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NCT ID: NCT03340688 Recruiting - Preterm Birth Clinical Trials

Cerclage for Twins With Short Cervical Length ≤ 15mm

TWIN-UIC
Start date: June 22, 2017
Phase: N/A
Study type: Interventional

This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.

NCT ID: NCT03340285 Completed - Clinical trials for Cardiovascular Risk Factor

Effects of a New Combination of Nutraceuticals (AkP06) Without Monacolin K on Plasma Lipids and Glucose

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The study is designed evaluate the effects of a new combination of nutraceuticals (AkP 06) without Monacolin K on lipid and glucose metabolism. The study will analyze the impact of 4 weeks treatment with Akp06 or placebo, according to a randomized scheme, on metabolic parameters in dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it will assess the ability of AkP 06 to reduce the plasma levels of LDL cholesterol, HbA1C, glicaemia and fasting insulin and to increase those of HDL cholesterol. In addition, effects on serum transaminase and creatine phosphokinase (CPK) concentration will be evaluated.

NCT ID: NCT03340272 Active, not recruiting - Clinical trials for Intermediate Risk Prostate Cancer

PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.

PRO-EPI
Start date: February 21, 2017
Phase:
Study type: Observational [Patient Registry]

The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen Deprivation hormone Therapy (ADT). The study aims at the definition of survival, toxicity and QoL data in a representative sample of intermediate, high and very high risk prostate cancer patients consecutively recruited in Italian Radiation Oncology Center over two years.

NCT ID: NCT03340103 Withdrawn - Clinical trials for Antioxidant Role of the Lutein in Preterm Newborn

Early Administration of the Lutein/Zeaxanthin in Premature Newborns

Start date: October 11, 2018
Phase: N/A
Study type: Interventional

Premature birth is the most common cause of mortality, morbidity and disability. Premature infants have a higher risk of developing damage in the eyes (retinopathy of prematurity ROP), in the central nervous system (intraventricular hemorrhage IVH), in the lungs (bronchial pulmonary dysplasia BPD), in the gut (NEC) and infections. Oxidative stress has been implicated in various capacities, in the etiology of these conditions. Lutein and Zeaxanthin are powerful anti-oxidants and commonly assimilated with different foods. Lutein and Zeaxanthin are present at level of umbilical cord, in the breast milk (particularly in colostrum) and pass the placental barrier. Concerning supplementations, the lutein presents, for its specific characteristics, a high bioavailability after oral administration. In the last few years, there have been more and more studies which have shown that lutein could constitute a valid and important preventive and protective factor against certain diseases related to oxidative stress. The preparations of lutein and zeaxanthin have never pointed out in the human being (included in the term newborn) adverse or toxic effects. This spontaneous / non-commercial pilot study involves the administration of a dietary supplement containing lutein / zeaxanthin, because the healthcare structures need to identify a natural antioxidant product that can reduce the incidence of serious diseases related to oxidative stress in the perinatal period. This study aims to evaluate if the administration of lutein in watery solution will reduce the rate of free radicals in preterm infants.

NCT ID: NCT03339401 Terminated - Adenovirus Clinical Trials

The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation

AdAPT
Start date: December 22, 2017
Phase: Phase 2
Study type: Interventional

This study was designed to assess the safety, overall tolerability, and antiviral activity of "short course" brincidofovir (BCV) therapy, as compared with current standard of care (SoC), for the treatment of adenovirus (AdV) infections in high-risk (i.e., T cell depleted) pediatric allogeneic hematopoietic cell transplant (HCT) recipients. A virologic response-driven approach to the duration of treatment was to be evaluated, in which subjects randomized to BCV therapy were to be treated until AdV viremia was confirmed as undetectable or until a maximum of 16 weeks of therapy, whichever occurred first. The formulation of BCV used in this study was oral tablet/suspension.

NCT ID: NCT03339336 Terminated - Diabetes Mellitus Clinical Trials

Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy

Start date: May 31, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score. The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.

NCT ID: NCT03339297 Completed - Clinical trials for Graft-versus-host Disease

An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

Start date: February 21, 2018
Phase: Phase 2
Study type: Interventional

This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

NCT ID: NCT03339115 Recruiting - Clinical trials for Mitral Regurgitation

AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System

AHEAD
Start date: April 23, 2018
Phase: N/A
Study type: Interventional

This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance, and long-term clinical outcomes over a follow-up of 2 years.

NCT ID: NCT03339063 Recruiting - Clinical trials for Nontuberculous Mycobacteria

The Italian REgistry of Pulmonary Non-tuberculous mycobactEria

IRENE
Start date: April 21, 2017
Phase:
Study type: Observational [Patient Registry]

The Italian registry of pulmonary non-tuberculous mycobacteria (NTM) -IRENE- is an observational, multicenter, prospective, cohort study enrolling consecutive adult patients with either a NTM respiratory infection or NTM-Pulmonary Disease. The coordinating center is located at the Pulmonary Department of the Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy. So far, more than 35 centers, including mainly pulmonary and infectious disease departments, joined the registry. The registry has been developed to accept an unlimited number of patients and no deadlines have been decided.

NCT ID: NCT03338816 Completed - Clinical trials for Acute Intermittent Porphyria

ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)

Start date: November 16, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).