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NCT ID: NCT00947245 Withdrawn - Hepatitis C Virus Clinical Trials

Japanese Bridging Study Conducted in the United States

Start date: October 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.

NCT ID: NCT00946426 Withdrawn - Type 1 Diabetes Clinical Trials

Insulin Resistance in Type I Diabetes in Pediatric Care

Start date: July 2009
Phase: N/A
Study type: Observational

24 children (12 African-American, Hispanic, or American Indian, 12 Caucasian) previously diagnosed with type 1 diabetes mellitus will participate in this pilot study to evaluate the presence of hepatic and peripheral insulin resistance. The investigators will use this pilot information to test the hypothesis that insulin resistance occurs in some children with type 1 DM, is secondary to underlying risk factors, and is responsible for increased insulin needs. Methods will include a "step-up" hyperinsulinemic euglycemic clamp and infusion of the stable isotope 6,6-[2H2]-glucose. Patient and parent interviews will be conducted to gather information about nutritional intake, ethnicity, family history, and socioeconomic status. The investigators will also measure inflammatory cytokines and free fatty acids to determine whether they are associated with differences in insulin resistance among type 1 diabetes mellitus patients.

NCT ID: NCT00946166 Withdrawn - Clinical trials for Cardiovascular Risk Factors

Impact of Statins on Cytokine Expression in Pneumonia

Start date: July 2009
Phase: Phase 4
Study type: Interventional

The investigators are conducting a study to determine the effects of a cholesterol-lowering medication, called simvastatin on pneumonia. People in the study will be in the hospital because they have pneumonia. The people will also have a medical condition like heart disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has been shown to prevent future disease and/or death but are not taking a cholesterol-lowering medication when they go to the hospital. Some people will get treated with antibiotics only and other people will get antibiotics and simvastatin while they are in the hospital. The study will compare the effects the combination of simvastatin and antibiotics has on people with pneumonia to treatment with antibiotics alone.

NCT ID: NCT00945620 Withdrawn - Pain Control Clinical Trials

Trans-Abdominis Plane Block Efficacy for Post-Cesarean Section Pain

Start date: September 2009
Phase: N/A
Study type: Interventional

The primary aim of this study is to measure the magnitude and duration of trans-abdominis plane (TAP) block analgesia in parturients undergoing elective cesarean section with concurrent standard of care operative analgesic regimens including intrathecal morphine sulfate (ITMS). A one sided block model takes advantage of the bilateral nature of the pain created by a bilateral surgical wound and allows each patient to serve as her own control. Reduced variability allows a more definitive establishment of analgesic benefit for this block. The current reports of conflicting data regarding efficacy make uncertain the role of TAP block in post cesarean section pain relief. This model would have a better potential for measuring the block's effectiveness. Quantitative sensory evaluation tools such as the von Frey hair tool provides a quantitative reproducible measure of skin sensation and also allows for assessment of block regression over time. Pressure algometry has been established as a clinical and research tool for quantitative assessment of pain levels in multiple pain conditions. A useful inexpensive reliable pressure algometer has recently been described. The assessment of serum ropivicaine levels with this block will provide useful data regarding the systemic absorption of local anesthetic compared to other peripheral nerve blocks and establish the safety of the technique. In addition this study will help establish a model for the study of TAP block modifications in the future. If block effectiveness is demonstrated, this model can be used to examine numerous block parameters including choice of local anesthetic and dose response analysis for optimal volume and concentration. Potential future study may be done also in the area of adjuncts found to have increased duration and effectiveness as used in other peripheral nerve blocks. Expected duration of this study is 18 months.

NCT ID: NCT00945412 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Topical Microporous Polysaccharide Hemospheres Versus Electrocautery for Control of Pediatric Post-Tonsillectomy Bleeding

Start date: July 2009
Phase: Phase 3
Study type: Interventional

The ultimate goal of this work is to establish a method for control bleeding after tonsillectomy in awake children. Treatment of post-tonsillectomy bleeding in children typically requires general anesthesia with currently used electrocautery techniques. Micropolysaccharide hemosphere technology is a unique absorbable agent that helps clot form. These hemospheres consist of 100% purified plant starch that enhances natural clotting by concentrating blood solids such as platelets, red blood cells, and blood proteins on the particle surfaces to form a gelled matrix. This device provides painless, non-irritating control of bleeding, and has been used effectively for control of nosebleeds in awake adult patients. This device, however, has not been tested in the tonsillar fossae in children; thus, this study is performed to determine if at least 50% of children with bleeding tonsillar fossae can be spared rescue treatment with electrocautery.

NCT ID: NCT00944606 Withdrawn - Hypovitaminosis D Clinical Trials

Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children

Start date: July 2009
Phase: N/A
Study type: Interventional

Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain. Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal pain in children.

NCT ID: NCT00943709 Withdrawn - Leukemia Clinical Trials

Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

Start date: May 2009
Phase: Phase 3
Study type: Interventional

RATIONALE: Controlling blood sugar levels may be effective in preventing infections in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia. PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic leukemia.

NCT ID: NCT00942838 Withdrawn - Clinical trials for Recurrent Ovarian Carcinoma

Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity

WAR
Start date: July 2009
Phase: Phase 1
Study type: Interventional

The proposed study is a prospective cohort study incorporating patients with first recurrence ovarian or primary peritoneal cancer who will receive intraperitoneal chemotherapy in conjunction with whole abdomen radiation. The primary end point of this investigator initiated research study is to determine the toxicity associated with whole abdomen radiation in combination with intraperitoneal chemotherapy. Primary Objective: - Determine the maximum tolerated dose (MTD) of whole abdomen radiation in conjunction with intraperitoneal cisplatin chemotherapy in the treatment of women with small volume (< 1 cm) recurrent ovarian cancer confined to the abdominal peritoneal cavity. Secondary Objective: - Quality of Life assessment.

NCT ID: NCT00942617 Withdrawn - Clinical trials for Platelet Aggregation

Measurement of Platelet Dense Granule Release in Healthy Volunteers

Start date: July 2009
Phase: N/A
Study type: Interventional

Aspirin has been shown to reduce cardiovascular events in at risk individuals. Elucidation of mechanisms of aspirin resistance and a possible loss of effect of aspirin over time with chronic aspirin treatment necessitate a more precise method of measuring the "release phase" of platelet activation, including the release of dense granules from platelets.

NCT ID: NCT00942396 Withdrawn - Breast Cancer Clinical Trials

Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography

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

Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer.