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NCT ID: NCT05092880 Recruiting - Clinical trials for Colorectal Cancer Metastatic

Radioembolization in Elderly/ Fragile Patients With mCRC

CAIRO7
Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

Radioembolization (RE) is a minimally invasive treatment with administration of radioactive microspheres into the hepatic artery via a microcatheter. Since tumors are preferentially supplied by the hepatic artery, most microspheres get trapped in the tumor. RE has been shown a feasible and safe procedure for the treatment of unresectable CRC liver metastases. These data compare favourably with the toxicity data of capecitabine plus bevacizumab, but this should be validated in a prospective study. The proposed study investigates the efficacy of RE as an alternative, better tolerated and more cost-effective treatment option in elderly or frail patients compared to chronic systemic treatment with comparable progression-free survival.

NCT ID: NCT05092009 Recruiting - Lung Cancer Clinical Trials

Lung Cancer Organoids and Patient Derived Tumor Xenografts

Lung organoids
Start date: October 5, 2022
Phase:
Study type: Observational

Extra tissue will be taken from patient during a procedure in standard of care. Also, through an existing line, 10ml of extra blood will be drawn. From this material the investigator will try to establish matched normal and primary human lung cancer organoids.

NCT ID: NCT05090891 Recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva (FOP)

To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

Progress
Start date: May 5, 2022
Phase: Phase 2
Study type: Interventional

This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).

NCT ID: NCT05090228 Completed - Clinical trials for Pulmonary Valve Insufficiency

Right Ventricle Remodeling After Pulmonary Valve Replacement and Percutaneous Pulmonary Valve Insertion

RV-REPAIR
Start date: February 1, 2016
Phase:
Study type: Observational

This study investigates damage of the right cardiac chamber in adult patients with a congenital heart defect involving the pulmonary valve (the heart valve between the right cardiac chamber and the lungs). The investigators want to investigate if novel, less invasive techniques are feasible to assess damage of this right cardiac chamber, to improve follow-up and timing of intervention (valve replacement) in this group of patients.

NCT ID: NCT05089734 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

EVOKE-01
Start date: November 17, 2021
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).

NCT ID: NCT05088785 Recruiting - Breast Cancer Clinical Trials

Dynamic and Test-retest Whole Body [18F]FES PET Imaging in Patients With Metastatic ER+ Breast Cancer

FEStastic
Start date: October 11, 2021
Phase: N/A
Study type: Interventional

16a-18F-fluoro-17b-estradiol ([18F]FES) is radioactive labeled estradiol, developed for in vivo visualization of the estrogen receptor (ER) using positron emission tomography (PET). To date, [18F]FES PET has been mainly explored as a diagnostic imaging tool to assess ER expression, thereby identifying locations of disease and their potential sensitivity to endocrine therapy, respectively. The primary aim of this project is to extend the application of [18F]FES PET as a baseline diagnostic imaging biomarker for ER expression to use it as an (early) treatment response marker. However, for such an application, visual assessment alone may not be sufficient and a more rigorous quantitative image analysis is needed. Therefore, in this project we shall first derive the optimal pharmacokinetic model for full quantitative analysis of [18F]FES uptake and, subsequently, we shall assess the validity of simplified, clinically feasible, quantitative parameters of [18F]FES uptake in 5 patients with metastatic estrogen receptor positive (ER+) breast cancer (part A). In addition, the repeatability of these simplified parameters will then be investigated in another 10 patients (part B).

NCT ID: NCT05087641 Active, not recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema

IAB-1
Start date: May 3, 2022
Phase: N/A
Study type: Interventional

The Pulmair Implantable Artificial Bronchus (IAB) is a device intended for implantation into the diseased bronchi of emphysema patients. The IAB is indicated for bronchoscopic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD)/emphysema to relieve hyperinflation and allow bidirectional ventilation of the affected lobes. The objective of this trial is to demonstrate a suitable benefit/risk profile to support a subsequent trial of the safety and effectiveness of the IAB to achieve its intended purpose. The trial will enroll 24 subjects implanted with IAB(s), at no more than three study centers.

NCT ID: NCT05086315 Recruiting - Clinical trials for Myelodysplastic Syndromes

First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Start date: December 8, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.

NCT ID: NCT05085470 Completed - Schistosomiasis Clinical Trials

Repeated Controlled Human Schistosoma Mansoni Infection

Start date: October 29, 2021
Phase: N/A
Study type: Interventional

A group of 24 healthy volunteers are challenged one or three times with 20 male Schistosoma mansoni cercariae to investigate whether this leads to protection and to identify potential correlates of protection

NCT ID: NCT05085223 Not yet recruiting - Critical Illness Clinical Trials

Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

HYPNIC II
Start date: October 2021
Phase:
Study type: Observational

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and sodium balance or renal replacement therapy is lacking. The predecessor of this study was the HYPNIC trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis. This study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the HYPNIC trial.