Bégard, France

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Dubousset Functional Test: an Investigation of Its Validity and Reliability in Individuals with Multiple Sclerosis

Socio-demographic characteristics, physical characteristics (age, body weight, height), educational status, occupation, duration of MS, age at onset of MS, clinical type of MS, number and site of attacks, presence of optic neuritis, EDSS score, medications, chronic diseases, and smoking will be recorded. Expanded Disability Status Scale (EDSS): All volunteers participating in the study will undergo a neurologic examination and the disability rate will be evaluated using the EDSS for each individual with MS. The EDSS is scored between 0 and 10, with higher scores indicating more disability. A score of zero indicates completely normal functioning, while a score of 10 indicates death due to MS. Individuals with a score of 3.5 and below will be included in the study. Test Procedures Demographic data will be recorded at the baseline assessment. Our study will be conducted in a "test-retest" design and the psychometric properties of the Dubousset Function Test (DFT) will be examined in individuals with MS. The DFT, TUG, dual-task TUG, Tinetti Performance Oriented Mobility Assessment (POMA), Berg Balance Scale (BBS), Functional Reach Test and 3-meter backward walking test (3MBWT) will be administered to individuals. The completion times of the DFT will be performed by the same physiotherapist. The second assessment (retest) will be performed 7 days after the first assessment (test) by the same physiotherapist to determine the reliability of the DFT. Rest periods of 2 minutes will be given between assessments to minimize the effects of fatigue. Participants will not receive any treatment for 7 days and the test-retest will be performed at the same time. Dubousset Functional Test (DFT): A conceptual four-component global functional assessment test - Dubousset Functional Test (DFT) will be applied to objectively measure the functional capacity of individuals (11). These four components are as follows; 1. Get Up and Walk Test: Individuals with MS will stand up unassisted from a seated position in a chair without arms, walk 5 meters (500 cm), turn around, walk back 5 meters and sit down again unassisted. 2. Step Test: individuals with MS will climb three steps of stairs from a starting position 50 cm away, turn around on the third step and walk back down. 3. Sit and stand test: Individuals with MS will sit on the floor from a standing position with assistance if necessary and stand up again with assistance if necessary. 4. Dual Task Test: Individuals with MS will walk 5 meters forward, turn around and walk 5 meters backward while performing a memory exercise (counting down from 50 in 2 intervals). TUG (Timed Up and Go) Test: The TUG test is a tool designed to assess dynamic balance, walking speed and mobility. To complete the test, participants are required to get up from a chair with armrests, walk 3 m, turn, walk back and sit on the chair. The completion time of the test is recorded with a stopwatch (3). Dual Task TUG (Additional Cognitive Task): During the TUG test, counting backwards by twos from 50 will be used as an additional cognitive task. When the test had to be repeated, individuals continued counting from the number they had left off. Counting errors will be ignored (12). Tinetti POMA: It is also called the Tinetti Mobility Test and is a reliable and valid clinical test used to measure balance and walking abilities. It consists of a total POMA scale (POMA-T), a balance subscale (POMA-B) and a gait subscale (POMA-G). Each step is scored between 0 (maximum inability) and 2 (complete independence) (13). Berg Balance Scale (BBS): It is a widely used measurement tool to assess functional balance. The BBS consists of 14 items and each item is scored between 0 and 4 according to the level of balance impairment. Higher scores on the BDI indicate better balance performance (14). 3 Meter Backward Walking Test (3MBWT): A distance of 3 meters (m) is measured and marked with black tape. Patients are asked to follow the black tape with their heels. When the "Start" command is given, they are asked to walk backwards quickly. When a distance of 3 meters is completed, they are told to stop (15). Functional Reach Test (FRT) : It is a test that evaluates dynamic bilateral postural balance. At the beginning of the test, the dominant arm is placed in a 90° flexion position and the distance between the feet is set to 10 cm. The maximum distance a person can extend their arm horizontally forward without moving their feet is measured in centimeters. The maximum distance he/she can reach and return to the starting position without losing balance is recorded. The test will be repeated three times and the average of these three values will be taken (16).

The Effect of Cardiac Rehabilitation on Oxidative DNA Damage and Inflammation in Patients With Coronary Artery Disease

Coronary artery disease (CAD) is a significant global health issue and the leading cause of cardiovascular mortality. Recent research has focused on the impact of oxidative stress, genetic damage, and inflammation in CAD development. Chronic inflammation and oxidative stress can cause cellular damage by increasing the formation of free oxygen radicals. Oxidative stress leads to endothelial dysfunction, inflammation of the vessel wall, and the formation of atherosclerotic plaques. Atherosclerosis is the most common pathological process associated with cardiovascular diseases, and the disease is characterized by a high oxidative stress state, which causes lipid and protein oxidation. Oxidative stress and an imbalance between oxidants and antioxidants can damage important biomolecules such as DNA, lipids, and proteins. Cardiac rehabilitation (CR) programmes are a recommended therapy with demonstrated efficacy in the treatment of patients with CAD. CR is a holistic approach that combines medical and exercise interventions to improve patients' cardiovascular health and general well-being. Exercise is the foundation of CR. While the literature describes it extensively, there is still some controversy surrounding oxidative stress and exercise. It has been suggested that exercise may increase the production of reactive oxygen molecules associated with oxidative stress, which is a factor in the pathogenesis of CAD. Regular and moderate exercise can have a positive impact on the body by balancing the production of antioxidants, reducing inflammation and oxidative stress. However, it is important to note that exercise should be approached in moderation to avoid any negative effects on the body. Previous studies have focused on risk factors associated with physical fitness, the fibrinolytic system, or lipid profile in cardiac patients. However, there have been relatively few investigations of induced changes in blood. This study aims to investigate the role of oxidative stress and inflammation in the pathogenesis of CAD and the effects of KR on these pathophysiological processes.

Determination of the Optimal Cut Off Value of the Modified Ashworth Scale in the Evaluation of Gait Performance and Functional Mobility in Individuals with Cerebral Palsy

Cerebral palsy (CP) is one of the common causes of disability in childhood. The prevalence of the disease has been evaluated as 2-3 per 1000 live births on average in various societies. In various prevalence studies conducted in our country, the prevalence of the disease was found to be 1.1- 4.4 per 1000 live births. CP is a disease with multifactorial etiology. Although antenatal, perinatal and neonatal effects often play a role together, the most important known risk factors are low birth weight and prematurity. Intrauterine infections have been identified as the most important cause of CP etiology in individuals with prematurity and low birth weight. These infections can trigger premature birth and cause damage to the central nervous system, which has not yet completed its development. In CP, classifications are made according to the extremity involvement, clinical features, etiologies and many different pathogenesis. Currently, the most common and widely used classification is the one defined by Phelps and Perlstein according to the involved extremity and tonus disorder. A) Spastic type: (pyramidal): Monoplegia, Diplegia, Hemiplegia, Triplegia, Tetraplegia B) Dyskinetic type: (Extrapyramidal): Athetoid, Choreic, Choreoathetoid, Dystonic C) Ataxic type D) Hypotonic type E) Mixed type Materials and Methods The study was designed to determine the optimal cut off value of the modified ashworth scale in the evaluation of gait performance and functional mobility in individuals with CP aged 6-15 years. Patients admitted to the CP outpatient clinic of Kayseri City Hospital, Physical Medicine and Rehabilitation Clinic and Twenty-five individuals who meet the inclusion criteria will be included in the study. Modified Ashworth Scale 0 : Normal muscle tone. 1 : Slight increase in muscle tone, minimal resistance is felt at the end of joint movement. 1+ : Minimal resistance in less than half of the joint movement. 2 : Significant increased muscle tone throughout the entire movement, but the joint can still be moved easily. 3 : There is significant increased muscle tone throughout the entire movement making passive movement difficult. 4 : The affected muscles are completely rigid, remaining in fixed flexion or extension. Gross Motor Function Measure Classification System (GMFCS) KMFSS, which is one of the most widely used scales to classify the severity of movement disorders in individuals with CP and to evaluate the current activity levels of the subjects, was developed by Palisano et al. in 1997. In 2012, El et al. conducted a validity and reliability study of the CMFCS for the Turkish population. Gross motor function classification system Level 1 Walks independently. There is limitation in advanced gross motor skills. Level 2 Walks without an assistive device. Has limitations when walking in public. Level 3 Walks with an assistive device. There is limitation while walking in the community. Level 4 Has limitations. Self-mobile. Transported in the community or uses a wheelchair. Level 5 Mobilization is severely limited even with assistive technologies. 10 meter walk test: It is used to measure walking speed from functional parameters. A 16-meter walking track is created to perform the test. The first 3 and last 3 meters of this track are completed without taking into account and the measurements are repeated 3 times each. Before the test is performed, starting and ending points are determined on non-slippery ground. The individual starts walking, the stopwatch is started after the first three meters. The stopwatch is stopped at the end of the tenth meter. After the individual walks the last 3 meters, walking is terminated. The completion time of the test is recorded in seconds. Assessment of Mobility TUG test: It was performed using a standard chair (46 cm high). Patients sat with their backs against the chair. Patients were instructed to get up from the chair without support, walk three meters marked on the floor, turn around, walk back to the chair and sit down again. Patients were told that the test should be performed at a normal pace. The stopwatch was started with the word "start" and stopped when the patient sat down. TUG time was measured in seconds (s). Five Times Sit and Stand Test: It is used for functional mobility measurements. In the test, the individual sits with arms crossed over the shoulders and back leaning against the chair. With the "go" command, the patient stands up and sits down five times quickly from the standard chair. The elapsed time is measured with a stopwatch.

The Efficacy of Wet Cupping Therapy on Cerebral Oxygenation

The importance of NIRS is that it can detect differences in tissue oxygen uptake that cannot be routinely identified by existing methods (24). The ability of near-infrared (NIR; near infrared; wavelength 650 - 1100nm) light to penetrate tissues and to be absorbed by some chromophores (such as haemoglobin, cytochrome oxidase, bilirubin, urobilin) has formed the basis of regional cerebral oxygen saturation (rScO2) measurement (15). NIRS is a technique in which the amount of absorption of NIR light by chromophore molecules [such as oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb), cytochrome-c oxidase (CCO), myoglobin] is measured while passing through tissues (16). rScO2 values less than 40% or changes greater than 25% from baseline values may be a harbinger of cerebral ischaemia (17). Cerebral oximetry has attracted attention because it is easy to use and uncomplicated. NIRS should be used as a trend monitor. In the current study, it is aimed to investigate the efficacy of wet cupping therapy (WCT) on cerebral oxygenation using the NIRS device. Following the enrollment of the healthy individuals, they will all receive one session of WCT. During the WCT application, the cerebral oxygenation levels will be measured with an NIRS device. In the outpatient clinic setting, the NIRS device's sensor pads will be attached to the arcus superciliaris (GB14) under the tuber frontalis on both sides. After the measurement is initiated, WCT will be applied to the planum occipitale (DU 20) and the pars squamosa (GB6-8) of the temporal bone on the sides. Measurement will continue for 10 minutes during and after the WCT application. The data obtained by NIRS will be compared before, during, and after the WCT application so that we will be able to find out any possible effects of WCT on cerebral oxygenation.

The Effect of Time-Restricted Feeding on Body Composition and Some Metabolic Parameters in Obese Adolescents

Effect of Whey Powder Bread on Blood Glucose

In cheese making, whey is the liquid that is separated from the clot formed as a result of coagulation of milk with rennet or acid, does not coagulate and contains milk dry matter. Serum proteins in whey increase the nutritional value of whey proteins and help the absorption of minerals. In addition to their nutritional value, whey proteins have important health effects in terms of other metabolic functions such as strengthening immunity, stimulating gastrointestinal hormone secretion, antiviral activity, and satiety response. Therefore, the aim of this study was to add whey powder, which is lost as waste in cheese production and has many health benefits, to bread, which is consumed very much daily in Turkey, to enrich bread in terms of nutrients and to examine the effect of whey powder added bread on postprandial blood glucose. The study is planned to be conducted in 20 healthy individuals aged 19-35 years with normal body mass index (18.5-25.0 kg/m2) between August 2024 and March 2025. In the study, all volunteer participants will be randomly assigned to a breakfast meal consisting of all bread types (bread made from white flour, bread made from white flour with whey powder added, bread made from whole wheat flour and bread made from whole wheat flour with whey powder added) for four consecutive days. During these days, participants will have their fasting blood glucose measured immediately before the meal containing the test bread and will then be asked to consume the entire test bread with their breakfast meal within 15 minutes. After breakfast, postprandial blood glucose will be measured at 15, 30, 45, 60, 90, 120 minutes. Food consumption records will be taken by the researchers and participants will be instructed not to eat or drink anything 8 hours before breakfast and not to perform any physical activity other than their daily activities during that day. Anthropometric measurements will be taken by the researchers using appropriate methods and food consumption records will be questioned in detail on a daily basis. According to the food consumption record, the types and amounts of foods consumed daily will be determined and energy, macro and micronutrient values will be analyzed using the Turkey Specific Nutrition Information System (BeBIS) computer program. There is no study in the literature investigating the effect of whey powder added to bread on blood glucose. In addition, enriching bread, which is very important in the nutrition of the Turkish nation, with whey powder, which is considered as "waste", will contribute to both sustainability and economy.

The Relationship Between Healthy Lifestyle Behaviors, Physical Activity and Blood Tests in Pregnancy

Pregnancy is a phase in women's lives characterized by psychological, biological, and emotional changes. The process of pregnancy typically spans nine months, divided into three trimesters (Küçükkaya et al., 2018). Identifying risk factors during pregnancy is essential, and these include ethnicity, maternal age, gestational age, antibody presence, iodine sufficiency, parity (number of births), multiple pregnancies, body mass index, and smoking (Curí L.L. et al., 2023). Pregnancy is also linked to various factors that affect a woman's psychological health, family dynamics, and overall quality of life. Pregnant women must collaborate with a multidisciplinary team (doctors, midwives, nurses, physiotherapists, etc.) to manage these risks effectively (Amirshahi et al., 2024). Pregnant women often experience anxiety about potential negative outcomes during labor and the postpartum period (Küçükkaya et al., 2018). Research indicates that women's concerns and anxieties change across different trimesters (Küçükkaya et al., 2018; Karataylı, S., 2007). Moreover, factors such as age, education level, employment status, and health insurance significantly influence their anxiety levels (Küçükkaya et al., 2018). These concerns-along with anxiety, depression, and stress-affect pregnancy-related responsibilities, nutrition, hygiene, physical activity, travel, and overall acceptance of pregnancy. Therefore, in our study, we plan to assess the healthy lifestyle behaviors of women in their first trimester using the "Pregnancy Healthy Lifestyle Behavior Scale" (Yılmaz E, Karahan N, 2019). This scale, developed by Yılmaz et al., consists of 29 items and 6 subscales (pregnancy responsibility, nutrition, hygiene, physical activity, travel, and pregnancy acceptance) and has undergone validity and reliability testing. It uses a five-point Likert scale, with higher scores indicating more positive health behaviors. Regular physical activity during pregnancy maintains and improves physical fitness, aids in weight management, reduces the risk of gestational diabetes in obese women, and enhances psychological well-being. It is recommended that women engage in at least 20-30 minutes of moderate-intensity exercise most days of the week. Studies show that physical activity during pregnancy reduces negative outcomes for both the mother and fetus, positively affecting maternal and child health (American College of Obstetricians and Gynecologists, 2015). Physical activity has multiple benefits, including maintaining physical condition, improving quality of life, reducing the risk of obesity-related diseases, and increasing longevity. Generally, physical activity during pregnancy carries minimal risks and benefits most women, particularly those with uncomplicated pregnancies, who are encouraged to engage in personalized exercise programs before, during, and after pregnancy (American College of Obstetricians and Gynecologists, 2015). However, despite its proven benefits, studies have shown that many pregnant women do not engage in adequate physical activity (Göker et al., 2021). Research has found that women's total physical activity levels in the first trimester are lower compared to other trimesters (Lee et al., 2016). Another study shows that physical activity levels increase in the second trimester, with significant improvements noted compared to the first and third trimesters (Özdemir et al., 2017). This decrease in activity in the first trimester may be attributed to efforts to ensure fetal safety and physical discomfort caused by pregnancy (Ko Y-L et al., 2016). However, the pregnancy process is individualized, and some women may engage in regular physical activity even in early pregnancy. Therefore, our study aims to assess physical activity levels in the first trimester. This evaluation will help us understand the frequency of physical activity in early pregnancy and explore its potential effects on pregnancy health. To achieve this, we will use the "Pregnancy Physical Activity Questionnaire" (Chasan-Taber et al., 2004), validated in Turkish by Tosun et al. (2015). This questionnaire consists of 36 items divided into four subscales: occupational activity, household chores, child care, and exercise. The scores will assess the physical activity levels of pregnant women during the first trimester. Pregnancy also affects thyroid function and can lead to various complications. Factors such as ethnicity, socio-economic status, iodine supplementation, and obesity influence Thyroid-Stimulating Hormone (TSH) levels. Monitoring trimester-specific TSH ranges is important for timely diagnosis and treatment (Yanachkova et al., 2024). Thyroid disorders are common during pregnancy, affecting 2-3% of all pregnancies, with 10% of women having autoimmune thyroid disease despite normal thyroid function. Over the past two decades, a better understanding of thyroid physiology during pregnancy has highlighted the importance of thyroid function adaptation and the negative maternal and neonatal outcomes associated with untreated thyroid disorders, such as hypothyroidism or hyperthyroidism. Increased awareness of thyroid diseases during pregnancy can help reduce complications (Tekin, Y. B., & Güven, E. S. D., 2014). In our study, we will evaluate TSH values during the first trimester. In addition to thyroid issues, liver dysfunction during pregnancy can be a concern. Around 3% of pregnancies are affected by liver dysfunction (Ch'ng et al., 2002), which can range from mild functional disturbances to rare severe liver diseases. These issues often arise at specific stages of pregnancy. Proper diagnosis and timely treatment are critical for reducing morbidity and mortality risks for both mother and baby (Güven, S., & Türkay, C., 2011). Pregnancy-specific liver diseases can cause changes in liver enzymes such as ALT and AST, which are crucial for identifying complications. Therefore, we will examine ALT and AST levels as part of our study. Monitoring hemoglobin (HGB) and hematocrit (HCT) levels during pregnancy is crucial for the health of both mother and baby. Low HGB and HCT levels can lead to pregnancy-related anemia. In a study examining multiparous women, the anemia rates based on HGB and ferritin levels were found to be 24.2% and 20.8%, respectively (Çıkım et al., 2020). Higher HGB and HCT levels were found in the control group, while the first trimester group had higher values compared to other trimester groups. In preeclamptic pregnancies, higher levels of HGB and HCT are observed in the umbilical cord (Sürücü et al., 2005). The required sample size for the study has been calculated using G-power analysis, yielding a total of 649 participants. The study is planned to take place from August 15, 2024, to August 15, 2025, at the Kayseri City Hospital's Obstetrics and Gynecology Clinic and will be a single-center study. Participants will complete the Demographic Information Form, Pregnancy Healthy Lifestyle Behavior Scale, and Pregnancy Physical Activity Questionnaire. Biochemical tests, including complete blood count (CBC) and biochemistry tests, will be performed at the Kayseri City Hospital's Medical Biochemistry Laboratory. CBC results will record HGB and HCT levels, while biochemistry results will record TSH, AST, and ALT levels.

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Moderatetosevere Asthma.

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