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NCT ID: NCT03813589 Active, not recruiting - Clinical trials for Heart Failure,Congestive

Congestive Heart Failure and Atrial Tachyarrhythmias in Pmk Patients

SEASIDE
Start date: January 19, 2019
Phase:
Study type: Observational

The aim is to correlate relationship between congestive heart failure and onset of atrial tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart failure are collected automatically by implanted device.

NCT ID: NCT03813238 Completed - Clinical trials for Cerebral Palsy, Dyskinetic

A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents

RECLAIM-DCP
Start date: August 6, 2019
Phase: Phase 3
Study type: Interventional

CP (cerebral palsy) refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. CP is caused by damage to or abnormalities inside the developing brain that disrupt the brain's ability to control movement and maintain posture and balance. The signs of CP usually appear in the early months of life, although specific diagnosis may be delayed until the age of 2 years or older. TEV-50717 (deutetrabenazine, also known as SD-809) has already provided evidence for safe and effective use in 2 other hyperkinetic movement disorders, namely chorea in Huntington's disease (HD) and tardive dyskinesia (TD). Currently, there is no approved treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options address some of the manifestations of DCP. The study population will include pediatric and adolescent participants (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had nonprogressive CP symptoms since infancy (≤2 years of age). Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria. This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered as oral tablets at a starting dose of 6 mg once daily in participants (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement disorder. The study will be conducted in multiple centers and will use 2 parallel treatment groups (ie, TEV-50717 and placebo) in which participants will be randomized in a 2:1 ratio. "Predominant" in this instance indicates that the choreiform movement disorder is the main cause of impairment or distress.

NCT ID: NCT03813160 Completed - Dermatomyositis Clinical Trials

Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

DETERMINE
Start date: December 17, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.

NCT ID: NCT03813134 Recruiting - Cardiogenic Shock Clinical Trials

Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock

EUROSHOCK
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

Cardiogenic shock (CGS) affects up to 10% of patients suffering acute coronary syndrome. It has a 30 day mortality of 45-50%. No pharmacological nor intervention/device trials have had any impact on this mortality in the last 20 years. The EURO SHOCK Trial (supported by the European Union Horizons 2020 programme) will randomise 428 patients with CGS following acute coronary syndrome from 44 EU centres to early intervention with Extra Corporeal Membrane Oxygenation (ECMO) therapy or to standard treatment (with no ECMO). This intervention is a high cost specialist centre procedure that warrants further investigation including economic appraisal. Multiple mechanistic and hypothesis generating sub-studies will be undertaken.

NCT ID: NCT03812926 Completed - Epidural Simulator Clinical Trials

Compuflo® vs Conventional Training With an Epidural Simulator

Start date: December 1, 2018
Phase:
Study type: Observational

Epidural block is one of the most difficult skills that can be mastered by trainees probably due to the difficulty of recognizing the ligamentum flavum (LF) during the loss of resistance technique (LORT).The CompuFlo® Instrument can measure the pressure of human tissues in real-time at the orifice of a needle and it has been successfully used in clinical practice to identify the epidural space.The aim of this study was to evaluate whether Compuflo® may help trainees to identify the ligamentum flavum using a realistic Epidural Simulator

NCT ID: NCT03811535 Active, not recruiting - Clinical trials for Growth Hormone Deficiency in Children

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

REAL4
Start date: May 20, 2019
Phase: Phase 3
Study type: Interventional

The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

NCT ID: NCT03811262 Withdrawn - Breast Cancer Clinical Trials

Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period. PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery. ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists. Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery. Study type: RCT, single blind.

NCT ID: NCT03810313 Terminated - Clinical trials for Central Retinal Vein Occlusion

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

RAVEN
Start date: July 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).

NCT ID: NCT03810222 Completed - Clinical trials for Brain Injuries, Traumatic

A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury

TBI-PRO
Start date: January 18, 2017
Phase:
Study type: Observational

Traumatic brain injury (TBI) is the leading cause of death, disability and cognitive impairment in young people worldwide. The majority of the traumatic deaths in developed countries results directly from lesions in the central nervous system. Furthermore, due to the persistence of disabling effects of TBI for many years, personal and public costs of supporting survivors have to be taken in consideration. Many patients rescued by ICU treatment may have been severely disabled or vegetative because of trauma. These data suggest that, despite improvement in medical and surgical treatments, other factors related to trauma itself and to patient's condition could have an impact on the final outcome. Aim of the TBI-PRO project is to collect high quality clinical and epidemiological data and to describe the outcome of moderate-to-severe TBI in a local contest (Bergamo area, Italy).

NCT ID: NCT03810118 Completed - Anesthesia, General Clinical Trials

Fluid Challenge Infusion and Response

REFILL
Start date: April 8, 2019
Phase: N/A
Study type: Interventional

It is unclear if the rate of administration of the fluid challenge could affect the rate of fluid responsiveness. The role of this small-dose (the so called mini-FC) has been recently tested to assess if the infusion of a small amount of fluids (100 ml in 1 minute) could predict the final effect of the residual aliquot (i.e., 250 ml of FC test subdivided as follows: 100 ml in 1 minute and 150 ml in 9 minutes). Both the sudden increase in the stroke volume and the reduction of PPV and SVV after a bolus of 100 ml of crystalloids administered in 1 minute showed high sensitivity and specificity in predicting the final outcome of the FC. The primary aim of the present study is assess whether the does the rate of infusion of fluid challenge affect fluid responsiveness in neurosurgical supine patients. The secondary aim is to assess the reliability of the changes in SV, PPV and SVV after a mini-FC test in predicting the final fluid responsiveness.