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NCT ID: NCT04071509 Completed - Clinical trials for Complications in Diagnostic Percutaneous Lung Biopsy Procedures

Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device

MIPP-PNX1
Start date: February 4, 2019
Phase: N/A
Study type: Interventional

The study will assess the safety and feasibility of a new medical device, MIPP-Kit, for the prevention of complications during diagnostic, CT guided ,percutaneous lung needle biopsy.

NCT ID: NCT04070820 Recruiting - Clinical trials for Bloodstream Infection

Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"

Start date: September 1, 2019
Phase:
Study type: Observational

Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis bloodstream infection (EF-BSI). The aims of our study are: Primary: To compare the efficacy of appropriate monotherapy vs combination treatment for EF-BSI, according to standard of care. Secondary: 1. To compare the impact on clinical outcome of the initial combination therapy in the subgroup of patients with enterococcal endocarditis. In this case we will evaluate only the antibiotic treatment administered before the diagnosis of endocarditis assuming that any case of endocarditis will be treated with a combination therapy. 2. To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients: A. Patients with low versus high risk of endocarditis according with the "Number of positive blood cultures, Origin of the bacteremia, previous Valve disease, Auscultation of heart murmur (NOVA) score". B. Patients with metastatic septic localizations. C. Patients with catheter-related BSI. D. Patients with indwelling cardiovascular device or prosthetic valve. 3. To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI. 4. To estimate optimal duration of treatment of EF-BSI in patients without endocarditis. 5. To evaluate the rate of 90-day development of Clostridium difficile infection. The promoting center is S. Orsola-Malpighi Hospital is a 1,420-bed tertiary care University Hospital in Bologna with an average of 72,000 admissions per year. A dedicate team of Infectious Diseases (ID) specialists is active in the promoting center. Investigators of this team have already coordinated multicenter studies on infections topics. Centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form. All consecutive, unselected patients with monomicrobial EF-BSI will be screened for study inclusion. We expect to enroll about 500 patients. Period of data collection will be from september 2019 to 31th December 2020.

NCT ID: NCT04070807 Recruiting - Clinical trials for Acute Myeloid Leukemia

Italian Observational Study of Patients With Acute Myeloid Leukemia Treated With Small Molecule Inhibiting BCL-2

AVALON
Start date: August 23, 2019
Phase:
Study type: Observational

This is a multi-center retrospective observational study. Every patient with Acute Myeloid Leukemia (AML) treated with anti-B-cell lymphoma 2 (BCL2) treatment outside clinical trial from 1st January 2015 up to 01 April 2019 may be included in this study. No additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. The decision to treat patient with ant-BCL2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study.

NCT ID: NCT04069156 Completed - Heart Failure Clinical Trials

The ARIES HeartMate 3 Pump IDE Study

Start date: July 14, 2020
Phase: N/A
Study type: Interventional

Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo

NCT ID: NCT04068181 Completed - Melanoma Clinical Trials

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Start date: January 22, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.

NCT ID: NCT04068012 Recruiting - Ards Clinical Trials

Clinical Decision Support Tool in PARDS Pilot Study

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Previous clinical trials in adults with acute respiratory distress syndrome (ARDS) have demonstrated that ventilator management choices can improve Intensive Care Unit (ICU) mortality and shorten time on mechanical ventilation. This study seeks to scale an established Clinical Decision Support (CDS) tool to facilitate dissemination and implementation of evidence-based research in mechanical ventilation of infants and children with pediatric ARDS (PARDS). This will be accomplished by using CDS tools developed and deployed in Children's Hospital Los Angeles (CHLA) which are based on the best available pediatric evidence, and are currently being used in an NHLBI funded single center randomized controlled trial (NCT03266016, PI: Khemani). Without CDS, there is significant variability in ventilator management of PARDS patients both between and within Pediatric ICUs (PICUs), but clinicians are willing to accept CDS recommendations. The CDS tool will be deployed in multiple PICUs, targeting enrollment of up to 180 children with PARDS. Study hypotheses: 1. The CDS tool in will be implementable in nearly all participating sites 2. There will be > 80% compliance with CDS recommendations and 3. The investigators can implement automatic data capture and entry in many of the ICUs Once feasibility of this CDS tool is demonstrated, a multi-center validation study will be designed, which seeks to determine whether the CDS can result in a significant reduction in length of mechanical ventilation (LMV).

NCT ID: NCT04067336 Recruiting - Clinical trials for Acute Myeloid Leukemia

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

Start date: September 12, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue in patients with NPM1-m AML.

NCT ID: NCT04067154 Completed - ARDS Clinical Trials

Gas Exchange and CT Effects of PEEP in ARDS

Start date: August 1, 2012
Phase: N/A
Study type: Interventional

The study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results

NCT ID: NCT04066842 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D in Systemic Sclerosis Patients With Periodontitis

Start date: November 1, 2015
Phase:
Study type: Observational

Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of Systemic Sclerosis (SSc) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and SSc and periodontitis in patients with SSc, CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

NCT ID: NCT04066517 Recruiting - Clinical trials for Refractory Ventricular Tachycardia

STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)

STRA-MI-VT
Start date: September 13, 2019
Phase: N/A
Study type: Interventional

Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.