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Found 9 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the effectiveness of an accelerated rehabilitation program compared to conventional rehabilitation for individuals aged 50 to 80 years undergoing primary unilateral total knee arthroplasty TKA due to knee osteoarthritis. This double-blind randomized controlled trial aims to assess improvements in knee joint function and quality of life following surgery. The study is conducted in Dali, Yunan, China, and seeks to provide important insights into post-operative recovery for TKA patients. Participants will be randomly assigned to one of two groups an accelerated rehabilitation group using exercise based on optimal and accelerated concepts, or a conventional rehabilitation group following routine exercise programs. Both programs focus on rehabilitation after total knee replacement and will be followed for six months post-surgery to evaluate longer-term outcomes. During the study, participants will have their knee function assessed using the Knee injury and Osteoarthritis Outcome Score KOOS from enrollment through the six-month follow-up. Quality of life will also be measured using the SF-36 surveys. The trial will monitor participants recovery progress, functional outcomes, and overall well-being after surgery under controlled conditions.

Age: 50Years - 80YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are studying the use 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 have experienced non-suicidal self-injury NSSI or suicidal thoughts and behaviors. This trial aims to compare the effects of active aiTBS to a placebo sham treatment on reducing self-injury and suicidal behavior, assessing changes in clinical symptoms and brain function. The study is conducted with hospitalized patients and includes careful safety monitoring due to the sensitive nature of the conditions. Participants will be randomly assigned to receive either active or sham aiTBS treatments applied to the left dorsolateral prefrontal cortex. The active treatment consists of 1800 pulses delivered in 9-minute sessions, five times per day, with 60-minute intervals between sessions, for 10 consecutive days. The sham group will receive a placebo stimulation schedule matching the active treatment. Magnetic resonance imaging MRI scans will be performed before and after the treatment period to observe changes in brain structure and activity. Blood tests will monitor endocrine and metabolic changes related to NSSI, and pain sensitivity will be tracked daily. Throughout the study, participants will undergo assessments at baseline, immediately after the 10-day treatment, and at 4 and 8 weeks post-treatment. These evaluations include depression and anxiety rating scales, suicide and self-injury inventories, functional disability assessments, and monitoring for treatment side effects. The primary outcome is the change in self-harm behavior measured by the Deliberate Self-Harm Inventory. Safety will be closely observed using symptom scales and adverse event records, ensuring participant well-being during the trial lasting approximately 8 weeks post-treatment.

Age: 12Years - 18YearsAll GendersPhase Not Applicable
2 locations
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Actively Recruiting

Researchers are evaluating the use of fecal microbiota transplantation FMT as an additional treatment for patients with major depressive disorder MDD who show a limited early response to antidepressant medication. This randomized, double-blind, placebo-controlled study includes participants who have started treatment with the antidepressant escitalopram but have not improved sufficiently within the first two weeks. The study also investigates how FMT affects biological markers, including gut microbiota and related metabolites, in individuals with MDD. Participants first receive escitalopram for two weeks, after which those with less than 20% improvement are randomly assigned to one of two groups. One group continues escitalopram and takes daily oral FMT capsules derived from healthy human fecal microbiota for four weeks. The other group continues escitalopram and takes placebo capsules containing corn starch for the same period. Following the treatment phase, participants are monitored through a 20-week follow-up to assess outcomes. During the study, participants undergo regular evaluations including depression rating scales such as the Hamilton Depression Rating Scale HAMD-17, as well as assessments of anxiety, sleep quality, cognitive function, and brain imaging including EEG. Safety and side effects are monitored throughout all study visits, which occur at baseline, week 4, week 8, week 12, and week 24. The primary measure of success is the rate of significant symptom improvement at various time points, with ongoing observation of remission rates and biological changes.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
9 locations
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Actively Recruiting

This research aims to evaluate the safety and effectiveness of intermittent theta burst stimulation iTBS in reducing increased appetite caused by antipsychotic medications in people with schizophrenia. The study addresses the metabolic side effects such as weight gain, high blood sugar, and cholesterol issues that raise the risk of death in these patients. It focuses on a less commonly studied iTBS mode compared to conventional repetitive transcranial magnetic stimulation rTMS. Participants will be randomly assigned to receive either active or sham iTBS applied to the left dorsolateral prefrontal cortex. The active group will undergo 600 pulses of iTBS lasting 3 minutes, five times daily with 60-minute breaks, for 5 consecutive days. The sham group will receive a similar schedule without active stimulation. This treatment period is followed by monitoring at 2 and 4 weeks after intervention. During the study, changes in appetite will be assessed using various questionnaires and a visual scale, while clinical symptoms, mood, and cognitive function will also be evaluated. Blood and feces samples will be collected to measure metabolic and neuroregulatory markers, including gut flora changes. Brain activity and blood flow will be monitored by MRI scans before and after treatment. Safety will be checked through symptom scales and adverse event records. The primary outcome is the change in body mass index BMI from baseline to 4 weeks post-treatment.

Age: 18Years - 40YearsAll GendersPhase Not Applicable
2 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients aged 70 and older who have experienced an acute ischemic stroke. This multicenter, randomized controlled trial focuses on treatment within 4.5 hours of stroke onset to assess how this therapy may improve neurological outcomes compared to a standard dose. Participants are randomly assigned to receive either a low dose 0.175 mgkg, up to 17.5 mg or a standard dose 0.25 mgkg, up to 25 mg of tenecteplase given intravenously. The study is designed as a parallel-group trial comparing these two dosing regimens to understand which may be more beneficial and safe for elderly stroke patients. Participants will be monitored for recovery and safety through neurological assessments using scales such as the Modified Rankin Scale and the National Institutes of Health Stroke Scale up to 90 days after treatment. Outcomes like neurological improvement, functional independence, quality of life, and any bleeding events will be closely measured. The trial will continue until December 2028, with follow-up visits planned to evaluate participants progress and overall health.

Age: 70Years +All GendersPhase 4
51 locations
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Actively Recruiting

Schizophrenia is a serious mental disorder linked to significant disability and health risks, including metabolic side effects like weight gain and dyslipidemia caused by antipsychotic medications. This trial investigates how atorvastatin, a cholesterol-lowering drug, affects glucose metabolism in patients with schizophrenia who have dyslipidemia, and whether metformin can help improve these metabolic issues. Researchers aim to understand the impact of statins on blood sugar and insulin resistance and explore metformins potential benefits for these patients. Participants will be randomly assigned to two groups one receiving atorvastatin 20 mg daily combined with metformin 1000 mg daily, and the other receiving atorvastatin 20 mg daily with a placebo that looks like metformin. The study lasts six months, with follow-up assessments at three and six months. During this time, patients will take their assigned medications daily, and researchers will monitor their glucose metabolism and lipid levels. Participants will undergo blood tests at baseline, three months, and six months to measure fasting blood glucose, glycated hemoglobin, insulin levels, and lipid profiles. Additional assessments include oral glucose tolerance tests, abdominal ultrasound, and mental health evaluations using standardized scales. The study monitors changes in glucose metabolism and schizophrenia symptoms while tracking safety and treatment adherence over six months.

Age: 18Years - 65YearsAll GendersPhase 3
8 locations
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Actively Recruiting

Researchers are evaluating normobaric hyperoxia NBO as a treatment for patients who have experienced an acute ischemic stroke and are transferred for endovascular thrombectomy EVT. The study aims to assess the effectiveness and safety of NBO in improving functional outcomes at 3 months after stroke. Stroke is a leading cause of death and disability, and although reperfusion treatments like thrombectomy improve blood flow, less than half of patients achieve favorable recovery. NBO is thought to protect the brain by rescuing hypoxic tissue and reducing damage processes, with advantages such as low cost and easy use. Participants will be randomly assigned to receive either NBO, which involves inhaling 100% oxygen alongside the best medical care, or best medical care alone. The study compares these two groups to see if NBO provides additional benefits. The treatment is given during the acute phase before or during transfer for EVT. The study includes a single-blind design and follows patients for outcomes over time. During the study, participants will have their disability level measured using the modified Rankin Scale at 90 days and one year after randomization. Other assessments include neurological function scores, imaging scans, infarct volume changes, and quality of life questionnaires at various time points. Safety and recovery progress are closely monitored throughout, with follow-up visits to track long-term effects. The total participation duration includes initial treatment and follow-up through one year.

Age: 18Years +All GendersPhase 3
112 locations
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Actively Recruiting

Researchers are evaluating the drug Kylo-11 in adults with atherosclerotic cardiovascular disease ASCVD who also have elevated levels of lipoproteina, a condition related to cardiovascular risk. This phase 2, double-blind, randomized, placebo-controlled study aims to find the effective dose and assess the safety of Kylo-11 compared to a placebo in this population. Participants will receive one of three different doses of Kylo-11 or a matched placebo, all administered by injection under the skin subcutaneously. The study is conducted across multiple centers with participants randomly assigned to one of the treatment groups. The treatment period includes monitoring of changes in lipoproteina levels over various weeks to assess the drugs impact. During the study, participants will have regular assessments including measuring lipoproteina levels at baseline and throughout weeks 8 to 52. Researchers will also track the proportion of participants achieving specific target levels of lipoproteina. Safety and efficacy will be closely monitored, with the primary focus on the percent change in lipoproteina from baseline during the treatment period. The total study duration extends until 2028 with primary completion expected by early 2027.

Age: 18Years - 80YearsAll GendersPhase 2
59 locations
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Actively Recruiting

Researchers are studying children with Tourette Syndrome TS to understand how the herbal treatment Pei Tu Ning Feng Tang may affect symptoms and brain function. The study focuses on examining changes in gut bacteria, blood stress hormones, oxidative stress markers, cytokines, neurotransmitters, and hair cortisol levels before and after treatment. Brain activity is measured using functional near-infrared spectroscopy fNIRS to explore how the treatment may influence brain function related to tics. Researchers also assess tic severity using the Yale Global Tic Severity Scale and a Traditional Chinese Medicine symptom score sheet specific to pediatric TS. Participants receive Pei Tu Ning Feng Tang, which is prepared by boiling a combination of specific herbs including Codonopsis pilosula, Astragalus membranaceus, and others in multiple steps to create the decoction. The treatment is given over a one-month period. Before and after this treatment, various biological samples and measurements are taken to observe changes in gut microbiota, short-chain fatty acids in feces, stress hormones, oxidative markers, cytokines, and neurotransmitters. The study is designed as a single-group interventional trial. During this one-month study period, children undergo brain scans using fNIRS and complete questionnaires to evaluate symptoms and treatment effects. Researchers collect and analyze biological samples to understand the treatments impact on physiological markers related to TS. The primary outcomes focus on brain function activation and changes in gut microbiota and biochemical markers from enrollment through the end of treatment. Continuous monitoring of symptoms and biological changes helps clarify the treatments potential mechanisms and effects.

Age: 4Years - 15YearsAll GendersPhase Not Applicable
1 location