Elazig Merkez

This research aims to investigate the frequency of Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) in children aged 2 to 6 who exhibit nonspecific neurological symptoms such as idiopathic seizures, speech disorders, and motor dysfunctions. The study targets children without hypoxic ischemic encephalopathy, head trauma, or developmental brain anomalies who visit Pediatric Metabolism, Neurology, and Developmental Pediatrics clinics over a 12-month enrollment period. It is a multicenter, non-drug screening study designed to better understand CLN2 disease among this population. During the study, demographic data, medical and family history will be collected at the first visit. Assessments will include seizure frequency, cognitive and language development evaluations, physical exams focusing on muscle strength, gait, and coordination, as well as neurological tests such as EEG and MRI scans. Children showing specific neurological signs or imaging findings will have blood samples taken for Tripeptidyl Peptidase 1 enzyme measurement. Those with low enzyme activity will undergo genetic testing to investigate CLN2 disease. Participants will be monitored for disease frequency over one year. Researchers will measure clinical and demographic characteristics including speech impairment, motor symptoms, EEG responses, and brain imaging changes. Safety monitoring includes obtaining informed consent and following up on enzyme and genetic test results. Total participation spans from initial screening through diagnostic testing and data collection during the 12-month study period.

Researchers are evaluating how well nipocalimab works compared to a placebo in adults with moderate to severe systemic lupus erythematosus (SLE), a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study focused on adults aged 18 to 75 who have active SLE symptoms and have been diagnosed for at least 24 weeks. Participants will receive either nipocalimab or a placebo alongside standard of care treatments, which include protocol-defined topical and systemic therapies. Nipocalimab and placebo are administered as drugs while maintaining background treatments. The study monitors participants over time, including a primary outcome measurement at Week 52 to assess the percentage of participants achieving a systemic lupus erythematosus responder index (SRI)-4 composite response. During the study, participants will be regularly assessed for disease activity, vital signs, and safety. Screening includes physical examinations, medical history review, vital signs, and electrocardiograms. Researchers will monitor disease activity scores and evaluate response to the treatment at Week 52. Safety is closely observed throughout the study, with particular attention to any adverse reactions or changes in health status. The total participation and follow-up extend at least through Week 52.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating etelcalcetide in children aged 28 days to under 18 years who have secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) while on hemodialysis. SHPT is a serious condition that develops early in CKD and worsens as kidney function declines, leading to bone problems, growth issues, and higher cardiovascular risks in children on dialysis. Current treatments like vitamin D sterols can sometimes worsen complications, so this phase 3 trial aims to assess etelcalcetide's safety and effectiveness in this pediatric population, building on its approval and use in adults with SHPT on hemodialysis. The study compares etelcalcetide treatment to standard care, which may include vitamin D sterols, calcium supplements, and phosphate binders. Etelcalcetide is given as a drug to control intact parathyroid hormone (iPTH), calcium, and phosphorus levels. The trial is randomized, open-label, and controlled, with multiple dosing to evaluate efficacy, safety, and related pharmacokinetics and pharmacodynamics. Participants continue on their hemodialysis regimen with stable dialysate calcium levels throughout the trial. Participants will have screenings and assessments including laboratory tests for iPTH, calcium, and phosphorus levels, as well as ECG monitoring and other safety evaluations. The primary outcomes measure the percentage of participants achieving at least a 30% reduction in mean iPTH from baseline during weeks 20 to 27. The study monitors participants closely for adverse effects and treatment response over the trial period to gather critical pediatric data on etelcalcetide's use in this vulnerable group.

Shoulder impingement syndrome occurs when the subacromial bursa and rotator cuff muscles get compressed between the acromion and the upper arm bone, possibly leading to degeneration and tears. This research compares two treatment methods—Mulligan mobilization and ozone therapy—to see how they affect pain, range of motion, and function in patients with this condition. Studies on these treatments for shoulder impingement are limited, so this study aims to provide clearer evidence on their effectiveness. Participants will be divided into two groups. One group will receive ozone therapy, which involves injecting 10 ml of ozone gas at a concentration of 10 µg/ml three times, each injection given one week apart by the same specialist doctor. The other group will receive Mulligan mobilization, a physical therapy technique performed once a week for three weeks. This involves the patient sitting with their arm raised about 90 degrees while the physiotherapist moves the shoulder joint in specific directions to improve mobility. Before and after treatment, researchers will assess participants' pain, range of motion, and shoulder function. The main outcome measure is a quick pain assessment lasting one minute. The study includes adults aged 18 to 65 years and monitors these measures to compare the effects of the two treatments. The total treatment period spans three weeks with assessments occurring at baseline and after the treatments.

Researchers are comparing two types of nerve blocks, the serratus posterior superior intercostal plane block (SPSIPB) and the serratus anterior plane block (SAPB), in patients undergoing non-intubated uniportal video-assisted thoracoscopic surgery (NI-UniVATS). This minimally invasive surgery uses a single port without intubation, aiming to reduce postoperative pain, shorten hospital stays, and improve recovery, especially benefiting patients with impaired lung function by preserving spontaneous breathing and avoiding complications related to intubation and neuromuscular blockers. In this study, patients receive either the SPSIPB or SAPB nerve block under ultrasound guidance before surgery. SPSIPB involves injecting bupivacaine between specific muscles near the scapula, while SAPB involves injecting ropivacaine near the serratus anterior muscle and ribs. Both procedures are performed with experienced anesthesiologists, followed by monitoring and sensory testing to ensure block effectiveness before proceeding to surgery. Participants' anesthetic and analgesic use during surgery, including remifentanil and propofol consumption, will be recorded to compare efficacy between the two blocks. The study also monitors patients for pain control and safety. The trial plans to enroll adults aged 18 to 65 years with specific health criteria, and participation involves assessing anesthesia needs during surgery and recovery progress, with data collected during and after the procedure.

Researchers are investigating the effects of connective tissue massage combined with an exercise program in patients with scleroderma, a condition affecting the skin and connective tissues. This study builds upon previous research that showed connective tissue massage and joint manipulation techniques improved hand function, quality of life, and mobility compared to exercise alone. The goal is to evaluate whether adding connective tissue massage to a standard exercise program benefits hand rehabilitation in patients diagnosed according to established criteria and followed at Fırat University Rheumatology Department. The study involves 30 patients divided into two groups of 15 each. One group will receive connective tissue massage on the hand and forearm alongside a detailed exercise program including stretching, strengthening, joint movement, functional exercises, and tendon sliding exercises. The other group will follow the same exercise program without massage. Both interventions focus on improving hand rehabilitation. Participants will undergo evaluations measuring range of motion, skin thickness, and hand mobility. The primary outcome includes a 2-minute mobility assessment. The study monitors hand function and skin condition changes throughout the intervention. Participants must be stable on medical treatment and able to perform exercises, with the total study duration and specific follow-up times defined by the research team.

Researchers are investigating electrocardiogram (ECG) changes in people diagnosed with Methamphetamine Use Disorder (MUD) and Methamphetamine-Induced Psychotic Disorder (MP) during their stay in a psychiatric hospital. The study aims to compare ECG results at admission and remission before discharge to see if psychosis linked to methamphetamine increases heart risks more than methamphetamine use alone. This prospective cohort study is conducted in a closed psychiatric ward with participants diagnosed according to DSM-5-TR and confirmed by positive methamphetamine urine tests at admission. Participants include patients with MUD or MP, and a healthy control group without psychiatric disorders. ECGs will be taken at admission and again during remission for the patient groups, while controls have ECG only at baseline. Clinical data such as blood counts and psychiatric symptom severity using the Positive and Negative Syndrome Scale (PANSS) will also be collected. ECG parameters like QTc interval, QRS duration, Tp-e interval, and others will be analyzed by a cardiologist. The study plans to include 80 participants in each group. During their participation, subjects will have ECGs and blood tests at admission and before discharge. Researchers will record demographic and substance use details and evaluate psychiatric symptoms. They will compare ECG findings within and between groups to assess cardiac risk related to methamphetamine use and psychosis. Statistical analyses will be done to identify significant differences. The study ensures safety by monitoring participants during hospitalization, with a total involvement spanning the inpatient stay until remission.

This research aims to assess how weight gained during pregnancy affects the characteristics of spinal anesthesia in women having planned cesarean deliveries. It focuses on pregnant women aged 18 to 45 with single pregnancies who are scheduled for elective cesarean sections. The study classifies participants based on their gestational weight gain according to 2009 Institute of Medicine guidelines to understand its impact on anesthesia and delivery outcomes. Participants will receive spinal anesthesia as part of their routine cesarean delivery care; no extra treatments or procedures will be performed. Women will be grouped by how much weight they gained during pregnancy, and the study will observe the effects of this weight gain on spinal anesthesia characteristics and related hemodynamic responses during surgery. During the study, researchers will track anesthesia block properties, blood pressure changes within the first 20 minutes after spinal anesthesia, and other perioperative outcomes. Information about pre-pregnancy and pre-delivery weights will be collected from medical records to calculate gestational weight gain. The study involves monitoring standard clinical care data without additional interventions or medications.

This research aims to compare the effects of different telerehabilitation methods on individuals with ankylosing spondylitis (AS), a chronic autoimmune disease affecting the spine and joints. The study evaluates how synchronous (live video) and asynchronous (pre-recorded video) exercise programs impact disease activity, physical function, mobility, fatigue, quality of life, fear of movement (kinesiophobia), and pain levels. AS can cause pain, stiffness, fatigue, and reduced quality of life, and while exercise is known to help, the most effective type and delivery method of exercise remain unclear. Participants will be randomly assigned to one of three groups: synchronous telerehabilitation with live video exercise sessions three times a week for 8 weeks, asynchronous telerehabilitation with pre-recorded exercise videos sent every two weeks and exercise performed three times a week, or a control group receiving exercise instructions via brochure updated every two weeks. Each session lasts about 40-50 minutes and includes strengthening, stretching, balance, coordination, posture, walking, and functional exercises. The exercise difficulty will progressively increase every two weeks, and participants in the telerehabilitation groups will receive feedback and keep exercise logs to monitor adherence. Participants will be assessed before starting and after completing the 8-week program using various validated tools to measure disease activity, physical function, mobility, fatigue, quality of life, fear of movement, and pain during rest, movement, and sleep. Assessments include questionnaires and physical measures such as cervical rotation and lumbar flexion. Researchers will monitor participants’ adherence through exercise logs and biweekly contact. The study's goal is to identify which telerehabilitation method offers better outcomes and to improve access to rehabilitation for individuals with AS.