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PURPOSE: Oral mucositis (OM) is a common debilitating toxicity associated with radiotherapy (RT) for malignant head and neck tumors. This prospective, randomized, double-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of Streptococcus salivarius K12 (SsK12) in reducing the incidence, duration, and severity of severe OM (SOM). METHODS: A total of 160 patients with malignant head and neck tumors undergoing definitive or postoperative adjuvant RT were randomly assigned (1:1) to receive SsK12 probiotic (n = 80) or placebo (n = 80) at West China Hospital, Sichuan University, Chengdu, China. Patients were instructed to suck SsK12 or placebo lozenges thrice daily from the initiation to the end of RT. OM was evaluated twice a week during RT and once a week thereafter for up to 8 weeks. The primary end point was the incidence of SOM. Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. RESULTS: Baseline patient characteristics were similar in the SsK12 and placebo groups. The incidence of SOM was significantly lower in the SsK12 group as compared with the placebo group (36.6% v 54.2%; P = .0351). The duration (median, 0.0 days v 7.0 days; mean, 8.9 days v 18.3 days; P = .0084) and time to develop SOM (median, not estimable v 42.0 days; hazard ratio, 0.55 [95% CI, 0.34 to 0.89]; log-rank test: P = .0123) were also improved in the case of the SsK12 group. Adverse events were similar between the groups, and mild or moderate gastrointestinal reactions (flatulence or dyspepsia) associated with the lozenges were observed in two patients in the SsK12 group. High-throughput sequencing results indicated that SsK12 inhibited opportunistic pathogens and enriched oral commensals during RT. CONCLUSION: In this prospective, randomized clinical trial, SsK12 probiotic significantly reduced the incidence, onset, and duration of SOM with a good safety profile.
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Neoplasias de Cabeça e Pescoço , Estomatite , Streptococcus salivarius , Humanos , Estudos Prospectivos , Radioterapia Adjuvante/efeitos adversos , Método Duplo-CegoRESUMO
STUDY DESIGN: Diagnostic accuracy study with prospectively collected data. OBJECTIVE: This study aimed to establish optimal cutoff values for the 10-second grip and release (10s-G&R) Test to distinguish between mild, moderate, and severe levels of hand dexterity impairment in patients with degenerative cervical myelopathy (DCM). BACKGROUND: The 10s-G&R test is widely utilized to assess hand function in DCM patients. However, whether this test can effectively distinguish between varying severities of hand dexterity impairment, along with the relevant cutoff values, remains unknown. MATERIALS AND METHODS: The authors analyzed hand motion data from 551 consecutively enrolled DCM patients using an artificial intelligent system. In addition, the authors conducted evaluations of functional status, quality of life, and outcome measures. Receiver operating curve analysis was performed to determine cutoff values that differentiate mild, moderate, and severe hand dexterity impairments based on the ability to fasten buttons, as assessed by the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire Q2-1. The validity of these cutoffs was assessed by comparing G&R parameters, upper limb disability, overall disease severity, and quality of life among patients in different severity groups. RESULTS: The authors identified 16 G&R cycles as the cutoff for moderate hand dexterity impairment and 13 G&R cycles as the cutoff for severe impairment. Patients with severe impairment exhibited significantly worse G&R parameters, more severe upper limb symptoms, greater overall disease severity, and reduced quality of life. Patients completing fewer than 13 G&R cycles within 10 seconds were more likely to have moderate-to-severe DCM, indicating the need for potential surgical intervention. CONCLUSION: The authors propose classifying mild hand dexterity impairment as 17 to 20 cycles on the 10s-G&R test, moderate as 14 to 16 cycles, and severe as 13 cycles or less. Our study underscores that the 10s-G&R test can serve as an effective supplementary tool within the context of other currently available measurement tools.
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Qualidade de Vida , Doenças da Medula Espinal , Humanos , Vértebras Cervicais/cirurgia , Doenças da Medula Espinal/cirurgia , Extremidade Superior , Força da MãoRESUMO
BACKGROUND: The risk of extracolonic cancer is increased in inflammatory bowel disease (IBD) patients, but it is not clear whether there is a causal relationship. We aimed to systematically estimate the causal relationship between IBD and extracolonic cancers. METHODS: Independent genetic variants strongly associated with IBD were extracted as instrumental variables from genome-wide association study (GWAS) conducted by the International IBD Genetics Consortium including 12,882 IBD patients, 5956 Crohn's disease (CD) patients, and 6968 ulcerative colitis (UC) patients. Three sources of cancer GWAS were selected as outcome data. Two-sample Mendelian randomization (MR) analysis was conducted to assess the causal effects of IBD on 32 extracolonic cancers. The meta-analysis was applied to assess the combined causal effect with multiple MR results. RESULTS: IBD, CD, and UC have potential causal associations with oral cavity cancer (IBD: OR = 1.180, 95% CI: 1.059 to 1.316, P = 0.003; CD: OR = 1.112, 95% CI: 1.008 to 1.227, P = 0.034; UC: OR = 1.158, 95% CI: 1.041 to 1.288, P = 0.007). Meta-analysis showed a significant positive causal relationship between IBD and breast cancer (OR = 1.059; 95% CI: 1.033 to 1.086; P < 0.0001) as well as a potential causal relationship between CD and breast cancer (OR = 1.029; 95% CI: 1.002 to 1.055; P = 0.032) based on combining multiple MR results. CONCLUSIONS: This comprehensive MR analysis suggested that genetically predicted IBD, as well as its subtypes, may be a risk factor in the development of oral cavity and breast cancer.
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Neoplasias da Mama , Colite Ulcerativa , Doença de Crohn , Doenças Inflamatórias Intestinais , Humanos , Feminino , Estudo de Associação Genômica Ampla , Análise da Randomização Mendeliana , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/epidemiologia , Doenças Inflamatórias Intestinais/genética , Doença de Crohn/epidemiologia , Doença de Crohn/genéticaRESUMO
BACKGROUND AND AIM: Prospective cohort studies have suggested that sugar-sweetened beverages (SSBs) intake is significantly associated with the risk of colorectal cancer (CRC). However, it remains unclear whether this observed association was susceptible to potential confounding factors due to the long-term development process of CRC, and the risk of CRC associated with sweet beverages has rarely been reported. We aimed to investigate the association between SSBs/sweet beverages and CRC risk. METHODS: We performed two-sample Mendelian randomization (MR) analysis using independent genetic variants for SSBs and sweet beverages from a published genome-wide association study (GWAS). Summary statistics for instrument-outcome associations from two databases for malignant neoplasms of the colon and the rectum (FinnGen and UK Biobank). The inverse weighted method (IVW) meta-analysis was the main method used to estimate the relationship, and sensitivity analyses were performed with Cochran's Q test, leave-one-out analysis, MR-Egger regression, Steiger filtering, and the MR PRESSO test. RESULTS: Genetically predicted SSBs intake was associated with a higher colonic malignant neoplasms risk (odds ratio (OR): 1.013; 95% confidence interval (CI) 1.001, 1.026; P = 0.036) in a combined sample size of 579,986 individuals (4029 cases). Such a significant causal effect of SSBs on rectal malignant neoplasms or sweet beverages on CRC was not observed. CONCLUSION: Our findings corroborated a causal association between SSBs and colonic malignant neoplasms risk but did not support such a relationship in the analysis of the rectal malignant neoplasms nor the sweet beverage intake, which might be interpreted with caution and further confirmed.
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Neoplasias Colorretais , Bebidas Adoçadas com Açúcar , Humanos , Neoplasias Colorretais/etiologia , Neoplasias Colorretais/genética , Estudo de Associação Genômica Ampla , Análise da Randomização Mendeliana , Polimorfismo de Nucleotídeo Único , Estudos Prospectivos , Bebidas Adoçadas com Açúcar/efeitos adversosRESUMO
BACKGROUND: Water exchange colonoscopy is the least painful method for unsedated colonoscopies. Simplified left colon water exchange (LWE) reduces the cecal intubation time but it is difficult to avoid the use of an additional pump. Minimal water exchange (MWE) is an improved novel method that eliminates the need for pumps, but it is not clear whether MWE has the same efficiency as LWE. METHODS: This was a prospective, randomized, controlled, noninferiority trial conducted in a tertiary hospital. Enrolled patients were randomized 1:1 to the LWE group or MWE group.âThe primary outcome was recalled insertion pain measured by a 4-point verbal rating scale. Secondary outcomes included adenoma detection rate (ADR), cecal intubation time, volume of water used, and patient willingness to repeat unsedated colonoscopy. RESULTS: 226 patients were included (LWE nâ=â113, MWE nâ=â113). The MWE method showed noninferior moderate/severe pain rates compared with the LWE method (10.6â% vs. 9.7â%), with a difference of 0.9 percentage points (99â% confidence interval [CI] -9.5 to 11.3; threshold, 15â%). ADR, cecal intubation time, and willingness to repeat unsedated colonoscopy were not significantly different between the two groups, but the mean volume of water used was significantly less with MWE than with LWE (163.7âmL vs. 407.2 mL; 99â%CI -298.28 to -188.69). CONCLUSION: Compared with LWE, MWE demonstrated a noninferior outcome for insertion pain, and comparable cecal intubation time and ADR, but reduced the volume of water used and eliminated the need for a water pump.
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Adenoma , Insuflação , Humanos , Colonoscopia/métodos , Ceco , Água , Estudos Prospectivos , Insuflação/métodos , Colo , Dor , Adenoma/diagnósticoRESUMO
Cervical spondylotic myelopathy (CSM) has a high incidence in the middle-aged and elderly people. According to clinical research, there is a connection between hand dexterity and cervical nerves. So the surgeon makes a preliminary assessment of the severity of CSM based on a 10-second grip and release (G&R) test. At present, the statistics of G&R test rely on the surgeon's manual counting. When a patient's hand motion speed is too fast, the surgeon's manual counting is prone to error, leading to potential misdiagnosis. On the other hand, in recent years, artificial intelligence has been developed rapidly, where three-dimensional convolutional neural networks (3D-CNNs) have been widely used in video analysis. This work proposes a hand motion analysis model using a 3D-CNN combined with a de-jittering mechanism to assess the severity of CSM on 10-second G&R videos. We collect 1500 10-second G&R videos recorded by 750 subjects to establish a dataset. The proposed model using 3D-MobileNetV2 as the classifier obtains a Levenshtein accuracy of 97.40% and an average GPU inference time of 3.31 seconds for each 10-second G&R video. Such accuracy and inference speed ensure that the proposed model can be used as a screening examination tool for CSM and a medical assistance tool to help decision making during CSM treatment planning.