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NCT ID: NCT03913481 Recruiting - Clinical trials for C.Surgical Procedure; Cardiac

Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

ANH
Start date: April 15, 2019
Phase: N/A
Study type: Interventional

Transfusions are one of the most overused treatments in modern medicine, and saving blood is one important issue all around the world. Cardiac surgery makes up a large percentage of the overall blood components consumption in surgery. Acute normovolemic hemo-dilution (ANH) is a well-known strategy which has been used for years without the support of high quality evidence based medicine to improve post-cardiopulmonary bypass coagulation and reduce red blood cells (RBC) transfusion. We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC transfusions during hospital stay. We will randomize 2000 patients to have sufficient power to demonstrate a 20% relative and 7% absolute risk reduction in the number of patients' RBC transfusion. If the results of the study will confirm our hypothesis, this will have a great impact on blood management in cardiac operating room.

NCT ID: NCT03913143 Active, not recruiting - Eye Diseases Clinical Trials

A Study to Evaluate Efficacy, Safety, Tolerability and Exposure After a Repeat-dose of Sepofarsen (QR-110) in LCA10 (ILLUMINATE)

ILLUMINATE
Start date: April 4, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this double-masked, randomized, controlled, multiple-dose study is to evaluate the efficacy, safety, tolerability and systemic exposure of sepofarsen (QR-110) administered via intravitreal injection in subjects with Leber's Congenital Amaurosis (LCA) due to the CEP290 p.Cys998X mutation after 24 months of treatment

NCT ID: NCT03912675 Completed - Clinical trials for Regenerative Medicine

Dermal Micrografts in Regenerative Surgery

Rigenera
Start date: July 11, 2017
Phase: N/A
Study type: Interventional

Objective assessment of the effectiveness of a micro-fragmented dermal extract obtained with Rigenera™ technology (patented by Human Brain Wave) in promoting the wound healing process in an in-vivo homogeneous experimental human acute surgical wound model.

NCT ID: NCT03912311 Not yet recruiting - Clinical trials for One-lung Ventilation

Auscultation, Lus, Fob In Olv (ALFIO)

ALFIO
Start date: April 2, 2019
Phase:
Study type: Observational [Patient Registry]

The study will be to demonstrate that, in patients undergoing elective thoracic surgery, lung ultrasound (LUS) in OR is more sensitive, specific and accurate method than thoracic auscultation, for the evaluation of OLV. The aim of the study is to demonstrate how lung ultrasound can be considered an attractive alternative to the routine use of fiberbronchoscope as a first line diagnostic tool to verify the correct position of left double lumen tube.

NCT ID: NCT03911869 Terminated - Brain Metastases Clinical Trials

An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

POLARIS
Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.

NCT ID: NCT03911570 Completed - Hand Osteoarthritis Clinical Trials

Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis

Start date: September 1, 2018
Phase:
Study type: Observational

The objective of this study is to retrospectively evaluate the symptomatic effects of crystalline glucosamine sulfate (GS), prescribed for the actually approved indication of knee OA, in addition to conventional therapy, in comparison to the conventional therapy alone in patients with primary hand osteoarthritis (HOA).This is a 6-months retrospective comparative study including patients with concomitant knee and primary HOA, according to the ACR criteria. To be eligible the patients had to present clinical symptoms of hand OA for at least 3 months, defined as global hand pain score superior to 40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score of at least 6. Furthermore, the patients have had a radiographic evidence of HOA within the previous 6 months with a Kellgren-Lawrence score of II-III. The participants are stratified into two groups based on whether or not crystalline GS at the daily dose of 1500 mg was added to the conventional therapy for HOA, including exercise, acetaminophen and non steroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase (COX)-2 inhibitors. Primary outcome measures are the difference between the two groups in the change of VAS pain and in the FIHOA, from baseline after 6 months. Secondary outcomes were health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption.

NCT ID: NCT03911193 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

CABozantinib in Non-Small Cell Lung Cancer (NSCLC) Patients With MET Deregulation

CABinMET
Start date: September 21, 2018
Phase: Phase 2
Study type: Interventional

This is a multicenter, single arm, phase II study evaluating efficacy in terms of RR in a cohort of NSCLC with MET amplification or MET exon 14 skipping mutation pre-treated or not with MET inhibitors.

NCT ID: NCT03910504 Completed - Clinical trials for Neuromuscular Blockade

Anaesthesia With or Without Rocuronium in Intubation and Intraoperative Nerve-monitoring During Thyroid Surgery.

Start date: April 17, 2019
Phase: N/A
Study type: Interventional

In this randomized controlled trial the investigators want to assess if, compared to controls, the administration of one single low-dose of rocuronium would increase the occurrence of absent or weak (i.e. amplitude <100 μV) signal at V1 and R1, indicating a residual NMBA activity. In addition, we also recorded: 1) the occurrence of difficult laryngoscopy; 2) the time-to-intubation; 3) the occurrence of difficult intubation; 4) the number of intubation attempts; 5) the intubation failure rate; 6) the need for oxygenation between intubation attempts; 7) the lowest peripheral saturation in oxygen (SpO2); 8) the number of severe desaturations; 9) the time-to-V1 and 10) the number of post-surgical complications.

NCT ID: NCT03910179 Recruiting - Anesthesia Clinical Trials

Dynamic Arterial Elastance During General Anesthesia Induction

Start date: September 10, 2019
Phase:
Study type: Observational

This study evaluates if dynamic arterial elastance measured before general anesthesia induction can predict the occurrence of hypotension due to general anesthesia induction.

NCT ID: NCT03909711 Not yet recruiting - Anemia Clinical Trials

Relationship Between Temperature and Intraoperative Bleeding in Patients Undergoing Multilevel Spinal Surgery

Start date: May 15, 2019
Phase:
Study type: Observational

The primary objective of this multicentric observational study is to define the role of intraoperative temperature decrease (defined as reduction of at least 1 ° C during surgery) as haemorrhagic risk factor, evaluated as reduction of at least 1 gr / dl of hemoglobin, and to correlate it with the need for transfusion. Secondary objectives are infections and complications affecting other organs and systems incidence in the first week after surgery.