Manisa Merkez

Researchers are evaluating roxadustat, an oral medicine, for treating anemia in children and teenagers with chronic kidney disease CKD. Anemia involves low red blood cell levels, and current treatments often use injections called erythropoietin stimulating agents ESAs with iron, but these have safety concerns. This Phase 3 open-label study aims to understand how roxadustat affects anemia in this young population, offering a potential alternative to ESA injections. Participants will take roxadustat orally or via gastric tube three times a week for up to 52 weeks. The study begins with a fixed dose for 4 weeks, during which blood hemoglobin levels are regularly checked to adjust dosing as needed to maintain target levels just below normal. The study starts with 10 teenagers and 10 children who receive fixed doses to determine appropriate dosing for others. After this, the remaining children and teenagers will take the optimized dose. Children and teenagers will visit the clinic frequently every 2 weeks during the first month and then every 4 weeks until the treatment ends, with a final visit 4 weeks after stopping roxadustat. At visits, vital signs, fluid status for dialysis patients, blood and urine tests, and medical exams will be conducted, including electrocardiograms at specific intervals. Researchers will monitor hemoglobin, iron levels, safety, growth, and quality of life over the study period, which may last up to 56 weeks including follow-up.

This trial investigates the safety and efficacy of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. Participants must have specific tumor characteristics including PD-L1 and HER2 status, and measurable disease according to established criteria. The study is a blinded, randomized phase 23 trial sponsored by Bristol-Myers Squibb. Participants will receive either Pumitamig or Nivolumab alongside chemotherapy regimens such as Folfox or Capox, with dosing given on specified days. The study uses a parallel design with multiple experimental arms to evaluate these combinations. Treatments and assessments will continue over several months following randomization. During the study, participants will undergo regular evaluations including tumor response assessments by RECIST criteria, survival monitoring, and safety checks. Researchers will measure objective response rates, progression-free survival, and overall survival up to several years after treatment starts. The trial includes long-term follow-up to monitor outcomes and safety over time, with the primary outcome tracked for up to two years after the last participant is randomized.

Researchers are evaluating SAR445399 in adults with moderate to severe hidradenitis suppurativa, a chronic skin condition. This Phase 2, multinational, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of two different doses of SAR445399 compared to placebo. The study is sponsored by Sanofi and involves adult participants who have had symptoms for at least six months and meet specific severity criteria. Participants will be randomly assigned to receive one of two SAR445399 dose regimens or a matching placebo. The study involves a 32-week treatment period, which is divided into a 16-week initial double-blind phase followed by a 16-week treatment-blinded extension phase. SAR445399 and placebo are given by injection. The trial includes a total of 16 visits over approximately 46 weeks. During the study, participants will undergo regular assessments to measure skin improvement, pain levels, quality of life, and safety. Researchers will monitor clinical responses using standardized scales such as the Hidradenitis Suppurativa Clinical Response HiSCR and other quality of life questionnaires. Laboratory tests, vital signs, and ECGs will also be performed. Safety will be tracked throughout the treatment and extension periods, with follow-up visits included in the 46-week study duration.

Researchers are investigating autoinflammatory diseases AID, which involve recurring inflammatory episodes without infection, cancer, or adaptive immune system problems. This study focuses on both monogenic hereditary periodic syndromes and polygenic or multifactorial AID, including rare conditions like Behets disease, Still disease, Schnitzlers disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, among others. The goal is to gather detailed data to improve understanding and management of these rare diseases through an international collaboration. The study uses the AIDA registry, a secure online platform for collecting demographic, genetic, clinical, laboratory, radiologic, and therapeutic information. Data are gathered retrospectively and prospectively during routine clinical visits scheduled every 3-6 months. Eleven registries focus on different AID conditions, enabling comprehensive data collection to identify clinical patterns, treatment impacts, and long-term outcomes over a period of at least 10 years. Participants provide information during their usual care visits, allowing researchers to track changes in disease activity, organ involvement, inflammatory markers, visual function, pain levels, fatigue, fertility, and socioeconomic factors. The study monitors these outcomes over multiple timepoints up to 120 months. Data privacy is ensured by pseudonymizing patient information. This registry supports multiple clinical studies and aims to enhance knowledge, awareness, and future research on autoinflammatory diseases worldwide.

This research aims to study the effects of the Helfer Skin Tap Technique and local cold application on pain and hemodynamic responses during intramuscular tetanus vaccination in pregnant women. The study will compare these two methods with the standard injection procedure to see how they influence pain intensity and vital signs such as heart rate and blood pressure. Pregnant women receiving tetanus vaccination will be randomly assigned to three groups for this evaluation. Participants will be divided into three groups one will receive the vaccine using the Helfer Skin Tap Technique, which involves gently tapping the skin during injection another will receive the injection after applying a cold gel compress to the injection site for one minute and the control group will receive the standard intramuscular injection without additional intervention. The process follows specific guidelines for each group to ensure consistency. During the study, vital signs including heart rate, blood pressure, respiratory rate, and oxygen saturation will be measured before, immediately after, and 15 minutes post-injection. Pain levels will be assessed right after injection, 15 minutes later, and again at 24 and 48 hours after vaccination through follow-up contact. This detailed monitoring aims to capture both immediate and longer-term effects of the interventions on pain and physiological responses.

Researchers are evaluating the use of Socratic questioning as a new approach to help adults aged 18 to 65 with obesity lose weight in a primary care setting. This pilot trial aims to determine if this questioning method can lead to greater weight loss compared to regular care. The study is a pragmatic randomized controlled trial led by S31d31ka Ece Yokuf, focusing on effective weight management strategies for patients with obesity. Participants will be divided into two groups one receiving counseling using the Socratic questioning technique during follow-up visits, and the other receiving routine obesity care from their physicians. The intervention group will have face-to-face sessions on days 0, 15, 30, and 60, each lasting about 10-15 minutes, where physicians will use a checklist and record notes with an obesity diagnosis code. The control group will receive standard care which may include nutritional and lifestyle advice but not Socratic questioning. Both groups will have measurements taken at specified visits over a 3-month period. During the study, participants will complete baseline and final questionnaires including demographic information and the Hospital Anxiety and Depression Scale. They will attend five in-person visits over three months, where weight, height, and waist circumference will be measured. Physicians will provide brief counseling at each visit and record data in the health information system. The main outcome measured is the change in body weight after 3 months, along with secondary outcomes like BMI and waist circumference changes. Safety monitoring includes referral to mental health services if needed. The total participation duration is about 3 months.

This research aims to evaluate how proprioceptive neuromuscular facilitation PNF affects shoulder girdle function and quality of life in people with scapular winging, a condition where the shoulder blade sticks out abnormally from the back. Scapular stability is crucial for proper arm movement, and this study focuses on improving that stability using PNF, which activates muscle groups to enhance coordination and strength. The trial is a randomized controlled study designed to assess the clinical impact of PNF on this condition. Participants in the study will be randomly assigned to one of two groups. The PNF group will receive therapy involving scapular diagonal movements lasting 20 to 30 minutes, three times a week for five weeks, aiming to improve scapular positioning and muscle tone. The control group will not receive any intervention during this time. This setup allows comparison between those receiving PNF and those without treatment. Before and after the five-week period, all participants will undergo evaluations including the Scapular Isometric Pinch Test for muscle endurance, Lateral Scapular Slide Test for scapular position, Rounded Shoulder Posture Assessment, Disabilities of the Arm, Shoulder, and Hand Questionnaire for arm function, and the Short Form-36 for quality of life. Additionally, the Biodex System 3 Pro will be used as a primary outcome measure after one week. The study will monitor these outcomes to understand the effects of PNF therapy.

Researchers are evaluating how well the Turkish Ministry of Healths three-level color-coded triage system Red, Yellow, Green predicts serious clinical outcomes in children aged 0 to 18 years who come to pediatric emergency departments with fever. This observational study also examines whether specific vital signs taken at triage, such as heart rate, respiratory rate, oxygen levels, capillary refill time, consciousness level, and overall appearance, add useful information beyond the triage category. The study involves multiple centers across Turkey and aims to better understand early indicators of serious illness in febrile children. Children presenting with a fever of 38.0C or higher at triage, or with a history of recent fever, are enrolled consecutively over a 3-month period at ten pediatric emergency departments. Each child receives routine triage using the Ministry of Healths system, and physiological data are recorded on a standardized form without influencing clinical decisions. The study does not alter usual care or triage, focusing instead on observing and analyzing data already collected during routine visits. Participants undergo standard triage assessments and their clinical outcomes are monitored for up to 30 days, including serious events like hospital admission, sepsis protocol activation, intravenous treatments, and re-attendance with admission. Researchers collect and analyze this data to evaluate triage accuracy and the added value of vital signs in predicting outcomes. The total participation period for each child corresponds to their emergency visit and follow-up within 30 days, with no additional interventions or changes to usual care.