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NCT ID: NCT02176096 Completed - Hypoglycemia Clinical Trials

Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial

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

The objective of this demonstration project is to compare a novel long-acting starch, Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade has been reported to increase the duration of euglycaemia. Its slow release and longer periods of normal blood sugar achieved would preclude the need for the overnight dextrose infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus potentially improving compliance to therapy. The investigators intend to evaluate Glycosade in our patients and determine its efficacy on glucose control, on the length of normoglycemia achieved and to determine if there are reduced side effects in our patients with GSD-I. This will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the protocol.

NCT ID: NCT02175615 Completed - Clinical trials for Acute-graft-versus-host Disease

Pharmacological Predictors of Successful Cyclosporine Acute GVHD Prophylaxis in Children Undergoing HSCT

Start date: October 2010
Phase:
Study type: Observational

The specific objectives of this study are: Primary: 1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and severe aGVHD (grade III and IV) Secondary: 1. To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV) 2. To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and 3. To describe the relationship between cyclosporine AUC and individual concentration-time points achieved prior to engraftment and other HSCT outcomes (clinically significant aGVHD (grade II to IV), hypertension, engraftment failure, relapse

NCT ID: NCT02175433 Completed - Clinical trials for Relapsed Lymphoid Malignancy

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

Start date: October 14, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be assessed.

NCT ID: NCT02175225 Completed - Clinical trials for Intracerebral Hemorrhage

Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

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

The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate, improves the outcome of patients with brain hemorrhage. The purpose of this study is to determine whether treatment with Deferoxamine Mesylate is of sufficient promise to improve outcome before pursuing a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.

NCT ID: NCT02174874 Completed - Clinical trials for Acute Gastroenteritis

Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

Start date: June 2011
Phase: N/A
Study type: Observational

In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less vomiting within 15 minutes of administration than those receiving Ondansetron OS.

NCT ID: NCT02174861 Completed - Clinical trials for Treatment for Prevention of Chronic Migraine

A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

Start date: June 30, 2014
Phase: Phase 2
Study type: Interventional

To assess the long-term safety and efficacy of erenumab.

NCT ID: NCT02174809 Completed - Clinical trials for Gestational Weight Gain

Gestational Weight Gain in Primary Care

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Excess weight gain in pregnancy is linked to a number of adverse outcomes for mothers and their offspring, and in 2011, 59 % of women in Nova Scotia gained weight in excess of recommendations. A number of factors influence how much weight a woman gains, including lack of knowledge, age, the number of previous pregnancies she's had, smoking, ethnicity, income, and education. Although a clinician's advice also plays a role, simply giving advice does not necessarily translate into patient behaviour change. On the other hand, advice that is given through a patient-centred approach is significantly associated with increased patient acceptance of and adherence to recommendations, and increased intentions and attempts at behaviour change. In addition, this approach has been shown to decrease costs to the health care system. Patient-centredness can measured from the perspective of the clinician, an observer, or the patient. Research suggests that the patient's perspective of patient-centredness is the perspective most significantly associated with improved health outcomes. Clinicians avoid discussing weight-related matters for a number of reasons, including a lack of time and general discomfort in raising the subject. There are some tools that can address some of these barriers, and example being the "5As of Obesity Management". This tool is based on principles of behaviour change science and patient-centredness. Pilot data on the use of this tool showed a two-fold increase in the initiation of weight-related discussions between clinicians and their patients. Our team was instrumental in the development, dissemination and initial evaluation of this tool, and Dr. Piccinini-Vallis has recently led a national multidisciplinary endeavor to adapt it to pregnancy, which has resulted in the "5As of Healthy Pregnancy Weight Gain" tool. It is now time to evaluate whether the use of this tool is acceptable to clinicians and whether its use translates into any patient outcomes.

NCT ID: NCT02174731 Completed - Anemia Clinical Trials

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.

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

The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.

NCT ID: NCT02174627 Completed - Anemia Clinical Trials

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis

NCT ID: NCT02174276 Completed - Chronic Hepatitis B Clinical Trials

Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment

Start date: July 24, 2014
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.