The Alzheimer Prevention Trials (APT) Webstudy is designed to accelerate enrollment into Alzheimer’s clinical trials by identifying and tracking individuals online, who may be at higher risk for developing Alzheimer’s. The Alzheimer’s Association estimates that 5.5 million Americans age 65 and older are currently living with Alzheimer’s dementia. It’s believed...
Atopic Dermatitis is a form of eczema that causes dry, scaly, itchy skin. More than 3 million cases are reported in the U.S. each year. People with this skin condition often have problems with bacterial skin infections caused by a specific bacteria known as, Staph aureus, or just Staph. Patients...
Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually and despite effective antivirals causes significant morbidity and mortality (estimated 24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the U.S) but in contrast...
Cardiovascular disease (narrowed or blocked blood vessels) is the leading cause of death, killing 1 of every 2 women. Atherosclerosis (hardening of the arteries) is the major cause of cardiovascular disease. More than 90% of deaths due to atherosclerosis occur after menopause when a women’s production of estrogen disappears....
RXDX-101-01 is a multicenter, open-label, Phase 1/2a study in which the safety and efficacy of RXDX-101 will be evaluated in adult patients with any locally advanced or metastatic solid tumor. The primary objective of the Phase 2a expansion cohorts is Objective Response (OR) defined as Complete Response(CR) and Partial Response...
This is a randomized, double blind, placebo and active controlled, multicenter, parallel group Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800 subjects will be randomized to 1 of 4...
Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns as assessed by time to healing and scarring
RATIONALE: Heart failure is a major cause of morbidity and mortality. CardioMEMS HF System is an FDA approved implantable device that wirelessly measures and monitors pulmonary arterial pressure and heart rate. The CHAMPION trial demonstrated that management of heart failure using pulmonary artery pressure information obtained with the CardioMEMS HF...
This study is 24 month, multicenter study in 280 living donor liver transplant patients from Asia, Europe and Canada. The study also have an long term extension in Japan and approximately 28 patients will be included to evaluate the long-term efficacy and safety of concentration-controlled everolimus regimen plus reduced tacrolimus...
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of the Inspire Upper Airway Stimulation System to treat obstructive sleep apnea.
Rationale: The aim of the project is to develop a long-acting once-weekly GH product which is a safe and efficacious but has greater convenience and thus potentially better compliance compared to standard once daily GH treatment. Intervention: Subjects will receive subcutaneous injection of study drug ( NNC0195-0092, Norditropin FlexPro or...
This study is aimed at understanding brain and hunger responses to different types of sugars and how this influences feeding behavior in lean and obese people.
The purpose of this study is to determine if colon cancer or precancerous colon polyps can be predicted from examining the lining of the rectum with a special harmless light. If so, primary care physicians will be able to determine from this simple test which of their patients actually needs...
Head and neck carcinomas (HNC) describe cancers of the upper digestive tract which include squamous cell cancers (SCCHN) of the mouth, throat, and vocal chords. At present, there is no effective standard of care that provides survival benefits beyond 4 - 6 months in second line treatment of SCCHN that...
Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries. The purpose of this trial is...
The purpose of this study is to explore the effects of early intensive antiretroviral therapy (ART) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among HIV-infected infants. The study will enroll two cohorts. Cohort 1 will include infants at high risk for in utero...
This is a phase II study of AZD1775 plus chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients will receive AZD1775 plus carboplatin or AZD1775 plus pegylated liposomal doxorubicin (PLD). The primary endpoint for the study is overall response rate (ORR) defined as the proportion...
Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to three hundred twenty-five (325) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older,...
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After re-placement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1...
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge...
This is an open-label, multicenter, randomized Phase 3 study of patients with Stage IIIB/IV NSCLC of adenocarcinoma histology.Primary Objective is to evaluate and compare overall survival (OS) in non-small cell lung cancer (NSCLC) patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel alone.Ganetespib is a novel...
