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## Epidemiology of Bunion and Risk Factors - NCT ID: NCT06335459 - Study ID: Epidemiology of bunion - Status: NOT_YET_RECRUITING - Start Date: 2024-07-24 - Completion Date: 2025-06-01 - Lead Sponsor: Assiut University ### Study Description Analysis of the collected data to determine:* Prevalence.* Risk factors. Radiological and clinical patterns and their association with specific risk factors Of Hallux Valgus ### Conditions - Hallux Valgus and Bunion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - epidemiology ### Outcomes Primary Outcomes - History taken and well clinical examination and AP Foot standing position of 2000 randomly case with determination of Hallux Valgus angles knowing if It's Hallux Valgus or not calculating The prevalence Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation - NCT ID: NCT06335446 - Study ID: 011040- AT validation phase - Status: COMPLETED - Start Date: 2016-10 - Completion Date: 2019-10 - Lead Sponsor: Barts & The London NHS Trust ### Study Description Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence is increasing partly due to the aging population and it has been referred to as a growing epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of palpitations and increasing the risk of stroke, heart failure and death. Percutaneous catheter ablation is a safe treatment option in symptomatic patients with AF. The success rate of these procedures have improved with time due to our better understanding of AF, development of new techniques and technology, and greater physician experience. However, the success rate of these procedures still only remains around 70%. This is secondary to our limited ability to find the areas that drive AF.STAR mapping is a novel mapping system that has been developed with a view of better identifying the sites that drive AF through taking into account the mechanisms of AF we have so far demonstrated. To validate this mapping system we aim to use it in patients with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can be readily identified with the existing mapping systems used in clinical practice. We will demonstrate that the STAR mapping algorithm can effectively map AT. ### Conditions - Atrial Tachycardia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Novel mapping algorithm ### Outcomes Primary Outcomes - STAR maps compared to conventional maps Secondary Outcomes ### Location - Facility: Barts Heart Centre, London, N/A, EC1A 7BE, United Kingdom @@
## Isometric Handgrip Training Frequency and Blood Pressure in People With Hypertension - NCT ID: NCT06335433 - Study ID: RM_30_06_22b - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-03 - Lead Sponsor: Swansea University ### Study Description Hypertension is the most important cause of cardiovascular disease (CVD), stroke, and premature death (WHO, 2021). It is estimated by The World Health Organisation in 2021 that 1.4 billion individuals across the globe have high blood pressure, with only 14% of people actively managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Physical activity is one possible strategy: in previous research, several different types of physical activity have been shown to have beneficial effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of physical activity (150 mins of moderate intensity physical activity per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort, exertion, and physical discomfort (Korkiakangas et al 2009). Thus, there is a need to identify alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021, Toohey et al, 2018).Low intensity isometric hand grip exercise training (IET) has been shown to result in large decreases in resting blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IET has almost universally involved performing 4 x 2 IET holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). There are very few studies that have investigated the effect of changing different protocol parameters on changes in blood pressure and vascular health, and the minimal effective dose of IET is unknown. Defining the minimal effective dose of different types of exercise may help overcome key barriers to exercise by lowering the required time commitment, reducing perceived effort/exertion, and promoting more positive affective responses. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IET will reduce the efficacy for improving blood pressure.Therefore, the primary objective of this study is to determine if reducing the frequency of isometric handgrip training from four times a week to two times a week will affect the improvements in resting blood pressure and vascular health in people with hypertension. A secondary objective is to investigate the acute affective and perceptual responses to sessions of IET and the effect of training on these acute affective/perceptual responses. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise Training (Isometric Handgrip Exercise) ### Outcomes Primary Outcomes - Office measured supine and seated systolic, diastolic and mean arterial pressure Secondary Outcomes - Office measured central systolic, diastolic and mean arterial pressure - 24-h mean ambulatory systolic, diastolic, and mean arterial pressure - Daytime ambulatory systolic, diastolic, and mean arterial pressure - Sleeping ambulatory systolic, diastolic and mean arterial pressure - Carotid-Femoral Pulse Wave Velocity - Affective Valence (Feeling Scale) - Ratings of perceived exertion ### Location - Facility: Swansea University, Swansea, Wales, SA18EN, United Kingdom @@
## Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps - NCT ID: NCT06335420 - Study ID: 324-2023-GB - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-09 - Lead Sponsor: Odense University Hospital ### Study Description The goal of this prospective randomized double-blinded bi-national study is to test the prophylactic effect of polyacetylenes from carrots on the population of patients who had a resection of high-risk adenomas of the large bowel.The main question it aims to answer is: Will carrot juice rich in polyacetylenes inhibit neoplastic transformation and growth in high-risk humans?Participants will have to drink 100 ml of juice daily after the adenoma resection for 1 year and keep a simple diary/calendar.Researchers will compare the group with ingestion of FaOH/FaDOH rich carrot juice versus the group consuming placebo juice, to see if the polyacetylenes significantly reduces neoplastic transformation and growth in high-risk patients. ### Conditions - Colorectal Cancer Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Carrot juice from Yellowstone carrots cultivars - Placebo juice ### Outcomes Primary Outcomes - Number and size of polyps found at the one-year follow up colonoscopy Secondary Outcomes - Polyp number and size in relation to carrot consumption measurement - Compliance rate (Juice consumption level) - Side effects - Acceptability of treatment ### Location - Facility: Department of Surgery, Odense University Hospital, Odense, N/A, 5000, Denmark @@
## Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study - NCT ID: NCT06335407 - Study ID: AS210006-A08 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2025-10-29 - Lead Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance ### Study Description The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials. ### Conditions - Alcohol Use Disorder (AUD) - Post Traumatic Stress Disorder (PTSD) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg - Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg ### Outcomes Primary Outcomes - Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28. - Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28. - Number and Proportion of Adverse Events Secondary Outcomes - Change in PTSD symptoms (measured via the PTSD Checklist for Diagnostic and Statistical Manual (DSM-5) - Posttraumatic Stress Disorder Checklist (PCL-5) from baseline (pre-treatment) through day 28. - Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28. - Change in compulsive drinking (measured via the Obsessive Compulsive Drinking Scale - OCDS) from baseline (pre-treatment) through day 28. - Change in mood (measured by the Differential Emotions Scale - DES-R) from baseline (pre-treatment) through day 28. - Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28. - Change in affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28. - Change in overall functioning (measured by the Veteran's RAND 12-item Health Survey - VR-12) from baseline (pre-treatment) through day 28. - Change in cognitive functioning (measured by the Hopkins Verbal Learning Test Revised - HVLT-R) from baseline (pre-treatment) through day 28. - Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28. - Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28. ### Location - Facility: VA Connecticut Healthcare System, West Haven, Connecticut, 06516, United States @@
## Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion - NCT ID: NCT06335394 - Study ID: NVD003-CLN01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2018-08-02 - Completion Date: 2028-05-15 - Lead Sponsor: Novadip Biosciences ### Study Description The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion. ### Conditions - Recalcitrant Lower Limb Nonunion ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NVD003 ### Outcomes Primary Outcomes - Safety - Adverse Events - Safety - Abnormalities of vital signs - Safety - Abnormalities of vital signs - Safety - Abnormalities of physical examination - Safety - Abnormalities of physical examination - Safety - Abnormalities of physical examination - Safety - Abnormalities of laboratories - Safety - Abnormalities of laboratories - Safety - Abnormalities of laboratories Secondary Outcomes - Healing efficacy: plain X-ray - Healing efficacy: CT-scan - Healing efficacy: average time from Investigational Medicinal Product grafting surgery till first observation of plain X-ray and CT-scan confirmed fracture healing - Healing efficacy: investigator assessed clinical healing - Healing efficacy: average time from IMP grafting surgery to Investigator assessed clinical healing - Grafting Surgery parameters - Grafting Surgery parameters - Complications: rate of subsequent surgical interventions - Quality of Life: pain evaluation - Quality of Life: questionnaire EuroQol-5 Dimensions - Quality of Life: overall treatment effect - General Pre-graft implantation safety: all SAEs, AESI and PRAE - All SAEs during the extended safety follow-up period ### Location - Facility: Centre Hospitalier Interregional Edith Cavel (CHIREC) - Clinique Ste Anne-St Remi, Anderlecht, N/A, 1070, Belgium @@
## MOMs Chat and Care Study - NCT ID: NCT06335381 - Study ID: 24-0131 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-06-30 - Lead Sponsor: Northwell Health ### Study Description The purpose of this pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care for high-risk Black birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black birthing people (n = 674) will be recruited and randomized to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities. ### Conditions - Severe Maternal Morbidity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Northwell Pregnancy & Peds Chats - Prenatal Telehealth Visits - Postpartum Telehealth Visits - Home Blood Pressure Monitor - Fitbit ### Outcomes Primary Outcomes - Severe maternal morbidity (SMM) Secondary Outcomes - Preeclampsia - Informational Support - Emotional Support - Tangible Support ### Location - Facility: Northwell Health, Manhasset, New York, 11030, United States @@
## Assessment of Nutritional and Growth Status in Rett Syndrome Patients - NCT ID: NCT06335368 - Study ID: 201512178RINC - Status: COMPLETED - Start Date: 2016-03-09 - Completion Date: 2020-10-26 - Lead Sponsor: National Taiwan University Hospital ### Study Description Children with Rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. Past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer from osteoporosis and other problems. Lack of proper nutritional support will seriously affect their growth, development and health. in view of There is a lack of relevant research in China, so the investigators would like to use this research to explore the nutritional, growth and postural status of Rett's disease patients, as the reference direction and goal of dietary adjustment and nutritional support for patients, and establish dietary and nutritional strategies for sick children in Taiwan. ### Conditions - Rett Syndrome - Neurologic Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nutrition and Growth Status ### Outcomes Primary Outcomes - gender, age , disease history checklist - Change in Body height - Change in Body weight - Change in knee height - Change in arms height - Change in waist - Change in hip circumferences Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients - NCT ID: NCT06335355 - Study ID: SHR-1316-307 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2030-10 - Lead Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd ### Study Description Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations ### Conditions - Non-squamous Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin - Camrelizumab + Pemetrexed + Carboplatin - Adebrelimab + Pemetrexed + Carboplatin ### Outcomes Primary Outcomes - Investigator-assessed Objective Response Rate (Phase One) - Overall Survival (Phase Two) Secondary Outcomes - The incidence and severity of Adverse Events (AEs) (Phases One and Two) - Duration of Response (DoR) based on Investigator Assessment (Phases One and Two) - Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two) - Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two) - Overall Survival (OS) (Phase One) - Objective Response Rate (ORR) based on Investigator Assessment (Phase Two) ### Location - Facility: Affiliated Tumor Hospital of Shandong First Medical University, Jinan, Shandong, 250117, China @@
## Radiotherapy Treatments for Neoplasms in the Head and Neck Region - NCT ID: NCT06335342 - Study ID: IEO 0726 - Status: RECRUITING - Start Date: 2018-02-22 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description The aim of this study is the evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of radiotherapy treatments in the head and neck region.Eligible patients undergoing radiotherapy for primary or secondary neoplasms localized in the head and neck anatomical region. ### Conditions - Head and Neck Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall Survival - Disease free survival Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Point-of-Care Ultrasound (POCUS) Findings and Impact on Vaping - NCT ID: NCT06335329 - Study ID: Pro00133616 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-07 - Lead Sponsor: Medical University of South Carolina ### Study Description Vaping has emerged as a prominent public health crisis in recent years. In 2023, the National Youth Tobacco Survey found that more than 2.1 million adolescents endorse vaping, with 25% of those endorsing daily use. Many adolescents also perceive vapes as safer than cigarettes, and more acceptable to use both indoors and outdoors compared to cigarettes. Vapes are available in numerous device and delivery systems, with the psychoactive agent commonly including nicotine or cannabis, although these can be of a wide variety of concentrations and formulations. They may be ultra-compact and allow for ease of concealment. In addition, they are produced in a variety of appealing flavorings such as candy, desserts, and fruits. Other constituents include the liquids and aerosolized components of the vaping cartridges, including formaldehyde, acetone, glycerol, propylene glycol, acetaldehyde, and heavy metals. Many of the flavoring concentrates, as well as the vaporized solvents, have not been evaluated for long term safety. One of these additives, vitamin E acetate, present in primarily illicit vaping devices, rose to national attention in 2019 for a suspected link to the dramatic increase in vaping/e-cigarette associated lung injury (EVALI) cases, with over 60 confirmed deaths since that time.To our knowledge, there are no studies evaluating the lung ultrasound findings of asymptomatic vapers. However, there is data to suggest that vaping can lead to pulmonary toxicity in in-vitro and animal models, including increased inflammatory cytokines, hyperreactivity, and oxidative stress. In addition, studies found the risk of bronchitic symptoms is twice as likely in current adolescent vapers, compared to those who have never vaped before. Given the potential pulmonary toxicity of vaping, as well as the increased percentage of adolescent vaping activity in recent years, investigators aim to evaluate baseline lung ultrasound findings in adolescents who vape. Concurrently, investigators will assess if observing their lung ultrasound findings can alter their attitudes and behaviors towards vaping. Prior adult studies have found that showing patients' their atherosclerosis plaque increased the motivation to quit and cessation rates. Additionally, data in pregnant patients found real-time ultrasound feedback of smoking effects on the fetus lead to near abstinence in light smokers. Given the frequent use of point-of-care ultrasound in the emergency department, investigators hope to assess an innovative intervention for cessation. ### Conditions - Vaping ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Discussion of point-of-care ultrasound lung findings ### Outcomes Primary Outcomes - Lung Ultrasound Findings - Behavioral Changes Secondary Outcomes ### Location - Facility: Medical University of South Carolina, Charleston, South Carolina, 29412, United States @@
## Effect of Stellate Nerve Block in Dysphagia - NCT ID: NCT06335316 - Study ID: wallenburg sym - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-05-28 - Lead Sponsor: Copka Sonpashan ### Study Description This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Injection - Lidocaine Hydrochloride - Comprehensive therapy - placebo ### Outcomes Primary Outcomes - Functional Oral Intake Scale Secondary Outcomes - Yale Pharyngeal Residue Severity Rating Scale - penetration-aspiration scale - The Swallowing Quality of Life Questionnaire ### Location - Facility: Huimin Hos., Pengfu, N/A, N/A, Taiwan @@
## A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) - NCT ID: NCT06335303 - Study ID: 1462-0004 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-20 - Completion Date: 2026-06-30 - Lead Sponsor: Boehringer Ingelheim ### Study Description This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff.At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects. ### Conditions - Idiopathic Pulmonary Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BI 1819479 - Placebo matching BI 1819479 ### Outcomes Primary Outcomes - Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year] Secondary Outcomes - Absolute change from baseline in FVC at Week 24 [in milliLiter] ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Radiotherapy Treatments for the Treatment of Thoracic District Tumors - NCT ID: NCT06335290 - Study ID: IEO 725 - Status: RECRUITING - Start Date: 2018-02-22 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of thoracic radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the thoracic anatomical region. ### Conditions - Thoracic Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall survival - Disease free survival Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Total Body Irradiation Treatments for Patients Treated at European Institute of Oncology - NCT ID: NCT06335277 - Study ID: IEO 0727 - Status: RECRUITING - Start Date: 2018-02-22 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description Patients eligible undergoing total body irradiation as candidates for bone marrow or peripheral stem cell transplant. ### Conditions - Leukemia - Leukemia, Chronic - Leukemia, Acute - Lymphoma - Aplastic Anemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall Survival - Disease free survival Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Screening for Heart Failure Using a Multimodal Wearable Device - NCT ID: NCT06335264 - Study ID: 2024-9987 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-12 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description The purpose of this study is to find out if there are any patterns in the way people's bodies react to physical activities and their voices when they have heart failure, a disease where the heart cannot function sufficiently. To do this, the investigators will use a smartwatch that can measure multiple signals like the participant's heart rate and movement. Investigators will ask participants with and without heart failure to wear the Watch HOP (from HOP-Child Technologies Inc.) and sensors during physical tasks at their clinic visit at the McGill University Health Centre. Researchers will also record the participants' voices between their visits. The key signals can help find who is at risk for heart failure or develop new ways to monitor and treat it. ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Watch HOP ### Outcomes Primary Outcomes - Presence or absence of heart failure Secondary Outcomes - left ventricular ejection fraction (LVEF) - Natriuretic peptide (NT-proBNP) level ### Location - Facility: McGill University Health Centre, Montreal, Quebec, H4A 3J1, Canada @@
## Radiotherapy Treatments for Neoplasms of the Limbs - NCT ID: NCT06335251 - Study ID: IEO 0728 - Status: RECRUITING - Start Date: 2018-02-22 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description In this observational study patients treated at European Institute of Oncology with radiotherapy to limbs will be included ### Conditions - Bone Neoplasms - Bone Metastases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall survival - Disease free survival Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Radiotherapy Treatments for Neoplasms in the Abdominal-pelvic Region - NCT ID: NCT06335238 - Study ID: IEO 0729 - Status: RECRUITING - Start Date: 2018-02-22 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of abdominal-pelvic region radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the tabdominal-pelvic region. ### Conditions - Abdominal Cancer - Pelvic Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall survival - Disease free survival Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics - NCT ID: NCT06335225 - Study ID: 2023-NHLHCRF-YXHZ-ZRMS-06 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2025-07-31 - Lead Sponsor: China-Japan Friendship Hospital ### Study Description With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. The medical nutritional treatment of diabetes is recommended as the cornerstone of diabetes treatment by various guidelines. With the development of nutrigenomics, it has been found that genes related to the absorption, metabolism, distribution and excretion of various nutrients are related to diabetes. This study intends to conduct precision nutrition intervention for prediabetic patients based on nutritional genes, and evaluate the effectiveness and safety of these nutritional interventions. ### Conditions - Prediabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Precise nutritional intervention - Conventional nutritional intervention ### Outcomes Primary Outcomes - HbA1c Secondary Outcomes - Concentration of fasting plasma glucose - Concentration of 2-hour plasma glucose - Concentration of fasting insulin - Concentration of fasting C peptide - Concentration of TC, TG, LDL-C, and HDL-C - Concentration of ALT, AST, TBIL - Concentration of creatinine - BMI - Waist hip ratio ### Location - Facility: China-Japan Friendship Hospital, Beijing, N/A, N/A, China @@
## Peripheral Defocus Profile of Multifocal Minus Contact Lenses - NCT ID: NCT06335212 - Study ID: IRBNET ID 1448963 - Status: COMPLETED - Start Date: 2019-06-01 - Completion Date: 2019-08-05 - Lead Sponsor: State University of New York College of Optometry ### Study Description Purpose: Numerous studies have proven that emmetropization in young animals including humans is regulated by visual input. It has long been hypothesized that peripheral myopic defocus may act as a stop signal to reduce myopia progression and axial elongation. As such, multifocal soft contact lenses (MFCLs) have been utilized for myopia control in school-aged children, with variable efficacies. One potential explanation is that the actual peripheral myopic defocus an eye experiences during MFCL wear may not be identical to the Add power and not sufficient to reduce myopia progression. Our study investigated and compared the peripheral power profiles of myopic eyes when they were uncorrected and wore single vision contact lenses (SVCLs) and MFCLs of different Add powers.Methods: Subjects with -1.00 D to -10.00 D of myopia (SE, determined with manifest refraction) were custom fit with both single vision (SV) and MFCLs (+2.00 and +4.00 D Add; provided by Specialeyes) in both eyes. These Specialeyes MFCLs had an aspheric design with a standard total optical zone of 8.0mm. Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor (Grand Seiko Co Ltd) and OPD OPD-Scan III Wavefront Aberrometer (Marco) on the subjects in the following conditions: (1) no CLs, (2) SVCLs, (3) MFCLs (+2.00D Add), and (4) MFCLs (+4.00D Add). Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia. Data in the right eye was used for analysis. ### Conditions - Myopia - Refractive Errors - Contact Lens ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Single vision and multifocal contact lenses ### Outcomes Primary Outcomes - refractive power Secondary Outcomes ### Location - Facility: State University of New York, College of Optometry, New York, New York, 10036, United States @@
## tVNS Responsiveness Testing With Pupil Size - NCT ID: NCT06335199 - Study ID: H24109 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-04-30 - Lead Sponsor: Georgia Institute of Technology ### Study Description The goal of this study is to learn about the acute pupil response to transcutaneous vagus nerve stimulation (tVNS) in stroke survivors and healthy adults. The main question it aims to answer is whether pupil size response is greater with bilateral tVNS compared to unilateral tVNS. Participants will receive tVNS and sham at the outer ear unilaterally and bilaterally in resting condition. The pupil size of the participants will be recorded during tVNS. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Unilateral tVNS stimulation - Bilateral tVNS stimulation - Unilateral Sham stimulation - Bilateral Sham stimulation ### Outcomes Primary Outcomes - Pupil size change Secondary Outcomes ### Location - Facility: Human Neuromuscular Physiology Lab, Atlanta, Georgia, 30318, United States @@
## Predictive and Prognostic Significance of Age,Blood Tests,Comorbidities(ABC) Score,Cologne Watch(C-watch)Score and Rockall Score for Risk of Variceal Re-bleeding Among Cirrhotic Patients - NCT ID: NCT06335186 - Study ID: Soh-Med-24-03-04MS - Status: RECRUITING - Start Date: 2024-02-10 - Completion Date: 2025-03 - Lead Sponsor: Sohag University ### Study Description IntroductionPortal hypertension is a common complication of liver cirrhosis and is often underestimated in clinical diagnosis. The incidence of portal hypertension is approximately 20% to 98% in patients with cirrhosis (Wu et al., 2022). It is the major driver in the transition from the compensated to the 'decompensated' stage of cirrhosis, defined by the presence of clinical complications, including ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, and hepatic encephalopathy (Berzigotti., 2017).Acute variceal bleeding is one of the most lifethreatening complications of liver cirrhosis. Twenty two percent to sixty one percent of cirrhotic patients receiving primary prophylaxis will develop first variceal bleeding during the first two years of follow up. Furthermore, variceal bleeding is associated with high risk of rebleeding and mortality (Tantai et al., 2019).Patients with cirrhosis, although much progress has been made in diagnosis and treatment using vasoactive drugs, preventive antibiotics, early endoscopy and interventional radiology, the 6-week mortality rate remains high, ranging from 10 to 20%, mainly due to failure to control bleeding in the first days. Therefore, the prognostic method of patients with acute variceal bleeding is to determine the risk of rebleeding and resistance to standard treatment (accounting for 20-30%) and mortality rate in order to be able to adopt more aggressive treatment measures. The prognosis is very important but also difficult, not only because of the bleeding status but also depending on the severity of the underlying cirrhosis (Huy et al., 2023).Many risk factors are known to influence the outcome in Upper Gastrointestinal Bleeding (UGIB) setting: Age, comorbidities, presence of shock, endoscopic diagnosis, haemoglobin values at the time of bleeding, stigmata of recent haemorhage and need for blood transfusion have all been described as significant risk factors for rebleeding and death (Monteiro S et al., 2016).Many risk assessment score systems, including pre-endoscopy and post-endoscopy evaluations, have been developed to predict outcomes such as the need for hospital-based intervention, endoscopic therapy, and admission to an intensive care unit (ICU), rebleeding, and mortality. Some studies showed that these scoring systems distinguish low-risk patients who can potentially be managed as outpatients, allowing more efficient use of resources. Other studies suggested that these score systems distinguish higher-risk patients who might require emergency endoscopy or management in an intensive care unit (Li et al., 2022).In 1993, the Rockall Scoring system was introduced to predict the mortality after UGIB and was validated for its use to identify the patients at high risk for re-bleed and mortality. Complete Rockall scoring system is based on an initial clinical score at the time of admission which consist of age (score 0-2), presence of shock (0-2), co-morbidities (score 0-3) and post endoscopic diagnosis (score 0-2) with stigmata of recent hemorrhages (score 0-2). Both clinical and post endoscopic scores added together gives a complete Rockall score with maximum score being 11 (Dewan et al., 2018).In 2020, Laursen S.B. and colleagues conducted a multicenter international study and developed a new prognostic scoring system for UGIB called the ABC score. This scoring system is based on three criteria: age, blood test results, and comorbidities. The score ranges from 0 to 18 points, categorizing the risk into low (≤3 points), moderate (4-7 points), and high (≥8 points) levels. The 30-day mortality rates for high-risk UGIB patients in these three risk groups were 1%, 7%, and 25%, respectively ( Ky et al., 2023)The new Cologne Watch (C-Watch) score was designed as a pre-endoscopic score for acute variceal and non-variceal UGIB and incorporates laboratory values only (c-reactive protein, white blood cell count, alanine-aminotransferase, thrombocytes, creatinine, and hemoglobin) with a minimum point value of 0 and a maximum point value of 8. Within the validation set, it predicted a composite endpoint consisting of recurrent bleeding, need for intervention (interventional radiology, surgery), or death within 30 days with an area under the receiver-operating characteristics curve (AUROC) of 0. About 38.7% of patients were within the high-risk group, i.e., ≥2 points, reached the composite endpoint, whereas no patient classified as low risk (≤1 point) (Allo et al., 2022). ### Conditions - Upper Gastrointestinal Variceal Bleeding in Cirrhotic Patients ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - upper endoscopy ### Outcomes Primary Outcomes - ABC score. - Rockall score Secondary Outcomes ### Location - Facility: Sohag university Hospital, Sohag, N/A, N/A, Egypt @@
## A Study to Evaluate Efficacy and Safety of Intravenous ACU193 in Participants With Early Alzheimer's Disease (ALTITUDE-AD) - NCT ID: NCT06335173 - Study ID: ACU193-201 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2031-01 - Lead Sponsor: Acumen Pharmaceuticals ### Study Description The primary purpose of this study is to evaluate the efficacy of ACU193 infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ACU193 - Placebo ### Outcomes Primary Outcomes - Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score Secondary Outcomes - Change from Baseline in ADCS-iADL Score - Change from Baseline in ADAS-Cog13 Score - Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) - Change from Baseline in Mini-Mental State Examination (MMSE) - Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) - Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score - Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) - Change from Baseline in Resource Utilization in Dementia (RUD) - Change from Baseline in Zarit Burden Interview (ZBI) - Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS - Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL - Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13 - Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB - Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE - Percentage of Participants with No Clinical Progression at One Year - Number of Participants with Treatment-Related Adverse Events (TEAEs) - Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) - Number of Participants who Discontinue or Withdraw due to TEAE - Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies - Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI) - Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) - Serum Concentration of ACU193 - Concentration of ACU193 in Cerebrospinal Fluid (CSF) - CSF Concentrations of ACU193 in a Subset of Participants - Correlation Between ACU193 Exposure with Clinical Efficacy Measures - Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids - Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest - Target Engagement Assessed by Measurement of ACU193- Amyloid-β oligomer (AβO) Complex in CSF - Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers - Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants - Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers - Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes ### Location - Facility: Banner Alzheimer's Institute- Clinical Trials Department, Phoenix, Arizona, 85006, United States @@
## Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine - NCT ID: NCT06335160 - Study ID: Mebendazole Ulcerative Colitis - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Tanta University ### Study Description To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine ### Conditions - Ulcerative Colitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mebendazole ### Outcomes Primary Outcomes - change in disease activity - change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity Secondary Outcomes - Change in Hemoglobin Concentration - Change in Erythrocyte sedimentation rate (ESR) - Change in Serum albumin - Change in Serum Interleukin -6 (IL-6) - Change in Serum Nitric oxide (NO) - Change in Serum Intra cellular adhesion molecule 1 (ICAM-1) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer - NCT ID: NCT06335147 - Study ID: HLX10IIT114 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-01-31 - Lead Sponsor: Henan Cancer Hospital ### Study Description Evaluate the efficacy and safety of PD1 monoclonal antibody combined with mFOLFOX6 neoadjuvant therapy for advanced resectable metastatic colon cancer with enriched pro-inflammatory pan macrophage subpopulations ### Conditions - Metastatic Colon Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Serplulimab, mFOLFOX6 ### Outcomes Primary Outcomes - pathologic complete response（pCR） Secondary Outcomes - Objective response rate (ORR) - 2-year overall survival rate - Incidence of Treatment-Emergent Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin - NCT ID: NCT06335134 - Study ID: SCW0502-1016 - Status: RECRUITING - Start Date: 2023-07-14 - Completion Date: 2024-03-31 - Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. ### Study Description This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - XW003 injection - Metformin - Warfarin - Rosuvastatin - Digoxin ### Outcomes Primary Outcomes - Pharmacokinetics of metformin: AUC0-inf - Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf - Pharmacokinetics of rosuvastatin: AUC0-inf - Pharmacokinetics of digoxin: AUC0-inf Secondary Outcomes ### Location - Facility: West China Second University Hospital, Sichuan University, Chengdu, Sichuan, N/A, China @@
## Implementation of PrEP Care Among Women in Family Planning Clinics - NCT ID: NCT06335121 - Study ID: 21120602 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-06 - Lead Sponsor: Rush University Medical Center ### Study Description This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers. ### Conditions - PrEP Uptake - HIV - Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - POWER Up strategies - ### Outcomes Primary Outcomes - PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP. Secondary Outcomes - Receipt of PrEP refills among Black women accessing FP services at 6 months. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 ) - NCT ID: NCT06335108 - Study ID: SenoEx_TLA_Maligne - Status: RECRUITING - Start Date: 2022-12-05 - Completion Date: 2024-12-01 - Lead Sponsor: University Hospital Tuebingen ### Study Description The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery. ### Conditions - Breast Carcinoma - Breast Carcinoma in Situ ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - General Anaesthesia - Local tumescent anaesthesia ### Outcomes Primary Outcomes - Postoperative Pain Secondary Outcomes - HRQoL/ Quality of life - Postoperative pain medication requirements - Complications - Length of hospital stay - Duration of surgery - Drainage delivery rate - Follow-up surgery for R1 situation - Preoperative fear of surgery and anaesthesia - Costs - Satisfaction of the surgeon with the course of the operation ### Location - Facility: University Women's Hospital, Tübingen, N/A, 72076, Germany @@
## Gait Analysis and Degenerative Spine - NCT ID: NCT06335095 - Study ID: a319 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-09 - Lead Sponsor: Universidade Nova de Lisboa ### Study Description The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:* What are the biomechanical variables affected by the disease* How they evolve with disease progression and treatment ### Conditions - Spinal Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Kinematic sensors ### Outcomes Primary Outcomes - Change from baseline in gait parameter - speed (m/s) - at 3 months - Change from baseline in gait parameter - speed (m/s) - at 6 months - Change from baseline in gait parameter - speed (m/s) - at 12 months - Change from baseline in gait parameter - step length (m) - at 3 months - Change from baseline in gait parameter - step length (m) - at 6 months - Change from baseline in gait parameter - step length (m) - at 12 months - Change from baseline in gait parameter - step width (m) - at 3 months - Change from baseline in gait parameter - step width (m) - at 6 months - Change from baseline in gait parameter - step width (m) - at 12 months Secondary Outcomes - Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months - Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months - Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months - Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months - Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months - Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months - Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months - Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months - Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months - Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months - Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months - Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF - NCT ID: NCT06335082 - Study ID: DISRUPT-AF - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-01-30 - Lead Sponsor: Heart Rhythm Clinical and Research Solutions, LLC ### Study Description The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF). ### Conditions - Atrial Fibrillation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pulsed Field Ablation ### Outcomes Primary Outcomes - Long term effectiveness - Long-term safety Secondary Outcomes ### Location - Facility: Arrhythmia Institute at Grandview, Birmingham, Alabama, 35243, United States @@
## 18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer. - NCT ID: NCT06335069 - Study ID: 2023-508066-15-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03 - Lead Sponsor: Maastricht University Medical Center ### Study Description The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients. ### Conditions - Breast Cancer - Breast Neoplasms - Breast Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI ### Outcomes Primary Outcomes - To investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a radioactive PET tracer in patients with ER+ breast cancer. Secondary Outcomes - To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI. ### Location - Facility: Maastricht University Medical Center+, Maastricht, N/A, 5800, Netherlands @@
## Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools - NCT ID: NCT06335056 - Study ID: IRBAM-21-0702 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-19 - Completion Date: 2026-04 - Lead Sponsor: Louisiana State University and A&M College ### Study Description This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost. ### Conditions - Treatment (ProudMe) - Waitlist Control ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - ProudMe - Waitlist Control ### Outcomes Primary Outcomes - Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers - Screen time - Food environment Secondary Outcomes - Body mass index z score - Waist circumference ### Location - Facility: LSU Pedagogical Kinesiology Lab, Baton Rouge, Louisiana, 70803, United States @@
## Personalized Pharmacotherapy Using Pharmacogenetics in Veterans - NCT ID: NCT06335043 - Study ID: 119245 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: Lawson Health Research Institute ### Study Description This study is an observational clinical trial aimed at to evaluate the use of pharmacogenetic testing (PGx) for mental health treatment in members and Veterans of the CAF and RCMP patient population as well as the attitudes of both St. Joseph's OSI Clinic Psychiatrists and patients towards PGx. Both OSI Clinic Psychiatrists participants and patient participants will be administered a brief demographic survey in addition to a survey examining their views on, and current knowledge of PGx. Patient participants will have an opportunity to opt-in to or opt-out of receiving PGx. For patient participants who opt-in to PGx (PGx-guided treatment group), a report summarizing the PGx results will be sent to each patient participants' respective OSI Clinic Psychiatrist, alongside a questionnaire that captures the OSI Clinic Psychiatrist participant's treatment planning and changes to treatment planning. Where applicable, past treatment data from patient participants acquired at the St. Joseph's OSI Clinic will be used to identify the number of prior medication changes. Patient participants who opt-out of PGx but continue to receive pharmacologic care at the St. Joseph's OSI Clinic will act as a standard care comparator treatment group. Patient participant's outcomes including PTSD, depression and anxiety severity, and medication-related side effects, will be assessed until the patient participant is discharged from the OSI Clinic or after 24 weeks, whichever comes first. All patient participants, regardless of their study treatment group, will have their symptomatology collected via standard care data collection protocol (Client Reported Outcomes Monitoring Information System (CROMIS) and electronic medical records (EMR)); a self-report assessing the presence of side effects will be completed via Lawson REDCap. OSI Clinic Psychiatrist participants and patient participants will be asked to complete a virtual exit interview at the end of their participation. ### Conditions - Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pharmacogenetics Testing ### Outcomes Primary Outcomes - PHQ-9 - Patient Health Questionnaire 9 - GAD-7 - General Anxiety Disorder-7 - PCL-5 - Posttraumatic Stress Disorder Checklist - 5 - OQ-45 - Outcome Questionnaire 45 - Pharmacological Side Effect Measure - Electronic Medical Record Extraction Measure Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism - NCT ID: NCT06335030 - Study ID: 2.1_AUT-SP2_001_Tancredi - Status: RECRUITING - Start Date: 2021-03-29 - Completion Date: 2024-11-30 - Lead Sponsor: IRCCS Fondazione Stella Maris ### Study Description Brief Summary: Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as Autism Spectrum Disorder (ASD) , both on an individual level, both on family and social ones .Children (2-6 years) diagnosed with ASD according to Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM5) criteria were enrolled in an observational, cross-sectional and multicentric study conducted by three different Italian clinical centers. Regarding this sample, principal aims of the study are to describe characteristics of food selectivity, to evaluate its correlation with ASD symptoms, with cognitive and adaptive functioning of ASD preschoolers, to describe its impact on parental stress. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Child Oral and Motor Proficiency Scale (ChOMPS) - Brief Autism Mealtime Behavior Inventory (BAMBI) - Sensory Profile 2 (SP2) - Child Behavior Checklist (CBCL) - Parenting Stress Index (PSI) - Observation of child meal-time - Food Diary - Gastrointestinal severity symptom index (GSSI) - Mac Arthur Secondary Outcomes - Autism Quotient (AQ) - Autism Diagnostic Observation Schedule-2 (ADOS-2) - Vineland-II scales (VABS II) ### Location - Facility: IRCCS Stella Maris, Pisa, PI, 56128, Italy @@
## Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous - NCT ID: NCT06335017 - Study ID: 294-2024-HFH - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-12 - Lead Sponsor: Holy Family Hospital, Nazareth, Israel ### Study Description The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in multiparous women.The main question it aims to answer are:Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline.In the control group, the catheter will be inserted into cervical canal without ingestion of castor oil. ### Conditions - Induction of Labor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Induction of labor ### Outcomes Primary Outcomes - time to delivery Secondary Outcomes - balloon expulsion time - Bishop score at catheter expulsion - Number of women that will have non-vertex presentation after removal of the catheter - Duration of active phase - Duration of second stage - Mode of delivery - Indications for cesarean or vacuum deliveries - Number of patients that will have intrapartum fever ≥ 38 °C - Number of patients that will require use of intrapartum use of antibiotic treatment - Number of Participants with that will develop clinical signs of chorioamnionitis. - Number of Participants with that will develop 3rd and 4th degrees perineal lacerations. - Number of Participants with develop postpartum hemorrhage. - Number of Participants with need blood transfusion. - Number of women that will have side effects related to castor oil use - Oxytocin dosage - Number of participants with Umbilical Cord prolapse. - Number of neonates that will have Apgar score (range 0 to 10) <7. - number of women with cord artery pH <7.1 - Neonatal birthweight - Number of neonates with Neonatal fever ≥ 38 °C - The number of neonates that will develop neonatal sepsis. - The number of neonates that will require antibiotic treatment. - number of neonates with any neonatal complications - The number of neonates that will Admit to neonatal intensive care unit (NICU) - Length of stay in NICU. - Number of neonatal death - Maternal hemoglobin level after delivery. - Number of participants that will require postpartum hysterectomy. - Number of participants that will require postpartum laparotomy. - Number of women that will develop postpartum complications - The length of stay from birth to discharge home. - Maternal satisfaction ### Location - Facility: Holy Family hospital, Nazareth, Nazareth, N/A, N/A, Israel @@
## Evaluation of Brain Waste Clearance Pathways Using Magnetic Resonance Imaging in Pediatric Patients With White Matter Diseases - NCT ID: NCT06335004 - Study ID: 926 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-03-01 - Completion Date: 2025-02-28 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description The dilation of perivascular spaces can be the result of various etiopathogenetic processes. White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies. Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. Dilation of PVS can be associated with changes in white matter and microhemorrhages. We want to study these etiopathogenetic phenomena by implementing specific MRI methods. ### Conditions - Glymphatic System - White Matter Disease - Pediatric Disorder - Perivascular Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Magnetic resonance imaging ### Outcomes Primary Outcomes - Extent of white matter lesions - Number of perivascular spaces - Volume of parasagittal dural space Secondary Outcomes ### Location - Facility: Scientific Institute IRCCS Eugenio Medea, Bosisio Parini, Lecco, 23842, Italy @@
## Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma - NCT ID: NCT06334991 - Study ID: QUILT-106 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-03-30 - Lead Sponsor: ImmunityBio, Inc. ### Study Description Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL). ### Conditions - Non-Hodgkin Lymphoma Refractory/ Relapsed ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CD19 t-haNK ### Outcomes Primary Outcomes - Overall safety evaluation in combining CD19 t haNK as a single agent with rituximab - Incidence of treatment-emergent AEs (TEAEs) and serious AEs (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 5.0.Clinically important changes in safety laboratory tests and vital signs. Secondary Outcomes - Best tumor response in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effectiveness of Osteopathic Treatment in Cervical Whiplash. - NCT ID: NCT06334978 - Study ID: 1-2024 - Status: COMPLETED - Start Date: 2021-01-13 - Completion Date: 2022-08-10 - Lead Sponsor: Hospital San Juan de Dios del Aljarafe de Sevilla ### Study Description Introduction. Whiplash is common after road traffic accidents and affects millions of people worldwide; 50% develop chronic symptoms and 15% have their ability to work compromised. The aim of this study was to evaluate an osteopathic intervention in whiplash and determine whether pain, mobility and quality of life improve with respect to conventional treatment.Methodology. A randomised, controlled clinical trial between 13/01/2021_10/08/2022 conducted at Hospital San Juan de Dios del Aljarafe. The control group followed the hospital's protocol, and the experimental group also received an osteopathic intervention. Statistical analysis: Statistical Package for the Social Sciences (SPSS-vs27.0); intra-subject comparison: Student's t-test for dependent samples, Wilcoxon's test; inter-group comparisons: Student's t-test for independent samples, Mann-Whitney U, chi-squared. ### Conditions - Whiplash Injury of Cervical Spine - Osteopathia - Quality of Life - Chronic Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Osteopathic intervention ### Outcomes Primary Outcomes - Cervical Pain - Quality of life in Whiplash Disability - Functionality-Neck Disability Index Secondary Outcomes - Number of sites - Number of analgesics ### Location - Facility: María Victoria RUIZ ROMERO, Bollullos de la Mitación, Sevilla, 41110, Spain @@
## Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort - NCT ID: NCT06334965 - Study ID: APHP230279 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2029-09 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI.Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic and follow-up PET-MRI, in patients with HCC treated with TARE. ### Conditions - Hepatocellular Carcinoma - Radioembolization ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Simultaneous 18F-Choline PET-MRI ### Outcomes Primary Outcomes - Clinical response Secondary Outcomes ### Location - Facility: Beaujon hospital, Clichy, N/A, N/A, France @@
## Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic - NCT ID: NCT06334952 - Study ID: RCAPHM23_0074 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-04-30 - Lead Sponsor: Assistance Publique Hopitaux De Marseille ### Study Description The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are:* Changes in quality of life* Percent of newly reported side effects after the stimulation period* Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total). ### Conditions - Epilepsy - Drug Resistant Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - transcranial direct current stimulation ### Outcomes Primary Outcomes - To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. - To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. - To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. - To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. Secondary Outcomes - Evaluation of the number of responders (defined as patient with >50% of seizure reduction) - Evaluation of the number of responders (defined as patient with >50% of seizure reduction) - Evaluation of the number of responders (defined as patient with >50% of seizure reduction) - Evaluation of the number of responders (defined as patient with >50% of seizure reduction) - Evaluate the number of seizure-free patients - Evaluate the number of seizure-free patients - Evaluate the number of seizure-free patients - Evaluate the number of seizure-free patients - Quality of life after stimulation sessions with the baseline period - Quality of life after stimulation sessions with the baseline period - Quality of life after stimulation sessions with the baseline period - Quality of life after stimulation sessions with the baseline period - Evaluation of the change in seizure severity - Evaluation of the change in seizure severity - Evaluation of the change in seizure severity - Evaluation of the change in seizure severity - Changes in psychiatric comorbidities - Changes in psychiatric comorbidities - Changes in psychiatric comorbidities - Changes in psychiatric comorbidities - Safety assessment and possible side effects - Safety assessment and possible side effects - Safety assessment and possible side effects - Safety assessment and possible side effects ### Location - Facility: Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques, Bordeaux, N/A, 33000, France @@
## Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries - NCT ID: NCT06334939 - Study ID: KSH.2023-32 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-05-30 - Lead Sponsor: Ahmet Yuksek ### Study Description Emergence agitation; generally refers to a situation that may occur after a surgical intervention or anesthesia. This situation describes the irritability and agitation of the patient during the recovery process and the period of recovery from anesthesia. Recovery agitation may occur when the patient begins to recover and is usually a short-term condition. It resolves spontaneously. However, in some cases, this agitation may be more pronounced and disturbing. This may affect the patient\&#39;s condition and relaxation. Rapid recovery from anesthesia in the clinic is also a risk factor for agitation.When the literature is examined, there are not enough studies on Bis suppression ratio and its relationship with recovery agitation is not yet known enough. For this purpose, our study aimed to question this relationship. ### Conditions - Emergence Agitation - Anesthesia Recovery - Bispectral Index Monitor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bispectal index Monitoring ### Outcomes Primary Outcomes - Relationship between BIS SR value and Emergence Agitation Secondary Outcomes - Relationship between average and lowest BIS values and Emergence agitation ### Location - Facility: Kocaeli City Hospital, Kocaeli, Izmıt, 41100, Turkey @@
## BMI and Lymph Node Count in Colorectal Cancer - NCT ID: NCT06334926 - Study ID: EK 18-002-VK - Status: COMPLETED - Start Date: 2017-12-01 - Completion Date: 2020-03-31 - Lead Sponsor: Klinikum Floridsdorf ### Study Description Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS. ### Conditions - The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long Term ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention, retrospective data analysis ### Outcomes Primary Outcomes - overall survival Secondary Outcomes ### Location - Facility: Klinik Floridsdorf, Wien, N/A, 1210, Austria @@
## A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms - NCT ID: NCT06334913 - Study ID: IRAS 332286 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-04-01 - Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust ### Study Description The investigators will assess the use of a smart phone app to monitor patient reported outcomes and record biometric data in patients with myeloproliferative neoplasms. ### Conditions - Myeloproliferative Neoplasm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Patient reported outcomes - Myeloproliferative Neoplasm-10 Total Symptom Score Secondary Outcomes - Healthcare adherence - Biometric data analysis - activity index - Biometric data analysis - sleep score - Biometric data analysis - heart rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia - NCT ID: NCT06334900 - Study ID: 69HCL24_0297 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-06-30 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic encephalitis (LE) and temporal lobe epilepsy. These syndromes all seem to result from a reduced transmission of GABA. These neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. When finding high levels of GAD65-Ab in the serum, a cerebrospinal fluid (CSF) sample should be taken to look for oligoclonal IgG bands and intrathecal GAD-Ab production to prove an auto-immune cause for the various neurological symptoms. ### Conditions - GAD-receptor Antibodies-associated Encephalitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - GAD patients ### Outcomes Primary Outcomes - GAD Patient Secondary Outcomes ### Location - Facility: Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est, Bron, N/A, 69677, France @@
## esTOCma, an App Used by Teachers: an RCT - NCT ID: NCT06334887 - Study ID: PID2021-124409OB-I00_O3 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-05-31 - Lead Sponsor: University of Valencia ### Study Description The aim of the present study is to assess the efficacy of a mobile application called esTOCma in promoting mental health literacy, reducing stigmatizing attitudes related to the Obsessive-Compulsive Disorder (OCD) and improving teachers' confidence in dealing with students that might have OCD. A parallel, randomized controlled trial with two conditions (experimental and control group) will be carried out in a sample of teachers that work in primary and secondary education. Pre-post changes will be assessed. Experimental group will use the app until they finish it (within a set period of 10 days), whereas control group will do nothing for 10 days. Primarily, it is expected that after the use of the app, participants will show an improvement in OCD-related literacy, stigmatizing attitudes, desired social distance and their comfort, confidence and perceived ability in teaching and handling students with OCD. Secondarily, the investigators hypothesize that experimental group might show a reduction in obsessive-compulsive symptoms. ### Conditions - Obsessive-Compulsive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Use of esTOCma ### Outcomes Primary Outcomes - Change in general OCD literacy - Change in OCD literacy associated with a vignette - Change in stigmatizing attitudes related to OCD associated with a vignette - Change in comfort in addressing OCD - Change in desired social distance Secondary Outcomes - Change in obsessive-compulsive symptoms ### Location - Facility: University of Valencia/ Universitat de València, Valencia, N/A, 46010, Spain @@
## Study of the Efficacy and Safety of Antioxidants Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients. - NCT ID: NCT06334874 - Study ID: REC-FPFUE-32/2023 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-08-01 - Lead Sponsor: Future University in Egypt ### Study Description Community acquired pneumonia (CAP) is one of the most common and morbid conditions encountered in clinical practice, which causes serious morbidity worldwide. In CAP, oxidative stress is linked to inflammation, demonstrated by increased production of interleukin (IL)-6 and tumor necrosis factor (TNF)-α, which attract inflammatory cells and increase oxidant production by these cells. Attenuation of oxidative stress via antioxidants would be expected to result in reduced pulmonary damage. Antioxidants have been found to be effective in alleviating lung injury and protecting against damage of other organs. ### Conditions - Community-acquired Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Astaxanthin Oral Capsule - Placebo ### Outcomes Primary Outcomes - change in IL-6 after treatment in the ASX group compared with those in the control group. - change in IL-10 after treatment in the ASX group compared with those in the control group. - change in tumor necrosis alpha after treatment in the ASX group compared with those in the control group. Secondary Outcomes - difference in CURB 65 scores after treatment in the ASX group compared with the control group. - o Adverse drug reactions related to ASX as increase bowel movement, stomach pain and increase PT and APTT will be assessed. - Length of hospital and ICU stay. ### Location - Facility: Elmatarya Teaching Hospital, Cairo, N/A, 4650201, Egypt @@
## Multidisciplinary Hospital-Territory Vaccine Center: a Model for Achieving the Herpes Zoster Vaccine Coverage - NCT ID: NCT06334861 - Study ID: 5001 - Status: RECRUITING - Start Date: 2022-06-23 - Completion Date: 2024-06-30 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The National Vaccination Program, updated by the Ministry of Health in 2021, provides a new vaccination opportunity for frail patients against Herpes zoster virus (HZ). The new treatment option, on the other hand, is designed by combining VZV-specific antigen (gE) with an adjuvant system (AS01B) to induce antigen-specific cellular and humoral immune responses in individuals with preexisting immunity to VZV. Efficacy, assessed in people given two doses 2 months apart, is around 97% in those aged 50 years and 91% in those over 70 years. In the studies conducted, HZ-related hospitalizations were significantly reduced. The vaccine schedule calls for the administration of two doses 2 months apart. The current HZ Vaccination Program implemented at the regional level recommends its active and free offer in people from 18 years of age with congenital and/or acquired immunodepression, through a collaborative relationship involving, on the one hand, multispecialist and multiprofessional medical staff and, on the other hand, citizens called to play a role that is no longer passive but the subject of empowerment by consciously making their own health choices. The collaboration with ASL Roma1, in this sense, acquires value as guarantor of the supply of the adjuvanted recombinant anti-HZ vaccine and of the appropriate reporting of vaccination coverage, which to date is still far from the targets set by the PNPV'17-'19 in adults at risk for disease.The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients' compliance with the proposed vaccination, the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting. ### Conditions - Herpes Zoster ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Herpes Zoster adjuvanted recombinant vaccine ### Outcomes Primary Outcomes - Compliance to vaccination Secondary Outcomes ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli - UCSC, Roma, RM, 00168, Italy @@
## Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence - NCT ID: NCT06334848 - Study ID: TOT versus mini sling - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-09 - Lead Sponsor: Ain Shams University ### Study Description To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence. ### Conditions - Stress Urinary Incontinence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transobturator tape ### Outcomes Primary Outcomes - Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications - Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain Secondary Outcomes - Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Long Non-coding RNAs and Their Role on Epigenome as Diagnostic Markers in Childhood Acute Lymphoblastic Leukemia of T Cells. - NCT ID: NCT06334835 - Study ID: 1/23 OSS SDN - Status: RECRUITING - Start Date: 2023-04-30 - Completion Date: 2026-05-31 - Lead Sponsor: IRCCS SYNLAB SDN ### Study Description Long non-coding RNAs (lncRNAs) are a class of biomarkers of crescent interest in the hematologic and oncologic field.They do not encode proteins and can alter gene expression by acting on different steps of regulation, including DNA methylation and chromatin structure. Recent data identified recurrent somatic alterations in genes involved in DNA methylation and post-translational histone modifications in T-ALL, suggesting that epigenetic homeostasis is critically required in restraining tumor development in the T-cell lineage. Further, recent studies showed that the expression levels of specific lncRNAs correlate with the prognosis of patients with Acute Lymphoblastic Leukemia of T-cells (T-ALL). The objectives of this research project are to identify T-ALL-specific lncRNAs to be used as new diagnostic and prognostic biomarkers of disease and to explore their role on chromatin reorganization and transcriptional regulation that may lead to the onset and progression of T-ALL. ### Conditions - Acute Lymphoblastic Leukemia, Pediatric ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lncRNA signature analyses ### Outcomes Primary Outcomes - Evaluation of the expression of selected lncRNAs in pediatric T-ALL patients and cellular models of T-ALL Secondary Outcomes ### Location - Facility: Irccs Synlab Sdn, Naples, N/A, 80143, Italy @@
## Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK. - NCT ID: NCT06334822 - Study ID: HFT-2024-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-04-30 - Lead Sponsor: Heartfelt Technologies ### Study Description The objective of our research is to evaluate the effectiveness of an innovative medical device designed to measure foot and lower leg sizes in detecting early indications of deteriorating heart failure. This health condition frequently causes leg swelling and breathing difficulties due to fluid accumulation. Early detection of these symptoms is vital for effective management, potentially preventing the need for hospitalization.Fluid retention in the lower legs and lungs, manifesting as swollen ankles and shortness of breath, is a common sign of progressing heart failure. Often, a slight increase in body weight is the first warning of fluid accumulation, occurring before noticeable swelling or breathing issues arise. Early identification of these fluid accumulation signs is critical for timely intervention, which can avert the necessity for hospital admittance. Patients are usually encouraged to monitor their weight, check for swelling in the ankles, observe their breathing, and consult with their healthcare provider or heart failure specialist at the first sign of these symptoms. In many cases, patients can report these symptoms in time for their healthcare team to adjust their treatment accordingly. Diuretics, or water pills, are often prescribed to help eliminate excess fluid, effectively preventing hospital admissions when used promptly.The Heartfelt device may provide a useful solution for individuals who find it challenging to consistently monitor these indicators and their weight. It is designed to detect early warning signs seamlessly without imposing additional tasks on the patient's daily routine. The device, intended to complement rather than replace self-monitoring practices, is user-friendly and operates by scanning the feet for any size changes, positioned conveniently by the bedroom floor. This capability allows healthcare professionals to make informed decisions swiftly about patient care, potentially adjusting treatments to avoid further health complications. The device captures images of the feet only, ensuring privacy.This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for patients facing heart failure challenges. ### Conditions - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Heartfelt Device installed - Standard care - Questionnaires - Heartfelt Device in pharmacy - Heartfelt device alerting system ### Outcomes Primary Outcomes - All-Cause Mortality Rate. - Heart Failure Hospitalisation Incidence. - Device-Related Complication Rate. Secondary Outcomes - Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices - Hospital Admission Duration - Cause of Hospitalization - Date of Changes in HF Medication Post-Discharge - Changes in dosage of HF Medication Post-Discharge - Cause of Death - Date of Death - Loss of Independence - Hospitalisation Admission Route - Scheduling of Care Events - Setting of Care Events - Timestamp of Health Alerts Generated by the Heartfelt Device - Frequency of Health Alerts Generated by the Heartfelt Device - Foot volume - Peripheral oedema grading - Weight ### Location - Facility: Dr R Raut & Partnership (General Practice), Hull, East Riding Of Yorkshire, HU7 5DD, United Kingdom @@
## INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations - NCT ID: NCT06334809 - Study ID: 028FPO22 - Status: RECRUITING - Start Date: 2023-03-09 - Completion Date: 2027-12-31 - Lead Sponsor: Fondazione del Piemonte per l'Oncologia ### Study Description 400 patients will be enrolled and divided into 3 cohorts: Cohort A: patients with high risk localized prostate cancer (PC) defined as \>cT3 or PSA \> 20 ng/mL or presence of ECE or SVI at mpMRI;Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC);Cohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment. ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number, type and frequency of DDR and MMR germline/somatic alterations - Changes in PSA levels in the 3 cohorts Secondary Outcomes - Number of patient-derived preclinical models ### Location - Facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, Candiolo, Turin, 10060, Italy @@
## Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology - NCT ID: NCT06334796 - Study ID: 10476 - Status: COMPLETED - Start Date: 2023-10-01 - Completion Date: 2024-01-01 - Lead Sponsor: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia ### Study Description This study examines the use of an AI-powered virtual assistant for quickly identifying and handling neurological emergencies, particularly in places with limited medical resources. The research aimed to check if this AI tool is safe and accurate enough to move on to more advanced testing stages. In a first-of-its-kind trial, the virtual assistant was tested with patients having urgent neurological issues. Neurologists first reviewed the AI's recommendations using clinical records and then assessed its performance directly with patients. The findings were as follows: neurologists agreed with the AI's decisions nearly all the time, and the AI outperformed earlier versions of Chat GPT in every tested aspect. Patients and doctors found the AI to be highly effective, rating it as excellent or very good in most cases. This suggests the AI could significantly enhance how quickly and accurately neurological emergencies are dealt with, although further trials are needed before it can be widely used. ### Conditions - Stroke - Guillain-Barre Syndrome - Facial Palsy - Migraine - Status Epilepticus - Vertigo Benign Positional - Delirium - Trigeminal Neuralgia - Meningitis - Subarachnoid Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Virtual Assistant ### Outcomes Primary Outcomes - Diagnostic performance Secondary Outcomes - Appropriate medical conduct or recommendation - Assessment of Usability and Satisfaction ### Location - Facility: Fleni, Buenos Aires, N/A, 1428, Argentina @@
## TIL for Patients With Advanced Solid Tumor - NCT ID: NCT06334783 - Study ID: HV-IIT - Status: RECRUITING - Start Date: 2023-05-30 - Completion Date: 2026-12-31 - Lead Sponsor: Hervor Therapeutics ### Study Description Background:Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to patients.TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical cancer.Objective:To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor.Eligibility:Adults aging 18-75 with advanced solid tumor.Design:1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.2. Freshly resected patient tumors were dissected by the surgeon.3. TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded.4. At last TIL cells will be re-infused into the patients. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Autologous tumor-infiltrating lymphocyte cells ### Outcomes Primary Outcomes - Safety of TIL Secondary Outcomes - Overall Response Rate (ORR) - Duration of Response (DOR) - Disease Control Rate (DCR) - Progression free survival (PFS) - Overall survival (OS) ### Location - Facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, Guangdong, N/A, China @@
## Influence of Roxolid Implant Material on the Implant Stability Implant Stability - NCT ID: NCT06334770 - Study ID: FDASuRecD032136 - Status: COMPLETED - Start Date: 2021-06-15 - Completion Date: 2023-12-12 - Lead Sponsor: Ain Shams University ### Study Description Fourteen completely edentulous patients were selected to participate in this study. From the outpatient clinic of Prosthodontic Department, Faculty of Dentistry, Ain Shams University.After fabrication of complete denture for all patients, patients were randomly divided to:Group A: Seven patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® implant were inserted opposed by mandibular complete denture.Group B: Seven patients were rehabilitated with implant retained maxillary overdenture where four conventional acid etched implants were inserted opposed by mandibular complete denture.After implant placement using surgical guide, smart peg and ostell device were used to measure the primary stability of the implant then cover screw was placed and after six weeks, secondary stability was measured for both groups.After four months, the second stage started in which exposure of the implant fixtures took place and pick up was carried out.Patients were recalled frequently for post-insertion inspection and adjustment. ### Conditions - Completely Edentulous Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Roxolid implants - Titanium implants ### Outcomes Primary Outcomes - measuring primary at time of surgery Secondary Outcomes - secondary implant stability after 6 weeks ### Location - Facility: Faculty of Dentistry of Dentistry Ainshams Univeristy, Cairo, N/A, N/A, Egypt @@
## Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure - NCT ID: NCT06334757 - Study ID: HLX10IIT22 - Status: RECRUITING - Start Date: 2023-05-08 - Completion Date: 2025-06-30 - Lead Sponsor: Henan Cancer Hospital ### Study Description The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients. ### Conditions - Non-Squamous Non-Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Serplulimab - Bevacizumab Biosimilar HLX04 - Pemetrexed - Carboplatin ### Outcomes Primary Outcomes - ORR(Overall Response Rate) Secondary Outcomes - PFS(Progression Free Survival) - OS(Overall Survival) - AE(Adverse Event) ### Location - Facility: Henan Cancer Hospital, Zhengzhou, Henan, 450003, China @@
## Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active. - NCT ID: NCT06334744 - Study ID: COVAR - Status: COMPLETED - Start Date: 2021-11-17 - Completion Date: 2023-06-08 - Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia ### Study Description To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine. ### Conditions - Oncologic Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Determination of the change in neutralizing antibodies against SARS-CoV-2 (CLIA method) towards VOCs before the third dose of COVID-19 vaccine and 21 days after the same. Secondary Outcomes - Evaluation of the kinetics of neutralizing antibodies and anti-SARS-CoV-2 IgG titer (CLIA method) up to 52 weeks after the third dose of COVID-19 vaccine - Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine. - Evaluation of the incidence of local and systemic adverse reactions (ARs), directly or indirectly linked to the vaccine, in an observation period up to 4 weeks later the third dose of vaccine. - Evaluation of the incidence of "New onset" immune-related adverse events (IRAEs), such as immune-related pruritus, rashes, hypophysitis, hepatitis, pneumonia, diarrhoea, colitis in patients undergoing immunotherapy. ### Location - Facility: Irccs San Matteo Pavia, Pavia, PV, 27100, Italy @@
## Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic - NCT ID: NCT06334731 - Study ID: 045.PHA.2021.D - Status: RECRUITING - Start Date: 2021-07-06 - Completion Date: 2024-12 - Lead Sponsor: Methodist Health System ### Study Description Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic. ### Conditions - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of third generation cephalosporin-resistant bacteria (3GCRB) Secondary Outcomes - Incidence of ESBLPE - Incidence of CRB - Incidence of other pathogens - Incidence of nosocomial infections - Incidence of clinical outcomes ### Location - Facility: Methodist Dallas Medical Center, Dallas, Texas, 75203, United States @@
## Drone Delivered Defibrillators (The 3D Project). - NCT ID: NCT06334718 - Study ID: 318417 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2024-10-31 - Lead Sponsor: University of Warwick ### Study Description The goal of this observational study is to explore the optimisation and integration of a drone-delivered Automated External Defibrillator (AED) system into the pre-hospital response to out-of-hospital cardiac arrest. The study is being conducted by the University of Warwick and Welsh Ambulance Service National Health Service Trust (both in the UK)There are two separate packages of work. In work package 1 the investigators will interview people who have been involved in emergency (999) calls for cardiac arrest, asking them about their experiences with the call-handler and how they feel they might have responded if they had received an AED that had been delivered by a flying drone.In work package 2 the investigators will conduct simulated cardiac arrests. The participants in the study will make an emergency (999) call to a trained call-handler and, once the cardiac arrest is identified during the call, a drone will be activated from a distant location and fly up to 2km to the test site and deliver an AED. The investigators will record how long it takes to retrieve and attach the AED, and ask the participants for their views about the interaction with the call-handler, AED and drone. ### Conditions - Cardiac Arrest, Out-Of-Hospital ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Interviews and simulation ### Outcomes Primary Outcomes - Time away from patient's side (SIMULATION) - Barriers and facilitators to drone-delivered AED use (INTERVIEW) Secondary Outcomes - Interventions to overcome barriers to drone delivered AED use (INTERVIEW) - Hands off CPR time (SIMULATION) - Total time from start of 999 call to AED application and first shock (SIMULATION) - Total drone flight time (SIMULATION) - Time from drone arrival to safe to approach (SIMULATION) ### Location - Facility: University of Warwick, Coventry, N/A, N/A, United Kingdom @@
## EGEA4 THE 30 YEAR FOLLOW UP OF THE EGEA STUDY - NCT ID: NCT06334705 - Study ID: C22-11 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2028-02-15 - Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France ### Study Description Cardiovascular (CV) diseases affect 523 million people worldwide, and are the leading cause of death, accounting for over 18 million deaths (around 30% of all deaths) every year. CV diseases account for around 45% of all deaths in Europe, or around 140,000 deaths a year in France. Asthma is one of the main non-communicable diseases, with a significant societal and individual burden, particularly in subjects suffering from severe asthma. The prevalence of asthma worldwide has risen rapidly over the past five decades, and now affects 272 million people worldwide, representing a prevalence of around 3.6%.Asthma is often associated with multimorbidity. Allergic rhinitis, chronic sinusitis, sleep apnea syndrome, gastro-oesophageal reflux disease, obesity and hormonal disorders are among the most common conditions associated with asthma. More recently, other chronic conditions linked to asthma have been suggested, including CV diseases.Although data from the literature in recent years suggest that asthma is associated with an increased risk of major CV events, the underlying mechanisms remain poorly understood. In particular, it is not known whether asthma and CV disease share common etiological processes, such as anthropometric parameters, lifestyle, social, environmental and/or genetic factors, or whether CV disease is a direct consequence of certain features of asthma, such as systemic inflammation or asthma treatments.Our study is based on the hypothesis that the risk of CV events is increased in patients with asthma, which is supported by a growing body of scientific data.However, it remains to be determined to what extent this increased risk is a consequence of asthma or is linked to shared risk factors between asthma and CV health.We hypothesize that asthma, and more specifically adult and moderate-to-severe asthma, are associated with early markers of CV risk. Furthermore, by providing a better understanding of the mechanisms involved in this association, we hypothesize that EGEA_30years may help to disentangle and prioritize actionable levers of life-threatening cardiovascular comorbidities in asthma. ### Conditions - Healthy Volunteer EGEA4 Cohort ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - blood test, food collection, hair collection, calcium scan, etc. ### Outcomes Primary Outcomes - Framingham score variability between asthmatics and non-asthmatics Secondary Outcomes - Aortic pulse wave velocity - validated predictive biomarkers of CV disease (NTproBNP, Troponin(I) hs), - Soluble ST2 - coronary calcium score ### Location - Facility: Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, N/A, 38043, France @@
## Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome - NCT ID: NCT06334692 - Study ID: BLINDER - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-05 - Lead Sponsor: Mario Negri Institute for Pharmacological Research ### Study Description This retrospective study is aimed at evaluating the levels of circulating anti-nephrin autoantibodies in patients with INS, including those with MCD/FSGS and in patients who have experienced relapse of FSGS post-transplant, compared to those of a control group of patients with nephrotic syndrome due to primary membranous nephropathy (MN). ### Conditions - Nephrotic Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa). ### Outcomes Primary Outcomes - Levels of circulating anti-nephrin autoantibodies Secondary Outcomes ### Location - Facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò, Ranica, BG, 24020, Italy @@
## The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage - NCT ID: NCT06334679 - Study ID: zeynepersoz - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-12-15 - Lead Sponsor: Marmara University ### Study Description Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. It has been reported that the incidence of itching is high in burn patients during the maturation stage of wound healing. The literature suggests that in managing the symptom of itching, skin hydration support along with cold application methods can also be used. The integrity of the skin, the duration, frequency, characteristics, areas of itching, and identifying conditions that increase or decrease itching are important for managing itching. This study is planned to be conducted with a randomized controlled design to examine the effect of applying cold gel packs to burn areas of burn patients during the maturation stage on itching. This researcher's hypothesis is that burn patients who applied cold gel packs to burn areas during the maturation phase had lower itching severity (frequency, duration, intensity) than those who did not. ### Conditions - Burns - Pruritus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cold Gel Packet Application ### Outcomes Primary Outcomes - Itching severity - Itching grade Secondary Outcomes ### Location - Facility: Kartal Dr.Lütfi Kırdar City Hospital, Istanbul, N/A, N/A, Turkey @@
## The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD. - NCT ID: NCT06334666 - Study ID: SI 172/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-01 - Lead Sponsor: Mahidol University ### Study Description The study conducted a health survey among Thai adults in 2022 and found a significant increase in obesity and nonalcoholic fatty liver disease (NAFLD), leading to metabolic-associated steatotic liver disease (MASLD). The prevalence of NAFLD was 19.7%, with higher rates in individuals with metabolic syndrome and diabetes. MASLD is associated with insulin resistance and genetic polymorphisms, particularly the patatin like phospholipase domain containing 3-rs738409 variant. Additionally, physical activity was inversely related to liver disease risk, with higher step counts associated with reduced incidence of NAFLD and liver-related mortality. The study aims to investigate the impact of dietary advice and pedometer use on physical activity levels and health outcomes in MASLD patients over 24 weeks. ### Conditions - Daily Step Count - MASLD - BMI - Metabolic Syndrome - NAFLD - Insulin Resistance - Genetic Polymorphism - Cardiovascular Disease (CVD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Encourage using pedometer ### Outcomes Primary Outcomes - To compare the changes in hepatic fat accumulation assessed by MRI-PDFF between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior. Secondary Outcomes - To compare changes in metabolic parameters between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments. - To study the impact of genes on changes in hepatic fat accumulation between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exercise-regulated Organ Crosstalk, Influence of IL-6 - NCT ID: NCT06334653 - Study ID: H-23069670 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-09 - Completion Date: 2024-11-01 - Lead Sponsor: Helga Ellingsgaard ### Study Description Overall the study investigates organ crosstalk during exercise. More specifically, the study investigates the role of IL-6 in regulating glucose, fatty acid, and amino acid kinetics at whole body level and in skeletal muscle, liver, and brain. Furthermore, the study investigates the uptake and release of extracellular vesicles in skeletal muscle, liver, and brain in reponse to exercise. ### Conditions - Healthy Volunteers Only - Energy Metabolism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - exercise ### Outcomes Primary Outcomes - Whole body substrate kinetics. - Tissue specific utilization and production of substrates. - IL-6 regulation of protein synthesis and degradation. - Number of EVs from muscle, liver, and brain. - Size of EVs from muscle, liver, and brain. - EVs from muscle, liver, and brain. - Influence of exercise on EV number. - Influence of exercise on EV size - Influence of exercise on EV content. - Tissue specific proteomic content of EVs. Secondary Outcomes - Lactate. - Pyruvate. - Keto acids. - Ketone bodies. - Influence of IL-6 on fatty acid oxidation rates. - Influence of IL-6 on insulin. - Influence of IL-6 on glucagon. - Influence of IL-6 on epinephrine. - Influence of IL-6 on norepinephrine. - IL-6 levels. - Influence of IL-6 on substrate usage. - Influence of IL-6 on perceived exertion. ### Location - Facility: Rigshospitalet, Copenhagen, Capital Region, 2100, Denmark @@
## Sleeping Quality and Chronic Ocular Diseases - NCT ID: NCT06334640 - Study ID: 37C302 - Status: RECRUITING - Start Date: 2023-10-17 - Completion Date: 2025-10-17 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description To assess the impact of sleep quality on chronic eyes diseases ### Conditions - Sleep Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Three questionaires ### Outcomes Primary Outcomes - Proportion of sleep disorders in patients and healthy volunteers Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano IRCCS, Milan, N/A, 20145, Italy @@
## Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania - NCT ID: NCT06334627 - Study ID: ENREACH - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-05-03 - Completion Date: 2024-09-15 - Lead Sponsor: London School of Hygiene and Tropical Medicine ### Study Description The goal of this clinical trial is to test the effect of a pre-primary education parent group intervention in children with and without disability in Nepal Bangladesh and Tanzania. The main question it aims to answer are:* What is the impact of a parent group intervention on primary school readiness in children aged 5-6 years old in three LMICs?* What is the feasibility and accessibility of a parent group intervention for these children?Participants will attend parent group sessions every two weeks for a total of 9 sessions. Researchers will compare a control group to see if there are impacts on school readiness and child development. ### Conditions - Child Development - Child Development Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Pre-Primary Intervention ### Outcomes Primary Outcomes - Measuring Early Learning Quality and Outcomes (MELQO Tool) - The Pediatric Evaluation of Disability Inventory Secondary Outcomes - Washington Group Questionnaire - The Wechsler Preschool & Primary Scale of Intelligence - Pre-school Register - Mental Health Questionnaire - Pediatric Quality of Life Inventory (PEDSQL Tool) ### Location - Facility: International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, N/A, N/A, Bangladesh @@
## iReach: a Rehabilitative Medical Device - NCT ID: NCT06334614 - Study ID: IIT_iReach - Status: NOT_YET_RECRUITING - Start Date: 2024-12-08 - Completion Date: 2025-12-08 - Lead Sponsor: Istituto Italiano di Tecnologia ### Study Description The broad goal of this clinical trial is to demonstrate whether a one-month rehabilitative training with our medical device, iReach, can promote the recovery of spatial and sensorimotor abilities and the cortical reorganization process in children with visual impairment between 3 and 36 months of age. ### Conditions - Blindness - Visual Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - iReach ### Outcomes Primary Outcomes - Incidence of Device Adverse Events Secondary Outcomes - Change in motor skills after training with iReach medical device - Perceptual responses to multisensory stimuli - Change in motor abilities following the rehabilitation with the iReach medical device - Variation in the power of the cortical activity following the rehabilitation with the iReach medical device ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness - NCT ID: NCT06334601 - Study ID: 09C333 - Status: RECRUITING - Start Date: 2023-01-15 - Completion Date: 2025-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description In the framework of pathophysiological trait in obstructive sleep apnea (OSA) patients, a simplified method is proposed to measure upper airway (UA) collapsibility and muscle responsiveness during wakefulness. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tests of upper airway collapsibility and muscle responsiveness. ### Outcomes Primary Outcomes - Upper airway collapsibility - Upper airway muscle responsiveness Secondary Outcomes ### Location - Facility: IRCCS Istituto Auxologico Italiano,Ospedale San Luca, Milano, N/A, 20145, Italy @@
## Understanding the Mechanisms of Autism : an MRI and Social Cognition Study - NCT ID: NCT06334588 - Study ID: APHP240105 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2031-04 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - MRI - Eye-tracking - Clinical Scales - Research of genetic anomalies ### Outcomes Primary Outcomes - Rest cerebral blood flow (CBF) Secondary Outcomes - Measurements of white matter microstructure - fractional anisotropy - Measurements of white matter microstructure - mean diffusivity - Measurements of white matter microstructure - radial diffusivity - Measurements of white matter microstructure - axial diffusivity - Measurements of resting state functional connectivity - Correlation between social perception and multimodal brain imaging - Correlation between clinical severity and multimodal brain imaging - Imaging abnormalities associated with known genetic mutations - Social perception abnormalities associated with known genetic mutations - Anatomic changes over time - study of developmental trajectory - Social perception changes over time - study of developmental trajectory - Brain imaging in young children associated with ASD - Early data on social perception ### Location - Facility: Hôpital Necker Enfants Malades, Paris, N/A, 75015, France @@
## Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels - NCT ID: NCT06334575 - Study ID: 2023-505245-13-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-12 - Lead Sponsor: Maria Joyera Rodríguez ### Study Description The 3TR-ICS COPD study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers COPD patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage, not receiving ICS (either naïve or \> 3 months since last usage). The overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ICS treatment in patients with COPD stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Budesonide ### Outcomes Primary Outcomes - Significant molecular changes in COPD stratified by their blood eosinophil counts. Secondary Outcomes - Significant molecular changes in COPD with different airflow limitation severities. ### Location - Facility: Philips University of Marburg, Marburg, N/A, N/A, Germany @@
## The Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery - NCT ID: NCT06334562 - Study ID: KY-2023-112 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-31 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description This study aims to compare the use of sugammadex (domestic) and neostigmine for antagonism after thoracic surgery, and observe the effect of sugammadex (domestic) on neuromuscular blockade antagonism after thoracic surgery, in order to provide a basis for optimizing the use of muscle relaxants and their antagonists during anesthesia. ### Conditions - Neuromuscular Blockade ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SUGAMMADEX SODIUM 100 Mg in 1 mL - Neostigmine ### Outcomes Primary Outcomes - Muscle relaxation recovery time Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia - NCT ID: NCT06334549 - Study ID: LSKY2023-107-01 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-12-05 - Lead Sponsor: Dalian Municipal Central Hospital ### Study Description The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane. ### Conditions - Hypotension Drug-Induced ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ephedrine-P - Phenylephrine-P - Norepinephrine-P - Ephedrine-S - Phenylephrine-S - Norepinephrine-S ### Outcomes Primary Outcomes - Continual changes in Cerebral Oxygen Saturation Secondary Outcomes - Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) - Continual changes in heart rate (HR) - Continual changes in stroke volume (SV) - Continual changes in cardiac output (CO) - Continual changes in systemic vascular resistance (SVR) ### Location - Facility: Dalian Municipal Central Hospital, Dalian, Liaoning, 116033, China @@
## Multi-country Survey on Violence Against Women Among Medical Staff - NCT ID: NCT06334536 - Study ID: 0832/66 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Chulalongkorn University ### Study Description The goal of this observational study is to investigate the knowledge, attitude, and practice (KAP) towards violence against women (VAW) among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countriesThe main question it aims to answer is:* the KAP towards VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries* the KAP towards support service of VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countriesParticipants will be asked to complete the online self-administrated questionnaire. ### Conditions - Violence Against Women ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - KAP towards VAW - KAP towards support service of VAW Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout - NCT ID: NCT06334523 - Study ID: Volem - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: Centre Hospitalier Intercommunal Creteil ### Study Description The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional ventilation to reduce or even cancel dead space due to respiratory prostheses. This objective is particularly interesting in the smallest preterm infants in which the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L/min at tip of endotracheal tube to purge expired CO2 trapped in the prostheses to have a CO2-free volume of gas available for subsequent insufflation. ### Conditions - Extremely Low Birthweight Infant - Continuous Tracheal Gas Insufflation - Medical Device - Lung Protection - Ventilator-Induced Lung Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ventilation ### Outcomes Primary Outcomes - cumulative duration of non-invasive ventilation periods in living patients Secondary Outcomes - The pressure gradient of the ventilation - The age at the definitive withdrawal of any ventilatory support (PPS) - Definitive weaning age of invasive ventilation - Definitive O2 weaning age - the death rate - The rate of recourse to the HFO - The level of pneumothorax - The rate of bronchopulmonary dysplasia (BPD) diagnosed - Rate of postnatal systemic corticosteroid therapy - Duration of exposure to systemic sedatives - The cumulative day invasive ventilation - Non-programmed extubation rate - Rate of secondary blooddstream infection - neuroimaging complication - Neurodevelopmental monitoring - Pulmonary inflammation by cytokine dosage for intubated patients - Pulmonary inflammation by cytokine dosage for intubated patients - Pulmonary inflammation by cytokine dosage for intubated patients - rate of Retinopathy rank >1 - severe hypoxemia - Additional dose of surfactant ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations. - NCT ID: NCT06334510 - Study ID: HL-SJLG-2021-Ⅳ-01 - Status: COMPLETED - Start Date: 2021-11-17 - Completion Date: 2023-03-28 - Lead Sponsor: Hualan Biological Bacterin Co. Ltd. ### Study Description To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare adverse reaction of 1‰. ### Conditions - GCP ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - One dose of quadrivalent influenza virus split vaccine was administered ### Outcomes Primary Outcomes - To evaluate the safety and immunogenicity of Hualan Biovar quadrivalent influenza vaccine in a larger population in the real world, and to observe rare adverse drug reaction (ADR) of 1‰. Secondary Outcomes - To explore the consistency of three consecutive batches of commercial vaccines for vaccination in adults aged 18-59 years. ### Location - Facility: Kou Zengqiang, Jinan, Shandong, 250000, China @@
## Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections - NCT ID: NCT06334497 - Study ID: APH220791 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy (in association with valganciclovir) in renal transplant recipients with CMV DNAemia, requiring valganciclovir treatment per investigator's judgment. ### Conditions - Cytomegalovirus Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Letermovir - Valganciclovir - Letermovir placebo ### Outcomes Primary Outcomes - Virological response to treatment on week-3 Secondary Outcomes - Eradication of CMV DNAemia (< 200 IU/ml) before Week-12 - Number of days between baseline and first measure of CMV DNAemia < 200 IU/mL - Absence of CMV-related symptoms at baseline and each visit - Adverse event (AE) occurence - Sequencing of whole UL97, UL54, UL56, UL89 and UL51 genes - Ganciclovir plasma concentration - Letermovir plasma concentration - Measure of the CMV specific T-cell immunity ### Location - Facility: Hôpital Necker Enfants Malades, Paris, N/A, 75015, France @@
## Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics - NCT ID: NCT06334484 - Study ID: 6413 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2026-03-26 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential in the therapeutical management of subjects with T1DM (1). The Diabetes Complications and Control Trial (DCCT) has showed that intensive insulin treatment was associated with a reduction in the onset of complications related to diabetes. In recent years, treatment of T1DM evolved rapidly because of the significant improvements in the use of technology (2). With the spread of continuous glucose monitoring (CGM) systems, standardized metrics, summarizing time spent within optimal glucose range (time in range - TIR), time below target glucose range (TBR) and time above target glucose range (TAR), have become commonly used metrics in clinical practice (3,4). Furthermore, glucose management indicator (GMI) estimates glycated haemoglobin from the average glucose level of CGM readings for 14 days and coefficient of variation (CV) evaluates the amplitude of glucose excursions.Advanced hybrid closed loop (AHCL) systems combine insulin pump infusion and real time CGM (rtCGM) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected and can administer automatic corrective boluses in case of hyperglycaemia (6). Different algorithms, as Model Predictive Control (MPC) or Proportional-Integral-Derivative (PID), are used by different systems available on the market and are currently used in clinical practice. Overall, AHCL are associated with improvement of glycated hemoglobin (HbA1c) and TIR opening to the possibility to gain even tighter glycemic control.The primary objective is therefore to evaluate the glycemic improvement expressed through adjunctive CGM metrics in subjects with T1DM 24 months after starting AHCL therapy ### Conditions - Diabetes Mellitus, Type 1 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Advanced hybrid closed loop systems ### Outcomes Primary Outcomes - change in time spent in tighter glucose range after 24 months of hybrid closed loop system Secondary Outcomes ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Whole Genome Sequencing in Breast Cancer - NCT ID: NCT06334471 - Study ID: INCS_WGS_B-001 - Status: RECRUITING - Start Date: 2022-08-02 - Completion Date: 2030-12-31 - Lead Sponsor: Inocras Korea Inc. ### Study Description This study aims to conduct whole genome sequencing in breast cancer patients to elucidate individual genetic characteristics and their correlation with breast cancer subtypes. The primary objective is to establish new treatment guidelines aligned with the paradigm shift in precision medicine. The study will include both prospective and retrospective cohorts totaling 1200 participants. Prospective participants must provide consent and be eligible for tissue collection, while retrospective participants must have histologically confirmed breast cancer and available tissue samples from Samsung Medical Center Biobank. The study period spans 3 years for subject enrollment and 5 years for follow-up observations, with an expected completion date of December 31, 2030. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention needed ### Outcomes Primary Outcomes - Establishing individual genetic characteristics of breast cancer patients through WGS Secondary Outcomes - Analysis of correlation between whole-genome sequencing results and genetic subtypes of breast cancer ### Location - Facility: Samsung Medical Center, Seoul, N/A, N/A, Korea, Republic of @@
## Epigenomic and Machine Learning Models to Predict Pancreatic Cancer - NCT ID: NCT06334458 - Study ID: IEO 1910 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-03 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description The goal of the multicentric and interdisciplinary IMAGene project is to pursue early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups, by developing and validating a comprehensive cancer risk prediction algorithm (CRPA) as a clinical support tool to calculate a personalized risk profile.The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients. ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups ### Outcomes Primary Outcomes - Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm - Identification of one or more abnormal methylation changes present in blood cells of participants with suspicious lesions versus methylation profiles of participants with no identified lesions - Validation of igenetic biomarker testing in liquid biopsy followed by radiological exam as early cancer diagnostic tool Secondary Outcomes ### Location - Facility: Toulouse University Hospital, Toulouse, N/A, N/A, France @@
## CARDIOCARE Prospective Clinical Study - NCT ID: NCT06334445 - Study ID: IEO 1874 - Status: RECRUITING - Start Date: 2023-09-14 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This is a prospective observational study to refine and validate risk stratification algorithms aimed at identifying elderly patients at higher risk of developing cardiotoxicity (us-ing risk factors and potential blood and stool biomarkers) and at assessing whether integrated patient-oriented behavioral and psychological interventions can mitigate, prevent or delay the onset of cardiotoxicity from chemotherapy. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Control group - Intervention group ### Outcomes Primary Outcomes - Evaluation of the onset of cardiotoxicity Secondary Outcomes - Intra-patient assessment of major adverse cardiac events (MACEs) - Intra-patient assessment of plasma Troponin I - Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation - Percentage in the two arm of hospital admission - Number of Cardiovascular death in the two arms - Number of Non-cardiovascular death in the two arms - Evaluation of Health Related Quality of Life in the two arms - Cost-effectiveness of provided healthcare pathways determined by costs combined with quality-adjusted life-years (QALYs) in the two arms ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors - NCT ID: NCT06334432 - Study ID: NUV-1511-01 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2027-10 - Lead Sponsor: Nuvation Bio Inc. ### Study Description NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors. ### Conditions - Advanced Solid Tumor - HER2-negative Breast Cancer - Metastatic Castration-resistant Prostate Cancer (mCRPC) - Pancreatic Cancer - Platinum-resistant Ovarian Cancer (PROC) ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NUV-1511 ### Outcomes Primary Outcomes - Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors - Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s)) - Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s) - Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development - Phase 2: Confirm the optimal NUV-1511 target tumor types for further development Secondary Outcomes - Phase 1: Explore preliminary efficacy of NUV-1511 - Phase 1: Explore preliminary efficacy of NUV-1511 - Phase 1: Explore preliminary efficacy of NUV-1511 - Characterize the PK profile of NUV-1511 - Characterize the PK profile of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 - Phase 2: Further evaluate the safety and efficacy of NUV-1511 ### Location - Facility: NEXT Oncology, Irving, Texas, 75038, United States @@
## Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS) - NCT ID: NCT06334419 - Study ID: 2023-0795 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2024-09-30 - Lead Sponsor: Craig Erickson ### Study Description This is a single dose, placebo-controlled study. Male subjects aged 18 to 40 years (inclusive) with a diagnosis of FXS. Eligible subjects may enroll in this study comprised of two in home and two in clinic visits each 14 days apart, for a total of four visits. Subjects will be given single dose gaboxadol (10 mg) or matched placebo at each of these visits to take orally. Thus, all enrolled subjects will receive placebo at home and in clinic and receive gaboxadol at home and in clinic in a blinded fashion. ### Conditions - Fragile X Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Gaboxadol - Placebo ### Outcomes Primary Outcomes - To evaluate target engagement of gaboxadol treatment on high density EEG recordings Secondary Outcomes - To investigate the feasibility of home research visits and procedures in adult males with FXS - To investigate the feasibility of high density EEG recording at home in adult males with FXS - To potentially explore the pharmacokinetics of gaboxadol treatment in single-dose trial design - To investigate the effect of gaboxadol treatment on neuropsychological assessments - To investigate the effect of gaboxadol treatment on eye tracking assessments - To investigate the effect of gaboxadol treatment on clinician-rated measures - To determine whether FMRP levels predict treatment response ### Location - Facility: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States @@
## Antitumor T Cell Responses in Patients With Bladder Cancer - NCT ID: NCT06334406 - Study ID: 098 DRC 210 ER03 012 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2026-04-02 - Lead Sponsor: Centre Hospitalier Universitaire de Besancon ### Study Description The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor. ### Conditions - Bladder Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biological samples ### Outcomes Primary Outcomes - Tumor antigen specific T-cell responses Secondary Outcomes - Monitoring of T cells in the blood - Monitoring of immune cell death parameters in the blood - Monitoring of immune suppressive cells in the blood - Overall survival - Progression-free survival - Local progression-free survival - Transcriptomic analysis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults - NCT ID: NCT06334393 - Study ID: VLA1601-102 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-12-28 - Lead Sponsor: Valneva Austria GmbH ### Study Description This phase 1 clinical trial consists of an initial open-label sentinel run-in (n=25) and a randomized, double-blind, dose-finding (n=125) investigating three antigen dose levels (low, medium and high) of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants (CpG1018®, 3M-052-AF/AP 60-702). VLA1601 will be administered according to a two-dose regimen (i.e., on Day 1 and Day 29).The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination; and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination. Additionally, safety and immune response of the vaccine candidate will be monitored throughout the trial. ### Conditions - Zika - Zika Virus Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - VLA1601 - CpG 1018® - 3M-052-AF ### Outcomes Primary Outcomes - Solicited Adverse Events - Solicited Adverse Events - Neutralizing antibodies against ZIKA virus (ZIKV) Secondary Outcomes - Solicited Adverse Events - Solicited Adverse Events - Unsolicited AEs - Unsolicited AEs - Vaccine-related unsolicited AEs - Vaccine-related unsolicited AEs - Any AEs - Any AEs - any vaccine-related AEs - Vaccine-related unsolicited AEs - Adverse Events of Special Interest (AESI) - Adverse Events of Special Interest (AESI) - Vaccine-related Adverse Events of Special Interest (AESI) - Vaccine-related Adverse Events of Special Interest (AESI) - Serious Adverse Events (SAE) - Serious Adverse Events (SAE) - Vaccine-related Serious Adverse Events (SAE) - Vaccine-related Serious Adverse Events (SAE) - ZIKV-specific neutralizing antibodies - Seroconversion rate (SCR) - Geometric Mean Fold Increase (GMFI) ### Location - Facility: Flourish Research, Chicago, Illinois, 60640, United States @@
## VR for Surgical Prehabilitation and Rehabilitation - NCT ID: NCT06334380 - Study ID: 73688 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-15 - Completion Date: 2024-12-31 - Lead Sponsor: Stanford University ### Study Description This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery. ### Conditions - Breast Cancer - Frailty - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Virtual Reality Modules Only - Virtual Reality Modules + Live Physical Therapist Support ### Outcomes Primary Outcomes - VR for remote Physical Therapy (PT) Secondary Outcomes ### Location - Facility: Stanford Hospital and Clinics, Palo Alto, California, 94305, United States @@
## Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT - NCT ID: NCT06334367 - Study ID: SWYX:NO.2022-1028 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2026-03-26 - Lead Sponsor: Wang Xin ### Study Description The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition. ### Conditions - GVHD ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - CD25 treatment - low-dose ATG ### Outcomes Primary Outcomes - The incidence of aGVHD - The incidence of cGVHD Secondary Outcomes - the time of immune reconstitution in haploidentical transplant - the time of infection occurrence - the time of donor cell engraftment - the time of disease relapse - the time of death of transplant patient ### Location - Facility: Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, 250021, China @@
## A Study of Changes in Thinking Related to Aging and Cancer in Breast Cancer Survivors (TRAC) - NCT ID: NCT06334354 - Study ID: 23-320 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2029-03 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description The purpose of this study is to look at how differences in cognitive (mental) function develop over time in breast cancer survivors compared to volunteers without a history of cancer (healthy volunteers). Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so the researchers can compare the results of neurocognitive testing (which looks at memory, attention, and information processing) on each group of participants. ### Conditions - Breast Cancer Survivors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Assessments - Assessment (Survivors Only) - APOE and DNA Isolation ### Outcomes Primary Outcomes - examine cognitive effects Secondary Outcomes - measure levels of smoking exposure ### Location - Facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP) - NCT ID: NCT06334341 - Study ID: R01MD018523-01A1 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-21 - Completion Date: 2028-04 - Lead Sponsor: Henry Ford Health System ### Study Description What is known: There are 1.2 million people in the US who meet the indications for PrEP; yet, disparities exist in uptake. For example, only 9% of Black and 16% of Latino individuals, compared to 65% of White individuals, have been prescribed PrEP. At Henry Ford Health (HFH) system, only 10% of eligible patients have been prescribed PrEP. Primary care is an ideal setting for PrEP to be offered as an HIV prevention method since providers see large numbers of patients who are HIV negative, with some who are at increased risk for HIV, and the primary care setting is often the point of entry to the healthcare system. The multiphase optimization strategy (MOST) framework is a novel, innovative way to identify an efficient intervention. What will be done: In this optimization trial, the investigators will test the effectiveness of intervention components, alone and in combination, on new PrEP prescriptions in primary care at HFH. First, feedback will be generated on context-specific (system and individual level) factors for intervention component delivery via focus groups with providers (n=15) and patients eligible for PrEP (n=30). Then, four intervention components will be tested in an optimization trial, with 16 conditions being implemented at 32 clinics. Finally, feedback will be generated on the factors that affected implementation via semi-structured interviews with providers (n=30) and patients (n=30). Participants will be primary care providers (PCPs) and patients eligible for PrEP in Henry Ford Health System. Clinics will be randomized (yes/no) to receive any combination of provider and patient intervention components. Provider intervention components include computer-based simulation training and/or best practice alerts delivered via the electronic health record (EHR). Patient intervention components include HIV risk assessment and/or PrEP informational video - both delivered via the EHR. Primary outcome is the rate of new PrEP prescriptions at the clinic level. Secondary outcomes will include PrEP maintenance, number of HIV tests ordered by a PCP, and number of PCPs trained. Sub analyses will test which factors moderate (e.g., patient sex, race, age, gender, sexual orientation) or mediate (e.g., perceived HIV risk, provider and patient PrEP knowledge) PrEP uptake, focusing on priority populations and disparities in rates of PrEP prescription. Implications: 1) Understanding which intervention components lead to increased PrEP prescriptions will represent an important advance in HIV prevention efforts. 2) Optimizing a multi-level intervention for providers and patients to increase PrEP prescriptions would lead to a new, efficient, evidence-based option. 3) Determining what factors are related to PrEP uptake will help reduce disparities in PrEP initiation among those most in need. 4) Understanding the context specific factors related to intervention component implementation will help identify best methods for replication/adaptation in other healthcare systems. ### Conditions - HIV Seropositivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: PREVENTION ### Interventions - Computer-based simulation training for providers - Best Practice Alert - HIV Risk Assessment - PrEP Informational Video ### Outcomes Primary Outcomes - Clinic-Level PrEP Prescription Secondary Outcomes - PrEP Knowledge - PrEP awareness - PrEP prescribing comfort - PrEP prescribing intentions - Perceived HIV risk - Preferences for patient- provider communication ### Location - Facility: Henry Ford Health, Detroit, Michigan, 48202, United States @@
## Virtual Reality-based Mindful Movement Therapy for Seniors - NCT ID: NCT06334328 - Study ID: 2205009237 - Status: COMPLETED - Start Date: 2022-08-15 - Completion Date: 2024-01-31 - Lead Sponsor: Drexel University ### Study Description The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a virtual reality-based mindful movement therapy (VR-MMT) protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. This study is innovative and high impact as this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach. ### Conditions - Cognitive Decline - Physical Activity - Psychological Wellbeing ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Virtual reality based mindful movement therapy ### Outcomes Primary Outcomes - Treatment adherence - Treatment acceptability - Treatment satisfaction - Qualitative feedback - Safety Secondary Outcomes - Montreal Cognitive Assessment (MoCA) - Trail making test - The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) - Physical Activity Scale for the Elderly (PASE) - Physical Performance Battery (SPPB) - General Self-Efficacy Scale - Positive Affect and Negative Affect Scale (PANAS) ### Location - Facility: Drexel Universitsy, Philadelphia, Pennsylvania, 19102, United States @@
## Oral Contraceptive Pill (OCP) Pharmacogenomics - NCT ID: NCT06334315 - Study ID: 2000037337 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-05 - Lead Sponsor: Yale University ### Study Description The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how our bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. We also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are:* Do individuals with the CYP3A7\1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill? Do individuals with the CYP3A7\1C variant experience higher rates of breakthrough ovulation while taking a desogestrel/ethinyl estradiol combined oral contraceptive pill? What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users?Participants will take a specific formulation of combined oral contraceptive pill (desogestrel/ethinyl estradiol) and undergo the following procedures:* Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill* Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill* Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill* A transvaginal ultrasound to measure any ovarian follicles (optional procedure) ### Conditions - Contraception - Pharmacogenomic Drug Interaction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Desogestrel / Ethinyl Estradiol Pill ### Outcomes Primary Outcomes - Serum etonogestrel concentration - Serum ethinyl estradiol concentration Secondary Outcomes - Serum estradiol concentration - Serum progesterone concentration - Modified Hoogland score - Positive and Negative Affect Scheduled - Sex hormone binding globulin levels - Serum albumin concentration ### Location - Facility: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States @@
## The Effect of Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" With 80% Reduced Sucrose on Glucose Response of People With TID - NCT ID: NCT06334302 - Study ID: RMC0362-23ctil - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-04-25 - Lead Sponsor: Rabin Medical Center ### Study Description Omega Galil has developed a novel fatty sweetener that allows the use of up to 80% less sugar (particularly sucrose) and yet achieves a natural sweet flavor, using a novel technology of milling the natural sucrose crystals together with oil and thus creating a micro-suspension of sugar in oil or fat. The suspension increases the surface area of the sugar particles and thus a lower quantity of sugar is required in order to reach an enhanced perception of sweetness at the sweet taste receptors in the mouth. Omega Galil provides fatty food products that use up to 80% less sucrose, while tasting as sweet as regular sugar sweetened foods, with no aftertastes of sugar substitutes, and no chemical modifications or additives.Postprandial glucose (PPG) excursions in Type 1 Diabetes happen mainly due to a delay in subcutaneous insulin absorption and action, but also among other factors, depend on the meal composition. The glycemic index (GI) ranks foods based on acute glycemic response over a 2-h period of 50 g of available carbohydrates (CHO) of a test food compared with the reference standard glucose. Glycemic Load (GL) is a GI-weighted measure of carbohydrate content, which estimates the impact of carbohydrate intake using the GI while taking into account the amount of carbohydrates that are eaten in a serving. Several studies have demonstrated differences in PPG after consumption of low versus high GI meals, with rapid glucose spikes following high GI meals . Helping people with T1D achieve a diet with a lower glycemic load can improve both their quality of life and their diabetes-associated complications.The proposed randomized, double blind, cross-over, active control, clinical trial aims to:1. compare the glycemic response of T1D subjects to 20 grams of the O'Sweet sugar-reduced spread containing 8% sugar and a total of 1.6 grams of sucrose per meal, with their glycemic response to 20 grams of control Nutella spread, containing 56% sugar and a total of 11 grams sucrose per meal.2. compare the acceptance ("Not sweet enough, just right or too sweet") Labeled Magnitude score of O'Sweet compared to the control spread (Nutella). ### Conditions - Type1diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" - Active Control-Nutella hazelnut cocoa spread ### Outcomes Primary Outcomes - Delta postprandial glucose level Secondary Outcomes - Incremental area under the curve (iAUC) - Peak postprandial glucose level - Time in range (TIR) of 70-180 mg/dl - Percentage of subjects who reached the desired glucose target - The percentage of time spent above 180 mg/dl - The percentage of time spent above 250 mg/dl - The percentage of time spent above 350 md/dl - Labeled Magnitude Scale (gLMS) ### Location - Facility: Schneider Children Medical Center of Israel, Petach-Tikva, N/A, N/A, Israel @@
## A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery - NCT ID: NCT06334289 - Study ID: YXLL-KY-2024(017) - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Qianfoshan Hospital ### Study Description Perioperative neurocognitive impairment (PND) mainly includes acute postoperative delirium (POD) and persistent postoperative cognitive impairment (POCD), which are common postoperative complications in elderly patients. Perioperative neurocognitive impairment (PND) is attracting increasing attention, but its exact mechanism is still unclear. The diagnosis of PND lacks the gold standard, so it is difficult to determine the incidence rate. At present, the diagnosis is mainly conducted through the scale. Therefore, this study aims to explore the correlation between peripheral blood biomarkers and PND in elderly frail patients undergoing gastrointestinal surgery. ### Conditions - Perioperative Neurocognitive Disorders - Frail Elderly ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Postoperative 7-day incidence of PND Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016 - NCT ID: NCT06334276 - Study ID: DROWN_INHOS - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Prehospital Center, Region Zealand ### Study Description This nationwide, registry-based study aims to link Danish Prehospital Drowning Data data with inhospital data to develop a Utstein-style Danish Drowning Registry. This study will report mortality and neurological outcomes 30 days after a drowning incident since 2016. ### Conditions - Drowning - Drowning, Near - Drowning; Asphyxia - Drowning and Nonfatal Submersion - Drowning or Immersion of Unknown Intent - Drowning and Submersion, Undetermined Intent - Drowning and Submersion While in Bath-Tub - Drowning and Submersion While in Natural Water - Drowning and Submersion While in Swimming-Pool ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Drowning ### Outcomes Primary Outcomes - 30-day mortality - Neurological outcome Secondary Outcomes - Hospital length of stay - Intensive care unit admission - Intensive care unit length of stay - Need for mechanical ventilation - Duration of mechanical ventilation - Survival to hospital discharge ### Location - Facility: Prehospital Center, Næstved, Region Zealand, 4700, Denmark @@
## Splenic Embolisation Decisions - NCT ID: NCT06334263 - Study ID: 332302 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-09-30 - Lead Sponsor: University Hospital Plymouth NHS Trust ### Study Description The spleen is often injured when the body sustains trauma. This leads to bleeding. The bleeding can be stopped by a big operation cutting open the belly or a small hole in your groin where a blood vessel can be accessed and through which the bleeding can be stopped. We do not know what types of injuries it is best to use this procedure. We do not know why we do not use the smaller technique in some instances. We also do not know exactly which of a number of ways to stop the bleeding could be better. We have a big data set in the trauma and audit research network (TARN) which we would like to use to help answer these questions and design further studies to better answer the questions. Adding a few other pieces of data, we are able to answer key questions into how the spleen will best be treated in trauma. ### Conditions - Trauma - Spleen Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To determine if service design significantly affects splenic embolisation (SE) rates in AAST grade 2-5 acute traumatic splenic injuries (ATSI) across the 22 Major Trauma Centres (MTCs) in the UK. - To determine if variation in treatment affects SE outcomes in ATSI Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pulsed Field Ablation During Left Atrial Appendage Occlusion: A Randomised Controlled Trial - NCT ID: NCT06334250 - Study ID: IRAS:327077 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust ### Study Description Atrial fibrillation (AF) is the most common abnormal heart rhythm. It is also a leading cause of stroke, due to blood clots forming within an area called the 'left atrial appendage'. Usually, blood thinners (anticoagulants) are given to patients to reduce this risk. However, some patients are not able to take these medications due to a high bleeding risk. In this situation, these patients are sometimes offered a 'left atrial appendage occlusion' (LAAO) procedure - this is performed by inserting wires through the veins in the groin into the heart, then deploying a device which blocks the appendage, thus stopping blood clots from forming. There is increasing interest within our professional community of combining this procedure with another, called 'catheter ablation', which is performed to improve the symptoms of AF. This procedure uses similar access to the heart, but is not often performed in the same sitting - and often not performed at all in this patient group as they are felt to be at higher risk of complications due to bleeding or clotting. Pulsed Field Ablation (PFA) is a new technology which significantly improves safety of ablation. In this randomised controlled trial, patients referred for LAAO will be randomised to receive LAAO+PFA (intervention) or LAAO alone (control). Patients will be blinded to treatment received, which allows thorough assessment of the benefit of ablation. ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Catheter ablation of atrial fibrillation using Pulsed Field Ablation - Left atrial appendage occlusion ### Outcomes Primary Outcomes - Change in quality of lfie Secondary Outcomes - Time to atrial fibrillation recurrence - Requirement for unplanned further ablation or cardioversion procedures - Procedural metrics - Procedural safety outcomes ### Location - Facility: Liverpool Heart and Chest Hospital, Liverpool, Merseyside, L14 3PE, United Kingdom @@
## Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine - NCT ID: NCT06334237 - Study ID: Y_113_0009 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-02-21 - Lead Sponsor: Changhua Christian Hospital ### Study Description This research project aims at exploring the psychosomatic factors that influence and moderate the efficacy of holistic care and personalized treatment for migraine patients. It is a prospective longitudinal observational study. The project's goal is to understand how physical, psychological, spiritual, and social factors affect the care and treatment outcomes for migraineurs. The study will include participants aged 18 to 65, who meet the International Headache Society's criteria for migraines. It will utilize a range of methodologies including questionnaires, interviews, and medical records to collect data on various factors like lifestyle, psychological state, and social support. The project will assess the effectiveness of treatments, compliance, and other outcomes such as emotional and sleep conditions. ### Conditions - Migraine ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - personalized treatment ### Outcomes Primary Outcomes - Migraine attack frequency - Migraine attack intensity - Migraine attack duration - Effectiveness of acute medication Secondary Outcomes - Compliance rate of migraine diary - Compliance rate of lifestyle modification - depression - anxiety - well-being - Pain Resilience ### Location - Facility: Changhua Christian Hospital, Chang Hua, N/A, 500, Taiwan @@
## Acute Physiological Responses to Twice Daily Blood Flow Restriction Training - NCT ID: NCT06334224 - Study ID: 2242/MODREC/23 - Status: RECRUITING - Start Date: 2023-11-06 - Completion Date: 2024-09 - Lead Sponsor: Defence Medical Rehabilitation Centre, UK ### Study Description The Academic Department of Military Rehabilitation (ADMR) is currently conducting a pan-defence, randomised control trial (RCT) investigating the utility of twice daily blood flow restriction training in UK military personnel with persistent knee pain (NCT05719922). Due to logistical confinements, this pan-defence RCT is confined to collecting outcome data pre and post-intervention. Therefore, the acute physiological mechanisms which underpin adaptation will remain unknown.Consequently, ADMR is undertaking an additional, single centre RCT which will compare the acute physiological responses to low load resistance training with and without the addition of blood flow restriction. Specifically, this study will elucidate the effect of twice daily blood flow restriction training on measures of muscle swelling, muscle damage and inflammation. This data may aid in the optimisation of blood flow restriction exercise prescription within UK Defence Rehabilitation and elsewhere. ### Conditions - Muscle Weakness - Muscle Damage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Low load resistance training with blood flow restriction - Low load resistance training ### Outcomes Primary Outcomes - Maximum isometric voluntary contraction of knee extensor muscles Secondary Outcomes - Vastus lateralis muscle thickness - Venous blood sampling for markers of exercise induced muscle damage - Delayed onset muscle soreness - Quadriceps discomfort - Discomfort caused by the BFR cuff - Rating of perceived exertion - Knee joint range of motion - Daily wellness questionnaire - Venous blood sampling for inflammatory markers ### Location - Facility: Defence Medical Rehabilitation Centre, Loughborough, N/A, LE12 5QW, United Kingdom @@
## Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers - NCT ID: NCT06334211 - Study ID: FP-020C-23-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-01-31 - Lead Sponsor: Foresee Pharmaceuticals Co., Ltd. ### Study Description This is a study to Investigate the Safety, Tolerability, and Pharmacokinetics, of Single (including Food Effect) and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - FP-020 - placebo ### Outcomes Primary Outcomes - The incidence, severity, and type of Adverse Events (AEs) and Serious Adverse Events (SAEs). - Clinically significant abnormalities. Secondary Outcomes - Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Cmax - Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Tmax - Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-24 hours - Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0 - last - Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-inf - Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - λz - Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - t1/2 - Evaluate the food effect on the PK profile of FP-020 - Cmax - Evaluate the food effect on the PK profile of FP-020 - Tmax - Evaluate the food effect on the PK profile of FP-020 - AUC - Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Cmax - Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Tmax - Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - 24 - Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUCo - last - Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - inf - Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects λz - Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - t1/2 - Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RCmax - Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RAUC ### Location - Facility: Scientia Clinical Research Ltd, Randwick, New South Wales, 2031, Australia @@
## The Effect of Naldemedine on Opioid-induced Bowel Dysfunction - NCT ID: NCT06334198 - Study ID: Naldemedine_OIBD - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2025-03 - Lead Sponsor: Asbjørn Mohr Drewes ### Study Description Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol ### Conditions - Opioid-Induced Bowel Dysfunction - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Naldemedine - Placebo - Tramadol ### Outcomes Primary Outcomes - Total gastrointestinal transit time - Colorectal transit time Secondary Outcomes - Constipation symptoms - Bowel movement frequency - Stool consistency - Gastrointestinal symptoms - Opioid-induced constipation - Diagnostic evaluation of opioid-induced constipation - Colonic motility patterns - Opiate withdrawal symptoms - Colon volume - Colonic water content - Defecation assessment ### Location - Facility: Aalborg University Hospital, Aalborg, N/A, 9000, Denmark @@
## Evaluation of Vaccination for Streptococcus Pneumoniae in Adults With an Episode of Invasive Pneumococcal Infection. - NCT ID: NCT06334185 - Study ID: pVax - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-01 - Lead Sponsor: Azienda Ospedaliera di Lecco ### Study Description Respiratory tract infections are among the leading causes of death worldwide and many of these infections are preventable through vaccination. One of the most important bacteria from an etiological and mortality point of view regarding respiratory and systemic infections is the gram-positive Streptococcus pneumoniae. Four types of vaccines are currently available for this pathogen: three pneumococcal conjugate vaccines (PCV13, PCV15, and PCV20) and one polysaccharide vaccine (PPSV23). In Italy, people over 65 years of age and people suffering from chronic pathologies with effects on the immune system would be advised to be vaccinated with the pneumococcal conjugate vaccine and with the polysaccharide vaccine as a second dose.However, there are no data available in Italy on vaccination coverage in these population categories and above all the vaccination rates in patients who have a history of an episode of invasive pneumococcal infection are not known. The aim of the study is to measure how many patients are vaccinated for S. pneumoniae after hospitalization for a systemic pneumococcal infection in order to understand patients' awareness of preventing this infection after receiving a first diagnosis. ### Conditions - Invasive Pneumococcal Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of antipneumococcal vaccination in hospitalized patients for invasive pneumococcal infection between 2015 and 2019. Secondary Outcomes - Rate of pneumococcal serotype that caused the invasive infection in patients vaccinated prior to the infectious event ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Role of Oxytocin in Regulating Blood Glucose - NCT ID: NCT06334172 - Study ID: H-23071221 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: University Hospital, Gentofte, Copenhagen ### Study Description Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose. ### Conditions - Glucose Metabolism Disorders (Including Diabetes Mellitus) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Oxytocin - Placebo ### Outcomes Primary Outcomes - Insulin secretion - c-peptide Secondary Outcomes - Glucose - Insulin - Glucagon - GIP - GLP-1 - Lipids - Cross-linked C-telopeptide of type I collagen( CTX) - Procollagen type I N-terminal propeptide (P1NP) ### Location - Facility: Center for Clinical Metabolic Research, Gentofte Hospital, Hellerup, Capital Region, 2900, Denmark @@

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