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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...
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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...
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Neuropathological Assessment as an Endpoint in Clinical Trial Design
Different neurodegenerative conditions can have complex, overlap** clinical presentations that make accurate diagnosis during life very...
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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,...
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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...
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The INGENIOUS trial: Impact of pharmacogenetic testing on adverse events in a pragmatic clinical trial
Adverse drug events (ADEs) account for a significant mortality, morbidity, and cost burden. Pharmacogenetic testing has the potential to reduce ADEs...
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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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Institutional barriers to clinical trial exploration experienced by the Latinx community
This study evaluated two types of barriers that the authors deemed important to resolve during the early stage of cancer clinical trial exploration...
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Interpersonal Values of Patients Participating in Phase II–III Clinical Trials: Implications for Clinical Trial Representativeness
BackgroundAn individual’s personal values strongly influence their immediate and long-term decisions. Psychological heterogeneity in clinical trial...
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Experiences of and recommendations on clinical trial design in Alzheimer’s disease from the participant’s point of view: a mixed-methods study in two clinical trial centers in the Netherlands
IntroductionIn the context of the development of pharmaceutical interventions, expectations and experiences of participants are essential. Their...
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The current status of clinical trials on cancer and age disparities among the most common cancer trial participants
ObjectiveTo illustrate the status of all cancer clinical trials and characterize clinical trial enrollment disparities in the most common cancer.
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Phase II clinical trial of sequential treatment with systemic chemotherapy and intraperitoneal paclitaxel for gastric and gastroesophageal junction peritoneal carcinomatosis - STOPGAP trial
BackgroundStudies from Asia indicate that normothermic intraperitoneal chemotherapy (NIPEC) may confer survival benefit in patients with gastric...
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Novel Clinical Trial Designs in Neuro-Oncology
Scientific and technologic advances have led to a boon of candidate therapeutics for patients with malignancies of the central nervous system. The...
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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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Impact of Clinical Trial Design on Recruitment of Racial and Ethnic Minorities
Knowledge related to how oncology treatment trial design influences enrollment of racial and ethnic minorities is limited. Rigorous identification of...
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Diagnostic accuracy and clinical value of [68Ga]Ga-FAPI-46 PET/CT for staging patients with ovarian cancer: study protocol for a prospective clinical trial
Background[ 18 F]Fluorodeoxyglucose ([ 18 F]FDG) positron emission tomography (PET) is recommended during diagnostic work-up for ovarian cancer;...
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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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Platelet-derived biomaterial with hyaluronic acid alleviates temporal-mandibular joint osteoarthritis: clinical trial from dish to human
BackgroundBioactive materials have now raised considerable attention for the treatment of osteoarthritis (OA), such as knee OA, rheumatoid OA, and...
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Centralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment
BackgroundRecruiting to multi-site trials is challenging, particularly when striving to ensure the randomized sample is demographically...
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How to Design a Therapeutic Trial in SCAs
Spinocerebellar ataxias (SCAs) are rare autosomal dominant inherited neurological disorders characterized by progressive cerebellar symptoms. In the...