Corrigendum to “Model and approach for assessing implementation context and fidelity in the HEALing Communities Study” [Drug Alcohol Depend. 217 (2020) 108330]

Background. The organization of clinical trials (CTs) requires the participation and coordination of healthcare providers, patients, public and private parties. Obstacles to the participation of any of these groups pose a risk of lowering the potential for the implementation of CTs. Researchers are a key human resource in conducting of CT. Their motivation for participation can have a significant impact on the recruitment and retention of patients, on the quality of the data collected, which determines the overall outcome of the study. Aims to assess the factors affecting the inclusion of Russian physicians-researchers in CT, and to determine their role in relations with patients-participants. Materials and methods. The study was organized as a part of the Russian multicenter face-to-face study. A survey was conducted of researchers from 10 cities of Russia (20172018). The participation in the survey for doctors was anonymous and voluntary. Results. The study involved 78 respondents. Most research doctors highly value the importance of research for science (4,84 0,39), society (4,67 0,46) and slightly lower for participating patients (4,44 0,61). The expectations of medical researchers are related to improving their financial situation and attaining new experience (n = 14; 18,18%). However, the opportunity to work with new technologies of treatment and diagnosis (n = 41; 52,56%) acted as a motivating factor. According to the questionnaire, the vast majority of research doctors (n = 29; 37,18%) believe that the main reason for patients to participate in CT is to receive quality and free medical care. The most significant obstacle to the inclusion of participants in CT was the side effects of the study drug (n = 38; 48,71%). Conclusions. The potential of clinical researchers in Russia is very high. The patient-participant acts for the research doctor as the subject of the study, and not the object, so the well-being of the patient is not indifferent to the doctor. However, the features of the functioning of our health care system form the motivation of doctors-researchers (additional earnings, professional self-development) and the way they perceive the motivation of patients (CT as an opportunity to receive quality medical care).

Download Full-text

Acyclovir Loaded Solid Lipid Nanoparticle Based Cream: A Novel Drug Delivery System

International Journal of Drug Delivery Technology ◽

10.25258/ijddt.v7i1.8917 ◽

2017 ◽

Vol 7 (1) ◽

Author(s):

EL- Assal I. A. ◽

Retnowati .

Keyword(s):

Drug Delivery ◽

Drug Release ◽

Antiviral Agent ◽

Study Drug ◽

Particle Size Analysis ◽

Stability Study ◽

Size Analysis ◽

Solid Lipid ◽

Dermal Delivery

Objective of the present investigation was enthused by the possibility to develop solid lipid nanoparticles (SLNs) of hydrophilic drug acyclovir. Also study vitro and vivo drug delivery. Methods: Drug loaded SLNs (ACV-SLNs) were prepared by high pressure homogenization of aqueous surfactant solutions containing the drug-loaded lipids in the melted or in the solid state with formula optimization study (Different lipid concentration, drug loaded, homogenization / stirring speed and compritol 888ATO: drug ratio). ACV - SLN incorporated in cream base. The pH was evaluated and rheological study. Drug release was evaluated and compared with simple cream- drug, ACV – SLN with compritol 888ATO and marketed cream. The potential of SLN as the carrier for dermal delivery was studied. Results: Particle size analysis of SLNs prove small, smooth, spherical shape particle ranged from 150 to 200 nm for unloaded and from 330 to 444 nm for ACV loaded particles. The EE% for optimal formula is 72% with suitable pH for skin application. Rheological behavior is shear thinning and thixotropic. Release study proved controlled drug release for SLNs especially in formula containing compritol88 ATO. Stability study emphasized an insignificant change in SLNs properties over 6 month. In-vivo study showed significantly higher accumulation of ACV in stratum corneum, dermal layer, and receptor compartment compared with blank skin. Conclusion: AVC-loaded SLNs might be beneficial in controlling drug release, stable and improving dermal delivery of antiviral agent(s).

Download Full-text

Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug

Case Medical Research ◽

10.31525/ct1-nct04299490 ◽

2020 ◽

Author(s):

Keyword(s):

Sleep Disturbances ◽

Study Drug ◽

Receptor Function

Download Full-text

Complex 3D Models to Study Drug Targeting of Invadopodia

Clinical Cancer Drugs ◽

10.2174/2212697x113016660003 ◽

2014 ◽

Vol 1 (2) ◽

pp. 85-5 ◽

Cited By ~ 2

Author(s):

Njainday Jobe ◽

Daniel Rosel ◽

Ondrej Tolde ◽

Jan Kosla ◽

Jan Brabek

Keyword(s):

Drug Targeting ◽

Study Drug ◽

3D Models

Download Full-text

Evidence-based eHealth interventions for caregivers of people with dementia (Myinlife and Partner in Balance): Evaluation of implementations in municipality contexts (Preprint)

10.2196/preprints.21629 ◽

2020 ◽

Author(s):

Hannah Liane Christie ◽

Lizzy Mitzy Maria Boots ◽

Huibert Johannes Tange ◽

Frans Rochus Josef Verhey ◽

Marjolein Elizabeth de Vugt

Keyword(s):

Self Efficacy ◽

Measurement Instrument ◽

Implementation Process ◽

Successful Implementation ◽

Evidence Based ◽

Multiple Sources ◽

Target Groups ◽

Face To Face ◽

People With Dementia ◽

Implementation Context

BACKGROUND Very few evidence-based eHealth interventions for caregivers of people with dementia are implemented into practice. Municipalities are one promising context to implement these interventions, due to their available policy and innovation incentives regarding (dementia) caregiving and prevention. In this study, two evidence-based eHealth interventions for caregivers of people with dementia (Partner in Balance and Myinlife) were implemented in eight municipalities in the Euregion Meuse-Rhine. OBJECTIVE This study’s objectives were to (1.) evaluate this implementation and (2.) investigate determinants of successful implementation. METHODS This study collected eHealth usage data, Partner in Balance coach evaluation questionnaires, and information on implementation determinants. This was done by conducting interviews with the municipality officials, based on the Measurement Instrument for Determinants of Implementation (MIDI). This data from multiple sources and perspectives was integrated and analysed to form a total picture of the municipality implementation process. RESULTS The municipality implementation of Partner in Balance and Myinlife showed varying levels of success. In the end, three municipalities planned to continue the implementation of Partner in Balance, while none planned to continue the implementation of Myinlife. The two Partner in Balance municipalities that did not consider the implementation to be successful, viewed the implementation as an external project. For Myinlife, it was clear that more face-to-face contact was needed to engage the implementing municipality and the target groups. Successful implementations were linked to implementer self-efficacy CONCLUSIONS The experiences of implementing these interventions suggested that this implementation context was feasible regarding the required budget and infrastructure. The need to foster sense of ownership and self-efficacy in implementers will be integrated into future implementation protocols, as part of standard implementation materials for municipalities and organisations implementing Myinlife and Partner in Balance.

Download Full-text

A proof of principle study of atomoxetine for the prevention of vasovagal syncope: the Prevention of Syncope Trial VI

EP Europace ◽

10.1093/europace/euz250 ◽

2019 ◽

Vol 21 (11) ◽

pp. 1733-1741 ◽

Cited By ~ 4

Author(s):

Robert S Sheldon ◽

Lucy Lei ◽

Juan C Guzman ◽

Teresa Kus ◽

Felix A Ayala-Paredes ◽

...

Keyword(s):

Cardiac Index ◽

Stroke Volume ◽

Vasovagal Syncope ◽

Resistance Index ◽

Stroke Volume Index ◽

Study Drug ◽

Norepinephrine Transporter ◽

Volume Index ◽

Head Up Tilt ◽

Invasive Techniques

Abstract Aims There are few effective therapies for vasovagal syncope (VVS). Pharmacological norepinephrine transporter (NET) inhibition increases sympathetic tone and decreases tilt-induced syncope in healthy subjects. Atomoxetine is a potent and highly selective NET inhibitor. We tested the hypothesis that atomoxetine prevents tilt-induced syncope. Methods and results Vasovagal syncope patients were given two doses of study drug [randomized to atomoxetine 40 mg (n = 27) or matched placebo (n = 29)] 12 h apart, followed by a 60-min drug-free head-up tilt table test. Beat-to-beat heart rate (HR), blood pressure (BP), and cardiac haemodynamics were recorded using non-invasive techniques and stroke volume modelling. Patients were 35 ± 14 years (73% female) with medians of 12 lifetime and 3 prior year faints. Fewer subjects fainted with atomoxetine than with placebo [10/29 vs. 19/27; P = 0.003; risk ratio 0.49 (confidence interval 0.28–0.86)], but equal numbers of patients developed presyncope or syncope (23/29 vs. 21/27). Of patients who developed only presyncope, 87% (13/15) had received atomoxetine. Patients with syncope had lower nadir mean arterial pressure than subjects with only presyncope (39 ± 18 vs. 69 ± 18 mmHg, P < 0.0001), and this was due to lower trough HRs in subjects with syncope (67 ± 30 vs. 103 ± 32 b.p.m., P = 0.006) and insignificantly lower cardiac index (2.20 ± 1.36 vs. 2.84 ± 1.05 L/min/m2, P = 0.075). There were no significant differences in stroke volume index (32 ± 6 vs. 35 ± 5 mL/m2, P = 0.29) or systemic vascular resistance index (2156 ± 602 vs. 1790 ± 793 dynes*s/cm5*m2, P = 0.72). Conclusion Norepinephrine transporter inhibition significantly decreased the risk of tilt-induced syncope in VVS subjects, mainly by blunting reflex bradycardia, thereby preventing final falls in cardiac index and BP.

Download Full-text