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NCT ID: NCT01826019 Completed - Hypertension Clinical Trials

Heart Outcomes Prevention and Evaluation 4

HOPE-4
Start date: August 2014
Phase: Phase 4
Study type: Interventional

The overall objective of the HOPE-4 Phases (HT and CVD) is to develop, implement and evaluate an evidence-based, contextually appropriate programme for cardiovascular disease (CVD) risk assessment, treatment and control involving: (1) simplified algorithms implemented by non-physician health workers (NPHW) and supported by e-health technologies (tablets programmed with decision and counselling support software); (2) initiation of evidence-based cardiovascular (CV) medications and (3) treatment supporters to optimize long-term medication and lifestyle adherence.

NCT ID: NCT01825798 Completed - Overweight Clinical Trials

Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)

MET
Start date: April 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether metformin is safe and effective in the treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who are currently taking atypical antipsychotic medication.

NCT ID: NCT01825161 Completed - Clinical trials for Secondary Malignant Neoplasm of Vertebral Column

The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)

EPOSO
Start date: August 2013
Phase:
Study type: Observational

The main purpose of this study is to utilize a comprehensive, prospective clinical database to collect patient, diagnostic and treatment variables along with disease specific and generic health related quality of life (HRQOL) data on consecutively treated patients with metastatic spine tumors. The objectives are to determine the validity and reliability of the Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes, to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool for predicting the stability of spine in metastatic spine disease, and to determine the efficacy of surgery versus radiotherapy for the treatment of impending instability secondary to metastatic disease of the spine.

NCT ID: NCT01824693 Completed - Clinical trials for Juvenile Myelomonocytic Leukemia

Busulfan, Cyclophosphamide, and Melphalan or Busulfan and Fludarabine Phosphate Before Donor Hematopoietic Cell Transplant in Treating Younger Patients With Juvenile Myelomonocytic Leukemia

Start date: June 24, 2013
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before donor hematopoietic cell transplant works in treating younger patients with juvenile myelomonocytic leukemia. Giving chemotherapy before a donor hematopoietic transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before a donor stem cell transplant is more effective in treating juvenile myelomonocytic leukemia.

NCT ID: NCT01824654 Completed - Clinical trials for Aortic Aneurysm, Abdominal

Enhanced Guidance for Endovascular Repair of Abdominal Aortic Aneurysm

AAA 2D/3D II
Start date: April 2013
Phase: N/A
Study type: Interventional

An increasing incidence of abdominal aortic aneurysms (AAA) is observed in our ageing population. Since it is less invasive, endovascular repair (EVAR) by stent-graft (SG) insertion is frequently indicated in patients with intermediate and high-operative risk. Patient selection and stent planning for EVAR is done on CT-scans based on specific anatomic criteria. SG are inserted in the catheterization laboratory under digital substraction angiography (DSA) and fluoroscopic guidance. With this technology, no soft-tissue differentiation is available during the intervention and important information are lacking such as thrombus and aneurysm extension close to proximal and distal landing zones. Our team has recently patented a software allowing the extraction of the AAA (lumen and thrombus) from pre-operative CT-scanner. In collaboration with Siemens medical, the investigators have integrated this technology to the Siemens workstation in the catheterization laboratory. The investigators can now import the aortic lumen and thrombus meshes segmented from pre-operative CT-scans and perform a rigid registration with fluoroscopy and DSA data to enhance visualization of soft tissue during EVAR. Our preliminary results are encouraging in terms of feasibility and visualization. However, the delivery device of the SG and the guidewire used during the intervention are stiff and induce a deformation of aortic lumen and thrombus. This deformation impairs the accuracy of rigid registration. The investigators propose to improve registration accuracy by implementing an elastic deformation of aortic lumen and wall based on the segmentation of endovascular devices (delivery device, guidewires and catheters) inserted during the procedure and by biomechanical modeling.

NCT ID: NCT01824628 Completed - Clinical trials for QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen

Comparison of the QT/QTc Interval Between an Outpatient HIV-Infected Population on Antiretroviral Therapy and Two Large HIV-Negative Cohorts

QTVIE
Start date: March 2013
Phase: N/A
Study type: Observational

This is a unicentric, two cohorts, observational transversal study. The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects receiving an antiretroviral therapy and those without HIV in an ambulatory care setting.

NCT ID: NCT01824277 Completed - Diabetes Clinical Trials

DCI: A Community Based Pre-cardiac Surgery Diabetes Care Project

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

The Canadian Diabetes Association recommends optimizing glycemic control to achieve a glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (A1C>7%). Recent research has demonstrated that such patients experience a higher rate of post-operative complications and significantly worse short-term and long-term post-operative survival. Therefore, it is recommended that attempts should be made to improve glycemic control while patients wait for their elective surgery. However, at present processes of care that facilitate pre-operative glycemic control optimization do not exist in Canada. The objective of this project is to determine the feasibility and effectiveness of a comprehensive community-based pre-operative diabetes optimization program for patients awaiting elective cardiac surgery.

NCT ID: NCT01823653 Completed - Clinical trials for Treatment of Adipose Tissue in the Thighs

Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound

Start date: July 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.

NCT ID: NCT01823341 Completed - Type 1 Diabetes Clinical Trials

Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children

PSO4
Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular laptop computer. A The system works by (1) measuring the glucose levels under the skin with the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is likely to occur, and (3) turning off the insulin pump when the computer program predicts that a low blood sugar will occur. We have tested the system in the home environment in individuals with type 1 diabetes age 15 years and older. We have found an indication that the system can decrease the frequency of hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We are now ready to further test the system in the home environment in a younger age group to learn more about its ability to reduce overnight low blood sugar risk. This study has several phases and will take about 3 months for a patient to complete. - First, the patient will use the CGM and pump at home for up to 15 days with the help of a parent/guardian. This is done to determine if the patient meets our study criteria to proceed with the next phase of the study. - If the patient is eligible to continue in the study, the patient will need to use the full study system for at least 5 nights at home with the help of a parent/guardian. This is done to make sure the patient and parent/guardian are able to use the system correctly. The patient may participate in starting and stopping the system at home, but the parent/guardian is responsible for making sure it is used as instructed. - After that, the patient will be asked to use the study system each night for an additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the system is used as instructed. The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the United States and Canada. First a study of children 8 to less than 15 years old will be done. Then, a study of children 3 to less than 8 years old will be conducted.

NCT ID: NCT01823016 Completed - Asthma Clinical Trials

A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma

Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asthma that is inadequately controlled despite current treatment.