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NCT01131676
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
NCT00483574
This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine.
NCT02011204
This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular diseases, and healthy volunteers to see if the EIM device can measure disease in muscle tissue.
NCT01211145
The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).
NCT00263042
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors. The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.
NCT00449605
The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months. The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
NCT00876044
The primary objective of this study is to evaluate the effects of aflibercept on the QTc interval in cancer patients. Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.
NCT01546519
This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate the pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies (including hepatocellular carcinoma and lymphoma) that are refractory to standard therapy or for whom no standard therapy exists.
NCT01585987
The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
NCT00212329
Type 1 diabetes is a condition that is caused in part by an abnormality of the immune system which occurs when T cells, which are part of the immune system, damage the insulin secreting cells (islet cells) in the pancreas. Although it is known that T cells are important mediators of the disease, progress in the development of reliable T cell assays has been modest. The purpose of this study is to learn which T cell assays are most reliable and reproducible so that the investigators can improve their understanding about how type 1 diabetes occurs.
NCT01880177
The purpose of this qualitative work is to inform the content and structure of a new screening measure for identifying undiagnosed at-risk COPD cases in primary care and support content validity of the measure. This work will build on the results of a comprehensive literature review and data mining analyses by identifying the symptomatic and health event experiences of at-risk and newly diagnosed patients, as described by the patients themselves. Specific objectives are as follows: Objective 1: To elicit concepts and symptom descriptions of COPD from patients with a recent diagnosis of COPD and those without a diagnosis but with risk factors for the disease. The qualitative information obtained in these focus groups will be used to develop a new questionnaire for identifying undiagnosed at-risk COPD cases in various clinic settings. Objective 2: To review the new questionnaire with a new set of participants with a recent COPD diagnosis or those at risk for COPD to ensure that: (a) the instructions are clear, (b) the content of each question is appropriate and understandable to participants, (c) the intended connotation of each questions is consistent with participants' interpretation or assigned meaning, and (d) to assure that content is not seen as redundant across items. This will be done through one-on-one cognitive interviews. Objective 3: To gather data on the ease/difficulty of peak flow meter use by people without or with a new diagnosis of COPD and the consistency of readings between electronic and mechanical readings in these patients. This information will be used to inform the development of peak-flow meter instructions for use as part of the screening methodology.
NCT00681291
This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.
NCT00262860
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.
NCT01599715
More than one in three US women suffers from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). UI severity increases with age and the financial cost exceeds $19 billion per year . The Adult Conservative Management Committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI; and that bladder training (BT) may be preferred to drug therapy. Conservative strategies are low risk and differ from other forms of UI management in that they do not prejudice future treatments. They also may decrease symptoms of urgency and frequency that do not entail UI, but greatly reduce the quality of life for nearly 1 in 11 US women.
NCT00291161
Background: Partners in Dementia Care (PDC) is a care coordination and support service intervention for veterans with dementia and their family caregivers, delivered through partnerships between VA medical centers and local Alzheimer's Association Chapters. PDC was designed to be a feasible and practical intervention to integrate health, community, and support services. PDC has a standardized protocol for care coordination and support services, including guidelines for care plan assessment, care plan development and implementation, ongoing monitoring, and reassessment. It also offers a structured training curriculum for providers and an operations manual for uniform implementation. Objectives: The primary objective was to test the impact of PDC on outcomes for veterans with dementia and family caregivers. Two specific research objectives and corresponding hypotheses were addressed: 1. To test the impact of PDC on three categories of outcomes: psychosocial well-being outcomes (patient and caregiver effects); health care service use (patient effects only); and health care cost (patient effects only). HI:PDC, compared to usual care, will improve psychosocial well-being for patients with dementia and their caregivers. H2:PDC, compared to usual care, will reduce health care service use for patients with dementia. H3:PDC is preferred to usual care based on cost-benefit analyses. H4:The PDC intervention will be more effective in improving psychosocial well-being and reducing health care service use for patients and caregivers dealing with more severe patient impairment (e.g., cognitive status, functional status, and level of problem behaviors). 2. To evaluate the impact of PDC on role and intra-psychic strains caused by dementia and its care (patient and caregiver effects). H5a:PDC, compared to usual care, will decrease patient role and intra-psychic strain. H5b:PDC, compared to usual care, will decrease caregiver role and intra-psychic strain. H6:The PDC intervention will be more effective in decreasing role and intra-psychic strains for patients and caregivers dealing with more severe patient impairment (e.g., cognitive status, functional status, and level of problem behaviors).
NCT01281202
The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.
NCT01944345
The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the VariLift device. Potential treatment procedures include bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be performed in either an inpatient or outpatient facility. It is anticipated that the VariLift devices will improve patient outcomes and lead to the development of treatment pathways to improve patient care.
NCT00321646
The main purpose of this trial is to collect information and to evaluate the effects, good or bad, the combination of docetaxel and bevacizumab has on patients with high risk prostate cancer that are undergoing radical prostatectomy.
NCT00848198
This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.
NCT01645280
The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.