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Filter by:The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.
This study will be a prospective, non-randomized study of low-vision individuals diagnosed with either age-related macular degeneration (AMD) or diabetic macular edema with ETDRS visual acuity from 20/60 to 20/400 in both eyes from the University of Texas - Southwestern (UTSW) Medical Center at Dallas. Specifically, the primary objective of this testing is to establish the benefits of a wide field-of-view (FOV) monocular head-mounted visual enhancement device display (HMD), aiding the most degraded eye, as compared to best corrected visual acuity with glasses. It should be noted that in this approach, the HMD incorporates a camera, mounted coaxially with the visual axis of the eye with worse vision, and also image-enhancing or correction algorithms. Following review and execution of the informed consent, each subject will undergo an examination of their eyes, including: 1) ETDRS Best-corrected distance visual acuity; 2) Best-corrected near visual acuity; 3) Tests based on questions 5,6,7 and 11 of the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25).
This study investigates the efficacy of secukinumab in necrobiosis lipoidica diabeticorum (NLD).
This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause. The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.
This study may determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Medical records will be accessed to find any information pertaining to postoperative complications. Additionally, it may determine the cognitive dysfunction of patients undergoing CEA, assessed by Mini Mental Status Examination (MMSE).
The primary objective of this study is to measure the prevalence of preoperative dehydration in elective major abdominal urologic surgery when we apply our daily standard operation procedures. Secondary objectives are to assess the impact of preoperative dehydration on postoperative outcome. The hypothesis is that preoperative dehydration leads to more postoperative complications.
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive, HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA will be extracted and sequenced at a central laboratory, using a HER2-targeted next generation sequencing (NGS) test. A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Participants who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and failed two weaning attempts. The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.
This is a randomized, double-blinded, placebo-controlled pilot study to determine the safety, acceptability, and feasible pediatric dosage/tolerability of enterade® solution, an amino acid-based oral rehydration solution (AA-ORS), for potential use in the management of environmental enteric dysfunction (EED) among children aged 12-24 months in Kakamega County, Kenya. Primary objectives: 1. To determine the safety of a 2-week course of AA-ORS among children with length-for-age Z-scores (LAZ) between -1 and -3. 2. To determine the feasibility and best tolerated dose of AA-ORS among children with LAZ between -3 and -1. Secondary objectives: 3. To determine the perceptions among caregivers on the acceptability of AA-ORS as a potential intervention for EED. (Qualitative) Exploratory objectives: 4. To determine the impact of AA-ORS on markers of metabolism, gut dysfunction, systemic inflammation, and micronutrient status among children with LAZ between -3 and - 1. Qualitative results will not be reported on ClinicalTrials.gov.