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Randomized Clinical Trials
Observational studies suffer from biases and confounding, which can never be completely eliminated. Whenever feasible and ethically appropriate, a... -
Common Clinical Trial Designs
Clinical Trials are studies conducted for the purpose of assessing the effect of an intervention in a defined population, or to evaluate one or more... -
NeuroEPO plus (NeuralCIM®) in mild-to-moderate Alzheimer’s clinical syndrome: the ATHENEA randomized clinical trial
BackgroundNeuroEPO plus is a recombinant human erythropoietin without erythropoietic activity and shorter plasma half-life due to its low sialic acid...
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A randomized clinical trial investigating the impact of magnesium supplementation on clinical and biochemical measures in COVID-19 patients
BackgroundThis study sought to examine the impact of magnesium supplementation on clinical outcomes and biochemical factors among hospitalized...
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Elements of Clinical Trial Protocol Design
Clinical trials are conducted for many reasons, including to determine whether a new drug is safe and effective for a therapeutic use. A clinical... -
AI-enabled electrocardiography alert intervention and all-cause mortality: a pragmatic randomized clinical trial
The early identification of vulnerable patients has the potential to improve outcomes but poses a substantial challenge in clinical practice. This...
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Bayesian interim analysis for prospective randomized studies: reanalysis of the acute myeloid leukemia HOVON 132 clinical trial
Randomized controlled trials (RCTs) are the gold standard to establish the benefit-risk ratio of novel drugs. However, the evaluation of mature...
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A randomized clinical trial of mindfulness meditation versus exercise in Parkinson’s disease during social unrest
Clinical practice guidelines support resilience training and exercise for patients with Parkinson’s disease (PD). This assessor-blinded, randomized...
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Novel technique for arterial reconstruction in simultaneous pancreas-kidney transplantation, a randomized clinical trial
IntroductionSimultaneous pancreas kidney (SPK) transplantation is an invaluable procedure to enhance the quality of life of insulin-dependent...
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Effects of intensive lifestyle changes on the progression of mild cognitive impairment or early dementia due to Alzheimer’s disease: a randomized, controlled clinical trial
BackgroundEvidence links lifestyle factors with Alzheimer’s disease (AD). We report the first randomized, controlled clinical trial to determine if...
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Phase I non-randomized clinical trial of allogeneic natural killer cells infusion in acute myeloid leukemia patients
IntroductionA new type of immune cell transplantation called allogeneic NK cell infusion is proposed as a potential universal off-the-shelf cell...
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Effects of flexor reflex stimulation on gait aspects in stroke patients: randomized clinical trial
BackgroundGait deficits are very common after stroke and therefore an important aspect in poststroke rehabilitation. A currently little used method...
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Evaluation of a new topical cream to psoriasis treatment: randomized clinical trial
The aim of this study is to develop a new topical cream for psoriasis and to test its results. Experimental clinical trial. Phase I: hypersensitivity...
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Insights adjusting for non-adherence in randomized clinical trials: a reanalysis of an adjuvant trial of tamoxifen duration in early breast cancer
BackgroundSeveral randomized clinical trials provide evidence of the survival benefit of extended adjuvant tamoxifen in women with estrogen receptor...
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Alliance for clinical trials in Oncology (Alliance) trial A022101/NRG-GI009: a pragmatic randomized phase III trial evaluating total ablative therapy for patients with limited metastatic colorectal cancer: evaluating radiation, ablation, and surgery (ERASur)
BackgroundFor patients with liver-confined metastatic colorectal cancer (mCRC), local therapy of isolated metastases has been associated with...
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Safety and efficacy of levetiracetam and carbamazepine monotherapy in the management of pediatric focal epilepsy: a randomized clinical trial
Due to the limited number of studies in children with focal epilepsy and the importance of choosing the most suitable drug to control seizures in...
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Thyroid V40 is a good predictor for subclinical hypothyroidism in patients with nasopharyngeal carcinoma after intensity modulated radiation therapy: a randomized clinical trial
BackgroundHypothyroidism (HT) and subclinical HT after radiotherapy is frequent in nasopharyngeal carcinoma (NPC) patients, results in negative...
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Considerations and Advances in Huntington’s Disease Clinical Trial Design
The characterization of the Huntingtin gene in 1993, 10 years after it was the first disease-associated gene to be mapped to a chromosome in humans,... -
Clinical Trial with Synbiotics in Various Disease State
Simultaneous use of prebiotics and probiotics for human health benefit is generally called synbiotic. Prebiotics is nonviable nutritional food... -
Consolidation chemotherapy after definitive concurrent chemoradiotherapy in patients with inoperable esophageal squamous cell carcinoma: a multicenter non-inferiority phase III randomized clinical trial
BackgroundDefinitive concurrent chemoradiotherapy (dCCRT) is the gold standard for the treatment of locally advanced esophageal squamous cell...