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NCT ID: NCT00911443 Completed - Malignant Melanoma Clinical Trials

Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma

Start date: July 2002
Phase: Phase 2
Study type: Interventional

The purpose of the study is to test safety and efficacy of different doses of thymosin alpha 1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon alpha in treating patients affected by stage IV melanoma. Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free Survival. Ninety-five patients are allocated to each arm to test the hypothesis that P0 <= 0.05 vs the alternative hypothesis that P1 >= 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).

NCT ID: NCT00911404 Completed - Clinical trials for Gestational Diabetes Mellitus (GDM)

Carbohydrate Restriction for Gestational Diabetes Mellitus

LO-CA
Start date: January 2009
Phase: N/A
Study type: Interventional

There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy. Insulin treatment is more expensive and not as well accepted as MNT. The investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates.

NCT ID: NCT00911001 Completed - Thromboembolism Clinical Trials

SALTO - Epidemiological Study on Compliance and Treatment Satisfaction

SALTO
Start date: November 2008
Phase: N/A
Study type: Observational

Patients that are on total knee/hip replacement initiate prophylaxis treatment on the hospital ground. Once they leave the hospital, as outpatients they continue with the treatment at least during two consecutive weeks. Patients will be instructed to follow treatment recommendations (either LMWH or oral treatment, at physician discretion) and to come back to the surgeon after that period. At that visit, the Treatment Satisfaction Questionaire with Medication (TSQM) test as well as the Moriski-Green Questionaire (measures compliance with medication) will be answer by the patient. TSQM is an self administered validated scale (validated also in spanish) that measures in a generic way the treatment satisfaction to a treatment. Morinski-Green test will be used to measure the compliance degree on medication.

NCT ID: NCT00910962 Completed - Clinical trials for Acute Coronary Syndrome

A Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation

Solstice
Start date: October 8, 2009
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately 525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.) All subjects will continue to receive the local standard of care for the duration of the study.

NCT ID: NCT00910910 Completed - Clinical trials for B-Cell Chronic Lymphocytic Leukemia

Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)

ORIGIN
Start date: October 13, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.

NCT ID: NCT00910429 Completed - Clinical trials for Pulmonary Hypertension

BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension

CHEST-2
Start date: July 1, 2009
Phase: Phase 3
Study type: Interventional

Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.

NCT ID: NCT00910403 Completed - Presbyopia Clinical Trials

Multicenter Evaluation of Safety and Effectiveness of Presbyopic LASIK for Hyperopes

PresbyLASIK
Start date: June 2009
Phase: Phase 3
Study type: Interventional

The Presbyopia Algorithm subject to this study has been specifically developed to prospectively generate a treatment file for the Technolas 217z100 laser that will provide Presbyopia correction among eyes with primary hyperopia or hyperopic astigmatism (distance correction). The treatment algorithm provides a bilateral, multifocal ablation with a center near addition, thereby allowing good focus over a range of object distances.

NCT ID: NCT00910091 Completed - Endometrial Cancer Clinical Trials

The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer

Start date: August 2009
Phase: Phase 2
Study type: Interventional

This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer.

NCT ID: NCT00910065 Completed - Clinical trials for Acute Coronary Syndrome

BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)

ACUTE
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate whether intravenous administration (injected into a vein) of acetylsalicylic acid (Aspirin) in doses of 250 and 500 mg is superior to oral treatment of ACS with tablets containing 300 mg of Aspirin.

NCT ID: NCT00909987 Completed - Rectum Cancer Clinical Trials

Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum

Start date: March 2009
Phase: Phase 2
Study type: Interventional

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.