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Found 13 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the bioavailability, safety, and tolerability of two different formulations of Torasemide 10 mg tablets in healthy adult volunteers under fasting conditions. This Phase I study compares the test medication Torasemide 10 mg tablets by Berlin-Chemie AG with Unat4 10 tablets by Viatris Healthcare GmbH to assess bioequivalence of the formulations. The study involves healthy men and women aged 18 to 55 years who meet specific health and lifestyle criteria. Participants receive single doses of each Torasemide 10 mg tablet formulation in a randomized, open-label, crossover design, where each participant receives both treatments in separate periods. The study focuses on measuring drug levels in the body to compare the two formulations. No additional treatments or devices are involved. During the study, participants undergo medical history reviews, clinical examinations, and laboratory tests to confirm health status and monitor safety. Key outcome measures include maximum drug concentration (C max) and total drug exposure over 24 hours (AUC 0-last). The study also monitors tolerability and adverse effects. Participants must comply with fasting and behavioral requirements, and the study duration includes screening, treatment periods, and follow-up assessments.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.
Actively Recruiting
Researchers are evaluating the clinical effectiveness of Ustekinumab in patients with Crohn's Disease through an observational study that includes both retrospective and prospective components. The study aims to assess the reduction in disease activity with a focus on the Crohn's Disease Activity Index over 24 weeks of therapy. The study involves patients who have been prescribed Ustekinumab for the first time between January 1 and December 31, 2024. Participants receive the usual care with Ustekinumab as prescribed, and the study observes their response to treatment without additional experimental interventions. Participants will be monitored for changes in their disease activity using the Crohn's Disease Activity Index at week 24. The study also involves collection of clinical data, monitoring for safety, and evaluating adherence to treatment. The total duration and detailed follow-up procedures are based on observing the patients through their routine care during the study period.
Actively Recruiting
Researchers are investigating how advanced assisted reproductive technologies (ART), including intracytoplasmic sperm injection (ICSI) and frozen embryo transfer (FET), affect the physical, cognitive, and reproductive health of children conceived through these methods. The study focuses on children under three years of age born in Kazakhstan, aiming to identify any deviations in health indicators compared to typical development. The project also explores the impact of maternal medication use during pregnancy and the reproductive health of fathers and their sons born after ICSI. The study includes retrospective analysis of medical histories and a detailed evaluation of 300 children conceived via ART. Physical growth measurements such as weight, height, and head and chest circumference will be collected using age-appropriate equipment. Psychomotor development will be assessed with standardized tools like the Griffiths Mental Development Scale and Denver Developmental Screening Tests, along with neurosonography for children under one year. The reproductive health of 200 male children conceived via ICSI will be compared to those conceived through classic IVF using clinical exams, ultrasounds, and hormonal tests measuring Inhibin B and Anti-Müllerian Hormone (AMH). Participants and their parents will provide medical history information and consent for biological sample collection where applicable. Clinical assessments will cover physical growth, neurodevelopment, and reproductive system development. Children identified with developmental risks will be referred for neurologist evaluation. Data analysis will involve statistical methods to explore health outcomes and associated risk factors. The study emphasizes ethical standards, including confidentiality and informed parental consent, aiming to improve management algorithms for children conceived by ART based on the findings.
Actively Recruiting
Healthy Volunteer
Researchers are investigating personalized and preventive care strategies for non-communicable diseases (NCDs) such as cardiovascular diseases, type 2 diabetes, chronic respiratory diseases, obesity, and chronic kidney diseases in Kazakhstan. The study focuses on examining epigenetic factors to predict biological age and reproductive function using machine learning models. These predictions aim to help develop tailored health improvement recommendations for individuals. Participants will undergo genetic analysis involving the measurement of telomere length and DNA methylation levels. These biological markers are used to build machine learning models that predict biological age and reproductive function. The study does not involve comparison groups or drug treatments but rather focuses on data collection and analysis to advance personalized health care approaches. During the study, participants' biological samples will be collected and analyzed to gather data on epigenetic markers. Researchers will evaluate the accuracy of the machine learning models within 10 months from the start of data collection. Participants are expected to be involved in providing consent and completing data collection procedures. The total duration and other follow-up details are not specified.
Actively Recruiting
Central Asia is experiencing the fastest-growing HIV epidemic globally, mainly affecting people who inject drugs and their sexual partners. The trial focuses on expanding opioid agonist therapies (OAT) in Kazakhstan, Kyrgyzstan, and Tajikistan, using the Network for the Improvement of Addiction Treatment (NIATx) strategy guided by the Exploration-Planning-Implementation-Sustainment (EPIS) framework. This approach aims to overcome barriers in healthcare delivery systems and improve prevention and treatment of HIV and opioid use disorder in the region. The study involves training Chief Narcologists and other professionals in OAT delivery through NIATx tools and quality improvement techniques. This includes a 2-3 day training for coaches and ongoing support from a US-based super coach. Participants will identify targets for improving OAT entry and retention using Plan-Do-Study-Act cycles and collaborative learning. The program will adapt to local cultural and healthcare contexts to promote sustainable OAT scale-up. Participants will be assessed through surveys, focus groups, and organizational evaluations involving people who inject drugs and OAT delivery staff. Researchers will measure OAT coverage and retention over 36 months to understand implementation trajectories and program effectiveness. Stakeholder meetings will inform policy changes to support sustainable OAT integration into primary and HIV care settings, aiming to reduce new HIV infections and improve treatment outcomes.
Actively Recruiting
This research aims to collect real world data on patient characteristics, disease management, healthcare use, and outcomes for people living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It focuses on understanding how these conditions are managed and the quality of care patients receive in everyday clinical practice across many countries. The registry is observational and voluntary, designed to fill gaps in knowledge about these diseases globally. The study uses a multinational, observational registry with a cloud-based electronic case report form (eCRF) to gather both prospective and retrospective data. This system is accessible to doctors managing patients with type 2 diabetes, hypertension, heart failure, or chronic kidney disease worldwide. There are no specific treatments or interventions given as part of this study since it is a data collection registry. Participants provide information for an average of 3 years during the study. Researchers will collect data on patient characteristics, disease management, healthcare use, quality of care indicators, cardiovascular outcomes, kidney outcomes, and other related complications. The registry allows ongoing data entry and monitoring to better understand real world outcomes and care quality for these conditions.
Actively Recruiting
Researchers are evaluating the effects of adding Anifrolumab to the usual treatment for Systemic Lupus Erythematosus (SLE) in a real-world setting. This international study, called INTERSTELLAR, aims to provide important evidence on how Anifrolumab helps patients with SLE, including those with skin symptoms related to the disease. The study uses standardized criteria and measures across multiple countries such as Qatar, Saudi Arabia, Mexico, Costa Rica, Panama, Dominican Republic, Colombia, Argentina, Taiwan, and Egypt to allow comparisons between different populations. INTERSTELLAR is a multi-country, single-arm observational study that includes both retrospective data from the year before starting Anifrolumab and prospective follow-up for one year after treatment begins. Patients join the study when they receive their first prescription and infusion of Anifrolumab, following the approved country-specific guidelines. The study will collect data until the patient dies, stops participating, or the study ends. Clinical assessments and patient-reported outcomes related to lupus activity, skin involvement, fatigue, and quality of life will be gathered throughout the study. Participants will be assessed at various times including before treatment and at 1, 3, 6, and 12 months after starting Anifrolumab. Researchers will monitor lupus disease activity, skin symptoms, fatigue, and quality of life using standardized tools. Data will continue to be collected even if patients stop the treatment, as long as they agree to stay in the study. This approach helps provide a comprehensive understanding of Anifrolumab's impact in routine clinical practice over a full year.
Actively Recruiting
Researchers are evaluating the effects of survodutide in adults aged 18 years and older who have a confirmed liver condition called non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH). Eligible participants must have a body mass index (BMI) of 27 kg/m2 or higher, or at least 25 kg/m2 if they are Asian. The study excludes those with other chronic liver diseases or a history of significant alcohol use. The main goal is to see if survodutide can improve liver function and delay progression of liver damage over time. Participants are randomly assigned to receive either survodutide or a placebo, with twice the chance of receiving survodutide. Both treatments are given as weekly injections under the skin using a pre-filled syringe. Alongside treatment, all participants receive regular counseling to encourage healthy diet and exercise habits. The study lasts up to four and a half years, with frequent visits or remote video calls during the first year and five months, then quarterly visits thereafter. During the study, doctors monitor participants' health, including body weight and liver function using imaging tests at certain visits. Participants complete symptom questionnaires to help assess their condition. Researchers track outcomes such as survival, need for liver transplant, worsening liver disease, and liver-related complications. Safety and any side effects are closely watched throughout the study period to understand the treatment's impact.
Actively Recruiting
Researchers are evaluating the effects of survodutide on adults living with obesity who have a liver disease called non-alcoholic steatohepatitis (NASH) or metabolic associated steatohepatitis (MASH), along with moderate or advanced liver fibrosis. The study focuses on whether survodutide can improve liver function and reduce liver damage in these participants. This Phase III trial aims to assess both the effectiveness and safety of survodutide over a long-term period. Participants are randomly assigned to one of two groups: one receiving weekly injections of survodutide and the other receiving placebo injections that look like the medicine but contain no active drug. The doses of survodutide are gradually increased until the target dose is reached. All participants receive counseling to support healthy diet changes and regular exercise throughout the study. The study lasts up to 7 years, with frequent visits to the study site or remote video calls. In the first year, visits occur every 2 weeks, then every 4 to 6 weeks, and later every 3 months alternating between in-person and remote. Throughout the study, researchers monitor participants' health, liver condition through imaging and biopsies, body weight, digestive system effects, and questionnaires about symptoms and quality of life. The main outcomes include liver fibrosis improvement, resolution of MASH without worsening fibrosis, and long-term safety and efficacy measures.
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