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NCT ID: NCT04842162 Recruiting - Clinical trials for Head and Neck Cancer

Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery

MAGNOLIA
Start date: December 15, 2020
Phase: Phase 2
Study type: Interventional

Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers

NCT ID: NCT04833894 Recruiting - Clinical trials for Generalized Myasthenia Gravis

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

Start date: October 26, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: - The maximum trial duration for each individual participant will be approximately 28 weeks - The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)

NCT ID: NCT04832607 Recruiting - Clinical trials for Stem Cell Transplant Complications

Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections

TRACE
Start date: August 27, 2019
Phase: Phase 3
Study type: Interventional

Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.

NCT ID: NCT04831957 Recruiting - Hypothyroidism Clinical Trials

Hypothyroidism After the TAVI Procedure in Elderly Patients

Start date: July 26, 2021
Phase: N/A
Study type: Interventional

Aortic stenosis is highly prevalent in advancing age. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve and the trans catheter aortic valve re-placement (TAVI). The TAVI procedure is also successful in octogenarians and frail patients. However, the evaluation before the TAVI procedure requires a high dosage of iodinated contrast agent with, consequently, an increased risk for thyroid dysfunction. The primary endpoint of this study is to assess, prospectively, the incidence and the predictive factors (underlying thyroid disease, medication, food preservative, topical antiseptics) of hypothyroidism after a TAVI procedure. The secondary endpoint is the influence of the occurrence of hypothyroidism after the TAVI procedure on the geriatric assessment.

NCT ID: NCT04831905 Recruiting - Clinical trials for Focal Treatment for Prostate Cancer

Micro-wave Ablation Under Organ-based Tracking in Patients With Prostate Cancer - FOSTINE

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

With the advent of multiparametric MRI (mpMRI), the concept of focal therapy continues to develop as a compromise between active surveillance and radical tratment. However, it must be combined with the most stringent quality control measures, such as exceptional Imaging, to allow close management of the index tumor. the choice of the energy is also crucial. Several have been tested such as HIFU, electroporation or cryotherapy. A new therapeutic alternative currently Under investigation resides in the use of microwaves delivered through a thin needle inserted precisely into the index lesion according to the same procedure as targeted biopsy under image fusion to induce coagulation necrosis and lead to the tumor destruction. Through an ablate, performed transrectally under real-time MRI/TRUS image registration and 3D mapping, in patients with localized prostate cancer (PCa).

NCT ID: NCT04830774 Recruiting - COVID-19 Clinical Trials

Natural History of COVID-19-Related Atrial Fibrillation

unCOVer-AF
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The unCOVer-AF prospective, multicenter registry aims at determining the natural history of atrial fibrillation (AF) via continuous cardiac rhythm monitoring in patients with a first arrhythmic episode during COVID-19 hospitalization.

NCT ID: NCT04830683 Recruiting - Covid19 Clinical Trials

Endothelial Dysfunction in Covid-19

ENDOCOVID
Start date: April 27, 2020
Phase:
Study type: Observational [Patient Registry]

SARS-CoV-2 targets endothelial cells via the angiotensin-converting enzyme 2 receptor. The specific impact of the resulting endothelial injury is currently unknown but may contribute to the pro-coagulant state classically described during Covid-19 disease and commonly associated with an exacerbated activation of the renin-angiotensin-aldosterone system.

NCT ID: NCT04828811 Recruiting - Clinical trials for Post- Market Clinical Follow-up

Boston Scientific Rhythm Management Registry

SOCRATES
Start date: March 3, 2021
Phase:
Study type: Observational [Patient Registry]

The objective of SOCRATES is to serve as one element within an overarching framework to systematically gather and record clinical data. The data to be collected is defined in separate individual Post- Market Clinical Follow-up (PMCF) Plans developed by Boston Scientific Corporation (BSC). All data will be collected under local standard of care (SoC) conditions of use. The data collected will be used to achieve relevant information about the safety, performance and quality of BSC Rhythm Management (RM) products throughout their entire lifetime. The individual PMCF plans each relate to one or more of BSC's medical devices. The PMCF plans will specify outcomes that will be evaluated per predetermined scientific, clinical or policy purposes using the data of populations treated or diagnosed with the applicable BSC devices. The populations are defined by a particular disease, condition or exposure (i.e. to a device). The data collected will be analysed per separate PMCF Data Analysis Plans (PDAP) linked to the PMCF plans.

NCT ID: NCT04824248 Recruiting - Clinical trials for Chronic Low-back Pain

Weight Reduction in CLBP

Start date: April 12, 2021
Phase: N/A
Study type: Interventional

We will recruit overweight/ obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered online and will be a combination of online education material and face-to-face video calls with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.

NCT ID: NCT04823663 Recruiting - Cardiac Disease Clinical Trials

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

SOCRATES
Start date: March 31, 2021
Phase:
Study type: Observational [Patient Registry]

SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.