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NCT ID: NCT06142682 Not yet recruiting - Cochlear Implant Clinical Trials

Dexamethasone Eluting Cochlear Implant: a Pivotal Study

CDEX2
Start date: June 30, 2024
Phase: N/A
Study type: Interventional

The newly developed MED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL) incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma. The aim of this clinical investigation is to obtain confirmatory data concerning safety and performances of the investigational device in the clinical population.

NCT ID: NCT06122701 Not yet recruiting - Healthy Clinical Trials

Dose-dependent Kinetics of Thiamin in Healthy Volunteers With and Without Functional OCT1 Hepatic Transporters

THIAMO-1
Start date: November 20, 2023
Phase: N/A
Study type: Interventional

This study investigates the differences in thiamin (vitamin B1) kinetic parameters in two cohorts of healthy volunteers: Cohort 1) OCT1 wild type genotypes n = 12 Cohort 2) OCT1 deficient genotypes n = 12 Participants will be selected according to their OCT1 genotypes and to achieve best matching according to sex, age, BMI, alcohol consumption, and smoking between Cohort 1 and 2, respectively. The purpose of this study is: 1. To determine the influence of OCT1 genetic variants on dose-dependent thiamin kinetics after oral administration. 2. To elucidate whether OCT1 genetic variants impact the kinetic properties of orally vs. intravenously administered thiamin.

NCT ID: NCT06118281 Not yet recruiting - Cardiovascular Risk Clinical Trials

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

ARTEMIS
Start date: June 25, 2024
Phase: Phase 3
Study type: Interventional

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

NCT ID: NCT06117176 Not yet recruiting - Clinical trials for Airway Complication of Anesthesia

Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III

PAPAYA-III
Start date: January 2025
Phase:
Study type: Observational [Patient Registry]

The overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. The patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to improve patient safety in the future.

NCT ID: NCT06115629 Not yet recruiting - Gastric Cancer Clinical Trials

Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial

SARONG-II
Start date: November 2023
Phase: Phase 3
Study type: Interventional

Cancer of the food pipe (oesophagus) and stomach are increasingly common. Currently, most patients with cancer of the oesophagus and stomach are treated with surgery with or without additional chemotherapy or radiotherapy. In recent years there have been improvements in survival from these two cancers, due to better therapies, less invasive surgery and earlier detection. Despite these improvements, in around half of patients treated with surgery, the cancer will return, usually within the first three years. At present there is very little evidence as to how patients who have been treated for cancer of the oesophagus or stomach should be followed up after surgery and whether different methods of follow-up could improve survival. Currently, national and international guidelines do not provide consistency in their recommendations for follow-up after surgery. The SARONG-II study will investigate if regular radiological scans can lead to earlier detection of a cancer returning, at a stage when it may be more readily treatable. This means that participants who agree to take part will be allocated by chance to either more intensive imaging surveillance (including regular radiological scans and a camera test (endoscopy)) or clinical follow-up. The study aims to recruit at least 952 participants in Europe over a 32-month period. Patients undergoing surgery for oesophageal or stomach cancer will be invited to participate in the study at around 4 to 8 weeks after their surgery. (i) The imaging surveillance group will receive a review in clinic or by telephone with a member of the surgical team, and a radiological scan at 6, 12, 18, 24, 30 and 36 months after randomisation. They will also receive endoscopy at 12 months after randomisation (ii) The clinical surveillance group will receive a review in clinic or by telephone at 6, 12, 18, 24, 30 and 36 months. After this they will be either discharged to their local doctor or receive a review in clinic with a member of the surgical team every year according to local practice The main aim of this study will be to determine whether earlier detection of cancer through more intensive follow-up results in improved survival and better quality of life for patients with oesophagus or stomach cancer. The investigators anticipate the results of the study may have significant practice-changing impact for patients undergoing follow-up after surgery for oesophagus and stomach cancer.

NCT ID: NCT06112171 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

CRACK-IT
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion. Patients will be stratified for total occlusions.

NCT ID: NCT06106997 Not yet recruiting - Clinical trials for Brain Tumor, Primary

Clinical Feasibility of Brain Radiotherapy Using Synthetic CTs in an MRI-only Workflow

Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this observational study is to show the feasibility of an MRI-only workflow in brain radiotherapy. The main question it aims to answer is: - Is an MRI-only workflow based on deep learning sCTs feasible in clinical routine? Participants will be treated as in clinical routine, but treatment planning will be based on sCTs, that are generated from MRI images. The dosimetrical equivalence to the standard CT based workflow will be tested at several points in the study.

NCT ID: NCT06105450 Not yet recruiting - Covid19 Clinical Trials

Respiratory Muscle Assesment in COVID-patients Without Hospitalization

RMA-COVID-19
Start date: December 1, 2023
Phase:
Study type: Observational

Fatigue and exercise intolerance after survived COVID-19-infection might be related to weakness of the respiratory muscles. The aim of the project is to measure respiratory muscle function and strength in our respiratory physiology laboratory in patients who were not hospitalized during the acute COVID-19-infection but still complain of different persistent symptoms including exertional dyspnea and fatigue.

NCT ID: NCT06097533 Not yet recruiting - Quality of Life Clinical Trials

Improvement of Quality of Life by Cannabinoids in Oncologic Patients

BELCANTO
Start date: December 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal is to explore whether the application of cannabis extract Avextra 10/10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.

NCT ID: NCT06060184 Not yet recruiting - Clinical trials for Genetic Predisposition

Initiative for Clinical Long-read Sequencing

IonGER
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The study aims to comprehensively introduce Long-read Genome sequencing (LR-GS) based genetic testing into clinical routine. In order to demonstrate the superiority of untargeted LR-GS over Short-read Genome sequencing (SR-GS) to establish firm genetic diagnoses, the investigators will rely on a multi-center "Translate Nationale Aktionsbündnis für Menschen mit Seltenen Erkrankungen" (Translate National Action Alliance for People with Rare Diseases Germany, TNAMSE) cohort of unsolved patients with neurological, neurodevelopmental, and imprinting disorders that is expectedly enriched for complex genomic variation. Within the framework of genomDE, the investigators will then implement, for the first time, LR-GS in the diagnostic work-up of a prospective cohort of patients with a broad range of clinical indications including rare diseases and cancer predisposition.