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NCT ID: NCT01724385 Completed - Clinical trials for Proliferative Diabetic Retinopathy

Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Start date: August 2012
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).

NCT ID: NCT01724021 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma

A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a

Start date: December 2012
Phase: Phase 3
Study type: Interventional

This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.

NCT ID: NCT01721109 Completed - HIV Infections Clinical Trials

Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents

Start date: December 6, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen (STR) (Part A) and to evaluate the safety and tolerability of EVG/COBI/FTC/TDF STR through Week 48 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents. A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive EVG/COBI/FTC/TDF as follows: - Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK, and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15 and at least 4 participants 15 to < 18 years of age. - Part B: Following confirmation of EVG exposure in at least 12 participants from Part A, 34 to 38 participants in addition to those enrolled in Part A will be enrolled to evaluate the safety, tolerability, and antiviral activity of EVG/COBI/FTC/TDF STR.

NCT ID: NCT01720446 Completed - Clinical trials for Diabetes Mellitus, Type 2

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

SUSTAIN™ 6
Start date: February 21, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.

NCT ID: NCT01719965 Completed - Community Members Clinical Trials

Evaluation of Tak Community Advisory Board

Start date: October 2012
Phase:
Study type: Observational

A popular form of community engagement is for the researchers to interact with a Community Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border for many years and has been informally engaging with the community for its healthcare and research initiatives, especially in the area of ethics and consent. In January 2009, community engagement was formalised with the establishment of the Tak Province Border Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the investigators have not come across any set up of similar nature involving mobile and unstable populations residing along a porous border. Three years on, SMRU questions if the T-CAB has been "successful" and if the current T-CAB model is the best model for this community. In order to evaluate the T-CAB, first an evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs, then the evaluation will be carried out.

NCT ID: NCT01719003 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

Start date: October 2012
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

NCT ID: NCT01715818 Completed - Clinical trials for Cardiovascular Disease, Diabetes Mellitus Type 2

A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

Start date: December 2012
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.

NCT ID: NCT01713946 Completed - Clinical trials for Tuberous Sclerosis Complex-associated Refractory Seizures

A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures

EXIST-3
Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)], Core phase [from randomization at Week 0 (V2) to Week 18 (V11)], Extension phase [from Week 18 (V11) until 48 weeks after the last patient had completed the core phase] and Post Extension phase [from end of Extension phase to end of study].

NCT ID: NCT01713621 Completed - Malaria Clinical Trials

OZ439 PhIIa Study in Plasmodium Falciparum: Extended Observation

Start date: March 2013
Phase: Phase 2
Study type: Interventional

This study aims to investigate the concentration dependent effects of OZ439 on the clearance of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum inhibitory concentration (MIC) of OZ439. Characterisation of PK-PD (Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based dosing. The adaptive investigation of a range of doses will provide the best chance of accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal concentration). Additionally the tolerability and pharmacokinetics of OZ439 will be confirmed. The PK/PD relationship between OZ439 exposure and subsequent effects on parasitaemia will be investigated.

NCT ID: NCT01713257 Completed - Critical Illness Clinical Trials

Study of Arginine Free IED in Critically Ill Patients.

ROSIED
Start date: January 2011
Phase: Phase 4
Study type: Interventional

This study intends to investigate the clinical outcomes of a new immunoenhancing formula which composed arginine free compare to isonitrogenous, isocaloric standard formula in ICU patients.The study design is multicenter, double-blind randomized controlled study with 3 periods of Screening, Run-in and Randomization period. Primary Objective: To evaluate the clinical outcomes of immunoenhancing diet (IED) arginine free in medical-surgical ICU patients. Secondary Objective: To evaluate the immunologic effects and safety of IED arginine free formula.