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NCT ID: NCT02189941 Completed - Healthy Volunteers Clinical Trials

Pilot Study of the Pharmacokinetic Profile of a Single Dose of Deferiprone Sustained-Release Formulation in Healthy Volunteers

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

The purpose of this study is to evaluate the pharmacokinetic and safety profile of the sustained-release formulation of deferiprone under both fasting and fed conditions, and evaluate the relative bioavailability of this sustained-release formulation when compared to immediate-release formulation of deferiprone under fasting conditions.

NCT ID: NCT02189694 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp

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

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp. The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia

NCT ID: NCT02189252 Completed - Clinical trials for Severe Hypertriglyceridemia

An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis

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

This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.

NCT ID: NCT02189148 Completed - Preterm Birth Clinical Trials

First-trimester Prediction of Preeclampsia

PREDICTION
Start date: November 2014
Phase:
Study type: Observational

Preeclampsia is a complication of pregnancy related to adverse maternal and neonatal outcomes, including fetal growth restriction and perinatal death. Several measures are used or under investigation (low-dose aspirin, low-molecular weight heparin, calcium, folic acid, among others) for the prevention of preeclampsia. Unfortunately, most high-risk women who could benefit from those preventive measures are not identified until late in pregnancy. Recent evidences suggest that the investigators could identify women at risk of developing preeclampsia using a combination of serum and ultrasound biomarkers in the first-trimester of pregnancy. This screening test needs external validation. A first-trimester screening strategy will strengthen clinical research on preeclampsia and will contribute to the development of strategy combining the prediction and prevention of the disease and its related complications.

NCT ID: NCT02188524 Completed - Accidental Falls Clinical Trials

The Effect of Training Older Adults in Tai Chi and Compensatory Stepping on Balance Control

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

For the duration of 10 weeks, participants will be asked to maintain their current levels of physical activity and to take part in three testing sessions over the course of 10 weeks. Objective and subjective measurements will be obtained at (week 0), at midpoint (week 5) and after the intervention terminates (week 10). The objective measurements will be taken by inserting pressure sensors directly into the shoe and recording the centre of pressure. Markers will be attached to the surface of the body on the shoulders, feet and belly button and video recording will be used to assess the movement of the centre of mass. The first task requires individuals to stand in one spot with their eyes open, and then eyes closed. Secondly, standing in one place, upon an auditory cue, arms will be lifted to the sky as fast as possible. Lastly, participants will walk around a set of chairs while music plays and when the music stops, this is a cue to stop walking. The Timed-Up-and-Go test requires participants to rise from a seated position, walk 3 meters, turn and return to their original seated position. The Berg Balance Scale requires the completion of a 14 task sequence which evaluates balance ability during seated, and various standing positions as well as transitioning movements. The other measurements taken are collected via a questionnaire about balance confidence level. Upon arrival, participants are required to report whether they have experienced a fall since the last class attended and if yes, a follow-up questionnaire is also required to gain information about the nature of the fall.

NCT ID: NCT02188290 Completed - Clinical trials for Acute Myeloid Leukemia

Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation

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

Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).

NCT ID: NCT02188251 Completed - Body Weight Clinical Trials

A Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants

14AWHG
Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effects of Activamp, a product containing gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy overweight adults.

NCT ID: NCT02187861 Completed - Follicular Lymphoma Clinical Trials

A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)

Start date: December 1, 2014
Phase: Phase 2
Study type: Interventional

This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.

NCT ID: NCT02187289 Completed - Breast Cancer Clinical Trials

Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects

LYNC
Start date: October 2014
Phase: N/A
Study type: Interventional

Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.

NCT ID: NCT02187055 Completed - Rhematoid Arthritis Clinical Trials

An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

ORAL STRATEGY
Start date: August 2014
Phase: Phase 4
Study type: Interventional

To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.