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NCT ID: NCT04892173 Recruiting - Aged Clinical Trials

NBTXR3 With or Without Cetuximab in LA-HNSCC

Start date: January 5, 2022
Phase: Phase 3
Study type: Interventional

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.

NCT ID: NCT04890145 Recruiting - Hearing Loss Clinical Trials

The RW-Precision-Coupler Clinical Investigation

Start date: May 19, 2021
Phase: N/A
Study type: Interventional

The RW-Precision-Coupler Clinical Investigation is prospective, non-randomized, open label, single subjects repeated measures, longitudinal monocentric trial. The primary aim of this pre-market clinical investigation is to evaluate the clinical performance and safety of VSB together with the VSB RWP-Coupler in the treatment of hearing loss. As secondary aims are to evaluate the clinical performance of VSB together with RWP-Coupler by measuring Sound Field audiometry (SF), to evaluate the safety of VSB together with RWP-Coupler by measuring bone conduction (BC) thresholds and collecting and assessing adverse events.

NCT ID: NCT04889235 Recruiting - Sarcopenia Clinical Trials

Diaphragm Kinetics Following Hepatic Resection

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

Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery. Liver surgery induces reactive pleural effusion in most patients, compromising post-operative pulmonary function. Hypotheses: - Both major hepatic resection and sarcopenia have a measurable impact on diaphragm function. - Sarcopenia is associated with reduced preoperative diaphragm function, and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection. Goals: The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared to non-sarcopenic patients, and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared to non-sarcopenic patients. Methods and analysis: Trans-costal B-mode, M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in patients undergoing major hepatic resection starting one day prior to surgery and up to thirty days after surgery. In addition, rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia, and pulmonary function will be measured using a hand-held bedside spirometer. Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level (L3). Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery (SPPB). A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status. Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively.

NCT ID: NCT04888247 Recruiting - Clinical trials for Mitral Regurgitation

HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

HighFLO
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

NCT ID: NCT04886869 Recruiting - Clinical trials for Autonomic Nervous System Imbalance

Caffeine and the Autonomic Nervous System

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Caffeine consumption has been linked to dysfunction of the autonomic nervous system. In this study the investigators analyze the effects of caffeine containing drinks (including energy drinks and coffee) on ECG based parameters of the autonomic nervous system.

NCT ID: NCT04886804 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

Start date: June 22, 2021
Phase: Phase 1
Study type: Interventional

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.

NCT ID: NCT04886713 Recruiting - Obesity Clinical Trials

Adipose Tissue Inflammation in HFpEF

SLIM-HFpEF
Start date: November 1, 2019
Phase:
Study type: Observational

To evaluate the role of adipose tissue inflammation in patients with heart failure with preserved ejection fraction (HFpEF). Patients undergoing coronary artery bypass grafting with HFpEF and without heart failure will be included in this prospective study. Epicardial, paracardial, paraaortic/paravascular, subcutaneous adipose tissue samples as well as myocardial tissue will be harvested during cardiac surgery. Inflammatory patterns of these tissues and their relation to circulating markers will be investigated.

NCT ID: NCT04886258 Recruiting - Clinical trials for Symptomatic Knee Osteoarthritis

Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis

Start date: September 20, 2021
Phase: Phase 2
Study type: Interventional

This is a double-blinded, two-arm, phase II study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis. The study includes a screening period, a treatment period and a follow-up period. At most, the study duration is 21 weeks.

NCT ID: NCT04884334 Recruiting - Clinical trials for Perforation of the Oesophagus

VAC-Stent Registry

Start date: July 1, 2020
Phase:
Study type: Observational [Patient Registry]

This registry is intended to collect data on quality assurance and use of the VAC-Stent® and thus verify the suitability of the VAC-Stent® for sealing leakages in the oesophagus or colon. Furthermore, the safety and efficacy of the VAC-Stent® shall be proven.

NCT ID: NCT04883905 Recruiting - Clinical trials for Acute Hepatic Porphyria

ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)

ELEVATE
Start date: April 26, 2021
Phase:
Study type: Observational

This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.