Canakkale Merkez

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating three different surgical techniques for treating chronic anal fissure (CAF) that has not improved after medical treatment. This trial compares Spasm-Controlled Lateral Internal Sphincterotomy (LIS), LIS up to the fissure apex, and LIS up to the dentate line. The goal is to assess which method provides better healing rates and lower risks of fecal incontinence. The study is a prospective randomized controlled trial enrolling 150 adult patients, with 50 patients assigned to each surgical group. The first technique, Spasm-Controlled LIS, involves performing serial small sphincterotomies under local anesthesia and sedation using an anal calibrator to achieve a 30 mm anal caliber. The second and third techniques, LIS up to the fissure apex and LIS up to the dentate line, use open sphincterotomy under spinal or general anesthesia, extended to the proximal end of the fissure or the dentate line, respectively. All surgeries are done using an open technique with patients in the lithotomy position. Randomization is stratified by sex and fissure location, and outcome assessors are blinded to the group assignment. Participants will be evaluated before surgery and at multiple time points after surgery: day 1, week 1, week 2, month 1, month 2, month 6, and month 12. Assessments include the Wexner Incontinence Score to monitor continence, fissure healing status defined by complete symptom-free epithelialization, postoperative pain, recurrence rate, patient satisfaction, and complications. The main outcomes measured at 12 months are fissure healing rate and incidence of fecal incontinence. The total follow-up duration for each participant is 12 months.

Aging leads to declines in muscle strength, muscle mass, and physical performance, making it harder for older adults to stay physically active. Weakness in respiratory muscles can raise the risk of diseases and disability in this population. The study aims to compare how inspiratory muscle training and peripheral muscle training, combined with aerobic exercise, affect muscle strength, physical performance, respiratory muscle strength, functional capacity, sarcopenia, and quality of life in geriatric individuals aged 65 to 80 years. Participants will be assigned to either peripheral muscle training with step aerobics or inspiratory muscle training with step aerobics. Both groups will follow a protocol including a 5-minute warm-up with calisthenic exercises, 30 to 40 minutes of resistance and step aerobic exercises, and a 5-minute cool-down with stretching exercises. This combined exercise approach is designed to improve various aspects of physical and respiratory function. Throughout the 10-week study, participants will undergo assessments including hand grip strength, maximal inspiratory and expiratory pressures, a 6-minute walk test, the Short Physical Performance Battery, and the WHOQOL-OLD questionnaire to evaluate quality of life. Researchers will collect sociodemographic data and monitor changes in physical and respiratory function to understand the effects of these training methods on health in older adults.

This research aims to compare the accuracy and agreement of three methods—Fluorescence-Aided Caries Excavation (FACE), caries detection dye, and clinical observation—in detecting leftover caries on cavity walls of primary teeth after Atraumatic Restorative Treatment (ART). ART is a minimally invasive treatment often used in children and resource-limited areas, which removes decayed tissue using hand instruments and restores the cavity with glass ionomer cement. The study focuses on improving detection methods to reduce residual caries, which can affect the long-term success of ART, especially in primary teeth with their unique anatomy. Children aged 4 to 9 years with multi-surface carious cavities will have their primary molars assessed in six specific regions using the three detection methods in sequence. FACE evaluation uses a non-contact fluorescence device, while the other methods involve visual and tactile examination under standard clinical conditions. If any method detects residual caries, further removal will be performed before final restoration with high-viscosity glass ionomer cement, following the ART protocol. Participants will be examined by two independent observers who will document caries presence or absence on each cavity wall. Data collected will include age, gender, dmft index, tooth location, and tooth type to analyze factors linked to residual caries. The main outcome is the accuracy of residual caries detection immediately after caries removal, without follow-up. This study helps to identify the most reliable detection method to guide clinical practice and improve ART outcomes.

Researchers are investigating how traditional behavior management techniques compare with AI-assisted child-friendly communication in reducing dental anxiety, physiological stress, and pain perception during local anesthesia in healthy children aged 7 to 12. The study focuses on children undergoing inferior alveolar nerve block anesthesia who show specific behavior ratings on the Frankl Behavior Rating Scale. The goal is to assess whether AI-supported communication can enhance comfort and cooperation during pediatric dental treatments, potentially improving outcomes and advancing technology use in this field. Participants are randomly assigned to one of two groups. The control group receives traditional behavior management methods selected by the pediatric dentist, including a modified Tell-Show-Do approach, voice control, and positive reinforcement, with explanations tailored to the child's understanding. The experimental group listens to AI-generated voice recordings created by ChatGPT that explain the anesthesia process in a child-friendly manner without anxiety-provoking words, along with a one-minute calming story played during anesthesia. The total anesthesia procedure lasts up to five minutes. During the study, researchers measure heart rate and oxygen saturation using a pulse oximeter before, during, and after anesthesia. They also assess anxiety and pain using various scales such as the Venham Picture Test, Facial Image Scale, Wong-Baker FACES Pain Rating Scale, Modified Child Dental Anxiety Scale, and behavior rating scales. After treatment, children and parents complete questionnaires about their perceptions of AI-assisted communication. This comprehensive evaluation aims to compare the effects of traditional versus AI-supported techniques on dental anxiety and related outcomes in children.

This research evaluates the effect of telenursing intervention on oral health in people with COPD using a pre-test and post-test control group design. Because oral health is important for patient care and medication adherence, the study focuses on education provided by nurses through a multidisciplinary team approach to reduce hospital readmissions and stays. Participants in the experimental group will receive oral health education via video call, covering topics like oral hygiene, toothbrushing techniques, and managing care-resistant behaviors. They will also get daily reminders to perform oral care twice a day and to rinse their mouths after using an inhaler. The control group will not receive education. The education session will occur within 24 hours after the pre-test and last about 20 minutes. Participants will be assessed before and one month after the intervention for oral health and quality of life related to oral health. Both groups will be invited for evaluation one month after their respective starting points. Researchers will measure oral health changes and quality of life improvements during these visits to understand the impact of telenursing.

This research aims to evaluate the clinical success of the Silver Modified Atraumatic Restorative Technique (SMART) with different modifications in treating asymptomatic deep cavities in primary molars of children aged 4 to 9 years. The study focuses on caries affecting dentin and uses international criteria to assess the condition of the teeth and restorations over time. Participants must have untreated, asymptomatic cavities in primary molars suitable for restoration and no history of serious systemic illness. Two treatment groups are compared: one group receives the SMART method applying silver diamine fluoride (SDF) and potassium iodide (KI), while the other group receives the same application plus an additional 20 seconds of LED light activation. After two weeks, both groups have their teeth restored with high-viscosity glass ionomer cements covered by a sealing agent. Treatments involve cleaning the decay, applying solutions, and performing restorations following manufacturers' instructions. Participants will be evaluated at the start and then at 3, 6, and 12 months after treatment. Assessments include clinical and radiological exams measuring retention, anatomical form, surface roughness, marginal staining, incisal wear, and other properties using standardized dental criteria. Data such as age, gender, brushing habits, and number of treated teeth will be recorded. The study monitors changes in these dental properties over the year to assess treatment success and safety.

This research aims to evaluate how training and reminders for using metered-dose inhalers affect medication adherence in elderly individuals aged 65 and older. It focuses on challenges faced by older adults, such as multiple health conditions, many medications, forgetfulness, and difficulties understanding or using inhalers correctly. Incorrect inhaler use can lead to receiving less medication than needed, worsening symptoms, and increased hospital visits. The study includes education and reminder interventions for inhaler use. Participants in the experimental group will receive training on proper inhaler techniques, a reminder card showing the inhaler steps, and access to an instructional video before using their inhalers. The study focuses on common errors like poor coordination, timing issues, and breath-holding during inhalation. The control group will not receive these additional supports. Participants will be assessed at the start and after three months for their inhaler skills and medication adherence using specific scales. Researchers will monitor how well participants use their inhalers and follow their medication schedules. The study requires participants to have internet access and a mobile device to use reminder tools and involves interviews about their use of training materials and reminder cards.