scholarly journals Clinical evidence on the efficacy and tolerability of a topical medical device containing benzoylperoxide 4%, retinol 0.5%, mandelic acid 1% and lactobionic acid 1% in the treatment of mild facial acne: an open label pilot study

2019 ◽  
Vol Volume 12 ◽  
pp. 363-369
Author(s):  
Virginia Garofalo ◽  
Maria Vittoria Cannizzaro ◽  
Sara Mazzilli ◽  
Luca Bianchi ◽  
Elena Campione
Keyword(s):  
Pilot Study ◽  
Medical Device ◽  
Mandelic Acid ◽  
Clinical Evidence ◽  
Open Label ◽  
Lactobionic Acid ◽  
Facial Acne

scholarly journals Use of a new transanal irrigation device for bowel disorder management by patients familiar with the irrigation technique: a prospective, interventional, multicenter pilot study

2020 ◽  
Vol 24 (7) ◽  
pp. 731-740
Author(s):  
K. Charvier ◽  
V. Bonniaud ◽  
D. Waz ◽  
C. Desprez ◽  
A.-M. Leroi
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Medical Device ◽  
Bowel Dysfunction ◽  
Secondary Outcome ◽  
Electric Pump ◽  
Open Label ◽  
Serious Adverse Events ◽  
New Device ◽  
Transanal Irrigation

Abstract Background The aim of this study was to evaluate the feasibility of transanal irrigation (TAI) with a new medical device incorporating an electric pump, the IryPump®R Set. Methods An interventional, prospective, open-label, non-comparative, multicenter pilot study on TAI was conducted at three French university hospitals. Patients with experience of TAI were enrolled for a 1-month period during which 5 consecutive TAIs were performed using the IryPump®R Set (B.Braun Melsungen AG Melsungen, Germany). The study’s primary efficacy criterion was successful TAI, defined as (i) use of the patient’s usual irrigation volume of water, (ii) stool evacuation, and (iii) the absence of leakage between TAIs. The first two TAIs were not taken into account in the main analysis. The secondary outcome measures were device acceptability, bowel dysfunction scores, tolerability, and safety. Results Fifteen patients were included between November 2016 and May 2017, and 14 were assessed in the main analysis. The TAI success rate was 72.4% (21 out of 29 procedures). The bowel dysfunction scores at the end of the study did not differ significantly from those recorded on inclusion. A high proportion of patients (> 70%) reported that TAI was feasible with the new medical device. There were no serious adverse events or device-related adverse events. At the end of the study, 50% of the participants were willing to consider further use of the new device. Conclusions In patients familiar with TAI, using a new medical device incorporating an electric pump was feasible. Levels of patient satisfaction were high, especially with regard to comfort of use and a feeling of security during TAI.

Evaluating Thrombin Inhibition in Alzheimer’s Disease (The BEACON Trial): Protocol for a Pilot Study (Preprint)

2019 ◽  
Author(s):  
Cláudia Yang Santos ◽  
Christine Getter ◽  
John Stoukides ◽  
Brian Ott ◽  
Stephen Salloway ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Cognitive Performance ◽  
Thrombin Inhibitor ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind ◽  
Thrombin Inhibition ◽  
Approved Drugs

BACKGROUND The precise mechanisms whereby cardiovascular risk factors increase the risk of Alzheimer’s disease (AD) have not been delineated. We reported that microvessels isolated from AD brains overexpress a diverse array of neurotoxic and inflammatory proteins, which is consistent with the process of vascular activation. In pre-clinical studies using AD animal models we showed that a vascular activation inhibitor reduced vascular-derived neuroinflammation and improved cognitive performance. Thrombin is a key mediator of cerebrovascular activation in AD. OBJECTIVE This study aims to investigate the safety and potential efficacy of the direct thrombin inhibitor dabigatran, in patients with mild cognitive impairment (MCI) or mild AD to decrease vascular-derived neuroinflammation and improve cognitive performance. METHODS Participants will be enrolled then evaluated quarterly throughout the 24-month study. This is a 24-month randomized-control, double-blind, placebo-controlled, multicenter, delayed-start, pilot study evaluating thrombin inhibition in people with biomarker-confirmed MCI probably due to AD or mild AD. 40 - 60 participants will be recruited between 50 - 85 years old. In the initial 9-months of study, either dabigatran or placebo will be orally administered to patients at a dose of 150 mg per day. After 9 months of the placebo-control (Phase I), the placebo arm will cross-over to an active, open-label (Phase II) where all patients will be treated with a 150 mg daily dose of dabigatran orally for an additional 12 months. A 3-month non-treatment follow-up period will assess duration of effects. RESULTS Beginning in July 2019, and concluding in August 2022, this study is expected to publish final results in January 2023. CONCLUSIONS BEACON is a first-in-kind randomized clinical trial targeting thrombin activation in AD therapeutics. This trial will stimulate translational investigations of an FDA-approved drugs in a newly defined therapeutic areas. CLINICALTRIAL Clinicaltrials.gov NCT03752294

An open-label, single-center pilot study to test the effects of an amino acid mixture in older patients admitted to internal medicine wards

Nutrition ◽  
2020 ◽  
Vol 69 ◽  
pp. 110588 ◽  
Author(s):  
Francesco Bellanti ◽  
Aurelio Lo Buglio ◽  
Elena Di Stasio ◽  
Giorgia di Bello ◽  
Rosanna Tamborra ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Amino Acid ◽  
Pilot Study ◽  
Older Patients ◽  
Amino Acid Mixture ◽  
Acid Mixture ◽  
Single Center ◽  
Open Label ◽  
Internal Medicine Wards

scholarly journals Effects of bumetanide on neurodevelopmental impairments in patients with tuberous sclerosis complex: an open-label pilot study

2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Dorinde M. van Andel ◽  
Jan J. Sprengers ◽  
Bob Oranje ◽  
Floortje E. Scheepers ◽  
Floor E. Jansen ◽  
...  
Keyword(s):  
Pilot Study ◽  
Tuberous Sclerosis ◽  
Tuberous Sclerosis Complex ◽  
Open Label
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