Denizli Merkez

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations teclistamab with daratumumab and lenalidomide Tec-DR, and talquetamab with daratumumab and lenalidomide Tal-DR, against the standard treatment of daratumumab, lenalidomide, and dexamethasone DRd. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

This research aims to evaluate the safety, performance, and usability of several Occlutech accessory medical devices used in heart disease treatment. These devices include the Occlutech Delivery Set ODS, Occlutech Pistol Pusher OPP, Occlutech Occlusions-Pusher OOP, and Occlutech Sizing Balloon OSB. The study is international, multicenter, non-randomized, and non-invasive, focusing on catheter-based implantation procedures for cardiac implants. The study involves physicians experienced in cardiac catheterization using these accessories during implantation procedures. Investigators complete detailed surveys to assess each devices safety, including success of implantation, adverse events during or after the procedure, user harm, and any device deficiencies. The surveys also evaluate the performance, usability, and compatibility of these accessories with other devices. Subjects receive treatment following standard clinical routines and specific instructions for use. Participants who have undergone implantation with an Occlutech accessory and cardiac implant are included. Researchers monitor safety events and assess device performance and usability over a 6-month period. Data is collected via investigator questionnaires, focusing on implantation outcomes and any related complications. The total participation duration varies depending on individual follow-up but includes at least 6 months of monitoring for safety and performance.

Low back pain LBP is a widespread musculoskeletal issue affecting people of various ages and causing significant personal, social, and healthcare burdens. The study focuses on chronic low back pain CLBP, which lasts more than 12 weeks and often leads to reduced daily activity due to fear of movement. Identifying risk factors and understanding those at risk of developing chronic LBP can help improve prevention and treatment strategies. This research aims to compare joint range of motion between individuals with low back pain and healthy people using artificial intelligence AI analysis methods. Participants in this observational study will have their joint range of motion ROM measured to assess specific movement limitations. The study includes two groups patients experiencing low back pain and healthy control participants. AI-supported analysis will be used to detect differences in joint motion ranges between these groups, aiming to improve understanding of how LBP affects physical movement. During the study, participants will undergo pain evaluations lasting about 5 minutes and joint ROM assessments lasting about 20 minutes. The researchers will collect data to analyze and compare differences between the groups. The study is open to adults aged 18 to 65 who meet eligibility criteria, and it involves no treatment but diagnostic testing. Total participant involvement includes these assessments, with results helping to identify movement patterns related to LBP.

Researchers are evaluating the effects of a breastfeeding support program based on a client health behavior interaction model on first-time mothers confidence, attitudes, and breastfeeding problems. This randomized controlled trial aims to understand how this program influences breastfeeding self-efficacy, attitudes toward breastfeeding, and the challenges mothers face. The study is conducted among primiparous mothers between 32 and 40 weeks of pregnancy. The study involves two groups an intervention group receiving a structured support program and a control group receiving standard care. The intervention includes educational sessions during the last trimester of pregnancy, five face-to-face motivational interviews postpartum at specified intervals up to 60 days, and two additional follow-up sessions via WhatsApp video calls at 4 and 5 months after birth. The control group receives routine breastfeeding education and support provided at Family Health Centers. Participants will be assessed multiple times, starting at 32-36 weeks of gestation and continuing through various postpartum time points up to 6 months. Assessments include measuring breastfeeding self-efficacy, attitudes, and problems using structured questionnaires. Researchers will monitor these outcomes to compare changes over time between the two groups. The study also includes ongoing support and data collection through in-person sessions and digital communication to track progress and challenges.

Researchers are evaluating the effectiveness of Extracorporeal Shock Wave Therapy ESWT for treating spasticity in wrist flexor muscles flexor carpi ulnaris and flexor carpi radialis of adults who have had a stroke at least six months ago. Spasticity causes muscle stiffness, pain, and limits function, which reduces quality of life and increases healthcare costs. The study aims to use objective ultrasound techniques alongside traditional scales to better assess and manage spasticity in chronic stroke patients. Participants will be randomly assigned to one of two groups. One group will receive conventional rehabilitation therapy daily for 1-2 hours, five days a week, for 12 weeks, including exercises, positioning, balance and gait training, occupational therapy, and speech therapy as needed. The other group will receive the same rehabilitation plus radial ESWT applied twice a week for four weeks eight sessions total to the wrist flexor muscles using a device delivering 2000 impulses per muscle at specified intensity and frequency. Participants will be assessed at the start and at 4, 8, and 12 weeks after treatment using the Modified Ashworth Scale to measure spasticity, as well as tests for wrist range of motion, functional independence, upper limb motor function, muscle tissue quality, and ultrasound strain index. These evaluations will help determine the short- and long-term effects of ESWT in managing post-stroke spasticity. The study is expected to last through August 2026.

Breast cancer is the most common cancer among women worldwide, and one of its major complications is breast cancer-related lymphedema BCRL. This condition can develop shortly after treatment or even years later, causing swelling, heaviness, discomfort, and reduced quality of life. Researchers are investigating how intermittent pneumatic compression IPC therapy compares to manual lymph drainage MLD, both standard parts of complete decongestive therapy CDT, to better understand IPCs role in treating BCRL. The study compares three groups one receiving the full CDT including MLD plus IPC, another receiving CDT without MLD but with IPC replacing it, and a third group receiving standard CDT with MLD alone. Treatments involve sessions five times a week for three weeks, using IPC at 20-50 mmHg pressure for 40 minutes per session when included. Total session durations vary from 75 to 115 minutes depending on the group and whether IPC is used alongside or instead of MLD. Participants will be monitored before and after the treatment period with measurements of arm volume and circumference, shoulder range of motion, and quality of life assessments. Other evaluations include questionnaires on arm function, swelling, heaviness, tightness, pain, and patient satisfaction. The study aims to assess acute effects within three weeks of starting rehabilitation, with all safety and outcome data collected under medical supervision.

Researchers are evaluating the effectiveness of two types of electrical stimulation, intravaginal electrical stimulation IVES and perineal electrical stimulation ES, compared to bladder training alone in women with idiopathic overactive bladder OAB. This randomized, double-blind, placebo-controlled study aims to determine which method better improves incontinence symptoms and quality of life in affected women. The trial involves 63 participants divided into three groups receiving different treatments. Participants in the first group will receive IVES along with bladder training. IVES is delivered via a vaginal probe using a device, three times a week for 20 minutes each session, over 8 weeks, totaling 24 sessions. The second group will receive perineal ES with bladder training, where surface electrodes are applied around the perianal area, also three times a week for 20 minutes per session for 8 weeks. The third group will perform bladder training alone, which includes education and exercises conducted at home, focusing on pelvic anatomy and urgency suppression strategies. Throughout the study, participants will be assessed before and after the 8-week treatment period. Researchers will measure changes in incontinence episodes, symptom severity, quality of life, anxiety and depression levels, sexual function, and pelvic floor muscle strength. Safety and side effects will also be monitored. The main outcome is improvement in the rate of incontinence episodes. Participants provide written consent and are involved in regular sessions with healthcare professionals for stimulation treatments and bladder training guidance.

This clinical trial investigates the effects of Connective Tissue Massage CTM and music-based Progressive Muscle Relaxation Training PMRT on women aged 18 to 30 years who have primary dysmenorrhea, a condition causing menstrual pain. The study evaluates changes in pain intensity, pressure pain threshold, pain-related symptoms, use of pain medication, and emotional and functional impact of dysmenorrhea. Participants are randomly assigned to one of three groups CTM, PMRT, or control without intervention. Participants in the CTM group will receive massage therapy focused on specific body regions including the sacrolumbar and pelvic areas, with sessions lasting 10-15 minutes, five days per week during the premenstrual intervention window from ovulation until the first day of menstruation in one menstrual cycle. The PMRT group will learn muscle relaxation techniques with face-to-face instruction followed by guided sessions using approved audio recordings, lasting 20-30 minutes with the same schedule. The control group will not receive any intervention during the study but will be asked to avoid other complementary therapies that could reduce menstrual pain. Throughout the study, assessments will take place during menstrual days 1-2 across three cycles baseline, post-intervention, and follow-up. Researchers will measure pain intensity, pain catastrophizing, menstrual symptoms, attitudes, functional and emotional effects, analgesic use, and pressure pain threshold. Participant satisfaction and adherence to the interventions will also be evaluated. The total study duration is approximately two menstrual cycles following the intervention period.

Researchers are evaluating the use of drug-coated balloons DCBs in treating various types of coronary artery disease, including in-stent restenosis, small vessel disease, de novo lesions, chronic total occlusions, and bifurcation lesions. This observational registry aims to gather real-world data on the safety, feasibility, and clinical outcomes of DCB angioplasty across diverse coronary lesion types and patient presentations in Turkey. The study seeks to provide comprehensive evidence beyond traditional uses, addressing both short- and long-term success rates. The study includes patients undergoing percutaneous coronary intervention PCI where DCBs are used either alone or with bailout stenting. Detailed information about patient demographics, clinical history, angiographic and procedural details, lesion preparation methods, intravascular imaging, and DCB characteristics will be collected. The registry will analyze procedural success and clinical outcomes such as major adverse cardiovascular events and need for further revascularization, focusing also on the role of lesion preparation and imaging guidance. Participants will be followed for at least 12 months, with data collected on death, revascularization of target lesions and vessels, myocardial infarction, bleeding events, and procedural success. Researchers will monitor clinical progress, collect angiographic and procedural data, and evaluate outcomes to identify factors influencing success or failure of DCB use. This study reflects routine clinical practice and aims to inform future randomized trials comparing DCB strategies with drug-eluting stents.