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NCT ID: NCT04495647 Completed - Frailty Clinical Trials

Feasibility of WB-EMS in Frail Older People

Start date: July 22, 2020
Phase: N/A
Study type: Interventional

Exercise in general and resistance training (RT) in particular have demonstrated positive effects on physical functioning and frailty. However, frail older people with functional impairments are among the least physically active and may have problems reaching high intensity levels. The use of special vests with integrated electrodes allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at low subjective effort level. This whole-body electromyostimulation (WB-EMS) may be a feasible option inducing training stimuli for functionally impaired frail older people. This study aims at investigating the feasibility and safety of WB-EMS in frail older people with functional limitations. To explore the effects of age and functional status, young and robust old reference groups will serve as comparators.

NCT ID: NCT04495621 Completed - Clinical trials for Metastatic Colorectal Cancer

MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)

C-PRECISE-01
Start date: July 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Open-label, dose-confirmation and cohort expansion, multicentre, Phase Ib/II study to assess the anti-tumour activity and safety of MEN1611 in combination with cetuximab for the treatment of patients with PIK3CA mutated metastatic colorectal cancer.

NCT ID: NCT04493541 Completed - Clinical trials for Lupus Erythematosus, Cutaneous

A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus

Start date: August 26, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.

NCT ID: NCT04492371 Completed - Multiple Myeloma Clinical Trials

COVID-19 Infection and Multiple Myeloma

EMN-COVID
Start date: July 1, 2020
Phase:
Study type: Observational

Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.

NCT ID: NCT04490226 Completed - Healthy Clinical Trials

Endogenous vs. Exogenous Ketone Bodies

Start date: August 21, 2020
Phase: N/A
Study type: Interventional

Aim of the study is to compare the origin of ketone bodies: endogenous ketone bodies due to 36 hours fasting or 24 hours of ketogenic diet vs. exogenous ketone bodies as supplements additional to normal diet. Secondary aim of the study is to validate the new metabolic chambers.

NCT ID: NCT04490005 Completed - Acute Brain Injury Clinical Trials

Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx

ORANGE
Start date: November 2, 2020
Phase:
Study type: Observational [Patient Registry]

The use of quantitative, automated, infrared technology for pupillary examination has long been used in ophthalmology and anesthesiology research. Its interest in neurocritical care has progressively grown, in parallel with the advancements in device technology. In this regard, the use of the noninvasive NPi®-200 pupillometer (Neuroptics, Laguna Hills, California, USA) allows the measurement of a series of dynamic pupillary variables (including the percentage pupillary constriction, latency, constriction velocity, and dilation velocity), which can be integrated into an algorithm, to compute the Neurological Pupil index (NPi). The NPi is a proprietary scalar index with values between 0 and 5 (with a 0.1 decimal precision), an NPi value < 3 indicating an abnormal pupillary reactivity. Importantly, the NPi is not influenced by sedation-analgesia, at the doses used in neurocritical care practice, and by mild hypothermia. Preliminary single-center data recently demonstrated that abnormal NPi is associated with worse outcome in patients with traumatic and hemorrhagic ABI, and can be a useful adjunct for ICP monitoring and therapy. There is currently a great need for quantitative tools to predict early prognostication in ABI patients, and the NPi appears of potential great value. We hypothesize that: 1. Abnormal NPi (defined as NPi <3) are strongly predictive of poor GOS-E (1-4) at 6 months after the acute event. 2. NPi=0 is strongly predictive of mortality (GOS 1). 3. Abnormal NPi is predictive of a higher ICP 20 index (number of end-hourly measures of ICP >20 mm Hg divided by the total number of measurements, multiplied by 100) and a greater burden of interventions needed to control ICP (measured by the Therapy Intensity Level scale for ICP management, Therapy Intensity Level (TIL) 4). Methods This international multicentre prospective observational study aims to recruit >400 patients admitted to intensive care units. Duration of the study 18 months, including 12-month of recruitment based on 60 patients/centre plus 6 months GOS-E follow-up.

NCT ID: NCT04489914 Completed - Clinical trials for Transcatheter Aortic Valve Replacement

Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral Aortic Valve Replacement

Start date: October 12, 2020
Phase:
Study type: Observational

Percutaneous catheter-assisted valve replacement in aortic position (TAVI) for patients with high perioperative risk has become a standard method in recent years. In addition to the detection of bleeding and cardiac rhythm complications, follow-up care is mainly focused on the monitoring of respiratory parameters after an operation under intubation anesthesia or deep analgosedation. In addition to normal oxygen therapy, non-invasive ventilation and, in case of weaning failure, renewed tracheal intubation in the first 24 h after TAVI have been considered. High flow oxygen therapy (HFOT) now provides a good opportunity to treat patients with a warmed and humidified air-oxygen mixture and to independently control the oxygen content in the inhaled air and the flow in the pharyngeal area. The aim of the Study is to investigate the Change in oxygenation after high-flow oxygen therapy as a measure of weaning success in postinterventional patients after TAVI.

NCT ID: NCT04489394 Completed - Trauma Clinical Trials

Quintex® Follow-up After One Year Minimum

Quintex
Start date: November 11, 2019
Phase:
Study type: Observational

Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the first thoracolumbar VBR (C2-T1), who received a Quintex plate for stabilisation

NCT ID: NCT04489277 Completed - Clinical trials for Aortic Arch Aneurysm

Silent Brain Infarction After Endovascular Arch Procedures

Start date: September 1, 2018
Phase:
Study type: Observational [Patient Registry]

This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization.

NCT ID: NCT04480840 Completed - Clinical trials for Primary Sclerosing Cholangitis

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis