Waterpipe device cleaning practices and disposal of waste associated with waterpipe tobacco smoking in homes in the USA

ObjectivesTo quantify postsmoking waterpipe tobacco (WPT) waste and describe postsmoking waterpipe (WP) device cleaning practices and disposal of associated waste in home settings.MethodsWe analysed data from a US convenience sample of 50 exclusive WPT smokers, mean age 25.3 years. Data were collected at a home visit during which participants smoked one WPT head and completed a self-administered questionnaire on WP cleaning practices and disposal of waste associated with WPT use. Research assistants provided and prepared a WP for participants by weighing and loading 10 g of WPT in the WP head and placing 470 mL of water in the WP bowl. At the completion of the smoking session, research assistants measured the remaining WPT and water. Descriptive analyses were performed.ResultsOf the 10 g of fresh WPT used for each smoking session, 70.1% (mean=7.01 g) was discarded postsmoking as waste; for each 470 mL of water used in the WP bowl, 94.3% (mean=443 mL) was discarded. WP device cleaning practices ranged from never cleaning the device to cleaning it after each smoking session. Respondents reported discarding smoked WPT residue in the trash (81.6%) or the kitchen sink (14.3%) and discarding postsmoking charcoal in the trash (57.6%), the kitchen sink (27.3%) or backyard soil (9.1%). Respondents reported discarding smoked WP water in the kitchen sink (76.5%), bathroom sink (14.7%), toilet (2.9%) and backyard soil (5.9%).ConclusionsInterventions and regulations are needed to inform proper WP device cleaning practices and disposal of waste associated with WPT use.Trial registration numberNCT03253653.

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Characteristics, reasons, behavior and knowledge towards waterpipe smoking in Saudi Arabia

International Journal of Adolescent Medicine and Health ◽

10.1515/ijamh-2017-0090 ◽

2017 ◽

Vol 0 (0) ◽

Cited By ~ 5

Author(s):

Elluru Venkatesh ◽

Mohammad Yousef Al Jemal ◽

Abdullah Saleh Al Samani

Keyword(s):

Tobacco Smoking ◽

Mediterranean Region ◽

Eastern Mediterranean ◽

Eastern Mediterranean Region ◽

Waterpipe Smoking ◽

Waterpipe Tobacco Smoking ◽

The Mean ◽

Amount Of Knowledge ◽

Self Administered Questionnaire ◽

Harmful Effects

AbstractBackgroundThe present scenario shows that waterpipe smoking, one of tobacco smoking methods, the practice off which dates back at least 400 year is appealing to the youth. Waterpipe tobacco smoking is frequently linked with nations of the Eastern Mediterranean Region (EMR) comprising Egypt, Kuwait, Lebanon and Syria. The present study shows the socio-demographic characteristics, behavior and knowledge of youth towards waterpipe smoking. Recognizing these features may help emphasize intervention methods.MethodsA self-administered questionnaire was used to collect the data about waterpipe smoking comprising sociodemographic, behavior, reasons and knowledge from 230 university students.Results230 questionnaires were distributed from which only 199 were included in the study as 31 were excluded because of incompleteness of the survey. The mean age for starting smoking was 19.49 ± 3.75 years with 32.5% of family members and the majority of their friends engaged with waterpipe smoking. Pleasure and happiness (76%), helps me to deal with pressure (78%) and acceptance by society (91%), were the major reasons cited for waterpipe smoking. It being less harmful and less addictive (55%) compared to cigarettes and no objection from the parents (58%) were the other cited reasons. Furthermore, less than 50% of the participants had correct knowledge of its harmful effects.ConclusionIt is clearly evident from our findings that there is a meagre amount of knowledge regarding the harmful effects of waterpipe smoking. It is essential that programs to impart knowledge regarding the harmful effects of waterpipe smoking and dependence should be of the utmost importance.

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Conundrum of mechanical knee symptoms: signifying feature of a meniscal tear?

British Journal of Sports Medicine ◽

10.1136/bjsports-2018-099431 ◽

2018 ◽

Vol 53 (5) ◽

pp. 299-303 ◽

Cited By ~ 1

Author(s):

Jonas Bloch Thorlund ◽

Kenneth Pihl ◽

Nis Nissen ◽

Uffe Jørgensen ◽

Jakob Vium Fristed ◽

...

Keyword(s):

Knee Arthroscopy ◽

Meniscal Tear ◽

Prevalence Ratio ◽

Trial Registration ◽

Baseline Questionnaire ◽

Link Type ◽

Patient Reported ◽

Registration Number ◽

Meniscal Surgery

BackgroundMechanical knee symptoms are often considered important in the decision to perform knee arthroscopy on the suspicion of a meniscal tear. We investigated if presence of a meniscal tear at knee arthroscopy in adults is associated with presence of preoperative self-reported mechanical knee symptoms.MethodsWe used data from Knee Arthroscopy Cohort Southern Denmark (KACS). KACS consists of patients aged 18 years or older referred to knee arthroscopy on the suspicion of a meniscal tear at four recruiting hospitals between 1 February 2013 and 31 January 2015. Of 1259 invited patients, 908 (72%) replied to the baseline questionnaire. With 91 patients excluded, the study sample consisted of 641 and 176 patientswithandwithouta meniscal tear confirmed at surgery, respectively. Exposure was meniscal tear as determined by the knee surgeon during arthroscopy. Main outcomes were preoperative mechanical knee symptoms defined as self-reported catching/locking or self-reported inability to straighten knee fully.Results55% of all patients reported symptoms of catching/locking and 47% were unable to straighten their knee fully. Preoperative mechanical symptoms were equally prevalent in patientswithandwithouta meniscal tear (prevalence ratio catching/locking 0.89, 95% CI 0.77 to 1.03, and inability to straighten knee fully, prevalence ratio 1.02, 95% CI 0.84 to 1.23).InterpretationPatient-reported mechanical symptoms were equally common irrespective of presence or absence of a meniscal tear in patients undergoing arthroscopy for suspicion of a meniscal tear. Our findings suggest that mechanical knee symptoms have a limited value when considering indication for meniscal surgery.Trial registration numberNCT01871272; Results.

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Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis

Stroke and Vascular Neurology ◽

10.1136/svn-2020-000388 ◽

2020 ◽

Vol 5 (4) ◽

pp. 348-352

Author(s):

Yi Dong ◽

Ye Han ◽

Haipeng Shen ◽

Yilong Wang ◽

Frank Ma ◽

...

Keyword(s):

Ischaemic Stroke ◽

Plasminogen Activator ◽

Tissue Plasminogen Activator ◽

Acute Ischaemic Stroke ◽

Standard Dose ◽

Trial Registration ◽

Comparable Efficacy ◽

Link Type ◽

Tissue Plasminogen ◽

Registration Number

BackgroundThe risk of symptomatic intracranial haemorrhage (sICH) after thrombolysis is low but severe. Lower dose of alteplase may reduce the risk of sICH. We aim to identify subsets of patients who could beneﬁt from lower dose of alteplase compared with standard dose.MethodsData from two observational registries were pooled together. A total of 3479 patients who had acute ischaemic stroke were entered into the interaction tree model. The response variable was the rate of sICH per the definition of the National Institute of Neurological Disorders and Stroke Study. Clinical improvement was measured by the National Institutes of Health Stroke Scale (NIHSS) and defined as NIHSS 0 or 1 or an improvement of more than 4 points (within 7 days or at discharge). Rare event logistic regression was performed to analyse the OR of safety outcome.ResultsTo optimise the interaction effect between tissue plasminogen activator (tPA) dosage (standard/lower) and patient subgroups, three subgroups based on the severity of stroke were identified: (1) NIHSS ≤4, (2) NIHSS between 5 and 14, and (3) NIHSS ≥15. The estimated difference of OR of having sICH was 2.71 (95% CI 0.80 to 7.69, p=0.10) for mild, 0.13 (95% CI 0.02 to 0.68, p=0.01) for moderate, and 0.65 (95% CI 0.19 to 2.55, p=0.52) for severe, respectively. In addition, patients who had moderate stroke treated with lower dose had comparable efficacy outcome (OR 1.23, 95% CI 0.71 to 2.13, p=0.45).ConclusionOur analysis demonstrated that in patients who had moderate stroke, lower doses of alteplase are associated with significant sICH reduction and non-inferior performance in efficacy, compared with those in the standard dose group.Trial registration numberThe TIMS-China was a national prospective stroke registry on thrombolytic therapy using intravenous tPA in patients who had acute ischaemic stroke. The results were initially published in 2012 without a clinical trial registration number. The Shanghai Stroke Service System was registered at www.clinicaltrial.gov (NCT02735226).

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Implementing two-stage consent pathway in neonatal trials

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2021-322960 ◽

2021 ◽

pp. fetalneonatal-2021-322960

Author(s):

Eleanor Mitchell ◽

Sam J Oddie ◽

Jon Dorling ◽

Chris Gale ◽

Mark John Johnson ◽

...

Keyword(s):

Critical Period ◽

Trial Registration ◽

Two Stage ◽

Trial Team ◽

Link Type ◽

National Guidance ◽

Registration Number ◽

Time Critical

Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number: ISRCTN89654042.

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The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-03981-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Yama Afghanyar ◽

Sebastian Joser ◽

Jonas Tecle ◽

Philipp Drees ◽

Jens Dargel ◽

...

Keyword(s):

Vitamin E ◽

Weight Bearing ◽

Trial Registration ◽

Harris Hip Score ◽

Full Weight Bearing ◽

Link Type ◽

Radiological Data ◽

Registration Number ◽

The Mean

Abstract Background The newest generation of cementless titanium-coated, isoelastic monoblock cup with vitamin E-blended highly cross-linked polyethylene (HXLPE) was introduced to the market in 2009. The aim of the present study was to obtain mid-term follow-up data including migration and wear analyses. Methods This prospective study investigated 101 primary total hip arthroplasty (THA) cases in 96 patients treated at a single institution. Patients were allowed full weight-bearing on the first day postoperatively. Harris hip score (HHS) and pain and satisfication on a visual analogue scale (VAS) were assessed at a mean follow-up of 79.0 months. Migration and wear were assessed using Einzel-Bild-Roentgen-Analyse (EBRA) software. Radiological acetabular bone alterations and complications were documented. Results At mid-term follow-up (mean 79.0 months, range: 51.8–101.7), 81 cases with complete clinical and radiological data were analyzed. Utilisable EBRA measurements were obtained for 42 hips. The mean HHS was 91.1 (range 38.0–100.0), VAS satisfaction was 9.6 (range 6.0–10.0), VAS rest pain was 0.2 (range 0.0–4.0), and VAS load pain was 0.6 (range 0.0–9.0). Mean migration was 0.86 mm (range: 0.0–2.56) at 24 months and 1.34 mm (range: 0.09–3.14) at 5 years, and the mean annual migration rate was 0.22 (range: − 0.24–1.34). The mean total wear was 0.4 mm (range: 0.03–1.0), corresponding to a mean annual wear rate of 0.06 mm per year (range: 0.0–0.17). Radiographic analysis did not reveal any cases of osteolysis, and no revision surgeries had to be performed. Conclusions After using vitamin-E blended HXLPE in cementless isoelastic monoblock cups, there were no obvious signs of osteolysis or aseptic loosening occurred. No patients required revision surgery after mid-term follow-up. Cup migration and wear values were well below the benchmarks considered predictive for potential future failure. Trial registration The trial registration number on ClinicalTrials.gov: NCT04322916 (retrospectively registered at 26.03.2020).

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Maternal age at birth and daughter’s fecundability

Human Reproduction ◽

10.1093/humrep/deab057 ◽

2021 ◽

Author(s):

Olga Basso ◽

Sydney K Willis ◽

Elizabeth E Hatch ◽

Ellen M Mikkelsen ◽

Kenneth J Rothman ◽

...

Keyword(s):

Risk Factors ◽

Cohort Study ◽

Maternal Age ◽

Limited Information ◽

Loss To Follow Up ◽

Older Mothers ◽

Registration Number ◽

The Usa ◽

Competing Interest

Abstract STUDY QUESTION Do daughters of older mothers have lower fecundability? SUMMARY ANSWER In this cohort study of North American pregnancy planners, there was virtually no association between maternal age ≥35 years and daughters’ fecundability. WHAT IS KNOWN ALREADY Despite suggestive evidence that daughters of older mothers may have lower fertility, only three retrospective studies have examined the association between maternal age and daughter’s fecundability. STUDY DESIGN, SIZE, DURATION Prospective cohort study of 6689 pregnancy planners enrolled between March 2016 and January 2020. PARTICIPANTS/MATERIALS, SETTING, METHODS Pregnancy Study Online (PRESTO) is an ongoing pre-conception cohort study of pregnancy planners (age, 21-45 years) from the USA and Canada. We estimated fecundability ratios (FR) for maternal age at the participant’s birth using multivariable proportional probabilities regression models. MAIN RESULTS AND THE ROLE OF CHANCE Daughters of mothers ≥30 years were less likely to have previous pregnancies (or pregnancy attempts) or risk factors for infertility, although they were more likely to report that their mother had experienced problems conceiving. The proportion of participants with prior unplanned pregnancies, a birth before age 21, ≥3 cycles of attempt at study entry or no follow-up was greater among daughters of mothers <25 years. Compared with maternal age 25–29 years, FRs (95% CI) for maternal age <20, 20–24, 30–34, and ≥35 were 0.72 (0.61, 0.84), 0.92 (0.85, 1.00), 1.08 (1.00, 1.17), and 1.00 (0.89, 1.12), respectively. LIMITATIONS, REASONS FOR CAUTION Although the examined covariates did not meaningfully affect the associations, we had limited information on the participants’ mother. Differences by maternal age in reproductive history, infertility risk factors and loss to follow-up suggest that selection bias may partly explain our results. WIDER IMPLICATIONS OF THE FINDINGS Our finding that maternal age 35 years or older was not associated with daughter’s fecundability is reassuring, considering the trend towards delayed childbirth. However, having been born to a young mother may be a marker of low fecundability among pregnancy planners. STUDY FUNDING/COMPETING INTEREST(S) PRESTO was funded by NICHD Grants (R21-HD072326 and R01-HD086742) and has received in-kind donations from Swiss Precision Diagnostics, FertilityFriend.com, Kindara.com, and Sandstone Diagnostics. Dr Wise is a fibroid consultant for AbbVie, Inc. TRIAL REGISTRATION NUMBER n/a

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Exploring the gateway hypothesis of e-cigarettes and tobacco: a prospective replication study among adolescents in the Netherlands and Flanders

Tobacco Control ◽

10.1136/tobaccocontrol-2021-056528 ◽

2021 ◽

pp. tobaccocontrol-2021-056528

Author(s):

Thomas Martinelli ◽

Math J J M Candel ◽

Hein de Vries ◽

Reinskje Talhout ◽

Vera Knapen ◽

...

Keyword(s):

The Netherlands ◽

Tobacco Use ◽

Tobacco Smoking ◽

Longitudinal Design ◽

Positive Association ◽

Cigarette Use ◽

Convenience Sample ◽

Frequent Use ◽

Never Smokers

BackgroundStudies demonstrated that adolescent e-cigarette use is associated with subsequent tobacco smoking, commonly referred to as the gateway effect. However, most studies only investigated gateways from e-cigarettes to tobacco smoking. This study replicates a cornerstone study revealing a positive association between both adolescent e-cigarette use and subsequent tobacco use; and tobacco and subsequent e-cigarette use in the Netherlands and Flanders.DesignThe longitudinal design included baseline (n=2839) and 6-month (n=1276) and 12-month (n=1025) follow-up surveys among a school-based cohort (mean age: 13.62). Ten high schools were recruited as a convenience sample. The analyses involved (1) associations of baseline e-cigarette use and subsequent tobacco smoking among never smokers; (2) associations of e-cigarette use frequency at baseline and tobacco smoking frequency at follow-up; and (3) the association of baseline tobacco smoking and subsequent e-cigarette use among non-users of e-cigarettes.FindingsConsistent with prior findings, baseline e-cigarette use was associated with higher odds of tobacco smoking at 6-month (OR=1.89; 95% CI 1.05 to 3.37) and 12-month (OR=5.63; 95% CI 3.04 to 10.42) follow-ups. More frequent use of e-cigarettes at baseline was associated with more frequent smoking at follow-ups. Baseline tobacco smoking was associated with subsequent e-cigarette use (OR=3.10; 95% CI 1.58 to 6.06 at both follow-ups).ConclusionOur study replicated the positive relation between e-cigarette use and tobacco smoking in both directions for adolescents. This may mean that the gateway works in two directions, that e-cigarette and tobacco use share common risk factors, or that both mechanisms apply.

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Efficacy of pediatric integrative manual therapy in positional plagiocephaly: a randomized controlled trial

Italian Journal of Pediatrics ◽

10.1186/s13052-021-01079-4 ◽

2021 ◽

Vol 47 (1) ◽

Author(s):

Iñaki Pastor-Pons ◽

María Orosia Lucha-López ◽

Marta Barrau-Lalmolda ◽

Iñaki Rodes-Pastor ◽

Ángel Luis Rodríguez-Fernández ◽

...

Keyword(s):

Manual Therapy ◽

Education Program ◽

Controlled Trial ◽

Asymmetry Index ◽

Trial Registration ◽

Control Group ◽

Parental Perception ◽

Positional Plagiocephaly ◽

Caregiver Education ◽

Registration Number

Abstract Background Positional plagiocephaly frequently affects healthy babies. It is hypothesized that manual therapy tailored to pediatrics is more effective in improving plagiocephalic cranial asymmetry than just repositioning and sensory and motor stimulation. Methods Thirty-four neurologically healthy subjects aged less than 28 weeks old with a difference of at least 5 mm between cranial diagonal diameters were randomly distributed into 2 groups. For 10 weeks, the pediatric integrative manual therapy (PIMT) group received manual therapy plus a caregiver education program, while the controls received the same education program exclusively. Cranial shape was evaluated using anthropometry; cranial index (CI) and cranial vault asymmetry index (CVAI) were calculated. Parental perception of change was assessed using a visual analogue scale (− 10 cm to + 10 cm). Results CVAI presented a greater decrease in PIMT group: 3.72 ± 1.40% compared with 0.34 ± 1.72% in the control group (p = 0.000). CI did not present significant differences between groups. Manual therapy led to a more positive parental perception of cranial changes (manual therapy: 6.66 ± 2.07 cm; control: 4.25 ± 2.31 cm; p = 0.004). Conclusion Manual therapy plus a caregiver education program improved CVAI and led to parental satisfaction more effectively than solely a caregiver education program. Trial registration Trial registration number: NCT03659032; registration date: September 1, 2018. Retrospectively registered.

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MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03227-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mohamad Hadi El Charif ◽

Samer Doughan ◽

Rawya Kredly ◽

Sara Kassas ◽

Rayan Azab ◽

...

Keyword(s):

Clinical Trial ◽

Wound Healing ◽

Anal Fissure ◽

Topical Therapy ◽

Trial Registration ◽

Clinical Trial Registration ◽

Anal Fissures ◽

Link Type ◽

Anorectal Region ◽

Registration Date

Abstract Background Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. Methods This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient’s global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. Discussion The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. Trial registration ClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.

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A novel MSC-based immune induction strategy for ABO-incompatible liver transplantation: a phase I/II randomized, open-label, controlled trial

Stem Cell Research & Therapy ◽

10.1186/s13287-021-02246-4 ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Yingcai Zhang ◽

Jiebin Zhang ◽

Huimin Yi ◽

Jun Zheng ◽

Jianye Cai ◽

...

Keyword(s):

Liver Transplantation ◽

Hepatic Failure ◽

Therapeutic Option ◽

Controlled Trial ◽

Trial Registration ◽

Biliary Complications ◽

Open Label ◽

Antibody Mediated Rejection ◽

Link Type ◽

Induction Strategy

Abstract Background ABO-incompatible liver transplantation (ABO-i LT) has become a rescue therapeutic option for patients with severe hepatic failure. Although the use of rituximab greatly reduces the morbidity of antibody-mediated rejection (AMR), severe adverse effects, such as infection and biliary complications, still seriously threaten the survival of transplant recipients. The aim of this study was to evaluate the safety and feasibility of using mesenchymal stem cells (MSCs) to replace rituximab in ABO-i LT. Methods Twenty-two patients with severe hepatic failure undergoing ABO-i LT were enrolled and randomly divided into two groups: the MSC group and the rituximab group. The safety of the application of MSCs and the incidence of allograft rejection, including antibody-mediated rejection (AMR) and acute cellular rejection (ACR), were evaluated in both groups at the 2-year follow-up period as primary endpoints. Recipients and graft survival and other postoperative complications were compared as secondary endpoints. Results No severe MSC-related adverse events were observed during the trial. MSC treatment yielded comparable, if not better, results than rituximab at decreasing the incidence of acute rejection (9.1% vs 27.3%). Inspiringly, compared to those in the rituximab group, the rates of biliary complications (0% vs 45.5%) and infection (9.1% vs 81.8%) were significantly decreased in the MSC group. In addition, there were no significant differences in 2-year graft and recipient survival between the two groups (81.8% vs 72.7%). Conclusions Our data show that MSC transfusion is comparable to rituximab treatment for AMR prophylaxis following ABO-i LT. Additionally, the results indicate that MSCs are more beneficial to the prevention of infection and biliary complications and may be introduced as a novel immunosuppressive approach for ABO-i LT. Trial registration Trial registration: chictr.org.cn, ChiCTR2000037732. Registered 31 August 2020- Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=57074.

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