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NCT ID: NCT04045691 Recruiting - Melanoma Stage IV Clinical Trials

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

BERING
Start date: October 17, 2019
Phase:
Study type: Observational

BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study - investigates real-world effectiveness, quality of life, safety and tolerability of encorafenib plus binimetinib in unresectable advanced or metastatic BRAF(Rapidly Accelerated Fibrosarcoma isoform B)-V600-mutant malignant melanoma after commercial availability of these two products in Germany, Austria and Switzerland. The study focusses on the documentation of the first and second line setting (i.e. after one line of prior checkpoint inhibition) by documenting patients treated according to the SmPC (Summary of Product Characteristics).

NCT ID: NCT04045613 Completed - Clinical trials for Urothelial Carcinoma

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

FIDES-02
Start date: August 2, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

NCT ID: NCT04045509 Completed - Cornea; Sense Loss Clinical Trials

Investigation in Corneal Sensation

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The aim is to find out more about how corneal sensory fibres react to different types of stimuli (liquid / tactile / nylon thread) and how this can be consciously perceived by the individual. Is it possible to generate a stimulus that delivers a repeatable and reliable response within a useful stimulus force range which allows an interpretation / evaluation of normal / expected activity of superficial nerve fibres in the cornea? The study group will be divided into two age groups, as sensitivity changes are thought to occur in dependence of age. In vivo confocal microscopy has shown that the density of corneal nerve fibres in the sub-basal nerve plexus decreases with age, which consequently would suggest that sensitivity should also decrease. A very interesting research question is to find out, if such sensitivity differences can be detected with the nature of the stimuli applied in this study.

NCT ID: NCT04044690 Active, not recruiting - Dermatomyositis Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

RECLAIIM
Start date: October 21, 2019
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.

NCT ID: NCT04044157 Completed - Cardiac Output Clinical Trials

Cardiac Output in Children During Anesthesia

COC
Start date: September 23, 2019
Phase:
Study type: Observational

This study investigates cardiac output in young children under 18 months of age during the perioperative period by means of electrical cardiometry.

NCT ID: NCT04043806 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

Start date: August 9, 2019
Phase: Phase 3
Study type: Interventional

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).

NCT ID: NCT04043598 Recruiting - Critical Illness Clinical Trials

Crystalloid Fluid Choice and Neurological Outcome in Patients After Subarachnoid Haemorrhage

CRYSTALLBrain
Start date: May 24, 2022
Phase: N/A
Study type: Interventional

Patients with subarachnoid hemorrhage are prone to suffer from dysnatriemia. Evidence shows that hyponatriemia is associated with increased incidence of vasospasm, brain swelling and mortality in these patients. Patients with subarachnoid hemorrhage often require large amounts of iv fluids in order to maintain euvolemia and support cardiocirculatory function. Prior evidence shows that the type of infusion fluid significantly influences blood sodium content. Hence, this study evaluated whether the sodium content of the infusion solution impacts mortality and morbidity in patients with subarachnoid hemorrhage.

NCT ID: NCT04043494 Recruiting - Clinical trials for Lymphoblastic Lymphoma, Childhood

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

LBL 2018
Start date: August 23, 2019
Phase: Phase 3
Study type: Interventional

Primary objectives: - Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) - Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

NCT ID: NCT04043325 Recruiting - Clinical trials for Community-acquired Pneumonia

Diagnosis of Mycoplasma Pneumoniae Infection With Detection of Specific Antibody-secreting Cells in Community-acquired Pneumonia (CAP) Patients of the Randomised Placebo-controlled Multi-centre Effectiveness Trial of Adjunct Betamethasone Therapy

myKIDS-STEP
Start date: May 20, 2019
Phase:
Study type: Observational

To compare presence and kinetics of Mycoplasma pneumoniae (Mp)-specific immunoglobulin (Ig) M antibody-secreting cells (ASCs) with Mp DNA and Mp-specific IgM antibodies in patients with community-acquired pneumonia (CAP) of the KIDS-STEP study.

NCT ID: NCT04042792 Completed - Rheumatic Diseases Clinical Trials

Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate

ADA in PiRD
Start date: September 26, 2019
Phase:
Study type: Observational

This study is to assess standardized Adalimumab (ADA) concentrations in Pediatric inflammatory rheumatic diseases (PiRD) patients treated with ADA for ≥ 12 weeks with and without concomitant methotrexate (MTX) therapy and to assess peak and trough ADA concentrations in ADA naïve patients after first ADA administration with and without MTX (pre-phase).