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NCT ID: NCT01973907 Completed - Septic Shock Clinical Trials

Pilot Study for the SQUEEZE Trial

SQUEEZE
Start date: January 2014
Phase: Phase 3
Study type: Interventional

The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. In this study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock Resuscitation Guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve ACCM recommended hemodynamic targets.

NCT ID: NCT01973777 Completed - Contraception Clinical Trials

A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A

IUB
Start date: December 2013
Phase: N/A
Study type: Interventional

The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.

NCT ID: NCT01973673 Completed - Clinical trials for Locally Advanced Malignant Neoplasm

Healthy Bones Study

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

Prostate cancer patients receiving hormone treatment (androgen deprivation therapy, or ADT) are at increased risk of developing bone loss and osteoporosis as side effects. To prevent this, guidelines recommend participation in healthy bone behaviours including weight-bearing exercise and adequate calcium/vitamin D intake. However, prior studies have shown that patients are not regularly screened or counselled regarding healthy bone behaviours while receiving ADT. Maintaining bone health in prostate cancer patients is important because men on ADT are at increased risk of fractures. In this study, the investigators will examine whether an intervention designed to improve healthy bone behaviours among prostate cancer patients on ADT can be implemented. The intervention consists of a written "healthy bones prescription", brief verbal counseling, and printed educational materials for participants. Investigators hope to obtain an initial estimate of whether the intervention works. They also hope to show that this simple intervention can be implemented in a real, working cancer clinic. The investigators hypothesize that an intervention to improve bone health in prostate cancer patients receiving ADT (healthy bones prescription, verbal counseling, and printed educational materials) is effective, implementable, and accepted by clinicians and patients.

NCT ID: NCT01973361 Completed - WOUNDS Clinical Trials

Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

UltraHeal
Start date: December 2013
Phase: N/A
Study type: Interventional

The UltraHeal Study is a randomized controlled trial to compare healing response of low frequency contact ultrasonic-assisted debridement in addition to best practice wound care to best practice wound care alone in a Vascular Surgery Clinic patient population with wounds of the lower extremity.

NCT ID: NCT01973049 Completed - Hepatitis C Clinical Trials

UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

Start date: December 2013
Phase: Phase 3
Study type: Interventional

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

NCT ID: NCT01972984 Completed - Breast Cancer Clinical Trials

Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients

NEO ER 11-05
Start date: October 2012
Phase: Phase 2
Study type: Interventional

1. Women with operable breast cancer with a 2-8 week preoperative waiting period will accept preoperative therapy trials and specifically taking a standard drug for breast cancer such as anastrozole in this study 2. Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor. 3. Degree of response to short term anastrozole varies with a) duration of treatment and b) breast cancer subtype (based on initial pre-treatment biomarker status)

NCT ID: NCT01972841 Completed - Overactive Bladder Clinical Trials

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

SYNERGY
Start date: November 5, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

NCT ID: NCT01972646 Completed - Clinical trials for Uncomplicated Outpatient Cellulitis

Predictors of Failure of Empiric Outpatient Antibiotic Therapy in Emergency Department Patients With Uncomplicated Cellulitis.

Start date: June 2010
Phase: N/A
Study type: Observational

Introduction: Despite several expert panel recommendations and cellulitis treatment guidelines, there are currently no clinical decision rules to assist clinicians in deciding which emergency department (ED) patients should be treated with oral antibiotics and which patients require intravenous therapy at first presentation of uncomplicated cellulitis. The objective of this prospective study is to determine potential patient risk factors associated with adult patients (>17years) presenting to the ED with a concern about a skin or soft tissue infection who fail initial antibiotic therapy for the treatment of standard cellulitis and require a change of antibiotics or admission to hospital. Methods: This study will be a prospective study conducted in two tertiary care EDs. Patients will be excluded if they have been treated with antibiotics for the current bout of cellulitis prior to presenting to the ED, patients admitted to hospital and those patients with abscesses only. Hired research assistants (RAs) will administer a questionnaire at the initial ED visit with telephone follow-up 2 weeks later. Treatment failure will be defined as patients requiring subsequent hospitalization, initiation of intravenous antibiotics (if oral antibiotics were prescribed initially), or a change of oral antibiotics for the original cellulitis. Results: This study will provide a detailed profile of patient risk factors associated with treatment failure of cellulitis. The results will be analyzed and used in formulating a clinical decision rule for effective treatment of cellulitis presenting to the ED. Each of the predictor variables associated (p ≤ 0.1) with failed treatment in the univariate analysis will be considered in a multivariate logistic regression model. Additionally, treatment variability among clinicians in regard to cellulitis will be evaluated and compared to treatment failures, thus providing data on successful treatment regimens. Conclusions: Results from this research may be used to generate a clinical prediction rule to assist clinicians in effectively treating patients presenting to emergency departments with cellulitis. Understanding which patient risk factors for treatment failure will assist clinicians in determining which patients will benefit from intravenous versus oral antibiotics.

NCT ID: NCT01972529 Completed - Clinical trials for Thrombocytopenia Associated With Liver Disease

Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure

Start date: February 2014
Phase: Phase 3
Study type: Interventional

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

NCT ID: NCT01972386 Completed - Lung Cancer Clinical Trials

EBUS/Spectrum Analysis

Start date: September 2013
Phase: N/A
Study type: Observational

To evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer.