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protocolSection identificationModule nctId: NCT06374472, orgStudyIdInfo id: IRB00001194, briefTitle: Surgical Treatment of Fractures of the Dorso-lombar Spine, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2022-01-01, completionDateStruct date: 2022-01-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Ibn Jazzar Hospital, class: OTHER, descriptionModule briefSummary: Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis, conditionsModule conditions: Spine Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Osteosynthesis, outcomesModule primaryOutcomes measure: Age (in years), primaryOutcomes measure: Sex, primaryOutcomes measure: Neurological status ( Frenkel classification), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IBN jazzar hospital, city: Kairouan, zip: 3190, country: Tunisia, geoPoint lat: 35.6781, lon: 10.09633, hasResults: False |
protocolSection identificationModule nctId: NCT06374459, orgStudyIdInfo id: 24-x109, secondaryIdInfos id: BC200714, type: OTHER_GRANT, domain: Department of Defense, briefTitle: Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2031-11-30, completionDateStruct date: 2031-11-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: United States Department of Defense, collaborators name: Aclaris Therapeutics, Inc., descriptionModule briefSummary: This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC)., conditionsModule conditions: Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The Phase I portion of the study is sequential and patients will not be randomized and the Phase II portion is parallel and patients will be randomized., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: Zumsemetinib, interventions name: Capecitabine, interventions name: Zoledronic acid, interventions name: Denosumab, outcomesModule primaryOutcomes measure: Number of participants with adverse events (Phase Ib only), primaryOutcomes measure: Recommended phase II dose of zunsemetinib (Phase Ib only), primaryOutcomes measure: Percent change in serum CTX (Phase II only), primaryOutcomes measure: Progression-free survival (PFS) (Phase II only), secondaryOutcomes measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase Ib only), secondaryOutcomes measure: Treatment-induced changes in sCTX by clinical assay (Phase II only), secondaryOutcomes measure: Objective response rate (ORR) (Phase II only), secondaryOutcomes measure: Clinical benefit rate (Phase II only), secondaryOutcomes measure: Overall survival (OS) (Phase II only), secondaryOutcomes measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase II only), secondaryOutcomes measure: Treatment-induced changes in quality of life as measured by EORTC QLQ-C30 (Phase II only), secondaryOutcomes measure: Treatment-induced changes in pain as measured by Brief Pain Inventory (BPI) (Phase II only), secondaryOutcomes measure: Number of participants with adverse events (Phase II only), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Kansas Cancer Center, city: Westwood, state: Kansas, zip: 66205, country: United States, contacts name: Qamar Khan, M.D., role: CONTACT, phone: 913-588-1227, contacts name: Qamar Khan, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.04056, lon: -94.6169, locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Matthew Goetz, M.D., role: CONTACT, phone: 507-284-2511, email: [email protected], contacts name: Matthew Goetz, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Cynthia X Ma, M.D., Ph.D., role: CONTACT, phone: 314-362-8903, email: [email protected], contacts name: Cynthia X Ma, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Sheila Stewart, Ph.D., role: SUB_INVESTIGATOR, contacts name: Roberto Civitelli, M.D., role: SUB_INVESTIGATOR, contacts name: Jingqin (Rosy) Luo, Ph.D., role: SUB_INVESTIGATOR, contacts name: Foluso Ademuyiwa, M.D., role: SUB_INVESTIGATOR, contacts name: Nusayba Bagegni, M.D., role: SUB_INVESTIGATOR, contacts name: Ron Bose, M.D., Ph.D., role: SUB_INVESTIGATOR, contacts name: Andrew Davis, M.D., role: SUB_INVESTIGATOR, contacts name: Ashley Frith, M.D., Ph.D., role: SUB_INVESTIGATOR, contacts name: Faisal Fa'ak, M.D., role: SUB_INVESTIGATOR, contacts name: Lindsay Peterson, M.D., role: SUB_INVESTIGATOR, contacts name: Rama Suresh, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False |
protocolSection identificationModule nctId: NCT06374446, orgStudyIdInfo id: 22-172, briefTitle: Effect of Virtual Reality in Patients With Long Covid-19, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Istinye University, class: OTHER, descriptionModule briefSummary: SARS-CoV-2 was first detected in Wuhan, Hubei Province, China, in late 2019. It is a highly contagious virus that has been reported to occur in humans and is said to cause pneumonia.Covid-19 infection is transmitted through droplets during coughing and sneezing and through contact with the mouth, nose or eyes after contaminated hands. The most obvious symptoms of Covid-19 symptoms include cough, dyspnea and fever. Covid-19, which can also be seen asymptomatic, is in intensive care it may be severe enough to require hospitalization, cause multiple organ failure and even death it could be. Musculoskeletal symptoms such as fatigue, myalgia, and arthralgia are common with Covid-19 are the symptoms. The first case in Turkey was reported on March 11, 2020.Long-term Covid or Chronic Post Covid Syndrome are multi-system syndromes that last more than 12 weeks and physical, cognitive, psychological, social and occupational domains. The most commonly reported long covid symptoms are; fatigue, shortness of breath, cough, joint pain, chest pain.Virtual reality application provides its users with content created using computer technology. In a virtual environment with a high perception of reality, the aim is to enable mirror neuron activation, enabling the individual to interact with virtual objects and events with three-dimensional movements and to create the perception of doing all these in the real world.Virtual reality for training, treatment, rehabilitation, analysis and testing purposes in healthcare can be used. It is possible to use virtual reality for different purposes, for treatment and rehabilitation. With virtual reality applications in treatment and rehabilitation processes It was stated that patient motivation will increase and patient fear and anxiety will decrease.No study was found in the literature investigating the effect of virtual reality application on fatigue, functional capacity and respiratory function in long-term Covid-19 patients. The purpose of this study; To investigate the effect of virtual reality application on fatigue, functional level and respiratory function in long-term Covid-19 patients., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Classical Treatment, interventions name: Virtual Reality Combined with Classical Treatment, interventions name: Virtual Reality, interventions name: Control Group, outcomesModule primaryOutcomes measure: Fatigue, primaryOutcomes measure: Kinesiophobia, primaryOutcomes measure: Evaluation of Respiratory Function, primaryOutcomes measure: Shuttle Walking Test, primaryOutcomes measure: Endurance Shuttle Walking Test, primaryOutcomes measure: Sit and Reach Test, primaryOutcomes measure: Peripheral Muscle Strength, primaryOutcomes measure: The Nottingham Health Profile, primaryOutcomes measure: Dyspnea, primaryOutcomes measure: Energy Consumption, primaryOutcomes measure: Posture Analysis, primaryOutcomes measure: Covid-19 Yorkshire Performance, primaryOutcomes measure: FACIT Fatigue Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374433, orgStudyIdInfo id: PREDICOM-01, briefTitle: Investigating the Plasticity of Human Predictive Coding Through Neuromodulation, acronym: PREDICOM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Università Vita-Salute San Raffaele, class: OTHER, collaborators name: Alessia Santoni, collaborators name: Sara Stottmeier, collaborators name: Klara Hemmerich, collaborators name: Giuseppe Di Dona, collaborators name: Luigi Ferini-Strambi, descriptionModule briefSummary: The hypothesis of the study is to investigate how different trm (tES) methods (transcranial Alternating Current Stimulation, tACS, and transcranial Random Noise Stimulation, tRNS) applied at different stimulation frequencies and networks can modulate the predictive mechanisms in human perception and cognition. This is an interventional, monocentric, cross-sectional randomized, single-blinded study on healthy adult volunteers, recruited through online advertisements, flyers and oral transmission. Volunteers will be recruited from the general population of young adults., conditionsModule conditions: Human Brain and Cognition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Occipital tACS at IAF-2Hz, interventions name: Occipital tACS at IAF+2Hz, interventions name: Frontal tACS at 4-7 Hz, interventions name: Occipital tRNS, interventions name: Frontal tRNS, interventions name: Sham/placebo tACS, interventions name: Sham/placebo tRNS, outcomesModule primaryOutcomes measure: Behavioral measures, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374420, orgStudyIdInfo id: MD.21.11.564, briefTitle: Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: The aim of this work is to estimate the frequency of small airway disease and/or the bronchial hyperreactivity in follow up of postacute covid survivors., conditionsModule conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ACTUAL, outcomesModule primaryOutcomes measure: investigating pulmonary sequelae of covid-19., primaryOutcomes measure: investigating pulmonary sequelae of covid-19., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mansoura University, city: Mansoura, state: Dakhlia, zip: 050, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False |
protocolSection identificationModule nctId: NCT06374407, orgStudyIdInfo id: GT-001, briefTitle: The MIND-GUT Digital Pilot Intervention Study, acronym: MINDGUT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Skövde, class: OTHER, collaborators name: State University of New York - Downstate Medical Center, collaborators name: Albert Einstein College of Medicine, collaborators name: Göteborg University, collaborators name: Uppsala University, collaborators name: Kristianstad University, collaborators name: University of Pavia, collaborators name: The Food Scientist AB (Sweden), descriptionModule briefSummary: This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations., conditionsModule conditions: Obesity, conditions: Depressive Symptoms, conditions: Anxiety, conditions: Stress, conditions: Eating Habit, conditions: Dysbiosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We plan to randomly assign participants to either the intervention or control group., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Participants will be blinded to their group assignment and will use a smartphone app for meal planning. However, those in the intervention group may have some awareness of their assignment due to specific food choices. Meanwhile, the control group will have access to a variety of foods and recipes, maintaining blinding between the groups regarding their assigned diets, addressing a common challenge in diet intervention studies., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Dietary intervention based on the MIND diet, outcomesModule primaryOutcomes measure: Program retention, primaryOutcomes measure: Adherence, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Study effectiveness: change in eating attitudes at follow-up, primaryOutcomes measure: Study effectiveness: change in stress levels at follow-up, primaryOutcomes measure: Study effectiveness: change in depression symptoms at follow-up, primaryOutcomes measure: Study effectiveness: change in anxiety symtoms at follow-up, primaryOutcomes measure: Study effectiveness: change in body weight at follow-up, primaryOutcomes measure: Study effectiveness: change in % total fat mass at follow-up, primaryOutcomes measure: Study effectiveness: change in % visceral fat mass at follow-up, primaryOutcomes measure: Study effectiveness: change in waist circumference at follow-up, primaryOutcomes measure: Study effectiveness: change in hip circumference at follow-up, primaryOutcomes measure: Study effectiveness: change in microbiome variety at follow-up, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Skövde, city: Skövde, zip: 54128, country: Sweden, contacts name: Gianluca Tognon, PhD, role: CONTACT, geoPoint lat: 58.39118, lon: 13.84506, hasResults: False |
protocolSection identificationModule nctId: NCT06374394, orgStudyIdInfo id: 217848, secondaryIdInfos id: 2023-510196-59-00, type: OTHER, domain: EU CTR Number, briefTitle: A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-12-03, completionDateStruct date: 2025-05-20, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above., conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: Click here to enter text., enrollmentInfo count: 850, type: ESTIMATED, armsInterventionsModule interventions name: RSVPreF3 OA investigational vaccine, interventions name: COVID-19 mRNA vaccine, outcomesModule primaryOutcomes measure: RSV-A neutralization titers, primaryOutcomes measure: RSV-B neutralization titers, primaryOutcomes measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein, secondaryOutcomes measure: RSV-A neutralization titers expressed as GMT, secondaryOutcomes measure: RSV-A neutralization titers expressed as Mean Geometric Increase (MGI), secondaryOutcomes measure: RSV-A neutralization titers expressed as Seroresponse Rate (SRR), secondaryOutcomes measure: Percentage of participants having RSV-A neutralizing titers >= assay cut-off value, secondaryOutcomes measure: RSV-B neutralization titers expressed as GMT, secondaryOutcomes measure: RSV-B neutralization titers expressed as MGI, secondaryOutcomes measure: RSV-B neutralization titers expressed as SRR, secondaryOutcomes measure: Percentage of participants having RSV-B neutralizing titers >= assay cut-off value, secondaryOutcomes measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT, secondaryOutcomes measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI, secondaryOutcomes measure: Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value, secondaryOutcomes measure: Percentage of participants reporting each solicited administration site event, secondaryOutcomes measure: Percentage of participants reporting each solicited systemic event, secondaryOutcomes measure: Percentage of participants reporting unsolicited adverse events (AEs), secondaryOutcomes measure: Percentage of participants reporting serious adverse events (SAEs), secondaryOutcomes measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs), eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Coral Gables, state: Florida, zip: 33134, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Jeffrey B. Rosen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.72149, lon: -80.26838, locations facility: GSK Investigational Site, city: Savannah, state: Georgia, zip: 31406, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Paul Bradley, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08354, lon: -81.09983, locations facility: GSK Investigational Site, city: Evansville, state: Indiana, zip: 47714, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Hubert Sulit Reyes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.97476, lon: -87.55585, locations facility: GSK Investigational Site, city: Omaha, state: Nebraska, zip: 68134, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Brandon James Essink, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.25626, lon: -95.94043, locations facility: GSK Investigational Site, city: Secaucus, state: New Jersey, zip: 07094, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Johnathan Blizzard, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.78955, lon: -74.05653, locations facility: GSK Investigational Site, city: Rochester, state: New York, zip: 14609, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Patrick Connors, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, locations facility: GSK Investigational Site, city: Winston-Salem, state: North Carolina, zip: 27103, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Jonathan Paul Wilson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, locations facility: GSK Investigational Site, city: North Charleston, state: South Carolina, zip: 29405, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Kelly Morales, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.85462, lon: -79.97481, locations facility: GSK Investigational Site, city: Newport News, state: Virginia, zip: 23606, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: George H Freeman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.08339, lon: -76.46965, locations facility: GSK Investigational Site, city: Antwerpen, zip: 2000, country: Belgium, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Yven Van Herrewege, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.21989, lon: 4.40346, locations facility: GSK Investigational Site, city: Edegem, zip: 2650, country: Belgium, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Nikita Hanning, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.15662, lon: 4.44504, locations facility: GSK Investigational Site, city: Gent, zip: 9000, country: Belgium, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Isabel Leroux-Roels, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: GSK Investigational Site, city: Kluisbergen, zip: 9690, country: Belgium, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Klaas Vercruysse, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Mechelen, zip: 2800, country: Belgium, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Claudia Cornelis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.02574, lon: 4.47762, locations facility: GSK Investigational Site, city: Breda, zip: 4818 CK, country: Netherlands, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Simone van der Sar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.58656, lon: 4.77596, locations facility: GSK Investigational Site, city: Enschede, zip: 7512 KZ, country: Netherlands, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Paolo Zocca, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.21833, lon: 6.89583, locations facility: GSK Investigational Site, city: Utrecht, zip: 3584 BA, country: Netherlands, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Marc Bonten, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, locations facility: GSK Investigational Site, city: Zutphen, zip: 7207 AE, country: Netherlands, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Martijn Goosens, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.13833, lon: 6.20139, locations facility: GSK Investigational Site, city: Boadilla del Monte, state: Madrid, zip: 28660, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Silvina Laura Natalini, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.405, lon: -3.87835, locations facility: GSK Investigational Site, city: Barcelona, zip: 08023, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Fernando Cereto Castro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: GSK Investigational Site, city: Barcelona, zip: 08907, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Cristina Masuet Aumatell, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: GSK Investigational Site, city: Coruña, zip: 15006, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Maria Jose Pereira Rodriguez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.37135, lon: -8.396, locations facility: GSK Investigational Site, city: Madrid, zip: 28040, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Helena Moza Moríñigo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: GSK Investigational Site, city: Madrid, zip: 28041, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Pablo Rojo Conejo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: GSK Investigational Site, city: Majadahonda, zip: 28222, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Jenry Borda Olivas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.47353, lon: -3.87182, hasResults: False |
protocolSection identificationModule nctId: NCT06374381, orgStudyIdInfo id: 854990, briefTitle: PEACE for ImPACT Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: Institute of Education Sciences, collaborators name: Michigan State University, descriptionModule briefSummary: Investigators will test the impact of the PEACE implementation toolkit and determine the level of implementation support needed to improve early intervention providers use of caregiver coaching with families of young children with autism who receive early intervention services. The study will also assess caregiver and child outcomes for families receiving caregiver coaching and the cost effectiveness of the PEACE implementation toolkit. The investigators will enroll 200 early intervention providers, and 400 parent-child dyads., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome assessors will be masked to randomization condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: PEACE Online Resources, interventions name: PEACE Weekly Group Facilitation, interventions name: PEACE Weekly Individual Facilitation, outcomesModule primaryOutcomes measure: Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool, secondaryOutcomes measure: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO), secondaryOutcomes measure: Autism Impact Measure (AIM), secondaryOutcomes measure: Social Communication Checklist (SCC), secondaryOutcomes measure: Confusion, Hubbub, and Order Scale (CHAOS), secondaryOutcomes measure: Acceptability, Appropriateness, and Adoption measure, secondaryOutcomes measure: Qualitative Interview, eligibilityModule sex: ALL, minimumAge: 12 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Mental Health, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-30, uploadDate: 2024-04-12T13:20, filename: Prot_SAP_000.pdf, size: 508769, hasResults: False |
protocolSection identificationModule nctId: NCT06374368, orgStudyIdInfo id: JID-SURG, briefTitle: Small Bowel Diversion, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Ostrava, class: OTHER, collaborators name: Institute for Clinical and Experimental Medicine, collaborators name: Vitkovice Hospital, descriptionModule briefSummary: In an effort to replicate metabolic surgery's durable results in metabolic disease while minimizing its risks, two innovative methods has been created. Two surgical methods to create a bowel-to-bowel anastomosis, similar to the type used in current metabolic surgeries. It be to create a jejuno-ileal, side-to-side anastomosis and jejunocolic side-to-side anastomosis. The side-to-side jejuno-ileal anastomosis and side-to-side jejunocolic anastomosis provides two routes for ingested food. The new, shorter route has a malabsorptive effect similar to that seen in Roux en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) - procedures which leads to weight loss. Additionally, delivery of non-absorbed macronutrients to the distal ileum, or transverse colon can enhance incretin effect and improve Type 2 Diabetes parameters. However, the native route is also preserved, which theoretically reduces the risk of malnutrition, diarrhea, and metabolic derangements seen in other metabolic surgeries.The side-to-side jejuno-ileal anastomosis was already tested in the Pilot Study of the GI Windows Self-Forming Magnetic (SFM) Anastomosis Device for Crea-tion of an Incisionless Small Bowel Bypass for Treatment of Obesity and Diabetes in year 2015 (15). The results of this study demonstrated the safety of this approach without seri-ous adverse events. This non-surgical approach resulted in Significant weight loss, favorable changes in insulin and incretin responses to a mixed meal and Significant improvement in A1C in T2DM (16).In summary, metabolic disease is a growing pandemic with suboptimal clinical solutions. The surgical side-to-side jejuno-ileal anastomosis and side-to-side jejuno-colic anastomosis without gastrectomy potentially represents a new class of therapy that may produce durable clinical results generally associated with surgery while minimizing its attendant risks., conditionsModule conditions: Obesity, conditions: Type2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: jejuno-ileal diversion, interventions name: jejuno-colic diversion, outcomesModule primaryOutcomes measure: Total body weight loss, primaryOutcomes measure: Glycated hemoglobin loss, primaryOutcomes measure: Diabetes medication loss, primaryOutcomes measure: Total cholesterol loss, primaryOutcomes measure: Low density lipoprotein loss, primaryOutcomes measure: High density lipoprotein loss, primaryOutcomes measure: Leptin metabolism evaluation, primaryOutcomes measure: Adiponectin metabolism evaluation, secondaryOutcomes measure: Change from baseline quality of life-Lite, secondaryOutcomes measure: Change from baseline quality of life - Sort Form Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Ostrava, Faculty of Medicine, city: Ostrava, country: Czechia, geoPoint lat: 49.83465, lon: 18.28204, hasResults: False |
protocolSection identificationModule nctId: NCT06374355, orgStudyIdInfo id: Semibranch_Retro, briefTitle: Semibranch Registry - Retrospective, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2030-10, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospital Muenster, class: OTHER, descriptionModule briefSummary: The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair., conditionsModule conditions: Aortic Aneurysm, conditions: Endovascular Aortic Repair, conditions: Stent-Graft Endoleak, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Semibranch CMD branched aortic stentgraft, outcomesModule primaryOutcomes measure: Freedom from target vessel instability, primaryOutcomes measure: Mortality, primaryOutcomes measure: Technical success, secondaryOutcomes measure: Morbidity, secondaryOutcomes measure: Freedom of Endoleak type I and III, secondaryOutcomes measure: Long term mortality, secondaryOutcomes measure: Branch patency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Muenster University Hospital, city: Münster, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, hasResults: False |
protocolSection identificationModule nctId: NCT06374342, orgStudyIdInfo id: SO01-TK-SUBSTITUTES, briefTitle: BONE SUBSTITUTES OUTCOMES, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-16, primaryCompletionDateStruct date: 2026-09-16, completionDateStruct date: 2032-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Teknimed, class: INDUSTRY, descriptionModule briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.TEKNIMED bone substitutes are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites., conditionsModule conditions: Bone Resorption, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 425, type: ESTIMATED, armsInterventionsModule interventions name: Bone defect, interventions name: Spine fusion, interventions name: Cage filling, outcomesModule primaryOutcomes measure: Successful bone repair, secondaryOutcomes measure: Alleviation of Pain, secondaryOutcomes measure: Bone reconstruction, secondaryOutcomes measure: Well-being, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pôle Rachis Hôpital Privé d'Eure et Loir, status: RECRUITING, city: Mainvilliers, state: Eure Et Loir, zip: 28300, country: France, contacts name: Jean MEYBLUM, MD, role: CONTACT, email: [email protected], contacts name: Jean MEYBLUM, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.45003, lon: 1.45607, locations facility: Hôpital Joseph Ducuing, status: RECRUITING, city: Toulouse, state: Haute Garonne, zip: 31000, country: France, contacts name: Gérard GIORDANO, MD, role: CONTACT, email: [email protected], contacts name: Gérard GIORDANO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Clinique Médipole Garonne, status: RECRUITING, city: Toulouse, state: Haute Garonne, zip: 31100, country: France, contacts name: Dominique VARDON, MD, role: CONTACT, email: [email protected], contacts name: Dominique VARDON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: CHRU Brabois, status: RECRUITING, city: Nancy, state: Meurthe Et Moselle, zip: 54000, country: France, contacts name: Didier MAINARD, MD, role: CONTACT, email: [email protected], contacts name: Didier MAINARD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, locations facility: Clinique du Pré, status: RECRUITING, city: Le Mans, state: Sarthe, zip: 72000, country: France, contacts name: Jean-Patrick RAKOVER, MD, role: CONTACT, phone: 02 43 77 54 21, email: [email protected], contacts name: Jean-Patrick RAKOVER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.0, lon: 0.2, locations facility: OCM Klinik GmbH, status: RECRUITING, city: München, state: Bavière, zip: D-81369, country: Germany, contacts name: Markus SCHROEDEL, MD, role: CONTACT, email: [email protected], contacts name: Markus SCHROEDEL, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False |
protocolSection identificationModule nctId: NCT06374329, orgStudyIdInfo id: S68717, briefTitle: Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines, acronym: RCTcanines2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2026-08-01, completionDateStruct date: 2027-08-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: University of Copenhagen, collaborators name: Palacky University, collaborators name: The University of Hong Kong, descriptionModule briefSummary: Canine impaction is a sign of abnormal dental development with potentially far-reaching consequences (such as significant root resorption and loss of lateral incisors. This compromises both aesthetics and function of the teeth, making the prediction of canine tooth impaction increasingly important. Interceptive orthodontic measures, such as extraction of deciduous canines or molars or maxillary expansion aim to create extra space in the dental arch, allowing the canines to position themselves better and normalizing their eruption pattern.This study corresponds to the second phase of an RCT, based on the results of the first phase, published in July 2023 (S59030) (Willems G, Butaye C, Raes M, Zong C, Begnoni G, Cadenas de Llano-Pérula M. Early prevention of maxillary canine impaction: a randomized clinical trial. Eur J Orthod. 31;45(4):359-369). The first phase compared the effect of 3 interceptive strategies (expansion, extraction and no intervention) on the position of impacted maxillary canines, finding that maxillary expansion provides the most improvement on impacted canine position. In second phase, 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with 'slow maxillary expansion with removable plates' or 'no treatment'. These groups are additionally compared with patients with a crossbite and lack of space, which always receive expansion treatment. All selected patients will be followed up for at least 18 months. The primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition, assessed on panoramic X-rays. The secondary endpoint is the assessment of the need for additional orthodontic treatment., conditionsModule conditions: Tooth Impaction, conditions: Canine Teeth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Interceptive Slow Maxillary Expansion with removable plates, outcomesModule primaryOutcomes measure: Position of the impacted maxillary canine towards the dental midline (3^ML)., secondaryOutcomes measure: Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure), eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374316, orgStudyIdInfo id: 2302888, briefTitle: Air Purifiers in Classrooms for Infection Control - a Pilot Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Norwegian Institute of Public Health, class: OTHER_GOV, collaborators name: SINTEF Health Research, descriptionModule briefSummary: This study aims to investigate the acceptability and feasibility of deploying air purifiers equipped with HEPA (high-efficiency particulate air) filters in classrooms, to study air purifiers as an infection control measure. It will also evaluate the direct effect of air purifiers on air quality, comparing ceiling-mounted purifiers, portable purifiers and no purifier., conditionsModule conditions: Feasibility, conditions: Acceptability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We will select schools for participation in arm 1 and 2, respectively, based on the feasibility of installing ceiling-mounted and placing portable air purifiers in each relevant classroom. In arm 3, all three classrooms will be equipped with both ceiling-mounted and portable air purifiers, as well as indoor air quality sensors.For this arm, we will randomize the three classrooms to each of three weekly programs for the air purifiers;Program 1) Week 1, 4, and 7: Ceiling-mounted ON, Week 2, 5, and 8: No purifier on, Week 3, 6, and 9: Portable ON. Program 2) Week 1, 4, and 7: Portable ON, Week 2, 5, and 8: Ceiling-mounted ON, Week 3, 6, and 9: No purifier on. Program 3) Week 1, 4, and 7: No purifier on Week 2, 5, and 8: Portable ON, Week 3, 6, and 9: Ceiling-mounted ON.Each classroom will be assigned a computer-generated random number and will based on the ascending order of the random numbers be allocated to the three predetermined sequences of programs., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ACTUAL, armsInterventionsModule interventions name: Ceiling-Mounted Air Purifiers, interventions name: Portable Air Purifiers, interventions name: Portable or Ceiling Mounted Air Purifiers, outcomesModule primaryOutcomes measure: Effectiveness of air purifiers versus no air purifier on improving air quality in classrooms., primaryOutcomes measure: Effectiveness of ceiling mounted versus portable air purifier on improving air quality in classrooms., primaryOutcomes measure: Acceptability of having Air Purifiers in Classrooms, primaryOutcomes measure: Untoward events when installing air purifiers in classrooms, primaryOutcomes measure: Untoward events when running air purifiers in classrooms, primaryOutcomes measure: How student absence data can be collected from existing school registration systems., secondaryOutcomes measure: Response rate of class teachers to the study surveys., secondaryOutcomes measure: Response rate of students/their guardians to study surveys., secondaryOutcomes measure: Proportion of absence due to respiratory disease., secondaryOutcomes measure: Absence frequency among students, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Norwegian Institute of Public Health, city: Oslo, country: Norway, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False |
protocolSection identificationModule nctId: NCT06374303, orgStudyIdInfo id: CHRBSS 00001940, briefTitle: Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder: A Randomized Clinical Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-19, primaryCompletionDateStruct date: 2023-11-20, completionDateStruct date: 2023-11-20, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Vermont, class: OTHER, descriptionModule briefSummary: The adverse consequences of illicit opioid use (e.g., overdose, premature death) are the focus of intensive research efforts. However, other serious health problems among individuals with opioid use disorder (OUD) have received far less attention. Food insecurity (FI) is 4-7 times greater among individuals with OUD than the general population. In addition to the increased healthcare utilization and costs, poor health outcomes, and adverse social consequences associated with FI in the general population, patients with co-occurring FI and OUD are at increased risk for licit and illicit drug use, sexual and drug risk behaviors, infectious disease, and a two-fold greater odds of premature death.In this randomized pilot study, we evaluated a novel, mail-based meal delivery intervention for improving household FI and other outcomes among individuals receiving methadone or buprenorphine maintenance for OUD.Fifty adults with FI and OUD were randomized to one of two 12-week experimental conditions: Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. NE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home.The primary outcome of household FI was measured at monthly assessments using the USDA Household Food Security Survey. Secondary measures included depression symptoms (Beck Depression Inventory), quality of life (RAND-36 Quality of Life Survey), and drug use as measured by biochemical urinalysis.The NE+MD intervention was associated with significant improvements in household FI, with fewer NE+MD participants meeting criteria for FI vs. NE participants at all three assessment timepoints (p's\<.05). Retention rates were similar between the two groups (88% and 84% for NE+MD and NE conditions, respectively; p=.68). Intervention acceptability was also high, with NE+MD participants rating the enjoyment and convenience of the meals at 81 and 93, respectively (range: 0-100).Changes in FI status were also associated with improvements in other areas of functioning. NE+MD participants experienced reductions in depression symptomatology, with Beck Depression Inventory scores lower than intake at Weeks 4 and 8 (p's\<.05) and no changes among NE participants. NE+MD participants also experienced improvements on four of the eight subscales of the RAND-36 Quality of Life Health Survey (i.e., General Health, Bodily Pain, Mental Health, Role Emotional; p's\<.05), with no changes among NE participants.This study represents the first effort to develop and evaluate a novel intervention to reduce FI and related problems among individuals with OUD. These pilot data support the feasibility, acceptability and initial efficacy of the NE+MD intervention for improving household FI, as well as provide exciting new preliminary evidence suggesting that FI may be linked to participants' mental and physical health., conditionsModule conditions: Food Security, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, parallel-groups pilot study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: NE + Meal Delivery (NE+MD) intervention, outcomesModule primaryOutcomes measure: Household food insecurity Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Vermont, city: Burlington, state: Vermont, zip: 05401, country: United States, geoPoint lat: 44.47588, lon: -73.21207, hasResults: False |
protocolSection identificationModule nctId: NCT06374290, orgStudyIdInfo id: HSC-MS-24-0024, briefTitle: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center, Houston, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia., conditionsModule conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Naltrexone (Vivitrol), interventions name: Bupropion, outcomesModule primaryOutcomes measure: Feasibility as assessed by the percentage of participants that enroll in the study, primaryOutcomes measure: Percentage of participants that complete 3 weeks of treatment, primaryOutcomes measure: Safety as assessed by the percentage of participants that show no serious adverse events, secondaryOutcomes measure: Change in number of cigarettes smoked per day (CPD), secondaryOutcomes measure: Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU), secondaryOutcomes measure: Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT), secondaryOutcomes measure: Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Texas health Science Center at Houston, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Jin H Yoon, PhD, role: CONTACT, phone: 713-486-2800, email: [email protected], contacts name: Jessica Vincent, role: CONTACT, phone: (713) 486-2645, email: [email protected], geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06374277, orgStudyIdInfo id: 23-09339-IAA, briefTitle: Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence, acronym: MedAAAction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2027-09-30, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Tennessee, class: OTHER, collaborators name: Sponsor GmbH, descriptionModule briefSummary: Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers, 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations., conditionsModule conditions: Diabetes, conditions: Hypertension, conditions: High Cholesterol/Hyperlipidemia, conditions: Coronary Artery Disease, conditions: Congestive Heart Failure, conditions: Chronic Lung Disease, conditions: Chronic Kidney Diseases, conditions: Arrythmia, conditions: Stroke, conditions: Depression, conditions: Anxiety, conditions: Pulmonary Embolism, conditions: Heart Attack, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible patients who sign consent forms and complete baseline surveys will be randomized to the Med AAAction intervention group or the usual care in a 1:1 ratio, stratified by health system. The participants will be enrolled before hospital discharge. The Med AAAction intervention will include the following components: 1) medications with zero copay, 2) bedside delivery and subsequent home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up after hospital discharge. The intervention will be provided for one-year., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 388, type: ESTIMATED, armsInterventionsModule interventions name: Med AAAction intervention, outcomesModule primaryOutcomes measure: Adherence to chronic disease medications, secondaryOutcomes measure: Health care utilization, secondaryOutcomes measure: Cost, secondaryOutcomes measure: Qualitative Evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Tennessee Medical Center, status: NOT_YET_RECRUITING, city: Knoxville, state: Tennessee, zip: 37920, country: United States, contacts name: Shauntá M Chamberlin, role: CONTACT, phone: 865-305-5061, email: [email protected], geoPoint lat: 35.96064, lon: -83.92074, locations facility: University of Tennessee Health Science Center/Regional One Health, status: RECRUITING, city: Memphis, state: Tennessee, zip: 38103, country: United States, contacts name: Kay Ryan, PharmD, role: CONTACT, phone: 901-545-7840, email: [email protected], geoPoint lat: 35.14953, lon: -90.04898, hasResults: False |
protocolSection identificationModule nctId: NCT06374264, orgStudyIdInfo id: NM100, briefTitle: Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder, acronym: aNiMatO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: MedRhythms, Inc., class: INDUSTRY, collaborators name: Alexion Pharmaceuticals, Inc., descriptionModule briefSummary: The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit., conditionsModule conditions: Neuromyelitis Optica Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: MR-C-014, outcomesModule primaryOutcomes measure: Participant acceptability of MR-C-014, primaryOutcomes measure: Number of device-related adverse events (AEs), secondaryOutcomes measure: 6-Minute Walk Test (6MWT), secondaryOutcomes measure: Number of walks per week, otherOutcomes measure: Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors, otherOutcomes measure: Spatiotemporal variability of gait as measured by the MR-C-014 sensors, otherOutcomes measure: Stride length as measured by the MR-C-014 sensors, otherOutcomes measure: Falls Efficacy Scale-International (FES-I), otherOutcomes measure: Number of falls as recorded in Falls Diary, otherOutcomes measure: Multiple Sclerosis Walking Scale (MSWS-12), otherOutcomes measure: Visual Analogue Scale (VAS), otherOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7), otherOutcomes measure: 9 Hole Peg Test (9-HPT), otherOutcomes measure: Symbol Digit Modalities Test (SDMT), otherOutcomes measure: Fatigue Scale for Motor and Cognitive Functions (FSMC), otherOutcomes measure: Expanded Disability Status Scale (EDSS) Ambulation Score, otherOutcomes measure: Activities-Specific Balance Confidence Scale (ABC), otherOutcomes measure: Patient Experience and Satisfaction Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Eric Klawiter, MD, role: CONTACT, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06374251, orgStudyIdInfo id: 0S-23-2, secondaryIdInfos id: NCI-2023-08890, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 0S-23-2, type: OTHER, domain: USC / Norris Comprehensive Cancer Center, secondaryIdInfos id: P30CA014089, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA014089, briefTitle: Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-09-27, completionDateStruct date: 2025-03-27, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This clinical trial assesses whether narrative medicine methods may improve the sense of well-being among gastrointestinal (GI) (digestive system) cancer patients. Narrative medicine is a clinical approach where providers can use a patient's own narrative (perspective) of their illness to promote healing and resilience. By applying narrative medicine's main tool, close reading, to clinical practice, clinicians learn to listen and attend to patients more deeply. This allows for freer communication and the creation of a healthcare encounter that centers on the psychological and emotional well being of the patient in addition to their medical conditions. Narrative medicine can include close reading, creative or reflective writing, and discussion. These methods may help patients with GI cancer to reflect on their life stories, both inside and outside of their illness experience, and help them gather skills to optimize their well-being., conditionsModule conditions: Malignant Digestive System Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Discussion, interventions name: Interview, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Number of participants who complete the narrative medicine sessions, primaryOutcomes measure: Change in well-being scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: USC / Norris Comprehensive Cancer Center, status: RECRUITING, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Eve L. Makoff, role: CONTACT, phone: 323-865-3000, email: [email protected], contacts name: Eve L. Makoff, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06374238, orgStudyIdInfo id: UG3HL165839, type: NIH, link: https://reporter.nih.gov/quickSearch/UG3HL165839, secondaryIdInfos id: UG3HL165839, type: NIH, link: https://reporter.nih.gov/quickSearch/UG3HL165839, briefTitle: Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain, acronym: PRESENCE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions.By leveraging existing infrastructure for delivering virtual peer support interventions, tailored digital CBT programs for individuals with SCD, and partnerships with CBOs, the study aims to provide valuable insights into the feasibility and effectiveness of digital CBT as a pain management strategy for this vulnerable population., conditionsModule conditions: Pain, conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three-arm, phase III randomized controlled effectiveness trial. Participants will be randomized 3:3:2 into (1) CBT + peer, (2) self-guided CBT, or (3) UC, stratified by site, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 470, type: ESTIMATED, armsInterventionsModule interventions name: CBT+ Health coach, interventions name: CBT w/o Health Coach ( self-guided), interventions name: Usual Care, outcomesModule primaryOutcomes measure: Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain intensity for AYAs with SCD and chronic pain, primaryOutcomes measure: Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain interference for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain intensity for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain interference for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374225, orgStudyIdInfo id: 23-0866, briefTitle: Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention, acronym: SAVE-O2 AI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: United States Department of Defense, collaborators name: O2matic ApS, collaborators name: IDTS Medical, Inc., descriptionModule briefSummary: This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%)., conditionsModule conditions: Critical Illness, conditions: Wounds and Injury, conditions: Disease Attributes, conditions: Pathologic Processes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Automated Titration (O2matic), outcomesModule primaryOutcomes measure: Proportion of time spent within the targeted normoxemia range, secondaryOutcomes measure: Amount of supplemental oxygen administered, secondaryOutcomes measure: Proportion of time spent in hypoxemia (SpO2<88%), secondaryOutcomes measure: Proportion of time spent in hyperoxemia (SpO2 >96%), secondaryOutcomes measure: Time to Room Air, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Oregon Health and Sciences University, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Vanderbilt University Medical Center, city: Nashville, state: Tennessee, zip: 37232, country: United States, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False |
protocolSection identificationModule nctId: NCT06374212, orgStudyIdInfo id: 24-0191, briefTitle: Anifrolumab for Hidradenitis Suppurativa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: This clinical trial aims to study if a drug called anifrolumab works to treat Hidradenitis Suppurativa (HS) as well as its effect in quality of life before and after treatment. Anifrolumab is a monoclonal antibody that inhibits several processes that have been shown to be involved in the development of HS.The study lasts approximately 40 weeks separated into a screening, treatment, and follow-up phase. Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening. If eligible for the study, the treatment phase lasts 24 weeks (or six months) with one follow-up visit 12 weeks after the last visit in the treatment phase.During the treatment phase, participants will be asked to come to clinic every two weeks for the first month of treatment, and monthly thereafter for a total of eight treatment visits. Participants will be asked to:* Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received.* Receive related medical evaluation* Receive the study drug intravenously* Stay 20 minutes after the infusion for monitoring, conditionsModule conditions: Hidradenitis Suppurativa, conditions: Acne Inversa, conditions: Hidradenitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All study participants, if eligible, will receive the study drug (anifrolumab)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Anifrolumab, outcomesModule primaryOutcomes measure: Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks, secondaryOutcomes measure: Percentage of participants achieving a HiSCR 50 at 24 weeks, secondaryOutcomes measure: Percentage of participants who achieve a Hidradenitis Suppurativa Clinical Response score of 75 (HiSCR 75) at 12 weeks, secondaryOutcomes measure: Percentage of participants who achieve a HiSCR 75 at 24 weeks of treatment., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UNC Dermatology and Skin Cancer Center, city: Chapel Hill, state: North Carolina, zip: 27516, country: United States, contacts name: Erika Hanami, role: CONTACT, phone: 984-974-3682, email: [email protected], contacts name: Christopher Sayed, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06374199, orgStudyIdInfo id: 24-0181, briefTitle: Med-South Lifestyle Program for Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, descriptionModule briefSummary: Eating a Mediterranean-style diet during pregnancy improves pregnancy outcomes, yet most Americans who are pregnant do not follow this type of dietary pattern. There is increasing interest in Food is Medicine programs, which provides foods to patients to improve health outcomes - food provided in this context is called medically tailored meals. The research team at the UNC Center for Health Promotion and Disease Prevention is developing a Food is Medicine program to improve pregnancy outcomes and at this point the team is ready to test the program.The purpose of this study is to assess the feasibility and acceptability of a Food is Medicine intervention when started during the first trimester of pregnancy. The eating pattern to be evaluated in this study is a Mediterranean-style dietary pattern adapted for the southern United States - thus, the program is called "Med-South." All who take part will receive Med-South dietary counseling. In addition, to help participants follow a Med-style dietary pattern, one group of study participants will receive extra virgin olive oil and nuts. The other group will receive extra virgin olive oil, nuts, and frozen meals (medically tailored meals) that align with the Med-South dietary pattern. Participants will be assigned at random (like flipping a coin) to one of these groups, conditionsModule conditions: Pregnancy Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Standard 2 group parallel randomized trial study design., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Med-South Lifestyle Intervention for Pregnancy--Arm 1, interventions name: Med-South Lifestyle Intervention for Pregnancy--Arm 2, outcomesModule primaryOutcomes measure: Percent that would recommend this program to others who are pregnancy, primaryOutcomes measure: Percent of participants who take part in the 10 study counseling sessions, secondaryOutcomes measure: Maternal diet quality, otherOutcomes measure: skin carotenoids, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Center for Health Promotion and Disease Prevention/UNC-Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06374186, orgStudyIdInfo id: 2095072, secondaryIdInfos id: 2095072, type: OTHER, domain: UMKC IRB, briefTitle: Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City, acronym: COMMITTED2-KC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-04-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Missouri, Kansas City, class: OTHER, descriptionModule briefSummary: This study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Because this is a behavioral intervention, participant blinding is not possible. Randomization will occur after baseline assessment and participants will be instructed to not tell their provider their assigned condition., whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Intervention with financial rewards and coaching, interventions name: Control, outcomesModule primaryOutcomes measure: Time in target blood glucose range per CGM, primaryOutcomes measure: Hemoglobin A1C, secondaryOutcomes measure: Diabetes Quality of Life Brief Inventory, secondaryOutcomes measure: Diabetes Distress Scale, secondaryOutcomes measure: PROMIS Medication Adherence Scale, secondaryOutcomes measure: Perceived Dietary Adherence Questionnaire, secondaryOutcomes measure: Motivation and Confidence Ruler, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Missouri - Kansas City School of Medicine, city: Kansas City, state: Missouri, zip: 64108, country: United States, contacts name: Carrie R Kriz, role: CONTACT, phone: 816-512-7473, email: [email protected], contacts name: Jared M Bruce, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, hasResults: False |
protocolSection identificationModule nctId: NCT06374173, orgStudyIdInfo id: TGI6-T1-01, briefTitle: A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-03, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Hefei TG ImmunoPharma Co., Ltd., class: OTHER, descriptionModule briefSummary: A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors, conditionsModule conditions: Advanced or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 123, type: ESTIMATED, armsInterventionsModule interventions name: TGI-6 Injection, outcomesModule primaryOutcomes measure: Dose-limiting Toxicity (DLT), primaryOutcomes measure: Dose-Finding, primaryOutcomes measure: Frequency and Severity of Adverse Events (AE), secondaryOutcomes measure: Pharmacokinetics of TGI-6, secondaryOutcomes measure: Pharmacokinetics of TGI-6, secondaryOutcomes measure: Number of subjects with Anti-TGI-6 antibody positive, secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Hang Zhou, role: CONTACT, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06374160, orgStudyIdInfo id: 70115371, briefTitle: Exercise in Patients With Advanced Non-small Cell Lung Cancer, acronym: BREATH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Hospital, Essen, class: OTHER, collaborators name: German Cancer Aid, descriptionModule briefSummary: Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise., conditionsModule conditions: Advanced Lung Carcinoma, conditions: First Line Treatment, conditions: Second Line Treatment, conditions: NSCLC Stage IV, conditions: NSCLC Stage IIIB, conditions: Palliative Treatment, conditions: NSCLC Stage IIIC, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: BREATH is a prospective 3-arm 2:1:1 randomized controlled trial (RCT). The first arm represents the control group, which will receive the standard treatment for the first 12 weeks (recommendations for physical activity during cancer treatment). The other two arms represent the exercise groups, one group will receive individualized endurance training and the other group a combination of individualized endurance and strength training. All arms will be treated for 12 weeks. Afterwards, the patients in the control group are randomized to one of the other two study arms and then also treated twice for 12 weeks., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Exercise intervention, outcomesModule primaryOutcomes measure: Maximum oxygen uptake (VO2 peak [ml/min/kg]), secondaryOutcomes measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F), secondaryOutcomes measure: European Organisation for Research and Treatment of Cancer (EORTC QLQ C30), secondaryOutcomes measure: European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13), secondaryOutcomes measure: Arterial blood pressure, secondaryOutcomes measure: Change in ECG, secondaryOutcomes measure: Adherence to exercise intervention, secondaryOutcomes measure: Drop-out rate, secondaryOutcomes measure: Recruitment rate, secondaryOutcomes measure: Serious Adverse Event/Adverse Events, secondaryOutcomes measure: Therapy response, secondaryOutcomes measure: Treatment Toxicity, secondaryOutcomes measure: Treatment scheme, secondaryOutcomes measure: NT-pro-BNP, secondaryOutcomes measure: High sensitive troponin I, secondaryOutcomes measure: Erythrocytes, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Leukocytes, secondaryOutcomes measure: Lymphocytes, secondaryOutcomes measure: Neutrophils, secondaryOutcomes measure: CRP, secondaryOutcomes measure: CYRFRA 21-1, secondaryOutcomes measure: Physical function (Hypothetical One-repetition maximum), secondaryOutcomes measure: Blood gas analysis pH value, secondaryOutcomes measure: Blood gas analysis (PAO2), secondaryOutcomes measure: Blood gas analysis (SaO2), secondaryOutcomes measure: Blood gas analysis (PCO2), secondaryOutcomes measure: Blood gas analysis (BE), secondaryOutcomes measure: Blood gas analysis (HCO3), secondaryOutcomes measure: Blood gas analysis (SBCe), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen, city: Essen, state: North Rhine-Westphalia, zip: 45147, country: Germany, contacts name: Mitra Tewes, PD. Dr., role: CONTACT, email: [email protected], contacts name: Nico De Lazzari, M. Sc., role: CONTACT, phone: +49 201 723-82035, email: [email protected], contacts name: Mitra Tewes, PD. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Marcel Wiesweg, PD. Dr., role: SUB_INVESTIGATOR, contacts name: Miriam Götte, PD. Dr., role: SUB_INVESTIGATOR, contacts name: Eva-Maria Hüßler, Dr., role: SUB_INVESTIGATOR, contacts name: Andreas Stang, Prof. Dr., role: SUB_INVESTIGATOR, contacts name: Matthias Totzeck, Prof. Dr., role: SUB_INVESTIGATOR, geoPoint lat: 51.45657, lon: 7.01228, hasResults: False |
protocolSection identificationModule nctId: NCT06374147, orgStudyIdInfo id: STUDY00004467, briefTitle: "Prapela® SVS Incubator Pad for Apnea of Prematurity, acronym: Prapela AOP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tufts Medical Center, class: OTHER, collaborators name: University of Alabama at Birmingham, descriptionModule briefSummary: The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay., conditionsModule conditions: Apnea of Prematurity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: SVS mattress, outcomesModule primaryOutcomes measure: Reduce apnea events by 30% or more in the three days after study entry, secondaryOutcomes measure: Reduce the number of days caffeine citrate is used after study entry by 3 days or more, secondaryOutcomes measure: Reduce the number of days of respiratory support by 3 days or more, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374134, orgStudyIdInfo id: STUDY00004835, briefTitle: The Impact of Community and Patient Engagement Practices on Vaccine Confidence in the United States, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tufts University, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: The primary objective of this study is to demonstrate an empirical relationship between community- engagement practices, and between patient-centric clinical trial design, execution and communication practices, and vaccine adoption experience.Our hypothesis is that patient-centric clinical trial activity, and community engagement in late-stage clinical trials and early-stage commercialization, reduces vaccine hesitancy and increases vaccine confidence among health care providers overall and within diverse patient communities and ultimately drives faster vaccine adoption., conditionsModule conditions: Vaccine Hesitancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Community Engagement Practice, interventions name: Patient-Centric Protocol Element, outcomesModule primaryOutcomes measure: Units of Vaccine Dispensed, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374121, orgStudyIdInfo id: POWER, briefTitle: Kidney Perfusion With or Without Absorption, acronym: POWER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, descriptionModule briefSummary: In this single-center, pilot, prospective, randomized study, the investigators will compare the biochemical profiles of the perfusate and the functional parameters of five kidneys perfused with Integrated PerLife® system and "PerSorb ECOS-300CY ™" sorbent (adsorption groups) with the profiles of the perfusate and functional parameters of five matched kidneys perfused with Integrated PerLife® system only (non-adsorption group). Kidneys from marginal donors with a clinical indication to pre-transplant histological evaluation (donor \>70-years-old or aged 60 to 69 years but with hypertension, diabetes and/or clinical proteinuria) will be allocated to perfusion with or without adsorption using a 1:1 randomization ratio. When both donor kidneys will have a score from 0 to 4, the two kidneys will be used for two single transplants. When one kidney will have a score from 0 to 4 and the other kidney will have a score of 5 or more, and when both kidneys will have a score from 5 to 7, the two kidneys will be transplanted together into the same recipient. If one kidney will have a score from 5 to 7 and the other kidney will have a score of 8 or greater, the two kidneys will be discarded. With the use of the minimization method, the randomization will be planned in order to have the same number of single or dual transplants in the perfusion kidney groups with or without adsorption. Donor selection, kidney evaluation and allocation and recipient management will be based on per center practice., conditionsModule conditions: Kidney Replacement, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To compare the biochemical profiles of the perfusate obtained from 5 kidneys treated with perfusion and concomitant adsorption, with that of the perfusate obtained from 5 kidneys treated with perfusion without adsorption., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: PerSorb cartridge (CytoSorbents Europe GmbH, Germany), interventions name: PerLife PerKidney, outcomesModule primaryOutcomes measure: Oxidative stress markers, primaryOutcomes measure: Acute kidney injury markers, primaryOutcomes measure: Inflammatory cytokine markers, primaryOutcomes measure: Complement activation markers, primaryOutcomes measure: Vascular resistances, primaryOutcomes measure: Perfusate sample collection, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST - Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/ Mario Negri Institute for Pharmacological Research - Clinical Research Center for Rare Diseases Aldo e Cele Daccò, city: Bergamo, state: BG, zip: 24027, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, hasResults: False |
protocolSection identificationModule nctId: NCT06374108, orgStudyIdInfo id: Neuro_Exercise, briefTitle: Resistance Training and Corticospinal Excitability in Multiple Sclerosis, acronym: NEXIMS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, collaborators name: Aarhus University Hospital, collaborators name: University of Copenhagen, descriptionModule briefSummary: The goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning (corticospinal excitability (CSE)) and walking capacity in persons with multiple sclerosis (pwMS). A total of 54 pwMS will be enrolled and randomized into 1 of 3 groups: high dose resistant training (RT), low dose RT, and waitlist control., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Progressive resistance training, outcomesModule primaryOutcomes measure: MEP/Mmax ratio, secondaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Voluntary activation I, secondaryOutcomes measure: Voluntary activation II, secondaryOutcomes measure: Force Steadiness, secondaryOutcomes measure: Rate of Force Developement, secondaryOutcomes measure: Ultrasound, secondaryOutcomes measure: Resting Motor Threshold (rMT), secondaryOutcomes measure: Active Motor Threshold (aMT), secondaryOutcomes measure: MEP latency (resting), secondaryOutcomes measure: MEP latency (active), secondaryOutcomes measure: MEP amplitude (resting), secondaryOutcomes measure: MEP amplitude (active), secondaryOutcomes measure: Short-interval intracortical Inhibition (SICI), secondaryOutcomes measure: Intracortical facilitation (ICF), secondaryOutcomes measure: Cortical Silent Period (CSP), secondaryOutcomes measure: Central Motor Conduction Time (CMCT), secondaryOutcomes measure: EEG-EMG coherence (0-1), secondaryOutcomes measure: Timed 25 feet walk test (T25FWT), secondaryOutcomes measure: 6-minute walk test (6MWT), secondaryOutcomes measure: Six spot step test (SSST), secondaryOutcomes measure: 5 sit-to-stand (5STS), secondaryOutcomes measure: 9-step stair ascend (9SSA), secondaryOutcomes measure: Patient determined disease steps (PDDS), secondaryOutcomes measure: Multiple Sclerosis Walking Scale (MSWS), secondaryOutcomes measure: Modified fatigue impact scale (MFIS), secondaryOutcomes measure: MS impact scale (MSIS), secondaryOutcomes measure: Falls-efficacy scale - international (FES-1), secondaryOutcomes measure: The Physical Activity Enjoyment Scale (PACES), secondaryOutcomes measure: Brief pain inventory (BPI), secondaryOutcomes measure: Baecke physical activity, secondaryOutcomes measure: Accelerometry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374095, orgStudyIdInfo id: ONSET, briefTitle: 1 vs 7 RATG Infusions in Renal Transplantation, acronym: ONSET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, descriptionModule briefSummary: This trial is to compare the risk/benefit profile over six-month follow-up of two induction immunosuppressive regimens based on one or seven low-dose perioperative RATG infusions on top of the same induction therapy with basiliximab and steroid (progressively tapered post-transplant) and maintenance therapy with calcineurin inhibitors and mycophenolate mofetil/mycophenolic acid in 75 recipients (25 Patients and 50 Reference-Patients) of a single or dual first kidney transplant from an ideal or marginal donor at a single Renal Transplant Center., conditionsModule conditions: Kidney Replacement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: RATG, interventions name: Basiliximab, outcomesModule primaryOutcomes measure: Incidence of thrombocytopenia and/or leukopenia, secondaryOutcomes measure: Occurrence of anemia, secondaryOutcomes measure: Occurrence of viral infections, secondaryOutcomes measure: Occurrence of pneumonia, secondaryOutcomes measure: Occurrence of opportunistic infections, secondaryOutcomes measure: Occurrence of delayed graft function, secondaryOutcomes measure: Occurrence of allograft rejection, secondaryOutcomes measure: Occurrence of biopsy proven rejection, secondaryOutcomes measure: Survival, secondaryOutcomes measure: Platelet and WBC counts, secondaryOutcomes measure: Creatinine levels, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST HPG23 - Unità di Nefrologia, city: Bergamo, state: BG, zip: 24127, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, hasResults: False |
protocolSection identificationModule nctId: NCT06374082, orgStudyIdInfo id: HKWC-2024-179, briefTitle: Instant Messaging Reinforcement for Smoking Cessation Counseling Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: This research aims to assess the impact of instant messaging reinforcement on the learning outcomes of smoking cessation counseling (SCC) training among master of nursing (MN) students at the University of Hong Kong. The hypotheses suggest that this reinforcement can enhance students' SCC knowledge and techniques, improve their perception of SCC, and increase their application of SCC in clinical work.The study is a pragmatic randomized controlled trial (RCT) with a 1:1 allocation ratio, using WhatsApp Messenger (WhatsApp) messages for intervention and control groups. The intervention group receives messages related to SCC, while the control group receives generic mental health information. The subjects are MN students enrolled in the "Tobacco Dependency Nursing Intervention and Management" course.The study uses various tools for measurement, including Ecological momentary assessment (EMA) and Providers Smoking Cessation Training Evaluation (ProSCiTE). The main outcome measures include SCC practice frequency, SCC knowledge score, SCC attitude score, and SCC practice score.Data analysis will be performed in Statistical Package for the Social Sciences (SPSS), using descriptive statistics, intention-to-treat analysis, Chi-square and t-tests, Cohen's d for effect size, and linear mixed models. The expected results suggest that instant messaging reinforcement will enhance SCC knowledge, attitude, and practice among MN students., conditionsModule conditions: Smoking Cessation Counseling Ability, conditions: Smoking Cessation Counseling Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Double-blinding technique will be used to conceal the allocation. Participants will not know which group they are in as placebo messages will be introduced. Using a central allocation web-based-controlled randomization, outcome assessors and data analysts will be blind to group allocation, only the principal investigator will be aware of who belongs to the control and intervention groups., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: WhatsApp message, outcomesModule primaryOutcomes measure: SCC practice measurement, secondaryOutcomes measure: SCC knowledge score, secondaryOutcomes measure: SCC attitude score, secondaryOutcomes measure: SCC practice score, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hong KongLKS Faculty of Medicine, city: Hong Kong, zip: 00, country: Hong Kong, contacts name: Derek Yee Tak Cheung, PhD, role: CONTACT, phone: +852 3917 6652, email: [email protected], contacts name: Derek Yee Tak Cheung, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Xiaoyun Xie, PhDcandidate, role: SUB_INVESTIGATOR, contacts name: Guowen Zhang, DN student, role: SUB_INVESTIGATOR, contacts name: Tzu Tsun Luk, PhD, role: SUB_INVESTIGATOR, contacts name: Man Ping Wang, PhD, role: SUB_INVESTIGATOR, contacts name: Siu Chee Chan, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06374069, orgStudyIdInfo id: NL81887.058.23, briefTitle: Longevity Families of the Netherlands, acronym: LOF-NL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-11, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, collaborators name: Jacobijn Gussekloo, Prof. dr., collaborators name: Simon P. Mooijaart, Prof. dr., descriptionModule briefSummary: The demographic life expectancy enhancement of the past 150 years imposes an urgent challenge in Western and economically growing societies to stimulate the healthy lifespan that is lagging behind. Families surviving into exceptionally high ages (longevity) in good physical and mental health illustrate that this is physiologically possible. Such families harbor cross generational socio-genetic mechanisms that mediate healthy aging and protection from (multi)morbidity.The purpose of our research is: to identify gene variants associated with healthy aging and protection from (multi)morbidity; to study the social-, environment- and behavioral factors of familial longevity, their role in (multi-)morbidity and its interaction with the genetic component., conditionsModule conditions: Longevity, conditions: Familial Longevity, conditions: Extreme Longevity, conditions: Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identifying the genetic variants of Familial Longevity, secondaryOutcomes measure: Studying the environmental factor of Familial Longevity through questionnaires and its interaction with the genetic component, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leiden University Medical Center, status: RECRUITING, city: Leiden, state: South Holland, zip: 2333ZA, country: Netherlands, geoPoint lat: 52.15833, lon: 4.49306, hasResults: False |
protocolSection identificationModule nctId: NCT06374056, orgStudyIdInfo id: 0458, briefTitle: Kintsugi Voice Device Pilot Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-03-22, completionDateStruct date: 2025-07-22, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Kintsugi Mindful Wellness, Inc., class: INDUSTRY, collaborators name: Sonar Strategies, collaborators name: Vituity Psychiatry, descriptionModule briefSummary: A prospective, single arm, non-randomized, pilot clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-CT) for up to 500 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks., conditionsModule conditions: Depression, conditions: Depression Moderate, conditions: Depression Severe, conditions: Depression Mild, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Kintsugi Voice Device, outcomesModule primaryOutcomes measure: Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5, secondaryOutcomes measure: PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5, secondaryOutcomes measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT, secondaryOutcomes measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kintsugi Mindful Wellness Inc., status: RECRUITING, city: Berkeley, state: California, zip: 94707, country: United States, contacts name: Alexa A Mazur, BA, role: CONTACT, phone: 610-724-1431, email: [email protected], contacts name: Victoria Graham, MS, role: CONTACT, email: [email protected], contacts name: Albert Ihochi, MBA, role: PRINCIPAL_INVESTIGATOR, contacts name: Prentice Tom, MD, role: SUB_INVESTIGATOR, geoPoint lat: 37.87159, lon: -122.27275, hasResults: False |
protocolSection identificationModule nctId: NCT06374043, orgStudyIdInfo id: 2020/1002, briefTitle: Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin., acronym: @HOME, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-11, primaryCompletionDateStruct date: 2022-09-13, completionDateStruct date: 2022-09-13, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: Randomized placebo-controlled double-blind cross-over N=1 trial in adult male and female patients with UACR \>20 mg/g (2.26 mg/mmol) with type 2 diabetes treated in primary or secondary healthcare.The goal of this clinical trial is to determine the individual response to the SGLT2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR). Secondary objectives are to determine the individual response to dapagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose.Participants will collect all study data in the comfort of their own environments:* First-morning void urine samples* Capillary blood samples* Blood pressure* Body weightParticipants will be randomly assigned to a cross-over study consisting of two periods of 1-week treatment with dapagliflozin 10 mg/day and two periods of 1-week treatment with placebo in random order with a 1-week wash-out period between every treatment period to avoid cross-over effects., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Diabetes Mellitus Type 2 With Proteinuria, conditions: Diabetes Mellitus, conditions: Diabetes, conditions: Diabetes Complications, conditions: Albuminuria, conditions: Chronic Kidney Diseases, conditions: Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, conditions: CKD, conditions: Proteinuria, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized placebo-controlled double-blind cross-over trial with repeated administration (i.e., a series of N=1 trials)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Dapagliflozin 10mg Tab, interventions name: Placebo, interventions name: Withings BPM Connect, interventions name: Withings Body+, interventions name: Hem-Col Capillary Blood Collection Device, interventions name: MEMS (Medication Electronic Monitoring System) Cap, interventions name: Questionnaire: participants' perspectives toward remote data collection, outcomesModule primaryOutcomes measure: UACR response, secondaryOutcomes measure: Systolic blood pressure response, secondaryOutcomes measure: Body weight response, secondaryOutcomes measure: eGFR response, secondaryOutcomes measure: Fasting plasma glucose response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ziekenhuisgroep Twente, city: Almelo, country: Netherlands, geoPoint lat: 52.35667, lon: 6.6625, locations facility: University Medical Center Groningen, city: Groningen, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False |
protocolSection identificationModule nctId: NCT06374030, orgStudyIdInfo id: EDSAM2024, briefTitle: Retrospective Study of Airway Management in Dutch ED's, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Medical Centre Leeuwarden, class: OTHER, collaborators name: VieCuri Medical Centre, collaborators name: Catharina Ziekenhuis Eindhoven, collaborators name: Rijnstate Hospital, collaborators name: Zuyderland Medical Centre, descriptionModule briefSummary: Describing characteristics of the practice of airway management in Dutch emergency departments, including information about patient demographics, indications, performer characteristics, equipment and medication used and complications due to intubation., conditionsModule conditions: Endotracheal Intubation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Endotracheal intubation, outcomesModule primaryOutcomes measure: Different complications of endotracheal intubation, otherOutcomes measure: Intubator characteristics, otherOutcomes measure: Indication for intubation, otherOutcomes measure: Sedation agent used, otherOutcomes measure: Paralytic agent used, otherOutcomes measure: Sedative agent after intubation, otherOutcomes measure: Method of intubation, otherOutcomes measure: Patient characteristics, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leeuwarden Medical Centre, city: Leeuwarden, zip: 8934AD, country: Netherlands, geoPoint lat: 53.20139, lon: 5.80859, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-15, uploadDate: 2024-03-20T05:01, filename: Prot_SAP_000.pdf, size: 247439, hasResults: False |
protocolSection identificationModule nctId: NCT06374017, orgStudyIdInfo id: N-258-2023, briefTitle: Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-10, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Kasr El Aini Hospital, class: OTHER, descriptionModule briefSummary: Many studies discussed attenuating stress response by various measures but to the interest of our study, No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs, , conditionsModule conditions: To Measure Systolic Blood Pressure Postintubation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Normal saline, Lidocaine, dexmetomidine, outcomesModule primaryOutcomes measure: To measure systolic blood pressure immediately after intubation., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo University hospitals, status: RECRUITING, city: Cairo, zip: 11559, country: Egypt, contacts name: Dina M Mohamed, MD, role: CONTACT, phone: 01005249134, phoneExt: MD, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06374004, orgStudyIdInfo id: HU-FTR-MC-01, briefTitle: The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-07-05, completionDateStruct date: 2024-07-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome., conditionsModule conditions: Subacromial Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One group received exercise therapy and the other group received manual therapy (thoracic mobilization) in addition to exercise therapy, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be randomly divided into two groups and participants will not know which group participants are in., whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Group, interventions name: Thoracic Mobilization Group, outcomesModule primaryOutcomes measure: Electromyography (EMG), primaryOutcomes measure: Acromiohumeral Distance (AHD), secondaryOutcomes measure: Muscle Tone, secondaryOutcomes measure: Functional Activity Level, secondaryOutcomes measure: Pain Intensity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation, city: Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06373991, orgStudyIdInfo id: EDI-901-SLE01, briefTitle: A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: EdiGene Inc., class: INDUSTRY, collaborators name: The First Affiliated Hospital of Henan University of Science and Technology, collaborators name: Changping Laboratory, descriptionModule briefSummary: The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is:• To evaluate the safety and tolerability of ATHENA CAR-T.After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months., conditionsModule conditions: Lupus Erythematosus, Systemic, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: ATHENA CAR-T, interventions name: Fludarabine, interventions name: Cyclophosphamide, outcomesModule primaryOutcomes measure: Dose Limiting Toxicity, primaryOutcomes measure: Frequency of AEs, SAEs, lab abnormalities, AESIs, secondaryOutcomes measure: Efficacy: Percent of patients achieved SRI-4, secondaryOutcomes measure: Efficacy: Patients SLEDAI-2000 change compared with baseline, secondaryOutcomes measure: Efficacy: Patients BILAG-2004 change compared with baseline, secondaryOutcomes measure: Efficacy: Percent of patients' PGA not worsen, secondaryOutcomes measure: Percent of patients responded by BILAG-2004, secondaryOutcomes measure: Efficacy: Immunologic parameters, secondaryOutcomes measure: Efficacy: Immunologic parameters (cont), otherOutcomes measure: PK characteristics, otherOutcomes measure: PK characteristics (cont), otherOutcomes measure: PK characteristics (cont), otherOutcomes measure: PD characteristics, otherOutcomes measure: PD characteristics (cont), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Henan University of Science and Technology, status: RECRUITING, city: Luoyang, state: Henan, zip: 471003, country: China, contacts name: Muchen Liu, role: CONTACT, phone: (86)-13663884080, geoPoint lat: 34.68361, lon: 112.45361, hasResults: False |
protocolSection identificationModule nctId: NCT06373978, orgStudyIdInfo id: 24-307, briefTitle: NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, descriptionModule briefSummary: This study is a double-blind, randomized controlled trial comparing the effectiveness of oral Diclofenac and Tramadol in reducing the consumption of narcotic pills (primary outcome) and minimizing patients\' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.The primary objective of this study is to illustrate a reduction in the consumption of narcotic pills following a percutaneous needle tenotomy procedure on the lateral elbow.The secondary aim is to assess the proportion of patients who have been randomly assigned to Diclofenac and successfully refrain from using the Tramadol rescue medication, measured at the 10 day (+/- 4 days) postoperative mark.The third objective is to uphold consistent early recovery outcomes as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) and Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores after percutaneous needle tenotomy of the lateral elbow, while also investigating the relationship between resiliency and pain catastrophizing in relation to Tramadol usage and response to Diclofenac., conditionsModule conditions: Elbow Pain, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will be a double-blind, randomized trial comparing a control group receiving the standard care narcotic Tramadol (50mg) to an experimental group receiving Diclofenac (50mg)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: Diclofenac, interventions name: Tramadol, outcomesModule primaryOutcomes measure: Number of pills taken, secondaryOutcomes measure: Non narcotic use, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Cleveland Clinic Florida, city: Coral Springs, state: Florida, zip: 33067, country: United States, contacts name: Jennifer Baldwin, role: CONTACT, phone: 216-390-5833, email: [email protected], contacts name: Alison Klika, role: CONTACT, phone: 216 444-4954, email: [email protected], contacts name: Michael Dakkak, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.27119, lon: -80.2706, locations facility: The Cleveland Clinic Ohio, city: Avon, state: Ohio, zip: 44011, country: United States, contacts name: Jennifer Baldwin, role: CONTACT, phone: 216-390-5833, email: [email protected], contacts name: Jason Genin, DO, role: SUB_INVESTIGATOR, contacts name: Vikas Patel, DO, role: SUB_INVESTIGATOR, geoPoint lat: 41.45171, lon: -82.03542, hasResults: False |
protocolSection identificationModule nctId: NCT06373965, orgStudyIdInfo id: B2024-000, briefTitle: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-19, primaryCompletionDateStruct date: 2025-01-06, completionDateStruct date: 2025-02-18, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Connecticut, class: OTHER, collaborators name: University of Malaya, descriptionModule briefSummary: The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for transgender women (TGW) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like TGW, and allows immediate engagement in the post-test linkage process to prevention or treatment services., conditionsModule conditions: HIV Prevention Program, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Online to offline counseling, outcomesModule primaryOutcomes measure: HIVST uptake, primaryOutcomes measure: Linkage to PrEP, primaryOutcomes measure: Linkage to HIV treatment services, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre of Excellence For Research in AIDS (CERiA), city: Kuala Lumpur, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False |
protocolSection identificationModule nctId: NCT06373952, orgStudyIdInfo id: 23-08-658-910, briefTitle: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men, acronym: CINTAI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-19, primaryCompletionDateStruct date: 2025-01-06, completionDateStruct date: 2025-02-18, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Connecticut, class: OTHER, collaborators name: University of Malaya, descriptionModule briefSummary: The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for men who have sex with men (MSM) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like MSM, and allows immediate engagement in the post-test linkage process to prevention or treatment services., conditionsModule conditions: HIV Prevention Program, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Online to offline counseling, outcomesModule primaryOutcomes measure: HIVST uptake, primaryOutcomes measure: Linkage to PrEP, primaryOutcomes measure: Linkage to HIV treatment services, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre of Excellence For Research in AIDS (CERiA), city: Kuala Lumpur, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False |
protocolSection identificationModule nctId: NCT06373939, orgStudyIdInfo id: Pneumoscope study, briefTitle: Performance and Safety of the Pneumoscope Device in Adults and Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Pediatric Clinical Research Platform, class: OTHER, collaborators name: University Hospital, Geneva, descriptionModule briefSummary: Respiratory diseases are associated with high morbidity and mortality worldwide. Proper diagnosis and risk assessment of these conditions are essential for optimal management. Clinicians use three particularly useful tools to identify these conditions when assessing the patient's status: the stethoscope, the pulse oximeter, and the thermometer. The Pneumoscope is an all-in-one device including a digital stethoscope, a pulse oximeter, and a thermometer. This study aims to assess the performance and safety of the Pneumoscope in recording respiratory sounds, body temperature, non-invasive blood oxygen saturation levels and heart rate in children and adults., conditionsModule conditions: Respiratory Diseases, conditions: Pneumonia, conditions: Asthma, conditions: Cyanotic Heart Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This single center, open, non-controlled investigation will be conducted at one site; the University Hospitals of Geneva, Switzerland. This will be a non-inferiority study between Pneumoscope and CE marked comparable medical devices in children and adults., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Digital lung auscultation, interventions name: Pulse oximetry measurement, interventions name: Non invasive body temperature measurement, outcomesModule primaryOutcomes measure: Evaluation of Pneumoscope's built-in sensors, secondaryOutcomes measure: Collect audio records of lung sounds for AI models training and sensor calibration, secondaryOutcomes measure: Pulse oximetry, secondaryOutcomes measure: Body temperature, eligibilityModule sex: ALL, minimumAge: 1 Year, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Geneva University Hospitals, city: Geneva, zip: 1205, country: Switzerland, contacts name: Alain Gervaix, Prof, role: CONTACT, phone: (0)22 372 45 55, phoneExt: +41, email: [email protected], contacts name: Johan Siebert, MD, role: CONTACT, phone: (0)79 553 40 72, phoneExt: +41, email: [email protected], contacts name: Johan N Siebert, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Laurence Lacroix-Duccardonnoy, MD, role: SUB_INVESTIGATOR, contacts name: Isabelle Ruchonnet-Métrailler, MD, role: SUB_INVESTIGATOR, geoPoint lat: 46.20222, lon: 6.14569, hasResults: False |
protocolSection identificationModule nctId: NCT06373926, orgStudyIdInfo id: PI2019_843_0010, briefTitle: Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome, acronym: MONOCYTAN, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-28, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, descriptionModule briefSummary: Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator, plays a pivotal role in regulation of fibrinolysis in vitro and in vivo and has been identified as a new autoantigen in antiphospholipid syndrome (APS). ANXA2 can exist as a monomer or a heterotetrameric complex with S100A10 protein. The aim of this study was to evaluate the cell membrane expression of ANXA2 on circulating monocytes in APS by flow cytometry. Several pathogenic mechanisms are involved in APS such as activation of endothelial cells, platelets and monocytes, inhibition of the natural anticoagulant protein C/protein S pathway, activation of the complement system and also impairment of fibrinolysis. Annexin A2 which hits binding partner S100A10, ANXA2 forms a cell surface complex that regulates generation of plasmin. ANXA2 is involved in the pathogenesis of APS-associated through several possible mechanisms. Human peripheral blood monocytes represent the major circulating ANXA2-expressing cell and ANXA2-mediated assembly of plasminogen and tissue activator of plasminogen (tPA) on monocyte/macrophages contributes to plasmin generation. Thus the investigators could suppose that decrease of cell membrane expression of ANXA2 on circulating monocytes represent a new pathogenic mechanism in APS., conditionsModule conditions: Antiphospholipid Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: blood withdrawal, outcomesModule primaryOutcomes measure: Cell membrane expression rate of ANXA2 on circulating monocytes in APS, secondaryOutcomes measure: Cellular expression of ANXA2 and S100A10 in APS patients, secondaryOutcomes measure: cell membrane expression of ANXA2 and S100A10 in APS patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens, status: RECRUITING, city: Amiens, zip: 80054, country: France, contacts name: Valéry SALLE, MD, role: CONTACT, phone: +33 3 22 66 82 30, email: [email protected], geoPoint lat: 49.9, lon: 2.3, hasResults: False |
protocolSection identificationModule nctId: NCT06373913, orgStudyIdInfo id: MASP2NSRZL, briefTitle: The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom, acronym: PCSK9, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2027-07-30, completionDateStruct date: 2028-07-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Kolding Sygehus, class: OTHER, collaborators name: Odense University Hospital, collaborators name: Vejle Hospital, descriptionModule briefSummary: Nephrotic syndrome (NS) is characterized by gross proteinuria (\>3.5 g/day), hypoalbuminaemia, edema and often hyperlipidemia. Hyperlipidemia is correlated with increased morbidity and mortality.The study aim is to investigate the role of the protein convertase subtilisin/kexin type 9 (PCSK9) in hyperlipidemia of NS, which has been suggested to play an important role. This is done by testing the following hypotheses:1. PCSK9 is increased in patients with NS and hyperlipidemia compared to kidney-healthy controls2. The level of PCSK9 in plasma correlates to the degree of proteinuria.3. PCSK9 i increased in the kidney tissue of patients with NSThe study will compare plasma levels of PCSK9 in correlation with degree of protein in the urine between test persons with NS and kidney healthy controls. Furthermore the investigators will study the the degree of PCSK9 in the kidney in biopsies obtained from test persons with nephrotic syndrome and test persons without proteinuria., conditionsModule conditions: Hyperlipidemias, conditions: Nephrotic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Plasma PCSK9 correlated to the degree of protein in the urine, primaryOutcomes measure: Degree of PCSK9 in kidney tissue, secondaryOutcomes measure: Localization of PCSK9 in kidney tissue, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kolding Sygehus, Lillebælt Hospital, status: RECRUITING, city: Kolding, zip: 6000, country: Denmark, contacts name: Rikke Z Langkilde, md, phd, role: CONTACT, phone: 004576362554, contacts name: Anne D Thuesen, md, phd, role: CONTACT, phone: 004576360555, email: [email protected], geoPoint lat: 55.4904, lon: 9.47216, hasResults: False |
protocolSection identificationModule nctId: NCT06373900, orgStudyIdInfo id: IndusH, briefTitle: Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-13, primaryCompletionDateStruct date: 2022-02-19, completionDateStruct date: 2022-03-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Indus Hospital and Health Network, class: OTHER, descriptionModule briefSummary: Comparison of wound complication and scar formation in patient undergone bilateral total knee replacement comparison between polypropylene and polyglactin 910 suture. patient randomised according to SNOS protocol into group A and B for their right and left knee closure with each suture. patient followed on 3rd, 7th, 15th and 30th post operative day for wound healing, wound dehiscence and scar formation., conditionsModule conditions: Wound Heal, conditions: Wound Dehiscence, conditions: Wound Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: SNOS protocol, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: wound closure, outcomesModule primaryOutcomes measure: Wound characteristics and complications, primaryOutcomes measure: Wound Infection Grade, primaryOutcomes measure: Hollander Cosmetic Wound Evaluation Score, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Indus Hospital and Health Network, city: Karachi, state: Sindh, zip: 74900, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2022-02-04, uploadDate: 2024-04-03T02:55, filename: Prot_SAP_ICF_000.pdf, size: 130365, hasResults: False |
protocolSection identificationModule nctId: NCT06373887, orgStudyIdInfo id: 2023-09-005A, briefTitle: The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-11-29, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Taipei Veterans General Hospital, Taiwan, class: OTHER_GOV, descriptionModule briefSummary: In recent years, the technology to detect the gut microbiome's function has become increasingly developed. GMMs are tools (GitHub - raeslab/GMMs: A manually curated database of human gut metabolic modules.) for describing metabolic pathways for linking microbial metabolic function to species associated with a single metabolite, helping to analyze the transcriptional characteristics and metabolic functions of each bacterium, and studying their role of the food chain in the ecosystem. According to our previous research, the group with good weight loss response (more than 10% body weight loss in 8 weeks) after low-carb diet intervention has higher Shannon's diversity and carbohydrate degradation activity test by GMMs, implying the deficiency of availability of energy sources may cause more weight changes.Based on the above research, we designed a low-carb diet (rich in monounsaturated fatty acids) and a low-fat diet (whole grains) with the same calories as a means of weight loss. The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet. Furthermore, we try to found the possible mechanism of whether metabolites of microbiota (e.g. SCFA) could affect the immune cell change which modulates adipose tissue ., conditionsModule conditions: Weight Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To compare the weight-loss efficacy of different carbohydrate degradation status under two different diet arm (low carbohydrate or low fat diet) to evaluate the benefits of initial gut microbiota profiling in precision weight loss dietary interventions., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, maskingDescription: Single-blinded, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: plant-based Low carbohydrate diet, interventions name: plant-based Low low fat diet, outcomesModule primaryOutcomes measure: Body weight loss/fat mass loss, secondaryOutcomes measure: microbiota change, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Taipei Veterans General Hospital, status: RECRUITING, city: Taipei, state: Beitou District, zip: 11217, country: Taiwan, contacts name: Chun-Ying Wu, role: CONTACT, phone: +886-28712121, phoneExt: 4190, email: [email protected], contacts name: HSIAO-PING CHEN, role: CONTACT, phone: +886-28712121, phoneExt: 4190, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06373874, orgStudyIdInfo id: MCBU-SBF-YC-04, briefTitle: The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-05-30, completionDateStruct date: 2023-05-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Celal Bayar University, class: OTHER, descriptionModule briefSummary: The researchers gave midwifery students theoretical training on how to take heel blood on a newborn model. Students were asked to take heel blood on the model in the high-reality simulation environment and simulation room. The student's ability to take heel blood before and after taking heel blood in a high-reality simulation environment or on a newborn model in a simulation environment, satisfaction with learning, anxiety and self-efficacy levels were compared., conditionsModule conditions: Students, conditions: Educational Problems, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment experimental study with experimental and control group, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ACTUAL, armsInterventionsModule interventions name: Heel blood collection in a newborn simulation model, outcomesModule primaryOutcomes measure: Skill checklist, primaryOutcomes measure: State and Trait Anxiety Scales, primaryOutcomes measure: Self-Efficacy Scale, primaryOutcomes measure: Student Satisfaction and Self-Confidence in Learning Questionnaire, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 32 Years, stdAges: ADULT, contactsLocationsModule locations facility: Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery, city: Manisa, zip: 45140, country: Turkey, geoPoint lat: 38.61202, lon: 27.42647, locations facility: Yonca çiçek okuyan, city: Manisa, zip: 45140, country: Turkey, geoPoint lat: 38.61202, lon: 27.42647, hasResults: False |
protocolSection identificationModule nctId: NCT06373861, orgStudyIdInfo id: 20-0482, briefTitle: Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY), acronym: GALAXY, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-28, primaryCompletionDateStruct date: 2037-04, completionDateStruct date: 2037-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: Children's Hospital Colorado, descriptionModule briefSummary: GALAXY is a registry research study that plans to learn more about individuals with X\&Y variations (also called sex chromosome aneuploidies) through collecting information from medical records.This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. The purpose of the GALAXY Registry is to collect and store this information with the overall goal to improve health outcomes in individuals with X\&Y variations and the care they receive., conditionsModule conditions: Sex Chromosome Aneuploidy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Health Conditions, secondaryOutcomes measure: Prevalence of mental health diagnoses, secondaryOutcomes measure: Cardiometabolic diagnoses - prevalence of obesity, secondaryOutcomes measure: Cardiometabolic diagnoses - prevalence of dyslipidemia, secondaryOutcomes measure: Cardiometabolic diagnoses-prevalence of hypertension, secondaryOutcomes measure: Autoimmune diagnoses - prevalence of hypothyroidism and of hyperthyroidism, secondaryOutcomes measure: Autoimmune diagnoses - prevalence of diabetes, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Children's Hospital Colorado, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Shanlee M Davis, MD, PhD, role: CONTACT, phone: 720-777-6073, email: [email protected], geoPoint lat: 39.72943, lon: -104.83192, hasResults: False |
protocolSection identificationModule nctId: NCT06373848, orgStudyIdInfo id: 346, briefTitle: Comparison of Salivary Parameters in Patients Receiving CoQ10 and Vitamin E Supplementation, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-08-20, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Islamic Azad University, Tehran, class: OTHER, descriptionModule briefSummary: Comparison of salivary markers in patients with Initial chronic periodontitis after non-surgical periodontal treatment with CoQ10 supplementation with vitamin E, conditionsModule conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, Randomized, Double-blind, Controlled design., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The study was carried out utilizing a double-blind approach. In order to guarantee objectivity, all three groups - the Vitamin E group, the Coq10 group, and the control group - received medications that were indistinguishable in terms of appearance, packaging, and color. Additionally, to minimize any potential bias, a clinician who had no association with the research labeled the medications as A, B, and C (empty) based on their content, and then distributed them among the patients., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Receive 30 mg of Coq10, outcomesModule primaryOutcomes measure: Total Antioxidant capacity (TAC) of saliva, secondaryOutcomes measure: Bleeding on probing, eligibilityModule sex: ALL, minimumAge: 28 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Amirhossein Farahmand, city: Tehran, zip: 1947833113, country: Iran, Islamic Republic of, geoPoint lat: 35.69439, lon: 51.42151, hasResults: False |
protocolSection identificationModule nctId: NCT06373835, orgStudyIdInfo id: EMODEPSIDE_LAOS, briefTitle: Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Swiss Tropical & Public Health Institute, class: OTHER, collaborators name: National Institute of Public Health, Vientiane, Laos, descriptionModule briefSummary: Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials, conditionsModule conditions: Strongyloides Stercoralis Infection, conditions: Strongyloidiasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Emodepside, outcomesModule primaryOutcomes measure: Cure rate (CR) of emodepside against Strongyloides stercoralis, secondaryOutcomes measure: Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin., secondaryOutcomes measure: Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis., secondaryOutcomes measure: Exposure response of emodepside in adults, secondaryOutcomes measure: Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373822, orgStudyIdInfo id: 2024/18JAN/028, briefTitle: New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs, acronym: ADENO-MIRNA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2031-09, completionDateStruct date: 2031-09, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Université Catholique de Louvain, class: OTHER, descriptionModule briefSummary: Objectives:To identify differentially expressed miRNAs in the blood of adenomyosis patients in view to develop new diagnostic methodsHypotheses Circulating miRNAs may be abnormally expressed in patients suffering from adenomyosis and could be used to diagnose the diseaseStudy Design Blood samples will be collected from healthy subjects and adenomyosis patients and miRNAs will be isolated and analyzed to detect potential differences., conditionsModule conditions: Adenomyosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Circulating-mirna, outcomesModule primaryOutcomes measure: Circulating-miRNA as diagnostic biomarkers, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CUSL, status: RECRUITING, city: Brussel, state: Woluwe-Saint-Lambert, zip: 1200, country: Belgium, contacts name: Emilie Wacheul, MD, role: CONTACT, phone: 027645246, email: [email protected], geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06373809, orgStudyIdInfo id: PDSC1970222, briefTitle: Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy, acronym: PDSC, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-08, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Michael H Carstens, class: OTHER, collaborators name: Ministerio de Salud de Nicaragua, collaborators name: Wake Forest Institute for Regenerative Medicine, descriptionModule briefSummary: This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot., conditionsModule conditions: Diabetic Foot, conditions: Diabetic Neuropathies, conditions: Diabetic Foot Ulcer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective an open label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Transplantation of Placenta Derived Stem Cells, outcomesModule primaryOutcomes measure: Foot Ulcer Healing, secondaryOutcomes measure: Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes., secondaryOutcomes measure: Vibration: Documenting diabetes-associated lower extremity pathophysiology changes., eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA), city: León, state: Leon, zip: 21000, country: Nicaragua, geoPoint lat: 12.43787, lon: -86.87804, locations facility: Hospital Escuela Cesar Amador Molina, city: Matagalpa, zip: 61000, country: Nicaragua, geoPoint lat: 12.92559, lon: -85.91747, hasResults: False |
protocolSection identificationModule nctId: NCT06373796, orgStudyIdInfo id: 2024-A00523-44, briefTitle: Ultrasound Index Fat Fraction, acronym: FAT-PLUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: SuperSonic Imagine, class: INDUSTRY, descriptionModule briefSummary: The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis., conditionsModule conditions: Steatosis of Liver, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Echographic scan, outcomesModule primaryOutcomes measure: FAT PLUS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06373783, orgStudyIdInfo id: 2023/05, briefTitle: Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-03-16, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth.Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments. The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results. The main indications for root coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical abrasion and root caries, improvement of restorative results, and facilitation of plaque control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments.De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or mesio-distal directions is required. In this technique, the graft of the required width and length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer.Ultrasonography (USG) is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities. This technique is widely used in medical practice. In dentistry, the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness. It also has functions to evaluate color power and color speed, as well as blood flow.The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession. This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography (USG)., conditionsModule conditions: Gingival Recession, Localized, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: subepithelial connective tissue graft, interventions name: de- epithelize gingival graft, interventions name: ultrasonography, outcomesModule primaryOutcomes measure: tissue thickness, secondaryOutcomes measure: pulsatility index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University of the Dentistry, city: Denizli, zip: 20160, country: Turkey, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False |
protocolSection identificationModule nctId: NCT06373770, orgStudyIdInfo id: MSRSW/Batch-Fall22/700, briefTitle: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Superior University, class: OTHER, descriptionModule briefSummary: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum, conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Ayres sensory integration therapy, interventions name: Behaviour Therapy, outcomesModule primaryOutcomes measure: sensory profile by winnie dunn, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: RICCER Institute, city: Faisalabad, state: Punjab, country: Pakistan, geoPoint lat: 31.41554, lon: 73.08969, hasResults: False |
protocolSection identificationModule nctId: NCT06373757, orgStudyIdInfo id: RECO6U/5-2023, briefTitle: Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects., conditionsModule conditions: Chitosan, conditions: Nano-hydroxyapatite Hydrogel, conditions: Intrabony Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: Nano-HAP/Chitosan hydrogel, outcomesModule primaryOutcomes measure: Gingival index, secondaryOutcomes measure: Plaque index, secondaryOutcomes measure: Clinical attachment level, secondaryOutcomes measure: Periodontal probing depth, secondaryOutcomes measure: Acrylic stent for pocket assessment, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: October 6 University, city: Giza, zip: 12511, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06373744, orgStudyIdInfo id: SYSU-022, briefTitle: Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 597, type: ACTUAL, armsInterventionsModule interventions name: cyclophosphamide, methotrexate, vinorelbine ,capecitabine, outcomesModule primaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shusen Wang, city: Guangzhou, state: Gangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06373731, orgStudyIdInfo id: SPIAM-301, briefTitle: ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD), acronym: ReNEW, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Stealth BioTherapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared., conditionsModule conditions: Age-Related Macular Degeneration, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects will be randomized (2:1) to once daily 40 mg SC of elamipretide or placebo for 96 weeks of treatment by a central randomization, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Trial personnel and subjects will be masked to treatment until the database is locked at the end of the trial, unless noted below. The Investigator will contact the Sponsor Medical Monitor prior to unmasking any subject's treatment sequence unless in the instance of a medical emergency. In case of an immediate medical emergency, or if directed by the Sponsor, and only if the information is required by the Investigator to manage a subject's AE, a subject's treatment assignment may be unmasked prematurely using the computerized system. The Sponsor must be notified as soon as possible regarding the reason for unmasking., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Elamipretide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Week 48 Rate of change in the macular area of photoreceptor loss, secondaryOutcomes measure: Week 72 Rate of change in the Macular area of photoreceptor loss, secondaryOutcomes measure: Week 96 Rate of change in the Macular area of photoreceptor loss, secondaryOutcomes measure: Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA), secondaryOutcomes measure: Proportion of subjects gaining ≥ 15 letters in Low Luminance Best-Corrected Visual Acuity (LL BCVA), eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373718, orgStudyIdInfo id: IRB-74553, briefTitle: A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target., conditionsModule conditions: Insomnia, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Enrolled participants will be randomized into either the Immediate Treatment group, or the Monitored Control group. Both study groups will receive CBT-I., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Therapy for Insomnia, outcomesModule primaryOutcomes measure: Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging, primaryOutcomes measure: Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging, primaryOutcomes measure: Change in Beck Depression Inventory, primaryOutcomes measure: Change in PSG Sleep Efficiency, secondaryOutcomes measure: Change in Columbia Suicide Severity Rating Scale, secondaryOutcomes measure: Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in Actigraph Number of Arousals as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in PSG Number of Arousals as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in Sleep Physiology measured by PSG, secondaryOutcomes measure: Change in Insomnia Severity Index (ISI) Scale Score, secondaryOutcomes measure: Change in 36-Item Short Form Survey (SF-36) Score, secondaryOutcomes measure: Change in Beck Anxiety Inventory, secondaryOutcomes measure: Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Stanford University, city: Palo Alto, state: California, zip: 94304, country: United States, contacts name: Pandora Lam, role: CONTACT, phone: 650-497-5130, email: [email protected], contacts name: Andrea Goldstein-Piekarski, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.44188, lon: -122.14302, hasResults: False |
protocolSection identificationModule nctId: NCT06373705, orgStudyIdInfo id: 74566, secondaryIdInfos id: 1R01HL173845 - 01, type: OTHER_GRANT, domain: NIH, briefTitle: Cardiac Simulator for Surgical Planning, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-04, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.To aid surgeons in envisioning different surgical approaches for each individual patient.To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.Participants will:Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group., conditionsModule conditions: Congenital Heart Disease in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1:1 randomization to either receive standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of computer simulation., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: After consent to participate in the study, patient will be entered into a random allocation sequence for standard of care (SOC) or cardiac simulator groups.Patient and surgeon will both be notified which group they have been assigned to., enrollmentInfo count: 275, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac simulator, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Number of cardioplegic arrest, otherOutcomes measure: Number of repair revisions needed, otherOutcomes measure: Time on cardiopulmonary bypass, otherOutcomes measure: Ventricular function, otherOutcomes measure: Ventricular function, otherOutcomes measure: Ventricular function, otherOutcomes measure: Valvular function, otherOutcomes measure: Valvular function, otherOutcomes measure: Valvular function, otherOutcomes measure: Number of days in hospital post-operation, otherOutcomes measure: Type of post-operative inotrope, eligibilityModule sex: ALL, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373692, orgStudyIdInfo id: TCM for Asthma Cohort, briefTitle: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Henan University of Traditional Chinese Medicine, class: OTHER, collaborators name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, collaborators name: Tianjin University of Traditional Chinese Medicine, collaborators name: The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine, collaborators name: Hebei Provincial Hospital of Traditional Chinese Medicine, collaborators name: Peking University People's Hospital, collaborators name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, collaborators name: The First Affiliated Hospital of Zhengzhou University, collaborators name: First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, collaborators name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, descriptionModule briefSummary: The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma., conditionsModule conditions: Bronchial Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1508, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Asthma control rate, secondaryOutcomes measure: Number of exacerbations, secondaryOutcomes measure: Asthma exacerbation severity, secondaryOutcomes measure: Change in severity of chronic persistent disease, secondaryOutcomes measure: The dose used by glucocorticoids, secondaryOutcomes measure: Rapid-acting beta2 agonists use drugs and doses, secondaryOutcomes measure: Asthma Control Test (ACT) score, secondaryOutcomes measure: Asthma Control Questionnaire (ACQ), secondaryOutcomes measure: Asthma Quality of Life Score (AQLQ), secondaryOutcomes measure: Anxiety Self-Assessment Form (SAS), secondaryOutcomes measure: Depression Self-Rating Scale (SDS), secondaryOutcomes measure: Pulmonary function, secondaryOutcomes measure: Exhaled nitric oxide (FeNO), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, city: Zhengzhou, state: Henan, country: China, contacts name: Hai-bin Yu, Ph.D, role: CONTACT, phone: +86 13526671773, email: [email protected], geoPoint lat: 34.75778, lon: 113.64861, hasResults: False |
protocolSection identificationModule nctId: NCT06373679, orgStudyIdInfo id: Pro00125514, secondaryIdInfos id: 1R01DA056445-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DA056445-01A1, briefTitle: Switch or Quit R01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks., conditionsModule conditions: Cigarette Smoking, conditions: Smoking Behaviors, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Switching to E-Cigarette, interventions name: Switching using Medication, outcomesModule primaryOutcomes measure: Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback, secondaryOutcomes measure: Greater than 50% reduction in cigarette smoking, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Univeristy of South Carolina, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False |
protocolSection identificationModule nctId: NCT06373666, orgStudyIdInfo id: SPZ4-02, briefTitle: A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4)., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Spatz FGIA, Inc, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Spatz4 Adjustable Balloon System, outcomesModule primaryOutcomes measure: Successful adjustment procedure at 16 ±2 weeks in > 85% of attempts., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373653, orgStudyIdInfo id: SOPHMAN-0922/IV, briefTitle: Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Laboratorios Sophia S.A de C.V., class: INDUSTRY, descriptionModule briefSummary: This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)., conditionsModule conditions: Eye Strain, conditions: Eye Strain of Both Eyes, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open-label,, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Manzanilla Sophia®, interventions name: Meticel Ofteno®, outcomesModule primaryOutcomes measure: Analog visual eyestrain test score, secondaryOutcomes measure: Incidence of unexpected adverse events related to the interventions, secondaryOutcomes measure: Incidence of conjunctival hyperemia, secondaryOutcomes measure: Incidence of sensation of ocular dryness., secondaryOutcomes measure: Incidence of ocular irritation, secondaryOutcomes measure: Incidence of sensation of (sleep-crust), secondaryOutcomes measure: Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373640, orgStudyIdInfo id: RHM NEU0458, briefTitle: Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage, acronym: HAPTO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Hospital Southampton NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The HAPTO study will recruit adult patients with aSAH due to a burst aneurysm. These patients must be scheduled to have their aneurysm treated surgically to prevent further bleeds, and need an external ventricular drain for clinical reasons (to drain fluid and relieve pressure on the brain). At the end of their surgery for their aneurysm, a further drain will be left at the site of the surgery (which is in the basal cisterns) and they will additionally have a drain sited in their lumbar spine. Vancomycin will be given through these drains. Additionally, these drains will allow the fluid in the brain to be collected to measure how haemoglobin levels and vancomycin levels differ between compartments and change over time. Patients will participate in the study over a period from recruitment at three days after aSAH to a maximum of ten days after aSAH. The data will be analysed to determine the relationship in haemoglobin concentrations between different areas of the brain and spine after aSAH, and how vancomycin distribution is related to its route of administration., conditionsModule conditions: Subarachnoid Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Insertion of drains, interventions name: Vancomycin, outcomesModule primaryOutcomes measure: CSF-haemoglobin concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06373627, orgStudyIdInfo id: 2024-A00534-43, briefTitle: Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease, acronym: PEACE-HYPNO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-05-02, completionDateStruct date: 2025-05-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Fondation Hôpital Saint-Joseph, class: OTHER, descriptionModule briefSummary: The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects., conditionsModule conditions: Procedural Pain, conditions: Congenital Heart Disease, conditions: Heart Surgery, conditions: Hypnosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Hypnosis, interventions name: Conventional medications used for sedation-analgesia, interventions name: Medications used in addition to hypnosis, outcomesModule primaryOutcomes measure: Primary Outcome : Pain evaluation by VAS self-assessment, secondaryOutcomes measure: Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal, secondaryOutcomes measure: Maximum heart rate, secondaryOutcomes measure: Cumulative doses of intravenous analgesics, secondaryOutcomes measure: Respiratory depression, secondaryOutcomes measure: Parental satisfaction using Visual Analogic Scale (VAS), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373614, orgStudyIdInfo id: 2023/18, briefTitle: The Effect of Foot Massage and Bed Bath on Individuals With Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer., conditionsModule conditions: Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: foot massage (intervention group) bed bath (intervention group) control (control group), primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: foot massage, interventions name: bed bath, outcomesModule primaryOutcomes measure: sleep quality, primaryOutcomes measure: fatigue, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Sciences, status: RECRUITING, city: Istanbul, state: Uskudar, country: Turkey, contacts name: Ayşe Kabuk, Dr, role: CONTACT, phone: 05469596616, email: [email protected], contacts name: Ayşe Kabuk, PhD, role: CONTACT, phone: +905469596616, email: [email protected], contacts name: Ayşe Kabuk, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06373601, orgStudyIdInfo id: SPAGO, briefTitle: SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective, acronym: SPAGO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS, class: OTHER, descriptionModule briefSummary: The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) at 12 months follow-up., conditionsModule conditions: Coronary Artery Disease, conditions: Stenosis Coronary, conditions: Coronary Artery Lesion, conditions: Percutaneous Coronary Intervention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A subject is randomized at a 1:1 ratio either to drug-coated balloon (DCB) angioplasty with a sirolimus-eluting Selution balloon (n=60 subjects) or DCB angioplasty with a paclitaxel-eluting Sequent Please Neo balloon (n=60 subjects)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: sirolimus-eluting balloon (Selution), interventions name: paclitaxel-eluting balloon (SeQuent Please Neo), outcomesModule primaryOutcomes measure: In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure, secondaryOutcomes measure: Device success (lesion based), secondaryOutcomes measure: Procedure success, secondaryOutcomes measure: Angiographic outcomes 1, secondaryOutcomes measure: Angiographic outcomes 2, secondaryOutcomes measure: Angiographic outcomes 3, secondaryOutcomes measure: Angiographic outcomes 4, secondaryOutcomes measure: Device oriented Composite Endpoint (DoCE/ TLF), secondaryOutcomes measure: Acute/subacute/early/late vessel thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373588, orgStudyIdInfo id: MP-37-2023-9418, briefTitle: Patient Navigator Intervention for Migrant Children With Special Healthcare Needs Experiencing Care Transitions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: Montreal Children's Hospital of the MUHC, collaborators name: Unity Health Toronto, collaborators name: The Hospital for Sick Children, collaborators name: Women's College Hospital, collaborators name: National Newcomer Navigation Network, collaborators name: Centre for Refugee Children, Toronto, descriptionModule briefSummary: The goal of this randomized controlled trial is to test if a patient navigator program improves healthcare experiences and outcomes for migrant families caring for a child or youth with special healthcare needs (i.e. chronic health condition).The main questions are, for migrant families with a child or youth with special healthcare needs:Does a patient navigator reduces barriers to care? Does a patient navigator improve care coordination, caregiver empowerment, caregiver stress and quality of life? What are the healthcare experiences for families with and without the patient navigator intervention?Participants will:* Receive the intervention, i.e., the patient navigator program, or continue with standard of care for 12 months* Fill out questionnaires at 3 time points on barriers to care, caregiver stress, care coordination, and their child's health, conditionsModule conditions: Patient Navigation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-centre, pragmatic, assessor-blinded, parallel randomized controlled trial with an embedded qualitative study. In the control arm, participants will receive a standard information package and care usually provided within their clinics. In the intervention arm, participants will receive support from a trained patient navigator. The patient navigator will contact participants: 1) Within 7 days of randomization; 2) At least once every 3 months up to 12 months; 3) As needed to follow-up on tasks identified in previous visits; and 4) As initiated by the participant. The navigator will tailor the topics addressed during these interactions according to the needs of the participant and compile a care plan with input from the patient, family, and clinicians., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Patient Navigator, outcomesModule primaryOutcomes measure: Barriers to Care (BCQ), secondaryOutcomes measure: Effective care coordination, secondaryOutcomes measure: Parental empowerment scale, secondaryOutcomes measure: Healthcare utilization, secondaryOutcomes measure: PROMIS - Pediatric Global Health 7, secondaryOutcomes measure: Short-form survey 12, secondaryOutcomes measure: Patient Health Questionnaire (PHQ-2), secondaryOutcomes measure: Distress Thermometer, secondaryOutcomes measure: Perceived stress scale, secondaryOutcomes measure: Patient Satisfaction with Interpersonal Relationships with Navigators (PSN-I), eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Unity Health Toronto, Compass Clinic, city: Toronto, state: Ontario, zip: M5B 1W8, country: Canada, contacts name: Ahrrabie Thirunavukkarasu, role: CONTACT, email: [email protected], contacts name: Shazeen Suleman, MD MPH FRCPC, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Women's College Hospital, Crossroads Clinic, city: Toronto, state: Ontario, zip: M5S 1B2, country: Canada, contacts name: Xinyang Ye, role: CONTACT, email: [email protected], contacts name: Meb Rashid, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: CLSC de Parc-Extension, city: Montréal, state: Quebec, zip: H3N 1Y9, country: Canada, contacts name: Patricia LI, role: CONTACT, email: [email protected], contacts name: Patricia Li, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan Carlos Chirgwin, role: SUB_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Montreal Children's Hospital, city: Montréal, state: Quebec, zip: H4A 3J1, country: Canada, contacts name: Melissa Tachdjian, role: CONTACT, phone: 514-233-1873, email: [email protected], contacts name: Patricia Li, role: CONTACT, phone: 438-402-0510, email: [email protected], contacts name: Patricia Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06373575, orgStudyIdInfo id: 2023-SR-891, briefTitle: IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term., conditionsModule conditions: End-stage Renal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Lung and inferior vena cava ultrasound guidance, interventions name: Conventional protocol guidance, outcomesModule primaryOutcomes measure: Improvement in pulmonary congestion score, primaryOutcomes measure: Improvement in heart failure symptoms score, secondaryOutcomes measure: Total ultrafiltration volume, secondaryOutcomes measure: Mean ultrafiltration rate during prolonged hemodialysis, secondaryOutcomes measure: Fluid balance (total outflow - total inflow), secondaryOutcomes measure: Lung B-line reduction, secondaryOutcomes measure: The change of width of inferior vena cava, secondaryOutcomes measure: Incidence of hypotension during prolonged hemodialysis, secondaryOutcomes measure: Blood pressure variability during the prolonged hemodialysis, secondaryOutcomes measure: In-hospital mortality, secondaryOutcomes measure: Length of hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiangsu Province Hospital, city: Nanjing, state: Jiangsu, zip: 210029, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06373562, orgStudyIdInfo id: Wrestlers, briefTitle: Effect of Hypoxic Exposure on Blood Variables in Elite Wrestlers, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-12-02, primaryCompletionDateStruct date: 2013-12-18, completionDateStruct date: 2013-12-18, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Poznan University of Physical Education, class: OTHER, descriptionModule briefSummary: Twelve male wrestlers of the National Polish Team were observed in the study during the camp. The hypoxia group (n=6) participated in sports training and hypoxic exposure, while the control group (n=6) included wrestlers participating only in sports training. The hypoxic group lived and slept in hypoxic rooms. During the camp, all wrestlers followed the same training schedule and diet. In the blood were determined levels of creatine kinase (CK), C-reactive protein (hsCRP) concentration, nitric oxide (NO), morphology, reticulocytes, lipid profile, and ferritin. Also vascular endothelial growth factor (VEGF, VEGFR2, and VEGFR3), erythropoietin (EPO), angiopoietin (Ang 1, Ang 2), endothelial cell adhesion factor-1 (VCAM-1), Erythropoietin (EPO) and hypoxia-inducible factor 1 (HIF-1). Body weight composition was determined., conditionsModule conditions: Hypoxia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Wrestlers in H group were living in hypoxic rooms for 8-14h/d and between that they were participating in sports training. C group was participating in the same training protocol., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: hypoxia, outcomesModule primaryOutcomes measure: CK, primaryOutcomes measure: hsCRP, primaryOutcomes measure: HIF-1, primaryOutcomes measure: EPO, primaryOutcomes measure: VEGF, VEGF 2, VEGF 3., primaryOutcomes measure: Ang 1, Ang 2, primaryOutcomes measure: VCAM-1, otherOutcomes measure: blood count, otherOutcomes measure: lipid profile, otherOutcomes measure: ferritin, otherOutcomes, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373549, orgStudyIdInfo id: 2022/183-3896, briefTitle: Investigation of Myocardial Protection Efficacy of Cardioplegia Solutions Used in Open Heart Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-08, primaryCompletionDateStruct date: 2023-07-24, completionDateStruct date: 2023-07-24, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tamer cebe, class: OTHER, collaborators name: Istanbul University - Cerrahpasa (IUC), descriptionModule briefSummary: Cardioplegias are different pharmacokinetic solutions routinely used in cardiac surgery to protect the heart from ischemia and induce arrest. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are used in clinical practice. There is no clear scientific data in the literature that demonstrates the superiority of one cardioplegia over the others. The choice of the appropriate cardioplegia depends on the surgeon's clinical experience and preference. In this study preferred the blood cardioplegia and del Nido cardioplegia, which are commonly used in clinic. Both cardioplegias have different advantages that contribute to their preference in clinical practice.Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals. The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. In addition to these different usage scenarios, the myocardial protective effects of cardioplegias on cellular redox homeostasis are also among the current research topics. Thesis project can contribute to the current literature and clinical practice on the cardioprotective advantages of cardioplegia solutions and the reasons for their preference in surgery., conditionsModule conditions: Cardiovascular Diseases, conditions: Myocardial Reperfusion Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2, type: ACTUAL, armsInterventionsModule interventions name: Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions, interventions name: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions, outcomesModule primaryOutcomes measure: Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SBÜ. Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi Erişkin Kalp ve Damar Cerrahisi Kliniği, city: Istanbul, state: Kadıköy, zip: 34668, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06373536, orgStudyIdInfo id: LMU-RAD-01167, briefTitle: Comparison of MRI-PDFF to TAEUS FLIP Device to Estimate Liver Fat Fraction in Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Endra Lifesciences, class: INDUSTRY, descriptionModule briefSummary: Primary nonalcoholic fatty Liver disease (NAFLD) is an excess of fat in the liver (steatosis) that is not a result of excessive alcohol consumption or other secondary causes11. NAFLD is defined by the presence of hepatic fat content (steatosis) in ≥ 5% of hepatocytes and is currently the most common liver disease worldwide14 . Non-Alcoholic Fatty Liver Disease (NAFLD) is the world\'s most common liver disease and affects around 33% of the adult population.Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease (NAFLD), is a growing clinical concern associated with the increasing prevalence of obesity, type 2 diabetes, and metabolic syndrome. NASH is characterized by the presence of hepatic steatosis, inflammation, and hepatocellular injury and is predicted to be the leading indication for liver transplantation by 20201. Patients with NASH have an increased risk of developing cirrhosis and its complications, such as ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, and liver failure. The prevalence worldwide of NAFLD in the general population is estimated at 20-35%2 . Around 2-3% of the population have NASH.In patients with type 2 diabetes, the prevalence is even over 50% (55.5% globally, 68% in Europe). In Germany, the NAFLD prevalence was 23% in 2016 and will be around 26% in 2030. The prevalence of non-alcoholic alcoholic steatohepatitis (NASH), i.e. the progressive form of NAFLD, is estimated at 4% of the adult population in Germany and will increase to 6% by 2030. This means that NAFLD is already the most common chronic liver disease worldwide and one of the leading causes of liver-related complications (cirrhosis, decompensation, hepatocellular carcinoma, liver transplantation) and deaths. NAFLD and NASH are largely underdiagnosed worldwide., conditionsModule conditions: Steatosis of Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Thermoacoustic imaging, MRI and Ultrasound imaging, outcomesModule primaryOutcomes measure: Thermoacoustic Fat Measurements, primaryOutcomes measure: Estimate Accuracy of Thermoacoustic Fat Fraction, secondaryOutcomes measure: Usability Metric, secondaryOutcomes measure: Estimate Operator Variability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinikum der Universität München Großhadern Klinik und Poliklink für Radiologie, city: München, zip: 81377, country: Germany, contacts name: Monika Dienst, M.Sc., role: CONTACT, phone: +49 89 4400 76642, email: [email protected], contacts name: Dirk-Andre Clevert, Prof. Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False |
protocolSection identificationModule nctId: NCT06373523, orgStudyIdInfo id: SHIELD, briefTitle: MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin, acronym: SHIELD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Post Graduate Institute of Medical Education and Research, Chandigarh, class: OTHER, descriptionModule briefSummary: Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis/hepatic fibrosis in NAFLD patients with Primary Hypothyroidism., conditionsModule conditions: Hepatic Steato-Fibrosis, conditions: Non-Alcoholic Fatty Liver Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible subjects will be randomly allocated to either the Dapagliflozin group or placebo group (i.e. control group), primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The placebo pills will be manufactured in identical appearance to the study drug (Dapagliflozin), whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin 10mg Tab, interventions name: Placebo, interventions name: Levothyroxine Replacement daily, outcomesModule primaryOutcomes measure: Change in liver fat content, secondaryOutcomes measure: Proportion of participants achieving 1 Stage decrease in steatosis at 6 months asassessed by Transient Elastography, secondaryOutcomes measure: Changes in Improvement in hepatic fibrosis measured by non invasive parameters like Fib4 score at 3 and 6 months, secondaryOutcomes measure: Changes in Lipid Profile at 3 and 6 months, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PGIMER, city: Chandigarh, state: Punjab, zip: 160012, country: India, contacts name: ASHU RASTOGI, MD,DM, role: CONTACT, phone: 9781001046, phoneExt: 91, email: [email protected], geoPoint lat: 30.73629, lon: 76.7884, hasResults: False |
protocolSection identificationModule nctId: NCT06373510, orgStudyIdInfo id: ELCAV, briefTitle: Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study, acronym: ELCAV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-20, primaryCompletionDateStruct date: 2027-04-03, completionDateStruct date: 2027-04-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: CerbaXpert, class: OTHER, descriptionModule briefSummary: The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population .Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies., conditionsModule conditions: Vaccination Reaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Blood collection, outcomesModule primaryOutcomes measure: Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373497, orgStudyIdInfo id: IIT2023-08-ATKINS-ATHERO-RT, briefTitle: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Katelyn Atkins, class: OTHER, descriptionModule briefSummary: The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction.Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT., conditionsModule conditions: Oligometastatic Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: 18-F-NaF Cardiac PET/MRI and, interventions name: CT Angiogram, outcomesModule primaryOutcomes measure: Feasibility of using F-NaF PET/MRI imaging, secondaryOutcomes measure: To measure changes in standard uptake value (SUV), secondaryOutcomes measure: To measure changes in coronary microcalcification activity (CMA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cedars Sinai Medical Center, city: Los Angeles, state: California, zip: 90048, country: United States, contacts name: Clinical Trial Recruitment Navigator, role: CONTACT, phone: 310-423-2133, email: [email protected], contacts name: Katelyn Atkins, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alan Kwan, MD, MS, role: SUB_INVESTIGATOR, contacts name: Louise Thomson, MD, role: SUB_INVESTIGATOR, contacts name: Andriana Nikolova, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Anja Karlstaedt, MD, Phd, role: SUB_INVESTIGATOR, contacts name: Eric Vail, MD, role: SUB_INVESTIGATOR, contacts name: Celeste Eno, PhD, role: SUB_INVESTIGATOR, contacts name: Stephen Shiao, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Elizabeth McKenzie, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06373484, orgStudyIdInfo id: 018-2022, briefTitle: Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents, acronym: MATCH-DB, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Centre for Addiction and Mental Health, class: OTHER, descriptionModule briefSummary: This study will develop and test whether personalized profiles of children with Disruptive Behaviour Disorder (DBD) and their parents based on important psychological, emotional, and neuropsychological indicators predict their response to child cognitive behavioral treatment and Behavioral Parent Training., conditionsModule conditions: Disruptive Behavior Disorder, conditions: Emotional Disorder, conditions: Behavioural Disorder, conditions: Attention Deficit Hyperactivity Disorder, conditions: Conduct Disorder, conditions: Oppositional Defiant Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Parent Training, outcomesModule primaryOutcomes measure: Changes in parenting skills between baseline, post-treatment, and follow-up (6 months - 1 year), primaryOutcomes measure: Changes in parenting competencies between baseline, post-treatment, and follow-up (6 months - 1 year), primaryOutcomes measure: Changes in child emotional and behavioral problems between baseline, post-treatment, and follow-up (6 months - 1 year), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre for Addiction and Mental Health, status: RECRUITING, city: Toronto, state: Ontario, zip: M6J 1H4, country: Canada, contacts name: Brendan F. Andrade, PhD, role: CONTACT, phone: 416-535-8501, phoneExt: 33642, email: [email protected], geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06373471, orgStudyIdInfo id: S-20230101, briefTitle: Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment, acronym: IMPROVE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Velux Fonden, collaborators name: Danish Cancer Research Foundation, collaborators name: The Dagmar Marshall Foundation, descriptionModule briefSummary: The Improve study is a randomized controlled trial investigating the efficacy of adding comprehensive geriatric assessment and treatment to standard of care compared with standard of care in older, frail patients with hematological cancer. The investigators aim to recruit 152 study participants who will be randomized 1:1 to intervention- or control group. Study participants in the intervention group will receive the intervention comprehensive geriatric assessment and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation of comorbidity and frailty as is usual standard at Department of Hematology. Primary endpoint is elderly functional Index at 12 weeks., conditionsModule conditions: Hematologic Malignancy, conditions: Treatment Adherence, conditions: Treatment Complication, conditions: Frailty, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive geriatric assessment (CGA) and treatment, outcomesModule primaryOutcomes measure: Elderly functional Index, secondaryOutcomes measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)., secondaryOutcomes measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14)., secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: 30-second chair stand test, secondaryOutcomes measure: Treatment toxicity, secondaryOutcomes measure: Adherence to hematological cancer treatment, secondaryOutcomes measure: Polypharmacy yes/no, secondaryOutcomes measure: Unplanned hospital admissions, secondaryOutcomes measure: Overall and cancer specific survival, eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Odense University Hospital, status: RECRUITING, city: Odense C, zip: 5000, country: Denmark, contacts name: Nina Andersen, M.D., role: CONTACT, phone: +4540437488, email: [email protected], geoPoint lat: 55.39594, lon: 10.38831, hasResults: False |
protocolSection identificationModule nctId: NCT06373458, orgStudyIdInfo id: STUDY-23-01508, briefTitle: Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, collaborators name: Pfizer, descriptionModule briefSummary: Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis., conditionsModule conditions: Keloid, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ritlecitinib, outcomesModule primaryOutcomes measure: Recurrence Rate, primaryOutcomes measure: Change in Detroid Keloid Scale Score, secondaryOutcomes measure: Change in Peak keloid tension, secondaryOutcomes measure: Change in Detroid Keloid Scale Score (DKS), secondaryOutcomes measure: Change in Pain Numerical Rating Scale (Pain-NRS), secondaryOutcomes measure: Change in Itch-NRS, secondaryOutcomes measure: Change in PGIC (Patient Global Impression of Change), secondaryOutcomes measure: Change in DLQI (Dermatology Life Quality Index), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Icahn School of Medicine at Mount Sinai, status: RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Giselle Singer, role: CONTACT, phone: 212-241-3288, email: [email protected], contacts name: Sharlene Martin, role: CONTACT, phone: 212-241-3288, contacts name: Emma Guttman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06373445, orgStudyIdInfo id: 36264PR596, briefTitle: Interventional Neuromodulation in Fibromyalgia, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: This study was conducted on 40 eligible fibromyalgia patients with sleep disorders. They were randomized to have 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over the right dorsolateral prefrontal area (DLPFC) for 5 sessions/week for 4 weeks. All participants were subjected to baseline evaluation with Fibromyalgia Impact Questionnaire, polysomnography, sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index and The Medical Outcomes Study Sleep Scale respectively.FM patients were reevaluated at 1, 3 months after the end of rTMS sessions., conditionsModule conditions: Neuromodulation and Sleep Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: participants randomly allocated to either no, one, some or all interventions simultaneously, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: repetitive transcranial magnetic stimulation active stimulation, interventions name: repetitive transcranial magnetic stimulation sham stimulation, outcomesModule primaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), primaryOutcomes measure: The Medical Outcomes Study Sleep Scale (MOS ), primaryOutcomes measure: polysomnography, secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: The Medical Outcomes Study Sleep Scale (MOS), secondaryOutcomes measure: polysomnography, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of medicine, status: RECRUITING, city: Tanta, state: ElGharbia, zip: 6620010, country: Egypt, contacts name: Marwa Y Badr, role: CONTACT, phone: 01003639125, phoneExt: Tanta, email: [email protected], geoPoint lat: 30.78847, lon: 31.00192, hasResults: False |
protocolSection identificationModule nctId: NCT06373432, orgStudyIdInfo id: STUDY-22-01607, briefTitle: Frequency of Glucose Monitoring in Labor, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-11-26, completionDateStruct date: 2024-11-26, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth., conditionsModule conditions: Neonatal Hypoglycemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Fingerstick, outcomesModule primaryOutcomes measure: Neonatal Hypoglycemia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai West Hospital, city: New York, state: New York, zip: 10019, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06373419, orgStudyIdInfo id: RP-1007, briefTitle: TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-16, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Thunder Bay Regional Health Research Institute, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.The main question it aims to answer is:Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?Participants will randomized to either TFL of MOSES arm for their bladder resection procedure., conditionsModule conditions: Urolithiasis of Bladder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: TFL, interventions name: MOSES holmium laser, outcomesModule primaryOutcomes measure: Presence of muscularis propria, primaryOutcomes measure: Incidence of inconclusive pathology, secondaryOutcomes measure: Tumor-free rate (TFR), secondaryOutcomes measure: Total operative time, secondaryOutcomes measure: Total procedural time, secondaryOutcomes measure: Number of recurrences, secondaryOutcomes measure: Total blood loss, secondaryOutcomes measure: Rate of complications, secondaryOutcomes measure: Number of inconclusive pathology, secondaryOutcomes measure: Lasing time, secondaryOutcomes measure: Total energy used, secondaryOutcomes measure: Frequency and severity of peri-operative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thunder Bay Regional Health Sciences Centre, status: RECRUITING, city: Thunder Bay, state: Ontario, zip: P7B 6V4, country: Canada, contacts name: Rabail Siddiqui, role: CONTACT, phone: (807) 684-6000, email: [email protected], contacts name: Hazem Elmansy, role: SUB_INVESTIGATOR, geoPoint lat: 48.38202, lon: -89.25018, hasResults: False |
protocolSection identificationModule nctId: NCT06373406, orgStudyIdInfo id: MHB036C-CP001CN, briefTitle: A Study of MHB036C for Advanced Solid Tumor, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-18, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Minghui Pharmaceutical (Hangzhou) Ltd, class: INDUSTRY, descriptionModule briefSummary: Phase I/II, dose escalation and dose expansion study to evaluate the efficacy and safety of MHB036C in advanced malignant tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: MHB036C, outcomesModule primaryOutcomes measure: Incidence of participants with adverse events (AE), primaryOutcomes measure: Number of participants with dose-limiting toxicity (DLT), secondaryOutcomes measure: Maximum Plasma Concentration (Cmax), secondaryOutcomes measure: The area under the plasma concentration-time curve (AUC), secondaryOutcomes measure: To detectable anti-drug antibodies with treated subjects, secondaryOutcomes measure: Objective response rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, zip: 200030, country: China, contacts name: Shun Lu, MD, role: CONTACT, phone: 13601813062, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06373393, orgStudyIdInfo id: 1, briefTitle: SPIRIT: Study of the Patency of Spinal aRteries After the STABILISE Technique, acronym: SPIRIT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA, class: OTHER, collaborators name: Cardiovascular Center of the University of Lisbon, collaborators name: Unidade Local de Saúde Santa Maria, descriptionModule briefSummary: The aim of the study is to evaluate the impact of the stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique in the patency of intercostal and lumbar arteries detectable on computed tomography angiography (CTA) in patients with type B aortic dissection and its correlation with the occurrence of spinal cord ischaemia (SCI).Primary end-point: patency of the intercostal and lumbar arteries on follow-up CTA.Secondary end-point: spinal cord ischaemia, conditionsModule conditions: Aortic Dissection, conditions: Spinal Cord Ischemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: STABILISE, outcomesModule primaryOutcomes measure: number of patent intercostal and lumbar arteries, secondaryOutcomes measure: number of patients with spinal cord ischemia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unidade Local de Saúde Santa Maria, city: Lisbon, zip: 1500, country: Portugal, geoPoint lat: 38.71667, lon: -9.13333, hasResults: False |
protocolSection identificationModule nctId: NCT06373380, orgStudyIdInfo id: 23-293, briefTitle: A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, collaborators name: Hookipa Biotech GmbH, collaborators name: Naveris, descriptionModule briefSummary: The researchers are doing this study to find out if HB-202/HB-201 is an effective treatment for people with HPV 16-positive head and neck squamous cell cancer (HPV 16+ HNSCC) who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx. Participants will have no evidence of cancer on imaging scans (radiographically) or by medical examination (clinically). Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer, though we do not know if testing positive will definitely lead to the cancer coming back (recurrence). The NavDx blood test has not been approved by the FDA and is considered investigational., conditionsModule conditions: HPV16+ Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This will be a randomized multi-centered, double-blind, placebo-controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The study will be conducted using a double-blind design., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: HB-200, interventions name: Placebo, outcomesModule primaryOutcomes measure: Disease free survival (DFS), secondaryOutcomes measure: Number of participants with adverse events (type, frequency, severity)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All Protocol Activites), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities), status: RECRUITING, city: Uniondale, state: New York, zip: 11553, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.70038, lon: -73.59291, hasResults: False |
protocolSection identificationModule nctId: NCT06373367, orgStudyIdInfo id: 461-24, briefTitle: Preeclampsia Educational Program Study (PrEPS), acronym: PrEPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: MemorialCare Health System, class: OTHER, descriptionModule briefSummary: Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions., conditionsModule conditions: Preeclampsia, conditions: Preeclampsia Severe, conditions: Preeclampsia Mild, conditions: Preeclampsia Postpartum, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Illustration based application, interventions name: Text based application, outcomesModule primaryOutcomes measure: Preeclampsia knowledge score - short, secondaryOutcomes measure: Preeclampsia knowledge score - long, secondaryOutcomes measure: GAD-7 score, secondaryOutcomes measure: 72 hour BP check, secondaryOutcomes measure: Postpartum visit, secondaryOutcomes measure: Daily BP recordings, secondaryOutcomes measure: Accessed material, secondaryOutcomes measure: Unplanned readmission, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373354, orgStudyIdInfo id: 2023-0924, secondaryIdInfos id: NCI-2024-03341, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Siemens Medical Solutions, descriptionModule briefSummary: To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT., conditionsModule conditions: Architectural Distortions, conditions: Breast Tomosynthesis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Digital Breast Tomosynthesis (DBT), outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Tanya Moseley, MD, role: CONTACT, phone: 713-792-5755, email: [email protected], contacts name: Tanya Moseley, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06373341, orgStudyIdInfo id: NL85317.099.23, briefTitle: Hand and Arm Rehabilitation Using VR, acronym: HANDQUEST, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Medical Centre Leeuwarden, class: OTHER, descriptionModule briefSummary: Patients admitted to the ICU due to critical illness often experience physical, mental, cognitive, or social issues. Research indicates that inadequate physical recovery is associated with lower handgrip strength, and hand function in ICU patients is lower compared to healthy individuals. To address this, a Virtual Reality (VR) exergame was developed to aid rehabilitation. This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength, hand and arm functionality, balance, mobility, and support needs in ICU patients staying for 48 hours or longer. It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients. The intervention involves a 4-week VR-exergame program. Main study parameters include handgrip strength, hand and arm functionality, range of motion, balance, mobility, and support needs. The burden and risks associated with participation are minimal, as VR-based exercises are deemed safe and voluntary. Overall, the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients., conditionsModule conditions: Post-Intensive Care Syndrome, conditions: ICU Acquired Weakness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: VR training for arm and hand rehabilitation, outcomesModule primaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Arm and hand functionality, secondaryOutcomes measure: Arm and hand functionality, secondaryOutcomes measure: Arm and hand range of motion, secondaryOutcomes measure: Balance and mobility, secondaryOutcomes measure: Support need and experience with VR training, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dept of intensive care, Medical Centre Leeuwarden, status: RECRUITING, city: Leeuwarden, state: Friesland, zip: 8901 BR, country: Netherlands, contacts name: Lise Beumeler, PhD, role: CONTACT, phone: (058) 286 6738, email: [email protected], contacts name: Lise Beumeler, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Carina Bethlehem, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.20139, lon: 5.80859, hasResults: False |
protocolSection identificationModule nctId: NCT06373328, orgStudyIdInfo id: STUDY00006081, briefTitle: Post Pandemic Pneumococcal Carriage Among Children and Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Central Florida, class: OTHER, collaborators name: Merck Sharp & Dohme Corporation, descriptionModule briefSummary: The PI propose to conduct a genomic epidemiology study of pneumococcal carriage among children and adults in a large metropolitan city. These data will allow PI to assess the post-pandemic population structure, investigate the phylogenetic relationship between isolates from children and adults, and compare pneumococcal populations across diverse geographic areas., conditionsModule conditions: Pneumococcal Carriage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR., secondaryOutcomes measure: Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries., secondaryOutcomes measure: Putative transmission networks between children and adult populations from online questionnaires., eligibilityModule sex: ALL, minimumAge: 7 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373315, orgStudyIdInfo id: 2023/11-18, briefTitle: The Effect of Smartphone and Hand Anthropometry on Pain and Upper Extremity Functions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2025-05-02, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Nigde Omer Halisdemir University, class: OTHER, descriptionModule briefSummary: Mobile phones have different uses in different disciplines, and this encourages long-term use. For optimum comfort use, it is important to ensure users' awareness when purchasing mobile phones that match their hand sizes. The number of studies in the literature on this subject is limited. In this context, the aim of our study is to investigate the relationship between smartphone and hand anthropometry measurements and upper extremity pain and functions., conditionsModule conditions: Upper Extremity Problem, conditions: Smartphone Addiction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Hand anthropometric measurements: Hand length, primaryOutcomes measure: Hand anthropometric measurements: Palm length, primaryOutcomes measure: Hand anthropometric measurements: Width of the hand (Metacarpal), primaryOutcomes measure: Hand anthropometric measurements: Maximum hand spread measurement, primaryOutcomes measure: Gross grip strength measurement, primaryOutcomes measure: Pinch grip strength, primaryOutcomes measure: Measurement of phone dimensions, primaryOutcomes measure: Upper extremity functional status assessment, secondaryOutcomes measure: Pain assessment, secondaryOutcomes measure: Smartphone addiction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nigde Omer Halisdemir University, Bor Faculty of Health Sciences, city: Niğde, state: Nigde, zip: 51700, country: Turkey, contacts name: Feyza Altindal Karabulut, Assoc. Prof., role: CONTACT, phone: +905056263833, email: [email protected], geoPoint lat: 37.96583, lon: 34.67935, hasResults: False |
protocolSection identificationModule nctId: NCT06373302, orgStudyIdInfo id: IRAS 323948, briefTitle: Peripheral Arterial Disease Biomarkers, acronym: PADBIRD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Norfolk and Norwich University Hospitals NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression., conditionsModule conditions: Peripheral Arterial Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Correlation between PAD biomarker levels and walking distance., primaryOutcomes measure: Change in PAD biomarker levels following exercise therapy., primaryOutcomes measure: Change in PAD biomarker levels following endovascular intervention, secondaryOutcomes measure: To determine whether biomarker levels normalise with improved walking distance., secondaryOutcomes measure: To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention., secondaryOutcomes measure: Levels of biomarkers and (Major Adverse Cardiovascular Events)., eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373289, orgStudyIdInfo id: 000539476, secondaryIdInfos id: 1K23HD113837-01A1, type: OTHER, domain: NICHD (pending), briefTitle: Target Oxygen Ranges in Infants With Pulmonary Hypertension, acronym: TORPH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-07-01, primaryCompletionDateStruct date: 2029-07-01, completionDateStruct date: 2030-07-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease., conditionsModule conditions: Bronchopulmonary Dysplasia, conditions: Pulmonary Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 2 weeks of exposure A, infants will cross over to exposure B for 2 weeks with a 1-week washout period., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The PI will perform bedside echocardiography precluding masking to group allocation. All echocardiograms will be further reviewed by a cardiologist masked to group allocation with additional cardiologist review in instances of disagreement. Inter-rater reliability testing will also be performed., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: higher oxygen saturation target using Nellcor pulse oximetry sensors, interventions name: lower oxygen saturation target using Nellcor pulse oximetry sensors, outcomesModule primaryOutcomes measure: Intermittent hypoxemia event duration, secondaryOutcomes measure: Echocardiographic shunting, secondaryOutcomes measure: Echocardiographic interventricular septal flattening, secondaryOutcomes measure: Echocardiographic tricuspid regurgitation, secondaryOutcomes measure: Intermittent hypoxemia frequency, secondaryOutcomes measure: Cumulative hypoxemia, secondaryOutcomes measure: Brain natriuretic peptide, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 5 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373276, orgStudyIdInfo id: 1511, briefTitle: The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Dilshaad Basrai Vad, class: OTHER, descriptionModule briefSummary: The primary goal of this dissertation study is to determine if a home-based multiplanar balance training program with electronic assistance, will be effective in reducing one's fall risk category.Hypothesis: After 12 weeks, there will be a statistically significant decrease in the fall risk category for individuals in a home-based multiplanar balance training and educational program with electronic assistance as compared to no change in the fall risk category for individuals in an educational control group with electronic assistance Hypothesis: To determine if an individual's fear of falling is lower following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in fear of falling following an educational control group with electronic assistance post-intervention.Hypothesis: An individual's quality of life will improve following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in the quality of life following an educational control group with electronic assistance post-intervention.Hypothesis: Adherence and feasibility will be greater with a home-based multiplanar balance training program, with electronic assistance as compared to a control group with electronic assistance.Hypothesis: There will be a statistically significant inverse relationship between an individual's fear of falling and their fall risk category., conditionsModule conditions: Fall Risk, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants in the multiplanar balance training home-based exercise and educational group (group A) will have a video, as well as written instructions, of the intervention and dosage, along with the five educational brochures loaded on their phone via the SAFE beta app. In the SAFE beta app, the participants will be prompted daily to click on the beta app to watch the demonstration of the interventional exercise. They are then prompted to begin their daily prescriptive intervention, which is a 7-day-a-week program for 12 weeks. Participants can view a video of the exercise intervention in real-time in order to "mirror" the exercises as they are completing the exercises., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The primary investigator, who delivers the treatment, is blinded to to the performance outcome measures., whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: multiplanar balance training exercise with education, interventions name: education only, outcomesModule primaryOutcomes measure: Timed up and Go Test measured in Seconds, primaryOutcomes measure: 3 stage balance test measured in seconds, primaryOutcomes measure: 30-second chair stand measured in repeitions, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Metro PT, status: RECRUITING, city: New York, state: New York, zip: 10021, country: United States, contacts name: dilshaad vad, DPT, role: CONTACT, phone: 917-478-2444, email: [email protected], contacts name: Lior Cohen, DPT, role: CONTACT, phone: 9175549511, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06373263, orgStudyIdInfo id: 2024-4165, briefTitle: Evaluating Tools to Communicate Scleroderma Research Results to Patients, acronym: SPIN-KT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Lady Davis Institute, class: OTHER, descriptionModule briefSummary: Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients.The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs., conditionsModule conditions: Scleroderma, conditions: Systemic Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 488, type: ESTIMATED, armsInterventionsModule interventions name: Plain-language summary, interventions name: Dissemination Tool (Infographic), outcomesModule primaryOutcomes measure: Completeness, primaryOutcomes measure: Understandability, primaryOutcomes measure: Ease of use, secondaryOutcomes measure: Please to have received results, secondaryOutcomes measure: Intention to participate in future studies, secondaryOutcomes measure: Open-ended items, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06373250, orgStudyIdInfo id: sdilek7, briefTitle: Maternal Consequences of Membrane Stripping, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2024-10-11, completionDateStruct date: 2024-11-11, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Kocaeli University, class: OTHER, descriptionModule briefSummary: This study aims to investigate the maternal effects of membrane stripping during vaginal birth. This study was designed as an experimental case-control study. The sample size in the study was determined by Njoku et al in 2023 to assess the effectiveness of membrane stripping applied to participants who had vaginal birth in reducing the incidence of prolonged pregnancy. Calculated based on the study conducted by. The sample size of the study was calculated using G\*Power 3.1.9.2, and the mean and standard deviation of the Bishop score in the relevant article were used to calculate the effect size. Using the mean and standard deviation of the relevant article, the blended effect size was calculated as 0.596. The minimum number of individuals that should be included in the sample of this research was calculated using G\*Power 3.1.9.2, effect size: 0.596, α= 0.05, power: 0.95 (stripping = 70, control = 70) and at least in each group in the sample size. The sample size was set at 70 participants. The research data will be collected by the researcher using the Informed Volunteer Consent Form, Participant Information Form, Bishop Scoring, Visual Analogue Scale, and Birth Satisfaction Scale Short Form, which were created by the researcher within the framework of the literature on the subject., conditionsModule conditions: Maternal Care for Other Abnormalities of Cervix, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Membrane stripping group, interventions name: Control group, outcomesModule primaryOutcomes measure: Visual analogue scale evaluation of vaginal examination pain, primaryOutcomes measure: Visual analogue scale evaluation of vaginal examination pain, primaryOutcomes measure: Evaluation of the cervix with Bishop score, primaryOutcomes measure: Evaluation of the amount of bleeding, primaryOutcomes measure: Birth Satisfaction Scale Short Form, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kocaeli University, status: RECRUITING, city: Kocaeli, zip: 41380, country: Turkey, contacts name: Burcu Ozturk, M.Sc., role: CONTACT, email: [email protected], geoPoint lat: 39.62497, lon: 27.51145, hasResults: False |
protocolSection identificationModule nctId: NCT06373237, orgStudyIdInfo id: INC-IG-2024-001, briefTitle: Outcome of Embryos Transferred After Initial Chaotic Results on PGT-A, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Inception Fertility, LLC, class: INDUSTRY, collaborators name: Igenomix, descriptionModule briefSummary: This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed., conditionsModule conditions: Infertility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Frequency of embryo re-biopsy, primaryOutcomes measure: Re-biopsy results, primaryOutcomes measure: Embryo disposition, primaryOutcomes measure: Embryo transfer outcome, primaryOutcomes measure: Pregnancy outcome, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inception Fertility LLC, city: Houston, state: Texas, zip: 77081, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06373224, orgStudyIdInfo id: 23-037, briefTitle: Cold Saline Irrigation Before Endobronchial Biopsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-02, completionDateStruct date: 2025-02-02, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: TriHealth Inc., class: OTHER, descriptionModule briefSummary: Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies., conditionsModule conditions: Lung Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Flush, outcomesModule primaryOutcomes measure: Incidence of unreadable biopsy slides, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule 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: NCT06373211, orgStudyIdInfo id: APHP230701, secondaryIdInfos id: 2023-506942-22-01, type: OTHER, domain: CTIS, briefTitle: Early Immunotherapy With Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients With Anti-Hu-associated Paraneoplastic Sensory Neuronopathy, acronym: NESPA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months., conditionsModule conditions: Paraneoplastic Sensory Neuronopathy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Immunoglobulins IV (CLAYRIG), interventions name: Cyclophosphamide IV, interventions name: Methylprednisolone IV, outcomesModule primaryOutcomes measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months, secondaryOutcomes measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 and 6 months, secondaryOutcomes measure: Percentage of patients with improvement in the ataxic component on the Score of Ataxia scale at 3 and 6 months, secondaryOutcomes measure: Percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months, secondaryOutcomes measure: Percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 months, secondaryOutcomes measure: Percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months, secondaryOutcomes measure: Percentage of patients alive and without tumor progression at 6 months, secondaryOutcomes measure: Tolerance to treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Pitié-Salpêtrière, city: Paris, zip: 75013, country: France, contacts name: Dimitri Psimaras, MD, role: CONTACT, email: [email protected], contacts name: Alice LEPRINCE-LAURENGE, MD, role: CONTACT, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06373198, orgStudyIdInfo id: 0040/2023-versión 1.0, briefTitle: Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Hospital El Cruce, class: OTHER, collaborators name: Gilead Sciences, descriptionModule briefSummary: Hepatitis C virus (HCV) is a leading cause of morbidity and mortality worldwide. This infection continues to represent a major global public health concern. This is why the introduction of potent antivirals for the treatment of HCV has been one of the major breakthroughs of the current medical era.From a public health perspective, HCV prevalence will be eliminated if the available treatment also targets those most likely to transmit the virus. Despite this scientific advance, a systematic review from the U.S. described that of the 43% of patients aware of their HCV diagnosis, only 16% started treatment. Clearly, the long-known barriers to accessing this treatment must be broken down in order to administer these effective antivirals. The World Health Organization (WHO) has set the ambitious goal of eliminating viral hepatitis as a public health threat by 2030. This goal is really difficult to achieve, especially in low and middle-income countries. Particularly in Argentina, there is a need to improve diagnosis, access to care, and treatment of viral hepatitis. The prospect of viral hepatitis elimination in our country is daunting due to the complexity of the health system and the cost of implementing different strategies. The most pragmatic approach would be to break down national elimination targets into smaller targets for individual populations, for which treatment and prevention interventions can be delivered more quickly and efficiently. This concept is known as micro-elimination. Focusing on micro-elimination of viral hepatitis means working to achieve the WHO target in specific subpopulations. Subpopulations known to have a higher prevalence of HCV infection include prisoners, people who inject drugs, and patients requiring hemodialysis, among others.Currently, patient unawareness of HCV infection represents one of the major barriers to treatment. In many cases, the diagnosis of HCV was established many years ago and patients do not seek treatment probably because they do not recognize the urgency of treating this asymptomatic infection. It is our goal, then, to identify the group of individuals who have been diagnosed with HCV infection but are not currently undergoing regular visits with health care professionals. This strategy is now called re-linking to the medical care of patients with chronic HCV., conditionsModule conditions: Hepatitis C Chronic, conditions: Hepatitis C, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: standard of care, outcomesModule primaryOutcomes measure: rate of relinked HCV patients, primaryOutcomes measure: proportion of relinked patients who received antiviral treatment, secondaryOutcomes measure: Evaluation and characteristics of the treatment established, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373185, orgStudyIdInfo id: 2023/21, briefTitle: Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children, acronym: SESPB, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Giresun University, class: OTHER, descriptionModule briefSummary: The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases., conditionsModule conditions: Urogenital Diseases, conditions: Nerve Block, conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled double blind study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Randomisation using a closed envelope method based on computer-generated random numbers was to assign patients to two equal groups. Group 1 received midline US-guided sacral erector spinae plane block and Group 2 received caudal block. The experienced anesthetist who opened the envelope performed the block according to the group code and patients were followed postoperatively by an anesthetist blinded to which block was performed. Patients were also blinded as to which block was performed., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-guided sacral erector spinae plane block, interventions name: Ultrasound-guided caudal block, outcomesModule primaryOutcomes measure: Face, Leg, Activity, Cry, Consolability (FLACC) score, secondaryOutcomes measure: Analgesic requirement, secondaryOutcomes measure: Satisfaction of the patient's parents, secondaryOutcomes measure: Satisfaction of the surgeons, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Giresun Research and Training Hospital, status: RECRUITING, city: Gi̇resun, state: Central, zip: 28100, country: Turkey, contacts name: Bilge Olgun Keleş, role: CONTACT, phone: 05317338805, email: [email protected], contacts name: Dilek Yeniay, role: CONTACT, phone: 05375521553, email: [email protected], geoPoint lat: 40.91698, lon: 38.38741, hasResults: False |
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