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NCT ID: NCT02186873 Completed - Clinical trials for Ankylosing Spondylitis

A Study of Golimumab in Participants With Active Ankylosing Spondylitis

Start date: September 3, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral joints).

NCT ID: NCT02186171 Completed - Osteoporosis in Men Clinical Trials

A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

BRIDGE
Start date: June 16, 2014
Phase: Phase 3
Study type: Interventional

The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.

NCT ID: NCT02185508 Active, not recruiting - Lumbar Disc Disease Clinical Trials

Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Lumbar Radiculopathy.

Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this study is to determine the relation among: (1) changes in voltage and amplitude of trans-operatory records obtained through the use of Intra-operative Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1 or 2 levels surgical decompression at lumbar spine. IONM is the use of real time neurophysiological techniques during spinal surgeries. The modalities included in this study are: - Somatosensory evoked potentials (SSEPs). - Trans-cranial electric motor evoked potentials (tceMEPs). - Spontaneous electromyography (EMG). Clinical outcome of the patients will be assessed through a careful evaluation of clinical data, as well as the application of three outcome scales: - Oswestry Disability Index 2.1a - Visual Analogue Scale for Pain - Patient's Overall Impression of Change

NCT ID: NCT02181413 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant

Start date: July 1, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

NCT ID: NCT02181244 Completed - Diabetes Mellitus Clinical Trials

Egg Effects on Atherogenic Dyslipidemias, Glucose Metabolism and Inflammation in Diabetic Subjects

Start date: May 2013
Phase: N/A
Study type: Interventional

There is concern in the literature regarding egg consumption in diabetic people. The investigators hypothesis is that compared to an oatmeal-based breakfast, an egg-based breakfast will not increase the risk for heart disease in diabetic people but it may reduce inflammation, in this population characterized by chronic low grade inflammation. This is a cross-over study in which subjects will be randomly allocated to consume 1 egg per day for breakfast or a bowl of oatmeal with lactose-free milk for 5 weeks. After a 3 wk washout period, subjects will be allocated to the alternate treatment for additional 5 weeks. Blood will be collected at baseline and at the end of each dietary period to measure plasma lipids, glucose, insulin, glycosylated hemoglobin and inflammatory markers.

NCT ID: NCT02178592 Completed - HIV Infections Clinical Trials

Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection

Start date: January 23, 2015
Phase: Phase 3
Study type: Interventional

HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide. Rifamycins (such as rifampicin [RIF]) are an important component of TB therapy because of their unique activity. The problem is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that can lead to reduced concentrations of these agents with risk of treatment failure or resistance. The non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does not present the same significant drug interactions with RIF. EFV-based HIV treatment was tested in patients concomitantly treated with RIF-containing TB therapy, demonstrating that their co-administration can be used safely and effectively. However, the side effect profile of EFV overlaps with the RIF-containing TB regimens and makes the management of treatment toxicities very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer an important alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug interaction study was conducted in healthy, HIV-seronegative subjects, and showed that DTG at 50 mg twice daily given together with RIF was well-tolerated and resulted in DTG concentrations similar to those of DTG 50 mg given once daily alone, which is the recommended dose for INI-naive patients. Therefore, ART regimens using DTG 50 mg twice daily may represent a new treatment option for TB-infected patients who require concurrent treatment for HIV infection. This is a Phase III b, randomized, open-label study describing the efficacy and safety of DTG and EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks. A total of approximately 115 +/-5% subjects will be randomly assigned in a 3:2 ratio to DTG (approximately 69 subjects) and EFV (approximately 46 subjects), respectively. This study will include a Screening Period, a Randomized Phase (Day 1 to 48 weeks plus a 4-week extension), and a DTG Open-label extension (OLE). During the DTG OLE, subjects will be supplied with DTG until it is locally approved and commercially available, the subject no longer derives clinical benefit, or the subject meets a protocol-defined reason for discontinuation, which ever comes first.

NCT ID: NCT02174731 Completed - Anemia Clinical Trials

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.

Start date: July 1, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.

NCT ID: NCT02174627 Completed - Anemia Clinical Trials

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis

NCT ID: NCT02174094 Withdrawn - Dravet Syndrome Clinical Trials

Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

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

The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.

NCT ID: NCT02171858 Enrolling by invitation - Stroke Clinical Trials

Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke

MAASP
Start date: June 2013
Phase: N/A
Study type: Observational

Stroke is one of main causes of death and impairment worldwide. Objective of this study is to analyze serum High Sensitivity C-Reactive Protein in acute phase stroke in patients attended at Petróleos Mexicanos Hospital Central Sur de Alta Especialidad and to correlate with stroke extension and clinical features.