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NCT ID: NCT03005028 Completed - Clinical trials for CAD - Coronary Artery Disease

Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study

Start date: January 2015
Phase: N/A
Study type: Observational

In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Investigation of a wide range of users in various conditions may strengthen the reliability of the FFRAngio measurements.

NCT ID: NCT03004924 Completed - Clinical trials for Bacterial Conjunctivitis

Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.

NCT ID: NCT03003806 Completed - Clinical trials for Type1 Diabetes Mellitus

Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study

Advice4U
Start date: October 2, 2017
Phase: N/A
Study type: Interventional

The DreaMed Advisor Pro is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary blood glucose measurements), insulin dosing and meal data during daily routine home care. Following a 5-minute data collection and analysis, the algorithm learns and suggests pump-setting changes for optimization of glucose control The algorithm is designed as an advisory tool and has three main components: 1. A statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia patterns. 2. Practical recommendations, alert messages based on aforementioned data 3. Recommendation for new insulin pump settings: including basal intervals and rate, different carbohydrate ratio according to time of day, correction factor and insulin sensitivity time. The main goal of the DreaMed Advisor Pro is to improve diabetes management for subjects with Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for pump users. The main objective of the proposed study is to evaluate the safety and efficacy of using the DreaMed Advisor Pro algorithm versus medical guided recommendation to determine insulin dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.

NCT ID: NCT03003533 Completed - Hemophilia A Clinical Trials

A Gene Transfer Study for Hemophilia A

Start date: January 26, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.

NCT ID: NCT03002519 Completed - Clinical trials for Incomplete HCT (Hematopoietic Cell Transplantation)

Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation

Start date: February 8, 2017
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the safety of intramuscular (IM) administration of PLX-R18 in subjects with incomplete hematopoietic recovery following HCT.

NCT ID: NCT03001206 Completed - Clinical trials for Acute Coronary Syndrome

The Use of the Master Caution System (MCS) for Continuous Monitoring and Detection of Dysrhythmias and Ischemic Events

Start date: January 2017
Phase:
Study type: Observational

The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU. The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test. The purpose of the study is to reassess the adequate size of the Master Caution Garment.

NCT ID: NCT03000439 Completed - Clinical trials for Arthritis Juvenile Idiopathic

A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

Start date: May 10, 2018
Phase: Phase 3
Study type: Interventional

A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. An interim analysis for efficacy and futility will be conducted when at least 20 flares have been observed. If either criterion is met, the study will be stopped. If neither criterion is met, the study will continue until the requisite number of flares are observed as determined by the number of flares included in the interim analysis and a statistical penalty for conducting the interim analysis.

NCT ID: NCT02997592 Completed - Clinical trials for Partial Thickness Burn

Evaluation of the SpinCareā„¢ System in the Treatment of Partial Thickness Burns

SPINCARE2
Start date: March 20, 2017
Phase: N/A
Study type: Interventional

Evaluation of the SpinCareā„¢ System in the Treatment of Partial Thickness Burns. A prospective, single arm, safety and efficacy, open labeled multi-center study

NCT ID: NCT02996903 Completed - Clinical trials for Coronary Artery Disease

Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017

PROTECTION-VI
Start date: March 1, 2017
Phase:
Study type: Observational [Patient Registry]

The "Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017" (PROTECTION-VI) study is a prospective registry and investigator-initiated initiative without third-party funding, which will collect and analyze the radiation dose exposure of Cardiac Computed Tomography Angiographic (CCTA) studies in current daily practice worldwide. Particularly, the study will assess the use of strategies for dose reduction during CCTA. A decade ago, the multicentre observational PROTECTION-I study has revealed that the dose-length-product of CCTA ranges between 568 - 1259 mGy x cm with a median of 885 mGy x cm. This corresponds to an estimated effective dose of approximately 12 mSv. Since then a variety of techniques have been developed and enhanced in order to reduce radiation exposure during CCTA. Recent studies demonstrated feasibility of dramatically reduced effective radiation doses during CCTA (0,1 - 0,3 mSv). This has been executed in small cohorts of patients at scientific expert centers. However, it remains unclear, if such low-level radiation dose exposure may be achieved in clinical routine and if diagnostic image quality is maintained. In order to analyze the magnitude of radiation dose exposure of CCTA in today's clinical practice and the current use of dose-saving techniques, we designed the PROTECTION-VI study. Eventually, this study may contribute to further improving radiation dose exposure for patients undergoing CCTA.

NCT ID: NCT02996305 Completed - Angelman Syndrome Clinical Trials

A Study in Adults and Adolescents With Angelman Syndrome (STARS)

Start date: January 2016
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol) in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory efficacy outcome measures will be investigated.