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NCT ID: NCT01183455 Withdrawn - Clinical trials for Diabetes Mellitus, Type 1

A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II

RETAIN
Start date: October 2010
Phase: Phase 2
Study type: Interventional

Aralast NP (alpha-1 antitrypsin, AAT), an alpha-1 proteinase inhibitor (human), was the drug to be tested in this clinical trial. Aralast NP is an anti-inflammatory drug that affects the cells that are thought to be involved in the development of type 1 diabetes mellitus (T1DM, T1D). This study, known as RETAIN, was planned as a two-part trial to investigate the effect of Aralast NP on preserving beta cell function and to determine if the intervention would slow the progression of type 1 diabetes. Part I of this trial (NCT 01183468) was an open-label, safety and dose level study consisting of two groups. After completion of Part I, including a satisfactory safety review, enrollment in Part II was to begin. Part II was designed as a two-arm, double-blind, placebo-controlled clinical trial, and participants were to be randomly assigned to either the Aralast NP treatment or placebo group.

NCT ID: NCT01183338 Withdrawn - Healthy Clinical Trials

Accuracy of Continuous SpO2 Measurement in Adults

SPO2
Start date: n/a
Phase: N/A
Study type: Observational

The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.

NCT ID: NCT01180764 Withdrawn - Clinical trials for Hypertriglyceridemia

Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia

Start date: August 2010
Phase: Phase 4
Study type: Interventional

Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good cholesterol") work better. Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels. Study funding: This study is being funded by an investigator-initiated research grant from Glaxo Smith Kline.

NCT ID: NCT01179932 Withdrawn - Anesthesia Clinical Trials

Anesthesia Charting Fidelity Study

Start date: August 2010
Phase:
Study type: Observational

Primary Objective: Conduct a prospective, observational pilot study that assesses the frequency and severity of anesthesia charting fidelity weaknesses in three separate clinical environments (Cardiac surgical operating room, cardiac surgical intensive care unit, and electrophysiology laboratory) as assessed by a customized error scoring system that focuses on the magnitude of errors among multiple continuous, categorical and dichotomous variables. The errors are being assessed in order to identify the most common charting inaccuracies so that target areas appropriate for testing of improvement strategies may be isolated.

NCT ID: NCT01179100 Withdrawn - Elderly Clinical Trials

How Lidocaine Affects Outcomes In Orthopedic Surgery Patients

Start date: June 2011
Phase: Phase 4
Study type: Interventional

This study will evaluate the effect of intraoperative lidocaine infusion on postoperative orientation and concentration in elderly patients having general anesthesia for orthopedic surgeries requiring a minimum 2 days hospitalization. This study will also aim to determine whether intraoperative lidocaine infusion during general anesthesia improves recovery and patient outcome, as well as to determine whether lidocaine infusion decreases postoperative opioid (pain medication) usage.

NCT ID: NCT01176812 Withdrawn - Loss of Facial Fat Clinical Trials

Dermal Fillers Patient Satisfaction

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

The face is arguably the most critical aesthetic unit of the body. As humans begin to age, numerous changes occur to the face. Changes include the formation of wrinkles, soft-tissue atrophy, gravitational descent resulting in sagging skin, loss of skin and muscle tone, and changes in bony architecture. These changes are potentiated in our population secondary to sun exposure and smoking. To combat the effects of aging on the face, a multitude of products and procedures exist to attempt to reverse the effects of sun damage and aging to achieve a youthful and rejuvenated appearance. There has been a shift from invasive procedures such as a facelift to noninvasive means using filling agents to restore lost contour deformities. The investigators hypothesis is that the use of dermal filling agents effectively delays the need for invasive procedures such as facelifts, and that patient satisfaction has increased with the evolution of recent dermal filling agents.

NCT ID: NCT01176500 Withdrawn - Lung Cancer Clinical Trials

A Pilot, Open-label Study of 18F-Fluciclatide PET/CT Imaging in the Evaluation of Anti-angiogenic Therapy in Solid Tumors

Start date: July 28, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which preferentially binds with high affinity to alpha(v)beta(3) integrins, which are up-regulated in and may regulate angiogenesis. - [18F]Fluciclatide is a new radiopharmaceutical developed for PET imaging - Changes in [18F]fluciclatide uptake will be evaluated before and after treatment of patients with targeted antiangiogenic drugs Objectives: Primary - To determine tumor uptake and retention of [18F]fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy - Secondary - To assess the safety of multiple intravenous (IV) administrations of Fluciclatide [18F] Injection in subjects with solid tumors - To obtain preliminary data on the relationships between [18F]fluciclatide as a pharmacodynamic marker and standard of care imaging markers of clinical response (e.g. contrast-enhanced (CE) static computed tomography (CT), bone scintigraphy, FDG-PET), obtained as part of routine clinical follow-up as specified in the referring protocols, as well as any optional imaging performed Eligibility: - Patients greater than or equal to 18 years, with documented malignancy, and solid tumor greater than or equal to 1 cm outside of the liver, who are scheduled to enroll in an NCI therapy protocol using one of the anti-angiogenic agents described in the full protocol - Platelet count greater than 75,000 x 10(6)/L, hemoglobin greater than 9g/dL, prothrombin time (PT) and aPTT less than 2 times normal limits. - The subject has not received any targeted anti-angiogenic agents within 60 days prior to pre-treatment (baseline) [18F]fluciclatide administration Design: This study is intended to obtain preliminary data on the uptake and retention of [18F]fluciclatide before and after anti-angiogenic therapy. This will enable optimization of the imaging protocol, identification of the most relevant imaging parameters, and allow for calculation of the number patients required to power a larger study to assess the utility of PET imaging with [18F]fluciclatide as a pharmacodynamic biomarker in the context of targeted anti-angiogenic therapies. We expect to enroll 30 evaluable patients in this single center study. Subjects will undergo at least two [18F]fluciclatide PET/CT imaging studies, one pre-therapy and one following completion of 1 cycle of chemotherapy. An optional early post-therapy (2-7 days post therapy commencement) [18F]fluciclatide PET/CT may be performed. The magnitude of [18F]fluciclatide uptake on the pre- and post- treatment PET/CT studies will be evaluated to determine if there is a measureable difference in uptake. Data from the subject's referring therapy protocol will be reviewed for up to one year. An optional DCE-MRI scans of the target lesion may also be performed.

NCT ID: NCT01176422 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Telomere and Telomerase

Start date: September 2010
Phase: N/A
Study type: Observational

Researchers hope to determine if the DNA is shortened in your body and determine if there is an increase in the protein that shortens DNA called telomerase.

NCT ID: NCT01173419 Withdrawn - Varicose Veins Clinical Trials

Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein

RECoN
Start date: July 2010
Phase: N/A
Study type: Interventional

This is a multi center, randomized, comparison study using two already cleared methods of treatment of the great saphenous vein (GSV). The hypothesis to be tested is that the use of the Venacure EVLT NeverTouch procedure is no worse than the RF ClosureFAST procedure for treatment of the GSV. Evaluation of post operative pain and bruising, quality of life assessments, adverse event assessments, confirmation of long term GSV closure, use of medications are criteria that will be evaluated during the course of this study.

NCT ID: NCT01173146 Withdrawn - Prostate Cancer Clinical Trials

Imaging of Residual Tumor During Prostatectomy

Start date: December 2011
Phase: N/A
Study type: Observational

Prostate Cancer is the most common cancer in men, affecting about as many men as women diagnosed with breast cancer, and killing about as many men per year as breast cancer kills women. The most common surgical treatment is prostatectomy, the removal of the prostate. During prostate surgery, tumor remains at the edge of the surgery, called residual tumor, in 30% of all prostatectomies. Such patients have a significantly higher risk of local recurrence of the cancer, and higher rates of death. In contrast, even patients with cancer outside of the prostate, but still nearby the prostate, do better when the margins are made clean of tumor during surgery. The investigators propose to reduce the number of patients with residual tumor after surgery. The investigators will test in patients a fluorescent molecule that allows cancer to be detected during surgery. If this trial works as designed, the investigators will reduce the number of patients who have to receive additional treatment, such as high doses of radiation to the lower abdomen, because the amount of residual tumor left behind has been minimized. This may also lead to higher rates of survival. This type of detection of cancer the investigators employ is called Molecular imaging. The investigators believe that molecular imaging will be the key to improved diagnosis, individualized treatment selection, and treatment monitoring. If successful, a large human trial will be conducted after this study with a corporate imaging partner.