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NCT ID: NCT04585789 Completed - Hepatitis B Clinical Trials

A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection

INSIGHT
Start date: March 11, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.

NCT ID: NCT04585750 Recruiting - Breast Cancer Clinical Trials

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Start date: October 29, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2 study will assess the safety, tolerability, and efficacy of multiple dose levels of PC14586 (INN: rezatapopt) alone (monotherapy) and in combination with pembrolizumab in participants with advanced solid tumors containing a TP53 Y220C mutation.

NCT ID: NCT04585334 Recruiting - Clinical trials for Low Back Pain, Mechanical

Effectiveness of Tricortin 1000 in Patients Affected by Chronic Low Back Pain

Start date: March 25, 2019
Phase: Phase 4
Study type: Interventional

PAES, double blind, double dummy, multicenter, randomized, controlled clinical study to demonstrate superiority of Tricortin 1000 over placebo in improvement in pain relief as change from baseline to 15 days in patients with chronic low back pain (LBP).

NCT ID: NCT04585321 Completed - Clinical trials for Bioequivalence Study

Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day

Start date: November 28, 2017
Phase: Phase 1
Study type: Interventional

Study Objectives Primary To evaluate the average bioequivalence in healthy volunteers between medicinal product of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to the reference medicinal product Flector®, applied once and twice a day. Secondary To evaluate pharmacokinetic profile on Day 1, adhesivity, local tolerability and safety of medicinal product Diclofenac Sodium 140mg Medicated Plaster EQI7 in healthy volunteers in comparison to the reference medicinal product Flector®, applied once and twice a day.

NCT ID: NCT04585152 Recruiting - Clinical trials for Nephrotic Syndrome Steroid-Dependent

Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Idiopathic Nephrotic Syndrome.

RTXvsMMF
Start date: October 15, 2020
Phase: Phase 2
Study type: Interventional

Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for nephrotic syndrome.This Randomized Clinical Trial seeks to evaluate whether Rituximab biosimilar maintains drug-free disease remission in patients with steroid-dependent nephrotic syndrome for 12-24 months and verify its superiority vs. mycophenolate mofetil (1,200 mg/m2 orally in 2 daily doses). The investigators will compare the risk of relapse to test this hypothesis (primary outcome). Secondary objectives will include assessing short- and long-term side-effects and developing specific biomarkers of sensitivity to therapy. Patients will be recruited, treated and followed at IRCCS G Gaslini and IRCCS Bambino Gesù where laboratory studies will be performed at in-site facilities.

NCT ID: NCT04584957 Active, not recruiting - Gynecologic Cancer Clinical Trials

Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.)

GO-VAC
Start date: September 18, 2020
Phase: N/A
Study type: Interventional

A prospective controlled randomized study aimed to prospectively evaluate, the impact and effectiveness of clean incision prophylactic vacuum negative pressure therapy on wound healing (ciNPWT) in women at high risk of developing wound complications who undergo major gynecologic surgery. Gynecologic Oncology patients appear to be more at risk of developing wound complications than the general surgery population, reaching infection rates of 36 vs. 24 % that become 40 and 60% for obese and morbidly obese patients, respectively. Data about the use of ciNPWT are few, controversial and are of poor quality. No randomized, controlled trials have yet been reported in support of the use of ciNPWT in the gynecologic population.

NCT ID: NCT04584892 Completed - Haemophilia A Clinical Trials

Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities

THIRd
Start date: April 12, 2021
Phase:
Study type: Observational

This is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions. The purpose of the study is to investigate the therapeutic scheme in a population of patients treated with Turoctocog alfa and to investigate the participation in recreational activities, the level of physical activity, and quality of life. Participants will get NovoEight® (Turoctocog alfa) as prescribed to them by the study doctor. The study will last for about 12 months. Participants will be requested to fill in the Questionnaires investigating the participation in recreational activities, the level of physical activity, and quality of life.

NCT ID: NCT04584203 Recruiting - Critical Illness Clinical Trials

Diastolic dYsfunctioN AssessMent in critICally Ill Patients

DYNAMIC
Start date: June 1, 2021
Phase:
Study type: Observational

The role of the left ventricular diastolic function (LVDD) in the weaning failure from mechanical ventilation in unclear. Specifically, is unclear whether the outcome of the weaning process could be affected by a pre-existing LVDD (before ICU admission), or by the worsening of a chronic pattern, or by a de-novo LVDD presentation.

NCT ID: NCT04583917 Recruiting - Clinical trials for Duchenne Muscular Dystrophy

Brain Involvement in Dystrophinopathies Part 1

Start date: March 30, 2021
Phase:
Study type: Observational

The objective of this study is to collect data from a large cohort of individuals with DMD and BMD focusing on the neurobehavioural aspects of these conditions and their correlation to the location of the DMD gene mutation.

NCT ID: NCT04583813 Not yet recruiting - Obesity Clinical Trials

Empagliflozin and Atrial Fibrillation Treatment

EMPA-AF
Start date: September 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation.