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Asian Pacific Journal of Cancer... Jun 2024Capecitabine has been widely prescribed to treat various cancers. The hand foot syndrome (HFS) is the most troublesome adverse effect. Urea cream has been pre-emptively... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
A Randomized Single-Blinded Phase II Trial Comparing Efficacy and Quality of Life of Topical Aloe Vera Gel Plus Urea Cream Versus Urea Cream Alone for Prevention of Hand Foot Syndrome in Cancer Patients Receiving Capecitabine.
INTRODUCTION
Capecitabine has been widely prescribed to treat various cancers. The hand foot syndrome (HFS) is the most troublesome adverse effect. Urea cream has been pre-emptively co-prescribed, even though its efficacy is doubtful. Aloe vera gel with urea cream might potentiate each other. This trial was intended to prove the efficacy of this combination.
MATERIALS AND METHODS
The investigators conducted a randomized single-blinded phase II study. The participants were randomized 1:1 to receive the combination of aloe vera gel and 10% urea cream (n = 30), the experimental A+U arm and 10% urea cream alone (n = 31), the U arm. The sample size was calculated to have 90% power to show the significant 20% reduction in the incidence of HFS grade 2-3 of the combination therapy with alpha level = 0.05. Both the CTCAE criteria version 5 and the dermatology life quality index (DLQI) were assessed to determine the severity of HFS and quality of life, respectively.
RESULTS
Most of the participants had rectal cancer (A+U: 43.3%; U: 41.9%). In the A+U group, 86.7% had grade 0-1 HFS and 13.3% had grade 2-3 HFS. In the U group, 64.5% had grade 0-1 HFS and 35.5% had grade 2-3 HFS (Mann-Whitney U test, p = 0.045). Grade 2-3 HFS was significantly lower in the combination group.
CONCLUSION
Combination of aloe vera gel and 10% urea cream ameliorated the severity of HFS in participants taking capecitabine; however, no significant difference in DLQI between the groups was demonstrated.
Topics: Humans; Capecitabine; Female; Male; Middle Aged; Quality of Life; Hand-Foot Syndrome; Urea; Antimetabolites, Antineoplastic; Single-Blind Method; Plant Preparations; Prognosis; Follow-Up Studies; Adult; Administration, Topical; Aged; Neoplasms; Skin Cream; Aloe
PubMed: 38918684
DOI: 10.31557/APJCP.2024.25.6.2203 -
Asian Pacific Journal of Cancer... Jun 2024The 2x2 factorial design is an effective method that allows for multiple comparisons, especially in the context of interactions between different interventions, without... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The 2x2 factorial design is an effective method that allows for multiple comparisons, especially in the context of interactions between different interventions, without substantially increasing the required sample size. In view of the considerable preclinical evidence for Curcumin and Metformin in preventing the development and progression of head and neck squamous cell carcinoma (HNSCC), this study describes the protocol of the clinical trial towards applying the drug combination in prevention of second primary tumors.
METHODS
We have applied the trial design to a large phase IIB/III double-blind, multi-centric, placebo-controlled, randomized clinical trial to determine the safety and efficacy of Metformin and Curcumin in the prevention of second primary tumours (SPT) of the aerodigestive tract following treatment of HNSCC (n=1,500) [Clinical Registry of India, CTRI/2018/03/012274]. Patients recruited in this trial will receive Metformin (with placebo), Curcumin (with placebo), Metformin, and Curcumin or placebo alone for a period of 36 months. The primary endpoint of this trial is the development of SPT, while the secondary endpoints are toxicities associated with the agents, incidence of recurrence, and identifying potential biomarkers. In this article, we discuss the 2x2 factorial design and how it applies to the head and neck cancer chemoprevention trial.
CONCLUSION
2x2 factorial design is an effective trial design for chemoprevention clinical trials where the effectiveness of multiple interventions needs to be tested parallelly.
Topics: Humans; Metformin; Curcumin; Head and Neck Neoplasms; Double-Blind Method; Neoplasms, Second Primary; Male; Female; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Combined Chemotherapy Protocols; Middle Aged; Adult; Follow-Up Studies; Prognosis; Research Design; Aged; Randomized Controlled Trials as Topic
PubMed: 38918654
DOI: 10.31557/APJCP.2024.25.6.1935 -
Asian Pacific Journal of Cancer... Jun 2024Exposure to noise by generation of free radicals causes oxidative stress in body. The aim of this study was the evaluation of oxidative stress in workers who have used...
BACKGROUND AND OBJECTIVE
Exposure to noise by generation of free radicals causes oxidative stress in body. The aim of this study was the evaluation of oxidative stress in workers who have used hearing protection devices during working time.
MATERIAL AND METHOD
Pressing workers (n=24) of a home appliance industry were studied using hearing protection devices to reduce noise exposure. Twenty two office staff (without exposure to noise) were considered as a control group. Two groups were matched for age, work experience and smoking. Exposure to noise was measured by dosimeter method at workstations. By obtaining 3 ml blood sample, Malondialdehyde levels, Thiol groups and total antioxidant capacity were evaluated in all subjects.
RESULTS
Exposure to sound pressure level in pressing workers by considering the noise reduction factor of the earplug was observed in 77.65 dB with minimum 75.1 dB and Maximum 81.22 dB. Plasma thiol groups (0.076 (0.041-0.119) vs (0.110 (0.076-0.197), mmol/l P =0.0001) and total antioxidant capacity (361.33± 54.65 vs 414.14± 96.82, µmol/ml P = 0.026) in pressing workers significantly decreased than control group. Pearson correlation showed significant results between exposure to noise and oxidative stress parameters.
CONCLUSION
Exposure to noise wave cause oxidative stress in different site of body. Oxidative stress is an intermediate way for different disease due to noise exposure. Reducing of noise exposure by earplug in pressing workers is not efficient protection for oxidative stress generation. Therefore, hearing protection devices are not a barrier to the harmful effects of noise in occupational exposure.
Topics: Humans; Oxidative Stress; Occupational Exposure; Adult; Male; Noise, Occupational; Case-Control Studies; Ear Protective Devices; Hearing Loss, Noise-Induced; Antioxidants; Middle Aged; Follow-Up Studies; Malondialdehyde; Female; Occupational Diseases; Industry; Prognosis
PubMed: 38918653
DOI: 10.31557/APJCP.2024.25.6.1929 -
Hong Kong Medical Journal = Xianggang... Jun 2024
Topics: Humans; Hong Kong
PubMed: 38918067
DOI: 10.12809/hkmj245162 -
Asian Spine Journal Jun 2024A retrospective cohort study using the Kaplan-Meier method with propensity-score matching.
Prevalent morphometric vertebral fractures as a risk factor for subsequent clinical vertebral fractures after shortfusion surgery in older Japanese women with degenerative spondylolisthesis.
STUDY DESIGN
A retrospective cohort study using the Kaplan-Meier method with propensity-score matching.
PURPOSE
To evaluate whether the presence of prevalent morphometric vertebral fractures (VFs) poses a risk for subsequent clinical VFs after short-fusion surgery in women aged ≥60 years with degenerative spondylolisthesis.
OVERVIEW OF LITERATURE
VFs are common osteoporotic fractures and are associated with a low quality of life. Subsequent VFs are a complication of instrumented fusion in patients with degenerative lumbar disorders. Thus, risk factors for subsequent VFs after fusion surgery must be analyzed. Population-based studies have suggested that prevalent morphometric VFs led to a higher incidence of subsequent VFs in postmenopausal women; however, no studies have investigated whether prevalent morphometric VFs are a risk factor for subsequent VFs after fusion surgery in patients with degenerative spondylolisthesis.
METHODS
The study enrolled a total of 237 older female patients: 50 and 187 patients had prevalent morphometric VFs (VF [+] group) and nonprevalent morphometric VFs (VF [-] group), respectively. The time to subsequent clinical VFs after fusion surgery was compared between the two groups using the Kaplan-Meier method. Moreover, 40 and 80 patients in the VF (+) and VF (-) groups, respectively, were analyzed and matched by propensity scores for age, follow-up duration, surgical procedure, number of fused segments, body mass index, and number of patients treated for osteoporosis.
RESULTS
Kaplan-Meier analysis indicated that the VF (+) group had a higher incidence of subsequent clinical VFs than the VF (-) group, and Cox regression analysis showed that the presence of prevalent morphometric VFs was an independent risk factor for subsequent clinical VFs before matching. Kaplan-Meier analysis demonstrated comparable results after matching.
CONCLUSIONS
The presence of prevalent morphometric VFs may be a risk factor for subsequent clinical VFs in older women with degenerative spondylolisthesis who underwent short-fusion surgery.
PubMed: 38917857
DOI: 10.31616/asj.2023.0327 -
International Journal of Surgery Case... Jun 2024Large cell neuroendocrine carcinomas of the colon (LCNECC) are exceptionally rare, comprising only 0.2 % of all colonic carcinomas. Their diagnosis poses a significant...
INTRODUCTION AND IMPORTANCE
Large cell neuroendocrine carcinomas of the colon (LCNECC) are exceptionally rare, comprising only 0.2 % of all colonic carcinomas. Their diagnosis poses a significant challenge due to their propensity to mimic colonic adenocarcinomas. Typically diagnosed at advanced stages, LCNECCs carry a grim prognosis. Herein, we present a rare case of LCNECC and aim to elucidate its clinico-pathological characteristics.
CASE PRESENTATION
A 56-year-old female patient presented with complaints of constipation, abdominal pain, and weight loss. On physical examination, a sizable mass was palpable in the right flank. Colonoscopy revealed a polyp in the descending colon and a friable multinodular stenosing mass in the ascending colon. Microscopic examination of the biopsy from the ascending colon mass exhibited a poorly differentiated large cell carcinomatous proliferation with positivity for synaptophysin and CD56, along with a Ki-67 proliferation index of 50 %. The polyp in the descending colon was consistent with a low-grade dysplastic tubular adenoma. A diagnosis of LCNECC with synchronous low-grade dysplastic tubular adenoma was established. A right hemicoloctomy was performed. Final pathological examination confirmed LCNECC invading the muscularis propria, with lymph node metastases. The tumor was classified as pT2N1M0 (Stage III).
CLINICAL DISCUSSION
LCNECCs often mimic adenocarcinomas clinically, endoscopically, and radiologically. Pathological examination is the key for diagnosis. An immunohistochemical study using neuroendocrine markers is imperative to prevent overlooking the diagnosis of LCNECC.
CONCLUSION
LCNECCs represent rare aggressive carcinomas. Their diagnosis might be challenging. A better knowledge of this rare entities would enable early diagnosis.
PubMed: 38917703
DOI: 10.1016/j.ijscr.2024.109929 -
Poultry Science Jun 2024This systematic review aimed at investigating the role that biosecurity can have in preventing or controlling colibacillosis in broiler production. Primary studies with...
This systematic review aimed at investigating the role that biosecurity can have in preventing or controlling colibacillosis in broiler production. Primary studies with natural or experimental exposure to avian pathogenic Escherichia coli, evaluating any biosecurity measure to prevent or control colibacillosis in broiler chickens with at least one of the following outcomes: feed conversion ratio (FCR), condemnations at slaughter, and mortality due to colibacillosis, were included. A systematic search was carried out in 4 databases according to the Cochrane handbook and reported following the PRISMA 2020 directions. Studies (n = 3,886) were screened in a 2-phase process and data matching the inclusion criteria were extracted. Risk of bias assessment was performed. Four studies reporting biosecurity measures to prevent or control colibacillosis in broiler production were included. In all studies, only disinfection during either the pre-hatching period (n = 3) or the post-hatching period (n = 1) was evaluated as biosecurity measure in broiler production, as well as its effect on FCR (n = 2) and mortality (n = 4) due to colibacillosis. No studies with effects on condemnations at slaughter were found. Due to the heterogeneity of studies in regard to interventions and outcomes, meta-analysis was not carried out. The limited findings of this systematic review do not provide a comprehensive evidence to statistically evaluate the efficacy of biosecurity to prevent or control colibacillosis in broiler production. The scarcity of evidence found suggests that further and deeper investigations on the topic are needed, considering the variety of interventions related to biosecurity.
PubMed: 38917608
DOI: 10.1016/j.psj.2024.103955 -
PLoS Neglected Tropical Diseases Jun 2024Severe fever with thrombocytopenia syndrome (SFTS) is an emerging tick-borne disease with susceptibility influenced by meteorological factors. However, there is limited...
BACKGROUND
Severe fever with thrombocytopenia syndrome (SFTS) is an emerging tick-borne disease with susceptibility influenced by meteorological factors. However, there is limited understanding of the delayed and interactive impacts of meteorological factors on SFTS incidence.
METHODS
Daily incidence data of SFTS and corresponding meteorological factors for the Jiaodong Peninsula in northeast China were collected from January 1, 2014, to December 31, 2020. Random forest regression model, based on custom search, was performed to compare the importance of meteorological factors. Generalized additive model with quasi-Poisson regression was conducted to examine the nonlinear relationships and interactive effects using penalized spline methods. A distributed lag nonlinear model with quasi-Poisson regression was constructed to estimate exposure-lag effects of meteorological factors.
RESULTS
The most important meteorological factor was weekly mean lowest temperature. The relationship between meteorological factors and SFTS incidence revealed a nonlinear and intricate pattern. Interaction analyses showed that prolonged sunshine duration posed a climatic risk within a specific temperature range for SFTS incidence. The maximum relative risk (RR) observed under extremely low temperature (-4°C) was 1.33 at lag of 15 week, while under extremely high temperature (25°C), the minimum RR was 0.65 at lag of 13 week. The RRs associated with both extremely high and low sunshine duration escalated with an increase in lag weeks.
CONCLUSIONS
This study underscores that meteorological factors exert nonlinear, delayed, and interactive effects on SFTS incidence. These findings highlight the importance of understanding the dependency of SFTS incidence on meteorological factors in particular climates.
PubMed: 38917232
DOI: 10.1371/journal.pntd.0012266 -
PloS One 2024Births at advanced maternal ages (≥ 35 years) are increasing. This has been associated with a higher incidence of placenta previa, which increases bleeding risk....
BACKGROUND
Births at advanced maternal ages (≥ 35 years) are increasing. This has been associated with a higher incidence of placenta previa, which increases bleeding risk. Hybrid operating rooms, designed to accommodate interventions and cesarean sections, are becoming more prominent because of their dual capabilities and benefits. However, they have been associated with increased postoperative hypothermia in pediatric settings; moreover, this has not been studied in pregnant women with placenta previa.
METHODS
This retrospective cohort study included pregnant women diagnosed with placenta previa who underwent elective cesarean section under general anesthesia between May 2019 and 2023. The patients were categorized according to the operating room type. The primary outcome was to determine whether the hybrid operating room is a risk factor for immediate postoperative hypothermia, defined as a tympanic membrane temperature below 36.0°C. The secondary outcomes were the effects of immediate postoperative hypothermia on the durations of postanesthetic care unit and postoperative hospital stays and incidence of complications.
RESULTS
Immediate postoperative hypothermia (tympanic membrane temperature < 36.0°C) was more prevalent in the hybrid than in the standard operating room group (20% vs. 36.6%, p = 0.033), with a relative risk of 2.86 (95% confidence interval 1.24-6.64, p < 0.001). Patients undergoing surgery in the hybrid operating room who experienced immediate postoperative hypothermia stayed longer in the postanesthetic care unit (26 min vs. 40 min, p < 0.001) and in the hospital after surgery (4 days; range 3-5 vs. 4 days; range 4-11, p = 0.021). However, the complication rates of both groups were not significantly different (11.3% vs 7.3%, p = 0.743).
CONCLUSION
Hybrid operating rooms may increase the risk of postoperative hypothermia. Postoperative hypothermia is associated with prolonged postanesthetic care unit and hospital stays. Preventing hypothermia in patients in hybrid operating rooms is of utmost importance.
Topics: Humans; Female; Pregnancy; Hypothermia; Retrospective Studies; Operating Rooms; Adult; Postoperative Complications; Cesarean Section; Risk Factors; Placenta Previa; Anesthesia, General
PubMed: 38917215
DOI: 10.1371/journal.pone.0305951 -
PloS One 2024Previous research has indicated the suitability of behavioural activation (BA) as an intervention for reducing depression in older adults. However, little research has...
Previous research has indicated the suitability of behavioural activation (BA) as an intervention for reducing depression in older adults. However, little research has investigated the potential of BA to increase active engagement and well-being in older adults. The current pilot study sought to investigate the usefulness and acceptability of BA to promote well-being in a group of non-clinical older adults. Participants (N = 18) aged between 65 and 86 (M = 77.82, SD = 5.59) who were retired and living independently in the community were provided a 6-week BA program predominantly delivered online. Treatment retention, self-ratings, and participants' compliance to treatment principles indicate preliminary feasibility for the use of BA as an approach for increasing active engagement in older adult populations. Participants also provided feedback on their experiences with the program post-intervention via individual structured interviews. Thematic analysis of these data revealed that participants found the program to be beneficial in terms of increased self-awareness and social engagement, and provided several recommendations for improving acceptability of the program and workbook. The unexpected events relating to the first wave of the novel coronavirus (COVID-19) led to necessary adaptations to delivery modalities, and provided the researchers with an opportunity to investigate the use of a structured well-being program on a high-risk population during a pandemic. Our findings support the proposition that BA is a suitable intervention for increasing engagement and well-being in older adults, provide insight into adapting programs for older adults, and suggest next steps for testing intervention efficacy.
Topics: Humans; Aged; Pilot Projects; Male; Female; Aged, 80 and over; COVID-19; SARS-CoV-2; Depression; Behavior Therapy
PubMed: 38917213
DOI: 10.1371/journal.pone.0305908