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NCT ID: NCT02910661 Completed - Clinical trials for Medication Adherence

Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)

TAKE-IT TOO
Start date: March 28, 2017
Phase: N/A
Study type: Observational

The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at improving medication adherence in adolescent kidney transplant, for use in 'real world' clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs and preferences of stakeholders (kidney transplant recipients, parents, and healthcare professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.

NCT ID: NCT02910063 Completed - Clinical trials for B-Cell Non Hodgkin Lymphoma

Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL

Start date: January 23, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to Investigator's Choice chemotherapy. In March 2019, decision made to not proceed with phase 3.

NCT ID: NCT02909829 Completed - Clinical trials for Diabetes Mellitus, Type 1

Safety and Efficacy of Artificial Pancreas With and Without a Meal Detection Module on Glycemic Control in Adolescents With Type 1 Diabetes After a Missed Bolus

Start date: October 31, 2017
Phase: N/A
Study type: Interventional

Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin. The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus. The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.

NCT ID: NCT02909803 Completed - Hyperglycemia Clinical Trials

Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties

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

It is not known whether different lentil varieties have the same efficacy in lowering blood glucose. Similarly, the carbohydrate component of lentils responsible for lowering blood glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol bioactive.

NCT ID: NCT02908945 Completed - Anesthesia Clinical Trials

The Effect of Ketamine on the WAVCNS Index During General Anesthesia: A Feasibility Study

Start date: September 2016
Phase: N/A
Study type: Interventional

Monitoring the brain using electroencephalography (EEG) during general anesthesia provides the anesthesiologist with valuable feedback of how deeply anesthetized their patient is, reducing the chances of under- or overdosing and potentially improving patient outcomes. However, commercial EEG monitors that output processed EEG (pEEG) were developed under carefully controlled, simple anesthetic regimes - in contrast to the multimodal "cocktail" of drugs often used in clinical practice. Ketamine is one potential adjunct to a standard anesthetic, which has a growing body of evidence suggesting that it may improve post-operative outcomes. The effects of ketamine on pEEG parameters are poorly understood. This randomized, open-label, feasibility study will be undertaken in a sample of 30 adult outpatient surgery patients. The primary objective is to observe the intra-operative raw and pEEG trends using the NeuroSENSE monitoring system in patients receiving one of two different analgesic doses of ketamine, compared to patients not receiving ketamine, during an otherwise comparable general anesthetic. Secondarily, we will consider other clinical data of interest from both intra- and post-operative contexts in order to establish a broader understanding of the potential influence of two analgesic ketamine doses on anesthetic depth and post-operative outcomes. Feasibility outcomes will be assessed with the ultimate goal of developing a larger-scale clinical trial.

NCT ID: NCT02908880 Completed - Clinical trials for Femoral Arteriotomy Closure

MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

SAFE_MANTA
Start date: December 2016
Phase: N/A
Study type: Interventional

Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.

NCT ID: NCT02908685 Completed - Clinical trials for Muscular Atrophy, Spinal

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants

SUNFISH
Start date: October 19, 2016
Phase: Phase 2
Study type: Interventional

Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.

NCT ID: NCT02907359 Completed - Clinical trials for Myelodysplastic Syndromes

Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs

Start date: January 13, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.

NCT ID: NCT02907281 Completed - Multiple Sclerosis Clinical Trials

Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

OCTIMS
Start date: May 29, 2012
Phase: N/A
Study type: Observational

This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome measure in patients with relapsing remitting multiple sclerosis (RRMS). Approximately 350 RRMS patients, either untreated or treated with an approved MS disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or neurologic disease are enrolled. No study medications are provided. Patients on disease-modifying therapy are treated according to the local prescribing information. For each MS patient and each reference subject, the study consists of Screening (up to 1 month), Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed during Screening.

NCT ID: NCT02907255 Completed - Clinical trials for Respiratory Depression

Vital Sign Monitoring With Continuous Pulse Oximetry and Wireless Clinician Notification After Surgery

VIGILANCE
Start date: October 2010
Phase: N/A
Study type: Interventional

Patients are at risk of respiratory depression after having surgery. The medications that patients are treated with to control their pain can impair their breathing and this can progress to respiratory and cardiac arrest and even death. Vital signs assessment on surgical wards is usually done every 4 hours and this may be insufficient to identify and manage many cases of respiratory depression. The aim of this study is to determine the impact on safety and nursing workflow of a respiratory monitoring on two surgical wards by measuring safety outcomes. Respiratory depression is a serious complication of pain treatment that can lead to patient complications and death. The level of monitoring available in hospitals by nursing staff is insufficient to manage this problem. If this new monitoring technology works as designed then patient safety can be improved while maintaining effective pain therapy.