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NCT ID: NCT04509791 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D)

Meld-ATG
Start date: November 24, 2020
Phase: Phase 2
Study type: Interventional

This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families. The MELD-ATG trial is a phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial. - to investigate the effect of 2.5 mg/kg og ATG on the preservation of stimulated C-peptide at 12 months compared to placebo - to identify the minimally effective dose of ATG that shows an effect on C-peptide when compared to placebo at 12 months

NCT ID: NCT04466358 Active, not recruiting - Clinical trials for Pulmonary Vein Isolation

CLOSE Versus High Density Mapping Guided Catheter Ablation of Paroxysmal Atrial Fibrillation

Start date: February 26, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to compare two methods of catheter ablation for treatment of paroxysmal atrial fibrillation (AF). The first method being a modified CLOSE protocol used for the control group and the second high density mapping guided isolation of pulmonary veins used for the interventional group. Comparison will be made according to clinical parameters and also durability of pulmonary vein isolation.

NCT ID: NCT04461639 Active, not recruiting - Hemophilia A Clinical Trials

Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding

HA-SAFE
Start date: May 14, 2021
Phase:
Study type: Observational

In this observational study researchers want to learn more about the safety of drug Jivi over a long period of time. Jivi (generic name: Damoctocog alfa pegol) is an approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). It is manufactured via recombinant technology and has an extended half-live, i.e. it will stay longer in the body than other FVIII products. Therefore Jivi acts longer in the body which reduces the frequency of drug injections. This study will enroll previously treated patients with hemophilia A who are receiving Jivi regularly at their treating doctors to prevent bleeding. Observation for each patient will last for at least 4 years, and medical data will be collected during patients' routine visits at their treating doctors.

NCT ID: NCT04353492 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

ARTIOS
Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

NCT ID: NCT04293523 Active, not recruiting - Hemophilia A Clinical Trials

A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health

A-MORE
Start date: March 30, 2020
Phase:
Study type: Observational

This is a 48-month observational, prospective, multicentre study. The overall aim of the study is to evaluate the long-term effectiveness of Elocta treatment on joint health in patients treated prophylactically with Elocta in a real-world setting.

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: NCT04253184 Active, not recruiting - Bradycardia Clinical Trials

Micra AV Transcatheter Pacing System Post-Approval Registry

Micra AV PAS
Start date: February 8, 2020
Phase:
Study type: Observational [Patient Registry]

Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

NCT ID: NCT04251533 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

EPIK-B3
Start date: June 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

NCT ID: NCT04201132 Active, not recruiting - Carotid Stenosis Clinical Trials

Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System

PERFORMANCE II
Start date: June 12, 2020
Phase: N/A
Study type: Interventional

A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).

NCT ID: NCT04148911 Active, not recruiting - Clinical trials for Triple-Negative Breast Cancer

A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer

EL1SSAR
Start date: December 17, 2019
Phase: Phase 3
Study type: Interventional

Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease.