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## Enhancing Clinical Reasoning Competency - NCT ID: NCT06373172 - Study ID: 202005-HR-003 - Status: COMPLETED - Start Date: 2020-05-01 - Completion Date: 2023-03-01 - Lead Sponsor: Tongmyong University ### Study Description Enhancing Clinical Reasoning Competency for Undergraduate Nursing Students Using Virtual Simulation-based Education based on the Rasch modelAims: Clinical reasoning is a core nursing competency that involves analyzing patient-related data and providing appropriate nursing practices. Simulation-based education is effective in improving the clinical reasoning competencies and communication skills of nursing students. This study aimed to verify the effectiveness of virtual simulation-based education. ### Conditions - Clinical Reasoning - Communication - Development, Human ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - virtual simulation-based education program ### Outcomes Primary Outcomes - Nurses Clinical Reasoning Scale - Communication Skills Scale Secondary Outcomes ### Location - Facility: Tongmyong Unoversity, Busan, N/A, 48520, Korea, Republic of @@
## An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan - NCT ID: NCT06373159 - Study ID: 22643 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-09-30 - Lead Sponsor: Bayer ### Study Description This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied.In observational studies, only observations are made without participants receiving any advice or changes to their healthcare.DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC.To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting.In this study, researchers will assess patient data from a hospital database in Japan.The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year.To learn about this, researchers will collect the following information:* The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis* The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores)* The number of days between diagnosis of sepsis and the beginning of DICResearchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan.In this study, only available data from routine care are collected. ### Conditions - Sepsis - Disseminated Intravascular Coagulation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No study intervention ### Outcomes Primary Outcomes - Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up - Distribution of JAAM DIC score - Distribution of ISTH DIC score - Distribution of MHLW DIC score - Distribution of SOFA score - Days from sepsis diagnosis to the onset of DIC Secondary Outcomes - Number of participants per clinical characteristics - Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC - Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC - Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC - Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC - Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC - Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC - Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC - Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC - Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC ### Location - Facility: Bayer, Tokyo, N/A, 100-8265, Japan @@
## A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity - NCT ID: NCT06373146 - Study ID: 18750 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-04 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to determine if combining tirzepatide with the mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 72 weeks and may include up to 19 visits. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tirzepatide - Mibavademab - Tirzepatide-Placebo - Mibavademab-Placebo ### Outcomes Primary Outcomes - Mean Percent Change from Baseline in Body Weight Secondary Outcomes - Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg) - Mean Absolute Change from Baseline for Body Weight (kg) - Percentage of Participants Who Achieve ≥5% Body Weight Reduction - Percentage of Participants Who Achieve ≥10% Body Weight Reduction - Percentage of Participants Who Achieve ≥15% Body Weight Reduction - Percentage of Participants Who Achieve ≥20 Body Weight Reduction - Mean Percent Change from Randomization 2 for Body Weight - Mean Change from Randomization 2 for Body Weight (kg) - Mean Absolute Change from Randomization 2 for Body Weight (kg) - Change from Baseline to Week 24 in CoEQ Scores - Change from Baseline to Week 24 in CoEQ Scores - Change from Baseline in FCQ-T-r Scores - Change from Baseline in FCQ-T-r Scores ### Location - Facility: Velocity Clinical Research, Gardena, Gardena, California, 90247, United States @@
## SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer - NCT ID: NCT06373133 - Study ID: 2024 (82) - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-11-01 - Lead Sponsor: West China Hospital ### Study Description To evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Bevacizumabin in the treatment of microsatellite stable (MSS) advanced colorectal cancer. ### Conditions - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SHR-8068 - Adebrelimab - BP102 ### Outcomes Primary Outcomes - Dose-limiting toxicity - PFS Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Interventional Ventricular Assist System for PCI in CHIP Patients - NCT ID: NCT06373120 - Study ID: QX20231057-X-1 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-30 - Lead Sponsor: Xijing Hospital ### Study Description In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP).During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter.There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients.The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system in providing circulatory support for complicated and high-risk patient with indications for PCI. ### Conditions - High-Risk Percutaneous Coronary Intervention (High-risk PCI) - Left Ventricular Assist Devices ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CorVad - VA-ECMO ### Outcomes Primary Outcomes - Major adverse event Secondary Outcomes - All-cause death - Stroke - Myocardial infarction - Revascularization - Cardiovascular hospitalization - MCS-ARC defined type 3, 4, 5 bleeding - Acute kidney injury - Serious device-related adverse events - Cardiopulmonary resuscitation - Hospitalization time - Intensive care unit (ICU/CCU) stay time - ECMO/Corvad utilization time - Hemodynamic disorder - Transfusion rate - Units of transfusion ### Location - Facility: Ling Tao, Xi'an, Shannxi, 710032, China @@
## Investigating Effects of High-intensity Gait Training on Gait, Balance and Depression Post-stroke - NCT ID: NCT06373107 - Study ID: 2117651-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-11 - Completion Date: 2026-01-31 - Lead Sponsor: Alvernia University ### Study Description The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - High intensity gait training ### Outcomes Primary Outcomes - 3-meter backwards walk test - 6-minute walk test - 10-meter walk test - Surface electromyography (EMG) - Berg Balance Scale - Functional Gait Assessment - Borg Rating Scale of Perceived Exertion (RPE) - Patient Health Questionnaire (PHQ-9) - Rate of patient attendance (Compliance) to physical therapy - Newest Vital Sign - Multidimensional Scale of Perceived Social Support (MSPSS) Secondary Outcomes ### Location - Facility: Lehigh Valley Health Network Outpatient Neurologic Rehab, Allentown, Pennsylvania, 18104-2310, United States @@
## A Single Dose Escalation Study of HHT201 in Healthy Subjects - NCT ID: NCT06373094 - Study ID: DON102-CTP - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-03-31 - Lead Sponsor: Shanghai Synergy Pharmaceutical Sciences Co., Ltd. ### Study Description The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Donepezil Dihydroxynaphthalate for Injection ### Outcomes Primary Outcomes - Adverse events - Number of Participants With Abnormal Laboratory Values - Number of Participants With Abnormal ECG QT Interval - Number of Participants With Abnormal Vital signs - Number of Participants With Abnormal Physical examination - VAS Secondary Outcomes - Cmax of Donepezil - Tmax of Donepezil - AUC0-t of Donepezil - AUC0-∞ of Donepezil - t1/2z of Donepezil - Vz/F - CLz/F ### Location - Facility: Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center), Taizhou, Zhe Jiang, 318000, China @@
## Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease - NCT ID: NCT06373081 - Study ID: CD19-CD3E-CN-A1 - Status: RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-04-15 - Lead Sponsor: Shanghai Changzheng Hospital ### Study Description This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases. ### Conditions - Systemic Lupus Erythematosus (SLE) - Sjogren's Syndrome - Systemic Sclerosis - Inflammatory Myopathy - ANCA Associated Vasculitis - Antiphospholipid Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Anti-CD19-CD3E-CAR-T cells ### Outcomes Primary Outcomes - The incidence of dose-limiting toxicities (DLTs) (Safety) - Proportion of patients for whom the desired dose of anti-CD19-CD3E-CAR-T cells can be successfully manufactured - Clinical response for relapsed/Refractory SLE - Clinical response for Sjögren's Syndrome - Clinical response for relapsed/refractory/progressive systemic sclerosis - Clinical response for relapsed/refractory/progressive inflammatory myopathy - Clinical response for relapsed/refractory anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: - Clinical response for relapsed/refractory/Catastrophic Antiphospholipid Syndrome Secondary Outcomes ### Location - Facility: Shanghai ChangZheng hospital, Shanghai, N/A, 200003, China @@
## Association Between Resuscitation Orders and Mortality in ICU Patients - NCT ID: NCT06373068 - Study ID: Resuscitation Orders ICU - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-03 - Lead Sponsor: Karolinska Institutet ### Study Description The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained. ### Conditions - Critical Illness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Resuscitation orders ### Outcomes Primary Outcomes - Mortality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics - NCT ID: NCT06373055 - Study ID: 4-2023-1232 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2033-11 - Lead Sponsor: Yonsei University ### Study Description Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection. ### Conditions - Muscle-invasive Bladder Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - neoadjuvant chemotherapy followed by radical cystectomy ### Outcomes Primary Outcomes - Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles Secondary Outcomes - overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy - cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy - progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy - recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy ### Location - Facility: Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea, Seoul, N/A, N/A, Korea, Republic of @@
## Tirofiban for Successful Endovascular Stroke Thrombectomy - NCT ID: NCT06373042 - Study ID: ADJUVANT-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2026-10-31 - Lead Sponsor: Zhongming Qiu ### Study Description Up to 50% of acute ischemic stroke patients with large vessel occlusion failed to achieve functional independence even after successful reperfusion therapy, a phenomenon that is referred to as "futile recanalization". The mechanism of futile recanalization is complex, and some studies have shown that it may be related to factors such as tissue no reflow, reocclusion, poor status of collateral circulation, hemorrhagic transformation, impaired cerebrovascular autonomic regulation, and low perfusion volume. Several studies suggested that maximizing the improvement of cerebral reperfusion is still the primary goal of acute large vessel occlusive stroke. Structural and functional alterations in the microvascular system may be a major obstacle to reperfusion. In animal models of cerebral ischemia, downstream microvascular thrombosis may occur in the early stage of cerebral ischemia and before vascular recanalization, which is the main factor leading to incomplete reperfusion and affecting the efficacy of endovascular thrombectomy.Mechanical thrombectomy mainly addressed the occluded large arteries, and does not consider the distal arteries. However, the recanalization of occluded large arteries does not necessarily translate into successful reperfusion of the ischemic tissue supplied by the distal capillaries. Even with complete recanalization, impaired microcirculatory reperfusion may lead to poor clinical outcomes. Therefore, we speculate that at the end of endovascular thrombectomy, microthrombi remain present in the microcirculation of brain tissue in patients with complete or near-complete cerebral angiography, and that microthrombi is more likely to be dissolved than thrombus more proximal to the heart. Therefore, intra-arterial administration of pharmaceutical, such as tirofiban, may be the only possible option to ensure complete reperfusion of ischemic tissue. Tirofiban is a platelet glycoprotein IIb/IIIa receptor antagonist, which has been widely used in acute coronary syndrome, and its role in acute ischemic stroke has attracted more and more attention from stroke experts. Previous studies have suggested that tirofiban can further increase the incidence of successful recanalization, while reducing the reocclusion rate.Whether early administration of intraarterial and intravenous tirofiban can further improve the clinical outcomes of patients with large vessel occlusive stroke after successful mechanical thrombectomy remains unclear. ### Conditions - Stroke, Acute Ischemic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intraarterial and intravenous tirofiban - Intraarterial and intravenous placebo ### Outcomes Primary Outcomes - Functional independence Secondary Outcomes - Recanalization on follow-up CTA or MRA - Early neurologic improvement - Level of disability - Excellent outcome - Independent ambulation - Health-related quality of life - Long-term of disability level - Health-related quality of life (long-term) - Incidence of symptomatic intracranial hemorrhage (SICH) - Radiologic intracranial hemorrhage rate - Mortality - Incidence of non-hemorrhagic serious adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury - NCT ID: NCT06373029 - Study ID: 2023PHB211-001(2) - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-12-30 - Lead Sponsor: Peking University People's Hospital ### Study Description Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. The investigators have already developed a deep convolutional network (DCNN) model that automates detailed classification of ATFL injuries. The investigators hope to use the DCNN in real-world clinical setting to test its diagnostic accuracy. ### Conditions - Ultrasound - Anterior Talofibular Ligament - Deep Learning ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound examination ### Outcomes Primary Outcomes - classification of ATFL injury Secondary Outcomes ### Location - Facility: Peking University People's Hospital, Beijing, Beijing, 100032, China @@
## Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder - NCT ID: NCT06373016 - Study ID: 2015P000652 - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2027-02-01 - Lead Sponsor: Stony Brook University ### Study Description The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior. ### Conditions - Bipolar Disorder - Bipolar Disorder Type 1 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Glucose - Ketones ### Outcomes Primary Outcomes - Stabilization of brain networks (general brain functioning) - Relative stabilization or destabilization of brain networks in response to metabolic bolus - Prefrontal-limbic circuit regulation - Cortico-striatal circuit regulation - Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS) Secondary Outcomes ### Location - Facility: McLean Hospital, Belmont, Massachusetts, 02478, United States @@
## Negative Antiphospholipid Syndrome: a Multicentric Study - NCT ID: NCT06373003 - Study ID: SNAPSITA - Status: RECRUITING - Start Date: 2024-03-31 - Completion Date: 2026-03-31 - Lead Sponsor: Italian Society for Rheumatology ### Study Description Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology.The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes.The recruited patients have the following criteria:(i)Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS) or patients with seronegative APS (SN-APS) or patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS; (ii) Age \<65 years; (iii) less than 5 years from the first event to the beginning of the study. ### Conditions - Antiphospholipid Syndrome - Seronegative Antiphospholipid Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnostic accuracy ### Outcomes Primary Outcomes - Primary endpoint Secondary Outcomes - Secondary endpoint_1 - Secondary endpoint_2 - Secondary endpoint_3 ### Location - Facility: UOC di Reumatologia - AOU Policlinico Umberto I, "Sapienza" Università di Roma, Roma, Rome, 00185, Italy @@
## Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease - NCT ID: NCT06372990 - Study ID: 0015338 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-09-30 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Prospective, non-pharmacological, single-center, non-profit observational study.The study design allows longitudinal evaluation of the immune response during the natural history of the infection and/or treatment, correlating the data with the outcome of the disease and antiviral therapies, which will be collected as study variables from the source documents.The study population will be patients suffering from chronic HBV infection with or without HBV-HDV co-infection followed at the Division of Gastroenterology and Hepatology of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico.The present study is part of an international cooperation project between the Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy) and the Duke-NUS Medical School, Singapore, financed by a grant (project MAECI-2023-23683653) and divided into two specific Work Packages:* WP 1 Milan team (WP1.1 - Clinical and virological phenotyping of CHB and CHD patients; WP1.2 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations)* WP 2 Singapore team (WP2.1 - Applicability of the rapid T cell assay approach; WP 2.2 - Optimization of the rapid T cell assay protocol)The primary objective of the study is to define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay. ### Conditions - HBV - HBV/HDV ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay Secondary Outcomes - Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV - Correlate the T cell response phenotype with the clinical profile (chronic infection vs. chronic hepatitis), disease severity (cirrhosis vs. non-cirrhosis) and response to specific HBV and HBV-HDV therapies - Improve the rapid T cell analysis protocol by simplifying the process, reducing analysis time and/or reducing the amount of material (blood) needed ### Location - Facility: Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy., Milano, MI, 20122, Italy @@
## Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity - NCT ID: NCT06372977 - Study ID: kappa index in ms - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Assiut University ### Study Description To:1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis) ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - kappa index ### Outcomes Primary Outcomes - Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases . - Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases . Secondary Outcomes - Assess the role of k FLC in predicting disease activity (conversion from CIS to MS) - Assess the role of OCBs in predicting disease activity (conversion from CIS to MS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients - NCT ID: NCT06372964 - Study ID: ITI-007-421 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2027-05 - Lead Sponsor: Intra-Cellular Therapies, Inc. ### Study Description This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5). ### Conditions - Bipolar Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lumateperone - Placebo ### Outcomes Primary Outcomes - Children's Depression Rating Scale-Revised (CDRS-R) Secondary Outcomes - Clinical Global Impression Scale-Severity (CGI-S) ### Location - Facility: Clinical Site, Anaheim, California, 92805, United States @@
## Lung Ultrasound in Neonatal Intensive Care Units - NCT ID: NCT06372951 - Study ID: Lung ultrasound in neonate - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-03 - Lead Sponsor: Assiut University ### Study Description Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray . ### Conditions - Neonatal Respiratory Distress ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound ### Outcomes Primary Outcomes - Identifying causes of neonatal respiratory distress Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Role of Inflammatory Markers and Doppler Parameters in Late-Onset Fetal Growth Restriction: A Machine Learning Approach - NCT ID: NCT06372938 - Study ID: AEŞH-BADEK-2024-43 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-31 - Completion Date: 2024-04-30 - Lead Sponsor: Ankara Etlik City Hospital ### Study Description Fetal growth restriction (FGR) is a serious complication in pregnancy that can lead to various adverse outcomes. It's classified into early-onset (before 32 weeks) and late-onset (after 32 weeks), with late-onset associated with long-term risks like hypoxemia and developmental delays. The study focuses on the role of inflammation in FGR, introducing new blood markers for better understanding and diagnosis. It also addresses the challenges of using advanced diagnostic tools in low-resource settings and explores the use of machine learning to predict FGR based on inflammatory markers, highlighting the potential of artificial intelligence in overcoming these challenges. ### Conditions - Fetal Growth Restriction - Inflammatory Response ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound measurement - Laboratory Tests and Inflammatory Markers ### Outcomes Primary Outcomes - Evaluation of data Secondary Outcomes - Machine learning modeling ### Location - Facility: Etlik City Hospital, Ankara, Yenimahalle, 06170, Turkey @@
## Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction - NCT ID: NCT06372925 - Study ID: CKJX839A1CN04 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-23 - Completion Date: 2026-06-24 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol (LDL-C). ### Conditions - Plaque, Atherosclerotic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - atorvastatin - IVUS/OCT - inclisiran ### Outcomes Primary Outcomes - Change in percent atheroma volume (PAV) Secondary Outcomes - Change in minimum fibrous cap thickness (FCT) - Change in mean minimum FCT of all images - Change in normalized total atheroma volume (NTAV) - Proportion of participants with progression, regression, or no change in PAV - Change in LDL-C - Change in TC - Change in HDL-C - Change in non-HDL-C - Change in ApoB - Change in ApoA1 - Change in Lp(a) - Change in TG - Proportion of participants with LDL-C target attainment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Early Postoperative Complications in Patients Undergoing Bariatric Surgery - NCT ID: NCT06372912 - Study ID: Complications-Bariatric-TJ - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Instituto Mexicano del Seguro Social ### Study Description This study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. Conducted at specialized high-volume bariatric surgery centers in Tijuana, Mexico. Predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. Surgical reintervention within 48 hours was required in 0.33% of cases. The study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery. ### Conditions - Bariatric Surgery Candidate - Complication,Postoperative ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries. ### Outcomes Primary Outcomes - Rate of Postoperative Complications Secondary Outcomes - Long-term Weight Loss Efficacy ### Location - Facility: Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico., Tijuana, Baja California, 22046, Mexico @@
## Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers - NCT ID: NCT06372899 - Study ID: 855140 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-03-31 - Lead Sponsor: University of Pennsylvania ### Study Description This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms. ### Conditions - E-cigarette Use - Cigarette Smoking - Harm Reduction - Tobacco Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - E-cigarettes - Oral nicotine pouches ### Outcomes Primary Outcomes - Cigarette Consumption - Cigarette Smoking Across Follow-Up Secondary Outcomes - Biomarkers of Exposure: Carbon Monoxide (CO) - Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%) - Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) - Biomarkers of Exposure:1-hydroxypyrene (1-HOP) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment - NCT ID: NCT06372886 - Study ID: 2402-147-1516 - Status: COMPLETED - Start Date: 2012-01-01 - Completion Date: 2024-03-01 - Lead Sponsor: Seoul National University Hospital ### Study Description 1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement. ### Conditions - Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - portal/superior vein resection ### Outcomes Primary Outcomes - 5-year overall survival - 5-year portal/superior mesenteric vein stenosis free survival Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Deep-learning For Ultrasound Classification of Anterior Talofibular Ligament Injury - NCT ID: NCT06372873 - Study ID: 2023PHB211-001 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-30 - Lead Sponsor: Peking University People's Hospital ### Study Description Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. Using datasets from multiple clinical centers, the investigators aimed to develop and validate a deep convolutional network (DCNN) model that automates classification of ATFL injuries using US images with the goal of providing interpretable assistance to radiologists and facilitating a more accurate diagnosis of ATFL injuries.The investigators collected US images of ATFL injuries which had arthroscopic surgery results as reference standard form 13 hospitals across China;Then the investigators divided the images into training dataset, internal validation dataset, and external validation dataset in a ratio of 8:1:1; the investigators chose an optimal DCNN model to test its diagnostic performance of the model, including the diagnostic accuracy, sensitivity, specificity, F1 score. At last, the investigators compared the diagnostic performance of the model with 12 radiologists at different levels of expertise. ### Conditions - Deep Learning - Ultrasound - Anterior Talofibular Ligament ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - re-evaluate by two senior radiologists in our medical center ### Outcomes Primary Outcomes - To evaluate whether the US images are in consensus with the ATFL injury classification of the reference standard Secondary Outcomes ### Location - Facility: Peking University People's Hospital, Beijing, Beijing, 100032, China @@
## DPP Feasibility Study of Breastfeeding - eMOMS 2.0 - NCT ID: NCT06372860 - Study ID: RKS2018350 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-02 - Lead Sponsor: University of Kansas Medical Center ### Study Description The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application. ### Conditions - Overweight or Obesity - Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Diabetes Prevention Program - Breastfeeding - Usual Care ### Outcomes Primary Outcomes - Maternal weight - Maternal body mass index (BMI) - Initiation of Lactation - Duration of Lactation - Type of Infant Feeding Secondary Outcomes - Recruitment Rate - Retention Rate - Research Engagement - Mobile Application Usage - Health Coach Interaction ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## DISE-HNS Effect Study - NCT ID: NCT06372847 - Study ID: Project ID 6214 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-23 - Completion Date: 2028-03-31 - Lead Sponsor: University Hospital, Antwerp ### Study Description The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.Furthermore, outcomes will be compared between responders and non-responders. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Hypoglossal nerve stimulation implant - Polysomnography - Drug-induced sleep endoscopy (DISE) ### Outcomes Primary Outcomes - Δ%area-of-collapse at the level of the lateral walls Secondary Outcomes - Δ%area-of-collapse at the level of the palate, tongue base and epiglottis - Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders - DISE-score during baseline DISE and during one-year follow-up DISE. - Non-invasive site and pattern of collapse ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients: A Randomized, Sham-controlled Trial - NCT ID: NCT06372834 - Study ID: B202205178 - Status: RECRUITING - Start Date: 2022-11-07 - Completion Date: 2024-12-31 - Lead Sponsor: Tri-Service General Hospital ### Study Description In this double-blind, randomized, sham-controlled trial, we aimed to examine the effect of accelerated piTBS on suicide risk in a group of treatment-resistant patients with MDD (i.e., TRD), using an extensive suicide assessment scale the primary outcome. We hypothesized that this intensified treatment protocol would be safe in TRD patients with suicide ideations and would result in significant decreases in suicide risk in the active treatment condition as compared to the sham condition. ### Conditions - Major Depressive Disorder - Treatment-Resistant Depression - Suicide Ideations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - piTBS being delivered using the Magstim Rapid2 stimulator ### Outcomes Primary Outcomes - The change over time in the score of Beck Scale for Suicide Ideation (BSS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). Secondary Outcomes - The change over time in the score of Snaith-Hamilton Pleasure Scale (SHAPS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). - The change over time in the score of Beck Hopelessness Scale (BHS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). - The change over time in the score of Montgomery-Å sberg Depression Rating Scale (MADRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). - The change over time in the score of 17-item Hamilton Depression Rating Scale (HDRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). - The change over time in the score of Hamilton Anxiety Rating Scale (HAM-A) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). - The change over time in the score of Young Mania Rating Scale (YMRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). - The changes over time in the results of Wisconsin Card Sorting Test (WCST) (from baseline to the timepoint at the end of piTBS). - The changes over time in the results of Color Trails Test (CTT) (from baseline to the timepoint at the end of piTBS). - The changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the timepoint at the end of piTBS). - The changes over time in the results of indices of heart rate variability (HRV) (from baseline to the timepoint at the end of piTBS) and the HRV indices during each piTBS session. - The changes over time in EEG absolute power and lag phase synchronization in the frontal electrodes in the delta, theta, alpha, beta and gamma range (from baseline to the end of piTBS). - The changes over time in high density near infrared spectroscopy (from baseline to the end of piTBS). - The changes over time in the results of Digit Symbol Substitution Test (DSST) (from baseline to the timepoint at the end of piTBS). ### Location - Facility: Tri-service general hospital, Taipei, N/A, 114, Taiwan @@
## A Trial Evaluating the Effect of NIO752 on Tau Synthesis Measured by a Process Known as SILK - NCT ID: NCT06372821 - Study ID: 158160 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-08 - Lead Sponsor: University College, London ### Study Description This study will assess if drug (NIO752) reduces production of a protein, tau, by the brain. Normally tau maintains the internal skeleton of nerve cells. In Alzheimer's disease (AD) it builds up in the brain, causing damage. Abnormal tau proteins cling to each other forming 'tangles' inside nerve cells, which interfere with how the nerve cells work, and eventually die. This is what causes the symptoms of dementia. It is thought that NIO752 reduces production of tau. ### Conditions - Alzheimer Disease - Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 1 (Disorder) - Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 2 (Disorder) - Autosomal Dominant Alzheimer Disease Due to Mutation of Amyloid Precursor Protein (Disorder) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NIO752 - Placebo ### Outcomes Primary Outcomes - Tau synthesis rate inhibition in individuals with sporadic AD and ADAD Secondary Outcomes - Compare efficacy of knockdown of tau production in sporadic AD and ADAD by measuring the synthesis rate of tau by determining the ratio of labelled to unlabeled tau (tracer to tracee ratio) in serial cerebrospinal fluid samples. - Number of participants with adverse events [safety and tolerability] - Comparison of number of Adverse Events reported between participants receiving one dose of NIO752 versus those receiving two doses of NIO752. - Compare rates of tau synthesis and clearance in sporadic AD and ADAD - Determine CSF tau concentration to tau production relationships in humans ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Plyometric Training in Freestyle Adolescent Wrestlers - NCT ID: NCT06372808 - Study ID: 2022/118 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-09-15 - Lead Sponsor: Hasan Kalyoncu University ### Study Description This study aims to determine the effect of plyometric exercises on physical fitness parameters in freestyle adolescent wrestlers. ### Conditions - Physical Fitness - Power ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The Plyometric Exercise - The Regular Training ### Outcomes Primary Outcomes - Change from Baseline in Strength at 8 weeks - Change from Baseline in Endurance at 8 weeks - Change from Baseline in Agility at 8 weeks - Change from Baseline in Wrestling Performance at 8 weeks Secondary Outcomes ### Location - Facility: Batipark Sports Hall, Kahramanmaraş, N/A, 46050, Turkey @@
## Resistance Swallowing Training in Patients With Tracheotomy - NCT ID: NCT06372795 - Study ID: KY2023635 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are:* Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients?* What medical problems do participants have when taking swallowing training?Researchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength.Participants will:-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week. ### Conditions - Swallowing Training on Muscle Strength ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - pure effortful swallowing - progressive resistance swallowing training ### Outcomes Primary Outcomes - Forced swallowing tongue pressure Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand - NCT ID: NCT06372782 - Study ID: 43CH2305 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-08 - Lead Sponsor: Galderma R&D ### Study Description This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal hands in Chinese subjects. ### Conditions - Skin Aging of Dorsal Hands ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Restylane Skinboosters Vital Lidocaine - Restylane Vital ### Outcomes Primary Outcomes - The within-subject difference in VAS score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at end of injection (T0). Secondary Outcomes ### Location - Facility: Galderma Research Site 01, Shanghai, Shanghai, N/A, China @@
## Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder - NCT ID: NCT06372769 - Study ID: 20240304 - Status: COMPLETED - Start Date: 2022-02-01 - Completion Date: 2023-02-10 - Lead Sponsor: Stomatological Hospital Affiliated with Fujian Medical University ### Study Description This study aimed to provide normal reference values of surface electromyography (sEMG) and mandibular kinematics in Chinese young adults, compare the sex differences and assess the diagnosis value of these indices. ### Conditions - Temporomandibular Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - electromyograph and kinesiograph ### Outcomes Primary Outcomes - Surface electromyography (μV) Secondary Outcomes - Mandibular kinematics (mm, mm/s) ### Location - Facility: The Affiliated Stomatological Hospital of Fujian Medical University, Fuzhou, Fujian, 350002, China @@
## Deep Learning Reconstruction Algorithms in Dual Low-dose CTA - NCT ID: NCT06372756 - Study ID: 102122 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2026-03 - Lead Sponsor: Hao Tang ### Study Description The goal of this observational study is to evaluate the impact of deep learning image reconstruction on the image quality and diagnostic performance of double low-dose CTA. The main question it aims to answer is to explore the feasibility of deep learning image reconstruction in double low-dose CTA. ### Conditions - Deep Learning ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Deep learning image reconstruction ### Outcomes Primary Outcomes - The specificity and sensitivity calculated through the optimal cutoff value of the receiver operating characteristic curve. Secondary Outcomes - The signal-to-noise ratio calculated from image CT values and noise ### Location - Facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China @@
## Nurse-led Physician-supported Care for Patients With Chronic Kidney Disease and Multimorbidity - NCT ID: NCT06372743 - Study ID: Alex Hospital - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2026-12-31 - Lead Sponsor: Alexandra Hospital ### Study Description Chronic kidney disease (CKD) is a prevalent chronic disease and is often intertwined with the management of cardiovascular disease and the optimization of metabolic risk factors. In light of steeply rising rates of end-stage kidney disease (ESKD) and increased healthcare resource utilization by CKD patients, the investigators propose that the role of nurses could be expanded to support the care of CKD patients in the community.A total of 220 patients will be randomized (1:1) to the intervention or control groups (usual care). The intervention entails enrolment into a nurse-led, physician-supported programme (INTEGREAT-CKD), comprising outpatient consultations and community-based ambulatory monitoring and counselling primarily driven by CKD-trained advanced practice nurses (APNs) and healthcare professionals conducted over 6 months. Patient-reported outcomes like health-related quality of life (HRQOL), as measured by EQ-5D and KDQOL, CKD self-management score and CKD health literacy will be assessed at baseline and after 6 months. The primary outcome is CKD self-management. Other secondary outcomes to be assessed and tracked including achievement of clinical targets relevant to slowing down CKD progression, attainment of CKD best practice guidelines as specified in the KDIGO CKD Evaluation and Management guidelines 2020. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - INTEGREAT-CKD Intervention ### Outcomes Primary Outcomes - Chronic Kidney Disease Self-Management (CKD-SM) Questionnaire Secondary Outcomes - Secondary outcome ### Location - Facility: Wei Zhen Hong, Singapore, N/A, 119228, Singapore @@
## Residual Pulmonary Vascular Obstruction Index Computed With Ventilation/Perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients With Pulmonary Embolism (PRONOSPECT) - NCT ID: NCT06372730 - Study ID: 29BRC23.0161 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-01 - Lead Sponsor: University Hospital, Brest ### Study Description Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group.Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence.Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation.In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan.In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images.Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO.The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence. ### Conditions - Pulmonary Embolism - Venous Thromboembolism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) ### Outcomes Primary Outcomes - Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study Secondary Outcomes - Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period. - Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study. - Different cut-offs of pulmonary vascular obstruction index will be evaluated to predict the risk of VTE recurrence at 2 years, by generating ROC curves - Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age - The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old) - Potential predictors of RPVO including : demographics - Symptomatic recurrent VTE during a 3 Months follow-up period in patients with suspicion of PE recurrence who has been left untreated based on a negative V/Q SPECT/CT scan - Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council) - Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life) - Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH). - Mortality of all causes. - Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton. - The following score will be computed : PADIS-PE score. - Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender - Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity - Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer - Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia - Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis ### Location - Facility: CHU Amiens, Amiens, N/A, 80054, France @@
## A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS - NCT ID: NCT06372717 - Study ID: AP30CP01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04-01 - Lead Sponsor: Apollo Therapeutics Ltd ### Study Description This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-4098 alone and/or in combination with azacitidine for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB). Participants with the MDS-EB subtype will be eligible for the Phase 1 part of the study only. ### Conditions - Acute Myeloid Leukemia Refractory - Myelodysplastic Syndrome Acute Myeloid Leukemia - Myelodysplastic Syndrome With Excess Blasts - Acute Myeloid Leukemia, in Relapse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - APL-4098 - Azacitidine and APL-4098 ### Outcomes Primary Outcomes - Incidence of Treatment Emergent Adverse Events [Safety] (Phase 1) - Incidence of Dose Limiting Toxicities [Tolerability] (Phase 1) - Estimate the Maximum Tolerated Dose (MTD) of APL-4098 alone and/or in combination with azacitidine (Phase 1) - Determine Recommended Phase 2 Dose (RP2D) levels of APL-4098 alone and/or in combination with azacitidine (Phase 1) - Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) - Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) - Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) - Assess efficacy of APL-4098 alone and/or in combination with azacitidine (Phase 2) Secondary Outcomes - Assess response to disease with APL-4098 alone and/or in combination with azacitidine (Phase 1) - Duration of response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) - Time to response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) - Event Free Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) - Overall Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) - Incidence of Treatment Emergent Adverse Events [Further Safety] (Phase 2) - Incidence of Adverse Events leading to discontinuation of APL-4098 [Further Tolerability] (Phase 2) - Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) - Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) - Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Is the HIFEM Procedure an Effective Treatment for Men With Post-prostatectomy Incontinence? - NCT ID: NCT06372704 - Study ID: 2024/72 - Status: COMPLETED - Start Date: 2024-02-01 - Completion Date: 2024-04-05 - Lead Sponsor: Kirsehir Ahi Evran Universitesi ### Study Description Urinary incontinence after radical prostatectomy surgery is a common condition that negatively affects daily life. Patients often experience discomfort due to urine leakage and the resulting need to use pads daily. This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic technology used therapeutically in patients with urinary incontinence after radical prostatectomy. ### Conditions - Prostate Cancer - Incontinence - Pelvic Floor Muscle Weakness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - HIFEM ### Outcomes Primary Outcomes - This study demonstrated the safe and effective use of HIFEM technology to prevent PPI by strengthening the pelvic floor muscles in a variety of patients. Secondary Outcomes ### Location - Facility: İbrahim Üntan, Kirşehi̇r, N/A, N/A, Turkey @@
## How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block? - NCT ID: NCT06372691 - Study ID: PoplitealApproach SciaticBlock - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09-01 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks. ### Conditions - Adult - Regional Anesthesia Morbidity - Anesthesia Injection Site ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Subparaneural Injection (Grup S), Block - Interneural Injection (Grup I), Block ### Outcomes Primary Outcomes - Onset Time Secondary Outcomes - Block Execution Times - Need for Multiple Injections Owing to Insufficient Anesthesia - Additional Rescue Analgesic - Adverse Effects to Anesthesia - Hemodynamic Effects Of The Block - Effects Of The Block On Heart Rate - Effects Of The Block On Peripheral Pulse Oximetry - Regression Time Of Sensory and Motor Block - Total Block Times ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis - NCT ID: NCT06372678 - Study ID: CM326-102102 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2026-06-30 - Lead Sponsor: Keymed Biosciences Co.Ltd ### Study Description This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). ### Conditions - Chronic Rhinosinusitis With Nasal Polyps ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CM326 - Placebo ### Outcomes Primary Outcomes - Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24. Secondary Outcomes ### Location - Facility: Beijing Tongren Hospital, CMU, Beijing, Beijing, N/A, China @@
## Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization - NCT ID: NCT06372665 - Study ID: CDB-IV-JE-025202301 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-06-30 - Lead Sponsor: Liaoning Chengda Biotechnology CO., LTD ### Study Description This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older. ### Conditions - Japanese Encephalitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events Secondary Outcomes ### Location - Facility: Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, 210009, China @@
## A Phase 1 Study of TE-8214 Solution in Healthy Volunteers - NCT ID: NCT06372652 - Study ID: TE-8214-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2024-12-26 - Lead Sponsor: Immunwork, Inc. ### Study Description This is a Phase 1, first-in-human, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and PK of TE-8214 in healthy volunteers. The study will assess single ascending doses (SAD) of TE-8214. ### Conditions - Acromegaly ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - TE-8214 - SAD - Placebo ### Outcomes Primary Outcomes - Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs) - Safety and tolerability of TE-8214 by the incidence of treatment-related adverse events - Safety and tolerability of TE-8214 by the incidence of injection site reactions (ISRs) - Safety and tolerability of TE-8214 by the incidence of clinically significant laboratory findings - Safety and tolerability of TE-8214 by the changes in physical examination findings - Safety and tolerability of TE-8214 by the changes in ECG findings Secondary Outcomes - PK Parameters: Maximum observed concentration (Cmax) - PK Parameters: Time to maximum observed concentration (Tmax) - PK Parameters: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last) ### Location - Facility: CMAX Clinical Research, Adelaide, South Australia, 5000, Australia @@
## Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS - NCT ID: NCT06372639 - Study ID: TAU-PTSD-TMS - Status: RECRUITING - Start Date: 2022-02-23 - Completion Date: 2024-11-24 - Lead Sponsor: Tel Aviv University ### Study Description Characterization and modulation of traumatic memories in PTSD patients using TMS. ### Conditions - Post Traumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Trans-Cranial Magnetic Stimulation ### Outcomes Primary Outcomes - CAPS-5 score - Neurological measures of functional connectivity - Intrusive memories Secondary Outcomes ### Location - Facility: Tel Aviv University, Tel Aviv, N/A, 69978, Israel @@
## Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma. - NCT ID: NCT06372626 - Study ID: ZG005-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-08 - Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd ### Study Description The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment. ### Conditions - Neuroendocrine Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ZG005 - Etoposide - Cisplatin - Placebo ### Outcomes Primary Outcomes - Dose Limiting Toxicity (DLT) - Objective Response Rate (ORR) - Adverse Event (AE) Secondary Outcomes ### Location - Facility: Chinese PLA General Hospital, Beijing, Beijing, 100853, China @@
## Association Between LRG and Endoscopic Remission in Ulcerative Colitis - NCT ID: NCT06372613 - Study ID: LRG&UC - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-12-31 - Lead Sponsor: Showa Inan General Hospital ### Study Description We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which predicts endoscopic remission in ulcerative colitis patients in this study. Colonoscopy with histology is performed when endoscopic remission will be predicted based on serum LRG values, irrespective of symptoms. Serum LRG levels were analyzed by an enzyme-linked immunosorbent assay. ### Conditions - Ulcerative Colitis in Remission ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Endoscopic remission of UC Secondary Outcomes ### Location - Facility: Showa Inan General Hospital, Komagane, N/A, N/A, Japan @@
## Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis - NCT ID: NCT06372600 - Study ID: 2023-181 - Status: NOT_YET_RECRUITING - Start Date: 2025-06-01 - Completion Date: 2026-02-20 - Lead Sponsor: Xiali Xue ### Study Description The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients; pain and return to normal life as soon as possible. ### Conditions - Rotator Cuff Tendinitis - Rotator Cuff Tendinosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Extracorporeal shock wave therapy device - Platelet-rich plasma ### Outcomes Primary Outcomes - Visual Analogue Scale,VAS Secondary Outcomes - American Shoulder and Elbow Surgeon's Form,ASES - the university of California at Los Angeles shoulder rating scale, UCLA - The location and size of the calcifications were examined by ultrasound ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Next-Generation alzheImer'S Therapeutics - NCT ID: NCT06372587 - Study ID: 5502 - Status: RECRUITING - Start Date: 2023-12-19 - Completion Date: 2027-02-28 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Is this the right time to use next-generation approaches in Alzheimer's disease (AD)? In recent years, several large clinical trials testing treatments for AD have failed, putting the entire field on a reset. AD drug trials have almost exclusively sought to use antibodies targeted toward misfolded amyloid and tau proteins. Of note, although these approaches have failed, they were designed to cover both familial and sporadic forms of AD. On the other hand, the failure in developing new effective drugs is attributed to, but not limited to, the highly heterogeneous nature of AD with multiple underlying hypotheses and multifactorial pathology. The idea underlying this project is based on the assumption that learning and memory disorders can arise when the connections between neurons do not change appropriately in response to experience. Thus, by intervening on the core mechanisms of the cellular correlate of learning and memory, i.e., synaptic plasticity, the investigators expect to preserve some of the essential brain functions in AD. By overcoming the limits of traditional AD therapeutic approaches, the investigators will use genetically encoded engineered proteins (GEEPs), which the investigators developed and tested in vitro and in murine models, to control their activity in living human neurons boosting synaptic plasticity. Indeed, outstanding and relevant progress in understanding synaptic physiology empowers the possibility to prevent or limit brain disease like never before. The investigators designed GEEPs to address some of the leading causes of synaptic plasticity failures documented in AD. Thus, GEEPs will be tested in human induced pluripotent stem cells (hiPSCs)-derived living neurons obtained from reprogrammed peripheral tissues of participants with Alzheimer's diseases. hiPSCs will be obtained from fibroblast-derived from a skin biopsy of participants with AD and controls performed in local anesthesia using a 4 mm punch. The findings will provide the first preclinical study on the effect of genetically engineered proteins to control essential pathways implicated in synaptic plasticity on AD-related cognitive decline. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - genetically encoded engineered proteins ### Outcomes Primary Outcomes - To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons preventing dendritic spines loss - To leverage genetically encoded engineered proteins to prevent alterations in the morphology of dendritic spines in living human neurons - To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons promoting functional synaptic plasticity - To use genetically encoded engineered proteins to obtain evaluate neuronal excitability in living human neurons Secondary Outcomes ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors - NCT ID: NCT06372574 - Study ID: GO44669 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2028-02-01 - Lead Sponsor: Genentech, Inc. ### Study Description This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A\02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors. ### Conditions - Refractory Cancer - Recurrent Cancer - Solid Tumor, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - RO7617991 - Tocilizumab ### Outcomes Primary Outcomes* - Incidence and Severity of Adverse Events - Number of Participants with Abnormal Values in Targeted Vital Signs - Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters Secondary Outcomes - Serum Concentration of RO7617991 at Specific Timepoints - Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1 - Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1 - Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 - Overall Survival (OS) - Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study - NCT ID: NCT06372561 - Study ID: Melatonin- vital pulp therapy - Status: RECRUITING - Start Date: 2023-05-20 - Completion Date: 2024-06-20 - Lead Sponsor: Suez Canal University ### Study Description The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts. ### Conditions - Dental Caries in Children - Vital Pulp Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mineral trioxide aggregate (dressing material) - Melatonin (dressing material) ### Outcomes Primary Outcomes - Clinically assessment (Modified visual analogue scale) - Clinically assessment (Millar's index) - Clinically assessment (presence or abscence) - Radiographic assessment (using Image J software program) - Radiographic assessment (using Image J software program) - Radiographic assessment (using Image J software program) - Radiographic assessment (using Image J software program) - Radiographic assessment (using Image J software program) Secondary Outcomes ### Location - Facility: Faculty of Medicine, Suez canal university, Ismailia, N/A, 41522, Egypt @@
## Rehabilitation Training Games for Children With Amblyopia - NCT ID: NCT06372548 - Study ID: NEADS0004 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2024-08-01 - Lead Sponsor: Zhu Dian ### Study Description A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game. ### Conditions - Amblyopia - Amblyopia Occlusion - Child Behavior - Adherence, Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Find You! Cure My Animal Friends - DuoBao Vision Training System ### Outcomes Primary Outcomes - 8-Item Morisky Medication Adherence Scale (MMAS-8): Secondary Outcomes - User Experience Questionnaire (UEQ) ### Location - Facility: Shanghai Jiao Tong University, Shanghai, Shanghai, 200240, China @@
## Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment - NCT ID: NCT06372535 - Study ID: FujianUTCM-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-09-30 - Lead Sponsor: Lidian Chen ### Study Description To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment. ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tai Chi Chuan （dose 1） - Tai Chi Chuan （dose 2） - Tai Chi Chuan （dose 3） - Tai Chi Chuan （dose 4） - Tai Chi Chuan （dose 5） - Tai Chi Chuan （dose 6） - Tai Chi Chuan （dose 7） - Tai Chi Chuan （dose 8） - Tai Chi Chuan （dose 9） ### Outcomes Primary Outcomes - Montreal Cognitive Assessment Secondary Outcomes - Montreal Cognitive Assessment - Wechsler Memory Scale - Digital Symbol test - Trial Making Test part B - Stroop color word test - Boston naming test - Rey-Osterrieth complex graphics test - Rey Auditory Verbal Learning Test ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oxytocin in Multiparous Women - NCT ID: NCT06372522 - Study ID: RMB-0517-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Rambam Health Care Campus ### Study Description This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery, without altering maternal or neonatal outcomes, in augmented deliveries, compared to intermittent infusion. ### Conditions - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pitocin Injectable Product ### Outcomes Primary Outcomes - The rate of women delivering within 24 hours. Secondary Outcomes - Length of latent and active phases of labor. - The rate of instrumental and caesarean deliveries. - chorioamnionitis - obstetric anal sphincter injuries (OASIS) - hyponatremia - post-partum hemorrhage (PPH) - neonatal outcome - 1 and 5-minute Apgar score - umbilical artery pH - NICU admission - Women's satisfaction. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease - NCT ID: NCT06372509 - Study ID: L2-070 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2025-10-30 - Lead Sponsor: Centro Cardiologico Monzino ### Study Description This is a multicenter, prospective observational study. Will be collecting data from 90 consecutive patients (aged 25- 60 years ) with and without migraine admitted at our Hospital. Primary aim of the study will be to assess the correlation between migraine and proteomic profiling of plasma and their possible correlation with known cardio and cerebrovascular disease and CV risk factors. ### Conditions - Coronary Artery Disease - Migraine - Cardiovascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Correlation between migraine and proteomic profiling of plasma Secondary Outcomes ### Location - Facility: Centro Cardiologico Monzino, Milano, Milan, 20131, Italy @@
## Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma - NCT ID: NCT06372496 - Study ID: 219912 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-16 - Completion Date: 2026-03-11 - Lead Sponsor: GlaxoSmithKline ### Study Description The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma ### Conditions - Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate - Inhaled corticosteroids/long-acting beta-2 agonists ### Outcomes Primary Outcomes - Change from baseline in trough forced expiratory volume in 1 second (FEV1) Secondary Outcomes - Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment - Number of participants achieving the composite endpoint at Week in participants after 52 weeks of treatment - Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment - Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment - Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-6 (ACQ-6) after 24 and 52 weeks of treatment - Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment - Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment - Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment - Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment - Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment - Number of participants achieving the composite endpoint among those on budesonide/formoterol prior to randomization - Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment - Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment - Change from baseline in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire (WPAI:Asthma) after 24 and 52 weeks of treatment - Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization - Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on budesonide/formoterol prior to randomization - Change from baseline in the ACQ-7 total score among participants on budesonide/formoterol prior to randomization - Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization. - Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization. - Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization. ### Location - Facility: GSK Investigational Site, Little Rock, Arkansas, 72205, United States @@
## Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant - NCT ID: NCT06372483 - Study ID: VMX-C001-03 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2024-09 - Lead Sponsor: VarmX B.V. ### Study Description A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts:Part 1: Single dose of VMX-C001 or placebo in healthy volunteers.Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects. ### Conditions - Coagulation Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VMX-C001 - Placebo - Rivaroxaban 20 mg Oral Tablet - Apixaban 5 mg Oral Tablet - Edoxaban 60 mg Oral Tablet ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1) - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2) - PK of VMX-C001 in plasma - Cmax - PK of VMX-C001 in plasma - tmax - PK of VMX-C001 in plasma - t1/2 - PK of VMX-C001 in plasma - AUC0-last - PK of VMX-C001 in plasma - AUC0-inf - PK of VMX-C001 in plasma - Lambda z - PK of VMX-C001 in plasma - CL - PK of VMX-C001 in plasma - Vz - DOAC plasma concentrations (Part 2) - Change in Prothrombin time (PT) following dosing with VMX-C001 - Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001 - Change in D-dimer following dosing with VMX-C001 - Change in prothrombin fragments F1 and 2 following dosing with VMX-C001 - Change in thrombin generation, measured by lag time, following dosing with VMX-C001 - Change in thrombin generation, measured by endogenous thrombin potential, following dosing with VMX-C001 - Change in thrombin generation, measured by peak height, following dosing with VMX-C001 - Change in thrombin generation, measured by time to peak, following dosing with VMX-C001 - Change in thrombin generation, measured by velocity index, following dosing with VMX-C001 - Change in thrombin generation, measured by time to tail, following dosing with VMX-C001 - Change in diluted prothrombin time (dPT) following dosing with VMX-C001 - Change in diluted Russell Viper Venom time (dRVVT) following dosing with VMX-C001 - Change in real time activated clotting time (ACT) following dosing with VMX-C001 Secondary Outcomes - Antibodies against VMX-C001 in plasma - Antibodies against human coagulation FX in plasma ### Location - Facility: ICON, Groningen, N/A, 9728 NZ, Netherlands @@
## Personalised Dose Optimisation of Zestril Supported by the Digital Blood Pressure Diary in a Primary Care Environment in England: Pragmatic Observational Pilot Study for Remote Hypertension Treatment - NCT ID: NCT06372470 - Study ID: CLM-HTN-005 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-08-31 - Lead Sponsor: Closed Loop Medicine ### Study Description A pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. By incorporating home blood pressure monitoring, the study seeks to offer a promising solution for personalised drug titration and self-management, potentially enhancing patient outcomes while optimising Zestril utilisation ### Conditions - Uncomplicated Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Zestril ### Outcomes Primary Outcomes - Achieving target Home Blood Pressure Secondary Outcomes - Reduction in systolic blood pressure (SBP) - Reduction in diastolic blood pressure (DBP) - The time to achieve BP Control (BPC) - Patient daily adherence to prescribed medication - Adherence to collecting data using the electronic BP diary - Patients' thoughts and feelings about BP/treatment - Discontinuation of Zestril due to unwanted side effects - Number and type of spontaneously reported unwanted side effects - User experience and feasibility of the blood pressure digital diary ### Location - Facility: Norwich Health Centre, Norwich, N/A, N/A, United Kingdom @@
## COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) - NCT ID: NCT06372457 - Study ID: CV027-1107 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-06-15 - Lead Sponsor: Bristol-Myers Squibb ### Study Description COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice. ### Conditions - Hypertrophic Cardiomyopathy (HCM) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Approved Hypertrophic Cardiomyopathy drug treatments - Mavacamten ### Outcomes Primary Outcomes - Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis - Participant age at mavacamten treatment initiation - Participant sex - Participant race/ethnicity - Participant insurance coverage - Participant employment status - Participant educational level - Date of Hypertrophic Cardiomyopathy (HCM) diagnosis - Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis - Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis - Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis - Participant New York Heart Association (NYHA) class - Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis - Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis - Participant height - Participant weight - Participant blood pressure - Participant heart rate - Participant Hypertrophic Cardiomyopathy (HCM) symptoms - European participant CYP2C19 genotype - Participant family history of Hypertrophic Cardiomyopathy (HCM) - Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM) - Participant family history of sudden cardiac death (SCD) - Participant smoking status - Participant alcohol use - Participant recreational drug use - Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT) - Participant cardiovascular (CV) and CV-related comorbidities - Participant non-cardiovascular (CV)-related comorbidities - Participant electrocardiogram (ECG) rhythm results - Participant cardiac magnetic resonance imaging (MRI) results - Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results - Participant cardiac troponin results - Participant cardiopulmonary exercise test (CPET) results - Participant cardiac monitoring results - Participant exercise test results - Participant blood creatine levels - Participant cardiovascular (CV) events - Type of procedures received by participants - Cardiovascular treatments prescribed to participants - Date of mavacamten prescription - Date of mavacamten treatment initiation - Date of mavacamten dosage change - Reason for mavacamten dosage change - Occurrence of mavacamten stable dose (a period of 6-months with the same dose) - Dates of follow-up after mavacamten treatment initiation - Date of mavacamten treatment interuption or discontinuation - Reason for mavacamten treatment interuption or discontinuation - Supportive care provided to participants - Heath care resource utilization (HCRU) - Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation Secondary Outcomes - Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms - Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM) - Participant family history of sudden cardiac death (SCD) - Cardiovascular (CV) and CV-related comorbidities - Non-cardiovascular (non-CV) comorbidities - Participant electrocardiogram (ECG) rhythm results - Participant echocardiogram (ECHO) results - Participant cardiac MRI results - Participant NT-proBNP results - Participant cardiac tropin results - Participant cardiopulmonary exercise test (CPET) results - Participant cardiac monitoring results - Participant exercise test results - Hypertrophic Cardiomyopathy (HCM) subtype - Participant symptoms at Hypertrophic Cardiomyopathy (HCM) - Participant New York Heart Association (NYHA) class - Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis - Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis ### Location - Facility: IQVIA, Durham, North Carolina, 27703, United States @@
## Mechanisms of Acute Kidney Injury in Severe Infections - NCT ID: NCT06372444 - Study ID: 995725 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-30 - Lead Sponsor: Uppsala University Hospital ### Study Description Renal perfusion and neutrophil-mediated inflammation will be assessed in the kidney in sepsis patients with acute kidney injury using positron emission tomography. For marked water will be used for renal perfusion and a newly developed PET tracer molecule (11C-GW457427) with specific binding to neutrophil elastase which provides a measure of the amount of infiltrating neutrophils in the renal parenchyma for inflammation. The study is performed in a PET-CT camera where anatomical imaging takes place at the same time as the PET examinations. ### Conditions - Sepsis - AKI - Acute Kidney Injury - Positron Emission Tomography (PET) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Positron emission tomography (PET) ### Outcomes Primary Outcomes - Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET) - Presence of neutrophil elastase in the kidneys in patients with sepsis and acute kidney injury (AKI) by 11C-GW457427 measured with dynamic positron emission tomography (PET) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of Russia - NCT ID: NCT06372431 - Study ID: D1843R00360 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-24 - Completion Date: 2025-10-31 - Lead Sponsor: AstraZeneca ### Study Description This study is a multi-centre, non-interventional, observational, prospective study with retrospective analysis. The main purpose of the study is to describe the rate of CKD diagnosis in patients with AH and CKD markers. This study will include 10 000 adult outpatients with arterial hypertension, who have one or more Chronic Kidney Disease laboratory markers (without recorded CKD diagnosis prior to enrolment) and have no diabetes mellitus or chronic heart failure, who are monitored and treated by cardiologists or internal medicine specialists in approximately 50 outpatient sites in about 20 regions in Russia.This observational study does not provide for any diagnostic and therapeutic procedures other than those used in routine practice. ### Conditions - Arterial Hypertension, Chronic Kidney Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To describe the rate of CKD diagnosis in patients with AH and CKD markers. Secondary Outcomes - To describe demographic and clinical characteristics of patients with AH and CKD markers - To describe clinical characteristics of patients with AH and diagnosed CKD during this study (on Visit 1 or Visit 2) and profile of routine therapy before and after CKD diagnosis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants - NCT ID: NCT06372418 - Study ID: KEMRI/SERU/CGMR-C/238/4326 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-02 - Lead Sponsor: University of Oxford ### Study Description The current guidelines used to manage malnutrition among infants aged below 6 months (u6m) recommend that infants admitted to hospital with malnutrition be supported to reestablish exclusive breastfeeding before discharge. Studies have shown that reestablishing exclusive breastfeeding among infants being treated for acute malnutrition is possible. However, follow-up of the infants after discharge has revealed poor growth raising questions about what happens to infant feeding practices after discharge and whether providing breastfeeding support to mothers after discharge would help improve the recovery and growth of their infants.Providing a package of home-based care with breastfeeding support to mothers of infants u6m recovering from acute malnutrition has the potential to improve the retention of exclusive breastfeeding and lead to enhanced infant growth and survival. To date, no such post-discharge package of care is available in Kenya or other lower and meddle income countries (LMICs). The aim of this study is to apply participatory, qualitative and quantitative approaches to develop and evaluate the impact of a post-discharge package of care on the growth and development of acutely ill malnourished infants after discharge from hospital. ### Conditions - Malnutrition, Infant - Breastfeeding, Exclusive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Breastfeeding peer support intervention - Standard Care ### Outcomes Primary Outcomes - Weight gain Secondary Outcomes - Morbidity - Mortality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia - NCT ID: NCT06372405 - Study ID: PSP-501/D125/79/00000 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-09-30 - Lead Sponsor: University of Warsaw, Poland ### Study Description Misophonia is a disorder causing intense reactions to specific sounds, disrupting daily life. Current treatments lack evidence-based support. The goal of this study is to explore the effectiveness of cognitive reappraisal (CR) in reducing misophonic responses. The study involves 100 participants assigned to either a 4-week CR program or Autogenic Training. Emotional regulation, symptoms of anxiety and depression, quality of life, and more will be assessed using various questionnaire-based measures; perseverations with a task-based test (Wisconsin Card Sorting Test); the presence of psychiatric and personality disorders using face-to-face interviews (The Mini-International Neuropsychiatric Interview (M.I.N.I.) and "Structured Clinical Interview for DSM-5® Personality Disorders" (SCID-5-PD) ### Conditions - Misophonia Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive reappraisal - Schultz Autogenic Training ### Outcomes Primary Outcomes - Change in misophonia symptoms measured by S-Five - Externalizing subscale - Change in misophonia symptoms measured by S-Five - Internalizing subscale - Change in misophonia symptoms measured by S-Five - Threat subscale - Change in misophonia symptoms measured by S-Five - Impact subscale - CHange in misophonia symptoms measured by S-Five - Outburst subscale - Change of aversiveness rating (valence/pleasure) on the Manikin Scales. - Change of arousal rating on the Manikin Scales. - Change in Galvanic Skin Response - Change in average HR during the trigger presentation - Diagnosis of personality disorders as a predictor of worse treatment outcome. - Working Alliance Inventory will be related to better treatment outcomes. Secondary Outcomes - Meeting criteria for psychiatric disorders - - Hearing test - standard and high frequency pure-tone audiometry ### Location - Facility: Faculty of Psychology, University of Warsaw, Warsaw, Masovian Voivodeship, 00-183, Poland @@
## Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps - NCT ID: NCT06372392 - Study ID: 1.0 - Status: RECRUITING - Start Date: 2023-10-10 - Completion Date: 2024-12-01 - Lead Sponsor: Tartu University Hospital ### Study Description Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport. ### Conditions - Type1diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Universal meal coefficient utilization ### Outcomes Primary Outcomes - Time in range (TIR) Secondary Outcomes - TBR - TAR - auto-corrections % - coefficient of variability ### Location - Facility: TartuUH, Tartu, Tartumaa, 50406, Estonia @@
## Development of a Multipurpose Dashboard to Monitor the Situation of Emergency Departments - NCT ID: NCT06372379 - Study ID: 8780_UC2 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-09 - Lead Sponsor: Mario Negri Institute for Pharmacological Research ### Study Description An emergency department (ED) is a healthcare service that provides the first clinical assessment and treatment to patients with various acute conditions. These departments, however, are often overwhelmed by the large volume of patients. As a consequence, ED crowding has become a global concern and has been correlated to reduced timeliness and effectiveness of care and increased patient mortality. Concerning input, 20% to 30% of patients are brought to the ED by ambulance; the remaining are self-presenting for the vast majority. Notably, non-urgent conditions characterize a high proportion of all ED visits worldwide, and almost all of these visits involve self-presenting patients. Increasing the awareness of these patients about the mandate of EDs and the real-time situation of the neighboring emergency departments has the potential to reduce the self-presentation of patients with minor, non-urgent conditions. Such patient empowerment can be achieved through a dashboard. Concerning throughput, working in the ED requires emergency physicians and nurses to treat many patients at once while maintaining situational awareness of the surroundings. This is especially true for the head of the department, but it also holds for all physicians. It can be crucial, for example, for physicians to know if there is a bottleneck in the flow of the entire patient care process, such as a particularly high average waiting time for radiology reporting or cardiologic consultation. The availability of this information allows countermeasures to be put in place to regain efficiency. All this can be achieved through dedicated dashboards automatically fed from various information system. In addition, appropriate dashboards also enable health policymakers to monitor specific epidemiological phenomena, such as the emergence of certain infectious diseases, in a timely manner. ### Conditions - Emergency Medicine ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Daschboards Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Relationship Between Vitamins Deficiency and Caries Experience Among a Group of Egyptian Children - NCT ID: NCT06372366 - Study ID: Dental caries and vit.difiency - Status: NOT_YET_RECRUITING - Start Date: 2024-07-15 - Completion Date: 2025-12-15 - Lead Sponsor: Cairo University ### Study Description Dental caries is a worldwide condition characterized by localized destruction of dental hard tissue by acidic by-products from bacterial fermentation of dietary carbohydrates . Dental caries is considered to be the single most common chronic childhood disease, and its prevalence is thought to have increased recently. ### Conditions - Dental Caries - Vitamin Deficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Caries prevalence Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect Of Baduanjin Exercises In Patients With Idiopathic Pulmonary Fibrosis - NCT ID: NCT06372353 - Study ID: 777 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2023-06-06 - Lead Sponsor: Marmara University ### Study Description Introduction and Objectives:IPF, characterized by shortness of breath and progressive deterioration in lung function.Baduanjin (BJ) is a mindbody health exercise that combines physical exercise with psychological properties to maximize both physical and mental health.The aim of the study is to investigate the effectiveness of these exercises in patients with IPF and to present an alternative in terms of the applicability of BJ exercises as a new treatment methodMethods: 28 volunteers were invited to the study.These patients were randomly divided into 2 groups.The subjects in the exercise group were given 24 sessions of supervised online BJ exercise training, 3 days a week, for 8 weeks. The patients included in the control group did not receive any training during the 8 week period ### Conditions - Pulmonary Fibrosis, Idiopathic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Baduanjin Exercise ### Outcomes Primary Outcomes - Functional capacity - Pulmonary Function Tests - Pulmonary Function Tests - Pulmonary Function Tests - Pulmonary Function Tests - Respiratory muscle strength - Respiratory muscle strength - St. George's Respiratory Questionnaire Secondary Outcomes ### Location - Facility: İstanbul University - Cerrahpaşa, Istanbul, Fatih, N/A, Turkey @@
## Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women - NCT ID: NCT06372340 - Study ID: 2023BJYYEC-217-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-31 - Lead Sponsor: Beijing Hospital ### Study Description The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2）How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive. ### Conditions - Pelvic Organ Prolapse - Urinary Incontinence - Diagnosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system. - Standard pelvic floor muscle training(PFMT) program ### Outcomes Primary Outcomes - Modified Oxford Scale (MOS) - Surface Electromyography Data Secondary Outcomes - The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) - The score of the Pelvic Floor Distress Inventory (PFDI-20) - Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Move Often eVery Day 2.0 - NCT ID: NCT06372327 - Study ID: 73468 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-07 - Lead Sponsor: Stanford University ### Study Description The purpose of this study is to assess a novel, widely-accessible intervention to both promote active breaks from work and improve cognitive and psychological performances at work in motivationally-accessible bouts. This will be done by interrupting prolonged sitting with 1-4 short (1-4 minutes), moderate-to-vigorous physical activity (MVPA) bouts with no equipment, and simple video-based instructions. The short bouts will be referred to as "exercise snacks." In this proposed exercise snacks intervention, investigators explicitly target a population with sedentary jobs due to the generalizability. ### Conditions - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: PREVENTION ### Interventions - Daily Exercise Snacks ### Outcomes Primary Outcomes - Number of self-reported exercise snack breaks at work at week 7 - Number of self-reported exercise snack breaks at work at week 18 - Number of self-reported exercise snack breaks at work at week 30 during follow-up Secondary Outcomes - Liking of exercise snacks ### Location - Facility: Stanford University School of Medicine, Stanford, California, 94305-7240, United States @@
## Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates - NCT ID: NCT06372314 - Study ID: 1000081221 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2027-12 - Lead Sponsor: The Hospital for Sick Children ### Study Description This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 4 amino acids.The investigators will determine the requirement for Isoleucine, Leucine, Valine and Tryptophan. The investigators will recruit 18- 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (isoleucine, leucine, valine and tryptophan) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for isoleucine, leucine, valine and tryptophan will be at least 50% lower than what is currently available in commercial solutions used for TPN feeding of neonates. ### Conditions - Stable Neonates Receiving Total Parenteral Nutrition (TPN) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Total parenteral nutrition (TPN): this is total nutrition provided by central vein. ### Outcomes Primary Outcomes - Amino acid oxidation using a labelled amino acid. Secondary Outcomes ### Location - Facility: Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil, Santa Maria, N/A, N/A, Brazil @@
## Dobutamine Stress Echocardiography in LF/LG Aortic Stenosis and Wild-type Transthyretin Amyloid Cardiomyopathy - NCT ID: NCT06372301 - Study ID: 1-10-72-179-23 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2026-04-01 - Lead Sponsor: Steen Hvitfeldt Poulsen ### Study Description The goal of this prospective clinical study is improve the diagnosis of Low-flow low-gradient aortic stenosis (LF/LG AS), in patients with co-existing wild-type transthyretin cardiac amyloidosis (ATTRwt). The main question it aims to answer is whether the classic dobutamine-stress echocardiography can be used to determine AS severity in patients with ATTRwt and LF/LG AS This question will be tried to answer by comparing dobutamine stress echocardiography, with the invasively measured aortic valve area (which is considered as the gold standard).In addition we aim to assess the degree of myocardial fibrosis and amyloid infiltration, assessed by light microscopy and cardiac magnetic resonance (CMRI) and evaluation of myocyte mitochondrial function by high resolution respirometry and their relation to AS severity and hemodynamic response to dobutamine. ### Conditions - Transthyretin Amyloid Cardiomyopathy - Aortic Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Dobutamine stress echocardiography ### Outcomes Primary Outcomes - The correlation between echocardiography derived projected aortic valve area (AVAproj) and invasively assessed AVAproj under dobutamine infusion. Secondary Outcomes - Correlation between echocardiography derived AVA and invasively assessed AVA at rest and at different dobutamine infusion levels. - Increase of SVI, LV ejection fraction and LV-global longitudinal strain of 10 % during maximal dobutamine stimulation. - Correlation between echo- and invasive measured SVI. - Degree of myocardial fibrosis, amyloid infiltration and mitochondrial dysfunction and its relation to AS severity and hemodynamic response to dobutamine - Reduction of mean pulmonary artery wedge pressure and/or mean pulmonary artery pressure by 10 %. - Complication rate and symptomatic side effects during dobutamine challenge ### Location - Facility: Department of Cardiology, Aarhus University Hospital, Aarhus, N/A, 8200, Denmark @@
## Theta Burst TMS for Treatment of Methamphetamine Use Disorder - NCT ID: NCT06372288 - Study ID: 22-1754 - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2025-12 - Lead Sponsor: Carilion Clinic ### Study Description This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm. ### Conditions - Methamphetamine Abuse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial Magnetic Stimulation - Sham Transcranial Magnetic Stimulation ### Outcomes Primary Outcomes - Stimulant Craving Questionnaire (STCQ) - Urine Drug Screen (UDS) Secondary Outcomes - Generalized Anxiety Disorder-7 (GAD-7) - Patient Health Questionnaire-9 (PHQ-9) - Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q) - Hamilton Anxiety Scale (HAM-A) - Montgomery Asberg Depression Rating Scale (MADRS) - Clinical Global Impression - Severity (CGI-S) - Clinical Global Impression - Improvement (CGI-I) ### Location - Facility: Carilion Clinic, Roanoke, Virginia, 24014, United States @@
## Investigating Two Prototype Mobile App Interventions to Increase Physical Activity - NCT ID: NCT06372275 - Study ID: 0000 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-08-31 - Lead Sponsor: Mississippi State University ### Study Description This randomized control trial aims to investigate whether writing about personal values helps enhance motivation to engage in physical activity, relative to general self-reflective writing. This study will help to (1) assess whether values clarification leads to increased motivation to engage in physical activity, greater stability in motivation, and improvements in engagement in physical activity and valued action, relative to engaging in self-reflection, (2) determine if the impact of values clarification on these outcomes vary depending on context (e.g., positive/negative affect, psychological inflexibility, stressful events), (3) explore whether values clarification procedures that employ distinct relational frames (hierarchical, conditional, distinction, and deictic) differentially impact motivation to engage in physical activity, and daily engagement in physical activity, and (4) explore whether the impact of values clarification vary depending on baseline self-compassion and/or intrinsic/extrinsic motivation. ### Conditions - Health-Related Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Values Clarification Mobile Application - Self-Reflection Mobile Application ### Outcomes Primary Outcomes - International Physical Activity Questionnaire (IPAQ) - Total physical activity Secondary Outcomes - Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Total score - Amotivation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - External Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Introjected Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Identified Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Integrated Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Intrinsic Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire v1.2 - Global Mental Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System) - Global Physical Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System) - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Satisfaction with Social Roles and Activities 8a - Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) - Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) - Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) - Values Clarity Questionnaire (VCQ) - Self-Compassion Scale Short Form (SCS-SF) - Random responding question - Credibility & Expectancy Questionnaire (CEQ) - System Usability Scale (SUS) - Treatment Evaluation Inventory-Short Form (TEI-SF) - Exercise ecological momentary assessment (EMA) questions - Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) - Momentary Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) - Momentary Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) - Emotion ratings - Current Motivation to Exercise - Previous Day Stress Level ### Location - Facility: Mindfulness and Acceptance Processes Lab, Starkville, Mississippi, 39759, United States @@
## Effect of 2000-meter Rowing Test on Parameters of Intestinal Integrity in Elite Rowers During Competitive Phase - NCT ID: NCT06372262 - Study ID: Rowers2022 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2022-06-30 - Lead Sponsor: Poznan University of Physical Education ### Study Description The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study. ### Conditions - Endothelial Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ergometer test ### Outcomes Primary Outcomes - I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury - zonulin to measure tight junction leakage - LBP (lipopolysaccharide binding protein) to measure endotoxin - LPS (lipopolysaccharide) to measure endotoxin - Lactic acid to measure fatigue after the race Secondary Outcomes - energy - fiber intake - protein - carbohydrate - body mass - Body composition - water - Body composition - fat - Lean body mass ### Location - Facility: Poznan University of Physical Education, Poznań, N/A, N/A, Poland @@
## A Clinical Trial of Soluble Fiber for Asthma - NCT ID: NCT06372249 - Study ID: 22-249 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2027-04 - Lead Sponsor: Phoenix Children's Hospital ### Study Description Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet. ### Conditions - Asthma in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NOVELOSETM 3490 ### Outcomes Primary Outcomes - Alpha diversity. Secondary Outcomes - Asthma control. - Gut microbiome composition. - Nasal inflammatory response. - Quantification of circulating short chain fatty acids. ### Location - Facility: Phoenix Children's, Phoenix, Arizona, 85016, United States @@
## UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors - NCT ID: NCT06372236 - Study ID: PG-001-025 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2026-12-01 - Lead Sponsor: Peking University ### Study Description This is a single-arm, open, early-stage clinical study. The main purpose of this study is to explore the maximum tolerated dose (MTD), the optimal phase II recommended dose, safety, initial anti-tumor activity, cytopharmacokinetics, immunogenicity, biomarkers and other characteristics of drug therapy in patients with advanced malignant solid tumors. Eligible subjects were transfused with UTAA06 injection after pretreatment, and their blood was collected before and after infusion for evaluation of cytopharmacokinetics, safety, immunogenicity and biomarkers. In this study, tumor evaluation was mainly performed using RECISTv1.1. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of Q3m during 4w, 2m, 3m, and 6-24m after cell infusion. Tumor evaluation was performed until disease progression (PD), new anti-tumor therapy, death, intolerable toxicity, investigator's decision, or patient's voluntary withdrawal. Whichever comes first. ### Conditions - Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - UTAA06 injection for treatment of advanced malignant solid tumors ### Outcomes Primary Outcomes - MTD - To evaluate the preliminary antitumor activity of UTAA06 injection in patients with advanced malignant solid tumors - To evaluate the number of participants with treatment-related adverse events of UTAA06 injection in patients with advanced malignant solidtumors. Secondary Outcomes - To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. - To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. - To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. - To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. - To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. - To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. - To evaluate the immunogenicity of UTAA06 injection in patients with advanced malignant solid tumors. ### Location - Facility: PersonGen Anke Cellular Therapeutice Co.,Ltd, Hefei, Anhui, 230088, China @@
## A Food Effect Study of SPH5030 Tablets. - NCT ID: NCT06372223 - Study ID: SPH5030-102 - Status: COMPLETED - Start Date: 2024-03-04 - Completion Date: 2024-03-25 - Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd ### Study Description The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - SPH5030 - SPH5030 ### Outcomes Primary Outcomes - Peak Plasma Concentration (Cmax) - Peak time（Tmax） - Area under the plasma concentration versus time curve (AUC) Secondary Outcomes - Incidence of Treatment-Emergent Adverse Events ### Location - Facility: West China Second Hospital ,Sichuan University, Chengdu, N/A, N/A, China @@
## A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion - NCT ID: NCT06372210 - Study ID: 031-201-00521 - Status: COMPLETED - Start Date: 2023-06-26 - Completion Date: 2023-07-19 - Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. ### Study Description The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch. ### Conditions - Mental Disorder - Schizophrenia - Major Depressive Disorder - Bipolar I Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Placebo IEM tablet - Abilify MyCite® - D-Tect Patch ### Outcomes Primary Outcomes - Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch - Cohort 1 and 2: Patch Detection Latency Period - Cohort 1 and 2: Ingestion Data Transfer Latency Period - Cohort 1 and 2: Total Detection Latency Period Secondary Outcomes - Number of Participants With Adverse Events (AEs) Graded By Severity, Device-related AEs, Serious AEs (SAEs), AEs Leading to Trial Discontinuation, and Unanticipated Adverse device Effects ### Location - Facility: Research site, Garden Grove, California, 92845, United States @@
## Low-Income Group Psilocybin Assisted Therapy for Depression - NCT ID: NCT06372197 - Study ID: LIGPATD - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2024-10 - Lead Sponsor: Matthew Hicks ### Study Description Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date has investigated the therapy in a low-income population.Psychedelic research in recent decades has used the model of two therapists to one client to demonstrate an abundance of caution and safety to regulators, but no evidence has demonstrated this model to be safer or more effective than one with less practitioner oversight. This feasibility study would be the first investigation of Oregon Psilocybin Services as a model of care and among the first few to use a group therapy model. This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability and safety of the treatment. In addition to an appropriate medical screening and intake the following questionnaire data will be collected: the Adverse Childhood Events (ACE) questionnaire, Credibility/Expectancy Questionnaire (CEQ), PROMIS-29, Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview.Participants will consist of adults in Oregon with an income at or below 200% of the federal poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression. Participants will be individually screened by a study investigator and placed into groups of five to six participants. Treatment will consist of two group preparation sessions, two psilocybin sessions, and two group integration sessions. An additional follow-up visit to collect further data will take place three months after conclusion of the treatment.The proposed study will provide valuable information for designing future clinical trials investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group therapy for depression in low-income populations. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Psilocybin ### Outcomes Primary Outcomes - Recruitment Feasibility - Retention Feasibility - Acceptability - Preliminary Safety and Tolerability: incidence and severity of adverse events Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Washed Microbiota Transplantation for Allergic Rhinitis - NCT ID: NCT06372184 - Study ID: WMT-AR-RCT - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2029-10-01 - Lead Sponsor: The Second Hospital of Nanjing Medical University ### Study Description Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR. ### Conditions - Rhinitis, Allergic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Washed Microbiota Transplantation - Placebo ### Outcomes Primary Outcomes - Changes in the reflective total nasal symptom score (rTNSS) Secondary Outcomes - Changes in the combined symptoms and medication score (CSMS) - Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score - Changes in the single reflective nasal symptoms score - Specific IgE - Inflammatory factors - Flow cytometric analysis of lymphocyte clusters - The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 - Changes in the Modified Lund-Kennedy endoscopic score - The changes in composition and metabolites of gut microbiota and nasal microbiota ### Location - Facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China @@
## Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism - NCT ID: NCT06372171 - Study ID: NYCU112182AEF - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: National Yang Ming University ### Study Description Vitamin C is an important antioxidant in the human body and plays many important roles. It is currently known that vitamin C has the functions of treating scurvy, assisting in collagen synthesis, whitening, and increasing immunity. Smokers, patients with cardiovascular disease, and patients with diabetes may have higher requirements for vitamins due to higher oxidative stress in the body. Liposome coating is a technology commonly used in food processing and medicine to protect active substances, increase absorption or slow release. Currently, vitamin C is commonly available on the market as an additive nutritional supplement in the form of powder packets, tablets, etc. The disadvantages are that vitamin C is relatively unstable, easily destroyed by gastric acid, and maintains blood concentration for a short time. Taking liposome microbial C has been Found to have the potential to increase bioavailability in the human body, it is expected that vitamin C coated with lecithin is relatively stable and can be stabilized in the small intestine without being damaged by gastric acid, while reducing the risk of gastrointestinal discomfort caused by the acidity of vitamin C. According to the revised seventh edition of the Reference Intake of Dietary Nutrients for Chinese People, the upper daily intake of vitamin C (tolerable upper intake levels, UL) for people aged 19 to 70 is 2,000 mg. According to literature, the absorption rate of vitamin C when consuming 30-180 mg per day is about 70-90%; when the daily intake exceeds 1000 mg, the absorption rate will drop to less than 50%. The dose of vitamin C used in this study is more than 1500 mg. The purpose is to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate and achieve better bioavailability when consuming high-dose vitamin C powder. It is expected that through the egg The liposome vitamin C powder made of phospholipids increases its maintenance time in the blood, thereby increasing the supplementary effect of vitamin C powder and serving as another supplement option for vitamin C. ### Conditions - Nutrition, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Satge 1 - Stage 2 ### Outcomes Primary Outcomes - General examination - Hematology Test Secondary Outcomes ### Location - Facility: National Yang Ming Chiao Tung University, Taipei, Beitou Dist., 112, Taiwan @@
## Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism - NCT ID: NCT06372158 - Study ID: NYCU112181AE - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-12 - Lead Sponsor: National Yang Ming University ### Study Description Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements. ### Conditions - Osteoporosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Stage 1 - Stage 2 ### Outcomes Primary Outcomes - General examination - Hematology Test Secondary Outcomes ### Location - Facility: National Yang Ming Chiao Tung University, Taipei, Beitou Dist., 112, Taiwan @@
## A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. - NCT ID: NCT06372145 - Study ID: LTS17043 - Status: RECRUITING - Start Date: 2024-04-25 - Completion Date: 2029-04-30 - Lead Sponsor: Sanofi ### Study Description This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]).SUBSTUDY: ToleDYNAMIC substudy ### Conditions - Relapsing Multiple Sclerosis - Secondary Progressive Multiple Sclerosis - Progressive Relapsing Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tolebrutinib - Placebo - Teriflunomide ### Outcomes Primary Outcomes - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation - Number of Participants with Potentially clinically significant abnormalities (PCSAs) Secondary Outcomes - Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies - Annualized Relapse Rate (ARR) for RMS only - Number of new and/or enlarging T2-hyperintense lesions per year - Change from baseline in total volume of T2-hyperintense lesions - ToleDYNAMIC substudy Change from baseline in biomarkers ### Location - Facility: Investigational Site Number : 0560005, Brugge, N/A, 8000, Belgium @@
## G-POEM vs PEG-J in Gastroparesis Patients - NCT ID: NCT06372132 - Study ID: NL85305.068.23 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2028-01-01 - Lead Sponsor: Maastricht University Medical Center ### Study Description Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up.Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM.Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment.Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point. ### Conditions - Gastroparesis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - G-POEM ### Outcomes Primary Outcomes - Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months. Secondary Outcomes - Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 12 months. - Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention. - Number and severity of (s)AEs in the treatment groups. - Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score. - Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score. ### Location - Facility: Maastricht University Medical Center, Maastricht, Zuid-Limburg, 6229 HX, Netherlands @@
## Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT) - NCT ID: NCT06372119 - Study ID: 13/23/DD-BVMD - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Mỹ Đức Hospital ### Study Description The goal of this randomized clinical trial is to evaluate the effectiveness of the letrozole-stimulated cycle strategy versus the artificial cycle strategy for endometrial preparation in women with irregular menstrual cycles after one cycle of endometrial preparation. The primary question it aims to answer is:• Does the letrozole-stimulated cycle strategy for endometrial preparation result in a higher live birth rate compared to the artificial cycle strategy in women with irregular menstrual cycles after one cycle of endometrial preparation?Participants will undergo screening before endometrial preparation for frozen embryo transfer, following which they will be randomly assigned to one of two groups: LETS or AC. In the LETS group, investigators will prescribe Femara® 2.5 milligrams (Novartis, Switzerland) at a dose of 5 milligrams/day for 5 days to stimulate follicular development and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day for luteal phase support. In contrast, the AC group will receive Valiera® 2 milligrams (Laboratories Recalcine, Chile) starting with a dose of 6 milligrams/day, up to a maximum dose of 12 milligrams/day) and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day. Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates. ### Conditions - Embryo Transfer - Irregular Menstruation - Letrozole - Hormone Replacement Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Letrozole-stimulated cycle strategy (LETS) - Artificial cycle strategy (AC) ### Outcomes Primary Outcomes - Live birth rate after one cycle of endometrial preparation Secondary Outcomes - Positive pregnancy test after one cycle of endometrial preparation - Clinical pregnancy after one cycle of endometrial preparation - Ongoing pregnancy after one cycle of endometrial preparation - Multiple pregnancy after one cycle of endometrial preparation - Implantation rate after one cycle of endometrial preparation - Cycle cancellation rate - Ectopic pregnancy rate after one cycle of endometrial preparation - Threatened miscarriage rate before 12 weeks of gestation after one cycle of endometrial preparation - Early miscarriage rate after one cycle of endometrial preparation - Late miscarriage rate after one cycle of endometrial preparation - Gestational age at birth - Onset of labor - Mode of delivery - Very low birth weight - Low birth weight - High birth weight (macrosomia) - Very high birth weight (macrosomia) - Gestational diabetes (GDM) - Hypertensive disorders of pregnancy - Preterm birth - Stillbirth - Antepartum hemorrhage - Postpartum hemorrhage - Small for gestational age (singleton/twins) - Large for gestational age (singleton/twins) - Birth weight - Congenital anomalies - NICU admission - Reason for NICU admission - Neonatal mortality rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Project Mountain - Comparing SpO2 and SaO2 for Accuracy - NCT ID: NCT06372106 - Study ID: MA_PM_Mountain_2022_11496 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Philips Clinical & Medical Affairs Global ### Study Description The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology. Oxygen saturation measurements (SpO2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (SaO2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. The study will aim to enroll a diverse population to help us understand the impact of skin pigmentation. ### Conditions - SpO2 - Nasal Alar Collapse, Bilateral - Oxygen - Measurement ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - SaO2 Sampling ### Outcomes Primary Outcomes - To observed accuracy expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth. Secondary Outcomes - Secondary Endpoint -Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology. - Secondary Endpoint- Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana - NCT ID: NCT06372093 - Study ID: PMH 2/11AII - Status: COMPLETED - Start Date: 2023-03-16 - Completion Date: 2024-02-26 - Lead Sponsor: Picterus AS ### Study Description The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin.The specific objectives for this study are:i. To assess the correlation between bilirubin level measurements obtained by Picterus Jaundice Pro with Total Serum Bilirubin (TSB), and TcB, in newborns with high melanin content in the skin.ii. To determine the accuracy of Picterus Jaundice Pro in newborns with high melanin content in the skin. ### Conditions - Jaundice, Neonatal ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Picterus Jaundice Pro ### Outcomes Primary Outcomes - Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP. Secondary Outcomes - Correlation of bilirubin levels obtained by Picterus JP with Tsb and TcB - Sensitivity and specificity of Picterus JP to detect jaundice in newborns with high melanin content in the skin ### Location - Facility: Princess Marina Hospital, Gaborone, N/A, N/A, Botswana @@
## Resistance Training and Hydrolyzed Collagen Supplementation in Healthy Young Adults - NCT ID: NCT06372080 - Study ID: 19/SPS/054 - Status: COMPLETED - Start Date: 2020-01-06 - Completion Date: 2023-03-31 - Lead Sponsor: Liverpool John Moores University ### Study Description The goal of this clinical trial is to investigate the effects of resistance training with hydrolyzed collagen ingestion on changes in muscle and tendon adaptation in healthy young men and women.The main questions it aims to answer are:* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone?* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone?Participants will be randomly assigned to collagen or placebo groups. Participants will perform resistance training three times per week for 10 weeks and hydrolyzed collagen or maltodextrin will be given to collagen or placebo group respectively immediately before each resistance training session. Also, vitamin C will be given to both groups.Researchers will compare collagen and placebo groups to see if hydrolyzed collagen ingestion with resistance exercise would have beneficial effects on changes in muscle and tendon more than resistance training alone. Therefore, using isokinetic dynamometer and ultrasonography, maximal leg strength, morphological, mechanical, and material properties of the patellar tendon and vastus lateralis muscle size and architecture will be assessed. ### Conditions - Healthy Participants - Nutrition - Exercise Training ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Resistance training with hydrolyzed collagen ingestion in healthy young men - Resistance training with hydrolyzed collagen ingestion in healthy young women ### Outcomes Primary Outcomes - Maximal knee extensor (quadriceps) muscle strength - Maximal knee flexor (hamstring) muscle strength - Patellar tendon cross-sectional area - Patellar tendon stiffness - Vastus lateralis (VL) muscle size - Vastus lateralis (VL) muscle fascicle length - Vastus lateralis (VL) muscle fascicle pennation angle Secondary Outcomes ### Location - Facility: Research Institute for Sport and Exercise Sciences, Liverpool, Merseyside, L3 3AF, United Kingdom @@
## IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures - NCT ID: NCT06372067 - Study ID: 17378 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-03-01 - Lead Sponsor: McMaster University ### Study Description When people break their fingers, sometimes surgery is needed to align the bones to heal them properly. There are different ways to fix broken bones in hands, such as plates, pins, or screws. Each method has pros and cons; fixing a broken bone with plates is usually a larger surgery with more cutting but holds the bones very securely. Pins require little to no cutting but the patient needs to immobilize their hand for a few weeks afterwards. Screws are a newer method of fixing broken fingers that requires little cutting and also holds the bones securely. The goal of this study is to compare the effectiveness of using pins versus screws in surgery for broken fingers. The investigators are studying whether using screws leads to better hand function, patient satisfaction, and quicker return to work. ### Conditions - Hand; Fracture, Phalanx ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intramedullary screw - Kirschner wire ### Outcomes Primary Outcomes - Percentage of Patient Eligibility - Study Feasibility - Recruitment rate - Study Feasibility - Crossover rate - Study Feasibility - Compliance with intervention rate - Study Feasibility - Patient retention rate - Study Feasibility Secondary Outcomes - Disability of the Arm, Shoulder, and Hand - Range of motion - Grip strength - Return to work - Complications/adverse events - Postoperative pain (visual analogue scale) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models - NCT ID: NCT06372054 - Study ID: TORNADO - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2027-02-05 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. The study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by Artificial Intelligence. Data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine. ### Conditions - Oxidative Injury - Stress Physiological - Discogenic Pain - Cardiovascular Risk Factor - Space Maintenance - Epigenetic Changes - LONGEVITY 1 - Neuroplasticity - NGS ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biological sample collection ### Outcomes Primary Outcomes - Assessment of flight-related exposure data and molecular modifications Secondary Outcomes - Assessment of General Health - Assessment of Sleep Quality - Assessment of eating habits - Creation of reliable AI and disease-based models for personalized medicine ### Location - Facility: CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy, Milan, N/A, 20139, Italy @@
## Transcranial Alternating Current Stimulation in Cerebral Palsy (BOOSTTACS) - NCT ID: NCT06372041 - Study ID: 944/B - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-05-14 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcranial alternating current stimulation (tACS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tACS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits. The investigators hypothesized that, thanks to the intensive bimanual training, both the active and the sham group will improve in motor functioning. However, in light of findings showing that tACS effectively improves motor learning, the investigators hypothesized that active tACS might improve in a greater and more lasting extent than sham tACS the motor functioning. Moreover, as suggested by previous studies investigating the effect of non-invasive brain stimulation (NIBS) in pediatric population, the investigators expected that the treatment will be safe and well tolerated. Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcranial Alternating Current Stimulation ### Outcomes Primary Outcomes - Assisting Hand Assessment (AHA) - Box and Block Test (BBT) - Visuomotor task Secondary Outcomes - Canadian Occupational Performance Measure (COPM) - Children's Hand-Use Experience Questionnaire (CHEQ) - Melbourne Assessment 2 (MA2) - Gross Motor Function Measure (GMFM-66) - Vineland Adaptive Behavior Scale Version 2 (VABS II) - Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL) - Cortical rhythms at rest and during the Visuomotor task ### Location - Facility: Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, 23842, Italy @@
## Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS) - NCT ID: NCT06372028 - Study ID: 944/A - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-05-14 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcutaneous Vagus Nerve Stimulation (tVNS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tVNS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits. The investigators hypothesized that, thanks to the intensive bimanual training, both the active and the sham group will improve in motor functioning. However, taking into account that tVNS has the potential to facilitate in a bottom-up way neural plasticity, particularly in chronic disease conditions, the investigators hypothesized that active tVNS might improve in a greater and more lasting extent than sham tVNS the motor functioning. Moreover, as suggested by previous studies investigating the effect of non-invasive brain stimulation (NIBS) in paediatric population, the investigators expected that the treatment will be safe and well tolerated. Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcutaneous vagus nerve stimulation (tVNS) ### Outcomes Primary Outcomes - Assisting Hand Assessment (AHA) - Box and Block Test (BBT) - Visuomotor task Secondary Outcomes - Canadian Occupational Performance Measure (COPM) - Children's Hand-UseExperienceQuestionnaire (CHEQ) - Melbourne Assessment 2 (MA2) - Gross Motor Function Measure (GMFM-66) - Vineland Adaptive Behavior Scale Version 2 (VABS II) - Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL) ### Location - Facility: Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, 23842, Italy @@
## Changes in the Lipidomic, Immunological and miRNA Profile in Patients Undergoing a Dietary Program or Bariatric Surgery - NCT ID: NCT06372015 - Study ID: RC2023-24 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-06-01 - Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis ### Study Description Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI\>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.The association of these pathologies compromises the patient's survival and quality of life. The multifactorial origin of obesity makes its etiopathology difficult to manage. It is often possible to follow only one therapeutic strategy, especially after the so-called standard treatments, such as dietary intervention and physical activity, have not brought benefit to the patient. In these cases, an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery.Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity, and treating the diseases associated with it.Among the different types of bariatric surgery, the techniques most used in common clinical practice are intragastric balloons, gastric by pass (RYGB) and sleeve gastrectomy.The choice of the surgeon, assisted by the multidisciplinary team, is binding in the choice of the type of operation to which the patient will be subjected. ### Conditions - Obesity - Liver Disease Parenchymal ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nutritional Approach - Surgery Approach ### Outcomes Primary Outcomes - Variation of lipidomic parameters - The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis - Variation in the microRNA profile Secondary Outcomes ### Location - Facility: IRCCS "Saverio de Bellis", Castellana Grotte, Bari, 70013, Italy @@
## Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia - NCT ID: NCT06372002 - Study ID: 05/23 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-16 - Completion Date: 2024-07-31 - Lead Sponsor: Instituto de Mayores y Servicios Sociales (IMSERSO) ### Study Description This study aims to evaluate the effectiveness and cost-effectiveness of CST-ES, the Spanish adaptation of Cognitive Stimulation Therapy (CST), to improve cognition and quality of life in people with mild to moderate dementia.The evaluation will be conducted as a pragmatic multicenter randomized controlled clinical trial. Participants will be randomized to receive 7 weeks of CST-ES followed by 24 weeks of maintenance CST-ES (intervention group) or to continue their usual treatment (control group). ### Conditions - Dementia - Neurocognitive Disorders - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Stimulation Therapy (CST) ### Outcomes Primary Outcomes - Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) - Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) - Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) - Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) - Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) - Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) Secondary Outcomes - Cognitive functioning assessed through Mini-Mental State Examination (MMSE) - Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE) - Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE) - Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L) - Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L) - Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L) ### Location - Facility: Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca, Alcoy, Alicante, N/A, Spain @@
## Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL - NCT ID: NCT06371989 - Study ID: 19/160 - Status: COMPLETED - Start Date: 2019-03-11 - Completion Date: 2022-12-20 - Lead Sponsor: Hospital Universitario 12 de Octubre ### Study Description BACKGROUND AND CURRENT STATUS:Advancements in neoadjuvant systemic treatments (NST) for HER2 positive and triple-negative (TN) breast cancer (BC) subtypes have led to high rates of pathologic complete response (pCR), raising questions about the necessity of subsequent surgery, especially for those undergoing adjuvant radiotherapy. While Magnetic Resonance Imaging (MRI) remains the most effective imaging technique for assessing neoadjuvant treatment response, surgery is still required to confirm pCR in cases of almost complete or complete MRI response (iCR). To safely avoid surgery in these BC "exceptional responders," a technique with high negative predictive value is imperative.OBJECTIVE:This study aims to establish the diagnostic efficacy of image-guided vacuum-assisted biopsy (VAB) in assessing pathological complete response (pCR) after NST in HER2 positive or TN breast cancer subtypes, particularly those showing post NST-MRI complete or almost complete response.METHODS:A prospective study was conducted at "Hospital Universitario 12 de Octubre de Madrid" from June 25, 2018, to October 25, 2029. Twenty-five patients with HER2-positive or TN operable invasive ductal carcinoma (IDC) BC subtype, at stages cT1-3/N0-2 undergoing primary NST and showing complete or almost complete response on post NST-MRI, were enrolled. Ultrasound or stereotactic-guided vacuum-assisted biopsy (VAB) of the previous clip and tumor bed area was performed before surgery. VAB pathological results were compared with surgical pathological results to evaluate the diagnostic efficacy of predicting pCR with VAB after NST. Pathological representativeness of the VAB sample was ensured. pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma. ### Conditions - Breast Cancer - Breast Biopsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Image guided vacuum assisted biopsy ### Outcomes Primary Outcomes - The negative Predictive Value (NPV), Positive predictive value, specificity and sensibility of the VAB compared to Standard Surgery with Pathologic Evaluation Secondary Outcomes ### Location - Facility: Sara Jimenez Arranz, Madrid, N/A, 28020, Spain @@
## Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery - NCT ID: NCT06371976 - Study ID: APH240230 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-04-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Vasoplegic syndrome after cardiac surgery is common and is associated with increased morbidity and mortality. It is characterized by early and prolonged arterial hypotension, with preserved cardiac output and low systemic vascular resistance. Vasoplegic syndrome therefore shares pathophysiological features with septic shock. There are no data in the literature on the function of the hypothalamic-pituitary-adrenal (HPA) axis during vasoplegic syndrome after cardiac surgery. In situations of acute stress and systemic inflammation, relative adrenal insufficiency has been reported in the most severe patients, particularly those in septic shock. The term ""CIRCI"" (Critical Illness-Related Corticosteroid Insufficiency) is currently defined as an increase in total plasma cortisol of less than 9 µg/dl after stimulation with 250 µg tetracosactide (synthetic ACTH), or a basal total plasma cortisol level of less than 10 µg/dl. However, recent studies have called into question the usefulness of the cosyntropin stimulation test for exploring the HPA axis in intensive care patients.Tandem mass spectrometry (LC-MS/MS) assays can be used to measure steroid metabolites (steroidome), enabling more precise exploration of the corticotropic axis.The aim of this study is to evaluate, on an exploratory basis, the impact of the presence of a post-cardiac surgery vasoplegic syndrome on adrenal function by steroidome mapping (LC-MS/MS). ### Conditions - Vasoplegic Syndrome in Adult Cardiac Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sampling - Vital status ### Outcomes Primary Outcomes - Impact of post-cardiac surgery vasoplegic syndrome on corticotropic function. Secondary Outcomes - Evaluate corticotropic function by measuring steroid metabolites according to the presence or absence of ""CIRCI"" in patients with vasoplegic syndrome. - Evaluate the association between CIRCI and the severity of vasoplegic syndrome after cardiac surgery. - To assess the association between ""CIRCI"" and the duration of post-cardiac surgery vasoplegic syndrome. - To assess the association between ""CIRCI"" and length of stay in intensive care. - Evaluate the association between ""CIRCI"" and in-hospital mortality ### Location - Facility: Pitié-Salpêtrière, Paris, Ile-de-France, 75013, France @@
## Relative Energy Deficiency in Sports (REDs) in Swedish Athletes - NCT ID: NCT06371963 - Study ID: LinnaeusU REDs - Status: RECRUITING - Start Date: 2022-05-10 - Completion Date: 2026-12 - Lead Sponsor: Linnaeus University ### Study Description Background: Relative Energy Deficiency in Sport (REDs) describes impairment of health and performance due to problematic (long-term/severe) low energy availability (LEA), with or without eating disorders. LEA is frequently reported in sports with high training volumes, especially in leanness demanding sports, and 20% of female and 9% of male Norwegian national team athletes have been reported to have eating disorders. Potential trigger factors are e.g., dieting, injuries, coaching behavior, and subculture aspects e.g., focus on low body weight. The main questions that will be addressed are: 1. What is the prevalence of eating disorders and REDs among Swedish elite athletes and controls? 2. What is the impact of problematic LEA on health and performance aspects in both male and female athletes? Methods: National team athletes and gender and matched controls will be invited to an anonymous on-line survey. Elite athletes who agree to participate, will be invited to assessment of eating disorders, nutritional and physiological status (e.g., metabolic and endocrine markers, bone health, microbiota, dietary intake, energy availability, and performance). ### Conditions - RED S - Eating Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Self-reported eating disorders Secondary Outcomes - Eating disorders - Self-reported reproductive function in females not using hormonal contraceptives - Reproductive function in females not using hormonal contraceptives - Self-reported reproductive function in males - Reproductive function in males - Gastrointestinal function - Injury - Self- reported symptoms of depression - Compulsive exercise - The motivation for behavioral changes - Psychological flexibility - Changes in immune markers from pre to post exercise - Microbiota - Dietary intake - Maximal aerobic capacity - Explosive lower body power - Whole body strength - Muscular power - Resting Metabolic Rate - Body composition - Body weight - Body height - Glucose levels ### Location - Facility: Linnaeus University, Kalmar, Småland, N/A, Sweden @@
## Gut Microbiome in Orthopaedics - NCT ID: NCT06371950 - Study ID: 123608 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-01-01 - Lead Sponsor: Lawson Health Research Institute ### Study Description Patients having knee replacement surgery regularly experience joint pain and compromised bone quality leading to implant loosening and periprosthetic fractures. The role of the gut microbiome, which is the collection of bacteria and other microbes within the human gastrointestinal tract, is just beginning to be recognized, including its potential effects on pain, infection, and loosening after total joint replacement. Antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, but they also harm gut microbiota and reduce their potentially beneficial effects. Probiotics may have a role to play in enhancing bone quality and decreasing synovial inflammation after joint replacement surgery, and this study will explore the potential relationship of probiotic use with implant migration, bone density, and patient outcomes.This study is a randomized, controlled, double-blinded trial comparing probiotic use with placebo in post-menopausal women undergoing primary total knee replacement. The main questions it aims to answer are:* to compare implant migration between groups from baseline to six weeks post-surgery* to compare bone density and joint inflammation between groups from baseline to six weeks post-surgery* to compare gut microbiome composition and patient-reported outcome measures between groups from baseline to six weeks post-surgery ### Conditions - Total Knee Arthroplasty - Inflammation - Gastrointestinal Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic Formula Bacillus subtilis - Placebo ### Outcomes Primary Outcomes - Implant Migration Secondary Outcomes - Bone Density - Magnitude of 18-F-Fluoroethyl(2-(2-fluoroethoxy)phenyl)-proprionate ([¹⁸F]FEPPA) Tracer Uptake ### Location - Facility: London Health Sciences Centre, London, Ontario, N6A 5A5, Canada @@
## iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease - NCT ID: NCT06371937 - Study ID: 120687 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2033-06-30 - Lead Sponsor: Lawson Health Research Institute ### Study Description The Investigators will create a clinical database and a Biobank of stem cells derived from the blood of participants with cardiovascular disease. The Investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. The Investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. The stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease. ### Conditions - Cardiovascular Diseases - Arrythmia - Cardiomyopathies - Heart Failure - Cerebrovascular Accident - Congenital Heart Disease - Cardiometabolic Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - REDCap Database - Induced pluripotent stem cell (iPSC) Biobank - Differentiation into Cardiovascular lineages - Molecular profiling of participants - Bioinformatics analysis Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Immunometabolism of Machine Perfusion Strategies - NCT ID: NCT06371924 - Study ID: KCH23-156 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05-31 - Lead Sponsor: King's College Hospital NHS Trust ### Study Description There are not enough donated livers for everybody who needs one, and as a result, thousands of patients worldwide are waiting for liver transplants, with many dying while waiting for a life-saving organ. One reason for this shortage is that some usable livers from donors who are considered of high risk are being thrown away out of concern that they might not work well after transplantation due to a problem called ischaemia reperfusion injury (IRI).The discarded organs are mostly those coming from donors who have died due to cardiac arrest (called 'donation after circulatory death' or DCD), with only 27% of them being used in the UK. The quality of these DCD organs could be improved by changing how they are preserved after being removed from the donor. The most commonly used strategy is still to remove the livers and put them in an icebox ('static cold storage' or SCS). The alternative approaches, which are more complex and expensive, but that can also improve the quality of the DCD livers, involve using machines to pump fluids through the livers ('machine perfusion' or MP).There are three MP methods being used in patients: 1) normothermic regional perfusion (NRP), which involves pumping the donor's blood through the liver after the donor has died but the liver is still in the donor's body; 2) normothermic machine perfusion (NMP), in which the liver is pumped with blood outside of the donor's body; and 3) hypothermic machine perfusion (HOPE), which is also used outside of the donor's body by pumping cold fluid into the liver. HOPE and NRP have been shown to improve how well DCD livers function after transplantation. NMP can also improve the quality of the DCD livers, but its main advantage is that it allows confirming that the donated liver functions well before proceeding with the transplant. Until now, there has not been a proper comparison of these methods, and the doctors do not understand well the mechanisms through which MP improves the quality of the DCD livers.The iInvestigators plan to conduct a study where 36 DCD human livers will be split into three groups: SCS, NRP, and HOPE. After that, they will be put in NMP to confirm that they are good enough to be transplanted and to study the mechanisms through which NRP, SCS and HOPE work. ### Conditions - Liver Transplantation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Machine Perfusion ### Outcomes Primary Outcomes - To determine the effect of different preservation strategies on the development of mitochondrial damage following reperfusion during NMP. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment - NCT ID: NCT06371911 - Study ID: 2023-A02762-43 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2024-12-03 - Lead Sponsor: Centre Francois Baclesse ### Study Description Currently, during usual care, it is critical to assess whether a patient is apt to receive injectable anticancer treatment in the days prior to the administration. To assess this, blood tests are usually performed in the days leading up to the planned administration. A hospital staff member then telephones the patients and evaluates, using the tests results and other patient data (including the presence of adverse events (AEs) and Eastern Cooperative Oncology Group \[ECOG\] performance status), whether the patient is apt for treatment or whether the treatment needs to be deferred.In France, the Centre François Baclesse in Caen (France) launched the OPTIMA program to optimize the prescription and preparation of chemotherapy in the ambulatory unit of the hospital.A prospective study validating the OPTIMA program found that the prescription of chemotherapy was accurate with significantly reduced waiting times for patients between the planned appointment time and initiation of chemotherapyThe OPTIMA program is now part of usual care at the Centre François Baclesse.Following the positive impact of both the OPTIMA and "Star" programs, several French healthcare centers have implemented similar programs. However, a large proportion of the data during the program are collected by telephone, particularly outgoing calls (from the hospital staff to patients). Thus, implementing these programs is expected to increase the number and/or duration of outgoing calls and consequently the workload of hospital staff.Since the deployment of the OPTIMA program (between 2014 and 2016), and other equivalent programs, more and more patients have asked for the telephone calls to be replaced by a web-based application. Indeed, patients do not always respond to the telephone calls made by hospital staff, thus forcing staff to repeat calls several times. Also, some patients with language or hearing difficulties are unable to answer the questionnaires by telephone: a web-based alternative would be more appropriate for these patients.Telemonitoring can collect blood test results and other patient data required to evaluate whether patients are apt for injectable cancer treatment. Telemonitoring can then identify the few patients that need to be contacted by hospital staff, thus reducing the number of outgoing telephone calls.There is growing evidence of the benefits of adding telemonitoring to usual care for patients undergoing cancer treatment. The benefits include the early detection of AEs, improved quality of life (QoL), fewer admissions to emergency rooms or hospitalization, the longer remaining on chemotherapy for patients, and extended overall survival.Cureety is a digital telemonitoring platform, specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients. The digital tool includes questionnaires for each class of medication to monitor patients' adverse events remotely. The data collected include blood results, treatment-related data (including delays, dose reductions), as well as QoL and safety data. In terms of safety, patients respond to an electronic patient-reported outcome (ePRO) questionnaire based on the NCI-CTCAE version (v)5.0. Depending on the responses, the Cureety TechCare algorithm classifies the patient state as "correct", "compromised", "to be monitored", or "critical". The patients are then notified of the actions to be taken according to their classification. In preparation for injectable cancer treatment, Cureety can collect the data necessary to evaluate whether patients are apt for treatment administration. The collection and evaluation of this data is expected to decrease outgoing calls by between 30% to 50%.This study was designed to evaluate whether adding Cureety telemonitoring to usual care would reduce the number of outgoing calls for hospital staff during the management of patients undergoing injectable at one of the participating centers compared with the usual care including a program for anticipation of injectable treatment (OPTIMA program or equivalent). ### Conditions - Adult Patients Initiating Injectable Anticancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Cureety telemonitoring - OPTIMA or equivalent programs ### Outcomes Primary Outcomes - Effectiveness of adding Cureety telemonitoring to usual care Secondary Outcomes ### Location - Facility: Centre hospitalier de Bligny, Bligny, N/A, N/A, France @@
## Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study (MORDIGO) - NCT ID: NCT06371898 - Study ID: 29BRC24.0088 - MORDIGO - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-06-17 - Lead Sponsor: University Hospital, Brest ### Study Description Propose a one-piece endoscopic resection such as endoscopic submucosal dissection (ESD) rather than surgery for benign lesions and superficial T1 cancers colorectal cancers offers comparable efficacy with better tolerability. This approach is all the more in the rectum, even for giant lesions lesions (over 8cm), as rectal surgery is particularly morbid, with particularly morbid, with a functional impact that can impact, whereas rectal ESD is less prone to complications fewer complications than in the colon. Colonic ESD for giant lesions is a longer and more morbid more time-consuming and morbid than for smaller lesions, the question of colonic surgery in this indication. this indication. In order to compare the morbidity data of patients of giant lesions with those of colectomy, a control group colectomy, a surgical control group will be set up, including patients including patients having undergone surgery for in situ T1 or T2 in situ colon cancer. Surgical resections of resection of benign lesions is generally not indicated not indicated and would not provide the necessary necessary for a comparison. T3 and T4 lesions with their own their own morbidity will be excluded. ### Conditions - Colonic Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 30 days severe morbidity Secondary Outcomes - morbidity of ESD group - comparison of morbidity in both groups - reintervention - stomia - length of hospital stay - readmission - mortality - risk factors for morbidity ### Location - Facility: Chu Brest, Brest, N/A, 29609, France @@
## Shock Wave on Pillar Pain After Carpal Tunnel Release in Hand Burn - NCT ID: NCT06371885 - Study ID: P.T.REC/012/004646 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-10 - Completion Date: 2024-06-28 - Lead Sponsor: Cairo University ### Study Description "In burn cases, the reported causes of CTS are increased volume of carpal tunnel content due to edema and synovitis, wrist hyperextension, tight dressing, fibrosis, and direct burn to the nerve. There are two types of pain that occur in the palm of the hand after carpal tunnel surgery: incisional pain and pillar pain. The incision pain typically only lasts for a few days or weeks after surgery, while the pillar pain occurs on the sides of the incision in the thicker parts of the palm, called the thenar and hypothenar eminences. This is where the transverse ligament attaches to the carpal bones, forming the carpal tunnel.So, in this study we will find out if shock wave therapy has therapeutic effect on pillar pain after carpal tunnel release in hand burn. ### Conditions - Hand Burn - Carpal Tunnel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - shock wave therapy - traditional physical therapy ### Outcomes Primary Outcomes - Visual Analog Scale - Hand held dynamometer Secondary Outcomes - Michigan hand out Comes questionnaire ### Location - Facility: Shaimaa Mohamed Ahmed El Sayeh, Cairo, New Cairo, 02, Egypt @@