Search Bar & Filters
Found 9 Actively Recruiting clinical trials
Actively Recruiting
This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.
Actively Recruiting
Chronic low back pain is common in older adults and often leads to problems with balance, increased risk of falls, frailty, depression, and reduced ability to perform daily activities. This trial evaluates how different focus of attention strategies during virtual reality-based core stabilization exercises affect frailty, balance, fall risk, muscle strength, sarcopenia risk, and depression in older adults with chronic low back pain. The study compares two approaches: focusing attention externally on movement effects or internally on body movements and muscle control. Participants aged 65 to 80 will be randomly assigned to one of two groups. Both groups will perform the same virtual reality-supported core stabilization exercises three times a week for six weeks, with each session lasting 45 to 60 minutes under physiotherapist supervision. The only difference is that one group receives verbal and visual instructions directing attention to external movement outcomes within the virtual environment, while the other group receives instructions focusing on internal body positioning and muscle activation. Throughout the study, participants will be assessed before and after the six-week intervention. Researchers will measure frailty using the Frailty Assessment Scale, sarcopenia risk with the SARC-T questionnaire, balance and fall risk using the Biodex Balance System, functional leg strength with the Five Times Sit-to-Stand Test, and depressive symptoms via the Beck Depression Inventory. The goal is to understand whether the type of attentional focus influences physical, functional, and psychological outcomes during virtual reality-based exercise training for chronic low back pain in older adults.
Actively Recruiting
Sacroiliac joint dysfunction is a common cause of chronic mechanical low back pain and is linked to pain, impaired posture control, and limited function. This research evaluates the effects of two manual therapy techniques, myofascial release and sacroiliac joint mobilizations, when added to a traditional physical therapy program. The goal is to compare their impact on pain intensity, spinal mobility, postural control, and endurance in women diagnosed with sacroiliac joint dysfunction. Participants will be randomly assigned to one of two groups. Both groups will receive a traditional physical therapy program three times per week for six weeks, which includes strengthening exercises for the abdominal and back muscles and ultrasound treatment to the sacroiliac region. One group will also receive myofascial release techniques targeting specific muscles, while the other group will receive sacroiliac joint mobilizations aimed at improving joint mobility. All treatments are delivered by experienced physical therapists. Before treatment and after the six-week intervention, participants will undergo assessments of pain using the Visual Analog Scale, postural control using the Biodex Balance System, and spinal mobility and endurance with the Spinal Mouse system. These evaluations will help determine the comparative effects of the manual therapy approaches. The study is designed to provide evidence to guide clinical decisions in treating sacroiliac joint dysfunction.
Actively Recruiting
Chronic nonspecific low back pain is a complex condition involving biomechanical, psychological, and neurocognitive factors such as fear of movement and pain catastrophizing, which contribute to ongoing pain and disability. This research evaluates the effects of combining virtual reality (VR)-supported pain neuroscience education with core stabilization exercises to address both cognitive and physical aspects of this condition. The goal is to improve pain, fear of movement, pain catastrophizing, functional status, and balance in adults with chronic nonspecific low back pain. Participants will receive either classical pain education with core stabilization exercises or VR-supported pain neuroscience education combined with these exercises. The VR program includes an introductory session with 20-30 minutes of interactive pain education modules during the first week, followed by weekly 10-15 minute VR reinforcement sessions for weeks 2 to 6, integrated with core exercises targeting muscles around the spine. The classical education group receives traditional verbal or brochure-based pain education alongside the same exercise protocol. Exercises focus on activating key muscles, posture control, stretching, and mobilization, performed in 2-3 sets of 10-15 reps with load adjustments based on tolerance. During the six-week study, participants will be monitored for changes in pain severity and functional status. Researchers will assess the impact on fear of movement, pain catastrophizing, and balance. The study includes evaluations through physical exercises, educational sessions, and use of VR technology to enhance motivation and cognitive understanding. This approach aims to provide a comprehensive rehabilitation program addressing both physical and psychological elements of chronic low back pain.
Actively Recruiting
Researchers are evaluating the safety and tolerability of tarperprumig in adults who have been newly diagnosed with or have relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. This Phase 2 study focuses on participants with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) subtypes, classified according to the 2022 ACR/EULAR criteria, who are considered for treatment with rituximab or cyclophosphamide. Participants must have a positive test for PR3-ANCA or MPO-ANCA antibodies and meet specific disease activity criteria based on the Birmingham Vasculitis Activity Score (BVAS). Participants will be randomly assigned to receive either tarperprumig or a placebo in a double-blind, placebo-controlled, parallel-group setup across multiple centers. The study evaluates the investigational drug tarperprumig against placebo to assess safety and efficacy in the target patient population. Treatment details and dosing schedules are not provided in the available information. Throughout the study, researchers will monitor the number of participants experiencing treatment-emergent adverse events from baseline to week 70. Safety and tolerability will be closely assessed during this period. Participants' health status and response to treatment will be regularly evaluated to determine the treatment effects and monitor any risks associated with tarperprumig.
Actively Recruiting
Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.
Actively Recruiting
Researchers are evaluating the effects of different kinesiology taping techniques on the thickness of the thoracolumbar fascia, pain levels, and functional disability in adults aged 18 to 65 years with nonspecific chronic low back pain. This randomized controlled trial compares a targeted fascial correction taping approach with a traditional muscle taping method. The study aims to provide evidence about the impact of these taping methods on tissue structure and symptoms, helping guide clinical decisions for managing chronic low back pain. Participants will be randomly assigned to one of two groups. The Functional Fascial Taping Group will receive kinesiology tape applied to the thoracolumbar fascia using "I" and "Y" shaped strips with oscillating tension, applied twice a week for two weeks. The Muscle Technique Taping Group will have traditional muscle taping on paravertebral muscles and sacroiliac joints, also twice weekly for two weeks. Both treatments focus on different taping strategies without additional therapies during the intervention period. Before and after treatment, pain intensity will be measured using a visual scale, pressure pain threshold with an algometer, functional disability using a specific questionnaire, and fascia thickness via ultrasound imaging. These assessments will help determine changes in pain, function, and tissue properties. The total participation time covers the treatment period and evaluations before and after the interventions, allowing close monitoring of outcomes related to taping effects in chronic low back pain.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the effects of virtual reality applications on balance, quality of life, and fall risk in postmenopausal women with osteoporosis. Osteoporosis is a progressive condition marked by bone loss and increased fragility, especially common in women over 50 and nearly all individuals over 75. As bone mineral density decreases after menopause, neuromuscular function worsens, leading to balance problems, slower walking, and higher fall risk, which can cause fractures and serious health consequences. This study aims to compare virtual reality treatments with conventional therapy for these patients. Participants will be assigned to either a conventional treatment group or a virtual reality treatment group. Conventional treatment includes posture, strengthening, balance, and aerobic exercises, patient education to prevent falls and fractures, pain management, and support for daily living activities. The virtual reality group will use videos and video-based games (exergames) designed for therapy. If any virtual reality application causes risk, the program will be adjusted. Both approaches focus on improving balance and reducing fall risk. During the study, participants will undergo assessments of balance, cognitive state, and fall risk after 6 weeks of treatment. Researchers will monitor these outcomes to evaluate the treatments' effects. Participants must be postmenopausal women aged 50 to 75, able to walk independently, with adequate cognitive function. The study also includes monitoring for any intolerance to virtual reality and excludes those with recent fractures or severe health problems. The study compares these treatments to understand their impact on osteoporosis-related balance and fall risks.
Actively Recruiting
Healthy Volunteer
Infertility is defined as the failure of couples of reproductive age to conceive or to continue a pregnancy despite having unprotected sexual intercourse at least twice a week for a year. When we look at infertility rates worldwide, it is thought that more than 80 million people cannot have children due to medical reasons, and in Turkey, an average of 15% of couples are diagnosed with infertility. Although infertility is not a life-threatening problem, it is often considered a stressful life event for couples or individuals due to the meaning that individuals or society attribute to having children. At the same time, it is a condition that brings medical, physiological, psychological and social problems, has cultural, religious and class aspects, confronts the individual with unexpected stressors, and changes the couple's quality of life. For all these reasons, the diagnosis of infertility creates a crisis in couples that they do not know how to cope with. Many studies revealing the psychological dimensions of infertility and assisted reproductive treatments have shown that infertility negatively affects individuals by causing an increase in their stress, depression and anxiety levels. Readiness is the person's evaluation of their own abilities and situation, considering existing options, producing and implementing new solutions. A high level of readiness encourages individuals to experience psychological reactions such as anger and depression less and to have a more positive approach. A lower level of readiness can cause individuals to feel depressed, afraid and vulnerable in the face of change. The level of fertility readiness, which is affected by social, economic and personal factors, is similarly linked to perceived abilities for parenting. This situation also affects fertility treatment, and it is reported that as the level of feeling ready for fertility treatment increases, treatment results are also positive. Web-based education is an internet-based distance education model that increases the quality of education services today. Studies indicate that web-based education is important in terms of eliminating physical or spatial distances and thus enabling individuals in geographically different places to easily access educational resources. In addition, web-based education offers the opportunity to access educational materials at the time and frequency desired by the participant. It allows the participant to control the pace of the training and to reinforce their knowledge with the opportunity to repeat the training when necessary, and to make the training effective and permanent. The infertility treatment process is a multidisciplinary team effort involving different professional groups. Especially the Controlled Ovarian Hyperstimulation (COH) protocols applied during the infertility treatment process require good nursing education, close monitoring and effective consultancy. The infertility nurse is responsible for educating the patient during this process, developing their self-application skills and monitoring them, and this directly affects the treatment process and its success. There is a need to determine the level of infertile individuals being affected by this process, to increase their knowledge level regarding the treatment process, and to ensure that individuals are closely supported and strengthened during the treatment process. This study was planned as a randomized controlled experimental study in order to determine the effect of web-based education to be given to women undergoing Intrauterine Insemination (IUI) treatment on the level of infertility and fertility readiness of women. In this way, it is thought that in addition to face-to-face nursing education and counseling given to female patients in infertility treatment, the usability of web-based education in this field can be evaluated, the effectiveness and quality of education can be increased by integrating web-based education into the process, the close and continuous follow-up of patients can be ensured, possible incorrect treatment process management can be prevented, and the couple can be prevented from being negatively affected by this process both materially and morally by preventing cycle losses. The study was planned to be conducted between 15.03.2024 and 15.12.2024 on women between the ages of 18-45 who applied to Düzce University Health Application and Research Center, Infertility Polyclinic.The study universe consists of all women who applied to Düzce University Health Application and Research Center, Infertility Polyclinic between 15.03.2024 and 15.08.2024 and met the inclusion criteria. Study sample; Based on a similar study conducted previously, the Power analysis (G\*Power 3.1.9.2) was performed, and the effect size was determined as 0.61, the power as 80%, and the α-type error estimate as 0.05, and the sample size for each group was determined as 34 infertile women. The drop-out number (the number of those who did not continue the study) was taken as 5, and the sample size was determined as 39 for each group. In the study, 45 patients will be tried to be reached in each group, including the experimental and control groups, considering possible data losses. Block randomization will be applied in determining the groups.Data will be collected using the Personal Information Form, Infertility Impact Scale (IAS) and Fertility Readiness Scale for Women Receiving Fertility Support. A preliminary application will be conducted to evaluate the understandability and usability of the Personal Information Form developed by the researchers by the individuals in the sample group. For this purpose, an average of 9 women, who constitute 10% of the 90-person sample determined according to the calculation of the minimum sample number to be reached in the place where the research will be conducted, will be included in the preliminary application. After the preliminary application, the data collection form will be finalized and the data collected for the preliminary application will not be included in the research. Research data will be collected between 15.03.2022-15.12.2023. The collection of research data will be completed within approximately 20 days for each patient from the beginning of the KOH treatment to pregnancy determination for patients scheduled for Controlled Ovarian Hiperstimulation (KOH) during the Intrauterine Insemination (IUI) treatment process. Before starting the research, women in the experimental and control groups who applied to the infertility clinic and met the inclusion criteria for the research will be interviewed face to face and informed about the purpose, duration, planned flow and the contribution that the research application can make to the treatment process will be provided, and verbal consent will be obtained from women who agree to participate in the research. Then, contact information (name, surname, telephone number, Turkish ID number) of all patients in the randomized experimental and control groups will be collected and user registrations will be completed in order to provide access to the website via www.asilamatedavisi.com only for women in the experimental group. The women in both groups will fill out the Personal Information Form, pre-test forms and the post-test forms within 1 week after the vaccination process, by reaching them through the survey link (Google forms) that will be prepared online. During the data collection phase, participants will be able to participate in the study after reading and approving the informed consent form that appears before they can access the questionnaires prepared via Google Forms. Filling out the questionnaires will take approximately 15-20 minutes.