Kusajili – Centralise les essais cliniques mondiaux

Safety Trial Of CTX Cells In Patients With Lower Limb Ischaemia The primary objective of the Phase I ascending dose trial is to investigate the safety and tolerability of intramuscular (gastrocnemius) injections of human neural stem cell product, CTX, in patients with peripheral arterial disease (Fontaine Stage II through IV). This trial is based on independent preclinical data from a leading academic research institution that has been submitted for publication. Inclusion of patients with Fontaine Stage II is justified as these patients have a lower incidence of background events and will facilitate distinction between events which are possibly intervention-related versus spontaneous events associated with underlying advanced atherosclerosis. The trial is designed to treat 9-18 patients and evaluate safety measures over a 12 month follow-up period.

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Asthma Learning Project The purpose of this study is to determine the effect on knowledge and behavior of playing an educational asthma computer game during a pediatric Emergency Department (ED) asthma visit among children ages 7 - 15 years. The ED cares for a high-risk population of children who have difficulty accessing preventive care well. The addition of a computer game to usual asthma emergency care could be a simple, effective, enjoyable way to improve patients' asthma knowledge, beliefs, and management practices. This project has the potential to lead to larger studies evaluating the benefit of education with and without behavioral interventions such as motivational interviewing. This project plans to implement and evaluate the use of a goal setting activity and the educational asthma computer game, "Quest for the Code" (Starlight Starbright Children's FoundationTM), in the ED of Seattle Children's Hospital. In a randomized trial of Spanish and English speaking children ages 7 - 15 years receiving ED care for their asthma, the investigators will evaluate the effects of the game on children's asthma knowledge, attitudes, and behaviors. The investigators aim to compare the change in asthma knowledge and locus of control after 3 months, for children who play the computerized asthma game, versus those who receive standard care in the ED. The investigators will also compare changes in asthma severity and activity limitations over 3 months, for children who play the asthma game without goal-setting, children who playing the game with goal-setting, and children who receive standard care. Overall, the investigators hypothesize that educational asthma game play by pediatric patients with acute asthma will improve asthma knowledge, compared with standard care.

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Effects of a Whole Body Vibration Training in Patients After Lung Transplantation Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients < 1 year after lung Transplantation and 70 patients > 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).

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Free Test Strips and Blood Glucose Control This study is designed to determine if there is an impact on blood glucose control in patients who receive free test strips. Patients in the study have no insurance or insurance that does not cover the purchase of test strips. A comparison of weight, blood pressure, and Hemoglobin A1C from entry to the final visit will be used to compare patients' management of their diabetes. Recommended values for these parameters will be used as the standard for comparisons. The investigators anticipate that patients receiving free test strips will show an improvement in the listed parameters as well as in satisfaction with their care.

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Glycemic Effects of Honey Honey has been used as a sweetener for centuries. Recent data indicate that honey consumption may have beneficial effects upon glucose intolerance, a health issue currently affecting 57 million Americans of every age and ethnicity. In order to evaluate the glycemic effect of honey, the investigators will carry out a human trial assessing biomarkers of blood glucose responses, insulin sensitivity, oxidative stress, and inflammatory markers. Our primary objective is to determine the glycemic effects of honey in comparison to sucrose and high fructose corn syrup (HFCS). The investigators hypothesize that honey will promote improved glucose tolerance and insulin sensitivity compared to both sucrose and high fructose corn syrup in normal glycemic and glucose intolerant adults.

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Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH (TRANOXY2015) The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal delivery ( the bleeding is defined severe if it exceeds 1000 mL). PPH is called "primary" when blood loss arose within 24 hours after birth. This is a open-trial randomized, longitudinal, controlled that including 486 subjects .

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Symbicort in Asthmatic Children - SEEDLING The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years

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Efficacy of Pioglitazone Compared to Glyburide in Treating Subjects With Type 2 Diabetes Mellitus and Mild Cardiac Disease The purpose of this study is to evaluate the cardiovascular effects of pioglitazone, once daily (QD), versus glyburide when administered to patients with type 2 diabetes mellitus and mild cardiac disease.

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Blood-based Identification and Monitoring of Patients With ALK-translocated Lung Cancer Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation of a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small cell lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor (TKI) crizotinib has produced remarkable results for ALK-positive patients, however the current diagnostic tests used in the clinic are not sufficiently detailed and require a tumor biopsy. The aim of this study is to use a new diagnostic test to detect ALK rearrangements using next generation sequencing, which will improve the diagnosis and treatment of ALK-positive NSCLC patients. Furthermore, this test will be performed on blood samples, making it minimally invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in blood can be employed as an easy accessible and comprehensive source of information to diagnose ALK-positive disease, but also as a means of monitoring patient response during treatment. Quantitation of the the amount of ALK rearrangement will give information about which patients benefit from treatment and when treatment is no longer effective. The project will be a multicenter study where blood samples will be collected every 6 weeks from patients treated at four major hospitals in Denmark. This study will benefit future patients with lung cancer, as it will improve both the monitoring and evaluation of their treatment. Monitoring patients during treatment will provide more knowledge of disease progression and the effect of ALK-TKI treatment, contributing to a greater selection of patients, who will respond to treatment. This will potentially allow effective treatment to continue longer than with conventional methods

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The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient. This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen. We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.

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