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NCT ID: NCT04489823 Recruiting - Clinical trials for Paravalvular Aortic Regurgitation

PARADIGM: Amplatzer Valvular Plug for PVL Closure

PARADIGM
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position.

NCT ID: NCT04489537 Terminated - Clinical trials for Hemophilia A With Inhibitor

Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

Start date: May 4, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC).

NCT ID: NCT04489225 Recruiting - Heart Failure Clinical Trials

Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

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

Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

NCT ID: NCT04489069 Completed - Clinical trials for Developmental Psychological Disorder

Developmental Psychopathology and the Gene-environment Interaction

TwinAger
Start date: January 16, 2019
Phase: N/A
Study type: Interventional

The present is a followup study that aims at investigating the effect of genetic and environmental factors on the possible development of psychopathological conditions in a longitudinal perspective. The final goal is to understand those factors that causing vulnerability to mental illness, eventually allowing better prevention and early detections of those persons with mental illness.

NCT ID: NCT04489017 Completed - Clinical trials for Frontotemporal Dementia

Palmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled Trial

PEA-FTD
Start date: June 1, 2019
Phase: Phase 2
Study type: Interventional

Frontotemporal dementia (FTD) is a devastating neurodegenerative disorder. It is the second most frequent cause of presenile neurodegenerative dementia in those less than 65 years of age. Currently, there is no effective pharmacological treatment to slow down the progression of FTD. Recently, it has been proposed that neuroinflammation could be involved in specific forms of FTD and that novel drugs targeting neuroinflammation could potentially be useful in FTD treatment. An available form of ultra-micronized PEA combined with luteoline (PEA-LUT) has gained attention for its proven anti-inflammatory and neuroprotective properties reported in neurodegenerative conditions related to FTD, such as Amyotrophic Lateral Sclerosis. The administration of PEA-LUT treatment may have a clinical impact in behavioural variant FTD (bv-FTD) patients. In particular, PEA-LUT treatment could be able to reduce behavioural disturbances, the more disabling symptoms in bv-FTD, with a related improvement of daily living activities of affected people. Moreover, a multimodal approach (cognitive/neurophysiological) can be used to assess the brain correlates related to the clinical improvement associated with PEA-LUT treatment, thus making remarkable strides in understanding how FTD affects the brain. Potentially the proposed project could provide a valid treatment for cognitive and behavioural dysfunction in FTD patients, with consistent impact for the National Health Systems and minimum cost for the patients.

NCT ID: NCT04488926 Completed - Fibromyalgia Clinical Trials

Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

Start date: July 16, 2020
Phase: Phase 4
Study type: Interventional

The onset of chronic Fibromyalgia symptomatology is due to central alterations, together with peripheral neuroimmune modifications. Using positron emission tomography (PET), it has been observed for the first time that fibromyalgia patients have a high activation of microglial cells compared to normal subjects. Experimental evidence in neuroinflammation models in vitro and in vivo have demonstrated the anti-inflammatory and neuroprotective effect of Palmitoylethanolamide (PEA), effects confirmed by observational clinical investigations conducted in patients with fibromyalgia in which micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA) reduced the intensity of pain improving the quality of life. The aim of this study is to investigate the efficacy and tolerability of PEA-m + PEA-um administered as an add-on therapy with a double-blind, randomized, placebo-controlled clinical investigation.

NCT ID: NCT04488549 Completed - Surgery Clinical Trials

Delayed Colorectal Cancer Care During Coronavirus Disease (COVID-19) Pandemic (DECOR-19)

DECOR-19
Start date: May 20, 2020
Phase:
Study type: Observational

To understand and analyse the global impact of COVID-19 on outpatient services, inpatient care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer surgery (DECOR-19) survey was conducted in collaboration with numerous international colorectal societies with the objective of obtaining several learning points from the impact of the COVID-19 outbreak on our colorectal cancer patients which will assist us in the ongoing management of our colorectal cancer patients and to provide us safe oncological pathways for future outbreaks.

NCT ID: NCT04488406 Completed - Clinical trials for Graves Ophthalmopathy

Genetics and Epigenetics of Graves' Orbitopathy

GeneGO
Start date: January 1, 2020
Phase:
Study type: Observational

Graves' orbitopathy (GO) is an autoimmune disease persisting when immunosuppression is achieved. Orbital fibroblasts from GO patients display peculiar phenotypes even if not exposed to autoimmunity, possibly reflecting genetic or epigenetic mechanisms, to be investigated here. Primary cultures of orbital fibroblasts from GO and control patients will be established. Cell proliferation, release of hyaluronic acid (HA) and HA synthases (HAS) will be measured. Next Generation Sequencing and gene expression analysis of the whole genome will be performed, as well as global DNA methylation assay.

NCT ID: NCT04488133 Active, not recruiting - Clinical trials for Muscular Atrophy, Spinal

A Study of Nusinersen Among Participants With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec

RESPOND
Start date: January 4, 2021
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the clinical outcomes following treatment with nusinersen in participants with spinal muscular atrophy (SMA) who previously received onasemnogene abeparvovec. The secondary objectives of this study are to evaluate the safety and tolerability; clinical outcomes and pharmacodynamics (PD) of nusinersen treatment in participants with SMA who previously received onasemnogene abeparvovec.

NCT ID: NCT04488042 Completed - Obesity, Morbid Clinical Trials

Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.