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NCT ID: NCT02383108 Completed - HIV Infection Clinical Trials

Strategy for Maintenance of HIV Suppression With Once Daily Integrate Inhibitor+Darunavir/Ritonavir in Children

SMILE
Start date: June 2016
Phase: Phase 2/Phase 3
Study type: Interventional

A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.

NCT ID: NCT02380170 Completed - Urosepsis Clinical Trials

Epidemiology and Outcomes of Gram Negative Urosepsis

SERPENS
Start date: September 2014
Phase:
Study type: Observational

The study aims to get an insight on the causative bacteria of sepsis derived from the urinary tract. Furthermore, it is the intention to understand the outcomes of these patients. For this purpose a non-interventional, observational study will be conducted.

NCT ID: NCT02377037 Completed - Metabolic Cost Clinical Trials

Metabolic Cost of Sitting, Standing, and Transitions

Start date: November 2014
Phase: N/A
Study type: Interventional

There is already a lot of scientific evidence supporting the benefits of public health recommendations regarding physical activity (the accumulation of at least 150 minutes of at least moderate intensity physical activity per week). However, these 30 daily minutes represent only about 3% of the waking period. Recent data suggest that most of the population spends on average 8-9 hours / day of sedentary behavior (SB). SB is characterized by any activity with a metabolic cost (MC) below 1.5 METs, mainly actions in the sitting position. In fact, there is evidence that the more time spent sitting higher the risk of disease and mortality, with sitting directly associated with diseases such as type II diabetes, cardiovascular diseases and even cancer. The average life expectancy may increase by ~ 2 years if the investigators reduce sitting about 3h/ day. Additionally, how people accumulate sitting time seems to be a major factor, with prolonged sitting associated with a higher risk of disease. Short-term experimental studies indicate that sedentary lifestyles affect energy balance enhancing weight gain. While there is some research regarding the MC associated with "sitting" and "standing" behaviors, the results are contradictory. Besides these conflicting results, the impact of transitions between these two types of behavior and how these transitions can contribute to MC increase have never been investigated. Our hypothesis is that, in both men and women, the simple replacement of sitting for "standing" may not substantially increase MC, but instead, the largest contribution may reside on the transitions between these two states of behavior. Therefore, the investigators will perform a study with the following purposes: Examine MC and HR associated with "sitting", "standing", and transitions between these two types of behavior in adults of both gender, apparently healthy with variable body composition profiles.

NCT ID: NCT02376790 Completed - Psoriatic Arthritis Clinical Trials

Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

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

The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.

NCT ID: NCT02373813 Completed - Clinical trials for Rheumatoid Arthritis

Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission

Start date: February 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy. This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.

NCT ID: NCT02367794 Completed - Clinical trials for Squamous Non-Small Cell Lung Cancer

A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

Start date: June 11, 2015
Phase: Phase 3
Study type: Interventional

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

NCT ID: NCT02366143 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

IMpower150
Start date: March 31, 2015
Phase: Phase 3
Study type: Interventional

This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).

NCT ID: NCT02359526 Completed - Clinical trials for Diabetic Macular Edema

A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients

RESPOND
Start date: October 2014
Phase: Phase 4
Study type: Interventional

To provide treating physicians with experience with ILUVIEN as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged insufficiently responsive to available therapies.

NCT ID: NCT02357303 Completed - Clinical trials for Gastric Mucosal Lesion

Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial

Start date: April 2015
Phase: Phase 4
Study type: Interventional

The upper endoscopy is one of the most common methods for the diagnosis and treatment of upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify early neoplastic lesions. Before an upper endoscopy it is required a 6 hour fasting period[1]. However, even with this fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired by the presence of foam, bubbles or gastric mucus. To improve visualization of the gastric mucosa, it is possible to administrate an oral solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or N-Acetylcysteine previously to the procedure. The aim of this project is to determine if the use of premedication with simethicone, alone or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI endoscopy.

NCT ID: NCT02354508 Completed - Acromegaly Clinical Trials

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

Start date: March 31, 2015
Phase: Phase 3
Study type: Interventional

This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal approved doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses (maximal approved) of first-generation somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit can move into the 32-week extension phase. Patients can continue with study treatment until pasireotide LAR is commercially available and reimbursed in their respective country or until the end of the extension phase whichever occurs first.