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Found 9 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating vepugratinib, a new medicine, to see if it is safe and helpful for people with advanced or metastatic urothelial carcinoma, a type of bladder cancer with FGFR3 genetic changes. This Phase 3 study compares vepugratinib combined with enfortumab vedotin and pembrolizumab against a placebo combined with these same drugs. The trial is sponsored by Eli Lilly and Company and aims to assess treatment safety and effectiveness over a long period. Participants receive either vepugratinib or a placebo orally, together with enfortumab vedotin and pembrolizumab given by intravenous infusion. The study uses a double-blind, randomized design with parallel groups to compare these treatments. There is a safety lead-in phase followed by the main treatment phase, and study participation may last up to approximately 6 years. During the trial, participants will have regular assessments including monitoring for treatment-related side effects, tumor response, progression-free survival, overall survival, and quality of life using questionnaires. Researchers will collect blood samples to measure drug levels and evaluate health status at baseline and throughout the study. Safety and effectiveness outcomes will be tracked up to 90 months, with continuous monitoring to ensure participant well-being over the long-term study period.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate how a case-based blended learning program affects nursing students abilities to identify and express psychosocial nursing diagnoses. It focuses on improving students skills in differentiating and correlating psychosocial needs, which are often overlooked in traditional nursing education that tends to emphasize physical needs. The study is designed as a randomized controlled trial led by the University of Yalova to enrich nursing curricula and enhance teaching methods. Participants will undergo an educational program consisting of three sessions that use interactive video-supported materials and case studies. The content covers topics like sexuality and body image, spirituality and hopelessness, social isolation and role performance, and the grieving process, all based on established models. The blended learning approach combines face-to-face teaching with digital learning environments to support various learning styles and provide instant feedback. During the study, nursing students will be assessed before and after the 4-week education module using specific forms to measure their knowledge and skills in psychosocial nursing diagnoses. Researchers will evaluate changes in their understanding and perception of nursing diagnoses. The study aims to strengthen students ability to analyze psychosocial needs holistically and incorporate these insights into care planning.
Actively Recruiting
Healthy Volunteer
Smoking is a major risk factor for heart, lung, and respiratory diseases, especially common among young people and university students in Turkey. Smoking reduces lung function and exercise performance by causing fatigue, breathlessness, and pain. This study aims to compare the effects of two chest-focused exercise techniques, proprioceptive neuromuscular facilitation PNF and chest mobility exercises, on lung function, chest expansion, and functional capacity in university students who are smokers. Participants are divided into three groups one receiving chest PNF exercises, another performing chest mobility exercises combined with diaphragmatic breathing, and a control group with no intervention. The exercise programs last 6 weeks with three 30-minute sessions each week. Chest PNF exercises involve specific hand placements and resistance movements in supine, side-lying, and prone positions, while chest mobility exercises include rotations, stretches, and mobilizations performed in various positions. Throughout the study, participants undergo multiple assessments at the beginning and after about 6 weeks. These include lung function tests using a portable spirometer, breathlessness evaluation, exercise capacity tests, depression and fatigue scales, quality of life questionnaires, chest expansion measurements, physical activity assessments, and endurance testing. Data will be analyzed to see how each intervention affects respiratory health and functional ability in young smokers.
Actively Recruiting
Chronic Obstructive Pulmonary Disease COPD is a serious lung condition that affects breathing and exercise ability, often caused by smoking. COPD leads to respiratory muscle weakness, increased breathlessness, and reduced lung function. Pulmonary rehabilitation, including respiratory muscle training, is a key part of managing COPD. This research aims to compare the early effects of two types of inspiratory muscle trainingbasic and functionalon the health and quality of life of people with COPD. Participants will be randomly assigned to one of three groups basic inspiratory muscle training IMT, functional inspiratory muscle training F-IMT, or a control group. Both IMT groups will use a device to train respiratory muscles at home and with a physiotherapist over eight weeks. The F-IMT group will add specific exercises focused on core and postural muscles during the last four weeks. The control group will perform simple breathing and upper body exercises with similar supervision and home practice. Throughout the study, participants will undergo various assessments including breathing tests, muscle strength measurements, exercise capacity tests, balance and core muscle evaluations, and quality of life questionnaires. These will be done at the start and after eight weeks to monitor changes. The study will also track symptoms like breathlessness, cognitive function, daily activity ability, fatigue, and depression to understand how the trainings affect the course of COPD over time.
Actively Recruiting
Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.
Actively Recruiting
Researchers are studying first-line treatment options for participants with non-small cell lung cancer NSCLC in this Phase 23, multisite, randomized, open-label trial. The study includes two substudies based on NSCLC histological subtypes, which have different chemotherapy standards. This design allows evaluation of pumitamig BNT327 combined with chemotherapy and other investigational agents in participants with advanced NSCLC who have not received prior systemic treatment. Participants are randomized to receive one of two dose levels of pumitamig plus chemotherapy during the Phase 2 part of each substudy. In Phase 3, an independent data monitoring committee and a blinded independent central review will oversee safety and tumor assessments. Treatments include pumitamig combined with carboplatin and either pemetrexed or paclitaxel, or pembrolizumab with the same chemotherapies as active comparators. All drugs are given by intravenous infusion. The study period for each participant may last up to 64 months. Throughout the study, participants undergo regular tumor assessments and safety monitoring, including evaluation of adverse events, response rates, progression-free survival, and quality of life using validated questionnaires. Data on dose adjustments and treatment discontinuations are collected. Follow-up continues up to five years to assess long-term outcomes and survival. Participants receive detailed evaluations to understand treatment effects and safety over time in this comprehensive lung cancer trial.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate the effects of Baduanjin, a traditional Chinese mind-body exercise, on pain, comfort, and quality of recovery in patients undergoing total knee arthroplasty TKA. The study focuses on understanding whether Baduanjin can improve postoperative outcomes compared to standard care. The trial will take place between July 2025 and July 2026 at Yalova Training and Research Hospitals Orthopedics Clinic with 60 participants randomly assigned into two groups. One group will perform supervised Baduanjin exercises daily starting on the first day after surgery and continuing for three weeks. These exercises consist of eight gentle movements incorporating physical posture, breathing, and mental focus. The control group will receive routine postoperative care and physical therapy without Baduanjin. Data will be collected at four time points before surgery, on the first postoperative day, and at weeks 4 and 8 post-surgery. Participants will undergo assessments using the Visual Analog Scale VAS for pain, the General Comfort Questionnaire, and the Quality of Recovery-40 QoR-40 questionnaire at each time point. The study will monitor pain levels, comfort, and recovery quality throughout the follow-up period. This trial aims to contribute evidence about complementary mind-body methods that may support recovery after knee replacement surgery.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate the effects of ney music, a traditional Turkish wind instrument, on pain, anxiety, sleep quality, and vital signs in patients undergoing lumbar disc herniation surgery. The trial investigates whether listening to ney music can support postoperative recovery by reducing discomfort and improving physiological parameters. It is a randomized controlled study designed to explore non-drug supportive methods in surgical care. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will listen to 15-minute sessions of ney music at three specific times before surgery on the day of the operation, three hours after surgery upon transfer to the clinic, and the morning of the first day after surgery. The control group will receive standard postoperative nursing care without any music intervention. Both groups will have measurements taken at these times for comparison. During the study, researchers will assess pain using the Visual Analog Scale, anxiety with the State-Trait Anxiety Inventory, sleep quality through the Richard-Campbell Sleep Questionnaire, and vital signs including blood pressure, pulse, and oxygen saturation before and after each music session in the intervention group. Similar assessments will be made in the control group without music. The studys outcomes will be reviewed over six months to understand the impact of ney music on recovery. Participants will attend scheduled sessions around their surgery and follow-up assessments.
Actively Recruiting
Healthy Volunteer
This research explores the impact of mandala coloring, a non-drug and art-based activity, on reducing anxiety and stress in patients scheduled for elective surgery. Anxiety before surgery is common and can lead to worse outcomes like increased pain and delayed recovery. The study seeks to see if a simple, low-cost mandala coloring session can help ease these feelings and improve patients overall preoperative experience. Participants will be randomly assigned to either an intervention group or a control group before their surgery. The intervention group will spend 20 minutes coloring mandalas in a quiet room the day before surgery, while the control group receives standard preoperative care without any coloring activity. Both groups will be assessed for anxiety, stress, and physiological measures like blood pressure and pulse before and after the activity or waiting period. During the study, participants will complete questionnaires measuring anxiety and stress, and their vital signs will be recorded. Data collection occurs one day before surgery, with evaluations done before and after the mandala coloring or the waiting period for the control group. The study aims to provide evidence supporting mandala coloring as a practical nursing approach to help patients manage preoperative anxiety and stress.