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NCT ID: NCT02719574 Completed - Clinical trials for Acute Myeloid Leukemia

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation

Start date: April 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.

NCT ID: NCT02719522 Completed - Clinical trials for Intracranial Aneurysm

Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy

SHIELD
Start date: March 2016
Phase:
Study type: Observational

This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.

NCT ID: NCT02719184 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Longitudinal Follow up to Assess Biomarkers Predictive of Emphysema Progression in Patients With COPD (Chronic Obstructive Pulmonary Disease)

Start date: April 13, 2016
Phase:
Study type: Observational

The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125 COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125 COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ genotype). Soluble and imaging biomarkers will be investigated addressing different aspects of disease pathways postulated to be relevant for COPD progression.

NCT ID: NCT02718937 Completed - Clinical trials for Respiratory Syncytial Virus (RSV) Infection

Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study

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

The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus.

NCT ID: NCT02718716 Completed - Thrombocytopenia Clinical Trials

Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia

Start date: March 2, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia.

NCT ID: NCT02718703 Completed - Diabetes Mellitus Clinical Trials

Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Start date: February 2015
Phase: N/A
Study type: Interventional

Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.

NCT ID: NCT02718326 Completed - Clinical trials for Nonproliferative Diabetic Retinopathy

Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

PANORAMA
Start date: March 29, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR). The secondary objectives of the study are: - To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR - To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME - To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR

NCT ID: NCT02717689 Completed - Clinical trials for Severe Persistent Asthma

A Pragmatic Trial of Corticosteroid Optimisation in Severe Asthma

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

This study explores if a composite biomarker strategy predicts exacerbation risk in patients with asthma on high dose inhaled corticosteroid (+/-long-acting beta agonist) treatment and to evaluate the utility of this composite score to facilitate personalised biomarker specific titration of corticosteroid therapy in this population.

NCT ID: NCT02717546 Completed - Clinical trials for Distal Tibia Fractures

Zimmer® MotionLoc® in Distal Tibia Fractures

Start date: February 2016
Phase:
Study type: Observational

The objective of this observational prospective study is to systematically document the clinical outcomes of Zimmer MotionLoc Screws for Periarticular Locking Plate System applied to distal tibia fracture treatment and confirm safety and performance of the screws.

NCT ID: NCT02717117 Completed - Healthy Clinical Trials

Magnetic Resonance Imaging of Motility in Crohn's 1

MIC1
Start date: June 2015
Phase: N/A
Study type: Interventional

Crohn's disease (CD) is becoming more common. One of the main features of this disease is weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems have a strong negative effect on the patients' quality of life but the causes of these problems are not well understood. Enteroendocrine cells are nutrient sensors in the bowel that secrete special chemicals (called hormones) that control appetite and the movements all the gut. The investigators think that this control mechanism goes wrong in Crohn's patients and they have set off to do more research on this. Looking at the inside work of the gut has always been difficult and at times unpleasant for patients, however recent developments in magnetic resonance imaging (MRI) are allowing the investigators to study the workings of the gut in greater detail and without discomfort for the patients. Before studying the Crohn's patients it is necessary to run a set of pilot experiments in healthy volunteers using a test meal and subsequent MRI imaging to look at the motion of the gut. This validation stage of the methodology is essential before embarking in more detailed studies in the patients.