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NCT ID: NCT00707590 Terminated - Clinical trials for Type 2 Diabetes Mellitus

Safety Study to Evaluate BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)

Start date: August 2008
Phase: Phase 1
Study type: Interventional

To assess the safety and tolerability and the PK/PD relationship of BMS-767778 administered as single and multiple oral doses in healthy subjects, and in subjects with T2DM

NCT ID: NCT00707239 Terminated - Clinical trials for Pneumonia, Bacterial

Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

Start date: December 2008
Phase: Phase 2
Study type: Interventional

This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of the investigator based on the subject's condition. Additional protocol specified antibiotics may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will be done 10 to 21 days after the last day of therapy. The total duration of subject participation will be between 17 and 44 days, including a follow up period of 30 days after the last day of therapy for SAEs. Subjects will be followed for safety and efficacy. The safety assessment will include: physical examinations, vital signs, assessment of the clinical signs and symptoms of pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology, serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before study entry for women of childbearing potential. The clinical and microbiological efficacy will both be evaluated.

NCT ID: NCT00706082 Terminated - Clinical trials for Pulmonary Hypertension

Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc)

DETECT
Start date: October 2008
Phase: N/A
Study type: Observational

A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension

NCT ID: NCT00705913 Terminated - Clinical trials for Aortic Valve Disease

Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Start date: June 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.

NCT ID: NCT00705601 Terminated - Clinical trials for Nonrestorative Sleep

Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study

Start date: August 2008
Phase:
Study type: Observational

To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning refreshment and uncovering problems in instrument administration in subjects with nonrestorative sleep

NCT ID: NCT00704847 Terminated - Osteoarthritis Clinical Trials

Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this phase III study is to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Patients with Osteoarthritis of the Knee

NCT ID: NCT00702819 Terminated - Clinical trials for Retinopathy of Prematurity

Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity

BLOCK-ROP
Start date: June 2008
Phase: Phase 1
Study type: Interventional

Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries. The retina lines the inside of the eye. It functions as "film" within the camera which is the eye. When an infant is born prematurely, the vascular network necessary to nourish the retina has not fully developed. As a consequence, in some infants abnormal vessels proliferate instead of the normal ones - a condition known as ROP. The abnormal vessels carry scar tissue along with them, and may lead to retinal detachment and blindness if the eye is not treated. The Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Study demonstrated that ablation of the peripheral avascular retina reduced the risk of poor structural and visual outcome due to retinal distortion or detachment in ROP (1980's). The ablated retina is not functional and is not amenable to regeneration. Peripheral retinal ablation is not universally effective in fostering regression of ROP. This is particularly true for an aggressive form of ROP (aggressive posterior ROP, or APROP) which typically afflicts profoundly premature and infirm neonates. In this subset of infants, progression of ROP to bilateral retinal detachment and blindness occurs despite timely and complete peripheral retinal laser ablation. Rationale The development of ROP is largely dependent on vascular endothelial growth factor (VEGF). When an infant is born prematurely the relatively hyperoxic environment the baby is introduced to shuts down the production of VEGF. Retinal maturation is delayed. Subsequently, at a time when intraocular VEGF levels would normally be declining late in the third trimester of pregnancy, abnormally high levels of VEGF are seen due to large areas of avascular retina and associated tissue hypoxia. The availability of FDA-approved drugs for anti-VEGF treatment renders it possible to treat such eyes off-label. Available drugs include pegaptanib sodium (Macugen) for partial blockage of VEGF-A, or drugs such as ranibizumab (Lucentis) and bevacizumab (Avastin), which cause complete blockage of VEGF-A. As VEGF is required in the developing retina for normal angiogenesis, and our goal is not to penetrate tissue, but to block the excessive levels of VEGF trapped within the overlying vitreous which is responsible for the abnormal vasculature in ROP. For purposes of this study the investigators have chosen bevacizumab (Avastin), which will: a) attain complete blockage (vs. Macugen) of intravitreal VEGF-A, and; b) which is limited in its ability to penetrate tissues because it is a full antibody (vs. Lucentis, an antibody fragment specifically designed for better tissue penetration), and is more likely to restore VEGF homeostasis within the developing retina.

NCT ID: NCT00701935 Terminated - Diabetes Mellitus Clinical Trials

Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Start date: August 2008
Phase: Phase 2
Study type: Interventional

A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.

NCT ID: NCT00701753 Terminated - Schizophrenia Clinical Trials

A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses

Start date: May 2008
Phase: N/A
Study type: Observational

An individual's genetic make-up is known to determine their response to antipsychotic medication. Genetic markers that determine efficacy and side effects of medication may be identified and used to predict treatment outcome. The study is a naturalistic study of routinely prescribed antipsychotics using outcome measures undertaken as part of the routine clinical care of the cohort. These clinical data are linked with genetic information obtained from DNA and RNA from blood samples undertaken as part of the study. No alteration is made to the subjects treatment regime or medication. The study is a two stage investigation: - The first stage involves the collection of a databank of clinical information and blood samples for DNA and RNA extraction from patients treated with antipsychotic medication. - The second stage is a molecular genetic investigation of treatment-related genetic factors that may contribute to response prediction and predisposition to side effects. From these genetic studies pharmacogenetic prediction tests will be validated and/or developed.

NCT ID: NCT00700700 Terminated - Clinical trials for Congestive Heart Failure

Cardiac Resynchronization Therapy, Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure (CHF)

Start date: October 2008
Phase: Phase 4
Study type: Interventional

A new therapy for patients with advanced heart failure (HF) involves the implantation of a specialized pacemaker device (Cardiac Resynchronization Therapy, CRT) that attempts to restore the synchronized contraction of the ventricular chambers of the heart. In some people, CRT improves exertional breathlessness and allows them to exercise for longer periods. However, to date, the mechanisms by which CRT improves symptoms and exercise tolerance is unknown. This study will use in-depth cardiopulmonary exercise testing and pulmonary function testing to explore these mechanisms in greater detail.