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NCT ID: NCT04461808 Active, not recruiting - Breast Cancer Clinical Trials

Tomosynthesis as Primary Test for Breast Cancer Screening

MAITA
Start date: July 15, 2019
Phase: N/A
Study type: Interventional

Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.

NCT ID: NCT04461639 Active, not recruiting - Hemophilia A Clinical Trials

Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding

HA-SAFE
Start date: May 14, 2021
Phase:
Study type: Observational

In this observational study researchers want to learn more about the safety of drug Jivi over a long period of time. Jivi (generic name: Damoctocog alfa pegol) is an approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). It is manufactured via recombinant technology and has an extended half-live, i.e. it will stay longer in the body than other FVIII products. Therefore Jivi acts longer in the body which reduces the frequency of drug injections. This study will enroll previously treated patients with hemophilia A who are receiving Jivi regularly at their treating doctors to prevent bleeding. Observation for each patient will last for at least 4 years, and medical data will be collected during patients' routine visits at their treating doctors.

NCT ID: NCT04460963 Recruiting - Clinical trials for Acute Myeloid Leukemia

Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches

Start date: June 9, 2021
Phase: N/A
Study type: Interventional

The present study will be divided into 5 phases: 1. Collection of bone marrow and peripheral blood (PB) samples from AML patients at diagnosis; 2. Measurement of Midregional Proadrenomedullin (MR-proADM) plasma concentrations with an Immunoluminometric Assay of newly diagnosed AML patients not affected by concomitant cardiovascular disease or sepsis. 3. Analysis of exosomes and microvesicles derived from PB and bone marrow samples of AML patients and culture media collected from AML samples stimulated with ADM and/or ADM (22-52) 4. Study of adrenomedullin system in leukemic stem cells (CD44+/CD38-/CD31+/Lin-) in order to define a correlated expression of ADM and ADM receptors (RAMPs, PAM) with adhesion molecules (CD31, CD38, CD44s, CD44v6), cell cycle regulatory proteins (p21, p27) and genes or molecules involved in the hematopoietic differentiation process (Cul5, CD11b, CD11c, CD66, CD14, CD15, PML-RARα) 5. In vitro evaluation of ADM activity in the growth, maturation and trans-endothelial migration of blasts and/or fusion of leukemic cells with endothelial cells. To do this, leukemic cells will be alternatively cultured by using in vitro models of endosteal and vascular niches.

NCT ID: NCT04460950 Recruiting - Clinical trials for Acute Myeloid Leukemia

Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms

Start date: December 16, 2020
Phase:
Study type: Observational

Observational study aimed at evaluating the incidence of familial AML/MDSs in patients with de novo MDSs or AML with almost one relative affected by hematologic neoplasms and/or other cancers at young age (< 40 years)

NCT ID: NCT04460885 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before

ONWARDS 1
Start date: November 25, 2020
Phase: Phase 3
Study type: Interventional

This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04460859 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome (ARDS)

RecruitmEnt Assessed by eleCtRical Impedance Tomography

RECRUIT
Start date: June 9, 2020
Phase:
Study type: Observational

The RECRUIT study is a multinational, multicenter physiological observational study conducted by the PLUG working group. It is a single-day study (1.5-2 hours) associated with specific lung (de)recruitment maneuvers to verify the feasibility of measuring the potential for lung recruitment in mechanically ventilated patients with ARDS by electrical impedance tomography (EIT).

NCT ID: NCT04460807 Terminated - Ovarian Cancer Clinical Trials

Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer

EXPERT
Start date: February 13, 2020
Phase: Phase 3
Study type: Interventional

In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment. The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS).

NCT ID: NCT04460209 Recruiting - Clinical trials for Cardiac Rhythm Disorder

EP Device Registry

Start date: June 12, 2020
Phase:
Study type: Observational [Patient Registry]

This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.

NCT ID: NCT04459884 Recruiting - Clinical trials for Mechanical Ventilation

Multicenter Observational Study on Practice of Ventilation in Brain Injured Patients

Start date: August 23, 2021
Phase:
Study type: Observational [Patient Registry]

Rationale Several experimental and clinical studies have shown how brain injury can cause secondary lung injury. Lung injury could be due either to mechanical ventilation- often necessary in brain injured patients- or to inflammatory response that follows primary acute brain injury. The concept of 'Protective lung ventilation' has shown to reduce morbidity and mortality of intensive care unit (ICU) patients with acute respiratory distress syndrome (ARDS) but seems also to have a beneficial effect on patients with healthy lungs and in the perioperative settings. However, these recommendations often come into conflict with the management of patients affected by acute brain injury, in which permissive hypercapnia and increased intrathoracic pressure as consequence of protective ventilation strategies can be dangerous. Study design This is an international multi-center prospective observational study. Study population This study will include all consecutive brain injured patients (traumatic brain injury (TBI) or cerebrovascular) intubated and ventilated in ICU and observed for a 7-day period. Nature and extent of the burden and risks associated with participation, benefit and group relatedness Seen the observational design of the study, there is no patient burden. Collection of data from ICU and hospital charts and/or (electronic) medical records systems is of no risk to patients.

NCT ID: NCT04459819 Completed - COVID-19 Clinical Trials

Respiratory Physiotherapy in Severe COVID-19 Patients

FTR-COVID
Start date: March 1, 2020
Phase:
Study type: Observational

COVID-19 is an infectious disease caused by SARS-CoV2 virus. COVID-19 patients can develop a severe disease that can lead to hypoxic respiratory failure and acute respiratory distress syndrome (ARDS). Severe patients can require access to intensive care unit (ICU). Early rehabilitation is known to be effective in critically ill patients and in ARDS. The role of respiratory physiotherapy in critical COVID-19 patients is still unclear. The aim of this study is to describe the bundle and the timing of respiratory physiotherapy used with severe COVID-19 patients from ICU to hospital discharge. Functional condition of patients at discharge will be assessed and described.