Elazig Merkez

Researchers are investigating the frequency of Neuronal Ceroid Lipofusinosis Type 2 CLN2 in children aged 2 to 6 years who have nonspecific neurological symptoms such as idiopathic seizures, speech disorders, and motor dysfunctions. This multicenter, non-drug screening study focuses on children without hypoxic ischemic encephalopathy, head trauma, or developmental brain anomalies, aiming to better understand the demographic and clinical features of those with possible CLN2 disease. Children first undergo assessments including recording demographic and medical history, seizure frequency, cognitive and language development evaluations, physical exams assessing muscle strength, gait, and coordination, as well as neurological evaluations using EEG and MRI scans. Those showing specific signs like speech disorder with seizures, movement problems, particular EEG responses, or MRI findings will have blood samples taken to measure Tripeptidyl Peptidase 1 enzyme levels. If enzyme activity is low, genetic testing is performed to investigate CLN2 disease. Participants are involved for up to one year during which various clinical, neurological, and imaging evaluations are done. Blood samples are collected for enzyme and genetic analyses. The main outcome measured is the frequency of CLN2 disease in this group. The study tracks each childs symptoms, neurological findings, and imaging results to better identify and understand CLN2 in children with these symptoms.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating nipocalimab 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 Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are evaluating etelcalcetide in children with secondary hyperparathyroidism SHPT who also have chronic kidney disease CKD and are receiving hemodialysis. SHPT is a serious condition that develops early in CKD and can cause bone and growth problems as well as increased cardiovascular risks in children on dialysis. This phase 3 trial aims to provide important safety and efficacy data for etelcalcetide in pediatric patients aged 28 days to under 18 years, addressing the limitations of current treatments like vitamin D sterols. Participants are randomly assigned in a 51 ratio to receive either etelcalcetide along with standard care or standard care alone. The standard care may include treatments such as vitamin D sterols, calcium supplements, or phosphate binders. The study involves multiple doses of etelcalcetide, with assessments conducted over weeks to monitor its effects on parathyroid hormone levels and mineral balance. During the study, participants will undergo regular evaluations including blood tests to measure intact parathyroid hormone, calcium, and phosphorus levels. Researchers will also monitor safety by tracking adverse events and changes in vital signs, growth, and development stages. The primary outcome focuses on the percentage of participants achieving a significant reduction in hormone levels over weeks 20 to 27. The trial includes careful monitoring throughout treatment and up to approximately 30 weeks after the last dose.

Researchers are evaluating how well artificial intelligence AI and machine learning models can predict difficult airways in adults undergoing bariatric surgery. The study focuses on comparing AIs ability to predict challenging intubation with traditional clinical scoring methods in obese patients, addressing an important safety concern during anesthesia. Participants will have preoperative airway assessments including the Upper Lip Bite Test, Mallampati score, Body Mass Index BMI, thyromental distance, and sternomental distance recorded. During surgery, the airway view is graded using the Cormack-Lehane classification via direct laryngoscopy. This observational study collects these measurements to analyze AIs diagnostic accuracy in predicting difficult intubations. During the study, participants will undergo standard preoperative assessments and intraoperative airway evaluation. Researchers will measure how accurately the AI model predicts difficult intubation, count the number of intubation attempts needed, and record if alternative airway management techniques are used. Participation involves routine clinical procedures before and during surgery, with all data collected to improve airway management in obese patients.

Researchers are evaluating the effects of two different regional anesthesia techniques, 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 surgical method is notable for avoiding intubation, maintaining spontaneous breathing, and reducing complications and recovery time. The trial aims to compare the intraoperative anesthetic and analgesic effects of SPSIPB, a recently described block, with the more commonly used SAPB to determine if SPSIPB provides similar pain control and anesthesia requirements during surgery. The study is a prospective, randomized, double-blind trial including 70 patients aged 18 to 65 years with certain health criteria. Participants are randomly assigned to receive either the SPSIPB or SAPB under ultrasound guidance before NI-VATS. SPSIPB involves injecting a local anesthetic near the serratus posterior superior muscle, while SAPB targets the myofascial plane near the serratus anterior muscle. Both techniques use specific volumes and concentrations of anesthetic and are performed with patients positioned laterally. Patients are monitored closely during and after the blocks, including nebulized lidocaine administration in the SPSIPB group to suppress cough reflex. During the trial, researchers will track anesthetic and analgesic use during surgery, postoperative pain using a numerical rating scale, total analgesic consumption, time to first rescue analgesia, recovery scores, and any block-related complications. Pain and analgesic use are assessed at multiple times up to 24 hours after surgery. The trial runs from January to August 2026, with careful monitoring to evaluate the effectiveness and safety of each block method in this surgical setting.

Researchers are comparing the effects of two types of full can exercisesconcentric and eccentricon the supraspinatus muscle structure in people with partial rotator cuff tears. These tears commonly cause shoulder pain and limit movement. The study focuses on understanding how different muscle contractions during exercise influence muscle architecture and clinical outcomes, aiming to improve rehabilitation strategies for this condition. Participants are randomly assigned to either a concentric or eccentric full can exercise group. Both groups receive a standard physiotherapy program that includes therapeutic ultrasound, transcutaneous electrical nerve stimulation TENS, and shoulder rehabilitation exercises. The concentric group emphasizes the lifting phase of the exercise, while the eccentric group focuses on the lowering phase. These exercise sessions are conducted three times a week for six weeks, totaling 18 sessions. During the study, participants will be assessed at the start and end of the six-week intervention. Researchers will measure changes in the supraspinatus muscle pennation angle using ultrasound imaging as the primary outcome. Secondary measures include muscle fiber length, cross-sectional area, pain levels, shoulder range of motion, muscle strength, functional status, and fear of movement. The study uses blinded assessors and randomized group assignment to monitor safety and effectiveness over the treatment period.

Researchers are investigating electrocardiogram ECG changes in adults diagnosed with Methamphetamine Use Disorder MUD and Methamphetamine-Induced Psychotic Disorder MP during psychiatric inpatient treatment. This prospective cohort study compares ECG results at hospital admission and during remission before discharge. The goal is to see if methamphetamine-induced psychosis is linked to more ECG abnormalities and higher heart risks than methamphetamine use without psychosis. The study includes three groups adults with MUD, adults with MP, and healthy controls without psychiatric disorders. Participants in the MUD and MP groups receive routine clinical care during six weeks of hospitalization. ECG and blood counts are taken at the start and after six weeks. The MP group also completes psychiatric assessments using the Positive and Negative Syndrome Scale PANSS and Insight Assessment Scale IAS. Healthy controls provide a baseline blood sample and clinical data. Participants undergo ECG and blood tests at admission and before discharge. Psychiatric symptoms and insight levels are evaluated in the MP group. Researchers record sociodemographic and substance use data. ECG parameters like QT interval, QTc interval, ST depression, and others are analyzed to assess cardiac risk. The study tracks changes within groups over time and compares between groups to understand psychosis-related heart risks. The total participation lasts about six weeks with follow-up assessments.

This observational study evaluates how gestational weight gain affects spinal anesthesia characteristics in pregnant women undergoing planned cesarean delivery. It focuses on women aged 18 to 45 with single pregnancies receiving spinal anesthesia and aims to assess anesthesia block features, blood pressure responses, and other outcomes during surgery. Participants are grouped by gestational weight gain based on 2009 Institute of Medicine guidelines. Participants are classified into two groups those with gestational weight gain below the recommended range and those within or above it. No extra treatments or procedures beyond routine care will be performed. The study monitors spinal anesthesia effects, hemodynamic responses, and perioperative outcomes during the cesarean delivery. During the study, researchers will collect pre-pregnancy and pre-delivery weight data to calculate weight gain categories. They will observe the incidence of spinal anesthesia-induced hypotension within the first 20 minutes after anesthesia. No additional interventions are done, and participation involves routine clinical care assessments related to anesthesia and surgery outcomes.