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NCT ID: NCT04595825 Active, not recruiting - Clinical trials for Primary Sclerosing Cholangitis

CM-101 in PSC Patients -The SPRING Study

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

This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.

NCT ID: NCT04595214 Recruiting - Premature Birth Clinical Trials

Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies

PRETWINSCREN
Start date: December 21, 2020
Phase:
Study type: Observational [Patient Registry]

Different screening modalities evaluation to develop algorithms to predict pregnancy complications in twin pregnancies, and evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.

NCT ID: NCT04595123 Completed - Depression Clinical Trials

Impact of COVID-19 Pandemic in Perinatal Mental Health (RISEUP-PPD-COVID-19)

Start date: June 15, 2020
Phase:
Study type: Observational

Introduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: The study and handling of the data will follow all national required data protection standards. Each researcher (or team of researchers) involved will submit the project to their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.

NCT ID: NCT04594707 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

STARSCAPE-OLE
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT04594694 Active, not recruiting - Clinical trials for Primary Biliary Cholangitis

Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC

Start date: October 2, 2019
Phase: Phase 2
Study type: Interventional

Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

NCT ID: NCT04594369 Active, not recruiting - Clinical trials for Non-Cystic Fibrosis Bronchiectasis

A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

ASPEN
Start date: December 1, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

NCT ID: NCT04593745 Recruiting - ALL, Childhood Clinical Trials

Intraocular Pressure in Children With Acute Lymphoblastic Leukemia (ALL) Treated With High Dose Steroids

ALL
Start date: July 9, 2018
Phase: N/A
Study type: Interventional

Childhood ALL patients are treated with high dose steroids. The study will follow the intraocular pressure of children treated in according to an AIEOP-BFM protocol, during the induction phase that will be compared to the pressure before treatment. Potential risk factors for developing elevated intraocular pressure will be estimated.

NCT ID: NCT04593342 Completed - Rotator Cuff Tears Clinical Trials

Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair

LLL&RotC01
Start date: November 26, 2020
Phase: N/A
Study type: Interventional

Rehabilitation following rotator cuff surgery is characterized with high levels of pain, limited range of motion, and decreased quality of life. The purpose of this study is to evaluate the B-Cure laser photobiomodulation home-use device in addition to standard care, for the reduction of pain, increase in functionality, and improvement of life quality during rehabilitation following rotator cuff arthroscopic surgery.

NCT ID: NCT04592497 Not yet recruiting - Atrial Fibrillation Clinical Trials

Evaluation of the Safety and Performance of the Very High Power-Short Duration QDOT

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

The aim of the present study is to compare the safety and short-term performance between THERMOCOOL SMARTTOUCH SF-5D QDOT system used with fast ablation mode and the standard Thermocool Smartouch SF in treatment of patients with atrial fibrillation (AF).

NCT ID: NCT04592419 Completed - Macular Edema Clinical Trials

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)

BEACON
Start date: September 25, 2020
Phase: Phase 3
Study type: Interventional

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).