title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Manual Participation Deception | RECRUITMENT | In total, 4.3% (294/6818) of randomized participants were identified as having engaged in manual participant deception during the entire recruitment period. As illustrated in Manual participant deception, bots, and actual recruitment throughout the study. CAPTCHA: Completely Automated Public Turing Test to Tell Compute... | PMC10540014 | |
Discussion | PMC10540014 | |||
Overview | RECRUITMENT | This paper presents a case study on participant deception experienced throughout a remotely conducted large randomized controlled trial. Two types of participant deception were detected: automated bots and manual participant deception. Automated bots were identified based on clusters of enrollments very early in the mo... | PMC10540014 | |
Recommendations | Based on our experiences, we have made 6 recommendations for other researchers for limiting bots and manual participant deception:Use CAPTCHAS.Use attention checks.Rigorous data management plan.Be cautious with mentioning financial compensation in web-based advertising.Consider the risk of introducing bias.Plan for the... | PMC10540014 | ||
Use CAPTCHAs (and Other Available Automated Security Protections) | Ensure there are safeguards against automated bots when creating a web-based survey, particularly if financial compensation is involved. We used a CAPTCHA, also recommended by other studies [ | PMC10540014 | ||
Use Attention Checks | Consider adding attention-check questions to the survey, which we found helpful. Examples include requiring participants to select a particular response option to a question, or use duplicate questions with absolute answers such as date of birth, and programming the survey to automatically flag respondents not providin... | PMC10540014 | ||
Rigorous Data Management Plan | A detailed data management plan and data checking methods are important to protect the validity of data. It is a challenge for researchers to stay ahead of bots and manual participant deception and prevent them from completing surveys [ | PMC10540014 | ||
Be Cautious With Mentioning Financial Compensation in Web-Based Advertising | Web-based advertising is often used in remote research to direct potential participants to surveys [However, advertising that financial compensation is available can invite participant deception, as in our case. A previous study investigated participation rates with and without financial incentives and reported that pa... | PMC10540014 | ||
Consider the Risk of Introducing Bias | Compromises are required to protect against participant deception while trying to avoid deterring genuine participants [ | PMC10540014 | ||
Plan for the Additional Resources Required | RECRUITMENT | Consider the time and resources required for appropriate data management and the associated costs within project plans and funding applications, depending on the recruitment target and study length, as continuous monitoring and verification while data collection is ongoing is essential [ | PMC10540014 | |
Conclusions | Conducting research remotely has many advantages, but it is vulnerable to manual participant deception and automated bots posing as genuine participants, which can disrupt research and lead to low-quality data. At the outset of planning a remote study, we recommend using CAPTCHAs, using at least one attention check que... | PMC10540014 | ||
Abbreviations | Completely Automated Public Turing Test to Tell Computers and Humans ApartConsolidated Standards of Reporting TrialsNational Health Service | PMC10540014 | ||
Summary | PMC10754264 | |||
What is already known about this topic? | Nirmatrelvir/ritonavir (Paxlovid) is recommended for treatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19. Rebound in SARS-CoV-2 shedding or COVID-19 signs and symptoms has been described after nirmatrelvir/ritonavir treatment, although the drug’s direct contribution to rebou... | PMC10754264 | ||
What is added by this report? | death | Similar SARS-CoV-2 RNA rebound rates were observed in nirmatrelvir/ritonavir and placebo recipients in two randomized, double-blind, clinical trials. Virologic rebound after nirmatrelvir/ritonavir treatment was not associated with COVID-19–related hospitalization or death. | PMC10754264 | |
What are the implications for public health practice? | SARS-CoV-2 RNA rebound can occur with or without nirmatrelvir/ritonavir treatment, supporting the Food and Drug Administration’s determination of safety and efficacy of nirmatrelvir/ritonavir in eligible patients at high risk for severe COVID-19. | PMC10754264 | ||
Abstract | death | COVID-19 REBOUND | Rebound of SARS-CoV-2 shedding or COVID-19 signs and symptoms has been described after treatment with nirmatrelvir/ritonavir (Paxlovid). The direct association of nirmatrelvir/ritonavir to COVID-19 rebound remains unclear because most reports are based on individual cases or nonrandomized studies. Viral RNA shedding da... | PMC10754264 |
Introduction | Nirmatrelvir/ritonavir (Paxlovid) | PMC10754264 | ||
Methods | PMC10754264 | |||
Data Sources | The authors conducted retrospective analyses of viral RNA shedding levels in nasopharyngeal samples from phase 2/3 clinical trials EPIC-HR and Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).Viral RNA levels were measured in nasopharyngeal swab samples collected by health care provide... | PMC10754264 | ||
Data Analyses | Subjects with posttreatment viral RNA rebound were identified based on an increase in viral RNA levels from day 5 to day 10 or day 14 (Exploratory statistical analyses were conducted using two-sided Fisher’s exact tests to provide nominal p-values, without multiplicity adjustments; p<0.05 was considered statistically s... | PMC10754264 | ||
Results | PMC10754264 | |||
SARS-CoV-2 RNA Rebound Rates | Demographic characteristics and predominant SARS-CoV-2 variants were similar between nirmatrelvir/ritonavir and placebo recipients within clinical trial EPIC-HR and within the 2021/pre-Omicron and 2022/Omicron periods of EPIC-SR (Supplementary Table, | PMC10754264 | ||
SARS-CoV-2 RNA Levels at Individual Timepoints | Across both trials, for all subjects irrespective of viral RNA rebound by any definition, a similar or higher percentage of nirmatrelvir/ritonavir recipients than placebo recipients had viral RNA below the lower limit of quantification (LLOQ) at all postbaseline visits, indicating nirmatrelvir/ritonavir treatment was n... | PMC10754264 | ||
Discussion | nirmatrelvir resistance-associated substitutions | VIRUS | Analyses of nasopharyngeal SARS-CoV-2 RNA levels from two randomized, double-blind, placebo-controlled trials that collectively enrolled approximately 3,000 subjects did not identify a consistent association between virologic rebound and nirmatrelvir/ritonavir treatment. One analysis from EPIC-HR indicated a statistica... | PMC10754264 |
Limitations | The findings in this report are subject to at least four limitations. First, rebound rates are highly dependent on analysis definitions and the types, frequency, and timing of sample collection. The described analyses used sensitive parameters (within limitations of available sampling timepoints) to identify viral RNA ... | PMC10754264 | ||
Implications for Public Health Practice | Data from randomized, double-blind clinical trials demonstrated similar rates of SARS-CoV-2 RNA rebound in nirmatrelvir/ritonavir and placebo recipients. These findings support FDA’s determination of safety and efficacy of nirmatrelvir/ritonavir in eligible patients at high risk for severe COVID-19. | PMC10754264 | ||
Acknowledgments | EMERGENCY | The nirmatrelvir/ritonavir sponsor (Pfizer) and the EPIC-HR and EPIC-SR study investigators and study volunteers; Glen Huang, Cristina Miglis, Barbara Styrt, and the Food and Drug Administration nirmatrelvir/ritonavir New Drug Application review team.Nirmatrelvir/ritonavir (Paxlovid) first became available in the Unite... | PMC10754264 | |
References | PMC10754264 | |||
Subject terms | neuropsychiatric disorders, psychiatric, cognitive disorders | Selective serotonin reuptake inhibitors (SSRIs) are widely used for treating neuropsychiatric disorders. However, the exact mechanism of action and why effects can take several weeks to manifest is not clear. The hypothesis of neuroplasticity is supported by preclinical studies, but the evidence in humans is limited. H... | PMC10827655 | |
Introduction | affective and anxiety-related disorders, heterogeneous syndrome, depressive disorder, MDD, depression, neuropsychiatric disorders | DYSFUNCTION | Drugs targeting the serotonin system, specifically the serotonin transporter, have long been the primary pharmacological treatment for affective and anxiety-related disorders [Despite years of research, the question of how inhibition of the serotonin transporter leads to symptom relief in neuropsychiatric conditions, r... | PMC10827655 |
Methods | PMC10827655 | |||
Study design | psychiatric | EVENTS, EPILEPSY, DISORDERS | The study was conducted in conjunction with a cross-sectional (i.e., single-scan), double-blinded, semi-randomized, placebo-controlled study (see Supplementary Fig SAll participants were recruited from a database of individuals who had expressed interest in participating in brain imaging studies. Following information ... | PMC10827655 |
MRI acquisition and preprocessing | All participants underwent MRI scans in a Siemens Magnetom Prisma 3 T scanner (Siemens AG, Erlangen, Germany) using a Siemens 32-channel head coil. Structural T1- and T2-weighted images were acquired (T1 protocol: Isotropic 0.9 × 0.9 × 0.9 mm | PMC10827655 | ||
PET acquisition | Radiosynthesis of [ | PMC10827655 | ||
Arterial blood acquisition and analysis | For determination of the arterial input function, arterial blood samples were collected from a 20 G catheter which had been placed in the radial artery under local anesthesia. For the first 15 min of each scan, whole blood radioactivity was continuously measured (2-s intervals, flow = 8 mL/min) using an Allogg ABSS aut... | PMC10827655 | ||
PET image processing | All PET images were motion corrected using the AIR software with the reconcile command (Automated Image Registration, v. 5.2.5, LONI, UCLA, | PMC10827655 | ||
Kinetic modeling | Kinetic modelling of [In addition, as a complementary analysis, time-activity curves from the hippocampus and neocortex were fitted to the simplified reference tissue model 2 (SRTM2) to estimate the non-displaceable binding potential ( | PMC10827655 | ||
Statistical analyses | SECONDARY, CORTEX, REGRESSIONS | The distributions of demographic variables and PET scan parameters were visually compared between the groups and formally tested with a Welch two-sample As a secondary analysis, we investigated if there was an effect on [Group means for [As exploratory analyses, we investigated the effects of escitalopram versus placeb... | PMC10827655 | |
Results | PMC10827655 | |||
Primary analyses | There was no statistically significant difference in [ | PMC10827655 | ||
Effects of escitalopram on SV2A density. | Comparison of [Including age, sex, and IQ as covariates did not reveal any significant group differences in the neocortex or the hippocampus (Supplementary Table Neocortical subregions and subcortical regions were not included in our a priori hypothesis; none of these regions showed significant differences in [ | PMC10827655 | ||
Secondary analyses | PMC10827655 | |||
Effect of intervention duration on [ | As the length of the intervention period ranged from 24 to 35 days for the escitalopram group, we investigated if longer exposure to escitalopram was associated with higher [ | PMC10827655 | ||
Time-dependent effects of escitalopram on SV2A density. | Relationship between [When including age, sex, and IQ in the models, the effects of intervention duration in the escitalopram group were further strengthened: in the neocortex, the effect of intervention duration on [ | PMC10827655 | ||
Effect s-escitalopram concentration on [ | We also investigated the effect of participants’ s-escitalopram level on [ | PMC10827655 | ||
Exploratory analyses | PMC10827655 | |||
Effects of escitalopram on hippocampus volume | The mean (SD) hippocampus volume was 4572 (389) mm | PMC10827655 | ||
Effects of escitalopram on cortical thickness | REGRESSION | Linear regression models with age and sex as covariates showed no difference in cortical thickness between the escitalopram group compared to the placebo group for the neocortical subregions (minimum | PMC10827655 | |
Discussion | depression, psychiatric, neurodegenerative and, cocaine-use disorder | SECONDARY, DISORDERS | In this study, we examine the effects of the SSRI escitalopram on brain synaptic density in SSRI-naïve healthy volunteers, as indexed by SV2A density measured with [This positive association with escitalopram intervention duration suggests that a reason why we do not find a group difference in the primary analysis coul... | PMC10827655 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41380-023-02285-8. | PMC10827655 | ||
Acknowledgements | Freddy | LARSEN, JENSEN | Assistance from Lone Freyr, Anna Søndergaard, Elisabeth Pedersen, Dorthe Givard, Peter Steen Jensen, Lucas Andreasen, Oliver Overgaard-Hansen, Caroline Lund, Ida Likaj, Anton Lund, Ida Møller Larsen, Christina Schulze, and Vibeke Jensen, is greatly acknowledged. The John and Birthe Meyer Foundation is gratefully acknow... | PMC10827655 |
Author contributions | DSS | RECRUITMENT | GMK and BJS conceptualized the study and designed the main study together with CL and DSS. BJS and GMK acquired funding for the study. AJ designed the PET experiments and data processing pipeline with input from CS, PPS, GMK, and SHK. SA was responsible for recruitment and MRI acquisition. AJ acquired the PET data with... | PMC10827655 |
Funding | Funding support was provided by the Danish Council for Independent Research (AJ, GMK), the Lundbeck Foundation (AJ, GMK, BJS, SA, CL), Rigshospitalet (AJ, GMK), and the Swedish Research Council (PPS). Open access funding provided by Royal Library, Copenhagen University Library. | PMC10827655 | ||
Data availability | Upon completion of the study, all data will be uploaded to the existing CIMBI Database [ | PMC10827655 | ||
Code availability | The code generated and used in the production of this manuscript is available from the corresponding authors upon request. | PMC10827655 | ||
Competing interests | GMK has received honoraria as a speaker for Sage Biogen and H. Lundbeck, and is a consultant for Onsero, Pangea, and Gilgamesh, Abbvie, PureTechHealth. BJS consults for Cambridge Cognition and receives technology transfer fees from PopReach via Cambridge Enterprise. All other authors declare no competing interests. Fun... | PMC10827655 | ||
References | PMC10827655 | |||
Methods | Low active adults (n = 47) were randomly assigned to a home-based HIIT intervention or wait-list control lasting 12 weeks. Participants in the HIIT intervention received motivational phone sessions based on Self-Determination Theory and accessed a website that included workout instructions and videos demonstrating prop... | PMC9942957 | ||
Results | RECRUITMENT | The HIIT intervention appears feasible based on retention, recruitment, adherence to the counseling sessions, follow-up rates, and the consumer satisfaction survey. HIIT participants reported more minutes of vigorous intensity PA at six weeks relative to control (no differences at 12 weeks). HIIT participants reported ... | PMC9942957 | |
Conclusions | This study provides evidence for feasibility and possible efficacy of a home-based HIIT intervention for vigorous intensity PA; however, additional studies are needed with larger samples sizes to confirm efficacy of home-based HIIT interventions. | PMC9942957 | ||
Trial registration | Clinical Trials Number: | PMC9942957 | ||
Data Availability | All relevant data are within the paper and its | PMC9942957 | ||
Introduction | stroke, depression, anxiety, sleep problems | STROKE, TYPE 2 DIABETES, CARDIOVASCULAR DISEASE, CHRONIC DISEASES | Physical activity (PA) is associated with numerous health benefits including the reduced risk of cardiovascular disease, type 2 diabetes, stroke, depression, anxiety, and sleep problems [Research indicates that vigorous intensity PA may be superior to moderate intensity PA for reducing the risk of chronic diseases such... | PMC9942957 |
Methods | PMC9942957 | |||
Overview of study | BLIND | This study was a randomized controlled single blind pilot study in which participant were recruited from August, 2018 to January, 2019 (assessments were completed by April, 2019). Participants (n = 47) were randomized 1:1 to either a home-based High Intensity Interval Training program (HIIT) or a wait-list control arm ... | PMC9942957 | |
Participants | ideation, angina, stroke, psychosis, psychiatric, diabetes | MYOCARDIAL INFARCTION, STROKE, OSTEOARTHRITIS, CORONARY HEART DISEASE, DIABETES | Low active participants ages 18 years of age or older were recruited from the northern region of the United States through worksite emails. Eligibility criteria were assessed using a telephone-based interview. Exclusion criteria included the following: (1) Engaging in PA for more than 90 minutes each week; (2) lack of ... | PMC9942957 |
Measures | PMC9942957 | |||
Primary aim: Feasibility | RECRUITMENT | Feasibility will be assessed by examining acceptability and implementation. Level of acceptability will be based on attendance at the motivational phone sessions and the consumer satisfaction questionnaire (items were on a seven point Likert scale). Implementation will be based on recruitment and retention rates. Addit... | PMC9942957 | |
Secondary dependent variables: PA minutes per week and psychosocial variables | PA minutes per week was assessed at baseline, six and 12 weeks based on a modified version of the 7-Day Physical Activity Recall Interview (PAR). The PAR is considered the gold standard for assessing PA via self-report [Social support for engaging in PA was measured using the 13-item Social Support for Physical Activit... | PMC9942957 | ||
Procedure | In response to the worksite emails, potential participants called, emailed, or texted a study line. A telephone screening interview, which was adapted from the 10-item Physical Activity Readiness Questionnaire [ | PMC9942957 | ||
HIIT intervention | The HIIT intervention was a 12-week high intensity interval training workout that consisted of home-based HIIT sessions prescribed by the telephone counselor. The content of the HIIT sessions were determined based on exercises the participant could confidently engage in (e.g., regular push-ups vs. knee push-ups vs. wal... | PMC9942957 | ||
Summary of intervention component targeting psychosocial variables. | Note: Behavior Change Techniques from Abraham & Michie [Sessions were approximately 30 minutes total including a five minute warm-up, 20 minutes of HIIT, and a five minute cool-down. The sessions were progressively overloaded using bodyweight. For example, a participant may have started with pushups on their knees, whi... | PMC9942957 | ||
Data analysis | SECONDARY | Descriptive statistics were used to summarize baseline variables in the aggregate sample and t-tests and chi-squared tests were used to compare groups at baseline (as appropriate). Unadjusted means were reported over time by condition for each of the primary and secondary study outcomes.A series of generalized linear m... | PMC9942957 | |
Results | Demographic information is summarized in | PMC9942957 | ||
Baseline characteristics by study arms. | Note: Age is reported as means with standard deviations in parentheses. | PMC9942957 | ||
Feasibility | RECRUITMENT | Recruitment is summarized in | PMC9942957 | |
HIIT flow chart. | PMC9942957 | |||
Consumer satisfaction survey. | Note: Items were on a seven point Likert scale. | PMC9942957 | ||
Physical activity | Unadjusted PA minutes per week by study arm are reported in | PMC9942957 | ||
The effect of the HIIT on physical activity: Unadjusted effects. | Abbreviations: MVPA = Moderate to Vigorous Intensity Physical Activity. The above values are means. Standard deviations are in parentheses. | PMC9942957 | ||
Psychosocial variables | The effect of the HIIT intervention on several psychosocial variables is summarized in | PMC9942957 | ||
The effect of HIIT on psychosocial variables: Unadjusted effects. | Note: EFI = Exercise Feeling Inventory. The above values are means (standard deviations in parentheses). | PMC9942957 | ||
Affective responses to moderate vs. HIIT sessions | Sixty-five percent of the participants completed at least one moderate intensity session affect log and 83% completed at least one HIIT log during the intervention. Participants completed a mean number of 4.26 (SD = 4.65) moderate intensity logs and 6.09 (SD = 6.84) HIIT logs. Among the participants randomly assigned t... | PMC9942957 | ||
Discussion | RECRUITMENT | The home-based HIIT intervention appears feasible based on meeting the acceptability and implementation parameters. Specifically, we met our recruitment goal within the intended timeframe, which was to recruit 40 participants in six months. Our retention rate (98%) was higher than our 90% retention goal. We randomized ... | PMC9942957 | |
Supporting information | PMC9942957 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file.(XLSX)Click here for additional data file.(DOCX)Click here for additional data file. | PMC9942957 | ||
References | PMC9942957 | |||
Keywords | Open access funding provided by Karolinska Institute. | PMC10435650 | ||
Background and Aims | arterial stiffness, bleeding, thrombus, airway inflammation | BLEEDING, THROMBUS, ARTERIAL STIFFNESS, OXIDATIVE STRESS, ENDOTHELIAL DYSFUNCTION | The electronic cigarette (EC) was introduced in 2003 as an alternative to traditional cigarette smoking. Over the years, the use of ECs has steadily increased across the world, especially among adolescents. This is partially due to major marketing efforts by the EC industry and e-liquid flavours especially targeting yo... | PMC10435650 |
Materials and Methods | PMC10435650 | |||
Study Design and Sample | infection | STASIS, INFECTION, BLOOD, CHRONIC DISEASE | Twenty-two healthy male and female occasional smokers or Swedish snus users (maximum 10 cigarettes or 10 pouches of snus per month) between 18 and 45 years of age were included in the study. Written informed consent was obtained at inclusion. The study design adhered to the 1975 Helsinki declaration and was approved by... | PMC10435650 |
T-TAS | thrombus | THROMBUS | Total-Thrombus-formation analysis system (T-TAS®. Fujimoro Kogyo Co., Ltd., Japan) evaluates thrombus formation in whole blood using a microchip flow chamber system that can simulate various venous or arterial blood flow conditions [Different shear rates simulate different flow conditions. For the PL chip, a flow rate ... | PMC10435650 |
Laser Speckle Contrast Imaging and Iontophoresis | SKIN | Skin microvascular function was evaluated through investigation of changes in skin perfusion, assessed by laser speckle contrast imaging (LSCI) in response to iontophoresis of vasoactive drugs at baseline and 30 min after exposure [ | PMC10435650 | |
Skin Temperature | SKIN | Skin temperature of the volar side of left forearm and distal phalange of the left fourth digit was recorded with an electronic thermistor (Exacon, Copenhagen, Denmark) at baseline and 30 min following exposure. | PMC10435650 | |
Statistical Analysis | It was planned to include 22 subjects due to the risk of drop-out and technical problems. Statistical analysis was performed in SPSS 27.0.0.0 64-bit edition (IBM Corporation, NY, US) and GraphPad Prism 8.4.2. (GraphPaSoftware Inc., CA, US). All data sets were tested for normality with Shapiro–Wilk test. Normally distri... | PMC10435650 | ||
Results | Twenty-two healthy individuals, 15 females and 7 males, were included in the study and analysis. Data collection took place between September 2019 and January 2020. Mean age was 27 ± 7, BMI was 24 kg/m | PMC10435650 | ||
Skin Temperature, Heart Rate and Blood Pressure | Forearm skin temperature decreased significantly after exposure in both groups (Table Temperature and circulatory results before and after exposure to electronic cigarette aerosol with and without nicotineNicotineNon-nicotine30.1 ± 1.430.2 ± 1.129.2 ± 1.229.4 ± 1.2NicotineNon-nicotine28.0 (5.8)29.1 (5.0)24.4 (2.8)25.2 ... | PMC10435650 | ||
T-TAS | fibrin-rich thrombus | T-TAS measurement data are presented in Fig. Platelet and fibrin-rich thrombus formation following exposure to electronic cigarette aerosol with and without nicotine. Graphs show individual values and bars median values. P-values for Friedman’s test (exposure and time) are shown on the right side. P-values above the br... | PMC10435650 | |
LSCI | LSCI data showing changes in skin microvascular reactivity following EC exposure are presented in Fig. Endothelial-dependent and independent skin microcirculation following exposure to electronic cigarette aerosol with and without nicotine. Basal skin flux before iontophoresis of ACh and SNP | PMC10435650 |
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