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NCT ID: NCT02437318 Completed - Breast Cancer Clinical Trials

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

SOLAR-1
Start date: July 23, 2015
Phase: Phase 3
Study type: Interventional

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

NCT ID: NCT02437123 Completed - HIV Clinical Trials

The Cedar Project: Impact of mHealth for HIV Prevention Among Young Indigenous People Who Use Illicit Drugs

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

This study will examine the effect of a culturally-safe two-way supportive text message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in a community-based setting. The study is nested within The Cedar Project, an ongoing cohort study addressing HIV and Hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia, Canada. Indigenous collaborators and investigators, collectively known as the Cedar Project Partnership, govern the entire research process. A stratified Zelen pre-randomized design will be used to identify a random selection of cohort members to be offered the Cedar Project mHealth intervention with consent. Participants in the intervention arm will receive a package of supports, including a mobile phone and long-distance plan, weekly two-way supportive text messaging via the WelTel platform, and support from Cedar Advocates. Those drawn from the cohort study population as the comparison group will continue on in the usual Cedar Project study under its existing informed consent with no change whatsoever to their participation in the overall study. The main outcome is an HIV propensity score, assessed at six months and one year. Secondary outcomes include HIV risk, resilience, access to drug-related services, psychological distress, and connection to culture measured at six months and one year. Primary analysis is by intention to treat.

NCT ID: NCT02436798 Completed - Clinical trials for Adverse Reaction to Other Drugs and Medicines

5-HT3 Antagonists (Antiemetics) and Cardiac Safety

Start date: June 2014
Phase:
Study type: Observational

5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea and vomiting. However, these medications also associated with potentially severe and life-threatening cardiac adverse drug reactions (ADRs), particularly QT prolongation. Data regarding the cardiac safety and inter-individual variability in cardiac effects of ondansetron when used in vulnerable populations such as children and pregnant women are very limited. The results of this study will enable better-informed therapeutic decision-making regarding the use of ondansetron in children and pregnant women, with the overall goal to improve the safety of these commonly used antiemetic medications. Furthermore, predictive pharmacogenetic markers of severe 5-HT3 antagonist toxicity could be used to identify patients at risk of cardiac toxicity before the drug is administered.

NCT ID: NCT02436785 Completed - Clinical trials for Arthritis, Rheumatoid

Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening?

Start date: May 6, 2015
Phase: N/A
Study type: Interventional

Pain management is rated by patients with inflammatory arthritis as the highest priority in their disease treatment. Past research showed that music therapy is associated with reduced pain and depression. The purpose of this study is to better understand the effectiveness of music therapy for people with inflammatory arthritis. Participants will be randomly assigned to: 1) Music Therapy group facilitated by a music therapist, or 2) Music Listening group that listens to a relaxation CD (compact disc). Standardized tests will determine if participating in music therapy group helps reduce pain and depression, improve physical function and confidence levels in applying self-management strategies.

NCT ID: NCT02436499 Completed - Chronic Migraine Clinical Trials

Chronic Migraine Treatment With Botulinum Toxin-A: an Investigation of Functional Magnetic Resonance Imaging Changes.

Start date: July 2015
Phase: Phase 4
Study type: Interventional

Pilot study evaluating effect of Botox injection treatment for 12 individuals suffering from chronic migraine on function MRI imaging, before and after treatment.

NCT ID: NCT02436239 Completed - Clinical trials for Major Depressive Disorder

A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

VLZ-MD-23
Start date: May 2, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).

NCT ID: NCT02436174 Completed - Shivering Clinical Trials

Assessment Of Shivering With iSeismograph

Start date: October 2014
Phase: N/A
Study type: Observational

Shivering is a common side-effect of epidural anesthesia. In studies to date, the assessment of shivering has been based on a simple scale using descriptive words rather than actual measurements. We believe that we can assess shivering more scientifically by using a novel method to quantify arm movements during shivering.

NCT ID: NCT02435992 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Start date: June 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

NCT ID: NCT02435849 Completed - Clinical trials for B-cell Acute Lymphoblastic Leukemia

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients

ELIANA
Start date: April 8, 2015
Phase: Phase 2
Study type: Interventional

This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r/r B-cell ALL.

NCT ID: NCT02435498 Completed - Bone Fractures Clinical Trials

Web-based Education Module for Pain Management

Start date: September 4, 2015
Phase: N/A
Study type: Interventional

This study's objectives are as follows: 1. To evaluate the utility of a website to provide information and guidance about pain management in children 2. To educate parents about the pathophysiology of pain, proper use of analgesic medications and signs of pain in children 3. To reduce the functional impact of pain in children following treatment for fracture 4. To endow parents with confidence to manage their child's pain at home 5. To dispel misconceptions about the use and safety of analgesics in children 6. To increase awareness of complications of fractures such as compartment syndrome