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NCT ID: NCT04794088 Terminated - Covid19 Clinical Trials

Intravenous Imatinib in Mechanically Ventilated COVID-19 Patients

INVENT COVID
Start date: March 14, 2021
Phase: Phase 2
Study type: Interventional

The SARS-CoV2 pandemic and resulting COVID-19 infection has led to a large increase in the number of patients with acute respiratory distress syndrome (ARDS). ARDS is a severe, life-threatening medical condition characterised by inflammation and fluid in the lungs. There is no proven therapy to reduce fluid leak, also known as pulmonary oedema, in ARDS. However, recent studies have discovered that imatinib strengthens the cell barrier and prevents fluid leak in the lungs in inflammatory conditions, while leaving the immune response intact. The investigators hypothesize that imatinib limits pulmonary oedema observed in ARDS due to COVID-19, and may thus help to reverse hypoxemic respiratory failure and to hasten recovery. The hypothesis will be tested by conducting a randomised, double-blind, parallel-group, placebo-controlled multi-centre clinical study of intravenous imatinib in 90 mechanically-ventilated, adult subjects with COVID-19-related ARDS. Study participants will receive the study drug (imatinib or placebo) twice daily for a period of 7 days. The effect of the intervention will be tested by measuring extravascular lung water (i.e. pulmonary oedema) difference between day 1 and day 4, using a PiCCO catheter (= pulse contour cardiac monitoring device). Other measurements will include regular blood tests to investigate the safety and the pharmacokinetic properties of imatinib, as well as biomarkers of inflammation and cellular dysfunction. Furthermore, parameters of ventilation and morbidity and mortality will be recorded as secondary outcome measures.

NCT ID: NCT04793958 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Start date: March 15, 2021
Phase: Phase 3
Study type: Interventional

Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.

NCT ID: NCT04793919 Recruiting - Clinical trials for Acute Promyelocytic Leukemia

Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

Start date: October 9, 2019
Phase: Phase 2
Study type: Interventional

The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.

NCT ID: NCT04791774 Completed - Critical Illness Clinical Trials

Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness

PANINI
Start date: March 27, 2018
Phase: N/A
Study type: Interventional

In the current study, we willquantitate the difference in digestion and absorption kinetics of dietary whole protein versus free amino acids in vivo in critically ill patients admitted to the intensive care unit suffering from malabsorption. 16 adult, mechanically ventilated ICU patients with clinical signs of malabsorption (faecal weight >350 g/day) will be included. All patients will receive a primed continuous intravenous infusion of L-[ring2H5]-phenylalanine and L-[3,5-2H2]-Tyrosine for the duration of the study period. After reaching an isotopic steady state (1.5 hours), patients will receive either [1-13C]- phenylalanine labelled milk protein or free amino acids with an identical constitution and [1-13C]-phenylalanine. Main study endpoint will be the splanchnic extraction of phenylalanine, calculated from systemic [1-13C]- and L-[ring2H5]-phenylalanine enrichment.

NCT ID: NCT04790916 Terminated - Clinical trials for Autoimmune Hepatitis

Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)

Start date: April 19, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the effect of RO7049665 on time to relapse following forced corticosteroid (CCS) tapering as measured by the hazard ratio between RO7049665 7.5 milligrams (mg) and placebo arm.

NCT ID: NCT04790422 Completed - Clinical trials for Irritable Bowel Syndrome

Nutrition to Relieve IBS Symptoms by Targeting the Microbiota

NUTRIMI
Start date: May 11, 2021
Phase: N/A
Study type: Interventional

Rationale: Irritable Bowel Syndrome (IBS) is functional gastrointestinal disorder that affects a large number of people. To date, no adequate treatment is available. This is partially due to the heterogeneity of the patients and the complicated pathology in which not all mechanisms are understood. Based on results of in vitro screening within the IBSQUtrition project, we selected promising dietary supplements for validation of their potential beneficial effects on the microbiota of IBS patients. Objective: The primary objective is to determine the bifidogenic effects of a 4-week intervention with one of four dietary supplements (Chondroitin sulfate, NOVELOSE® 3490, and Pea Fiber, and Lactium®) in IBS patients. The secondary objective is to determine the effects of the same intervention on fecal microbiota composition and SCFA concentration, IBS-related complaints, Quality of Life, and stool frequency and consistency in IBS patients. Study design: a double-blind, randomized, placebo-controlled trial with five parallel arms. Study population: 70 adult (18-65 yrs) IBS patients Intervention: 4-week intervention period with five parallel arms: 1) Chondroitin sulfate, 2) NOVELOSE® 3490, 3) Pea Fiber, 4) Lactium®, and 5) Placebo supplement (Maltodextrin control), during which the study participants consume the respective supplement twice per day. Main study parameters/endpoints: The main study parameter is the (relative) abundance of fecal Bifidobacterium. The secondary study parameters are fecal microbiota composition and Short-Chain Fatty Acids (SCFAs) concentration, stool frequency and consistency, IBS-related complaints, and Quality of Life (QoL). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study participants have to invest about 7.4 hours of their time in this study mainly to complete several questionnaires (short daily questionnaire, longer questionnaires at two occasions), which is conveniently all possible from home. On two occasions they have to collect stool (transported via courier to the research facility). They have to comply to consume a commercially available supplement twice daily for four weeks. There are limited risks for the study participants.

NCT ID: NCT04790370 Recruiting - Pulmonary Embolism Clinical Trials

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

HI-PEITHO
Start date: August 2, 2021
Phase: Phase 4
Study type: Interventional

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

NCT ID: NCT04790110 Completed - Bruxism Clinical Trials

7 Year Follow up Analysis on the Speed of Progression of Tooth Wear Using 3D Subtraction

Start date: March 3, 2011
Phase:
Study type: Observational [Patient Registry]

Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and 1, 3 5, and the 7-year recall digital 3D scans will be made, which will be compared and subtracted.

NCT ID: NCT04789174 Completed - Clinical trials for Obstructive Sleep Apnea

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

SHARP
Start date: May 17, 2021
Phase: Phase 4
Study type: Interventional

The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired cognitive function.

NCT ID: NCT04788888 Recruiting - Clinical trials for Symptomatic Severe Aortic Stenosis

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

VANTAGE
Start date: June 13, 2021
Phase: N/A
Study type: Interventional

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.