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NCT ID: NCT04251039 Not yet recruiting - Coronary Disease Clinical Trials

in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"

Start date: December 2022
Phase:
Study type: Observational [Patient Registry]

Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI. Prospective, observational, multicenter registry.

NCT ID: NCT04250246 Not yet recruiting - Melanoma Clinical Trials

A Study of NIVO Plus IPI and Guadecitabine or NIVO Plus IPI in Melanoma and NSCLC Resistant to Anti-PD1/PDL1

NIBIT-ML1
Start date: March 2020
Phase: Phase 2
Study type: Interventional

This is a run-in, randomized, non-comparative, phase II study designed according to a two stages optimal design by Simon. This phase II design will be preceded by a safety evaluation after the first cohort of 6 patients to preserve a high-grade of overlapping and/or unexpected toxicity rate. The study will assess the immune-objective response rate (iORR) (assessed using iRECIST criteria) of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab, in Melanoma and non-small cell lung cancer (NSCLC) patients resistant to anti-PD-1/PD-L1 therapy. Immune biologic correlates to treatment will be assessed as exploratory endpoints.

NCT ID: NCT04238221 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of add-on Doxofylline on Lung Function in Stable COPD

EDAI
Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

It is a phase IV, prospective, interventional, single blind, randomized, crossover trial in which the investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg bid, in add-on to maximal inhalation therapy, in clinically stable COPD patients.

NCT ID: NCT04193839 Not yet recruiting - Adverse Drug Event Clinical Trials

Reducing Errors In The Neonatal Intensive Care Unit

SAPHET-i
Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry in reducing medication erros (MEs) in the Neonatal Intensive Care Unit (NICU)

NCT ID: NCT04175197 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries

LEGDEB2
Start date: November 2019
Phase:
Study type: Observational

LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon

NCT ID: NCT04157647 Not yet recruiting - Cardiac Surgery Clinical Trials

Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response

IMHeS
Start date: November 15, 2020
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) is a risk factor for the development of cardiovascular disease, which increases the risk of death after cardiac surgery. High interleukin 6 (IL-6) blood levels is commonly observed in patients with CKD, and this is particularly high after cardiac surgery. High IL-6 levels are also associated with increased long-term mortality rate after cardiac surgery. To date, the use of ultrafiltration or endotoxin adsorption systems were not found to improve the clinical outcome, although able to reduce the inflammatory mediators concentrations. In the last years, a new extracorporeal hemadsorption filter (CytoSorb) has been developed for removal of inflammatory cytokines and it has been approved by the European Union. However, data lack about the impact on clinical outcome of the use of CytoSorb in patients with CKD undergoing cardiac surgery with cardio-pulmonary bypass (CPB). The investigators have therefore designed this pilot prospective randomized trial to evaluate the efficacy the intraoperative use of CytoSorb for cytokines removal to prevent the inflammatory response associated with the cardiac surgery and complications in patients with CKD.

NCT ID: NCT04152876 Not yet recruiting - Rare Diseases Clinical Trials

Functional Genomics of Rare Genetic Diseases: Realization of Innovative Tools With High Diagnostic Power

Start date: October 31, 2019
Phase:
Study type: Observational

The project aims to improve the understanding of a significant group of rare diseases both from a genetic/diagnostic and clinical/experimental point of view and aims to develop one or more diagnostic protocols. The study will be conducted through the application of complementary experimental strategies, ranging from the clinical, genetic and molecular characterization of the pathology to the search for rare variants and the development of cellular disease models.

NCT ID: NCT04151316 Not yet recruiting - Clinical trials for Dental Prosthesis Failure

Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth

Start date: November 2019
Phase: N/A
Study type: Interventional

When the tooth is severely compromised, it needs a prosthetic crown. The tooth is prepared to allow the housing of the prosthetic crown without difficulty. This study aims to compare two different types of preparations to see with which of the two the gingival tissue reacts best.

NCT ID: NCT04148820 Not yet recruiting - Clinical trials for Ischemic Heart Disease

One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease

ONCE
Start date: November 1, 2019
Phase: Phase 4
Study type: Interventional

Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta-blockers. Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists. The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

NCT ID: NCT04145713 Not yet recruiting - Asphyxia Neonatorum Clinical Trials

Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment

VISNAT
Start date: January 1, 2020
Phase: Phase 3
Study type: Interventional

The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia. It is designed as a randomized, placebo-controlled, blinded, multicentre superiority trial with two parallel groups and a primary outcome of mortality and/or disability at 18 months of age. After informed consent is obtained from both parents, randomization will be performed as block randomization with a 1:1 allocation using a computer-generated allocation sequence, while the allocation concealment will be performed using locked bags. Randomization data and allocation list will be stored in a secure place and will not be available to any of the components of the study apart of data collectors. Participant files will be stored for a period of 10 years after completion of the study. All the components of the study will be blinded including: participants and their parents, healthcare providers, outcome assessors, data collectors, data analysts.