Search Bar & Filters
Found 16 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
This research evaluates the bioavailability, safety, and tolerability of two formulations of Torasemide 10 mg tablets in healthy adults under fasting conditions. It is a Phase I study comparing the test medication by Berlin-Chemie AG to Unat4 10 tablets by Viatris Healthcare GmbH to determine if the two formulations are bioequivalent. Participants receive a single 10 mg dose of either Torasemide 10 mg tablet by Berlin-Chemie AG or Unat4 10 tablets by Viatris Healthcare GmbH, orally with 240 mL of water while fasting. The study uses a randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design, where each participant receives both treatments in separate periods. During the study, researchers measure the maximum concentration C max and area under the curve AUC 0-last over 24 hours to assess bioavailability. Additional measures include other pharmacokinetic parameters such as T max, half-life, and elimination rate. Participants undergo clinical and laboratory assessments to confirm health status and monitor safety. The total participation time and follow-up duration span up to one year for secondary outcomes.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.
Actively Recruiting
Researchers are evaluating whether adding the NutriSteppe digital dietary intervention to routine medical care improves metabolic health in adults aged 21 to 65 years who have type 2 diabetes, obesity, or are overweight with related health issues. Participants in this study are already receiving or have been prescribed glucagon-like peptide-1 GLP-1 receptor agonist therapy by their doctors outside of this trial. The main goal is to see if the NutriSteppe app improves glycated hemoglobin HbA1c, a measure of average blood glucose, after 12 weeks compared to routine care alone. Participants are randomly assigned to one of two groups. Both groups continue their routine medical care including GLP-1 receptor agonist therapy. The control group receives general lifestyle advice, while the intervention group uses the NutriSteppe mobile app, which provides personalized meal planning, food diaries, nutritional analysis, educational modules, reminders, and dietary recommendations for 12 weeks. All participants photograph their food and drink, and these photos are analyzed by an automated system called Tagam-AI. Only the intervention group receives personalized dietary advice based on this analysis. During the study, participants attend visits for examinations, laboratory tests, and questionnaires. Researchers measure changes in HbA1c, fasting glucose, body weight, body mass index, waist circumference, cholesterol levels, blood pressure, diet quality, quality of life, and dietary adherence. Safety is monitored by tracking adverse events and laboratory parameters. Participants use the NutriSteppe app at least five days per week and record body weight weekly. The total participation lasts 12 weeks with regular assessments throughout.
Actively Recruiting
Researchers are investigating the health outcomes of children conceived through advanced assisted reproductive technologies ART such as intracytoplasmic sperm injection ICSI and frozen embryo transfer FET. The study aims to understand the effects of these methods on the physical growth, cognitive development, and reproductive health of children up to three years old, exploring potential deviations from typical health norms. This observational project also considers maternal medication use during pregnancy and paternal infertility factors. The research involves multiple assessments including retrospective analysis of medical histories, measurement of physical growth parameters like weight, height, and head and chest circumference, and evaluation of psychomotor development using standardized tests like the Griffiths Mental Development Scale and Denver Developmental Screening Tests. Male children conceived via ICSI will undergo examinations by pediatric andrologists, including ultrasounds and hormone level evaluations such as Inhibin B and Anti-Mllerian Hormone AMH. Data collection incorporates clinical exams, lab tests, and parental medical histories to build a comprehensive health profile. Participants will have a single clinical assessment up to 36 months of age, during which physical growth, neurodevelopmental status, and reproductive health will be measured. Neurosonography will be used for children under one year to assess brain structure. Researchers will analyze data using statistical methods to identify health patterns and risk factors, aiming to develop predictive models and management algorithms for children conceived via ART. The study emphasizes ethical standards, including informed parental consent and data confidentiality, with findings intended to improve clinical care and health outcomes for this population.
Actively Recruiting
Healthy Volunteer
Researchers are exploring ways to improve personalized and preventive care for non-communicable diseases such as cardiovascular diseases, type 2 diabetes, chronic respiratory diseases, obesity, and chronic kidney diseases in Kazakhstan. This observational study focuses on understanding epigenetic factors and uses machine learning models to predict biological age and reproductive function, aiming to tailor health recommendations for individuals. The study involves one cohort divided into four age groups 18-29 years, 30-44 years, 45-59 years, and 60-69 years, with an equal number of men and women in each group. Participants will undergo genetic investigations including DNA analysis to examine telomere length and DNA methylation levels. Data collection and model predictions will take place within ten months from the start of the study. Participants will be residents of Kazakhstan aged 18 to 69 years who consent to participate. The study will monitor the accuracy of machine learning models in predicting biological age and reproductive function. All data collection will be observational, with no treatments administered. The total participation timeline includes data collection and assessment periods within the planned study duration ending in 2026.
Actively Recruiting
Central Asia is experiencing the fastest growing HIV epidemic globally, mainly affecting people who inject drugs PWID and their sexual partners. This research focuses on expanding opioid agonist therapies OAT in Kazakhstan, Kyrgyzstan, and Tajikistan, as scaling up OAT combined with antiretroviral therapy ART is considered the most cost-effective way to prevent new HIV infections. The study uses the NIATx implementation strategy guided by the Exploration-Planning-Implementation-Sustainment EPIS framework to understand and improve OAT delivery in this challenging healthcare context. The study involves training and coaching national experts and Chief Narcologists in these countries using NIATx tools and quality improvement techniques. This includes initial training sessions, ongoing coaching, and collaborative learning to overcome barriers and improve OAT entry and retention. The researchers will also conduct formative research to assess facilitators and barriers at client, program, and structural levels, aiming to create sustainable and locally adapted OAT models integrated with primary and HIV care. Participants include PWID meeting opioid dependence criteria, OAT delivery staff, and Chief Narcologists involved in OAT programs. Assessments include surveys, organizational evaluations, and focus groups, with ongoing monitoring of OAT census, new patient numbers, and dropout rates over 36 months. Stakeholder meetings will help guide implementation and policy changes to support sustainability. The total study duration includes long-term follow-up to assess implementation trajectories and outcomes.
Actively Recruiting
Comparing Ten Surgical Techniques for Full-Thickness Macular Hole Repair Using Pars Plana Vitrectomy
Researchers are evaluating ten different vitreoretinal surgical techniques for repairing full-thickness macular holes, a condition that threatens vision. This study aims to identify which surgical method leads to the highest rate of hole closure as seen on optical coherence tomography OCT and the best visual outcomes. The trial includes adults with varying sizes of macular holes and uses stratified randomization based on hole size to balance participant groups. The study involves pars plana vitrectomy PPV procedures with various approaches, such as internal limiting membrane ILM peeling, different ILM flap configurations, adjunct use of autologous platelet-rich plasma PRP, human amniotic membrane hAM grafts, and macular edge hydrodissection. Participants are randomly assigned to one of the ten surgical techniques. Postoperative care and follow-up are standardized across all groups. Participants will have follow-up visits on Day 7, Month 1, and Year 1 after surgery to undergo clinical exams and OCT imaging to assess macular hole closure, visual acuity, and safety outcomes including complications and reoperations. The study will measure anatomical closure on OCT at these time points as the primary outcome, along with secondary outcomes like best-corrected visual acuity and morphological recovery. Safety and adverse events will be monitored through the first year post-surgery.
Actively Recruiting
This research aims to collect real-world data on the characteristics, management, healthcare use, and outcomes of patients living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It is an international observational registry that includes patients from many countries to better understand how these conditions are treated in everyday clinical practice. Participants in this registry are observed without receiving experimental treatments. Data are collected both retrospectively and prospectively using a cloud-based electronic case report form accessible to investigators and a scientific committee. The registry includes groups of patients with type 2 diabetes, hypertension, chronic kidney disease, or heart failure, either as their primary condition or as a coexisting condition. Patients provide information about their health status, treatments, and outcomes over time. Researchers collect data on demographics, disease characteristics, laboratory tests, treatments, healthcare visits, hospitalizations, and lifestyle factors. The study measures many outcomes such as blood sugar levels, kidney function, heart function, medication use, and health events over an average of three years. Participation is voluntary and ongoing, with data collection continuing until the study end date in 2030.
Actively Recruiting
Researchers are conducting the INTERSTELLAR study to gather important real-world evidence about adding anifrolumab to the usual treatment for systemic lupus erythematosus SLE. This observational study is taking place across multiple countries, including regions like GCC, Mexico, Central America, Colombia, Argentina, Taiwan, and Egypt. It aims to provide data useful for doctors, payers, and patients by using consistent criteria and measures for SLE and skin symptoms related to lupus. Participants will be observed for one year before starting anifrolumab and followed for one year after beginning treatment. The study starts after anifrolumabs commercial launch in each country and includes patients from the time of their first anifrolumab prescription and infusion. Data collection continues even if participants stop taking anifrolumab, unless they withdraw their consent. During the study, clinical assessments and patient-reported outcomes will be collected at baseline and at months 1, 3, 6, and 12. These include disease activity scores PGA, SLEDAI-2K, skin involvement measures CLASI, fatigue assessments FACIT-Fatigue, and quality of life questionnaires LupusQoL, EQ-5D-5L. The study monitors participants until death, loss to follow-up, withdrawal, or study end, aiming to reflect real-world use and outcomes of anifrolumab in routine care.
Actively Recruiting
Researchers are evaluating whether survodutide can help adults with liver diseases called non-alcoholic steatohepatitis NASH or metabolic-associated steatohepatitis MASH who have cirrhosis and a body mass index BMI of 27 kgm2 or higher 25 kgm2 for Asian participants. The study compares survodutide to a placebo to see if it improves liver function and related health outcomes over time. This is a Phase III trial with participants randomly assigned to groups, and it is double-blind, meaning neither participants nor doctors know who gets the medicine or placebo. Participants receive weekly injections of survodutide or placebo under the skin and get regular counseling on diet and exercise. The study lasts up to four and a half years, with visits either in person or via video call every 2, 4, or 6 weeks for about 17 months, then every 3 months thereafter until the study ends. The study collects health data including body weight, liver imaging results, and symptom questionnaires to assess the treatment effects. During the study, doctors monitor participants health and record any side effects. Liver health is checked using imaging methods at certain visits, and participants fill out questionnaires about their symptoms. The primary outcome measures include time to serious liver-related events and overall survival. Secondary outcomes look at changes in liver fibrosis, body weight, blood sugar control, liver stiffness, and other blood markers. The study aims to provide detailed long-term information on survodutides impact on liver disease and safety.
1-10 of 16
1