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NCT ID: NCT03591510 Recruiting - Clinical trials for FLT3-mutated Acute Myeloid Leukemia

A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

Start date: March 13, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia. The study has two parts: Part 1 to define the Recommended Phase 2 Dose, and Part 2 to evaluate safety and tolerability and efficacy of midostaurin. Both parts will consist of 2 induction blocks, 3 consolidation blocks, 12 cycles of post-consolidation consisting of continuous therapy with midostaurin, and a follow-up phase.

NCT ID: NCT03590171 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia (ALL)

International Study for Treatment of High Risk Childhood Relapsed ALL 2010

Start date: September 1, 2017
Phase: Phase 2
Study type: Interventional

The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.

NCT ID: NCT03587922 Recruiting - Clinical trials for Coronary Artery Disease

FANTOM Post Market Clinical Trial

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold

NCT ID: NCT03581201 Recruiting - Clinical trials for Microbial Colonization

The Relationship of the Intestinal Microbiome and the Menstrual Cycle

Start date: July 18, 2018
Phase:
Study type: Observational

In the present study the dynamic changes of the intestinal microbiome are observed over a 4-week period in the different stages of the menstrual cycle in women at childbearing age. The focus is on how the dynamic changes of sex hormones during a menstrual cycle of women at childbearing age (with or without contraception) are related to microbiological colonization of the gut. In Addition the Expression of the β-glucuronidase by the bacteria will be investigated.

NCT ID: NCT03571360 Recruiting - Clinical trials for Non Small Cell Lung Cancer

CTA Expression/Methylation and Response to Pembrolizumab of NSCLC Patients

Start date: February 10, 2020
Phase: Phase 2
Study type: Interventional

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. KeytrudaTM (pembrolizumab) has been approved by the FDA and the EMA for the therapy of with chemotherapy pretreated NSCLC patients with PD-L1 expression (TPS ≥ 1%) on tumor cells. In addition, pembrolizumab was approved for the first line treatment of metastatic NSCLC patients with high PD-L1 expression (TPS ≥ 50%) on tumor cells. Pembrolizumab will be given in a flat dose of 200 mg i.v. every 3 weeks until disease progression, toxicity or patient withdrawal for a maximum of 2 years. Patients with untreated advanced stage lung adenocarcinoma, without an EGFR mutation or ALK translocation, will be included.

NCT ID: NCT03567577 Recruiting - ARDS Clinical Trials

Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDS

Start date: May 23, 2018
Phase: Phase 2
Study type: Interventional

This phase IIb, randomized, placebo-controlled, double-blind, dose escalation study will assess the local and systemic safety of 7 days orally inhaled sequential multiple ascending doses of solnatide in patients with pulmonary permeability oedema and moderate-to-severe ARDS and review potential efficacy endpoints for a future phase III pivotal trial.

NCT ID: NCT03566797 Recruiting - Clinical trials for Secondary Sclerosis Cholangitis in Critically Ill Patients

Secondary Sclerosis Cholangitis Prospective

SSCpro
Start date: July 20, 2018
Phase:
Study type: Observational

SC-CIP is increasing in patients after critical illness. Pathogenesis is still largely unclear. Gut microbiome composition, gut permeability, bacterial translocation, inflammation and/or genetic variants contribute to the pathogenesis The aim of this project is to study gut microbiome composition, gut permeability, bacterial translocation, inflammation, bile acid composition and genetic polymorphisms by conducting a prospective cohort study in patients with a high risk to develop SC-CIP.

NCT ID: NCT03557138 Recruiting - Clinical trials for Type2 Diabetes Mellitus

Study to Develop a Kinetic Model for FDG and Me4FDG in Kidneys of Type 2 Diabetic Patients

Start date: February 22, 2017
Phase: N/A
Study type: Interventional

In this study, using 18F-FDG and Gd-DTPA PET/MRI, we are aiming to perform a dynamic PET/MRI imaging using 18F-FDG and Me4FDG for a group of type 2 diabetic patients scheduled for Glifozine therapy due to the bad metabolic control to assess changes in renal function before and 1 to 2 weeks after initiating therapy with Gliflozine. Furthermore we aim to study the temporal behavior of 18F-FDG and Me4FDG activity in certain kidney regions of the diabetic participants to estimate basic kidney parameters using time activity curve. Further, we intend to find a kinetic model that describes the behavior of glucose in each part of the kidney can be acquired mathematically and to find out whether conclusions about the glucose reabsorption capability of the kidney in diabetes can be achieved in general. In addition, we aim to simultaneously determine renal lesions as well as obstructions with the fused, high definition, and three dimensional images of the kidney and estimate kidney function parameters from the dynamic Gd-DTPA MRI scan and compare them to the kidney function determined with the kinetic model.

NCT ID: NCT03553420 Recruiting - Clinical trials for Lipodystrophy Acquired

Registry for Patients With Lipodystrophy

ECLip Registry
Start date: December 16, 2017
Phase:
Study type: Observational [Patient Registry]

Given the lack of knowledge on lipodystrophies, the medical and social responsibility for the persons affected by it calls for the monitoring of the progression over long periods of time. Sensible clinical and basic research into rare diseases such as lipodystrophy is only possible in multi-location networks with sufficient case numbers. Also, reliable information on the incidence of certain manifestation patterns, health status, etc. is of utmost importance for health care and health policy in this rare disease. Therefore, the European Consortium of Lipodystrophies (ECLip), an association of European experts on lipodystrophy, has launched a registry (OSSE) for lipodystrophies which is committed to help to improve the research conditions by consolidating this kind of information in a registry.

NCT ID: NCT03552562 Recruiting - Retinal Blood Flow Clinical Trials

Measurement of Total Retinal Blood Flow and Oxygen Extraction in Patients With Diabetes and Healthy Subjects

Start date: November 21, 2018
Phase: N/A
Study type: Interventional

The prevalence of diabetes and diabetes-associated complications is still increasing. Several major long-term complications of diabetes such as cardiovascular disease, chronic renal failure, diabetic retinopathy and others relate to the damage of blood vessels. Given that the eye provides the unique possibility in the human body to directly visualize blood vessels, much interest has been directed towards studying the ocular circulation and retinal oxygen metabolism. Although data of large epidemiological studies indicate that changes in retinal vessel caliber reflect other diabetes related factors, such as fasting glucose levels, there is still conflicting evidence on blood flow alterations in patients with diabetes. Strongly related to ocular blood flow, investigation of retinal oxygen metabolism has received a lot attention. In particular, hypoxia is assumed to be major trigger of neovascularisation in the retinal of diabetic patients The present study seeks to investigate both ocular blood flow and tissue oxygen extraction in patients with type II diabetes. For this purpose, total retinal blood flow will be assessed with bi-directional Fourier Domain Doppler Optical Coherence Tomography (FDOCT). Furthermore, retinal oxygen saturation will be measured non-invasively by a fundus camera based system. Based on data of retinal blood flow and retinal oxygen saturation, retinal oxygen. This will help to better understand ocular blood flow changes and oxygen metabolism in patients with type II diabetes.