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NCT ID: NCT01977651 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide

UPWARD
Start date: September 25, 2013
Phase: Phase 4
Study type: Interventional

The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for seizure.

NCT ID: NCT01977573 Completed - Anaemia Clinical Trials

A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)

Start date: October 31, 2013
Phase: Phase 2
Study type: Interventional

This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

NCT ID: NCT01977547 Completed - Anemia Clinical Trials

Age of Blood in Children in Pediatric Intensive Care Units

ABC-PICU
Start date: January 2014
Phase: Phase 3
Study type: Interventional

ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC storage duration in 1538 critically ill children. Laboratory and observational evidence points to serious concerns about the lack of safety and effectiveness of older RBCs, especially in more vulnerable populations. Physicians and institutions have been systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed high quality evidence to answer the question "do RBCs of reduced storage duration improve outcomes?" The ABC PICU Trial will conduct a RCT comparing development of New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of 17-21 days).

NCT ID: NCT01977482 Completed - Anaemia Clinical Trials

Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia

Start date: November 1, 2013
Phase: Phase 2
Study type: Interventional

This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

NCT ID: NCT01977300 Completed - Bipolar I Disorder Clinical Trials

Atypical Antipsychotics for Continuation and Maintenance Treatment After an Acute Manic Episode

Start date: January 2003
Phase: Phase 3
Study type: Interventional

Hypothesis: Continuation of an atypical antipsychotic medication in combination with a Mood Stabilizer, following remission from an acute manic episode, lowers the rates of relapse and recurrence of mood episodes compared to discontinuing the antipsychotics within days of resolution of manic symptoms.

NCT ID: NCT01977183 Completed - Clinical trials for Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota

Effects of MSPrebiotic on Gut Health in the Elderly

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

The purpose of this clinical trial is to study the effects of potato resistant starch on the microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels will be measured and compared between elderly adults and in pre-elderly, adults from the general public. A correlation between the use of potato resistant starch and specific clinical and quality of life endpoints between elderly adults and in pre-elderly, adults from the general public will be studied. Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70 years) is less diverse and more prone to imbalance compared to adults (30-50 years) from the general population and that this imbalance of the gut microflora in the elderly adults is partially related to inadequate RS in their diet. Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of food grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the general population), thereby improving gut health and reducing the risk of diarrhea and/or gut infection.

NCT ID: NCT01976728 Completed - Clinical trials for Primary Amenorrhea With Hypogonadotropic Hypogonadism

LutrePulse Hypogonadotropic Hypogonadism

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

To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the OmniPod pump versus placebo

NCT ID: NCT01976364 Completed - Clinical trials for Arthritis, Psoriatic

Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

OPAL BALANCE
Start date: February 17, 2014
Phase: Phase 3
Study type: Interventional

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication. This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.

NCT ID: NCT01976104 Completed - Clinical trials for Thrombocytopenia Associated With Liver Disease

Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure

Start date: November 2013
Phase: Phase 3
Study type: Interventional

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

NCT ID: NCT01975987 Completed - Clinical trials for Endotracheal Intubation

Characteristics to Predict Successful Intubation With the Bonfils Fiberscope

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

This study is designed to identify patients' features predictive of successful intubation using the Bonfils fiberscope. Our hypothesis is that some patients' characteristics are predictors of successful intubation with the Bonfils fiberscope.