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NCT ID: NCT01310738 Terminated - Clinical trials for Visceral Leishmaniasis

Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil

LVBrasil
Start date: February 2011
Phase: Phase 4
Study type: Interventional

This study is aimed to compare the efficacy and safety of medications currently used in Brazil for treatment of visceral leishmaniasis. The investigators will compare the effects of meglumine antimoniate, two formulations of amphotericin B: deoxycholate and liposomal, and a combination of meglumine plus the liposomal amphotericin B formulation. The study is designed to demonstrate the difference in efficacy measured as cure rate at six months after treatment and the safety profile based on the adverse event rate observed with each intervention.

NCT ID: NCT01310712 Completed - Hyperhidrosis Clinical Trials

Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study

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

Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

NCT ID: NCT01308580 Completed - Prostate Cancer Clinical Trials

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer

PROSELICA
Start date: April 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the non inferiority in term of overall survival (OS) of cabazitaxel 20 mg/m² (Arm A) versus cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in patients with metastatic castration resistant prostate cancer (MCRPC) previously treated with a docetaxel-containing regimen. Secondary Objectives: - To evaluate safety in the 2 treatment arms and to assess if cabazitaxel 20 mg/m² is better tolerated than cabazitaxel 25 mg/m². - To compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² for: - Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), PSA progression, pain progression or death due to any cause - Prostate-Specific Antigen (PSA)-Progression - Pain progression - Tumor response in patients with measurable disease (RECIST 1.1). - PSA response - Pain response in patients with stable pain at baseline. - To compare Health-related Quality of Life (HRQL) - To assess the pharmacokinetics and pharmacogenomics of cabazitaxel

NCT ID: NCT01308567 Completed - Prostate Cancer Clinical Trials

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

FIRSTANA
Start date: May 5, 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: - To evaluate safety in the 3 treatment arms. - To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for: - Progression Free Survival (PFS) (RECIST 1.1) - Tumor progression free survival (RECIST 1.1) - Tumor response in participants with measurable disease (RECIST 1.1), - PSA response - PSA-Progression free survival (PSA-PFS). - Pain response in participants with stable pain at baseline - Pain progression free survival - Time to occurrence of any skeletal related events (SRE) - To compare Health-Related Quality of Life (HRQL). - To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

NCT ID: NCT01308528 Completed - Clinical trials for Venous Thromboembolism

Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery

Start date: February 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.

NCT ID: NCT01308229 Completed - Coronary Disease Clinical Trials

Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent

BIPAX
Start date: December 2008
Phase: N/A
Study type: Interventional

The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.

NCT ID: NCT01308047 Withdrawn - Clinical trials for Fracture of Lower Limb

Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.

Start date: n/a
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.

NCT ID: NCT01307969 Completed - Clinical trials for Underdosing of Local Anesthetics, Initial Encounter

Formulations of Liposomal Local Anesthetics

Start date: February 2007
Phase: Phase 1
Study type: Interventional

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

NCT ID: NCT01307397 Completed - Malignant Melanoma Clinical Trials

A Study of Vemurafenib in Participants With Metastatic Melanoma

Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

NCT ID: NCT01306708 Completed - Adhesive Capsulitis Clinical Trials

Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

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

The adhesive capsulitis is a disease of the shoulder characterized by pain and limitation of movement amplitude. It is defined as for etiology, having discordant theories that related it to an inflammatory condition or to an algoneurodystrophy process. There is not yet a consensus about the best option of treatment. The non-steroidal anti-inflammatories have analgesic and anti-inflammatory activity, where the mechanism of action is the inhibition of prostaglandin synthesis. The antidepressants have been increasingly used in the control of chronic pain and the major action mechanism to have the analgesic effect seems to be based on inhibition of neurotransmitters reuptake noradrenaline and/or serotonin) in nerve cell endings. Literature studies associate the practice of the nerve suprascapular blockade with anaesthetics to good results of clinical improvement of the pain, however, so far, no clinical studies comparing the efficacy of the non-steroidal antiinflammatories or tricyclic antidepressants to nervous blockage were registered in the acute treatment of adhesive capsulitis.