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NCT ID: NCT04293146 Active, not recruiting - Clinical trials for Breast Reconstruction

Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC

OPBC-02PREPEC
Start date: July 28, 2020
Phase: N/A
Study type: Interventional

This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.

NCT ID: NCT04287621 Active, not recruiting - Asthma Clinical Trials

Registry of Asthma Patients Initiating DUPIXENT®

RAPID
Start date: March 2, 2020
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life. This includes characterization of: - Patient demographics (eg, gender, age, and race) - Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height) The secondary objectives of the study are: - To characterize real-world use patterns of DUPIXENT® for asthma - To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting - To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT® - To collect long-term safety data on study participants in the real-world setting

NCT ID: NCT04285567 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation

CRISTALLO
Start date: May 28, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale [CIRS]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).

NCT ID: NCT04285372 Active, not recruiting - Coronary Disease Clinical Trials

Keep bIfurcation Single Stenting Simple

KISS
Start date: August 3, 2020
Phase: N/A
Study type: Interventional

KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection

NCT ID: NCT04283227 Active, not recruiting - Clinical trials for Metachromatic Leukodystrophy

OTL-200 in Patients With Late Juvenile Metachromatic Leukodystrophy (MLD)

Start date: January 17, 2022
Phase: Phase 3
Study type: Interventional

OTL-200 is a cryopreserved dispersion for infusion containing autologous CD34+ cell enriched population that contains haematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A (ARSA) gene. MLD is an autosomal recessive lysosomal storage disorder (LSD) characterized by severe and progressive demyelination affecting the central and peripheral nervous system. The aim of this clinical study is to assess the pharmacodynamic effect and long-term clinical efficacy and safety of OTL-200 in Late Juvenile MLD patients.

NCT ID: NCT04281485 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy

Start date: November 5, 2020
Phase: Phase 3
Study type: Interventional

The study will evaluate the safety and efficacy of gene therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study with two thirds of participants assigned to gene therapy. The one third of participants who are randomized to the placebo arm will have an opportunity for treatment with gene therapy at the beginning of the second year.

NCT ID: NCT04280718 Active, not recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

ADHERE+
Start date: September 18, 2020
Phase: Phase 2
Study type: Interventional

This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.

NCT ID: NCT04278924 Active, not recruiting - Clinical trials for Primary Immune Thrombocytopenia

A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia

Start date: November 9, 2020
Phase: Phase 2
Study type: Interventional

Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot. The main aim of the study is to check for side effects from taking TAK-079 at three different dose levels. Another aim is to learn if TAK-079 can increase the platelet count in people with ITP. In addition to receiving stable background therapy for ITP, participants will receive an injection of either TAK-079 or a placebo once a week for 2 months. A placebo looks like TAK-079 but will not have any medicine in it. After treatment, all participants will be followed-up for another 2 months. Then, participants who received TAK-079 will continue to be followed-up for an extra 4 months. Participants who received the placebo and would like to receive TAK-079 may be able to do this in an extension period in the study.

NCT ID: NCT04278144 Active, not recruiting - Clinical trials for HER2-positive Breast Cancer

A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

Start date: February 24, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies

NCT ID: NCT04272931 Active, not recruiting - Clinical trials for Colorectal Cancer Liver Metastases

DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE

DRAGON
Start date: May 8, 2020
Phase: N/A
Study type: Interventional

Brief Summary: Some colorectal liver metastases can only be resected after inducing liver regeneration by portal vein embolization (PVE) to increase size function of the future liver remnant (FLR). While PVE is standard, embolization of portal vein and hepatic veins (PVE/HVE) on one side of the liver may faster and more extensive liver size and function growth. PVE/HVE is a novel procedure and requires a safety and feasibility evaluation in a pretrial (DRAGON1) to then be compared in a randomized controlled trial (RCT) to PVE (DRAGON 2).