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NCT ID: NCT04086095 Completed - Clinical trials for Respiratory Distress Syndrome in Premature Infant

Feasibility Study - Neofact

Start date: May 13, 2019
Phase: N/A
Study type: Interventional

For therapy of respiratory distress syndrome (RDS) in premature babies, there are several established options. An important therapeutic aspect is the tracheal administration of exogenous surfactant into the child's lung. In the recent years, several methods have been developed. The methods differ in the selected ventilation mode (intubation with mechanical ventilation vs. Continous Positive Airway Pressure (CPAP)-supported spontaneous breathing) and in the way in which the application of surfactant is technically conducted (via endotracheal tube, endotracheal catheter or nebulization). In selection of ventilation technique, there is an upcoming trend towards less invasive respiratory support via CPAP. While this may increase the rate of complications on the one side (i.e. pneumothorax), it shows much lower oxygen demand and a shorter need for mechanical ventilation on the other side. In the selection of the administration technique, different methods were repeatedly developed to adapt the surfactant administration to the CPAP therapy. In this study, a newly developed and in the European Community now certified (CE-Mark) application aid (Neofact) will be tested for the first time on preterm infants, to verify the feasibility.

NCT ID: NCT04085666 Completed - Phenylketonuria Clinical Trials

Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU)

Start date: June 1, 2019
Phase: Phase 1
Study type: Interventional

This study is an international, multi-center, randomized, double-blind, placebo-controlled, two-treatment, two-period cross-over study to evaluate the pharmacodynamics, safety, tolerability and pharmacokinetics of a single oral dose of CDX-6114 in patients with phenylketonuria (PKU).

NCT ID: NCT04084951 Completed - Adult Solid Tumor Clinical Trials

Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Start date: January 28, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab or other immune checkpoint inhibitors in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

NCT ID: NCT04084314 Completed - Migraine Clinical Trials

Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study

APOLLON
Start date: September 30, 2019
Phase: Phase 4
Study type: Interventional

This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab in migraine patients.

NCT ID: NCT04083989 Completed - Anorexia Nervosa Clinical Trials

Investigation of Psycho-Physiological Parameters in Adolescent Inpatients With Anorexia Nervosa

Start date: May 1, 2013
Phase:
Study type: Observational

A study to assess changes in mental and physical symptoms in adolescent inpatients with anorexia nervosa, a severe eating disorder.

NCT ID: NCT04082754 Completed - Asthma Clinical Trials

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers

Start date: November 28, 2019
Phase: Phase 1
Study type: Interventional

This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.

NCT ID: NCT04082221 Completed - Healthy Clinical Trials

Comparison of Different Methods for the Analysis of Gut Microbiome Composition

COLLECT
Start date: March 11, 2019
Phase:
Study type: Observational

The human gastrointestinal tract shelters a complex and dynamic population of microorganisms, the gut microbiota, which plays an important role in immune and metabolic homeostasis. In recent years several major diseases were linked with alterations in the gut microbiome composition. There are known factors which can influence gut microbiata composition. For example diet is known to play a fundamental role in determining the composition of the intestinal microbiota over time. However, there are very few studies evaluating how collection and DNA isolation methods affect microbiome composition.

NCT ID: NCT04081519 Completed - Depression Clinical Trials

Stimulation of Parieto-hippocampal Connectivity in Patients With Major Depressive Disorder

Start date: August 2, 2016
Phase: N/A
Study type: Interventional

This study aims to investigate the effects of individualized repetitive transcranial magnetic stimulation (rTMS) of parieto-hippocampal functional connectivity in patients with major depressive disorder (MDD). Specifically, patients will be randomized to one of three groups and will receive 15 days of rTMS over three weeks. Each day they will receive one active session of rTMS over the dorsolateral parietal cortex (DLPFC) and depending on group assignment another session either A) active rTMS over DLPFC, B) active rTMS over left and right lateral parietal cortex (LPC), or C) sham rTMS over DLPFC or LPC. Stimulation targets in the LPC will be individualized for each patient based on their resting-state functional connectivity between the hippocampus and LPC. Clinical, neuropsychological and fMRI data will be acquired before and after the treatment course.

NCT ID: NCT04080193 Completed - Clinical trials for Overweight and Obesity

Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity

I-GENDO
Start date: December 7, 2019
Phase: N/A
Study type: Interventional

The major aim of the proposed study is to develop a gender-sensitive individually tailored add-on intervention that focusses on improving individual gender-specific SIRs (subjective illness representations) in obese or overweight individuals. We will investigate whether this will improve compliance with and long-term success of common weight loss interventions. The effectiveness of this intervention in every-day-life with regard to weight-related behavioral changes and weight loss will be evaluated within a randomized controlled setting.To enhance the applicability of the intervention in every-day-life and its dissemination we plan to develop a smart-phone-based intervention.

NCT ID: NCT04078126 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.

Start date: September 10, 2019
Phase: Phase 3
Study type: Interventional

Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.