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NCT ID: NCT04588311 Recruiting - Clinical trials for Traumatic Brain Injury

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

EPO-TRAUMA
Start date: November 9, 2020
Phase: Phase 3
Study type: Interventional

The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. 2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.

NCT ID: NCT04585750 Recruiting - Breast Cancer Clinical Trials

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Start date: October 29, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2 study will assess the safety, tolerability, and efficacy of multiple dose levels of PC14586 (INN: rezatapopt) alone (monotherapy) and in combination with pembrolizumab in participants with advanced solid tumors containing a TP53 Y220C mutation.

NCT ID: NCT04583930 Recruiting - Hemophilia A Clinical Trials

Clinical and Health-related Outcome of rFVIIIFc Prophylaxis

CLHEAR
Start date: February 1, 2021
Phase:
Study type: Observational

Current standard therapy for patients with haemophilia (PwH) in the prevention of bleeding episodes is a prophylactic intravenous treatment with recombinant coagulation factor (F) VIII (Haemophilia A) or rather FIX (Haemophilia B) two to three times weekly. With the development of recombinant factor VIII Fc fusion protein (rFVIIIFc) the conventional routine prophylaxis regime is complemented by an extended half-life (EHL) factor replacement prophylaxis with the potential of improved bleed prevention and reduced injection frequency at similar factor consumption. Aim of this longitudinal multicentre study is to evaluate the influence of an EHL factor replacement regime with rFVIIIFc on haemophilic specific parameters (annual bleeding rate, bleeding localisation), joint status, pain, functional parameters, treatment adherence and health-related quality of life in PwH A.

NCT ID: NCT04582513 Recruiting - Major Surgery Clinical Trials

Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome

AnCHor
Start date: October 29, 2020
Phase:
Study type: Observational

The aim of the study is to collect information on feasibility and effect size of a confirmatory, prospective study with the question: Does a standardized checklist during intraoperative handover of anaesthesia care reduce the rate of postoperative complications?

NCT ID: NCT04581707 Recruiting - Clinical trials for Vertebral Compression Fracture

Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOs® Inject Bone Cement

Start date: March 1, 2020
Phase:
Study type: Observational

The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone cement for treatment of Vertebral Compression Fractures.

NCT ID: NCT04581148 Recruiting - SARS-Cov2 Clinical Trials

SARS-CoV2 Antibodies in Pediatric Patients (COVID-19)

SARS-CoV2_KIDS
Start date: October 1, 2020
Phase:
Study type: Observational

Since the beginning of the year, the entire world has been concerned with the novel SARS-CoV2 virus. After the first case descriptions in Wuhan, there has been a rapid increase in the number of cases in Germany as well. In case of an illness with the virus, the affected patients can suffer from a slight infection of the upper respiratory tract up to severe lung failure and death. Interestingly, up to now, children are usually less severely affected than adults. However, the actual infection rates are probably similar to those of adults, even if the actual prevalence in children is difficult to quantify so far. The extent of the disease in children has also been less researched to date than in adults, and the same applies to pregnant women and their newborns. In addition, intensive research into possible therapeutic strategies and new vaccines is necessary. Here, however, the number of clinical studies in children is also far behind. In order to be able to understand the infection process and to protect the population with their children, comprehensive testing is necessary. However, this poses great challenges for local health authorities. Scientific investigations are also costly, but are already being carried out by many institutes. So far, for example in the SeBlueCo study, a very low prevalence of antibodies (1.3% of people) has been show. In children, however, both the routes of infection and the way the immune system deals with the virus are probably different than in adults. In this study the investigators now want to examine residual blood samples from pediatric patients of the pediatric and adolescent clinic in the time course after the beginning of the pandemic in order to better understand and monitor the development of antibody prevalence.

NCT ID: NCT04580420 Recruiting - Clinical trials for End Stage Renal Disease

Safety & Efficacy of DCR-PHXC in Patients With PH1/2 and ESRD

PHYOX7
Start date: April 15, 2021
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate DCR-PHXC in participants with PH1 or PH2 and severe renal impairment, with or without dialysis.

NCT ID: NCT04579835 Recruiting - Breech Presentation Clinical Trials

Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)

TWEXIT
Start date: September 28, 2020
Phase:
Study type: Observational

A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.

NCT ID: NCT04579367 Recruiting - Clinical trials for Hypercholesterolemia

Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia

MILOS
Start date: January 15, 2021
Phase:
Study type: Observational

The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic acid and/or its fixed-dose combination with ezetimibe in managing plasma levels of low-density lipoprotein cholesterol (LDL-C). Secondary objectives are to document and evaluate as applicable: - Assessment of the cardiovascular risk of patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe using different risk scores (e.g. Systematic Coronary Risk Estimation (SCORE) system, SMART score for Very High Risk patients and Framingham risk score for High Risk patients. The scores will be re-calculated during the analysis and used as an analytical tool only). - Changes in low-density lipoprotein cholesterol (LDL-C) levels prior to treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe compared to 1 year follow-up and subsequent data collection points, if applicable. - Characterize plasma levels of other potentially ASCVD-modifying cholesterol fragments, namely, LDL-C, total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, triglycerides (TGs) and lipoprotein A (Lp[a]) compared to 1 year follow-up and subsequent data collection points, if applicable. - Changes in the levels of inflammatory marker hsCRP compared to 1 year follow-up and subsequent data collection points, if applicable. - Adverse Drug Reactions associated to bempedoic acid and/or its fixed-dose combination with ezetimibe. - Changes in uric acid levels compared to 1 year follow-up and subsequent data collection points, if applicable. - Relevant CV events: - Myocardial infarction - Unstable angina - Coronary artery bypass graft surgery (CABG) - Percutaneous transluminal coronary angioplasty (PTCA) - Stroke - Transient ischemic attack (TIA) - Acute peripheral arterial occlusion - All-cause death - Cardiovascular (CV)-death - Adverse effects associated with lipid-modifying treatment (LMT) - Laboratory abnormalities - Muscle-associated symptoms - New onset and/or worsening diabetes - Changes in the patients´ glycemic status over time - Site characteristics (sites and practitioners) caring for patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe. - Use of LMTs prior or concomitantly to receiving bempedoic acid and/or its fixed-dose combination with ezetimibe (therapies including combination treatments). - Bempedoic acid and/or its fixed-dose combination with ezetimibe treatment parameters such as treatment duration by therapy, dosage, prescription intervals, permanent discontinuations, switches and reasons for these, (concomitant medication, additional therapy/interventions). - Healthcare resource use especially consultation visits with specialist, nurse time and hospitalizations as well as patient-reported outcome using EQ-5D-5L and PAM-13.

NCT ID: NCT04578678 Recruiting - Parkinson's Disease Clinical Trials

Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease

Steeropt
Start date: August 9, 2019
Phase:
Study type: Observational

The primary objective of the study is to determine if subthalamic nucleus (STN) deep brain stimulation (DBS) using the Vercise directional leads improves neuropsychiatric state and neuropsychiatric fluctuations 12 months after surgery in a large consecutive series of STN-DBS Parkinson's disease (PD) patients.