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NCT ID: NCT01989468 Completed - Psoriatic Arthritis Clinical Trials

24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

Start date: April 10, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

NCT ID: NCT01989455 Completed - Healthy Volunteers Clinical Trials

A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers

Start date: November 2013
Phase: Phase 1
Study type: Interventional

Single center, randomized, double-blind, placebo-controlled, adaptive sequential ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of single doses of deferiprone administered by intravenous infusion to healthy males and females. A bioavailability comparison will be included.

NCT ID: NCT01988961 Completed - Colitis, Ulcerative Clinical Trials

A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

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

The purpose of this study is to evaluate the accuracy of a subset of the length-109 probe set panel (a genetic test) in predicting response to golimumab treatment in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT01988896 Completed - Solid Tumors Clinical Trials

Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: December 27, 2013
Phase: Phase 1
Study type: Interventional

This is a Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no standard therapy exists.

NCT ID: NCT01988181 Completed - Clinical trials for End Stage Renal Failure on Dialysis

Adjusting Fluid Removal Based on Blood Volume in Hemodialysis: A Randomized Study

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

As kidney function declines, the ability to maintain water balance is impaired and is most often treated with hemodialysis. The removal of excess water in hemodialysis often leads to a sudden drop of blood pressure and causes symptoms of dizziness, light-headedness, cramping, and chest pain. This sudden drop in blood pressure has been linked with complications of heart attacks, strokes and even death. Research has focused on different ways to prevent dangerous drops in blood pressure during hemodialysis. One way is the use of blood volume monitoring biofeedback technology to monitor the patient's relative blood volume and automatically reduce the amount of fluid that is being removed when the blood volume is low to prevent the drop in blood pressure from occurring. This type of biofeedback device is currently available on some hemodialysis machines and while this approach appealing, it is not clear how effective this form of biofeedback is in preventing the drops in blood pressure. We plan to determine if the use of biofeedback based on the changes in the patient's blood volume will reduce the number of sudden drops in blood pressure that occur during hemodialysis. To do this, we will compare patients treated with this technology to current hemodialysis practices and follow them for important adverse outcomes. The result of interest will be the frequency of hemodialysis sessions complicated by a sudden symptomatic drop in blood pressure. We also plan to monitor the amount of water in the different body compartments, blood pressure, blood pressure medication use, markers of heart function, and patient symptoms and quality of life. We hope that by providing information on this technology we can reduce the sudden drops in blood pressure in hemodialysis, the associated rates of serious disease or death, and improve patient quality of life.

NCT ID: NCT01987973 Completed - Rotator Cuff Injury Clinical Trials

Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

Start date: February 2015
Phase: N/A
Study type: Interventional

The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.

NCT ID: NCT01987947 Completed - Urticaria Clinical Trials

A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria

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

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of additional quilizumab therapy in adult patients with Chronic Spontaneous Urticaria resistant to antihistamine treatment.

NCT ID: NCT01987921 Completed - Acute Kidney Injury Clinical Trials

Observational Study of Pediatric Acute Kidney Injury, Risk Factors and Outcomes

AWARE
Start date: January 2014
Phase: N/A
Study type: Observational [Patient Registry]

Pediatric acute kidney injury (AKI) is associated with increased morbidity and mortality in critically ill patients. Currently, understanding of the epidemiology and diagnosis of AKI in children is limited by single center retrospective data and inconsistent diagnostic and stratification criteria. The hypotheses of the AWARE study is that 1) renal angina, a composite of early injury signs and risk of disease, will predict severe subsequent AKI in critically ill children and 2) the incorporation of urinary biomarkers into the renal angina scoring system will improve the prediction of the severe injury. The AWARE study is conducted to describe AKI epidemiology in a heterogeneous multinational cohort of critically ill children, characterize AKI risk factors and associated morbidity, and validate the KDIGO AKI criteria as a predictor of pediatric AKI outcomes. The multi-center, multi-national registry will create the largest ever repository of information available on AKI in children.

NCT ID: NCT01987895 Completed - Clinical trials for Clostridium Difficile Infection

Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea

Start date: March 27, 2014
Phase: Phase 3
Study type: Interventional

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

NCT ID: NCT01987492 Completed - Asthma Clinical Trials

A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

Start date: February 28, 2014
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.