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NCT ID: NCT03625934 Recruiting - Hepatitis B Clinical Trials

Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001

Start date: August 6, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The Study will evaluate the effects of VVX001, a novel vaccine for hepatitis B, to - elicit a robust protective IgG immune response in vaccine naive subjects - in subjects who failed to demonstrate seroconversion after treatment with a licensed hepatitis B vaccine and - in patients chronically infected with HBV.

NCT ID: NCT03623295 Recruiting - Hemophilia Clinical Trials

The Dynamic Interplay Between Bleeding Phenotype and Baseline Factor Level in Moderate and Mild Hemophilia A and B

DYNAMO
Start date: January 1, 2018
Phase:
Study type: Observational

There are large inter-individual differences in the bleeding pattern of patients with moderate or mild hemophilia. The major determinant of bleeding phenotype is the level of coagulant factor VIII or IX. In hemophilia A, studies addressing the association between factor VIII level and the clinical bleeding pattern yield conflicting results. In hemophilia B such studies have not yet been performed. The primary aim of this project is to analyze the association between factor VIII and factor IX levels and the bleeding phenotype. The secondary aim is to analyze potential differences in phenotype between hemophilia A and B. The project is a multicentre observational cohort study. We will include 500 patients with moderate or mild hemophilia A (FVIII 0.02-0.35 IU/mL) and 500 patients with moderate or mild hemophilia B (FIX 0.02-0.35 IU/mL) who are 12 to 55 years old. The main cohort study consists of clinical data collection, one blood sample and an online questionnaire for patients. Data will be collected on the nature and duration of all bleeding episodes, disease and treatment characteristics, physical activity level and musculoskeletal status. One blood withdrawal will be performed for centralized laboratory assays for FVIII or FIX levels (both one-stage and chromogenic assays) and genetic analysis for the most prevalent prothrombotic mutations. The online questionnaire for patients focuses on bleeds experienced in the past. A subset of 200 patients aged 24 years or older (100 with moderate or mild hemophilia A and 100 with moderate or mild hemophilia B) will be investigated in more detail by longitudinal data collection including analysis of physical joint status, MRI imaging of joints and biomarkers for joint damage. This longitudinal observation will consist of two time points that lie two years apart, allowing us to identify any changes that occur over the observed time period with respect to joint status.

NCT ID: NCT03622580 Not yet recruiting - Clinical trials for Diabetic Macular Edema

A Study to Evaluate the Efficacy and Safety of RO6867461 in Participants With Diabetic Macular Edema (YOSEMITE)

Start date: September 22, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of RO6867461 administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

NCT ID: NCT03617133 Recruiting - Clinical trials for Uterine Cervical Neoplasms

Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer

EMBRACEII
Start date: April 2016
Phase: Phase 2
Study type: Interventional

The research group on adaptive image-guided radiotherapy for locally advanced cervical carcinoma completed the protocol for the EMBRACE II study in October 2018. This study will be carried out in the next few years at the University Clinic for Radiotherapy at the Medical University of Vienna and other international partner institutes. EMBRACE II builds on the findings of the current EMBRACE study. These are already implemented in everyday clinical practice in order to further improve the accuracy of the entire therapy of cervical carcinomas, using state-of-the-art techniques of tele- and brachytherapy. The aim of the EMBRACE II study is to maintain and enhance the excellent local tumor control as well as the nodal and systemic control for all tumor stages while minimizing the adverse reaction rates for all affected organs (rectum, sigmoid, urinary bladder, and vagina) to increase the quality of life of patients with cervical carcinomas.

NCT ID: NCT03613584 Recruiting - Clinical trials for Acquired Von Willebrand Disease

Von Willebrand Factor Concentrate During ECMO Support

Start date: April 16, 2018
Phase: Phase 2
Study type: Interventional

During treatments with extracorporeal circuits such as extracorporeal membrane oxygenation (ECMO) degradation of high molecular weight (HMW) of von Willebrand factor (vWF) multimers occur leading to an acquired von Willebrand disease. This disease is associated with increased bleeding and requirement for the transfusion with allogenic blood products especially packed red blood cells (PRBCs). A continuous treatment with von Willebrand factor concentrate (vWFC) may restore the multimers and bleeding can be avoided. Therefore a randomized, double-blind, prospective, controlled, two-arm clinical trial was designed, comparing patients receiving vWFC versus placebo.

NCT ID: NCT03613207 Completed - Clinical trials for Dermatology/Skin - Other

An Exploratory Pilot Study in Healthy Volunteers to Assess the Parameters for the Design of Bioequivalence Studies on Moderately Lipophilic, Moderately to Highly Protein Bound Drugs Using Dermal Open Flow Microperfusion (dOFM)

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

The overall aim of this clinical pilot study is to develop an optimal design (e.g. dose, study duration) for the main clinical study. In the main study factors that influence dOFM data variability will be measured to develop a general BE testing method using dOFM for dermatological drug products.

NCT ID: NCT03611491 Active, not recruiting - Clinical trials for Correction of Nasolabial Folds

Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds

FINO
Start date: September 20, 2017
Phase: N/A
Study type: Interventional

In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® FILLER Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator

NCT ID: NCT03607422 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

Start date: July 27, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe AD who are candidates for systemic therapy.

NCT ID: NCT03603964 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Guadecitabine Extension Study

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

This is a multicenter, open-label extension study for subjects who participated in a previous Astex-sponsored guadecitabine clinical study (including but not limited to SGI-110-01, SGI-110-04, SGI-110-06, and SGI-110-07).

NCT ID: NCT03603535 Not yet recruiting - Clinical trials for Stress Urinary Incontinence

Prospective Study of the sensiTVT

sensiTVT
Start date: August 31, 2018
Phase:
Study type: Observational

sensiTVT is a relatively new MUS. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.