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Found 10 Actively Recruiting clinical trials
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Researchers are evaluating roxadustat, an oral medicine, to treat anemia in children and teenagers with chronic kidney disease (CKD). Anemia is a condition where the body has a low level of red blood cells. Currently, anemia is often treated with injections called erythropoietin stimulating agents (ESAs), but these have some safety concerns. Roxadustat is already licensed for adults with CKD, and this study aims to learn how it affects anemia in younger patients, providing a potential alternative to injections. Participants in this open-label Phase 3 study will take roxadustat three times a week for up to 52 weeks. The study starts with 10 teenagers taking a fixed dose for 4 weeks to determine the best dose, followed by 10 children doing the same. After dosing is established, the rest of the children and teenagers will take roxadustat at the suitable dose. Blood samples will be taken regularly, and doses may be adjusted to keep hemoglobin levels just below the normal range. Visits occur every 2 weeks for the first month, then every 4 weeks, with a final visit 4 weeks after treatment ends. During the study, participants will have their vital signs checked, including blood pressure, temperature, and heart rate. Those on dialysis will have fluid levels monitored. Blood and urine tests will be done regularly, including checks for hemoglobin, iron, liver enzymes, and heart function through ECGs. Medical exams occur before treatment and at 6 and 13 months. Researchers will monitor safety, treatment effects, and hemoglobin changes throughout the study.
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Researchers are assessing the safety and effectiveness of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This phase 2/3 study focuses on participants with specific tumor characteristics, including PD-L1 status and HER2-negative cancer, aiming to provide new treatment options for this serious condition. Participants receive either Pumitamig along with chemotherapy drugs Folfox or Capox, or Nivolumab combined with chemotherapy, each given at specified doses on set days. The study is randomized and blinded, involving two parts: phase 2 and phase 3, with treatment tailored based on PD-L1 expression levels. During the study, researchers monitor tumor response using RECIST v1.1 criteria, track progression-free survival up to about 33 months, and overall survival up to approximately 47 months after randomization. Assessments include imaging and clinical evaluations to measure treatment effects and safety over the course of participation, which may last up to 2 years or more for certain outcomes.
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Healthy Volunteer
This research aims to study how acupressure affects physical signs and anxiety in adults diagnosed with Acute Coronary Syndrome (ACS), which includes conditions like unstable angina and heart attacks. ACS causes symptoms such as chest pain, fast heartbeat, sweating, fatigue, dizziness, breathing difficulties, nausea, anxiety, and depression. The study is designed as a randomized controlled trial to explore how acupressure might influence anxiety, blood pressure, heart rate, breathing rate, pain, and cortisol levels in these patients. Participants will receive acupressure after their coronary angiography (CAG) procedure, but only if their vital signs are within normal limits. The treatment involves applying pressure to specific points and is given to individuals who meet safety criteria. This non-drug intervention is being tested to evaluate its effects compared to standard care. No other integrative pressure-based therapies have been used by participants in the past month. During the study, researchers will monitor participants' blood pressure, heart rate, respiratory rate up to 30 minutes, and cortisol levels up to 60 minutes after treatment. Anxiety and pain levels will also be assessed. The study includes multiple assessments to track physiological and psychological responses, ensuring patient safety by checking vital signs before treatment. Participants are adults who have not had prior coronary angiography and meet specific health and language criteria for the study.
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This research aims to improve understanding of rare autoinflammatory diseases (AID), which cause repeated inflammatory episodes without infection or cancer. The study focuses on hereditary periodic syndromes (monogenic AID) caused by gene mutations, as well as related polygenic or multifactorial AID like Behcet's disease, Still disease, Schnitzler's disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, spondyloarthritis, and Castleman disease. The goal is to gather detailed clinical and therapeutic data to expand knowledge of these rare conditions, which are often difficult to diagnose outside specialized centers. Participants will be enrolled in the AIDA international registry, which uses a secure online platform to collect retrospective and prospective information. Data collected include demographics, genetics, clinical features, laboratory and radiologic results, treatments, and socioeconomic impact. The registry covers multiple specific AID types and will track patients over at least 10 years through routine clinical visits usually every 3-6 months. The platform supports data sharing and analysis to identify disease patterns, treatment responses, and long-term outcomes. During the study, patients' medical records will be regularly updated with clinical and laboratory data. Researchers will analyze changes in patient numbers and disease characteristics over time. The registry also aims to foster international collaboration, improve early diagnosis, assess quality of life and socioeconomic effects, and support future research and clinical trials. Patient data privacy is maintained by using pseudonyms and complying with data protection laws throughout the study.
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Researchers are evaluating the effects of the Helfer Skin Tap Technique and local cold application on pain and hemodynamic responses during intramuscular tetanus vaccination in pregnant women aged 18 to 42. This randomized controlled study aims to compare these two methods against the standard injection to see how they impact pain levels and vital signs such as heart rate, blood pressure, oxygen saturation, and respiratory rate. Participants will be randomly assigned to one of three groups: one receiving vaccination with the Helfer Skin Tap Technique, another receiving vaccination with local cold application using a cold compress gel, and a control group receiving the standard intramuscular injection. Before vaccination, vital signs are measured, and pain is assessed immediately and 15 minutes after the injection. Participants in the intervention groups will have their treatments administered following specific procedural guidelines. To assess longer-term pain effects, participants will report their pain levels at 24 and 48 hours after vaccination through a follow-up link. Throughout the study, vital signs are measured before the injection, immediately after, and 15 minutes post-injection. Pain levels are recorded using a numerical pain scale at the same times and during follow-up. The study collects personal information and uses standardized guidelines to ensure consistent procedures. This design allows researchers to monitor immediate and delayed pain responses and physiological changes related to the vaccination.
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Healthy Volunteer
This research aims to study volleyball players who regularly perform overhead sports activities that heavily involve the shoulder and elbow joints. It focuses on evaluating how an 8-week myofascial release technique affects joint mobility, muscle strength, proprioception, sensorimotor functions, and performance. The study explores these effects because maintaining joint stability, flexibility, and muscle strength is important for preventing injuries and enhancing sports performance in overhead sports like volleyball. Volleyball players will be divided into groups where one group receives myofascial release therapy three times a week for eight weeks using a foam roller and rolling stick on specific muscles around the shoulder and elbow. Each session includes two sets of rolling exercises lasting one minute each, with rest intervals and controlled pressure using body weight. The control group will receive a sham myofascial release technique involving light palm pressure without the rolling tools. After the study, the control group can also receive the real myofascial release program. Participants will undergo assessments before treatment, after 4 and 8 weeks of therapy, and six months later. These assessments will measure proprioception, muscle strength, shoulder mobility, and performance speed to observe changes over time. The study also monitors participant well-being and adherence to the treatment schedule. The goal is to understand the long-term benefits of myofascial release techniques on athletic performance and injury prevention in volleyball players.
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Healthy Volunteer
Researchers are studying pregnant women with placenta previa and placenta percreata, conditions linked to risks such as severe bleeding during labor. Placenta previa involves the placenta covering the cervix and is classified into total, partial, marginal, and asymptomatic types. Placenta percreata occurs when the placenta invades the uterine muscle and outer surface, increasing complications and requiring careful management. This study aims to examine specific molecules including decorin, laminin, collagen-1, TGFβ-1, and PDGF in placentas from affected women to better understand these conditions. Participants hospitalized for treatment of placenta previa or percreata will have blood samples taken before surgery and cord blood collected after birth. A piece of placenta and umbilical cord tissue will also be collected after delivery from medical waste. Samples will be processed and stored for analysis and future research. Control group participants, matched by gestational age and pregnancy number, will also provide tissue and blood samples if they deliver at term. Women involved in the study will undergo routine blood testing and provide consent for sample collection during hospitalization and delivery. Researchers will measure levels of the targeted molecules in placenta tissue and maternal and cord blood. The study includes storage of samples at -80 degrees Celsius for current and future studies. Participation depends on meeting eligibility and exclusion criteria, and those delivering prematurely or withdrawing will be excluded from the control group.
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Researchers are evaluating whether Socratic questioning can be an effective alternative method to promote weight loss in adults aged 18 to 65 with obesity in a primary care setting. This pragmatic randomized controlled pilot trial compares the use of Socratic questioning during follow-up visits with regular care to see if it leads to greater weight loss. The study also includes training for physicians on the Socratic questioning technique and uses the Hospital Anxiety and Depression Scale to screen participants. Participants are randomly assigned to either the intervention group, where physicians apply Socratic questioning during counseling, or the control group, where physicians provide routine obesity management. The study involves five in-person visits over three months, occurring every 15 or 30 days. At these visits, participants receive brief counseling and have their weight, height, and waist circumference measured at certain visits. Initial screening and group assignments are recorded, and mental health referrals are made if needed. During the study, participants complete baseline and final questionnaires, including demographic questions and anxiety and depression assessments. Researchers monitor changes in body weight from baseline to three months as the primary outcome. Physicians record data in the health system and share it with the research team for analysis. At the end of the study, feedback surveys are collected from participants and physicians in the intervention group to evaluate the process.
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This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.
Actively Recruiting
Scapular winging is a condition where the shoulder blade sticks out abnormally, affecting shoulder movement and function. This research evaluates the effects of proprioceptive neuromuscular facilitation (PNF) on shoulder girdle function and quality of life in people with scapular winging. The study is designed as a randomized controlled trial to explore how PNF might improve muscle coordination and strength around the shoulder blade, potentially leading to better clinical outcomes and enhanced quality of life. Participants in the PNF group will receive therapy focusing on scapular diagonal movements for about 20 to 30 minutes per session, three times a week, over a period of five weeks. This approach aims to improve scapular positioning and muscle tone. A control group will receive no intervention during the study period. Both groups will be assessed before and after the intervention period. Throughout the study, participants will undergo various evaluations including tests for scapular muscle endurance, shoulder posture assessment, and questionnaires measuring arm and shoulder function as well as overall quality of life. These assessments will help researchers measure the impact of PNF on shoulder function and life quality. The main outcome will be measured using the Biodex System 3 Pro after one week. The total involvement in the study spans the five-week treatment period with pre- and post-study evaluations.