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NCT ID: NCT04510480 Recruiting - Cardiac Arrest Clinical Trials

Systems Saving Lives - Long-term Survival of Out-of-hospital Cardiac Arrest in the Urban Area of Bologna

SSL
Start date: July 1, 2020
Phase:
Study type: Observational

Evaluation of clinical, logistical, and technical factors (e.g. implementation of pre-arrival instructions, implementation of the DAE RespondER, mechanical chest compressor, REBOA, and E-CPR) that impact on the outcomes of out-of-hospital cardiac arrest patients.

NCT ID: NCT04509791 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D)

Meld-ATG
Start date: November 24, 2020
Phase: Phase 2
Study type: Interventional

This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families. The MELD-ATG trial is a phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial. - to investigate the effect of 2.5 mg/kg og ATG on the preservation of stimulated C-peptide at 12 months compared to placebo - to identify the minimally effective dose of ATG that shows an effect on C-peptide when compared to placebo at 12 months

NCT ID: NCT04509700 Recruiting - B-Cell Malignancies Clinical Trials

Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Start date: August 3, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.

NCT ID: NCT04509609 Completed - LGMD2E Clinical Trials

Clinical Determinants of Disease Progression in Patients With Limb Girdle Muscular Distrophy Type 2E

NeuroLGMD2E
Start date: June 1, 2020
Phase:
Study type: Observational

A retrospective observational study that will enable us to collect retrospective data from the clinical records of LGMD 2E patients in order to highlight any possible correlation between: - clinical variables and patient age, - clinical variables and other clinical variables, - clinical variables and clinical outcomes. The study will help to define the natural history of this rare disease and to ameliorate the management of these patients.

NCT ID: NCT04508530 Active, not recruiting - Clinical trials for Pediatric Acute-Onset Neuropsychiatric Syndrome

Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS)

Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

A Superiority Study To Compare The Effect of Panzyga Versus Placebo in Patients with Pediatric Acute-onset Neuropsychiatric Syndrome

NCT ID: NCT04508140 Terminated - Colorectal Cancer Clinical Trials

Study of BO-112 With Pembrolizumab for Colorectal or Gastric/GEJ Cancer With Liver Metastasis

Start date: June 17, 2020
Phase: Phase 2
Study type: Interventional

This is an open, single arm, multicenter phase 2 trial in which BO-112 will be administered intratumorally in combination with intravenous pembrolizumab in patients with liver metastasis from colorectal, gastric or gastroesophageal junction cancers. The objective is to reverse the primary resistance that a subgroup of patients from these tumors having microsatellite stability present to the PD-1 inhibitors. Treatment will be administered every 3 weeks, with the exception of the first cycle, in which BO-112 will be also administered on D8, for up to 2 years. The primary objective is overall response rate based on RECIST 1.1 and safety, specifically referred to treatment emergent adverse events (TEAEs) with severity ≥ Grade 3 related to the study treatment (NCI-CTCAE v 5.0). The secondary endpoints include other efficacy endpoints (duration of response, disease control rate, progression-free survival, overall survival at 6 months, all based on RECIST 1.1, and overall response rate based on a specific tumor assessment criteria to evaluate the response to immunotherapies, IRECIST) and safety, in this case considering the number and proportion of subjects with treatment TEAEs (any grade) . In addition, the changes in the tumor microenvironment induced by the injection of BO-112 will be also evaluated as exploratory endpoints.

NCT ID: NCT04507893 Completed - Covid19 Clinical Trials

Comparison Between Positive and Negative COVID-19 Pneumonia

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

In the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Following the progressive spread of the infection in other countries of the world, WHO declared the Pandemic on 11 March 2020. Italy was the first European country involved in the spread of the infection and among those with the highest number of victims. The Coronavirus responsible for COVID-19 has, as its main target organ, the respiratory system, being able to determine a serious acute respiratory syndrome similar to that of the cases found during the SARS epidemic of 2003: hence the name of the virus as SARS-CoV-2. The diagnosis of SARS-COV-2 infection is made by direct detection by PCR of viral RNA on different biological materials from patients with suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal swab. However, even if the specificity of the nasopharyngeal swab is high, its sensitivity can be affected by technical causes (sampling mode), as well as by intrinsic factors related to the method. The purpose of the study is to identify the clinical, laboratory and imaging characteristic which are similar or which can differentiate the hospitalized patients affected by COVID-19 pneumonia (with positive PCR on naso-pharyngeal swab) and patients with pneumonia with negative PCR for COVID-19. To do this, the investigators will compare the clinical, laboratory and imaging characteristics between interstitial pneumonia secondary to SARS-COV-2 infection, confirmed by molecular biology investigations (viral RNA research by PCR on nasopharyngeal swab) and cases of interstitial pneumonia negative to the nasopharyngeal swab.

NCT ID: NCT04507061 Completed - Clinical trials for Chronic Kidney Disease

Study on the Safety of the Drug Runcaciguat and How Well it Works When Given at the Highest Dose as Tolerated by Individual Patient Whose Kidneys Are Not Working Properly and Suffering at the Same Time From High Blood Sugar and/or High Blood Pressure and a Disease of the Heart and the Blood Vessels.

CONCORD
Start date: September 1, 2020
Phase: Phase 2
Study type: Interventional

Researchers in this study want to learn more about the safety of the drug runcaciguat and how well it works when given at the highest dose as tolerated by the individual patient whose kidneys are not working properly and suffering at the same time from high blood sugar and/or high blood pressure and a disease of the heart and the blood vessels. Runcaciguat is a new drug under development for the improvement of kidney function. It works by activating proteins that helps to dilate blood vessels, including vessels in the kidneys. This can improve blood flow in kidney and may slow down the progression of kidney disease. This dilative effect can also influence the heart rate and blood pressure. Researchers also wants to find the best dose of the drug during the study. Participants in this study will receive either runcaciguat or placebo tablets every morning for 8 weeks. A placebo looks like the study drug but does not have any active medicine in it. On a weekly basis, the dose of the runcaciguat will be increased step by step. In total, participants will visit the doctors about 10 times, and the observation will last for about 16 weeks. Blood and urine samples will collected from the participants.

NCT ID: NCT04507048 Completed - Melanoma (Skin) Clinical Trials

Passive Versus Active Educational Interventions for Melanoma Recognition

PAMela
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of a passive versus an active educational intervention in increasing the ability of laypersons at low risk for melanoma development, in recognizing atypical skin melanocytic lesions. Patients will be randomized (1:1) to receive the active or the passive intervention.

NCT ID: NCT04506619 Terminated - Clinical trials for Bronchopulmonary Dysplasia

Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants

Start date: September 9, 2020
Phase:
Study type: Observational

The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.