Yalova Merkez

Researchers are evaluating the safety and effectiveness of a new oral medicine called vepugratinib compared with a placebo in adults with advanced or metastatic urothelial carcinoma, a type of bladder cancer that has a specific FGFR3 genetic alteration. This Phase 3 study aims to see if vepugratinib combined with two other drugs, enfortumab vedotin (EV) and pembrolizumab, can improve treatment outcomes for people who have not received prior systemic therapy for their cancer. Participants will receive either vepugratinib or placebo taken orally alongside enfortumab vedotin and pembrolizumab, both administered by intravenous infusion. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the vepugratinib and placebo groups. Treatment and monitoring will continue for up to approximately 6 years, allowing long-term assessment of safety and treatment effects. During the study, participants will be regularly evaluated for treatment-related side effects, response rates, and how long the cancer remains controlled without progression. Researchers will use established criteria to measure tumor response and will conduct thorough safety monitoring over the entire study period. Participation may last up to six years, during which participants will undergo laboratory tests, imaging, and clinical assessments to track their health and treatment response.

Smoking, due to the various chemical substances it contains, constitutes a risk factor for many diseases, primarily heart and lung diseases. It has been reported that smoking rates are higher among students living in underdeveloped or developing countries. Most users start smoking at a young age. Figures show that 31.9% of individuals aged 15-24 in Türkiye use tobacco (CDC, 2016). While there is no national study on universities across Turkey, studies report smoking prevalence rates ranging from 20.6% to 43.6%. Due to harmful substances like nicotine, smoking can lead to COPD, atherosclerosis, and other respiratory diseases. Furthermore, individuals who smoke are more likely to stop exercising due to fatigue, dyspnea, and pain. Smoking negatively impacts lung capacity, reducing FVC, FEV1, and FEV1/FVC volumes while increasing RV volume. Proprioceptive neuromuscular facilitation (PNF) techniques targeting the chest area are used in various populations to enhance respiratory muscle function and improve respiratory parameters. Improvements in range of motion, flexibility, and thoracic congruence can be achieved through both active and passive chest mobility exercises. Lengthening of the intercostal muscles allows for more efficient contraction. The underlying mechanism of chest mobility exercises involves increasing intercostal muscle length, facilitating effective muscle contraction. Facilitating the downward movement of the diaphragm and increasing the forward and backward movement capability of both the superior and inferior costal muscles improves the biomechanics of chest movement. Intercostal muscle rotation is best achieved by fully retracting the chest wall. Chest PNF technique has only recently begun to be used in smokers. Studies have shown that chest PNF techniques positively improve lung function and chest expansion in male smokers. A study conducted on female smokers showed that chest PNF technique followed by breathing exercises regulated blood pressure. Objective: The aim of study is to compare the effectiveness of chest PNF techniques and chest mobility exercises in university students who are smokers. Study Hypotheses: H0: There is no difference between chest PNF techniques and chest mobility exercises in respiratory functions, chest expansion, and functional capacity in university students who are smokers. H1: There is a difference between chest PNF techniques and chest mobility exercises in respiratory functions, chest expansion, and functional capacity in university students who are smokers. H2: The effects of chest PNF techniques on respiratory functions, chest expansion, and functional capacity in university students who are smokers are not different from the control group. H3: The effects of chest PNF techniques on respiratory functions, chest expansion, and functional capacity in university students who are smokers are different from the control group. H4: The effects of chest mobility exercises on respiratory functions, chest expansion, and functional capacity in university students who are smokers are not different from the control group. H5: The effects of chest mobility exercises on respiratory function, chest expansion, and functional capacity differ in university students who are smokers compared to the control group. Scope: This research is a prospective experimental study. The study will be conducted on 30 individuals who meet the inclusion criteria. The study population will be formed through announcement and invitation, and interventions will be implemented at the Yalova University Physiotherapy and Rehabilitation Application and Research Center. Method: In calculating the minimum sample size for the study, FEV1 was used as the primary variable, and the effect size was calculated by considering data from a previous study in the literature that investigated the effectiveness of exercise in smoking addiction. Using the GPower 3.1 program, with a 95% confidence interval, 90% power, and Cohen's f=0.7797218 effect size, the calculation revealed that the minimum sample size for the study should be 27 individuals. Considering participant dropout and data loss, 10% more participants will be included. Accordingly, the study is planned to be conducted with 30 people. Participants will be included in the study through invitation and announcement. The study will be conducted with individuals who meet the inclusion criteria. Participants will be randomized into 3 groups: Chest PNF Techniques, Chest Mobility Exercises, and Control. This randomization will be performed using randomizer.org, an open-access randomization site. Both groups will be evaluated during the initial interview, and after completing an informed consent form, the participants will be informed about the process. The study will be conducted on individuals with smoking addiction. The inclusion criteria include a Fagerström Nicotine Dependence Questionnaire score of ≥4, which is considered indicative of nicotine dependence. Turkish validity and reliability were established by Uysal et al. Data Collection Tools: Demographic Information, Pulmonary Function Test Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the person is in a seated position, Dyspnea Assessment: Modified Medical Research Council, Functional Capacity Assessment: Six-Minute Walk Test - 6MWT, Depression Assessment: The Beck Depression Inventory (BDI), Quality of Life Assessment: Patients' quality of life will be assessed using the Short Form-36 (SF-36), Chest Expansion: Chest expansion was assessed by measuring the circumference of the chest wall at maximum inspiration and maximum expiration, Fatigue: Patients' fatigue was assessed using the Turkish adaptation of the Fatigue Severity Scale, Physical Activity Level Assessment: International Physical Activity Questionnaire Short Form - IPAQS, Harvard Step Test: This test, used to measure cardiopulmonary endurance and physical fitness, involves individuals climbing and descending steps for 5 minutes. Group Exercise Programs: The Chest PNF Techniques and Chest Mobility Exercises group will receive treatment for a total of 6 weeks, with 3 sessions of 30 minutes per week. The control group will not receive any treatment. Chest PNF Techniques Group: Chest PNF exercises will be performed in supine, side, and prone positions. The combined isotonic contractions technique will be used to improve respiratory control. Each technique will be performed for 12 repetitions. In all positions, the patient is first asked to exhale. Pressure and stretching are applied in the opposite direction of the movement. While the patient inhales, the physiotherapist controls the resistance to allow movement. If necessary, more resistance is applied to stronger areas to distribute the force to weaker areas. Supine position: Both hands are placed on the sternum and pressure is applied obliquely downwards. The hands are placed parallel and diagonally on the lateral chest wall, over the lower ribs. To focus on the upper chest area, the hands are similarly placed on the pectoral muscles. Side-lying position: Both hands are placed parallel and diagonally on the lateral chest wall, over the lower ribs. This position is beneficial in distributing the force to the upper chest movement as it will provide resistance to the lower chest movement. Prone position: Hands are placed parallel and diagonally on the lower ribs. In the forearm support position, one hand is placed on the sternum and the other hand on the intercostal region Chest Mobility Exercises Group: Chest mobility exercises will be performed. The exercises will be performed in combination with diaphragmatic breathing exercises, with 18-20 repetitions and 30-second breaks. Chest rotation: The person is in a supine position. They extend their arms into an inverted T position. The physiotherapist places their hands on the underside of the rib cage and applies stress in the opposite direction. Passive lateral flexion in side lying position: The person is positioned in a side lying position with their arms hanging down from the stretcher, supported by a pillow. The therapist performs passive flexion of the rib cage from the head to the left and right sides, with slight overextension in the final range. Thoracic facet joint mobilization in supine position: The physiotherapist places one hand on the person's thoracic region and the other on the chest, and performs mobilization with the person lying supine with their arms crossed in front. Trunk rotation in sitting position: The physiotherapist stands behind the person in a sitting position. They actively and passively rotate the trunk on both sides. Arm movement in front of the chest while sitting: While sitting, the person raises their arms. While exhaling, they raise their arms above their head, then slowly lower them while inhaling. Cat-camel exercise: While in a crawling position, inhale, arch your back, and bring your head forward. Then, exhale, lower your back towards the ground and extend your head backward. Pectoral stretch: With elbows bent and hands clasped behind the neck, hold the shoulder in abduction and stretch the pectoralis major muscle. Breathe diaphragmatically through the nose for 4 seconds and exhale through the mouth for 6 seconds. Encourage chest opening while inhaling. Chest movement in crawling position: While in a crawling position, try to bring one hand towards the opposite knee, return to the starting position, rotate the trunk, and perform upper extremity flexion and abduction. Repeat for the opposite side. Control Group: No intervention will be performed. Statistical Analysis The data obtained in the study will be loaded into the SPSS 26.0 software package and analyzed. Numerical data will be presented as mean and standard deviation; categorical data will be presented as number and percentage. Normality will be analyzed using the Shapiro-Wilks test. For within-group comparisons between pre-tests and post-tests, a paired t-test will be used if the assumptions of normal distribution are met; otherwise, the Wilcoxon signed-rank test will be used. For between-group comparisons, a one-way ANOVA test and the Tukey test (post-hoc test) will be used if the assumptions of normal distribution are met; otherwise, the Kruskal-Wallis test and the Bonferroni correction (post-hoc test) will be applied. The significance level will be set at p\<0.05.

Chronic Obstructive Pulmonary Disease (COPD) is a serious lung condition expected to become the third leading cause of death by 2030, with smoking as the main risk factor. COPD reduces lung volume, causes breathing difficulty, and leads to respiratory muscle weakness over time. This weakness contributes to symptoms like hypercapnia, nighttime oxygen drops, and decreased ability to exercise. Pulmonary rehabilitation, including respiratory muscle training, is a key part of managing COPD. This research aims to study the effects of Functional Inspiratory Muscle Training (F-IMT) on COPD progression. The study involves 51 patients with COPD, divided into three groups: basic Inspiratory Muscle Training (IMT), Functional IMT, and a control group. All participants will receive training for 8 weeks. The basic IMT group trains once weekly with a physiotherapist and daily unsupervised sessions. The Functional IMT group starts with basic IMT for four weeks, then adds supervised exercise sessions three times weekly combined with IMT, plus unsupervised basic IMT on other days. The control group performs simple upper body and breathing exercises weekly with a physiotherapist and daily at home. Exercises include various positions and movements designed to improve respiratory muscle function. Participants will undergo assessments including breathing difficulty, COPD symptom tests, lung function tests, respiratory muscle strength, exercise capacity, muscle strength, balance, core muscle function, endurance, depression, daily activity ability, quality of life, fatigue, and physical activity levels. These will be measured at the start and throughout the 8-week study. The study monitors these outcomes to compare the effects of the different training approaches on COPD symptoms, function, and quality of life.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are evaluating the effects of cervical segmental mobilization on pain, functionality, grip strength, and quality of life in people with chronic lateral epicondylitis, a condition affecting the elbow. This study is designed as a randomized controlled experimental trial to compare different treatments and understand how cervical mobilization influences these outcomes. Participants receive either cervical segmental mobilization combined with exercise, deep friction therapy, or standard treatment. These interventions are applied to patients with chronic lateral epicondylitis to assess their impact on symptoms and physical abilities. During the study, researchers measure pain levels, quality of life using the Short Form-36 questionnaire, functionality, and grip strength after three weeks of treatment. These assessments help evaluate the effectiveness of the interventions and monitor participants' progress over the study period.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of pumitamig (BNT327) combined with chemotherapy and other investigational agents in adults with first-line non-small cell lung cancer (NSCLC). The study includes two substudies based on NSCLC histological subtypes due to differences in chemotherapy treatments. This Phase 2/3, multisite, randomized, open-label trial aims to assess treatments in participants with advanced NSCLC who have not previously received systemic treatment. Each substudy has a Phase 2 part where participants are randomly assigned to one of two doses of pumitamig combined with chemotherapy drugs such as pembrolizumab, carboplatin, pemetrexed, or paclitaxel, given intravenously. The Phase 3 part will include independent data monitoring and blinded central review of tumor scans for all treated participants. The overall planned duration per participant is up to 64 months, covering both study parts and follow-up. Participants will undergo regular tumor assessments and monitoring for safety, including recording treatment-emergent adverse events, dose changes, and serious side effects up to 90 days after the last dose. Effectiveness will be measured by tumor response rates, changes in tumor size, and progression-free survival, with tumor imaging reviewed by a blinded independent committee. This long-term study involves careful evaluation of treatment impact and participant health over approximately five years.

Researchers are evaluating the effects of an audiobook and local vibration on pain and fear during intramuscular (IM) injections in children aged 4 to 6 years. The study is a randomized controlled trial conducted in a pediatric emergency unit to explore non-drug methods that may reduce the pain and fear children experience during these procedures. The goal is to improve children's experiences and reduce long-term negative effects associated with painful medical procedures. Participants are divided into three groups: one group listens to an audiobook during the entire IM injection procedure, the second group receives the injection with a vibrating massage device applied locally, and the third group serves as a control. The IM injection is administered in the vastus lateralis muscle with ondansetron as directed by a doctor. After the procedure, children rest for 1 to 2 minutes before rating their pain and fear levels. Parents and an independent nurse also assess the child's pain and fear during the procedure. Children's pain is measured using the Wong-Baker FACES Pain Scale one minute after the procedure, and fear is assessed with the Children's Fear Scale one minute before and after the injection. Demographic information is collected, and all assessments are done in the pediatric emergency unit. The study aims to enroll 120 children between October 2023 and April 2024. Safety and adherence are monitored throughout the study period to evaluate the effectiveness of these nonpharmacological interventions on procedural pain and fear.

Researchers are evaluating the effects of Baduanjin, a traditional Chinese mind-body exercise, on pain, comfort, and quality of recovery in patients who have undergone total knee arthroplasty (knee replacement surgery). This randomized controlled trial will take place at Yalova Training and Research Hospital's Orthopedics Clinic between July 2025 and July 2026. The study aims to see if practicing Baduanjin can improve postoperative outcomes compared to standard care, addressing challenges like pain, reduced comfort, and limited mobility after surgery. Sixty patients will be randomly divided into two groups: an intervention group practicing Baduanjin and a control group receiving routine postoperative care. The Baduanjin exercises, consisting of eight gentle, coordinated movements, will begin on the first day after surgery and continue daily for three weeks under nurse supervision. The control group will receive standard physical therapy and pain management without Baduanjin. Participants will be assessed weekly for three weeks using the Visual Analog Scale to measure pain, the General Comfort Questionnaire to assess comfort, and the Quality of Recovery-40 questionnaire to evaluate recovery quality. These evaluations will help determine the effects of Baduanjin on postoperative pain, comfort, and recovery. The study focuses on enhancing recovery and well-being through a safe, accessible, non-pharmacological approach.

This research examines how listening to ney music, a traditional Turkish wind instrument, might affect pain, anxiety, sleep quality, and vital signs in patients having lumbar disc herniation surgery. The study focuses on patients aged 18 to 70 who have undergone this surgery under general anesthesia. It aims to explore whether this non-drug intervention can improve recovery by reducing common postoperative issues such as pain, anxiety, and sleep disturbances. Participants are randomly assigned to two groups: one group listens to 15-minute ney music sessions at three specific times—before surgery (the evening prior), three hours after surgery, and on the first postoperative day before bedtime. These sessions take place in a quiet, dimly lit room using headphones. The control group receives standard postoperative nursing care without music. Both groups are assessed at the same times using validated tools to measure pain, anxiety, sleep quality, and vital signs including blood pressure, pulse, and oxygen saturation. Throughout the study, researchers collect data before and after each music session in the intervention group and at matching times in the control group. Assessments include the Visual Analog Scale for pain, State-Trait Anxiety Inventory for anxiety, and the Richard-Campbell Sleep Questionnaire for sleep quality. Vital signs are monitored to evaluate physiological effects. The study lasts through the immediate postoperative period, with a focus on outcomes measured over six months to evaluate the lasting impact of ney music on recovery.

Researchers are studying infants aged 3 weeks to 6 months who have been diagnosed with infantile colic to see if Reiki therapy can reduce colic symptoms and crying duration, and improve mothers' fatigue levels and quality of life. This double-blind, randomized controlled trial aims to compare the effects of Reiki therapy with no intervention on both infants and their mothers. Infants in the Reiki group will receive Reiki therapy twice on alternate days, with each session lasting between 20 and 30 minutes, delivered by a certified Reiki practitioner following a standardized protocol. The control group will not receive any intervention. The study will enroll 44 infants, randomly assigning 22 to the Reiki group and 22 to the control group. Participants will be assessed using various tools including the Infantile Colic Scale, Crying Duration Recording Form completed by the mother over 7 days, the Visual Analogue Scale for maternal fatigue, and the World Health Organization Quality of Life Scale for mothers. Outcomes measured include changes in infants' colic symptoms and crying duration, as well as changes in maternal fatigue and quality of life from baseline to day 7. Data collection and monitoring will occur throughout the 7-day study period.