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NCT ID: NCT04524364 Completed - Atrial Fibrillation Clinical Trials

A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

inspIRE
Start date: August 23, 2020
Phase: N/A
Study type: Interventional

The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

NCT ID: NCT04523220 Completed - Hemodialysis Clinical Trials

Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis

CONVERT
Start date: August 28, 2020
Phase: Phase 2
Study type: Interventional

In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

NCT ID: NCT04522180 Completed - Acromegaly Clinical Trials

A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly

Start date: January 4, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and efficacy of IONIS-GHR-LRx subcutaneous (SC) injection as monotherapy in patients with acromegaly.

NCT ID: NCT04522167 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

MAGELLAN-AMD
Start date: July 21, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.

NCT ID: NCT04521504 Completed - Rotator Cuff Tears Clinical Trials

The ISEO Biofeedback Tool During the Rehabilitation of Patients Treated for Rotator Cuff Tear

PDT1-1
Start date: November 21, 2017
Phase: N/A
Study type: Interventional

The present study addresses the issue about post-surgical recovery process, for patients arthroscopically treated for rotator-cuff tear. The aim of the research is to test the effectiveness of a new rehabilitation protocol that includes kinematic biofeedback with the motion analysis system ISEO.

NCT ID: NCT04520997 Completed - Clinical trials for Lower Face Folds and Lines

Restylane Defyne in a Stepwise Treatment Approach

Start date: December 7, 2020
Phase: N/A
Study type: Interventional

This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.

NCT ID: NCT04519827 Completed - Allergy;Food Clinical Trials

A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

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

Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with CMA maternal dairy exclusion is recommended as first line treatment. In non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. The AAP and other societies such as EAACI and ESPGHAN considers a formula to be 'hypoallergenic' if at least 90% of children with documented CMA tolerate it, with a 95% CI, under double-blind, placebo-controlled conditions.This equates to at least 29 children who should tolerate the product following blind and open challenge.

NCT ID: NCT04515680 Completed - Iron Overload Clinical Trials

Endocrine Function During Deferasirox Therapy

Start date: November 2, 2016
Phase:
Study type: Observational

A national survey on the prevalence and natural history of endocrine complications in thalassemia transfusion--dependent patients treated with deferasirox was designed, in order to assess a larger population during a longer follow up and improve the quality of previous investigations.

NCT ID: NCT04515433 Completed - Alzheimer Disease Clinical Trials

Gamma tACS in Alzheimer's Disease

GammAD
Start date: August 20, 2020
Phase: N/A
Study type: Interventional

Brain oscillations are ubiquitous in the human brain and have been implicated in cognitive and behavioral states defined in precisely tuned neural networks. In neurodegenerative disorders, neurodegeneration is accompanied by changes in oscillatory activity leading to the emerging concept of neurological and psychiatric disorders as "oscillopathies". Alzheimer's disease, which accounts for the vast majority of age-related dementias, is characterised by a prominent disruption of oscillations in the gamma frequency band. The restoration of gamma oscillations by neural entrainment in animal models of Alzheimer's disease have shown a remarkable decrease in the pathological burden of amyloid and tau via increased microglial activity, resulting in a significant increase of cognitive performances. Transcranial alternating current brain stimulation (tACS), is a neurophysiological method of non-invasive modulation of the excitability of the central nervous system that is having an increasingly numerous spectrum of potential therapeutic applications. Recent studies have demonstrated the effectiveness of this method in modulating the natural frequencies of cerebral oscillation, underlying multiple cognitive processes such as verbal memory, perception and working memory. On the basis of these premises, the treatment with gamma tACS is proposed in patients affected by Alzheimer's disease. In this randomized, double-blind, sham-controlled, cross-over study, the investigators will evaluate whether a single stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with Mild Cognitive Impairment due to Alzheimer's disease.

NCT ID: NCT04514263 Completed - Quality of Life Clinical Trials

Oral Biopsies: Evaluation of the Post-surgical Discomfort

Start date: January 8, 2018
Phase:
Study type: Observational

Aim of this study is to evaluate the post-operative course in patients undergoing diagnostic or therapeutic oral mucosal biopsies. To evaluate the wound healing, all variables connected with the surgery (including post-operative complications) were recorded. To evaluate the psychological and behavioral impact of the post-operative discomfort, two survey tools were administered: OHIP-14 and visual number scale of pain (VNS) were administered at 6h, 7 days and 21 days after biopsy.