Clinical Trials Logo

Filter by:
NCT ID: NCT02274233 Terminated - Iron Overload Clinical Trials

Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia

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

The purpose of this study is to assess safety and amount of the study drug in the blood after increasing doses of SP-420. The study will be conducted in patients with β-thalassemia.

NCT ID: NCT02273284 Terminated - Pain Clinical Trials

Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®

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

The use of Botulinum toxin injections (BoNT-A) has become a standard therapy for children and youth who suffer from stiffness of their muscles due to a neurological problem. These injections are given into each muscles which require treatment, which often means receiving multiple injections in one session. Intramuscular injections are typically painful. Treatment can be provided unsedated and then should incorporate distraction and relaxation techniques, or can be alternatively be provided with the use of sedation. To improve the pain experience the investigators want to assess the feasibility and impact on the pain perception when using a vibration device called the Buzzy during BoNT-A injections. The Buzzy creates a vibration that is applied over the injection site for 30 seconds before the injection and will be continued just above the injection site during the injection. The Buzzy has been shown to help reduce pain in procedures such as i.v. insertions and immunizations, but has not been tested in children and youth receiving multiple BoNT-A injections.

NCT ID: NCT02267408 Terminated - Hypoprothrombinemia Clinical Trials

Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin

Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Patients on warfarin but with unstable international normalized ratio (INR) will be recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after the mathematician Michael Fearon), which uses historical data to estimate patients' sensitivity to warfarin and to dose changes as well as the lag time until a dose adjustment takes effect, or to the investigators standard management Main outcome is improvement in time in therapeutic range.

NCT ID: NCT02265900 Terminated - Parkinson Disease Clinical Trials

Parkinson's Disease Exercise TMS PET Study

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

The therapeutic effects of exercise in Parkinson's disease (PD) are commonly reported, however the mechanisms are unknown. The purpose of this study is to investigate the potential mechanisms of exercise in the brain for the treatment of PD.

NCT ID: NCT02263508 Terminated - Melanoma Clinical Trials

Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma

MASTERKEY-265
Start date: December 8, 2014
Phase: Phase 3
Study type: Interventional

The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma. The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and overall survival (OS).

NCT ID: NCT02262936 Terminated - Nocturia Clinical Trials

Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older

DEFEND
Start date: July 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Nocturia, or voiding at night, is an extremely troublesome symptom which is highly prevalent in the elderly. Desmopressin is a treatment for nocturia but it can result in hyponatremia (low blood sodium), particularly in those aged 65 and older. Fesoterodine is used for the treatment of overactive bladder (OAB). Recent trials showed Fesoterodine was effective in reducing nocturia. This study aims to answer the following: In women 65 and older with severe nocturia, is Fesoterodine more effective than Desmopressin in reducing the number of night time voids? Does Fesoterodine have a better side effect profile compared to Desmopressin? The study design is a 12 week randomized double-blinded trial of Fesoterodine and Desmopressin in the treatment of severe nocturia in women aged 65 and older. This will be conducted at the Urogynecology Unit at Mount Sinai Hospital (MSH) and Baycrest. A 3 day voiding diary and Nocturia, Nocturnal Enuresis and Sleep-interruption Questionnaire (NNES-Q) will be completed at baseline and at week 12. The primary outcome will be the number of night time voids in the Fesoterodine group compared to the Desmopressin group, 12 weeks after starting treatment. Secondary outcomes include changes in the NNES-Q scores and the safety of each medication. This study is expected to show that, in women 65 and older with severe nocturia, Fesoterodine will be more effective in reducing the number of night time voids, reducing the volume of voided urine, increasing the duration of sleep prior to first nocturnal void and improving quality of life relative to Desmopressin. Fesoterodine will also be better tolerated, with fewer significant adverse events, relative to Desmopressin.

NCT ID: NCT02258581 Terminated - Chronic Hepatitis B Clinical Trials

Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection

Start date: December 9, 2014
Phase: N/A
Study type: Observational

This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).

NCT ID: NCT02258464 Terminated - Breast Neoplasms Clinical Trials

Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

Start date: March 2, 2015
Phase: Phase 2
Study type: Interventional

The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy

NCT ID: NCT02257749 Terminated - Clinical trials for Mild Traumatic Brain Injury

Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion

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

The purpose of this randomized control trial study is to determine if an active rehabilitation (low intensity exercise program) in combination with a comprehensive education intervention (standard care) is more effective than the comprehensive education intervention alone in reducing post-concussion symptoms and improving participation in daily activities in youth who have persistent post-concussion symptoms.

NCT ID: NCT02252315 Terminated - Clinical trials for Mild Traumatic Brain Injury

Written Versus Verbal Education for Mild Traumatic Brain Injury

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

Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or alteration in mental status induced by an external mechanical force to the head. Education about symptoms and reassurance of a prompt recovery usually results in full recovery. However, a subgroup appears to have persistent symptoms and disability. This study will recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable patient characteristics that can delay or prevent full recovery. A secondary aim is to determine if providing education in writing or in-person makes a difference.