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NCT ID: NCT05743387 Recruiting - Clinical trials for Type 2 Diabetes Mellitus (T2D)

Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho

ComBaCaL T2D
Start date: May 13, 2023
Phase: N/A
Study type: Interventional

This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs). The overall objective of the ComBaCaL cohort study and nested TwiCs is to assess the impact of eHealthsupported, lay-led chronic disease control measures in rural Lesotho. In this T2D TwiC, the effect, safety and feasibility of a community-based T2D care package (which includes the offer of first-line oral antidiabetic and lipid-lowering treatment for uncomplicated T2D by lay CC-VHWs in comparison to facility-based care after community-based screening and diagnosis) will be evaluated.

NCT ID: NCT05741892 Recruiting - Fracture Tibia Clinical Trials

3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care

3DFRG
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The aim of the study is to assess the accuracy of fracture reduction performed with surgical guides designed and 3D printed at the point of care in comminuted fractures of femur- and tibia-shaft.

NCT ID: NCT05740657 Recruiting - Clinical trials for Opioid Use, Unspecified

Observational Study on the Incorporation of Opioids and Their Metabolites Into Hair of Pediatric Patients

Start date: December 6, 2022
Phase:
Study type: Observational [Patient Registry]

Hair analysis is a well-established and important tool in both forensic and clinical context. When it comes to the interpretation of positive hair analysis results, reliable and comprehensive reference data is essential. Such data on opioids, especially novel synthetic ones (such as fentanyl and its analogues (fentalogs)) is currently highly limited. This applies especially to hair with pediatric origin, due to differences in the metabolism and hair anatomy in children compared to adults. Investigators hypothesize that opioids, both traditional and novel synthetic ones exhibit detectable concentrations and distinct metabolite ratios within the hair matrices of pediatric patients. Thus, this observational, prospective research study provides 150 hair and sweat samples from children who received opioids as part of surgery or pain management. The samples will be consecutively extracted and analyzed using a sensitive targeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, enabling the quantitative determination of the opioid and metabolite concentrations. The study thereby contributes valuable reference data for both forensic and clinical applications, addressing challenges in interpreting hair analysis results in especially pediatric populations. Further, a deeper understanding of the mechanisms (e.g. via sweat) and pharmacokinetic processes involved in the opioid incorporation to hair will be achieved. The study has received ethical approval from the Swiss Ethics Board (approval number: 2022-01693 / amendment approval date: 09.01.2024).

NCT ID: NCT05740566 Recruiting - Clinical trials for Small Cell Lung Cancer (SCLC)

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

DeLLphi-304
Start date: May 31, 2023
Phase: Phase 3
Study type: Interventional

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

NCT ID: NCT05740228 Recruiting - Stroke Clinical Trials

Transcranial Direct Current Stimulation for Gait Recovery Following Stroke

TransGait
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Background: Stroke is a leading cause of adult disability. The ability to walk is considered as the most important physical activity in daily life and strongly associated with quality of life in patients with stroke sequela. Conventional transcranial Direct Current Stimulation (tDCS) can induce mixed effects to improve gait impairment after stroke. The problem of limited focal specificity of tDCS may lead to an ineffective stimulation and in turn may be reduced the potential application of tDCS in clinical routine. High-definition transcranial Direct Current Stimulation (HD-tDCS) allows inducing, in a non-invasive way, a transient excitatory neuromodulation of a given cerebral region and to obtain a very focused cortical effect. However, the clinical and neurophysiological effects of HD-tDCS remain largely unknown for enhancing gait recovery in patients with stroke. The investigators hypothesize that anodal HD-tDCS will enhance neural interactions between motor networks and, thereby, improve motor processing and gait relearning. The investigators propose to carry out a study on chronic stroke patients involving anodal HD-tDCS of the affected primary motor cortex combined with a physical therapy. This study has three main objectives: - To compare the effects of two techniques of tDCS (anodal tDCS, anodal HD-tDCS) on clinical recovery in patients with chronic stroke. - To assess the effects of these brain stimulation techniques on brain reorganization with electroencephalography (EEG). - To assess the effects of these brain stimulation techniques on spatiotemporal gait parameters during walking with wearable motion sensors. Methods: 36 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of 3 groups: anodal tDCS, anodal HD-tDCS, or sham stimulation. Each group will receive the corresponding stimulation therapy 3 times per week for 2 weeks, simultaneously with physical therapy. Before (T0) and immediately after the treatment period (T1) and again one month later (T2), standardized assessments of sensorimotor function areas are obtained together with spatio-temporal analysis. Brain reorganization is assessed with EEG before and immediately after the treatment period. These recordings will be used to compare and investigate the clinical and physiological effects of each treatment modality.

NCT ID: NCT05739383 Recruiting - Clinical trials for Primary Prevention of Atherosclerotic Cardiovascular Disease

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Start date: March 9, 2023
Phase: Phase 3
Study type: Interventional

CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

NCT ID: NCT05738161 Recruiting - Clinical trials for Advanced Urothelial Carcinoma

Magrolimab in Combination With Cytotoxic Chemotherapy in Advanced Urothelial Carcinoma

MACOCUC-01
Start date: June 21, 2023
Phase: Phase 1
Study type: Interventional

In their "Magrolimab" research project, the investigators want to find out whether the new drug Magrolimab in combination with conventional chemotherapy is well tolerated and whether survival or progression-free survival improves.

NCT ID: NCT05735834 Recruiting - Clinical trials for Splenic Marginal Zone Lymphoma

Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients

RITZ
Start date: May 21, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare the efficacy and tolerability of the combination of two medicinal products, rituximab, and zanubrutinib, compared to rituximab monotherapy in patients with Splenic Marginal Zone Lymphoma (SMZL), previously untreated and who need systemic treatment. The main questions it aims to answer are: - Is the combination rituximab and zanubrutinib a more effective therapy than rituximab monotherapy? - Is the combination therapy, rituximab and zanubrutinib, well tolerated? Study participants will be put into one of the two treatment groups (rituximab and zanubrutinib or rituximab alone) for a maximum of two years and will undergo regular visits until three years from treatment start.

NCT ID: NCT05734677 Recruiting - Clinical trials for Borderline Personality Disorder

Emotion Regulation Group Study

EmoReg
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

A clinical trial to evaluate the effects of an eight-week emotion regulation group intervention designed for adolescents (16-20 years old) on the levels of emotion dysregulation both self-reported by the adolescent and reported by his/her parent/caregiver (pre-post comparison). The long-term effect will also be measured at a third-time point, three months after the end of the intervention. The intervention will consist of 90-minute sessions once a week for 8 weeks, in groups of eight participants. The intervention proposed for this study is an adaptation from different interventions already in use for adolescents in clinical practice, such as Dialectical Behavior Therapy (DBT), Mentalization-Based Treatment (MBT) and Mindfulness-Based Intervention (MBI).

NCT ID: NCT05734378 Recruiting - Clinical trials for Cerebral Amyloid Angiopathy

Prognosis of Cerebral Small Vessel Disease

PRO-SVD
Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation. The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.