Faculty Opinions recommendation of The United Kingdom Glaucoma Treatment Study: a multicenter, randomized, placebo-controlled clinical trial: design and methodology.

2012 ◽  
Author(s):  
Elizabeth Hodapp
Keyword(s):  
Clinical Trial ◽  
United Kingdom ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Controlled Clinical Trial ◽  
The United Kingdom ◽  
Glaucoma Treatment

scholarly journals Impact of a Dementia-friendly Program on Detection and Management of Patients with Cognitive Impairment and Delirium in Acute-care Hospital Units: A Controlled Clinical Trial Design

2021 ◽  
Author(s):  
Nina Mickelson Weldingh ◽  
Marte Rognstad Mellingsæter ◽  
Bendik Westlund Hegna ◽  
Jūratė Šaltytė Benth ◽  
Gunnar Einvik ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cognitive Impairment ◽  
Acute Care ◽  
Trial Design ◽  
Acute Care Hospital ◽  
Clinical Trial Design ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Early Screening

Abstract Background: Frail older persons with cognitive impairment (CI) are at special risk of experiencing delirium during acute hospitalisation. The purpose of this study was to investigate whether a dementia-friendly hospital program contributes to improved detection and management of patients with CI and risk of delirium at an acute-care hospital in Norway. Furthermore, we aimed to explore whether the program affected the prevalence of delirium, pharmacological treatment, 30-day re-hospitalisation, 30-day mortality and institutionalisation afterwards. Methods: This study had a controlled clinical trial design with a historical control group. It was conducted at two different medical wards at a large acute-care hospital in Norway from September 2018 to December 2019. A total of 423 acute hospitalised patients 75 years of age or older were included in the study. Delirium screening and cognitive tests were recorded by research staff with the 4 ‘A’s Test (4AT) and the Confusion Assessment Measure (CAM), while demographic and medical information was recorded from the electronic medical records (EMR). Results: Implementation of the dementia-friendly hospital program did not show any significant changes in the identification of patients with CI. However, the share of patients screened with 4AT within 24 hours increased from 0% to 35.5% (P<.001). The proportion of the patients with CI identified by the clinical staff, who received measures to promote “dementia-friendly” care and reduce the risk for delirium increased by 32.2% (P<.001), compared to the control group. Furthermore, the number of patients with CI who were prescribed antipsychotic, hypnotic or sedative medications was reduced by 24.5% (P<.001). There were no differences in prevalence of delirium, 30-day readmission or 30-day mortality. Conclusions: A model for early screening and multifactorial non-pharmacological interventions for patients with CI and delirium may improve management of this patient group, and reduce prescriptions of antipsychotic, hypnotic and sedative medications. The implementation in clinical practice of early screening using quality improvement methodology deserves attention. Trial registration: The protocol of this study was retrospectively registered in the ClinicalTrials.gov Protocol Registration and Results System with the registration number: NCT04737733 and date of registration: 03/02/2021.

A survey of patients with laryngotracheal stenosis on future clinical trial design

2022 ◽  
pp. 174077452110657
Author(s):  
Ioan Lina ◽  
Alexandra Berges ◽  
Rafael Ospino ◽  
Kevin Motz ◽  
Ruth Davis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Trial Design ◽  
Treatment Options ◽  
Clinical Trial Design ◽  
Trial Participation ◽  
Controlled Clinical Trial ◽  
Laryngotracheal Stenosis ◽  
Oral Ulcers ◽  
Gastrointestinal Side Effects

Background/Aims Laryngotracheal stenosis is a rare but devastating proximal airway fibrosis that restricts a patient’s ability to breathe. Treatment is primarily surgical and to date, there has never been a multi-institutional, randomized, prospective, and interventional clinical trial for a medical therapy to treat laryngotracheal stenosis. Therefore, we aimed to obtain patient feedback to guide successful trial design, recruitment, retention, and for identifying potential barriers to study participation. Methods Over 1000 members of an international laryngotracheal stenosis online support community (the Living with Idiopathic Subglottic Stenosis Facebook group) were sent two questionnaires for a proposed interventional double-blinded, randomized, placebo-controlled clinical trial. Results A total of 317 and 558 participants responded to the first and second surveys, respectively. The majority of participants (77%) were willing to consider enrollment, regardless of having a 50% chance of receiving placebo versus treatment (78%). The majority (84%) of participants were willing to travel 200 miles to participate for up to six in-person visits over 50 days. Specific side effects, including anemia/thrombocytopenia (72%) or risk of infection (69.3%) had the greatest impact on clinical trial participation with other side effects (peripheral edema (53%), oral ulcers (51%), and gastrointestinal side effects (41%)) having less impact. Conclusion Patients with laryngotracheal stenosis possess nuanced insight into their disease and treatment options. As a group, they are extremely motivated for better therapies. Future laryngotracheal stenosis clinical trials should focus on providing excellent side effect -related education and utilizing feedback from online advocacy groups to optimize recruitment and retention.

Integrating radiomics into clinical trial design

2019 ◽  
Vol 63 (4) ◽  
Author(s):  
Jessica J. Waninger ◽  
Michael D. Green ◽  
Catherine Cheze Le Rest ◽  
Benjamin Rosen ◽  
Issam El Naqa
Keyword(s):  
Clinical Trial ◽  
Trial Design ◽  
Clinical Trial Design

scholarly journals RIC in COVID-19—a Clinical Trial to Investigate Whether Remote Ischemic Conditioning (RIC) Can Prevent Deterioration to Critical Care in Patients with COVID-19

2021 ◽  
Author(s):  
Sean M. Davidson ◽  
Kishal Lukhna ◽  
Diana A. Gorog ◽  
Alan D. Salama ◽  
Alejandro Rosell Castillo ◽  
...  
Keyword(s):  
South Africa ◽  
Clinical Trial ◽  
United Kingdom ◽  
Inflammatory Cytokines ◽  
In Vitro Cytotoxicity ◽  
Cytokine Storm ◽  
Remote Ischemic Conditioning ◽  
Ischemic Conditioning ◽  
The United Kingdom

Abstract Purpose Coronavirus disease 19 (COVID-19) has, to date, been diagnosed in over 130 million persons worldwide and is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Several variants of concern have emerged including those in the United Kingdom, South Africa, and Brazil. SARS-CoV-2 can cause a dysregulated inflammatory response known as a cytokine storm, which can progress rapidly to acute respiratory distress syndrome (ARDS), multi-organ failure, and death. Suppressing these cytokine elevations may be key to improving outcomes. Remote ischemic conditioning (RIC) is a simple, non-invasive procedure whereby a blood pressure cuff is inflated and deflated on the upper arm for several cycles. “RIC in COVID-19” is a pilot, multi-center, randomized clinical trial, designed to ascertain whether RIC suppresses inflammatory cytokine production. Methods A minimum of 55 adult patients with diagnosed COVID-19, but not of critical status, will be enrolled from centers in the United Kingdom, Brazil, and South Africa. RIC will be administered daily for up to 15 days. The primary outcome is the level of inflammatory cytokines that are involved in the cytokine storm that can occur following SARS-CoV-2 infection. The secondary endpoint is the time between admission and until intensive care admission or death. The in vitro cytotoxicity of patient blood will also be assessed using primary human cardiac endothelial cells. Conclusions The results of this pilot study will provide initial evidence on the ability of RIC to suppress the production of inflammatory cytokines in the setting of COVID-19. Trial Registration NCT04699227, registered January 7th, 2021.

scholarly journals X-change symposium: status and future of modern radiation oncology—from technology to biology

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Stefanie Corradini ◽  
Maximilian Niyazi ◽  
Dirk Verellen ◽  
Vincenzo Valentini ◽  
Seán Walsh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Oncology ◽  
Trial Design ◽  
Rapid Development ◽  
Clinical Trial Design ◽  
Current Status ◽  
Treatment Modalities ◽  
Special Treatment ◽  
Image Guided Radiotherapy

AbstractFuture radiation oncology encompasses a broad spectrum of topics ranging from modern clinical trial design to treatment and imaging technology and biology. In more detail, the application of hybrid MRI devices in modern image-guided radiotherapy; the emerging field of radiomics; the role of molecular imaging using positron emission tomography and its integration into clinical routine; radiation biology with its future perspectives, the role of molecular signatures in prognostic modelling; as well as special treatment modalities such as brachytherapy or proton beam therapy are areas of rapid development. More clinically, radiation oncology will certainly find an important role in the management of oligometastasis. The treatment spectrum will also be widened by the rational integration of modern systemic targeted or immune therapies into multimodal treatment strategies. All these developments will require a concise rethinking of clinical trial design. This article reviews the current status and the potential developments in the field of radiation oncology as discussed by a panel of European and international experts sharing their vision during the “X-Change” symposium, held in July 2019 in Munich (Germany).

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