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NCT ID: NCT04023396 Active, not recruiting - Ulcerative Colitis Clinical Trials

Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

Start date: January 13, 2020
Phase: Phase 2
Study type: Interventional

A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

NCT ID: NCT04018287 Active, not recruiting - Clinical trials for Bone Diseases, Metabolic

Circulating miRNAs and Bone Microstructure in Adults With Hypophosphatasia

Start date: August 1, 2017
Phase:
Study type: Observational

The aim of the study is to accomplish a complete bone status of patients with HPP using new approaches to assess bone quality.

NCT ID: NCT04017052 Active, not recruiting - Clinical trials for Tick Borne Encephalitis

Application of a TBE-Vaccine in Obese Persons

Start date: April 15, 2015
Phase: Phase 4
Study type: Interventional

Obese people have an altered immune responsiveness. The present study investigates whether this influences immune responses to booster vaccinations (i. e. booster vaccination with TBE vaccine "FSME Immun") and if a modification of vaccination schedules is needed. Obese adults (BMI >30) >18 - 60 years are compared with adults with normal weight (BMI <25) concerning TBE-NT- antibody titers, TBE- NT antibody titer course and cellular immunity. Metabolic parameters and sexual hormones will be tested and compared as well.

NCT ID: NCT04006210 Active, not recruiting - Parkinson's Disease Clinical Trials

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations

BouNDless
Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD. Subjects can continue to an optional open-label extension period.

NCT ID: NCT03995108 Active, not recruiting - WHIM Syndrome Clinical Trials

Efficacy and Safety Study of Mavorixafor in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome

Start date: October 24, 2019
Phase: Phase 3
Study type: Interventional

This study has a double-blind, Randomized Placebo-Controlled Period and an Open-Label Period. The primary objective of the Randomized Placebo-Controlled Period is to demonstrate the efficacy of mavorixafor in participants with WHIM syndrome as assessed by increasing levels of circulating neutrophils compared with placebo, and relative to a clinically meaningful threshold. The primary objective of the Open-Label Period is to evaluate the safety and tolerability of mavorixafor in participants with WHIM syndrome. Participants are allowed to continue treatment in the Open-Label Period, if regionally applicable, until mavorixafor becomes commercially available, or until the study is terminated by the Sponsor.

NCT ID: NCT03992521 Active, not recruiting - Breast Cancer Clinical Trials

Breast Cancer Liquid Biopsy Stratification

BALIBISTRA
Start date: October 1, 2018
Phase:
Study type: Observational

Breast cancer is the most common cancer in Austrian women. Estimation of prognosis and treatment strategies is increasingly being dependent on stratification of tumors into different entities or classes. Currently, clinical routine stratification of tumors is mostly based on hormone receptor, HER2 status, and estimation of proliferation. However, a more robust and objective classification of tumors can be achieved by elucidation of further biological properties, which is also of increasing significance, as novel anticancer therapies are based on biological mechanisms. Consequently, available information from molecular analyses is increasingly being implemented in routine diagnostic assays with the aim to improve stratification for optimal treatment selection. To date the most extensive molecular-based taxonomy of breast cancer has been achieved by a classification based on combining gene expression and somatic copy number alterations (SCNAs), referred to as integrative clusters. Tissue biopsies are the current gold standard to attain such a classification. However, they can often be difficult to obtain in the metastatic setting and are subject to sampling bias due to intratumor heterogeneity. "Liquid biopsies" are, among other analytes, based on the analysis of cell-free DNA (cfDNA) which contains circulating tumor DNA (ctDNA), i.e. DNA fragments shed from normal and tumor cells into the blood, in patients with cancer. cfDNA can be obtained minimally invasive with a blood draw, allows for the "real time" analysis of tumor DNA from the circulation, and blood samples can be repeated at any time point, which is especially important for monitoring response to therapy. The investigator's group has extensive expertise in the analysis of cfDNA and has developed a plethora of approaches for ctDNA analysis. Recently, the investigators have developed a new approach, which relates to nucleosome positions and gene expression. cfDNA fragments have been associated with the release of DNA from apoptotic cells after enzymatic processing and hence consist mainly of mono-nucleosomal DNA. By performing whole-genome sequencing of cfDNA the investigators could demonstrate that at transcriptional start sites, the nucleosome occupancy results in different read-depth coverage patterns in expressed and silent genes. By employing machine learning for gene classification, the investigators were able to classify genes in cells releasing their DNA into the circulation as expressed. The main hypothesis of the project is that integrative breast cancer clusters can be established from directly blood without the need for an invasive tissue biopsy. Hence, the study aims include refining stratification of patients for an improved selection of treatment strategies. Furthermore, the investigators will obtain novel insights into the biology of metastatic breast cancer, so that this project will have important implications for patients, clinical oncologists, pathologists, pharmacologists, and all basic researchers interested in cancer.

NCT ID: NCT03992417 Active, not recruiting - Dermatitis Atopic Clinical Trials

Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)

GLOBOSTAD
Start date: June 11, 2019
Phase:
Study type: Observational [Patient Registry]

Primary Objective: To characterize the patients who receive Dupixent® (dupilumab) for AD in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD Secondary Objectives: - To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching) - To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting - To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD - To collect safety data on study participants

NCT ID: NCT03991923 Active, not recruiting - Clinical trials for Heart Transplantation

Non-ischemic Preservation of the Donor Heart in Heart Transplantation

Start date: November 25, 2020
Phase: N/A
Study type: Interventional

The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial. The primary hypothesis is that the non-ischemic hypothermic cardioplegic preservation (NIHP) is safe and superior to ischemic cold static storage (ICSS) of donor hearts. The study will investigate the safety and superiority of the new methodology in terms of improved immediate and prolonged organ function in adult heart transplanted patients.

NCT ID: NCT03989206 Active, not recruiting - Clinical trials for Moderate-to-Severe Atopic Dermatitis

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Start date: December 30, 2019
Phase: Phase 3
Study type: Interventional

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

NCT ID: NCT03987061 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

MOTIV Bioresorbable Scaffold in BTK Artery Disease

MOTIV BVS BTK
Start date: September 5, 2019
Phase: N/A
Study type: Interventional

The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in a controlled prospective investigation for the treatment of patients with rest pain or minor tissue loss (CLI) due to the presence of lesions of max 100mm in length at the level of the below-the-knee arteries.