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NCT ID: NCT04579445 Active, not recruiting - Clinical trials for Transcatheter Aortic Valve Implantation (TAVI)

Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe

BENCHMARK
Start date: May 3, 2021
Phase:
Study type: Observational [Patient Registry]

Non-interventional, multi-center, international registry in patients with severe aortic stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK Registry aims to implement standardized, reproducible and scalable quality improvement measures, which will help to reduce resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety. The registry will consist of the following phases: - Retrospective phase (purpose: capture the status quo of each site prior to any Quality of Care improvement measures): The TAVI of patients being eligible for retrospective documentation must have been performed prior to the site's enrollment into the BENCHMARK prospective phase (follow-up: 30 days, 12 months). - Education phase: Each center will undergo an online BENCHMARK education. The contents of the education will be: Reflection on treatment pathways with the TAVI team, education on 8 defined Quality of Care improvement measures, followed by a center self-assessment (to self-assess the current alignment of hospital performance with the BENCHMARK Quality od Care measures). - Implementation phase: After having self-assessed the current alignment of hospital performance with the following BENCHMARK Quality of care measures, each center will start to introduce the tailored Quality of Care improvement measures to their hospital routine within a time frame of 2 months. - Prospective phase (purpose: to document the effects of defined quality of care improvement measure and to make sure patient safety is as least as good as in the retrospective phase. (8 months of recruitment, Follow-up: 30 days, 12 months)

NCT ID: NCT04579380 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Start date: January 11, 2021
Phase: Phase 2
Study type: Interventional

This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.

NCT ID: NCT04578834 Active, not recruiting - IgA Nephropathy Clinical Trials

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

APPLAUSE-IgAN
Start date: January 25, 2021
Phase: Phase 3
Study type: Interventional

The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

NCT ID: NCT04575662 Active, not recruiting - Atrial Fibrillation Clinical Trials

Radiotherapy and Atrial Fibrillation

STAR
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Current European guidelines recommend catheter ablation of AF in symptomatic patients refractory to antiarrhythmic therapy. Pulmonary vein isolation (PVI) remains the cornerstone of any ablation procedure irrespective of patient characteristics. Recently, stereotactic arrhythmia radioablation (STAR) with precise high-dose of radiation was used to treat ventricular arrhythmias in patients with a high risk of complications during transcatheter ablation.

NCT ID: NCT04573920 Active, not recruiting - Clinical trials for Diabetic Kidney Disease

Atrasentan in Patients With Proteinuric Glomerular Diseases

AFFINITY
Start date: February 1, 2021
Phase: Phase 2
Study type: Interventional

The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.

NCT ID: NCT04573881 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK)

#HOPE4LIVER
Start date: June 4, 2021
Phase: N/A
Study type: Interventional

This trial is a single arm, non-randomized prospective trial. The objective of this trial is to evaluate the efficacy and safety of the HistoSonics System for the treatment of primary or metastatic tumors located in the liver.

NCT ID: NCT04573478 Active, not recruiting - IgA Nephropathy Clinical Trials

Atrasentan in Patients With IgA Nephropathy

ALIGN
Start date: December 11, 2020
Phase: Phase 3
Study type: Interventional

The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.

NCT ID: NCT04572854 Active, not recruiting - Renal Transplant Clinical Trials

Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

NOBLE
Start date: February 23, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.

NCT ID: NCT04572230 Active, not recruiting - Clinical trials for Intracranial Aneurysm

International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

IMPACT
Start date: December 21, 2020
Phase:
Study type: Observational

IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.

NCT ID: NCT04570631 Active, not recruiting - Multiple Myeloma Clinical Trials

Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma

Start date: November 5, 2020
Phase: Phase 1
Study type: Interventional

Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM. Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world. Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.