Search results for "Study protocol"
showing 10 items of 114 documents
Evaluation Instruments for Assessing Back Pain in Athletes: A Systematic Review Protocol
2020
Back pain is a public health problem that affects adolescents and adults worldwide. However, studies on back pain present inconsistent findings in part due to the use of different instruments, especially for athletes. Therefore, the objective of this systematic review protocol was to map the existing evidence on such tools. The systematic review will be conducted according to PRISMA guidelines. Five electronic databases, Embase, MEDLINE, SPORTDiscus, CINAHL, and Scopus will be searched. This review includes studies that investigated prevalence, incidence, and other variables. Titles and abstracts will be selected. Two independent reviewers will read the articles carefully and discrepancies,…
Prevention and management of musculoskeletal pain in nursing staff by a multifaceted intervention in the workplace: design of a cluster randomized co…
2018
Musculoskeletal pain (MSP) is the leading cause of years lived with disability. In consequence, to reduce MSP and its associated sickness absence is a major challenge. Previous interventions have been developed to reduce MSP and improve return to work of workers with MSP, but combined approaches and exhaustive evaluation are needed. The objective of the INTEVAL_Spain project is to evaluate the effectiveness of a multifaceted intervention in the workplace to prevent and manage MSP in nursing staff. The study is designed as a two-armed cluster randomized controlled trial with a late intervention control group. The hospital units are the clusters of randomization and participants are nurses an…
"Card sorting" : a tool for research in ethics on treatment decision-making at the end of life in Alzheimer patients with a life threatening complica…
2011
Abstract Background End stage dementia is a particularly difficult aspect of care for patients with Alzheimer's disease and related dementias. In care institutions, caregivers and family are concerned by treatment decision-making for an acute life threatening complication occurring in Alzheimer patients at the end of life. How should the best treatment pathway be decided: to treat or not to treat? Which arguments are used for decision-making? These are mainly ethical questions which are currently difficult to express and investigate. Methods/Design Cross sectional multicentre study of clinical cases involving 67 health centres (university hospitals, general hospitals, local hospitals and ho…
The addition of simvastatin administration to cold storage solution of explanted whole liver grafts for facing ischemia/reperfusion injury in an area…
2018
Abstract Background Liver transplantation is the best treatment for end-stage liver disease. The interruption of the blood supply to the donor liver during cold storage damages the liver, affecting how well the liver will function after transplant. The drug Simvastatin may help to protect donor livers against this damage and improve outcomes for transplant recipients. The aim of this study is to evaluate the benefits of treating the donor liver with Simvastatin compared with the standard transplant procedure. Patient and methods We propose a prospective, double-blinded, randomized phase 2 study of 2 parallel groups of eligible adult patients. We will compare 3-month, 6-month, and 12-month g…
A School-Based Randomized Controlled Trial to Promote Cycling to School in Adolescents: The PACO Study
2021
This manuscript describes the rationale and protocol of a school-based randomized controlled trial called “Cycling and Walk to School” (PACO, by its Spanish acronym) that aims to promote cycling to and from school and physical activity (PA) in adolescents. This study will examine the effects of this intervention in cycling and active commuting to and from school (ACS), PA and several ACS-related factors based on self-determination theory (SDT) and a social-ecological model (SEM). A total of 360 adolescents attending six high schools (three experimental and three control) from three Spanish cities will participate in this randomized controlled trial. The intervention (four cycling sessions; …
A Multimodal Speech-Gesture Training Intervention for Patients With Schizophrenia and Its Neural Underpinnings – the Study Protocol of a Randomized C…
2020
Dysfunctional social communication is one of the most stable characteristics in patients with schizophrenia that also affects quality of life. Interpreting abstract speech and integrating nonverbal modalities is particularly affected. Considering the impact of communication on social life but failure to treat communication dysfunctions with usual treatment, we will investigate the possibility to improve verbal and non-verbal communication in schizophrenia by applying a multimodal speech-gesture training (MSG training). Here we describe the newly developed MSG training program and the study design for the first clinical investigation. The intervention contains perceptive rating (match/mismat…
Correction to: Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR…
2019
Background Postoperative pulmonary complications (PPC) may result in longer duration of in-hospital stay and even mortality. Both thoracic surgery and intraoperative mechanical ventilation settings add considerably to the risk of PPC. It is unclear if one-lung ventilation (OLV) for thoracic surgery with a strategy of intraoperative high positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) reduces PPC, compared to low PEEP without RM. Methods PROTHOR is an international, multicenter, randomized, controlled, assessor-blinded, two-arm trial initiated by investigators of the PROtective VEntilation NETwork. In total, 2378 patients will be randomly assigned to one of two differe…
A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Stud…
2020
Roland Buhl,1 Michael Dreher,2 Stephanie Korn,1 Christian Taube,3 Christian Stock,4 Christoph M Zehendner,5 Anke Kondla,5 Claus F Vogelmeier6 1Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany; 2Clinic of Cardiology, Pneumology, Angiology and Internal Medicine Intensive Care, University Hospital RWTH Aachen, Aachen, Germany; 3Clinic for Pneumonology, University Medicine Essen – Ruhrlandklinik, Essen, Germany; 4Biostatistics + Data Sciences Corp, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 5HP Country Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 6Department of Pneumology,…
Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Sin…
2021
Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the rescue treatment proposed to patients with refractory cardiogenic shock. The VA-ECMO implantation promotes inflammation and ischemia-reperfusion injuries through the VA-ECMO flow, causing digestive mucosa barrier disrupture and inducing translocation of bacterial wall components—Lipopolysaccharides (LPS) with further inflammation and circulatory impairment. LPS is a well-studied surrogate indicator of bacterial translocation. Oxiris membrane is a promising and well-tolerated device that can specifically remove LPS. The main study aim is to compare the LPS elimination capacity of Oxiris membrane vs. a non-absorban…
Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: Study protocol for a pilot randomized controlled trial, the PROT…
2018
Background Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). Methods PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and under…