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<\|newrecord\|> nctId: NCT06374498 id: 2023P003247 briefTitle: Study to Determine the Clinical Significance of Intravascular OCT-NIRAF overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2027-04-30 date: 2024-04-18 date: 2024-04-18 name: Massachusetts General Hospital class: OTHER briefSummary: Patients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that:
1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease.
2. NIRAF coronary artery signal level is a predictor of plaque progression on a per patient, per artery, or per lesion basis. conditions: Cardiovascular Diseases conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: OCT-NIRAF measure: Plaque size estimation using OCT-NIRAF measure: Plaque progression estimate using OCT-NIRAF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Nitasha Bhat, MD role: CONTACT phone: 617-724-4515 email: Tearneylabtrials@partners.org lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06374485 id: AU409-LEES-2021-03 briefTitle: Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment overallStatus: RECRUITING date: 2024-04-12 date: 2026-02-28 date: 2026-08-28 date: 2024-04-18 date: 2024-04-18 name: Lee's Pharmaceutical Limited class: INDUSTRY briefSummary: This study is a Phase I, dose-escalation study of AU409 in advanced hepatocellular carcinoma patients who failed standard treatment. A '3+3' dose-escalation design will be utilized to gradually increase the dose of AU409, aiming to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of multi-dose AU409 in patients with advanced HCC. conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: AU409 capsules measure: Dose Limiting Toxicity measure: Maximum Tolerated Dose measure: Recommended Phase 2 Dose measure: Objective Response Rate measure: Disease Control Rate measure: Duration of Response measure: Progression-free Survival measure: Overall Survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Clinical Oncology, Queen Mary Hospital status: RECRUITING city: Hong Kong country: China name: Chi Leung Chiang role: PRINCIPAL_INVESTIGATOR name: Albert Chan role: SUB_INVESTIGATOR name: Aya El HELALI role: SUB_INVESTIGATOR lat: 22.39407 lon: 114.13737 hasResults: False
<\|newrecord\|> nctId: NCT06374472 id: IRB00001194 briefTitle: Surgical Treatment of Fractures of the Dorso-lombar Spine overallStatus: COMPLETED date: 2018-01-01 date: 2022-01-01 date: 2022-01-01 date: 2024-04-18 date: 2024-04-18 name: Ibn Jazzar Hospital class: OTHER 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 conditions: Spine Fracture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 80 type: ACTUAL name: Osteosynthesis measure: Age (in years) measure: Sex measure: Neurological status ( Frenkel classification) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IBN jazzar hospital city: Kairouan zip: 3190 country: Tunisia lat: 35.6781 lon: 10.09633 hasResults: False
<\|newrecord\|> nctId: NCT06374459 id: 24-x109 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 overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2031-11-30 date: 2031-11-30 date: 2024-04-18 date: 2024-04-18 name: Washington University School of Medicine class: OTHER name: United States Department of Defense name: Aclaris Therapeutics, Inc. 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). conditions: Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 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 masking: NONE count: 138 type: ESTIMATED name: Zumsemetinib name: Capecitabine name: Zoledronic acid name: Denosumab measure: Number of participants with adverse events (Phase Ib only) measure: Recommended phase II dose of zunsemetinib (Phase Ib only) measure: Percent change in serum CTX (Phase II only) measure: Progression-free survival (PFS) (Phase II only) measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase Ib only) measure: Treatment-induced changes in sCTX by clinical assay (Phase II only) measure: Objective response rate (ORR) (Phase II only) measure: Clinical benefit rate (Phase II only) measure: Overall survival (OS) (Phase II only) measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase II only) measure: Treatment-induced changes in quality of life as measured by EORTC QLQ-C30 (Phase II only) measure: Treatment-induced changes in pain as measured by Brief Pain Inventory (BPI) (Phase II only) measure: Number of participants with adverse events (Phase II only) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Kansas Cancer Center city: Westwood state: Kansas zip: 66205 country: United States name: Qamar Khan, M.D. role: CONTACT phone: 913-588-1227 name: Qamar Khan, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.04056 lon: -94.6169 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Matthew Goetz, M.D. role: CONTACT phone: 507-284-2511 email: Goetz.Matthew@mayo.edu name: Matthew Goetz, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Cynthia X Ma, M.D., Ph.D. role: CONTACT phone: 314-362-8903 email: cynthiaxma@wustl.edu name: Cynthia X Ma, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Sheila Stewart, Ph.D. role: SUB_INVESTIGATOR name: Roberto Civitelli, M.D. role: SUB_INVESTIGATOR name: Jingqin (Rosy) Luo, Ph.D. role: SUB_INVESTIGATOR name: Foluso Ademuyiwa, M.D. role: SUB_INVESTIGATOR name: Nusayba Bagegni, M.D. role: SUB_INVESTIGATOR name: Ron Bose, M.D., Ph.D. role: SUB_INVESTIGATOR name: Andrew Davis, M.D. role: SUB_INVESTIGATOR name: Ashley Frith, M.D., Ph.D. role: SUB_INVESTIGATOR name: Faisal Fa'ak, M.D. role: SUB_INVESTIGATOR name: Lindsay Peterson, M.D. role: SUB_INVESTIGATOR name: Rama Suresh, M.D. role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False
<\|newrecord\|> nctId: NCT06374446 id: 22-172 briefTitle: Effect of Virtual Reality in Patients With Long Covid-19 overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-06-15 date: 2024-06-30 date: 2024-04-18 date: 2024-04-18 name: Istinye University class: OTHER 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. conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Classical Treatment name: Virtual Reality Combined with Classical Treatment name: Virtual Reality name: Control Group measure: Fatigue measure: Kinesiophobia measure: Evaluation of Respiratory Function measure: Shuttle Walking Test measure: Endurance Shuttle Walking Test measure: Sit and Reach Test measure: Peripheral Muscle Strength measure: The Nottingham Health Profile measure: Dyspnea measure: Energy Consumption measure: Posture Analysis measure: Covid-19 Yorkshire Performance measure: FACIT Fatigue Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06374433 id: PREDICOM-01 briefTitle: Investigating the Plasticity of Human Predictive Coding Through Neuromodulation acronym: PREDICOM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Università Vita-Salute San Raffaele class: OTHER name: Alessia Santoni name: Sara Stottmeier name: Klara Hemmerich name: Giuseppe Di Dona name: Luigi Ferini-Strambi 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. conditions: Human Brain and Cognition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 210 type: ESTIMATED name: Occipital tACS at IAF-2Hz name: Occipital tACS at IAF+2Hz name: Frontal tACS at 4-7 Hz name: Occipital tRNS name: Frontal tRNS name: Sham/placebo tACS name: Sham/placebo tRNS measure: Behavioral measures sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06374420 id: MD.21.11.564 briefTitle: Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome overallStatus: COMPLETED date: 2021-09-01 date: 2023-09-01 date: 2024-04-01 date: 2024-04-18 date: 2024-04-19 name: Mansoura University class: OTHER 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. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ACTUAL measure: investigating pulmonary sequelae of covid-19. measure: investigating pulmonary sequelae of covid-19. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University city: Mansoura state: Dakhlia zip: 050 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06374407 id: GT-001 briefTitle: The MIND-GUT Digital Pilot Intervention Study acronym: MINDGUT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-05 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: University of Skövde class: OTHER name: State University of New York - Downstate Medical Center name: Albert Einstein College of Medicine name: Göteborg University name: Uppsala University name: Kristianstad University name: University of Pavia name: The Food Scientist AB (Sweden) 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. conditions: Obesity conditions: Depressive Symptoms conditions: Anxiety conditions: Stress conditions: Eating Habit conditions: Dysbiosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We plan to randomly assign participants to either the intervention or control group. primaryPurpose: TREATMENT 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 count: 126 type: ESTIMATED name: Dietary intervention based on the MIND diet measure: Program retention measure: Adherence measure: Acceptability measure: Study effectiveness: change in eating attitudes at follow-up measure: Study effectiveness: change in stress levels at follow-up measure: Study effectiveness: change in depression symptoms at follow-up measure: Study effectiveness: change in anxiety symtoms at follow-up measure: Study effectiveness: change in body weight at follow-up measure: Study effectiveness: change in % total fat mass at follow-up measure: Study effectiveness: change in % visceral fat mass at follow-up measure: Study effectiveness: change in waist circumference at follow-up measure: Study effectiveness: change in hip circumference at follow-up measure: Study effectiveness: change in microbiome variety at follow-up sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: University of Skövde city: Skövde zip: 54128 country: Sweden name: Gianluca Tognon, PhD role: CONTACT lat: 58.39118 lon: 13.84506 hasResults: False
<\|newrecord\|> nctId: NCT06374394 id: 217848 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 overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-12-03 date: 2025-05-20 date: 2024-04-18 date: 2024-04-18 name: GlaxoSmithKline class: INDUSTRY 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. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE maskingDescription: Click here to enter text. count: 850 type: ESTIMATED name: RSVPreF3 OA investigational vaccine name: COVID-19 mRNA vaccine measure: RSV-A neutralization titers measure: RSV-B neutralization titers measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein measure: RSV-A neutralization titers expressed as GMT measure: RSV-A neutralization titers expressed as Mean Geometric Increase (MGI) measure: RSV-A neutralization titers expressed as Seroresponse Rate (SRR) measure: Percentage of participants having RSV-A neutralizing titers >= assay cut-off value measure: RSV-B neutralization titers expressed as GMT measure: RSV-B neutralization titers expressed as MGI measure: RSV-B neutralization titers expressed as SRR measure: Percentage of participants having RSV-B neutralizing titers >= assay cut-off value measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI measure: Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value measure: Percentage of participants reporting each solicited administration site event measure: Percentage of participants reporting each solicited systemic event measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting serious adverse events (SAEs) measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs) sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Coral Gables state: Florida zip: 33134 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jeffrey B. Rosen role: PRINCIPAL_INVESTIGATOR lat: 25.72149 lon: -80.26838 facility: GSK Investigational Site city: Savannah state: Georgia zip: 31406 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Paul Bradley role: PRINCIPAL_INVESTIGATOR lat: 32.08354 lon: -81.09983 facility: GSK Investigational Site city: Evansville state: Indiana zip: 47714 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Hubert Sulit Reyes role: PRINCIPAL_INVESTIGATOR lat: 37.97476 lon: -87.55585 facility: GSK Investigational Site city: Omaha state: Nebraska zip: 68134 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Brandon James Essink role: PRINCIPAL_INVESTIGATOR lat: 41.25626 lon: -95.94043 facility: GSK Investigational Site city: Secaucus state: New Jersey zip: 07094 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Johnathan Blizzard role: PRINCIPAL_INVESTIGATOR lat: 40.78955 lon: -74.05653 facility: GSK Investigational Site city: Rochester state: New York zip: 14609 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Patrick Connors role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: GSK Investigational Site city: Winston-Salem state: North Carolina zip: 27103 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jonathan Paul Wilson role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: GSK Investigational Site city: North Charleston state: South Carolina zip: 29405 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kelly Morales role: PRINCIPAL_INVESTIGATOR lat: 32.85462 lon: -79.97481 facility: GSK Investigational Site city: Newport News state: Virginia zip: 23606 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: George H Freeman role: PRINCIPAL_INVESTIGATOR lat: 37.08339 lon: -76.46965 facility: GSK Investigational Site city: Antwerpen zip: 2000 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yven Van Herrewege role: PRINCIPAL_INVESTIGATOR lat: 51.21989 lon: 4.40346 facility: GSK Investigational Site city: Edegem zip: 2650 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Nikita Hanning role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 facility: GSK Investigational Site city: Gent zip: 9000 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Isabel Leroux-Roels role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: GSK Investigational Site city: Kluisbergen zip: 9690 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Klaas Vercruysse role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Mechelen zip: 2800 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Claudia Cornelis role: PRINCIPAL_INVESTIGATOR lat: 51.02574 lon: 4.47762 facility: GSK Investigational Site city: Breda zip: 4818 CK country: Netherlands name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Simone van der Sar role: PRINCIPAL_INVESTIGATOR lat: 51.58656 lon: 4.77596 facility: GSK Investigational Site city: Enschede zip: 7512 KZ country: Netherlands name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Paolo Zocca role: PRINCIPAL_INVESTIGATOR lat: 52.21833 lon: 6.89583 facility: GSK Investigational Site city: Utrecht zip: 3584 BA country: Netherlands name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Marc Bonten role: PRINCIPAL_INVESTIGATOR lat: 52.09083 lon: 5.12222 facility: GSK Investigational Site city: Zutphen zip: 7207 AE country: Netherlands name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Martijn Goosens role: PRINCIPAL_INVESTIGATOR lat: 52.13833 lon: 6.20139 facility: GSK Investigational Site city: Boadilla del Monte state: Madrid zip: 28660 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Silvina Laura Natalini role: PRINCIPAL_INVESTIGATOR lat: 40.405 lon: -3.87835 facility: GSK Investigational Site city: Barcelona zip: 08023 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Fernando Cereto Castro role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site city: Barcelona zip: 08907 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Cristina Masuet Aumatell role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site city: Coruña zip: 15006 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Maria Jose Pereira Rodriguez role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: GSK Investigational Site city: Madrid zip: 28040 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Helena Moza Moríñigo role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site city: Madrid zip: 28041 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Pablo Rojo Conejo role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site city: Majadahonda zip: 28222 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jenry Borda Olivas role: PRINCIPAL_INVESTIGATOR lat: 40.47353 lon: -3.87182 hasResults: False
<\|newrecord\|> nctId: NCT06374381 id: 854990 briefTitle: PEACE for ImPACT Study overallStatus: ENROLLING_BY_INVITATION date: 2023-12-01 date: 2027-11 date: 2027-11 date: 2024-04-18 date: 2024-04-18 name: University of Pennsylvania class: OTHER name: Institute of Education Sciences name: Michigan State University 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. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessors will be masked to randomization condition. whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: PEACE Online Resources name: PEACE Weekly Group Facilitation name: PEACE Weekly Individual Facilitation measure: Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool measure: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) measure: Autism Impact Measure (AIM) measure: Social Communication Checklist (SCC) measure: Confusion, Hubbub, and Order Scale (CHAOS) measure: Acceptability, Appropriateness, and Adoption measure measure: Qualitative Interview sex: ALL minimumAge: 12 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Mental Health city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 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
<\|newrecord\|> nctId: NCT06374368 id: JID-SURG briefTitle: Small Bowel Diversion overallStatus: ACTIVE_NOT_RECRUITING date: 2019-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-24 name: University of Ostrava class: OTHER name: Institute for Clinical and Experimental Medicine name: Vitkovice Hospital 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. conditions: Obesity conditions: Type2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: jejuno-ileal diversion name: jejuno-colic diversion measure: Total body weight loss measure: Glycated hemoglobin loss measure: Diabetes medication loss measure: Total cholesterol loss measure: Low density lipoprotein loss measure: High density lipoprotein loss measure: Leptin metabolism evaluation measure: Adiponectin metabolism evaluation measure: Change from baseline quality of life-Lite measure: Change from baseline quality of life - Sort Form Survey sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Ostrava, Faculty of Medicine city: Ostrava country: Czechia lat: 49.83465 lon: 18.28204 hasResults: False
<\|newrecord\|> nctId: NCT06374355 id: Semibranch_Retro briefTitle: Semibranch Registry - Retrospective overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-04 date: 2030-10 date: 2024-04-18 date: 2024-04-22 name: University Hospital Muenster class: OTHER 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. conditions: Aortic Aneurysm conditions: Endovascular Aortic Repair conditions: Stent-Graft Endoleak studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Semibranch CMD branched aortic stentgraft measure: Freedom from target vessel instability measure: Mortality measure: Technical success measure: Morbidity measure: Freedom of Endoleak type I and III measure: Long term mortality measure: Branch patency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Muenster University Hospital city: Münster country: Germany lat: 51.96236 lon: 7.62571 hasResults: False
<\|newrecord\|> nctId: NCT06374342 id: SO01-TK-SUBSTITUTES briefTitle: BONE SUBSTITUTES OUTCOMES overallStatus: RECRUITING date: 2021-09-16 date: 2026-09-16 date: 2032-09-30 date: 2024-04-18 date: 2024-04-18 name: Teknimed class: INDUSTRY 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. conditions: Bone Resorption studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 425 type: ESTIMATED name: Bone defect name: Spine fusion name: Cage filling measure: Successful bone repair measure: Alleviation of Pain measure: Bone reconstruction measure: Well-being measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pôle Rachis Hôpital Privé d'Eure et Loir status: RECRUITING city: Mainvilliers state: Eure Et Loir zip: 28300 country: France name: Jean MEYBLUM, MD role: CONTACT email: jeanmeyblum@hotmail.com name: Jean MEYBLUM, MD role: PRINCIPAL_INVESTIGATOR lat: 48.45003 lon: 1.45607 facility: Hôpital Joseph Ducuing status: RECRUITING city: Toulouse state: Haute Garonne zip: 31000 country: France name: Gérard GIORDANO, MD role: CONTACT email: ortho.giordano@gmail.com name: Gérard GIORDANO, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Clinique Médipole Garonne status: RECRUITING city: Toulouse state: Haute Garonne zip: 31100 country: France name: Dominique VARDON, MD role: CONTACT email: dr-dominique.vardon@orange.fr name: Dominique VARDON, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: CHRU Brabois status: RECRUITING city: Nancy state: Meurthe Et Moselle zip: 54000 country: France name: Didier MAINARD, MD role: CONTACT email: didier.mainard@univ-lorraine.fr name: Didier MAINARD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Clinique du Pré status: RECRUITING city: Le Mans state: Sarthe zip: 72000 country: France name: Jean-Patrick RAKOVER, MD role: CONTACT phone: 02 43 77 54 21 email: jeanpatrickrakover@me.com name: Jean-Patrick RAKOVER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.0 lon: 0.2 facility: OCM Klinik GmbH status: RECRUITING city: München state: Bavière zip: D-81369 country: Germany name: Markus SCHROEDEL, MD role: CONTACT email: Markus.schroedel@ocm-muenchen.de name: Markus SCHROEDEL, MD role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 hasResults: False
<\|newrecord\|> nctId: NCT06374329 id: S68717 briefTitle: Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines acronym: RCTcanines2 overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-01 date: 2027-08-01 date: 2024-04-18 date: 2024-04-24 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Karolinska Institutet name: University of Copenhagen name: Palacky University name: The University of Hong Kong 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. conditions: Tooth Impaction conditions: Canine Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Interceptive Slow Maxillary Expansion with removable plates measure: Position of the impacted maxillary canine towards the dental midline (3^ML). measure: Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure) sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06374316 id: 2302888 briefTitle: Air Purifiers in Classrooms for Infection Control - a Pilot Study overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-05-01 date: 2024-05-01 date: 2024-04-18 date: 2024-04-18 name: Norwegian Institute of Public Health class: OTHER_GOV name: SINTEF Health Research 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. conditions: Feasibility conditions: Acceptability studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 6 type: ACTUAL name: Ceiling-Mounted Air Purifiers name: Portable Air Purifiers name: Portable or Ceiling Mounted Air Purifiers measure: Effectiveness of air purifiers versus no air purifier on improving air quality in classrooms. measure: Effectiveness of ceiling mounted versus portable air purifier on improving air quality in classrooms. measure: Acceptability of having Air Purifiers in Classrooms measure: Untoward events when installing air purifiers in classrooms measure: Untoward events when running air purifiers in classrooms measure: How student absence data can be collected from existing school registration systems. measure: Response rate of class teachers to the study surveys. measure: Response rate of students/their guardians to study surveys. measure: Proportion of absence due to respiratory disease. measure: Absence frequency among students sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Norwegian Institute of Public Health city: Oslo country: Norway lat: 59.91273 lon: 10.74609 hasResults: False
<\|newrecord\|> nctId: NCT06374303 id: CHRBSS 00001940 briefTitle: Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder: A Randomized Clinical Trial overallStatus: COMPLETED date: 2022-04-19 date: 2023-11-20 date: 2023-11-20 date: 2024-04-18 date: 2024-04-18 name: University of Vermont class: OTHER 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. conditions: Food Security studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, parallel-groups pilot study primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: NE + Meal Delivery (NE+MD) intervention measure: Household food insecurity Survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vermont city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 hasResults: False
<\|newrecord\|> nctId: NCT06374290 id: HSC-MS-24-0024 briefTitle: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-15 date: 2025-04-15 date: 2024-04-18 date: 2024-04-18 name: The University of Texas Health Science Center, Houston class: OTHER 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. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Naltrexone (Vivitrol) name: Bupropion measure: Feasibility as assessed by the percentage of participants that enroll in the study measure: Percentage of participants that complete 3 weeks of treatment measure: Safety as assessed by the percentage of participants that show no serious adverse events measure: Change in number of cigarettes smoked per day (CPD) measure: Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU) measure: Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT) measure: Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Jin H Yoon, PhD role: CONTACT phone: 713-486-2800 email: jin.ho.yoon@uth.tmc.edu name: Jessica Vincent role: CONTACT phone: (713) 486-2645 email: Jessica.N.Vincent@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06374277 id: 23-09339-IAA briefTitle: Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence acronym: MedAAAction overallStatus: RECRUITING date: 2024-04-06 date: 2027-09-30 date: 2028-01-31 date: 2024-04-18 date: 2024-04-25 name: University of Tennessee class: OTHER name: Sponsor GmbH 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. 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 studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 388 type: ESTIMATED name: Med AAAction intervention measure: Adherence to chronic disease medications measure: Health care utilization measure: Cost measure: Qualitative Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Tennessee Medical Center status: NOT_YET_RECRUITING city: Knoxville state: Tennessee zip: 37920 country: United States name: Shauntá M Chamberlin role: CONTACT phone: 865-305-5061 email: schamberlin@utmck.edu lat: 35.96064 lon: -83.92074 facility: University of Tennessee Health Science Center/Regional One Health status: RECRUITING city: Memphis state: Tennessee zip: 38103 country: United States name: Kay Ryan, PharmD role: CONTACT phone: 901-545-7840 email: kryan@regionalonehealth.org lat: 35.14953 lon: -90.04898 hasResults: False
<\|newrecord\|> nctId: NCT06374264 id: NM100 briefTitle: Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder acronym: aNiMatO overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-24 name: MedRhythms, Inc. class: INDUSTRY name: Alexion Pharmaceuticals, Inc. 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. conditions: Neuromyelitis Optica Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: MR-C-014 measure: Participant acceptability of MR-C-014 measure: Number of device-related adverse events (AEs) measure: 6-Minute Walk Test (6MWT) measure: Number of walks per week measure: Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors measure: Spatiotemporal variability of gait as measured by the MR-C-014 sensors measure: Stride length as measured by the MR-C-014 sensors measure: Falls Efficacy Scale-International (FES-I) measure: Number of falls as recorded in Falls Diary measure: Multiple Sclerosis Walking Scale (MSWS-12) measure: Visual Analogue Scale (VAS) measure: Generalized Anxiety Disorder-7 (GAD-7) measure: 9 Hole Peg Test (9-HPT) measure: Symbol Digit Modalities Test (SDMT) measure: Fatigue Scale for Motor and Cognitive Functions (FSMC) measure: Expanded Disability Status Scale (EDSS) Ambulation Score measure: Activities-Specific Balance Confidence Scale (ABC) measure: Patient Experience and Satisfaction Survey sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Eric Klawiter, MD role: CONTACT email: EKLAWITER@mgh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06374251 id: 0S-23-2 id: NCI-2023-08890 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 0S-23-2 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers overallStatus: RECRUITING date: 2023-09-27 date: 2024-09-27 date: 2025-03-27 date: 2024-04-18 date: 2024-04-18 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) 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. conditions: Malignant Digestive System Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 10 type: ESTIMATED name: Discussion name: Interview name: Survey Administration measure: Number of participants who complete the narrative medicine sessions measure: Change in well-being scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USC / Norris Comprehensive Cancer Center status: RECRUITING city: Los Angeles state: California zip: 90033 country: United States name: Eve L. Makoff role: CONTACT phone: 323-865-3000 email: makoff@usc.edu name: Eve L. Makoff role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06374238 id: UG3HL165839 type: NIH link: https://reporter.nih.gov/quickSearch/UG3HL165839 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 overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-12 date: 2028-05 date: 2024-04-18 date: 2024-04-18 name: University of Pittsburgh class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) 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. conditions: Pain conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 470 type: ESTIMATED name: CBT+ Health coach name: CBT w/o Health Coach ( self-guided) name: Usual Care 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 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 measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain 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 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 measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain sex: ALL minimumAge: 16 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06374225 id: 23-0866 briefTitle: Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention acronym: SAVE-O2 AI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12-31 date: 2026-05-01 date: 2024-04-18 date: 2024-04-18 name: University of Colorado, Denver class: OTHER name: United States Department of Defense name: O2matic ApS name: IDTS Medical, Inc. 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%). conditions: Critical Illness conditions: Wounds and Injury conditions: Disease Attributes conditions: Pathologic Processes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Automated Titration (O2matic) measure: Proportion of time spent within the targeted normoxemia range measure: Amount of supplemental oxygen administered measure: Proportion of time spent in hypoxemia (SpO2<88%) measure: Proportion of time spent in hyperoxemia (SpO2 >96%) measure: Time to Room Air sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Oregon Health and Sciences University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 hasResults: False
<\|newrecord\|> nctId: NCT06374212 id: 24-0191 briefTitle: Anifrolumab for Hidradenitis Suppurativa overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: University of North Carolina, Chapel Hill class: OTHER name: AstraZeneca 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 conditions: Hidradenitis Suppurativa conditions: Acne Inversa conditions: Hidradenitis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All study participants, if eligible, will receive the study drug (anifrolumab). primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Anifrolumab measure: Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks measure: Percentage of participants achieving a HiSCR 50 at 24 weeks measure: Percentage of participants who achieve a Hidradenitis Suppurativa Clinical Response score of 75 (HiSCR 75) at 12 weeks measure: Percentage of participants who achieve a HiSCR 75 at 24 weeks of treatment. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Dermatology and Skin Cancer Center city: Chapel Hill state: North Carolina zip: 27516 country: United States name: Erika Hanami role: CONTACT phone: 984-974-3682 email: erika_hanami@med.unc.edu name: Christopher Sayed, MD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
<\|newrecord\|> nctId: NCT06374199 id: 24-0181 briefTitle: Med-South Lifestyle Program for Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-18 date: 2024-04-18 name: University of North Carolina, Chapel Hill class: OTHER 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 conditions: Pregnancy Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Standard 2 group parallel randomized trial study design. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Med-South Lifestyle Intervention for Pregnancy--Arm 1 name: Med-South Lifestyle Intervention for Pregnancy--Arm 2 measure: Percent that would recommend this program to others who are pregnancy measure: Percent of participants who take part in the 10 study counseling sessions measure: Maternal diet quality measure: skin carotenoids sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Center for Health Promotion and Disease Prevention/UNC-Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 hasResults: False
<\|newrecord\|> nctId: NCT06374186 id: 2095072 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 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-04-08 date: 2024-04-18 date: 2024-04-18 name: University of Missouri, Kansas City class: OTHER 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. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA 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 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 count: 40 type: ESTIMATED name: Behavioral Intervention with financial rewards and coaching name: Control measure: Time in target blood glucose range per CGM measure: Hemoglobin A1C measure: Diabetes Quality of Life Brief Inventory measure: Diabetes Distress Scale measure: PROMIS Medication Adherence Scale measure: Perceived Dietary Adherence Questionnaire measure: Motivation and Confidence Ruler sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Missouri - Kansas City School of Medicine city: Kansas City state: Missouri zip: 64108 country: United States name: Carrie R Kriz role: CONTACT phone: 816-512-7473 email: mckinleycr@umkc.edu name: Jared M Bruce, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 hasResults: False
<\|newrecord\|> nctId: NCT06374173 id: TGI6-T1-01 briefTitle: A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-01-03 date: 2027-09 date: 2027-12 date: 2024-04-18 date: 2024-04-18 name: Hefei TG ImmunoPharma Co., Ltd. class: OTHER briefSummary: A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors conditions: Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 123 type: ESTIMATED name: TGI-6 Injection measure: Dose-limiting Toxicity (DLT) measure: Dose-Finding measure: Frequency and Severity of Adverse Events (AE) measure: Pharmacokinetics of TGI-6 measure: Pharmacokinetics of TGI-6 measure: Number of subjects with Anti-TGI-6 antibody positive measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing country: China name: Hang Zhou role: CONTACT email: hang.zhou@tgimmunopharma.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06374160 id: 70115371 briefTitle: Exercise in Patients With Advanced Non-small Cell Lung Cancer acronym: BREATH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-08-31 date: 2024-04-18 date: 2024-04-18 name: University Hospital, Essen class: OTHER name: German Cancer Aid 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. 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 studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 104 type: ESTIMATED name: Exercise intervention measure: Maximum oxygen uptake (VO2 peak [ml/min/kg]) measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F) measure: European Organisation for Research and Treatment of Cancer (EORTC QLQ C30) measure: European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13) measure: Arterial blood pressure measure: Change in ECG measure: Adherence to exercise intervention measure: Drop-out rate measure: Recruitment rate measure: Serious Adverse Event/Adverse Events measure: Therapy response measure: Treatment Toxicity measure: Treatment scheme measure: NT-pro-BNP measure: High sensitive troponin I measure: Erythrocytes measure: Hemoglobin measure: Leukocytes measure: Lymphocytes measure: Neutrophils measure: CRP measure: CYRFRA 21-1 measure: Physical function (Hypothetical One-repetition maximum) measure: Blood gas analysis pH value measure: Blood gas analysis (PAO2) measure: Blood gas analysis (SaO2) measure: Blood gas analysis (PCO2) measure: Blood gas analysis (BE) measure: Blood gas analysis (HCO3) measure: Blood gas analysis (SBCe) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT 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 name: Mitra Tewes, PD. Dr. role: CONTACT email: mitra.tewes@uk-essen.de name: Nico De Lazzari, M. Sc. role: CONTACT phone: +49 201 723-82035 email: nico.delazzari@uk-essen.de name: Mitra Tewes, PD. Dr. role: PRINCIPAL_INVESTIGATOR name: Marcel Wiesweg, PD. Dr. role: SUB_INVESTIGATOR name: Miriam Götte, PD. Dr. role: SUB_INVESTIGATOR name: Eva-Maria Hüßler, Dr. role: SUB_INVESTIGATOR name: Andreas Stang, Prof. Dr. role: SUB_INVESTIGATOR name: Matthias Totzeck, Prof. Dr. role: SUB_INVESTIGATOR lat: 51.45657 lon: 7.01228 hasResults: False
<\|newrecord\|> nctId: NCT06374147 id: STUDY00004467 briefTitle: "Prapela® SVS Incubator Pad for Apnea of Prematurity acronym: Prapela AOP overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-06-01 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Tufts Medical Center class: OTHER name: University of Alabama at Birmingham 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. conditions: Apnea of Prematurity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: SVS mattress measure: Reduce apnea events by 30% or more in the three days after study entry measure: Reduce the number of days caffeine citrate is used after study entry by 3 days or more measure: Reduce the number of days of respiratory support by 3 days or more sex: ALL minimumAge: 0 Days maximumAge: 3 Months stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06374134 id: STUDY00004835 briefTitle: The Impact of Community and Patient Engagement Practices on Vaccine Confidence in the United States overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-11 date: 2025-02 date: 2024-04-18 date: 2024-04-18 name: Tufts University class: OTHER name: Merck Sharp & Dohme LLC 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. conditions: Vaccine Hesitancy studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: Community Engagement Practice name: Patient-Centric Protocol Element measure: Units of Vaccine Dispensed sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06374121 id: POWER briefTitle: Kidney Perfusion With or Without Absorption acronym: POWER overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-18 date: 2024-04-18 name: Mario Negri Institute for Pharmacological Research class: OTHER 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. conditions: Kidney Replacement studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 10 type: ESTIMATED name: PerSorb cartridge (CytoSorbents Europe GmbH, Germany) name: PerLife PerKidney measure: Oxidative stress markers measure: Acute kidney injury markers measure: Inflammatory cytokine markers measure: Complement activation markers measure: Vascular resistances measure: Perfusate sample collection sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT 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 lat: 45.69601 lon: 9.66721 hasResults: False
<\|newrecord\|> nctId: NCT06374108 id: Neuro_Exercise briefTitle: Resistance Training and Corticospinal Excitability in Multiple Sclerosis acronym: NEXIMS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-05-31 date: 2024-04-18 date: 2024-04-29 name: University of Aarhus class: OTHER name: Aarhus University Hospital name: University of Copenhagen 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. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Progressive resistance training measure: MEP/Mmax ratio measure: Muscle strength measure: Voluntary activation I measure: Voluntary activation II measure: Force Steadiness measure: Rate of Force Developement measure: Ultrasound measure: Resting Motor Threshold (rMT) measure: Active Motor Threshold (aMT) measure: MEP latency (resting) measure: MEP latency (active) measure: MEP amplitude (resting) measure: MEP amplitude (active) measure: Short-interval intracortical Inhibition (SICI) measure: Intracortical facilitation (ICF) measure: Cortical Silent Period (CSP) measure: Central Motor Conduction Time (CMCT) measure: EEG-EMG coherence (0-1) measure: Timed 25 feet walk test (T25FWT) measure: 6-minute walk test (6MWT) measure: Six spot step test (SSST) measure: 5 sit-to-stand (5STS) measure: 9-step stair ascend (9SSA) measure: Patient determined disease steps (PDDS) measure: Multiple Sclerosis Walking Scale (MSWS) measure: Modified fatigue impact scale (MFIS) measure: MS impact scale (MSIS) measure: Falls-efficacy scale - international (FES-1) measure: The Physical Activity Enjoyment Scale (PACES) measure: Brief pain inventory (BPI) measure: Baecke physical activity measure: Accelerometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06374095 id: ONSET briefTitle: 1 vs 7 RATG Infusions in Renal Transplantation acronym: ONSET overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-18 date: 2024-04-18 name: Mario Negri Institute for Pharmacological Research class: OTHER 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. conditions: Kidney Replacement studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 75 type: ESTIMATED name: RATG name: Basiliximab measure: Incidence of thrombocytopenia and/or leukopenia measure: Occurrence of anemia measure: Occurrence of viral infections measure: Occurrence of pneumonia measure: Occurrence of opportunistic infections measure: Occurrence of delayed graft function measure: Occurrence of allograft rejection measure: Occurrence of biopsy proven rejection measure: Survival measure: Platelet and WBC counts measure: Creatinine levels measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST HPG23 - Unità di Nefrologia city: Bergamo state: BG zip: 24127 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False
<\|newrecord\|> nctId: NCT06374082 id: HKWC-2024-179 briefTitle: Instant Messaging Reinforcement for Smoking Cessation Counseling Training overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-10 date: 2024-04-18 date: 2024-04-18 name: The University of Hong Kong class: OTHER 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. conditions: Smoking Cessation Counseling Ability conditions: Smoking Cessation Counseling Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER 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 count: 60 type: ESTIMATED name: WhatsApp message measure: SCC practice measurement measure: SCC knowledge score measure: SCC attitude score measure: SCC practice score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hong KongLKS Faculty of Medicine city: Hong Kong zip: 00 country: Hong Kong name: Derek Yee Tak Cheung, PhD role: CONTACT phone: +852 3917 6652 email: derekcheung@hku.hk name: Derek Yee Tak Cheung, PhD role: PRINCIPAL_INVESTIGATOR name: Xiaoyun Xie, PhDcandidate role: SUB_INVESTIGATOR name: Guowen Zhang, DN student role: SUB_INVESTIGATOR name: Tzu Tsun Luk, PhD role: SUB_INVESTIGATOR name: Man Ping Wang, PhD role: SUB_INVESTIGATOR name: Siu Chee Chan, PhD role: SUB_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06374069 id: NL81887.058.23 briefTitle: Longevity Families of the Netherlands acronym: LOF-NL overallStatus: RECRUITING date: 2023-09-11 date: 2026-12 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: Leiden University Medical Center class: OTHER name: Jacobijn Gussekloo, Prof. dr. name: Simon P. Mooijaart, Prof. dr. 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. conditions: Longevity conditions: Familial Longevity conditions: Extreme Longevity conditions: Aging studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: Identifying the genetic variants of Familial Longevity measure: Studying the environmental factor of Familial Longevity through questionnaires and its interaction with the genetic component sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT facility: Leiden University Medical Center status: RECRUITING city: Leiden state: South Holland zip: 2333ZA country: Netherlands lat: 52.15833 lon: 4.49306 hasResults: False
<\|newrecord\|> nctId: NCT06374056 id: 0458 briefTitle: Kintsugi Voice Device Pilot Study overallStatus: RECRUITING date: 2024-03-22 date: 2025-03-22 date: 2025-07-22 date: 2024-04-18 date: 2024-04-19 name: Kintsugi Mindful Wellness, Inc. class: INDUSTRY name: Sonar Strategies name: Vituity Psychiatry 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. conditions: Depression conditions: Depression Moderate conditions: Depression Severe conditions: Depression Mild studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Kintsugi Voice Device measure: Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5 measure: PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5 measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9 sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kintsugi Mindful Wellness Inc. status: RECRUITING city: Berkeley state: California zip: 94707 country: United States name: Alexa A Mazur, BA role: CONTACT phone: 610-724-1431 email: alexa@kintsugihealth.com name: Victoria Graham, MS role: CONTACT email: victoria@kintsugihealth.com name: Albert Ihochi, MBA role: PRINCIPAL_INVESTIGATOR name: Prentice Tom, MD role: SUB_INVESTIGATOR lat: 37.87159 lon: -122.27275 hasResults: False
<\|newrecord\|> nctId: NCT06374043 id: 2020/1002 briefTitle: Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin. acronym: @HOME overallStatus: COMPLETED date: 2021-05-11 date: 2022-09-13 date: 2022-09-13 date: 2024-04-18 date: 2024-04-22 name: University Medical Center Groningen class: OTHER name: AstraZeneca 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 weight
Participants 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. 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 studyType: INTERVENTIONAL phases: PHASE4 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 masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 20 type: ACTUAL name: Dapagliflozin 10mg Tab name: Placebo name: Withings BPM Connect name: Withings Body+ name: Hem-Col Capillary Blood Collection Device name: MEMS (Medication Electronic Monitoring System) Cap name: Questionnaire: participants' perspectives toward remote data collection measure: UACR response measure: Systolic blood pressure response measure: Body weight response measure: eGFR response measure: Fasting plasma glucose response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuisgroep Twente city: Almelo country: Netherlands lat: 52.35667 lon: 6.6625 facility: University Medical Center Groningen city: Groningen country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False
<\|newrecord\|> nctId: NCT06374030 id: EDSAM2024 briefTitle: Retrospective Study of Airway Management in Dutch ED's overallStatus: ACTIVE_NOT_RECRUITING date: 2019-01-01 date: 2023-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Medical Centre Leeuwarden class: OTHER name: VieCuri Medical Centre name: Catharina Ziekenhuis Eindhoven name: Rijnstate Hospital name: Zuyderland Medical Centre 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. conditions: Endotracheal Intubation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Endotracheal intubation measure: Different complications of endotracheal intubation measure: Intubator characteristics measure: Indication for intubation measure: Sedation agent used measure: Paralytic agent used measure: Sedative agent after intubation measure: Method of intubation measure: Patient characteristics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Leeuwarden Medical Centre city: Leeuwarden zip: 8934AD country: Netherlands lat: 53.20139 lon: 5.80859 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
<\|newrecord\|> nctId: NCT06374017 id: N-258-2023 briefTitle: Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response overallStatus: RECRUITING date: 2023-09-20 date: 2024-04-30 date: 2024-05-10 date: 2024-04-18 date: 2024-04-18 name: Kasr El Aini Hospital class: OTHER 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 , conditions: To Measure Systolic Blood Pressure Postintubation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Normal saline, Lidocaine, dexmetomidine measure: To measure systolic blood pressure immediately after intubation. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University hospitals status: RECRUITING city: Cairo zip: 11559 country: Egypt name: Dina M Mohamed, MD role: CONTACT phone: 01005249134 phoneExt: MD email: Dinamahmoud@kasralainy.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06374004 id: HU-FTR-MC-01 briefTitle: The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome overallStatus: ENROLLING_BY_INVITATION date: 2024-04-10 date: 2024-07-05 date: 2024-07-05 date: 2024-04-18 date: 2024-04-18 name: Hacettepe University class: OTHER 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. conditions: Subacromial Pain Syndrome studyType: INTERVENTIONAL phases: NA 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 masking: SINGLE maskingDescription: Participants will be randomly divided into two groups and participants will not know which group participants are in. whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Exercise Group name: Thoracic Mobilization Group measure: Electromyography (EMG) measure: Acromiohumeral Distance (AHD) measure: Muscle Tone measure: Functional Activity Level measure: Pain Intensity sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06373991 id: EDI-901-SLE01 briefTitle: A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus overallStatus: RECRUITING date: 2024-04-24 date: 2027-04-30 date: 2027-04-30 date: 2024-04-18 date: 2024-04-29 name: EdiGene Inc. class: INDUSTRY name: The First Affiliated Hospital of Henan University of Science and Technology name: Changping Laboratory 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. conditions: Lupus Erythematosus, Systemic studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: ATHENA CAR-T name: Fludarabine name: Cyclophosphamide measure: Dose Limiting Toxicity measure: Frequency of AEs, SAEs, lab abnormalities, AESIs measure: Efficacy: Percent of patients achieved SRI-4 measure: Efficacy: Patients SLEDAI-2000 change compared with baseline measure: Efficacy: Patients BILAG-2004 change compared with baseline measure: Efficacy: Percent of patients' PGA not worsen measure: Percent of patients responded by BILAG-2004 measure: Efficacy: Immunologic parameters measure: Efficacy: Immunologic parameters (cont) measure: PK characteristics measure: PK characteristics (cont) measure: PK characteristics (cont) measure: PD characteristics measure: PD characteristics (cont) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan zip: 471003 country: China name: Muchen Liu role: CONTACT phone: (86)-13663884080 lat: 34.68361 lon: 112.45361 hasResults: False
<\|newrecord\|> nctId: NCT06373978 id: 24-307 briefTitle: NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-18 date: 2024-04-18 name: The Cleveland Clinic class: OTHER 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. conditions: Elbow Pain conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE4 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 masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Diclofenac name: Tramadol measure: Number of pills taken measure: Non narcotic use sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Florida city: Coral Springs state: Florida zip: 33067 country: United States name: Jennifer Baldwin role: CONTACT phone: 216-390-5833 email: baldwij3@ccf.org name: Alison Klika role: CONTACT phone: 216 444-4954 email: klikaa@ccf.org name: Michael Dakkak, DO role: PRINCIPAL_INVESTIGATOR lat: 26.27119 lon: -80.2706 facility: The Cleveland Clinic Ohio city: Avon state: Ohio zip: 44011 country: United States name: Jennifer Baldwin role: CONTACT phone: 216-390-5833 email: baldwij3@ccf.org name: Jason Genin, DO role: SUB_INVESTIGATOR name: Vikas Patel, DO role: SUB_INVESTIGATOR lat: 41.45171 lon: -82.03542 hasResults: False
<\|newrecord\|> nctId: NCT06373965 id: B2024-000 briefTitle: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI) overallStatus: NOT_YET_RECRUITING date: 2024-05-19 date: 2025-01-06 date: 2025-02-18 date: 2024-04-18 date: 2024-04-18 name: University of Connecticut class: OTHER name: University of Malaya 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. conditions: HIV Prevention Program studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Online to offline counseling measure: HIVST uptake measure: Linkage to PrEP measure: Linkage to HIV treatment services sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre of Excellence For Research in AIDS (CERiA) city: Kuala Lumpur country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False
<\|newrecord\|> nctId: NCT06373952 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 overallStatus: NOT_YET_RECRUITING date: 2024-05-19 date: 2025-01-06 date: 2025-02-18 date: 2024-04-18 date: 2024-04-22 name: University of Connecticut class: OTHER name: University of Malaya 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. conditions: HIV Prevention Program studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 78 type: ESTIMATED name: Online to offline counseling measure: HIVST uptake measure: Linkage to PrEP measure: Linkage to HIV treatment services sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre of Excellence For Research in AIDS (CERiA) city: Kuala Lumpur country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False
<\|newrecord\|> nctId: NCT06373939 id: Pneumoscope study briefTitle: Performance and Safety of the Pneumoscope Device in Adults and Children overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Pediatric Clinical Research Platform class: OTHER name: University Hospital, Geneva 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. conditions: Respiratory Diseases conditions: Pneumonia conditions: Asthma conditions: Cyanotic Heart Disease studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 225 type: ESTIMATED name: Digital lung auscultation name: Pulse oximetry measurement name: Non invasive body temperature measurement measure: Evaluation of Pneumoscope's built-in sensors measure: Collect audio records of lung sounds for AI models training and sensor calibration measure: Pulse oximetry measure: Body temperature sex: ALL minimumAge: 1 Year stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Geneva University Hospitals city: Geneva zip: 1205 country: Switzerland name: Alain Gervaix, Prof role: CONTACT phone: (0)22 372 45 55 phoneExt: +41 email: Alain.Gervaix@hcuge.ch name: Johan Siebert, MD role: CONTACT phone: (0)79 553 40 72 phoneExt: +41 email: Johan.Siebert@hcuge.ch name: Johan N Siebert, MD role: PRINCIPAL_INVESTIGATOR name: Laurence Lacroix-Duccardonnoy, MD role: SUB_INVESTIGATOR name: Isabelle Ruchonnet-Métrailler, MD role: SUB_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False
<\|newrecord\|> nctId: NCT06373926 id: PI2019_843_0010 briefTitle: Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome acronym: MONOCYTAN overallStatus: RECRUITING date: 2023-03-28 date: 2025-03 date: 2025-03 date: 2024-04-18 date: 2024-04-18 name: Centre Hospitalier Universitaire, Amiens class: OTHER 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. conditions: Antiphospholipid Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: blood withdrawal measure: Cell membrane expression rate of ANXA2 on circulating monocytes in APS measure: Cellular expression of ANXA2 and S100A10 in APS patients measure: cell membrane expression of ANXA2 and S100A10 in APS patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens status: RECRUITING city: Amiens zip: 80054 country: France name: Valéry SALLE, MD role: CONTACT phone: +33 3 22 66 82 30 email: salle.valery@chu-amiens.fr lat: 49.9 lon: 2.3 hasResults: False
<\|newrecord\|> nctId: NCT06373913 id: MASP2NSRZL briefTitle: The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom acronym: PCSK9 overallStatus: RECRUITING date: 2023-06-01 date: 2027-07-30 date: 2028-07-30 date: 2024-04-18 date: 2024-04-18 name: Kolding Sygehus class: OTHER name: Odense University Hospital name: Vejle Hospital 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 controls
2. The level of PCSK9 in plasma correlates to the degree of proteinuria.
3. PCSK9 i increased in the kidney tissue of patients with NS
The 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. conditions: Hyperlipidemias conditions: Nephrotic Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED measure: Plasma PCSK9 correlated to the degree of protein in the urine measure: Degree of PCSK9 in kidney tissue measure: Localization of PCSK9 in kidney tissue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kolding Sygehus, Lillebælt Hospital status: RECRUITING city: Kolding zip: 6000 country: Denmark name: Rikke Z Langkilde, md, phd role: CONTACT phone: 004576362554 name: Anne D Thuesen, md, phd role: CONTACT phone: 004576360555 email: Anne.Daugaard.Thuesen2@rsyd.dk lat: 55.4904 lon: 9.47216 hasResults: False
<\|newrecord\|> nctId: NCT06373900 id: IndusH briefTitle: Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture. overallStatus: COMPLETED date: 2022-02-13 date: 2022-02-19 date: 2022-03-30 date: 2024-04-18 date: 2024-04-18 name: Indus Hospital and Health Network class: OTHER 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. conditions: Wound Heal conditions: Wound Dehiscence conditions: Wound Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: SNOS protocol whoMasked: PARTICIPANT count: 40 type: ACTUAL name: wound closure measure: Wound characteristics and complications measure: Wound Infection Grade measure: Hollander Cosmetic Wound Evaluation Score sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indus Hospital and Health Network city: Karachi state: Sindh zip: 74900 country: Pakistan lat: 24.8608 lon: 67.0104 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
<\|newrecord\|> nctId: NCT06373887 id: 2023-09-005A briefTitle: The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs) overallStatus: RECRUITING date: 2024-04-10 date: 2024-11-29 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV 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 . conditions: Weight Loss studyType: INTERVENTIONAL phases: NA 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 masking: NONE maskingDescription: Single-blinded count: 150 type: ESTIMATED name: plant-based Low carbohydrate diet name: plant-based Low low fat diet measure: Body weight loss/fat mass loss measure: microbiota change sex: ALL minimumAge: 20 Years maximumAge: 64 Years stdAges: ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei state: Beitou District zip: 11217 country: Taiwan name: Chun-Ying Wu role: CONTACT phone: +886-28712121 phoneExt: 4190 email: chptaiwan07@gmail.com name: HSIAO-PING CHEN role: CONTACT phone: +886-28712121 phoneExt: 4190 email: chptaiwan07@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False

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