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## Surgical Treatment of Fractures of the Dorso-lombar Spine - NCT ID: NCT06374472 - Study ID: IRB00001194 - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2022-01-01 - Lead Sponsor: Ibn Jazzar Hospital ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Osteosynthesis ### Outcomes Primary Outcomes - Age (in years) - Sex - Neurological status ( Frenkel classification) Secondary Outcomes ### Location - Facility: IBN jazzar hospital, Kairouan, N/A, 3190, Tunisia @@
## Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis - NCT ID: NCT06374459 - Study ID: 24-x109 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2031-11-30 - Lead Sponsor: Washington University School of Medicine ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Zumsemetinib - Capecitabine - Zoledronic acid - Denosumab ### Outcomes Primary Outcomes - Number of participants with adverse events (Phase Ib only) - Recommended phase II dose of zunsemetinib (Phase Ib only) - Percent change in serum CTX (Phase II only) - Progression-free survival (PFS) (Phase II only) Secondary Outcomes - Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase Ib only) - Treatment-induced changes in sCTX by clinical assay (Phase II only) - Objective response rate (ORR) (Phase II only) - Clinical benefit rate (Phase II only) - Overall survival (OS) (Phase II only) - Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase II only) - Treatment-induced changes in quality of life as measured by EORTC QLQ-C30 (Phase II only) - Treatment-induced changes in pain as measured by Brief Pain Inventory (BPI) (Phase II only) - Number of participants with adverse events (Phase II only) ### Location - Facility: The University of Kansas Cancer Center, Westwood, Kansas, 66205, United States @@
## Effect of Virtual Reality in Patients With Long Covid-19 - NCT ID: NCT06374446 - Study ID: 22-172 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-06-30 - Lead Sponsor: Istinye University ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Classical Treatment - Virtual Reality Combined with Classical Treatment - Virtual Reality - Control Group ### Outcomes Primary Outcomes - Fatigue - Kinesiophobia - Evaluation of Respiratory Function - Shuttle Walking Test - Endurance Shuttle Walking Test - Sit and Reach Test - Peripheral Muscle Strength - The Nottingham Health Profile - Dyspnea - Energy Consumption - Posture Analysis - Covid-19 Yorkshire Performance - FACIT Fatigue Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigating the Plasticity of Human Predictive Coding Through Neuromodulation - NCT ID: NCT06374433 - Study ID: PREDICOM-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Università Vita-Salute San Raffaele ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Occipital tACS at IAF-2Hz - Occipital tACS at IAF+2Hz - Frontal tACS at 4-7 Hz - Occipital tRNS - Frontal tRNS - Sham/placebo tACS - Sham/placebo tRNS ### Outcomes Primary Outcomes - Behavioral measures Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome - NCT ID: NCT06374420 - Study ID: MD.21.11.564 - Status: COMPLETED - Start Date: 2021-09-01 - Completion Date: 2024-04-01 - Lead Sponsor: Mansoura University ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - investigating pulmonary sequelae of covid-19. - investigating pulmonary sequelae of covid-19. Secondary Outcomes ### Location - Facility: Mansoura University, Mansoura, Dakhlia, 050, Egypt @@
## The MIND-GUT Digital Pilot Intervention Study - NCT ID: NCT06374407 - Study ID: GT-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: University of Skövde ### Study Description 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 - Depressive Symptoms - Anxiety - Stress - Eating Habit - Dysbiosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dietary intervention based on the MIND diet ### Outcomes Primary Outcomes - Program retention - Adherence - Acceptability - Study effectiveness: change in eating attitudes at follow-up - Study effectiveness: change in stress levels at follow-up - Study effectiveness: change in depression symptoms at follow-up - Study effectiveness: change in anxiety symtoms at follow-up - Study effectiveness: change in body weight at follow-up - Study effectiveness: change in % total fat mass at follow-up - Study effectiveness: change in % visceral fat mass at follow-up - Study effectiveness: change in waist circumference at follow-up - Study effectiveness: change in hip circumference at follow-up - Study effectiveness: change in microbiome variety at follow-up Secondary Outcomes ### Location - Facility: University of Skövde, Skövde, N/A, 54128, Sweden @@
## 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 - NCT ID: NCT06374394 - Study ID: 217848 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2025-05-20 - Lead Sponsor: GlaxoSmithKline ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - RSVPreF3 OA investigational vaccine - COVID-19 mRNA vaccine ### Outcomes Primary Outcomes - RSV-A neutralization titers - RSV-B neutralization titers - SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein Secondary Outcomes - RSV-A neutralization titers expressed as GMT - RSV-A neutralization titers expressed as Mean Geometric Increase (MGI) - RSV-A neutralization titers expressed as Seroresponse Rate (SRR) - Percentage of participants having RSV-A neutralizing titers >= assay cut-off value - RSV-B neutralization titers expressed as GMT - RSV-B neutralization titers expressed as MGI - RSV-B neutralization titers expressed as SRR - Percentage of participants having RSV-B neutralizing titers >= assay cut-off value - SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT - SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI - Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value - Percentage of participants reporting each solicited administration site event - Percentage of participants reporting each solicited systemic event - Percentage of participants reporting unsolicited adverse events (AEs) - Percentage of participants reporting serious adverse events (SAEs) - Percentage of participants reporting potential immune-mediated diseases (pIMDs) ### Location - Facility: GSK Investigational Site, Coral Gables, Florida, 33134, United States @@
## PEACE for ImPACT Study - NCT ID: NCT06374381 - Study ID: 854990 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-12-01 - Completion Date: 2027-11 - Lead Sponsor: University of Pennsylvania ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - PEACE Online Resources - PEACE Weekly Group Facilitation - PEACE Weekly Individual Facilitation ### Outcomes Primary Outcomes - Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool Secondary Outcomes - Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) - Autism Impact Measure (AIM) - Social Communication Checklist (SCC) - Confusion, Hubbub, and Order Scale (CHAOS) - Acceptability, Appropriateness, and Adoption measure - Qualitative Interview ### Location - Facility: Center for Mental Health, Philadelphia, Pennsylvania, 19104, United States @@
## Small Bowel Diversion - NCT ID: NCT06374368 - Study ID: JID-SURG - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of Ostrava ### Study Description 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 - Type2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - jejuno-ileal diversion - jejuno-colic diversion ### Outcomes Primary Outcomes - Total body weight loss - Glycated hemoglobin loss - Diabetes medication loss - Total cholesterol loss - Low density lipoprotein loss - High density lipoprotein loss - Leptin metabolism evaluation - Adiponectin metabolism evaluation Secondary Outcomes - Change from baseline quality of life-Lite - Change from baseline quality of life - Sort Form Survey ### Location - Facility: University of Ostrava, Faculty of Medicine, Ostrava, N/A, N/A, Czechia @@
## Semibranch Registry - Retrospective - NCT ID: NCT06374355 - Study ID: Semibranch_Retro - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2030-10 - Lead Sponsor: University Hospital Muenster ### Study Description 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 - Endovascular Aortic Repair - Stent-Graft Endoleak ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Semibranch CMD branched aortic stentgraft ### Outcomes Primary Outcomes - Freedom from target vessel instability - Mortality - Technical success Secondary Outcomes - Morbidity - Freedom of Endoleak type I and III - Long term mortality - Branch patency ### Location - Facility: Muenster University Hospital, Münster, N/A, N/A, Germany @@
## BONE SUBSTITUTES OUTCOMES - NCT ID: NCT06374342 - Study ID: SO01-TK-SUBSTITUTES - Status: RECRUITING - Start Date: 2021-09-16 - Completion Date: 2032-09-30 - Lead Sponsor: Teknimed ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bone defect - Spine fusion - Cage filling ### Outcomes Primary Outcomes - Successful bone repair Secondary Outcomes - Alleviation of Pain - Bone reconstruction - Well-being - Patient satisfaction ### Location - Facility: Pôle Rachis Hôpital Privé d'Eure et Loir, Mainvilliers, Eure Et Loir, 28300, France @@
## Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines - NCT ID: NCT06374329 - Study ID: S68717 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2027-08-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description 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 - Canine Teeth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Interceptive Slow Maxillary Expansion with removable plates ### Outcomes Primary Outcomes - Position of the impacted maxillary canine towards the dental midline (3^ML). Secondary Outcomes - Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Air Purifiers in Classrooms for Infection Control - a Pilot Study - NCT ID: NCT06374316 - Study ID: 2302888 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-05-01 - Lead Sponsor: Norwegian Institute of Public Health ### Study Description 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 - Acceptability ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Ceiling-Mounted Air Purifiers - Portable Air Purifiers - Portable or Ceiling Mounted Air Purifiers ### Outcomes Primary Outcomes - Effectiveness of air purifiers versus no air purifier on improving air quality in classrooms. - Effectiveness of ceiling mounted versus portable air purifier on improving air quality in classrooms. - Acceptability of having Air Purifiers in Classrooms - Untoward events when installing air purifiers in classrooms - Untoward events when running air purifiers in classrooms - How student absence data can be collected from existing school registration systems. Secondary Outcomes - Response rate of class teachers to the study surveys. - Response rate of students/their guardians to study surveys. - Proportion of absence due to respiratory disease. - Absence frequency among students ### Location - Facility: Norwegian Institute of Public Health, Oslo, N/A, N/A, Norway @@
## Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder: A Randomized Clinical Trial - NCT ID: NCT06374303 - Study ID: CHRBSS 00001940 - Status: COMPLETED - Start Date: 2022-04-19 - Completion Date: 2023-11-20 - Lead Sponsor: University of Vermont ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NE + Meal Delivery (NE+MD) intervention ### Outcomes Primary Outcomes - Household food insecurity Survey Secondary Outcomes ### Location - Facility: University of Vermont, Burlington, Vermont, 05401, United States @@
## Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia - NCT ID: NCT06374290 - Study ID: HSC-MS-24-0024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-15 - Lead Sponsor: The University of Texas Health Science Center, Houston ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Naltrexone (Vivitrol) - Bupropion ### Outcomes Primary Outcomes - Feasibility as assessed by the percentage of participants that enroll in the study - Percentage of participants that complete 3 weeks of treatment - Safety as assessed by the percentage of participants that show no serious adverse events Secondary Outcomes - Change in number of cigarettes smoked per day (CPD) - Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU) - Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT) - Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS) ### Location - Facility: The University of Texas health Science Center at Houston, Houston, Texas, 77030, United States @@
## Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence - NCT ID: NCT06374277 - Study ID: 23-09339-IAA - Status: RECRUITING - Start Date: 2024-04-06 - Completion Date: 2028-01-31 - Lead Sponsor: University of Tennessee ### Study Description 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 - Hypertension - High Cholesterol/Hyperlipidemia - Coronary Artery Disease - Congestive Heart Failure - Chronic Lung Disease - Chronic Kidney Diseases - Arrythmia - Stroke - Depression - Anxiety - Pulmonary Embolism - Heart Attack ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Med AAAction intervention ### Outcomes Primary Outcomes - Adherence to chronic disease medications Secondary Outcomes - Health care utilization - Cost - Qualitative Evaluation ### Location - Facility: University of Tennessee Medical Center, Knoxville, Tennessee, 37920, United States @@
## Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder - NCT ID: NCT06374264 - Study ID: NM100 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2024-12-31 - Lead Sponsor: MedRhythms, Inc. ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MR-C-014 ### Outcomes Primary Outcomes - Participant acceptability of MR-C-014 - Number of device-related adverse events (AEs) Secondary Outcomes - 6-Minute Walk Test (6MWT) - Number of walks per week ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers - NCT ID: NCT06374251 - Study ID: 0S-23-2 - Status: RECRUITING - Start Date: 2023-09-27 - Completion Date: 2025-03-27 - Lead Sponsor: University of Southern California ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Discussion - Interview - Survey Administration ### Outcomes Primary Outcomes - Number of participants who complete the narrative medicine sessions - Change in well-being scores Secondary Outcomes ### Location - Facility: USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States @@
## Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain - NCT ID: NCT06374238 - Study ID: UG3HL165839 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2028-05 - Lead Sponsor: University of Pittsburgh ### Study Description 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 - Sickle Cell Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CBT+ Health coach - CBT w/o Health Coach ( self-guided) - Usual Care ### Outcomes Primary Outcomes - 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 - 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 Secondary Outcomes - Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain - Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain - 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 - 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 - Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain - Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention - NCT ID: NCT06374225 - Study ID: 23-0866 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05-01 - Lead Sponsor: University of Colorado, Denver ### Study Description 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 - Wounds and Injury - Disease Attributes - Pathologic Processes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Automated Titration (O2matic) ### Outcomes Primary Outcomes - Proportion of time spent within the targeted normoxemia range Secondary Outcomes - Amount of supplemental oxygen administered - Proportion of time spent in hypoxemia (SpO2<88%) - Proportion of time spent in hyperoxemia (SpO2 >96%) - Time to Room Air ### Location - Facility: University of Colorado, Aurora, Colorado, 80045, United States @@
## Anifrolumab for Hidradenitis Suppurativa - NCT ID: NCT06374212 - Study ID: 24-0191 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description 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 - Acne Inversa - Hidradenitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Anifrolumab ### Outcomes Primary Outcomes - Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks Secondary Outcomes - Percentage of participants achieving a HiSCR 50 at 24 weeks - Percentage of participants who achieve a Hidradenitis Suppurativa Clinical Response score of 75 (HiSCR 75) at 12 weeks - Percentage of participants who achieve a HiSCR 75 at 24 weeks of treatment. ### Location - Facility: UNC Dermatology and Skin Cancer Center, Chapel Hill, North Carolina, 27516, United States @@
## Med-South Lifestyle Program for Pregnancy - NCT ID: NCT06374199 - Study ID: 24-0181 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-01 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Med-South Lifestyle Intervention for Pregnancy--Arm 1 - Med-South Lifestyle Intervention for Pregnancy--Arm 2 ### Outcomes Primary Outcomes - Percent that would recommend this program to others who are pregnancy - Percent of participants who take part in the 10 study counseling sessions Secondary Outcomes - Maternal diet quality ### Location - Facility: Center for Health Promotion and Disease Prevention/UNC-Chapel Hill, Chapel Hill, North Carolina, 27599, United States @@
## Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City - NCT ID: NCT06374186 - Study ID: 2095072 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-04-08 - Lead Sponsor: University of Missouri, Kansas City ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Behavioral Intervention with financial rewards and coaching - Control ### Outcomes Primary Outcomes - Time in target blood glucose range per CGM - Hemoglobin A1C Secondary Outcomes - Diabetes Quality of Life Brief Inventory - Diabetes Distress Scale - PROMIS Medication Adherence Scale - Perceived Dietary Adherence Questionnaire - Motivation and Confidence Ruler ### Location - Facility: University of Missouri - Kansas City School of Medicine, Kansas City, Missouri, 64108, United States @@
## A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors - NCT ID: NCT06374173 - Study ID: TGI6-T1-01 - Status: RECRUITING - Start Date: 2024-01-03 - Completion Date: 2027-12 - Lead Sponsor: Hefei TG ImmunoPharma Co., Ltd. ### Study Description A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors ### Conditions - Advanced or Metastatic Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TGI-6 Injection ### Outcomes Primary Outcomes - Dose-limiting Toxicity (DLT) - Dose-Finding - Frequency and Severity of Adverse Events (AE) Secondary Outcomes - Pharmacokinetics of TGI-6 - Pharmacokinetics of TGI-6 - Number of subjects with Anti-TGI-6 antibody positive - Objective Response Rate (ORR) - Duration of Response (DoR) - Disease Control Rate (DCR) - Progression Free Survival (PFS) - Overall Survival (OS) ### Location - Facility: Beijing Cancer Hospital, Beijing, N/A, N/A, China @@
## Exercise in Patients With Advanced Non-small Cell Lung Cancer - NCT ID: NCT06374160 - Study ID: 70115371 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-08-31 - Lead Sponsor: University Hospital, Essen ### Study Description 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 - First Line Treatment - Second Line Treatment - NSCLC Stage IV - NSCLC Stage IIIB - Palliative Treatment - NSCLC Stage IIIC ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exercise intervention ### Outcomes Primary Outcomes - Maximum oxygen uptake (VO2 peak [ml/min/kg]) Secondary Outcomes - Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F) - European Organisation for Research and Treatment of Cancer (EORTC QLQ C30) - European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13) - Arterial blood pressure - Change in ECG - Adherence to exercise intervention - Drop-out rate - Recruitment rate - Serious Adverse Event/Adverse Events - Therapy response - Treatment Toxicity - Treatment scheme - NT-pro-BNP - High sensitive troponin I - Erythrocytes - Hemoglobin - Leukocytes - Lymphocytes - Neutrophils - CRP - CYRFRA 21-1 - Physical function (Hypothetical One-repetition maximum) - Blood gas analysis pH value - Blood gas analysis (PAO2) - Blood gas analysis (SaO2) - Blood gas analysis (PCO2) - Blood gas analysis (BE) - Blood gas analysis (HCO3) - Blood gas analysis (SBCe) ### Location - Facility: West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen, Essen, North Rhine-Westphalia, 45147, Germany @@
## "Prapela® SVS Incubator Pad for Apnea of Prematurity - NCT ID: NCT06374147 - Study ID: STUDY00004467 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2026-12-31 - Lead Sponsor: Tufts Medical Center ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SVS mattress ### Outcomes Primary Outcomes - Reduce apnea events by 30% or more in the three days after study entry Secondary Outcomes - Reduce the number of days caffeine citrate is used after study entry by 3 days or more - Reduce the number of days of respiratory support by 3 days or more ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impact of Community and Patient Engagement Practices on Vaccine Confidence in the United States - NCT ID: NCT06374134 - Study ID: STUDY00004835 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-02 - Lead Sponsor: Tufts University ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Community Engagement Practice - Patient-Centric Protocol Element ### Outcomes Primary Outcomes - Units of Vaccine Dispensed Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Kidney Perfusion With or Without Absorption - NCT ID: NCT06374121 - Study ID: POWER - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Mario Negri Institute for Pharmacological Research ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PerSorb cartridge (CytoSorbents Europe GmbH, Germany) - PerLife PerKidney ### Outcomes Primary Outcomes - Oxidative stress markers - Acute kidney injury markers - Inflammatory cytokine markers - Complement activation markers - Vascular resistances - Perfusate sample collection Secondary Outcomes ### Location - 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, Bergamo, BG, 24027, Italy @@
## Resistance Training and Corticospinal Excitability in Multiple Sclerosis - NCT ID: NCT06374108 - Study ID: Neuro_Exercise - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-31 - Lead Sponsor: University of Aarhus ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Progressive resistance training ### Outcomes Primary Outcomes - MEP/Mmax ratio Secondary Outcomes - Muscle strength - Voluntary activation I - Voluntary activation II - Force Steadiness - Rate of Force Developement - Ultrasound - Resting Motor Threshold (rMT) - Active Motor Threshold (aMT) - MEP latency (resting) - MEP latency (active) - MEP amplitude (resting) - MEP amplitude (active) - Short-interval intracortical Inhibition (SICI) - Intracortical facilitation (ICF) - Cortical Silent Period (CSP) - Central Motor Conduction Time (CMCT) - EEG-EMG coherence (0-1) - Timed 25 feet walk test (T25FWT) - 6-minute walk test (6MWT) - Six spot step test (SSST) - 5 sit-to-stand (5STS) - 9-step stair ascend (9SSA) - Patient determined disease steps (PDDS) - Multiple Sclerosis Walking Scale (MSWS) - Modified fatigue impact scale (MFIS) - MS impact scale (MSIS) - Falls-efficacy scale - international (FES-1) - The Physical Activity Enjoyment Scale (PACES) - Brief pain inventory (BPI) - Baecke physical activity - Accelerometry ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 1 vs 7 RATG Infusions in Renal Transplantation - NCT ID: NCT06374095 - Study ID: ONSET - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-06 - Lead Sponsor: Mario Negri Institute for Pharmacological Research ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - RATG - Basiliximab ### Outcomes Primary Outcomes - Incidence of thrombocytopenia and/or leukopenia Secondary Outcomes - Occurrence of anemia - Occurrence of viral infections - Occurrence of pneumonia - Occurrence of opportunistic infections - Occurrence of delayed graft function - Occurrence of allograft rejection - Occurrence of biopsy proven rejection - Survival - Platelet and WBC counts - Creatinine levels - Adverse events ### Location - Facility: ASST HPG23 - Unità di Nefrologia, Bergamo, BG, 24127, Italy @@
## Instant Messaging Reinforcement for Smoking Cessation Counseling Training - NCT ID: NCT06374082 - Study ID: HKWC-2024-179 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: The University of Hong Kong ### Study Description 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 - Smoking Cessation Counseling Practice ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - WhatsApp message ### Outcomes Primary Outcomes - SCC practice measurement Secondary Outcomes - SCC knowledge score - SCC attitude score - SCC practice score ### Location - Facility: Hong KongLKS Faculty of Medicine, Hong Kong, N/A, 00, Hong Kong @@
## Longevity Families of the Netherlands - NCT ID: NCT06374069 - Study ID: NL81887.058.23 - Status: RECRUITING - Start Date: 2023-09-11 - Completion Date: 2026-12 - Lead Sponsor: Leiden University Medical Center ### Study Description 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 - Familial Longevity - Extreme Longevity - Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Identifying the genetic variants of Familial Longevity Secondary Outcomes - Studying the environmental factor of Familial Longevity through questionnaires and its interaction with the genetic component ### Location - Facility: Leiden University Medical Center, Leiden, South Holland, 2333ZA, Netherlands @@
## Kintsugi Voice Device Pilot Study - NCT ID: NCT06374056 - Study ID: 0458 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-07-22 - Lead Sponsor: Kintsugi Mindful Wellness, Inc. ### Study Description 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 - Depression Moderate - Depression Severe - Depression Mild ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Kintsugi Voice Device ### Outcomes Primary Outcomes - Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5 Secondary Outcomes - PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5 - Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT - Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9 ### Location - Facility: Kintsugi Mindful Wellness Inc., Berkeley, California, 94707, United States @@
## Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin. - NCT ID: NCT06374043 - Study ID: 2020/1002 - Status: COMPLETED - Start Date: 2021-05-11 - Completion Date: 2022-09-13 - Lead Sponsor: University Medical Center Groningen ### Study Description Randomized placebo-controlled double-blind cross-over N=1 trial in adult male and female patients with UACR \>20 mg/g (2.26 mg/mmol) with type 2 diabetes treated in primary or secondary healthcare.The goal of this clinical trial is to determine the individual response to the SGLT2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR). Secondary objectives are to determine the individual response to dapagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose.Participants will collect all study data in the comfort of their own environments:* First-morning void urine samples* Capillary blood samples* Blood pressure* Body weightParticipants will be randomly assigned to a cross-over study consisting of two periods of 1-week treatment with dapagliflozin 10 mg/day and two periods of 1-week treatment with placebo in random order with a 1-week wash-out period between every treatment period to avoid cross-over effects. ### Conditions - Diabetes Mellitus, Type 2 - Diabetes Mellitus Type 2 With Proteinuria - Diabetes Mellitus - Diabetes - Diabetes Complications - Albuminuria - Chronic Kidney Diseases - Chronic Kidney Disease Due to Type 2 Diabetes Mellitus - CKD - Proteinuria ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Dapagliflozin 10mg Tab - Placebo - Withings BPM Connect - Withings Body+ - Hem-Col Capillary Blood Collection Device - MEMS (Medication Electronic Monitoring System) Cap - Questionnaire: participants' perspectives toward remote data collection ### Outcomes Primary Outcomes - UACR response Secondary Outcomes - Systolic blood pressure response - Body weight response - eGFR response - Fasting plasma glucose response ### Location - Facility: Ziekenhuisgroep Twente, Almelo, N/A, N/A, Netherlands @@
## Retrospective Study of Airway Management in Dutch ED's - NCT ID: NCT06374030 - Study ID: EDSAM2024 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Medical Centre Leeuwarden ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Endotracheal intubation ### Outcomes Primary Outcomes - Different complications of endotracheal intubation Secondary Outcomes ### Location - Facility: Leeuwarden Medical Centre, Leeuwarden, N/A, 8934AD, Netherlands @@
## Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response - NCT ID: NCT06374017 - Study ID: N-258-2023 - Status: RECRUITING - Start Date: 2023-09-20 - Completion Date: 2024-05-10 - Lead Sponsor: Kasr El Aini Hospital ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Normal saline, Lidocaine, dexmetomidine ### Outcomes Primary Outcomes - To measure systolic blood pressure immediately after intubation. Secondary Outcomes ### Location - Facility: Cairo University hospitals, Cairo, N/A, 11559, Egypt @@
## The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome - NCT ID: NCT06374004 - Study ID: HU-FTR-MC-01 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-10 - Completion Date: 2024-07-05 - Lead Sponsor: Hacettepe University ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise Group - Thoracic Mobilization Group ### Outcomes Primary Outcomes - Electromyography (EMG) - Acromiohumeral Distance (AHD) Secondary Outcomes - Muscle Tone - Functional Activity Level - Pain Intensity ### Location - Facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, N/A, 06100, Turkey @@
## A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus - NCT ID: NCT06373991 - Study ID: EDI-901-SLE01 - Status: RECRUITING - Start Date: 2024-04-24 - Completion Date: 2027-04-30 - Lead Sponsor: EdiGene Inc. ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ATHENA CAR-T - Fludarabine - Cyclophosphamide ### Outcomes Primary Outcomes - Dose Limiting Toxicity - Frequency of AEs, SAEs, lab abnormalities, AESIs Secondary Outcomes - Efficacy: Percent of patients achieved SRI-4 - Efficacy: Patients SLEDAI-2000 change compared with baseline - Efficacy: Patients BILAG-2004 change compared with baseline - Efficacy: Percent of patients' PGA not worsen - Percent of patients responded by BILAG-2004 - Efficacy: Immunologic parameters - Efficacy: Immunologic parameters (cont) ### Location - Facility: The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471003, China @@
## NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow - NCT ID: NCT06373978 - Study ID: 24-307 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-01 - Lead Sponsor: The Cleveland Clinic ### Study Description 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 - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Diclofenac - Tramadol ### Outcomes Primary Outcomes - Number of pills taken Secondary Outcomes - Non narcotic use ### Location - Facility: The Cleveland Clinic Florida, Coral Springs, Florida, 33067, United States @@
## Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI) - NCT ID: NCT06373965 - Study ID: B2024-000 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-19 - Completion Date: 2025-02-18 - Lead Sponsor: University of Connecticut ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Online to offline counseling ### Outcomes Primary Outcomes - HIVST uptake - Linkage to PrEP - Linkage to HIV treatment services Secondary Outcomes ### Location - Facility: Centre of Excellence For Research in AIDS (CERiA), Kuala Lumpur, N/A, N/A, Malaysia @@
## Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men - NCT ID: NCT06373952 - Study ID: 23-08-658-910 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-19 - Completion Date: 2025-02-18 - Lead Sponsor: University of Connecticut ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Online to offline counseling ### Outcomes Primary Outcomes - HIVST uptake - Linkage to PrEP - Linkage to HIV treatment services Secondary Outcomes ### Location - Facility: Centre of Excellence For Research in AIDS (CERiA), Kuala Lumpur, N/A, N/A, Malaysia @@
## Performance and Safety of the Pneumoscope Device in Adults and Children - NCT ID: NCT06373939 - Study ID: Pneumoscope study - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-12-31 - Lead Sponsor: Pediatric Clinical Research Platform ### Study Description 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 - Pneumonia - Asthma - Cyanotic Heart Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Digital lung auscultation - Pulse oximetry measurement - Non invasive body temperature measurement ### Outcomes Primary Outcomes - Evaluation of Pneumoscope's built-in sensors Secondary Outcomes - Collect audio records of lung sounds for AI models training and sensor calibration - Pulse oximetry - Body temperature ### Location - Facility: Geneva University Hospitals, Geneva, N/A, 1205, Switzerland @@
## Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome - NCT ID: NCT06373926 - Study ID: PI2019_843_0010 - Status: RECRUITING - Start Date: 2023-03-28 - Completion Date: 2025-03 - Lead Sponsor: Centre Hospitalier Universitaire, Amiens ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - blood withdrawal ### Outcomes Primary Outcomes - Cell membrane expression rate of ANXA2 on circulating monocytes in APS Secondary Outcomes - Cellular expression of ANXA2 and S100A10 in APS patients - cell membrane expression of ANXA2 and S100A10 in APS patients ### Location - Facility: CHU Amiens, Amiens, N/A, 80054, France @@
## The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom - NCT ID: NCT06373913 - Study ID: MASP2NSRZL - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2028-07-30 - Lead Sponsor: Kolding Sygehus ### Study Description Nephrotic syndrome (NS) is characterized by gross proteinuria (\>3.5 g/day), hypoalbuminaemia, edema and often hyperlipidemia. Hyperlipidemia is correlated with increased morbidity and mortality.The study aim is to investigate the role of the protein convertase subtilisin/kexin type 9 (PCSK9) in hyperlipidemia of NS, which has been suggested to play an important role. This is done by testing the following hypotheses:1. PCSK9 is increased in patients with NS and hyperlipidemia compared to kidney-healthy controls2. The level of PCSK9 in plasma correlates to the degree of proteinuria.3. PCSK9 i increased in the kidney tissue of patients with NSThe study will compare plasma levels of PCSK9 in correlation with degree of protein in the urine between test persons with NS and kidney healthy controls. Furthermore the investigators will study the the degree of PCSK9 in the kidney in biopsies obtained from test persons with nephrotic syndrome and test persons without proteinuria. ### Conditions - Hyperlipidemias - Nephrotic Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Plasma PCSK9 correlated to the degree of protein in the urine - Degree of PCSK9 in kidney tissue Secondary Outcomes - Localization of PCSK9 in kidney tissue ### Location - Facility: Kolding Sygehus, Lillebælt Hospital, Kolding, N/A, 6000, Denmark @@
## Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture. - NCT ID: NCT06373900 - Study ID: IndusH - Status: COMPLETED - Start Date: 2022-02-13 - Completion Date: 2022-03-30 - Lead Sponsor: Indus Hospital and Health Network ### Study Description 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 - Wound Dehiscence - Wound Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - wound closure ### Outcomes Primary Outcomes - Wound characteristics and complications - Wound Infection Grade - Hollander Cosmetic Wound Evaluation Score Secondary Outcomes ### Location - Facility: Indus Hospital and Health Network, Karachi, Sindh, 74900, Pakistan @@
## The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs) - NCT ID: NCT06373887 - Study ID: 2023-09-005A - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-12-31 - Lead Sponsor: Taipei Veterans General Hospital, Taiwan ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - plant-based Low carbohydrate diet - plant-based Low low fat diet ### Outcomes Primary Outcomes - Body weight loss/fat mass loss Secondary Outcomes - microbiota change ### Location - Facility: Taipei Veterans General Hospital, Taipei, Beitou District, 11217, Taiwan @@
## The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection - NCT ID: NCT06373874 - Study ID: MCBU-SBF-YC-04 - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2023-05-30 - Lead Sponsor: Celal Bayar University ### Study Description The researchers gave midwifery students theoretical training on how to take heel blood on a newborn model. Students were asked to take heel blood on the model in the high-reality simulation environment and simulation room. The student's ability to take heel blood before and after taking heel blood in a high-reality simulation environment or on a newborn model in a simulation environment, satisfaction with learning, anxiety and self-efficacy levels were compared. ### Conditions - Students - Educational Problems - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Heel blood collection in a newborn simulation model ### Outcomes Primary Outcomes - Skill checklist - State and Trait Anxiety Scales - Self-Efficacy Scale - Student Satisfaction and Self-Confidence in Learning Questionnaire Secondary Outcomes ### Location - Facility: Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery, Manisa, N/A, 45140, Turkey @@
## Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY) - NCT ID: NCT06373861 - Study ID: 20-0482 - Status: RECRUITING - Start Date: 2022-04-28 - Completion Date: 2037-04 - Lead Sponsor: University of Colorado, Denver ### Study Description GALAXY is a registry research study that plans to learn more about individuals with X\&Y variations (also called sex chromosome aneuploidies) through collecting information from medical records.This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. The purpose of the GALAXY Registry is to collect and store this information with the overall goal to improve health outcomes in individuals with X\&Y variations and the care they receive. ### Conditions - Sex Chromosome Aneuploidy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Health Conditions Secondary Outcomes - Prevalence of mental health diagnoses - Cardiometabolic diagnoses - prevalence of obesity - Cardiometabolic diagnoses - prevalence of dyslipidemia - Cardiometabolic diagnoses-prevalence of hypertension - Autoimmune diagnoses - prevalence of hypothyroidism and of hyperthyroidism - Autoimmune diagnoses - prevalence of diabetes ### Location - Facility: Children's Hospital Colorado, Aurora, Colorado, 80045, United States @@
## Comparison of Salivary Parameters in Patients Receiving CoQ10 and Vitamin E Supplementation - NCT ID: NCT06373848 - Study ID: 346 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-20 - Completion Date: 2024-09-15 - Lead Sponsor: Islamic Azad University, Tehran ### Study Description Comparison of salivary markers in patients with Initial chronic periodontitis after non-surgical periodontal treatment with CoQ10 supplementation with vitamin E ### Conditions - Periodontal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Receive 30 mg of Coq10 ### Outcomes Primary Outcomes - Total Antioxidant capacity (TAC) of saliva Secondary Outcomes - Bleeding on probing ### Location - Facility: Amirhossein Farahmand, Tehran, N/A, 1947833113, Iran, Islamic Republic of @@
## Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis - NCT ID: NCT06373835 - Study ID: EMODEPSIDE_LAOS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-07-31 - Lead Sponsor: Swiss Tropical & Public Health Institute ### Study Description Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials ### Conditions - Strongyloides Stercoralis Infection - Strongyloidiasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Emodepside ### Outcomes Primary Outcomes - Cure rate (CR) of emodepside against Strongyloides stercoralis Secondary Outcomes - Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin. - Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis. - Exposure response of emodepside in adults - Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs - NCT ID: NCT06373822 - Study ID: 2024/18JAN/028 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2031-09 - Lead Sponsor: Université Catholique de Louvain ### Study Description Objectives:To identify differentially expressed miRNAs in the blood of adenomyosis patients in view to develop new diagnostic methodsHypotheses Circulating miRNAs may be abnormally expressed in patients suffering from adenomyosis and could be used to diagnose the diseaseStudy Design Blood samples will be collected from healthy subjects and adenomyosis patients and miRNAs will be isolated and analyzed to detect potential differences. ### Conditions - Adenomyosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Circulating-mirna ### Outcomes Primary Outcomes - Circulating-miRNA as diagnostic biomarkers Secondary Outcomes ### Location - Facility: CUSL, Brussel, Woluwe-Saint-Lambert, 1200, Belgium @@
## Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy - NCT ID: NCT06373809 - Study ID: PDSC1970222 - Status: COMPLETED - Start Date: 2021-10-08 - Completion Date: 2024-03-31 - Lead Sponsor: Michael H Carstens ### Study Description This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot. ### Conditions - Diabetic Foot - Diabetic Neuropathies - Diabetic Foot Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transplantation of Placenta Derived Stem Cells ### Outcomes Primary Outcomes - Foot Ulcer Healing Secondary Outcomes - Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes. - Vibration: Documenting diabetes-associated lower extremity pathophysiology changes. ### Location - Facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA), León, Leon, 21000, Nicaragua @@
## Ultrasound Index Fat Fraction - NCT ID: NCT06373796 - Study ID: 2024-A00523-44 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-09 - Lead Sponsor: SuperSonic Imagine ### Study Description The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis. ### Conditions - Steatosis of Liver ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Echographic scan ### Outcomes Primary Outcomes - FAT PLUS Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage - NCT ID: NCT06373783 - Study ID: 2023/05 - Status: COMPLETED - Start Date: 2023-06-15 - Completion Date: 2024-03-16 - Lead Sponsor: Pamukkale University ### Study Description Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth.Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments. The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results. The main indications for root coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical abrasion and root caries, improvement of restorative results, and facilitation of plaque control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments.De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or mesio-distal directions is required. In this technique, the graft of the required width and length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer.Ultrasonography (USG) is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities. This technique is widely used in medical practice. In dentistry, the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness. It also has functions to evaluate color power and color speed, as well as blood flow.The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession. This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography (USG). ### Conditions - Gingival Recession, Localized ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - subepithelial connective tissue graft - de- epithelize gingival graft - ultrasonography ### Outcomes Primary Outcomes - tissue thickness Secondary Outcomes - pulsatility index ### Location - Facility: Pamukkale University of the Dentistry, Denizli, N/A, 20160, Turkey @@
## Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum - NCT ID: NCT06373770 - Study ID: MSRSW/Batch-Fall22/700 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-09-30 - Lead Sponsor: Superior University ### Study Description Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Ayres sensory integration therapy - Behaviour Therapy ### Outcomes Primary Outcomes - sensory profile by winnie dunn Secondary Outcomes ### Location - Facility: RICCER Institute, Faisalabad, Punjab, N/A, Pakistan @@
## Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect - NCT ID: NCT06373757 - Study ID: RECO6U/5-2023 - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2023-09-01 - Lead Sponsor: October 6 University ### Study Description The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects. ### Conditions - Chitosan - Nano-hydroxyapatite Hydrogel - Intrabony Defect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nano-HAP/Chitosan hydrogel ### Outcomes Primary Outcomes - Gingival index Secondary Outcomes - Plaque index - Clinical attachment level - Periodontal probing depth - Acrylic stent for pocket assessment ### Location - Facility: October 6 University, Giza, N/A, 12511, Egypt @@
## Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients - NCT ID: NCT06373744 - Study ID: SYSU-022 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-01-01 - Lead Sponsor: Sun Yat-sen University ### Study Description The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - cyclophosphamide , methotrexate , vinorelbine ,capecitabine ### Outcomes Primary Outcomes - Progression free survival Secondary Outcomes - Overall Survival - Objective Response Rate - Disease Control Rate ### Location - Facility: Shusen Wang, Guangzhou, Gangdong, N/A, China @@
## ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) - NCT ID: NCT06373731 - Study ID: SPIAM-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-08 - Lead Sponsor: Stealth BioTherapeutics Inc. ### Study Description The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared. ### Conditions - Age-Related Macular Degeneration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Elamipretide - Placebo ### Outcomes Primary Outcomes - Week 48 Rate of change in the macular area of photoreceptor loss Secondary Outcomes - Week 72 Rate of change in the Macular area of photoreceptor loss - Week 96 Rate of change in the Macular area of photoreceptor loss - Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA) - Proportion of subjects gaining ≥ 15 letters in Low Luminance Best-Corrected Visual Acuity (LL BCVA) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase) - NCT ID: NCT06373718 - Study ID: IRB-74553 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-06 - Lead Sponsor: Stanford University ### Study Description This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target. ### Conditions - Insomnia - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Behavioral Therapy for Insomnia ### Outcomes Primary Outcomes - Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging - Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging - Change in Beck Depression Inventory - Change in PSG Sleep Efficiency Secondary Outcomes - Change in Columbia Suicide Severity Rating Scale - Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity - Change in Actigraph Number of Arousals as a Measure of Sleep Continuity - Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity - Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity - Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity - Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture - Change in PSG Number of Arousals as a Measure of Sleep Architecture - Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture - Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture - Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture - Change in Sleep Physiology measured by PSG - Change in Insomnia Severity Index (ISI) Scale Score - Change in 36-Item Short Form Survey (SF-36) Score - Change in Beck Anxiety Inventory - Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG ### Location - Facility: Stanford University, Palo Alto, California, 94304, United States @@
## Cardiac Simulator for Surgical Planning - NCT ID: NCT06373705 - Study ID: 74566 - Status: NOT_YET_RECRUITING - Start Date: 2026-04 - Completion Date: 2029-04 - Lead Sponsor: Stanford University ### Study Description The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.To aid surgeons in envisioning different surgical approaches for each individual patient.To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.Participants will:Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group. ### Conditions - Congenital Heart Disease in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cardiac simulator ### Outcomes Primary Outcomes - Mortality Secondary Outcomes - Mortality - Number of cardioplegic arrest ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma) - NCT ID: NCT06373692 - Study ID: TCM for Asthma Cohort - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-30 - Lead Sponsor: Henan University of Traditional Chinese Medicine ### Study Description The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma. ### Conditions - Bronchial Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Asthma control rate Secondary Outcomes - Number of exacerbations - Asthma exacerbation severity - Change in severity of chronic persistent disease - The dose used by glucocorticoids - Rapid-acting beta2 agonists use drugs and doses - Asthma Control Test (ACT) score - Asthma Control Questionnaire (ACQ) - Asthma Quality of Life Score (AQLQ) - Anxiety Self-Assessment Form (SAS) - Depression Self-Rating Scale (SDS) - Pulmonary function - Exhaled nitric oxide (FeNO) ### Location - Facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan, N/A, China @@
## Switch or Quit R01 - NCT ID: NCT06373679 - Study ID: Pro00125514 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-05 - Lead Sponsor: Medical University of South Carolina ### Study Description This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks. ### Conditions - Cigarette Smoking - Smoking Behaviors ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Switching to E-Cigarette - Switching using Medication ### Outcomes Primary Outcomes - Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback Secondary Outcomes - Greater than 50% reduction in cigarette smoking ### Location - Facility: Medical Univeristy of South Carolina, Charleston, South Carolina, 29425, United States @@
## A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4). - NCT ID: NCT06373666 - Study ID: SPZ4-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-06 - Lead Sponsor: Spatz FGIA, Inc ### Study Description The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27. ### Conditions - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Spatz4 Adjustable Balloon System ### Outcomes Primary Outcomes - Successful adjustment procedure at 16 ±2 weeks in > 85% of attempts. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes. - NCT ID: NCT06373653 - Study ID: SOPHMAN-0922/IV - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2024-12-30 - Lead Sponsor: Laboratorios Sophia S.A de C.V. ### Study Description This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI). ### Conditions - Eye Strain - Eye Strain of Both Eyes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Manzanilla Sophia® - Meticel Ofteno® ### Outcomes Primary Outcomes - Analog visual eyestrain test score Secondary Outcomes - Incidence of unexpected adverse events related to the interventions - Incidence of conjunctival hyperemia - Incidence of sensation of ocular dryness. - Incidence of ocular irritation - Incidence of sensation of (sleep-crust) - Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage - NCT ID: NCT06373640 - Study ID: RHM NEU0458 - Status: NOT_YET_RECRUITING - Start Date: 2024-11 - Completion Date: 2028-01 - Lead Sponsor: University Hospital Southampton NHS Foundation Trust ### Study Description The HAPTO study will recruit adult patients with aSAH due to a burst aneurysm. These patients must be scheduled to have their aneurysm treated surgically to prevent further bleeds, and need an external ventricular drain for clinical reasons (to drain fluid and relieve pressure on the brain). At the end of their surgery for their aneurysm, a further drain will be left at the site of the surgery (which is in the basal cisterns) and they will additionally have a drain sited in their lumbar spine. Vancomycin will be given through these drains. Additionally, these drains will allow the fluid in the brain to be collected to measure how haemoglobin levels and vancomycin levels differ between compartments and change over time. Patients will participate in the study over a period from recruitment at three days after aSAH to a maximum of ten days after aSAH. The data will be analysed to determine the relationship in haemoglobin concentrations between different areas of the brain and spine after aSAH, and how vancomycin distribution is related to its route of administration. ### Conditions - Subarachnoid Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Insertion of drains - Vancomycin ### Outcomes Primary Outcomes - CSF-haemoglobin concentration Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease - NCT ID: NCT06373627 - Study ID: 2024-A00534-43 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2025-05-03 - Lead Sponsor: Fondation Hôpital Saint-Joseph ### Study Description The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects. ### Conditions - Procedural Pain - Congenital Heart Disease - Heart Surgery - Hypnosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hypnosis - Conventional medications used for sedation-analgesia - Medications used in addition to hypnosis ### Outcomes Primary Outcomes - Primary Outcome : Pain evaluation by VAS self-assessment Secondary Outcomes - Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal - Maximum heart rate - Cumulative doses of intravenous analgesics - Respiratory depression - Parental satisfaction using Visual Analogic Scale (VAS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Foot Massage and Bed Bath on Individuals With Cancer - NCT ID: NCT06373614 - Study ID: 2023/18 - Status: RECRUITING - Start Date: 2023-11-20 - Completion Date: 2024-06-20 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer. ### Conditions - Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - foot massage - bed bath ### Outcomes Primary Outcomes - sleep quality - fatigue Secondary Outcomes ### Location - Facility: University of Health Sciences, Istanbul, Uskudar, N/A, Turkey @@
## SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective - NCT ID: NCT06373601 - Study ID: SPAGO - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-02-01 - Lead Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS ### Study Description The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) at 12 months follow-up. ### Conditions - Coronary Artery Disease - Stenosis Coronary - Coronary Artery Lesion - Percutaneous Coronary Intervention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - sirolimus-eluting balloon (Selution) - paclitaxel-eluting balloon (SeQuent Please Neo) ### Outcomes Primary Outcomes - In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure Secondary Outcomes - Device success (lesion based) - Procedure success - Angiographic outcomes 1 - Angiographic outcomes 2 - Angiographic outcomes 3 - Angiographic outcomes 4 - Device oriented Composite Endpoint (DoCE/ TLF) - Acute/subacute/early/late vessel thrombosis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Patient Navigator Intervention for Migrant Children With Special Healthcare Needs Experiencing Care Transitions - NCT ID: NCT06373588 - Study ID: MP-37-2023-9418 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-08 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description The goal of this randomized controlled trial is to test if a patient navigator program improves healthcare experiences and outcomes for migrant families caring for a child or youth with special healthcare needs (i.e. chronic health condition).The main questions are, for migrant families with a child or youth with special healthcare needs:Does a patient navigator reduces barriers to care? Does a patient navigator improve care coordination, caregiver empowerment, caregiver stress and quality of life? What are the healthcare experiences for families with and without the patient navigator intervention?Participants will:* Receive the intervention, i.e., the patient navigator program, or continue with standard of care for 12 months* Fill out questionnaires at 3 time points on barriers to care, caregiver stress, care coordination, and their child's health ### Conditions - Patient Navigation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Patient Navigator ### Outcomes Primary Outcomes - Barriers to Care (BCQ) Secondary Outcomes - Effective care coordination - Parental empowerment scale - Healthcare utilization - PROMIS - Pediatric Global Health 7 - Short-form survey 12 - Patient Health Questionnaire (PHQ-2) - Distress Thermometer - Perceived stress scale - Patient Satisfaction with Interpersonal Relationships with Navigators (PSN-I) ### Location - Facility: Unity Health Toronto, Compass Clinic, Toronto, Ontario, M5B 1W8, Canada @@
## IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure - NCT ID: NCT06373575 - Study ID: 2023-SR-891 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-05-01 - Completion Date: 2025-06-30 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term. ### Conditions - End-stage Renal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lung and inferior vena cava ultrasound guidance - Conventional protocol guidance ### Outcomes Primary Outcomes - Improvement in pulmonary congestion score - Improvement in heart failure symptoms score Secondary Outcomes - Total ultrafiltration volume - Mean ultrafiltration rate during prolonged hemodialysis - Fluid balance (total outflow - total inflow) - Lung B-line reduction - The change of width of inferior vena cava - Incidence of hypotension during prolonged hemodialysis - Blood pressure variability during the prolonged hemodialysis - In-hospital mortality - Length of hospital stay ### Location - Facility: Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China @@
## Effect of Hypoxic Exposure on Blood Variables in Elite Wrestlers - NCT ID: NCT06373562 - Study ID: Wrestlers - Status: COMPLETED - Start Date: 2013-12-02 - Completion Date: 2013-12-18 - Lead Sponsor: Poznan University of Physical Education ### Study Description Twelve male wrestlers of the National Polish Team were observed in the study during the camp. The hypoxia group (n=6) participated in sports training and hypoxic exposure, while the control group (n=6) included wrestlers participating only in sports training. The hypoxic group lived and slept in hypoxic rooms. During the camp, all wrestlers followed the same training schedule and diet. In the blood were determined levels of creatine kinase (CK), C-reactive protein (hsCRP) concentration, nitric oxide (NO), morphology, reticulocytes, lipid profile, and ferritin. Also vascular endothelial growth factor (VEGF, VEGFR2, and VEGFR3), erythropoietin (EPO), angiopoietin (Ang 1, Ang 2), endothelial cell adhesion factor-1 (VCAM-1), Erythropoietin (EPO) and hypoxia-inducible factor 1 (HIF-1). Body weight composition was determined. ### Conditions - Hypoxia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - hypoxia ### Outcomes Primary Outcomes - CK - hsCRP - HIF-1 - EPO - VEGF, VEGF 2, VEGF 3. - Ang 1, Ang 2 - VCAM-1 Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigation of Myocardial Protection Efficacy of Cardioplegia Solutions Used in Open Heart Surgery - NCT ID: NCT06373549 - Study ID: 2022/183-3896 - Status: COMPLETED - Start Date: 2022-12-08 - Completion Date: 2023-07-24 - Lead Sponsor: Tamer cebe ### Study Description Cardioplegias are different pharmacokinetic solutions routinely used in cardiac surgery to protect the heart from ischemia and induce arrest. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are used in clinical practice. There is no clear scientific data in the literature that demonstrates the superiority of one cardioplegia over the others. The choice of the appropriate cardioplegia depends on the surgeon's clinical experience and preference. In this study preferred the blood cardioplegia and del Nido cardioplegia, which are commonly used in clinic. Both cardioplegias have different advantages that contribute to their preference in clinical practice.Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals. The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. In addition to these different usage scenarios, the myocardial protective effects of cardioplegias on cellular redox homeostasis are also among the current research topics. Thesis project can contribute to the current literature and clinical practice on the cardioprotective advantages of cardioplegia solutions and the reasons for their preference in surgery. ### Conditions - Cardiovascular Diseases - Myocardial Reperfusion Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions - Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions ### Outcomes Primary Outcomes - Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules. Secondary Outcomes ### Location - Facility: SBÜ. Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi Erişkin Kalp ve Damar Cerrahisi Kliniği, Istanbul, Kadıköy, 34668, Turkey @@
## Comparison of MRI-PDFF to TAEUS FLIP Device to Estimate Liver Fat Fraction in Adults - NCT ID: NCT06373536 - Study ID: LMU-RAD-01167 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-09-01 - Lead Sponsor: Endra Lifesciences ### Study Description Primary nonalcoholic fatty Liver disease (NAFLD) is an excess of fat in the liver (steatosis) that is not a result of excessive alcohol consumption or other secondary causes11. NAFLD is defined by the presence of hepatic fat content (steatosis) in ≥ 5% of hepatocytes and is currently the most common liver disease worldwide14 . Non-Alcoholic Fatty Liver Disease (NAFLD) is the world\'s most common liver disease and affects around 33% of the adult population.Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease (NAFLD), is a growing clinical concern associated with the increasing prevalence of obesity, type 2 diabetes, and metabolic syndrome. NASH is characterized by the presence of hepatic steatosis, inflammation, and hepatocellular injury and is predicted to be the leading indication for liver transplantation by 20201. Patients with NASH have an increased risk of developing cirrhosis and its complications, such as ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, and liver failure. The prevalence worldwide of NAFLD in the general population is estimated at 20-35%2 . Around 2-3% of the population have NASH.In patients with type 2 diabetes, the prevalence is even over 50% (55.5% globally, 68% in Europe). In Germany, the NAFLD prevalence was 23% in 2016 and will be around 26% in 2030. The prevalence of non-alcoholic alcoholic steatohepatitis (NASH), i.e. the progressive form of NAFLD, is estimated at 4% of the adult population in Germany and will increase to 6% by 2030. This means that NAFLD is already the most common chronic liver disease worldwide and one of the leading causes of liver-related complications (cirrhosis, decompensation, hepatocellular carcinoma, liver transplantation) and deaths. NAFLD and NASH are largely underdiagnosed worldwide. ### Conditions - Steatosis of Liver ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Thermoacoustic imaging, MRI and Ultrasound imaging ### Outcomes Primary Outcomes - Thermoacoustic Fat Measurements - Estimate Accuracy of Thermoacoustic Fat Fraction Secondary Outcomes - Usability Metric - Estimate Operator Variability ### Location - Facility: Klinikum der Universität München Großhadern Klinik und Poliklink für Radiologie, München, N/A, 81377, Germany @@
## MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin - NCT ID: NCT06373523 - Study ID: SHIELD - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-07-30 - Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh ### Study Description Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis/hepatic fibrosis in NAFLD patients with Primary Hypothyroidism. ### Conditions - Hepatic Steato-Fibrosis - Non-Alcoholic Fatty Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dapagliflozin 10mg Tab - Placebo - Levothyroxine Replacement daily ### Outcomes Primary Outcomes - Change in liver fat content Secondary Outcomes - Proportion of participants achieving 1 Stage decrease in steatosis at 6 months asassessed by Transient Elastography - Changes in Improvement in hepatic fibrosis measured by non invasive parameters like Fib4 score at 3 and 6 months - Changes in Lipid Profile at 3 and 6 months ### Location - Facility: PGIMER, Chandigarh, Punjab, 160012, India @@
## Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study - NCT ID: NCT06373510 - Study ID: ELCAV - Status: NOT_YET_RECRUITING - Start Date: 2024-06-20 - Completion Date: 2027-04-03 - Lead Sponsor: CerbaXpert ### Study Description The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population .Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies. ### Conditions - Vaccination Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Blood collection ### Outcomes Primary Outcomes - Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography - NCT ID: NCT06373497 - Study ID: IIT2023-08-ATKINS-ATHERO-RT - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2026-04 - Lead Sponsor: Katelyn Atkins ### Study Description The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction.Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT. ### Conditions - Oligometastatic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 18-F-NaF Cardiac PET/MRI and - CT Angiogram ### Outcomes Primary Outcomes - Feasibility of using F-NaF PET/MRI imaging Secondary Outcomes - To measure changes in standard uptake value (SUV) - To measure changes in coronary microcalcification activity (CMA) ### Location - Facility: Cedars Sinai Medical Center, Los Angeles, California, 90048, United States @@
## Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents - NCT ID: NCT06373484 - Study ID: 018-2022 - Status: RECRUITING - Start Date: 2022-10-01 - Completion Date: 2027-09 - Lead Sponsor: Centre for Addiction and Mental Health ### Study Description This study will develop and test whether personalized profiles of children with Disruptive Behaviour Disorder (DBD) and their parents based on important psychological, emotional, and neuropsychological indicators predict their response to child cognitive behavioral treatment and Behavioral Parent Training. ### Conditions - Disruptive Behavior Disorder - Emotional Disorder - Behavioural Disorder - Attention Deficit Hyperactivity Disorder - Conduct Disorder - Oppositional Defiant Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Behavioral Parent Training ### Outcomes Primary Outcomes - Changes in parenting skills between baseline, post-treatment, and follow-up (6 months - 1 year) - Changes in parenting competencies between baseline, post-treatment, and follow-up (6 months - 1 year) - Changes in child emotional and behavioral problems between baseline, post-treatment, and follow-up (6 months - 1 year) Secondary Outcomes ### Location - Facility: Centre for Addiction and Mental Health, Toronto, Ontario, M6J 1H4, Canada @@
## Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment - NCT ID: NCT06373471 - Study ID: S-20230101 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2026-09-30 - Lead Sponsor: Odense University Hospital ### Study Description The Improve study is a randomized controlled trial investigating the efficacy of adding comprehensive geriatric assessment and treatment to standard of care compared with standard of care in older, frail patients with hematological cancer. The investigators aim to recruit 152 study participants who will be randomized 1:1 to intervention- or control group. Study participants in the intervention group will receive the intervention comprehensive geriatric assessment and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation of comorbidity and frailty as is usual standard at Department of Hematology. Primary endpoint is elderly functional Index at 12 weeks. ### Conditions - Hematologic Malignancy - Treatment Adherence - Treatment Complication - Frailty - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Comprehensive geriatric assessment (CGA) and treatment ### Outcomes Primary Outcomes - Elderly functional Index Secondary Outcomes - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14). - Handgrip strength - 30-second chair stand test - Treatment toxicity - Adherence to hematological cancer treatment - Polypharmacy yes/no - Unplanned hospital admissions - Overall and cancer specific survival ### Location - Facility: Odense University Hospital, Odense C, N/A, 5000, Denmark @@
## Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy - NCT ID: NCT06373458 - Study ID: STUDY-23-01508 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-05 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis. ### Conditions - Keloid ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ritlecitinib ### Outcomes Primary Outcomes - Recurrence Rate - Change in Detroid Keloid Scale Score Secondary Outcomes - Change in Peak keloid tension - Change in Detroid Keloid Scale Score (DKS) - Change in Pain Numerical Rating Scale (Pain-NRS) - Change in Itch-NRS - Change in PGIC (Patient Global Impression of Change) - Change in DLQI (Dermatology Life Quality Index) ### Location - Facility: Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States @@
## Interventional Neuromodulation in Fibromyalgia - NCT ID: NCT06373445 - Study ID: 36264PR596 - Status: RECRUITING - Start Date: 2022-11-01 - Completion Date: 2024-04-15 - Lead Sponsor: Tanta University ### Study Description This study was conducted on 40 eligible fibromyalgia patients with sleep disorders. They were randomized to have 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over the right dorsolateral prefrontal area (DLPFC) for 5 sessions/week for 4 weeks. All participants were subjected to baseline evaluation with Fibromyalgia Impact Questionnaire, polysomnography, sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index and The Medical Outcomes Study Sleep Scale respectively.FM patients were reevaluated at 1, 3 months after the end of rTMS sessions. ### Conditions - Neuromodulation and Sleep Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - repetitive transcranial magnetic stimulation active stimulation - repetitive transcranial magnetic stimulation sham stimulation ### Outcomes Primary Outcomes - Pittsburgh Sleep Quality Index (PSQI) - The Medical Outcomes Study Sleep Scale (MOS ) - polysomnography Secondary Outcomes - Pittsburgh Sleep Quality Index (PSQI) - The Medical Outcomes Study Sleep Scale (MOS) - polysomnography ### Location - Facility: Faculty of medicine, Tanta, ElGharbia, 6620010, Egypt @@
## Frequency of Glucose Monitoring in Labor - NCT ID: NCT06373432 - Study ID: STUDY-22-01607 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-11-26 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth. ### Conditions - Neonatal Hypoglycemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Fingerstick ### Outcomes Primary Outcomes - Neonatal Hypoglycemia Secondary Outcomes ### Location - Facility: Mount Sinai West Hospital, New York, New York, 10019, United States @@
## TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors - NCT ID: NCT06373419 - Study ID: RP-1007 - Status: RECRUITING - Start Date: 2023-10-16 - Completion Date: 2026-10 - Lead Sponsor: Thunder Bay Regional Health Research Institute ### Study Description The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.The main question it aims to answer is:Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?Participants will randomized to either TFL of MOSES arm for their bladder resection procedure. ### Conditions - Urolithiasis of Bladder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TFL - MOSES holmium laser ### Outcomes Primary Outcomes - Presence of muscularis propria - Incidence of inconclusive pathology Secondary Outcomes - Tumor-free rate (TFR) - Total operative time - Total procedural time - Number of recurrences - Total blood loss - Rate of complications - Number of inconclusive pathology - Lasing time - Total energy used - Frequency and severity of peri-operative complications ### Location - Facility: Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, P7B 6V4, Canada @@
## A Study of MHB036C for Advanced Solid Tumor - NCT ID: NCT06373406 - Study ID: MHB036C-CP001CN - Status: RECRUITING - Start Date: 2023-05-18 - Completion Date: 2024-12 - Lead Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd ### Study Description Phase I/II, dose escalation and dose expansion study to evaluate the efficacy and safety of MHB036C in advanced malignant tumors. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MHB036C ### Outcomes Primary Outcomes - Incidence of participants with adverse events (AE) - Number of participants with dose-limiting toxicity (DLT) Secondary Outcomes - Maximum Plasma Concentration (Cmax) - The area under the plasma concentration-time curve (AUC) - To detectable anti-drug antibodies with treated subjects - Objective response rate (ORR) ### Location - Facility: Shanghai Chest Hospital, Shanghai, N/A, 200030, China @@
## SPIRIT: Study of the Patency of Spinal aRteries After the STABILISE Technique - NCT ID: NCT06373393 - Study ID: 1 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-16 - Completion Date: 2024-12-31 - Lead Sponsor: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA ### Study Description The aim of the study is to evaluate the impact of the stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique in the patency of intercostal and lumbar arteries detectable on computed tomography angiography (CTA) in patients with type B aortic dissection and its correlation with the occurrence of spinal cord ischaemia (SCI).Primary end-point: patency of the intercostal and lumbar arteries on follow-up CTA.Secondary end-point: spinal cord ischaemia ### Conditions - Aortic Dissection - Spinal Cord Ischemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - STABILISE ### Outcomes Primary Outcomes - number of patent intercostal and lumbar arteries Secondary Outcomes - number of patients with spinal cord ischemia ### Location - Facility: Unidade Local de Saúde Santa Maria, Lisbon, N/A, 1500, Portugal @@
## A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) - NCT ID: NCT06373380 - Study ID: 23-293 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-04 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description The researchers are doing this study to find out if HB-202/HB-201 is an effective treatment for people with HPV 16-positive head and neck squamous cell cancer (HPV 16+ HNSCC) who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx. Participants will have no evidence of cancer on imaging scans (radiographically) or by medical examination (clinically). Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer, though we do not know if testing positive will definitely lead to the cancer coming back (recurrence). The NavDx blood test has not been approved by the FDA and is considered investigational. ### Conditions - HPV16+ Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HB-200 - Placebo ### Outcomes Primary Outcomes - Disease free survival (DFS) Secondary Outcomes - Number of participants with adverse events (type, frequency, severity). ### Location - Facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## Preeclampsia Educational Program Study (PrEPS) - NCT ID: NCT06373367 - Study ID: 461-24 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-11-01 - Lead Sponsor: MemorialCare Health System ### Study Description Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions. ### Conditions - Preeclampsia - Preeclampsia Severe - Preeclampsia Mild - Preeclampsia Postpartum ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Illustration based application - Text based application ### Outcomes Primary Outcomes - Preeclampsia knowledge score - short Secondary Outcomes - Preeclampsia knowledge score - long - GAD-7 score - 72 hour BP check - Postpartum visit - Daily BP recordings - Accessed material - Unplanned readmission ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems - NCT ID: NCT06373354 - Study ID: 2023-0924 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2027-12-31 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT. ### Conditions - Architectural Distortions - Breast Tomosynthesis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Digital Breast Tomosynthesis (DBT) ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Hand and Arm Rehabilitation Using VR - NCT ID: NCT06373341 - Study ID: NL85317.099.23 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2027-01 - Lead Sponsor: Medical Centre Leeuwarden ### Study Description Patients admitted to the ICU due to critical illness often experience physical, mental, cognitive, or social issues. Research indicates that inadequate physical recovery is associated with lower handgrip strength, and hand function in ICU patients is lower compared to healthy individuals. To address this, a Virtual Reality (VR) exergame was developed to aid rehabilitation. This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength, hand and arm functionality, balance, mobility, and support needs in ICU patients staying for 48 hours or longer. It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients. The intervention involves a 4-week VR-exergame program. Main study parameters include handgrip strength, hand and arm functionality, range of motion, balance, mobility, and support needs. The burden and risks associated with participation are minimal, as VR-based exercises are deemed safe and voluntary. Overall, the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients. ### Conditions - Post-Intensive Care Syndrome - ICU Acquired Weakness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - VR training for arm and hand rehabilitation ### Outcomes Primary Outcomes - Handgrip strength Secondary Outcomes - Handgrip strength - Arm and hand functionality - Arm and hand functionality - Arm and hand range of motion - Balance and mobility - Support need and experience with VR training ### Location - Facility: Dept of intensive care, Medical Centre Leeuwarden, Leeuwarden, Friesland, 8901 BR, Netherlands @@
## Post Pandemic Pneumococcal Carriage Among Children and Adults - NCT ID: NCT06373328 - Study ID: STUDY00006081 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-03 - Lead Sponsor: University of Central Florida ### Study Description The PI propose to conduct a genomic epidemiology study of pneumococcal carriage among children and adults in a large metropolitan city. These data will allow PI to assess the post-pandemic population structure, investigate the phylogenetic relationship between isolates from children and adults, and compare pneumococcal populations across diverse geographic areas. ### Conditions - Pneumococcal Carriage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR. Secondary Outcomes - Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries. - Putative transmission networks between children and adult populations from online questionnaires. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Smartphone and Hand Anthropometry on Pain and Upper Extremity Functions - NCT ID: NCT06373315 - Study ID: 2023/11-18 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2025-05-02 - Lead Sponsor: Nigde Omer Halisdemir University ### Study Description Mobile phones have different uses in different disciplines, and this encourages long-term use. For optimum comfort use, it is important to ensure users' awareness when purchasing mobile phones that match their hand sizes. The number of studies in the literature on this subject is limited. In this context, the aim of our study is to investigate the relationship between smartphone and hand anthropometry measurements and upper extremity pain and functions. ### Conditions - Upper Extremity Problem - Smartphone Addiction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Hand anthropometric measurements: Hand length - Hand anthropometric measurements: Palm length - Hand anthropometric measurements: Width of the hand (Metacarpal) - Hand anthropometric measurements: Maximum hand spread measurement - Gross grip strength measurement - Pinch grip strength - Measurement of phone dimensions - Upper extremity functional status assessment Secondary Outcomes - Pain assessment - Smartphone addiction ### Location - Facility: Nigde Omer Halisdemir University, Bor Faculty of Health Sciences, Niğde, Nigde, 51700, Turkey @@
## Peripheral Arterial Disease Biomarkers - NCT ID: NCT06373302 - Study ID: IRAS 323948 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust ### Study Description The study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression. ### Conditions - Peripheral Arterial Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Correlation between PAD biomarker levels and walking distance. - Change in PAD biomarker levels following exercise therapy. - Change in PAD biomarker levels following endovascular intervention Secondary Outcomes - To determine whether biomarker levels normalise with improved walking distance. - To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention. - Levels of biomarkers and (Major Adverse Cardiovascular Events). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Target Oxygen Ranges in Infants With Pulmonary Hypertension - NCT ID: NCT06373289 - Study ID: 000539476 - Status: NOT_YET_RECRUITING - Start Date: 2025-07-01 - Completion Date: 2030-07-01 - Lead Sponsor: University of Alabama at Birmingham ### Study Description Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease. ### Conditions - Bronchopulmonary Dysplasia - Pulmonary Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - higher oxygen saturation target using Nellcor pulse oximetry sensors - lower oxygen saturation target using Nellcor pulse oximetry sensors ### Outcomes Primary Outcomes - Intermittent hypoxemia event duration Secondary Outcomes - Echocardiographic shunting - Echocardiographic interventricular septal flattening - Echocardiographic tricuspid regurgitation - Intermittent hypoxemia frequency - Cumulative hypoxemia - Brain natriuretic peptide ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category - NCT ID: NCT06373276 - Study ID: 1511 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-05 - Lead Sponsor: Dilshaad Basrai Vad ### Study Description The primary goal of this dissertation study is to determine if a home-based multiplanar balance training program with electronic assistance, will be effective in reducing one's fall risk category.Hypothesis: After 12 weeks, there will be a statistically significant decrease in the fall risk category for individuals in a home-based multiplanar balance training and educational program with electronic assistance as compared to no change in the fall risk category for individuals in an educational control group with electronic assistance Hypothesis: To determine if an individual's fear of falling is lower following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in fear of falling following an educational control group with electronic assistance post-intervention.Hypothesis: An individual's quality of life will improve following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in the quality of life following an educational control group with electronic assistance post-intervention.Hypothesis: Adherence and feasibility will be greater with a home-based multiplanar balance training program, with electronic assistance as compared to a control group with electronic assistance.Hypothesis: There will be a statistically significant inverse relationship between an individual's fear of falling and their fall risk category. ### Conditions - Fall Risk ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - multiplanar balance training exercise with education - education only ### Outcomes Primary Outcomes - Timed up and Go Test measured in Seconds - 3 stage balance test measured in seconds - 30-second chair stand measured in repeitions Secondary Outcomes ### Location - Facility: Metro PT, New York, New York, 10021, United States @@
## Evaluating Tools to Communicate Scleroderma Research Results to Patients - NCT ID: NCT06373263 - Study ID: 2024-4165 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-06 - Lead Sponsor: Lady Davis Institute ### Study Description Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients.The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs. ### Conditions - Scleroderma - Systemic Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Plain-language summary - Dissemination Tool (Infographic) ### Outcomes Primary Outcomes - Completeness - Understandability - Ease of use Secondary Outcomes - Please to have received results - Intention to participate in future studies - Open-ended items ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Maternal Consequences of Membrane Stripping - NCT ID: NCT06373250 - Study ID: sdilek7 - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2024-11-11 - Lead Sponsor: Kocaeli University ### Study Description This study aims to investigate the maternal effects of membrane stripping during vaginal birth. This study was designed as an experimental case-control study. The sample size in the study was determined by Njoku et al in 2023 to assess the effectiveness of membrane stripping applied to participants who had vaginal birth in reducing the incidence of prolonged pregnancy. Calculated based on the study conducted by. The sample size of the study was calculated using G\Power 3.1.9.2, and the mean and standard deviation of the Bishop score in the relevant article were used to calculate the effect size. Using the mean and standard deviation of the relevant article, the blended effect size was calculated as 0.596. The minimum number of individuals that should be included in the sample of this research was calculated using G\Power 3.1.9.2, effect size: 0.596, α= 0.05, power: 0.95 (stripping = 70, control = 70) and at least in each group in the sample size. The sample size was set at 70 participants. The research data will be collected by the researcher using the Informed Volunteer Consent Form, Participant Information Form, Bishop Scoring, Visual Analogue Scale, and Birth Satisfaction Scale Short Form, which were created by the researcher within the framework of the literature on the subject. ### Conditions - Maternal Care for Other Abnormalities of Cervix ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Membrane stripping group - Control group ### Outcomes Primary Outcomes - Visual analogue scale evaluation of vaginal examination pain - Visual analogue scale evaluation of vaginal examination pain - Evaluation of the cervix with Bishop score - Evaluation of the amount of bleeding - Birth Satisfaction Scale Short Form Secondary Outcomes ### Location - Facility: Kocaeli University, Kocaeli, N/A, 41380, Turkey @@
## Outcome of Embryos Transferred After Initial Chaotic Results on PGT-A - NCT ID: NCT06373237 - Study ID: INC-IG-2024-001 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2026-05 - Lead Sponsor: Inception Fertility, LLC ### Study Description This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed. ### Conditions - Infertility ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Frequency of embryo re-biopsy - Re-biopsy results - Embryo disposition - Embryo transfer outcome - Pregnancy outcome Secondary Outcomes ### Location - Facility: Inception Fertility LLC, Houston, Texas, 77081, United States @@
## Cold Saline Irrigation Before Endobronchial Biopsy - NCT ID: NCT06373224 - Study ID: 23-037 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-02-02 - Lead Sponsor: TriHealth Inc. ### Study Description Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies. ### Conditions - Lung Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Flush ### Outcomes Primary Outcomes - Incidence of unreadable biopsy slides Secondary Outcomes ### Location - Facility: Bethesda North Hospital, Cincinnati, Ohio, 45242, United States @@
## Early Immunotherapy With Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients With Anti-Hu-associated Paraneoplastic Sensory Neuronopathy - NCT ID: NCT06373211 - Study ID: APHP230701 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-06 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months. ### Conditions - Paraneoplastic Sensory Neuronopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Immunoglobulins IV (CLAYRIG) - Cyclophosphamide IV - Methylprednisolone IV ### Outcomes Primary Outcomes - Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months Secondary Outcomes - Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 and 6 months - Percentage of patients with improvement in the ataxic component on the Score of Ataxia scale at 3 and 6 months - Percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months - Percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 months - Percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months - Percentage of patients alive and without tumor progression at 6 months - Tolerance to treatment ### Location - Facility: Hôpital Pitié-Salpêtrière, Paris, N/A, 75013, France @@
## Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina. - NCT ID: NCT06373198 - Study ID: 0040/2023-versión 1.0 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-01-15 - Lead Sponsor: Hospital El Cruce ### Study Description Hepatitis C virus (HCV) is a leading cause of morbidity and mortality worldwide. This infection continues to represent a major global public health concern. This is why the introduction of potent antivirals for the treatment of HCV has been one of the major breakthroughs of the current medical era.From a public health perspective, HCV prevalence will be eliminated if the available treatment also targets those most likely to transmit the virus. Despite this scientific advance, a systematic review from the U.S. described that of the 43% of patients aware of their HCV diagnosis, only 16% started treatment. Clearly, the long-known barriers to accessing this treatment must be broken down in order to administer these effective antivirals. The World Health Organization (WHO) has set the ambitious goal of eliminating viral hepatitis as a public health threat by 2030. This goal is really difficult to achieve, especially in low and middle-income countries. Particularly in Argentina, there is a need to improve diagnosis, access to care, and treatment of viral hepatitis. The prospect of viral hepatitis elimination in our country is daunting due to the complexity of the health system and the cost of implementing different strategies. The most pragmatic approach would be to break down national elimination targets into smaller targets for individual populations, for which treatment and prevention interventions can be delivered more quickly and efficiently. This concept is known as micro-elimination. Focusing on micro-elimination of viral hepatitis means working to achieve the WHO target in specific subpopulations. Subpopulations known to have a higher prevalence of HCV infection include prisoners, people who inject drugs, and patients requiring hemodialysis, among others.Currently, patient unawareness of HCV infection represents one of the major barriers to treatment. In many cases, the diagnosis of HCV was established many years ago and patients do not seek treatment probably because they do not recognize the urgency of treating this asymptomatic infection. It is our goal, then, to identify the group of individuals who have been diagnosed with HCV infection but are not currently undergoing regular visits with health care professionals. This strategy is now called re-linking to the medical care of patients with chronic HCV. ### Conditions - Hepatitis C Chronic - Hepatitis C ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - standard of care ### Outcomes Primary Outcomes - rate of relinked HCV patients - proportion of relinked patients who received antiviral treatment Secondary Outcomes - Evaluation and characteristics of the treatment established ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children - NCT ID: NCT06373185 - Study ID: 2023/21 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-06 - Lead Sponsor: Giresun University ### Study Description The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases. ### Conditions - Urogenital Diseases - Nerve Block - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ultrasound-guided sacral erector spinae plane block - Ultrasound-guided caudal block ### Outcomes Primary Outcomes - Face, Leg, Activity, Cry, Consolability (FLACC) score Secondary Outcomes - Analgesic requirement - Satisfaction of the patient's parents - Satisfaction of the surgeons ### Location - Facility: Giresun Research and Training Hospital, Gi̇resun, Central, 28100, Turkey @@