Clinical Trials Logo

Filter by:
NCT ID: NCT01121237 Completed - Clinical trials for Chronic Kidney Disease

MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5

MONITOR-CKD5
Start date: February 2010
Phase: N/A
Study type: Observational

MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis.

NCT ID: NCT01121003 Completed - Metabolism Clinical Trials

Effects of Fructose and Exercise on Hepatic Lipid Metabolism

FRUCTEXER
Start date: May 2010
Phase: N/A
Study type: Interventional

8 healthy male volunteers will be studied each on 3 occasions, ie - after 4 days on a weight maintenance diet containing 5% simple sugars + low physical activity - after 4 days on a weight maintenance diet containing 30% fructose + low physical activity - after 4 days on a weight maintenance diet containing 30% fructose + high physical activity At the end of each of these 3 periods, fructose induced hepatic de novo lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load) and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol) will be measured

NCT ID: NCT01120730 Completed - Renal Failure Clinical Trials

Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury

Start date: April 1997
Phase: Phase 3
Study type: Interventional

HES 200/0.5 10% is equal to ringers lactat solution.

NCT ID: NCT01120301 Completed - Clinical trials for Acute Ischemic Stroke

Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)

NEST-3
Start date: September 2010
Phase: Phase 3
Study type: Interventional

The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

NCT ID: NCT01120184 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

Start date: July 31, 2010
Phase: Phase 3
Study type: Interventional

This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

NCT ID: NCT01119989 Completed - Metabolic Syndrome Clinical Trials

Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism

AMINOFRUCT
Start date: May 2010
Phase: N/A
Study type: Interventional

10 healthy male volunteers will be studied after - a 6 day weight maintenance, balanced diet - a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day - a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day and 20g amino-acids per day At the end of each 6 days period, the following measurements will be obtained - intrahepatic lipids (1H-MRS) - metabolic effects of fructose ingestion (measurement of substrate oxidation, gluconeogenesis from fructose, palmitate synthesis from fructose, plasma VLDL-kinetics) This is a randomized, double blinded study

NCT ID: NCT01119859 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

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

This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.

NCT ID: NCT01117987 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

IMPRES Extn
Start date: April 2010
Phase: Phase 3
Study type: Interventional

This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

NCT ID: NCT01117441 Completed - Leukemia Clinical Trials

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia

Start date: June 2010
Phase: Phase 3
Study type: Interventional

Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia (ALL). This trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with ALL. Study objectives Primary study questions: - Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone marrow on day 15 <0.1% or with TEL/AML1-positive ALL (randomized study question R1): Can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)? - Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2): Can the clinical outcome be improved by protracted asparagine depletion achieved through application of intensified PEG-L-asparaginase during reintensification and early maintenance? - High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during Protocol IB? Secondary study questions: - Standard risk (SR) patients identified by at least one sensitive marker: Is the clinical outcome comparable to that obtained in SR patients (identified with two sensitive markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of PEG-L-asparaginase instead of native E. coli L-ASP? - T-ALL non-HR patients: Can the high level of outcome which was obtained for these patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of PEG-L-ASP instead of native E. coli L-ASP? - HR patients with persisting high MRD levels despite the use of the HR blocks in the intensified consolidation phase "MRD Non-Responders": Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule (DNX-FLA)? - Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are asparaginase activity and asparaginase antibodies associated with development of allergic reactions, and do they have an effect on the outcome of the patients? - What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol?

NCT ID: NCT01116219 Completed - Lung Cancer Clinical Trials

Bevacizumab, Pemetrexed Disodium, and Cisplatin or Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).

Start date: June 2010
Phase: Phase 2
Study type: Interventional

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bevacizumab given together with pemetrexed disodium and cisplatin is more effective than erlotinib hydrochloride given together with bevacizumab in treating patients with non-small cell lung cancer. PURPOSE: This phase II trial is studying giving bevacizumab together with pemetrexed disodium and cisplatin to see how well it works compared with giving erlotinib hydrochloride together with bevacizumab in treating patients with stage IV non-small cell lung cancer.