inter-operator repeatability of the REMS,(Radiofrequency Echographic Multi Spectrometry) ultrasound diagnostic technology implemented in the EchoStation device (Echolight Spa, Lecce) and the diagnostic accuracy in comparison with DXA (used as standard reference)., conditionsModule conditions: Osteoporosis Diagnosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 296, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound examination with REMS technology, outcomesModule primaryOutcomes measure: 1. REMS Technology intra - and inter-operator repeatability Evaluation., secondaryOutcomes measure: 1. Evaluation of the accuracy of the REMS Technology in comparison with the conventional DXA technique., eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, status: RECRUITING, city: Milano, state: MI, zip: 20157, country: Italy, contacts name: Carmelo Messina, Professor, role: CONTACT, phone: 0039 02 8350 1406, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06371742, orgStudyIdInfo id: 539HydrationNutr, briefTitle: Study of the Fluid Intake Effect During Labour, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-02-01, primaryCompletionDateStruct date: 2017-07-14, completionDateStruct date: 2017-09-14, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Egas Moniz - Cooperativa de Ensino Superior, CRL, class: OTHER, descriptionModule briefSummary: Ingestion during labor is an issue that has attracted the attention of the scientific community in recent decades, with different practices occurring in different countries. However, the scientific evidence of the risk / benefit of fluid intake in labor is still not fully understood. The aim of this study was to contribute with data that allow the evaluation of an eventual relationship between the amount of fluid ingested during labor and the type of delivery, the duration of labor, the occurrence of nausea and vomiting and the value of the Index of Apgar at the 1st and 5th minutes of the newborn's life. An observational study, with a convenience sample of 144 parturient from two hospitals of Portugal were employed. The analysis was based on recording the before mentioned variables and potentially confounding variables. In order to control for potential sources of bias in the study and to guarantee the homogeneity of the sample in the specific statistical treatment of each dependent variable, an observation grid was drawn up for all the participants in the study. Twenty eight of the parturient, the parturient's ambulation, labour analgesia, food intake during labour, the use of oxytocin during labour, the occurrence of postpartum complications, the birth weight of the newborn and the occurrence of birth complications., conditionsModule conditions: Labor Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 144, type: ACTUAL, armsInterventionsModule interventions name: Liquid ingestion during labour, outcomesModule primaryOutcomes measure: Type of labour, primaryOutcomes measure: Duration of labour, primaryOutcomes measure: Occurrence of nausea and vomiting, primaryOutcomes measure: Apgar index of the newborn (From 0 to 10), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: Egas Moniz School of Health and Science, city: Almada, state: Monte De Caparica, zip: 2829-699, country: Portugal, geoPoint lat: 38.67902, lon: -9.1569, hasResults: False |
protocolSection identificationModule nctId: NCT06371729, orgStudyIdInfo id: DEEP-VT, briefTitle: Substrate-based DEEP Mapping Versus Activation Mapping. A Prospective Randomized Multicenter Study., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: IRCCS Ospedale San Raffaele, class: OTHER, descriptionModule briefSummary: Substrate-based DEEP mapping and activation mapping are the two main techniques used for ventricular tachycardia (VT) ablation. There is no sufficiently reliable data in the medical scientific literature comparing the extent of applicability, the results of the procedure strategy, and the long-term outcomes between the two mapping strategies. This randomized clinical trial aims to test whether activation mapping is superior to DEEP mapping to reduce ventricular tachycardia recurrence.The primary outcome of the study is to compare the efficacy as a recurrence-free survival rate of ventricular tachycardia, at 6 and 12 months, of substrate-based DEEP mapping versus activation mapping in guiding catheter ablation to prevent VT recurrence., conditionsModule conditions: Ventricular Tachycardia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 222, type: ESTIMATED, armsInterventionsModule interventions name: DEEP mapping, interventions name: Activation Mapping, outcomesModule primaryOutcomes measure: Compare the efficacy of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371716, orgStudyIdInfo id: EUS-RFA ex-vivo 2016, briefTitle: Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions, statusModule overallStatus: TERMINATED, startDateStruct date: 2019-09-12, primaryCompletionDateStruct date: 2020-06-12, completionDateStruct date: 2020-06-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: The study investigates the feasibility and the efficacy to treat pancreatic solid lesions as pancreatic adenocarcinomas (PDAC) and neuroendocrine tumors (NET) with ex-vivo radiofrequency ablation (RFA) under ultrasound (US) control.The study intent is to define the optimal radiofrequency ablation POWER of the system in terms of maximum sizes (diameters) of histological coagulative necrosis obtained at pathological samples. Results will be useful to define the optimal settings to ablate pancreatic solid lesions (PDAC and neuroendocrine tumours)., conditionsModule conditions: Pancreatic Cancer, conditions: Endoscopic Ultrasound, conditions: Radiofrequency Ablation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 15 resected PDAC without neoadjuvant treatment 15 resected PDAC with neoadjuvant treatment 15 resected neuroendocrine tumorsEach group (15 patients each) Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients), primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: pathologists (two different pathologist blinded about the power of RFA applied and respect to the other pathologist) will evaluate the effect of ablation (coagulative necrosis at microscopic evaluation), whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions, interventions name: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions, interventions name: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions, outcomesModule primaryOutcomes measure: diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Raffaele Hospital, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06371703, orgStudyIdInfo id: PETCT_INTEGO, briefTitle: Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automat-ed Radiopharmaceutical Preparation and Administration System, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: This project aims to evaluate the impact of the introduction of an automated system for radiopharmaceutical preparation and administration on the radiation safety of the radiographers working in nuclear medicine. This study will help to fill the existing gap in the scientific literature and provide useful guidance for the selection of the safest and most effective automated infusion system., conditionsModule conditions: Radiation Exposure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: automated system in reducing radiation exposure, outcomesModule primaryOutcomes measure: Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv)., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs San Raffaele, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06371690, orgStudyIdInfo id: 17-11/37, briefTitle: The Effects of Using the Web-Based Double Eye Control Program on Medication Error, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-11-01, primaryCompletionDateStruct date: 2018-06-30, completionDateStruct date: 2018-09-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Izmir Katip Celebi University, class: OTHER, collaborators name: Ege University, descriptionModule briefSummary: Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". The sample of the study consisted of all high-risk drugs administered by 24 nurses working in these clinics, taking part in medication and agreeing to take part in the study. Data were collected by the researcher using the Medication Observation Form. The Form was created based on the literature, and by making use of the "10 Correct Rules in Medication" and the Medication Skills Steps in the Double Eye Control Program. In the first step, medication error rates were determined through observation method. In the second step; the Web-Based Double-Eye Control Program, which is a standard drug dose calculation and medication program created by the researchers, was started to be implemented. Medication error rates were determined again through post-intervention observation method. Informed voluntary consent, ethics committee and hospital permissions were obtained for the implementation of the study., conditionsModule conditions: Main Heading (Descriptor) Terms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1070, type: ACTUAL, armsInterventionsModule interventions name: Web-Based Double-Eye Control Program, outcomesModule primaryOutcomes measure: Error rates, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Izmir Katip Celebi University, city: İzmir, state: Çi̇ğli̇, zip: 35620, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False |
protocolSection identificationModule nctId: NCT06371677, orgStudyIdInfo id: KB/2024, briefTitle: Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units, acronym: POL-CICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: Cardiac Intensive Care Units (CICUs) provide care for a diverse patient population. Understanding the clinical characteristics, analysis of treatment modalities, and prognosis of patients hospitalized in the CICU are important to improve cardiovascular care. The purpose of this registry is to determine the demographics, clinical, treatment, and prognosis of patients hospitalized in the Polish CICUs. Data from this multicenter, prospective observational study will provide more robust data to facilitate quantitative characterization of cardiac care in contemporary Polish CICUs and enable the development of infrastructure for clinical trials in CICUs., conditionsModule conditions: Shock, conditions: Death, conditions: Cardiac Intensive Care Unit, conditions: Treatment Complication, conditions: Stroke, conditions: Multiple Organ Failure, conditions: Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, outcomesModule primaryOutcomes measure: All-cause death, secondaryOutcomes measure: Shock (cardiogenic/hypovolemic/anaphylactic/septic/neurogenic/obstructive), secondaryOutcomes measure: Treatment-related complications (tamponade, dissection, stroke, embolism, etc.), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371664, orgStudyIdInfo id: 2023/02, briefTitle: Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-04-05, completionDateStruct date: 2023-04-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Santiago de Compostela, class: OTHER, descriptionModule briefSummary: The primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Additionally, it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening., conditionsModule conditions: Gingival Inflammation, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, triple-blind clinical trial, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Conventional Tray (1 mm), interventions name: Extended Tray (3 mm), outcomesModule primaryOutcomes measure: Subjective questionnaire of gingival irritation, primaryOutcomes measure: Objective clinical examination of gingival irritation, secondaryOutcomes measure: Questionnaire of dental sensitivity, secondaryOutcomes measure: Shade evaluation with a dental spectrophotometer, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: School of Medicine and Dentistry, city: Santiago De Compostela, state: A Coruña, zip: 15705, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, hasResults: False |
protocolSection identificationModule nctId: NCT06371651, orgStudyIdInfo id: 23-1462-3, briefTitle: Creatine and GAA for Brain Oxygenation, acronym: CREGAA-OXY, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-04-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Novi Sad, Faculty of Sport and Physical Education, class: OTHER, descriptionModule briefSummary: The main aim of this randomized controlled trial is to evaluate cerebral blood oxygenation after 7-day administration of a creatine-guanidinoacetic acid (GAA) mixture in healthy adults before, during, and after a series of cognitive tests., conditionsModule conditions: Oxygen Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 19, type: ACTUAL, armsInterventionsModule interventions name: Supplement, interventions name: Placebo, outcomesModule primaryOutcomes measure: Brain oxygen saturation, secondaryOutcomes measure: Hemoglobin index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Applied Bioenergetics Lab at Faculty of Sport and PE, city: Novi Sad, state: Vojvodina, zip: 21000, country: Serbia, geoPoint lat: 45.25167, lon: 19.83694, hasResults: False |
protocolSection identificationModule nctId: NCT06371638, orgStudyIdInfo id: 2024-01, briefTitle: Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD), acronym: CODE-POCD, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-07, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-07, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Udayana University, class: OTHER, descriptionModule briefSummary: Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Previous studies found that dexmedetomidine reduced POCD incidence in non-cardiac and cardiac surgery. Therefore, the goal of this study was to specifically investigate if using TCI dexmedetomidine to maintain anaesthesia in laparotomy surgeries reduces the incidence of POCD compared to inhalation anaesthesia by sevoflurane., conditionsModule conditions: Postoperative Cognitive Dysfunction, conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 112, type: ACTUAL, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Sevoflurane, outcomesModule primaryOutcomes measure: Postoperative cognitive dysfunction (POCD), primaryOutcomes measure: Postoperative cognitive dysfunction (POCD), secondaryOutcomes measure: Intraoperative hemodynamics: mean arterial pressure (MAP), secondaryOutcomes measure: Intraoperative hemodynamics: heart rate (HR), secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Postoperative pain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prof. Ngoerah General Hospital, city: Denpasar, state: Bali, zip: 80114, country: Indonesia, geoPoint lat: -8.65, lon: 115.21667, hasResults: False |
protocolSection identificationModule nctId: NCT06371625, orgStudyIdInfo id: AP2202-30104, briefTitle: U/S Guided Transversus Thoracic and Pectoral Nerve Block Versus Pectoral Nerve Block in MRM, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-02, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2023-10-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Ahmed Mohamed Soliman, class: OTHER, descriptionModule briefSummary: Interfascial blocks score over regional anesthetic techniques such as Transversus Thoracic Plane Block and Pectoral Nerves (PECS) Block as they have no risk of sympathetic blockade, intrathecal or epidural spread, which may lead to hemodynamic instability and prolonged hospital stay. The transversus thoracic muscle plane block (TTP) block is a newly developed regional anesthesia technique which provides analgesia to the anterior chest wall. First described by Ueshima et al. in 2015, the TTP block is a single-shot nerve block that deposits local anesthetic in the transversus thoracic muscle plane between the internal intercostal and transversus thoracic muscles. TTP block targets the anterior branches of the intercostal nerves (T2-6).Pectoral plane blocks are recently described . PECS block involves deposition of local anesthetic drug between muscle planes. PECS I block, between Pectoralis Major and Minor at third rib level, and PECS II block, the drug is deposited between Pectoralis minor and Serratus anterior muscle.The pectoral nerves (PECS) block provides analgesia of the lateral mammary region, the intercostobrachial and lateral cutaneous branches of the intercostal nerves (T2-T6), the medial cutaneous nerve of the arm and forearm, and the long thoracic and thoracodorsal nerves. The modified PECS block produces excellent analgesia and can be used to provide balanced anesthesia., conditionsModule conditions: Breast Cancer, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: to determine the analgesic effect of ultrasound guided Transversus Thoracic and Pectoral Nerve Block compared to ultrasound guided Pectoral Nerve Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 11 per group. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Transeversus Thoracic Plane Block (TTPB) and Pectoral Nerves (PECS) Block, interventions name: Pectoral Nerves (PECS) Block, outcomesModule primaryOutcomes measure: visual analogue scale "VAS score", secondaryOutcomes measure: total morphine consumption, secondaryOutcomes measure: mean blood pressure, secondaryOutcomes measure: heart rate, secondaryOutcomes measure: first analgesic dose, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National cancer Insititute Cairo university, city: Cairo, zip: 11796, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, locations facility: National cancer Insititute, city: Cairo, zip: 11796, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Ahmed Mohamed Soliman, city: Giza, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06371612, orgStudyIdInfo id: MersinU*GUGUCU_004, briefTitle: Effect of Ball Squeezing and Adhesive Remover Use on Pain and Fear in Children Aged 6-9 Years During the Removal of Peripheral Intravenous Cannula, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-11-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mersin University, class: OTHER, descriptionModule briefSummary: Pediatric nurses have a key role in reducing pain related to interventions during the hospitalisation process. In this context, according to the type of invasive intervention, the nurse determines the appropriate non-pharmacological methods for the effective management of pain, taking into account the child's individuality, developmental stage and clinical presentation. For children during the hospitalisation process, the removal of a peripheral venous line is a painful and stressful experience, as is the insertion of a peripheral venous line. Children experience acute pain during the removal of hypoallergenic adhesives used for fixation of the peripheral venous line. The practice guideline recommends the use of alcohol-free silicone-based aerosol sprays for the removal of medical adhesive/ fixation materials (NICU Brain Sensitive Care Committee, 2015).In this study, it was aimed to examine the effect of ball squeezing (active distraction) as a distraction method and the use of alcohol-free silicone-based aerosol adhesive remover spray on pain and fear in children aged 6-9 years during peripheral intravenous cannula removal., conditionsModule conditions: Procedural Pain, conditions: Fear of Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A, B and C. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Standard Care, interventions name: Adhesive Remover Spray, interventions name: Ball Squeezing + Adhesive Remover Spray, outcomesModule primaryOutcomes measure: Pain assesed by Wong-Baker FACES, primaryOutcomes measure: Fear by Children's Fear Scale, secondaryOutcomes measure: Pain assesed by Wong-Baker FACES, secondaryOutcomes measure: Fear by Children's Fear Scale, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mersin University, city: Mersin, state: Yenişehir, zip: 33343, country: Turkey, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False |
protocolSection identificationModule nctId: NCT06371599, orgStudyIdInfo id: MersinU*GUGUCU_003, briefTitle: The Effect of Watching Cartoons and Playing Games as Distraction Method During Peripheral Intravenous Cannula Placement on Pain and Fear in Children Aged 6-9 Years, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-11-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mersin University, class: OTHER, descriptionModule briefSummary: Active and passive distraction methods are frequently used in the nursing management of procedural pain in children. There are no studies comparing the effects of watching cartoon (passive) and playing game (active) as distraction methods on pain and fear associated with peripheral intravenous cannula placement in children aged 6-9 years.This study aimed to compare the effects of playing game (active distraction) and watching cartoon (passive distraction) techniques on pain and fear during peripheral intravenous cannula placement in children aged 6-9 years., conditionsModule conditions: Procedural Pain, conditions: Fear of Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A and B. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Playing game, interventions name: Watching cartoon, outcomesModule primaryOutcomes measure: Pain assesed by Wong-Baker FACES, primaryOutcomes measure: Fear by Children's Fear Scale, secondaryOutcomes measure: Pain assesed by Wong-Baker FACES, secondaryOutcomes measure: Fear by Children's Fear Scale, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mersin University, city: Mersin, state: Yenişehir, zip: 33343, country: Turkey, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False |
protocolSection identificationModule nctId: NCT06371586, orgStudyIdInfo id: NCC4537, briefTitle: Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer., conditionsModule conditions: Gastric Cancer, conditions: Diffuse Type Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 67, type: ESTIMATED, armsInterventionsModule interventions name: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy, outcomesModule primaryOutcomes measure: Pathological response rate, secondaryOutcomes measure: EFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: R0, secondaryOutcomes measure: Safety (adverse events) and surgical complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer hospital，Chinese acadamy of medical sciences, status: RECRUITING, city: Beijing, country: China, contacts name: Chunxia Du, role: CONTACT, phone: 87787121, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06371573, orgStudyIdInfo id: MPN-USspleen, briefTitle: Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-04-20, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2024-03-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Federico II University, class: OTHER, descriptionModule briefSummary: Adult patients (\>18 years) with newly diagnosis of Ph negative myeloproliferative neoplasms (MPNs) according to WHO 2016 criteria, will be recruited to this study.This study is the result of the collaboration the Hematology Division of Federico II University Medical School of Naples (Italy), that performed the US investigation and the IRCCS SYNLAB SDN where the patients carried out MR. The study is conducted in accordance with the Declaration of Helsinki. All subjects gave informed consent to receive both US and MR scans of the spleen.All spleen US scans were performed by the same operator (with\>10 years of experience in abdominal US), who used an EPIQ 5 Philips instrument with a 1-5 MHz broadband curvilinear probe. The spleen was scanned in patients who were fasting, in the longitudinal and transverse planes by using an intercostal approach, a subcostal approach, or both.The patient was placed in a supine or right-sided position until complete organ visualization was achieved. Perimeter, longitudinal diameter (LD), and area, defined as the maximum measurements with splenic borders and angles clearly defined, were measured, and SV (in milliliters) was calculated automatically. For each subject, the mean value of 3 measurements repeated on the same imaging session was calculated and recorded for final analysis. Within two weeks from the US, each patient underwent an MRI of the upper abdomen to evaluate the splenic volume. MRI examinations were performed using a 3T Biograph mMR scanner (Siemens Healthcare, Erlangen, Germany) with 4-channel flex phased-array body coil. Routine clinical abdominal MRI acquisition includes coronal T2W Half-Fourier Acquisition Single-shot Turbo spin Echo imaging (HASTE), axial T1 Dual-echo FSE, axial T2 TSE Fat Sat, and an axial diffusion-weighted imaging (DWI). The DWI includes an apparent diffusion coefficient (ADC) map that was automatically generated at the time of acquisition. At last, an isotropic 2mm3 axial Volumetric Interpolated Breath-hold Examination (VIBE) sequence for SV evaluation was acquired. For the latter, attention was paid to optimize the field of view to the spleen, in order to reduce patient's apnea and possible respiratory artifacts. A radiologist with mote than 10 years of experience in abdominal MRI reporting performed measurement of the three orthogonal diameters of the spleen for each patient. Subsequently, SV was calculated using ITK-SNAP software and semi-automatic 3D segmentation approach, firstly based on a signal threshold., conditionsModule conditions: Myeloproliferative Neoplasm, conditions: Polycythemia Vera, conditions: Essential Thrombocythemia, conditions: Primary Myelofibrosis, conditions: Prefibrotic/Early Primary Myelofibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: ULTRASOUND EXAM AND MRI SCAN, outcomesModule primaryOutcomes measure: agreement between two different diagnostic methods, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federico II University, city: Naples, zip: 80131, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False |
protocolSection identificationModule nctId: NCT06371560, orgStudyIdInfo id: KAP-ABR-Perio, briefTitle: Antibiotics, Antibiotic Resistance, and Prescribing Practices Among Periodontists: Cross Sectional KAP Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Antibiotic resistance is a global health threats that require attention from all healthcare providers. In Periodontology, antibiotic is prescribed in many clinical situations. The aim of this study is to assess the followings among Periodontists (1) The knowledge, attitude, and practices (KAP) towards antibiotics and antibiotic resistance; (2) The prescribing practices of antibiotics in periodontal therapy; (3) The correlation between personal perception of antibiotics uses and the professional prescription patterns; and (4) The differences in antibiotics prescription in relation to the years of experience and the academic background., conditionsModule conditions: Antibiotic Resistance, conditions: Antibiotic Use, conditions: Periodontitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: KAP, secondaryOutcomes measure: The prescribing practices of antibiotics in periodontal therapy, secondaryOutcomes measure: The correlation between personal perception of antibiotics uses and the professional prescription patterns, secondaryOutcomes measure: The differences in antibiotics prescription in relation to the years of experience and the academic background., eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371547, orgStudyIdInfo id: BEUFTR-3, briefTitle: Efficiency of Different Gastrocnemius Stretching Exercises, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Bitlis Eren University, class: OTHER, descriptionModule briefSummary: The primary aim of this study is to investigate the effects of different types and durations of gastrocnemius stretching on the viscoelastic properties of the gastrocnemius muscle, Achilles tendon, and plantar fascia.In addition, pain threshold of the gastrocnemius muscle and plantar fascia, as well as on hamstring tightness will be measured., conditionsModule conditions: Muscle Tightness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Interventions and assessment will be performed by separate researchers., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Stretching Exercise, outcomesModule primaryOutcomes measure: Measurement of the Viscoelastic Properties, primaryOutcomes measure: Ankle-foot Dorsiflexion Index, secondaryOutcomes measure: Measurement of the Mechanosensitivity, secondaryOutcomes measure: Assessment of Hamstring Tightness, otherOutcomes measure: Dominant Leg Determination, otherOutcomes measure: Navicular Drop Test, otherOutcomes measure: Self-reported Effects of Stretching Exercises, otherOutcomes measure: The Satisfaction Level with the Stretching, otherOutcomes measure: Compliance with Stretching Exercise Program, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bitlis Eren University, city: Bitlis, state: Merkez, zip: 13000, country: Turkey, geoPoint lat: 38.40115, lon: 42.10784, hasResults: False |
protocolSection identificationModule nctId: NCT06371534, orgStudyIdInfo id: QL2109-101, briefTitle: A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Qilu Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2109 with DARZALEX FASPRO® in healthy male volunteers.Participants will receive a single injection of QL2109/ DARZALEX FASPRO® Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the two groups., conditionsModule conditions: Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 228, type: ESTIMATED, armsInterventionsModule interventions name: QL2109, interventions name: DARZALEX FASPRO®, outcomesModule primaryOutcomes measure: AUC0-∞, primaryOutcomes measure: Cmax, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310006, country: China, contacts name: qingwei zhao, Professor, role: CONTACT, email: [email protected], contacts name: qingwei zhao, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: xingjiang hu, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The First Affiliated Hospital of Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310006, country: China, contacts name: qingwei ZHAO, Professor, role: CONTACT, email: [email protected], contacts name: xingjiang HU, Professor, role: CONTACT, email: [email protected], contacts name: qingwei ZHAO, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: xingjiang HU, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06371521, orgStudyIdInfo id: 4933, briefTitle: Ergogenic Effects of Sportlegs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Christopher Bell, class: OTHER, descriptionModule briefSummary: Sportlegs is a commercially available dietary/sports supplement. It is manufactured by a local, Colorado-based company: Sport Specifics Inc. Although Sportlegs has been on the market for approximately 20-years, very little empirical research has been completed to determine if Sportlegs improves exercise performance. Sport Specifics Inc. has commissioned Colorado State University to investigate the ergogenic effects of Sportlegs., conditionsModule conditions: Performance Enhancing Product Use, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized, Placebo-Controlled, Double Blind Crossover Intervention, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Investigators and Participants are both blinded to whether the participants will be consuming Sportlegs or Placebo during a given study visit., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Sportlegs, interventions name: Placebo, outcomesModule primaryOutcomes measure: Maximal Oxygen Uptake, primaryOutcomes measure: Lactate Threshold, primaryOutcomes measure: Rating of Perceived Exertion (RPE), primaryOutcomes measure: Maximal sustained mean power, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Colorado State University, status: RECRUITING, city: Fort Collins, state: Colorado, zip: 80523, country: United States, contacts name: Christopher Bell, Ph.D., role: CONTACT, phone: 970-491-7522, email: [email protected], contacts name: Taylor R Ewell, MS, role: CONTACT, phone: 7197611417, email: [email protected], geoPoint lat: 40.58526, lon: -105.08442, hasResults: False |
protocolSection identificationModule nctId: NCT06371508, orgStudyIdInfo id: 14042024, briefTitle: Breast Cancer and Breast Self-examination Education, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sakarya University, class: OTHER, descriptionModule briefSummary: According to a news published by the World Health Organization (WHO); More than 2.3 million cases of breast cancer occur each year, making it the most common cancer among adults. In 95% of all countries, breast cancer is the first or second cause of female cancer death. In 2020, 2.3 million women worldwide were diagnosed with breast cancer and 685,000 deaths occurred (WHO, 2023; https://www.who.int/news/item/03-02-2023-who-launches-new-roadmap- on-breast-cancer). In our country, breast cancer ranks first among the most common cancer types in women, and the number of breast cancer cases in women in 2020 was recorded as 74 638 (IARC, 2023). As a result of this situation, WHO (2023) published the Global Breast Cancer Initiative Framework to save 2.5 million lives from breast cancer by 2040. This published framework includes health promotion for early detection, timely diagnosis and comprehensive management of breast cancer.One of the most effective ways to reduce breast cancer mortality and morbidity rate is early diagnosis. It is important to determine early diagnosis and signs and symptoms of cancer before they appear. Early diagnosis of breast cancer is possible with breast self-examination (BSE), clinical breast examination and mammography (Kayar, 2019). Breast self-examination is an important examination method in terms of detecting changes in breast tissue and preventing subsequent complications (Abo Al-Shiekh et al., 2021). It is also an easy-to-apply, cheap and non-invasive method. In our country, it is recommended that women regularly perform breast self-examination every month after the age of 20, women between the ages of 20 and 40 should have a clinical breast examination every two years, and women between the ages of 40 and 69 should have a clinical breast examination every year and have a mammogram every two years (Ministry of Health, 2019). .There are studies showing that fear of breast cancer has a positive and negative impact on early diagnosis behaviors (Champion et al., 2004; Yavan et al., 2010). Champion et al. (2004) stated that women with moderate breast cancer fear had a high rate of early detection behavior, whereas low and high fear levels had a negative effect on behavior. In the study conducted by Yavan et al. (2010) on 188 women, 2% of the women. They found that 3 of them had regular BSE and 78.7% of them had never had a mammography. In addition, 85% of the women included in the study stated that they had a fear of breast cancer due to a family history of breast cancer, being diagnosed with breast cancer, and the presence of risk factors. Study results show that fear of breast cancer affects screening results. Therefore, our aim in the study is; To determine the effect of breast cancer and BSE training given to women on breast cancer fear and BSE skills., conditionsModule conditions: Breast Cancer, conditions: Breast Self-Examination, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Education based on breast cancer and breast examination, outcomesModule primaryOutcomes measure: Champion Breast Cancer Fear Scale Change, primaryOutcomes measure: Breast Self Examination Checklist Success Score, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kocadere Sağlık Evi, status: RECRUITING, city: Yalova, country: Turkey, contacts name: Muge Saglık, Msc., role: CONTACT, phone: +905343817563, email: [email protected], geoPoint lat: 40.65501, lon: 29.27693, hasResults: False |
protocolSection identificationModule nctId: NCT06371495, orgStudyIdInfo id: statins in ischemic stroke, briefTitle: Statins Role in Acute Ischemic Stroke, acronym: observation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-13, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Strokes is amajor cause of death and disabilities in different countried, conditionsModule conditions: Stroke, Acute, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: rosuvastatin, outcomesModule primaryOutcomes measure: Carotid duplex will be done at the onset and after 1 month and 3 months of the onset., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06371482, orgStudyIdInfo id: Camel-01, briefTitle: Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer (Camel-01), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Hebei Medical University Fourth Hospital, class: OTHER, descriptionModule briefSummary: This trial aims to assess efficacy and safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung cancer., conditionsModule conditions: SCLC, Limited Stage, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Durvalumab, interventions name: Chemotherapy drug of EP regimen, interventions name: radiotherapy, outcomesModule primaryOutcomes measure: Assessment of objective remission rate (ORR) in limited stage small cell lung cancer treated with durvalumab combined with chemoradiotherapy, primaryOutcomes measure: Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events., secondaryOutcomes measure: Assessment of overall survival (OS) in limited stage small cell lung cancer., secondaryOutcomes measure: Assessment of progression-free survival (PFS) in limited stage small cell lung cancer., secondaryOutcomes measure: Assessment of disease control rate (DCR) in limited stage small cell lung cancer., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fourth Hospital of Hebei Medical University, status: RECRUITING, city: Shijiazhuang, state: Hebei, zip: 050011, country: China, contacts name: Wenbin Shen, PhD, role: CONTACT, phone: +86 15831183879, email: [email protected], contacts name: Hesong Wang, PhD, role: CONTACT, phone: +86 18810775196, email: [email protected], geoPoint lat: 38.04139, lon: 114.47861, hasResults: False |
protocolSection identificationModule nctId: NCT06371469, orgStudyIdInfo id: KAEK-769, briefTitle: Program of Health Behaviour Against to Cancer (PHeBAC), acronym: PHeBAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-07-20, completionDateStruct date: 2024-08-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, descriptionModule briefSummary: The European Code Against Cancer contains 12 recommendations to reduce the risk of cancer. It is estimated that about half of all cancers could be prevented if all recommendations are followed.The aim of this study was to evaluate the effectiveness of the Program of Health Behaviour Against Cancer (PHeBAC) applied to mothers of children with intellectual disabilities in increasing the participation of mothers and their children with intellectual disabilities in cancer screenings and their health behaviors against cancer. The goal is to improve the preventive health behaviors of children with intellectual disabilities and their mothers against cancer and to increase the rate of participation in cancer screenings. Specific targets are; not smoking and not being exposed to smoking, increasing physical activity, healthy nutrition, limiting alcohol consumption, protection from sunlight, HPV vaccination and increasing participation in breast, cervical and colorectal cancer screenings., conditionsModule conditions: Cancer Prevention, conditions: Health Behavior, conditions: Disability, Intellectual, conditions: Parents, conditions: Cancer Screening, conditions: Experimental Study Designs, conditions: Mothers, conditions: Disabilities Mental, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Mothers participating in the research will not know that they are in the intervention or control group. The data of the research will be collected by an independent investigator. In addition telephone support during the research process will be provided by the independent investigator, too, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: PHeBAC, interventions name: Control Group, outcomesModule primaryOutcomes measure: Health Behaviors and Participation in Cancer Screenings Data Collection Form, primaryOutcomes measure: Healthy Life Style Behaviors Scale II (Physical Activity and Nutrition Sub-Factors), primaryOutcomes measure: Sun Protection Behavior Scale, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371456, orgStudyIdInfo id: Ain Shams university 111, briefTitle: A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Epidural anesthesia for pain control during normal vaginal delivery is a blind maneuver and so we need a confirmatory sign for being in the correct epidural space.Loss of resistance sign using air may guide us wrongly as it may occur if we entered into the paravertebral muscles or cavities in the interspinal ligaments.So, additional confirmatory sign beside loss of resistance sign by air is strongly needed.We noticed that after occurence of loss of resistance sign by air and insertion of the epidural catheter a dew was formed on the internal sides of the epidural catheter after aspiration to be sure that there are no blood or cerebrospinal fluid in the catheter.This dew formation (Ramy sign) is characteristic for air in the epidural space when transferred from the warm epidural space (temperature about 38-39 celsius degree) to the colder aspect of the catheter outside the patient which nearly has the same operating room temperature (22 celsius degree).This sign may be associated with correct placement and good function of the epidural catheter., conditionsModule conditions: Normal Delivery Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: epidural catheter placement, outcomesModule primaryOutcomes measure: appearance of the dew sign, secondaryOutcomes measure: epidurogram, secondaryOutcomes measure: visual analogue score, secondaryOutcomes measure: mean blood pressure, secondaryOutcomes measure: mean blood pressure, secondaryOutcomes measure: heart rate, secondaryOutcomes measure: heart rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06371443, orgStudyIdInfo id: ayselkokcudogan, briefTitle: Suction and Swalloing Exercises for Premature Babies, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-03, primaryCompletionDateStruct date: 2022-06-01, completionDateStruct date: 2022-08-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Istanbul Medipol University Hospital, class: OTHER, descriptionModule briefSummary: Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported.This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants.The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul. The study sample consisted of 82 premature infants. Of these infants, 41 were assigned to the experimental group and 41 to the control group. Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool. Throughout the study, preterm infants in the experimental group (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days. SPSS21 was used to analyze the data., conditionsModule conditions: Premature Infant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 41, type: ACTUAL, armsInterventionsModule interventions name: Sucking and swallowing exercises, outcomesModule primaryOutcomes measure: The early feeding skills assessment tool (EFS), eligibilityModule sex: ALL, minimumAge: 34 Weeks, maximumAge: 37 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Medipol University, city: Istanbul, state: Beykoz, zip: 34810, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06371430, orgStudyIdInfo id: Biointelligent Technology Syst, briefTitle: Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery, acronym: BBLIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-14, primaryCompletionDateStruct date: 2024-02-14, completionDateStruct date: 2024-06-14, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Biointelligent Technology Systems SL, class: INDUSTRY, collaborators name: Universidad Pública de Navarra, collaborators name: Dasman Diabetes Institute, descriptionModule briefSummary: The investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages., conditionsModule conditions: Wound Healing Disorder, conditions: Wounds and Injuries, conditions: Wound Surgical, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Dental Implant insertion and tooth extraction, outcomesModule primaryOutcomes measure: ISQ measurements, primaryOutcomes measure: Pain, secondaryOutcomes measure: CBCTs analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Biointelligent Technology Syst, status: RECRUITING, city: Barcelona, zip: 08009, country: Spain, contacts name: Maher Atari, PhD, role: CONTACT, email: [email protected], geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06371417, orgStudyIdInfo id: RAY902CT, briefTitle: Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Chugai Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP)., conditionsModule conditions: Antiphospholipid Syndrome (APS), conditions: Bullous Pemphigoid (BP), conditions: Behçet's Syndrome (BS), conditions: Dermatomyositis (DM), conditions: Immune-mediated Necrotizing Myopathy (IMNM), conditions: Immune Thrombocytopenia (ITP), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: RAY121, outcomesModule primaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: RAY121 concentration, secondaryOutcomes measure: AUCτ, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Cmin, secondaryOutcomes measure: Active C1s, secondaryOutcomes measure: Total C1s, secondaryOutcomes measure: Complement activity (classical pathway), secondaryOutcomes measure: Anti-RAY121 antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oregon Health & Science University, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Hokkaido University Hospital, city: Sapporo, state: Hokkaido, zip: 060-0808, country: Japan, geoPoint lat: 43.06667, lon: 141.35, locations facility: Tohoku University Hospital, city: Sendai, state: Miyagi, zip: 980-8574, country: Japan, geoPoint lat: 38.26667, lon: 140.86667, locations facility: Osaka University Hospital, city: Suita, state: Osaka, zip: 565-0871, country: Japan, geoPoint lat: 34.76143, lon: 135.51567, locations facility: Hamamatsu University Hospital, city: Hamamatsu, state: Shizuoka, zip: 431-3192, country: Japan, geoPoint lat: 34.7, lon: 137.73333, locations facility: Toho University Omori Medical Center, city: Ota-ku, state: Tokyo, zip: 143-8540, country: Japan, geoPoint lat: 36.3, lon: 139.36667, hasResults: False |
protocolSection identificationModule nctId: NCT06371404, orgStudyIdInfo id: 2000037129, briefTitle: Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2030-06-01, completionDateStruct date: 2031-06-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, descriptionModule briefSummary: The overall objective of this study it to use Positron Emission Tomography (PET) brain imaging and a radiotracer that measures the epigenetic marker Histone Deacetylase 6 (HDAC6) to examine HDAC6 expression in people with Post-Traumatic Stress Disorder (PTSD), Alcohol Use Disorder (AUD), or concurrent PTSD and AUD with control groups. While there are a large number of studies conducted in preclinical stress and addiction models, these findings have not been translated to people living with these disorders. We will examine relationships between HDAC6 and clinical variables of interest. Findings could direct treatment development., conditionsModule conditions: Alcohol Use Disorder, conditions: Post Traumatic Stress Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Bavarostat, outcomesModule primaryOutcomes measure: HDAC6 expression in people with Post-Traumatic Stress Disorder, primaryOutcomes measure: HDAC6 expression in people with Alcohol use Disorder, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yale University, city: New Haven, state: Connecticut, zip: 06518, country: United States, contacts name: Kelly Cosgrove, PhD, role: CONTACT, phone: 203-737-6969, email: [email protected], contacts name: Marc Grasso, Ba, role: CONTACT, phone: 2037377074, email: [email protected], contacts name: Kelly Cosgrove, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, hasResults: False |
protocolSection identificationModule nctId: NCT06371391, orgStudyIdInfo id: 2023-02077, briefTitle: Environmental and Occupational Noise Exposure in Relation to Incidence of Type 2 Diabetes, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 1992-01-01, primaryCompletionDateStruct date: 2013-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: The Swedish Research Council, descriptionModule briefSummary: Large parts of the population are exposed to traffic noise, particularly in urban areas, and high noise levels occur in many workplaces. The aims of this project are to estimate exposure-response relationships for incidence of type 2 diabetes (T2D) related to long-term exposure to road traffic, railway and aircraft noise, as well as occupational noise. Furthermore, mediation by sleep disturbances and overweight/obesity is investigated, as well as interactions with air pollution and clinical biomarkers, to elucidate important etiological pathways. The project is based on pooled analyses of nine Scandinavian cohorts, totally including more than 300 000 individuals. Detailed longitudinal exposure to traffic noise from different sources, air pollutants and greenness, as well as occupational exposures, are estimated with state-of-the-art methods and supplemented with questionnaire and registry data on risk factors as well as clinical measurements. Incidence of T2D is assessed by combining information from medical examinations, high quality registers, questionnaires and biomarker measurements. Population attributable risks are estimated by combining population data on exposure with information on exposure-response relationships. In several aspects the project is unique and addresses questions which have never been studied before. Our results will provide important guidance for prioritization of preventive measures to promote health sustainable urban development and safe workplaces., conditionsModule conditions: Environment Related Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300000, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Type 2 diabetes (T2D), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 98 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371378, orgStudyIdInfo id: gastric residual volume, briefTitle: Effect of Different Peep Values on Gastric Residual Volume, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: The aim of this study was to predict the effect of gastric antrum diameter before extubation on intra-abdominal pressure changes and consequently on the risk of pulmonary aspiration in patients undergoing elective spinal surgery under general anaesthesia in the prone position in the Neurosurgery Operating Theatre of the Ministry of Health Ankara City Hospital and to take precautions accordingly. Gastric antrum diameter and intraabdominal pressure measurements may contribute to the improvement of anaesthetic practice by reducing the risk of pulmonary aspiration and additional complications., conditionsModule conditions: Respiratory Aspiration of Gastric Content, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: PEEP 0, interventions name: PEEP 4, interventions name: PEEP 8, outcomesModule primaryOutcomes measure: Gastric antrum diameter, secondaryOutcomes measure: Intraabdominal pressure (IAP) measurement, secondaryOutcomes measure: gastric volume measurement, otherOutcomes measure: Vital parameters Pulse oximetry (%), otherOutcomes measure: Vital parameters systolic and diastolic blood pressure (mmHg), otherOutcomes measure: Vital parameters heart rate (beats/minute), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara City Hospital, city: Ankara, state: Çankaya, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06371365, orgStudyIdInfo id: KMUHIRB-E(II)-20220204, briefTitle: Adverse Events for Free Flap Surgery in Head and Neck Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-19, primaryCompletionDateStruct date: 2023-09-24, completionDateStruct date: 2023-09-24, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Kaohsiung Medical University, class: OTHER, collaborators name: Kaohsiung Medical University Chung-Ho Memorial Hospital, descriptionModule briefSummary: This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022., conditionsModule conditions: Surgical Flaps, conditions: Flap Failure Risk Factors, conditions: Hematoma Risk Factors, conditions: Thrombosis Risk Factors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 540, type: ACTUAL, armsInterventionsModule interventions name: Free Flap surgery, outcomesModule primaryOutcomes measure: Number of participants with flap failure, secondaryOutcomes measure: Number of participants with hematoma, secondaryOutcomes measure: Number of participants with thrombosis, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, city: Kaohsiung, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False |
protocolSection identificationModule nctId: NCT06371352, orgStudyIdInfo id: JagiellonianU73, briefTitle: Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Jakub Antczak, class: OTHER, collaborators name: Institute of Psychiatry and Neurology, Warsaw, descriptionModule briefSummary: Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression., conditionsModule conditions: Unipolar Depression, conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized, sham-controlled clinical trial in parallel design, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Placebo intervention will be delivered with a sham-coil for magnetic stimulation, which looks identical and elicits similar sounds as the coil used for active stimulation, but induces only negligible magnetic field., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: iTBS, interventions name: cTBS, interventions name: Sham, outcomesModule primaryOutcomes measure: Beck Depression Inventory 2, primaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Brief Psychiatric Rating Scale, secondaryOutcomes measure: Epworth Sleepiness Scale, secondaryOutcomes measure: Fatigue Assessment Scale, secondaryOutcomes measure: Quality of Life in Depression Scale, secondaryOutcomes measure: Sleep propensity non-rapid eye movement 1 sleep stage, secondaryOutcomes measure: Sleep propensity non-rapid eye movement 2 sleep stage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Psychiatry and Neurology, city: Warsaw, zip: 02957, country: Poland, contacts name: Bogdan Stefanowski, role: CONTACT, phone: +48 22 45 82 532, email: [email protected], contacts name: Jakub Antczak, MD, role: CONTACT, phone: +48 12 400 25 50, email: [email protected], geoPoint lat: 52.22977, lon: 21.01178, hasResults: False |
protocolSection identificationModule nctId: NCT06371339, orgStudyIdInfo id: 23 VADS 03, briefTitle: Optimization With a Gamma Camera of the Individualized Patient Dosimetry in Radioiodine Therapy of Thyroid Diseases, acronym: THIDOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Institut Claudius Regaud, class: OTHER, collaborators name: Laboratoire IJCLab, descriptionModule briefSummary: This is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " MoTI " (Mobile Therapy Imager)) for patients with hyperthyroidism (Graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131I treatment is indicated.Its aim is to assess the feasibility of using this ambulatory gamma camera (MoTI) in the clinic in this patient population. The camera will be used to measure the 131I uptake/fixation rates during the thyroid scintigraphy.20 patients will be included in the study., conditionsModule conditions: Hyperthyroidism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Additional acquisitions with the investigational gamma-camera " MoTI "., outcomesModule primaryOutcomes measure: The clinical feasibility of using an ambulatory gamma camera., secondaryOutcomes measure: The level of acceptance of the gamma camera by operators for carrying out examinations, secondaryOutcomes measure: The quality of the images for the expected clinical use, secondaryOutcomes measure: The ability of the gamma camera to generate images compatible with the Picture Archiving and Communication System (PACS), secondaryOutcomes measure: The quality of the images obtained with the ambulatory gamma camera compared with those obtained during the standard examination (i.e. gamma camera used in the department, Syngula), secondaryOutcomes measure: The 131I fixation rates will be measured in percent at different times., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IUCT-O, city: Toulouse, country: France, contacts name: Slimane ZERDOUD, role: CONTACT, phone: 05 31 15 56 28, email: [email protected], geoPoint lat: 43.60426, lon: 1.44367, hasResults: False |
protocolSection identificationModule nctId: NCT06371326, orgStudyIdInfo id: BJQLZT002004, briefTitle: A Study of ZT002 Injection in Participants With Overweight or Obesity, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-21, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Beijing QL Biopharmaceutical Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: This study will comprise a randomized, double-blind, placebo-controlled, multiple-ascending-dose, safety, tolerability, and pharmacokinetics study of ZT002 in participants with Overweight or Obesity., conditionsModule conditions: Overweight or Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: ZT002 Injection, interventions name: Placebo, outcomesModule primaryOutcomes measure: Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events., primaryOutcomes measure: Safety and tolerability of a multiple escalation dose of ZT002 through the incidence severity of serious adverse events in MAD Cohorts. Number of participants with serious adverse events., secondaryOutcomes measure: The Pharmacokinetics (PK) profile of a multiple escalation dose of ZT002 in participants with overweight or obesity., secondaryOutcomes measure: The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in participants with overweight or obesity., secondaryOutcomes measure: The anti-drug antibody (ADA) response through testing serum or plasma of the participants post-dosing., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Bengbu Medical College, city: Bengbu, country: China, geoPoint lat: 32.94083, lon: 117.36083, hasResults: False |
protocolSection identificationModule nctId: NCT06371313, orgStudyIdInfo id: GuangdongWCH-LiLi03, briefTitle: Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-03-05, completionDateStruct date: 2024-03-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Guangdong Women and Children Hospital, class: OTHER, descriptionModule briefSummary: This study is a cross-sectional study to explore the endocrine metabolism and inflammatory characteristics of the offspring of mothers with PCOS hyperandrogenism, in order to provide a theoretical basis for finding the cause of PCOS., conditionsModule conditions: PCOS, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Testosterone, primaryOutcomes measure: Androstenedione, primaryOutcomes measure: Dehydroepiandrosterone Sulfate, primaryOutcomes measure: Sex Hormone Hinding Globulin, primaryOutcomes measure: Free Androgen Index, primaryOutcomes measure: Fasting Insulin, primaryOutcomes measure: White Blood Cell Count, primaryOutcomes measure: Neutrophil Count, primaryOutcomes measure: High-sensitivity C-reactive Protein, primaryOutcomes measure: Interleukin-6, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Guangdong Women and Children Hosptial, city: Guanzhou, state: Guangdong, zip: 511400, country: China, hasResults: False |
protocolSection identificationModule nctId: NCT06371300, orgStudyIdInfo id: HLS21156, briefTitle: Photobiomodulation With REd vs BluE Light (REBEL), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Aston University, class: OTHER, descriptionModule briefSummary: The use of photobiomodulation or low-level light therapy (LLLT) in the ophthalmic field stemmed from dermatology which has shown impact on skin blood flow and regeneration. There has been a rise in clinical interest with emerging evidence in the benefits of photobiomodulation in managing chronic inflammatory conditions such as dry eye disease including improvements in ocular discomfort symptoms, tear film stability and tear volume. Despite the observed clinical benefits, limited research has been done to compare photobiomodulation utilising different wavelengths, as most research on dry eye disease has focused on red wavelengths. It has been purported that blue wavelengths may disrupt microbial growth while red wavelengths stimulate energy production and hence increase heat in the affected tissues, although research into these differential impacts at the ocular surface and external eye has been limited. Hence, the aim of this exploratory clinical trial is to compare the impact of using LLLT incorporating red versus blue wavelengths on eyelid haemodynamics and microbiome, as well as conventional ocular surface measures of patients with dry eye disease and blepharitis (inflammation of the eyelids).Participants with dry eye disease, oil gland disruption and blepharitis will receive 3 treatments with these LLLT, each separted by 1 week apart, and followed up to 1 month after the final treatment session. Participants will be randomised to either of 3 groups: Red light only group, Red + Blue light group, or a sham treatment group., conditionsModule conditions: Dry Eye Syndromes, conditions: Meibomian Gland Dysfunction, conditions: Blepharitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Each participant is randomised to either of 3 groups: Red light only group, red plus blue light group, or sham treatment group., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Red LLLT, interventions name: Blue LLLT, interventions name: Sham Red LLLT, interventions name: Sham Blue LLLT, outcomesModule primaryOutcomes measure: Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Visual Acuity to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Blink Rate to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Tear Meniscus Height to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Lipid Layer Pattern Grading to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Limbal Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Bacterial Colony to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Blood Flow to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Saponification Grading to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Demodex Presence to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Meibum Expressibility to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Meibum Quality to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Fluorescein Corneal Staining to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Bulbar Conjunctival Staining to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Meibography Meiboscore to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Total Corneal Nerve Length to the Final Follow-up 1 Month After Final Treatment Session, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aston Dry Eye Clinic, city: Birmingham, state: West Midlands, zip: B4 7ET, country: United Kingdom, contacts name: Jeremy Chung Bo Chiang, PhD, role: CONTACT, phone: +441212043934, phoneExt: 3934, email: [email protected], geoPoint lat: 52.48142, lon: -1.89983, hasResults: False |
protocolSection identificationModule nctId: NCT06371287, orgStudyIdInfo id: 64696022.1.0000.5346, briefTitle: Effect of Musical Auditory Training on Subjects With Tinnitus Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-20, primaryCompletionDateStruct date: 2024-08-10, completionDateStruct date: 2025-02-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Universidade Federal de Santa Maria, class: OTHER, descriptionModule briefSummary: Among the theories of tinnitus generation, there is that of central neuroplastic changes, which reports the association between changes and reorganization that occur in central auditory pathways and impacts on associated areas due to the altered neural signal. Auditory training modifies these altered pathways through auditory exercises, which provoke positive neuroplasticity. Musical auditory training is a proposal to stimulate auditory, cognitive and metalinguistic skills with activities focused on musicality. Therefore, the objective of this study is to verify the effect of musical auditory training (MAT) on the neuroplasticity of the auditory system and the perception of tinnitus disorder in young adults., conditionsModule conditions: Tinnitus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Treinamento Auditivo Musical, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in latency of the long latency auditory evoked potential (LLAEP), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Universidade Federal de Santa Maria, status: RECRUITING, city: Santa Maria, state: RS, zip: 97.105-970, country: Brazil, contacts name: Dayane Domeneghini Didoné, role: CONTACT, phone: 553220-9362, email: [email protected], contacts name: Dayane Domeneghini Didoné D Dayane Domeneghini Didoné, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -29.68417, lon: -53.80694, locations facility: Universidade Federal de Santa Maria, status: RECRUITING, city: Santa Maria, state: RS, zip: 97.105-970, country: Brazil, contacts name: Dayane D Didoné, Professora, role: CONTACT, phone: 553220-9362, email: [email protected], contacts name: Christine G Schumacher, Mestranda, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -29.68417, lon: -53.80694, hasResults: False |
protocolSection identificationModule nctId: NCT06371274, orgStudyIdInfo id: ZYYY-IIT-TNBC-001, briefTitle: A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Zhejiang University, class: OTHER, collaborators name: Shanghai Longfine Biotechnology Co., Ltd., collaborators name: TopAlliance, descriptionModule briefSummary: To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy., conditionsModule conditions: Triple-negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: ATRA, interventions name: Toripalimab, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Overall Survival (OS), otherOutcomes measure: Incidence of Treatment-Emergent Adverse events as assessed by NCI-CTCAE 5.0, otherOutcomes measure: Exploratory biomarkers-peripheral blood lymphocyte analysis, otherOutcomes measure: Exploratory biomarkers-Serum Metabolomics Analysis, otherOutcomes measure: Exploratory biomarkers-Fecal Microbiota Analysis, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The first affiliated hospital, Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang Province, P.R. China, zip: 310003, country: China, contacts name: Meihua Lin, MS, role: CONTACT, contacts name: Jian Liu, MS, role: PRINCIPAL_INVESTIGATOR, contacts name: Xiaochen Zhang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06371261, orgStudyIdInfo id: 2023/CHU/07, briefTitle: Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis, acronym: ACHROMO-MUCO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de la Réunion, class: OTHER, descriptionModule briefSummary: The pathogenicity of Achromobacter bacteria is not yet well established, but studies show a decline in respiratory function and an increase in mortality associated with chronic colonisation, making it possible to classify the Achromobacter genus as an emerging pathogen in cystic fibrosis. It is possible that certain species or clones are more virulent or resistant, requiring the adaptation of measures to prevent cross-transmission in the centres concerned.However, until now, the identification of Achromobacter species has involved the use of molecular biology techniques that are not routinely applicable in diagnostic laboratories, limiting studies and the collection of epidemiological data. Recently, a database using MALDI-TOF mass spectrometry has been built for rapid and accurate species identification.In view of the local epidemiology and the current lack of data, it would be necessary and interesting to use this tool to study a cohort of cystic fibrosis patients in Réunion island (North and South sites) to see whether one species has a greater clinical impact than another (pathogenicity), and/or is more responsible for chronic colonisation., conditionsModule conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Biological analyses, outcomesModule primaryOutcomes measure: Frequency of pulmonary exacerbations according to the species of the Achromobacter genus colonising/infecting cystic fibrosis patients., secondaryOutcomes measure: Frequency of pulmonary exacerbations as a function of Achromobacter spp. colonisation status., secondaryOutcomes measure: Emergence or existing presence of clones within the species of the genus Achromobacter circulating among cystic fibrosis patients in Réunion, using genomic analyses., secondaryOutcomes measure: Presence of virulence factors in these strains using genomic analyses, secondaryOutcomes measure: Search for genes responsible for antibiotic resistance by genomic analysis of these strains, secondaryOutcomes measure: To describe the epidemiology of Achromobacter spp. in cystic fibrosis patients in Réunion, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU la Réunion North, status: RECRUITING, city: Saint-Denis, country: Réunion, contacts name: VERHILLE Juliette, MD, role: CONTACT, email: [email protected], contacts name: Juliette VERHILLE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -20.88231, lon: 55.4504, locations facility: CHU la Réunion South, status: RECRUITING, city: Saint-Pierre, country: Réunion, contacts name: PERISSON Caroline, MD, role: CONTACT, email: [email protected], contacts name: Caroline PERISSON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -21.3393, lon: 55.47811, hasResults: False |
protocolSection identificationModule nctId: NCT06371248, orgStudyIdInfo id: 2850, briefTitle: Steady Feet: Preventing Falls in the Community, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-11-19, primaryCompletionDateStruct date: 2019-12-20, completionDateStruct date: 2019-12-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Changi General Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to examine the feasibility of Steady Feet, a three-month community-based falls prevention exercise program., conditionsModule conditions: Fall, conditions: Feasibility, conditions: Older Adults, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ACTUAL, armsInterventionsModule interventions name: Steady Feet, interventions name: Usual care for fall prevention, outcomesModule primaryOutcomes measure: Short Physical Performance Battery (SPPB), secondaryOutcomes measure: CONFbal, secondaryOutcomes measure: Six-minute walk test (6MWT), secondaryOutcomes measure: Timed up and go (TUG), secondaryOutcomes measure: Four square step test (FSST), secondaryOutcomes measure: Feedback and satisfaction survey, otherOutcomes measure: Attendance and completion rates, otherOutcomes measure: Safety of Steady Feet, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changi General Hospital, city: Singapore, zip: 529889, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
protocolSection identificationModule nctId: NCT06371235, orgStudyIdInfo id: 2024-A00739-38, briefTitle: Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier, acronym: Pregiferon, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: CerbaXpert, class: OTHER, descriptionModule briefSummary: The main objective of the study is to evaluate the frequency of placental transfer of self-Ab directed against the mother's IFN alpha in the newborn, in all women suffering from a pathology frequently associated with the presence of these autoantibodies and in those seropositive during the pregnancy., conditionsModule conditions: Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Pregiferon, outcomesModule primaryOutcomes measure: Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06371222, orgStudyIdInfo id: BSMMU/2023/6502, briefTitle: Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, class: OTHER, descriptionModule briefSummary: Mitral stenosis, a condition characterized by narrowing of the mitral valve orifice, remains a significant cause of morbidity and mortality worldwide, particularly in regions where rheumatic fever is endemic. Despite advancements in medical and surgical management, patients with mitral stenosis often suffer from symptoms such as dyspnea, fatigue, and reduced exercise tolerance, significantly impacting their quality of life (QoL) \[1\].One of the hallmark features of mitral stenosis is the development of sinus rhythm, which can be associated with elevated heart rates due to decreased diastolic filling time and compensatory mechanisms to maintain cardiac output. Persistent tachycardia in patients with mitral stenosis contributes to increased myocardial oxygen demand, exacerbating symptoms and potentially leading to adverse outcomes \[2\].In recent years, ivabradine, a selective inhibitor of the If current in the sinoatrial node, has emerged as a promising therapeutic option for controlling heart rate in various cardiovascular conditions, including chronic heart failure and ischemic heart disease \[3\]. By specifically targeting the cardiac pacemaker cells, ivabradine reduces heart rate without affecting myocardial contractility or conduction, offering a unique mechanism of heart rate control compared to traditional beta-blockers or calcium channel blockers \[4\].However, the role of ivabradine in patients with mitral stenosis in sinus rhythm remains uncertain, and there is limited evidence regarding its efficacy and impact on QoL in this specific patient population. Therefore, the aim of this randomized controlled trial (RCT) is to investigate the effects of ivabradine on heart rate control and QoL in patients with mitral stenosis in sinus rhythm., conditionsModule conditions: Mitral Stenosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule interventions name: Ivabradine, interventions name: Beta blocker, outcomesModule primaryOutcomes measure: effect of ivabradine in MS patients, secondaryOutcomes measure: quality of life of MS patients, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: BSMMU, city: Dhaka, zip: 1200, country: Bangladesh, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False |
protocolSection identificationModule nctId: NCT06371209, orgStudyIdInfo id: 2022P000619, briefTitle: Kinematics of Ewing Amputees, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-05-17, primaryCompletionDateStruct date: 2024-06-29, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: The agonist-antagonist myoneural interface (AMI) construct, known as the Ewing amputation at the trans-tibial level, has been shown to create a bi-directional neural communication platform as a means of controlling and interpreting proprioceptive feedback from a prosthetic joint. In AMI constructs, agonist-antagonist muscles are mechanically coupled within the residual limb, and volitional contraction of an agonist passively stretches that muscle's antagonist. The natural neural responses from muscle spindles within both muscles are then interpreted by the central nervous system as sensations of joint position and speed, associated with movement of the prosthesis.The aim of this research protocol is to evaluate the electromyographic and kinematic patterns of participants who have undergone unilateral lower extremity Ewing Amputation in order to determine how similar their residual limb data is when compared to their intact limb data. A secondary aim of this research may include comparison of the Ewing participant cohort's biomechanical patterns to a similar cohort of participants who have undergone standard amputation.The investigators hypothesize that the affected limb of patients with the Ewing procedure will demonstrate a pattern of electromyographic activation of their AMI constructs and kinematic data that recapitulates the pattern seen in their intact limb. The investigators secondarily hypothesize that the kinematic assessment of Ewing Amputation patients will demonstrate patterns that are significantly more physiologic than those witnessed in similar assessments of standard amputees., conditionsModule conditions: Lower Extremity Amputation, conditions: Trans-Tibial Amputation, conditions: Traumatic Lower Extremity Amputation, conditions: Agonist-Antagonist Myoneural Interface, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Modified Amputation, interventions name: Standard Amputation, outcomesModule primaryOutcomes measure: Duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait, primaryOutcomes measure: Symmetry of duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait, secondaryOutcomes measure: Symmetry of ankle power generation, secondaryOutcomes measure: Symmetry of peak knee flexion during stance, otherOutcomes measure: Symmetry of step length, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mass General Brigham, city: Boston, state: Massachusetts, zip: 02129, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06371196, orgStudyIdInfo id: BBD-PBC 2024-03, briefTitle: Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2025-07-25, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mei Han, class: OTHER, descriptionModule briefSummary: 1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin;2. To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin., conditionsModule conditions: Primary Biliary Cholangitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Babaodan Capsule, outcomesModule primaryOutcomes measure: Total bilirubin (TBil) reversion rate, primaryOutcomes measure: Total bilirubin (TBil) efficacy rate, secondaryOutcomes measure: biological response rate, secondaryOutcomes measure: ALT, secondaryOutcomes measure: AST, secondaryOutcomes measure: ALP, secondaryOutcomes measure: TBA, secondaryOutcomes measure: DBil, secondaryOutcomes measure: IBil, secondaryOutcomes measure: 5-D Pruritus Scale Score, secondaryOutcomes measure: Fatigue section of the PBC-40 questionnaire, secondaryOutcomes measure: Immunological indicators - serum IgM, secondaryOutcomes measure: Immunological indicators - serum IgG, secondaryOutcomes measure: Immunological indicators - serum IgA, secondaryOutcomes measure: Immunological indicators - anti-gp210 antibody, secondaryOutcomes measure: Immunological indicators - anti-sp100 antibody, secondaryOutcomes measure: Immunological indicators - autoantibodies AMA/AMA-M2, secondaryOutcomes measure: Histopathology of the liver - grading of inflammatory activity, secondaryOutcomes measure: Histopathology of the liver - staging of the degree of fibrosis, secondaryOutcomes measure: 12-lead electrocardiogram, secondaryOutcomes measure: Physical examination, secondaryOutcomes measure: Routine blood test, secondaryOutcomes measure: Renal Function Tests-BUN, secondaryOutcomes measure: Renal Function Tests-UA, secondaryOutcomes measure: Renal Function Tests-Scr, secondaryOutcomes measure: Urinalysis, secondaryOutcomes measure: Coagulation tests-PT, secondaryOutcomes measure: Coagulation tests-APTT, secondaryOutcomes measure: Coagulation tests-TT, secondaryOutcomes measure: Coagulation tests-FIB, secondaryOutcomes measure: Urine beta-hCG pregnancy test, secondaryOutcomes measure: adverse event, secondaryOutcomes measure: Body temperature, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Number of breaths in 1 min, secondaryOutcomes measure: Blood pressure-Diastolic blood pressure(mmHg), secondaryOutcomes measure: Blood pressure-Systolic blood pressure(mmHg), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371183, orgStudyIdInfo id: AOMSaidB, briefTitle: A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children on June 2024, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2027-05-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: A Comparative study of clinical, endoscopic and histopathological features of colitis in children, conditionsModule conditions: Role of Ileoscopy in Diagnosis of Colitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients who complaining of lower GI manifestations, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 196, type: ESTIMATED, armsInterventionsModule interventions name: Colonoscope, outcomesModule primaryOutcomes measure: Role of ileoscopy in diagnosis of colitis, secondaryOutcomes measure: To correlate clinical manifestations by colonoscopic picture, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371170, orgStudyIdInfo id: CCPC- 001/22, briefTitle: Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero, Universitaria Ospedali Riuniti, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (\< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment?Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis., conditionsModule conditions: Intracardiac Thrombus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Rivaroxaban, outcomesModule primaryOutcomes measure: Thrombus resolution, secondaryOutcomes measure: Bleeding, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: CCPC, status: RECRUITING, city: Ancona, state: Marche, zip: 60123, country: Italy, contacts name: Francesco Bianco, M.D., role: CONTACT, phone: +39 071 596 5316, email: [email protected], geoPoint lat: 43.5942, lon: 13.50337, hasResults: False |
protocolSection identificationModule nctId: NCT06371157, orgStudyIdInfo id: AK104-308, briefTitle: A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-02, primaryCompletionDateStruct date: 2025-10-25, completionDateStruct date: 2026-05-23, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Akeso, class: INDUSTRY, descriptionModule briefSummary: A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma, conditionsModule conditions: Hepatocellular Carcinoma, 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: 469, type: ESTIMATED, armsInterventionsModule interventions name: AK104, interventions name: Lenvatinib, interventions name: TACE, interventions name: Placebo for AK104, interventions name: Placebo for Lenvatinib, outcomesModule primaryOutcomes measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: PFS per RECIST 1.1, secondaryOutcomes measure: Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST), secondaryOutcomes measure: Duration of Response (DOR) per RECIST 1.1 and mRECIST, secondaryOutcomes measure: Disease Control Rate (DCR) per RECIST 1.1 and mRECIST, secondaryOutcomes measure: Time to Response (TTR) per RECIST 1.1 and mRECIST, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Cancer Hospital, city: Zhengzhou, state: Henan, zip: 450004, country: China, contacts name: Hailiang Li, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 410006, country: China, contacts name: Shanzhi Gu, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Zhongda Hospital Southeast University, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Gaojun Teng, role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Shanxi Cancer Hospital, city: Taiyuan, state: Shanxi, zip: 030009, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Sichuan Cancer Hospital, city: Chengdu, state: Sichuan, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Yunnan Cancer Hospital, city: Kunming, state: Yunnan, zip: 650100, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Zhejiang Cancer Hospital, city: Hangzhou, state: Zhejiang, zip: 310005, country: China, contacts name: Guoliang Shao, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06371144, orgStudyIdInfo id: NHREC/16/05/22/130, briefTitle: A Randomized Control Trial on Intravenous Paracetamol Versus Intramuscular Tramadol as Intra Partum Labor Analgesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-03, primaryCompletionDateStruct date: 2022-09-10, completionDateStruct date: 2022-09-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Darlington-Peter Chibuzor Ugoji, class: OTHER, descriptionModule briefSummary: ABSTRACT BACKGROUND: Labor pain is one of the most excruciating pain experienced by women. It affects maternal psychology and the course of labor causing apprehension, anxiety, and stress. Therefore there is a need for a safe and effective analgesic with minimal maternal and fetal side effects like intravenous paracetamol which has been shown to have great analgesic effect in labour with minimal maternal and neonatal side effects.OBJECTIVE: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs.METHOD: This would be a hospital based randomized controlled trial comparing intravenous paracetamol to intramuscular tramadol as labour analgesia in pregnant women in active phase of labour in the department of obstetrics and gynecology at Alex-Ekwueme Federal University Teaching Hospital and St. Patrick Mile 4 hospital, Abakaliki. A total of 194 pregnant women in active phase of labour will be included in study after fulfilling the inclusion criteria. These women will be divided into 2 groups of 97 each. Group A will receive a 100ml intravenous infusion containing 1000mg of paracetamol single dose over 15min. Group B: will receive intramuscular tramadol hydrochloride 100mg single dose. Pain intensity of women with both drugs will be noted before administration of drug, one hour, two hours and three hours after administration of drug using the visual analog scale. Perinatal outcome will also be recorded.10 ANALYSIS AND RESULTS: Data will be collated, tabulated and then statistically analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables will be presented as mean and standard deviation (Mean ± 2SD) or median and range as appropriate, while categorical variables will be presented as frequencies and percentages. Chi-square test( or Fisher's exact test where applicable) will be used for comparison between groups for categorical variables while student t test or Mann-Whitney U test will be used for comparison between groups for continuous variables KEYWORDS Labour analgesia, intravenous paracetamol, intramuscular tramadol, visual analog scale, neonate, side effects., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Double blinded, whoMasked: PARTICIPANT, enrollmentInfo count: 194, type: ACTUAL, armsInterventionsModule interventions name: Paracetamol, outcomesModule primaryOutcomes measure: Mean pain score, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: AEFUTHA, city: Abakaliki, state: Ebonyi, zip: 234, country: Nigeria, geoPoint lat: 6.32485, lon: 8.11368, hasResults: False |
protocolSection identificationModule nctId: NCT06371131, orgStudyIdInfo id: PONV of Thyroid Surgery, briefTitle: Effect of Stellate Ganglion Block on Postoperative Nausea and Vomiting, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-17, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Chongqing Medical University, class: OTHER, descriptionModule briefSummary: Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as thyroid surgery is even up to 70-80%. PONV not only increased discomfort and prolonged hospital stay; Severe cases can lead to wound dehysis, acid-base imbalance, water and electrolyte metabolism disorders, seriously affect the prognosis of patients. Although various prevention and treatment measures have been adopted in clinical practice, it still cannot be completely eliminated. Therefore, postoperative nausea and vomiting of thyroid is still a concern in clinical anesthesia work, so it is urgent to explore more simple and effective measures to prevent thyroid PONV. SGB is the injection of local anesthetics into loose connective tissue containing stellate ganglion. It has a clear effect on postoperative analgesia of thyroid surgery, and can play a certain role in preventing thyroid PONV by reducing the application of perioperative opioids. Few studies have reported that the incidence of PONV can be significantly reduced after the application of SGB in patients with thyroid surgery, which provides a certain basis for the prevention of thyroid PONV. Therefore, this study aims to explore the effect of right stellate ganglion block on preventing postoperative nausea and vomiting of thyroid, and to explore the possible mechanism of action., conditionsModule conditions: Stellate Ganglion Block, conditions: Thyroid Surgery, conditions: Postoperative Nausea and Vomiting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental group: right stellate ganglion block 30 minutes before anesthesia induction.Control group: No treatment was given 30minutes before anesthesia induction.Data was recorded at the corresponding time points., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Right -stellate ganglion block, outcomesModule primaryOutcomes measure: Incidence of Postoperative nausea and vomiting, secondaryOutcomes measure: Incidence of Postoperative nausea and vomiting during preemptive analgesia, secondaryOutcomes measure: Intensity of nausea and vomiting during preemptive analgesia, secondaryOutcomes measure: Intensity of nausea and vomiting during hospitalization, secondaryOutcomes measure: Hemodynamic parameters after preemptive analgesia, secondaryOutcomes measure: Postoperative pain intensity, secondaryOutcomes measure: Recovery of gastrointestinal function, secondaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Satisfaction score and postoperative analgesia satisfaction score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Chongqing Medical University, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400000, country: China, contacts name: ling Dan, BD, role: CONTACT, phone: 86 13983072922, email: [email protected], geoPoint lat: 29.56278, lon: 106.55278, hasResults: False |
protocolSection identificationModule nctId: NCT06371118, orgStudyIdInfo id: PI 20210032, briefTitle: HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme, acronym: HERSELF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Universidade do Porto, class: OTHER, collaborators name: Unidade de Saúde Familiar de Garcia de Orta, Porto, collaborators name: Unidade de Saúde Familiar da Prelada, Porto, collaborators name: Unidade de Saúde Familiar de Cedofeita, Porto, collaborators name: Instituto Portugues de Oncologia, Francisco Gentil, Porto, descriptionModule briefSummary: This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening.An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post.Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway., conditionsModule conditions: Papillomavirus Infections, conditions: Early Detection of Cancer, conditions: Cervix Cancer, conditions: Self-Examination, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Directly mailed self-sampling kit to collect a vaginal sample, interventions name: Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure, interventions name: Standard of care - screening in a clinical setting, outcomesModule primaryOutcomes measure: Adherence to conventional screening in control group, primaryOutcomes measure: Adherence to HPV self-sampling in intervention 1 (directly mailed) group, primaryOutcomes measure: Adherence to HPV self-sampling in intervention 2 (opt-in) group, primaryOutcomes measure: Adherence proportion to HPV self-sampling in intervention 1 (directly mailed) group VS Adherence proportion to conventional screening in control group, primaryOutcomes measure: Adherence proportion to HPV self-sampling in intervention 2 (opt-in) group VS Adherence proportion to conventional screening in control group, secondaryOutcomes measure: Adherence to first follow-up step in control group, secondaryOutcomes measure: Adherence to first follow-up step in intervention 1 (directly mailed) group, secondaryOutcomes measure: Adherence to first follow-up step in intervention 2 (opt-in) group, secondaryOutcomes measure: Adherence to first follow-up step in control group among women referred for follow-up, secondaryOutcomes measure: Adherence to first follow-up step in intervention 1 (directly mailed) group among women referred for folow-up, secondaryOutcomes measure: Adherence to first follow-up step in intervention 2 (opt-in) group among women referred for folow-up, secondaryOutcomes measure: Adherence to colposcopy in control group, secondaryOutcomes measure: Adherence to colposcopy in intervention 1 (directly mailed) group, secondaryOutcomes measure: Adherence to colposcopy in intervention 2 (opt-in) group, secondaryOutcomes measure: Adherence to colposcopy in control group among women referred for colposcopy, secondaryOutcomes measure: Adherence to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy, secondaryOutcomes measure: Adherence to colposcopy in intervention 2 (opn-in) group among women referred for colposcopy, secondaryOutcomes measure: Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 1 (directly mailed) group, secondaryOutcomes measure: Timelapse (in days) between the invitation to receive a self-sampling kit and the return of the opt-in answer, in intervention 2 (opt-in) group, secondaryOutcomes measure: Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 2 (opt-in) group, secondaryOutcomes measure: Adherence proportion to first follow-up step in intervention 1 (directly mailed) group VS Adherence proportion to first follow-up step in control group, secondaryOutcomes measure: Adherence proportion to first follow-up step in intervention 2 (opt-in) group VS Adherence proportion to first follow-up step in control group, secondaryOutcomes measure: Adherence proportion to first follow-up step in intervention 1 (directly mailed) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up, secondaryOutcomes measure: Adherence proportion to first follow-up step in intervention 2 (opt-in) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up, secondaryOutcomes measure: Adherence proportion to colposcopy in intervention 1 (directly mailed) group VS Adherence proportion to colposcopy in control group, secondaryOutcomes measure: Adherence proportion to colposcopy in intervention 2 (opt-in) group VS Adherence proportion to colposcopy in control group, secondaryOutcomes measure: Adherence proportion to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy, secondaryOutcomes measure: Adherence proportion to colposcopy in intervention 2 (opt-in) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy, secondaryOutcomes measure: Proportion of HR-HPV positivity in control group, secondaryOutcomes measure: Proportion of HR-HPV positivity in intervention 1 (directly mailed) group, secondaryOutcomes measure: Proportion of HR-HPV positivity in intervention 2 (opt-in) group, secondaryOutcomes measure: Proportion of HR-HPV positivity in control group among women who adhered to conventional screening, secondaryOutcomes measure: Proportion of HR-HPV positivity in intervention 1 (directly mailed) group among women who returned the self-sample, secondaryOutcomes measure: Proportion of HR-HPV positivity in intervention 2 (opt-in) group among women who returned the self-sample, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in control group, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in control group among women who adhered to conventional screening, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group among women who returned the self-sample, secondaryOutcomes measure: Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group among women who returned the self-sample, secondaryOutcomes measure: Positive predictive value of self-sampling for the detection of HR-HPV, using clinician-sampling results as gold standard, secondaryOutcomes measure: Sensitivity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Specificity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Positive likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Negative likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Accuracy of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Sensitivity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Specificity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Positive likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Negative likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Accuracy of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Sensitivity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Specificity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Positive likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Negative likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, secondaryOutcomes measure: Accuracy of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard, eligibilityModule sex: FEMALE, minimumAge: 26 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371105, orgStudyIdInfo id: 014_2018, briefTitle: Aquatic_Training in Obese Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-02, primaryCompletionDateStruct date: 2019-03-30, completionDateStruct date: 2019-03-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Taipei, class: OTHER, descriptionModule briefSummary: This study aims to assess the effects of 10-week water-based aerobic training (thrice a week) on anthropometrics, biochemicals, cardiovascular parameters, and explosive strength in young overweight and obese women. The findings indicate that water-based aerobic training could be a useful program to enhance body composition, biochemical, cardiovascular, and explosive strength parameters in young overweight and obese women compared to inactive persons, conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 31, type: ACTUAL, armsInterventionsModule interventions name: 10-week water-based aerobic training, outcomesModule primaryOutcomes measure: fasting glycemia in millimoles per liter, primaryOutcomes measure: total cholesterol in millimoles per liter, primaryOutcomes measure: high-density lipoprotein cholesterol in millimoles per liter, primaryOutcomes measure: low-density lipoprotein cholesterol in millimoles per liter, primaryOutcomes measure: triglyceride concentrations in millimoles per liter, primaryOutcomes measure: systolic blood pressure in millimeters of mercury, primaryOutcomes measure: diastolic blood pressure in millimeters of mercury, primaryOutcomes measure: heart rate in beat per minute, primaryOutcomes measure: fasting glycemia in millimoles per liter, primaryOutcomes measure: total cholesterol in millimoles per liter, primaryOutcomes measure: high-density lipoprotein cholesterol in millimoles per liter, primaryOutcomes measure: low-density lipoprotein cholesterol in millimoles per liter, primaryOutcomes measure: triglyceride concentrations in millimoles per liter, primaryOutcomes measure: systolic blood pressure in millimeters of mercury, primaryOutcomes measure: diastolic blood pressure in millimeters of mercury, primaryOutcomes measure: heart rate in beat per minute, secondaryOutcomes measure: countermovement jump in centimetres, secondaryOutcomes measure: squat jump in centimeters, secondaryOutcomes measure: chest 3-kg medicine ball throw in meters, secondaryOutcomes measure: countermovement jump in centimetres, secondaryOutcomes measure: squat jump in centimeters, secondaryOutcomes measure: chest 3-kg medicine ball throw in meters, eligibilityModule sex: FEMALE, minimumAge: 29 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Exercise and Health Sciences, University of Taipei, city: Taipei, zip: 11153, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06371092, orgStudyIdInfo id: 2023/01, briefTitle: Efficacy of a Desensitizing Agent During At-home Bleaching, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-31, primaryCompletionDateStruct date: 2023-02-22, completionDateStruct date: 2023-03-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Santiago de Compostela, class: OTHER, descriptionModule briefSummary: The main objective of this study is to evaluate if the use of UltraEZ during at-home bleaching treatment is effective in reducing tooth sensitivity, as well as doesn't affect the degree of tooth bleaching., conditionsModule conditions: Sensitivity, Tooth, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, triple-blind clinical trial, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: UltraEZ, interventions name: Placebo, outcomesModule primaryOutcomes measure: Questionnaire of dental sensitivity, secondaryOutcomes measure: Shade evaluation with a dental spectrophotometer, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: School of Medicine and Dentistry, city: Santiago De Compostela, state: A Coruña, zip: 15705, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, hasResults: False |
protocolSection identificationModule nctId: NCT06371079, orgStudyIdInfo id: NO-OVD-ICL, briefTitle: Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Loay Abdulmutalib Almusawi, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to test whether surgeries for lenses designed to be implanted in the eye to correct refractive error can be done without the need for using viscoelastic substances that are used routinely nowadays to make it easier to introduce them inside the human eye and protect the inside of the eye during the operation.The main question it aims to answer is that is it safe to do the surgery without using them? to answer this question researchers will access recorded data of patients that underwent refractive surgeries in a private clinic since 2017 and compare them as two groups: those who underwent the traditional procedures and those who had it without the use of dispersive viscoelastics in regard to their vision before and after surgery, their ocular pressure and biomicroscopic analysis of the inside of their corneas before and after surgery., conditionsModule conditions: Refractive Errors, conditions: Myopia, conditions: Myopic Astigmatism, conditions: Hypermetropia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: phakic intraocular lens implantation traditional, interventions name: phakic intraocular lens implantation reduced OVD, outcomesModule primaryOutcomes measure: unaided visual acuity after the procedure, primaryOutcomes measure: best corrected visual acuity after the procedure, secondaryOutcomes measure: Intraocular pressure postoperatively, secondaryOutcomes measure: Specular microscopy parameter: endothelial cell density, secondaryOutcomes measure: Specular microscopy parameter: endothelial cells hexagonality, secondaryOutcomes measure: Specular microscopy parameter: coefficient of variation of corneal endothelial cells, otherOutcomes measure: postoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Al-Ferdows private eye hospital, status: RECRUITING, city: Baghdad, country: Iraq, contacts name: Sohaib A Mahmood, CABMS, role: CONTACT, phone: 00971585358111, email: [email protected], contacts name: Sami A Hasoon, role: CONTACT, phone: +9647901867279, email: [email protected], contacts name: Sohaib A Mahmood, CABMS, role: PRINCIPAL_INVESTIGATOR, contacts name: Loay A Almusawi, FIBMS, role: SUB_INVESTIGATOR, contacts name: Hamid M Altaha, CABMS, role: SUB_INVESTIGATOR, contacts name: Bashar Alwash, CABMS, role: SUB_INVESTIGATOR, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False |
protocolSection identificationModule nctId: NCT06371066, orgStudyIdInfo id: EAkyuz-2, briefTitle: The Effect of Video-based Training on the Knowledge Levels of Nursing Students, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-01, primaryCompletionDateStruct date: 2021-04-01, completionDateStruct date: 2021-06-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Kırıkkale University, class: OTHER, descriptionModule briefSummary: Although face-to-face education is widely used as a traditional method, emerging computer technology has allowed new training approaches such as video-based training (VBT) platforms to flourish, especially in the last four decades. Educators adopted VBT as a cost-effective and accessible medium to address some of their training needs. It contains purposely designed visual cues and draws learners' attention during the learning process, and the dynamic details enable learners to better understand the learning contents. The use of new technologies such as e-learning, computer-assisted learning, VBT, and web-based applications for clinical skill education has increased learner satisfaction compared with conventional education methods. Preoperative patient preparation is a crucial element of preoperative nursing care. A surgical nurse is a specialized coordinator of patient care, and the main purposes of this role are to meet the patient's and the family's needs individually and to prepare them for the scheduled procedure and postoperative recovery. Preoperative patient preparation contains multiple components and steps such as preoperative education, including physical, social, psychological, and legal preparation, and preparation for the night and day of surgery. the nature of the process has many components and steps, it is not easy for students to learn this subject, and nursing educators were able to experience this in a clinical practice environment. And the educators started to search for new teaching techniques to teach this subject like the other colleagues. the investigator's aim in this project is to determine the effect of VBT on the knowledge levels of nursing students on preoperative patient preparation when compared to traditional training methods., conditionsModule conditions: Student Nursing, conditions: Medical-surgical Nursing, conditions: Nursing Care, conditions: Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: intervention, control, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: it was an educational intervention. All participants were in the same class so we blinded only statisticians., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 97, type: ACTUAL, armsInterventionsModule interventions name: experimental group, interventions name: Control group, outcomesModule primaryOutcomes measure: The Student Information Form, primaryOutcomes measure: The Knowledge Form for Preoperative Patient Preparation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kirikkale University, city: Kirikkale, country: Turkey, geoPoint lat: 39.84528, lon: 33.50639, hasResults: False |
protocolSection identificationModule nctId: NCT06371053, orgStudyIdInfo id: community - dementia, briefTitle: The Effect of Community Intervention on Different Degrees of Dementia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Babujinaya Cela, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore the impact of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals (≥60 year old) with Alzheimer's disease. It primarily aims to address: the effects of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals with Alzheimer's disease in different degrees. All participants are required to undergo a continuous 2-week (14 days) Community Intervention, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Community Intervention, outcomesModule primaryOutcomes measure: Mini-Mental State Examination, secondaryOutcomes measure: Barthel Index, secondaryOutcomes measure: Functional near-infrared spectroscopy, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371040, orgStudyIdInfo id: V1.0, CART-20230619, briefTitle: Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ting Chang, MD, class: OTHER, descriptionModule briefSummary: This study is a single-center, open-label, single-arm, dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose (MTD). A total of 12 MG patients who meet the inclusion criteria are expected to be recruited., conditionsModule conditions: Myasthenia Gravis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: CD19-BCMA Targeted CAR-T Dose 1 5.0 e5/ kg CD19-BCMA CAR-T positive T cellsCD19-BCMA Targeted CAR-T Dose 2 1.5 e6/ kg CD19-BCMA CAR-T positive T cellsCD19-BCMA Targeted CAR-T Dose 2 5 e6/ kg CD19-BCMA CAR-T positive T cells, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: CD19-BCMA Targeted CAR-T Dose 1, interventions name: CD19-BCMA Targeted CAR-T Dose 2, interventions name: CD19-BCMA Targeted CAR-T Dose 2, outcomesModule primaryOutcomes measure: Frequency, type, and severity of adverse events, secondaryOutcomes measure: Frequency, type, and severity of abnormal laboratory indicators related to treatment, secondaryOutcomes measure: Changes of blood pressure, secondaryOutcomes measure: Changes of pulse rate, secondaryOutcomes measure: Changes of weight, secondaryOutcomes measure: Changes of Myasthenia Gravis Activities of Daily Living (MG-ADL) scores, secondaryOutcomes measure: Changes of Quantitative Myasthenia Gravis (QMG) scores, secondaryOutcomes measure: Changes of Myasthenia Gravis Composite (MGC) scores, secondaryOutcomes measure: Proportion of subjects who achieved improvement, secondaryOutcomes measure: Time to achieve clinical improvement, secondaryOutcomes measure: Changes of myasthenia gravis-specific autoantibody titers, secondaryOutcomes measure: Changes of immunoglobulins, otherOutcomes measure: Changes in proportion of peripheral blood immune cell, otherOutcomes measure: serum inflammatory markers levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tangdu Hospital, The Fourth Military Medical University, city: Xi'an, state: Shaanxi, zip: 710038, country: China, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False |
protocolSection identificationModule nctId: NCT06371027, orgStudyIdInfo id: RECO6U/22-2022, briefTitle: Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: Clinically and radiographically by cone beam CT evaluate the regenerative potentials of silk fibroin (SF) nanofiber membrane, using minimally invasive surgery, for the regenerative treatment of intrabony periodontal defects., conditionsModule conditions: Intrabony Periodontal Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Minimally Invasive Surgery Technique (MIST) + Novel Silk Fibroin (SF) nanofiber membrane, interventions name: Minimally Invasive Surgery Technique (MIST) + collagen membrane, interventions name: Minimally Invasive Surgery Technique (MIST), outcomesModule primaryOutcomes measure: Novel Silk Fibroin Nanofiber Membrane using minimally invasive surgery in Treatment of Periodontal Intrabony Defects, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of dentistry O6U, city: Giza, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06371014, orgStudyIdInfo id: Ondansetron mouth soluble film, briefTitle: Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy, acronym: Ondansetron, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Shanghai Children's Medical Center, class: OTHER, descriptionModule briefSummary: Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Children recruited to arm-B received Ondansetron tablet plus dexamethasone. Ondansetron and dexamethasone were given continuously until 48hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy, conditionsModule conditions: To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Ondansetron oral membrane, outcomesModule primaryOutcomes measure: Complete Remission Rates in the Acute Phases, secondaryOutcomes measure: Complete Remission Rates in the Delayed Phases, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 15 Years, stdAges: CHILD, hasResults: False |
protocolSection identificationModule nctId: NCT06371001, orgStudyIdInfo id: Helicobacter Pyloi and CKD, briefTitle: Prevalance Of Helicobacter Pylori Infection In Chonic Kidney Diseased Patient Admitted To Luxor Medical Complex, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Detect prevalence of Helicobacter pylori infection in chronic kidney diseased patient admitted to Luxor medical complex and possible role of Helicobacter pylori in pathogenesis of chronic kidney diseased patient of unknown etiology, conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule interventions name: disease, outcomesModule primaryOutcomes measure: Helicobacter pylori infection and Chronic kidney diseased patient, secondaryOutcomes measure: possible role of H pylori in pathogenesis of chronic kidney diseased patient of unkown etiology, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370988, orgStudyIdInfo id: 4343, briefTitle: Theta-Burst Stimulation for Bipolar Depression, acronym: TRIBE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Centre for Addiction and Mental Health, class: OTHER, collaborators name: University Health Network, Toronto, descriptionModule briefSummary: The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion., conditionsModule conditions: Bipolar Depression, conditions: Bipolar Disorder, conditions: Treatment- Resistant Bipolar Disorder, conditions: Type 2 Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This trial will use a multi-centre randomized controlled trial for individuals with treatment-resistant Bipolar Depression comparing iTBS applied to the left DLPFC with sham treatment and examining differences in efficacy and safety outcomes between groups over 6 weeks of treatment., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: rTMS treatment will be delivered using the MagPro X100/R30 stimulator and use the Cool-B70 A/P coil (MagVenture, Farum, Denmark), a figure 8 coil with active cooling, in which both the sham and active coils are contained internally. Its symmetric design ensures there is no indication of which side is active or sham with only the side of the coil delivering the treatment differing. The sham coil has been designed in such a way that it produces a similar auditory experience as the active coil. To account for the tactile sensation of active stimulation, both treatment allocations will have scalp electrodes placed that deliver a weak electrical stimulation to mask this tactile sensation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: iTBS Stimulation, interventions name: Sham iTBS Stimulation, outcomesModule primaryOutcomes measure: Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17), secondaryOutcomes measure: Symptoms of Mania, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, city: Toronto, state: Ontario, zip: M5T 2S8, country: Canada, contacts name: Eileen Lam, role: CONTACT, phone: 437-553-0367, email: [email protected], contacts name: Daphne Voineskos, M.D., Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Centre for Addiction and Mental Health, city: Toronto, state: Ontario, zip: M6J 1H4, country: Canada, contacts name: Elizabeth Clancy, role: CONTACT, phone: 416-535-8501, phoneExt: 36434, email: [email protected], contacts name: Tyler Kaster, M.D., Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06370975, orgStudyIdInfo id: Fluid resuscitation in trauma, briefTitle: Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The study aims to investigate the effect of 3% hypertonic saline resuscitation on lactate clearance in comparison to ringer's lactated solution and 0.9% normal saline in traumatic injury patients.Also to provide insights into the optimal fluid resuscitation strategy for traumatic injury patients, conditionsModule conditions: Fluid Resuscitation, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: 3% hypertonic Saline, interventions name: Ringer's lactated solution, interventions name: 0.9% Normal saline, outcomesModule primaryOutcomes measure: Rate of lactate clearance following resuscitation with different solutions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370962, orgStudyIdInfo id: 69HCL24_0076, secondaryIdInfos id: 2024-A00343-44, type: OTHER, domain: ID-RCB, briefTitle: Circadian Rhythm Disorders in Children With Cystic Fibrosis Under CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators, acronym: CHRONO-MUCO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Cystic fibrosis (CF) is a rare disease affecting one out of 4,500 newborns in France (INSERM 2021). Despite major advances in patient care over the past two decades, with significant improvements in life expectancy, cystic fibrosis remains a pathology that considerably impairs quality of life.Several studies have reported the possibility of respiratory and non-respiratory sleep disorders (SD) in patients with CF. Respiratory disorders are reported to affect 30% of children with CF (Barbosa 2020). Among non-respiratory SD, sleep onset and maintenance insomnia are well known in these patients, while chronotype abnormalities (circadian rhythm disorders) are understudied. Chronotype refers to a person's tendency to be more efficient in the morning or evening.The existence of chronotype abnormalities has been suggested in CF patients, but no precise data are available (Louis 2022). The involvement of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) protein dysfunction in the central nervous system (CNS) has been hypothesized as a contributory factor. In vivo, in a mouse model of CF, dysregulation of clock genes such as Clock, Cry2 and Per2 was found in the CNS (Barbato 2019). Among them, certain genes such as Rev-erbα could regulate endobronchial inflammation and contribute to the severity of respiratory pathology. All in all, chronotype abnormalities could be at the origin of sleep debt, impaired cognitive functions or metabolic disturbances.In the era of highly effective modulator therapy (HEMT) for the treatment of CF, the impact of these new therapies on chronotype has been understudied. Assuming that chronotype abnormalities are a direct consequence of CFTR protein dysfunction in the retina and anterior hypothalamus, HEMT should improve sleep quality. However, between 20% and 30% of adult and pediatric patients express an increase in chronotype abnormalities following initiation of treatment.Paradoxically, the perceived gain in respiratory quality of life is counterbalanced by the occurrence of these disorders. Some patients would effectively reverse their treatment in order to limit the phenomenon. A single polysomnographic study evaluated the effect of HEMT Kaftrio-Kalydeco on sleep in adults with CF (Welsner 2022). After 3 months of treatment, patients had a significant reduction in respiratory events, with no change in total sleep time, sleep efficiency or sleep architecture. Chronotype was not mentioned. Currently, no studies on chronotype in children or adults with CF have been carried out. Our hypothesis is that CF patients treated with HEMT would develop an abnormal chronotype of late sleep onset.The aim of this study is to evaluate the chronotype of children with CF treated with HEMT. Chronotype abnormalities could have major consequences for quality of life, the immune system, cognitive functions and metabolism. Systematic detection of these disorders via anamnesis, followed by diagnosis by questionnaire, actimetrics and/or urinary melatonin dosage, would enable their early management, starting with the reversal of Kaftrio-Kalydeco intake between morning and evening., conditionsModule conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Result of the Horne and Ostberg questionnaire., eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Service de pédiatrie, CHRU de Nancy - Hôpitaux de Brabois, city: Nancy, zip: 54500, country: France, contacts name: Iulia IOAN, MD, role: CONTACT, phone: 03.83.15.47.94, phoneExt: +33, email: [email protected], contacts name: Iulia IOAN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, locations facility: Service de pneumologie pédiatrique, Hôpital Armand Trousseau, city: Paris, zip: 75012, country: France, contacts name: Jessica TAYTARD, MD, role: CONTACT, phone: 01 44 73 63 46, phoneExt: +33, email: [email protected], contacts name: Jessica TAYTARD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06370949, orgStudyIdInfo id: 2024-01/17, briefTitle: The Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block, acronym: TAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. Thus, TAP block is widely implemented in perioperative management of colorectal cancer patients.Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries., conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacain, interventions name: bupivacain+dexmedetomidine, outcomesModule primaryOutcomes measure: Analgesic effectiveness of bupivacain and bupivacain+dexmedetomidine combination in colorectal cancer surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Turkey Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital, city: Ankara, state: Cankaya, zip: 06110, country: Turkey, contacts name: Hazal E Guran Aytug, MD, role: CONTACT, phone: 05078448449, email: [email protected], geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06370936, orgStudyIdInfo id: NL84824.091.23, secondaryIdInfos id: NL84824.091.23, type: OTHER, domain: CCMO / Toetsingonline, briefTitle: The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health, acronym: EXPLAIN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Wageningen University, class: OTHER, descriptionModule briefSummary: Plant-based diets with little to no meat are considered healthy and sustainable by the general public. The increasingly popular plant-based meat analogues (PBMAs) allow consumers to easily decrease meat intake while maintaining their dietary patterns. However, scientific knowledge on the health impact of PBMAs on humans is currently very limited.The primary objective of this clinical trial is to evaluate if and to what extent replacing all meat products in an average Dutch diet with currently commercially available PBMAs affects the systolic blood pressure of middle-aged men and women in a 2x8 week fully dietary controlled crossover intervention study. The secondary objectives are to assess the effect of this replacement of meat products with PBMAs on cardiometabolic health, gut microbiome, intestinal health, well-being, and underlying biological mechanisms.114 men and women with a BMI of 23-40 kg/m2, aged 45-75 years will be included in the study. Participants will follow both an 8-week completely controlled diet in which all meats are of plant-based origin (PBMAs) and an 8-week diet in which all meats are of animal origin in randomized order with a 10-week wash-out period. Before the intervention starts, the participants will be characterized to describe them on anthropometrics, glucose tolerance and insulin sensitivity, genetics, sleep patterns, and stress levels. Before the start and at the end of each 8-week dietary intervention period, several measurements, including systolic blood pressure monitoring and secondary outcome measures will be done. Additionally, systolic and diastolic blood pressure will be monitored throughout the dietary interventions and a small quantity of parameters related to the secondary objectives will be measured., conditionsModule conditions: Blood Pressure, conditions: Cardiometabolic Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will follow both an 8-week completely controlled dietary intervention followed by a 10-week washout period followed by another 8-week completely controlled dietary intervention., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Treatment order (PBMA intervention - Meat intervention versus Meat intervention - PBMA intervention) is masked for the researchers. The order is not masked for participants., whoMasked: INVESTIGATOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Standardized diet with commercially available animal meats (comparator products), interventions name: Standardized diet with commercially available PBMAs (intervention products), outcomesModule primaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Diastolic blood pressure, secondaryOutcomes measure: Home systolic blood pressure, secondaryOutcomes measure: Home diastolic blood pressure, secondaryOutcomes measure: Home heart rate, secondaryOutcomes measure: Fasting blood HbA1c levels, secondaryOutcomes measure: Fasting blood glucose levels, secondaryOutcomes measure: Fasting blood insulin levels, secondaryOutcomes measure: Fasting blood lipid spectrum, secondaryOutcomes measure: Fasting blood metabolite profile, secondaryOutcomes measure: Fasting blood proteomic profile, secondaryOutcomes measure: Fasting blood cell transcriptomic profile, secondaryOutcomes measure: Fasting blood nutritional status, secondaryOutcomes measure: Blood immune markers, secondaryOutcomes measure: Blood immune cell populations, secondaryOutcomes measure: Metabolites in 24-hour urine, secondaryOutcomes measure: Interstitial glucose profile, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Fecal microbiome composition, secondaryOutcomes measure: Fasting and postprandial circulating metabolites with a high fat mixed meal (HFMM) challenge, secondaryOutcomes measure: Oral microbiome composition, secondaryOutcomes measure: Microbiome metabolites, secondaryOutcomes measure: Microbiome functionality, secondaryOutcomes measure: Self-reported gastro-intestinal symptoms, secondaryOutcomes measure: Self-reported constipation, secondaryOutcomes measure: Self-reported stool consistency and frequency, secondaryOutcomes measure: Gastro-intestinal transit time, secondaryOutcomes measure: Self reported product-specific attitude towards meat and PBMAs, secondaryOutcomes measure: Self reported meal-specific satiety with meat and PBMAs, secondaryOutcomes measure: Self-reported general attitude toward meat and PBMAs, otherOutcomes measure: Body composition, otherOutcomes measure: Genetic variation, otherOutcomes measure: Oral glucose tolerance test (OGTT), otherOutcomes measure: Habitual dietary intake, otherOutcomes measure: Perceived stress, otherOutcomes measure: Chronotype assessment, otherOutcomes measure: Sleeping habits, otherOutcomes measure: Self reported habitual meat and PBMA consumption, otherOutcomes measure: 24-hour dietary recall, otherOutcomes measure: Home environment microbiome composition, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wageningen University, Division of Human Nutrition, status: RECRUITING, city: Wageningen, state: Gelderland, zip: 6708 WE, country: Netherlands, geoPoint lat: 51.97, lon: 5.66667, hasResults: False |
protocolSection identificationModule nctId: NCT06370923, orgStudyIdInfo id: 1R01MH133488-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01MH133488-01, briefTitle: Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention, acronym: IMPERATIVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Stellenbosch, class: OTHER, collaborators name: Biomedical Research and Training Institute, Zimbabwe, collaborators name: Imperial College London, collaborators name: University of Lincoln, collaborators name: University College London Hospitals, collaborators name: University of Copenhagen, collaborators name: University of Washington, collaborators name: Heidelberg University, descriptionModule briefSummary: Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination. Suboptimal engagement with HIV prevention by men increases their risk of HIV acquisition, and is an important driver of new HIV infections in women. HIV self-testing (HIVST) addresses several key facility-based access barriers and HIVST distribution through leveraging male peer networks for HIV prevention is feasible, acceptable and effective in SSA.The objective of this project is to use an implementation science approach to establish the impact of HIVST distribution through male social networks, with phone-based support and improved risk perception, on PrEP (Pre-Exposure Prophylaxis) uptake among men in Eastern Zimbabwe. The project will leverage infrastructure and data associated with 20-year programme of HIV surveillance and behavioural research in a well-characterized population cohort hosted by the Manicaland Centre for Public Health Research, Zimbabwe.The study will utilise a cluster randomised design of 44 clusters (22 Intervention:22 control) comprising on average 81 men in each cluster (total N = 3591) followed for 6 months (giving \>80% power to detect a difference in PrEP initiation among men of 2% versus 8.5%). In intervention clusters the investigators will identify initial distributors who will receive an HIVST kit for personal use and HIVST kits to distribute to local peers. These peers can subsequently become distributors, allowing the intervention to propagate through peer networks. A toll-free helpline will provide pre- and post-test support and an SMS (Short Message Service) -based risk assessment will expedite PrEP initiation at the clinic. The study team will conduct a performance (process) evaluation of the intervention. to assess implementation fidelity, causal mechanisms underlying trial effectiveness including how characteristics of peer networks affect outcomes. Results of the study will be used to quantify the population level impacts and cost-effectiveness of male peer to peer HIVST distribution strategies on the uptake of PrEP in HIV hyper-endemic settings using a fully calibrated individual-based mathematical model. The envisaged long-term impact of this research is the development of a generalizable, multicomponent male peer-based HIVST and PrEP uptake model for settings where HIV incidence is high., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster randomised trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Analysts blinded to allocation, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 3591, type: ESTIMATED, armsInterventionsModule interventions name: Peer Distribution, interventions name: Community Health Worker Distribution, outcomesModule primaryOutcomes measure: PrEP initiation, secondaryOutcomes measure: PrEP adherence, secondaryOutcomes measure: ART adherence, secondaryOutcomes measure: Confirmatory tests, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-11-07, uploadDate: 2024-04-11T04:41, filename: Prot_000.pdf, size: 766804, hasResults: False |
protocolSection identificationModule nctId: NCT06370910, orgStudyIdInfo id: CAAE 58569421.5.0000.5327, briefTitle: Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction, acronym: CL, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-01-05, completionDateStruct date: 2024-01-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Federal University of Rio Grande do Sul, class: OTHER, descriptionModule briefSummary: The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery.Objective: To compare the use of photobiomodulation with cryotherapy in the immediate postpartum period of 2 hours in parturients who suffered 1st and 2nd-degree lacerations and/or episiotomies.Methods: A randomized clinical trial will be conducted to compare two interventions. Data collection will be through a questionnaire and scales for the evaluation of pain and edema, with women who experienced vaginal delivery and those who suffered 1st and 2nd-degree lacerations or episiotomies.Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery., conditionsModule conditions: Episiotomy; Complications, conditions: Laceration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Low-Level Laser Therapy, outcomesModule primaryOutcomes measure: To compare two techniques: Low-level laser and cryotherapy, secondaryOutcomes measure: Pain reduction assessed by the Visual Analog Scale (VAS)., secondaryOutcomes measure: Pain reduction assessed by McGill Pain Scale, secondaryOutcomes measure: Evaluate reduction of swelling using the REEDA scale., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital de Clínicas de Porto Alegre, city: Porto Alegre, zip: RS, country: Brazil, geoPoint lat: -30.03306, lon: -51.23, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-04-04, uploadDate: 2024-04-12T18:23, filename: Prot_SAP_000.pdf, size: 47665, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-04, uploadDate: 2024-04-12T18:21, filename: ICF_001.pdf, size: 66023, hasResults: False |
protocolSection identificationModule nctId: NCT06370897, orgStudyIdInfo id: 337421, briefTitle: Prediction & Mechanisms of Recovery Following IEDS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-09, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Plymouth, class: OTHER, descriptionModule briefSummary: Inner Ear Decompression sickness (IEDS) accounts for 20% of all types of decompression sickness (the bends) in divers. The condition commonly affects the peripheral vestibular system (inner ear). IEDS results in acute symptoms of dizzyness (vertigo) and imbalance. Even with the recommended treatment of hyperbaric oxygen therapy some people do not recovery fully. However, even in the presence of a permanent vestibular deficit many people can show a behavioural recovery where symptoms improve over time. Recovery can be aided by vestibular rehabilitation (VR) which is now routine for acute IEDS but was not provided before 2021, and is not widespread across the UK (United Kingdom) or world, meaning people may have a suboptimal recovery.This project will investigate if and how people recover after an acute episode of IEDS and whether people who had IEDS in the past show changes in the central (brain) processing of vestibular function and in symptoms of dizziness, balance and posture.This project has two main parts. Part one is a prospective observational study where people with an acute onset of IEDS are serially monitored while they are receiving hyperbaric treatment and VR over 10-14 days. Part two is a retrospective observational study where who have had IEDS in the past 15 years are re-assessed in a one-off session. The tests in both parts involve clinical tests and specialist eye movement recordings that assess vestibular function. We will also determine the site of any vestibular pathology by using selective stimulation of the vestibular end organ or nerve and assess whether there are any changes in how the structure and function of central vestibular pathways in the brain. In people with chronic IEDS with vestibular symptoms we will offer participants a course of VR over 12 weeks and assess whether this is associated with any improvement in symptoms., conditionsModule conditions: Decompression Sickness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 41, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Side of peripheral vestibular damage: Prospective cohort, primaryOutcomes measure: Site of peripheral vestibular damage: Prospective cohort, primaryOutcomes measure: Extent of peripheral vestibular damage: Prospective cohort, primaryOutcomes measure: Side of peripheral vestibular damage: Retrospective cohort, primaryOutcomes measure: Site of peripheral vestibular damage:Retrospective cohort, primaryOutcomes measure: Extent of peripheral vestibular damage:Retrospective cohort, secondaryOutcomes measure: VOR gain v HIT: Prospective Study, secondaryOutcomes measure: VOR gain: Prospective Study, secondaryOutcomes measure: VOR Time constant:Prospective Study, secondaryOutcomes measure: Patient reported outcome measure: Prospective Study, secondaryOutcomes measure: Clinical measure of walking: Prospective Study, secondaryOutcomes measure: Clinical measure of balance: Prospective Study, secondaryOutcomes measure: Posturography: Prospective Study, secondaryOutcomes measure: Perception of verticality: Prospective Study, secondaryOutcomes measure: Functional MRI response to an optokinetic stimulus: Prospective Study, secondaryOutcomes measure: Vestibular Evoked myogenic Potentials latency: Prospective Study, secondaryOutcomes measure: Vestibular Evoked myogenic Potentials amplitude: Prospective Study, secondaryOutcomes measure: VOR gain: Retrospective Study, secondaryOutcomes measure: VOR Time constant: Retrospective Study, secondaryOutcomes measure: Patient reported outcome measure: Retrospective Study, secondaryOutcomes measure: Clinical measure of walking: Retrospective Study, secondaryOutcomes measure: Clinical measure of balance: Retrospective Study, secondaryOutcomes measure: Posturography: Retrospective Study, secondaryOutcomes measure: Perception of verticality: Retrospective Study, secondaryOutcomes measure: Functional MRI response to an optokinetic stimulus: Retrospective Study, secondaryOutcomes measure: Vestibular Evoked myogenic Potentials latency: Retrospective Study, secondaryOutcomes measure: Vestibular Evoked myogenic Potentials amplitude: Retrorospective Study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06370884, orgStudyIdInfo id: SURG-2023-29833, briefTitle: Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis will be enrolled to have a feeding tube placed at the time of surgery and receive either IMT or a saline solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT or saline, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT/saline, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics)., conditionsModule conditions: Recurrent Clostridioides Difficile Infection, conditions: Colonic Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of intestinal microbiota transplantation (IMT) in patients undergoing colon resection., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The study will be double-blinded; assignments of study staff to either the blinded or unblinded team will be made in advance of enrollment of the first study participant and will be recorded as such on regulatory documents (e.g., blinded/unblinded DOA)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: IMT, interventions name: Saline solution, outcomesModule primaryOutcomes measure: Evaluate safety of IMT in patients undergoing colon surgery, primaryOutcomes measure: compare fecal microbiota prior to and after IMT, secondaryOutcomes measure: Evaluate engraftment of donor microbiota, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: WBC, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: Hemoglobin, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: Platelets, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: Electrolytes, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: alkaline phosphatase, secondaryOutcomes measure: Evaluate changes in circulating markers: Albumin, secondaryOutcomes measure: Evaluate changes in microbial metabolites: Fecal short-chain fatty-acids, secondaryOutcomes measure: Evaluate changes in microbial metabolites: Fecal IgA, secondaryOutcomes measure: Compare baseline microbiome characteristics with changes over time after IMT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Minnesota, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Kathryn Vera, PhD, role: CONTACT, phone: 612-625-5018, email: [email protected], geoPoint lat: 44.97997, lon: -93.26384, hasResults: False |
protocolSection identificationModule nctId: NCT06370871, orgStudyIdInfo id: 1403-0006, secondaryIdInfos id: 2022-502985-26-00, type: REGISTRY, domain: CTIS (EU), secondaryIdInfos id: U1111-1292-9594, type: REGISTRY, domain: WHO Registry, briefTitle: Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-04, primaryCompletionDateStruct date: 2026-07-03, completionDateStruct date: 2028-10-13, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene. This is a study for people whose earlier treatment isn't working anymore, and their doctors suggest a new treatment to stop the sarcoma from getting worse.The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy. Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer.Participants are put into 3 groups by chance:* Ezabenlimab group: Participants receive ezabenlimab as an infusion into a vein every 3 weeks* Brigimadlin + ezabenlimab group: Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks* Chemotherapy group: Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks. Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma.There are twice as many participants in the brigimadlin + ezabenlimab group and in the chemotherapy group, compared to those in the ezabenlimab group.Participants can continue treatment in the study as long as they benefit from it and can tolerate it.Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being. This is to find out if their quality of life is changing., conditionsModule conditions: Advanced Soft Tissue Sarcoma, conditions: Undifferentiated Pleomorphic Sarcoma (UPS), conditions: Myxofibrosarcoma (MFS), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 263, type: ESTIMATED, armsInterventionsModule interventions name: Brigimadlin, interventions name: Ezabenlimab, interventions name: Gemcitabine, interventions name: Docetaxel, outcomesModule primaryOutcomes measure: Progression-free survival, primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Objective response, secondaryOutcomes measure: Duration of objective response, secondaryOutcomes measure: Disease control, secondaryOutcomes measure: Duration of disease control, secondaryOutcomes measure: Occurrence of treatment-emergent adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5, secondaryOutcomes measure: Occurrence of treatment-emergent AEs leading to study drug discontinuation, secondaryOutcomes measure: Mean change from baseline to Week 12 in the domain fatigue (based on items from the European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) and the EORTC item library), secondaryOutcomes measure: Mean change from baseline to Week 12 in the domain fatigability (based on items from the EORTC QLQ-C30 and the EORTC item library), secondaryOutcomes measure: Mean change from baseline to week 12 in the domain physical functioning (based on items from the EORTC QLQ-C30), secondaryOutcomes measure: Mean change from baseline to week 12 in the domain pain (based on items from the EORTC QLQ-C30), secondaryOutcomes measure: Mean change from baseline to week 12 in the domain dyspnea (based on items from the EORTC QLQ-C30), secondaryOutcomes measure: Mean change from baseline to week 12 in the domain global health status / quality of life (based on items from the EORTC QLQ-C30), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370845, orgStudyIdInfo id: 0000-00000; kt24timper, briefTitle: Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure, acronym: OLFO-Brain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the abundance of a natural odour in human cerebrospinal fluid in obese and lean participants after inhalation thereof. Participants will undergo blood sample collection and inhalation of either a natural odour or placebo through an inhaler in addition to a liquor puncture prescribed in standard of care context., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Inhalation - Natural Odour, interventions name: Inhalation - Placebo, outcomesModule primaryOutcomes measure: Detection of a natural odour in human CSF, secondaryOutcomes measure: Abundance of a natural odour in human CSF of obese versus lean participants, secondaryOutcomes measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF., secondaryOutcomes measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in obese as compared to lean participants., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Hospital Basel, city: Basel, zip: 4031, country: Switzerland, contacts name: Katharina Timper, Prof. Dr. med., role: CONTACT, phone: 0041 61 328 57 42, email: [email protected], contacts name: Isabel M Hofer, role: CONTACT, phone: 0041 61 328 68 14, email: [email protected], geoPoint lat: 47.55839, lon: 7.57327, hasResults: False |
protocolSection identificationModule nctId: NCT06370832, orgStudyIdInfo id: 22-5171, briefTitle: Inspiratory Muscle Training in Lung Transplant Candidates, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: Canadian National Transplant Research Program, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: Ozmosis Research Inc., descriptionModule briefSummary: Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL). In the critical care setting, diaphragm atrophy and weakness have been associated with difficulty weaning from MV, increased risk for readmission to hospital or ICU, and increased mortality. Increasing respiratory muscle strength by inspiratory muscle training (IMT) as part of pre-rehabilitation mitigates respiratory muscle dysfunction peri-operatively and may reduce the risk of post-operative complications. However, IMT is not widely used prior to LTx and the benefits of pre-operative IMT on post-transplant outcomes in LTx candidates have not been studied. Objectives: 1) To evaluate the feasibility of a randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, safety and outcome ascertainment. 2)To establish whether IMT improves pre-transplant dyspnea perception, diaphragm structure and function, HRQoL and post-transplant ICU, hospital and 3-month outcomes. 3)To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area, oxidative capacity, inflammatory markers and diaphragm muscle thickness and function. Methods: Prospective study of 50 LTx candidates recruited from the pulmonary rehabilitation program at University Health Network (UHN). Participants will have baseline evaluations of maximal inspiratory pressure (MIP), dyspnea, respiratory muscle endurance, diaphragm thickness and thickening fractions, as well as health-related quality of life questionnaires. After baseline assessments, participants will be randomized to the two study groups: IMT or usual care. IMT will be progressed weekly (max of 70% total MIP) until transplant. Participants will have repeat assessments (from baseline) at 4,8 and 12 weeks and then every 3 months until transplant (final assessment 3 months post-LTx)., conditionsModule conditions: Inspiratory Muscle Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pre-lung transplant candidates will be randomized to one of two groups: (1) IMT + exercise training; or (2) exercise training alone., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Ascertainment of post-transplant clinical outcomes (including histopathology assessments) will be blinded by assessors to study group up to 3 months post-transplant., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: IMT and exercise training group, outcomesModule primaryOutcomes measure: Study Recruitment According to Research Team Records, primaryOutcomes measure: Participant Retention in the Study According to Research Team Records, primaryOutcomes measure: Self-Reported Adherence to Inspiratory Muscle Training According to Participant IMT Diary, primaryOutcomes measure: Adverse Events and IMT Training Side Effects Reported by Participants, primaryOutcomes measure: Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only), secondaryOutcomes measure: Respiratory Muscle Endurance Test, secondaryOutcomes measure: Dyspnea Severity Assessed by Medical Research Council Dyspnea Scale, secondaryOutcomes measure: Qualitative Measures of Dyspnea Assessed by Qualitative Dyspnea Scale, secondaryOutcomes measure: Mood Assessed by Depression, Anxiety, and Stress Scale, secondaryOutcomes measure: Health-Related Quality of Life Assessed by St. George's Respiratory Questionnaire, secondaryOutcomes measure: Respiratory Muscle Strength Assessed by Maximal Inspiratory Pressure, secondaryOutcomes measure: Physical Activity and Exercise Behaviors Assessed by International Physical Activity Questionnaire, secondaryOutcomes measure: Pulmonary Function Testing (Spirometry), secondaryOutcomes measure: Aerobic Endurance Assessed by the Six-Minute Walk Test, secondaryOutcomes measure: Physical Function Assessed by the Short Physical Performance Battery, secondaryOutcomes measure: Pre-Transplant Hospitalizations, secondaryOutcomes measure: Peri-Transplant Mechanical Ventilation Bridging, secondaryOutcomes measure: Post-Transplant Duration of Mechanical Ventilation (Days), secondaryOutcomes measure: WIND Weaning Classification, secondaryOutcomes measure: Post-Transplant Hospital Length of Stay (Days), secondaryOutcomes measure: Post-Transplant Discharge Disposition, secondaryOutcomes measure: Primary Graft Dysfunction, secondaryOutcomes measure: Post-Transplant Mortality, secondaryOutcomes measure: Days Alive and at Home at 90 Days (DAAH90), otherOutcomes measure: Diaphragm Thickness and Thickening Fraction Assessed by Ultrasound, otherOutcomes measure: Histopathology Analyses of Diaphragm Biopsies (Optional), otherOutcomes measure: Biochemical Analyses of Diaphragm Biopsies (Optional), otherOutcomes measure: Mitochondrial Respirometry Analyses of Diaphragm Biopsies (Optional), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, city: Toronto, state: Ontario, zip: M5G 2C4, country: Canada, contacts name: Dmitry Rozenberg, MD, PhD, role: CONTACT, phone: 416-340-4800, phoneExt: 7358, email: [email protected], geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06370819, orgStudyIdInfo id: NN9541-4923, secondaryIdInfos id: U1111-1292-3441, type: OTHER, domain: Universal Trial Number, secondaryIdInfos id: 2023-506381-32, type: OTHER, domain: EU CT Number, briefTitle: A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-19, completionDateStruct date: 2025-04-19, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: NNC0519-0130, outcomesModule primaryOutcomes measure: Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment, secondaryOutcomes measure: Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment, secondaryOutcomes measure: AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure, secondaryOutcomes measure: Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure, secondaryOutcomes measure: Number of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité Research Organisation GmbH, city: Berlin, zip: 10117, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False |
protocolSection identificationModule nctId: NCT06370806, orgStudyIdInfo id: INTERAPNEA-Women, briefTitle: Lifestyle Intervention for Obstructive Sleep Apnea in Women, acronym: INTERAPNEA-W, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Universidad de Granada, class: OTHER, collaborators name: Fundación BBVA, collaborators name: Universidad Loyola Andalucia, descriptionModule briefSummary: Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Weight loss and lifestyle intervention, outcomesModule primaryOutcomes measure: Apnoea-hypopnoea index (AHI), secondaryOutcomes measure: Oxygen desaturation index (ODI), secondaryOutcomes measure: Oxygen saturation (SaO2) mean, secondaryOutcomes measure: Oxygen saturation (SaO2) nadir, secondaryOutcomes measure: Sleep efficiency, secondaryOutcomes measure: Light sleep (N1 and N2 stages), secondaryOutcomes measure: Deep sleep (N3 stage), secondaryOutcomes measure: Rapid eye movement (REM) sleep, secondaryOutcomes measure: Excessive daytime sleepiness (EDS), secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Wake After Sleep Onset (WASO), secondaryOutcomes measure: Fat mass (kg), secondaryOutcomes measure: Visceral adipose tisue (g), secondaryOutcomes measure: Body weight (kg), secondaryOutcomes measure: Neck circumference (cm), secondaryOutcomes measure: Chest circumference (cm), secondaryOutcomes measure: Waist circumference (cm), secondaryOutcomes measure: Mean blood pressure (mm HG), secondaryOutcomes measure: Plasma glucose (mg/dL), secondaryOutcomes measure: Change in total cholesterol (mg/dL) from baseline to post-intervention, secondaryOutcomes measure: Change in total triglycerides (mg/dL) from baseline to post-intervention, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370793, orgStudyIdInfo id: NBU-2024-011, briefTitle: Ningbo Severe Mental Disorders Cohort, acronym: NEED, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Ningbo University, class: OTHER, collaborators name: The Affiliated Kangning Hospital of Ningbo University, descriptionModule briefSummary: In recent years, the prevalence of severe mental disorders in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with severe mental disorders and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-diagnosis, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with severe mental disorders.Currently, NEED has accumulated data on more than 50,000 patients with severe mental disorders and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies., conditionsModule conditions: Severe Mental Disorder, conditions: Schizophrenia, conditions: Bipolar Disorder, conditions: Schizo-Affective Psychosis, conditions: Paranoid Psychoses, conditions: Mental Retardation, conditions: Epileptic Psychosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 57212, type: ACTUAL, armsInterventionsModule interventions name: Patient with severe mental disorder without intervention, outcomesModule primaryOutcomes measure: Risk of circulatory system diseases, primaryOutcomes measure: Risk of endocrine system diseases, primaryOutcomes measure: Risk of pulmonary system and allergy diseases, primaryOutcomes measure: Risk of gastrointestinal system diseases, primaryOutcomes measure: Risk of musculoskeletal system diseases, primaryOutcomes measure: Risk of urogenital system diseases, primaryOutcomes measure: Risk of hematological system diseases, primaryOutcomes measure: Risk of cancers, primaryOutcomes measure: Risk of neurological system diseases, primaryOutcomes measure: Risk of suicide, primaryOutcomes measure: Risk of violence, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ningbo Mental Health Information System, city: Ningbo, state: Zhejiang, zip: 315000, country: China, geoPoint lat: 29.87819, lon: 121.54945, hasResults: False |
protocolSection identificationModule nctId: NCT06370780, orgStudyIdInfo id: 5UG3AI176592-02, type: NIH, link: https://reporter.nih.gov/quickSearch/5UG3AI176592-02, briefTitle: Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically, acronym: EPI-LoVE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, collaborators name: Florida State University, collaborators name: University of California, Irvine, collaborators name: University of North Carolina, Chapel Hill, collaborators name: AIDS Healthcare Foundation, descriptionModule briefSummary: Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: N/A - all participants get the app, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: EPI LOVE, outcomesModule primaryOutcomes measure: Incidence of HIV Viral Suppression, primaryOutcomes measure: Level of Adherence to HIV medication, primaryOutcomes measure: Level of Adherence based on HIV appointments, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, Los Angeles, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Pamina Gorbach, DrPh, MHS, role: CONTACT, phone: 310-794-2555, email: [email protected], contacts name: Valerie El-Alfi, MA, role: CONTACT, email: [email protected], geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06370767, orgStudyIdInfo id: 25634, briefTitle: Peer Facilitated Waitlist Controlled Transportation Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Temple University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses:1. Individuals with SMI receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills.2. Participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community.3. Individuals with SMI receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention.Participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. All participants will complete three data-collection research interviews., conditionsModule conditions: Serious Mental Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to either start the intervention program immediately, or be placed on an 8-week waitlist. Once randomized, the participant will again be randomized into a treatment condition: 1) peer-mediated bikeshare training intervention; or 2) peer-mediated public travel training intervention. 20 participants from each condition who have not opted out of being in the GPS subsample will be randomly assigned to be invited to a GPS subgroup., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Bike-Share Travel Training, interventions name: Public Transportation Travel Training, outcomesModule primaryOutcomes measure: Temple University Community Participation Measure, primaryOutcomes measure: LASA Sedentary Behaviors Questionnaire, primaryOutcomes measure: Transportation Appraisal Scale, primaryOutcomes measure: Indego Skills Survey, primaryOutcomes measure: SEPTA Skills Survey, primaryOutcomes measure: University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified), primaryOutcomes measure: National Household Travel Survey, primaryOutcomes measure: GPS, secondaryOutcomes measure: Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version), secondaryOutcomes measure: University of California, Los Angeles, Loneliness Scale, secondaryOutcomes measure: Pearlin Mastery Scale (Coping), secondaryOutcomes measure: SF- 36 v2, secondaryOutcomes measure: The PERMA - Profiler Measure, secondaryOutcomes measure: Recovery Assessment Scale (RAS), secondaryOutcomes measure: Group Identification Scale (GIS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-07, uploadDate: 2024-04-10T09:43, filename: Prot_SAP_000.pdf, size: 450285, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-07, uploadDate: 2024-04-10T09:43, filename: ICF_001.pdf, size: 235105, hasResults: False |
protocolSection identificationModule nctId: NCT06370754, orgStudyIdInfo id: 2401289-19-2403, briefTitle: Newly Emerging Immunotherapy for Pancreatic Cancer Treatment, acronym: FD-IMPACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This is a Phase Ib/II platform clinical study to evaluate the initial efficacy and safety of different novel immunotherapies in patients with advanced pancreatic cancer., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 117, type: ESTIMATED, armsInterventionsModule interventions name: JS001, interventions name: JS004, interventions name: JS007, interventions name: JS015, interventions name: Irinotecan Liposome Injection, interventions name: 5-Fluorouracil (5-FU), interventions name: Leucovorin (LV), interventions name: Nab paclitaxel, interventions name: Gemcitabine, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicity (DLT) (phase IB), primaryOutcomes measure: Objective Response Rate (ORR) (phase II), secondaryOutcomes measure: Objective Response Rate (ORR) (phase IB), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06370741, orgStudyIdInfo id: OkanUni., briefTitle: Effect of Stretching Exercises on Plantar Fascia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Okan University, class: OTHER, descriptionModule briefSummary: The plantar fascia (PF) extends over the calcaneal bone with a thin band corresponding to the calcaneal periosteum, continuing as the paratenon of the Achilles tendon.The triceps surae complex, serving as the main extensor and propulsion system of the foot, involves the Achilles tendon, posterior part of the calcaneus, and Plantar Aponeurosis, all integrated with the fibrous skeleton of the triceps surae. Plantar fasciitis, a prevalent musculoskeletal condition affecting individuals of various ages and activity levels (Hye Chang Rhim), is a primary cause of heel pain in adults. Studies have identified the superior efficacy of stretching protocols targeting the Achilles tendon and/or plantar fascia compared to alternative treatments. However, the limitations of traditional approaches become apparent when considering the intricate biomechanics of the foot and ankle. Conventional calf stretches often prove inadequate for addressing its specific lengthening requirements. While contemporary methods like PF-Specific Stretching integrate plantar fascia and calf stretches, their reliance on individual upper extremity strength introduces potential limitations.Therefore, although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be aimed to determine whether an instrument aid to be designed will have an effect and which method is more effective. In this way, it is planned to guide clinicians in the rehabilitation of possible pathologies specific to the plantar fascia in clinical practice.Myotonometry is a convenient method to assess the stiffness of the plantar fascia because it is cheap, simple and fast. Previous studies have shown that MyotonPRO can reliably assess the stiffness of the plantar fascia. Although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be determined whether stretching with an instrument to be designed will have an effect and which method is more effective with or without an instrument., conditionsModule conditions: Stretch, conditions: Plantar Fascia; Contracture, conditions: Fasciitis, Plantar, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pilot study, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Stretching with/without device, outcomesModule primaryOutcomes measure: Plantar Fascia Mechanical Properties, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06370728, orgStudyIdInfo id: 18621, secondaryIdInfos id: J2A-MC-GZPJ, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Orforglipron, interventions name: Carbamazepine, outcomesModule primaryOutcomes measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron, primaryOutcomes measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron, primaryOutcomes measure: PK: Maximum Observed Concentration (Cmax) of Orforglipron, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ICON Early Phase Services, city: San Antonio, state: Texas, zip: 78209, country: United States, contacts role: CONTACT, phone: 210-255-5437, contacts name: Robert Bass, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False |
protocolSection identificationModule nctId: NCT06370715, orgStudyIdInfo id: 18269, secondaryIdInfos id: I8B-MC-ITTA, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, collaborators name: Cipla Ltd., descriptionModule briefSummary: The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks)., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Insulin Lispro-aabc, interventions name: Insulin Glargine, outcomesModule primaryOutcomes measure: Percentage of Participants with at least 1 Episode of Hypoglycemia, secondaryOutcomes measure: Percentage of Participants with Severe Hypoglycemic Events, secondaryOutcomes measure: Percentage of Participants with Nocturnal Hypoglycemia Events, secondaryOutcomes measure: Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events, secondaryOutcomes measure: Change from Baseline to Week 26 in Body Weight, secondaryOutcomes measure: Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score, secondaryOutcomes measure: Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c), secondaryOutcomes measure: Percentage of Participants Achieving HbA1c Less Than (<) 7%, secondaryOutcomes measure: Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values, secondaryOutcomes measure: Change from Baseline to Week 26 in Bolus Insulin Dose, Basal Insulin Dose, and Basal: Bolus Ratio, secondaryOutcomes measure: Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King George Hospital, Visakhapatnam, city: Vizag, state: Andhra Pradesh, zip: 530002, country: India, contacts name: Bongi Vivekanand, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 17.68009, lon: 83.20161, locations facility: Diabetes Research Centre, city: Royapuram, state: Chennai, zip: 600013, country: India, contacts name: VIJAY VISHWANATHAN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.11405, lon: 80.29474, locations facility: Vijyaratna Dibetes Diagnosis Treatment Centre, city: Ahmedabad, state: Gujarat, zip: 380007, country: India, contacts name: Sanjeev Phatak, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.02579, lon: 72.58727, locations facility: Center for Diabetes and Endocrine Care, city: Bengaluru, state: Karnataka, zip: 560043, country: India, contacts name: K M Prasanna Kumar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Chellaram Diabetes Institute, city: Pune, state: Maharashtra, zip: 411021, country: India, contacts name: Unnikrishnan Gopalkrishnan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Sahyadri Super Speciality Hospital, city: Pune, state: Maharashtra, country: India, contacts name: Uday Phadke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: S. P. Medical College & A G Hospital, city: Bikaner, state: Rajasthan, zip: 334003, country: India, contacts name: Bal Kishan Gupta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.01762, lon: 73.31495, locations facility: Rajasthan University of Health Sciences, city: Jaipur, state: Rajasthan, zip: 302033, country: India, contacts name: Sudhir Bhandari, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.91962, lon: 75.78781, locations facility: Kovai Diabetes Speciality Center and Hospital, city: Coimbatore, state: Tamil Nadu, zip: 641009, country: India, contacts name: Ramanathan Balamurugan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 11.00555, lon: 76.96612, locations facility: Osmania Medical College & Hospital, city: Hyderabad, state: Telangana, zip: 500012, country: India, contacts name: Rakesh Sahay, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 17.38405, lon: 78.45636, locations facility: Brij Medical Center Pvt. Ltd., city: Kanpur, state: Uttar Pradesh, zip: 208020, country: India, contacts name: brij mohan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.46523, lon: 80.34975, locations facility: Medical College & Hospital, Kolkata, city: Kolkata, state: West Bengal, zip: 700073, country: India, contacts name: Animesh Maiti, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.56263, lon: 88.36304, hasResults: False |
protocolSection identificationModule nctId: NCT06370702, orgStudyIdInfo id: 23-054, briefTitle: Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-06, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: TriHealth Inc., class: OTHER, descriptionModule briefSummary: Patients who have a peripherally-inserted central catheter (PICC) placed are at a risk of developing a deep vein thrombosis (DVT). At TriHealth, approximately 2-4 patients per month who have a PICC placed experience a subsequent DVT. One innovative way to possibly mitigate the risk of DVTs is hand grip exercises. The current study will be the first study to evaluate hand grip exercises for the prevention of DVTs in adult patients hospitalized in the United States., conditionsModule conditions: Deep Vein Thrombosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Handgrip Exercises, outcomesModule primaryOutcomes measure: Deep vein thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Good Samaritan Hospital, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45220, country: United States, contacts name: Rachel Baker, PhD, RN, role: CONTACT, phone: 513-569-6191, email: [email protected], geoPoint lat: 39.12713, lon: -84.51435, locations facility: Bethesda North Hospital, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45242, country: United States, contacts name: Rachel Baker, PhD, RN, role: CONTACT, phone: 513-569-6191, email: [email protected], geoPoint lat: 39.12713, lon: -84.51435, hasResults: False |
protocolSection identificationModule nctId: NCT06370689, orgStudyIdInfo id: PRE-OX, briefTitle: Comparison of Three Pre-oxygenation Strategies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-23, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Institute of Mountain Emergency Medicine, class: OTHER, descriptionModule briefSummary: Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers.Study endpointsPrimary Endpoint:The time taken from the start of preoxygenation until reaching an expiratory oxygen concentration (FeO2) of ≥ 90% or a maximum preoxygenation time of 3 min.Secondary endpoints:* Changes in regional ventilation within the posterior lung regions from baseline to the time when FeO2≥ 90% is achieved, assessed using electrical impedance tomography (EIT)* Difference in Oxygen Reserve Index (ORi) when FeO2≥ 90% is achievedNumber of participants 15 participants per subgroup, i.e. 45 participants in total.Inclusion criteria* Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II* Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3* Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day.After informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow., conditionsModule conditions: Emergencies, conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Preoxygenation, outcomesModule primaryOutcomes measure: Difference in Oxygen Reserve index (ORi) after 3 minutes of preoxygenation, secondaryOutcomes measure: Difference in expiratory oxygen concentration (FeO2) after 3 minutes of preoxygenation, secondaryOutcomes measure: Time to Oxygen Reserve index (ORi) = 1.0, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370676, orgStudyIdInfo id: ESO-TIP, briefTitle: Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location, acronym: ESO-TIP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-23, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Institute of Mountain Emergency Medicine, class: OTHER, descriptionModule briefSummary: Background An accurate measurement of the core body temperature (CBT) is of pivotal importance in the management of severely hypothermic patients. For instance, triage decisions for or against extracorporeal rewarming of hypothermic patients in cardiac arrest strongly depend on CBT. CBT measurement with an oesophageal probe is currently considered the gold standard in hypothermic patients with a secured airway in the prehospital setting, with the tip of the probe placed into the distal third of the oesophagus (i.e., posteriorly to the heart and distal to the tracheal bifurcation). However, the correct placement of the probe tip cannot be verified in the prehospital setting, and it is unknown how incorrect placement affects temperature readings.Hypothesis and aim The investigators hypothesise that an incorrect placement of the oesophageal temperature probe tip could lead to inaccurate measurements (i.e., temperature readings not reflecting the real CBT). Particularly, a tip location too high in the oesophagus in close proximity to the trachea could lead to falsely low temperature readings, especially when the patient is ventilated with cold air. The aim of the proposed study is to investigate the influence of oesophageal temperature probe tip location on CBT measurement.Methods Experimental, interventional study on 16 healthy volunteers. During the test oesophageal temperature is measured while participants are breathing ambient air first at 20°C (baseline) followed by cold (-20°C) ambient air in supine position for 20 minutes each test in an environmental simulator (terraXcube). Each participant repeats the 20-min test two times with the oesophageal temperature probe tip placed either in the lower third of the oesophagus (i.e., correct position) or too high in the oesophagus, i.e. behind the trachea., conditionsModule conditions: Emergencies, conditions: Hypothermia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: The participant is blinded for the location of the oesophageal temperature probe tip., whoMasked: PARTICIPANT, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Oesophageal temperature measurement, outcomesModule primaryOutcomes measure: Difference in core body temperature between the two tip positions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370663, orgStudyIdInfo id: SDZLEC2023-109-01, briefTitle: First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Shandong Cancer Hospital and Institute, class: OTHER, descriptionModule briefSummary: The median survival of intrahepatic cholangiocarcinoma remains less than one year, highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity. A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma. However, clinical research on this combination is lacking as first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study aims to assess this treatment approach's safety, efficacy, and molecular predictors. Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment. In conclusion, exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Combining radiotherapy with Hepatic Arterial Infusion Chemotherapy, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, interventions name: HAIC (GEMOX), interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Progression-Free Survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinbo Yue, status: RECRUITING, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Jin Bo Yue, Doctor, role: CONTACT, phone: 0531-67626929, email: [email protected], geoPoint lat: 36.66833, lon: 116.99722, hasResults: False |
protocolSection identificationModule nctId: NCT06370650, orgStudyIdInfo id: soh-med-24-1-9, briefTitle: Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-08, primaryCompletionDateStruct date: 2024-01-25, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Each patient will sign a written consent form to be included in the study and to be photographed., conditionsModule conditions: Management of Stable Vitiligo, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: platelet rich plasma, narrow band UVB, outcomesModule primaryOutcomes measure: Improvement of vitiligo, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Sohag University, city: Sohag, zip: 82515, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False |
protocolSection identificationModule nctId: NCT06370637, orgStudyIdInfo id: Survey Protocol, briefTitle: Efficacy of Cream for Moisture Associated Skin Damage From Fecal Incontinence and/or Diarrhea, acronym: Survey, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Scotiaderm, class: OTHER, descriptionModule briefSummary: Scotiaderm Inc. has developed a cream formulation to be used in the treatment of MASD caused diarrhea or fecal incontinence. This study aims to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence., conditionsModule conditions: Incontinence-associated Dermatitis, conditions: Moisture Associated Skin Damage (MASD) (E.G., Incontinence-Associated Dermatitis [IAD], Perspiration, Drainage), conditions: Fecal Incontinence Incontinence-associated Dermatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The aim of this study is to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: A total of 40 patients will be enrolled in the study. If the patient agrees to participate and written consent is given to participate, the research coordinator will assess the eligibility criteria of the patient based on the inclusion and exclusion criteria. Participants will be provided 2x2cm patch test on the forearm to test for contact dermatitis to the cream D after obtaining consent. Participants do not react to the Cream D will be randomized. Participants who react will be excluded from the study. The research coordinator will have a list for arm 1 and arm 2 where the code for the participant enrolled will be entered daily. The first participants to be enrolled on any given day will be assigned to arm 1, and the second patient to arm 2. The research coordinator will have 40 envelopes with the protocols coded with arm 1 or arm 2, and cream containers also coded with arm 1 and arm 2., whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: MASD Control Arm, outcomesModule primaryOutcomes measure: Analysis of Efficacy and Safety for Cream D Primary Outcome, secondaryOutcomes measure: Analysis of Efficacy and Safety for Cream D Secondary Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370624, orgStudyIdInfo id: 2022/03OCT/360, briefTitle: PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment., acronym: PEDI-REAVASC, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-17, primaryCompletionDateStruct date: 2025-09-15, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, class: OTHER, descriptionModule briefSummary: This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores.The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours.A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned., conditionsModule conditions: Encephalopathy, Hypoxic-Ischemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: One group will be followed - with both the standard of care continuous EEG monitoring and near infrared spectroscopy (NIRS) \& the MRI-scan performed at the same time., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: MRI-scan, outcomesModule primaryOutcomes measure: quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE), eligibilityModule sex: ALL, minimumAge: 1 Hour, maximumAge: 14 Months, stdAges: CHILD, contactsLocationsModule locations facility: Cliniques Universitaires Saint Luc, city: Brussels, zip: 1200, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06370611, orgStudyIdInfo id: 2314027, briefTitle: Early Remote Rehabilitation to Improve Health of the Elderly After Cardiac Surgery. (RECARD Trial), acronym: RECARD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ivy susanne Modrau, MD, class: OTHER, collaborators name: Aalborg University Hospital, descriptionModule briefSummary: An increasing number of older patients undergo heart surgery. Despite seemingly successful outcomes, these vulnerable patients may face prolonged decreased functional capacity, reduced self-efficacy, and impaired quality of life after discharge. Early engagement in physical activity and education plays a key role in health and well-being after heart surgery The goal of this clinical trial is to evaluate the effectiveness of an app-based exercise program and weekly calls from a physiotherapist in the early stages after open heart surgery.Eligible patients will be randomly assigned to either a control group receiving standard care or an intervention group, which will be introduced to an individually tailored exercise program as an addition to standard care.Follow-up is planned with an out-patient visit six weeks after discharge and a telephone interview six months post-surgery.All participants will undergo assessments at enrollment and during follow-up. Physical performance will be evaluated through physical tests. General well-being, quality of life, self-reported physical activity, and cost-effectiveness of the intervention will be assessed through questionnaires. Muscle health will be examined through blood sampling, CT scans, and muscle biopsies.The primary endpoint is the 30-second Chair Stand Test serving as a measurement of physical function., conditionsModule conditions: Cardiac Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Bi-center, prospective, randomized, controlled, parallel (1:1), two-arm, open-label, blinded evaluation (PROBE) trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Allocation cannot be concealed from the participants, care providers or investigator. Outcome assessors will be blinded regarding allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Early mobile health intervention supplemented by weekly calls from a physiotherapist, outcomesModule primaryOutcomes measure: Change (Δ) 30-second chair stand test (30CST) baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in 10-meter Walk Test (10MWT) baseline vs. 6-week FU, secondaryOutcomes measure: Difference in 6-minute Walk Test (6MWT) between groups at 6-week FU, secondaryOutcomes measure: Change (Δ) in WHO-5-score baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in ASS-2-score baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in MDI-2-score baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in Self-reported Physical Activity baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in EuroQol-score baseline vs. 6-week FU, secondaryOutcomes measure: Change in skeletal muscle mass maximum 3 months prior to surgery vs. 6-week FU, secondaryOutcomes measure: Cost-effectiveness analysis, secondaryOutcomes measure: Changes in markers of musculoskeletal health through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of inflammation through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of nutrition through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of liver function through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of kidney function through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of hormone levels through blood samples baseline vs. 6-week FU, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aarlborg University Hospital, city: Aalborg, zip: 9000, country: Denmark, contacts name: Stian Ingemann-Molden, PT, MHSc, role: CONTACT, phone: +45 97664210, email: [email protected], geoPoint lat: 57.048, lon: 9.9187, locations facility: Aarhus University Hospital, city: Aarhus, zip: 8200, country: Denmark, contacts name: Rikke Daugaard, PT, MHSc, role: CONTACT, phone: +45 41282266, email: [email protected], geoPoint lat: 56.15674, lon: 10.21076, hasResults: False |
protocolSection identificationModule nctId: NCT06370598, orgStudyIdInfo id: TP-122, briefTitle: Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia, acronym: RECOVER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Technophage, SA, class: INDUSTRY, collaborators name: VectorB2B, descriptionModule briefSummary: Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . For this study, an effective sample of 15 subjects will be randomly allocated into two arms, in a 3:2 ratio, with 9 subjects receiving TP-122A, in addition to SoC, and 6 subjects receiving the SoC alone., conditionsModule conditions: Pneumonia, Ventilator-Associated, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: TP-122A, outcomesModule primaryOutcomes measure: Evaluate safety and tolerability following nebulization of multiple doses of TP-122A, secondaryOutcomes measure: Proportion of subjects achieving "Clinical Cure" CR, secondaryOutcomes measure: Time to achieve "Clinical Cure" CR, secondaryOutcomes measure: Proportion of subjects achieving "Eradication" or "Presumed Eradication" MR of TP-122A target bacteria, secondaryOutcomes measure: Time to achieve "Eradication" or "Presumed Eradication" MR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CH Nantes, city: Nantes, country: France, contacts name: Antoine Roquilly, MD, role: CONTACT, contacts name: Antoine Roquilly, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False |
protocolSection identificationModule nctId: NCT06370585, orgStudyIdInfo id: SOPH229-0823/I, briefTitle: Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Laboratorios Sophia S.A de C.V., class: INDUSTRY, descriptionModule briefSummary: This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects., conditionsModule conditions: Dry Eye Disease, conditions: Ocular Surface Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase I, controlled, comparative, double-masked, single-center, randomized, controlled clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: PRO-229, interventions name: Lagricel® Ofteno PF, outcomesModule primaryOutcomes measure: Incidence Unexpected Related Adverse Reactions, secondaryOutcomes measure: Changes in Best Corrected Visual Acuity (BCVA), secondaryOutcomes measure: Changes in ocular surface staining using SICCA ocular staining score scale, secondaryOutcomes measure: Incidence of chemosis, secondaryOutcomes measure: Incidence of grade 3 or 4 conjunctival hyperemia., secondaryOutcomes measure: Adherence to treatment (adherence), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06370572, orgStudyIdInfo id: CIRB23-1162, secondaryIdInfos id: U54AG063546, type: NIH, link: https://reporter.nih.gov/quickSearch/U54AG063546, briefTitle: Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, collaborators name: National Institute on Aging (NIA), collaborators name: University of North Carolina, Chapel Hill, descriptionModule briefSummary: The purpose of this study is to learn if the Pain in Advanced Dementia (PAINAD) scale can improve emergency pain care in persons living with dementia (PLWD). It is hypothesized that a PAINAD electronic health record (EHR) prompt that appears to emergency department (ED) staff will enable them to accurately assess pain levels and lead to better pain treatment for PLWD., conditionsModule conditions: Dementia, conditions: Hip Pain, conditions: Emergency Department Patient, conditions: Pain in Advanced Dementia Scale, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1899, type: ESTIMATED, armsInterventionsModule interventions name: PAINAD EHR Prompt, outcomesModule primaryOutcomes measure: Percentage of eligible patients receiving a PAINAD assessment upon ED arrival, secondaryOutcomes measure: Change in time to administration of first analgesic medication, secondaryOutcomes measure: Change in pain score for patients receiving a repeat PAINAD assessment, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Teresita M Hogan, MD, role: CONTACT, phone: 773-702-9500, contacts name: Teresita M Hogan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: University of North Carolina at Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Michelle Meyer, PhD, MPH, CPH, role: CONTACT, phone: (919) 966-6442, contacts name: Michelle Meyer, PhD, MPH, CPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
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