About 976,673 results

A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy

Sep 24th, 2021 - This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.

Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).

Sep 24th, 2021 - Background: Among the new cases of bile tract carcinoma (BTC) that are diagnosed every year in the United States, there are approximately 6,500 cases of gallbladder carcinoma, 3,000 cases of extrahepatic cholangiocarcinoma, and 3,000 cases of intrahepatic cholangiocarcinoma. Current treatment options for patients with cholangiocarcinoma are limited and take no account of the known biological an...

Sample Collection Registry for Quality Control of Biological and Environmental Specimens and Assay Development and Testing

Sep 24th, 2021 - We propose a sample collection registry protocol for use in obtaining biologic and environmental samples anonymously from adult volunteers for use in laboratory assay evaluation. The samples will be used to determine if new tests are sufficiently valid and precise to be used in research studies and for quality control purposes. In studies involving the storage and analysis of laboratory specime...

Ipsilateral Peripheral Intravenous Access Procedures (The iPIVAP Study)

Sep 24th, 2021 - This prospective single arm study will be conducted within DUH Department of Radiology CT Imaging. The study team will enroll 50 patients with a history of axillary SLNP presenting for routine radiographic scan to undergo ipsilateral IV insertion. Patients will complete baseline bilateral arm volumetric measurements and self-reported symptom assessments. Patients will be followed every 3 months...

aCute HemORrhoidal Disease evALuation International Study

Sep 24th, 2021 - The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease

Physical, Functional and Neural Effects of Two Lower Extremity Exercise Protocols in Children With Cerebral Palsy

Sep 24th, 2021 - Objectives: Our primary objectives are to: 1) characterize and compare lower extremity motor coordination in children with cerebral palsy (CP) across mobility levels and to children without CP; and 2) evaluate the effects of two home-based exercise programs on motor coordination, as well as other physical, functional and neurological outcomes in children with CP. We hypothesize children with CP...

A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

Sep 24th, 2021 - This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.

Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design

Sep 24th, 2021 - The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental stu...

Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS)

Sep 24th, 2021 - This was a multicenter, open-label, single-arm, phase II, pilot study to evaluate the efficacy and safety of apremilast involving 21 patients with PPP. The screening period was up to 4 weeks and treatment took place over 20 weeks per patient. No follow up period took place. No extension was done. Recruitment period was 4 months; hence study duration from first patient in to last patient out was...

Stargardt-like Macular Dystrophy (STDG3) Secondary to Mutations in ELOVL4

Sep 24th, 2021 - Title: An Observational Prospective Natural History Study of Stargardt-like Macular Dystrophy (STDG3) Secondary to Mutations in ELOVL4 Study Description: Potential therapeutics for Stargardt-like macular dystrophy (STDG3) have been proposed. Cross-sectional studies of large families suggest progressive macular atrophy in STDG3 but there is a paucity of longitudinal data for these patients. The ...

Defining the COVID-19 Immunity Denominator in the Mekong: a Cross-Sectional Seroprevalence Study of SARS-CoV-2 in HealthyVolunteers

Sep 24th, 2021 - This is a cross-sectional study performed annually over 3 years to procure blood samples by fingerstick from healthy individuals living in the Phnom Penh area to evaluate seroprevalence to SARS-CoV-2. A mobile unit will move between various markets, schools, hospitals, clinics, parks, and other public places with local authority permissions. Participants with a positive result on the screening ...

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Sep 24th, 2021 - The purpose of this study is to assess the long-term safety, tolerability and clinical efficacy of repeated treatment with rozanolixizumab.

Open Label Extension for 43USSA1812

Sep 24th, 2021 - To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 to help characterize the long-term safety and effectiveness profile of the more dilute suspension.

Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen

Sep 24th, 2021 - OBJECTIVES: I. To precisely quantify the absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites in men consuming the two bread products to define relationships between dietary intake, isoflavone metabolism and the biological outcomes. II. To describe the safety as well as incidence and severity of toxicity in men consuming the control soy bread or ...

A Study of ZN-c3 in Patients With Platinum-Resistant Ovarian Cancer

Sep 24th, 2021 - This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3. This study consists of 4 cohorts in participants with platinum-resistant ovarian, peritoneal, or fallopian tube cancer. Each cohort will test a combination of ZN-c3 with either pegylated liposomal doxorubicin (PLD), carboplat...

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures

Sep 24th, 2021 - The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.

Selumetinib Paediatric NF1 Japan Study

Sep 24th, 2021 - This is a phase I open label study designed to evaluate the safety, tolerability, PK and efficacy of selumetinib in Japanese paediatric patients with neurofibromatosis type 1 and inoperable and symptomatic plexiform neurofibroma.

Cardiovascular Complications of Sickle Cell Disease

Sep 24th, 2021 - Cardiac magnetic resonance (CMR) has gained increasing clinical application in cardiopulmonary diseases. Due to its 3-dimensional nature, CMR is considered the gold-standard for quantifying left and right ventricular systolic function and size. Additionally, its high tissue contrast allows for a detailed characterization of myocardial tissue. Specifically, the use of techniques such as late gad...

AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma

Sep 24th, 2021 - The primary object of this study is to determine the efficacy of a targeted environmental intervention among overweight inner city children as compared to normal weight inner city children with asthma. Specific Aim #1: To determine if overweight inner-city children, compared to lean inner-city children, have greater improvement in asthma with an air purifier intervention aimed at reducing indoo...

Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease

Sep 24th, 2021 - The study will include up to 3 cohorts, with 12 subjects in each, for a total of up to 36 randomised subjects. The study comprises a screening period of up to 49 days, an 8-week double-blind treatment period, and a 13-week follow-up period. Each subject will receive three 60 minute iv infusions of MEDI1341 or placebo during the 8-week treatment period, with 4 weeks between infusions. The overal...