Torbali

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 studying the effects of Body Awareness Therapy BAT on young adults aged 20 to 30 who experience high stress levels. This randomized controlled trial aims to evaluate how BAT influences functional capacity, balance, sleep quality, and psychological state. BAT is a holistic approach that addresses physical, physiological, psychological, and existential aspects of human movement. Participants in the intervention group will take part in BAT exercises in groups of six, performed in supine, sitting, standing, and walking positions. These exercises will be led by a trained instructor twice a week for eight weeks, with the program progressively increasing in intensity every two weeks. The control group will not receive any training during this period but will be assessed alongside the BAT group. Throughout the study, participants will be assessed at the start and after eight weeks using several tests the 6-minute walk test for functional capacity, the single-leg balance test for static balance, the Y-balance test for dynamic balance, the Depression Anxiety Stress Scale-21 for psychological status, and the Pittsburgh Sleep Quality Index for sleep quality. The study will also use the International Physical Activity Questionnaire-Short Form as a secondary measure. All evaluations will be conducted in person by the research team.

Researchers are evaluating the effect of the 4-7-8 breathing technique on shoulder pain and lung function after laparoscopic cholecystectomy, a common surgery for gallbladder removal. This technique is being studied because many patients experience shoulder pain and reduced lung function after surgery, which can affect breathing and recovery. The study will randomly assign 96 patients to either the breathing exercise group or a control group receiving routine care, to compare outcomes. The study group will learn the 4-7-8 breathing technique, which involves controlled breathing cycles, starting about four hours after surgery. They will practice one set of four breaths every two hours, with initial training lasting about 15 minutes. The control group will receive usual care without specific breathing exercise training, though use of a breathing aid is recommended but not monitored. Participants will be monitored for shoulder pain and lung function through tests conducted within the first 24 hours and again at discharge. The study will assess lung volumes and airflow measures to understand breathing recovery. Data will be analyzed statistically. The total duration of participation varies with hospital stay but includes monitoring through the early postoperative period for safety and effectiveness.

Researchers are evaluating the safety and effectiveness of LY4268989 combined with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis. This phase 2 study aims to understand if the combination can better manage the condition. The study is sponsored by Eli Lilly and Company and involves a randomized, double-blind design with parallel groups. Participants receive either LY4268989 orally along with mirikizumab given intravenously and then subcutaneously, or mirikizumab with a placebo pill matching LY4268989. Responders to treatment will be re-randomized for a second study period. Treatment lasts approximately 104 weeks with up to 21 visits planned throughout the study. During the study, participants undergo assessments including clinical remission evaluation using the modified Mayo Score at weeks 12, 24, and 48, endoscopic improvement, and symptomatic remission measurements. Safety and response are closely monitored through scheduled visits. Overall participation lasts about 118 weeks, allowing researchers to gather long-term data on the treatments being studied.

Researchers are evaluating the safety and effectiveness of LY4268989 compared to a placebo in adults with moderately to severely active ulcerative colitis UC. The study focuses on participants with a diagnosis of UC for at least 3 months, confirmed by specific clinical and endoscopic criteria. This Phase 2 trial aims to better understand how LY4268989 may impact clinical remission and response in this patient group over a long-term period. Participants will receive either one of two doses of LY4268989 or a placebo, all administered orally. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to approximately 108 weeks, excluding the screening phase, allowing for assessment of the drug over an extended time. During the study, participants will undergo regular evaluations including clinical assessments using the Modified Mayo Score to measure remission and response at multiple time points, including weeks 10 and 52. Researchers will also monitor symptomatic response and measure plasma concentrations of LY4268989. Safety and effectiveness will be tracked through these clinical and laboratory tests to understand the drugs impact on UC over the study duration.

Researchers are evaluating whether treatment with both mirikizumab and tirzepatide compared to mirikizumab and placebo can reduce or eliminate symptoms of moderately to severely active ulcerative colitis UC in adults who are also overweight or have obesity. This Phase 3b randomized controlled study aims to determine if this combination treatment leads to clinical remission and at least a 10% reduction in body weight. Participants receive mirikizumab initially by intravenous IV infusion followed by subcutaneous SC injections. They are randomly assigned to receive either tirzepatide SC or a placebo SC alongside mirikizumab. The treatment period lasts for 52 weeks, with the whole study participation lasting up to 61 weeks. Both study drugs and placebo are administered under medical supervision. During the study, participants are monitored regularly for symptom improvement and weight loss. Researchers assess clinical remission, endoscopic response, histologic-endoscopic mucosal improvement, bowel movement urgency, and histologic remission at weeks 24 and 52. Safety and treatment effects are carefully followed throughout the trial. Participants undergo evaluations to measure changes in UC symptoms and body weight over the study period.

Researchers are evaluating the effectiveness and safety of mirikizumab combined with either tirzepatide or a placebo in adults with moderately to severely active Crohns disease who also have obesity or are overweight. This Phase 3b study aims to compare these treatments in participants who have a confirmed diagnosis and meet specific disease activity and weight criteria. The study is conducted by Eli Lilly and Company and lasts up to 61 weeks. Participants receive mirikizumab initially via intravenous infusion, followed by subcutaneous injections. They are randomly assigned to receive either tirzepatide with mirikizumab or placebo with mirikizumab, both administered subcutaneously. The study involves two experimental groups where treatments are given according to this schedule. During the study, participants will undergo regular assessments to monitor clinical remission using the Crohns Disease Activity Index and endoscopic remission, as well as track weight reduction. Evaluations include inflammatory bowel disease questionnaires and monitoring of corticosteroid use. The main measure is the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight loss by week 52. Safety and maintenance of remission are also assessed throughout the trial.

Researchers are evaluating the clinical effectiveness of total pulpotomy, radicular pulpotomy, and root canal treatment in mandibular premolar and molar teeth diagnosed with symptomatic irreversible pulpitis. The study aims to compare these treatments in terms of postoperative pain control and treatment success over time. A total of 99 teeth will be included and randomly assigned to one of the three treatment groups to assess outcomes using standardized protocols. The study involves three treatment groups total pulpotomy, radicular pulpotomy, and root canal treatment. Total pulpotomy consists of removing the coronal pulp and applying mineral trioxide aggregate MTA after achieving hemostasis. Radicular pulpotomy involves removing pulp tissue a few millimeters below the canal orifices, followed by MTA application. Root canal treatment includes cleaning and shaping of the root canals with irrigation and obturation using a calcium silicate-based sealer. All treated teeth will receive a final restoration with glass ionomer cement and composite resin. Participants will receive local anesthesia and undergo treatment according to their assigned group. Postoperative pain will be recorded using a visual analog scale at specified times up to 7 days after treatment. Clinical and radiographic evaluations to assess treatment success and periapical health will occur at 3, 6, and 12 months. Additional assessments include restorative integrity and pulp sensibility testing. Patients will be monitored for up to one year, with measures of pain and healing recorded as primary outcomes.

This research focuses on patients with sickle cell disease SCD who have previously taken part in a Novartis-sponsored study using crizanlizumab. The study provides continued access to crizanlizumab for those who are benefiting from the treatment as judged by their doctor. It is a multi-center and multi-national phase IV rollover study aimed at offering ongoing treatment options for these patients. Participants will continue receiving crizanlizumab at the same dose and schedule they had in their prior study. There is no screening period since patients transfer directly from the parent studies. After giving consent, treatment should begin as soon as possible, following the last dose schedule from the parent study. The study will remain open for up to 10 years or until the treatment becomes commercially available and reimbursed, or when the patients no longer need crizanlizumab. During the study, participants will have regular visits to monitor safety and treatment effects. A safety follow-up visit is planned 105 days after the last dose for those who stop treatment. However, this follow-up is not required if patients continue treatment commercially or through approved plans. Researchers will track any treatment-related side effects from the first dose until 105 days after the last dose. Overall participation duration varies based on treatment continuation and availability.

Researchers are evaluating the effects of two different intracanal medicaments, calcium hydroxide and diclofenac sodium, on the healing of periapical lesions following endodontic retreatment. The study plans to include 54 patients with apical periodontitis after initial root canal treatment. Healing will be monitored by measuring changes in bone regeneration around the tooth using fractal analysis of radiographic images taken at the start and after 12 months. Participants will be randomly assigned to receive either calcium hydroxide or diclofenac sodium as the intracanal medicament. Both medicaments will be prepared in a similar way and placed inside the root canal by a single experienced endodontist under standardized conditions. After one week, the medicaments will be removed, and the root canals will be refilled using established techniques. All procedures use local anesthesia and specialized dental tools to ensure consistency. During the study, patients will undergo clinical and radiographic evaluations at baseline and after one year to assess healing and any symptoms such as pain or swelling. Radiographs will be analyzed by blinded experts to measure the reduction in lesion size. Patients will also be invited for an additional follow-up around four years after treatment to evaluate long-term restoration quality. Safety and treatment effects will be closely monitored throughout the study period.