Prediction of treatment outcome in burning mouth syndrome patients using machine learning based on clinical data.

The purpose of this study is to apply a machine learning approach to predict whether patients with burning mouth syndrome (BMS) respond to the initial approach and clonazepam therapy based on clinical data. Among the patients with the primary type of BMS who visited the clinic from 2006 to 2015, those treated with the initial approach of detailed explanation regarding home care instruction and use of oral topical lubricants, or who were prescribed clonazepam for a minimum of 1 month were included in this study. The clinical data and treatment outcomes were collected from medical records. Extreme Gradient-Boosted Decision Trees was used for machine learning algorithms to construct prediction models. Accuracy of the prediction models was evaluated and feature importance calculated. The accuracy of the prediction models for the initial approach and clonazepam therapy was 67.6% and 67.4%, respectively. Aggravating factors and psychological distress were important features in the prediction model for the initial approach, and intensity of symptoms before administration was the important feature in the prediction model for clonazepam therapy. In conclusion, the analysis of treatment outcomes in patients with BMS using a machine learning approach showed meaningful results of clinical applicability.

Observational cohort study of the effect of a single lubricant exposure during transvaginal ultrasound on cell-shedding from the vaginal epithelium.

The outer layers of the vaginal epithelium (VE) are important because they accumulate glycogen which, under optimal conditions, Lactobacillus spp. consume to grow and acidify the vaginal microenvironment with lactic acid. We hypothesized that exposure to lubricant, for example in the conduct of a transvaginal ultrasound (TVUS), may contribute to the shedding of mature epithelial cells, exposing immature cells. Cervicovaginal fluid (CVF) was sampled at four time points by menstrual cup (Softdisc™) from 50 women referred for TVUS, during which a controlled volume of lubricant was applied to the TVUS wand. Samples were collected (1) immediately before TVUS and (2) 6-12 hours, (3) within one week, and (4) two weeks after TVUS. Clinical vaginal lubricants are similar to commercial lubricants, and often have a high osmolality or pH, and contain bactericides such as methylparaben and propylparaben. The number and maturity of epithelial cells in each CVF sample were measured by quantitative and differential fluorimetry (maturity index, MI). Comparisons of cell-counts and maturity were made by paired Wilcoxon signed-rank tests. Among women with a high pre-TVUS MI (> 3), there was a decrease in median cell-count and mean MI in the sample collected 6-12 hours after TVUS (p<0.001, n = 26 and p < 0.001, n = 26, respectively). For these women, cell-count and MI remained lower in the sample collected within the subsequent week (p<0.001, n = 29 and p<0.01, n = 29, respectively), and MI remained lower in the sample collected within two weeks of TVUS (p<0.01, n = 25), compared to the pre-TVUS sample. Among participants with a low pre-TVUS MI (< 3), cell-count was higher in the sample collected within two weeks of TVUS compared to the pre-TVUS sample (p = 0.03, n = 15), but no significant changes in MI were observed. Results were similar when restricted to reproductive-age women. This preliminary data indicates hypertonic vaginal lubricants may increase vaginal epithelial cell shedding.

Rectal douching in a community sample of men and women.

Rectal douching (RD) may be a vector for sexually transmitted infection (STI) acquisition. The aim of this study was to describe the relationship between RD, and the prevalence of various STIs and sexual behaviors in a sample of women and men in Long Beach, California. Five hundred and forty-seven men (mean age 42.8 years) and 530 women (mean age 37 years) recruited from a community-based setting between April 2010 and August 2014 completed the Risk Behavior Assessment and a questionnaire eliciting information on use of lubricants and enemas for vaginal intercourse (VI) and anal intercourse (AI). Participants were screened for high-risk behaviors for human immunodeficiency virus infection including injection drug use. Bivariate analyses were conducted separately for women and men. Based on the empirical results, separate logistic regression models for women and men were constructed. Sensitivity analysis was conducted to assess model fit for reduced samples of only those men and women who reported AI. For men, RD was associated with a lower odds of being hepatitis C antibody positive, greater odds of being positive for hepatitis B virus surface antigen, syphilis, and using lubricants for receptive anal intercourse (RAI). RD in women was associated with higher odds of a positive test for syphilis, ever vaginally douching for VI, and using lubricants for RAI. Men and women who practice RD report positive syphilis test results and use of lubricants for RAI. RD should not be perceived as preventing STIs.

Lubricants and rectal douching: associations with rectal gonorrhea, chlamydia, and/or syphilis infection among men who have sex with men.

Despite widespread prevalence of lubricant use and rectal douching for receptive anal intercourse (RAI) among men who have sex with men (MSM), research evaluating the association of these behaviors with sexually transmitted infections (STIs) is limited. This is an observational analysis of a longitudinal cohort of predominantly Black/Latino MSM in Los Angeles. Every six months from August 2014 to January 2018, participants received STI screening and surveys evaluating lubricant use, douching, substance use, and sexual risk behaviors. General estimating equations evaluated the association between consistent lubricant use and douching for RAI with positive rectal Neisseria gonorrhoeae, Chlamydia trachomatis, and/or syphilis (positive STI). Among 313 participants across 552 study visits, 16.5% (91/552) had positive STI. Consistent lubricant use was reported in 52.7% (243/552) and rectal douching in 57.6% (318/552) of study visits. Consistent lubricant use was associated with STI diagnosis (adjusted OR [AOR] 1.81; 95% CI 1.11-2.96; p = 0.018). Each episode of rectal douching before RAI was associated with 2% increased odds of positive STI (AOR 1.02; 95% CI 1.00-1.04; p = 0.041). Among this cohort of HIV-positive and high-risk HIV-negative MSM, lubricant use and douching was common and independently associated with an STI, suggesting the utility of prevention messaging around barrier methods/condoms for sexual encounters involving douching/lubricant use.

Dry Eyes, Ocular Lubricants, and Use of Systemic Medications Known or Suspected to Cause Dry Eyes in Residents of Aged Care Services.

Ocular issues are common, burdensome, and under-researched among residents of aged care services. This study aims to investigate the prevalence of dry eyes or use of ocular lubricants among residents, and the possible association with systemic medications known or suspected to cause dry eyes. A cross-sectional study of 383 residents of six aged care services in South Australia was conducted. Data were extracted from participants' medical histories, medication charts, and validated assessments. The main exposure was systemic medications known to cause, contribute to, or aggravate dry eyes. The primary outcome was documented dry eyes or regular administration of ocular lubricants. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the association between systemic medications and dry eyes/use of ocular lubricants. Dry eyes were documented for 53 (13.8%) residents and 98 (25.6%) residents were administered ocular lubricants. Overall, 116 (30.3%) residents had documented dry eyes/used ocular lubricants. Of these, half (n = 58) were taking a medication known to cause, contribute to, or aggravate dry eyes. Taking one or more medications listed as known to cause dry eyes was associated with having dry eyes/use of ocular lubricants (OR 1.83, 95% CI 1.15-2.94). In sub-analyses, no individual medication was associated with dry eyes/use of ocular lubricants. Dry eyes and use of ocular lubricants are common in residential aged care. Our hypothesis generating findings suggest the need for further research into the clinical significance of systemic medications as a possible cause of dry eyes.

Anogenital Dermatitis in Men Who Have Sex with Men.

Evaluation of anogenital dermatitis requires a detailed history, including a sexual history. Men who have sex with men have different risk of certain infectious causes compared with men who have sex with women. Infectious causes of balanitis and anal dermatitis are easily treatable once identified. Irritant contact dermatitis is a common cause of balanitis, and avoidance of irritants, including decreased soap washing, helps many patients improve. Detailed histories of the personal products used by the patient and partner(s), including soaps, lotions, perfumes, lubricants, condoms, topical medications, hygiene sprays, personal wipes, and laundry detergent, may reveal possible irritants or contact allergens.

Clinical recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia: results from a randomised clinical trial.

STUDY DESIGN: Clinical trial. OBJECTIVE: Spinal cord injury (SCI) impacts autonomic function and bowel management. Bowel care is a potential trigger for autonomic dysreflexia (AD; paroxysmal hypertension elicited by sensory stimuli below the level of lesion). AD can be life threatening so strategies to minimise AD are prioritised after SCI. Lidocaine lubricant is recommended during bowel care with the rationale to minimise the sensory stimulus, reducing AD. The objective of this study was to assess whether lidocaine lubricant (Xylocaine 2%) ameliorates AD during at-home bowel care compared with standard lubricant (placebo). SETTING: Community. METHOD: Participants (n = 13; age 44.0 ± 3.3 years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring. Injury to spinal autonomic (sympathetic) nerves was determined from low-frequency systolic arterial pressure (LF SAP) variability. RESULTS: Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg2), suggesting impaired autonomic control. Bowel care duration was increased with lidocaine (79.1 ± 10.0 min) compared to placebo (57.7 ± 6.3 min; p = 0.018). All participants experienced AD on both days, but maximum SAP was higher with lidocaine (214.3 ± 10.5 mmHg) than placebo (196.7 ± 10.0 mmHg; p = 0.046). Overall, SAP was higher for longer with lidocaine (6.5 × 105 ± 0.9 × 105 mmHg • beat) than placebo (4.4 × 105 ± 0.6 × 105 mmHg • beat; p = 0.018) indicating a higher burden of AD. Heart rate and rhythm disturbances were increased during AD, particularly with lidocaine use. CONCLUSIONS: At-home bowel care was a potent trigger for AD. Our findings contradict recommendations for lidocaine use during bowel care, suggesting that anaesthetic lubricants impair reflex bowel emptying, resulting in longer care routines with an increased burden of AD.

Consumer protection provided by the European medical device and cosmetic legislation for condoms and lubricants.

Personal lubricants and lubricants used in condoms contain a number of ingredients which are also present in cosmetic products. These have to comply to the medical device regulation (745/2017) which should provide the same level of consumer protection, if not more, as foreseen in the legal framework of cosmetics (1223/2009). In the current study we developed an analytical method capable of identifying and quantifying 15 ingredients, commonly found in lubricants and cosmetics. Based upon their most important toxicological endpoint, the substances involved were grouped in three toxicological classes provoking either irritation, contact allergic dermatitis or systemic toxicity. The method was applied on 30 condoms and 54 personal lubricants present on the EU market. Their safety was assessed using the same reasoning as commonly applied for cosmetic ingredients. Higher mucosae susceptibility, the main exposed area for lubricants, was taken into account in this assessment. The results show that the majority of the products studied are safe. Nevertheless, for some products the safety could not be confirmed. The results also highlight the fact that there is no consensus for a number of ingredients, used as well in cosmetics as in medical devices. Alignment between both legislations would improve the safety of these products and further raise the general level of consumer protection.

Prescribing lessons from an ocular chemical injury: Vitaros inadvertently dispensed instead of VitA-POS.

We wish to report an ocular chemical injury caused by inadvertent dispensing and administration of an erectile dysfunction cream (Vitaros) instead of an ocular lubricant (VitA-POS) to highlight this potential source of error. Prescribing errors are common, and medications with similar names/packaging increase risk. However, it is unusual in this case that no individual (including the patient, general practitioner or dispensing pharmacist) questioned erectile dysfunction cream being prescribed to a female patient, with ocular application instructions. The patient was treated for a mild ocular chemical injury with topical antibiotics, steroids and lubricants, with good response. However, we believe this to be an important issue to report to enhance awareness and promote safe prescribing skills.

Specific Skin Lesions of Sarcoidosis Located at Venipuncture Points for Blood Sample Collection.

It has been suggested that the predilection of sarcoidosis to affect scars is due to the presence of antigens or foreign bodies that can serve as a stimulus for granuloma formation. Several patients with sarcoidosis-specific skin lesions in venous puncture sites have been reported. However, in these patients the pathogenesis of the cutaneous lesions is not clear because the presence of foreign bodies is not to be expected. Our objective was to describe 3 patients who developed specific lesions of sarcoidosis in areas of venipuncture and to discuss their possible pathogenesis. The database of the Sarcoid Clinic of Bellvitge Hospital (an 800-bed university referral center providing tertiary care to approximately 1 million people in Barcelona, Spain) was reviewed to detect those patients with specific cutaneous lesions of systemic sarcoidosis in areas of venipuncture. Three patients with biopsy-proven specific cutaneous lesions of systemic sarcoidosis in areas of venipuncture for blood collection were detected (3 women, mean age 56 years). In one case, the histopathological image shows the hypothetical path of a needle through the skin. In 2 cases, an amorphous birefringent material was detected under polarized light. This material was consistent with silicone. In patients who are developing sarcoidosis, the smallest amount of oil used as lubricant in the needle for sample blood collection may induce the formation of granulomas. In addition to exploring scars, it is advisable to explore the cubital folds to detect specific cutaneous lesions of sarcoidosis.

Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy.

INTRODUCTION: The efficacy of heparin based flush solutions in rotational atherectomy (RA) has not been validated. Recently, a single center study demonstrated the feasibility of an alternative flush solution with 10,000U of unfractionated heparin (UFH) in 1L of normal saline. We aimed to evaluate the safety and efficacy of an alternative flush solution intermittently utilized at our institution. METHODS: We retrospectively identified 150 patients undergoing RA over a three year period. One hundred cases utilized an alternative flush solution containing 10,000U UFH, 400mcg nitroglycerin, and 10mg verapamil in 1L normal saline and fifty cases utilized RotaGlide Lubricant (Boston Scientific) in addition to heparin and vasodilators in the same dose. The primary end point was to compare rates of procedural success. Secondary endpoints were to report procedural characteristics including the incidence of major adverse cardiac events (MACE) and minor periprocedural complications. RESULTS: Procedural success was achieved in 98% (98/100) of cases utilizing the alternative Rota-Flush solution compared to 100% (50/50) in the Rota-Glide group (P=0.553). A total of 292 lesions (200 Rota-Flush vs 92 Rota-Glide) were targeted for intervention. MACE occurred in 13 (13%) and 4 (8%) cases in the Rota-Flush and Rota-Glide groups, respectively (P=0.425). CONCLUSION: Rotational atherectomy performed with the previously defined Rota-Flush or Rota-Glide solutions resulted in similar rates of procedural success. There were no significant disparities in incidence of MACE and minor periprocedural complications between the two groups. Heparin based rota-flush solutions can be effective alternatives to traditional solutions containing RotaGlide Lubricant.

Fatal orbito-cerebral penetration by industrial grease viscous: Rare case report.

Assorted projectiles including shrapnel, sling shots, stones, metal and rock fragments and other missiles cause fatal penetrating skull injuries. In this case, a 34-year-old foreman suffered a fatal penetrating orbito-cerebral injury while lubricating a hydraulic rock-splitting machine with industrial grease viscous.

Effects of Vaginal Lubricants on In-Vitro Progressive Spermatozoa Motility.

Vaginal lubricants are used to solve intercourse difficulties or as sexual enhancers, but recent reports raise questions about their safety in terms of fertility. In this study, twenty semen samples were tested against commercially available vaginal lubricants for progressive spermatozoa motility and vitality with varying exposure time intervals. Results showed that the vaginal lubricant which least affected progressive spermatozoa motility was the oil-based vaginal lubricant, which kept the mean percentage of progressive spermatozoa motility within the minimum normal range of 32%, following 60 minutes of exposure. The silicone-based vaginal lubricant produced similar results to the oil-based vaginal lubricant, however the progressive spermatozoa motility dropped below the minimum normal range within 60 minutes of exposure. The fertility lubricant did not produce mean progressive motilities that were within the normal minimum range at any of the three time intervals, producing poor results overall. The vaginal lubricant which produced the poorest results was the water-based, which immobilized all of the spermatozoa within 5 minutes of exposure and killed on average 95.23% within 60 minutes. Although further assessment is required, these results highlight potential fertility issues related to the formulation of commercially available vaginal lubricants.

Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove. Final rule.

The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.

A randomized clinical trial in subjects with dry mouth evaluating subjective perceptions of an experimental oral gel, an oral rinse and a mouth spray compared to water.

PURPOSE: This multicenter, randomized, parallel group study analyzed the effectiveness of an experimental oral gel, a commercially available oral rinse and a commercially available mouth spray versus water alone at relieving self-reported symptoms of dry mouth over a 28-day home use treatment period. The effects of the study treatments on dry mouth-related quality of life (QoL) were also investigated. METHODS: Eligible subjects were stratified by dry mouth severity (mild, moderate or severe) and randomized to receive one of the study treatments. Prior to first use they completed a questionnaire designed to assess their baseline dry mouth-related QoL. Following first use and on Day 8 (2 hours post-treatment only) and Day 29, subjects completed the modified Product Performance and Attributes Questionnaire (PPAQ) I at 0.5, 1, 2 and 4 hours post-treatment. Subjects further assessed treatment performance using the PPAQ II questionnaire on Days 8 and 29 and the dry mouth-related QoL questionnaire on Day 29. RESULTS: In 396 randomized subjects almost all comparisons of responses to PPAQ I, including those for the primary endpoint (response to PPAQ I Question 1 'Relieving the discomfort of dry mouth' after 2 hours on Day 29), were statistically significant in favor of active treatment groups versus water (P < 0.05). All comparisons of responses to PPAQ II on Days 8 and 29 were statistically significant in favor of active treatments versus water (P < 0.05). Moreover, nearly all comparisons for dry mouth-related QoL scores on Day 29 were statistically significant in favor of the active treatments versus water. All the dry mouth management strategies in this trial were well tolerated.

Postoperative Granulomas at Liposuction Incision Sites.

Since most liposuction incisions heal uneventfully, difficult healing in such incisions must be investigated. In the cases of two gynecomastia liposuction patients in which a water-based lubricating gel was used on the liposuction incisions, the incisions failed to heal. For both patients, workup uncovered palisading granulomas at the lateral inframammary fold incision sites several months after otherwise successful surgeries. These two cases are presented and the previous literature is reviewed, with consideration given to the etiology and prevention of such granulomas. LEVEL OF EVIDENCE 5: Risk.