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NCT ID: NCT02064933 Completed - Clinical trials for Wiskott-Aldrich Syndrome

Patients Treated for Wiskott-Aldrich Syndrome (WAS) Since 1990

Start date: February 2, 2014
Phase:
Study type: Observational

Wiskott - Aldrich syndrome (WAS) is a rare serious medical condition that causes problems both with the immune system and with easy bruising and bleeding. The immune abnormalities cause patients with WAS to be very susceptible to infections. Depending on the specific type of primary immune deficiency diseases, there are effective treatments, including antibiotics, cellular therapy and gene therapy, but studies of large numbers of patients are needed to determine the full range of causes, natural history, or the best methods of treatment for long term success. This multicenter study combines retrospective, prospective and cross-sectional analyses of the transplant experiences for patients with WAS who have already received HCT since 1990, or who will undergo Hematopoietic cell transplant (HCT) during the study period. The retrospective and prospective portions of the study will address the impact of a number of pre and post-transplant factors on post-transplant disease correction and ultimate benefit from HCT and the cross-sectional portion of the study will assess the benefit of HCT 2 years post-HCT in consenting surviving patients.

NCT ID: NCT02064894 Completed - Clinical trials for Musculoskeletal Injury

Oral Analgesic Utilization for CHildhood Musculoskeletal Injuries

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

Pain management for children presenting to the emergency department (ED) with an injured limb is often under-treated, even though it is known that broken arms and legs cause moderate to severe pain. Further, children are less likely to receive appropriate pain medicine than adults with similar injuries. This study aims to improve the pain treatment of children who present to the ED with a suspected fracture, or broken bone or severe sprain. The investigators will compare the use of 3 different possible medication combinations (ibuprofen alone, oral morphine alone, or combined ibuprofen and oral morphine) to determine which combination is the best at treating children's pain. The investigators also plan to verify the safety of using these different drugs to treat children's pain. The investigators strongly believe that children's pain should be optimally treated in the ED. Adequately relieving children's pain is crucial, as inadequate pain treatment can have both short and longterm effects on the child. It also generates unnecessary stress for both the child and their caregivers/parents. Given this knowledge, the investigators feel that their study has the potential to impact care provided in EDs, and improve pain management safely, for children.

NCT ID: NCT02064647 Completed - Clinical trials for Diabetes Mellitus, Type 1

Evaluation of Novel Trend Arrow Adjustment Tool for Diabetes Patients Using Continuous Glucose Monitoring to Guide Insulin Bolus Adjustment (TAAT Study)

TAAT
Start date: July 2014
Phase: N/A
Study type: Interventional

Continuous glucose monitoring (CGM) provides up to 288 blood glucose levels per day, updated every 5 minutes and displayed in real-time on the insulin pump, which can be used to enhance delivery of insulin through pump therapy. In addition this real-time CGM data includes "trend arrows" which indicate when the blood glucose is rapidly falling or rising thus enabling the pump user to make immediate adjustments in insulin delivery to prevent subsequent low or high blood sugars. The trend arrows are displayed when the blood glucose is rapidly falling or rising. For example, if the glucose is increasing by 1-2 mmol/L over 20 minutes, a single upward arrow alerts the pump wearer, who can then decide to give a bolus of insulin or increase the meal bolus. Should the glucose level be increasing at a rate greater than 2mmol/L over 20 minutes, 2 upward arrows are displayed and the user could decide to give a larger bolus. The purpose of the bolus adjustment is to add insulin for the predicted rise in glucose to prevent or reduce subsequent hyperglycemia. Similarly, a decrease in the insulin bolus is advised if glucose levels are falling as evidenced by one or two downward arrows. However, effective strategies for adjusting insulin boluses based on CGM trend arrows are lacking. The JDRF CGM Study Group recommended that boluses be adjusted based on trend arrows using a standard 10-20% increase/decrease of the total original recommended bolus dose (10% for one arrow up or down, and 20% for two arrows up or down), with the original bolus dose calculated by the pump calculator (i.e. Bolus Wizard). However, the original recommended bolus dose is dependent on the amount of food to be consumed (grams of carbohydrate) and the current blood glucose (if above or below target range), as well as the amount of active insulin, and therefore increasing or decreasing the total recommended bolus by 10-20% may overcompensate for the trend arrows and result in postprandial hypoglycemia. Attempts to use the10/20% formula within CHEO's large pediatric pump/CGM population resulted in low acceptance and adherence by CGM users. The CGM TIME Trial Study Group develop an innovative tool for adjusting boluses for CGM trend arrows based on the patient's own insulin sensitivity factor (ISF). The Trend Arrow Adjustment Tool formula is: if CGM shows a single arrow up or down: adjust bolus by +/- (1.5/ISF) and for 2 arrows up or down +/- (3/ISF). Use of the Trend Arrow Adjustment Tool within the CGM TIME Trial appears to lead to more appropriate adjustment in bolus dosing, and more effective prevention of subsequent hyper- and hypoglycemia. Furthermore, this tool appears to have excellent uptake amongst the TIME Trial participants, with observations that there is continued usage of the tool throughout the 12 month study, and greater satisfaction with this component of CGM. However, the tool has not been systematically evaluated. The proposed study will evaluate the Trend Arrow Adjustment Tool, to determine its effectiveness in reducing postprandial hyper- and hypoglycemia, as well as parent, child/youth satisfaction, and ease of use of the tool based on self-report measures. Comparison will be made with the 10/20% bolus adjustment & also to no adjustments to meal boluses (i.e. ignoring CGM trend arrows). Should use of the Trend Arrow Adjustment Tool lead to more time spent within the target glucose range, this will have immediate clinical benefit for patients, including improved quality of life, and potentially a reduction in HbA1c and prevention of long-term complications.

NCT ID: NCT02064439 Completed - Pulmonary Embolism Clinical Trials

Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)

EinsteinChoice
Start date: March 5, 2014
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

NCT ID: NCT02064387 Completed - Multiple Myeloma Clinical Trials

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916

Start date: July 29, 2014
Phase: Phase 1
Study type: Interventional

This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas that express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely administered to subjects with MM and with BCMA positive malignancies at doses where target engagement can be demonstrated. This study will determine if adequate target engagement of BCMA receptors translates into clinical benefit for subjects with MM and BCMA positive lymphomas. The study will consists of two parts: a Part 1 dose escalation phase and a Part 2 expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study will enroll a total of approximately 80-95 subjects with relapsed/refractory MM or BCMA-expressing hematologic malignancies. The maximum dose to be administered in this trial will not exceed 5 milligram/kilogram(mg/kg).

NCT ID: NCT02063997 Completed - Gout Clinical Trials

Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients

Start date: March 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether arhalofenate is effective in preventing flares and reducing serum uric acid in gout patients.

NCT ID: NCT02063659 Completed - Carcinoid Syndrome Clinical Trials

Telotristat Etiprate for Carcinoid Syndrome Therapy

TELECAST
Start date: March 11, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

NCT ID: NCT02063646 Completed - Healthy Elderly Clinical Trials

Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults

Neurophenol
Start date: February 2014
Phase: N/A
Study type: Interventional

Several preliminary studies have shown that diet can have beneficial effects on cognitive decline. Among food shown to have such effects are some polyphenols from selected botanicals. Preclinical studies have concluded that polyphenols play a role in moderation of oxidative stress and inflammation, increased neuronal signaling, and improved metabolic function among other effects. Noteworthy, a positive and statistically significant association between the midlife level of polyphenol intake and cognitive function assessed 13 years later was found in a cohort of 2574 adults. Several mechanisms may be involved in these positive effects of food polyphenols on cognitive function in older adults: experimental studies suggest that polyphenols display neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and inducing neurogenesis, and might prevent age-related damage to the central nervous system through their antioxidant and anti-inflammatory activities. Based on these promising results, a food supplement from botanicals offering complementary polyphenol profile was developed. This food supplement is aimed to aid at maintenance of cognitive function in older adults.

NCT ID: NCT02061761 Completed - Clinical trials for Hematologic Neoplasms

A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies

Start date: March 13, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of relatlimab administered alone or in combination with nivolumab to subjects with relapsed or refractory B-cell malignancies. Co-primary objective is to investigate the preliminary efficacy of relatlimab in combination with nivolumab in subjects with relapsed or refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffused Large B Cell lymphoma (DLBCL)

NCT ID: NCT02061709 Completed - Clinical trials for Seasonal Allergic Rhinitis

Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber

Start date: January 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen