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NCT ID: NCT02405091 Completed - Tardive Dyskinesia Clinical Trials

Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Kinect 4
Start date: March 2015
Phase: Phase 3
Study type: Interventional

Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.

NCT ID: NCT02404480 Completed - Cancer Clinical Trials

PTC596 in Patients With Advanced Solid Tumors

Start date: January 2016
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in patients with advanced cancer.

NCT ID: NCT02404441 Completed - Melanoma Clinical Trials

Phase I/II Study of PDR001 in Patients With Advanced Malignancies

Start date: April 27, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this "first-in-human" study of PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent to adult patients with solid tumors. By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.

NCT ID: NCT02404350 Completed - Psoriatic Arthritis Clinical Trials

Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

FUTURE5
Start date: August 31, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

NCT ID: NCT02403492 Completed - Obesity Clinical Trials

Treatment of Obstructive Sleep Apnea in Children: An Opportunity for Cardiovascular Risk Modification

TREAT
Start date: August 2013
Phase: N/A
Study type: Interventional

Heart disease is a major cause of ill-health and death in adults. The risk factors for heart disease, if present in children, carry over into adult life. Childhood obesity has reached epidemic proportions in Canada and is associated with many heart disease risk factors such as high blood pressure. Another complication of obesity is obstructive sleep apnea. Sleep apnea is marked by snoring at night, pauses in breathing and low oxygen levels and occurs in up to 60% of obese children, but it is diagnosed in less than 20% of obese children. Importantly, sleep apnea in children, like obesity, is linked with high blood pressure and heart disease. Thus, children with sleep apnea who are obese are likely to have an increased risk for high blood pressure and heart disease. Currently, there is little knowledge of the extent of heart disease in obese children with sleep apnea. The best treatment for both obesity and sleep apnea is weight loss. Weight loss strategies are generally not very successful and since 75% of obese children will become obese adults, urgent treatments are needed to reduce heart disease in the long-term. Treating sleep apnea in obese children may be one of the ways to reduce heart disease. Sleep apnea can be treated with continuous positive airway pressure (CPAP), which involves wearing a mask attached to a breathing machine while asleep. It is unknown how effective CPAP is in reducing heart disease in obese children. The investigators will recruit children with sleep apnea who are obese and test for heart disease risk. The investigators will then treat these children with CPAP. After 6 months of CPAP, the investigators will repeat the tests to determine if CPAP lowers the risk for heart disease. At the end of the 6 months, those receiving CPAP will be randomized to either continue CPAP or discontinue CPAP for a 2 week period. At the end of the 2 week period the participants will repeat the tests again to determine the magnitude of the effect of CPAP. The investigators expect that CPAP treatment for sleep apnea in obese children will reduce blood pressure and lower heart disease. These results will increase awareness of the dangers of sleep apnea in obese children, which will facilitate early diagnosis and treatment, ultimately reducing heart disease long-term.

NCT ID: NCT02403479 Completed - Rhinosinusitis Clinical Trials

The Effectiveness of Topical Silver Colloid in Treating Patients With Recalcitrant Chronic Rhinosinusitis

CRS
Start date: December 10, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Chronic rhinosinusitis without polyposis (CRSsP) is a very common condition that occurs when the lining of the sinuses becomes persistently irritated. Standard management options include topical steroids, antibiotics and surgery, but treatment-resistant CRSsP is frequently encountered. Bacterial biofilms are routinely detected within the nasal mucosa of CRSsP patients and are now thought to play an important role in the protracted nature of the disease. Colloidal silver is a widely used naturopathic agent that has recently been shown to eliminate bacteria, and in particular in vitro sinusitis biofilms, in laboratory studies. Although silver is currently used in a variety of chronic wound therapies, it has not yet been formally studied in people with CRSsP. It is our intention with this project to determine whether colloidal silver is a useful treatment strategy for patients with refractory CRS.

NCT ID: NCT02403466 Completed - Clinical trials for Serious Medical Errors

IIPE-PRIS Accelerating Safe Signouts

I-PASS
Start date: September 2010
Phase: N/A
Study type: Interventional

Because communication and handoff failures are a root cause of two-thirds of "sentinel events"- serious, often fatal preventable adverse events in hospitals improving handoffs has been identified by AHRQ and the Joint Commission as a priority in nationwide efforts to improve patient safety. Comparative Effectiveness Research on handoff tools and processes has identified specific strategies to improve handoffs and reduce medical errors: 1) team training; 2) verbal mnemonics; and 3) use of written/computerized tools to supplement verbal sign-outs. To accelerate residents' use of CER-based handoff practices and improve patient safety, the investigators are implementing the three inventions above as a Resident Handoff Bundle (RHB) in eight pediatric hospitals in the United States and Canada.

NCT ID: NCT02402868 Completed - Bone Fractures Clinical Trials

Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children

Start date: January 2016
Phase: Phase 3
Study type: Interventional

This study will examine the effectiveness of intranasal (IN) ketamine compared to standard intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the paediatric population. The aim is to assess if IN administration is equivalent to the current standard of care, IV. The population to be studied is children 5-17 years of age who require a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty in masking interventions, each participant will recieve both IV and IN interventions, only one of which will be the real drug. Procedural conscious sedation (PCS) will be assessed using the University of Michigan Sedation Scale (UMSS).

NCT ID: NCT02402712 Completed - Breast Cancer Clinical Trials

Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer

Start date: May 6, 2015
Phase: Phase 3
Study type: Interventional

This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.

NCT ID: NCT02402517 Completed - Obesity Clinical Trials

PERFECT Project - Part 2 - Study 1

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

The objectives are to test the acute effects of different extruded pulse snacks on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite on an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of food products containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. The investigators also hypothesize that consumption of extruded pulse snacks will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.