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## Does the AMH Concentration Depend on the Menstrual Cycle? - NCT ID: NCT06330259 - Study ID: new AMH assay - Status: COMPLETED - Start Date: 2017-07-01 - Completion Date: 2019-12-31 - Lead Sponsor: University of Basel ### Study Description During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum. ### Conditions - Reproductive Sterility ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - menstrual cycle monitoring ### Outcomes Primary Outcomes - AMH Elecsys Assay Secondary Outcomes - Effect of handling of the serum on measured AMH concentrations - 3D ultrasound of both ovaries ### Location - Facility: Christian De Geyter, Basel, N/A, 4031, Switzerland @@
## O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease - NCT ID: NCT06330246 - Study ID: IRB300005280 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2031-12-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease.The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes.Participants will* ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time* collect urine, blood and stool samples during the fixed diets* ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes ### Conditions - Kidney Stone - Kidney Calculi - Urolithiasis - Urolithiasis, Calcium Oxalate - Nephrolithiasis - Nephrolithiasis, Calcium Oxalate - Oxalate Urolithiasis - Oxaluria ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Low oxalate fixed diets pre-colonization - Moderately high oxalate fixed diets pre-colonization - Colonization with Oxalobacter formigenes - Low oxalate fixed diets post-colonization - Moderately high oxalate fixed diets post-colonization ### Outcomes Primary Outcomes - Change in urinary oxalate excretion following colonization with Oxalobacter formigenes Secondary Outcomes - Sustainability of colonization with Oxalobacter formigenes ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study - NCT ID: NCT06330233 - Study ID: YJiang - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: Zhejiang Chinese Medical University ### Study Description This study is designed to provide the treatment plan for moxibustion for diabetic peripheral neuropathy (DPN) and provide a reference for clinical moxibustion for DPN. The patients will be randomly assigned to three clinical centers each center 44, then they will be distributed equally into 4 groups, which include the conventional treatment group and the moxibustion different minutes (5 minutes, 10 minutes, 15 minutes) per point group. The conventional treatment group will receive mecobalamin tablets and alpha-lipoic acid tablets for four weeks in conjunction with the patient's daily treatment (basal drug treatment for patients with combined hypertension and hyperlipidaemia). The frequency of moxibustion treatment is twice a week for 4 weeks. The outcomes were evaluated in the baseline period (the day before grouping), the treatment period (end of the 8th treatment) and the follow-up period (2 weeks after the end of treatment). The results of this study are expected to confirm the optimal amount of moxibustion for the treatment of diabetic peripheral neuralgia and to observe the efficacy of moxibustion in the treatment of diabetic peripheral neuralgia. It provides a reference for the clinical therapeutic operation standardization of moxibustion. ### Conditions - Diabetic Peripheral Neuropathy - Pain - Moxibustion - Randomized Controlled Trial ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Moxibustion ### Outcomes Primary Outcomes - Electrophysiological examination of the tibial nerve of the lower limb - Electrophysiological examination of the peroneal nerve of the lower limb Secondary Outcomes - Total clinical effectiveness - Toronto Clinical Scoring System - Visual Analogue Scale - Traditional Chinese Medicine Syndrome Score Scale - regional temperature testing - infrared thermography testing ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Visual Function Change in Wet Age-related Macular Degeneration Patients With Better Baseline Visual Acuity - NCT ID: NCT06330220 - Study ID: 2010-015-1161 - Status: COMPLETED - Start Date: 2021-02-10 - Completion Date: 2022-02-28 - Lead Sponsor: Seoul National University Hospital ### Study Description Although the number of wet AMD patients with the better visual acuity is increasing, the visual improvement in patients with the better vision may not be so significant after anti-vascular endothelial growth factor (VEGF) treatments because of 'ceiling effect'. The aim of current study is to investigate the improvement of visual function after aflibercept treatments using microperimetry in wet AMD patients with the better baseline visual acuity (≥20/40). ### Conditions - Age-Related Macular Degeneration ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Aflibercept Injection [Eylea] ### Outcomes Primary Outcomes - Retinal sensitivity change after aflibercept treatment using microperimetry in wet age-related macular degeneration patients Secondary Outcomes - The correlation of OCT and OCT angiography parameters with retinal sensitivity change measured by microperimetry ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 03080, Korea, Republic of @@
## An Emergency Department (ED) Provider Centered Intervention for Non-Traumatic Dental Condition Management (NTDC) - NCT ID: NCT06330207 - Study ID: IRB202301471 - Status: NOT_YET_RECRUITING - Start Date: 2025-08-01 - Completion Date: 2027-08-01 - Lead Sponsor: University of Florida ### Study Description The overall objective of this proposal is to understand the barriers and facilitators to non-traumatic dental condition (NTDC) management in the emergency department (ED) through quantitative and qualitative methods. The first aim will determine the national variation in NTDC prescribing in the ED and subsequent ED/urgent care revisits and hospitalizations within 30-days of an index ED visit. Using national electronic health records and integrated claims datasets and a random effects model, we will identify factors associated with prescribing for NTDC and variation at the patient, provider, hospital and state levels. The second aim identifies ED providers' perceived barriers and facilitators to the management of NTDC in the ED. Using individual in depth interviews, ED providers (physicians, advanced practice providers) will identify the facilitators and barriers to management and prescribing for NTDC in the ED. ### Conditions - Emergency Department Visit - Odontalgia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Clinical decision support tool ### Outcomes Primary Outcomes - Acceptability and feasibility Secondary Outcomes - Prescribing behavior ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease - NCT ID: NCT06330194 - Study ID: AID-study - Status: RECRUITING - Start Date: 2024-04-18 - Completion Date: 2024-12-31 - Lead Sponsor: Steno Diabetes Center Copenhagen ### Study Description The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD).The main objective is:• To test if the AID is superior in regulating blood sugar levels compared with usual care in patients with advanced renal diseaseSecondary objectives are:• To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this populationParticipants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks.Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels. ### Conditions - Dialysis - Chronic Kidney Disease - Diabetes Mellitus, Type 2 - Diabetes Mellitus, Type 1 - Hemodialysis - Peritoneal Dialysis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - 2nd Generation Automated Insulin Delivery (AID) system ### Outcomes Primary Outcomes - Percent time in sensor glucose target range (3.9-10.0 mmol/L) Secondary Outcomes - Proportion of time spent <2.8 mmol/L - Proportion of time spent <3.0 mmol/L - Proportion of time spent <3.3 mmol/L - Proportion of time spent <3.9 mmol/L - Proportion of time spent 3.9-7.8 - Proportion of time spent >10.0 mmol/L - Proportion of time spent >13.9 mmol/L - Proportion of time spent >16.7 mmol/L - Glucose variability (SD and coefficient of variation) - Mean glucose - HbA1c - Episodes of CGM time in < 3.0 mmol/L range lasting >15 minutes - Diabetic ketoacidosis og Hyperosmolar non-ketotic hyperglycemia - eGFR (estimated glomerular filtration rate) - Potassium pre-dialysis - Urine albumine-to-creatinine ratio - Actigraph Metrics for sleep architecture - Sleep diary - Proportion of time Automode is active - Diabetic ketoacidosis - Severe hypoglycemia - Serious Adverse Event - Unanticipated Serious Adverse Device Event - Satisfaction with diabetes treatment - Satisfaction with diabetes treatment - Fear of hypoglycaemia - Hypoglycaemia awareness - Diabetes distress - Sleep Quality - Cognitive function - Sarcopenia - Semi-structured interview - Health-related quality of life - Frailty ### Location - Facility: Tobias Bomholt, Copenhagen, N/A, 2100, Denmark @@
## Virtual Walking Therapy for Neuropathic Pain Following Incomplete Spinal Cord Injury - NCT ID: NCT06330181 - Study ID: SC220178 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2027-01 - Lead Sponsor: Texas A&M University ### Study Description The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete spinal cord injury. ### Conditions - Spinal Cord Injuries - Neuropathic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VR Game 1 - VR Game 2 ### Outcomes Primary Outcomes - Change in Pain Intensity Secondary Outcomes - Change in Pain Quality - Change in Pain Interference - Post treatment change - Change in mood - Change in quality of life - Neurological changes ### Location - Facility: Texas A&M University, College Station, Texas, 77843, United States @@
## Paravertebral Calcitonin in Thoracotomy - NCT ID: NCT06330168 - Study ID: 36264PR573/2/24 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2025-04-10 - Lead Sponsor: Tanta University ### Study Description This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy. ### Conditions - Calcitonin - Paravertebral - Thoracotomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - bupivacaine-calcitonin-fentanyl - Bupivacaine-fentanyl ### Outcomes Primary Outcomes - morphine consumption Secondary Outcomes - numerical rating scale scores - incidence of chronic pain - Side effects ### Location - Facility: Tanta University Hospitals, Tanta, Gharbiya, 31527, Egypt @@
## A Genetic Study for Alzheimer Dementia: Case-control Study - NCT ID: NCT06330155 - Study ID: 2024-01-032 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2026-12-31 - Lead Sponsor: MinYoung Kim, MD, PhD ### Study Description The purpose of this study is to find out the difference in genetic test results between Alzheimer's dementia patients and healthy subjects.The investigators want to identify genes that are importantly related to Alzheimer's dementia. ### Conditions - Alzheimer Dementia (AD) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - genetic analysis Secondary Outcomes - Measurement of Korean version of mini-mental state examination (K-MMSE) - Measurement of Clinical Dementia Rating (CDR) - Measurement of Geriatric Depression Scale (GDSd) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Hippotherapy Teenager-pediatric Radiotherapy - NCT ID: NCT06330142 - Study ID: 2022-006 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-15 - Lead Sponsor: Institut de cancérologie Strasbourg Europe ### Study Description This study proposes a horse-assisted therapy (HAT) approach to accompany children and young adults undergoing irradiation in the ICANS Radiotherapy Department.The aim of this new approach is to improve quality of life and reduce anxiety in children and adolescents treated with radiotherapy. The impact of equine-assisted therapy on quality of life and anxiety disorders will be described prospectively between the start and end of irradiation in children and parents who agree to inclusion. ### Conditions - Radiotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Participation in 10 horse-assisted therapy sessions ### Outcomes Primary Outcomes - Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy Secondary Outcomes - Improving children's quality of life between the start and end of irradiation (hetero-questionnaire) by HAT - Decrease anxiety disorders between the beginning - child version and end of irradiation in children (self-questionnaire) with HAT - Decrease anxiety disorders between the beginning - parents' version and end of irradiation in children (self-questionnaire) with HAT - Assessing the acute side effects of radiotherapy at the start and end of irradiation - Study the relevance of the various equestrian activities proposed as a strategy for improving care through the horse - Evaluate participant's expectations and satisfaction with their care - Assess the medical electroradiology technician's (MERT's) impression of the child's well-being during irradiation - Assessing the impact of HAT on the child during irradiation according to the MERT - Evaluate the rider's impression of the child's well-being of the child during HAT sessions - Assessing the impact of an alternative activity on parents' satisfaction with care ### Location - Facility: Institut de Cancerologie Strasbourg Europe, Strasbourg, N/A, 67033, France @@
## Validity and Reliability of Trunk Strength Device - NCT ID: NCT06330129 - Study ID: Pegasus01_Val - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-12-31 - Lead Sponsor: Schulthess Klinik ### Study Description The study aims to evaluate the accuracy and consistency of assessing trunk muscle strength using an isometric device (Pegasus, Leipzig, Germany). Thirty healthy volunteers will undergo maximal isometric strength testing with the device, repeated one week later to assess repeatability. Surface electrodes will measure muscle activation, while MRI scans will assess structural condition. ### Conditions - Trunk Muscle Strength ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - CTT Pegasus ### Outcomes Primary Outcomes - maximal isometric trunk muscle strength Secondary Outcomes - MRI muscle morphology - Electromyography (EMG) activity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Different Forms of OMT as Methods for Reducing Snoring and Mild to Moderate Sleep Apnea - NCT ID: NCT06330116 - Study ID: 2023-05348-01 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-29 - Completion Date: 2025-03-28 - Lead Sponsor: Region Västerbotten ### Study Description Objective the present project aims to assess the impact of 1) oral screen training, group training, and the use of neuromuscular electrical training (NMES) as orofacial myofunctional therapy (OMT) methods for reducing the apnea-hypopnea index (AHI) among adults with mild to moderate sleep apnea and 2) if these different training methods can reduce snoring and affect the level of sleepiness and quality of life. Study design The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase, and follow-up measurements.Methods 141 consecutive adult subjects, 71 men and 70 women referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sites, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the three different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Participants in Umeå will be randomized to either training with IQoro or serving as controls. Participants in Köge will be randomized to either training with Exciteosa, group training, or controls.The primary outcome is a change in AHI before and after three months of training with the different methods according to overnight ambulatory sleep apnea recordings.The secondary outcomes are change in snoring frequency, sound level dB (A) according to a questionnaire, the Basic Nordic Sleep Questionnaire (BNSQ), daytime sleepiness using the Epworth Sleepiness Scale (ESS), change in quality of life using the short form -36 (SF-36) and muscle strength in tongue before and after treatment. ### Conditions - Sleep Apnea, Obstructive - Snoring ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IQoro - eXciteosa - Grouptraining ### Outcomes Primary Outcomes - Apnea-hyponpnea index (AHI) Secondary Outcomes - Questionnaries - Snoring - Tounge strenght ### Location - Facility: Zealand University Hospital, Köge, Sjaelland, 4600, Denmark @@
## Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX View Cardiac Ultrasound Video Clips - NCT ID: NCT06330103 - Study ID: RayongH - Status: COMPLETED - Start Date: 2023-05-01 - Completion Date: 2023-07-31 - Lead Sponsor: Rayong Hospital ### Study Description Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video ClipsABSTRACT BACKGROUND: Echocardiography serves as a fundamental diagnostic procedure for managing heart failure patients. Data from Thailand's Ministry of Public Health reveals that there is a substantial patient population, with over 100,000 admissions annually due to this condition. Nevertheless, the widespread implementation of echocardiography in this patient group remains challenging, primarily due to limitations in specialist resources, particularly in rural community hospitals. Although modern community hospitals are equipped with ultrasound machines capable of basic cardiac assessment (e.g., parasternal long axis view), the demand for expert cardiologists remains a formidable obstacle to achieving comprehensive diagnostic capabilities. Leveraging the capabilities of Artificial Intelligence (AI) technology, proficient in the accurate prediction and processing of diverse healthcare data types, offers a promising for addressing this prevailing issue. This study is designed to assess the effectiveness of AI in evaluating cardiac performance from parasternal long axis view ultrasound video clips obtained via the smartphone application.OBJECTIVES: To evaluate the effectiveness of artificial intelligence in screening cardiac function from parasternal long axis view cardiac ultrasound video clips obtained through the smartphone application. ### Conditions - Heart Failure - Heart Failure With Reduced Ejection Fraction - Cardiac Failure - Echocardiography - Artificial Intelligence ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Easy EF ### Outcomes Primary Outcomes - efficiency of AI in screening left ventricular cardiac function by use smartphone application Secondary Outcomes ### Location - Facility: Rayong Hospital, Rayong, N/A, 066, Thailand @@
## COgnitive Dynamics in Early Childhood - NCT ID: NCT06330090 - Study ID: NL84688.091.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-12 - Lead Sponsor: Radboud University Medical Center ### Study Description The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical methodologies to investigate three core questions:1. How does cognitive variability differ between individuals?2. What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?3. What are the long-term consequences and outcomes associated with differences in cognitive variability? ### Conditions - Cognitive Change ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Reaction times from the vocabulary cognitive task - Reaction times from the exploration cognitive task - Reaction times from the Working Memory cognitive task - Reaction times from the speed cognitive task - Reaction times from the fluid reasoning cognitive task - Mood score on smiley slider - Sleep score on smiley slider - MP-RAGE MRI sequence baseline - Functional MRI sequence of low time constraint reasoning task at baseline - gaze direction during reasoning task at baseline - pupil dilation during reasoning task at baseline - Naturalistic viewing fMRI at baseline - Naturalistic viewing fMRI at follow-up - Functional MRI sequence of high time constraint reasoning task at follow-up - gaze direction during reasoning task at baseline at follow-up - pupil dilation during reasoning task at baseline at follow-up - Functional MRI sequence of low time constraint reasoning task at follow-up - Sparse MP2-Rage MRI sequence baseline - Diffusion weighted imaging MRI sequence baseline - MP-RAGE MRI sequence follow up - Sparse MP2-Rage MRI sequence follow up - Diffusion weighted imaging MRI sequence follow up - Total score for Highly Sensitive Child scale at baseline - Total score for Strengths and difficulties questionnaire at baseline - Total score for BRIEF-2 questionnaire at baseline - Total score for BRIEF-2 questionnaire at follow-up - Total score for Strengths and difficulties questionnaire at follow-up - Total score for Mind Excessively Wandering Scale scale at baseline - Originality score for the Alternative Uses Tasks at baseline - Originality score for the Alternative Uses Tasks at follow-up - Total score for Parent-reported Mind Excessively Wandering Scale scale at baseline - Total score for Parent-reported Socio-demographic questionnaire at baseline - Total score for Parent-reported Socio-demographic questionnaire at follow-up - Total score for Mind Excessively Wandering Scale scale at follow-up - Total score for Parent-reported Mind Excessively Wandering Scale scale at follow-up - Total score for Highly Sensitive Child scale at follow-up Secondary Outcomes - motivation rating for cognitive tasks - Decibel of background noise during cognitive testing - Academic school result baseline - Academic school result follow-up - Parent reaction times on cognitive battery at baseline - Parent reaction times on cognitive battery at follow-up ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis - NCT ID: NCT06330077 - Study ID: APHP200027 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-06 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Multiple sclerosis (MS) is the most frequently acquired demyelinating disease and the first cause of non-traumatic chronic disability in young adults. Major progress has been achieved in the treatment of MS through the development of therapies targeting the adaptative immune system, which drastically reduce the relapse rate, with various efficiency and safety profiles (Ontaneda, 2015). However, these drugs generally fail to prevent disability worsening along the disease course, and we are now assisting to a shift in therapeutic objectives from the development of new immune drugs towards the identification of therapeutic strategies that could prevent neurodegeneration by promoting myelin regeneration (Stangel, 2017; Stankoff, 2016), in order to prevent neurological disability in MS (Irvine and Blakemore, 2008; Patrikios, 2006; Duncan I, 2017, Bodini, 2016).Among the first candidate compounds developed to promote remyelination was the anti Lingo1 antibody, which enhance remyelination (Mi, 2009). Medium and large throughput screening of drug libraries subsequently identified several chemical classes of compounds with strong promyelinating properties, such as the antifongic drug miconazole (Najm, 2015) or the muscarinic antagonist clemastine (Wei, 2014). A recent innovative trial has investigated the effect of clemastine, compared to placebo, in a small sample of subjects (25 patients per group) and showed that clemastine could significantly improve the optic nerve conduction speed which reflecting myelin integrity and functionality (Green, 2017).Our preclinical research has allowed us to identify ifenprodil as a powerful drug to promote myelin repair in vitro and in vivo across species. In parallel our team recently pioneered and optimized a PET imaging approach for quantifying remyelination in the whole brain, that allowed to enhance the sensitivity to detect the myelin repair process, and showed that patients are characterized by heterogeneous profiles of spontaneous remyelination profiles that are closely linked to disability accrual (Bodini, 2016). ### Conditions - Multiple Sclerosis - Remitting Relapsing Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ifenprodil - Placebo ### Outcomes Primary Outcomes - Change in P100 latency according to visual evoked potential. Secondary Outcomes - Proportion of voxels within white matter lesions classified as remyelinating - Proportion of remyelinating voxels extracted in cortical regions from magnetization transfer imaging (MTR) acquisitions - Change in amplitude of P100 on to visual evoked potential - Change in retinal nerve fibre layer (RNFL) and ganglion cell complex (GCC) thickness on OCT - Change in blood concentration of NfL fragments - Change in the brain atrophy rate - The correlation between the change in the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions - The comparison of the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions - Incidence of adverse drug reactions ### Location - Facility: Hôpital Neurologique Pierre WERTHEIMER - HCL, Bron, N/A, 69677, France @@
## A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors - NCT ID: NCT06330064 - Study ID: DS7300-203 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2028-07-01 - Lead Sponsor: Daiichi Sankyo ### Study Description This study is designed to assess the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); non-squamous non-small cell lung cancer (NSCLC); and urothelial carcinoma (UC). ### Conditions - Recurrent or Metastatic Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ifinatamab deruxtecan ### Outcomes Primary Outcomes - Objective Response Rate (ORR) as Assessed by Investigator Secondary Outcomes - Number of Dose-limiting Toxicities in the HCC Cohort - Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) - Duration of Response (DoR) - Progression-free Survival (PFS) - Disease Control Rate (DCR) - Overall Survival (OS) - Pharmacokinetic Parameter Maximum Concentration (CMax) for I DXd, total anti-B7-H3 antibody, and DXd - Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (TMax) for I DXd, total anti-B7-H3 antibody, and DXd - Pharmacokinetic Parameter Half-life (t1/2) for I DXd, total anti-B7-H3 antibody, and DXd - Pharmacokinetic Parameter Minimum Concentration (Ctrough) for I DXd, total anti-B7-H3 antibody, and DXd - Pharmacokinetic Parameter Area Under the Curve (AUC) for I DXd, total anti-B7-H3 antibody, and DXd - Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) - Percentage of Participants Who Have Treatment-emergent ADA ### Location - Facility: Clinical Research Alliance, Inc., Westbury, New York, 11590, United States @@
## The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing in China - NCT ID: NCT06330051 - Study ID: KY 2023-184-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-04-20 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description This study intends to construct the goal-oriented integrated intervention model for AIS in-hospital procedure through the spatiotemporal positioning and the P-D-C-A cycle for continuous improvement (FAST model). Then a multicenter, evaluator-blind, cluster-randomized controlled study aims to verify the validity and safety of this FAST model. ### Conditions - Acute Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - improvement acute reperfusion treatment quality for stroke through spatiotemporal computing ### Outcomes Primary Outcomes - The Door to Needle time (DNT) for intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset. Secondary Outcomes - The Door to Puncture time (DPT) for endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset. - The rate of intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset. - The rate of endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset. - Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours of receiving reperfusion therapy. - Proportion of patients with 90-day favorable functional outcome. - Proportion of patients with 90-day independent functional outcome. - in-hospital mortality - 90-day mortality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Anesthesia and Non-small Cell Lung Cancer Recurrence - NCT ID: NCT06330038 - Study ID: SMC 2024-01-065 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials. ### Conditions - Non-small Cell Lung Cancer - Surgery - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Propofol - Inhaled anesthetics ### Outcomes Primary Outcomes - Recurrence free survival Secondary Outcomes - Overall survival - Postoperative complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploring Food Rejection Dispositions as Potential Risk Factors for Undernutrition in Hospitalized Children Aged 2 to 8 - NCT ID: NCT06330025 - Study ID: 69HCL23_1180 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Undernutrition affects over 30% of hospitalized children in France, with 10% severely malnourished yet only half of the cases are diagnosed. Undernutrition deteriorates children's health during hospital stays, weakening immunity and hindering recovery. Children suffering from acute malnutrition can stay in the hospital 45% longer than non-malnourished patients.One of the primary causes of malnutrition is the reduction in children's food intake. Several researchers have emphasized that the young age of patients is associated with reduced food intake. For example, data on 923 children aged 1 day to 16 years indicates that patients under 8 years old are at a higher risk of undernutrition than older children.The MEDIC project aims to investigate if increased food rejection dispositions contribute to reduced food intake in hospitalized children. Food rejections are typically observed between 2 and 8 years. Some children are more challenging and eat only a few different foods, while others try everything. Around the age of 2, children become more selective about the foods they consume. This is largely due to two common dispositions in young children: food neophobia and food pickiness. Food neophobia is defined as the reluctance to eat or even try foods that appear new, whereas food pickiness is defined as the rejection of a substantial number of familiar foods, including foods previously tasted. Both pickiness and neophobia have been associated with a significant reduction in food consumption (especially of vegetables), a decrease in food variety, and less enjoyment derived from food. A study showed that children aged 2 to 5 were twice as likely to be underweight if they were picky eaters.Studies have shown that the socioeconomic status has a significant impact on food rejection in children. For instance, longitudinal studies reveal a higher proportion of picky eaters in low-income families. Parental education was also found to be inversely associated with children's food rejection levels.The MEDIC project seeks to assess health inequalities by studying the impact of food rejection dispositions on the nutritional status of children in pediatric services. A qualitative study supports the notion that food rejection is heightened during the hospitalization: half of the parents of hospitalized children interviewed reported that foods accepted outside the hospital were rejected in the ward. Parents indicated that their child's food preferences were more limited, and they only alternated between a few foods after entering the hospital. According to the majority of interviewed nurses, children refuse any food other than that provided by parents.The research hypotheses of the MEDIC project focus on understanding the moderating effects of food rejection dispositions and socioeconomic backgrounds on children's food intake during hospitalization. Two hypotheses are formulated: (H1) the pre-hospitalization food rejection levels predict the amount of food consumed during the hospital stay, and (H2) children from disadvantaged socioeconomic backgrounds are more likely to refuse food during their hospital stay than those from more advantaged backgrounds. To test these hypotheses, parents of children aged 2 to 8 will complete questionnaires on food rejection dispositions upon admission, and food consumption (in grams and calories) will be assessed through weighing and photographs of meal trays taken 48 hours (± 24 hours) post-admission. The project aims to shed light on the complexities of childhood malnutrition, addressing social inequalities and contributing valuable insights for interventions and public health policy. ### Conditions - Undernutrition ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Children between 2 and 8 years, without medical treatments or pathologies impacting food intake and his parents ### Outcomes Primary Outcomes - Grams of hospital meals consumed by the patients at lunch - Calories of hospital meals consumed by the patients at lunch, 48 hours after their admission to the hospital. Secondary Outcomes ### Location - Facility: Hôpital Femme Mère Enfant de Lyon, Bron, N/A, 69677, France @@
## The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients. - NCT ID: NCT06330012 - Study ID: GeoMx_Breast - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2027-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients. ### Conditions - HER2-positive Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - GeoMx data analysis with clinical outcome ### Outcomes Primary Outcomes - Spatial transcriptomic analysis Secondary Outcomes ### Location - Facility: Ji-Yeon Kim, Seoul, N/A, 06351, Korea, Republic of @@
## A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML - NCT ID: NCT06329999 - Study ID: CMG-sAML-001 - Status: RECRUITING - Start Date: 2024-02-03 - Completion Date: 2027-12-31 - Lead Sponsor: Ruijin Hospital ### Study Description The goal of this clinical trial\] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid leukemia\]. The main questions it aims to answer are:* Evaluation of the efficacy* Evaluation of the safety ### Conditions - Recurrent Adult Acute Myeloid Leukemia - Myelodysplastic Syndrome - Adult Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CMGV ### Outcomes Primary Outcomes - CRc Secondary Outcomes - ORR - OS - RFS - MRD- - Adverse Event ### Location - Facility: Ruijin Hospital, Shanghai, Shanghai, N/A, China @@
## Crossover RCT of TAMER Lenses in Myopia Control - NCT ID: NCT06329986 - Study ID: SEDPTC20240109 - Status: RECRUITING - Start Date: 2024-02-24 - Completion Date: 2026-01 - Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center ### Study Description This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses. ### Conditions - Myopia - Progressive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - TAMER Lens Spectacle - SV lenses ### Outcomes Primary Outcomes - Spherical Equivalent change Secondary Outcomes - Axial Length change - Spherical Equivalent change ### Location - Facility: Shanghai Eye Disease Prevention and Treatment Center, Shanghai, Shanghai, 200041, China @@
## Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer - NCT ID: NCT06329973 - Study ID: 2023-237 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2028-02-15 - Lead Sponsor: Henan Cancer Hospital ### Study Description Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies ### Conditions - Metastatic Gastroesophageal Junction Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Fruquintinib in combination with Sintilimab and CAPEOX ### Outcomes Primary Outcomes - Objective response rate - Maximum tolerated dose Secondary Outcomes - Overall Survival - Progression Free Survival - Disease Control Rate ### Location - Facility: Henan Cancer Hospital, Zhengzhou, Henan, 450008, China @@
## Dorsal Scapular Nerve Injection Combined With Muscle Needle Release - NCT ID: NCT06329960 - Study ID: 2024PHB019-001(3) - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-11-30 - Lead Sponsor: Peking University People's Hospital ### Study Description Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Generally, the DSN entrapment causes the stiffness of the major and minor rhomboideus(2). In clinical practice, the investigators observed that ultrasound-guided PIT using D5W HD combined with needle release of major and minor rhomboideus significantly relieved the pain of scapular region. Therefore, the investigators aimed to evaluate the 6-month efficacy of this procedure for the participants with DSN entrapment. ### Conditions - Dorsal Scapular Nerve Entrapment ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ultrasound-guided injection combined with needle release ### Outcomes Primary Outcomes - visual analogue scale (VAS) Secondary Outcomes ### Location - Facility: Jiaan Zhu, Beijing, N/A, N/A, China @@
## A Phase II Study of Surufatinib Combined With PD-L1 and mFOLFOX6 as Second-line Treatment for Advanced PRAD - NCT ID: NCT06329947 - Study ID: HMPL-012-SPRING-P106 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-22 - Completion Date: 2026-09-30 - Lead Sponsor: Rui-hua Xu, MD, PhD ### Study Description To preliminarily evaluate whether there is a survival benefit of surufatinib in combination with Caralizumab and mFOLFOX6 in the second-line treatment of advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer ### Conditions - Advanced Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Surufatinib in combination with Caralizumab and mFOLFOX6 ### Outcomes Primary Outcomes - objective response rate (ORR) Secondary Outcomes - disease control rate (DCR) - Progression-Free Survival (PFS) - overall survival (OS) - quality of life (QoL) - adverse events (AE) ### Location - Facility: SunYat-senUniversity Cancer Center, Guangzhou, N/A, N/A, China @@
## Refined Nursing in Rehabilitation Training - NCT ID: NCT06329934 - Study ID: XXZY-003 - Status: COMPLETED - Start Date: 2022-05-01 - Completion Date: 2024-01-01 - Lead Sponsor: Xinxiang Central Hospital ### Study Description This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications. ### Conditions - Brain Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Establishment of a hierarchical monitoring and management team - Assessment of pressure injury - Communication - Intervention for pressure ulcer - Rehabilitation training - introduction of the current patient's condition to family members - maintaining appropriate temperature and humidity in the ward - careful observation of vital signs in patients ### Outcomes Primary Outcomes - GCS scores - GCS scores - cognitive function scores - cognitive function scores - functional independence scores - functional independence scores - Newcastle Satisfaction with Nursing Scale (NSNS) - Newcastle Satisfaction with Nursing Scale (NSNS) - incidence of adverse reactions - incidence of adverse reactions Secondary Outcomes ### Location - Facility: Effect of Refined Nursing in Rehabilitation Training for Patients with Brain Injury During the Recovery Period: An Observational Study, Xinxiang, Henan, 453000, China @@
## Inpatient Monitoring of Unfractionated Heparin - NCT ID: NCT06329921 - Study ID: 232192 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Vanderbilt University Medical Center ### Study Description Unfractionated heparin (UFH) is the most widely used intravenous (IV) anticoagulant for treating and preventing thromboembolic disease (e.g., blood clots ). UFH must be closely monitored and adjusted in the hospital. There are two assays used to monitor UFH: 1) the activated partial thromboplastin time (PTT) and 2) the chromogenic anti-factor Xa assay (anti-Xa). This study aims to compare PTT and anti-Xa methods for monitoring UFH in a pragmatic, randomized controlled trial to determine which helps patients reach a therapeutic anticoagulation range faster. ### Conditions - Blood Clot - Thrombosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - PTT protocol - anti-Xa protocol ### Outcomes Primary Outcomes - Time to therapeutic anticoagulation range Secondary Outcomes - Measurements in therapeutic anticoagulation range - Coagulation laboratory measurements - New thrombotic events - New clinically relevant bleeding events - New coagulation events ### Location - Facility: Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States @@
## DC Combined With ICIs in the Treatment of Advanced Lung Cancer Resistant to ICIs - NCT ID: NCT06329908 - Study ID: TSLG-001 - Status: RECRUITING - Start Date: 2023-09-27 - Completion Date: 2026-10-31 - Lead Sponsor: Zhen-Yu Ding ### Study Description This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - LG002 ### Outcomes Primary Outcomes - The safety of Neo-DCVac combined with ICIs. Secondary Outcomes - The efficacy of Neo-DCVac combined with ICIs. - The efficacy of Neo-DCVac combined with ICIs. ### Location - Facility: West China Hospital, Chengdu, Si Chuan, 610000, China @@
## A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are Taken Together in Healthy Participants - NCT ID: NCT06329895 - Study ID: 22252 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-05-23 - Lead Sponsor: Bayer ### Study Description Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations.Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.Researchers think that BAY2927088 inhibits drug transporters such as P-gp (P-glycoprotein) and breast cancer resistance protein (BCRP). Drug transporters are proteins that help in the movement of certain drugs into, through, and out of the body's cells. Dabigatran is a drug used in the treatment of blood clots in a vein and rosuvastatin is a drug used in the treatment of high cholesterol in the blood.The main purpose of this study is to find out how BAY2927088, taken as multiple doses, affects the levels of dabigatran and rosuvastatin in the blood of healthy participants. For this, researchers will measure the following for dabigatran and rosuvastatin, when given with and without BAY2927088:* Area under the curve (AUC): a measure of the total amount of the drug in participants' blood over time* Maximum observed concentration (Cmax): the highest amount of the drug in participants' bloodIn this study, participants will take the following treatments:* Dabigatran in the morning of Day 1 and 9.* Rosuvastatin in the morning of Day 3 and 12.* BAY2927088 two times a day in the morning and evening of Days 6 to 15.Participants will be in this study for about 8 weeks with 3 visits to the study clinic.Participants will visit the study clinic:* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study* once on the day before the treatment starts and will stay in the clinic until Day 16 of the treatment* once, 7 to 10 days after last dose of BAY2927088, for a health check-upDuring the study, the doctors and their study team will:* do physical examinations* collect blood samples from the participants to measure the levels of dabigatran, rosuvastatin and of BAY2927088* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)* ask the participants questions about how they are feeling and what adverse events they are havingAn adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. ### Conditions - Advanced Non-small Cell Lung Cancer - EGFR Mutation - HER2 Mutation - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - BAY2927088 - Dabigatran etexilate - Rosuvastatin ### Outcomes Primary Outcomes - Cmax of unconjugated dabigatran when given with and without BAY2927088 - AUC of unconjugated dabigatran when given with and without BAY2927088 - Cmax of rosuvastatin when given with and without BAY2927088 - AUC of rosuvastatin when given with and without BAY2927088 Secondary Outcomes - Number of participants with treatment-emergent adverse events (TEAEs) - Severity of TEAEs ### Location - Facility: PAREXEL International Early Phase Clinical Unit (London), Harrow, N/A, HA1 3UJ, United Kingdom @@
## Doxycycline in Type II Diabetes - NCT ID: NCT06329882 - Study ID: 14789 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-04-20 - Lead Sponsor: Mostafa Bahaa ### Study Description Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of insulin in response to glucose burden ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sitagliptin 100mg - Doxycyclin ### Outcomes Primary Outcomes - Change in glycemic profile - Change in glycemic profile Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma - NCT ID: NCT06329869 - Study ID: 202401158MIFD - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-11 - Lead Sponsor: National Taiwan University Hospital ### Study Description The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma. ### Conditions - Esophageal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sacituzumab govitecan ### Outcomes Primary Outcomes - Overall objective response rates (ORR) Secondary Outcomes - Overall survival (OS) - Progression-free survival (PFS) - Duration of response (DOR) - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients in Taiwan - NCT ID: NCT06329856 - Study ID: 202301218RIND - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-07 - Lead Sponsor: National Taiwan University Hospital ### Study Description Background: The issue of artificial hydration for terminal cancer patients is a classic ethical dilemma in palliative care. It is a common practice especially when patients are incapable of oral intake; however, there is a lack of research on indications and practices for the provision of artificial hydration to terminal cancer patients in Taiwan. The investigators aim to conduct a nationwide survey of palliative care physicians on their indications (general or specific), and practices of providing artificial hydration to terminal cancer patients. With that understanding of reasoning and clinical practice, the investigators would further establish an indigenous, evidence-based consensus guideline to serve as a reference for physicians in Taiwan.Methods: The study is comprised of two parts. The first part is to conduct a nationwide survey of palliative and oncology care specialists with a questionnaire designed from literature reviews and principles of clinical ethics. After validation of the questionnaire, the investigators will e-mail it to members of the Taiwan Academy of Hospice Palliative Medicine and the Taiwan Society of Cancer Palliative Medicine. The primary outcome measure of the study is the indication and clinical practice of artificial hydration, and the secondary outcome is factors associated with the administration or withdrawal of hydration.The second part is to establish a national consensus on clinical guidelines for administering artificial hydration, where the investigators will conduct a modified Delphi method for 6 rounds. Literature reviews will be first performed and 14 sessions of one-to-one interviews in Round 1 to develop a draft. Subsequent rounds comprise questionnaire surveys among all panelists, teleconferences and e-mail discussions among core members, and cancer patients/patients' family discussions. Statistical criteria include median and disagreement scores according to the Inter-Percentile Range Adjusted for Symmetry. Items voted for by 70% or more panelists will be selected and formalized into a consensus guideline.Expected results: The investigators hypothesize that the indication to administer artificial hydration to the terminal cancer patient is multi-factorial and culturally based.Conclusion: The establishment of a consensus guideline will help clinicians to make an appropriate decision from ethical, medical, cultural, and emotional factors and facilitate cancer patients to achieve a good quality of dying. ### Conditions - Terminal Cancer - Hospice - Palliative Medicine ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Administering of artificial hydration ### Outcomes Primary Outcomes - Likert scale on alteration of administer artificial hydration to the terminal cancer patient and principles of clinical ethics - Distributive statistics - Disagreement score according to the Interpercentile Range Adjusted for Symmetry (IPRAS) for survey results Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro - NCT ID: NCT06329843 - Study ID: Intermountain - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2024-05 - Lead Sponsor: Picterus AS ### Study Description The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy. ### Conditions - Neonatal Jaundice ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Picterus Jaundice Pro (JP) ### Outcomes Primary Outcomes - Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP. Secondary Outcomes - Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy. - Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy. - Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy. - Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy. ### Location - Facility: Intermountain Health, Salt Lake City, Utah, 84132, United States @@
## 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer - NCT ID: NCT06329830 - Study ID: 2023-GAR-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-05 - Lead Sponsor: Rohan Garje ### Study Description The purpose of this research study is to test the safety and possible side effects of Lutetium-177 (177Lu)-Prostate-Specific Membrane Antigen (PSMA)-617 along with niraparib and abiraterone acetate plus prednisone when it is given to people diagnosed with metastatic castration-resistant prostate cancer (prostate cancer that has spread to other parts of the body and does not improve with hormonal therapies) at different dose levels. Once an optimal dose is selected, the researchers want to find out what how well these treatments work to improve survival and control the growth of the tumor. ### Conditions - Metastatic Prostate Cancer - Castration-resistant Prostate Cancer - Metastatic Castration-resistant Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 177Lu-PSMA-617 - Niraparib abiraterone acetate - Prednisone ### Outcomes Primary Outcomes - Determination of the recommended phase 2 dose (RP2D) - Prostatic-specific antigen (PSA)-50 response rate Secondary Outcomes - Radiographic progression-free survival (rPFS) - Overall survival (OS) - PSA-80 response rate - Duration of response (DOR) - Objective response rate (ORR) ### Location - Facility: Miami Cancer Institute, Miami, Florida, 33176, United States @@
## Incidence of Regurgitation in Patients Undergoing Intubation in Semi-fowler v/s Supine Position - NCT ID: NCT06329817 - Study ID: A/28/ER/532/23 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-09 - Lead Sponsor: Pak Emirates Military Hospital ### Study Description One of the most dreaded complication of general anaesthesia is aspiration of gastric contents after induction of general anaesthesia.Many endeavours and measures have been practiced to reduce the incidence of aspiration pneumonia.One such method is to intubate the patient in semi-fowler or supine posture.My study is aimed to find out safe and best position between these two after induction of general anaesthesia to prevent aspiration pneumonia. ### Conditions - Inguinal Hernia Bilateral ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Incidence of regurgitation in two different position. ### Outcomes Primary Outcomes - Prevention of aspiration pneumonia Secondary Outcomes ### Location - Facility: PEMH, Rawalpindi, Punjab, 44000, Pakistan @@
## The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure in Normotensive Individuals - NCT ID: NCT06329804 - Study ID: RM_01-11-21b - Status: RECRUITING - Start Date: 2021-11-01 - Completion Date: 2024-05-31 - Lead Sponsor: Swansea University ### Study Description It is estimated by WHO (2021) that 1.4 billion individuals across the globe have high blood pressure with only 14% of people 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. Exercise is one possible strategy: in previous research, several different types of exercise have been shown to have effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of exercise (150 mins of moderate intensity exercise per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort / exertion and discomfort (Korkiakangas et al 2009). Thus, there is a need to investigate alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021).Low intensity isometric hand grip training (IHGT) has been shown to result in large decreases in rest-ing 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, IHGT has typically involved performing 4 x 2 IHGT holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). Interestingly, there are very few studies that have investigated the effect of changing different protocol parameters on the adaptations in blood pressure, and the minimal effective dose of IHGT is unknown. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IHGT will reduce the efficacy for improving blood pressure. Therefore, the aim of this randomised controlled trial is to compare the effect of IHGT with a frequency of 2 or 4 sessions/week on resting blood pressure. ### Conditions - Blood Pressure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Isometric Handgrip Exercise Training (IHGT) ### Outcomes Primary Outcomes - Resting Systolic Blood Pressure Secondary Outcomes - Resting Diastolic Blood Pressure - Resting Mean Arterial Blood Pressure ### Location - Facility: National Taiwan Normal University, Taipei, N/A, N/A, Taiwan @@
## A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED) - NCT ID: NCT06329791 - Study ID: AZ202401 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: Azura Ophthalmics ### Study Description This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months. ### Conditions - Dry Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AZR-MD-001 - Vehicle ### Outcomes Primary Outcomes - Change from baseline in Meibomian Glands Yielding Liquid Secretion - Change from baseline in Total Ocular Surface Disease Index Score Secondary Outcomes ### Location - Facility: Arizona Eye Center, Chandler, Arizona, 85225, United States @@
## Home-Based Child Care Toolkit for Nurturing School-Age Children Study - NCT ID: NCT06329778 - Study ID: 50884b - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-10-27 - Lead Sponsor: Mathematica Policy Research, Inc. ### Study Description The goal of this observational study is to build psychometric evidence for the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) provider questionnaire. The main objectives of the study are to: 1) assess the reliability of the HBCC-NSAC Toolkit provider questionnaire, 2) assess the evidence for its validity compared to other existing measures of HBCC quality, and 3) examine invariance across subgroups (that is, look for the absence of any differential item functioning \[DIF\]). HBCC provider participants will complete a questionnaire in the HBCC-NSAC Toolkit. A subset of providers will also participate in an observation of their child care setting. Parents or guardians of children receiving care from HBCC providers will complete a survey. ### Conditions - Child Development ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The Home-Based Child Care Toolkit for Nurturing School-Age Children provider questionnaire - Emlen Scales - Multicultural Teaching Competency Scale - Family Child Care Program Quality Assessment (FCC PQA) Secondary Outcomes ### Location - Facility: Mathematica Policy Research, Washington, District of Columbia, 20002, United States @@
## CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation - NCT ID: NCT06329765 - Study ID: HR- 4380 - Status: RECRUITING - Start Date: 2023-08-07 - Completion Date: 2025-04-04 - Lead Sponsor: Marquette University ### Study Description The goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community. Few stroke survivors achieve this goal. Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke. Our team has developed a novel exercise intervention called CUped (pronounced cupid, like the Roman god) to address barriers to recovery and improve walking after stroke. CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling. This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response relationships. Results will provide preliminary data for an R01 to support a randomized controlled trial (RCT). CUped is designed to help stroke survivors recover lower limb movement lost to stroke, thereby improving walking. It is intended to be used as an adjunct to gait training. CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery, compels use of the paretic lower limb, and targets 3 key movement impairments caused by stroke: decreased muscle output from the paretic limb, inappropriate paretic muscle timing, and abnormal interlimb coordination. Exercise is done in sitting which enables high repetition practice. Like walking, CUped requires continuous, reciprocal use of both lower limbs; effects are likely to transfer to walking. The risk-reward profile of this proposal is ideal for an R21, which is an NIH funding opportunity intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory. The investigators have pilot data suggesting that CUped fulfills its design specifications, and this study will be the first to test its therapeutic effects. In this Stage 1 rehabilitation trial, The investigators will support or quickly refute the hypothesis that CUped is safe, acceptable, and capable of eliciting a therapeutic response in stroke survivors. The investigators will also examine tolerance to CUped and dose-response effects. If our hypotheses are supported, the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care. Future work will investigate physiologic mechanisms underlying the effects of CUped. ### Conditions - Stroke - Hemiplegia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exercise with CUped - a motor-assisted, split crank pedaling device and undergo 50 m of gait training. ### Outcomes Primary Outcomes - Paretic limb use in walking - Paretic limb use in pedaling - Interlimb coordination in walking - Interlimb coordination in pedaling - Motorized intervention during pedaling split-crank (i.e., bilateral uncoupled) pedaling - Absences - Adverse events Secondary Outcomes - Muscle activity - timing - Muscle activity - amplitude - Physiological response to exercise - Blood pressure - Physiological response to exercise - Heart rate - Physiological response to exercise - Rate of perceived exertion ### Location - Facility: Marquette University, Milwaukee, Wisconsin, 53201, United States @@
## Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department - NCT ID: NCT06329752 - Study ID: Not available yet - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: IRCCS Policlinico S. Matteo ### Study Description The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.The trial aims to assess:* The acceptability of sciatic nerve block* The technical feasibility of sciatic nerve block* The technical success of sciatic nerve block* The analgesic efficacy of sciatic nerve blockIn addition to that, this study aims to* Describe patient-reported and physician-reported satisfaction* Assess the Adverse Event rate at 48 hours post intervention ### Conditions - Ankle Fractures - Leg Fracture ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) ### Outcomes Primary Outcomes - To assess the technical feasibility of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures. Secondary Outcomes - Technical success of US-guided sciatic nerve block - Analgesic efficacy of US-guided sciatic nerve block - Patient-reported and physician-reported satisfaction ### Location - Facility: Emergency Department, IRCCS Fondazione Policlinico San Matteo, Pavia, N/A, 27100, Italy @@
## Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes - NCT ID: NCT06329739 - Study ID: NeuroPsico_Dopa&PD - Status: RECRUITING - Start Date: 2021-12-14 - Completion Date: 2031-12-14 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description The genetic landscape of Parkinson's disease (PD) is characterised by rare high penetrance pathogenic variants causing familial disease, genetic risk factor variants driving PD risk in a significant minority in PD cases and high frequency, low penetrance variants, which contribute a small increase of the risk of developing sporadic PD. This knowledge has the potential to have a major impact in the clinical care of people with PD.The goal of this observational study is to evaluate the impact of genetic mutation on behavior and cognition in PD patients.Patients will be assessed over time using test, questionnaire and standardised clinica scales. An initial assessment and annual follow-up assessments will be carried out for 5 years.Researchers will compare data collected from patients with genetic mutation versus patients without mutation. ### Conditions - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Clinical examinations and clinical scales administration ### Outcomes Primary Outcomes - Montreal Cognitive Assessment - Beck Depression Inventory - State-Trait Anxiety Inventory - Questionnaire for Impulsive-Compulsive Disorders in Parkinson - Pittsburgh Sleep Quality Index - Parkinson's Disease Questionnaire-8 - Minnesota Multiphasic Personality Inventory 2-RF Secondary Outcomes ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy @@
## Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease - NCT ID: NCT06329726 - Study ID: NeuroPsico_DBS&PD - Status: RECRUITING - Start Date: 2021-12-13 - Completion Date: 2032-12-15 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description The goal of this observational study is to evaluate the long-term effect of DBS-STN on cognitive and behavioral outcomes in Parkinson's disease (PD) patients.PD patients will be assessed over time using tests, questionnaires and standardized clinical scales. An initial assessment (T0) and annual follow-up assessments will be carried out for 5 years.Researchers will compare data collected from patients with DBS versus patients with best medical therapy. ### Conditions - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Clinical examinations and clinical scales administration ### Outcomes Primary Outcomes - Long-term characterization of DBS-STN on cognitive outcomes - Beck Depression Inventory - State-Trait Anxiety Inventory - Questionnaire for Impulsive-Compulsive Disorders in Parkinson - Pittsburgh Sleep Quality Index - Parkinson's Disease Questionnaire-8 - Minnesota Multiphasic Personality Inventory 2-RF Secondary Outcomes ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Lombardia, 20135, Italy @@
## Effect of Auto-Bolus Interval on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural - NCT ID: NCT06329713 - Study ID: 2024-03/11 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-08-01 - Lead Sponsor: Ataturk University ### Study Description It is aimed in this study to compare the effect of changing the interval time for programmed auto boluses of local anaesthetics on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique. ### Conditions - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Group I: 30 Min Interval Time - Group II: 60 Min Interval Time ### Outcomes Primary Outcomes - Difference between total local anaesthetic consumption Secondary Outcomes ### Location - Facility: Atatürk University, Erzurum, N/A, N/A, Turkey @@
## Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy - NCT ID: NCT06329700 - Study ID: ParSparInLivAtrophy - Status: COMPLETED - Start Date: 2010-05-01 - Completion Date: 2022-06-30 - Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita ### Study Description Major hepatectomy in patients with colorectal liver metastases (CLM) and post-chemotherapy liver atrophy is associated with increased complications. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. The aim of this study was to assess the clinical impact of post-chemotherapy liver atrophy on patients undergoing PSH for CLM. For this purpose, the occurrence of liver atrophy was recorded and then computed against the occurrence of postoperative morbidity and mortality. ### Conditions - Colorectal Cancer Stage IV ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hepatectomy ### Outcomes Primary Outcomes - Postoperative complications Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study Evaluating the Safety of the Nasal Pump - NCT ID: NCT06329687 - Study ID: OPP-010 - Status: TERMINATED - Start Date: 2024-02-21 - Completion Date: 2024-02-28 - Lead Sponsor: Oyster Point Pharma, Inc. ### Study Description The objective of this study is to determine the safety of the Tyrvaya nasal pump. ### Conditions - Dry Eye - Kerato Conjunctivitis Sicca ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tyrvaya Nasal Pump ### Outcomes Primary Outcomes - Incidence of Adverse Events Secondary Outcomes ### Location - Facility: United States, California, Newport Beach, California, 92663, United States @@
## Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients - NCT ID: NCT06329674 - Study ID: 20DM30203 - Status: COMPLETED - Start Date: 2021-04-27 - Completion Date: 2023-06-13 - Lead Sponsor: AJU Pharm Co., Ltd. ### Study Description A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2 ### Conditions - Type2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AJU-A51 - A51R2 - A51R3 - AJU-A51 Placebo - A51R2 Placebo ### Outcomes Primary Outcomes - Changes in HbA1c Secondary Outcomes ### Location - Facility: Asan Medical Center, Seoul, N/A, N/A, Korea, Republic of @@
## A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine - NCT ID: NCT06329661 - Study ID: CYS-007 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-31 - Lead Sponsor: Novaliq GmbH ### Study Description The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED) ### Conditions - Dry Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cyclosporine ophthalmic solution, 0.1% (VEVYE) - Saline solution, 0.6% ### Outcomes Primary Outcomes - Change from baseline in corneal ECD Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Distributed Learning of Edic and CardIac Dose Effects in Lung Cancer - NCT ID: NCT06329648 - Study ID: DECIDE - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-06-01 - Lead Sponsor: The Netherlands Cancer Institute ### Study Description Cardiac dose was not a major concern in lung radiotherapy patients until the results of the RTOG (Radiation Therapy Oncology Group) 0617 trial, which showed an association between cardiac dose and survival. Since then, many papers have studied the association between cardiac (substructure) dose and either survival or cardiac toxicity. Ideally, cardiac toxicity would be separated from survival. However, scoring cardiac toxicity prospectively was not standard practice, and retrospective scoring is challenging because of the overlap of cardiac toxicity symptoms and lung cancer (treatment) symptoms. Therefore in real world cohorts, cardiac toxicity is usually not scored properly and most larger studies pragmatically consider overall survival as primary endpoint, and the relation between cardiac dose and cardiac toxicity is not well established for lung cancer patients.Cardiac toxicity might not be the only factor in decreased survival; toxicity of the immune system might be a competing risk or a major contributing factor, where dose to the heart is a surrogate for dose to blood. Dose to the immune system is defined as EDIC (Effective Dose to circulating Immune Cells), comprising heart dose, lung dose and body dose combined. As EDIC dose and cardiac dose partly overlap, a large cohort with substantial variation will be required to disentangle the two effects. Such vast amounts of routine care data are immediately available in many radiotherapy centers all over the world. The problem we face is not the lack of routine care data, but making such data available for analysis. DECIDE adopts a federated learning approach, which implies that data does not have to be centralized within a single institution to be fit for use. We aim to include an unprecedentedly large-scale cohort of 20,000 patients.In this proposal, we need to add on scientific and technological innovations that exploit the existing federated learning framework to scale up to supporting \>25 simultaneously connected partners. We will be training (generalized) linear epidemiological models as well as new computer vision-based models for outcome predictions. As cause-specific survival (cardiac toxicity or immune toxicity) is unavailable or unreliable in major studies, we will use the more pragmatic endpoint of survival. By elucidating the clinical contributions of whole heart dose, cardiac substructure dose and EDIC dose in combination with known clinical risk factors, the desired impact is to change clinical practice for lung cancer radiotherapy and improve survival. ### Conditions - NSCLC ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Optimize EDIC dose Secondary Outcomes - cardiac toxicity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial - NCT ID: NCT06329635 - Study ID: 2023070K - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: The Affiliated Hospital Of Guizhou Medical University ### Study Description To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage. ### Conditions - Aneurysmal Subarachnoid Hemorrhage - Vasospasm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intrathecal Nicardipine - No intervention ### Outcomes Primary Outcomes - Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6 Secondary Outcomes - Extended Glasgow Outcome Score (GOS-E). - Modified Rankin Scale ordinal shift with mRS 5 and 6 combined - Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6 - Hamilton Depression Rating Scale (HAM-D) score - Hamilton Anxiety Rating Scale (HAM-A) score - Mini-Mental State Examination (MMSE) score - Montreal Cognitive Assessment (MoCA) scale score - Change of National Institutes of Health Stroke Scale (NIHSS) score - Cerebrospinal fluid shunt surgery rate - Overall mortality rate - Rate of CSF infection - Rate of any type of new intracranial hemorrhage. - Adverse Event - Serious Adverse Event ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease - NCT ID: NCT06329622 - Study ID: KY2023-972 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-30 - Lead Sponsor: Huashan Hospital ### Study Description The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD. ### Conditions - Chronic Kidney Disease - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - low-protein diet + Ketosteril - low-protein diet ### Outcomes Primary Outcomes - skeletal muscle mass index (SMI) Secondary Outcomes - changes in eGFR(ml/min/1.73m2) - serum albumin(g/l) - grip strength(kg) - BMI(kg/m2) - 6m walking speed(s) ### Location - Facility: Nephrology, Huashan hospital, Shanghai, N/A, 200040, China @@
## Airvo 3 Respiratory Rate Validation Study - NCT ID: NCT06329609 - Study ID: ClA-333 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: Fisher and Paykel Healthcare ### Study Description This is a clinical performance testing to validate the accuracy of the Airvo 3 device with respiratory rate algorithm manufactured by Fisher \& Paykel Healthcare for continuous respiratory rate monitoring. ### Conditions - COPD - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Airvo 3 with respiratory rate algorithm ### Outcomes Primary Outcomes - Respiratory rate Secondary Outcomes - Respiratory rate ### Location - Facility: Element Boulder, Louisville, Colorado, 80027, United States @@
## Microbiome Alterations With Xylitol (MAX) in Pregnancy - NCT ID: NCT06329596 - Study ID: H-55146 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-03-31 - Lead Sponsor: Baylor College of Medicine ### Study Description The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease), and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi. ### Conditions - Dysbiosis - Inflammation Gum ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Xylitol gum - Sorbitol gum ### Outcomes Primary Outcomes - Periodontal disease at 28-30 weeks of pregnancy Secondary Outcomes - Periodontal disease at 6 weeks postpartum - Alterations in the maternal oral microbiome communities delivery - Alterations in the maternal vaginal microbiome communities - Inflammatory mediator changes in the maternal gingival crevicular fluid at - Alterations within the infants' oral microbiome communities - Alterations within the infants' gut microbiome communities ### Location - Facility: Area 25 Health Center, Lilongwe, N/A, N/A, Malawi @@
## Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry - NCT ID: NCT06329583 - Study ID: 23-012635 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: Mayo Clinic ### Study Description The goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm. ### Conditions - Gastroesophageal Reflux - Dysphagia - Esophageal Motility Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - diaphragmatic breathing ### Outcomes Primary Outcomes - Pressure at the esophagogastric junction Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM) - NCT ID: NCT06329570 - Study ID: NF-2023-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-03-31 - Lead Sponsor: NaviFUS Corporation ### Study Description This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide. ### Conditions - Glioblastoma Multiforme - Glioblastoma - Glioma - Brain Tumor - Neoplasms - Neoplasms, Nerve Tissue ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NaviFUS System - Lumason - Bevacizumab ### Outcomes Primary Outcomes - Adverse Events (AEs) Secondary Outcomes - 6-month Progression-Free Survival (PFS-6) - Progression-Free Survival (PFS) - One-year Survival Rate - Overall Survival (OS) - Objective Response Rate (ORR) - Clinical Benefit Rate (CBR) - Local Disease Control on the MRI Images - Corticosteroid Consumption - Quality of life (QoL) assessment ### Location - Facility: University of Virginia, Charlottesville, Virginia, 22903, United States @@
## Optimizing the Patient Experience Through Provider Coaching or Communication Intervention - NCT ID: NCT06329557 - Study ID: 23-007188 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-08 - Completion Date: 2026-02 - Lead Sponsor: Mayo Clinic ### Study Description Hypothesis: Clinicians who receive patient experience coaching or communication classes have improved patient satisfaction scores and improved clinician satisfaction. ### Conditions - Patient Satisfaction - Communication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Intervention 1 ### Outcomes Primary Outcomes - To identify if patient experience coaching or communication classes have an effect on patient satisfaction scores and clinician satisfaction. Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## High Fructose Diet, the Gut Microbiome, and Metabolic Health - NCT ID: NCT06329544 - Study ID: STUDY-23-01572 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-11 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description Americans commonly consume excess amounts of dietary fructose. Added fructose has been shown to have an adverse impact on metabolic health, including increased insulin resistance and type 2 diabetes (T2D) risk. However, the mechanisms that link dietary fructose and metabolic health are poorly understood. Malabsorption or incomplete metabolism of fructose in the small intestine is common in the population. Excess fructose reaches the colon where it may change the structure and function of the gut microbiome, alter bacterial metabolites and trigger inflammatory responses impacting T2D risk. To elucidate whether commonly consumed levels of dietary fructose influence metabolic outcomes through altering the gut microbiome, the research team will randomize 30 participants to a controlled cross-over dietary intervention, in which the participants will consume 12-day isocaloric, added fructose or glucose diets (25% of total calories) separated by a 10-day controlled diet washout period.The research team aims to:1. Determine the relationships between high fructose consumption, the gut microbiome and metabolic risk.2. Characterize the causal role(s) that fructose-induced alterations to the gut microbiome have on metabolic risk using a germ-free mouse model.The research team will measure 1) microbiota community structure and function via metagenomic sequencing of stool, 2) fecal metabolites via targeted and untargeted metabolomics, 3) anthropometrics, 4) insulin resistance, serum markers of T2D risk and inflammatory cytokines, 5) fecal microbial carbohydrate oxidation capacity and 6) liver fat via MRI elastography. The research team will use novel statistical approaches, including Distributed Lag Modeling, to understand the complex relationships between diet, the microbiome, metabolites and health outcomes.The research team will then conduct controlled dietary interventions and fecal microbiome transplantation studies in germ-free mice. Donor fecal samples from human participants in both the glucose and fructose arms of the clinical intervention will be transplanted into germ-free and colonized mice to establish a causal relationship between fructose-induced changes to the gut microbiome, liver fat and metabolic and inflammatory changes known to increase risk for T2D.The research team aims to comprehensively assess the structural and functional changes to the gut microbiome brought about by a high fructose diet. Determining the impact of excess fructose on the microbiome will help identify novel means by which fructose contributes to metabolic disease risk. In addition to identifying strategies to improve metabolic health in adults, data from this proposal could help inform targeted approaches to mitigate future disease risk in vulnerable populations that consume high levels of fructose, such as children. ### Conditions - MASLD - Type 2 Diabetes - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Fructose - glucose ### Outcomes Primary Outcomes - Liver proton density fat fraction (PDFF) - Degree of fibrosis Secondary Outcomes ### Location - Facility: Mount Sinai Morningside, New York, New York, 10025, United States @@
## Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic - NCT ID: NCT06329531 - Study ID: 2022-0992 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-22 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To compare the results of the SOCS-OTS to another standardized screening measure that is currently being used by rehabilitation services at MD Anderson Cancer Center and to ensure that the SOCS-OTS correctly identifies those individuals needing OT services in cancer care. ### Conditions - Cancer - Occupational Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Rezafungin PK in Patients on ECMO - NCT ID: NCT06329518 - Study ID: HHC-2024-0064 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Hartford Hospital ### Study Description Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum echinocandin, Rezafungin, in critically ill patients receiving ECMO ### Conditions - Sepsis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Rezafungin ### Outcomes Primary Outcomes - Rezafungin Clearance Secondary Outcomes - Rezafungin Area Under the Curve (AUC) ### Location - Facility: Hartford Hospital, Hartford, Connecticut, 06102, United States @@
## Impact of Extracorporeal Membrane Oxygenation Care Strategy Application Development - NCT ID: NCT06329505 - Study ID: 111-085-B - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-12-31 - Lead Sponsor: Pei-Hung Liao ### Study Description The objective of this study was to develop an educational training App for ECMO care, and to apply a blended learning approach to improve the knowledge and skills of nurses. ### Conditions - Learning Problem ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Comparison of knowledge and skills of nurses between groups after the intervention For 6 months. Secondary Outcomes ### Location - Facility: National Taipei university of nursing and health science, Taipei, N/A, N/A, Taiwan @@
## Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis - NCT ID: NCT06329492 - Study ID: 23-007937 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-09 - Completion Date: 2025-12-31 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA). ### Conditions - Osteoarthritis - OA - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) ### Outcomes Primary Outcomes - Adverse Events Secondary Outcomes - Visual Analog Scale (VAS) for Pain - Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Pain interference - Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Physical function - Knee Injury and Osteoarthritis Outcome Score (KOOS): - Procedure Recommendation ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI) - NCT ID: NCT06329479 - Study ID: 1926B - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-09-01 - Lead Sponsor: University of Dublin, Trinity College ### Study Description Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention. ### Conditions - Circadian Rhythm Disorders - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cognitive behavioural therapy for Insomnia (CBT-I) - Bright Light Therapy - Individualised activity plan - Clincial review ### Outcomes Primary Outcomes - Acceptability and usability of a multi-modal non-pharmacological intervention - Adherence to interventions - Adverse events - Completion rates of research assessments - Recruitment rate Secondary Outcomes - Symptom assessment - Quality of Life assessment - Daytime Sleepiness - Sleep Quality - Physical activity assessment - Physical activity and sleep assessment ### Location - Facility: Our Lady's Hospice & Care Services, Dublin, N/A, D6W RY72, Ireland @@
## The Effect of Emotional Freedom Technique (EFT) on Pain Intensity and Menstruation Symptoms - NCT ID: NCT06329466 - Study ID: 0000-0002-4205-669X - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-01-28 - Completion Date: 2024-07-25 - Lead Sponsor: Gulay Coskun ### Study Description The most important indicator of the fertility period, which has an important place in a woman's life, is the menstrual cycle, which begins with menarche and continues until menopause. In this natural process that takes place every month physiologically, some women experience significant pain \[1\]. This condition, defined as dysmenorrhea (painful menstruation), is classified in two ways as primary dysmenorrhea (PD) and secondary dysmenorrhea (SD) \[2,3\]. PD is the most common women's health problem, especially in adolescents and young adults (10-20 years of age) \[1,5\].When studies on the incidence and severity of primary dysmenorrhea are examined, the incidence of PD is seen at rates ranging from 40-90% \[5-8\].The main goal of the treatment approach to PD, which negatively affects women's quality of life in many ways, is to relieve the woman by reducing the pain. Emotional Freedom Technique (EFT) is one of the non-pharmacological and integrated treatment methods for women with primary dysmenorrhea. This practice, which is also referred to as EFT stroke/touch in most sources, is based on expressing the problem by touching the energy meridian points of the body, as in acupuncture and acupressure.Considering the results of the studies, it can be said that EFT is effective in the management of pain and the negative effects caused by the restrictions in the life of the person (social and daily living activities, etc.) \[27-30\]. Thanks to EFT, it is thought that women will contribute to the reduction of the fear and anxiety of experiencing pain just before menstruation and the anxiety that their life will be limited due to this.Studies investigating the effect of EFT on pain have reported that it is effective in coping with pain \[33-35\]. However, no randomized controlled study was found in the literature search for the application of EFT in high school students with dysmenorrhea. For this reason, it is thought that if EFT is applied in this age period with a high incidence of dysmenorrhea, important findings can be achieved in terms of parameters such as pain intensity and menstrual symptoms, and it will contribute to the literature by shedding light on similar studies. \[36\]. Therefore, in this study, it was aimed to determine the effect of the emotional freedom technique applied to high school students with primary dysmenorrhea on pain severity and menstruation symptoms. ### Conditions - Dysmenorrhea Primary ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - intervention (EFT) group ### Outcomes Primary Outcomes - Mcgill Pain Scale - Menstruation Symptom Scale - VAS pain scale Secondary Outcomes ### Location - Facility: Mersin University, Yenişehir, Mersin, 33343, Turkey @@
## Intestinal Immunity in Neurologic Disease - NCT ID: NCT06329453 - Study ID: 2000033081 - Status: RECRUITING - Start Date: 2022-08-02 - Completion Date: 2027-08-31 - Lead Sponsor: Yale University ### Study Description The purpose of this study is to ascertain the functional profiles of the immune cells within the gastrointestinal tract and to determine how these cells contribute to autoimmune and neurologic diseases. ### Conditions - Multiple Sclerosis - Parkinson Disease - REM Sleep Behavior Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Colon Tissue Biopsy ### Outcomes Primary Outcomes - Characterization of immune cells from the gastrointestinal mucosa Secondary Outcomes - Evaluate spatial transcriptomics of intestinal tissue - Characterize the microbiome at different anatomic sites within the gastrointestinal tract ### Location - Facility: Yale MS Clinic, North Haven, Connecticut, 06473, United States @@
## Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Adult Patients - NCT ID: NCT06329440 - Study ID: 2023/880 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-05 - Lead Sponsor: Istanbul University ### Study Description Hemidiaphragmatic paresis is a common side effect of brachial plexus blocks such as supraclavicular or infraclavicular block techniques. It has been shown that diaphragma thickness is affected at some extent in supraclavicular block and also in costoclavicular block which is accepted as an infraclavicular approach. However, these two approaches have not been extensively investigated before in terms of the diaphragmatic paresis. Here, it is aimed to compare these two methods considering their effects on diaphragma thickness in inspirium and in expirium. Moreover, the performance properties such as motor and sensory block onset, needle visualization time, needle visualization difficulty, postoperative pain scores, and lastly the perfusion index which is known to be reflecting vasodilation will be investigated. ### Conditions - Diaphragm Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Ultrasonographic measurement of diaphragm thickness ### Outcomes Primary Outcomes - Diaphragm thickness fraction (centimeters) Secondary Outcomes - Diaphragm thickness at the end of expirium (centimeters). - Diaphragm thickness at the end of inspirium (centimeters). - Perfusion index change - Motor and sensory block onset time - Postoperative pain scores (0-10) ### Location - Facility: Istanbul University Istanbul Faculty of Medicine, Istanbul, N/A, N/A, Turkey @@
## Dragon Ambient eXperience (DAX) Copilot Evaluation - NCT ID: NCT06329427 - Study ID: IRB00098063 - Status: COMPLETED - Start Date: 2023-06-19 - Completion Date: 2023-12-15 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description AI solutions like, Dragon Ambient eXperience (DAX) Copilot (Nuance/Microsoft), hold the potential to significantly enhance provider and patient interactions and alleviate pain points that contribute to burn out. Atrium Health was the first healthcare system in the world to pilot Nuance's DAX Copilot intelligence (AI) enabled scribe software, which synthesizes a draft clinic note by "listening" to the conversation between a provider and patient. After 180 days of use by primary care clinicians and advanced practice providers (APPs), along with a control group, the investigators assess provider satisfaction, patient experience, and provider efficiency through qualitative and quantitative methods. ### Conditions - Automated Clinical Documentation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Dragon Ambient eXperience (DAX) Copilot ### Outcomes Primary Outcomes - Total EHR time - Work outside of work - Time on encounter note documentation - Completed appointment rate - Same day closure rate - Note length - Gross revenue per visit - wRVU per visit Secondary Outcomes - Provider satisfaction - Provider interview - Patient satisfaction ### Location - Facility: Atrium Health Navicent, Macon, Georgia, 31201, United States @@
## Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis - NCT ID: NCT06329414 - Study ID: 00164631 - Status: RECRUITING - Start Date: 2024-01-16 - Completion Date: 2026-01 - Lead Sponsor: University of Utah ### Study Description The goal of this single-arm, observational pilot study is to learn about the safety, feasibility, preliminary efficacy of TMS for the treatment of depression in people with MS. Participants will receive outpatient TMS treatment over the course of 5-6 weeks. Participants will complete validated questionnaires and exams before, during, and after treatment. ### Conditions - Multiple Sclerosis - Major Depressive Disorder - Treatment Resistant Depression ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Feasibility of TMS treatment for MDD, per participant retention rates. - Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment. Secondary Outcomes - Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment. - Depression remission rates will be measured using MADRS scores before and after treatment. - MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden. ### Location - Facility: University of Utah Health, Salt Lake City, Utah, 84108, United States @@
## A Study Evaluating the Safety and Efficacy of AP01 in Participants With Progressive Pulmonary Fibrosis (PPF) - NCT ID: NCT06329401 - Study ID: AP01-007 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2026-04 - Lead Sponsor: Avalyn Pharma Inc. ### Study Description A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in participants with PPF over 52 weeks. ### Conditions - Progressive Pulmonary Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AP01 - Placebo ### Outcomes Primary Outcomes - To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID) Secondary Outcomes - To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL) - To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52) - To evaluate the change from baseline in quantitative lung fibrosis score. ### Location - Facility: Newport Native MD, Inc., Newport Beach, California, 92663, United States @@
## Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns - NCT ID: NCT06329388 - Study ID: CSD-SFRI-013 - Status: COMPLETED - Start Date: 2023-01-18 - Completion Date: 2023-08-11 - Lead Sponsor: TruHeight Vitamins ### Study Description This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen concentration in urine, height via a stadiometer, and body composition using an INBODY device. ### Conditions - Growth Disorders - Dietary Exposure - Child Development - Bone Development Abnormal - Body Weight - Child Malnutrition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TruHeight Growth Protein Shake ### Outcomes Primary Outcomes - Change in Height Secondary Outcomes - Change in Type X Collagen Concentration in Urine - Change in Body Composition - Incidence of Adverse Events ### Location - Facility: SF Research Institute, San Francisco, California, 94127, United States @@
## Food Insecurity Reduction & Strategy Team - NCT ID: NCT06329375 - Study ID: 72967 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-02-05 - Lead Sponsor: Stanford University ### Study Description This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:1. To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.2. To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options.3. To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program. ### Conditions - Diabetes Mellitus, Type 2 - Food Insecurity - Diabetes Mellitus, Type 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Nutrition program ### Outcomes Primary Outcomes - Food insecurity at 30-days post initial discharge Secondary Outcomes - Food insecurity at 60- and 90- days post post initial discharge - Measures of diabetes stress - Measures of hypoglycemia - Measures of medication adherence - Hospitalization ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique - NCT ID: NCT06329362 - Study ID: 2-7-23 - Status: RECRUITING - Start Date: 2023-07-31 - Completion Date: 2025-07 - Lead Sponsor: The Royal College of Surgeons of Edinburgh ### Study Description The goal of this clinical trial is to compare implant stability, and crestal bone loss, when using minimal invasive ridge splitting versus convenient open flap technique. The main question is Does Minimal Invasive Implant ridge splitting ("transmucosal" without flap) influence the implant stability and crystal bone loss, when compared with the conventional open flap techniques? Researchers will compare Group A: Minimal Invasive Implant ridge splitting and Group B: Triangular flap technique is used to see if there is significant difference between the two groups when measuring implant stability, and crestal bone density. ### Conditions - Alveolar Bone Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Minimally invasive implantation - Open flap procedure for ridge expansion. ### Outcomes Primary Outcomes - Implant stability. - CBCT assessment Secondary Outcomes - Postoperative Pain - Operation Time ### Location - Facility: Faculty of Dentistry Cairo University, Cairo, N/A, 35855, Egypt @@
## Metabolic Flexibility to Predict Lifestyle Interventions Outcomes - NCT ID: NCT06329349 - Study ID: EK VP57/0/2023 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2026-04-01 - Lead Sponsor: Charles University, Czech Republic ### Study Description Weight loss is a cornerstone of diabetes (T2D) management, yet in clinical practice, its delivery is limited by its perceived burdensome nature and variability in response. Personalization of the interventions to increase their success rate is an unmet clinical need. The proposed project MEPHISTO (Whole body and gut microbiome metabolic flexibility to predict lifestyle intervention outcomes) would aim to identify predictive features related to successful weight loss upon sequential exercise and diet intervention in people living with obesity. To this end, the study aims to conduct a clinical trial where the investigators would implement state-of-the-art physiological phenotyping of metabolic flexibility at the whole-body level and at the level of the gut in persons with obesity before and after exercise and diet + exercise intervention to identify predictive signatures of successful weight loss ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise - Combined Exercise + Diet ### Outcomes Primary Outcomes - Change in metabolic flexibility (MetFlex (ΔRQ 200-0)) - Change in insulin sensitivity Secondary Outcomes - Glucose tolerance relate to primary outcomes changes - HbA1c relate to primary outcomes changes - Insulin sensitivity relate to primary outcomes changes ### Location - Facility: University Hospital Kralovske Vinohrady, Prague, N/A, 10034, Czechia @@
## Parenting Support for Justice Involved Families - NCT ID: NCT06329336 - Study ID: STUDY00019653 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-04 - Lead Sponsor: University of Washington ### Study Description Together with the Community Care Team of King County Community Partnership for Transition Solutions (KCCPTS), the investigators propose to collaborate in adapting parenting intervention(s) to support the well-being and effective parenting of parents re-entering the community, as well as that of their children's primary caregiver. The aim is promoting the well-being of the parents/caregivers and their children, fostering positive child development, and ultimately, preventing the intergenerational transmission of adversity. The KCCPTS Community Care Team includes re-entry navigators who have lived experience of adversity and incarceration, bringing their unique insights regarding the re-entry experience, from both personal and professional experiences. This study will evaluate a task-sharing approach to offering formerly incarcerated parents and their families a parenting support intervention. That is, re-entry navigators will be trained to deliver evidence-based parenting interventions. This increases the feasibility and accessibility of the program, particularly because facilitators have shared experiences and trusted connections with their clients. This project proposes four main activities: 1) conduct focus groups with parents re-entering the community to better understand their parenting needs, 2) work with KCCPTS re-entry navigators to incorporate information from their experience and the focus group to adapt a parenting intervention, 3) train re-entry navigators to deliver the program, and 4) conduct a preliminary evaluation of the impact of the program on parents' well-being and parenting when the program is delivered by KCCPTS re-entry navigators. If this preliminary evaluation shows promise in supporting parent well-being and parenting effectiveness, the investigators will seek funding to conduct a larger, more rigorous evaluation. ### Conditions - Parenting - Well-Being, Psychological - Mental Health Wellness 1 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Social Emotional Competence for Children and Parents ### Outcomes Primary Outcomes - Parenting Behavior Inventory - Very short Form - PHQ-9 Depressive Symptoms - GAD-7 Anxiety Symptoms - Brief Resilience Scale - Self-Compassion Scale - Short Form - Strengths and Difficulties Questionnaire Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours - NCT ID: NCT06329323 - Study ID: 23CX8477 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-14 - Completion Date: 2028-04 - Lead Sponsor: Imperial College London ### Study Description The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression, imaging and radiomic profiles of malignant ovarian germ cell tumours (MOGCT) compared to patients with a benign OGCT and no ovarian pathology.The main question\[s\] it aims to answer are:1. To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs)2. To understand the imaging profile of MOGCTs compared to that of BOGCTs3. To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease4. To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI5. To see if we can link the micro RNAs in tumour samples to those found in blood samples, and to find a plausible explanation for why these micro RNAs are raised (in terms of the tumour biology itself).aimsParticipants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment and/or remission and/or relapse. If they have surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their mass.Researchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie. If a patient with a BOGCT requires surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their benign mass. ### Conditions - Germ Cell Ovarian Cancer - Germ Cell Tumor - Germ Cell Cancer - Germ Cell Neoplasia - Ovary Cancer - Ovary Neoplasm - Ovarian Cancer - Ovarian Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood test - Pathology specimen miRNA expression ### Outcomes Primary Outcomes - Difference in microRNA expression (plasma) between benign and malignant masses - Difference in microRNA expression (serum) between benign and malignant masses - microRNA expression (plasma) - microRNA expression (serum) Secondary Outcomes - Quantitative measure of circulating miRNA before treatment - Quantitative measure of circulating miRNA before treatment - Quantitative measure of circulating miRNA after treatment - Quantitative measure of circulating miRNA after treatment - Performance of segmentation model on ultrasound images - Performance of segmentation model on MRI images - Performance of classification model on ultrasound images - Performance of classification model on MRI images ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Xeltis Hemodialysis Access Conduit: aXess-E Study - NCT ID: NCT06329310 - Study ID: XEL-CR-14 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-12 - Lead Sponsor: Xeltis ### Study Description A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation. ### Conditions - End Stage Renal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - aXess-E conduit ### Outcomes Primary Outcomes - Primary Patency rate - Freedom from device-related SAE Secondary Outcomes - Implantation success rate - Primary patency rate - Primary assisted patency rate - Secondary patency rate - Functional patency rate - Time (expressed in months) to first intervention and to access abandonment - Rate of access-related interventions required to achieve/maintain patency - Freedom from device-related SAE - Rate of access site infections - Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment - Time to first cannulation - Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Continuous Glucose Monitoring in Inpatients - NCT ID: NCT06329297 - Study ID: NUR23-1005 INPTCGM1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Parkview Health ### Study Description The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations. ### Conditions - Hyperglycemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CGM monitor ### Outcomes Primary Outcomes - CGM vs point of care test (POCT) glucose Secondary Outcomes - Slow downward trend arrow on CGM device ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Midkine Role With Deregulated Oxidative and Immune Milieu in Induction of Preeclampsia - NCT ID: NCT06329284 - Study ID: RC 31.1.2024 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-15 - Lead Sponsor: Benha University ### Study Description Preeclampsia (PE) is a hypertensive pregnancy-related disorder that endangers maternal and fetal outcomes and accounts for 9-10% of maternal mortalities with its early-onset phenotype is the most dangerous, but its etiology is still not fully elucidated.Midkine (MDK) is a multifunctional protein that plays a unique role in the development of hypertension (HTN), via its proatherogenic effect and induction of overexpression of angiotensin converting enzyme. Oxidative stress (OS) upregulates the expression of MDK and MDK induces propagation of neoangiogenesis and acts as chemotactic for neutrophils. ### Conditions - Pre-Eclampsia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - ELISA ### Outcomes Primary Outcomes - Severity of Pre-Eclampsia (PE) Secondary Outcomes ### Location - Facility: Banha University, Banhā, El- Qalyobia, 13511, Egypt @@
## After Hip Fracture Nailing, Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR) - NCT ID: NCT06329271 - Study ID: 113022-E - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2025-04-29 - Lead Sponsor: Far Eastern Memorial Hospital ### Study Description Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.Patients and methods:For this prospective single-center clinical trial study, we recruited 60 geriatric proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. The participants were assigned to the Early-weight-bearing group (n= 30) or the Weight-bearing restriction group (n = 30). Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded. ### Conditions - Bony Weight Bearing Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Early-Weight bearing ### Outcomes Primary Outcomes - Harris Hip Functional score - Harris Hip Functional score - Harris Hip Functional score - Harris Hip Functional score - Harris Hip Functional score Secondary Outcomes - Visual analog pain score - Visual analog pain score - Visual analog pain score - Visual analog pain score - Visual analog pain score - Complication ### Location - Facility: Far-Eastern Memorial Hospital, New Taipei City, N/A, 220, Taiwan @@
## Combination of Sotyktu and Enstilar for Plaque Psoriasis - NCT ID: NCT06329258 - Study ID: PTC09 - Status: COMPLETED - Start Date: 2022-12-06 - Completion Date: 2023-11-13 - Lead Sponsor: Psoriasis Treatment Center of Central New Jersey ### Study Description combination deucravacitinib and enstilar foam ### Conditions - Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Enstilar - Deucravacitinib ### Outcomes Primary Outcomes - Psoriasis Area and Severity Index 75 at week 12 Secondary Outcomes ### Location - Facility: Schweiger Derm Group, East Windsor, New Jersey, 08520, United States @@
## Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD - NCT ID: NCT06329245 - Study ID: brainpro2022 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-07-01 - Lead Sponsor: Children's Hospital of Fudan University ### Study Description The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). The main questions it aims to answer are what the differences in prosocial behaviors and related brain network connections between infants/toddlers at high and low risk of ASD are. Participants will receive developmental and social communicational assessments (Griffiths Mental Developmental Scales, Peabody Developmental Motor Scales, The Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist), resting-state EEG and MRI in a natural sleeping state. ### Conditions - Autism or Autistic Traits - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Do not take any interventions ### Outcomes Primary Outcomes - clinical diagnosis - neurodevelopmental outcome - Prosocial behaviors - nuclear magnetic resonance imaging(MRI) - Event related potentials (ERPs) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis - NCT ID: NCT06329219 - Study ID: wIRA - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2025-12 - Lead Sponsor: Charite University, Berlin, Germany ### Study Description The aim of this clinical trial is to evaluate the effects of water-filtered Infrared-A radiation on patients suffering from hand osteoarthritis. The main questions it aims to answer are:* Does water-filtered Infrared-A radiation reduce pain and improve the function of finger joints over time?* Are patients satisfied with the treatment results when compared to those who were on a wait-list? ### Conditions - Hand Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - water-filtered Infrared-A radiation ### Outcomes Primary Outcomes - Pain in the finger joints on visual analogue scale Secondary Outcomes - Hand Dynamometer - Disabilities of Arm, Shoulder and Hand (DASH) questionnaire - Pain Self-Efficacy Questionnaire - Hospital Anxiety and Depression Scale (HADS) - Short Form (SF)-36 Health Survey (SF-36) - Functional Index for Hand OsteoArthritis (FIHOA) - Tolerability of the intervention - Pain medication (number per day) ### Location - Facility: Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin, Berlin-Wannsee, Berlin, 14109, Germany @@
## A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors - NCT ID: NCT06329206 - Study ID: GH2616-101 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2026-09-01 - Lead Sponsor: Suzhou Genhouse Bio Co., Ltd. ### Study Description This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib). ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - GH2616 Tablets ### Outcomes Primary Outcomes - Safety assessment Secondary Outcomes - Objective response rate (ORR) - Progression-free survival (PFS) - Duration of response (DOR) - Plasma concentration (Cmax) - Area under the plasma concentration-time curve (AUC) - Time to achieve Cmax (Tmax) ### Location - Facility: Zhejiang Cancer Hospital, Zhejiang, N/A, N/A, China @@
## Effects of Mid-Season Camp Period Loading on Sports Injury Anxiety and Physical Performance - NCT ID: NCT06329193 - Study ID: CBU-FTR-ES-O4 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-05-15 - Lead Sponsor: Celal Bayar University ### Study Description The aim of this study is to investigate the effects of 3-week mid-season camp period loading on sports injury anxiety level and physical performances of professional male soccer players. ### Conditions - Anxiety - Exercise - Athletic Performance ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Mid-Season Camp Period Loading ### Outcomes Primary Outcomes - Sports Injury Anxiety Secondary Outcomes - Muscle strength - Flexibility - Dynamic balance - Single-leg jump - Agility - Sprint ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exercise in Mental Illness Questionnaire: French Validation - NCT ID: NCT06329180 - Study ID: 26.02.2024 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-19 - Completion Date: 2024-06-01 - Lead Sponsor: KU Leuven ### Study Description The validation of the French version of the Exercise in Mental Illness Questionnaire - Health Practitioner Version (EMIQ-HP) is a prospective observational case-only study involving: (a) translation to French, (b) an expert consensus meeting with French speaking experts from Canada to reach a first version, (c) back translation to English, (d) evaluation of the back-translation by the original authors of the EMIQ-HP, (e) an expert consensus meeting with French speaking experts from Canada to reach a final version based on comments of the original authors, and (f) test-retest reliability study. Test-retest reliability will be analysed through two points of measurement with an interval of 7 days. ### Conditions - Exercise ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Intra-class-correlation coefficients (ICC 3,1 Secondary Outcomes ### Location - Facility: Centre Hospitalier Psychiatrique Chêne aux Haies, Mons, N/A, N/A, Belgium @@
## Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery - NCT ID: NCT06329167 - Study ID: 2024-HS-012 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-07-31 - Lead Sponsor: The First Hospital of Jilin University ### Study Description This clinical trial is designed to learn more about treating patients with lower limb lymphoedema following gynaecological surgery. The main question to be answered is To evaluate the efficacy of Daphnetin capsule in the treatment of patients with lower limb lymphedema following gynaecological malignancy surgery. Participants will take Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) orally at the same time as gradient compression stocking treatment. Researchers will compare 150mg Forte tablets (2 capsules/time, 2 times daily) and gradient compression stockings to see if Daphnetin capsule can be used to treat patients with lower extremity lymphedema following gynaecological malignancy surgery. ### Conditions - Lower Extremity Lymphedema ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Daphnetin - Aescuven ### Outcomes Primary Outcomes - The difference in the circumference of the lower limbs - Gynaecological Cancer Lymphedema Questionnaire - Fibrinogen content Secondary Outcomes ### Location - Facility: the 1st hospital of Jilin University, Chang Chun, Jilin, N/A, China @@
## Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries - NCT ID: NCT06329154 - Study ID: PJ-KS-KY-2024-03(X) - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2025-02-27 - Lead Sponsor: Yong Liu, MD ### Study Description This clinical trial aims to learn about the effect of extracorporeal shock wave therapy on rotator cuff injuries. The main question it aims to answer is the efficacy of extracorporeal shock wave therapy on the improvement of pain, shoulder function, and quality of life in patients with rotator cuff injuries. The experimental group of patients received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group only received conventional rehabilitation therapy. Compare the two groups to explore the therapeutic effect of extracorporeal shock wave therapy on rotator cuff injuries. ### Conditions - Rotator Cuff Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Extracorporeal shock wave therapy - conventional rehabilitation therapy ### Outcomes Primary Outcomes - Change from Baseline Visual Analogue Scale at 4 weeks - Change from Baseline Range of Motion at 4 weeks - Change from Baseline Constant-Murley Score at 4 weeks - Change from Baseline Isokinetic muscle strength testing at 4 weeks - Change from Baseline Magnetic resonance imaging at 4 weeks - Change from Baseline Musculoskeletal ultrasound at 4 weeks Secondary Outcomes - Change from Baseline American Shoulder and Elbow Surgeons Score at 4 weeks - Change from Baseline Shoulder Pain and Disability Index at 4 weeks - Change from Baseline Disability of the Arm, Shoulder and Hand Score at 4 weeks - Change from Baseline University of California at Los Angeles Shoulder Scale at 4 weeks - Change from Baseline Pittsburgh sleep quality index at 4 weeks ### Location - Facility: The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116011, China @@
## A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients - NCT ID: NCT06329141 - Study ID: HSG4112-P2-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-06-30 - Lead Sponsor: Glaceum ### Study Description 1. Study Objective - To assess the efficacy and safety of vutiglabridin in early Parkindson's disease patients2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of vutiglabridin in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in early Parkinson's disease patients.3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled, parallel-group trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 24 weeks according to the study protocol. Several parameters (i.e., MDS-UPDRS, CGI-C, K-NMSS, modified Hoehn-Yahr stage and SNBR) will be evaluated to assess the efficacy of vutiglabridin. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of vutiglabridin. Blood samples will be collected for pharmacokinetic assessment. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vutiglabridin - Placebo ### Outcomes Primary Outcomes - Change From Baseline in MDS-UPDRS Part III Subscore Secondary Outcomes - Change From Baseline in MDS-UPDRS Part III Subscore - Change From Baseline in MDS-UPDRS Part II + Part III - Change From Baseline in CGI-C score - Change From Baseline in K-NMSS score - Change From Baseline in Modified Hoehn-Yahr stage - Change From Baseline in PET SNBR (Specific to Non-specific Binding Ratio) in the putamen, acudate and nucleus - Drop-out rate due to taking anti-parkinson drug ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Effectiveness of Manual Therapy in Patients With Knee Osteoarthritis - NCT ID: NCT06329128 - Study ID: 2022/04 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-09-30 - Lead Sponsor: Hasan Kalyoncu University ### Study Description The aim of this study is to investigate the effects of three different applications (Manual therapy, electrotherapy and home program) on long-term pain, joint range of motion and, secondarily, the functional level of the knee. ### Conditions - Osteoarthritis, Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental: Study Group - Active Comparator: Control Group ### Outcomes Primary Outcomes - The pain - Functional status - The quality of Life - Lower extremity functional strength and balance test - Functional mobility Secondary Outcomes ### Location - Facility: Hasan Kalyoncu University, Gaziantep, Şahinbey, 27100, Turkey @@
## Investigation of the Effectiveness of Regular Physical Activity in University Students - NCT ID: NCT06329115 - Study ID: 2024/23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-06-30 - Lead Sponsor: Hasan Kalyoncu University ### Study Description In our study, university students who coded the course from various faculties and departments within the scope of a university-wide free elective course, after regular physical activity; It was aimed to examine the effects on lifelong learning, physical activity, fatigue, sleepiness, depression, anxiety and stress levels, quality of life and walking distances and physiological expenditure indices. ### Conditions - Regular Physical Activity - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exercise training ### Outcomes Primary Outcomes - Lifelong learning - Physical activity - Fatique - Daytime sleepiness - Depression, anxiety and stress - Quality of life measurement - Physiological expenditure indices Secondary Outcomes ### Location - Facility: Hasan Kalyoncu University, Gaziantep, Şahinbey, 27100, Turkey @@
## Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen - NCT ID: NCT06329102 - Study ID: 93628 - Status: RECRUITING - Start Date: 2021-01-01 - Completion Date: 2025-09-01 - Lead Sponsor: Haukeland University Hospital ### Study Description Aim of the project is to surveil results after extended lymphadenectomy for right sided colon resection for cancer with different operative techniques. Patients operated for right sided colon cancer will be involved. There are different operative methods used in terms of extend of lymphadenectomy and access (open, laparoscopic and robotic assisted) that are already implemented. The Norwegian standard operation contains less extended lymph node dissection. Patients operated by the standard method will serve as control group. Choice of access and extend of lymph node dissection in Norway is dependant on the surgeon and hospital. At Haukeland University Hospital extend and access of surgery are determined by a multidisciplinary team meeting. More radical surgery might result in more complications and the benefit for the patients in terms of oncological result and survival is uncertain. At Haukeland University Hospital, extended lymphadenectomy has been mostly performed by open surgery. During the study phase we will introduce extended lymphadenectomy by laparoscopy and robotassisted surgery. Hypothesis is that more radical surgery performed by minimal invasive surgery will result in equal or better oncological results, and less complications, shorter hospital stay and better quality of life. As method we choose a prospective observational study. All eligible patients with adenocarcinoma of the right colon without another ongoing oncological treatment for other cancers will be included. Patientdata will be prospectively registered in a web-based database. Aim of the study will be to define the optimal extend of lymphadenectomy to achieve the best oncological result. In addition, we will analyse the results dependent on the surgical access (open, laparoscopic or robotic). The assumed difference between the operative methods is small. Therefore, the study is designed and approved as a multicenter registration in order to achieve the necessary statistical power. ### Conditions - Right Sided Colon Cancer - Right Colectomy - Lymphadenectomy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surgical access ### Outcomes Primary Outcomes - Surgical complications defined by Calvien Dindo II to V Secondary Outcomes - Surgical quality described by the specimen quality and number of lymph nodes harvested - Oncological quality will be measured by overall survival and recurrence - Quality of life after surgery measured with the 15D instrument ### Location - Facility: Haukeland University Hospital, Bergen, N/A, 5009, Norway @@
## Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer - NCT ID: NCT06329089 - Study ID: HCB/2023/0840 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Hospital Clinic of Barcelona ### Study Description The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are:* What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries?* How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit?Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team. ### Conditions - Recurrent Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Reoperative Sentinel Lymph Node Biopsy ### Outcomes Primary Outcomes - Re-Sentinel Lymph node harvesting rate - Drainage pathways description Secondary Outcomes - Complications rate - Axillary metastasis rate - Correlation Between Axillary and Internal Mammary Chain Infiltration - Quality of life in recurrent breast cancer ### Location - Facility: Hospital Clínic de Barcelona, Barcelona, N/A, 08036, Spain @@
## Losartan Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study - NCT ID: NCT06329076 - Study ID: BAM_lab_eyetracking_04 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-07-30 - Lead Sponsor: University of Electronic Science and Technology of China ### Study Description The main aim of the present study is to investigate the effects of orally administered losartan on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Losartan - Placebo ### Outcomes Primary Outcomes - Ratio of judged-time-to-collision to actual-time-to-collision for threatening versus non-threatening stimuli after losartan administration Secondary Outcomes - First saccade latency(ms) for threatening versus non-threatening stimuli after losartan administration - Fixation duration(ms) for threatening versus non-threatening stimuli after losartan administration ### Location - Facility: University of Electronic Science and Technology of China, Chengdu, Sichuan, N/A, China @@
## Oral Vasopressin Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study - NCT ID: NCT06329063 - Study ID: BAM_lab_eyetracking_03 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-07-30 - Lead Sponsor: University of Electronic Science and Technology of China ### Study Description The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Vasopressin - Placebo ### Outcomes Primary Outcomes - Ratio of judged-time-to-collision to actual-time-to-collision for threatening versus non-threatening stimuli after oral vasopressin administration Secondary Outcomes - First saccade latency(ms) for threatening versus non-threatening stimuli after oral vasopressin administration - Fixation duration(ms) for threatening versus non-threatening stimuli after oral vasopressin administration ### Location - Facility: University of Electronic Science and Technology of China, Chendu, Sichuan, N/A, China @@
## The Effects of Losartan on Attention Control: An Eye-tracking Study - NCT ID: NCT06329050 - Study ID: BAM_lab_eyetracking_02 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-07-30 - Lead Sponsor: University of Electronic Science and Technology of China ### Study Description The main aim of the present study is to investigate the effects of orally administered Losartan on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Losartan - Placebo ### Outcomes Primary Outcomes - Saccade/antisaccade latency difference between social and non-social stimuli after losartan administration - Error rate of saccade/antisaccade for social versus non-social stimuli after losartan administration Secondary Outcomes - Saccade/antisaccade latency for different facial emotions after losartan administration - Error rate of saccade/antisaccade for different facial emotions after losartan administration ### Location - Facility: University of Electronic Science and Technology of China, Chengdu, Sichuan, 611731, China @@
## The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study - NCT ID: NCT06329037 - Study ID: BAM_lab_eye-tracking_01 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-07-30 - Lead Sponsor: University of Electronic Science and Technology of China ### Study Description The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Vasopressin - Placebo ### Outcomes Primary Outcomes - Saccade/antisaccade latency difference between social and non-social stimuli after oral vasopressin administration - Error rate of saccade/antisaccade for social versus non-social stimuli after oral vasopressin administration Secondary Outcomes - Saccade/antisaccade latency for different facial emotions after oral vasopressin administration - Error rate of saccade/antisaccade for different facial emotions after oral vasopressin administration ### Location - Facility: University of Electronic Science and Technology of China, Chengdu, Sichuan, 611731, China @@
## The Impact of Myofascial Release Therapy on Dysphagia in Post-stroke Patients - NCT ID: NCT06329024 - Study ID: myofascial dysphagiapoststrok - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:• Can Myofascial Release Therapy improve swallowing function in Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation treatment - Myofascial Release Therapy ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Swallowing Quality of Life questionnaire - Patient health questionnaire-9 - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Combining Transcranial Direct Current Stimulation With Intermittent Oral to Esophageal Tube for Stroke-related Dysphagia - NCT ID: NCT06329011 - Study ID: TDC+IOE - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Comprehensive rehabilitation therapy - Intermittent Oro-esophageal Tube Feeding - Transcranial direct current stimulation - Placebo Transcranial direct current stimulation ### Outcomes Primary Outcomes - Penetration Aspiration Scale Secondary Outcomes - Functional Oral Intake Scale - Swallowing Quality of Life Questionnaire - Patient Health Questionnaire-9 - Body weight ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intra-articular Injection Versus Normal Rehabilitation Therapy on Temporomandibular Joint Dysfunction - NCT ID: NCT06328998 - Study ID: Intra-articular Injection - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint DysfunctionThe main question it aims to answer is:• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction ### Conditions - Temporomandibular Joint Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Routine rehabilitation treatment - Intra-articular Injection - Lidocaine Hydrochloride ### Outcomes Primary Outcomes - Friction Index Secondary Outcomes - The Visual Analog Scale - The maximum mouth opening limit - Mann Assessment of Swallowing Ability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients - NCT ID: NCT06328985 - Study ID: IOETraumatic Brain Injury - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Rehabilitation therapy - Intermittent Oro-esophageal Tube Feeding - Nasogastric tube feeding ### Outcomes Primary Outcomes - Concentration of hemoglobin - Concentration of albumin - Concentration of prealbumin - body mass index Secondary Outcomes - Decannulation of tracheostomy tube-placement duration - Decannulation of tracheostomy tube-Successful removal - Level of consciousness - Feeding Amount ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia - NCT ID: NCT06328972 - Study ID: IOE-Cerebral Palsy - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - systemic therapy - Intermittent Oro-Esophageal Tube Feeding - Persistent Nasogastric Tube Feeding ### Outcomes Primary Outcomes - The Oral Motor Assessment Scale Secondary Outcomes - Pneumonia - Hemoglobin - Total Protein - Albumin - Prealbumin - body weight - Penetration-Aspiration Scale - Functional Oral Intake Scale for Infants - Feeding amount ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Oral Feeding in Infants With Pierre Robin Syndrome - NCT ID: NCT06328959 - Study ID: IOE- Pierre Robin - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. ### Conditions - Pierre Robin Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - intermittent oro-esophageal tube feeding - gastric tube feeding ### Outcomes Primary Outcomes - Number of patients diagnosed as the pulmonary infection "Positive" Secondary Outcomes - Concentration of total protein - Concentration of hemoglobin - Concentration of albumin - Body weight - The Functional Oral Intake Scale for Infants ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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