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DATA AVAILABILITY
The source data (containing the subjects personal information) that support the findings of this study are available from Jiangsu Hansoh Pharmaceutical Group Co., Ltd. Restrictions apply to the availability of these data, which were used under license for this study. Data are available from Shuwen Yu with the permissio...
PMC10720486
SUPPLEMENTAL MATERIAL
The following material is available online at
PMC10720486
aac.01075-23-s0001.docx
Criteria for inclusion and exclusion and Tables S1 and S2.Click here for additional data file.ASM does not own the copyrights to Supplemental Material that may be linked to, or accessed through, an article. The authors have granted ASM a non-exclusive, world-wide license to publish the Supplemental Material files. Plea...
PMC10720486
REFERENCES
PMC10720486
Background
skin cancer
DISEASE, SKIN CANCER, OF SKIN CANCER
Incidence of skin cancer has been increasing among U.S. Hispanics, who often are diagnosed with larger lesions and at later stage disease. Behaviors to decrease exposure to ultraviolet radiation can reduce risk of skin cancer. We describe skin cancer prevention behaviors and psychosocial variables among Hispanic partic...
PMC10644628
Methods
REGRESSION
Self-reported Hispanic participants from eight primary care clinics in Tampa, Florida and Ponce, Puerto Rico were recruited into a randomized controlled prevention trial. Information on demographics, sun-related behaviors, and psychosocial variables were collected before intervention materials were provided. Multivaria...
PMC10644628
Results
sunburned, skin cancer, sunburn
SKIN CANCER
Participants reported low levels of intentional outdoor tanning, weekday and weekend sun exposure, and very low levels of indoor tanning. However, only a minority of participants practiced sun-protective behaviors often or always, and about 30% experienced a sunburn in the past year. Participants had low levels of rece...
PMC10644628
Conclusions
skin cancer
SKIN CANCER
Our results mirror previous observations of low levels of sun-protective behavior among U.S. Hispanics compelling the need for culturally appropriate and translated awareness campaigns targeted to this population. Because Hispanics in Tampa and Puerto Rico reported modest levels of perceived risk and severity, and high...
PMC10644628
Keywords
PMC10644628
Background
melanoma, SCC, basal cell carcinoma, skin cancer, skin cancer-related psychosocial variables
MELANOMA, BCC, SKIN CANCER, OF SKIN CANCER, SQUAMOUS CELL CARCINOMA, BASAL CELL CARCINOMAS
Incidence rates of skin cancer, including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma, have risen among U.S. Hispanics over the past several decades [The major environmental risk factor common to melanoma, SCC, and BCC is exposure to ultraviolet radiation [One of the strongest predictors of ...
PMC10644628
Methods
PMC10644628
Participants
HD, Damas, melanoma
BCC, MELANOMA
Full details and efficacy results of the intervention trial have been published (Lacson et al., 2022). Briefly, we recruited participants from eight primary care clinics in Tampa, FL (hereafter referred to as Tampeños), and Ponce, Juana Díaz, and Salinas, PR (Puerto Ricans) between September 2018 and January 2020. Part...
PMC10644628
Study questionnaires
cancers, ’s cancer worry, melanoma, cancer, skin cancer
CANCER, CANCERS, SKIN CANCER, MELANOMA
The baseline questionnaire (A) was completed using tablet computers while participants were in clinic, or a paper copy and prepaid envelope were given to participants who preferred to complete it at home. Baseline questionnaire A solicited information on age, sex, marital status, educational level, family history of me...
PMC10644628
Statistical analyses
sunburned, ’s cancer worry, melanoma, sunburn, sunburns, skin cancer
REGRESSION, SKIN CANCER, MELANOMA
All participants who completed baseline questionnaire were included in these analyses, regardless of whether they contributed further to the intervention study. Differences in baseline participant characteristics across groups defined by geography and language (English-preferring Tampeños, Spanish-preferring Tampeños, ...
PMC10644628
Results
SD
Of 974 participants who consented to the study, 944 (96.9%) completed baseline questionnaire A, including 497 Tampeños (121 Spanish-preferring and 376 English-preferring) and 447 Puerto Ricans (440 Spanish-preferring and 7 English-preferring). Of these, 795 (84.2%) completed supplemental questionnaire B. Overall, the m...
PMC10644628
Behaviors, beliefs, distress, and worry in the overall study population
intentional tanning, sunburned, sunburn, sunburns, SD, skin cancer worry, skin cancer
SKIN CANCER, OF SKIN CANCER
Participants reported an average of 1.70 h/day (SD = 1.62) of weekday sun exposure, 2.02 h/day (SD = 1.62) of weekend sun exposure, and rare outdoor intentional tanning (M = 1.65, SD = 0.87) over the past year. Nearly a third of participants (29.7%) reported ever having a sunburn in the past 12 months, with an average ...
PMC10644628
Comparison of behaviors, beliefs, distress, and worry across groups defined by geographic location and language preference
cancers, skin cancer
CANCERS, SKIN CANCER
Crude differences in behaviors, beliefs, distress, and worry across Spanish-preferring Tampeños, English-preferring Tampeños, Spanish-preferring Puerto Ricans, and English-preferring Puerto Ricans are presented in Table After adjustment for age, sex, marital status, education, race, ethnic identity, family history of o...
PMC10644628
Discussion
sunburned, sunburn, sunburns, indoor intentional tanning, skin cancer, low skin cancer worry
STRUCK, SKIN CANCER
We found low to modest baseline levels of weekday and weekend sun exposure and outdoor and indoor intentional tanning among our Hispanic participants. However, about 30% of our participants reported having a sunburn in the past 12 months, with an average of almost two sunburns among those ever sunburned; and most parti...
PMC10644628
Conclusions
skin cancer, sunburn
SKIN CANCER
Although Hispanics in Florida and Puerto Rico have low levels of risky sun-related behavior, they also have suboptimal levels of sun-protective behavior and had a high occurrence of sunburn in the past year. Thus, we recommend culturally appropriate Spanish-language awareness campaigns about skin cancer risk targeted a...
PMC10644628
Acknowledgements
We thank the patients at the USF Morsani Family Medicine and General Internal Medicine Clinics, the Suncoast Community Health Centers of Brandon and Palm River, Hospital Damas, Ponce Health Sciences University Wellness Center, Juana Díaz Wellness Center, and Centro Médico Salinas for their interest in our study, and th...
PMC10644628
Authors' contributions
Conceptualization, P.A.K.; data curation, J.C.A.L., S.H.D.; formal analysis, J.C.A.L., S.H.D., P.A.K.; funding acquisition, B.S.T., P.A.K.; investigation, S.T.V.; methodology, J.C.A.L., Y.K., S.K.S., P.A.K.; supervision, R.R., S.T.V., B.S.T., P.A.K.; validation, J.C.A.L.; visualization, J.C.A.L.; writing—original draft...
PMC10644628
Funding
Cancer
CANCER
This work was supported by the National Cancer Institute Ponce Health Sciences University-Moffitt Cancer Center Partnership (U54 CA163071 and U54 CA163068). This work also was supported, in part, by the Tissue, Molecular Genomics, and Biostatistics and Bioinformatics Shared Resources at the H. Lee Moffitt Cancer Center...
PMC10644628
Availability of data and materials
Data used in this manuscript can be obtained upon request from the corresponding author.
PMC10644628
Declarations
PMC10644628
Ethics approval and consent to participate
Damas
All participants gave written informed consent. The study was conducted based on the Declaration of Helsinki and was approved by the Institutional Review Boards of the University of South Florida (Tampa, FL; Pro00020044, approved August 30, 2018), Ponce Health Sciences University (Ponce, PR; 170807-BS, approved Decembe...
PMC10644628
Consent for publication
Not applicable.
PMC10644628
Competing interests
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
PMC10644628
References
PMC10644628
Subject terms
Sjogren’s Syndrome, pSS
The purpose of this trial was to clinically assess the effect and safety of Adipose Tissue-derived Stem Cells (ADSCs) treatment on primary Sjogren’s Syndrome (pSS). In this 6-month randomized, triple-blind, placebo-controlled clinical trial, pSS patients were randomly assigned to two groups. After demographic character...
PMC10439962
Introduction
SS, pSS, autoimmune chronic disease, Sjogren’s syndrome, dryness of mouth, exocrine glandular dysfunction
INFILTRATION, AUTOIMMUNE DISEASE
Sjogren’s syndrome (SS) is a systemic autoimmune chronic disease characterized by marked exocrine glandular dysfunction such as salivary and lachrymal glands, presenting a persistent dryness of mouth and eyespSS has a very heterogeneous clinical presentations and the etiology has not been fully elucidated. Infiltration...
PMC10439962
Methods
PMC10439962
Ethical statement
This trial was conducted in full accordance with the 2010 CONSORT guidelines of the World Medical Association Declaration of Helsinki. The study protocol was approved by the Ethic Committee of the the Affiliated Huai'an Hospital of Xuzhou Medical University (institutional approval number: HEYLL2020325). It was register...
PMC10439962
Participants
sarcoidosis, pSS, ’s Syndrome, amyloidosis, glaucoma, head and neck radiation, Systemic lupus erythematosus
SARCOIDOSIS, POSITIVE, ACQUIRED IMMUNODEFICIENCY SYNDROME, GRAFT VERSUS HOST DISEASE, DISEASE, LYMPHOCYTIC INFILTRATION, HEPATITIS C INFECTION, SYNDROMES, AMYLOIDOSIS, GLAUCOMA, IGG4-RELATED DISEASE, RHEUMATOID ARTHRITIS, SYSTEMIC LUPUS ERYTHEMATOSUS
Patients were consecutively recruited referred to Department of Rheumatology, Stomatology and Ophthalmology, Affiliated Huai'an Hospital of Xuzhou Medical University. Eligible patients were diagnosed as having pSS according to the American College of Rheumatology (ACR) Diagnostic Criteria for Sjögren’s Syndrome. At lea...
PMC10439962
Randomization and masking
Patients were assigned to two groups via a computer-generated randomization schedule. The ADSCs Group was injected with ADSCs while Placebo Group was received 0.9% saline solution administration. Concealed allocated codes were kept in signed and sealed envelopes. An external investigator performed the randomization. In...
PMC10439962
Sample size analysis
Sample size analysis using G Power version3.1.9.2 was determined with Walters’s method by considering two groups of subjects, an effect size of 0.30 and a standard deviation of 1.7 by a previous randomized controlled clinical study. With an assumption of normal sample distribution, we set power of 0.8 and an error of
PMC10439962
The preparation of ADSCs
The drug in this trial was a solution of ADSCs. Adipose tissues were harvested with liposuction of abdomen from a healthy donor. They are washed in phosphate-buffered saline (PBS) and digested of fat aspirates with 0.075% collagenase. These stem cells were then packed in dimethyl sulfoxide and human platelet lysate and...
PMC10439962
Procedures
STERILE
The final therapeutic drug solution was composed of 5 million cells per milliliter of solution. After disinfecting the surface projection of bilateral parotid glands with Iodophor and draping in a sterile fashion, the injection site was anesthetized with 1% lidocaine. A dose of 1 ml ADSCs solution was diluted in 5 ml 0...
PMC10439962
Outcome measures
PMC10439962
Sialometry
STERILE
Patients were asked to attend at 8:00–10:00 am in the same room with constant temperature and humidity to minimize diurnal variation. Eating/chewing, drinking and brushing teeth were refrained 90 min prior to each appointment. After resting for 10 min, unstimulated whole saliva (UWS) was collected by a sterile and pre-...
PMC10439962
Schirmer I test
We introduced the Schirmer I test to measure lacrimal flow (LF) without previous topical anesthetic to measure the tear secretion. A Whatman special filter paper strip of 20 mm*5 mm (Cytiva®, Shanghai, China) were placed in the lateral 1/3 of the lower bilateral eyelid. The length of the moistened portion of the strip ...
PMC10439962
ESSDAI and ESSPRI
’s Syndrome Disease Activity, dryness, fatigue, pain
DISEASE, DISEASE, RHEUMATISM
Disease activity was assessed using and European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index (ESSDAI). These questionnaires were filled out by the patients at baseline and the follow-ups. The ESSDAI includes 12 domains, including cutaneous, respiratory, kidney, articular, muscular, peripheral ne...
PMC10439962
Immunological indexes
’ venous blood samples
Patients’ venous blood samples were drawn at 6:00–8:00 am prior to administration of ADSCs injection and at each follow-up. Serum samples were transported at − 20 °C and kept at − 80 °C in a freezer until analysis. Immunological indexes, including IgA, IgG, IgM, complement 3 (C3), complement 4 (C4) and erythrocyte sedi...
PMC10439962
Safety assessments
ADVERSE EVENTS
To evaluate safety and toxic effects, clinical laboratory values, vital sign, physical examination and 12-lead electrocardiography were recorded at baseline and follow-ups. A treatment-emergent adverse events (AE) was defined as any untoward symptom, occurred from the first dose of medication until the end of the study...
PMC10439962
Statistical analysis
In this study, data were statistically analyzed using SPSS v20.0 software (IBM Corp, Armonk, NY, USA) and visualized using GraphPad Prism 7 (GraphPad Software Inc., La Jolla, CA, USA). The demographic and health status information at baseline was summarized using Means (Standard Deviation, SD) for continuous variables ...
PMC10439962
Discussion
pSS, itching sensation
ADVERSE EVENTS, PATHOGENESIS, SYSTEMIC LUPUS ERYTHEMATOSUS, OTHER AUTOIMMUNE DISEASE
This is a triple-blinded clinical trial aiming at the effect of ADSCs treatment on pSS patients. In general, the results of our study indicate that ADSCs improved the symptoms in to a certain extend objectively and subjectively. The dysfunction of salivary and lachrymal glands was significantly improved in a short peri...
PMC10439962
Author contributions
F.L. designed the trial, analyzed the clinical data and wrote the manuscript as first author. J.L., X.S., D.L., T.Z. contributed to clinical therapy and follow-up evaluation. T.J. analyzed the clinical data, S.W. analyzed the clinical data, edited and reviewed the manuscript.
PMC10439962
Competing interests
The authors declare no competing interests.
PMC10439962
References
PMC10439962
Materials and methods
MAY
We conducted a cluster randomized controlled trial in 45 administrative Locations (clusters) in Nyanza Region between May 2014 and June 2016 among uncircumcised men aged 25–34 years. In arm one, an IPC toolkit was used to address barriers to VMMC. In the second arm, men were referred to DSO that were modified to addres...
PMC9897540
Results
At baseline, 9,238 households with men aged 25–39 years were enumerated, 9,679 men were assessed, and 2,792 (28.8%) were eligible. For enrollment, 577 enrolled in the IPC arm, 825 in DSO, 723 in combined IPC + DSO, and 667 in SOC. VMMC uptake among men in the SOC arm was 3.2%. In IPC, DSO, and combined IPC + DSO arms, ...
PMC9897540
Discussion
Using these interventions among men aged 25–39 years did not significantly impact VMMC uptake. These findings suggest that alternative demand creation strategies for VMMC services are needed to reach men aged 25–39 years.
PMC9897540
Trial registration
clinicaltrials.gov identifier:
PMC9897540
Data Availability
All relevant data are within the paper and its
PMC9897540
Introduction
infections
INFECTIONS
Male circumcision (MC) has been demonstrated to reduce female-to-male transmission of HIV by approximately 60% in randomized controlled trials [Kenya’s Ministry of Health began implementing voluntary medical male circumcision (VMMC) for HIV prevention services in 2008, with a four-year goal of increasing the proportion...
PMC9897540
Intervention groups
pain
COMPLICATIONS
Those residing in the intervention clusters (IPC, DSO, and combined IPC + DSO) were reached with the respective intervention within two weeks of study enrollment. For the IPC arm, we developed a toolkit consisting of common barriers and facilitators related to VMMC based on a literature review and from TASCO’s formativ...
PMC9897540
Statistical methods
PMC9897540
Sample size calculation
A previous demand creation and HIV community-based study found that circumcision prevalence among men aged 25–49 years in sub-Locations included in our study area was 35.6% [
PMC9897540
Statistical analyses
We summarized baseline characteristics at individual level stratified by study arm. Categorical variables were summarized using counts and proportions with Rao-Scott Chi-square [
PMC9897540
Results
MAY
Between May 2014 and June 2016, 9,238 households with men aged 25–39 years were enumerated, from which 9,679 men were screened and 2,792 (28.8%) enrolled in the study. The main reasons for men not enrolling included already being circumcised (41.3%), planning to move away from the study area (18.4%), ineligibility due ...
PMC9897540
Participant screening, enrollment, and follow-up.
*Clinicaltrials.gov incorrectly lists the number of participants “actually enrolled” as 2,785, which is incorrect, as 2,792 participants were enrolled into the study.In all arms at baseline, most uncircumcised men were married, Christian, had completed up to primary level education, and employed. Baseline socio-demogra...
PMC9897540
Baseline socio-demographic characteristics of uncircumcised men by study arm.
The proportion of VMMC uptake documented at the service delivery sites or via home visits among enrolled men aged 25–39 years within 3 months of enrollment in the standard of care arm was 3.2%. In the IPC, DSO, and the combined IPC + DSO arms, VMMC uptake was 3.3%, 4.5%, and 4.4%, respectively. There were no significan...
PMC9897540
Analysis of the effects of the interventions on uptake of VMMC three months after enrollment.
*Adjusted for baseline factors: age, marital status, religion, education and employment.** Men who underwent VMMC who were verified to have enrolled in the study via referral coupon, names, national identification, and/or phone number
PMC9897540
Discussion
This cluster randomized trial did not provide sufficient evidence that targeted demand creation strategies for men aged 25–39 years were effective at significantly increasing the odds of VMMC uptake among men aged 25–39 years in the Nyanza Region of western Kenya. Overall VMMC uptake across each of the four study arms ...
PMC9897540
Supporting information
PMC9897540
CONSORT 2010 checklist of information to include when reporting a cluster randomised trial.
(DOCX)Click here for additional data file.
PMC9897540
TASCO locations by randomization into the 4 study arms.
This map was generated by the implementing partner, IRDO, and was previously published in another manuscript related to this study: (DOC)Click here for additional data file.(DOCX)Click here for additional data file.The authors wish to thank the study participants for giving their time to take part in this study. And we...
PMC9897540
References
PMC9897540
Background
non-alcoholic
The use of alcohol-flavored beverages not containing alcohol (hereinafter referred to as non-alcoholic beverages) is recommended to reduce alcohol consumption. However, it is unclear if this reduces excessive drinking.
PMC10544561
Objective
non-alcoholic beverages
To verify whether non-alcoholic beverages impact the alcohol consumption of excessive drinkers.
PMC10544561
Study design
Single-center, open-label, randomized, parallel-group study.
PMC10544561
Methods
non-alcoholic, alcoholism
Participants aged 20 years or older who were not diagnosed with alcoholism, who drank at least four times a week, and whose alcohol consumption on those days was at least 40 g in males and 20 g in females, were recruited. Participants were randomized into the intervention or control group by simple randomization using ...
PMC10544561
Results
Fifty-four participants (43.9%) were allocated to the intervention group and 69 (56.1%) to the control group. None of the participants in the intervention group dropped out, compared to two (1.6%) in the control group. The change in alcohol consumption was − 320.8 g (standard deviation [SD], 283.6) in the intervention ...
PMC10544561
Conclusions
non-alcoholic beverages
Providing non-alcoholic beverages significantly reduced alcohol consumption, an effect that persisted for 8 weeks after the intervention.
PMC10544561
Trial registration
UMIN UMIN000047949. Registered 4 June 2022.
PMC10544561
Supplementary Information
The online version contains supplementary material available at 10.1186/s12916-023-03085-1.
PMC10544561
Keywords
PMC10544561
Background
non-alcoholic beverages
Excessive alcohol consumption is a global public health issue. In 2020, an estimated 1.34 billion people (1.03 billion males and 310 million females) consumed a harmful amount of alcohol [In Japan, efforts to reduce excessive drinking have been made through Health Japan 21, a program that constitutes Japan’s primary pr...
PMC10544561
Methods
PMC10544561
Study design
This was a single-center, open-label, randomized, parallel group study.
PMC10544561
Participants
With reference to preceding studies [
PMC10544561
Setting
non-alcoholic beverages, alcoholism
MAY
The survey was conducted from May 2022 to January 2023. Participants were recruited from May 30 to July 15, 2022, through the employee website of the University of Tsukuba, by putting up flyers inside and outside the University of Tsukuba campus, and by snowball sampling by the study personnel. The participants were ra...
PMC10544561
Intervention
non-alcoholic
During the 12-week intervention period, free non-alcoholic beverages were provided once every 4 weeks (three times in total). Each case included 24 350-mL bottles. Up to three cases were provided at a time, with the exact number depending on each participant’s preference. Participants selected beverages from among 22 p...
PMC10544561
Measurement
HED, non-alcoholic, ®
The self-administered questionnaire used in the briefing included questions regarding basic attributes such as age, sex, race, marital status, the highest level of education, employment status, household income, smoking history, and subjective view of health [As genetic information related to alcohol metabolism, the ge...
PMC10544561
Outcome
The primary endpoint was the change in total alcohol consumption from baseline during the past 4 weeks at Week 12 [
PMC10544561
Sample size
The necessary sample size was calculated based on the effect size of the change in alcohol consumption (Cohen’s
PMC10544561
Randomization and blinding
non-alcoholic, non-alcoholic beverages
A random number table was used to perform simple randomization and to select the number of participants in the intervention group. After the eligibility and exclusion criteria were confirmed and consent was obtained, participants were allocated into either the intervention or control group and notified of the randomiza...
PMC10544561
Statistical methods
The available data of all participants were included according to the original allocation in an intention-to-treat analysis. The unsubmitted data of the participants who dropped out were treated as missing data. The normality of the data was evaluated by the Kolmogorov–Smirnov test. Intergroup comparisons of baseline d...
PMC10544561
Discussion
non-alcoholic, alcoholism, non-alcoholic beverages consumed, non-alcoholic beverage, alcohol-related problems, non-alcoholic beverages
DISORDER
In this study, the provision of free non-alcoholic beverages for 12 weeks significantly reduced alcohol consumption. In the intervention group, this effect persisted not only during the intervention period but also up to 8 weeks following completion of the 12-week intervention. Our study is the first to suggest that pr...
PMC10544561
Conclusions
non-alcoholic beverages
Our results suggested that providing free non-alcoholic beverages was associated with significantly reduced alcohol consumption. This effect persisted for 8 weeks after the completion of the intervention. Providing non-alcoholic beverages may be a strategic option for reducing alcohol consumption among people with exce...
PMC10544561
Acknowledgements
The authors thank all participants in this study.
PMC10544561
Authors’ contributions
H.Y. conceived and designed the study. H.Y., K.K., G.S., and Y.O. performed the intervention and data collection. S.D. analyzed the data. All authors interpreted the data. H.Y. and S.D. drafted the manuscript. S.D. prepared the table and figures. K.K., G.S., and Y.O. revised it critically for important intellectual con...
PMC10544561
Funding
This study was conducted jointly with Asahi Breweries, Ltd., which provided funding.
PMC10544561
Availability of data and materials
Not applicable.
PMC10544561
Declarations
PMC10544561
Ethics approval and consent to participate
This study was conducted after approval by the ethics committee of the University of Tsukuba (Notification Number G299) and written informed consent was provided prior to participation.
PMC10544561
Consent for publication
Not applicable.
PMC10544561
Competing interests
H.Y. received research funding from Asahi Breweries. H.Y. also received them from Sanwa Shurui, which is not related to the conduct of our study. Study planning and conduct, data analysis, and writing of the manuscript were performed only by the investigators, independently from the company, under the supervision and i...
PMC10544561
References
PMC10544561
1. Introduction
obesity, health-risk behaviors, adiposity, overweight or obesity, sedentary behaviors
OBESITY, CHILDHOOD OBESITY, ADIPOSITY
Some studies have found associations between the peer network and childhood obesity. The present study aimed to analyze the association of the peer network with obesity-related cognition, behaviors and adiposity indicators, and explore whether peer network influences the effect of a childhood-obesity intervention. Base...
PMC10574409
2. Methods
PMC10574409