Umraniye

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

Researchers are evaluating the efficacy and safety of pegozafermin in adults with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH, previously known as nonalcoholic steatohepatitis NASH. This study focuses on participants with biopsy-confirmed advanced liver fibrosis stage F4 due to MASH. The research aims to understand how pegozafermin affects liver health over time compared to a placebo. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections. The study follows a randomized, parallel design with quadruple masking to ensure unbiased results. The treatment period extends up to 24 months, with additional long-term follow-up lasting up to five years to assess disease progression and liver fibrosis regression. During the study, participants will undergo various assessments including measurements of liver fibrosis, disease progression through clinical events, and liver function tests such as alanine aminotransferase ALT levels. Tools like Enhanced Liver Fibrosis ELF score and FibroScan Vibration-controlled Transient Elastography VCTE will be used to monitor liver condition up to 60 months. Safety and efficacy will be closely monitored throughout the study period, which may last up to seven years in total.

Researchers are evaluating the pharmacokinetics, pharmacodynamics, efficacy, and safety of intravenous anifrolumab compared with placebo in children aged 5 to under 18 years with moderate to severe active systemic lupus erythematosus SLE who are receiving standard care. This phase III clinical trial aims to better understand how anifrolumab works and its effects in this pediatric population. Participants are randomly assigned to receive either anifrolumab or matching placebo via intravenous infusion every 4 weeks. The study includes several periods Part A is a 4-week double-blind pharmacokinetic phase Part B is a 48- to 52-week double-blind safety and efficacy phase Part C is a 52-week open-label extension and Part D involves a safety follow-up visit 12 weeks after the last dose. During the approximately 116-week study, participants undergo screening for up to 30 days, followed by regular infusions and assessments including blood tests to measure drug levels and immune markers. Researchers evaluate responses using disease activity scores and track safety throughout. The study concludes with a safety follow-up visit to monitor participants after completing treatment.

Researchers are evaluating the impact of the Accu-Chek SmartGuide continuous glucose monitoring CGM system compared with traditional self-monitoring of blood glucose SMBG in adults with Type 1 or insulin-dependent Type 2 diabetes who use multiple daily insulin injections. This open-label, randomized, multi-center clinical device study aims to see how the CGM system affects the time participants blood glucose levels stay within the target range of 70-180 mgdL. The study is sponsored by Hoffmann-La Roche and focuses on measuring blood glucose control improvements. Participants are assigned to one of two groups one uses the Accu-Chek SmartGuide CGM solution, which includes a sensor applicator and smartphone apps providing real-time glucose data and analysis the other group continues standard care with SMBG devices while wearing a blinded CGM sensor intermittently during assessment periods. The blinded sensors record data without providing feedback to participants. The study includes baseline, assessment periods A, B, and C occurring over several weeks to compare glucose control over time. During the study, participants will have their blood glucose monitored continuously or through SMBG devices, complete questionnaires on diabetes distress and fear of hypoglycemia, and have laboratory tests including HbA1c at multiple time points. Researchers will track various glucose metrics such as time in range, hypoglycemia events, and glycemic variability. The study duration extends through several assessment periods up to approximately 26 weeks, with ongoing evaluations to assess the usability and impact of the CGM system on diabetes management.

Researchers are conducting an observational study to screen adults aged 18 and over who visit hospital outpatient clinics in Turkey for malnutrition and sarcopenia risks. The study focuses on patients attending oncology, neurology, and geriatric clinics to better understand these conditions across diverse patient groups. This non-interventional, cross-sectional design means participants are observed without receiving experimental treatments. Participants are screened once during their outpatient visit without any study treatments or interventions. The study collects information on malnutrition risk, sarcopenia risk, body mass index, calf circumference, hand grip strength, biochemical parameters, healthcare use, and nutrition treatments. Data is gathered on the screening day only. During the study visit, researchers will assess physical and biochemical measures to evaluate nutrition and muscle health. Participants provide informed consent before any assessments. The study measures malnutrition and sarcopenia risks as primary outcomes on the first day and includes several secondary measures related to body composition and healthcare use. The study will continue enrolling participants until April 2027.