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NCT ID: NCT04131309 Active, not recruiting - Clinical trials for Light Chain (AL) Amyloidosis, Stage 3B

A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis

Start date: September 23, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed stage 3B light chain (AL) amyloidosis.

NCT ID: NCT04130243 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

Biomarkers in Pediatric Congenital Heart Disease and PAH

Start date: December 5, 2017
Phase:
Study type: Observational [Patient Registry]

Nowadays, biomarkers are broadly used in clinical practice. Blood-derived biomarkers fulfil an important role in the field of cardiology. However, most biomarkers have been investigated for adult left ventricular disease. In congenital heart diseases (CHD) and pulmonary arterial hypertension (PAH), which involves children and mostly the right ventricle, less is known about the clinical and predictive value of blood-derived biomarkers. Since the group of survivors of CHD and PAH is growing because of the improved techniques nowadays, development of better tools to maintain the quality of life for the longer term in these patients is urgently needed. Blood-derived biomarkers are minimally invasive biomarkers, are quantitative and have shown to be able to reveal pathological processes in an early stage. Hence, blood-derived biomarkers may be a good addition to current diagnostic means in CHD and PAH. Objective: The primary objective of this study is to investigate cross-sectionally the association between various emerging blood-derived biomarkers and right ventricular (RV) function:defined as tricuspid annular plane systolic excursion (TAPSE) measured with echocardiography, in children with (a history of ) an abnormally loaded, volume and/or pressure loaded, right ventricle associated with CHD and/or PAH.

NCT ID: NCT04129502 Active, not recruiting - Clinical trials for Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Start date: January 10, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.

NCT ID: NCT04127110 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients

ALKALINE
Start date: November 17, 2020
Phase: Phase 2
Study type: Interventional

This study includes patients diagnosed with a metastatic non small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) translocation. The standard treatment for patients with metastatic non small cell lung cancer with ALK translocation is represented by personalized treatment with drugs called ALK inhibitors. During the treatment with an ALK inhibitor, the tumour can start to grow again, because the tumour adapts to the drug and develops escape mechanisms, becoming resistant. At the tumour cells level, the mechanisms underlying resistance can include the development of other alterations, mainly mutations, including in the ALK gene. The alterations that developed depend on the drug the tumour has been exposed to. The alterations can be identified by analysing tumour tissue obtained through a biopsy, however, repeating a tumour biopsy is difficult and risky and might not be able to provide sufficient tissue for the test. Therefore in the last years, new tests have been developed to identify the mutations in the blood. Lorlatinib is a drug that inhibits ALK and has already been identified to be able to control the tumour growth when ALK mutations are identified and is already approved as standard treatment after progression to a previous treatment with ALK inhibitors. The purpose of this study is to identify which patient populations may benefit most from treatment with lorlatinib, based on the alterations found in their genes.

NCT ID: NCT04127006 Active, not recruiting - Clinical trials for Retinitis Pigmentosa

Rate of Progression in EYS Related Retinal Degeneration

Pro-EYS
Start date: February 25, 2020
Phase:
Study type: Observational

The overall goal of this project funded by the Foundation Fighting Blindness is to characterize the natural history of disease progression in patients with EYS mutations in order to accelerate the development of outcome measures for clinical trials.

NCT ID: NCT04120298 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Effects of Exercise in Patients With Metastatic Breast Cancer

EFFECT
Start date: January 8, 2020
Phase: N/A
Study type: Interventional

Currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting. The investigators designed the EFFECT study to assess the effects of a 9-month structured and individualised exercise intervention in 350 patients with metastatic breast cancer (stage IV) on cancer-related physical fatigue, Health-Related Quality of Life (HRQoL), and other disease and treatment-related side effects at six months (primary endpoint).

NCT ID: NCT04119440 Active, not recruiting - Clinical trials for MERS (Middle East Respiratory Syndrome)

Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS

MVA-MERS-S
Start date: April 16, 2021
Phase: Phase 1
Study type: Interventional

The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S_DF-1 the data will be compared to a placebo control group.

NCT ID: NCT04118803 Active, not recruiting - Clinical trials for Inappropriate Shocks From Implanted Defibrillator

Observational Study on Inappropriate Therapies

OSIRIS
Start date: January 31, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)

NCT ID: NCT04118179 Active, not recruiting - Sepsis Clinical Trials

New Strategy to Predict Early Sepsis

Start date: August 1, 2018
Phase:
Study type: Observational

This is an observational prospective multicentre study on patients attending the emergency department and suspected to have sepsis. Blood markers characteristic of a Cellular Reprogramming (CR) signature and predicting severe sepsis and organ failure will be measured and validated.

NCT ID: NCT04111458 Active, not recruiting - Clinical trials for Solid Tumors, KRAS Mutation; SOS1

A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)

Start date: October 28, 2019
Phase: Phase 1
Study type: Interventional

This is a study in adults with advanced cancer (solid tumours) in whom previous chemotherapy was not successful. Only people who have a tumour with a KRAS mutation can participate in the study. A KRAS mutation makes cancer grow faster. The study tests 2 medicines called BI 1701963 and trametinib. BI 1701963 prevents reactivation of KRAS. In this study, BI 1701963 is given to humans for the first time. Trametinib is an approved medicine (MEK inhibitor). The purpose of this study is to find out the highest dose of BI 1701963 alone and in combination with trametinib the participants can tolerate. Another purpose is to check whether BI 1701963 in combination with trametinib is able to make tumours shrink. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they get tablets of BI 1701963 and trametinib once daily. The doctors regularly monitor the size of the tumour. Doctors also regularly record any unwanted effects and check participants' health.