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NCT ID: NCT01294644 Completed - Clinical trials for Moderate or Severe Submental Fullness

Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat

Start date: January 2011
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

NCT ID: NCT01294605 Completed - Tetanus Clinical Trials

Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)

Start date: April 2003
Phase: Phase 4
Study type: Interventional

This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.

NCT ID: NCT01294410 Completed - Colitis, Ulcerative Clinical Trials

Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

Start date: March 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

NCT ID: NCT01293435 Completed - Clinical trials for Community Acquired Pneumonia (CAP)

Study Evaluating Management of Patients With Community-Acquired Pneumonia (CAP) or Complicated Skin Infections

REACH
Start date: March 2011
Phase: N/A
Study type: Observational

This study will collect real-life data from patients with community acquired pneumonia (CAP) OR complicated skin and skin structure infections (cSSSI) to assess the burden of the disease, review the treatment pathways, evaluate how health resources are used and identify any areas of unmet medical needs. The aim of the study is to compare how patients who are admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by collecting data to understand the patient and disease characteristics, current practice of treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10 European countries.

NCT ID: NCT01291810 Completed - Crohn's Disease Clinical Trials

Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising. The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

NCT ID: NCT01291472 Completed - Postoperative Pain Clinical Trials

Disposition of Intravenous Ketorolac

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

The purpose of this study is: - to document ketorolac disposition (concentration/time profile, protein binding, metabolism) and its covariates following intravenous (iv) administration of ketorolac right after caesarean section and to compare those observations (n=32) with non-pregnant state (n=8) (intra-subject PK comparison) - to document biochemical tolerance of ketorolac - to evaluate if optimalisation of ketorolac dose regimen during pregnancy and labor are appropriated and needed - to quantify the neonatal exposure to ketorolac through excretion in the breast milk

NCT ID: NCT01291420 Completed - Glioblastoma Clinical Trials

Dendritic Cell Vaccination for Patients With Solid Tumors

Start date: May 3, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal vaccination with autologous RNA-modified dendritic cells (DCs) - engineered to express the WT1 protein - in patients with limited spread metastatic solid tumors, i.e. breast cancers, glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the results of our previously performed phase I study with autologous WT1 mRNA-transfected DC, the investigators hypothesize that the vaccination with DC will be well-tolerated and will result in an increase in WT1-specific CD8+ T cell responses.

NCT ID: NCT01291030 Completed - Clinical trials for Renal Transplantation

The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients

Start date: January 2011
Phase: N/A
Study type: Interventional

Hypomagnesemia is common in renal transplant recipients and is mainly because of enhanced renal magnesium wasting, caused by immunosuppressive drugs (calcineurin inhibitors). Glucose metabolism disorders, including insulin resistance and decreased insulin secretion, are also prevalent post-transplantation and often precede the development of diabetes. As magnesium supplementation has been demonstrated to increase insulin sensitivity in both diabetic and non-diabetic patients, its potential therapeutic supplementation (post-transplantation) deserves further examination. The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on insulin resistance and/or secretion.

NCT ID: NCT01290926 Completed - Colorectal Cancer Clinical Trials

Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer

SoMore
Start date: February 2011
Phase: Phase 2
Study type: Interventional

Prospective non-randomized phase II study assessing the activity of the Capecitabine-Sorafenib combination by estimating overall survival of the study population at a fixed time point (6 months) and, as an exploratory analysis the overall survival of metabolic responders versus non-responders.

NCT ID: NCT01290679 Completed - Hepatitis C Clinical Trials

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

QUEST-2
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.