It is estimated that at least 5 million Americans have the autoimmune disease lupus, with more than 16,000 new cases of lupus being reported annually in the U.S. Many patients take to Twitter to share their disease experience. With this study, we want to better understand Lupus patients who use...
Engaging in even modest physical activity improves health and well-being, such as decreasing cholesterol and improving mood. However, despite the benefits of physical activity, less than 10% of older adults meet national physical activity guidelines. Health-related smartphone applications (apps) provide a promising approach to increase older individuals' physical activity. The purpose...
Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a major cause of death and disability (secondary to myocardial infarction, stroke and amputation). The mortality in patients...
Parkinson’s Disease involves the loss of brain cells that produce dopamine, a messenger that sends information to the parts of the brain that control movement and coordination. Lower than normal levels of dopamine in the brain causes the symptoms of Parkinson’s, including muscle stiffness, resting tremor (uncontrollable shaking), and slowing...
Several drugs (blood vessel dilators), including macitentan, are currently approved for the treatment of pulmonary arterial hypertension (PAH) in many parts of the world. These drugs have significantly improved the outcome of the condition. However, none of these treatments have been evaluated in portopulmonary hypertension, a form of PAH caused...
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...
This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best...
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...
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 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...
An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease
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...
The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
This is a phase 2 trial seeking to define the safety and activity of gemcitabine, cisplatin, plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy.
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.
