Torbali

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 a care protocol designed to support pregnant women living in areas affected by earthquakes. This study aims to see if such a protocol can improve the physical and psychological health of these women, especially during the challenging post-disaster period. The research highlights the importance of family and spousal support, as well as spiritual care, in helping pregnant women cope with trauma, fear, sleep problems, and depression after an earthquake. The intervention focuses on developing a care protocol that provides both physical and psychosocial support during the months following the earthquake, particularly between 2 to 36 months after the disaster. This behavioral support addresses the limitations of psychological first aid services over time and targets vulnerable pregnant women who were affected. The study does not mention comparison groups, but it emphasizes comprehensive care tailored to the needs of earthquake-affected pregnant women. Participants provide data at several points: up to the 16th week of pregnancy, between the 36th and 38th weeks, and between 4 and 8 weeks after giving birth. Researchers assess physical health, psychosocial well-being, trauma levels, and postpartum depression. The study monitors participants' health through questionnaires and interviews, aiming to measure how well the care protocol supports their overall well-being during and after pregnancy. Participation is voluntary and includes ongoing evaluations through the pregnancy and postpartum periods.

Researchers are evaluating how the 4-7-8 breathing technique affects shoulder pain and lung function after laparoscopic cholecystectomy, a common surgery to treat gallbladder issues. This surgery often causes shoulder pain and lung problems due to anesthesia and carbon dioxide used during the procedure. The study aims to see if this breathing exercise can help reduce pain and improve breathing tests after surgery. In this randomized controlled trial, 96 patients will be divided into two groups. One group will practice the 4-7-8 breathing technique after surgery, which involves breathing in for four counts, holding the breath for seven counts, and exhaling for eight counts in a cycle repeated four times per set. The other group will receive the usual care provided by the hospital ward. Shoulder pain and lung function will be measured within the first 24 hours after surgery and again at discharge. Participants will be monitored for shoulder pain and lung function through specific tests on the second day after surgery. The study will collect data on these outcomes to compare the effects of the breathing exercise against routine care. Participants will stay in the hospital for at least one night after surgery, and their pain and lung function will be assessed before they leave. Researchers will analyze the results to understand the breathing technique's impact better.

Researchers are evaluating the safety and effectiveness of LY4268989 when given together with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on adults aged 18 to 80 years who have had UC diagnosed for at least 3 months and have active symptoms confirmed by specific clinical scores and endoscopic evidence. The study aims to assess clinical remission using the Modified Mayo Score at 12 weeks. Participants will receive either LY4268989 by mouth combined with mirikizumab administered first intravenously and then by subcutaneous injection, or mirikizumab alone with a placebo pill. The entire study treatment period will last about 104 weeks, with up to 21 visits planned for monitoring. Treatment schedules and dosing are designed to compare the combination therapy to mirikizumab alone. During the study, participants will undergo regular assessments including clinical evaluations, endoscopy, and monitoring of symptoms and safety. Researchers will track the percentage of participants achieving clinical remission by week 12 using the Modified Mayo Score. Participants will be followed closely throughout the study duration, which totals approximately 118 weeks from start to finish, including treatment and follow-up visits.

Researchers are evaluating the safety and effectiveness of LY4268989 compared to a placebo in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on participants who have had UC for at least 3 months and have specific disease activity scores. The study aims to understand how well LY4268989 works in treating this condition over a long period. Participants will receive either LY4268989 or a placebo, both administered orally. The study includes a treatment period lasting up to approximately 108 weeks, not including the screening phase. Participants are monitored to assess their response to the medication, including whether they achieve clinical remission based on the Modified Mayo Score (mMS). During the study, researchers will conduct various assessments to monitor disease activity and participant safety. They will track the percentage of participants achieving clinical remission at Week 10 and among those who responded at Week 10, the remission status at Week 52. The study involves regular evaluations, including endoscopic confirmation of disease activity and safety monitoring over the entire duration.

Researchers are investigating if combining mirikizumab with tirzepatide can reduce symptoms of moderately to severely active ulcerative colitis (UC) and help adults with obesity or overweight lose at least 10% of their body weight. This Phase 3b study compares this combination treatment to mirikizumab with a placebo to see which is more effective over a 52-week treatment period, followed by additional monitoring up to 61 weeks. Participants receive mirikizumab either intravenously (IV) or subcutaneously (SC), along with either tirzepatide or a placebo administered subcutaneously. The study randomly assigns adults with UC and obesity or overweight into these treatment groups to evaluate the effects over the full treatment duration. During the study, participants will undergo various assessments including evaluations of UC symptoms and body weight changes. Researchers will measure the percentage of participants who achieve clinical remission of UC and at least 10% weight loss at week 52. Safety and health monitoring will continue throughout the study to ensure participant well-being during the treatment and follow-up periods, which together can last up to 61 weeks.

Researchers are evaluating the effectiveness and safety of mirikizumab alone or combined with tirzepatide compared to mirikizumab with placebo in adults who have moderately to severely active Crohn's disease along with obesity or overweight conditions. This Phase 3b study focuses on patients with confirmed Crohn's disease or perianal fistulizing Crohn's disease who also meet specific weight-related criteria and have shown inadequate response or intolerance to previous Crohn's disease treatments. The study may last up to 61 weeks. Participants receive treatments involving mirikizumab administered intravenously or subcutaneously, tirzepatide given subcutaneously, or placebo administered subcutaneously. The trial includes groups receiving mirikizumab with placebo or mirikizumab combined with tirzepatide to compare outcomes. Dosage schedules and exact administration details are provided throughout the treatment period. During the study, participants will undergo various assessments including clinical evaluations using the Crohn's Disease Activity Index, endoscopic examinations, and monitoring of weight changes. Researchers will track the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight reduction by week 52. Safety and response to treatments will be closely monitored throughout the duration of up to 61 weeks.

Researchers are evaluating the effectiveness of three dental treatments—total pulpotomy, radicular pulpotomy, and root canal treatment—in patients with symptomatic irreversible pulpitis affecting mandibular premolar and molar teeth. The study aims to compare how well these treatments control postoperative pain and achieve long-term treatment success, including healing of the affected area. A total of 99 teeth will be randomly assigned to one of the three treatment groups for this evaluation. Each treatment involves specific dental procedures: total pulpotomy removes the entire coronal pulp, radicular pulpotomy removes pulp tissue a few millimeters below the canal orifices, and root canal treatment uses standardized cleaning and sealing protocols. Both pulpotomy procedures use mineral trioxide aggregate to cover the treated pulp area, followed by restoration with glass ionomer cement and composite resin. Root canal treatment involves cleaning, shaping, and filling the canals in a single visit, then restoring the tooth similarly. Local anesthesia and rubber dam isolation are used for all treatments. Participants will record their pain levels before treatment and at several points up to one week after. Clinical and X-ray examinations will be performed at 3, 6, and 12 months to check healing and treatment success, including absence of pain, healthy surrounding tissues, and no new damage. Patients will also record any pain medication use. The study includes safety monitoring and assessments of the restorations and pulp health over the year-long follow-up.

This research focuses on patients with sickle cell disease (SCD) who have previously participated in a Novartis-sponsored crizanlizumab study. It aims to provide continued access to crizanlizumab treatment for those who are benefiting from it, as determined by their investigator. This is a Phase IV, open-label, multi-center, multinational rollover study designed for patients who have completed treatment in a parent study. Participants will start crizanlizumab treatment following the same dose and schedule as in their previous study, with no screening period since they transfer directly from the parent studies. Treatment will resume as soon as possible after the last dose in the parent study, maintaining the 28-day treatment cycle. The study is planned to remain open for up to 10 years or until crizanlizumab becomes commercially available and reimbursed, or until patients no longer require treatment or a patient support plan is approved locally. During the study, participants will be monitored with a safety follow-up visit 105 days after their last dose, unless they continue treatment commercially or through a patient support program. Researchers will assess participant safety and treatment compliance throughout the study. This long-term follow-up ensures ongoing evaluation of crizanlizumab treatment in patients with SCD who have previously benefited from it.

Researchers are evaluating the effects of two different intracanal medicaments, calcium hydroxide and diclofenac sodium, on the healing of periapical lesions following endodontic retreatment. This study involves 54 patients with apical periodontitis after primary root canal treatment and aims to compare how these medicaments influence bone regeneration. Healing will be measured over a 12-month period using fractal analysis of radiographs to quantitatively assess changes in bone structure. The study includes root canal retreatment procedures performed by a single experienced endodontist under standardized conditions. Patients will be randomly assigned to receive either calcium hydroxide or diclofenac sodium mixed with distilled water, which will be applied inside the root canal using a lentulo spiral. After one week, the medicaments will be removed, and the canals will be filled using a lateral condensation technique. Follow-up evaluations will take place 12 months after treatment, with an additional follow-up planned around four years post-treatment to assess restoration quality. Participants will undergo clinical and radiographic assessments at baseline and after one year to measure periapical lesion healing and identify any symptoms such as pain or swelling. Digital radiographs will be taken with consistent settings for accurate comparison. Two blinded evaluators will analyze the images, and safety will be monitored through patient reports and clinical examination. The primary outcome is the change in fractal dimension values reflecting bone healing around the treated teeth.