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NCT ID: NCT03525574 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

Start date: October 9, 2018
Phase: Phase 3
Study type: Interventional

The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

NCT ID: NCT03525444 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

NCT ID: NCT03524651 Completed - Clinical trials for Iron Deficiency Anemia

Ferrous Acetyl-Aspartate Casein Formulation Evaluation Over Ferrous Sulfate in Iron Deficiency Anemia

ACCESS
Start date: May 2, 2018
Phase: Phase 4
Study type: Interventional

The scope of this study is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with iron deficiency anemia (IDA) for the restoration of decreased circulating Hb. The improvement of symptoms of anemia, the restoration of biomarkers of iron deficiency into the normal range and the incidence of GI tract side effects are the study secondary endpoints.

NCT ID: NCT03524612 Completed - Clinical trials for Immune Thrombocytopenic Purpura (ITP)

A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP

TAPER
Start date: November 2, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with steroids.

NCT ID: NCT03519334 Completed - Employment Clinical Trials

PATHWAYS in Europe

PATHWAYS
Start date: May 2015
Phase:
Study type: Observational

PATHWAYS is a 3-year project that directly contributes to the 2014 Work Programme by focusing on action 2.1.1.3 regarding the development of innovative approaches to promote the professional integration and reintegration of people with chronic diseases and improve their employability. The main aim of PATHWAYS is to provide evidence-based recommendations for the effective professional integration of people with chronic health conditions in Europe

NCT ID: NCT03518983 Completed - Clinical trials for Erectile Dysfunction

Low-intensity Shockwaves Therapy for the Treatment of Patients With Moderate Vasculogenic Erectile Dysfunction

Start date: May 22, 2018
Phase: N/A
Study type: Interventional

This is a double-blind, sham-controlled randomized, 2 parallel arms, clinical trial with a 12-month recruitment period. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 70 men with vasculogenic ED.Patients will be randomized in 2 groups (35 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) either at energy level 7 or at sham-control , without treatment interval. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.

NCT ID: NCT03509623 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration

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

This study aims to evaluate coagulation parameters in treatment naive patients with neovascular age-related macular degeneration (AMD). Treatment naive patients with neovascular AMD, scheduled to undergo treatment with intravitreal injections of aflibercept will be enrolled in the study. Blood samples will be collected before the first intravitreal injection and at 7 and 30 days after aflibercept administration.

NCT ID: NCT03503812 Completed - Atrial Fibrillation Clinical Trials

Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches

MEDEA
Start date: September 24, 2018
Phase: N/A
Study type: Interventional

The MEDEA project is envisioned to provide the field-based evidence for the adoption of a strategic plan for mitigating the health effects of desert dust storm (DDS) events in South-Eastern Europe. Over the past decade, several studies have demonstrated that DDS in Mediterranean countries, originating mostly from the Sahara and Arabian Peninsula deserts, have been increasing in number and magnitude and linked it to desertification, climatic variability and global warming. EU legislation considers DDS impossible to prevent, implicitly harmless and discounts their contribution to daily and annual air quality standards of particulate matter up to 10 microns (PM10). However, there is increasing evidence from epidemiological studies, which correlates exposure to PM10 during DDS with a significant increase in mortality and hospital admissions from cardiovascular and respiratory causes. Therefore, there is a pressing need for EU policies to reduce population exposures and increase individual, population and institutional resilience to the growing frequency and intensity of DDS. MEDEA ultimate goal is to demonstrate the feasibility and effectiveness of an adaptation strategy to DDS and better inform EU policy making. The adaptation strategy will be carried out within two panel studies, with two different groups of patients; 1. Children with asthma and 2. Adults with atrial fibrillation (AF). The primary objective will be to quantify the vulnerability of children with asthma and adults with AF during DDS outbreaks and provide evidence-based estimates demonstrating which interventions/recommendations work best in mitigating adverse health effects in this group of patients after randomization of each group of patients to three parallel intervention groups: a) No intervention for DDS; b) Intervention for outdoor exposure reduction, and c) Interventions for both outdoor and indoor exposure reduction. The secondary objective of the study is to demonstrate which of the recommendations are effective in reducing outdoor and indoor exposures to DDS in a panel of children with asthma and in a panel of AF adults. Intervention: Each group of patients (children with asthma and AF patients) will be recruited and will be randomized during the high DDS outbreaks season (Spring 2019 and 2020) with 1:1:1 ratio into three parallel groups to receive: a) No intervention for DDS; b) Intervention for outdoor exposure reduction, by reducing the time spend outdoors and by avoiding physical activity and c) Interventions for outdoor (as above) and indoor exposure reduction (by minimizing home ventilation and filtering indoor air). Disease-related adverse health outcomes will be assessed in the three parallel arms of the study. Approaches for delivering the intervention: A bidirectional, patient-centered e-Platform will be developed in order to facilitate prompt communication with the participants and provide early warnings regarding forecasted upcoming DDS events through text messaging and smartphone applications. Furthermore, the same IT platform and mobile application will be utilised for the dissemination of the exposure reduction guidelines that the participants will follow. Assessment of adherence to intervention: 1.Monitor compliance to exposure-reduction guidelines using remote sensors. The intervention for outdoor exposure reduction, entailing reduction of the time spend outdoors and avoidance of physical activity, will be assessed with the use of smart wristwatches that will be equipped with Global Positioning System (GPS) and an accelerometer. 2.The intervention for indoor exposure reduction, entailing minimization of home ventilation and filtering of indoor air, will be assessed with the use of particle samplers that will be placed outside and inside of houses and school classrooms.

NCT ID: NCT03499288 Completed - Cerebral Palsy Clinical Trials

Profiling Children and Youth With Cerebral Palsy in Relation to Feeding and Nutrition

Purple-N
Start date: April 11, 2017
Phase:
Study type: Observational

HCPs will complete questionnaires about their patients with Cerebral Palsy (CP) and invite parents/caregivers of these patients to fill in questionnaires as well. Questionnaires include questions on individualized treatment, nutritional profile and management, and patient characteristics.

NCT ID: NCT03495102 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

AWARD-11
Start date: April 5, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.