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NCT ID: NCT04818762 Recruiting - Preterm Birth Clinical Trials

Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates

pFTOE
Start date: February 26, 2021
Phase:
Study type: Observational

This is a prospective observational pilot study investigating if peripheral fractional tissue oxygen extraction (pFTOE) measured by five short near-infrared spectroscopy (NIRS) (re-)applications within the first 6 hours after birth in neonates with respiratory distress differs in neonates with early onset infection and neonate without infection

NCT ID: NCT04817488 Recruiting - Echocardiography Clinical Trials

Live Stream of Prehospital Emergency Ultrasound in Patients With Acute Dyspnoea

Start date: July 1, 2021
Phase:
Study type: Observational

Background: Acute dyspnoea is a common symptom in prehospital emergency medicine. As ultrasound gained in importance for diagnosis in patients with acute respiratory distress, it plays even a role in the prehospital setting. However, prehospital emergency ultrasound (PEU) remains challenging and requires knowledge and skills. New prehospital ultrasound devices offer the possibility for tele-supervision. The impact of tele-supervision of PEU in patients with acute dyspnoea is unclear. Objective: This prospective observational study aims to evaluate the effect of PEU with tele-supervision on diagnosis, treatment strategies and cognitive load in comparison to PEU without tele-supervision in patients with acute dyspnoea. Methods: In total 350 prehospital emergency patients with acute dyspnoea will be included in this study. Patients will be observed in two groups. In group 1 PEU will be performed with tele-supervision, whereas in group 2 PEU will be performed without tele-supervision (tele-supervision not available).

NCT ID: NCT04811846 Recruiting - Neoplasms Clinical Trials

CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood

Start date: March 14, 2021
Phase: N/A
Study type: Interventional

Transurethral resection of bladder tumor (TURBT) is usually performed in a piecemeal technique. Tumor fragmentation and cell spilling could be responsible for high recurrence rates. Circulating tumor cells (CTCs) have been shown to be a prognostic predictor in disease progression in transitional cell carcinoma. In the current study the investigators aim to quantify CTCs in purging fluid and blood for recurrent intermediate risk bladder cancer during surgery for two different methods: TURBT and Plasma-kinetic vaporization of bladder tumor (PKVBT). Also correlations for recurrence will be investigated for the two different surgical methods.

NCT ID: NCT04811092 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

HYPERION
Start date: March 18, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.

NCT ID: NCT04804748 Recruiting - Clinical trials for Post-operative Atrial Fibrillation POAF

The DefiPace Study

Start date: March 28, 2023
Phase:
Study type: Observational

Prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery. The DefiPace registry is designed in two phases 1. to document the standard of care in 50 patients with atrial fibrillation (AF) 2. to assess the treatment and outcomes of patients with post-operative atrial fibrilllation using low-energy cardioversion and subsequent bi-atrial pacing in clinical practice in 100 patients

NCT ID: NCT04804553 Recruiting - Clinical trials for Active Juvenile Psoriatic Arthritis

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

PEAPOD
Start date: March 17, 2022
Phase: Phase 3
Study type: Interventional

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

NCT ID: NCT04803994 Recruiting - Clinical trials for Hepatocellular Carcinoma

The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma

Start date: July 6, 2021
Phase: Phase 3
Study type: Interventional

The ABC-HCC trial is a Phase IIIb, randomised, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab versus TACE in patients with intermediate-stage HCC. Approximately 434 patients in two arms of treatment will be enrolled.

NCT ID: NCT04802629 Recruiting - Preterm Birth Clinical Trials

Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.

HbFIN
Start date: June 8, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS (near-infrared spectroscopy ), and the FHbF (fraction of fetal hemoglobin) and absolute HbF (fetal hemoglobin) concentration in postnatal conditions in term and preterm neonates.

NCT ID: NCT04801953 Recruiting - Clinical trials for Vestibular Schwannoma

Nimodipine in Vestibular Schwanommas

Start date: May 4, 2021
Phase: Phase 2
Study type: Interventional

Title: Intraoperative application of nimodipine to the facial and cochlear nerves during vestibular schwannoma resection to avoid spasm-related postoperative facial paralysis and deafness - a prospective randomized study Background: In patients undergoing microsurgical resection of a vestibular schwannoma, the facial and vestibulocochlear nerves are at risk. Prior studies suggested positive effects of nimodipine for preservation of the nerve function in these patients. A prospective, randomized, placebo controlled double-blinded study will be conducted to evaluate the neuro-protective effect of locally administered nimodipine during resection of vestibular schwannomas. Investigational drug: active group: "Nimotop® 10mg - Infusionsflasche" placebo: "Natrium chloratum physiologicum 0,9% - Medica Infusionslösung" Rationale for the study: Nimodipine is supposed to counteract the vasoconstriction of cerebral arteries caused by microsurgical manipulation and might thereby preserve facial and cochlear nerve function Aims of the study: Evaluation of the effect of intraoperative local administration of nimodipine on the postoperative function of the facial and vestibulocochlear nerves after microsurgical resection of vestibular schwannomas Study design: prospective, double-blinded, single-center, randomized phase III trial Study population: Patients undergoing microsurgical resection of a vestibularis schwannoma with a maximum diameter of 10-25mm on MRI at the Department of Neurosurgery, Medical university of Vienna. Number of Patients: 30 Methods: In 15 patients, nimodipine will be administered locally to the facial and vestibulocochlear nerves during resection of a vestibular schwannoma (= treatment group). In another 15 patients, a placebo (sodium chloride solution) will be administered. In both cases, a soaked gel foam pad will be used. The operating team and the patient will both be blinded during the procedure. Facial nerve function and hearing will be assessed prior and three months after surgery. Outcome variables: Serviceable or non-serviceable hearing according to Gardner-Robertson hearing scale and House-Brackmann score for the assessment of facial nerve function Statistical analysis: For the evaluation of the postoperative function of the vestibulocochlear nerve, the number of patients with postoperative serviceable hearing (Gardner-Robertson I-II) and postoperative non-serviceable hearing (Gardner-Robertson III-V) will be compared between both groups. For the evaluation of the facial nerve function, the number of patients with favorable postoperative outcome (House-Brackmann I-III) and non-favorable postoperative outcome (House-Brackmann IV-VI) will be compared. In both cases, fisher's exact test will be used. Expected risks/inconveniences: Administration of nimodipine is associated with the following adverse effects: thrombocytopenia, allergic reactions, headache, tachycardia, hypotension, nausea (occasionally) and bradycardia, ileus, reversibly elevated liver enzymes (seldom) Risk/benefit assessment: Expected adverse effects of local nimodipine administration are manageable and patients may profit from the use of nimodipine. No severe adverse events are expected.

NCT ID: NCT04797780 Recruiting - Clinical trials for Myelodysplastic Syndromes

Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

Start date: February 8, 2021
Phase: Phase 3
Study type: Interventional

This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms.