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NCT ID: NCT00404651 Completed - Hepatitis B Clinical Trials

Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent. The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series. The secondary objectives are: - To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series - To assess the overall safety in each group one month after the third dose of the primary series.

NCT ID: NCT00404508 Completed - Clinical trials for Refractory Solid Tumors

A Phase II Study of Epigenetic Therapy to Overcome Chemotherapy Resistance in Refractory Solid Tumors

Start date: September 2005
Phase: Phase 2
Study type: Interventional

Chemotherapy resistance, either innate or acquired requires for its development, expression changes on a large number of genes therefore, it has been hypothesized that epigenetic-mediated changes could be the responsible driving force for chemotherapy resistance. Aberrant DNA methylation and histone deacetylation are the main epigenetic alterations hence, their reversal by inhibitors of DNA methylation and histone deacetylases (HDACs) may overcome resistance in refractory solid tumors. Patients will be treated with hydralazine and magnesium valproate starting from day -7 until chemotherapy ends which consists on the same pre-study protocol regimen on which patients progressed. Response and toxicity were evaluated. Global DNA methylation and HDAC activity were evaluated in the peripheral blood cells, as well as the plasma levels of valproic acid and hydralazine.

NCT ID: NCT00404326 Completed - Cervical Cancer Clinical Trials

Hydralazine and Valproate Plus Cisplatin Chemoradiation in Cervical Cancer

Start date: May 2005
Phase: Phase 2
Study type: Interventional

The current standard for locally advanced cervical cancer is concurrent cisplatin-based chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations play an important role in cancer progression by silencing growth regulatory genes and there is now evidence that inhibitors of DNA methylation and HDAC inhibition synergize the radiation and chemotherapy effects. Objective. To determine response rate, safety and biological effects of hydralazine and magnesium valproate when added to cisplatin chemoradiation. Hypothesis. Hydralazine and magnesium valproate associated to chemoradiation will increase the clinical complete response rate to 95% as compared to 75% as seen in historical controls treated with cisplatin chemoradiation in FIGO stage IIIB patients. Metodology. A total of 17 FIGO stage IIIB patients with histologically confirmed cervical carcinoma with no previous treatment will be included. Patients will be typed for acetylator status and and then receive either 182 or 83 mg of hydralazine, and magnesium valproate at 40mg/Kg from day -7 to the end of chemoradiation (external and brachytherapy). Clinical response rate, safety and transcriptome changes will be analyzed.

NCT ID: NCT00404209 Terminated - Retinal Detachment Clinical Trials

Pressurized PPV 23GA Vitrectomy in Complicated Diabetic Tractional Retinal Detachment

Start date: March 2007
Phase: Phase 3
Study type: Interventional

To investigate the feasibility and advantages of using pressurized perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual, dynamic drive (3D)technology, in complicated retinal detachment surgeries.

NCT ID: NCT00403767 Completed - Stroke Clinical Trials

An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

NCT ID: NCT00403702 Withdrawn - Retinal Detachment Clinical Trials

Comparison High-density Silicone Oils in Retinal Detachment

Start date: August 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to compare the safety, intraocular adverse effects and the anatomic and functional outcome with two endotamponade silicone oil after a 3-month in complex inferior retinal re-detachments.

NCT ID: NCT00402168 Completed - Renal Transplant Clinical Trials

A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

NCT ID: NCT00402090 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

DHPLC Determination of TPMT Polymorphisms.

Start date: April 2005
Phase: N/A
Study type: Observational

TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described and are associated with a decrease activity of such enzyme. Therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations. Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of such polymorphisms in mestizos mexican population has not been analyzed, and we considered important to determine this frequency in healthy and patients requiring thiopurines, particularly acute lymphoblastic leukemia.

NCT ID: NCT00401973 Completed - Schizophrenia Clinical Trials

Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The goal of this study is to answer the following questions: - Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine - Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain - How weight gain associated with olanzapine can affect people - Whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases

NCT ID: NCT00400478 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma (DLBCL)

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

Start date: January 2006
Phase: Phase 3
Study type: Interventional

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.