Clinical trials

Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with conventional high-flux membranes, which may improve inflammatory status and cardiovascular health. The aim of this study is to compare the effects of MCO and high-flux hemodialysis membranes on inflammatory biomarkers and cardiovascular function in adult patients receiving maintenance hemodialysis. The primary outcomes are changes in serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) levels. Secondary outcomes include arterial stiffness assessed by pulse wave velocity (PWV), body composition assessed by Body Composition Monitor (BCM), handgrip strength, and patient-reported outcomes including quality of life, pruritus, and pain scores. This is a prospective, randomized, open-label, two-sequence, two-period crossover study conducted at Gazi University Faculty of Medicine. Thirty adult hemodialysis patients will be randomized to one of two treatment sequences. Participants in Sequence A will receive MCO dialysis membranes for the first 3 months followed by high-flux membranes for the next 3 months. Participants in Sequence B will receive high-flux membranes for the first 3 months followed by MCO membranes for the next 3 months. Blood samples and clinical assessments will be performed at baseline, month 3, and month 6. The study is expected to provide evidence regarding the effects of different dialysis membrane technologies on inflammation and cardiovascular health and may contribute to optimizing membrane selection in routine hemodialysis practice.

Ultrasonographic evaluation of the inferior vena cava (IVC) is widely used in emergency and critical care settings for noninvasive assessment of intravascular volume status. The subcostal (SC) window is the standard approach; however, it is frequently limited by obesity, bowel distension, or postoperative anatomical changes. In such cases, the right coronal (RC) and anterior transhepatic (aTH) windows have been proposed as alternatives.

Benign perianal diseases such as chronic anal fissure, hemorrhoidal disease, and cryptoglandular anal fistula may negatively affect female sexual function through pain, bleeding, discharge, discomfort, and impairment in quality of life. Although improvement in male sexual function after surgery for benign anorectal disorders has been reported, data regarding female sexual function remain limited. This prospective observational cohort study aims to evaluate changes in Female Sexual Function Index (FSFI) scores following surgical treatment of benign perianal diseases. Female patients undergoing surgery for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula will be assessed preoperatively and at postoperative 3 and 6 months using the FSFI, Cleveland Clinic Incontinence Score (CCIS/Wexner), and Visual Analog Scale (VAS). The primary objective is to determine whether female sexual function improves following surgical treatment. Secondary objectives include evaluating the relationship between symptom improvement, continence status, pain reduction, and changes in female sexual function.

Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.

This study investigates whether tightness of a small chest muscle called the pectoralis minor is associated with the development of partial rotator cuff tears in the shoulder. Using a propensity score matched case-control design, the study compares patients with rotator cuff tears (case group, n=45) to patients with intact rotator cuffs (control group, n=45). Adults aged 18-55 with shoulder pain who are evaluated by MRI and/or shoulder arthroscopy at Gazi University Hospital may be invited. The case group includes patients found to have partial rotator cuff tears during arthroscopy. The control group includes patients whose rotator cuff was documented as intact by MRI. Groups are matched 1:1 on age, sex, BMI, and dominant side. Before surgery, two trained clinician measures shoulder posture and pectoralis minor length using simple external tools (a digital caliper and ruler-like square). For arthroscopy patients, the surgeon records general arthroscopic findings. No extra procedures are added for research. We expect to include 90 participants total. The primary hypothesis is that pectoralis minor tightness is more prevalent in patients with rotator cuff tears compared to controls. A secondary hypothesis is that tears in patients with pectoralis minor tightness more often partial-thickness bursal side rotator cuff tear. Results may help clinicians understand shoulder mechanics and improve prevention or rehabilitation strategies.

To our knowledge, no studies have been conducted in the literature investigating the relationship between the success of physical therapy programs applied in knee osteoarthritis and patients' pre-treatment expectations. The rationale for this study is to demonstrate the possible relationship between treatment expectations and the benefits seen from conventional physical therapy programs in patients with knee osteoarthritis, and to provide clinicians with a different perspective in knee osteoarthritis treatment planning.

Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.

Patients with metastatic non-small cell lung cancer (NSCLC) and programmed death-ligand 1 (PD-L1) expression below 50% are commonly treated with different chemo-immunotherapy regimens in routine clinical practice. Although these regimens are widely used, comparative real-world data on survival outcomes and patient-reported quality of life are limited. This prospective observational study aims to compare two commonly used treatment approaches in patients with metastatic NSCLC and PD-L1 expression \<50%: chemotherapy plus pembrolizumab versus nivolumab plus ipilimumab combined with chemotherapy. Patients will receive treatment according to routine clinical decisions made by their treating physicians; no treatment assignment or intervention will be performed as part of the study. The primary outcomes of the study are progression-free survival and overall survival. In addition, health-related quality of life will be assessed using validated patient-reported outcome questionnaires during routine follow-up. Exploratory analyses will examine treatment outcomes in relation to selected clinical and patient-related factors, such as biological age, antibiotic exposure, and dietary patterns, in subsets of patients with available data. The results of this study are expected to provide real-world evidence on survival and quality of life outcomes associated with commonly used chemo-immunotherapy strategies in metastatic NSCLC.

This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group. Infants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities. Infants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills. Families will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.

This randomized controlled trial aims to evaluate the effectiveness of the mind mapping method in enhancing critical thinking and problem-solving skills among nursing students. The study will be conducted with 65 nursing students enrolled in a "Critical Thinking in Nursing" course at Gazi University during the 2025-2026 academic year. Participants will be assigned to experimental and control groups using stratified randomization based on pre-test scores from the "Marmara Critical Thinking Tendencies Scale" and the "Problem-Solving Inventory." The five-week intervention focuses on five clinical case studies: infection control, medication administration, patient safety, ethical issues, and systematic approaches. While both groups receive the same theoretical content, they follow different practical methodologies: The Control Group will engage in standard case analysis methods. The Experimental Group will work in small teams (4-5 students) to create and present visual mind maps for each case study, using either traditional or digital tools. Following the intervention, both groups will complete post-tests to assess changes in their critical thinking and problem-solving competencies.

This study will be conducted in a randomized controlled experimental design to examine The effect of art-based intervention on fatigue, anxiety, perception of nurse presence, and quality of life in patients with hematological cancer. The study will be conducted with 52 patients (26 intervention, 26 control groups) treated in the Hematology department of a training and research hospital between May 2025 and October 2026. Art-based intervention will be applied to the intervention group for 2 week (3 sessions per week), No application will be made to the control group. The data collection tools in the study are the Patient Identifier Information Form, Cancer Fatigue Scale, Functional Assessment of Cancer Therapy-General Scale (FACT-G), Hospital Anxiety and Depression Scale (HADS), and Nurse Presence Scale (PONS).

Childhood is a critical period for the development of lifelong health behaviors, and early interventions play an essential role in promoting long-term health and preventing future health problems. This study is planned to evaluate the effect of health education on children's healthy lifestyle skills.

The aim of this study is to evaluate gait in individuals diagnosed with PD under tasks involving different cognitive domains, to compare the results with those of age and sex-matched healthy individuals, and to determine which cognitive function has the greatest impact on gait in PD.

This randomized, controlled, parallel-group, interventional study aims to evaluate the effects of Crossword-Based Learning for Parenteral Drug Administration on the knowledge level, self-efficacy perception, and learning motivation of Nursing Department students. It is considered original because it examines the effects of crossword-based learning on cognitive and psychosocial outcomes in parenteral drug administration, a skill with a high risk of error in the clinical field. The study will be conducted with 80 (40 Experimental, 40 Control) nursing students selected through a power analysis. Participants will be assigned to groups by random assignment, and the study will be conducted in accordance with the triple-blind principle (participant, data collector, statistician). The experimental group will receive Crossword Activities in four different phases (Initial, Theoretical, Laboratory, and Post-Clinical Practice) in addition to the standard educational content. The control group will only complete the standard education. The primary outcomes of the study are; At the end of the 4th stage, the Parenteral Drug Administration Knowledge Test will be evaluated based on the Safe Parenteral Drug Administration Self-Efficacy Scale (SES-SES) and the Higher Education Learning Motivation Scale (SLS-SES) scores.

This study aims to evaluate the effect of artificial intelligence (AI)-supported virtual reality (VR) simulation on nursing students' holistic care skills. The study is a randomised controlled trial involving fourth-year nursing students, divided into an experimental and a control group. Whilst the experimental group will receive AI-supported VR simulation training, the control group will receive traditional case-based training. Outcomes to be assessed include decision-making, symptom identification, nursing diagnosis, simulation design and satisfaction with the training methods.

This randomized crossover study aims to address an important gap in manual therapy by examining the acute physiological effects of different Graston Technique application speeds (60 BPM vs. 120 BPM) on the dominant upper trapezius muscle in patients with bruxism. Although the Graston Technique is widely used, the specific impact of application speed on parameters such as muscle stiffness, muscle oxygenation, pressure pain threshold, and pain intensity remains under-investigated. By utilizing a crossover design with a 1-week washout period, this study allows for a precise within-subject comparison of the two speeds. The findings will clarify the optimal application frequency, providing objective data to guide the development of more effective, evidence-based manual therapy protocols for bruxism management.

his study aims to determine the effect of a gamification-based educational method on nursing students' learning of stoma care. The research will be conducted as a pretest-posttest, parallel-group randomized controlled experimental study. This research will be prepared under the guidance of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) protocol, and the reporting of the randomized controlled study will be carried out under the Consolidated Standards of Reporting Trials (CONSORT). Participants will consist of fourth-year nursing students who voluntarily agree to participate in the study. After obtaining informed consent, participants will complete a descriptive characteristics form and the Stoma Care Knowledge Test. Randomization will be performed based on baseline knowledge levels, and participants will be assigned to experimental and control groups. Students' knowledge levels will be assessed using the "Stoma Care Knowledge Test," and their skills will be evaluated using a "Skills Checklist." Following baseline knowledge and skill assessment, the experimental group will receive gamified stoma care education, while the control group will receive standard education. The gamification intervention is designed based on the Werbach D6 Model and aims to enhance students' knowledge and skills in stoma care. Post-intervention knowledge and skill assessments will be conducted one week after the training. In addition, follow-up measurements will be performed four weeks later to evaluate the retention of knowledge and skills.

This case-control study aims to investigate the effects of occupational hand-arm vibration exposure on median and ulnar nerve functions in tattoo artists. Chronic exposure to vibration generated by tattoo machines may lead to neurosensory impairment, reduced tactile sensitivity, and decreased hand strength. Objective assessments including nerve provocation tests, sensory threshold evaluation, two-point discrimination, vibration perception, grip and pinch strength measurements, and validated patient-reported outcome questionnaires will be used. Findings will be compared with age- and sex-matched healthy controls.

Post-stroke dysphagia is a common complication that negatively affects nutritional status, quality of life, and morbidity. Conventional swallowing rehabilitation, including oropharyngeal exercises and neuromuscular electrical stimulation (NMES), is widely used to improve swallowing function. This randomized controlled clinical study aims to investigate the effectiveness of visual biofeedback-assisted oropharyngeal exercises combined with NMES in patients with post-stroke dysphagia. Participants will be randomly assigned to either a visual biofeedback-assisted exercise group or a conventional exercise group, with both groups receiving NMES. Treatment will be administered five days per week for four weeks. Changes in swallowing function, suprahyoid muscle activity assessed by surface electromyography, and muscle stiffness evaluated by shear wave elastography will be analyzed to determine the effectiveness of the intervention.

This study aims to increase the width and thickness of peri-implant keratinized mucosa (KM) by transferring a properly dimensioned free gingival graft (FGG) from the palatal donor site and to evaluate its effect as an adjunctive approach to non-surgical peri-implantitis therapy. The procedure is indicated for patients diagnosed with peri-implantitis who present with an inadequate KM (midbuccal KM height \< 2 mm). One month after non-surgical therapy, patients in the test group will undergo keratinized mucosa augmentation using an FGG, while patients in the control group will continue with supportive periodontal therapy and regular follow-up visits. The primary outcome measure of the study is the change in probing depth (PD) at 12 months following peri-implantitis treatment.

Stroke is a disease characterized by symptoms such as weakness on one side of the body, speech impairment or inability to understand spoken language, vision problems, and loss of balance, walking, and coordination, resulting from a disruption in cerebral circulation that prevents oxygenation and nourishment of brain tissue. Currently, treatment approaches that adopt motor learning principles after stroke are fundamentally based on motor learning, neural plasticity, biomechanics, and the systems model of motor control. Task-Oriented Training (TOT), one of these treatment approaches, is used in the physiotherapy process for neurological diseases, and there is significant clinical evidence regarding the benefits of TOT. While the effects of TOT in physiotherapy have been primarily studied on balance and walking, there are a limited number of studies examining its effects on upper extremity function. Task-Oriented Circuit Training (TOCT) is a task-oriented training program consisting of 15 exercise stations where task-oriented training is applied in the form of exercise stations. TOCT improved upper extremity skills in Parkinson's patients. However, no study examines its effects on stroke. Therefore, this study aims to examine the effects of TOCT on upper extremity motor functions and dual-task performance in stroke patients.

Objective: This study aims to determine the effect of using word search and case-based puzzles in stoma care education on nursing students' knowledge levels. Given that traditional teaching methods may have limited effectiveness in helping students acquire knowledge and skills, the study aims to demonstrate the contribution of integrating active learning and gamification-based approaches into education. Design: The study is planned as a randomized controlled experimental design and will use a pre-test-post-test measurement approach. Method: The study will be conducted with second-year students from the Nursing Department at Gazi University. This research will be prepared under the guidance of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) protocol, and the reporting of the randomized controlled study will be carried out under the Consolidated Standards of Reporting Trials (CONSORT). In the study, students will be randomly assigned to the experimental and control groups. The experimental group will receive training that includes word search and case-based puzzles during the stoma care training process, while the control group will receive training using traditional teaching methods. Students' knowledge levels will be assessed with measurements applied before and after the training, and student opinions regarding the training method will also be analyzed. The "Stoma Care Knowledge Level Assessment Test" will be used to evaluate knowledge levels, and the "Student Opinions on the Use of Puzzles and Word Searches in Stoma Education" form will be used to determine student opinions. Hypothesis: The null hypothesis (H0) of the study states that the use of word search and case-based puzzles in stoma care education has no effect on students' knowledge level; the alternative hypothesis (H1) states that this educational method significantly affects students' knowledge level.

Heart valve diseases are the most common cause of mortality and morbidity after coronary artery disease, hypertension, and heart failure. In patients with mitral stenosis, the narrowed valve restricts blood flow, causing symptoms such as shortness of breath, fatigue, exertional dyspnea, orthopnea, and paroxysmal nocturnal dyspnea. These patients may experience decreased exercise capacity and physical activity levels, deterioration in quality of life, and deterioration in respiratory function. When reviewing the literature, we see that the study groups evaluating these factors are generally not homogeneous, and most studies conducted in patients with mitral stenosis evaluate patients who have undergone percutaneous mitral balloon valvuloplasty.

This randomized controlled trial aims to evaluate the effects of an Interactive Digital Art-Based Relaxation Program on physiological parameters, anxiety levels, and emotional distress in children aged 7-12 years receiving care in a pediatric intensive care unit (PICU). Children in the intervention group will receive three short, nurse-guided digital art-based relaxation sessions delivered via tablet, while the control group will receive standard PICU nursing care. Outcomes will be assessed using physiological measurements and validated psychological assessment tools before and after the intervention.

Interstitial lung diseases (ILD)impaired gas exchange and reduced lung elasticity lead to marked reductions in exercise capacity and decreased oxygen consumption due to circulatory limitations. Blood flow restriction (BFR) exercise involves applying external pressure to partially restrict venous return without entirely blocking arterial inflow. This controlled compression induces temporary hypoxic and metabolic stress, triggering high-intensity-like responses that stimulate growth hormone release, increase protein synthesis, and promote muscle hypertrophy. However, the most crucial advantage of blood flow restriction during exercise is its ability to increase muscle mass during aerobic training. IIn individuals with ILD, BFR may offer a safe and practical way to improve muscle mass and exercise capacity with minimal additional strain on the cardiovascular and musculoskeletal systems.Our study aimed to compare the acute effects of low-intensity blood flow restriction aerobic exercise training and low-intensity aerobic exercise training on hemodynamic responses and muscle oxygenation in patients with ILD. Method: 30 patients with a diagnosis of ILD being followed up will be included in the study. Our study was a randomized, crossover, triple-blind, prospective study. Assessments will be performed at the beginning of the study. On the first day, demographic data and clinical findings of the individuals will be collected. Patients will be asked questions, and their responses will be recorded in their medical records. Respiratory function, respiratory muscle strength and endurance, and peripheral muscle strength will be evaluated. 48 hours from the first day, patients' maximal exercise capacity will be assessed with a cardiopulmonary exercise test (CPET), and muscle oxygenation during CPET will be assessed with a Moxy® monitor. Respiratory muscle fatigue will be assessed with an oral pressure monitor before and after the exercise test. The assessments will be completed over two days. One week after the evaluations, patients will be randomly assigned to two groups. One group will receive low-intensity aerobic exercise training, and the other will receive low-intensity aerobic exercise training with blood flow restriction. Muscle oxygenation will be assessed during both exercise sessions, and respiratory muscle fatigue will be measured before and after each session. All participants will receive both exercise sessions.