Canakkale Merkez

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 in people who have excess body weight and knee osteoarthritis. This study compares two doses of NNC0487-0111 given as weekly injections under the skin against a placebo, with the goal of helping participants lose weight and reduce knee pain. Participants have knee osteoarthritis confirmed by clinical and radiographic criteria and will follow a reduced-calorie diet and increased physical activity throughout the study. Participants will be randomly assigned to receive one of three treatments NNC0487-0111 dose level 1, NNC0487-0111 dose level 2, or a placebo, all given once weekly by subcutaneous injection using a pre-filled pen injector. The injections will be administered to the thigh, abdomen, or upper arm. All participants will be encouraged to follow a reduced-calorie diet and increase physical activity during the trial. The treatment period lasts for 80 weeks. Throughout the study, participants will have regular assessments of body weight, knee pain, physical function, and other health measures. Researchers will collect data on changes in weight, knee pain scores using the WOMAC index, physical function, blood pressure, cholesterol levels, blood sugar markers, and use of pain medication. Safety will be monitored through reporting of adverse events. The study is expected to continue until August 2028, with visits and evaluations occurring at scheduled intervals during the treatment period.

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 the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating three different surgical techniques of lateral internal sphincterotomy LIS for patients with chronic anal fissure that has not improved with medical treatment. The study aims to compare the healing rates and the occurrence of fecal incontinence among these techniques over 12 months. This trial is a prospective randomized controlled study involving 150 adult patients, assessing how different extents of sphincterotomy affect outcomes. The three techniques being compared are Spasm-Controlled LIS, which uses serial small sphincterotomies under local anesthesia and sedation until a target anal canal size is reached LIS up to the Fissure Apex, an open procedure under spinal or general anesthesia extending to the fissures end and LIS up to the Dentate Line, the traditional open method extending to the dentate line, also under spinal or general anesthesia. Randomization assigns patients equally to one of these groups, and all surgeries are performed with an open technique in the lithotomy position. Participants will be evaluated before surgery and at several points after surgery including day 1, weeks 1 and 2, and months 1, 2, 6, and 12. Researchers will use the Wexner Incontinence Score to assess continence and will check for fissure healing, pain levels, recurrence, patient satisfaction, and complications. The study includes careful monitoring to compare the effectiveness and safety of the different surgical approaches over a full year.

This research aims to compare the effects of two types of muscle trainingperipheral muscle training and inspiratory muscle trainingcombined with aerobic exercise on muscle strength, physical performance, respiratory muscle strength, functional capacity, sarcopenia, and quality of life in older adults. It focuses on geriatric individuals aged 65 to 80 years, who often experience declines in muscle strength, respiratory function, and physical activity, increasing their risk for health problems and disability. The study addresses gaps in previous research by combining aerobic and strengthening exercises for this population. Participants will be randomly assigned to one of two groups. One group will engage in group exercise training that includes aerobic and resistance training twice a week for ten weeks, with each session lasting one hour and supervised by a physiotherapist. The other group will perform the same aerobic and resistance training schedule, plus inspiratory muscle training involving 30 breathing cycles per day, six days a week, for ten weeks, with two sessions in the clinic and four sessions at home. During the study, participants will be assessed on various measures including hand grip strength, maximal inspiratory and expiratory pressures, the 6-Minute Walk Test, and the Short Physical Performance Battery over ten weeks. Quality of life will be evaluated using the WHOQOL-OLD questionnaire, and sarcopenia will be assessed with the SARC-F questionnaire. Researchers will monitor participant progress and outcomes throughout the intervention period to evaluate the impact of each training method on physical and respiratory function.

Effective management of dental caries in primary teeth is important for relieving pain, preventing infection, and maintaining a childs overall health. This research aims to compare three methodsFluorescence-Aided Caries Excavation FACE, caries detection dye, and clinical observationto see which best detects leftover caries on cavity walls after Atraumatic Restorative Treatment ART. ART is a minimally invasive treatment often used in children that removes decay without rotary tools and fills cavities with glass ionomer cement, but detecting residual caries can be challenging. Children aged 4 to 9 years who are healthy and cooperative will have their primary molars examined in six cavity wall regions. The study compares residual caries detection using FACE with the D-light Pro GC device, caries detection dye, and clinical observation in a randomized, double-blinded manner. If any method finds residual caries, additional removal is done before final restoration with high-viscosity glass ionomer cement following ART protocols. Participants will undergo examination during a single visit lasting up to 10 minutes. Two independent observers will record if caries are present or absent on each cavity wall for statistical analysis. Data on age, gender, tooth location, tooth type, and dental health index will also be collected. The primary outcome measures focus on detection accuracy immediately after caries removal, with no follow-up visits required. This study seeks to guide clinicians in improving long-term success of ART in children.

Researchers are evaluating how traditional behavior management techniques compare to AI-assisted child-friendly communication in reducing dental anxiety, physiological stress, and pain perception during local anesthesia in healthy children aged 6 to 12 years. The study focuses on children undergoing dental procedures requiring inferior alveolar nerve block anesthesia and aims to improve pediatric dental treatment comfort and outcomes by integrating AI tools. Participants will be randomly assigned to either a control group using traditional techniques like Tell-Show-Do, voice control, and positive reinforcement, or an experimental group using AI-generated voice explanations and calming stories tailored to the childs age, gender, and developmental stage. The traditional procedure and AI-assisted communication both occur during a local anesthesia process not exceeding 5 minutes. Childrens heart rate and oxygen levels will be measured before, during, and after anesthesia using a pulse oximeter. Anxiety will be assessed with various scales including the Venham Picture Test and Facial Image Scale, while pain perception will be measured using the Wong-Baker FACES Pain Rating Scale. Behaviors during anesthesia and cooperation levels will also be recorded. Both children and parents will complete questionnaires after treatment to evaluate attitudes toward AI communication. The total study participation includes these assessments and monitoring during the procedure.

This research evaluates the effect of telenursing intervention on oral health in individuals with Chronic Obstructive Pulmonary Disease COPD. The study recognizes the importance of maintaining oral health as part of patient care and aims to improve medication adherence and prevent related health issues through nurse-led education. A multidisciplinary approach involving nurses is noted to reduce hospital stays and readmissions for COPD patients. The study uses a pre-test and post-test control group experimental design to assess these effects.