METHODOLOGY: Sixty-four healthy volunteers received either a single dose (200 mg) of modafinil (n = 32) or placebo (n = 32) in a randomized, double-blind, placebo-controlled, parallel group study in which the principal outcome measures were response latencies on the response initiation and response inhibition sections of the HSCT.
PRINCIPAL FINDINGS: Participants dosed with modafinil had significantly longer mean response latencies on the HSCT for both the response initiation and response inhibition compared to participants dosed with placebo. However, participants in both groups made a similar number of errors on each of these measures, indicating that modafinil did not enhance the accuracy of performance of the task relative to placebo.
CONCLUSIONS: This study demonstrated that administration of single 200 mg doses of modafinil to healthy individuals increased the latency of responses in the performance of the HSCT, a task that is highly sensitive to prefrontal executive function, without enhancing accuracy of performance. This finding may provide important clues to defining the limitations of modafinil as a putative cognitive enhancer.
TRIAL REGISTRATION: ClinicalTrials.gov NCT02051153.
PATIENTS AND METHODS: Mefloquine pharmacokinetics was assessed in 24 healthy adults and 43 patients with Plasmodium falciparum malaria administered mefloquine in combination with artesunate. Population pharmacokinetic modelling was conducted using NONMEM.
RESULTS: A two-compartment model with a single transit compartment and first-order elimination from the central compartment most adequately described mefloquine concentration-time data. The model incorporated population parameter variability for clearance (CL/F), central volume of distribution (VC/F) and absorption rate constant (KA) and identified, in addition to body weight, malaria infection as a covariate for VC/F (but not CL/F). Monte Carlo simulations predict that falciparum malaria infection is associated with a shorter elimination half-life (407 versus 566 h) and T>MIC (766 versus 893 h).
CONCLUSIONS: This is the first known population pharmacokinetic study to show falciparum malaria to influence mefloquine disposition. Protein binding, anaemia and other factors may contribute to differences between healthy individuals and patients. As VC/F is related to the earlier portion of the concentration-time profiles, which occurs during acute malaria, and CL/F is more related to the terminal phase during convalescence after treatment, this may explain why malaria was found to be a covariate for VC/F but not CL/F.
METHODOLOGY: A cross-sectional study involved 105 apparently healthy adults. Interview questionnaire was used to collect personal information. Participants were excluded if they suffered from acute or chronic inflammatory diseases, or continued using medicines, which might affect the biomedical results.
RESULTS: In association with increased Body Mass Index (BMI), the obese group displayed significant higher markers including: interleukin 6 (IL-6), high sensitivity C reactive protein (hs-CRP), total cholesterol (TC), systolic blood pressure (SBP), and diastolic blood pressure (DBP). Obese group in association with increased waist circumference (WC) was higher significantly in inflammatory markers (IL-6, hs-CRP), lipid profile (TC) and triglyceride (TG), and blood pressure (SBP, DBP). A tertile of a feature of systemic inflammation (hs-CRP) was created, by Ordinal Logistic Regression, after adjusting for the age, gender, smoking habits, physical activity pattern, father and mother's health history; risk factors were the increased BMI [OR: 1.24] (95% CI: 1.005-1.548, P=0.050), IL-6 [OR: 3.35] (95% CI: 1.341-8.398, P=0.010), DBP [OR: 1.19] (95% CI: 1.034-1.367, P=0.015), and reduced Adiponectin [OR: 0.59] (95% CI: 0.435-0.820, P=0.001). Finally, BMI correlated with IL-6 and hs-CRP (r=0.326, P=0.005; r=0.347, P<0.001; respectively), and hs-CRP correlated with IL-6 (r=0.303, P=0.010), and inversely with Adiponectin (r=-0.342, P=0.001).
CONCLUSION: The increased level of IL-6 and reduced Adiponectin, which strongly associated with obesity, indicated that having high BMI is a useful marker in association with IL-6 and further developed systemic inflammation.
METHODS: Sixteen healthy adult participants donned one antimicrobial surgical glove and one non-antimicrobial surgical glove randomly allocated to their dominant and non-dominant hand following a crossover design. During a 2-h wear time, participants performed standardized finger and hand movements. Thereafter, the interior surface of excised fingers of the removed gloves was challenged with 8.00 log10 cfu/mL S. aureus (ATCC 6538) or K. pneumoniae (ATCC 4352), respectively. The main outcome measure was the viable mean log10 cfu counts of the two glove groups after 5 min contact with the interior glove's surface.
RESULTS: When comparing an antimicrobial glove against an untreated reference glove after 2-h simulated use wear-time, a mean reduction factor of 6.24 log10 (S. aureus) and 6.22 log10 (K. pneumoniae) was achieved after 5 min contact.
CONCLUSION: These results demonstrate that wearing antibacterial gloves on hands does not negatively impact their antibacterial activity after 2-h of wear. This may have a potential benefit for patient safety in case of glove puncture during surgical procedures.
Methods: One hundred and eighty-eight healthy subjects aged between 18 and 50 years with varying oral hygiene status who gave consent to participate were included in this cross-sectional study. The subjects were recruited from primary oral health care of MAHSA University. Oral hygiene of all the participants was measured using Oral Hygiene Index-Simplified (OHI-S). Stimulated saliva collected using paraffin wax was analyzed for salivary statherin, aPRP, and calcium. The relationship between salivary statherin, aPRP, and calcium levels with OHI-S was assessed using Spearman's Rank correlation coefficient; the strength of relationship was assessed by multiple linear regression analysis.
Results: The study found a weak positive correlation (r = 0.179, p = 0.014) between salivary statherin and OHI-S; weak negative correlation (r = -0.187, p = 0.010) between salivary aPRP and OHI-S; and moderate negative correlation between salivary statherin and salivary aPRP levels (r = -0.50, p
METHODS: Twenty-nine asymptomatic subjects were enrolled prospectively (age: mean 34.31, range 23-50; 14 men, 15 women) from August 2016 to April 2017. Qualitative analysis of muscles was done using Goutallier's system on CT and MRI. Quantitative analysis entailed cross sectional area (CSA) on CT and MRI, Hounsfield unit (HU) on CT, fat fraction using two-point Dixon technique on MRI. Three readers independently analyzed the images; intra- and inter-observer agreements were measured. Linear regression and Spearman's analyses were used for correlation with demographic data.
RESULTS: CSA values were significantly higher in men (p
PURPOSE: The purposes of this study were to compare SFCT in PE, normal pregnant, and nonpregnant women using spectral domain optical coherence tomography and to correlate SFCT with severity of pre-eclampsia.
METHODS: A cross-sectional, observational study was performed. A total of 150 participants were divided into three groups: group 1 (50 PE women), group 2 (50 normal pregnant women), and group 3 (50 nonpregnant healthy women). Subfoveal choroidal thickness was measured using spectral domain optical coherence tomography. Other parameters including mean arterial blood pressure (MABP), central corneal thickness, macular thickness, IOP, ocular perfusion pressure (OPP), and urine protein-to-creatinine ratio were also measured. ANOVA and Pearson correlation analysis were used to look at differences between the groups. P < .05 was considered as statistically significant.
RESULTS: The MABP was higher in group 1 than in groups 2 and 3 (103.0 ± 12.9 vs. 83.2 ± 9.8 vs. 89.5 ± 7.2 mmHg, respectively; all P < .001). The SFCT of the PE group was higher than in groups 2 and 3 (370.7 ± 23.8 vs. 344.5 ± 30.8 vs. 315.8 ± 49.9 μm, respectively; all P < .001). There were no statistically significant differences in central corneal thickness, macular thickness, or IOP between the PE and healthy pregnant groups (all P > .05). The OPP was greater in PE patients (52.8 ± 8.5 vs. 41.9 ± 6.9 vs. 43.4 ± 5.2 mmHg, respectively; both P < .001). The SFCT was positively correlated with MABP (r = 0.464, P < .001), OPP (r = 0.495, P < .001), and urine protein-to-creatinine ratio (r = 0.635, P < .001) in the PE group.
CONCLUSIONS: Subfoveal choroidal thickness is higher in pre-eclampsia and is proportional to established markers of severity of the condition. This parameter might serve as a novel predictive marker for the severity of pre-eclampsia.
METHOD: This study was conducted on 19 healthy subjects (non-habitual 8; habitual 11), non-smoking and between 21 and 30 years of age. Using laser speckle flowgraphy (LSFG), three areas of optical nerve head were analyzed which are vessel, tissue, and overall, each with ten pulse waveform parameters, namely mean blur rate (MBR), fluctuation, skew, blowout score (BOS), blowout time (BOT), rising rate, falling rate, flow acceleration index (FAI), acceleration time index (ATI), and resistive index (RI). Two-way mixed ANOVA was used to determine the difference between every two groups where p
Method: Quasi-experimental and repeated-measures study designs were used in this study. Twenty-six adults with normal hearing (17 females, 9 males) participated. ABRs were acquired from the study participants at 3 intensity levels (80, 60, and 40 dB nHL), 3 frequencies (500, 1000, and 2000 Hz), 2 electrode montages (ipsilateral and vertical), and 2 stimuli (NB LS CE-Chirp and tone-burst) using 2 stopping criteria (fixed averages at 4,000 sweeps and F test at multiple points = 3.1).
Results: Wave V amplitudes were only 19%-26% larger for the vertical recordings than the ipsilateral recordings in both the ABRs obtained from the NB LS CE-Chirp and tone-burst stimuli. The mean differences in the F test at multiple points values and the residual noise levels between the ABRs obtained from the vertical and ipsilateral montages were statistically not significant. In addition, the ABR elicited from the NB LS CE-Chirp was significantly larger (up to 69%) than those from the tone-burst, except at the lower intensity level.
Conclusion: Both the ipsilateral and vertical montages can be used to record ABR to the NB LS CE-Chirp because of the small enhancement in the wave V amplitude provided by the vertical montage.
OBJECTIVES: To evaluate the efficacy and safety of a botanical-based Rosa E pigmentation serum in healthy fair skin female volunteers with wrinkles, skin tone, and pigmentation.
METHODS: This was a single-arm, open label study conducted in healthy Indian females; 18 subjects aged 30-55, having fair Caucasian-like skin with at least 2 dark skin pigments with facial wrinkles diagnosed by dermatologist were selected. Rosa E pigmentation serum was applied twice a day for 84 days. Effect was evaluated by (i) instrumental technique (spectrophotometer® 2600D), (ii) clinically by dermatologist regarding product efficacy (skin tone, antiwrinkle, pigmentation), and (iii) volunteers self-evaluation.
RESULTS: The L* value of spectrophotometer reading represents lightness in the skin pigment. Reduction in the pigment was reported from day 14, with significant reductions observed till day 84 compared with baseline. Significant (P < .0001) skin pigmentation lightening was seen on day 14 (1.11) vastly improving on day 84 (1.94) based on photographic assessments. The significant reduction in skin pigment was 76.85%, Felix von Luschan skin color score was 30.24% (P < .0001) with a 7.38-fold reduction in skin tone and 57% reduction in facial wrinkles at day 84 from baseline.
CONCLUSIONS: Rosa E pigmentation serum was found safe and effective in significant reduction in skin pigments, improvement of skin tone, and antiwrinkle properties instrumentally, clinically, and self-evaluation by volunteers. In these evaluations, best results were seen the longer the Rosa E was used.
METHODS: Our aim was to determine normative EGJ metrics in a large international cohort of healthy volunteers undergoing HRM (Medtronic, Laborie, and Diversatek software) acquired from 16 countries in four world regions. EGJ-CI was calculated by the same two investigators using a distal contractile integral-like measurement across the EGJ for three respiratory cycles and corrected for respiration (mm Hg cm), using manufacturer-specific software tools. EGJ morphology was designated according to Chicago Classification v3.0. Median EGJ-CI values were calculated across age, genders, HRM systems, and regions.
RESULTS: Of 484 studies (28.0 years, 56.2% F, 60.7% Medtronic studies, 26.0% Laborie, and 13.2% Diversatek), EGJ morphology was type 1 in 97.1%. Median EGJ-CI was similar between Medtronic (37.0 mm Hg cm, IQR 23.6-53.7 mm Hg cm) and Diversatek (34.9 mm Hg cm, IQR 22.1-56.1 mm Hg cm, P = 0.87), but was significantly higher using Laborie equipment (56.5 mm Hg cm, IQR 35.0-75.3 mm Hg cm, P
METHOD: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2-period crossover study with a washout period of 7 days. Paracetamol/Orphenadrine tablets were administered after a 10-h fast. Blood samples for pharmacokinetic analysis were collected at scheduled time intervals prior to and up to 72 h after dosing. Blood samples were centrifuged, and separated plasma were kept frozen (- 15 °C to - 25 °C) until analysis. Plasma concentrations of orphenadrine and paracetamol were quantified using liquid-chromatography-tandem mass spectrometer using diphenhydramine as internal standard. The pharmacokinetic parameters AUC0-∞, AUC0-t and Cmax were determined using plasma concentration time profile for both preparations. Bioequivalence was assessed according to the ASEAN guideline acceptance criteria for bioequivalence which is the 90% confidence intervals of AUC0-∞, AUC0-t and Cmax ratio must be within the range of 80.00-125.00%.
RESULTS: There were 28 healthy subjects enrolled, and 27 subjects completed this trial. There were no significant differences observed between the AUC0-∞, AUC0-t and Cmax of both test and reference preparations in fasted condition. The 90% confidence intervals for the ratio of AUC0-t (100.92-111.27%), AUC0-∞ (96.94-108.08%) and Cmax (100.11-112.50%) for orphenadrine (n = 25); and AUC0-t (94.29-101.83%), AUC0-∞ (94.77-101.68%) and Cmax (87.12-101.20%) for paracetamol (n = 27) for test preparation over reference preparation were all within acceptable bioequivalence range of 80.00-125.00%.
CONCLUSION: The test preparation is bioequivalent to the reference preparation and can be used interchangeably.
TRIAL REGISTRATION: NMRR- 17-1266-36,001; registered and approved on 12 September 2017.