Search Bar & Filters
Found 9 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating how an accelerated rehabilitation program compares to conventional rehabilitation in improving knee joint function and quality of life for individuals undergoing primary unilateral total knee arthroplasty (TKA) in Dali, Yunan, China. This double-blind randomized controlled trial includes patients aged 50 to 80 years with end-stage knee osteoarthritis requiring surgery. The goal is to provide insights into how faster rehabilitation might affect recovery and long-term outcomes after knee replacement surgery. Participants will be randomly assigned to receive either an accelerated exercise program based on optimal and accelerated concepts or a routine conventional exercise program after their surgery. Both groups will follow their respective rehabilitation protocols postoperatively to help restore knee function and improve quality of life. Throughout the six months following surgery, researchers will measure knee joint function using the Knee injury and Osteoarthritis Outcome Score (KOOS) and assess quality of life with the SF-36 survey. The study includes regular monitoring and assessments to track recovery progress and long-term benefits of the rehabilitation approaches, with the entire participation lasting six months after surgery.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of accelerated intermittent theta burst stimulation (aiTBS), a form of repetitive transcranial magnetic stimulation (rTMS), in adolescents aged 12 to 18 years with major depressive disorder who exhibit non-suicidal self-injury (NSSI) and suicidal thoughts or behaviors. This study aims to compare active aiTBS treatment with a placebo control to see if it can reduce self-injury and suicidal attempts, measuring changes in clinical ratings and brain activity. The trial involves hospitalized patients and assesses mood, anxiety, mania, self-harm behaviors, suicidal ideation, and overall functioning using various standardized scales and interviews.
Actively Recruiting
Researchers are evaluating the efficacy and safety of fecal microbiota transplantation (FMT) in patients with major depressive disorder (MDD) who show limited early improvement from antidepressant treatment. This study focuses on patients who have a suboptimal response to initial treatment with escitalopram and aims to understand how FMT affects depression symptoms as well as biological factors like intestinal microbiota and metabolites. Participants will first receive escitalopram for 2 weeks. Those who show less than a 20% improvement in depression symptoms will be randomly assigned to one of two groups. One group will continue escitalopram and take FMT capsules daily for 4 weeks, while the other group will take placebo capsules made of corn starch alongside escitalopram. After the 4-week treatment, all participants will be followed for an additional 20 weeks to assess outcomes. During the study, participants' depression levels will be measured using the Hamilton Depression Rating Scale at baseline, week 4, and week 8 to assess changes in symptoms. Researchers will also monitor safety and any side effects throughout the study and follow-up periods. The total study duration includes screening, treatment, and long-term follow-up over several months to thoroughly evaluate the effects of FMT as an adjunct to antidepressant therapy.
Actively Recruiting
Researchers are investigating the effects of intermittent theta burst stimulation (iTBS) on increased appetite caused by antipsychotic medications in people with schizophrenia. Antipsychotics often lead to metabolic side effects such as weight gain and insulin resistance, increasing mortality risk. This study aims to evaluate the safety and effectiveness of iTBS in reducing appetite in this population. The trial involves 60 patients with schizophrenia who will be randomly assigned to receive either active or sham iTBS targeted at the left dorsolateral prefrontal cortex. The active treatment consists of 600 pulses delivered over 3 minutes, repeated five times daily at 60-minute intervals for 5 days. The study compares changes in appetite, clinical symptoms, mood, cognition, metabolic indicators, and brain activity before and after the intervention. Participants will undergo multiple assessments including appetite questionnaires, clinical scales for symptoms and mood, cognitive tests, blood and feces sample collection for metabolic and microbiota analysis, and brain imaging with MRI and arterial spin labeling. Safety will be monitored through symptom and adverse event scales. Outcomes will be measured at baseline, immediately after treatment, and at 2 and 4 weeks post-treatment to track changes in body mass index and other key indicators.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients who have experienced an acute ischemic stroke. This prospective, multicenter, randomized controlled Phase 4 trial focuses on patients aged 70 years and older who receive treatment within 4.5 hours of stroke onset. The study aims to compare low-dose tenecteplase with the standard dose to understand its impact on stroke recovery in aging patients. Participants are randomly assigned to one of two groups: a low-dose group receiving tenecteplase at 0.175 mg/kg (up to 17.5 mg per patient) or a standard-dose group receiving tenecteplase at 0.25 mg/kg (up to 25 mg per patient). Treatment is administered intravenously as thrombolysis. The trial monitors patients closely to assess how these dosing strategies affect recovery and safety. During the study, researchers will evaluate neurological function using the Modified Rankin Scale 90 days after treatment, measuring the percentage of participants who achieve a score of 0 or 1, indicating no symptoms or no significant disability. Patients will undergo neurological assessments and safety monitoring throughout the trial. The study ensures informed consent and collects relevant clinical data to support its findings on tenecteplase use in elderly stroke patients.
Actively Recruiting
Schizophrenia is a serious mental illness that often leads to significant health challenges, including metabolic side effects from antipsychotic medications such as weight gain and abnormal cholesterol levels. This research focuses on patients with schizophrenia who also have dyslipidemia, a condition affecting blood lipid levels, and aims to understand how atorvastatin, a cholesterol-lowering drug, impacts glucose metabolism. The study also investigates whether adding metformin, a diabetes medication, can improve these metabolic issues. The goal is to better manage the risks of cardiovascular disease and diabetes in this patient group through more effective treatment strategies. Participants in this study will be randomly assigned to one of two groups. One group will receive atorvastatin at a dose of 20 mg daily combined with metformin at 1000 mg daily, while the other group will receive atorvastatin 20 mg daily with a placebo that looks like metformin but has no active ingredients. The treatment period lasts six months, with evaluations at the start, three months, and six months. Participants must meet specific cholesterol and glucose criteria before joining, and their symptoms and medications must be stable. Throughout the study, participants will undergo multiple blood tests to measure fasting blood glucose, glycated hemoglobin (HbA1c), and glucose tolerance to monitor changes in glucose metabolism and lipid levels. These assessments will occur at baseline, three months, and six months to track how atorvastatin affects insulin resistance and blood sugar control, and whether metformin can reduce any negative effects. The results will help clarify how to best manage metabolic complications in schizophrenia patients on statins, aiming to improve their overall health and reduce risks related to heart disease and diabetes.
Actively Recruiting
Healthy Volunteer
Researchers are investigating how metformin treatment affects cognitive impairment in people with schizophrenia. This Phase 3 study will compare individuals with schizophrenia to healthy volunteers in terms of cognition and brain MRI features. It also aims to evaluate differences between those receiving metformin and those given a placebo over a 24-week treatment period. Biological samples will be collected to explore the underlying mechanisms of metformin's effects. Participants diagnosed with schizophrenia will be randomized in a 2:1 ratio to receive either metformin or placebo for 24 weeks. The metformin group will start with 500 mg once daily in the evening, increasing gradually to 500 mg three times daily, maintaining the highest tolerated dose. The placebo group will have matching dose adjustments to keep consistency. Participants without metabolic syndrome will only undergo baseline evaluations. Healthy volunteers will also be recruited and assessed at baseline. Throughout the study, participants will undergo assessments at baseline, 12 weeks, and 24 weeks. These include physical exams, blood tests, MRI scans, and various psychiatric and cognitive function scales. The cognitive function will be measured using the MATRICS Consensus Cognitive Battery. Safety and clinical symptoms will be monitored using multiple standardized scales. The primary outcomes measured are changes in cognition scores and brain blood flow from baseline to weeks 12 and 24.
Actively Recruiting
Researchers are studying the effects of normobaric oxygen (NBO) therapy on patients who have experienced an acute ischemic stroke (AIS) and are transferred for endovascular thrombectomy (EVT). The goal is to assess the safety and effectiveness of NBO in improving functional outcomes three months after stroke. Stroke is a major cause of death and disability worldwide, and while treatments like mechanical thrombectomy can improve blood flow, less than half of patients with large vessel occlusion achieve good recovery. NBO offers potential brain protection by improving oxygen delivery to affected areas and reducing damage through multiple mechanisms. Participants will receive either inhaled 100% oxygen (NBO) or best medical care without NBO. The study focuses on patients transferred for EVT who meet specific stroke severity and imaging criteria. NBO treatment is delivered through oxygen inhalation, aiming to increase oxygen availability to the brain before reperfusion. The study is conducted in a Phase 3 setting and compares outcomes between those receiving NBO and those receiving standard care. During the study, participants will be monitored for disability levels using the modified Rankin scale at 90 days and one year after treatment. Assessments include neurological exams and imaging to confirm stroke details and severity. Researchers will also track safety and functional outcomes to evaluate the impact of NBO therapy. Participants are followed for at least three months after randomization to observe recovery and potential benefits.
Actively Recruiting
Researchers are conducting a phase 2, double-blind, randomized, placebo-controlled, multi-center study to evaluate the effectiveness and safety of Kylo-11 in people with atherosclerotic cardiovascular disease (ASCVD) who have elevated lipoprotein(a) levels. The study aims to find the appropriate dose of Kylo-11, which is given as a subcutaneous injection, compared to a placebo. Elevated lipoprotein(a) is a type of lipoprotein disorder that may contribute to cardiovascular risks. Participants will receive either Kylo-11 or a matched placebo by subcutaneous injection. The study is designed to find the best dose by comparing different amounts of the drug against placebo over the treatment period. The treatments are administered in a blinded manner, meaning neither the participants nor the researchers know who receives the active drug or placebo. During the study, researchers will monitor participants' lipoprotein(a) levels to measure the percent change from baseline over weeks 8 through 26. Participants will undergo various safety and efficacy assessments throughout the trial to evaluate Kylo-11's effects. The total age range for participants is from 18 to 80 years old, and safety monitoring will ensure participants meet the study criteria and do not experience adverse effects.