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NCT ID: NCT04898335 Recruiting - Clinical trials for Mitral Regurgitation

Tendyne European Experience Registry

TENDER
Start date: April 15, 2021
Phase:
Study type: Observational [Patient Registry]

TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

NCT ID: NCT04896931 Recruiting - Clinical trials for Biliary Tract Cancer

New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)

Start date: July 12, 2022
Phase:
Study type: Observational

Permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and QoL for all types of biliary tract cancers.

NCT ID: NCT04895722 Recruiting - Colorectal Cancer Clinical Trials

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)

Start date: June 25, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.

NCT ID: NCT04895709 Recruiting - Melanoma Clinical Trials

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Start date: May 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

NCT ID: NCT04895696 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

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

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.

NCT ID: NCT04895436 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

ReVenG
Start date: March 28, 2022
Phase: Phase 2
Study type: Interventional

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. 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 and completing questionnaires.

NCT ID: NCT04894968 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Prediction of the Development of Heart Failure With Preserved Ejection Fraction

PREDICT-HFpEF
Start date: December 1, 2018
Phase:
Study type: Observational

The ultimate goal of the PREDICT-HFpEF study is to identify and unravel predictors for the development of heart failure with preserved ejection fraction (HFpEF) in a cohort at increased cardiovascular risk. Patients that were initially included in another prospective cohort study (LIFE-Heart study) and did not show evident heart failure at that timepoint, will be followed-up approximately 7-years after their initial inclusion in the LIFE-Heart study. Patients will be screened for the development of HFpEF and characterized with thorough clinical as well as laboratory assessment. Patients will be classified according to the presence of absence of heart failure and predictors for the development will be identified by using measurements taken at their initial inclusion in the LIFE-Heart study.

NCT ID: NCT04894708 Recruiting - Clinical trials for Screening Colonoscopy

Study on the Use of Artificial Intelligence (Fujifilm) for Polyp Detection in Colonoscopy

Fuji AI
Start date: October 28, 2020
Phase: N/A
Study type: Interventional

Colonoscopy is currently the best method of detection of intestinal tumors and polyps, particularly because polyps can also be biopsied and removed. There is a clear correlation between the adenoma detection rate and prevented carcinomas, so adenoma detection rate is the main parameter for the outcome quality of diagnostic colonoscopy. The efficiency of preventive colonoscopy needs optimisation by increase in adenoma detection rate, as it is known from many studies that approximately 15-30% of all adenomas can be overlooked. This mainly applies to smaller and flat adenomas. However, since even smaller polyps may be relevant for colorectal cancer development, the aim of colonoscopy should be to preferably be able to recognize all polyps and other changes.The latest and by far the most interesting development in this field is the use of artificial intelligence systems. They consist of a switched-on software with a small computer connected to the endoscope processor; the patient's introduced endoscope is completely unchanged. The present study therefore compares the adenoma detection rate (ADR) of the latest generation of devices with high-resolution imaging from Fujifilm with and without the connection of artificial intelligence.

NCT ID: NCT04892849 Recruiting - Esophageal Cancer Clinical Trials

Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy

ST-ICI02
Start date: April 30, 2021
Phase:
Study type: Observational

Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1/PD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects

NCT ID: NCT04892407 Recruiting - Clinical trials for Age-Related Volume Deficit in the Mid-Face

Algeness DF 3.5% Compared to Voluma in Volume Deficit in Mid-face

Start date: September 6, 2021
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled study of Algeness® DF 3.5% Deep Volumizing Filler comparing to Juvéderm Voluma to correct midface volume loss.