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NCT ID: NCT04739774 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)

Start date: February 22, 2021
Phase: Phase 1
Study type: Interventional

The objective of this proposed study is to investigate the pharmacokinetics interaction between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug interaction study.

NCT ID: NCT04739761 Completed - Breast Cancer Clinical Trials

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

DESTINY-B12
Start date: June 22, 2021
Phase: Phase 3
Study type: Interventional

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

NCT ID: NCT04738695 Completed - Covid19 Clinical Trials

SARS-CoV-2 Seroprevalence Among Nursing Home Staff and Residents (COVID-19)

SCOPE
Start date: February 1, 2021
Phase:
Study type: Observational

Assessment of the seroprevalence and sero-incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) among Nursing Home (NH) residents and staff in Belgium.

NCT ID: NCT04737668 Completed - Cerebral Palsy Clinical Trials

Virtual Reality During Intrathecal Pump Refills in Children

VAMPIRE
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

The aim of the current study is to explore the effect of virtual reality on pain in children who undergo an intrathecal pump refill compared to usual care and distraction.

NCT ID: NCT04737187 Completed - Clinical trials for Refractory Metastatic Colorectal Cancer

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

SUNLIGHT
Start date: November 25, 2020
Phase: Phase 3
Study type: Interventional

This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

NCT ID: NCT04736147 Completed - Healthy Clinical Trials

A Study of JNJ-64300535 in Healthy Participants

Start date: February 3, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the cellular immunogenicity of 3 monthly electroporation-mediated intramuscular (IM) injections of JNJ-64300535 in healthy participants.

NCT ID: NCT04735432 Completed - Clinical trials for Generalized Myasthenia Gravis

Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

ADAPTsc
Start date: February 5, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)

NCT ID: NCT04732949 Completed - COVID-19 Clinical Trials

Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19

SPRINTER
Start date: January 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

NCT ID: NCT04731129 Completed - Pleural Diseases Clinical Trials

Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis

Start date: December 15, 2020
Phase:
Study type: Observational

Recently, probe based confocal laser endomicroscopy showed to be able to distinguish malignant from benign pleura during medical thoracoscopy. However The clinical usefulness of this new tool remains to be determined. The investigators believe that pCLE could be part of mini invasive pleural disease management and could be used during thoracentesis in order to increase the diagnostic yield of this procedure. The investigators are starting a prospective trial to recruit patients referred for medical thoracoscopy to the endoscopy unit. First, the pCLE probe will be introduced through the Boutin's needle or the thoracentesis catheter, just before the thoracoscopy, in order to investigate the pleural pCLE features and to identify or exclude malignant infiltration. Second those features will be compared to the pCLE acquisition obtained during the medical thoracoscopy (the probe is introduced through the working chanel of the thoracoscope), under visual control. In order to compare the invasive and mini invasive acquisition, 10 criteria will be prospectively assessed.Third, These features will be compared to the histological samples performed during thoracoscopy. Finally, the interpretation of different investigators will be compared. The 10 criteria are presented below: 1. Abnormal tissular architecture No: Correct identification of the previously described normal pleura characteristics Yes: identification of cellular/tissular structures which are not known to correspond to normal pleura (cellular clusters or dark clumps, glands, cells cordons, dysmorphic cells, papillar distribution….) 2. Cellular homogeneity is size, shape and fluorescence, as subjectively assessed by the investigator yes no 3. Mean cellular size: Small: < 10µm Moderate: 10 - 20µm Large: > 20µm 4. Cellular density (with reference to the Chia seed sign) Low (lower than the Chia seed sign) Moderate High 5. Dysplastic vessels: Yes: (vascular leaks, tortuous or giant vessels) No: no dysplasia 6. Vascular density (on a full optical area) Low: 0 -2 vessels Moderate: 3 - 4 vessels High: > 4 vessels 7. Organized or anarchic connective fibers Anarchic: coarse fibers, irregular in shape, without well-defined architecture Organized : regular in shape and direction, well defined architecture. 8. Chia seed sign on a full optical areal yes No

NCT ID: NCT04728477 Completed - Hypotension Clinical Trials

Evaluation of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients

Start date: February 3, 2021
Phase:
Study type: Observational

Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in intensive care unit patients